chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe stomach pains; diarrhea; This is a spontaneous report from a contactable consumer (patient himself). A 59-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in arm right on 08Jun2021 15:30 (Batch/Lot Number: EW0180) (at the age of 59-year-old) as unknown, single dose for covid-19 immunisation. Medical history included asthma (the patient was diagnosed 10-15 years ago). It takes certain things to bring on asthma attacks, like a cat will do it. patient tries to avoid certain things. There were no concomitant medications. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No adverse event prior vaccinations. The patient stated that, he was wondering if anyone else reported side effects 2 and a half days after receiving the COVID shot. Patient reports that he got the shot on Tuesday afternoon (08Jun2021), the next two days was nothing, the patient was fine when he woke up on Friday morning (11Jun2021, 5:00) with severe stomach pains and he has had diarrhea for 4 days. Patient reports that, the diarrhea was starting to clear up a little bit, but still going to the bathroom and still had pretty severe stomach pains, in his lower stomach. The stomach pains were ongoing, they were not as often. They were still as strong, they were less, verified then as persisting. Patient reports that, he had gone to the bathroom like 17 times since like Friday, 11Jun2021. That was totally unusual, he was a day guy. Patient states that, it was clearing up and he was starting to return to regular stools. The patient went to work and was unsure how he got through the day. He tried to hide holding his belly, he has been in bed all weekend. The patient reports that, he got a physical a month ago and his annual physical was ok and a bunch of blood tests and they were fine. The patient states after physical he was signed up a bunch of tests to see if he had a risk for aneurysms. The patient reported that "sonograms and stuff" and that he did have a test down around my belly and such he had received 6 or 7 tests ultrasounds on different parts of the body looking for certain blockages and stuff but he had not received the results yet. He also shared that he didn't get the flu shot and declined the shingles shot at his last physcial, about a month and half ago. The patient confirms he received all tests occurred prior to receiving the COVID 19 vaccine. The outcome of the events severe stomach pains was not resolved and diarrhea was resolving.
pt recv vax & exp stinging;sx resolved w/o tx in 24 hr;
Maculopapular rash of hand left & lower legs. (? Neomycin preservative).
Facial swelling. Welts. From initial information received on 09/Apr/2003 from a public health department regarding an adverse event occurring in the USA, it was reported that a 14-month old male patient received Daptacel, lot number C0950AB, administered intra-muscularly on 25/Mar/2003 at 7:00 PM. The patient also received Varicella, lot number 0968M, manufactured by Merck, administered subcutaneously on the same date and time. One hour later the patient developed welts on his body and swelling over the face. He presented to the physician's office at 8:30 PM. Past medical history included otitis media. There was no history of allergies. It was not reported whether the patient received any treatment. The reporting facility attempted to contact the patient's family for an update on the patient's condition, but was unsuccessful. It is unknown whether the patient recovered. The reporting facility of this case is the same reporting facility as for case 2003-00820.
I had a blood test for a digestive problem and my platelet count had dropped to 85,000.  I was checked again on 01/30/14 and my platelet count had dropped to 4,000.
Large red spot on arm. Injection site became tender the day before the red spot appeared. Tender and warm to the touch, but not super painful so far.
This is a spontaneous report from a contactable consumer. A 65-year-old female patient received the first dose of PREVNAR 13 (batch number requested) via an unspecified route of administration in upper arm on 11Nov2016 at a single dose for immunization. The patient's medical history was not reported. There were no concomitant medications. On 11Nov2016, the patient was supposed to be given pneumococcal 23 but was given with pneumococcal 13-valent conjugated vaccine. The patient stated that last 11Nov2016, when she went to her PCP, they gave her a pneumonia vaccine and then they said that this November (2017), when she went for her physical, that she would receive the other pneumonia vaccine. It was reported that what happened was that they gave her the same shot twice; they gave her the pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) both in 2016 and this past year Nov2017. The patient stated when probed for the dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) administered in Nov2016 that she did not know and that it was whatever they gave her. Then on the same day of 11Nov2016, the patient had headache, kind of chills and felt kind of cold and stuff and was tired. The patient received no treatment for the events and had no lab works done. The patient recovered from all of the events within 24 hours (12Nov2016). The patient queried if the result of immunization diminished because she received the vaccine twice. The following information on the batch number has been requested.
