chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Still having migraines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 42 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 01May2021 (Batch/Lot number: unknown) as dose 1, single and administration date 30May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; botulinum toxin type a (BOTOX) (ongoing) (Batch/Lot number: unknown) for migraine. Relevant medical history included: "Migraines" (ongoing), notes: Migraines. The patient's concomitant medications were not reported. The following information was reported: MIGRAINE (non-serious), outcome "not recovered", described as "Still having migraines". Therapeutic measures were taken as a result of migraine.  Additional information: The patient received Qulipta as treatment for the adverse event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Petechiae, Vomiting
Clinical narrative: Petechia to face and chest developed prior to vomiting; nausea and vomiting.; Petechia to face and chest developed prior to vomiting; nausea and vomiting.; Petechia to face and chest developed prior to vomiting; nausea and vomiting.; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 6 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 24Nov2021 13:00 (Lot number: FL00007) at the age of 6 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "AUTISM" (unspecified if ongoing); "INSOMNIA" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: YES. The patient's concomitant medications were not reported. Past drug history included: None. The following information was reported: NAUSEA (non-serious), PETECHIAE (non-serious), VOMITING (non-serious) all with onset 24Nov2021 13:30, outcome "recovering" and all described as "Petechia to face and chest developed prior to vomiting; nausea and vomiting.". The event "petechia to face and chest developed prior to vomiting; nausea and vomiting.", "petechia to face and chest developed prior to vomiting; nausea and vomiting." and "petechia to face and chest developed prior to vomiting; nausea and vomiting." was evaluated at the emergency room visit. Therapeutic measures were not taken as a result of nausea, petechiae, vomiting.  Additional Information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was diagnosed with COVID-19 prior vaccination. Patient has not been tested for COVID-19 since vaccination. The patient was not received treatment for the adverse events. The patient was no known allergies.  Follow-Up#1 (01Dec2021): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling abnormal, Headache, Pyrexia
Clinical narrative: Chills; had a fever; Headache; Overall, did not feel well at all; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Nov2021 (Lot number: 33026BD) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Migraine headaches" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose: 19Mar2021 , lot: Unknown, NDC: Unknown, Expiration: Unknown , Route of administration: left arm), administration date: 19Mar2021, when the patient was 61 years old, for COVID-19 immunization; Bnt162b2 (Second dose: 09Apr2021 , lot: Unknown, NDC: Unknown, Expiration: Unknown, route of administration: left arm), administration date: 09Apr2021, when the patient was 61 years old, for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 24Nov2021, outcome "recovered" (25Nov2021), described as "Chills"; PYREXIA (non-serious) with onset 24Nov2021, outcome "recovered" (25Nov2021), described as "had a fever"; HEADACHE (non-serious) with onset 24Nov2021, outcome "not recovered", described as "Headache"; FEELING ABNORMAL (non-serious) with onset 24Nov2021, outcome "unknown", described as "Overall, did not feel well at all". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: The patient woke up in the early morning on 24Nov2021 with chills, had a fever and a headache. She overall, did not feel well at all. She had a temperature of 101.6 and took some Tylenol. The Tylenol did help with the fever. Throughout the day on 24Nov2021, she felt pretty unwell.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Chills, Diarrhoea, Dizziness
Clinical narrative: diarrhea; Recurring chills; dizziness; fatigue; joint ache; nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 (Lot number: ER8733) at the age of 69 years as dose 1, single and administered in arm left, administration date 14Apr2021 (Lot number: EW0153) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: ASPIRINE; VITAMIN D3; CENTRUM SILVER +50; TURMERIC CURCUMIN. The following information was reported: DIARRHOEA (non-serious) with onset 07Apr2021, outcome "not recovered", described as "diarrhea"; CHILLS (non-serious) with onset 07Apr2021, outcome "not recovered", described as "Recurring chills"; DIZZINESS (non-serious) with onset 07Apr2021, outcome "not recovered", described as "dizziness"; FATIGUE (non-serious) with onset 07Apr2021, outcome "not recovered", described as "fatigue"; ARTHRALGIA (non-serious) with onset 07Apr2021, outcome "not recovered", described as "joint ache"; NAUSEA (non-serious) with onset 07Apr2021, outcome "not recovered", described as "nausea". The events "diarrhea", "recurring chills", "dizziness", "fatigue", "joint ache" and "nausea" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of diarrhoea, chills, dizziness, fatigue, arthralgia, nausea.  