chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever; Body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Feb2021 (Lot number: EN6198) at the age of 65 years as dose 1, single and intramuscular, administered in arm left, administration date 16Mar2021 (Lot number: EN6204) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Fever"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "Body aches".  Additional information: No concomitant drugs, Patients medical history (including any illness at time of vaccination), Relevant tests noted. Specific relevant test for thromboembolic events with thrombocytopenia was found. Unspecified information provided as Adverse events with Onset date: 03Nov2021, Seriousness Criteria; Persistent/Significant disability/Incapacity, Important medical event, AE Outcome: Recovering, Treatment: No and Onset date: 01Nov2021, Seriousness Criteria: Important medical event, AE Outcome: Recovered, Treatment: No. Facility where the most recent COVID-19 vaccine was administered was Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever 103; Chills; Fatigue; Muscle aches; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 31Jan2021 (Lot number: EL3248) at the age of 50 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SERTRALINE (ongoing); ZOLOFT (ongoing). Vaccination history included: Bnt162b2 (First Dose, Site and Route of injection:, Route of administration: Intramuscular, Batch/Lot number: EK5730), administration date: 24Dec2020, when the patient was 50 years old, for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Fever 103"; CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Chills"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Fatigue"; MYALGIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Muscle aches". Relevant laboratory tests and procedures are available in the appropriate section.  Clinical information: The patient consider that Pfizer product had a causal effect to the adverse event. Specific relevant test for thromboembolic events with thrombocytopenia were none.  Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: fever; body pain; shivering; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Jan2021 10:00 (Lot number: EL3302) at the age of 51 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Name of Drug as Reported: Pfizer, DOSE 1, SINGLE, Batch/Lot No: EL3246, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 08Jan2021, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 30Jan2021, outcome "not recovered", described as "fever"; PAIN (non-serious) with onset 30Jan2021, outcome "not recovered", described as "body pain"; CHILLS (non-serious) with onset 30Jan2021, outcome "not recovered", described as "shivering". The events "fever", "body pain" and "shivering" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of pyrexia, pain, chills. Additional Information: Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.Device Date was 22Nov2021 Facility type was vaccine Nursing Home Senior Living Facility. Patient had not suffered from Covid prior vaccination. Patient gone through Covid tested after post vaccination. There was no known allergies and other medical history. Privacy policy consent was available.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Headache, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: Had a fever; fever was terrible/ Had fever again; I had so many blankets on top of me still I was cold; Headache; Weakness; I had a terrible experience last night; Sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 21Nov2021 21:00 (Lot number: FH8027) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 21Nov2021 21:00, outcome "recovering", described as "Had a fever; fever was terrible/ Had fever again"; NASOPHARYNGITIS (non-serious) with onset 21Nov2021 21:00, outcome "recovering", described as "I had so many blankets on top of me still I was cold"; HEADACHE (non-serious) with onset 21Nov2021 21:00, outcome "recovering", described as "Headache"; ASTHENIA (non-serious) with onset 21Nov2021 21:00, outcome "recovering", described as "Weakness"; OROPHARYNGEAL PAIN (non-serious) with onset Nov2021, outcome "recovering", described as "Sore throat"; FEELING ABNORMAL (non-serious) with onset 21Nov2021, outcome "recovered" (Nov2021), described as "I had a terrible experience last night".  Additional information: Consumer stated, he had second dose of Pfizer (COVID 19 Vaccine) yesterday noon, he got the second done noon, by 9 pm  had a fever, headache, weakness, the fever was terrible though like  had so many blankets on top of me still I was cold. So, by 5 am the fever was out, was gone and then now had fever again since lets say 5 am like as of now he had a fever and a sore throat. The patient asked what he needs to do. Consumer further stated, he cannot have, he had a terrible experience last night, cannot have it again. He does not know what to take, should he take Nyqul, Tylenol, Ibuprofen. Consumer was suggested to visit Emergency room in case of emergency and informed the role of Pfizer Drug Safety and Pfizer Medical Information again. consumer who stayed he has not fully recovered.