chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: I have not been feeling well since the vaccine.; This is a spontaneous report from a contactable consumer reported for herself, through Pfizer sponsored programfor Lyrica and Lyrica CR. A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient have not been feeling well since the vaccine on an unspecified date with outcome of unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute myocardial infarction
Clinical narrative: STEMI; This is a spontaneous report from a contactable healthcare professional. An 80-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), intramuscularly, administered in the left arm on 29Mar2021 13:30 (at the age of 80 years old) at a single dose for COVID-19 immunization. Medical history included hypertension, hyperlipidemia, asthma, chronic kidney disease (CKD) 3, all from an unknown date and unknown if ongoing. Concomitant medications included tamsulosin, amlodipine, doxazosin mesilate (CARDURA), albuterol [salbutamol], umeclidinium bromide (INCRUSE ELLIPTA) atorvastatin (LIPITOR) and montelukast sodium (SINGULAIR), all taken for an unspecified indication, start and stop date were not reported. The patient previously took enalapril and augmentin [amoxicillin; clavulanic acid] and experienced allergies with both. The patient previously received first dose of BNT162B2 (lot number and expiry date were not reported), intramuscularly, administered in the left arm on 05Mar2021 13:00 (at the age of 80 years old) at a single dose for COVID-19 immunization. The patient experienced ST-elevation myocardial infarction (STEMI) on 31Mar2021. The event was reported to have resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization (also reported as number of days hospitalization: 0; pending clarification) and was reported as life threatening. Treatment included cardiac catheterization. There was no other vaccine in four weeks.  It was unknown if the patient had COVID prior vaccination and was not COVID tested post vaccination. The outcome of the event was recovering.  Information on the batch/lot number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute myocardial infarction, Electrocardiogram
Clinical narrative: STEMI; This is a spontaneous report from a contactable healthcare professional. An 80-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), intramuscularly, administered in the left arm on 29Mar2021 13:30 (at the age of 80 years old) at a single dose for COVID-19 immunization. Medical history included hypertension, hyperlipidemia, asthma, chronic kidney disease (CKD) 3, all from an unknown date and unknown if ongoing. Concomitant medications included tamsulosin, amlodipine, doxazosin mesilate (CARDURA), albuterol [salbutamol], umeclidinium bromide (INCRUSE ELLIPTA) atorvastatin (LIPITOR) and montelukast sodium (SINGULAIR), all taken for an unspecified indication, start and stop date were not reported. The patient previously took enalapril and augmentin [amoxicillin; clavulanic acid] and experienced allergies with both. The patient previously received first dose of BNT162B2 (lot number and expiry date were not reported), intramuscularly, administered in the left arm on 05Mar2021 13:00 (at the age of 80 years old) at a single dose for COVID-19 immunization. The patient experienced ST-elevation myocardial infarction (STEMI) on 31Mar2021. The event was reported to have resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization (also reported as number of days hospitalization: 0; pending clarification) and was reported as life threatening. Treatment included cardiac catheterization. There was no other vaccine in four weeks.  It was unknown if the patient had COVID prior vaccination and was not COVID tested post vaccination. The outcome of the event was recovering.  Information on the batch/lot number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscular weakness, Tongue paralysis, Tremor
Clinical narrative: left tongue deviation; right radial numbness in the right arm/ left facial numbness/ numbness in feet; left facial tremors; weakness in legs; This is a spontaneous report from a contactable physician's assistant in Emergency Medicine. This physician's assistant reported similar events for three patients. This is the second of three reports.  A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date after receiving the vaccine, the patient experienced right radial numbness in the right arm, left facial numbness and left facial tremors, left tongue deviation, numbness in feet, and weakness in legs. The clinical outcomes of the right radial numbness in the right arm, left facial numbness and left facial tremors, left tongue deviation, numbness in feet, and weakness in legs were unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.          Amendment: This follow-up report is being submitted to amend previously reported information: to correct the patient initials and patient information.  Follow-up (01Apr2021): New information received from the same physician's assistant includes: reporter occupation updated.   Follow-up (05Apr2021): This is a follow-up report to notify that the case 2021276385 and case 2021372512 are duplicates.  All subsequent follow-up information will be reported under manufacturer report number 2021372512.; Sender's Comments: Based on the limited information currently available, a possible association of the suspect drug administration with the reported event left tongue deviation cannot be excluded, due to a plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : PFIZER INC-2021154431 same reporter, product, and event; different patient; PFIZER INC-2021372580 same reporter, product, and event; different patient
