chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning his 18 year old daughter with asthma and no known drug allergies, who on 05-FEB-2007 was vaccinated with a dose of Pneumovax 23 (lot# 651539/0607R).  Concomitant therapy included montelukast sodium (MSD).  On 06-FEB-2007 the patient experienced fever, chills, and a rash from the shoulder to the elbow.  The consumer reported that his daughter received antibiotics and pain killers because she could not lift her arm.  No diagnostic laboratory studies were performed.  At the time of this report, she had not recovered.  No product quality complaint was involved.  Additional information has been requested.
She reported that her arm where the injection was also "whelped" up.; lips numb and tingly; lips numb and tingly; stomach rash and itching; full body itching; stomach rash and itching; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (lips numb and tingly), PARAESTHESIA ORAL (lips numb and tingly), PRURITUS (stomach rash and itching), PRURITUS (full body itching) and RASH (stomach rash and itching) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, the patient experienced HYPOAESTHESIA ORAL (lips numb and tingly), PARAESTHESIA ORAL (lips numb and tingly), PRURITUS (stomach rash and itching), PRURITUS (full body itching) and RASH (stomach rash and itching). On an unknown date, the patient experienced VACCINATION SITE REACTION (She reported that her arm where the injection was also "whelped" up.). On 04-Apr-2021, HYPOAESTHESIA ORAL (lips numb and tingly) and PARAESTHESIA ORAL (lips numb and tingly) had resolved. On 08-Apr-2021, PRURITUS (stomach rash and itching) outcome was unknown, PRURITUS (full body itching) and RASH (stomach rash and itching) had resolved. At the time of the report, VACCINATION SITE REACTION (She reported that her arm where the injection was also "whelped" up.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported. No treatment drugs are not provided by reporter.
severe arm pain and numb hand emergency arterial occlusion of upper extremity still have numb finger tips and hand gets extremly cold
This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 08-SEP-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L003855 exp date 05-FEB-2017) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
on morning of day 6 p/vax felt feverish, tired, irritable, legs & hip pain, sore neck w/nodules, fever inc to 101 by day 12, h/a & raised red rash to face, chest, arms, back;
Redness, swelling, pain, burning sensation at local injection site; no system side effects.
A patient was suppose to receive the second dose of the covid vaccine, but yesterday she tested positive for covid.; A patient was suppose to receive the second dose of the covid vaccine, but yesterday she tested positive for covid; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient was supposed to receive the second dose of the COVID vaccine, but yesterday (14Apr2021) she tested positive for COVID.The pharmacist was asking if the patient would need to restart the COVID vaccine. If so, then pharmacist was asking when the patient could restart the COVID vaccines. Pharmacist was asking if the patient could just receive the second dose a couple of weeks later. The outcome of the event was unknown. The events were assessed as serious-medically significant.  Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event drug ineffective and COVID-19 and the suspect drug BNT162B2.
No immediate symptoms other than a sore arm. Two  months later developed bells palsy. Was prescribed an anti-viral and steroids to increase the likelihood of recovery.
possible interaction with her monoclonal antibody; severe nose bleed; nausea; This is a spontaneous report from a contactable physician. A 35-years-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as first dose, single for an COVID-19 immunization.  The patient medical history and concomitant medications were not reported. The Patient's Physician stated that she experienced nausea 2 days after receiving her 1st dose of the vaccine and then 2 days later she had severe nosebleed. Wants to know if this could be a possible interaction with her monoclonal antibody therapy since she is currently on it and had received the Covid vaccine within 30 days of her therapy.  Follow-up attempts are completed. No further information is expected.
Previously healthy child had vaccines 4/18/12. He had gastroenteritis type illness. The next week, about 5/5/12 he developed hip pain which progressed to difficulty walking then inability to walk. He had an ascending weakness & areflexia. Dx'd as Guillain Barre.
My menstrual cycle was completely normal until I received the second dose in May 2021. In June 2021, my period was delayed by one week. This had never happened before. In July 2021, I missed my period. I was spotting very faintly off and on through August 2021. August 2021 - I got my period and it lasted 7 days and it was heavy. I met my OBGYN in August. She ran blood tests and a pelvic ultrasound which were both normal. I am not waiting to see what happens next month.
large red hive, hard to the touch,  appeared at injection site 7 days after 1st dose. It is itchy, but can be soothed by anti-itch cream.
Information has been received from a Nurse Practitioner concerning a 14 year old female who was vaccinated with her third dose of GARDASIL. On an unspecified date, the patient developed a staph infection on her face. She sought unspecified medical attention. The patient's staph infection persisted. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 02-NOV-2012 12:02, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Headache/Migraine that does not give in to max doses of ibuprofen (2400mg per day) around the clock. Headache has lasted about 10 days as of today. Went to urgent care and was RX'd Imitrex which only barely got rid of the pain temporarily. Was advised to see a neurologist at the urgent care and postpone or cancel second shot.
