chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Immunisation
Clinical narrative: 24 hours later, chills; Vomiting; Diarrhea; Headache; Dose number: 3; Sore left arm; Fatigue; This is a spontaneous report from a contactable reporter (nurse). The reporter is the patient.  A 55-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 01Dec2021 at 14:00 (Lot number: FJ1620) at the age of 55 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medications included: LEVOTHYROXINE; VITAMIN D; LIPITOR; ZINC and TYLENOL. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EH9899, Route of administration: Unspecified),administered on an unknown date, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE ,Lot Number: EK9231, Route of administration: Unspecified), administered on an unknown date, for COVID-19 immunisation The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021 at 14:00, outcome "unknown", described as "Dose number: 3"; PAIN IN EXTREMITY (non-serious) and FATIGUE (non-serious), both with onset 01Dec2021, outcome "recovering", described as "Sore left arm and fatigue same day"; CHILLS (non-serious), VOMITING (non-serious),DIARRHOEA (non-serious) and HEADACHE (non-serious), all with onset 02Dec2021, outcome "recovering", described as "24 hours later, chills, vomiting, diarrhea, headache". The patient underwent the following laboratory tests and procedures: SARS-CoV2 test: (03Dec2021) pending. Therapeutic measures were not taken as a result of pain in extremity, fatigue, chills, vomiting, diarrhoea and headache.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had been tested for COVID-19 and the results were pending. The events resulted in doctor or other healthcare professional office/clinic visit.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test, Vomiting
Clinical narrative: 24 hours later, chills; Vomiting; Diarrhea; Headache; Dose number: 3; Sore left arm; Fatigue; This is a spontaneous report from a contactable reporter (nurse). The reporter is the patient.  A 55-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 01Dec2021 at 14:00 (Lot number: FJ1620) at the age of 55 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medications included: LEVOTHYROXINE; VITAMIN D; LIPITOR; ZINC and TYLENOL. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EH9899, Route of administration: Unspecified),administered on an unknown date, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE ,Lot Number: EK9231, Route of administration: Unspecified), administered on an unknown date, for COVID-19 immunisation The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021 at 14:00, outcome "unknown", described as "Dose number: 3"; PAIN IN EXTREMITY (non-serious) and FATIGUE (non-serious), both with onset 01Dec2021, outcome "recovering", described as "Sore left arm and fatigue same day"; CHILLS (non-serious), VOMITING (non-serious),DIARRHOEA (non-serious) and HEADACHE (non-serious), all with onset 02Dec2021, outcome "recovering", described as "24 hours later, chills, vomiting, diarrhea, headache". The patient underwent the following laboratory tests and procedures: SARS-CoV2 test: (03Dec2021) pending. Therapeutic measures were not taken as a result of pain in extremity, fatigue, chills, vomiting, diarrhoea and headache.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had been tested for COVID-19 and the results were pending. The events resulted in doctor or other healthcare professional office/clinic visit.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: fatigue; chills; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Nov2021 10:30 (Lot number: Fh8030) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Partial thyroid removal" (unspecified if ongoing); "allergy to pineapple, kiwi" (unspecified if ongoing); "penicillin allergy" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. Past drug history included: Z-pak, reaction(s): "z-pak allergy"; Biaxin, reaction(s): "biaxin allergy". The following information was reported: FATIGUE (non-serious) with onset Nov2021, outcome "recovering", described as "fatigue"; CHILLS (non-serious) with onset Nov2021, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset Nov2021, outcome "recovering", described as "fever". Therapeutic measures were not taken as a result of fatigue, chills, pyrexia.  Additional information: The patient didn't receive other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Follow-Up (07Dec2021): Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Chills, Dyspepsia, Gastrooesophageal reflux disease
Clinical narrative: Nausea; Vomiting/constant vomiting; Severe stomach and back pain; Severe stomach and back pain; Chills; Severe acid reflux; Night sweats; That feels like shooting pain and a knot; Severe ingestion; Dose received 3/ dose number=3; This is a spontaneous report received from a contactable reporter (nurse). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 19Nov2021 at 18:00 (Lot number: 32030BD) at the age of 46 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medications included: SYNTHROID and LISINOPRIL. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EL9261, Anatomical site: left arm), administration date: 23Jan2021, when the patient was 45 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: EL9266, Anatomical site: right arm), administration date: 19Feb2021, when the patient was 45 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021 at 18:00, outcome "unknown", described as "Dose received 3/ dose number=3"; NAUSEA (non-serious) described as "Nausea"; VOMITING (non-serious) described as "Vomiting/constant vomiting"; ABDOMINAL PAIN UPPER (non-serious) and BACK PAIN (non-serious); both described as "Severe stomach and back pain"; CHILLS (non-serious) described as "Chills"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious) described as "Severe acid reflux"; NIGHT SWEATS (non-serious) described as "Night sweats"; PAIN (non-serious) described as "That feels like shooting pain and a knot"; DYSPEPSIA (non-serious) described as "Severe ingestion"; all with onset 27Nov2021, outcome "recovering''. The events "Nausea", "Vomiting/constant vomiting", "Severe stomach and back pain", "Chills", "Severe acid reflux", "Night sweats", "That feels like shooting pain and a knot" and "Severe ingestion" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had been tested for COVID-19. On 02Nov2021, the patient underwent SARS-COV-2 test by test type nasal swab and the result was negative.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Nausea, Night sweats, Pain, SARS-CoV-2 test
Clinical narrative: Nausea; Vomiting/constant vomiting; Severe stomach and back pain; Severe stomach and back pain; Chills; Severe acid reflux; Night sweats; That feels like shooting pain and a knot; Severe ingestion; Dose received 3/ dose number=3; This is a spontaneous report received from a contactable reporter (nurse). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 19Nov2021 at 18:00 (Lot number: 32030BD) at the age of 46 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medications included: SYNTHROID and LISINOPRIL. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EL9261, Anatomical site: left arm), administration date: 23Jan2021, when the patient was 45 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: EL9266, Anatomical site: right arm), administration date: 19Feb2021, when the patient was 45 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021 at 18:00, outcome "unknown", described as "Dose received 3/ dose number=3"; NAUSEA (non-serious) described as "Nausea"; VOMITING (non-serious) described as "Vomiting/constant vomiting"; ABDOMINAL PAIN UPPER (non-serious) and BACK PAIN (non-serious); both described as "Severe stomach and back pain"; CHILLS (non-serious) described as "Chills"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious) described as "Severe acid reflux"; NIGHT SWEATS (non-serious) described as "Night sweats"; PAIN (non-serious) described as "That feels like shooting pain and a knot"; DYSPEPSIA (non-serious) described as "Severe ingestion"; all with onset 27Nov2021, outcome "recovering''. The events "Nausea", "Vomiting/constant vomiting", "Severe stomach and back pain", "Chills", "Severe acid reflux", "Night sweats", "That feels like shooting pain and a knot" and "Severe ingestion" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had been tested for COVID-19. On 02Nov2021, the patient underwent SARS-COV-2 test by test type nasal swab and the result was negative.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Nausea; Vomiting/constant vomiting; Severe stomach and back pain; Severe stomach and back pain; Chills; Severe acid reflux; Night sweats; That feels like shooting pain and a knot; Severe ingestion; Dose received 3/ dose number=3; This is a spontaneous report received from a contactable reporter (nurse). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 19Nov2021 at 18:00 (Lot number: 32030BD) at the age of 46 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medications included: SYNTHROID and LISINOPRIL. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EL9261, Anatomical site: left arm), administration date: 23Jan2021, when the patient was 45 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: EL9266, Anatomical site: right arm), administration date: 19Feb2021, when the patient was 45 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021 at 18:00, outcome "unknown", described as "Dose received 3/ dose number=3"; NAUSEA (non-serious) described as "Nausea"; VOMITING (non-serious) described as "Vomiting/constant vomiting"; ABDOMINAL PAIN UPPER (non-serious) and BACK PAIN (non-serious); both described as "Severe stomach and back pain"; CHILLS (non-serious) described as "Chills"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious) described as "Severe acid reflux"; NIGHT SWEATS (non-serious) described as "Night sweats"; PAIN (non-serious) described as "That feels like shooting pain and a knot"; DYSPEPSIA (non-serious) described as "Severe ingestion"; all with onset 27Nov2021, outcome "recovering''. The events "Nausea", "Vomiting/constant vomiting", "Severe stomach and back pain", "Chills", "Severe acid reflux", "Night sweats", "That feels like shooting pain and a knot" and "Severe ingestion" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had been tested for COVID-19. On 02Nov2021, the patient underwent SARS-COV-2 test by test type nasal swab and the result was negative.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy
Clinical narrative: Swollen lymph on neck; Dose received:3/ dose number=3; This is a spontaneous report from a non-contactable reporter (consumer or other non HCP). The reporter is the patient.   A 52 year-old male patient received bnt162b2 (BNT162b2), administered in left arm, administration date 01Dec2021 at 12:30 (Lot number: FJ8762) at the age of 52 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EP6955; Anatomical site: Right arm; Administration time: 12:00), administration date: an unknown date in Mar2021, when the patient was 52 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EL3247; Anatomical site: Left arm; Administration time: 12:00), administration date: an unknown date in Apr2021, when the patient was 52 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021 at 12:30, outcome "unknown", described as "Dose received 3/ dose number=3"; LYMPHADENOPATHY (non-serious) with onset 02Dec2021, outcome "recovering", described as "Swollen lymph on neck". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Memory impairment, Myocardial infarction