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscular weakness, Tongue paralysis, Tremor
Clinical narrative: left tongue deviation; right radial numbness in the right arm/left facial numbness/numbness in feet; left facial tremors; weakness in legs; This is a spontaneous report from a contactable physician's assistant in Emergency Medicine. This physician's assistant reported similar events for three patients. This is the third of three reports.  A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date after receiving the vaccine, the patient experienced right radial numbness in the right arm, left facial numbness and left facial tremors, left tongue deviation, numbness in feet, and weakness in legs. The clinical outcomes of the right radial numbness in the right arm, left facial numbness and left facial tremors, left tongue deviation, numbness in feet, and weakness in legs were unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.          Amendment: This follow-up report is being submitted to amend previously reported information: to correct the patient initials and patient information.  Follow-up (01Apr2021): New information received from the same physician's assistant includes: reporter occupation updated.   Follow-up (05Apr2021): This is a follow-up report to notify that the case 2021290853 and case 2021372580 are duplicates.  All subsequent follow-up information will be reported under manufacturer report number 2021372580.; Sender's Comments: As there is limited information in the case provided for tongue paralysis the causal association between the event and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021154431 Same reporter/product, different patient, similar events;US-PFIZER INC-2021372512 same reporter, product, and event; different patient
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: very sick; Initial information received on 07-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves patient (age not reported) who got very sick (sickness), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got very sick (illness) within a week  following the administration of INFLUENZA VACCINE.  It is unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine was not reported.   It is unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for illness.  There will be no information available on the batch number for this case.
Age: 0.17
Sex: M
Vaccine: HIBV
Symptoms: Syringe issue, Underdose
Clinical narrative: syringe issue; when reconstituting ACTHIB the needle popped off the syringe and about 1/4 of the diluent spilled from the syringe onto the counter; Initial information received on 17-Feb-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 month old male patient who had received a 0.5 mL dose HIB (PRP/T) VACCINE [ACT-HIB] whose needle popped off the syringe while reconstituting and about 1/4 of the diluent spilled from the syringe onto the counter and syringe issue,(lot UJ347ABA and expiry date 30-july-2021) and received via intramuscular route in the right thigh for prophylactic vaccination on 15-Feb-2021(underdose and syringe issue).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX); PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); ROTAVIRUS VACCINE (ROTAVIRUS VACCINE); and WATER FOR INJECTION (STERILE WATER FOR INJ.).  Caller stated that when they drew the vaccine up, they used the package diluent and when they administered the vaccine, the needle popped off and not all of the vaccine was administered because part of it spilled out.   this case associated with syringe issue.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 2.0
Sex: F
Vaccine: IPV
Symptoms: Swelling of eyelid
Clinical narrative: right eye lid swelling; Initial information was received on 09-Mar-2021 regarding an unsolicited valid non-serious case from a physician.  This case involves a two-year-old female patient who experienced right eye lid swelling (swelling of eyelid), after she received vaccine IPV (VERO) [IPOL].  Medical history, medical treatment, past vaccination and concomitant medications family history were not provided.  On 02-Nov-2020, the patient received a dose of 0.5 ml suspect IPV (VERO) (lot P1F54, expiry date not reported) via an intramuscular route in the left thigh for prophylactic vaccination.  On 02-Nov-2020, the patient developed non-serious right eye lid swelling (swelling of eyelid) within 3 hours following the administration of IPV (VERO).  Details of laboratory data were not reported.  On 03-Nov-2020 in the morning the patient recovered from the event after treating with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]).
