chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Palpitations
Clinical narrative: high pulse multiple times over several days; intensely racing heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE: MANUFACTURE UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE: MANUFACTURE UNKNOWN), for COVID-19 immunization. The following information was reported: HEART RATE INCREASED (non-serious), outcome "unknown", described as "high pulse multiple times over several days"; PALPITATIONS (non-serious), outcome "unknown", described as "intensely racing heart". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter stated that his wife received a third dose of the Pfizer COVID vaccination and, in the week that followed, she suffered from an intensely racing heart and high pulse multiple times over several days. She can't say for certain that it was because of the vaccine, but it does seem to be a rare side effect of the vaccination. What can she do to find out of this was a result of the vaccine or not and what to do to make sure she doesn't suffer any permanent damage to her heart.  Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Joint Pain in Fingers; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  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: ARTHRALGIA (non-serious), outcome "unknown", described as "Joint Pain in Fingers".  Additional information: The reporter was reporting on Adverse Events for herself and during the supplemental form questions mentioned Adverse Events for her Brother.  Family Medical History Relevant to AE(s): Mom and Brother also got Joint Pain in Fingers but no neurological issues. Not sure on details. Dates, NDC, Lot, Expiration Unknown. Declines to complete a full report at this time.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: HERPES ZOSTER (non-serious), outcome "unknown", described as "shingles".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; 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 number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Unknown Manufacturer), for Covid-19 Immunization. The following information was reported: HERPES ZOSTER (non-serious), outcome "unknown", described as "shingles".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Antibody test, COVID-19, Drug ineffective, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: two patients were tested positive for COVID-19 infection/one patient before receiving the second dose; two patients were tested positive for COVID-19 infection/one patient before receiving the second dose; This is a literature report.  A 15 year-old (range 12 -18-year-old) patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Post-transplant" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "two patients were tested positive for COVID-19 infection/one patient before receiving the second dose". The patient underwent the following laboratory tests and procedures: antibody test: unknown results; sars-cov-2 antibody test: unknown result; sars-cov-2 test: positive.  Additional information: In a study, assessing the effectiveness of Pfizer in 12 -18-year-old adolescents, among 57 participants, only two patients were tested positive for COVID-19 infection, one patient before receiving the second dose and another one 46 days after the second dose. Two patients tested positive for SARS-CoV-2 infection during the study period. The first experienced 7 days of mildly symptomatic infection not requiring hospitalization between their two vaccine doses without an available post-V1 serology.  Follow-up (26Feb2022): This is a literature report. This is a follow-up report; the case has been updated to include additional information identified in the publication. Updated information: Literature information, medical history, patient's age, vaccination date, event onset date and clinical course.; Sender's Comments: Based on the compatible time association, the lack of efficacy cannot be excluded for suspect vaccine BNT162B2 administration.,Linked Report(s) : PFIZER INC-202200200573 Same article/drug/event and different patient.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Oropharyngeal pain
Clinical narrative: pain at site of injection; fever; headache; chills; nausea; Sore throat; Body Aches; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the parent.  A 16-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Feb2022 15:00 (Batch/Lot number: unknown) at the age of 16 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "OCD" (unspecified if ongoing); "migraine" (unspecified if ongoing). Concomitant medication(s) included: PROPRANOLOL; FLUVOXAMINE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: 04Jun2021, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: May2021, for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 03Feb2022 22:00, outcome "recovering", described as "pain at site of injection"; PYREXIA (non-serious) with onset 03Feb2022 22:00, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 03Feb2022 22:00, outcome "recovering", described as "headache"; CHILLS (non-serious) with onset 03Feb2022 22:00, outcome "recovering", described as "chills"; NAUSEA (non-serious) with onset 03Feb2022 22:00, outcome "recovering", described as "nausea"; OROPHARYNGEAL PAIN (non-serious) with onset 03Feb2022 22:00, outcome "recovering", described as "Sore throat"; PAIN (non-serious) with onset 03Feb2022, outcome "recovering", described as "Body Aches"; FATIGUE (non-serious) with onset 02Feb2022 22:00, outcome "recovering", described as "fatigue". Therapeutic measures were not taken as a result of vaccination site pain, pyrexia, headache, chills, nausea, oropharyngeal pain, pain, fatigue.