Pediatric patients be given Havrix Adult Dose; Pediatric patients be given Havrix Adult Dose; This case was reported by a other health professional via sales rep and described the occurrence of overdose in a 12-year-old female patient who received HAV (Havrix adult) (batch number EK59B, expiry date 20th November 2020) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   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 age at vaccination was not reported. The reporter stated that, the Pediatric patient received Havrix adult dose, which led to  overdose and adult product administered to child. The reporter consented to follow up. This was 1 of 4 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR159012:Same reporter US-GLAXOSMITHKLINE-US2021AMR159011:Same reporter US-GLAXOSMITHKLINE-US2021AMR159013:Same reporter
symptoms include persistent cough, stuffed and runny nose and  joint inflammation and swelling; symptoms include persistent cough, stuffed and runny nose and  joint inflammation and swelling; symptoms include persistent cough, stuffed and runny nose and  joint inflammation and swelling; symptoms include persistent cough, stuffed and runny nose and  joint inflammation and swelling; symptoms include persistent cough, stuffed and runny nose and  joint inflammation and swelling; staph infection; contracted COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization series complete, Pfizer vaccine and booster), for COVID-19 immunization.  The following information was reported: SUSPECTED COVID-19 (hospitalization) with onset 31May2022, outcome "unknown", described as "contracted COVID"; STAPHYLOCOCCAL INFECTION (hospitalization) with onset 31May2022, outcome "unknown", described as "staph infection"; COUGH (hospitalization), RHINORRHOEA (hospitalization), NASAL CONGESTION (hospitalization), ARTHRITIS (hospitalization), SWELLING (hospitalization) all with onset 31May2022, outcome "unknown" and all described as "symptoms include persistent cough, stuffed and runny nose and joint inflammation and swelling". Clinical course includes Reporter writing to report that his husband, (Name withheld), contracted COVID after receiving the Pfizer vaccine and booster. She does not have the dates available at this moment of the vaccinations. He was diagnosed 31May. Symptoms include persistent cough, stuffed and runny nose and joint inflammation and swelling. She did not report within 24 hours as an oversight due to his hospitalization at the same time with a staph infection that distracted me. She confirmed the date of awareness as 31May.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I receive flu shot to my left arm. The area where the shot was given to turned red, swollen and felt hot to touch for about 4 days.
On 7/25/2022, the day of vaccine, she had her last 2 doses of amoxicillin for an ear infection. Started running a fever of 102.9 the next day at day care (7/26/2022). Started TYLENOL that night. The next day (07/27/2022) she woke up with a fever of 104.5. As we called her doctor, we were giving her TYLENOL and giving her cool baths. We were given an emergency visit at our doctor's office first thing the next morning. They tested her for COVID-19, a UTI and an ear infection, they were all negative. She vomited at 9:30AM and 1PM that day. Dr. said it was likely a vaccination reaction and it was decided that she'd be alternately given MOTRIN then TYLENOL. Eventually her fevers were averaging at 100. Has been slowly subsiding since then.
Pfizer-BioNTech COVID-19 Vaccine EUA: Experienced SORE on roof of mouth (left side), painful and lasted for one week. Also upper GUMS on both sides of mouth were painful and lasted for 7 to 10 days.  No treatment administered.    Problems have resolved themselves.
Developed Acute Labyrinthitis of the Right Inner Ear, lost hearing in the right year, vertigo, dizziness.
A spontaneous report was received from a consumer concerning himself a 67-year-old, male patient who developed injection site swelling and swelling progress down whole arm/ peripheral swelling. The patient's medical history was not provided.  Concomitant product use was unknown by the reporter. The patient received their first of two planned doses of mRNA-1273 (Batch number: 021M20A) on 15-FEB-2021. On 16-MAR-2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 001321A) for prophylaxis of COVID-19 infection. The patient experienced injection site swelling, swelling progress down to my whole arm like it has blood clot. Treatment for the events included Benadryl. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the event(s) is not applicable. The outcomes of events, Injection site swelling and peripheral swelling were unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
pt presented with cva, and asymptomatic covid. Pt treated in the icu with biarbonate infusion and dialysis. pt discharged home when stable.
Patient came to hospital 6 days after vaccination on 4/19/2021.  He was diagnosed with cryptogenic stroke.  Patient was on anticoagulation at the time of his stroke.  Thought that patient was non-compliant with his medications but patient and family insist he took his Xarelto consistently.
