chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My stomach started having problems such that I was having diarrhea 6 times in the morning. Then it started after lunch and dinner. I went to the doctor, and they figured it could be lactose intolerance and it could be because my daughter is very lactose. I will follow up with doctor next week.
severe joint pain in left hip; Upper abdominal bloating; rapid weight gain; severe joint pain in left hip, knee and ankle; severe joint pain in left hip, knee, and ankle; severe joint pain in left hip, knee, and ankle; This is a spontaneous report from a non-contactable consumer, the patient. A 62-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Mar2021(at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included arthritis, sulfonamide allergy, sulfites allergy and covid-19. The patient did not receive concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Feb2021(at the age of 62-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 29March2021 the patient experienced upper abdominal bloating, rapid weight gain and severe joint pain in left hip, knee, and ankle. Therapeutic measures were not taken as a result of the event(s). The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 19Nov2020, the patient underwent lab test which included nasal swab and the result was negative. The clinical outcome of the events upper abdominal bloating, rapid weight gain and severe joint pain in left hip, knee, and ankle were not recovered/not resolved/ongoing.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt rcvd vax; uncontrolable crying for 45mn; started 4 hrs after vax; t 110.3;
Injection site pain Muscle pain in arm on injected arm  Treated with OTC acetaminophen (1000mg po x1 dose)
got the shot, then he got the shingles/suspected vaccination failure; got the shingles; This case was reported by a consumer and described the occurrence of Suspected vaccination failure in a male 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 and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported.  The reporter was patient's wife. The patient got Shingles after Shingles shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory confirmation, time to onset of shingles were unknown at the time of reporting.
discomfort and itching; Diffused purpuric rash on both legs; Erythema; Discomfort; This is a spontaneous report from a non-contactable healthcare professional. A 65-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via intramuscular route of administration in the right arm on 05Apr2021 at 12:30 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication was not reported. The patient underwent blood test to monitor platelet count and the result was normal limits. On an unknown date in Apr2021, the patient experienced diffused purpuric rash on both legs, erythema, discomfort and itching. The clinical outcome of the event purpuric rash, erythema, discomfort and itching was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected
Pt had a monkeypox on 8/19/2022, pt came in for second dose today and there was notable bruising, redness, and a harden area measuring 22 mm. According to the CDC and HD it is recommended that if a pt still has a wheel  and/or redness and bruising to give second dose in other arm, thus pt received his second dose of monkeypox in the the RLFA.
Had a HA evening and next day with mild chills but this was all. On 12/9/21, I awoke and when I went to get up, I had vertigo, I was spinning uncontrollably and nearly fell out of bed. I had to lie down again. Since then, vertigo has continued, worse when i'm laying down and turn side to side or go to sit. When able, I checked my blood pressure and HR, this was normal 118-120/60-70. I have not started any new medications/treatments, no dietary changes, no lifestyle changes, nor have I been ill. I have also not had any other vaccines, nor any symptoms of COVID, flu, cold, or otherwise. I am a nurse practitioner, hence I performed Epley and Brandt-Daroff maneuvers which have helped considerably, and while improving, the symptoms have persisted which prompted me to submit this. I have an upcoming appt with my PCP on 12/30/21, first available, and have been unable to obtain COVID testing. I considered the possibility of having also contracted COVID as I attended my sons tournament in PRIVACY Dec 17-19. I wore a mask the entire time and stayed in my room other than going to/from the tournament. I have empirically quarantined at home (just in case), however I've been unsuccessful at obtaining a COVID test either at a site or at home.