Follow-Up (03Dec2021):Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: diarrhea; Recurring chills; dizziness; fatigue; joint ache; nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 (Lot number: ER8733) at the age of 69 years as dose 1, single and administered in arm left, administration date 14Apr2021 (Lot number: EW0153) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: ASPIRINE; VITAMIN D3; CENTRUM SILVER +50; TURMERIC CURCUMIN. The following information was reported: DIARRHOEA (non-serious) with onset 07Apr2021, outcome "not recovered", described as "diarrhea"; CHILLS (non-serious) with onset 07Apr2021, outcome "not recovered", described as "Recurring chills"; DIZZINESS (non-serious) with onset 07Apr2021, outcome "not recovered", described as "dizziness"; FATIGUE (non-serious) with onset 07Apr2021, outcome "not recovered", described as "fatigue"; ARTHRALGIA (non-serious) with onset 07Apr2021, outcome "not recovered", described as "joint ache"; NAUSEA (non-serious) with onset 07Apr2021, outcome "not recovered", described as "nausea". The events "diarrhea", "recurring chills", "dizziness", "fatigue", "joint ache" and "nausea" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of diarrhoea, chills, dizziness, fatigue, arthralgia, nausea.  Follow-Up (03Dec2021):Follow-up attempts are completed. No further information is expected.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Vaccination site rash
Clinical narrative: 48 hours after vaccine was administered a raised red dotted rash formed on both arms especially on the left arm where it was administered/The rash also covered his abdomen and back; 48 hours after vaccine was administered a raised red dotted rash formed on both arms especially on the left arm where it was administered; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 10 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Nov2021 12:00 (Lot number: FK5127) at the age of 10 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: RASH (non-serious) with onset 21Nov2021 14:30, outcome "recovering", described as "48 hours after vaccine was administered a raised red dotted rash formed on both arms especially on the left arm where it was administered/The rash also covered his abdomen and back"; VACCINATION SITE RASH (non-serious) with onset 21Nov2021 14:30, outcome "recovering", described as "48 hours after vaccine was administered a raised red dotted rash formed on both arms especially on the left arm where it was administered". Therapeutic measures were not taken as a result of rash, vaccination site rash.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Headache, Lymph node pain, Swelling face
Clinical narrative: This is a spontaneous report received from contactable other HCP (patient). A 57-year-old female patient (not pregnant) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FH8028), at the age of 57, intramuscularly, in left arm, Nov 2021, single dose, for COVID-19 immunisation. Medical history included hypothyroidism (unspecified if ongoing); pre diabetes (unspecified if ongoing) and COVID-19 (unspecified if ongoing). Concomitant medication included synthroid. The patient developed a headache (entire lower back of head very sore), swollen face, facial pain (outer edge of entire face swollen and painful) and lymph node pain (lymph nodes beneath ears very sore), onset Nov 17, 2021, with outcome of not recovered. No therapeutic measures taken as a result of headache, swelling face, facial pain and lymph node pain. Additional information: Patient did not receive any other vaccine in four weeks. Patient had COVID-19 prior to vaccination. Patient has not tested for COVID-19 post vaccination. No follow-up attempts possible. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: has the sniffles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: RHINORRHOEA (non-serious), outcome "unknown", described as "has the sniffles".  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea
Clinical narrative: Since I received the second shot, my menstrual periods have become more painful; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18May2021 12:30 (Lot number: EW0185) at the age of 34 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Torn ACL", start date: 2017 (unspecified if ongoing), notes: Torn ACL in 2017; "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0171, Location of injection: Arm Right, Vaccine Administration Time: 12:30 PM), administration date: 27Apr2021, when the patient was 34 years old, for COVID-19 immunization. The following information was reported: DYSMENORRHOEA (non-serious) with onset 2021, outcome "recovering", described as "Since I received the second shot, my menstrual periods have become more painful". Therapeutic measures were not taken as a result of dysmenorrhoea.  Follow-up attempts are completed. No further information is expected.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Oropharyngeal pain
Clinical narrative: Sorry throat; cough; feeling tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 10 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 10:30 (Lot number: Fks127) at the age of 10 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: OROPHARYNGEAL PAIN (non-serious) with onset 19Nov2021, outcome "not recovered", described as "Sorry throat"; COUGH (non-serious) with onset 19Nov2021, outcome "not recovered", described as "cough"; FATIGUE (non-serious) with onset 19Nov2021, outcome "not recovered", described as "feeling tired".  No follow-up attempts are possible. No further information is expected.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 9 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Nov2021 14:30 (Lot number: FK5127) at the age of 9 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing); "Dairy sensitivity" (unspecified if ongoing); "OCD" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL. Past drug history included: Known allergies: amoxicillin, reaction(s): "Drug allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FK5127, Location of injection: Arm Left), administration date: 06Nov2021, when the patient was 9 years old, for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 28Nov2021 13:00, outcome "recovering", described as "Headache"; PAIN IN EXTREMITY (non-serious) with onset 28Nov2021 13:00, outcome "recovering", described as "sore left arm". Therapeutic measures were not taken as a result of headache, pain in extremity.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Gastric disorder, Malaise