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient not diagnosed with covid-19 prior to vaccination and since vaccination patient not tested for covid-19.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site pain
Clinical narrative: pain at site of injection; fever; headache; chills; nausea; Sore throat; Body Aches; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the parent.  A 16-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Feb2022 15:00 (Batch/Lot number: unknown) at the age of 16 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "OCD" (unspecified if ongoing); "migraine" (unspecified if ongoing). Concomitant medication(s) included: PROPRANOLOL; FLUVOXAMINE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: 04Jun2021, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: May2021, for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 03Feb2022 22:00, outcome "recovering", described as "pain at site of injection"; PYREXIA (non-serious) with onset 03Feb2022 22:00, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 03Feb2022 22:00, outcome "recovering", described as "headache"; CHILLS (non-serious) with onset 03Feb2022 22:00, outcome "recovering", described as "chills"; NAUSEA (non-serious) with onset 03Feb2022 22:00, outcome "recovering", described as "nausea"; OROPHARYNGEAL PAIN (non-serious) with onset 03Feb2022 22:00, outcome "recovering", described as "Sore throat"; PAIN (non-serious) with onset 03Feb2022, outcome "recovering", described as "Body Aches"; FATIGUE (non-serious) with onset 02Feb2022 22:00, outcome "recovering", described as "fatigue". Therapeutic measures were not taken as a result of vaccination site pain, pyrexia, headache, chills, nausea, oropharyngeal pain, pain, fatigue.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient not diagnosed with covid-19 prior to vaccination and since vaccination patient not tested for covid-19.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Burning sensation, Ear pain, Fibrin D dimer, Haemoglobin
Clinical narrative: I started having numbness on the right side of face from ear/unilateral numbness on the right side of her face, from her ear all the way down to chin; loss taste/lost ultra-sense of taste on the right side of her month and tongue; burning sensation/burning sensation on her tongue and mouth unilaterally; Trimengular" neuralgia; pain in her right ear; an outbreak of a cold sore; an outbreak of a cold sore; had a herpes zoster outbreak, on my lip; I had 2 teeth(rt side) extracted after the booster; I have had symptoms but they feel like they are swollen, even though they are not swollen; 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 68 year-old female patient received bnt162b2 (BNT162B2), administration date 25Oct2021 (Lot number: EW0185) at the age of 67 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 (First dose: , NDC: Unknown, Lot:  EN6198, Expiry date: Unknown, Date of vaccination: 24Feb2021), administration date: 24Feb2021, for COVID-19 Immunization; Bnt162b2 (Second Pfizer covid-19 vaccine: , NDC: Unknown, Lot:  EN6198, Expiry date: Unknown, Date of vaccination:  13Mar2021), administration date: 31Mar2021, for COVID-19 Immunization. The following information was reported: HERPES ZOSTER (non-serious) with onset 25Nov2021, outcome "unknown", described as "had a herpes zoster outbreak, on my lip"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "I started having numbness on the right side of face from ear/unilateral numbness on the right side of her face, from her ear all the way down to chin"; AGEUSIA (non-serious), outcome "unknown", described as "loss taste/lost ultra-sense of taste on the right side of her month and tongue"; BURNING SENSATION (non-serious), outcome "unknown", described as "burning sensation/burning sensation on her tongue and mouth unilaterally"; TRIGEMINAL NEURALGIA (non-serious), outcome "unknown", described as "Trimengular" neuralgia"; NASOPHARYNGITIS (non-serious), PAIN (non-serious) all with onset Dec2021, outcome "unknown" and all described as "an outbreak of a cold sore"; EAR PAIN (non-serious), outcome "unknown", described as "pain in her right ear"; TOOTH EXTRACTION (non-serious) with onset 05Nov2021, outcome "unknown", described as "I had 2 teeth(rt side) extracted after the booster"; SWELLING (non-serious) with onset 05Nov2021, outcome "unknown", described as "I have had symptoms but they feel like they are swollen, even though they are not swollen". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of trigeminal neuralgia. No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Hypoaesthesia, Nasopharyngitis, Pain, Pneumocystis jirovecii pneumonia
