chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dry cough; Sore throat; Diarrhea; Nausea; muscle aches; joint aches; extreme fatigue; Headache; have been sick ever since; flu like symptoms; hoarse; This is a spontaneous report received from a contactable consumer (patient). This consumer reported similar events for herself and her husband. This is the first of 2 reports.  A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3247, expiry date: unknown), via an unspecified route of administration on the right arm, on 20Jan2021 at 10:15-10:30 (as reported), at single dose, for COVID-19 immunization, at the hospital. There were no medical history, family history and concomitant medications. The patient had no vaccinations within four weeks prior to the first administration of BNT162B2 vaccine. The patient reported that she and her husband had the Pfizer Covid 19 shot on 20Jan2021 (last Wednesday). She stated that they have been sick ever since. On 20Jan2021, the patient had flu-like symptoms and at 11:00, she experienced headache. On 21Jan2021, the patient experienced nausea, muscle aches, joint aches and extreme fatigue. On 22Jan2021, the patient had sore throat during the night and diarrhea. On 23Jan2021, the patient had dry cough. On an unspecified date in Jan2021, the patient was hoarse. The events did not require emergency room visit of physician office visit. The patient wanted to know if they should get the second shot. The outcome of the events "have been sick ever since", "flu like symptoms", headache, nausea, extreme fatigue and "hoarse" was not recovered; the patient was recovering from muscle aches and joint aches; the patient recovered with sequel from dry cough on 23Jan2021 and sore throat on 24Jan2021; the patient recovered from diarrhea on 24Jan2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021093716 Same reporter, suspect drug and events; different patients
Severe pain in the arm after injection, nausea, and still having hives to the site after 8 days later
pain; swelling; This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced pain in arm and injection site swelling. On an unknown date, the outcome of the pain in arm and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the pain in arm and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The medical assistant reported that the physician at her office received the first dose of Shingrix about 1 month ago. Afterwards he had pain like someone punched him in the arm and swelling at the injection site. The reporter would not provide her full name.
This is a spontaneous report from a contactable physician who reported for a patient through a Pfizer Sales Representative. This is fourth of the 4 reports from same reporter. A patient of unknown age and gender received PREVNAR 13 single dose on unknown date. The patient experienced cellulitis at injection site and fever.
Information has been received from a physician for GARDASIL, a pregnancy registry product, concerning a female patient, who on an unknown date, was vaccinated with a dose of GARDASIL (Lot #, dose and route not reported), and experienced a miscarriage. At the time of the report, the patient's outcome was unknown. Upon internal review, miscarriage was considered to be an other important medical event. This is one of several reports from the same source. Additional information has been requested.
Reported to our office on 6/27/19 that he has had soreness and painful ROM since his injection on 4/17/19
2 days after infusion,  severe arm pain and fever, body aches, and extreme nausea (unable to eat anything).   Started on 1/6 in morning and gone by night of 1/6.
Breakthrough case admission after 4 vaccines Moderna 2/321 Lot# 038K20A;  Moderna 3/3/21 Lot# 030A21A;  Moderna 9/17/21 Lot# 052E21A;  Moderna 4/8/22 Lot# 005M21A;
COVID arm; big round red spot at the injection site; can barely touch it and it is tender; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm), VACCINATION SITE ERYTHEMA (big round red spot at the injection site), TENDERNESS (can barely touch it and it is tender) and VACCINATION SITE REACTION (COVID arm) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LISINOPRIL for Hypertension.    On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, the patient experienced MYALGIA (Sore arm). On 31-May-2021, the patient experienced VACCINATION SITE ERYTHEMA (big round red spot at the injection site) and TENDERNESS (can barely touch it and it is tender). On 20-Jun-2021, the patient experienced VACCINATION SITE REACTION (COVID arm). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 24-May-2021, MYALGIA (Sore arm) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (big round red spot at the injection site), TENDERNESS (can barely touch it and it is tender) and VACCINATION SITE REACTION (COVID arm) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.  Treatment medication include ice compress.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-231343 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: added new treatment medication
This is a spontaneous report from a contactable reporter reporting for her son, via Pfizer sponsored program.  A 16-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 24Apr2021 (Batch/Lot number was not reported) as single dose at the age of 16-year-old for COVID-19 immunisation.   The patient medical history and concomitant medications were not reported.  After 24 hours from vaccination, on 25Apr2021, he felt pain on the injection site. For that, the mother gave her son Tylenol to treat the symptoms. Then after 24 hours, on 26Apr2021 he felt fine. However, 2 days after, on 28Apr2021, he felt pain underneath the left side of his armpit, had a fever with a temperature of 102.8 F, and the right side of his neck was swollen. In addition to this, he was experiencing a lot of body aches, headache, and pain on his neck. They already contacted their HCP and prescribed him with antibiotics in Apr2021. He was tired and almost lethargic in Apr2021. Reporter wanted to know if her son should still receive the 2nd dose. The reporter was invited to consult her HCP. The outcome of pain on the injection site was recovering, of all other events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events Neck swelling, Armpit pain, and Fever cannot be excluded.  The case will be reassessed if additional information becomes available.  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.