Clinical narrative: Heart attack; I also have memory problem; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101731179 (Pfizer).  A 78 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10Feb2021 (Batch/Lot number: unknown) at the age of 78 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing). Family history included: "One heart attack" (unspecified if ongoing), notes: "My parents, both died form heart attack.". The patient took concomitant medications. The patient had no prior vaccines (within 4weeks). Vaccination history included: Bnt162b2 (Dose no: 1), administration date: 20Jan2021, when the patient was 78 years old, for COVID-19 immunization. The following information was reported: MYOCARDIAL INFARCTION (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "Heart attack"; MEMORY IMPAIRMENT (non-serious) with onset 2021, outcome "unknown", described as "I also have memory problem". The patient was hospitalized for myocardial infarction (start date: 2021, discharge date: 2021, hospitalization duration: 10 day(s)). Therapeutic measures were taken as a result of myocardial infarction. After second Pfizer shot, the patient had a heart attack and then after that at 16Nov2021, he had a booster shot. The next day (17Nov2021), patient read the information sheet that was given to him with the shot and that was when he discovered the side effects and record contacts and next week, his 3 weeks which occurred on my second heart attack would be coming up (3 weeks from 16Nov2021 will be next week). The patient wanted to know there was anything he could do so that he would not have another heart attack. When probed for the event is worsened, improved or persisting, Consumer stated, he was taking medications, blood thinners. What he was worried about was the Heat attack coming up from the Pfizer Vaccine. Consumer stated he had memory problem from the heart attack. The patient was in the hospital for 10 days. That was when they told the patient that he would have memory problems. If that sounds big because it was difficult to remember exactly.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Fatigue, Immunisation, SARS-CoV-2 test
Clinical narrative: Exhausted, fatigue; I have a adverse event. It is a covid positive test after three shots with Pfizer.; I have a adverse event. It is a covid positive test after three shots with Pfizer.; three shots with Pfizer.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 39 year-old patient received bnt162b2 (BNT162B2), administered in arm right, administration date 28Nov2021 (Lot number: HE8030) as dose 3 (booster), single, administered in arm right, administration date 2021 (Lot number: ER8733) as dose 2, single and administered in arm right, administration date 01Apr2021 (Lot number: ER8733) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 28Nov2021, outcome "unknown", described as "three shots with Pfizer."; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Nov2021, outcome "unknown" and all described as "I have a adverse event. It is a covid positive test after three shots with Pfizer."; FATIGUE (non-serious), outcome "unknown", described as "Exhausted, fatigue". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (02Dec2021) positive, notes: PCR results on 02Dec. Therapeutic measures were not taken as a result of drug ineffective, covid-19, fatigue.  Additional information: Other medical condition and other medications: Consumer stated, "No. I am trying to do IVS, I am taking medications for that and then symptoms exhausted, fatigue."  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Immunisation, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Lump under arm put; Body aches; Sore at injection site; Fever; Dose received: 3; This is a spontaneous report from a contactable reporter (Nurse). The reporter is the patient.   A 34-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 03Dec2021 at 18:00 (Lot number: unknown) at the age of 34 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot number: UNKNOWN), for COVID-19 immunisation and Bnt162b2 (DOSE 1, SINGLE, Lot number: UNKNOWN), administration date: 22Dec2020, when the patient was 33 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 03Dec2021 at 18:00, outcome "unknown", described as "Dose received: 3"; AXILLARY MASS (non-serious) with onset 04Dec2021 at 07:00, outcome "recovering", described as "Lump under arm put"; PAIN (non-serious) with onset 04Dec2021 at 07:00, outcome "recovering", described as "Body aches"; VACCINATION SITE PAIN (non-serious) with onset 04Dec2021 at 07:00, outcome "recovering", described as "Sore at injection site"; PYREXIA (non-serious) with onset 04Dec2021 at 07:00, outcome "recovering", described as "Fever". Therapeutic measures were not taken as a result of axillary mass, pain, vaccination site pain and pyrexia.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: I am in pain; 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 female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergic to penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Flu vaccine, reaction(s): "Sick", notes: She had taken the flu vaccine 4-5 years ago and felt very sick.; Advil, reaction(s): "GI issues", notes: Can't take Advil due to GI issues. The following information was reported: PAIN (non-serious), outcome "unknown", described as "I am in pain".  