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Medication error, Product preparation issue
Clinical narrative: patient received a dose of PENTACEL without reconstituting with the Hib portion of the vaccine/no AE; Initial information was received on 16-Mar-2021 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a four-month-old female patient who received a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ336AA, expiry date not reported) via an intramuscular route in the left thigh without reconstituting with the HIB portion of the vaccine for prophylactic vaccination on 10-Mar-2021 (product preparation issue).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  It was a case of an actual medication error due to inappropriate reconstitution technique (latency on the same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received expired dose IPOL (expiry date- 13-Mar-2021)/no AE; Initial information was received on 16-Mar-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional .  This case involves child patient (age and gender unknown) who received a expired dose of IPV (VERO) [lot number: R1B251M and expiry date: 13-Mar-2021] via an unknown route at an unknown administration site on 15-Mar-2021 for prophylactic vaccination (expired product administered).  Medical history, medical treatment, vaccination, concomitant medications and family history were not provided.  It was an actual medication error due to expired vaccine used (latency: same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, IPV, PPV, RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired dose of IPOL was administered to a patient with no adverse event; Initial information received on 16-Mar-2021 regarding an unsolicited valid non-serious case received from the other health care professional (HCP) via Agency (Reference number- 00521683).  This case involves a six months old male patient who received an expired 0.5mL third dose of IPV (VERO) [IPOL] Strength: Standard, lot number: R1B25, expiry date: 13-Mar-2021 via intramuscular route in the right thigh on 16-Mar-2021for prophylactic vaccination (expired product administered).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) via oral route, DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP), PNEUMOCOCCAL VACCINE CONJ (PCV) and HEPATITIS B VACCINE for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (latency: same day).  At the time of reporting patient had no adverse event.  Causality: not reported, Reporter can be contacted by Sanofi: Yes Potential Product Technique Complain: No. Caller with questions on whether dose needs repeating. Caller with questions on adverse reactions to expect. Pasteur Adverse Event Reporting Refunds/ Credits will not be issued due to adverse events. Emergency Room/ Doctor Visit and date: well visit 16-Mar-2021, Reporter relationship: HCP. Product: Used.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Erythema, Pruritus
Clinical narrative: slow anaphylaxis reaction; redness; itching; Initial information regarding an unsolicited valid serious case was received from a pharmacist (reporting on behalf of a consumer) via Medical Information (Reference number- 00541352) and transmitted to Sanofi on 30-Mar-2021.   This case involves patient (age and gender not reported) who experienced anaphylaxis reaction (anaphylactic reaction), redness (erythema) and itching (pruritus), while he/she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   In 2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious slow anaphylaxis reaction (anaphylactic reaction), redness (erythema) and itching (pruritus) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant.  Pharmacist asked what are the excipients in the 2018 FLUZONE QUADRIVALENT HD vaccine. A consumer would like to know. A Pharmacist also wanting to know would having a reaction to the Fluzone High dose affect if get a Covid-19 vaccine. Case resent to PV marking possible hospitalization. The Pharmacist reported that the consumer did go to the hospital either the same day or the next day. There is no more information for the report. Pharmacist asked what are the excipients in the 2018 FLUZONE QUADRIVALENT HD vaccine. A consumer would like to know.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for all events.  Batch number has been requested for suspect product for this case.; Sender's Comments: This case concerns a patient (age not reported) who presented with anaphylactic reaction after vaccination with FLUZONE HIGH DOSE. The time to onset was unknown. There is, however, no information regarding patient's condition at time of vaccination, past history and lab tests ruling out alternate etiologies. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: Nausea / Days 3-7 after vaccine    fatigue / first 23 hours
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pruritus, Rash macular