Received both dose of Pfizer vaccine and also received the Moderna Vaccine; off label use( first 2 pfizer vaccine and 3rd one Moderna vaccine); chills; ore arm/pain but not extremely sore and couldn't sleep on it; Slight throbbing behind the forehead and eyes but it is not a migraine; nausea; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (Received both dose of Pfizer vaccine and also received the Moderna Vaccine), OFF LABEL USE (off label use( first 2 pfizer vaccine and 3rd one Moderna vaccine)), CHILLS (chills), MYALGIA (ore arm/pain but not extremely sore and couldn't sleep on it) and HEADACHE (Slight throbbing behind the forehead and eyes but it is not a migraine) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 immunisation: Pfizer (Receive both doses of Pfizer vaccine in 2021.).   On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXTRA DOSE ADMINISTERED (Received both dose of Pfizer vaccine and also received the Moderna Vaccine), OFF LABEL USE (off label use( first 2 pfizer vaccine and 3rd one Moderna vaccine)), CHILLS (chills), MYALGIA (ore arm/pain but not extremely sore and couldn't sleep on it), HEADACHE (Slight throbbing behind the forehead and eyes but it is not a migraine) and NAUSEA (nausea). On 17-Jun-2021, NAUSEA (nausea) had resolved. At the time of the report, EXTRA DOSE ADMINISTERED (Received both dose of Pfizer vaccine and also received the Moderna Vaccine), OFF LABEL USE (off label use( first 2 pfizer vaccine and 3rd one Moderna vaccine)), CHILLS (chills), MYALGIA (ore arm/pain but not extremely sore and couldn't sleep on it) and HEADACHE (Slight throbbing behind the forehead and eyes but it is not a migraine) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   The patient administered both doses of Pfizer vaccine in the year 2021 (was not sure of the exact month). The patient then administered Moderna vaccine as a booster shot.  No concomitant medication were reported. No treatment information was reported
Patient received a dose of Pfizer covid 19 immunization that was expired by about 17 hours. No adverse reaction has been reported at this time.
Patient fainted approximately 2 minutes after receiving the vaccine. Her skin became clammy and EMS responded. All vital signs returned to normal and she was transported home by her husband.
Fever 6+hrs, severe chills 6+hrs, severe soreness at injection site 72ish hrs., bad headache 96ish hrs.  I took acetaminophen for 4 days and it seemed to help with the fever but not the soreness in the arm which was so bad that I could hardly raise my arm to a horizontal position.
dose which expired on 14-JUN-2022 was administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 62-year-old female patient who received HAV (Havrix) (batch number X9A9B, expiry date 14th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th June 2022, the patient received the 1st dose of Havrix and Havrix Pre-Filled Syringe Device. On 28th June 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-JUN-2022 Reporter's Comments: The physician assistant reported that a dose of Havrix was given to the patient and it was already expired. The reporter did not consent to follow up. Additional Supportive Information: The use of Havrix dose which was already expired on 14th June 2022, which led to expired vaccine used.
mom stated that pt had crying episode following vax; pt was hospitalized 4 to 5 days that wk then returned 2 to 3 days of wk starting 20JUN94;
Mom called back about one hour ago. Child has had 3-4 yellow runny stools since leaving office. Asked Mom if child had been sick recently or anyone else in the home. Mom states child had vomited 4 times this am, two that Mom did not see but Dad did and the other two were mostly mucous and that child seem to have a cough. Advised Mom that perhaps the loose stools are sx. of a "stomach bug" or gastroenteritis which frequently starts with vomiting. The vomiting usually subsides and loose stools begin. Mom states stools have been yellow and very loose. There has been no fever. Advised to monitor liquid intake and follow bland diet as in Bananas, crackers, jello, white grape or pear juice. Advised if sx. worse to call back.
Severe heart palpitations between 55 up to 195 Bpm while sitting still and cannot do activities as a result. Shortness of breath and pain in the left side breast. Never had any of the symptoms before taking the 2nd dose of Pfizer vaccine.
This spontaneous report as received from a health care worker refers to a patient of unknown age and gender. The patient received the first dose of GARDASIL (lot number, expiry date, route and dose were not reported) series on 06-NOV-2012, the second dose on 21-NOV-2012 and the third dose on 22-JAN-2013. No adverse effects reported. Additional information is not expected.
Headache, Myalgia, Arthralgia, Fever, 100.0-101.5 Narrative:
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Spikevax (Primary series dose 1) and Spikevax (Primary series dose 2). Past adverse reactions to the above products included No adverse event with Spikevax and Spikevax.    On an unknown date, 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. In December 2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter.  It was reported that reporter's mother in law received her Moderna primary series vaccine and two Moderna booster doses and that his Mother-In-Law caught Covid-19 in December 2022.  No treatment medication reported by reporter.   Reporter did not allow further contact
A company representative reported that an infant received an injection of Prevnar. One month, post vax, the infant developed bloody stools. No further information was available at the date of this report. The reporter indicated that 2 infants experienced this event; however, they are not presently identifiable. An additional report will be generated when identifying information is provided.