DIARRHEA; MUCOUS STOOLS; STOMACH TURNING; STOMACH GAS; STOMACH ACHE; FLU LIKE SYMPTOMS EXCEPT FEVER; This spontaneous report received from a patient concerned a 68 year old female. The patient's weight was 169 pounds, and height was 172 centimeters. The patient's concurrent conditions included lactose intolerant, sulfonamide allergy, abstains from alcohol, and non smoker, and other pre-existing medical conditions included no pertinent medical history. no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced flu like symptoms except fever. On 17-APR-2021, the subject experienced stomach gas. On 17-APR-2021, the subject experienced stomach ache. On 17-APR-2021, the subject experienced stomach turning. On 17-APR-2021 12:00, the subject experienced diarrhea. On 17-APR-2021 12:00, the subject experienced mucous stools. On 24-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative, and Urine analysis (NR: not provided) Negative. Treatment medications (dates unspecified) included: omeprazole. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhea, flu like symptoms except fever, stomach ache, stomach gas, and mucous stools, and the outcome of stomach turning was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
The morning after the vaccine everything was normal. She ate breakfast and got ready for school. She suddenly needed medicine her stomach was hurting bad. I was going to give her some chewable tablets of Pepto-Bismol she turned her back to me and before I could give her the medicine she fainted. She was unresponsive for 30 seconds; she was so pale. Her blood pressure and heartrate dropped low. I checked her vitals and fever, and she didn't have a fever, about 1-2 hour she had a low fever 99.7. We went and saw the doctor around noon whenever we got to the doctor her fever was 101.6 and by the time, we left her fever was 102.4. They tested her for Strep, Flu, and did some bloodwork. After the fever went away, she was perfectly fine like nothing ever happened. She just ended up with some bruises from the fall. She has a twin sister who received the same vaccine at the same time and had no issues.
This spontaneous report as received from a Registered Nurse refers to patients of unknown age and gender. It was reported that on unknown dates, doses of ROTATEQ (lot number L033543, expiration date 30-MAY-2017) which were exposed to temperatures outside of the recommended range, were administered orally to the patients. No adverse experience had been reported. Temperature and time frame were: 1.2 degrees Celsius (C) for 22 minutes; 1.3C for 1 hour and 57 minutes; 1.4C for 2 hours and 15 minutes; 0.9C for 36 minutes; 1.3C for 21 minutes (duration: 331min). There were no previous temperature excursions. This was reported because of a data logger. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA009624: US-009507513-1611USA009626: US-009507513-1611USA009623: US-009507513-1611USA009625.
This was second injection in series. Within 24 hours Left arm whole arm swelled, red rash feverish skin. Over next few days became nauseated, diarrhea body & joint aches & extreme fatigue. Symptoms continued all month to present day. 8-7-19, Symptoms slowly improving
Neuropathy; neuropathy in his left foot; first shot: both of his hips died (polymyalgia rheumatica or osteonecrosis); first shot: both of his hips died (polymyalgia rheumatica or osteonecrosis); first shot: pain in both hips; numerous nerve and bone issues; numerous nerve and bone issues; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: ER8734) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history included: "Had three spinal surgeries" (not ongoing), notes: Had three spinal surgeries on unknown dates; "brain surgery", start date: 26Jul2012 (not ongoing). There were no concomitant medications. The following information was reported: BONE DISORDER (non-serious), NERVOUS SYSTEM DISORDER (non-serious) all with onset 2021, outcome "not recovered" and all described as "numerous nerve and bone issues"; NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "Neuropathy; neuropathy in his left foot"; POLYMYALGIA RHEUMATICA (medically significant), OSTEONECROSIS (medically significant), outcome "recovered with sequelae" and all described as "first shot: both of his hips died (polymyalgia rheumatica or osteonecrosis)"; ARTHRALGIA (medically significant), outcome "not recovered", described as "first shot: pain in both hips". The events "first shot: both of his hips died (polymyalgia rheumatica or osteonecrosis)", "first shot: pain in both hips" and "numerous nerve and bone issues" required physician office visit. Therapeutic measures were taken as a result of polymyalgia rheumatica, osteonecrosis, arthralgia.  Clinical course: Report was not related to study. No investigations and no other products. As he was doing his research he eventually a year after or so both hips were dead and believed it was called polymyalgia rheumatica or osteonecrosis. Had no idea if that was related. Neuropathy was the worst one. Had left hip replaced 29Dec2022. Pain in both hips was after his first shot. Experienced for a while before he saw a doctor. Even the one that was replaced was still actively bugging him and was ongoing. Right was worsened left had some relief after surgery but for some reason has still been bothering him. Treatment was Vicodin and Baclofen, muscle relaxer. Both of his hips died: First time he saw the doctor in regards to that was last summer (2022) maybe around June, July or August. Recovered with lasting effects still in a lot of left hip pain, one he had replaced and right hip pain and needed that one replaced. Was worried that the necrosis might have traveled. After surgery care was physical therapy on the left hip.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300207982 same patient, different dose/event;
Client's mom called at home approximately 10:00pm & said pt's leg has red welts, mom treated him with one dose of cold & allergy.