Clinical narrative: Big red spot on arm, itchy. Gets worse with exposure to heat (hot yoga, hiking in 80° weather). Periodically shows up and then goes away. Started night of vaccination, has continued for about a week. Treating with ice to stop the itching. Fatigue and headache for three days following vaccination.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Cough, Dysphonia, Throat clearing
Clinical narrative: approximately 30 minutes after receiving vaccine pt had a coughing fit and then continued to have R sided chest pain/tightness causing continued throat clearing/coughing. Hoarse voice as well. We treated as allergic reaction with IV solumedrol 125mg, IV benadryl 25mg, and one 5mg Albuterol neb treatment with good resolution of symptoms.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound chest
Clinical narrative: approximately 30 minutes after receiving vaccine pt had a coughing fit and then continued to have R sided chest pain/tightness causing continued throat clearing/coughing. Hoarse voice as well. We treated as allergic reaction with IV solumedrol 125mg, IV benadryl 25mg, and one 5mg Albuterol neb treatment with good resolution of symptoms.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Nausea, Pain, Pyrexia
Clinical narrative: body aches, fever, chills, nausea, vomiting, decreased appetite; treated with tylenol, motrin, zofran, pedialyte, rest
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: body aches, fever, chills, nausea, vomiting, decreased appetite; treated with tylenol, motrin, zofran, pedialyte, rest
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Neck pain, Pain in extremity, Pain in jaw
Clinical narrative: At 3:30 pm, pain in left side under ear/jaw area, pins and needles in jaw area starting. By 5:30 pm, pins and needles moving between jaw, top of head, left finger tips, and left cheek/sinus area. Took 1 Ibuprofen for neck/arm pain. Laid down at 5:30 pm. Fatigue. Cold enough to get a blanket but no chills. Laid down rest of the evening until bedtime. Woke up many times overnight from arm pain.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Sleep disorder
Clinical narrative: At 3:30 pm, pain in left side under ear/jaw area, pins and needles in jaw area starting. By 5:30 pm, pins and needles moving between jaw, top of head, left finger tips, and left cheek/sinus area. Took 1 Ibuprofen for neck/arm pain. Laid down at 5:30 pm. Fatigue. Cold enough to get a blanket but no chills. Laid down rest of the evening until bedtime. Woke up many times overnight from arm pain.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Haemoglobin decreased, Heavy menstrual bleeding, Laboratory test, Packed red blood cell transfusion, Ultrasound scan
Clinical narrative: Heavy menstruation  Hemoglobin fell to 6.1
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Eye pain, Eye swelling, Headache, Neck pain
Clinical narrative: Headache  Sore neck Sore arm Sore armpit  Sore throat  Right eye swelling and pain
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in extremity
Clinical narrative: Headache  Sore neck Sore arm Sore armpit  Sore throat  Right eye swelling and pain
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site reaction, Rash erythematous
Clinical narrative: A large red lesion around the injection site with itchiness
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Condition aggravated, Tinnitus
Clinical narrative: Normally had mild, manageable tinnitus in both ears 24/7. However, after this shot, the volume has exploded to 2-3 times what it used to sound like. It first became loud about 30 minutes after the shot, then became better the next day, then became loud again, and has persisted for the past 2 weeks. I am trying to deal with it mentally but sometimes I am just barely holding down anxiety attacks.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: After taking the vaccine Janssen 24 hours, injection area appeared a dime size red rash, and it turned into 2 x 3.5 in. Swelling.  In the 48 hr,  it expanded to downwards towards elbow, around 1/2 upper arm, the 72hrs, it expanded to 2/3 of the upper arm. Feeling sore, swelling, itchy. Took the Advil, Vick?s cold medicine, and benadry, did not relieve the symptoms much.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in both ears but  worse in left
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Urticaria
Clinical narrative: Hives (truncal and bilateral arms); 'dizziness' and mild headache
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Feeling hot, Headache, Influenza like illness
Clinical narrative: Fever (100.6), headache, hot/chills, flu like
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: Hives over entire torso and abdomen, scalp, neck, arms.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Swelling