Body ache; fever (T- 99.4F at 4:00PM; 100.8F at 5:00PM); Headache; Chills; Nausea; Sore arm (injection site); This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Body ache), PYREXIA (fever (T- 99.4F at 4:00PM; 100.8F at 5:00PM)), HEADACHE (Headache), CHILLS (Chills) and NAUSEA (Nausea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced PAIN (Body ache), PYREXIA (fever (T- 99.4F at 4:00PM; 100.8F at 5:00PM)), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and VACCINATION SITE PAIN (Sore arm (injection site)). On 31-Mar-2021, PAIN (Body ache), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and VACCINATION SITE PAIN (Sore arm (injection site)) had resolved. At the time of the report, PYREXIA (fever (T- 99.4F at 4:00PM; 100.8F at 5:00PM)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.4 (High) Temperature taken at 4:00 PM - 99.4F and 100.8 (High) Temperature taken at 5:00 PM - 100.8 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-064232 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-064232:Case created for events after first dose of Moderna Vaccine
16yr old patient received vaccine first dose; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16yr old patient received vaccine first dose) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16yr old patient received vaccine first dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16yr old patient received vaccine first dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
PATIENT RECEIVED INJECTION AT 2PM SHE STATED TODAY ON CALL THAT BY 5:30PM SAME DATE AS VACCINATION SHE WAS NAUSEOUS VOMITING VERY DIZZY HAD SWELLING AT THE INJECTION SITE AND FELT PARALYZED IN HER ARMS - SHE WAS TRANSPORTED TO THE ER AND RECEIVED TREATMENT FOR HER ACUTE SYMPTOMS - SHE WAS INSTRUCTED TO ICE THE ARM - SHE STATED TODAY 9/29/17 THAT SHE WAS STILL FEELING THE ARM WAS SWOLLEN BUT THE OTHER SYMPTOMS HAVE SUBSIDED.
Pain in arm and hand below elbow.  Had carpal tunnel surgery a few years ago.  Wrist became very painful in the area that surgery was done. Iced it intermittently all weekend.  Soreness at injection site next day or 2. Wrist pain is on going.
One of five pts who was immun w/DTP/OPV/HIB & exp swelling & redness @ DTP inject site & extreme irritability; pt also exp high fever according to parent, but temp was not taken;
I felt a flush of heat and itching travel up my left forearm and when I looked at my arm it was red and hot.
I immediately got a period out of cycle after my first dose of the Pfizer vaccine and it continued and worsened after the second vaccine. I have now had a period for five weeks without stopping. I have been on the same birth control for over 12 years and I have never seen this happen. My mom is also experiencing period like cramps after her second dose and she went through menopause years ago.
10 TO 15 MINUTES AFTER RECIEVING  1ST DOSE OF PFIZER COVID VACCINE PATIENT STATED HIS ARM FELT LIKE IT WAS TINGLING AND IT RADIATED TO HIS CHEST. HE STATES HE DID NOT HAVE CHEST PAIN BUT IT FELT STRANGE. PATIENT STATED HE HAD NOT HAD ANY PO FLUIDS SINCE 4:30 THAT MORNING. HE WAS GIVEN WATER  TO DRINK AND  OBSERVED.  PATIENT'S SYMPTOMS WERE RESOLVED BEFORE LEAVING FACILITY.  FOLLOW UP CALL ON 6/28/21 PATIENT STATED HE  CONTINUED TO BE ASYMPTOMATIC OVER THE WEEKEND  AND WAS BACK AT WORK TODAY.
About 7 hours after administration patient had high fever (103.5), shaking and headache. Was examined, treated & released from medical center after about 1 hour & told to rest for 2 days.
Scattered blotches on non inoculation sites of extremities and face no systemic illness/fever or respiratory distress. They are mildly pruritic and resolve within 4-5 days.  No scaling, bullous or papular  component.
Hospitalized for 3 days then discharged home, weaned off oxygen. Had acute hypoxic respiratory failure secondary to COVID-19 infection.
I had sudden onset vertigo 4 hours after the injection that put me to bed. The following night I woke up from a sound sleep and vomited. Had stomach cramps. I have been dizzy since. The worst lasted about a week. Am still not completely right, but dizziness is something that happens to me some times. I have had Muniere's in the past.
Tingling down right arm into right hand, spread to left arm and hand. Stiffness in neck. After an hour progressed into muscle weakness in both forearms, more noticeable in the right arm. Best described as lactic acid buildup feel in forearm-had trouble lifting/pulling door handles. Has subsided over a day, no general soreness in both arms/ neck. Injection site has developed noticeable pain/soreness, somewhat like a tetanus shot . There was a fair amount of blood at the injection site (not typical for me), and the administration of the shot was a touch high in the arm.