Clinical narrative: I started having numbness on the right side of face from ear/unilateral numbness on the right side of her face, from her ear all the way down to chin; loss taste/lost ultra-sense of taste on the right side of her month and tongue; burning sensation/burning sensation on her tongue and mouth unilaterally; Trimengular" neuralgia; pain in her right ear; an outbreak of a cold sore; an outbreak of a cold sore; had a herpes zoster outbreak, on my lip; I had 2 teeth(rt side) extracted after the booster; I have had symptoms but they feel like they are swollen, even though they are not swollen; 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 68 year-old female patient received bnt162b2 (BNT162B2), administration date 25Oct2021 (Lot number: EW0185) at the age of 67 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 (First dose: , NDC: Unknown, Lot:  EN6198, Expiry date: Unknown, Date of vaccination: 24Feb2021), administration date: 24Feb2021, for COVID-19 Immunization; Bnt162b2 (Second Pfizer covid-19 vaccine: , NDC: Unknown, Lot:  EN6198, Expiry date: Unknown, Date of vaccination:  13Mar2021), administration date: 31Mar2021, for COVID-19 Immunization. The following information was reported: HERPES ZOSTER (non-serious) with onset 25Nov2021, outcome "unknown", described as "had a herpes zoster outbreak, on my lip"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "I started having numbness on the right side of face from ear/unilateral numbness on the right side of her face, from her ear all the way down to chin"; AGEUSIA (non-serious), outcome "unknown", described as "loss taste/lost ultra-sense of taste on the right side of her month and tongue"; BURNING SENSATION (non-serious), outcome "unknown", described as "burning sensation/burning sensation on her tongue and mouth unilaterally"; TRIGEMINAL NEURALGIA (non-serious), outcome "unknown", described as "Trimengular" neuralgia"; NASOPHARYNGITIS (non-serious), PAIN (non-serious) all with onset Dec2021, outcome "unknown" and all described as "an outbreak of a cold sore"; EAR PAIN (non-serious), outcome "unknown", described as "pain in her right ear"; TOOTH EXTRACTION (non-serious) with onset 05Nov2021, outcome "unknown", described as "I had 2 teeth(rt side) extracted after the booster"; SWELLING (non-serious) with onset 05Nov2021, outcome "unknown", described as "I have had symptoms but they feel like they are swollen, even though they are not swollen". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of trigeminal neuralgia. No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Thyroid function test, Tooth extraction, Trigeminal neuralgia
Clinical narrative: I started having numbness on the right side of face from ear/unilateral numbness on the right side of her face, from her ear all the way down to chin; loss taste/lost ultra-sense of taste on the right side of her month and tongue; burning sensation/burning sensation on her tongue and mouth unilaterally; Trimengular" neuralgia; pain in her right ear; an outbreak of a cold sore; an outbreak of a cold sore; had a herpes zoster outbreak, on my lip; I had 2 teeth(rt side) extracted after the booster; I have had symptoms but they feel like they are swollen, even though they are not swollen; 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 68 year-old female patient received bnt162b2 (BNT162B2), administration date 25Oct2021 (Lot number: EW0185) at the age of 67 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 (First dose: , NDC: Unknown, Lot:  EN6198, Expiry date: Unknown, Date of vaccination: 24Feb2021), administration date: 24Feb2021, for COVID-19 Immunization; Bnt162b2 (Second Pfizer covid-19 vaccine: , NDC: Unknown, Lot:  EN6198, Expiry date: Unknown, Date of vaccination:  13Mar2021), administration date: 31Mar2021, for COVID-19 Immunization. The following information was reported: HERPES ZOSTER (non-serious) with onset 25Nov2021, outcome "unknown", described as "had a herpes zoster outbreak, on my lip"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "I started having numbness on the right side of face from ear/unilateral numbness on the right side of her face, from her ear all the way down to chin"; AGEUSIA (non-serious), outcome "unknown", described as "loss taste/lost ultra-sense of taste on the right side of her month and tongue"; BURNING SENSATION (non-serious), outcome "unknown", described as "burning sensation/burning sensation on her tongue and mouth unilaterally"; TRIGEMINAL NEURALGIA (non-serious), outcome "unknown", described as "Trimengular" neuralgia"; NASOPHARYNGITIS (non-serious), PAIN (non-serious) all with onset Dec2021, outcome "unknown" and all described as "an outbreak of a cold sore"; EAR PAIN (non-serious), outcome "unknown", described as "pain in her right ear"; TOOTH EXTRACTION (non-serious) with onset 05Nov2021, outcome "unknown", described as "I had 2 teeth(rt side) extracted after the booster"; SWELLING (non-serious) with onset 05Nov2021, outcome "unknown", described as "I have had symptoms but they feel like they are swollen, even though they are not swollen". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of trigeminal neuralgia. No follow-up attempts are possible. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cardiac disorder, Chest discomfort, Electrocardiogram, Electrocardiogram ambulatory
