chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extremely sore arm. 30 minutes after the shot. Whole body started itching within an hour of the shot. Took a 10mg zyrtec about 3 hours from taking shot. That helped itching. Whole body started to hurt about about 4 hours after the shot. As the hours went on it got worse, skin hurt, then around midnight my body felt like it was on fire. Took 4 advil and a muscle relaxer. Took an hour and body calmed down enough to sleep. Woke 5 hours later all symptoms back. Took 4 more advil, about an hour was able to fall abck asleep. 5 hours later all pain was back. Took 4 advil and a muscle relaxer. Took hour to help. 5 hours later all pain was back took 4 more advil this time it about 2 hours for the pain to stop and it was back 2 hours later. About 10 pm I took 4 more advil and a muscle relaxer took about an hour and then I went to sleep. Woke up on Sunday and only my arm hurt. My arm hurt through out the whole process
15 minutes after injection, both arms and hands experienced a tingling sensation similar to when a limb "falls asleep".  This continued for about 8 hours.  When I went to sleep and woke up, the tingling sensation was gone.  Tingling on the lower arms (below elbow) and hands.
immun given 27APR94 in PM site became hot to touch, swollen, red
This spontaneous report as received from a healthcare worker regarding unspecified patients of unknown demographics. There was no information regarding concurrent condition and historical medication. On an unknown date, the patient was vaccinated with improperly stored PROQUAD which was exposed to 12F for 40 minutes. No concomitant medication was reported. No product quality complaint was involved. No adverse effect was reported. The outcome of event was unknown. This is one of several repots received from the same reporter. Additional information has been requested.
2nd vaccination on 7/6/2021@7pm On 7/7/2021 at 10am I began to feel achy, fevered and nauseous.  By 12:00pm I was completely incapacitated with pain throughout my body, back and joints and injection sight arm. Extreme headache and both chills and fevered with vomiting . These symptoms subsided 8-10hrs later and had  no symptoms the following morning 7/8/2021 and resumed normal work and activities. On 7/17/2021 @8:00am I felt some muscle spasms and pain in my left  arm (injection site) by 10:00am I was completely incapacitated again with all of the listed symptoms above  lasting through 11:00pm at which time they began to subside somewhat. Today 7/18/2021 I woke up to chills/fever, lower back pain, headache and general body aches and soreness.  This continues at this time.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 78-year-old male patient who received SHINGRIX for prophylaxis.  Previously administered products included SHINGRIX (1st dose received on 25th October 2018). On 1st February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 1st February 2019, immediately after receiving SHINGRIX, the patient experienced injection site erythema, injection site induration and injection site warmth. In February 2019, the patient experienced hives and erythromacular rash. On an unknown date, the outcome of the injection site erythema, injection site induration and injection site warmth were recovered/resolved and the outcome of the hives was not recovered/not resolved and the outcome of the erythromacular rash was unknown. It was unknown if the reporter considered the injection site erythema, injection site induration, injection site warmth, hives and erythromacular rash to be related to SHINGRIX. Additional details were provided as follows: The reporter indicated that her husband had the 1st dose of the SHINGRIX via intramuscularly 0.5 ml, in left arm vaccine and had no issues. Immediately after receiving the 2nd dose of the SHINGRIX vaccine and he developed a hard, red, hot area at the injection site. This resolved within 6 or 7 days. Approximately five days after receiving the vaccine, he developed hives in between his fingers, on both hands, and both wrists. The hives then developed under both of his arms, and then moved to his groan. Two days ago he developed hives on his chest and around his abdomen. Now there are just red dots on his chest, not hives but he still has the hives on his wrist. The reporter indicated that the hives had resolved on the other parts of his body. However, she stated that the hives come on one location, resolve, and then appear somewhere else. The reporter given permission for his physician to be contacted. The reporter gave consent to follow up.