Additional Information: The patient stated "I am in pain. I don't know what to do".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: "her arm (at the injection site) had a red spot; her arm (at the injection site) had sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 67-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 18Feb2021 (Batch/Lot number: unknown) at the age of 67 years as single dose for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.   Vaccination history included: Bnt162b2 (Caller reported that his wife is 67 years old and she received her first dose of Pfizer-BioNTech COVID-19 Vaccine on 28Jan2021), administration date: 28Jan2021, when the patient was 67 years old, for COVID-19 immunization.  The following information was reported: INJECTION SITE ERYTHEMA (non-serious), outcome "recovered", described as ""her arm (at the injection site) had a red spot"; INJECTION SITE PAIN (non-serious), outcome "recovered", described as "her arm (at the injection site) had sore".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: just a little bit of soreness; I noticed that my arm was itching a little; there's a red patch about 6 inches long and 2-3 inches wide at the injection site.; 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 84 year-old female patient received bnt162b2 (BNT162B2), administration date 25Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single), for covid-19 immunization.  The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "just a little bit of soreness"; VACCINATION SITE PRURITUS (non-serious) with onset 02Mar2021, outcome "unknown", described as "I noticed that my arm was itching a little"; VACCINATION SITE ERYTHEMA (non-serious) with onset 02Mar2021, outcome "unknown", described as "there's a red patch about 6 inches long and 2-3 inches wide at the injection site."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Memory impairment
Clinical narrative: Brain fog,forgetfulness; Brain fog,forgetfulness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2021 (Batch/Lot number: unknown) at the age of 48 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergy Shrimp" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (dose number 1, vaccine location: Left arm.), administration date: 02Feb2021, when the patient was 47 years old, for COVID-19 immunization. The following information was reported: MEMORY IMPAIRMENT (non-serious), FEELING ABNORMAL (non-serious) all with onset 26Feb2021, outcome "unknown" and all described as "Brain fog,forgetfulness". Therapeutic measures were not taken as a result of memory impairment, feeling abnormal.  Additional Information: This consumer reported similar events for 2 patients. This is 1st of 2 reports. The patient had no other medical history. The patient received no other vaccine in four weeks. The patient reported that "Both my husband (who is also vaccinated) noticed yesterday that we were forgetting simple things." The patient had no COVID prior vaccination. The patient was not tested for COVID post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : -PFIZER INC-2021254036 same reporter/drug/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Nausea, Pain in extremity
Clinical narrative: achy in my legs and my back; achy in my legs and my back; felt like I was going to throw up; This is a spontaneous report received from a contactable reporter (other healthcare professional) from medical information team. The reporter is the patient.  A 56-year-old female patient received bnt162b2 (PFIZER-BIOTECH COVID-19 mRNA VACCINE, solution for injection) (Lot number: EN6200) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), BACK PAIN (non-serious), outcome "unknown" and all described as "achy in my legs and my back"; NAUSEA (non-serious), outcome "unknown", described as "felt like I was going to throw up".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: pain and soreness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 28Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "pain and soreness".  Additional Information: The patient reported that she had the vaccine shot on her left side and pain and soreness was on her right side.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: reoccurring gout; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Medical Information Team.  A 70 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GOUT (non-serious), outcome "unknown", described as "reoccurring gout".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Sensory disturbance
Clinical narrative: she could feel the vaccine going through the muscle/ felt this on the left side of her back; This is a spontaneous report received from a contactable consumer from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SENSORY DISTURBANCE (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "she could feel the vaccine going through the muscle/ felt this on the left side of her back".  Additional information: The patient's age was reported as 75 (unit: unspecified). The event started 6 hours after receiving the first dose 3 weeks prior and it lasted one minute.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm pain in his right arm, at the injection site; This is a spontaneous report received from a non-contactable reporter (consumer or other non-healthcare professional) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 62-year-old male patient received bnt162b2 (PFIZER-BIOTECH COVID-19 mRNA VACCINE, solution for injection), administered in arm right, administration date 27Jan2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "arm pain in his right arm, at the injection site".  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