Clinical narrative: having a raise in heart rate/ heart rate was over a 150 beats per min; Heart racing; chest was heavy; having some heart issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 15 year-old female patient received bnt162b2 (COMIRNATY), administration date 07Jan2022 (Lot number: FF8841) at the age of 15 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthmatic" (ongoing), notes: it does like exercise or allergy induced, so she does not take a normal inhaler; "fruit allergies" (ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Manufacturer unknown, dose1), for Covid-19 immunization; Covid-19 vaccine (Manufacturer unknown, dose 2), for Covid-19 immunization. The following information was reported: CARDIAC DISORDER (non-serious) with onset 08Jan2022, outcome "unknown", described as "having some heart issues"; TACHYCARDIA (non-serious), outcome "unknown", described as "having a raise in heart rate/ heart rate was over a 150 beats per min"; PALPITATIONS (non-serious), outcome "unknown", described as "Heart racing"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "chest was heavy". The event "having a raise in heart rate/ heart rate was over a 150 beats per min" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of cardiac disorder, tachycardia, palpitations, chest discomfort.  Additional information: It was reported that the patient was having some heart issues which were "intermittent" started the day after she received the dose, since then she was having a raise in heart rate, then a week after that would raise again then another week will raise again after and so on and so fort. The patient visited ER this past week because her heart rate was over a 150 beats per min. Prior vaccination (Within four weeks) was none.   Follow-up attempts are completed. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Palpitations, Tachycardia
Clinical narrative: having a raise in heart rate/ heart rate was over a 150 beats per min; Heart racing; chest was heavy; having some heart issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 15 year-old female patient received bnt162b2 (COMIRNATY), administration date 07Jan2022 (Lot number: FF8841) at the age of 15 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthmatic" (ongoing), notes: it does like exercise or allergy induced, so she does not take a normal inhaler; "fruit allergies" (ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Manufacturer unknown, dose1), for Covid-19 immunization; Covid-19 vaccine (Manufacturer unknown, dose 2), for Covid-19 immunization. The following information was reported: CARDIAC DISORDER (non-serious) with onset 08Jan2022, outcome "unknown", described as "having some heart issues"; TACHYCARDIA (non-serious), outcome "unknown", described as "having a raise in heart rate/ heart rate was over a 150 beats per min"; PALPITATIONS (non-serious), outcome "unknown", described as "Heart racing"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "chest was heavy". The event "having a raise in heart rate/ heart rate was over a 150 beats per min" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of cardiac disorder, tachycardia, palpitations, chest discomfort.  Additional information: It was reported that the patient was having some heart issues which were "intermittent" started the day after she received the dose, since then she was having a raise in heart rate, then a week after that would raise again then another week will raise again after and so on and so fort. The patient visited ER this past week because her heart rate was over a 150 beats per min. Prior vaccination (Within four weeks) was none.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Patient reported shaking arms after receiving COVID vaccine. Uncertain if vaccine was Pfizer.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, (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: TREMOR (non-serious), outcome "unknown", described as "Patient reported shaking arms after receiving COVID vaccine. Uncertain if vaccine was Pfizer".  Additional information: Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Hypoaesthesia, Hypoaesthesia oral, Hysteroscopy, Paraesthesia oral
Clinical narrative: Tingling in right-half of tongue, numbness of right tongue, palate and of the neck. I had tongue tingling with all my shots; but not the neck/swallowing issue. After my first 2 shots, I also had abnormal menstrual bleeding (excessive). Shot 3, tingling and numbness of tongue and throat continue today. Abnormal menses since.