He got his shot about 4 pm 3-23-04 and about 10 pm he started vomiting and it last for 2-3 days.
Felt sharp stabbing pain in chest about three days after I received the first dose of the vaccine.
12 year old dose was given to a 11 year old child, No adverse effects noted.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 21-AUG-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength, dose and frequency were not reported).  The improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
The day after my shot, I started experiencing the symptoms of a genital herpes outbreak.It was one of the most severe attacks I've had. Luckily I keep a supply of Valacyclovir on hand so I was able to start treating the outbreak right away. I contacted my primary care physician's office to let them know. They made sure I was not having an allergic reaction and offered to prescribe more antivirals.
first dose July 2020, 2nd dose 10/13/2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in July 2020).   On 13th October 2021, the patient received the 2nd dose of Shingrix. On 13th October 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received first dose of shingrix a year ago and 2nd dose on the day of reporting, which led to lengthening of vaccination schedule. The reporter consented to follow up. No details of patient or vaccine available.
After receiving the Encephalitis vaccine she was fine. Within 10 minutes she had swelling at injection site and itching of feet. We followed protocol by administrating BENADRYL 50 mg, Epinephrine 0.3 ml, SOLUMEDROL 125 mg, PEPCID.
This morning I woke up with a headache, achy joints, overall fatigue. Injection site red, warm, slight swelling, hardness and tender to touch. took two  over the counter Tylenol pills for pain and headache and have been resting all day, however no change at this time.
soreness in his arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunocompromised, white blood cell count decreased and shoulder operation (little usage of left arm due to shoulder surgery).   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 1 day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix six months ago and experienced soreness in his arm the following day after receiving the vaccine.   The soreness resolved after two days. The reporter did not consent to follow up. No follow up was requested.
mild hives and itching on upper thighs, torso, shoulders and underarms, no treatment, verified it was not anything else.
Patient presented to ER with rash/itching and shortness of breath and difficulty swallowing.
1st shot  Aug2019, 2nd 25Oct2022; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a 81-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine  (received first dose in August 2019).   On 25th October 2022, the patient received the 2nd dose of Shingles vaccine. On 25th October 2022, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 26-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient asked that because of the long time between shots should he/she get a third one and if so, when should get it. Additional supportive information: The patient received the second dose of Shingles vaccine later than the recommended interval, which led to lengthening of vaccine schedule. The follow-up could not be possible as no contact details were available.
Racing heart rate >100 for five days.  Fever > 100.4 for two days. Fatigue, brain fog, confusion continued for seven to ten days.  Stomach and back aches followed by stabbing pains in stomach and back continuing for two weeks.  Pins and needles in hands and feet along with numbness and pain in bottom of feet that is ongoing.  Pins and needles worse in left hand.
This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional. A 62-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), at the age of 62, via an unspecified route of administration, in right arm, on Apr 7, 2021, single dose, for COVID-19 immunization. Medical history included high blood pressure from an unknown date and unknown if ongoing (diagnosed probably in 1985, but does not know the exact date). Concomitant medications included losartan 100 mg tablet, one time daily for high blood pressure, start and stop date not reported. Historical vaccine included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. On Apr 7, 2021, patient experienced headache, body ache, combination of fever and chills. The patient reported she was trying to report an adverse event after having the COVID-19 vaccine yesterday (Apr 7, 2021). She was having an adverse reaction and trying to report the adverse event triggered by the vaccine. The outcome of the events: not resolved. No follow-up attempts possible. Information about batch/lot number cannot be obtained.
Headache, fever about 8 hours after injection.  Lasted until 10am next  day.  Broke out in hives 5 days after injection - lasted 13 days
Shortly after DTaP injection, pt became quiet and pale for a short time. She responded well to stimulation and resumed normal appearance and activity immediately after stimulation.
arm pain where the injection occured for 3 days, mild headache for 2 days
Cranky, crying for 1 wk following immun; Seen by MD for ill visit 17DEC91; temp 99R; dx viral URI; rx Rondec DM drops;
My adverse event started on 05/2022 in the evening. I had severe cough that lasted for days. I went to my doctor's office where they did X-rays . It didn't reveal anything. They said it just allergies. My doctor didn't prescribe me any medication at all so, I took over the counter medication such as ROBITUSSIN as per needed. I went back to the doctor's office he assumed that it was Asthma so, he prescribed me 2 Asthma medication ADVAIR and the other one I can't recall. It helped till January this year 2023. I went back to the doctor again this time he prescribed me antibiotics and steroids. I got it 2 weeks ago. Now I feel a little better but I haven't recovered yet.