Clinical narrative: Was feeling unwell (possibly stomach issues); Was feeling unwell (possibly stomach issues); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient received bnt162b2 (BNT162B2) (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: MALAISE (non-serious), GASTRIC DISORDER (non-serious) all with onset 25Nov2021, outcome "recovered" (26Nov2021) and all described as "Was feeling unwell (possibly stomach issues)".  Additional Information: I do not think I have further information for this one  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Myalgia
Clinical narrative: felt horrible; Exhausted; Muscle pain; Chills; 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 parent.  A 26-years-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as DOSE 2, SINGLE for covid-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), when the patient was 26 years old, for Covid-19 immunization, reaction(s): "didn't feel so great". The following information was reported: FEELING ABNORMAL (medically significant), outcome "unknown", described as "felt horrible"; FATIGUE (non-serious), outcome "unknown", described as "Exhausted"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain"; CHILLS (non-serious), outcome "unknown", described as "Chills".  Additional Information: Caller stated that her son felt horrible. He was just exhausted, had muscle pain, chills, just exhaustion, so that was why she wondered if the booster would be the same if that was what happened to him after the second vaccine. She asked if does the booster have twice as much medicine. She was a little bit scared for her son, but he was otherwise healthy. The investigation assessment was not provided.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Mar2021 12:00 (Lot number: ER8733) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergies: Bee venom" (unspecified if ongoing). Concomitant medication(s) included: TAMOXIFEN. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EH6206, Location of injection: Arm Left, Vaccine Administration Time: 01:30 PM), administration date: 06Mar2021, for COVID-19 immunization. The following information was reported: TINNITUS (non-serious) with onset 28Mar2021, outcome "not recovered", described as "tinnitus". The event "tinnitus" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of tinnitus. Prior to vaccination, was the patient diagnosed did not diagnosed with COVID-19 and since the vaccination, patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: After his initial dose didn't feel so great; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the parent.  A 26 year-old male patient received bnt162b2 (BNT162B2) (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: FEELING ABNORMAL (non-serious), outcome "recovered", described as "After his initial dose didn't feel so great".  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 in extremity
Clinical narrative: arm pain; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the parent.  A 11 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Pain in extremity, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Sore arm; The caller previously reported an incident where two kids were given the Pediatric Pfizer Covid 19 Vaccine that was expired; The caller previously reported an incident where two kids were given the Pediatric Pfizer Covid 19 Vaccine that was expired; Mixed 0850 am 24Nov2021, given 26Nov2021 @ 1400; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 7 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Nov2021 14:00 (Lot number: FK5618, Expiration Date: 27Jan2022) at the age of 7 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cold" (unspecified if ongoing); "fever" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) with onset Nov2021, outcome "unknown", described as "Mixed 0850 am 24Nov2021, given 26Nov2021 @ 1400"; POOR QUALITY PRODUCT ADMINISTERED (non-serious), EXPIRED PRODUCT ADMINISTERED (non-serious) all with onset 26Nov2021, outcome "unknown" and all described as "The caller previously reported an incident where two kids were given the Pediatric Pfizer Covid 19 Vaccine that was expired"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm".  Additional information: The reporter stated that two kids were given the Pediatric Pfizer Covid 19 Vaccine that was expired. The caller also submitted a temperature document to Pfizer to see if the patients needed to be revaccinated. Both kids had sore arm. No fever, no other side effects recorded from the twins. NDC: 59267105501. There was no Specific relevant test for thromboembolic events with thrombocytopenia.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101676888 same reporter/product/event, diff patients
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Parosmia
Clinical narrative: Metallic taste in mouth and smell in nose; Metallic taste in mouth and smell in nose; This is a spontaneous report received from contactable reporter other HCP. The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 27Nov2021 15:15 (Lot number: 32030BD) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Fruit allergy" (unspecified if ongoing), notes: Known allergies: Pineapple; "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin; "Reactive airways disease" (unspecified if ongoing), notes: Reactive airway disorder; "Hypertension" (unspecified if ongoing), notes: Htn. Concomitant medication(s) included: DYAZIDE; ESTRACE. Past drug history included: Botox, reaction(s): "Urinary urgency", notes: Other medical history: Urinary urgency on botox injections; Cefepime, reaction(s): "Drug allergy", notes: Known allergies: cefepine. The following information was reported: DYSGEUSIA (non-serious), PAROSMIA (non-serious) all with onset 27Nov2021 15:45, outcome "not recovered" and all described as "Metallic taste in mouth and smell in nose". Therapeutic measures were not taken as a result of dysgeusia, parosmia.  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 vaccination.The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, SARS-CoV-2 test