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Had a fever; fever was terrible/ Had fever again; I had so many blankets on top of me still I was cold; Headache; Weakness; I had a terrible experience last night; Sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 21Nov2021 21:00 (Lot number: FH8027) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 21Nov2021 21:00, outcome "recovering", described as "Had a fever; fever was terrible/ Had fever again"; NASOPHARYNGITIS (non-serious) with onset 21Nov2021 21:00, outcome "recovering", described as "I had so many blankets on top of me still I was cold"; HEADACHE (non-serious) with onset 21Nov2021 21:00, outcome "recovering", described as "Headache"; ASTHENIA (non-serious) with onset 21Nov2021 21:00, outcome "recovering", described as "Weakness"; OROPHARYNGEAL PAIN (non-serious) with onset Nov2021, outcome "recovering", described as "Sore throat"; FEELING ABNORMAL (non-serious) with onset 21Nov2021, outcome "recovered" (Nov2021), described as "I had a terrible experience last night".  Additional information: Consumer stated, he had second dose of Pfizer (COVID 19 Vaccine) yesterday noon, he got the second done noon, by 9 pm  had a fever, headache, weakness, the fever was terrible though like  had so many blankets on top of me still I was cold. So, by 5 am the fever was out, was gone and then now had fever again since lets say 5 am like as of now he had a fever and a sore throat. The patient asked what he needs to do. Consumer further stated, he cannot have, he had a terrible experience last night, cannot have it again. He does not know what to take, should he take Nyqul, Tylenol, Ibuprofen. Consumer was suggested to visit Emergency room in case of emergency and informed the role of Pfizer Drug Safety and Pfizer Medical Information again. consumer who stayed he has not fully recovered.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Fever; Tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old male patient received bnt162b2 (BNT162B2), administration date 04Mar2021 (Lot number: EN6204) at the age of 74 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Fever"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Tiredness".  Additional information: Patient confirmed that he maybe have had tiredness after the first shot and maybe fever but that was it; this only lasted a couple days. AE did not require a visit to emergency room or physician office. No prior vaccination within 4 weeks, no AE's following prior vaccination and no additional vaccines was administered on Same Date of the Pfizer Suspect.  Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: fever; headache; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 30Apr2021 (Lot number: EW0164) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Osteoporosis" (unspecified if ongoing); "Dry eyes" (unspecified if ongoing). Concomitant medication(s) included: PROLIA taken for osteoporosis (ongoing); XIIDRA taken for dry eye (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Her first COVID vaccine dose was given on 09Apr2021, with lot number ER8729., Anatomical location: left arm), administration date: 09Apr2021, when the patient was 63 years old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "fever"; HEADACHE (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "headache"; CHILLS (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "chills".  Additional information: Additional Vaccines Administered on Same Date of the Pfizer Suspect: no. Patient's Medical History (including any illness at time of vaccination): Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: no. Relevant Tests: List other relevant diagnostic and confirmatory test results for event(s), for example, from blood tests, cerebrospinal fluid culture, bacterial sero-type, diagnostic imaging, (e.g., chest X-ray, MRI): No. Prior vaccinations within 4 weeks was reported as no. After the second dose she had fever, chills, and headache for a day or so. She was fine after that. She wasn't nervous about that because she had read ahead and knew that those could be possible side effects. Adverse events did not result in Emergency or physician office visit. Investigation assessment was reported as no.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Nausea, Pyrexia, Rhinorrhoea
Clinical narrative: fever; runny nose; coughing; feeling really tired; nauseous; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 26 year-old male patient received bnt162b2 (COMIRNATY), administration date 09Nov2021 (Batch/Lot number: unknown) at the age of 26 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 23Nov2021, outcome "not recovered", described as "fever"; RHINORRHOEA (non-serious) with onset 23Nov2021, outcome "not recovered", described as "runny nose"; COUGH (non-serious) with onset 23Nov2021, outcome "not recovered", described as "coughing"; FATIGUE (non-serious) with onset 23Nov2021, outcome "not recovered", described as "feeling really tired"; NAUSEA (non-serious) with onset 23Nov2021, outcome "not recovered", described as "nauseous".  Additional Information: Agent stated that he knew someone who received the Pfizer Biontech Covid 19 vaccines, experiencing quite a few side effects. Agent stated that the reporter reported he was experiencing fever, did not provide an exact temperature, runny nose, coughing, feeling really tired and nauseous. States he received the first dose administered about 2 weeks ago, 09Nov2021. Stated he started experiencing the effects yesterday and they were worse today.  