Clinical narrative: swollen lymph node; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Medical Information Team. The reporter is the patient.  A male patient (reported as patient's age: 74; unit: unspecified) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph node".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Gingival disorder
Clinical narrative: problems with his gums; This is a spontaneous report received from a contactable consumer from medical information team. The reporter is the patient.  A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GINGIVAL DISORDER (non-serious), outcome "unknown", described as "problems with his gums". The event "problems with his gums" was evaluated at the physician office visit.  Additional information: Before the patient took the second dose of Pfizer COVID vaccine on 15Feb2021, he was having problems with his gums. His dentist gave him antibiotics, but he hasn't started taking them because he didn't want anything to effect the effects of the vaccines. He wanted to start the antibiotics, but he was wondering if it would negate the effects of the vaccine. He mentioned that his doctor was not aware that he has not received the medication, it was his decision. He had another appointment to go back to the dentist, it was a 20-day dose and needed to be taken completely.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: 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 male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administration date 03Mar2021 14:45 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: SOMNOLENCE (non-serious) with onset 03Mar2021 16:30, outcome "unknown", described as "He then fell asleep on the couch around 4:30pm, and woke up at 6pm which is very out of character for him.".Additional information: The patient was wondering if it was due to the vaccine and if it was an allergic reaction. The patient also wants to know what he should be worried about or if he should keep track of symptoms. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site hyperaesthesia
Clinical narrative: Site injection sensitivity that is lingering; This is a spontaneous report received from a contactable reporter, Consumer. The reporter is the patient. A 57-year-old female patient (not pregnant) received (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 03Mar2021 09:00 (Batch/Lot number: unknown) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "rt hip replacement", start date: Aug2019 (unspecified if ongoing), notes: right; "bilateral frozen shoulders" (unspecified if ongoing), notes: bilateral frozen shoulders that had resolved; "bilateral frozen shoulders", start date: Aug2019 (unspecified if ongoing), notes: came back in Aug2019. Concomitant medications included: NAPROXEN and daily vitamin. The following information was reported: VACCINATION SITE HYPERAESTHESIA (non-serious) with onset 03Mar2021, outcome "not recovered", described as "Site injection sensitivity that is lingering". Therapeutic measures were not taken as a result of vaccination site hyperaesthesia. Additional information: The patient had no known allergies. The patient did not have Covid prior to vaccination and was not tested for Covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021373325 same patient, same drug, different, different dose of vaccine
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea bout; This is a spontaneous report received from a contactable reporter, Consumer, from medical information team. The reporter is the patient.  An 85 year-old female patient received (PFIZER-BIONTECH COVID-19 VACCINE), administration date 03Mar2021 (Batch/Lot number: unknown) at the age of 85 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious) with onset Mar2021, outcome "unknown", described as "diarrhea bout". Additional information: patient developed a "diarrhea bout" within several hours after the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: chills; headache; This is a spontaneous report received from a contactable reporter, Consumer, from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 03Mar2021 (Batch/Lot number: unknown) at the age of 68 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset Mar2021, outcome "unknown", described as "chills"; HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "headache". Additional information: the patient was only 108 lbs and her sister was concerned that she may need to take a lesser dose of the vaccine due to her weight.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: she was "very tired in the evening on the first day and was tired on the second day; This is a spontaneous report received from a contactable reporter, Consumer, from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 63 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 02Mar2021 (Batch/Lot number: unknown) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "mastectomy" (unspecified if ongoing); "has no lymph nodes under her left arm" (unspecified if ongoing); "Breast cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 02Mar2021, outcome "recovering", described as "she was "very tired in the evening on the first day and was tired on the second day". Additional information: the patient received her first dose of the Pfizer COVID-19 vaccine in her right arm and she was told that when she returned to receive her second dose it would need to be in her left arm. The caller was concerned because she had a history of having a mastectomy on her left breast and has no lymph nodes under her left arm due to a history of breast cancer. She was "very tired in the evening on the first day and was tired on the second day but today which is the third day after receiving the vaccine feels good.