Clinical narrative: Initially my left gland in my neck was swollen for about three days. About 10 to 14 days later I discovered 2 pea-sized lumps in my neck, left side.   I have a doctors appointment two get ultrasound on Thursday, April 8.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Hypoaesthesia, Injection site pain
Clinical narrative: Initial reaction:  night of April 1-2: moderate leg aches, restlessness, hip joint pain, feeling feverish w/out fever, mild chills April 2-3: moderate to severe fatigue, lethargy symptoms eased on evening of April 3 Secondary reaction: April 4, evening through today, April 7: lymph nodes in left armpit, left side of neck, left jaw sore and tender, possibly slightly swollen. Back left jaw felt slightly numb on first day. Left side of neck feels as if muscles sprained. No fever. Brief, mild tenderness at injection site on right arm.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Lymph node pain, Lymphadenopathy, Migraine, Neck pain
Clinical narrative: Initial reaction:  night of April 1-2: moderate leg aches, restlessness, hip joint pain, feeling feverish w/out fever, mild chills April 2-3: moderate to severe fatigue, lethargy symptoms eased on evening of April 3 Secondary reaction: April 4, evening through today, April 7: lymph nodes in left armpit, left side of neck, left jaw sore and tender, possibly slightly swollen. Back left jaw felt slightly numb on first day. Left side of neck feels as if muscles sprained. No fever. Brief, mild tenderness at injection site on right arm.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pain in jaw, Pyrexia, Restlessness, Tenderness
Clinical narrative: Initial reaction:  night of April 1-2: moderate leg aches, restlessness, hip joint pain, feeling feverish w/out fever, mild chills April 2-3: moderate to severe fatigue, lethargy symptoms eased on evening of April 3 Secondary reaction: April 4, evening through today, April 7: lymph nodes in left armpit, left side of neck, left jaw sore and tender, possibly slightly swollen. Back left jaw felt slightly numb on first day. Left side of neck feels as if muscles sprained. No fever. Brief, mild tenderness at injection site on right arm.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Initial reaction:  night of April 1-2: moderate leg aches, restlessness, hip joint pain, feeling feverish w/out fever, mild chills April 2-3: moderate to severe fatigue, lethargy symptoms eased on evening of April 3 Secondary reaction: April 4, evening through today, April 7: lymph nodes in left armpit, left side of neck, left jaw sore and tender, possibly slightly swollen. Back left jaw felt slightly numb on first day. Left side of neck feels as if muscles sprained. No fever. Brief, mild tenderness at injection site on right arm.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Lymph node pain, Myalgia, Peripheral swelling
Clinical narrative: -Heavy muscular pain -Lymph node pain (left armpit) -Red swollen (left arm I got the shot)
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Syncope, Urinary incontinence
Clinical narrative: Patient had syncopal episode, urinated, became nauseous upon rousing. Placed in trendelenburg, left side lying for nausea. Patient bp 85/52, HR 110. Patient sent to ER via medics
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Fatigue, Somnolence, Urticaria
Clinical narrative: hives, slight shortness of breath, feeling tired, no energy, sleepy starting from approximately 45 minutes after vaccine administration.  pt instructed to take loratadine 20mg (2 10mg tabs), went to sleep for approximately 3 hours and woke up feeling fine
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: I have intermittent high pitched ringing in both ears. I've never had this before. I noticed it a few days after I received the vaccine and didn't think much about it, but it has continued since then and is starting to worry me a bit.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Electrocardiogram, Eye swelling, Laboratory test
Clinical narrative: patient came into the ed for bilateral eye swelling that started Monday night two days after vaccination - treated for allergic rxn Benadryl solumedrol Pepcid
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypovolaemia, Loss of consciousness, Nausea, Vomiting
Clinical narrative: Found on floor by EMS nausea, vomiting, diaphoretic. Felt need to have a BM. Patient considered hypovolemic and unable to increase bp with position. Patient transferred by EMS to nearest hospital
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Depression, Dysmenorrhoea, Thinking abnormal
Clinical narrative: Excruciating and unbarearable menstrual pain that woukd not subside with pain medication, heating pad, or supplements. Depression and anxiety worsened with scary thoughts
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Syncopal episode. Recovered at site. Patient states history of passing out with vaccines in past.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea, Paraesthesia
