chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body aches (muscles and joints); Body aches (muscles and joints); tiredness; weakness; left arm very sore; left earache; back and neck pain; back and neck pain; Fever 102; Chills; Body aches (muscles and joints); This is a spontaneous report from a contactable consumer (patient herself).  This 45-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL33029), via an unknown route, on 16Jan2021 (at 09:45) at single dose administered on the left arm for COVID-19 immunisation, administered at hospital. Relevant medical history included high blood pressure, asthma and COVID-19 (prior to vaccination). The patient was receiving concomitant medications (unspecified). On 17Jan2021 (at 08:00 AM), the patient developed fever 102, chills, body aches (muscles and joints), tiredness, weakness, left arm very sore, left earache, back and neck pain. It was unknown if the patient received treatments for the events. The patient was recovering from the events.
RN administered 0.5mL dose of the COVID-19 vaccine instead of 0.3mL. No adverse reactions were documented.
vaginal itching; intense rectal itching; redness at the injection site; tenderness at the injection site; warmth at the injection site; woke her up in the middle of the night; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 75BS5) for prophylaxis.   Concurrent medical conditions included hemorrhoids (Pre-existing hemorrhoid issues). Concomitant products included INFLUENZA VACCINE, COVID-19 VACCINE (COVID VACCINE) and estradiol (Estrace).   On 22-SEP-2023, the patient received Arexvy. In SEP-2023, an unknown time after receiving Arexvy, the patient experienced sleep disturbance (Verbatim: woke her up in the middle of the night). On 22-SEP-2023, the patient experienced injection site erythema (Verbatim: redness at the injection site), injection site tenderness (Verbatim: tenderness at the injection site) and injection site warmth (Verbatim: warmth at the injection site). On 23-SEP-2023, the patient experienced vaginal itching (Verbatim: vaginal itching) and anal pruritus (Verbatim: intense rectal itching).  The patient was treated with antihemorrhoidals nos (Hemorrhoid Cream). On 22-SEP-2023, the outcome of the injection site erythema, injection site tenderness and injection site warmth were resolved. The outcome of the vaginal itching and anal pruritus were resolving and the outcome of the sleep disturbance was not reported.   It was unknown if the reporter considered the injection site erythema, injection site tenderness, injection site warmth, vaginal itching, anal pruritus and sleep disturbance to be related to Arexvy.     It was unknown if the company considered the injection site erythema, injection site tenderness, injection site warmth, vaginal itching, anal pruritus and sleep disturbance to be related to Arexvy.   Additional Information: GSK Receipt Date: 28-SEP-2023 The patient's current condition was reported as eating a lot of berries lately. It was reported that the patient experienced redness, tenderness, and warmth at the injection site. These issues resolved. The next day on after receiving vaccine she experienced intense rectal itching and vaginal itching. The itching was so intense that it woke her up in the middle of the night. She used a hemorrhoid cream (sounded like Rexicure). She reported that she still had left with this itching all these days later. The itching was not as bad as it was initially, but it had not resolved. The reporter did not consent to follow up. The reporter provided limited information. She refused to provider her street address. The reporter did not get a chance to ask for her date of birth or ask other questions as she ended the call abruptly. This case is linked with US2023133803, same reporter.; Sender's Comments:  US-GSK-US2023133803:Same reporter, different patient
hard to walk; hard to do anything; allergic reaction; muscle pain / muscle pain still ongoing, still incredibly severe, if not worse; joint pain/ joint pain still ongoing incredibly severe, if not worse; threw up a little bit; Fever; Chills; exhaustion/ feels as if she had aged to a 95 years old woman; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (hard to walk), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (hard to do anything), ALLERGY TO VACCINE (allergic reaction), MYALGIA (muscle pain / muscle pain still ongoing, still incredibly severe, if not worse) and ARTHRALGIA (joint pain/ joint pain still ongoing incredibly severe, if not worse) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Sep-2021, the patient experienced MYALGIA (muscle pain / muscle pain still ongoing, still incredibly severe, if not worse), ARTHRALGIA (joint pain/ joint pain still ongoing incredibly severe, if not worse), VOMITING (threw up a little bit), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (exhaustion/ feels as if she had aged to a 95 years old woman). On an unknown date, the patient experienced GAIT DISTURBANCE (hard to walk), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (hard to do anything) and ALLERGY TO VACCINE (allergic reaction). On 25-Sep-2021, VOMITING (threw up a little bit), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (exhaustion/ feels as if she had aged to a 95 years old woman) had resolved. At the time of the report, GAIT DISTURBANCE (hard to walk), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (hard to do anything), MYALGIA (muscle pain / muscle pain still ongoing, still incredibly severe, if not worse) and ARTHRALGIA (joint pain/ joint pain still ongoing incredibly severe, if not worse) had not resolved and ALLERGY TO VACCINE (allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information was unknown.