Left deltoid with swelling, redness & hot.  Lymph nodes under armpit hurts.  Pt. states "rash still there, but pain's gone" on 4/8/10.
ax temp 102-105 for 2 1/2 days p/vax; pt was lethargic wanted to sleep a lot; rapid breathing 1st 24 hrs; inc temp cont from 97 to 102 ax; had reddened area @ site of vax;
Headache, neck pain resulting in partial immobility, rash/hives, flu-like symptoms. Symptoms were more severe 1 day post-vaccination, but have begun to improve starting day 2 after vaccination. Managed with NSAIDs and rest.
June 7: pt received injection. June 7-9: extremely sore arm. June 13: skin sensitivity on right waist and right upper thigh. June 14: Pain and sensitivity increased significantly, rash appears on upper thigh, difficulty tolerating clothing touching waist and upper thigh. Pt took ibuprofen twice daily to control pain. June 15-16: rash becomes worse. June 21: rash and pain start to diminish. June 28: rash and pain are gone. Pictures of rash were shown to internist who agreed that the rash was a shingles rash.
This spontaneous report as received from a physician (M.D.) refers to a 24 year old female patient with mild mitral valve prolapse and no drug reactions/allergies. On 05-APR-2013 the patient was vaccinated intramuscularly with a 0.5 ml dose of GARDASIL (lot# not reported). There was no concomitant therapy. Sometime this month (May 2013, date unspecified) patient had a positive test of Epstein Barr virus with an unspecified lab test. The patient had an office visit. The physician did not make the diagnosis of Epstein Barr, and therefore did not have additional information about diagnostic testing. The patient had symptoms of malaise and fatigue (onset date unknown). The patient was not currently receiving treatment. The outcome of the events was unknown. Additional information has been requested.
chills lasting six or more hours, fatigue, muscle pain in both legs, pain in both knees.
developed numbness/tingling of tongue, headache and also pain across chest, as well as high BP and HR. Given water, benadryl 50 mg IM with improvement of everything except chest pain. Sent to CSMC ER for further evaluation.
Nausea, headache, dizzy, fast heart rate. was being monitored. after 15 min of observation, patient stated she was better and didnt want to go to ED. after another 15 min, she said she was fine, but we insisted she go get checked in ED.
Fatigue/tired with second shot of covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue/tired with second shot of covid vaccine) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. In 2021, the patient experienced FATIGUE (Fatigue/tired with second shot of covid vaccine). At the time of the report, FATIGUE (Fatigue/tired with second shot of covid vaccine) had not resolved.            No relevant concomitant medications were reported.  It was unknown if patient was enrolled in COVID-19 vaccine trial.  The reporter causality for the event fatigue/tired with second shot of covid vaccine with humira was reported as not provided.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
The patient received 2 doses of 0.25 mL Moderna COVID 19 Vaccine - the equivalent of (0.5mL) this is the correct amount of vaccine for the 2nd dose of Moderna mRNA vaccine.
Taste of the vaccine in my mouth as soon as administered followed by full body flushing and sweating and hypersensitivity to sound and touch sense of depersonalization, anxiety Next morning, severe muscle and joint pain
Fever 101.1; Chills; Body aches; Sinus infection; This is a spontaneous report from a contactable consumer or other non-hcp (patient herself). A 56-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection) via intramuscularly administered in Arm Left on 26Feb2021, 08:30 (Lot Number: EM9809, Expiry date: Unknown) as dose 2, single for COVID-19 immunisation, metoprolol (METOPROLOL), via an unspecified route of administration from an unspecified date (Lot number was not reported) and ongoing, at unspecified dose for an unspecified indication, have been taking for a couple of years. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (BNT162B2, Formulation: Solution for injection) via intramuscularly administered in Arm Left on 05Feb2021, 09:30 (Lot Number: EL9264, Expiry date: Unknown) as dose 1, single for COVID-19 immunisation and experienced red inflamed/very little redness when I got the vaccine/very red, itchy circle where vaccine was given, swelling on site, runny nose and stuffed nose. On 26Feb2021, the patient experienced fever 101.1, chills, body aches and sinus infection. The patient underwent lab tests and procedures which included body temperature: 101.1 and body temperature: 100.9. Therapeutic measures were not taken as a result of events fever, chills and body aches. Therapeutic measures were taken for the event sinus infections. The outcome of events fever, chills and body aches recovered on an unspecified date in 2021 and event sinus infection was not recovered.  No follow up attempts are possible. No further information is expected.