Clinical narrative: Patient felt nauseated, diaphoretic, tingling sensation in mouth. Patient watched and recovered at site
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Eye irritation, Myalgia, Pyrexia
Clinical narrative: Fever, chills, muscle aches, joint pain, burning eyes
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling jittery, Nausea
Clinical narrative: Faint feeling, lightheaded, Felt jittery, nauseated. Layed down and recovered at site
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Syncpal episode. Patient placed in trendelenburg, left lying position. Patient recovered at site
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose decreased, Unevaluable event
Clinical narrative: I DID NOT HAVE AN ADVERSEN REACTION.  I am reporting a coincidence that happened both times on vaccines within 5 days or more.  I took first vaccine on March 1st and on March 5th I went for a blood test.  The results showed my glucose level was 67.  I am not diabetic nor have I ever had such low glucose level.  On March 29th I took my  second vaccine. Yesterday, April 6 I went to get another blood test and my glucose was 75.  Again,  I never prior to vaccination have I had such low sugar level.  However, I do have primary Myleofibrosis.   Because I have low hemoglobin and experience occassion lightheadness, I did not previously reported.  But having 2 blood test done and both glucose level being so low was concerning and reason why I am reporting it.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Nausea
Clinical narrative: Left arm extremely sore at injection site, very strong nausea and headache
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Work up in the middle of the night itching profusely.  Checked all documentation on possible side effects after receiving vaccine.  Based on my findings, the itching I'm experiencing is listed as a possible side effect for the other vaccines but not this one.  There are no visible signs of rashes or hives, but extremely itchy.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Feeling abnormal, Headache, Malaise
Clinical narrative: About 4 hours after the injection I developed terrible rigors.  I had a fever up to 102 degrees, but I was also under blankets at the time.  I continued to have a low grade fever for much of the next day and generally felt bad with headache and malaise.  On the second day after my vaccination, 3/28/2021, I felt fine.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: About 4 hours after the injection I developed terrible rigors.  I had a fever up to 102 degrees, but I was also under blankets at the time.  I continued to have a low grade fever for much of the next day and generally felt bad with headache and malaise.  On the second day after my vaccination, 3/28/2021, I felt fine.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Hypopnoea, Myalgia, Sleep disorder
Clinical narrative: Muscle pain, joint pain, because of muscle pain it hurts to breathe in lower back. Have to take shallow breathes. Can?t sleep the pain is so bad. Still probably better than getting COVID... but darn this sucks.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Dizziness, Dyspnoea
Clinical narrative: About 20 after the shot I started to feel dizzy and weak the next day I woke up with a caugh now again this morning I woke up unable to breath now the paper I sighed and filled out did not ask if I had a compromised immune system. I was in the paperwork they gave me after the shot I called the er tonight and the lady I spoke to said that I had now got covid from that shot she said and I quote the way I am talking almost making full sentences with out hardly gasping for and I was born with asthma by the way she said fir it gets to the point where 3 word can't come out without gasping then I need to come in asap.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Nausea, Pain
Clinical narrative: Woke up at 2am achey, dizzy, headache, nausea, chills, tingling hands
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Woke up at 2am achey, dizzy, headache, nausea, chills, tingling hands
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased
Clinical narrative: 102 temperature
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Extreme pain around hip, lower left front torso first night; subsequently, very sore left leg front of thigh ever since and unable to sleep.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus onset a couple hours later. Still persists today. Noticible mostly at night in silence.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Feeding disorder, Weight decreased
Clinical narrative: I started with chills and not being able to eat. Chills have left but I still can?t eat. Anything makes my stomach upset...I?ve lost weight already
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Tinnitus
Clinical narrative: Ringing in my ears and nausea, started in the first two hours after getting the shot.