Incredibly tired; Had chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Incredibly tired) and CHILLS (Had chills) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M204B) for COVID-19 vaccination.     Concurrent medical conditions included Obesity.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced FATIGUE (Incredibly tired) and CHILLS (Had chills). On 27-Feb-2021, FATIGUE (Incredibly tired) and CHILLS (Had chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 with the events was considered as not applicable  concomitant medicines was not reported by reporter   Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Fallow up received on 30-apr-21 contains no new information
Large red, swollen, feverish circle at injection site.  Diameter of about 1 1/2 inches.
Urticaria on body - no difficulty breathing - no swelling. Pt complained of itching.
a lot of sleeping; This is a spontaneous report received from a contactable reporter(s) (Consumer) from medical information team. A 79-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Tromethamine, reaction(s): "gets very ill". Vaccination history included: Bnt162b2 (DOSE 1, lot# FJ8762.), for COVID-19 Immunization, reaction(s): "she had seizure". The following information was reported: HYPERSOMNIA (non-serious), outcome "unknown", described as "a lot of sleeping". Additional information: The reporter stated that s she was going for her pre-registration last month for the vaccination, she saw tromethamine listed as part of the bivalent vaccine. The patient got very ill if she received tromethamine orally or through IV. The reporter wanted to know if there was a way to trace if the Pfizer vaccine they had contained tromethamine as they were able to "tolerate it". The information will help her decide if they should get the bivalent vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.   Sender's Comments: Linked Report(s) : PFIZER INC-202201402857 same patient/drug, different dose/event;
I got very dizzy 4 days after the vaccine (on 3/10 in the evening).  I continued to feel lightheaded with occasional dizzy spells up until Friday 3/19.
Right arm and shoulder were painful and felt "heavy" for 2 days.  Around a month after the booster injection (~Nov 8), my right shoulder started feeling  sore, and lifting my arm completely was difficult. Symptom has continued unabated.  Around Dec 28, I noticed bulge on right arm near injection site
high fever 104 for 24hr p/vax screaming, hallucinations, frothing at mouth, arching of back;inconsolable;this lasted 24hr for the next 3mo;hyperactivity-clumsy, dramatic reduction in verbalization;ear infect;dx as verbally apraxic;
Father states pt has redness and swelling on the left arm one week after vaccination.  Next day, swelling gone and redness decreased.  Cool compress to affected site.
Patient was given an H1N1 vaccine at her request last week and within 24 hours, she developed a blistering rash that was bilateral on her chest and on her upper extremities. She went to see Dr., her primary physician, who gave her some oral corticosteroid to take and she is better by Monday (today), but the rash still is there. She has a history of having had an adverse reaction to a number of medications (penicillin, sulfa, ZITHROMAX, ASMANEX) in the past. She is on a number of medications today that have been chronic for her, but they are unchanged. This is probably a result of the H1N1 vaccine. Nothing else has changed. Pictures are taken to document that there are one or two clear blisters on an erythematous base that are still visible. Much of the rest of it is resolving. It is not terribly pruritic and it does not hurt. It is not painful. She was not given any other medications and then she will be seen for a scheduled follow-up visit.