Fever 102deg within 24 hours with body aches and chills. Resolved with Tylenol - afebrile 72 hours after vaccine.
On 09/27/2021 I started having cough, shortness of breath, congestion, headache, high fever, chills, fatigue, nausea diarrhea. On 09/28/2021 I went to the doctor. Lost taste and smell, but just beginning to get that back as of 10/21/2021.  10/07/2021 I got an antibodies infusion.
pt recv vax 25NOV98 & 5 days p/vax pt broke out in an eye infect, rash & anemia;pt also dx w/infect mononucleosis;pt sought unspecified medical attention;  Information has been received from a health care professional concerning a 17 year old male. Who on 13-AUG-1998 and 25-NOV-1998 was vaccinated with the first and second doses of RECOMBIVAX HB
Information has been received from a physician concerning a 4 month old female who on 10-OCT-2007 was vaccinated with the first dose of RotaTeq vaccine. No symptoms or problems were noted. It was unknown whether medical attention was sought. There was no product quality complaint. Additional information has been requested.
Questionable petechiae developed on face and some on chest after vaccines were administered pt was given 10ml of prednisone 15mg/5ml as a precaution. Patient had no SOB and looked ok. Patient was observed for 15 min. and was released. Patient left happy no difficulties.
sore body; Headache; Arm soreness; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm soreness), PYREXIA (Fever), CHILLS (Chills), MYALGIA (sore body) and HEADACHE (Headache) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030AUA) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE PAIN (Arm soreness), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). On an unknown date, the patient experienced MYALGIA (sore body). At the time of the report, VACCINATION SITE PAIN (Arm soreness), PYREXIA (Fever) and HEADACHE (Headache) was resolving and CHILLS (Chills) and MYALGIA (sore body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were Blood pressure medication and Thyroid medication.  Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Mar-2021: Significant follow-up : Added  new events Headache  and Arm soreness and changed outcome for the event fever from unknown to recovering.
feeling really under the weather; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (feeling really under the weather) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Atopic dermatitis.    No Medical History information was reported.   In May 2021, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 1 dosage form. On 20-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, the patient experienced MALAISE (feeling really under the weather). At the time of the report, MALAISE (feeling really under the weather) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided.  No treatment information provided.
Extreme pain at the injection site; difficulty raising arm and lifting objects; SIRVA; vaccine was administered too high on the deltoid resulting in symptoms that occur with Sirva; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 44-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number E975Y, expiry date 25th June 2020) for prophylaxis.   On 17th October 2019, the patient received FluLaval Tetra 2019-2020 season (intramuscular). On 17th October 2019, less than a day after receiving FluLaval Tetra 2019-2020 season, the patient experienced injection site pain, injected limb mobility decreased, shoulder injury related to vaccine administration and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved and the outcome of the shoulder injury related to vaccine administration and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site pain, injected limb mobility decreased and shoulder injury related to vaccine administration to be related to FluLaval Tetra 2019-2020 season.  Additional case details were reported as follows: The patient received a dose of FluLaval Tetra in an unknown deltoid. The patient had extreme pain at the injection site. The patient had difficulty raising his arm and lifting objects.  The reporter suspects the vaccine was administered too high on the deltoid, which led to vaccine administered at inappropriate site. This resulted in symptoms that occur with Sirva (shoulder injury related to vaccine administration).  The reporter consented to follow up. This is 1 of 9 linked cases, reported by same reporter.
MEDICATION ERROR; OFF LABEL USE; PARTIAL DRUG ADMINISTERED; This spontaneous report received from a patient concerned a 28 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, and  expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced medication error. On 08-APR-2021, the subject experienced off label use. On 08-APR-2021, the subject experienced partial drug administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the medication error, off label use and partial drug administered was not reported. This report was non-serious.