I got COVID after Dose 3 received Paxlovid it didn't work well for me after 5 days. On February 11, 2022 had a Rapid test still was testing positive which turned into Pneumonia. I started experiencing migraines and feverish from Jan 25, 2022 to March 23, 2022.
Spoke with Mother who has noticed no difference in the childs behavior or in the injection site. Informed mom of error and told her that she might notice more redness at the site and child may be more drowsy than normal. Mom hasn't noticed either of those at this time. I told the mom not to hesitate to call if she notices anything.
One hour and 15 minutes after the injection , patient experienced generalized itching and a few hives on her face and legs.  Injection site has erythema and some swelling.
chills for 5 hours, fever and pounding headache for more than 5 hours; muscle aches and fatigue for more than 10 hours
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced injection site pain and product supply issue. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the product supply issue was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine on right arm. The patient reported that she had pain and soreness at the injection site, which had lasted for 3 days. At the time of reporting, it had been 6 months and 2 weeks since the 1st dose, the patient did not receive the 2nd dose of the SHINGRIX vaccine due to shortage. The patient had denied permission to contact their physician. No further details were provided.
Itchy, redness, swelling, burning sensation at site 1 day after injection. No reactions to previous flu shots.
This is a spontaneous report from a contactable physician communicated to a Pfizer sales representative reporting similar events for two patients. This is the 2nd of 2 reports. A 62 years old male patient received PREVNAR 13 intramuscular, on an unspecified date in Aug2017, at 0.5 ml single, for immunization. Medical history and concomitant medications were not reported. Since an unspecified date in Aug2017 the patient experienced lightheadedness, weakness and dizziness lasting 2 to 3 minutes after the injection. The physician resolved it by having the patient laid down and giving fluids and a glucose tablet. The patient completely recovered from the events on an unspecified date in Aug2017. Sender's Comments: Linked Report(s): US-PFIZER INC-2017380818 same reporter/product/events, different patient.
3 hours post vaccine, extreme arm pain. Couldn?t lift my arm to get my sweater off. By 10pm I had extreme chills (shaking so hard my jaw locked from being so tense). Sharp shooting pain in my right leg started (still sore today). I then had extreme muscle aches, I could hardly walk to the bathroom. Finally at 12:15 am I took Tylenol.  Was able to sleep until 4 am and woke up with all the same symptoms... still extreme. Kidney pain started around 6am.  I took some more Tylenol and went back to sleep until 10am. Woke up feeling just as bad- couldn?t eat. Went back to sleep. Woke up at noon with a headache on top of the rest and had to take ibuprofen (I didn?t want to exceed the allowed amount of acetaminophen in 24 hrs). Kidney pain continued, muscle aches as well. Chills went away around 4pm.  Woke up today feeling pretty good except the headache and kidney pain. Headache subsided around noon. Noticed a giant, raised, hot spot about an inch below vaccine sore tonight... assuming it?s ?Covid arm? . Super strange! Thankful for the vaccine, but dang- I?ve never had any kind of reaction from any vaccine, ever. I get my flu shot yearly.
Patient given ZOSTAVAX at pharmacy on 4-27-15. Also, patient was given ZOSTAVAX at doctor office on 7-21-10.
Tenivac expired on 12-Oct-2020 and the patient received the on 16-Oct-2020/no AE; Initial information was received on 19-Oct-2020 regarding an unsolicited valid non-serious case received from other health care professional via call center.  This case involved a 40-year-old male patient who was vaccinated with DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] which expired on 12-Oct-2020 and received a 0.5 mL dose once on 16-Oct-2020 (Expired product administered) (lot U6091AA) via an intramuscular route at left deltoid for prophylactic vaccination.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  At the time of report, no adverse event 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.
FELT PAIN IN ALL OF JOINTS; NAUSEA TO THE POINT THAT COULD NOT EAT DINNER; SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included back injury, back surgery, previous car accident, and rare case of chicken pox in mouth, and concurrent conditions included herniated disks, nerve damage, and low cholesterol level, and other pre-existing medical conditions included medical anomaly, high pain threshold. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAY-2021, the subject experienced felt pain in all of joints. On MAY-2021, the subject experienced nausea to the point that could not eat dinner. On MAY-2021, the subject experienced soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea to the point that could not eat dinner, felt pain in all of joints and soreness at injection site was not reported. This report was non-serious.