Information has been received from a physician concerning a 9 year old female with sulfonamide allergy, and a history of recurrent sinusitis and sinobronchitis and lower respiratory tract infections, who on 10-JUL-2006 was vaccinated intramuscularly in the left deltoid with a 0.5 mL dose of Pneumovax 23 (lot # 651319-1007P). There was no concomitant medication. On 12-JUL-2006 the mother reported that the child had a fever of 101.5 and swelling at the site of injection. The patient was treated with ibuprofen. On 12-JUL-2006 it was also reported that the patient developed large sterile abscess at deltoid administration site. It was also reported that patient developed cellulitis (6" diameter). The patient was treated with cephalexin (KEFLEX) and prednisone. On 17-JUL-2006 the patient was "much better." On 26-JUL-2006 the patient had persistent induration at the site of injection. On 26-JUL-2006 it was also reported that there was a persistent induration at the site of injection 5 x 6 inches. The abscess was drained (5 cc, 15 cc, and 15 cc) pus on 3 different occasions. It was reported that there was no gas in the tissue and abscess was packed. The culture of the pus did not grow any bacteria. On 22-AUG-2006 the physician stated that the patient's mother said "the abscess gradually healed and today the patient is fine." The patient was going to follow up with the family practitioner in September 2006. The patient recovered. Additional information is not expected.
could not recall location of rooms in house or route to Emergency room; profuse crackles in my head (no pain); tremendous confusion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunisation series completed, unknown manufacturer.), for COVID-19 immunisation. The following information was reported: MEMORY IMPAIRMENT (non-serious) with onset Oct2023, outcome "unknown", described as "could not recall location of rooms in house or route to Emergency room"; HEAD DISCOMFORT (non-serious) with onset Oct2023, outcome "unknown", described as "profuse crackles in my head (no pain)"; CONFUSIONAL STATE (non-serious) with onset Oct2023, outcome "unknown", described as "tremendous confusion". The events "could not recall location of rooms in house or route to emergency room", "profuse crackles in my head (no pain)" and "tremendous confusion" required emergency room visit.  Additional information: Patient ended up in the Emergency room on 14Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300171527 Different patient, same product (Dose 4), different events;
Information has been received from a nurse concerning a 60 year old male with gout, thalamic syndrome, gastroesophageal reflux disease, benign prostatic hyperplasia, ppd skin test positive and a history of bladder cancer who on 08-OCT-1998 was vaccinated IM with his first dose of PNEUMOVAX vaccine (lot number not reported). On 03-OCT-2008, he was vaccinated IM with the second dose of PNEUMOVAX vaccine (lot number 662100/0742X) into the left arm. Concomitant therapy included FLUZONE which was vaccinated IM into the right arm on the same day, metoprolol, allopurinol, omeprazole, LIPITOR, amlodipine, ascorbic acid/vitamin B complex, vitamins (unspecified), aspirin, testosterone and VIAGRA. On 06-OCT-2008 the patient experienced redness and swelling of the whole arm from the shoulder to the wrist. patient was seen on 07-OCT-2008 and his symptoms receded drastically. He was diagnosed with cellulitis and was treated with KEFLEX. This one of several reports received from the same source. Additional information has been requested.
This spontaneous report was received from a non-healthcare worker refers to a 17 year old patient, gender unspecified. Approximately on an unknown date in July 2006 (reported as 7 years ago), the patient was vaccinated with dose 1, GARDASIL (lot#, expiration date and route not reported). On 26-JUL-2013 the patient was vaccinated dose 2, 0.5 milliliter (ml) with GARDASIL (lot# and expiration date not reported), intramuscularly. No adverse effects reported. Additional information has been requested.
Patient reports that her arm turned red around the injection site and "looked like a sunburn." She reports that it was very painful and took around 5 days to resolve.
I had shingles after taking the vaccines; I had shingles for 5 weeks; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 12-June-2022 Reporter's comment: This case was reported by a consumer via interactive digital media. The patient had shingles for 5 weeks After taking the vaccines. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles not provided.