Declined to provide reporter information, consent to contact. There was no additional Vaccines Administered on Same Date of the Pfizer Suspect. There was no prior Vaccinations (within 4 weeks. There was no family Medical History Relevant to AE(s).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: fever, chills and headache; fever, chills and headache; fever, chills and headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 08Mar2021 09:30 (Lot number: EN6201) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Low Thyroid" (unspecified if ongoing); "elevated BP" (unspecified if ongoing); "restless leg syndrome" (unspecified if ongoing); "Tachycardia" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for hypothyroidism (ongoing); LISINOPRIL taken for blood pressure increased (ongoing); TOPROL XL taken for tachycardia (ongoing); CRESTOR taken for blood cholesterol increased (ongoing); GABAPENTIN taken for restless legs syndrome (ongoing). Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6201, Location of injection: Arm Left, Vaccine Administration Time: 09:15, route: Intramuscular), administration date: 15Feb2021, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious), CHILLS (non-serious), HEADACHE (non-serious) all with onset 08Mar2021 09:30, outcome "recovered" (09Mar2021 09:30) and all described as "fever, chills and headache". Therapeutic measures were taken as a result of chills.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101499373 same patient and drug, different dose and events
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache
Clinical narrative: tinnitus; exhausted; chills; diarrhea; felt absolutely terrible; The day after I got my second shot I had a fever, about 102 degrees, and felt absolutely terrible.; I had a really bad headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 (Lot number: ER8729) at the age of 32 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "flu" (unspecified if ongoing), notes: I had the flu a couple years ago.; "tinnitus" (unspecified if ongoing), notes: I had tinnitus earlier in my life, about 15 years before this, but hadn't had it since. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1,, Lot number: ER2613, Anatomical location: Arm Right), administration date: 19Mar2021, when the patient was 32 years old, for covid-19 immunisation. The following information was reported: PYREXIA (non-serious) with onset Apr2021, outcome "recovered", described as "The day after I got my second shot I had a fever, about 102 degrees, and felt absolutely terrible."; HEADACHE (non-serious) with onset Apr2021, outcome "recovered", described as "I had a really bad headache"; TINNITUS (non-serious) with onset 09Apr2021, outcome "recovered", described as "tinnitus"; FATIGUE (non-serious) with onset Apr2021, outcome "recovered", described as "exhausted"; CHILLS (non-serious) with onset Apr2021, outcome "recovered", described as "chills"; DIARRHOEA (non-serious) with onset Apr2021, outcome "recovered", described as "diarrhea"; FEELING ABNORMAL (non-serious) with onset Apr2021, outcome "recovered", described as "felt absolutely terrible". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, headache, fatigue, chills, diarrhoea, feeling abnormal. Therapeutic measures were taken as a result of tinnitus.  Additional information: The day after I got my second shot I had a fever, about 102 degrees, and felt absolutely terrible. I could not get out of bed. I had a really bad headache. Was completely exhausted and couldn't stay awake. Had the chills and had diarrhea. I felt worse than I did when I had the flu a couple years ago. Immediately after the second shot I also started having bad tinnitus that lasted a few months. I had tinnitus earlier in my life, about 15 years before this, but hadn't had it since. After my booster shot (3rd dose) I felt the exact same way all over again. I can't take this vaccine anymore if it is going to make me feel this way every time.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101625013 similar report from same reporter
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tinnitus
Clinical narrative: tinnitus; exhausted; chills; diarrhea; felt absolutely terrible; The day after I got my second shot I had a fever, about 102 degrees, and felt absolutely terrible.; I had a really bad headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 (Lot number: ER8729) at the age of 32 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "flu" (unspecified if ongoing), notes: I had the flu a couple years ago.; "tinnitus" (unspecified if ongoing), notes: I had tinnitus earlier in my life, about 15 years before this, but hadn't had it since. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1,, Lot number: ER2613, Anatomical location: Arm Right), administration date: 19Mar2021, when the patient was 32 years old, for covid-19 immunisation. The following information was reported: PYREXIA (non-serious) with onset Apr2021, outcome "recovered", described as "The day after I got my second shot I had a fever, about 102 degrees, and felt absolutely terrible."; HEADACHE (non-serious) with onset Apr2021, outcome "recovered", described as "I had a really bad headache"; TINNITUS (non-serious) with onset 09Apr2021, outcome "recovered", described as "tinnitus"; FATIGUE (non-serious) with onset Apr2021, outcome "recovered", described as "exhausted"; CHILLS (non-serious) with onset Apr2021, outcome "recovered", described as "chills"; DIARRHOEA (non-serious) with onset Apr2021, outcome "recovered", described as "diarrhea"; FEELING ABNORMAL (non-serious) with onset Apr2021, outcome "recovered", described as "felt absolutely terrible". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, headache, fatigue, chills, diarrhoea, feeling abnormal. Therapeutic measures were taken as a result of tinnitus.  Additional information: The day after I got my second shot I had a fever, about 102 degrees, and felt absolutely terrible. I could not get out of bed. I had a really bad headache. Was completely exhausted and couldn't stay awake. Had the chills and had diarrhea. I felt worse than I did when I had the flu a couple years ago. Immediately after the second shot I also started having bad tinnitus that lasted a few months. I had tinnitus earlier in my life, about 15 years before this, but hadn't had it since. After my booster shot (3rd dose) I felt the exact same way all over again. I can't take this vaccine anymore if it is going to make me feel this way every time.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101625013 similar report from same reporter
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dehydration, Fatigue, Pain, Pyrexia
Clinical narrative: dehydrated; body ache; fever, chills, and body ache, and pain in the muscle where vaccine injected; fever, chills, and body ache, and pain in the muscle where vaccine injected; pain in the muscle where vaccine injected; tired all day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 29Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Muscle sore" (unspecified if ongoing); "Body ache" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2), for Covid-19 immunization; Bnt162b2 (Dose 1), for Covid-19 immunization. The following information was reported: DEHYDRATION (non-serious), outcome "recovering", described as "dehydrated"; PAIN (non-serious) with onset 30Nov2021, outcome "recovered" (01Dec2021), described as "body ache"; PYREXIA (non-serious), CHILLS (non-serious) all with onset 30Nov2021, outcome "recovered" (01Dec2021) and all described as "fever, chills, and body ache, and pain in the muscle where vaccine injected"; VACCINATION SITE PAIN (non-serious) with onset 30Nov2021, outcome "recovered" (01Dec2021), described as "pain in the muscle where vaccine injected"; FATIGUE (non-serious) with onset 30Nov2021, outcome "recovered", described as "tired all day". Therapeutic measures were taken as a result of pain, pyrexia, chills, vaccination site pain, fatigue.  Additional information: Patient took 2 ibuprofen every 4 hours to manage symptoms and was extremely tired all day. Symptoms disappeared today, 01Dec, when patient woke up. Patient was muscle sore from working out on Saturday, 27Nov, which patient believe exacerbated patient's body ache symptoms. patient was not similarly affected after first two doses of Comirnaty. Patient was also dehydrated and had to drink a lot of water, which may have improved patient's symptoms. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: dehydrated; body ache; fever, chills, and body ache, and pain in the muscle where vaccine injected; fever, chills, and body ache, and pain in the muscle where vaccine injected; pain in the muscle where vaccine injected; tired all day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 29Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Muscle sore" (unspecified if ongoing); "Body ache" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2), for Covid-19 immunization; Bnt162b2 (Dose 1), for Covid-19 immunization. The following information was reported: DEHYDRATION (non-serious), outcome "recovering", described as "dehydrated"; PAIN (non-serious) with onset 30Nov2021, outcome "recovered" (01Dec2021), described as "body ache"; PYREXIA (non-serious), CHILLS (non-serious) all with onset 30Nov2021, outcome "recovered" (01Dec2021) and all described as "fever, chills, and body ache, and pain in the muscle where vaccine injected"; VACCINATION SITE PAIN (non-serious) with onset 30Nov2021, outcome "recovered" (01Dec2021), described as "pain in the muscle where vaccine injected"; FATIGUE (non-serious) with onset 30Nov2021, outcome "recovered", described as "tired all day". Therapeutic measures were taken as a result of pain, pyrexia, chills, vaccination site pain, fatigue.  Additional information: Patient took 2 ibuprofen every 4 hours to manage symptoms and was extremely tired all day. Symptoms disappeared today, 01Dec, when patient woke up. Patient was muscle sore from working out on Saturday, 27Nov, which patient believe exacerbated patient's body ache symptoms. patient was not similarly affected after first two doses of Comirnaty. Patient was also dehydrated and had to drink a lot of water, which may have improved patient's symptoms. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Nausea, Pain in extremity