1wk post vax developed general malaise, fever, nausea, dizziness, sore throat, parotitis, rash, arthralgia & arthritic, tingling in hands;
Caused an eczema flareup with itchy rashes in various areas of my body, as well as "Covid Arm", the itchy rash at the injection site for four days.  Currently, the injection site is still itchy from time to time, though all rashes have subsided.
product storage error; no adverse event; assistants reported excursion on 14Feb2023; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (assistants reported excursion on 14Feb2023), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1903B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2023, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (assistants reported excursion on 14Feb2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (assistants reported excursion on 14Feb2023), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (assistants reported excursion on 14Feb2023) and PRODUCT STORAGE ERROR (product storage error).    No concomitant medication were reported.  It was reported that one of the medical assistants reported excursion on 14-Feb-2023. Maximum temperature was -1.8 C. At time of excursion vaccine was in freezer. Excursion duration was unknown, was for each day starting on 01-Feb-2023 and continued until 14-Feb-2023. Reporter said they were unable to access and print off the data logger. No treatment information was provided by the reporter.
Patient describing the following symptoms:  "runny nose, congestion, mild cough, eyes feel hot, checked the temperature but no fever."  Patient stating she is working with clinic and going to get a COVID 19 test today.
Tendonitis; This spontaneous case was reported by a consumer and describes the occurrence of TENDONITIS (Tendonitis) in a 33-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) solution for injection for Crohn's disease.    Previously administered products included for COVID-19 vaccination: Pfizer BioNTech COVID-19 vaccine (1st dose; RoA: Intramuscular) on 01-Jun-2020 and Pfizer BioNTech COVID-19 vaccine (2nd dose; RoA: Intramuscular) on 01-Jul-2020. Past adverse reactions to the above products included No adverse event with Pfizer BioNTech COVID-19 vaccine and Pfizer BioNTech COVID-19 vaccine.   On 23-Sep-2022, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 600 milligram every four weeks. On 10-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Oct-2022, the patient experienced TENDONITIS (Tendonitis). At the time of the report, TENDONITIS (Tendonitis) had not resolved.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       No medical history was reported. No concomitant medications were reported. The patient had joint pains, the physician treated as tendonitis. No treatment medications were reported.
Immediate weakness in right arm, flushing of face and chest, minor  shortness if breath
Pt recvd vax 7NOV91 9AM, returned to work noted numbness/tingling in hands by 10AM; noted inc paresthesia extending up arms, across chest accompanied by dyspnea & vertigo & nausea by noon; Pt was taken to ER; ER MD felt dehydrated a/immun;
8 days after first injection a rash appeared on injection site (upper arm)   The rash was red,  with hives, and it was warm to the touch. Rash was the size of a deck of cards.
On evening of 10-14-16, patient experienced a burning sensation in his thighs. It progressed to a partial paralysis of his legs. His torso from knees to shoulders were involved. He had severe pain and saw MDs three times now. He said they ruled out Guillain-Barre Syndrome but definitely thought it was due to the flu shot. Diagnosed with polymyalgia rheumatica.
Patient returned and was evaluated by Dr. on 1/21/16. Large (approx. 5"0), swollen, red reaction in right arm. Some antihistamines and localized care at present. Dr. recommends no future HPV or MCV4 shots (BENADRYL Cream and TYLENOL).