Age: 42.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal pain upper, Burning sensation, Dizziness, Fatigue, Feeling cold
Clinical narrative: A few hours after getting my second dose I started getting a swollen arm. The next day early in morning I started feeling the chills fatigue a stomach ache light headed body ache and my arm was super swollen and on fire. Could not lift it I was in so much pain the next few days I've never felt anything like what I felt. I never get sick and this was the worst
Age: 42.0
Sex: F
Vaccine: UNK
Symptoms: Mobility decreased, Pain, Peripheral swelling
Clinical narrative: A few hours after getting my second dose I started getting a swollen arm. The next day early in morning I started feeling the chills fatigue a stomach ache light headed body ache and my arm was super swollen and on fire. Could not lift it I was in so much pain the next few days I've never felt anything like what I felt. I never get sick and this was the worst
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Itchy, warm to touch and swelling at injection spot. Area seems to be getting larger over 24hrs.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Hypoaesthesia, Limb discomfort
Clinical narrative: Lower extremity tingling sensation same night and sporadically over the next 2 days. Then started progressing to heavy legs, numbness, tingling/pins & needles, and pain. While running on 4/5/21, my right foot got numb. Symptoms present all day, nonstop.   Other symptoms experienced: muscle pain, fatigue, headache, diarrhea. All, except fatigue, have now subsided.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Paraesthesia
Clinical narrative: Lower extremity tingling sensation same night and sporadically over the next 2 days. Then started progressing to heavy legs, numbness, tingling/pins & needles, and pain. While running on 4/5/21, my right foot got numb. Symptoms present all day, nonstop.   Other symptoms experienced: muscle pain, fatigue, headache, diarrhea. All, except fatigue, have now subsided.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Night sweats, Pain, Pyrexia
Clinical narrative: Night sweats, fever, body aches, unable to sleep, chills, headache
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: Night sweats, fever, body aches, unable to sleep, chills, headache
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: High fever 8 hours after Johnson & Johnson dose
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Headache, Myalgia, Vertigo
Clinical narrative: Slight pressure in ears, headache, vertigo, slight muscle soreness
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Feeling cold, Feeling hot, Head discomfort, Mobility decreased
Clinical narrative: Woke up and unable to move. My body felt as if I was 'hit by a bus'-pain from head to toe. I felt ice cold but when someone touched me, they said I felt to be on fire. Head congestion so bad it felt as if someone was squeezing my head and when I coughed, it hurt worse and I coughed up phlegm. I was not able to perform any activities as I was in terrible pain and slept on/off for about 30 hours.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder, Pain, Productive cough, Sinus congestion, Somnolence
Clinical narrative: Woke up and unable to move. My body felt as if I was 'hit by a bus'-pain from head to toe. I felt ice cold but when someone touched me, they said I felt to be on fire. Head congestion so bad it felt as if someone was squeezing my head and when I coughed, it hurt worse and I coughed up phlegm. I was not able to perform any activities as I was in terrible pain and slept on/off for about 30 hours.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Flank pain, Pain
Clinical narrative: Acute right flank and back pain. No n/v. Unable to lay, walk, stand without severe pain. No fever.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Chills, Dyspnoea, Headache
Clinical narrative: chills, vomiting, severe joint pain, heavy chest (difficulty breathing), headache, fever
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: chills, vomiting, severe joint pain, heavy chest (difficulty breathing), headache, fever
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Electrocardiogram, Hypertension
Clinical narrative: Around 48 hours after vaccination, blood pressure was very high, 173/105; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EP6955), via an unspecified route of administration administered in left arm at a pharmacy or drug store facility on 19Mar2021 12:30 as SINGLE DOSE for COVID-19 immunisation. The patient had no other vaccine in four weeks. The patient was not pregnant at the time of vaccination. Medical history included hypertension which was controlled and never had it been over 155/98. The patient had no known allergies. The patient had no COVID prior vaccination and was not COVID tested post vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID), losartan, and sertraline. On 21Mar2021 at 12:15 PM, around 48 hours after vaccination, blood pressure was very high, 173/105. Contacted doctor a took 2 additional dosage of losartan 25 mg. Two hours after 3rd pill BP was 192/114. The patient had not consumed salt or alcohol and did not have any preoccupations or anxiety. The event caused hospitalization on an unspecified date. The event resulted in emergency room and physician office visits. Therapeutic measures were taken as a result of the event includes had electrocardiogram (EKG) and waited more time until losartan lower. On an unspecified date, the patient recovered from the event.
Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Dyspnoea, Nausea, Pain in extremity, Vascular pain
Clinical narrative: 10 minutes after the vaccination I developed a vascular pain in the left calf. It is continuous and doesn?t stop but mild enough to be able to carry on with daily routine. At the time of writing this report 2.5 day passed since it started. On top of that 19 hours after the shot I had brief but scary 10-15 minutes episode of violent nausea+inability to catch a breath to the point I couldn?t produce a voice to call for help. The episode was severe enough for my housemates to get me ready for ER. After applying ice to my neck and head symptoms subsided enough for me to reconsider ER and just observe the further development.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Cough, Eye irritation, Eye pruritus, Headache
Clinical narrative: Patient complaining of severe headache, chills, body aches, sore throat, running nose, cough, nausea and vomiting and watery, itchy, burning eyes
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lacrimation increased, Nausea, Oropharyngeal pain, Pain, Rhinorrhoea
Clinical narrative: Patient complaining of severe headache, chills, body aches, sore throat, running nose, cough, nausea and vomiting and watery, itchy, burning eyes
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Patient complaining of severe headache, chills, body aches, sore throat, running nose, cough, nausea and vomiting and watery, itchy, burning eyes
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: Headache-2 days Fever-8 hours Muscle ache-2 days (hip joint still feels achey almost a week later Fatigue-1 day Swollen lymph nodes in armpit and collar bone 3 days Tylenol taken as needed
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Incomplete course of vaccination, Unevaluable event
Clinical narrative: My son is 10 months and breastfed he's been sick and has not slept since the shot.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pruritus, Myalgia, Nausea, Pyrexia
Clinical narrative: Janssen Covid-19 Vaccine EUA  Slight headache  Itching at injection site muscle aches nausea fever  wheezing
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: Janssen Covid-19 Vaccine EUA  Slight headache  Itching at injection site muscle aches nausea fever  wheezing
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood creatine phosphokinase, Electrocardiogram, Fatigue, Full blood count
Clinical narrative: Patient felt fatigue day one, then fever day two, then developed weakness and blurred vision, went to see eye doctor a few days later, was recommended to come to pcp due to eye findings, pt went home and checked sugar which glucometer read HI, which prompted her to go to er because this has never happened to her before
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Pyrexia, SARS-CoV-2 test, Vision blurred
Clinical narrative: Patient felt fatigue day one, then fever day two, then developed weakness and blurred vision, went to see eye doctor a few days later, was recommended to come to pcp due to eye findings, pt went home and checked sugar which glucometer read HI, which prompted her to go to er because this has never happened to her before
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Nodule
Clinical narrative: Swollen lymph nodes neck and jaw is ongoing  Extreme fatigue and knots on face and scalp 4/1 - 4/3
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Red lesion slightly itchy after 5 days of shot
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Fatigue, muscle ache, injection site pain, headache, fever