Clinical narrative: Fever; chills; nausea; headache; pain in arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 12 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Nov2021 15:15 (Lot number: FE3592) at the age of 12 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, prev dose brand=Pfizer, prev dose brand unknown=False, prev dose lot number=FK5127, prev dose lot unknown=False, prev dose administrator route=Intra muscular, prev dose administration date=05Nov2021, prev dose administration time=03:30PM , prev dose dose number=1, prev dose vaccine location=Left arm), administration date: 05Nov2021, when the patient was 12 years old, for COVID-19 Immunization, reaction(s): "The patient inadvertently received the pediatric dose for her first shot instead of the regular dose". The following information was reported: PYREXIA (non-serious) with onset 30Nov2021, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 30Nov2021, outcome "recovering", described as "chills"; NAUSEA (non-serious) with onset 30Nov2021, outcome "recovering", described as "nausea"; HEADACHE (non-serious) with onset 30Nov2021, outcome "recovering", described as "headache"; PAIN IN EXTREMITY (non-serious) with onset 30Nov2021, outcome "recovering", described as "pain in arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, chills, nausea, headache, pain in extremity.  Additional information:The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient treated with Tylenol. No Other medications in two weeks.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101690899 similar report from same reporter
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; chills; nausea; headache; pain in arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 12 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Nov2021 15:15 (Lot number: FE3592) at the age of 12 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, prev dose brand=Pfizer, prev dose brand unknown=False, prev dose lot number=FK5127, prev dose lot unknown=False, prev dose administrator route=Intra muscular, prev dose administration date=05Nov2021, prev dose administration time=03:30PM , prev dose dose number=1, prev dose vaccine location=Left arm), administration date: 05Nov2021, when the patient was 12 years old, for COVID-19 Immunization, reaction(s): "The patient inadvertently received the pediatric dose for her first shot instead of the regular dose". The following information was reported: PYREXIA (non-serious) with onset 30Nov2021, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 30Nov2021, outcome "recovering", described as "chills"; NAUSEA (non-serious) with onset 30Nov2021, outcome "recovering", described as "nausea"; HEADACHE (non-serious) with onset 30Nov2021, outcome "recovering", described as "headache"; PAIN IN EXTREMITY (non-serious) with onset 30Nov2021, outcome "recovering", described as "pain in arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, chills, nausea, headache, pain in extremity.  Additional information:The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient treated with Tylenol. No Other medications in two weeks.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101690899 similar report from same reporter
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Pain, Pyrexia
Clinical narrative: Fever; diarrhea; headache; chills; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19May2021 12:00 (Lot number: Ew0177) at the age of 41 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing), notes: Other medical history: anxiety. There were no concomitant medications. Past drug history included: Keflex, reaction(s): "Known allergies: Keflex", notes: Known allergies: Keflex. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Ew0177, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 19May2021, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 19May2021 22:45, outcome "recovered" (2021), described as "Fever"; DIARRHOEA (non-serious) with onset 19May2021 22:45, outcome "recovered" (2021), described as "diarrhea"; HEADACHE (non-serious) with onset 19May2021 22:45, outcome "recovered" (2021), described as "headache"; CHILLS (non-serious) with onset 19May2021 22:45, outcome "recovered" (2021), described as "chills"; PAIN (non-serious) with onset 19May2021 22:45, outcome "recovered" (2021), described as "body aches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, diarrhoea, headache, chills, pain.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19. The patient was not tested with COVID-19 since the vaccination.  Follow-Up (08Dec2021): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Fever; diarrhea; headache; chills; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19May2021 12:00 (Lot number: Ew0177) at the age of 41 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing), notes: Other medical history: anxiety. There were no concomitant medications. Past drug history included: Keflex, reaction(s): "Known allergies: Keflex", notes: Known allergies: Keflex. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Ew0177, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 19May2021, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 19May2021 22:45, outcome "recovered" (2021), described as "Fever"; DIARRHOEA (non-serious) with onset 19May2021 22:45, outcome "recovered" (2021), described as "diarrhea"; HEADACHE (non-serious) with onset 19May2021 22:45, outcome "recovered" (2021), described as "headache"; CHILLS (non-serious) with onset 19May2021 22:45, outcome "recovered" (2021), described as "chills"; PAIN (non-serious) with onset 19May2021 22:45, outcome "recovered" (2021), described as "body aches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, diarrhoea, headache, chills, pain.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19. The patient was not tested with COVID-19 since the vaccination.  Follow-Up (08Dec2021): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Myalgia, Pain