Severe arm pain (worse than the first vaccination), fatigue, bad headache, achy everywhere and nauseous.  Took acetametaphen at about 8:30 AM with food.  Some symptoms are easing  up slightly as of this writing, but arm pain is still fairly intense and headache and feeling completely exhausted are not letting up.
Patient was given undiluted Pfizer Ped Dose, resulting in higher concentration administered.
"1 week after receiving H1N1, Rt arm with muscle weakness, unable to lift, decrease ROM.
Patient called me (Pharmacist) to state that 24 hours after his shot he experienced convulsions, high temperatures and no ability to eat. He called 3 weeks after the shot, he did not go to the doctor. He said that he was better but still had headaches. I very much encouraged him to go to the doctor, I don't know if he will. He said as a kid he was allergic to eggs but was sensitive now. He never stated this on his consent.
3rd dose; significant hair loss; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2, Solution for injection) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE-1, Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE- 2, Unknown manufacturer), for Covid-19 immunization, reaction(s): "hair loss". The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "3rd dose"; ALOPECIA (non-serious), outcome "unknown", described as "significant hair loss". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101863625 same drug and patient, different event and drug dose
Several red papules (four on face and one on upper chest) one is a vesicle on a red macule the others are crusted x 1 day.
Patient presented to the ER with severe headache, nausea and pain at the injection site. Vital signs noted hypotension and sinus tachycardia. Labs notable for wbc 24.6. Further work up for wbc included a negative CT brain, MRI brain, lumbar puncture and CT abdomen and pelvis. He had redness at the site of injection which was treated for possible cellulitis.
Patient received the vaccine on 02/15/19 around 7:20 pm and started feeling chills and general malaise and strong back spasm, she also developed nausea/vomiting, headache and shakiness along with that. Patient stated it last for about 2 days and she was better by 02/18/2019.
on the evening of 04/13/21 patient began feeling bad - fever, headache, sinus congestion, respiratory issues, loss of taste and smell,  lots of congestion, body aches and pains - 'felt like a bad case of the flu'. Symptoms lasted approximately three weeks, went away with no medication
This case was considered medically important (OMIC). Info regarding Haemophilus B conjugate vaccine was received from an attorney regarding a male pt who experienced mercury poisoning and neurodevelopmental injuries. The pt received a dose on an unspecified date. It is alleged that as a result of cumulative exposure to mercury in the thimerosal-containing vaccine (s), the child developed "severe" neurodevelopmental injuries of mercury poisoning. No additional info was available at the time of this report.
she had a severe allergic reaction to it; with her airways blocked; This case was reported by a other health professional via call center representative and described the occurrence of allergic reaction in a female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2019-2020 season) (batch number T9N35, expiry date 30th June 2020) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   In November 2019, the patient received Fluarix Tetra 2019-2020 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, less than 2 years after receiving Fluarix Tetra 2019-2020 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced allergic reaction and airways obstruction. On an unknown date, the outcome of the allergic reaction and airways obstruction were recovered/resolved.   It was unknown if the reporter considered the allergic reaction and airways obstruction to be related to Fluarix Tetra 2019-2020 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not reported. The patient experienced severe allergic reaction and her airways was blocked. At the time of reporting, the patient was recovered from reactions. The reporter did not consent nor declined follow up. No further information was provided.
Fatigue, shaking chills, headache, nausea and repeated vomiting.  Vomiting last 2+ hours.
severe swelling of entire upper rt extremity w/induration & erythema; limited movement of arm noted & it was extremely painful to touch; no systemic react noted; lasted approx 72 hrs; had prev series w/DT only @ 2,4 & 6m
Starting at about 10 hrs last injection through 36hrs ran a low grade fever, chills, body aches, exhaustion. At around hour 36 I noticed my right armpit hurting and visibly swollen
The patient received a 3rd dose without having any qualifications. The client did not have any adverse symptoms or signs. The patient was observed for 15 minutes without any issues. The patient was notified of the additional dose. She stated she forgot she received 1st and 2nd dose already. The writer saw the state vaccine registration and only saw 1st dose prior to administrating the vaccine. When the writer added the dose to the vaccine registration, the writer noticed the 3rd dose.