Lose lot of blood; Vein broken; Flu like symptoms; Neck is like a balloon; Pressure in the heart; Pain in the back; Severe headache; Fatigue; Felt like being choked; Side effects after 20 days; Neck swollen; Neck hard; Pressure in the neck; Allergic reaction; A spontaneous report was received from a consumer concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced side effects after 20 days, neck swollen, neck hard, accident that caused broken vein and loss of lot of blood, headache, pressure in the neck, rigidness in the neck, felt like being choked, allergic reaction, flu like symptoms, neck is like a balloon, pressure in the heart, pain in the back and fatigue.  The patient's medical history was not provided. Concomitant medications were not reported. On 10 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 003M20A) for prophylaxis of COVID-19 infection.  Patient received the vaccine on 10 Feb 2021 and reports that the doctor said not to take the second dose as they have had an allergic reaction. After 20 days reports adverse side effects. Reports neck was swollen and hard. Had severe headache and pressure in the neck. Felt the feeling of rigidness in the neck like she was being choked. Later the caller got into an accident and was in the urgent care for 5 days. The caller is unsure if this is related to the vaccine and reports a broken vein and loss of lot of blood due to the accident. Caller felt flu like symptoms after visiting the urgent care and said neck was swelling like a balloon. Felt pressure in the heart, pain in the back and fatigue. Treatment for the events as reported by the caller were Advil and 2 or 3 Claritin but says has stopped Claritin cause was feeling worse. No Lab tests mentioned but says she is scheduled to take a COVID-19 test. Action taken with mRNA-1273 in response to the events was withdrawn as per her HCP. The events, had an accident that caused loss of blood and broken vein and felt like being choked, was considered as medically significant. The outcome of the events, side effects after 20 days, neck swollen, neck hard, accident that caused broken vein and loss of lot of blood, headache, pressure in the neck, rigidness in the neck, felt like being choked, allergic reaction, flu like symptoms, neck is like a balloon, pressure in the heart, pain in the back and fatigue, was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
3 to 5 minutes after vaccine was given (only the MMR was given) patient started to experience the following symptoms:  1) sneezing 2) runny nose clear 3) rubbing throat and saying "My throat feels weird.  My throat itches.  My throat hurts.  4) Coughing 5) Threw up/spit mucousy saliva. 6) Became VERY tired/worn out.  Felt like he had to lay down and felt sick overall. 7) Started to drool and said he had to let that yucky spit come out--it hurt to swallow.  8) Tried drinking water but could not.  Said it hurt/felt weird to swallow.  Water just came out when he tried. 9) A few red bumps on his cheek/around his lips became visual.  Then saw Dr.  His lungs were fine--no wheezing.  Doc said give Benadryl about 1 tsp.  About 15 more minutes went by and we were in the car.  Patient said his throat still felt funny and he threw saliva/mucus up again.  So I pulled over and saw his rash (red dots) were WAY worse--all over his cheeks, around his lips, spread to nose, chin, neck and upper shoulder area.  Gave him Benadryl 1 tsp.  He fell asleep but as he was said he felt a little better but did not want that shot again.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old male patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 26Jul2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 22Oct2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "type 1 diabetes" (unspecified if ongoing). Concomitant medication(s) included: FIASP. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course information: Patient received the vaccine and other medication in 2 weeks brand.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Ringing in the ears 3 days after first vaccine. Have had for over a month now. Sound is coming from inside the head, changes ears and pitch quite frequently.
Did not connect adverse event to the vaccination until roughly three days after it was recognized. Had first dose of Pfizer COVID-19 on Friday, January 29, 2021. On the following Sunday or Monday (2 or 3 days post vaccination), I noticed ringing in my ears. I have always had perfect hearing, no issues whatsoever. I knew nothing about tinnitus, so just figured it would go away. Days later, it hadn't gone away so did some research and wondered if it could be associated with the vaccine. Searched the web, but found nothing. Considered calling a hearing specialist (long story so will keep it short), but all info found said there was little that could be done, so did not make the call.  Since couldn't find relation to vaccine, received second dose on February 19, 2021 without any other issues. Tinnitus continues as originally noticed. Finally yesterday, I related the Covid vaccine to tinnitus after reading an article on J&J's vaccine candidate that stated tinnitus had been seen as an adverse reaction in the clinical trials.
Early miscarriage; This is a spontaneous report from a contactable other health care professional (Patient). A 30-year-old female patient (pregnant, last menstrual date 19Jan2021, Delivery date: 26Oct2021, Gestational period 4 weeks) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9269), via an unspecified route of administration on right arm on 19Feb2021 at 15:15 at the age of 30 years old at a single dose for COVID-19 immunisation at hospital. The patient's medical history included rheumatoid arthritis. There were no known allergies. Concomitant medications included prenatal vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient experienced early miscarriage on 01Mar2021. No treatment was received in response to the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient was recovering from the event.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Pending the limited information on clinical course, the company does not attribute the event early miscarriage to BNT162B2. The detailed document of pregnancy, relevant risk factors, status of rheumatoid arthritis are missing for a medically meaningful assessment.   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 RAs, Ethics Committees, and Investigators, as appropriate.