Employee started to feel itchy at the site and there was blotchy redness. Bandaid removed at the site immediately. Given PO Benadryl 50 mg at 11:10 am, started vomiting about 2mins later. Moved to room with assistance from writer to lie down. Rolled to side and continued vomiting periodically. Nurse Practitioner gave Epi pen to L thigh at 11:25. Immediately after Epi pen, 911 called to transfer to Emergency. Oxygen 2 l by Nasal canula applied.  Patient continued to vomit.  Red Blotchy area spread to chest area. Patient Awake, Alert and Oriented during the entire event.  Ambulance arrived and patient transferred by stretcher.  Report given to EMT's handling care for the patient.
VERY MILD BREAKTHROUGH CASE OF COVID; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via a company representative via social media concerned a male of unspecified age and race. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series was 1) (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total, administered on an unspecified date of APR-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date of AUG-2021, the patient experienced very mild breakthrough case of covid, and had suspected clinical vaccination failure. As per the reporter "I had the Johnson and Johnson vaccine in April of 2021. I had a very mild breakthrough case of Covid in August of 2021. Now I need the Booster. I am being told not to get the JNJ booster but to get one of the mRNA (messenger ribonucleic acid) boosters. What should I get". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mild breakthrough case of covid and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint (PQC) 90000208725.; Sender's Comments: V0: 20211255562-COVID-19 VACCINE AD26.COV2.S- Very mild breakthrough case of Covid. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. 20211255562-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Fever of 102F after 3rd dose; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever of 102F after 3rd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced PYREXIA (Fever of 102F after 3rd dose). On 09-Sep-2021, PYREXIA (Fever of 102F after 3rd dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Sep-2021, Body temperature: 102 (High) High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.   This case was linked to MOD-2021-319554, MOD-2021-319548 (Patient Link).
Patient had syncope.  Became dizzy and fell in and out of consciousness.  Began perspiring and became clammy.  Breathing was normal.  Patient fully recovered after emergency room visit.
Vomiting 1-2 x1 day 6/15/12 - 8/12/12, non-projectile wgt loss, failure to thrive 6/14/12 13# 3oz wgt 8/3/12 12# 2oz wgt Mother nursing q1-2 hrs dur day with full milk supply. Started to regain growth 8/23/12 13# 5 oz 9/6/12 15# 6 oz.
Within ~15 mins of receiving the injection, I started yawning excessively/uncontrollably. It?ll come and go - it?ll happen for 5 mins and then stops for a while before happening again. That has continued to the time of this writing (6:29pm).
Heart attack; Weakness; Wanted to sleep a lot; Fatigue; COVID-19; Did not receive 2 nd dose; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not receive 2 nd dose). On 08-Apr-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion medically significant), ASTHENIA (Weakness), HYPERSOMNIA (Wanted to sleep a lot) and FATIGUE (Fatigue). The patient was treated with Surgery (Received heart stent in June 2021) for Myocardial infarction and Immunotherapy (Received antibody infusion on 10 Apr 2021) for COVID-19. In March 2021, PRODUCT DOSE OMISSION ISSUE (Did not receive 2 nd dose) had resolved. At the time of the report, MYOCARDIAL INFARCTION (Heart attack), HYPERSOMNIA (Wanted to sleep a lot), COVID-19 (COVID-19) and FATIGUE (Fatigue) outcome was unknown and ASTHENIA (Weakness) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, SARS-CoV-2 test: positive (Positive) tested positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.   Patient was informed that second dose cant be received for 90 days after infusion.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded except for the event of Myocardial infarction as the event started over four (4) months after the vaccination and the causality is unlikely.   This case was linked to MOD-2021-213417 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Case has been upgraded to serious with the addition of event heart attack. New treatment was reported.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded except for the event of Myocardial infarction as the event started over four (4) months after the vaccination and the causality is unlikely.