Clinical narrative: Extreme Hair loss over 3 months after 2nd dose (~70% of all hair volume); This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Apr2021 (Lot number: ER2613) at the age of 45 years 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, Batch/Lot No: ER8731), administration date: Mar2021, when the patient was 45 years old, for COVID-19 immunization. The following information was reported: ALOPECIA (non-serious) with onset Apr2021, outcome "recovering", described as "Extreme Hair loss over 3 months after 2nd dose (~70% of all hair volume)". The event "extreme hair loss over 3 months after 2nd dose (~70% of all hair volume)" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Father of 9-yr old female mentioned pt feeling unwell after her second dose of Covid vaccination.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the parent.  A 9 year-old female patient received bnt162b2 (BNT162B2) (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), for COVID-19 immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "Father of 9-yr old female mentioned pt feeling unwell after her second dose of Covid vaccination.".  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 in extremity
Clinical narrative: leg pain by patient after receiving her second Covid vaccination.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the parent.  A 9 year-old female patient received bnt162b2 (BNT162B2) (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), for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "leg pain by patient after receiving her second Covid vaccination.".  Additional information: Awareness Date was on 28Nov2021  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Anti-platelet factor 4 antibody test, Pain in extremity, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Before puncture and I know after puncture it's only good for 12 hours.; Before puncture and I know after puncture it's only good for 12 hours./total time of storage from the time of dilution to the time of administration was 53 hours; sore arm; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team. Other Case identifier(s): US-PFIZER INC-202101690247 (Pfizer).  A 7 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Nov2021 14:00 (Lot number: FK5618, Expiration Date: 27Jan2022) at the age of 7 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cold" (unspecified if ongoing), notes: Weeks of vaccination; "Fever" (unspecified if ongoing), notes: Weeks of vaccination. There were no concomitant medications. The following information was reported: PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) with onset 26Nov2021 14:00, outcome "unknown", described as "Before puncture and I know after puncture it's only good for 12 hours."; POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 26Nov2021 14:00, outcome "unknown", described as "Before puncture and I know after puncture it's only good for 12 hours./total time of storage from the time of dilution to the time of administration was 53 hours"; PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "unknown", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: No fever, no other side effects recorded from the twins. The reporter stated that the vial of the vaccine was diluted and kept in the fridge between 37.2° to 40°F and from the total time of storage from the time of dilution to the time of administration was 53 hours. It was unknown if prior vaccination (within 4 weeks). Specific Relevant Test Thromboembouc Events with thrombocytopenia: Antibody test to platelet factor IV, result: unknown. No Autopsy information. Pediatric vaccine was mixed on 24Nov2021 at 9 am and was not salvaged by closing pharmacist end of Day. Pharmacy was closed on thanksgiving. On 26Nov2021 at 2 pm, the pharmacist drew out 1 dose from the expired diluted vaccine kept in the fridge since 9 am 24Nov2021 and gave it to the patient. On 29Nov2021 at around 8:20 am, patient's parent was contacted, and where they informed that patient experienced sore arm and no fever or other side effects reported. The reporter stated that the date of second dose, Its from the 21 days from 26Nov so its around 17Dec2021'.  No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-202101676457 same reporter/product/event, diff patients