Age: 36.0
Sex: F
Vaccine: DTAP
Symptoms: Abdominal discomfort, Abdominal pain upper, Chest pain, Chills, Diarrhoea
Clinical narrative: Day of vaccine: extreme stomach pain, fever, chills, body shaking, diarrhea, hot flashes, chest pain, heart rate of 130. Days later, still feel nauseated and tired and have increased heart rate and upset stomach
Age: 36.0
Sex: F
Vaccine: DTAP
Symptoms: Fatigue, Heart rate increased, Hot flush, Nausea, Pyrexia
Clinical narrative: Day of vaccine: extreme stomach pain, fever, chills, body shaking, diarrhea, hot flashes, chest pain, heart rate of 130. Days later, still feel nauseated and tired and have increased heart rate and upset stomach
Age: 36.0
Sex: F
Vaccine: DTAP
Symptoms: Tremor
Clinical narrative: Day of vaccine: extreme stomach pain, fever, chills, body shaking, diarrhea, hot flashes, chest pain, heart rate of 130. Days later, still feel nauseated and tired and have increased heart rate and upset stomach
Age: 84.0
Sex: U
Vaccine: COVID19
Symptoms: Alopecia, Rash
Clinical narrative: loss of hair; skin rashes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 85 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Mar2021 13:00 (Lot number: EN6198) at the age of 84 years as dose 1, 0.3ml single, intramuscular, administered in arm left, administration date 23Mar2021 13:00 (Lot number: EN6207) as dose 2, 0.3 ml single and intramuscular, administered in arm left, administration date 19Oct2021 13:00 (Lot number: EW0185) as dose 3 (booster), 0.3ml single for covid-19 immunisation. Relevant medical history included: "Lowering blood pressure" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: COZAAR taken for hypertension (ongoing); CALCIUM taken for osteoporosis (ongoing); VITAMIN A [RETINOL] taken for supplementation therapy (ongoing); VITAMIN B COMPLEX taken for supplementation therapy (ongoing); VITAMIN C [ASCORBIC ACID] taken for supplementation therapy (ongoing); VITAMIN D [COLECALCIFEROL] taken for supplementation therapy (ongoing); VITAMIN E [TOCOPHEROL] taken for supplementation therapy (ongoing). The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "loss of hair"; RASH (non-serious), outcome "unknown", described as "skin rashes". No follow-up attempts are possible. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Blood test normal, Cardiac stress test normal, Dizziness, Echocardiogram normal
Clinical narrative: Dizziness, extreme fatigue, numbness in legs, brain fog, weight loss, hot and cold flashes, sensitivity to noise and light, anxiety and panic attacks. Continue to persist 10 months later.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Fatigue, Feeling abnormal, Feeling cold, Hot flush
Clinical narrative: Dizziness, extreme fatigue, numbness in legs, brain fog, weight loss, hot and cold flashes, sensitivity to noise and light, anxiety and panic attacks. Continue to persist 10 months later.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperacusis, Hypoaesthesia, Magnetic resonance imaging head normal, Panic attack, Photophobia
Clinical narrative: Dizziness, extreme fatigue, numbness in legs, brain fog, weight loss, hot and cold flashes, sensitivity to noise and light, anxiety and panic attacks. Continue to persist 10 months later.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Scan with contrast normal, Ultrasound abdomen normal, Weight decreased
Clinical narrative: Dizziness, extreme fatigue, numbness in legs, brain fog, weight loss, hot and cold flashes, sensitivity to noise and light, anxiety and panic attacks. Continue to persist 10 months later.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Urticaria
Clinical narrative: Urticaria of the hands and feet, resolved in 24 hours
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Non-small cell lung cancer stage IV
Clinical narrative: Stage 4 non  small  cell lung cancer
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Atrial fibrillation, Blood test normal, Cardiac monitoring abnormal, Cardiac stress test abnormal
Clinical narrative: Received vaccine -injection #1 on March 1st. March 10 began with symptoms of cardiac irregularity-heart rate- 105(I am an RN) and took my extra doses of cardizem and atenolol and tried to "break it" as it felt like a.fib.waited a few days- Contacted my endocrinologist I believe about 3/15- and also the cardiologist - my irregularity was persistent and did not change   and also just the rate became slower- 60/min. still very irregular- on 3/23- I was sent for an entire endocrinology workup as I have a adrenal adenomas- all was fine- cardiologist had cardiac monitor applied - worn for 10 days- showed severe arrhythmia- and the  nuclear stress test that was followed also highly irregular.Cardiologist changed my meds- d/c cardizem add atenolol and started me on eplerenone and bisoprolol which caused me to have diarrhea so I stopped them and went back to cardizem and atenolol.Received my secon vaccine on the 29th- symptoms continued thru July -middle of.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Endocrine test normal, Heart rate irregular, Metanephrine urine, Vaccine positive rechallenge