Clinical narrative: Fever; chills; muscle pain; body ache; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 02Dec2021 14:00 (Lot number: FD7220) at the age of 32 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SPRINTEC, start date: Jan2018 (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Anatomical Location: Arm, Route of administration: Intramuscular, Lot: EL3247), administration date: 02Feb2021, when the patient was 31 years old, for COVID-19 immunization; Bnt162b2 (Dose; 2, Anatomical Location: Arm, Lot: EL3247), administration date: 15Mar2021, when the patient was 32 years old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 03Dec2021, outcome "recovered" (04Dec2021), described as "Fever"; CHILLS (non-serious) with onset 03Dec2021, outcome "recovered" (05Dec2021), described as "chills"; MYALGIA (non-serious) with onset 03Dec2021, outcome "recovered" (05Dec2021), described as "muscle pain"; PAIN (non-serious) with onset 03Dec2021, outcome "recovered" (05Dec2021), described as "body ache"; HEADACHE (non-serious) with onset 03Dec2021, outcome "recovered", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia. Therapeutic measures were not taken as a result of chills, myalgia, pain, headache.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; chills; muscle pain; body ache; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 02Dec2021 14:00 (Lot number: FD7220) at the age of 32 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SPRINTEC, start date: Jan2018 (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Anatomical Location: Arm, Route of administration: Intramuscular, Lot: EL3247), administration date: 02Feb2021, when the patient was 31 years old, for COVID-19 immunization; Bnt162b2 (Dose; 2, Anatomical Location: Arm, Lot: EL3247), administration date: 15Mar2021, when the patient was 32 years old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 03Dec2021, outcome "recovered" (04Dec2021), described as "Fever"; CHILLS (non-serious) with onset 03Dec2021, outcome "recovered" (05Dec2021), described as "chills"; MYALGIA (non-serious) with onset 03Dec2021, outcome "recovered" (05Dec2021), described as "muscle pain"; PAIN (non-serious) with onset 03Dec2021, outcome "recovered" (05Dec2021), described as "body ache"; HEADACHE (non-serious) with onset 03Dec2021, outcome "recovered", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia. Therapeutic measures were not taken as a result of chills, myalgia, pain, headache.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding
Clinical narrative: menstrual spotting that started on 22Oct21/ didn't stop until my period finished on 04Nov21; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 22Oct2021 02:30 (Lot number: RF2593) at the age of 27 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Yes, sulfa, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: RF2589), administration date: 01Oct2021, when the patient was 27 years old, for COVID-19 Immunization, reaction(s): "my period started a few hours after receiving the first dose, usually it takes 2 days after I stop taking the pill (birth control) for my period to start.". The following information was reported: INTERMENSTRUAL BLEEDING (non-serious) with onset 22Oct2021, outcome "recovered", described as "menstrual spotting that started on 22Oct21/ didn't stop until my period finished on 04Nov21". The event "menstrual spotting that started on 22oct21/ didn't stop until my period finished on 04nov21" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of intermenstrual bleeding. Additional Information: Other vaccine within 4 weeks was reported as none. Other medications in two weeks was reported as prescribed medicines.The patient had COVID prior vaccination and COVID tested post vaccination was reported as none. The patient stated that, on 01Oct21 her period started a few hours after receiving the first dose, usually it takes 2 days after she stop taking the pill (birth control) for her period to start. She stopped taking her pill for that month on Friday 01Oct21 and her period stopped on 07Oct21. After her second dose she had menstrual spotting that started on 22Oct21, a few hours after receiving her second dose, and didn't stop until her period finished on 04Nov21. She was still taking the pill during that week she was spotting, and it was a medium amount of spotting during that week. She had a doctors appointment on 28Oct21 and mentioned it then, but nothing came about from it.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Malaise, Urticaria