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: I still get pain where I got that shot and it hurts like in area where I got that shot; my arm is still hurting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administration date 17Aug2021 (Lot number: FC3181, Expiration Date: Oct2021) at the age of 58 years 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, Single), for Covid-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "not recovered", described as "I still get pain where I got that shot and it hurts like in area where I got that shot"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "not recovered", described as "my arm is still hurting". No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives; Itching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Apr2021 (Lot number: EW0158, Expiration Date: Jul2021) at the age of 51 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Ankylosing spondylitis", start date: 2016 (unspecified if ongoing), notes: Verbatim: Ankylosing spondylitis. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Lot Number EP6955/ Expiry Date Jun2021, Anatomical Location: Left arm  ), administration date: 25Mar2021, when the patient was 51 years old, for Covid-19 immunization. The following information was reported: URTICARIA (non-serious) with onset Apr2021, outcome "unknown", described as "Hives"; PRURITUS (non-serious) with onset Apr2021, outcome "unknown", described as "Itching". Therapeutic measures were taken as a result of urticaria, pruritus.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscle aches; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD21-166476 (Moderna).  A 55-year-old female patient received bnt162b2 (BNT162B2) (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: MYALGIA (non-serious), outcome "unknown", described as "muscle aches".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Vomiting
Clinical narrative: Swollen lymph nodes; vomiting; severe headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 31-years-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Nov2021 14:00 (Lot number: F48030) at the age of 31 years as DOSE 1, SINGLE for covid-19 immunization; influenza vaccine (FLU VACCINE VII), administered in arm right, administration date 24Nov2021 (Batch/Lot number: unknown) as DOSE 1, SINGLE for immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 25Nov2021 14:30, outcome "recovering", described as "Swollen lymph nodes"; VOMITING (non-serious) with onset 25Nov2021 14:30, outcome "recovering", described as "vomiting"; HEADACHE (non-serious) with onset 25Nov2021 14:30, outcome "recovering", described as "severe headache". Therapeutic measures were not taken as a result of lymphadenopathy, vomiting, headache.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. No other medications were received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Nightmare, Pyrexia
Clinical narrative: Nightmares; Fever; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (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: PYREXIA (non-serious), outcome "recovered", described as "Fever"; NIGHTMARE (non-serious), outcome "not recovered", described as "Nightmares". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Postpartum disorder
Clinical narrative: My postpartum lochia returned after having diminished immediately after both Covid vaccines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Nov2021 11:00 (Lot number: FF2590) at the age of 32 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VACCINE, administration date 19Nov2021; PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]. Vaccination history included: Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand unknown=False,, prev dose lot number=FF2590,, prev dose lot unknown=False,, prev dose administration date=05Nov2021,, prev dose administration time=11:00AM, prev dose dose number=1,, prev dose vaccine location=Left arm), administration date: 05Nov2021, when the patient was 32 years old, for COVID-19 immunization, reaction(s): "My postpartum lochia returned", "My postpartum lochia returned". The following information was reported: Postpartum Disorder(non-serious) with onset 05Nov2021 18:00, outcome "not recovered", described as "My postpartum lochia returned after having diminished immediately after both Covid vaccines". Therapeutic measures were not taken as a result of postpartum disorder.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Nausea, Pain
Clinical narrative: body aches; nausea; chills; weakness; 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 received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LENVIMA. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for Covid-19 immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "body aches"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; CHILLS (non-serious), outcome "unknown", described as "chills"; ASTHENIA (non-serious), outcome "unknown", described as "weakness". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: slight headache; mild nausea; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 10 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 26Nov2021 11:30 (Lot number: FK5127) at the age of 10 years 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, Batch/Lot No: FK5127, Location of injection: Arm Right, Vaccine Administration Time: 09:30 AM, Route of Administration: Intramuscular), administration date: 05Nov2021, when the patient was 10 years old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 26Nov2021 23:30, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 27Nov2021, outcome "recovering", described as "slight headache"; NAUSEA (non-serious) with onset 27Nov2021, outcome "recovering", described as "mild nausea". Therapeutic measures were taken as a result of pyrexia. No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Contusion, Fatigue