Clinical narrative: Received vaccine -injection #1 on March 1st. March 10 began with symptoms of cardiac irregularity-heart rate- 105(I am an RN) and took my extra doses of cardizem and atenolol and tried to "break it" as it felt like a.fib.waited a few days- Contacted my endocrinologist I believe about 3/15- and also the cardiologist - my irregularity was persistent and did not change   and also just the rate became slower- 60/min. still very irregular- on 3/23- I was sent for an entire endocrinology workup as I have a adrenal adenomas- all was fine- cardiologist had cardiac monitor applied - worn for 10 days- showed severe arrhythmia- and the  nuclear stress test that was followed also highly irregular.Cardiologist changed my meds- d/c cardizem add atenolol and started me on eplerenone and bisoprolol which caused me to have diarrhea so I stopped them and went back to cardizem and atenolol.Received my secon vaccine on the 29th- symptoms continued thru July -middle of.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Chills, Computerised tomogram abdomen abnormal, Culture urine, Cystogram
Clinical narrative: 9/11/21-9/12/21: severe right abdominal pain, nausea, and chills 9/12/21-9/15/21: hospitalization; CT scan of abdomen and pelvis showed "severe right hydronephrosis". Patient underwent cystoscopy surgery with right ureteral stent placement. 1/17/22: patient underwent dismembered pyleoplasty to repair ureteropelvic junction obstruction. 1/17/22: Final diagnosis of tissue exam: "A. Right ureteropelvic junction, excision: benign ureteropelvic junction with severe acute inflammation" F/U in 3-6 months for US Retroperitoneal Limited and and NM Kidney Morphology Vasc Flow Function exams and urology check-up once a year afterwards
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cystoscopy, Differential white blood cell count, Full blood count, Hydronephrosis, Inflammation
Clinical narrative: 9/11/21-9/12/21: severe right abdominal pain, nausea, and chills 9/12/21-9/15/21: hospitalization; CT scan of abdomen and pelvis showed "severe right hydronephrosis". Patient underwent cystoscopy surgery with right ureteral stent placement. 1/17/22: patient underwent dismembered pyleoplasty to repair ureteropelvic junction obstruction. 1/17/22: Final diagnosis of tissue exam: "A. Right ureteropelvic junction, excision: benign ureteropelvic junction with severe acute inflammation" F/U in 3-6 months for US Retroperitoneal Limited and and NM Kidney Morphology Vasc Flow Function exams and urology check-up once a year afterwards
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Metabolic function test, Nausea, Pelvi-ureteric obstruction, Pyeloplasty
Clinical narrative: 9/11/21-9/12/21: severe right abdominal pain, nausea, and chills 9/12/21-9/15/21: hospitalization; CT scan of abdomen and pelvis showed "severe right hydronephrosis". Patient underwent cystoscopy surgery with right ureteral stent placement. 1/17/22: patient underwent dismembered pyleoplasty to repair ureteropelvic junction obstruction. 1/17/22: Final diagnosis of tissue exam: "A. Right ureteropelvic junction, excision: benign ureteropelvic junction with severe acute inflammation" F/U in 3-6 months for US Retroperitoneal Limited and and NM Kidney Morphology Vasc Flow Function exams and urology check-up once a year afterwards
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Scan with contrast abnormal, Ultrasound abdomen, Ureteral stent insertion, Urine analysis
Clinical narrative: 9/11/21-9/12/21: severe right abdominal pain, nausea, and chills 9/12/21-9/15/21: hospitalization; CT scan of abdomen and pelvis showed "severe right hydronephrosis". Patient underwent cystoscopy surgery with right ureteral stent placement. 1/17/22: patient underwent dismembered pyleoplasty to repair ureteropelvic junction obstruction. 1/17/22: Final diagnosis of tissue exam: "A. Right ureteropelvic junction, excision: benign ureteropelvic junction with severe acute inflammation" F/U in 3-6 months for US Retroperitoneal Limited and and NM Kidney Morphology Vasc Flow Function exams and urology check-up once a year afterwards
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Menstruation irregular
Clinical narrative: Irregular menstruation, constant and severe headaches.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Confusional state, Fatigue, Injection site pain, Nausea