Info has been received from a consumer from a medical office concerning a 76-year-old female with an "unremarkable" medical history who on 10/10/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #642749/0111M). Concomitant therapy was noted to be "unremarkable." In October 2002 the pt developed injection site reactions. The pt sought unspecified medical attention. A product quality complaint was not involved. The reporter provided into regarding 3 other patients with similar experiences after vaccination with a dose of pneumococcal vaccine 23 polyvalent (WAES #0210USA02077, 0210USA02078 and 0210USA02079). Additional info has been requested.
Patient complains on knot in injection site & arm pain lasting since 9/28/12.
Excruciating headaches; Dizziness; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 10Apr2021 (Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received dose 1 for COVID-19 immunization. The patient experienced excruciating headaches, had the headache and dizziness, have all the possible symptoms. The patient did the neuro exam and got some migraine medications (Unspecified medication). The event outcome of excruciating headaches was not recovered, dizziness was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Fever up to 102.3 deg F, chills, body aches, fatigue, headache.
Severe itching and bumps on my back.  Started itching about 7 hours after shot and continued for about 18 hours.  Could not sleep.  Almost the same reaction that I have with hydrocodone.
Pt was recieving dose 2 of jynneos. Received dose as SQ instead of ID by vaccinator. Clinical staff and pt made aware. Pt was revaccinate by another vaccinator via correct intradermal route.
Extreme soreness in right breast and throughout by entire body. Vomited after my shower and felt sick but this only lasted about an hour and a half.  After that, I was wore out, which last a few days. Nothing serious other than the vomiting was tough.
Fever 102, productive cough, malaise, myalgia x 1 week.
This spontaneous report as received from a pharmacist refers to a 67-year-old female patient. The patient had no pertinent medical history, no drug reactions and no allergies. On 03-MAR-2016, the patient was vaccinated with ZOSTAVAX subcutaneously, lot # L034724, expiration date: 09-DEC-2016 (dose was not reported). The patient had no concomitant medications. On 04-MAR-2016, the patient noticed red, warm quarter size welts around the injection site. They went away after 5 days. On 10-MAR-2016, the redness and a 2 inch welt appeared. The patient was treated with TYLENOL and BENADRYL. The outcome of the red, warm quarter size welts around the injection site was recovered on 09-MAR-2016 (reported as after 5 days). The outcome of the redness and 2 inch welt was not reported. The causality assessment between the events and ZOSTAVAX was not provided. Additional information has been requested.
mild pain on the injection site/my husband's hurt a little more; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported same event for herself and her husband. This is the second of the two reports. An elderly male patient above 75 years old received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the arm, on an unspecified date at single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. After the first vaccination, patient experienced very mild pain on the injection site that went away the next day, the pain hurt a little more than his wife, but by the next day was fine'. Patient took an acetylsalicylic acid and did not experience hematoma/bleeding on the injection site. The wife has been told that some friends experienced a higher incidence/severity of adverse events after the 2nd dose (including pain on the injection site, fever, chills, vomiting) (AER#2021092618). Patient is about to receive their 2nd dose 21 days later (this Friday). The wife is wondering if the diphenhydramine hydrochloride/paracetamol (TYLENOL PM) and aspirin will affect the vaccine-induced antibody response and if it is true that patients get 'sicker' after the 2nd dose. (Is the incidence of AEs higher after the 2nd dose?). She is referring to the Pfizer-BioNTech COVID-19 vaccine. Outcome of the event was recovered.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021069500 same product/event, different patient
Measles like rash started on face, extended to trunk, then arms and legs. Benadryl given, did not help.
Subsequently following the second dose of the varicella vaccine, the pt discovered that she was pregnant. Follow-up information from a physician indicated that on 7/31/00 an ultrasound was done. A maternal serum alpha-fetoprotein was also performed on 7/31/00 and was within normal limits. It was noted that there was no local reaction at the vaccination site and there were no varicella or herpes zoster symptoms post vax. Follow-up information received from a parinatologist indicated that the pt underwent a level II ultrasound which revealed anomaly. The fetus was diagnosed with left multicystic renal dysplasia. It was noted that the pt is continuing with her pregnancy. Followup information states pt took Benadryl from 10/01/00 until 10/16/00 for congestion. On 1/3/01 gave birth with no other complications or anomalies other than noted.  Follow up on 03/28/2001: "Adverse event time and Lot # for vaccine 1 is not provided."