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph glands/lymph nodes on the throat; This is a spontaneous report received from a contactable reporter, Consumer, from medical information team. The reporter is the patient.  A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 13Feb2021 (Batch/Lot number: unknown) at the age of 69 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 20Feb2021, outcome "unknown", described as "swollen lymph glands/lymph nodes on the throat". Additional information: Got Pfizer 1st dose on 13Feb2021. A week later started developing swollen lymph glands mainly on the side of the injection site and a bit the other side. The patient stated that it was not at the injection site but the lymph nodes on the throat.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypokinesia, Nausea, Vertigo
Clinical narrative: bad case of dizzy; Nausea; head rolling; cannot do anything; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 26Feb2021 (Batch/Lot number: unknown) as dose number, unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 27Feb2021, outcome "unknown", described as "bad case of dizzy"; NAUSEA (non-serious) with onset 27Feb2021, outcome "unknown", described as "Nausea"; VERTIGO (non-serious) with onset 27Feb2021, outcome "unknown", described as "head rolling"; HYPOKINESIA (non-serious) with onset 27Feb2021, outcome "unknown", described as "cannot do anything".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Limb discomfort, Vaccination site discolouration, Vaccination site inflammation
Clinical narrative: felt something running down her arm when she got the vaccine; has a 1.5 inch whelp at injection site; black and blue at injection site; burning feeling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 02Mar2021 08:00 (Lot number: EN6202) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: She takes high blood pressure medications. The patient took concomitant medications. Vaccination history included: Bnt162b2 (She received the first dose on 05Feb2021. It was given in her right arm. Lot: EL9264.), administration date: 05Feb2021, when the patient was 66 years old, for covid-19 immunization. The following information was reported: LIMB DISCOMFORT (non-serious) with onset 02Mar2021, outcome "recovered" (02Mar2021), described as "felt something running down her arm when she got the vaccine"; VACCINATION SITE INFLAMMATION (non-serious) with onset 02Mar2021, outcome "not recovered", described as "has a 1.5 inch whelp at injection site"; VACCINATION SITE DISCOLOURATION (non-serious) with onset 02Mar2021, outcome "not recovered", described as "black and blue at injection site"; BURNING SENSATION (non-serious) with onset 02Mar2021, outcome "unknown", described as "burning feeling". Therapeutic measures were taken as a result of limb discomfort. Additional information: For event- She didn't watch but felt something running down her arm when she got the vaccine. At first she thought it was excess medication. The nurse put a band aid on her arm. She felt a burning feeling. When she got home she took the band aid off. The band aid was filled with blood. She has a 1.5 inch whelp at the injection site. The injection site is black and blue. She is wondering if this is from the way it was administered or if it was a reaction to the vaccine. She didn't know if she should put ice on it. Is this typical or as a result of the vaccine. She has never had this happen before. Any adverse event did not result in emergency room or physician office. No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 73 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Feb2021 20:00 (Lot number: EL9245) at the age of 73 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "MAC Lung Infection", start date: 04Aug2020 (unspecified if ongoing); "GERD" (unspecified if ongoing), notes: Chronic; "High Blood Pressure" (unspecified if ongoing), notes: Chronic; "LPR" (unspecified if ongoing), notes: Chronic; "Arthritis" (unspecified if ongoing), notes: Chronic. Concomitant medication(s) included: AMLODIPINE, start date: Aug2020 (ongoing); HCTZ, start date: Aug2020 (ongoing); GAVISCON ADVANCE [POTASSIUM BICARBONATE;SODIUM ALGINATE], start date: Aug2020 (ongoing); TELMISARTAN, start date: May2018 (ongoing). Vaccination history included: Bnt162b2 (1st dose, time administered: 20:15, Lot no: EL1283), administration date: 14Jan2021, when the patient was 73 years old, for Covid-19 immunisation, reaction(s): "nasal congestion", "headache", "Arm soreness". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "arm soreness"; HEADACHE (non-serious), outcome "recovered", described as "headache".Additional information: Events did not result to physician and emergency room visit.  No follow up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: experienced significant arm pain in the area of injection site; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 03Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "experienced significant arm pain in the area of injection site". Therapeutic measures were not taken as a result of vaccination site pain. Additional Information: Description of Event: Following administration of the first Pfizer Covid vaccine shot, I experienced significant arm pain in the area of injection site which began about 6 hours after the vaccine shot. Arm pain with lifting of arm. Still present on day 2, about the same intensity.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.