Clinical narrative: extreme tiredness; Have lots of purple bruising on my legs, both legs/had dark blue bruising/blushing down both legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Nov2021 (Lot number: FH 8028) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Migraines" (ongoing). Concomitant medication(s) included: IMITREX taken for migraine (ongoing). Vaccination history included: Bnt162b2 (Dose:1,, Anatomical site of injection: left arm, Batch/lot number: ER2613), administration date: 17Mar2021, for COVID-19 Immunization; Bnt162b2 (Dose:2, Anatomical site of injection: left arm, Batch/lot number: EP7533), administration date: 08Apr2021, for COVID-19 Immunization; Flu (Anatomical site of injection: left arm, No. of previous doses:1), administration date: 05Nov2021. The following information was reported: CONTUSION (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "Have lots of purple bruising on my legs, both legs/had dark blue bruising/blushing down both legs"; FATIGUE (non-serious) with onset Dec2021, outcome "unknown", described as "extreme tiredness". The event "have lots of purple bruising on my legs, both legs/had dark blue bruising/blushing down both legs" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of contusion. Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications). After Pfizer booster had dark blue bruising/blushing down both legs. Did not hurt, no swelling. Gone the next morning waves of extreme tiredness 1 week after booster.  No follow-up attempts are possible. No further information is expected.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Anti-platelet factor 4 antibody test, Malaise, Nausea, Vomiting
Clinical narrative: Vomiting; feeling sick; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 7 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Nov2021 09:00 (Lot number: FK5127) at the age of 7 years as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: NAUSEA (non-serious) with onset 27Nov2021, outcome "unknown", described as "Nausea"; VOMITING (non-serious) with onset 28Nov2021 06:30, outcome "unknown", described as "Vomiting"; MALAISE (non-serious) with onset 27Nov2021 20:00, outcome "unknown", described as "feeling sick". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of nausea, vomiting.  Additional information: A 7 year-old female patient received bnt162b2 (BNT162B2), administration date 26Nov2021 (Lot number: FK5127) at the age of 7 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: NAUSEA (non-serious) with onset 27Nov2021, outcome "unknown", described as "Nausea"; VOMITING (non-serious) with onset 27Nov2021, outcome "unknown", described as "Vomiting". Therapeutic measures were not taken as a result of nausea, vomiting. Drug Lot number and expiration date: FK5127. Patient details: Patient age at time of vaccination: 7years. Prior vaccinations, concomitant drugs, patient's medical history, relevant tests were none. Specific relevant test for thromboembolic events with thrombocytopenia were none, Test: Antibody test to platelet factor IV, Date: 17Oct2019, Result: Positive 1 copy, Comments: 1 copy of he factor IV variant. Comment included: possibly caused by stomach bug as there was no reaction to 2nd dose, Timeline: 1st Dose-Friday 9:00 am, Feeling sick -Saturday 8:00 pm, Throwing up-Sunday 6:30 am, Throwing up- Monday 6:00am. Run down and off school for 4 days. Returned to school on Friday.  Follow-up attempts are completed. No further information is expected.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: nose bleeds every day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent. Other Case identifier(s): US-PFIZER INC-202101689601 (Pfizer).  A 8 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 13Nov2021 (Lot number: FK5127, Expiration Date: 31Jan2022) at the age of 8 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Verbatim: Asthma. There were no concomitant medications. The following information was reported: EPISTAXIS (non-serious) with onset 18Nov2021, outcome "not recovered", described as "nose bleeds every day".  Additional Information: it was a Pfizer COVID Vaccine for age group 5 to 11 a Pfizer product. She had asthma, but it was not severe anymore like it was. She was not on any medications now. Nose bleeds every day: it started 5 days after the vaccine. It either happens during the night when she sleeps and will wake her up or it happens during the day. It happens everyday. There have been no other changes besides getting vaccine. She was a tall girl and weight was around 85 to 90 pounds. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. She didn't even get her flu vaccine. Adverse event did not required visit to emergency room or physician office. No Prior Vaccinations within 4 weeks. No AE(s) following prior vaccinations. no relevant tests. Caller was calling on behalf of her 8 year old daughter that got her first dose of the Pfizer pediatric (5-11years old) vaccine on 13nov2021. Five days after the vaccine, she started having nose bleeds. She's been bleeding everyday since. Caller wants to know if this is a common side effect. Caller stated that she just wanted to know if this was a common side effect. Had heard stories about blood clots and bleeding and she wanted to make sure it is nothing serious.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: He developed tinnitus in ears; 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. Other Case identifier(s): US-PFIZER INC-202101689631 (Pfizer). A 54-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 19Mar2021 (Lot number: ER2613, Expiration Date: Jul2021) at the age of 54 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: TINNITUS (non-serious) with onset 21Mar2021, outcome "not recovered", described as "He developed tinnitus in ears". The event "he developed tinnitus in ears" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of tinnitus.  Additional Information:  Time the Vaccination was early afternoon. Received call from consumer regarding Pfizer Adult dose COVID 19 vaccine. After Patient had 1st shot, 2 days later. The patient was not hospitalized. Prior Vaccinations (within 4 weeks) , list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was none. Relevant Tests was none. AE(s) following prior vaccinations was none. Patient reports onset of tinnitus after primary dose Pfizer vaccine 19Mar21, second dose 09Apr21.   Follow-up attempts are completed. No further information is expected.