Clinical narrative: Day of shot, roughly 8 hours later, I was suffering from chills, nausea, confusion, exhaustion, fevers. These ended after I slept through the night, waking up feeling better.  Minor arm pain near injection site, lasting over 5 months so far. Have not felt these pains before the shot, or have I felt similar pains in any other location of my body for any other shots I've taken before.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Day of shot, roughly 8 hours later, I was suffering from chills, nausea, confusion, exhaustion, fevers. These ended after I slept through the night, waking up feeling better.  Minor arm pain near injection site, lasting over 5 months so far. Have not felt these pains before the shot, or have I felt similar pains in any other location of my body for any other shots I've taken before.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests normal, Asthenia, Balance disorder, Fall, Laboratory test
Clinical narrative: Moderate to severe vertigo started in December approximately 10 days after receiving Moderna COVID-19 booster. Prior two doses of COVID-19 vaccine were Pfizer.  Moderate to severe vertigo has persisted from December 2021 to present day (March 2022), occurring daily, often in evenings. Sensation is off-balance and falling, not spinning, and often triggered by movement or laying on side with eyes closed. Impairs ability to look at screens occasionally due to blurry vision.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo, Vestibular disorder, Vestibular function test abnormal, Vision blurred
Clinical narrative: Moderate to severe vertigo started in December approximately 10 days after receiving Moderna COVID-19 booster. Prior two doses of COVID-19 vaccine were Pfizer.  Moderate to severe vertigo has persisted from December 2021 to present day (March 2022), occurring daily, often in evenings. Sensation is off-balance and falling, not spinning, and often triggered by movement or laying on side with eyes closed. Impairs ability to look at screens occasionally due to blurry vision.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: PATIENT HAD RASH TWO DAYS AFTER VACCINATION OF RIGHT UNDERARM. SHE REPORTS PERSISTENT RASH. PRESENTS INTO CLINIC TODAY WITH HISTORY OF WORSENING RASH. PATIENT EVALUATED AND PROVIDED TOPICAL PRESCRIPTION CORTICOSTEROIDS AND ANTIHISTAMINE, WITH RECOMMENDAITON FOR RE-EVALUATION IN A WEEK WITH DERMATOLOGY/URGENT CARE.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Cardiac function test, Fat tissue increased, Fluid retention, Immune system disorder
Clinical narrative: Within 24 hours I had all-over swelling. Then 11 days after the injection, when I woke up my legs, ankles and feet had swollen to the point of being grotesque.  Strange pockets of fluid/fat had formed around my ankles.  Blood pressure also became elevated. Reported the incident to my physician who did not appear to know what to do and did not seriously address my condition.  Found doctor, who said that it appeared that I had developed possible panniculitis, but she was unable to perform a biopsy due to the amount of nerves in the site affected.  Later in October, I had a cold and when I woke up the next morning, I had more strange pockets of fluid/fat in my hands. Doctor said this was also the same situation and unable to biopsy. She said that the pockets on my hands and ankles are probably permanant.   Since the vaccine, my body seems unable to cope with basic immune responses such as a common cold or common summer insect bites like mosquito bites. The swelling in my legs and feet has finally mostly subsided, but the pockets of fluid/fat still remain.   I was told that the vaccine was safe for people with Hashimoto's or other immune disorders and now I am permanently disfigured and my immune system is further damaged due to the vaccine.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Liver function test, Nasopharyngitis, Nervous system disorder, Peripheral swelling
Clinical narrative: Within 24 hours I had all-over swelling. Then 11 days after the injection, when I woke up my legs, ankles and feet had swollen to the point of being grotesque.  Strange pockets of fluid/fat had formed around my ankles.  Blood pressure also became elevated. Reported the incident to my physician who did not appear to know what to do and did not seriously address my condition.  Found doctor, who said that it appeared that I had developed possible panniculitis, but she was unable to perform a biopsy due to the amount of nerves in the site affected.  Later in October, I had a cold and when I woke up the next morning, I had more strange pockets of fluid/fat in my hands. Doctor said this was also the same situation and unable to biopsy. She said that the pockets on my hands and ankles are probably permanant.   Since the vaccine, my body seems unable to cope with basic immune responses such as a common cold or common summer insect bites like mosquito bites. The swelling in my legs and feet has finally mostly subsided, but the pockets of fluid/fat still remain.   I was told that the vaccine was safe for people with Hashimoto's or other immune disorders and now I am permanently disfigured and my immune system is further damaged due to the vaccine.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Renal function test, Swelling