Clinical narrative: Was supposed to take the 2nd shot on 08Oct2021 and caught covid19 and so he had to get quarantined for 14 days/ he got the 2nd shot of the Pfizer vaccine; Whole body broke out in hives again on the upper body and back and lower back was covered in hives except for his arms; Not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, AE: Broke out with bumps in between his knees and it was a whole bunch and looked like hives), administration date: 17Sep2021, for COVID-19 Immunization, reaction(s): "Broke out with bumps in between his knees and it was a whole bunch and looked like hives", "Covid19", "He got into a car accident". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 2021, outcome "unknown", described as "Was supposed to take the 2nd shot on 08Oct2021 and caught covid19 and so he had to get quarantined for 14 days/ he got the 2nd shot of the Pfizer vaccine"; URTICARIA (non-serious) with onset 2021, outcome "unknown", described as "Whole body broke out in hives again on the upper body and back and lower back was covered in hives except for his arms"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "Not feeling well".  Additional Information: It was reported that, the patient was calling about the Pfizer vaccine he had and had the 2nd shot and when he got the first shot he broke out with bumps in between his knees and it was a whole bunch and looked like hives and then he got the 2nd shot of the Pfizer vaccine. The patient stated he had the 1st shot on 17Sep2021 and then 21 days later he was supposed to take the 2nd shot on 08Oct2021 and caught covid19 and so he had to get quarantined for 14 days and some other stuff happened where he got into a car accident. The patient stated he took the 2nd Pfizer shot and had to wait 24 or 30 days after he got covid to get the next dose and bot the next dose the other day of last week and on Friday or Thursday his whole body broke out in hives again on the upper body and back and lower back was covered in hives except for his arms. The caller was asking what should he do about the hives and so then what should he do and should he go to his regular doctor or what. Caller stated can Pfizer help him with the hives; aware that Pfizer unable to offer medical advice or treatment recommendations and caller was referred to his HCP or doctor; stated he declined the report and stated he was just not feeling well now. Investigation assessment was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Urticaria
Clinical narrative: Large lumps grew in my arm pits the size of a half tennis ball. Lumps have shrunken but are still there somewhat; Hives started 2 days later on my forearms and calves for about 2 days.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Apr2021 14:00 (Lot number: EW0158 7/21) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Candida Albicon airborne" (unspecified if ongoing), notes: excessive Candida Albicon airborne in house during that, period, since then addressed and corrected.; "COVID-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: TURMERIC CURCUMIN; CYMBALTA. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 10Apr2021 08:00, outcome "not recovered", described as "Large lumps grew in my arm pits the size of a half tennis ball. Lumps have shrunken but are still there somewhat"; URTICARIA (non-serious) with onset 10Apr2021 08:00, outcome "recovered" (11Apr2021), described as "Hives started 2 days later on my forearms and calves for about 2 days.". Therapeutic measures were not taken as a result of lymphadenopathy, urticaria.  Additional information: The patient did not receive any other vaccine in four weeks. Hives started 2 days later on his forearms and calves for about 2 days. Large lumps grew in his arm pits the size of a half tennis ball. Lumps have shrunken but are still there somewhat. Covid hotline told him to ask hid doctor before his next shot. He has not received his second shot because his doctor recommended that he should wait for more information. Nobody seems to know what he should do? He was looking for an answer.   No follow-up attempts are possible. No further information is expected.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: with second dose of COVID19 vaccine he had a little fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 84 year-old male patient received bnt162b2 (BNT162B2), administration date 10Feb2021 (Lot number: EL9266, Expiration Date: May2021) at the age of 83 years as dose 2, single for covid-19 immunisation. Family history included: "Pacemaker" (ongoing), notes: he has had the pacemaker for several years, maybe 2 to 3 years. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EL9262. Expiry: May2021.), administration date: 21Jan2021, when the patient was 83 years old, for Covid-19 Immunization, reaction(s): "He didn't have anything with the first dose of COVID19 vaccine". The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "with second dose of COVID19 vaccine he had a little fever".  Additional information: The patient's grandmother may have had some problems a long time ago, but caller did not know much about that because his grandmother died before he was involved with the family. Additional vaccines administered on same date of the Pfizer suspect was none.  Follow-up attempts are completed. No further information is expected.