pt exp diarrhea & irritable bowel p/ each vax 3/18/98, 2nd dose;
Heart Palpitations for approx. 36 hours.; Fatigue; Irritability; Some light nausea; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8733) via an unspecified route of administration in the left arm on 31Mar2021 at 10:00 and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration on 21Apr2021 both (at the age of 50-year-old) as a single dose for COVID-19immunisation. Medical history included allergy to shellfish, cats, dogs, dust, pollen, trees and grasses. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC), EMERITA WOMEN'S BALANCE, etc for unknown indication on an unknown date and unknown if ongoing. The patient previously took iodine (MANUFACTURER UNKNOWN) for unknown indication on unknown date and experienced drug allergy. On 31Mar2021 at 10:15, beginning 20 minutes post first injection, the patient experienced heart palpitations for approximately 36 hours, other symptoms like fatigue, irritability, some light nausea, but most notably were the heart palpitations with no associated rash, hives or shortness of breath. The patient consulted primary care physician to confirm the safety of receiving the second dose of the vaccination and received the second dose. So far the patient had no long-lasting heart palpitations. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event heart palpitations, fatigue, irritability and nausea was recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
I woke up around 3am and was extremely disoriented and feverish. I ached all over. I could not straighten my right leg to get off the bed. It felt like electricity surging thru it. Everytime i tried to straighten right leg, it felt as though something inside my inner right thigh would snap into. It lasted about 20 minutes until i was finally able to stand. I slept for 48 hours straight without food, beverage, medications. Missed 2 days of work. After the 48 hr mark, the brain fog and muscle aches slowly started easing off. I was nearly back to normal on 3rd day
Initial information received on 25-Sep-2018 regarding an unsolicited valid serious case received from a pharmacist. This case involves one-day old female patient who accidentally received a 0.5 ml dose of FLUZONE QUADRIVALENT (batch number, expiry date, route and site of administration were not reported) which was ordered for her mother on an unspecified dose. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration. No known reported symptoms. 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. Documents held by sender: none.
After severe body aches on the friday after the shot, I thought everything was better. Then on Sunday morning, 72 hours after the shot I started to have severe stomach pains yet hadnt really eaten much of anything. Stomach pains became more severe after noon. Pain continued throughout the night, followed by chills and fever. Lower back was on fire. Then began vomiting at 2 a.m. Have had a flu shot but this was unlike anything I had ever experienced before
Lightheadedness, dizziness, fast heartbeat, nervousness, shaking, confusion
Got injection Friday at 12 noon, Saturday morning woke up with fever 101.2, diarrhea x 12 hours, headache x 3 days (frontal) on Sunday developed a baseball size red, hard and warm to touch raised area around injection site.  This lasted for 3 days
Full body urticaria, symmetric  mostly extremities, 48 hours after injection ( 2 previous doses were Pfizer, this was the 3rd but first Moderna, no previous reactions to Pfizer) Rash continues for 4 days, Patient self treated with Zyrtec and Benadryl. This is limited to skin and highly pruritic and clearly visibly resembling urticaria.
Mom called on Wed., 9-26-07 in the am and stated that child was very nauseated, fatigued and had a low grade fever. Advised mom to give Tylenol and take child to Dr if no better by Fri - 9-28-07. Mom verbalized understanding. 9-28-07 TC to mom for follow up - no answer. 10-1-07 TC to mom - no answer.
7/25--7/27 76y.o. male who was admitted to the hospital with shortness of breath and COVID-19 pneumonia.  Medical problems treated during this admission are detailed below:  Acute hypoxic respiratory failure due to COVID-19 pneumonia - Tested positive on 7/22, with onset of symptoms 7/20. Vaccinated but not boosted. History of CLL. Mild O2 requirement to 2-3L during admission with evidence of pneumonia seen on CTA pulmonary. Infectious disease consulted during admission and recommended remdesivir, which patient declined. He was able to be weaned off O2 and home O2 evaluation did not reveal need for home oxygen.
This morning (my vaccine was yesterday), I woke up feeling groggy. I attended a class in from 8:00am-9:00am, then went home since I felt bad. I took my temperature around 10:00am and it was 98, then 45 minutes later it was 99.8. I took some Ibuprofen and my fever reduced after a few hours, now I'm just left with a sore arm and a headache. I more or less feel fine now as of 3:00pm but I'm just very tired since I was feverish for a few hours straight. (I didn't think these were adverse reactions but I was recommended to report the symptoms)
The morning following vaccination, I noticed intense ringing in the ears.  Since then, the ringing has been persistent and constant. The sound changes from that of secadas to a high-pitched ringing
17 year old male received a booster dose of Moderna instead of the approved Pfizer vaccine.  First and second doses were Pfizer.
She immediately started feeling dizzy and faint, threw up several times, and felt like her heart was racing.  911 was called and paramedics ultimately determined that she was severely dehydrated and hadn't eaten all day.