Clinical narrative: Within 24 hours I had all-over swelling. Then 11 days after the injection, when I woke up my legs, ankles and feet had swollen to the point of being grotesque.  Strange pockets of fluid/fat had formed around my ankles.  Blood pressure also became elevated. Reported the incident to my physician who did not appear to know what to do and did not seriously address my condition.  Found doctor, who said that it appeared that I had developed possible panniculitis, but she was unable to perform a biopsy due to the amount of nerves in the site affected.  Later in October, I had a cold and when I woke up the next morning, I had more strange pockets of fluid/fat in my hands. Doctor said this was also the same situation and unable to biopsy. She said that the pockets on my hands and ankles are probably permanant.   Since the vaccine, my body seems unable to cope with basic immune responses such as a common cold or common summer insect bites like mosquito bites. The swelling in my legs and feet has finally mostly subsided, but the pockets of fluid/fat still remain.   I was told that the vaccine was safe for people with Hashimoto's or other immune disorders and now I am permanently disfigured and my immune system is further damaged due to the vaccine.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: Tiredness, nausea, diarrhea, headache, stomach discomfort
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Blood thyroid stimulating hormone, Electrocardiogram, Free thyroxine index, Heart rate
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 37 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 11Feb2022 19:00 (Lot number: FK9895) at the age of 37 years as dose 3 (booster), single for Covid-19 immunisation. Relevant medical history included: "Stomach pain", stop date: Mar2011, notes: Appendectomy; "Flu like symptoms", start date: 03Jan2022, stop date: 10Jan2022, notes: Did multiple Covid tests, they were all negative. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0181, Date/time, Date: 19Jun2021, Route of administration: intramuscular [checked], Batch/lot number: EW0181), administration date: 19Jun2021, when the patient was 37 years old, for Covid-19 immunization, reaction(s): "TSH/ abnormal", "free thyroxine/ abnormal"; Bnt162b2 (Dose Number: 1, Batch/Lot No: Fk9895, Dose: 1st, Date/time, Date: 29May2021, Route of administration: intramuscular [checked], Batch/lot number: PEW0178), administration date: 29May2021, when the patient was 37 years old, for Covid-19 immunization. The following information was reported: TACHYCARDIA (medically significant) with onset 12Feb2022, outcome "unknown", described as "Tachycardia"; THYROID DISORDER (medically significant) with onset 12Feb2022, outcome "unknown", described as "Thyroid problem"; HEART RATE INCREASED (medically significant) with onset 12Feb2022 14:00, outcome "recovering", described as "Rapid heart rate the next day of the vaccination with resting rate of 100+ bpm and standing rate of 120+ bpm". The events "tachycardia", "thyroid problem" and "rapid heart rate the next day of the vaccination with resting rate of 100+ bpm and standing rate of 120+ bpm" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (12Feb2022) thyroid results, notes: showed that my thyroid results only on 16Feb2022; blood thyroid stimulating hormone (0.35-5.5): (02Feb2022) 0.020 MiU/mL, notes: Abnormal; electrocardiogram: (12Feb2022) tachycardia; free thyroxine index (0.61-1.30): (02Feb2022) 1.44 ng/dL, notes: Abnormal; heart rate: (unspecified date) 100+ bpm; (unspecified date) 120+bpm, notes: while I was sitting and watching TV, the next day around 02:00PM eastern time. Since 02:00 PM-08:00 PM on 12Feb2022 (next day) my heart rate was mostly high at which point; (12Feb2022) mostly high, notes: while I was sitting and watching TV, the next day around 02:00PM eastern time. Since 02:00 PM-08:00 PM on 12Feb2022 (next day) my heart rate was mostly high at which point; sars-cov-2 test: (unspecified date) negative, notes: Did multiple Covid tests, they were all negative; thyroid function test: (Nov2021) normal. Therapeutic measures were taken as a result of tachycardia, heart rate increased. It was unknown if therapeutic measures were taken as a result of thyroid disorder.