chrisvoncsefalvay/vaers-outcomes huggingface dataset:
LOSS OF USE OF THEIR ARM; CHILLS; HEADACHE; This spontaneous report received from a consumer who heard of multiple (unspecified) patients of an unspecified age, sex, race and ethnicity.   The patient's weight, height, and medical history were not reported. The patients received primary dose with covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 1). The patients received first booster with covid-19 vaccine ad26.cov2.s (Dose number in series 2), (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. It was unknown whether patient had any adverse events following vaccination (Dose number in series 2). The patients received second booster with non-company suspect vaccine Moderna covid-19 vaccine (elasomeran) or another approved covid-19 vaccine (unspecified manufacturer), (Dose number in series 3), (form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for covid-19 prophylaxis. No concomitant medications were reported.  On an unspecified date, after second booster, the patients experienced loss of use of their arm, chills, and headache (Dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The outcome of the chills, headache and loss of use of their arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20220744486.
Swelling at injection site, triceps painful, severe headache, severe muscle pain in lower back (never had before in my life, this symptom lasted 24 hrs only). Headache alleviated 01/16/2011 AM only to return in PM and continue through today, 1/18/2011.
A patient received an expired diluent at the time of vaccination, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Agency (Reference number- 00525075) and transmitted to Sanofi on 18-Mar-2021.  This case involves an one-year-old female patient who received an expired 0.5 mL dose of  diluent of HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ567AA and expiry date: 01-Mar-2021) via an intramuscular route in the left thigh for prophylactic vaccination on 18-Mar-2021 (expired product administered).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   This was a case of  actual medication error due to expired product administered (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Prior to first vax, pt had mild arthritis symptoms of joint pain and stiffness. On 4/23/1999 post third vax,  one morning in early May, 2000 pt awoke reportedly experiencing severe pain and stiffness in his legs and feet (nos). No treatment was given.
This case was reported by a pharmacist and described the occurrence of dizziness in a 69-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline), (non-gsk) FLUZONE. On 27 August 2012 at 12:35 the subject received a dose of BOOSTRIX (.5 ml, unknown, right arm) and on 27 August 2012 the subject received a dose of FLUZONE (details unknown). On 27 August 2012, within hours of vaccination with BOOSTRIX and FLUZONE, the subject experienced dizziness and on 29 August 2012, 2 days after vaccination with BOOSTRIX and FLUZONE, the subject experienced hoarseness. According to the pharmacist, the subject experienced the dizziness when she turned over while lying in bed the evening of the vaccinations, 27 August 2012. On 29 August 2012, the subject was told that she sounded hoarse while talking on the phone. At the time of reporting the dizziness was resolved and the hoarseness was unresolved. The lot number was reported as AC2B081AA by the reporter, but was corrected to AC52B081AA based on the BOOSTRIX rules for the vaccine batch numbering system.
15 min post Hepatitis A vaccination, Mother reported to Nurse that her daughter was feeling nauseas and vomited in the bathroom. Nurse further assessed patient who appeared alert and oriented, but looked pale in the face, weak, and felt nauseas. Nurse had patient lie down with feet elevated. Blood pressure, pulse, and respirations taken every 5 min -10 min until client was stable and began to feel better.  Patient never fainted and was able to respond to all questions asked by nurse. 20 min post incident, client was able to sit up and reported feeling much better. Denied being short of breath, nauseas, or weak. Client complexion looked much better and patient was able to stand/walk without feeling light headed or dizzy. Nurse educated parent on vasovagal symptoms as well as adverse reaction signs/symptoms to report. Parent was instructed to dial EMS if any adverse reactions symptoms (itching, rash/hives, swelling of lips/face/throat, shortness of breath, light headed/fainting, nausea/vomiting/abdominal cramping, etc.) was to occur at home. Nurse advised parent to inform healthcare provider of incident as well.  Parent (mom), verbalized understanding to all the above and denied further questions at this time.  Client was able to leave clinic setting with no further concerns or acute reaction symptoms noted.
Patient received undiluted second dose of pfizer 5-11 years orange cap covid vaccine.
Patient fainted about 10 min after taking vaccine. The patient woke up a few seconds later.  An ambulance came to check vitals but the patient seemed fine and left on his own power.  I checked on the patient about 3 hours later and he was fine.
Positive rapid test and PCR test after 1st vaccination; Positive rapid test and PCR test after 1st vaccination; This is a spontaneous report from a contactable nurse reporting for her/himself. A patient of unspecified age and gender received the 1st dose of bnt162b2 (BNT162B2), via an unspecified route of administration, on 15Dec2020, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient tested positive on 27Dec2020 on a rapid test and on 28Dec2020 on a respiratory panel by PCR. Next dose was scheduled  on 05Jan2021.  The information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event Positive rapid test and PCR test based on the known safety profile. However the short duration of 12 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
Mother states at midnight on day of shots, child had fever of 103.5, crying, restless. Mom gave Tylenol for fever which only bought it down to 102.3 by next morning. Child was given Tylenol before shots. Morning of 2-9-06,mom noticed rash on child's legs, and when she changed diaper noticed a "cluster" of bumps on stomach with a raised area around rash. Took to Doctor. Given Rx for Zantac. Also began runny nose/congestion. Congestion, runny nose continues.
No additional AEs; HCP calling to report a TE for ROTATEQ, product administered after the excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, or drug reactions or allergies was provided.  On 05-APR-2023, the patient started therapy with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1x dose, lot #W026136, has been verified to be a valid lot number, expiration date reported and upon internal validation established as 31-JAN-2024, administered orally for prophylaxis (strength, vaccination scheme frequency, and dose were not provided) after a temperature excursion (temperature: 61.7 Fahrenheit (F); time frame: 4 hours 39 minutes) (product storage error). There was no previous temperature excursion. No additional adverse event was reported (no adverse event).
severe under arm rash; used hydrocortizone to manage symptoms, started on Tuesday, has not yet gone away
March 11: fever, headache, pain fatigue, arms turned bright red for about 10 minutes March 12:fever, headache, fatigue, nausea March 13:fever, pain, fatigue March 14:fever, pain, chills, fatigue, nausea, vomiting March 15: fever, chills, headache, tinnitus March 16: fever March 17:  March 18: fever March 19: fever March 24: fever March 25: fever  Last week or so: chest pains, really high heart rate
Anxiety, flushing, EPs-tremors 12:30 increasing. MD on site assessing. Pharmacist administered epi pen at 12:40. 911 called. Left facility at 12:45
Whole shoulder is swollen; Whole shoulder is painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of swollen joints in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced swollen joints (Verbatim: Whole shoulder is swollen) and shoulder pain (Verbatim: Whole shoulder is painful). The outcome of the swollen joints and shoulder pain were not reported.   It was unknown if the reporter considered the swollen joints and shoulder pain to be related to Shingles vaccine.     It was unknown if the company considered the swollen joints and shoulder pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 17-MAR-2023 This case was reported by a patient via interactive digital media. The patient just had a shingles shot and his/her whole shoulder was swollen and painful But, he/she reckon it's better than having shingles.  The follow-up could not be possible as no contact details were available.
Aching after 1st dose; Feverish after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aching after 1st dose) and PYREXIA (Feverish after 1st dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Aching after 1st dose) and PYREXIA (Feverish after 1st dose). At the time of the report, PAIN (Aching after 1st dose) and PYREXIA (Feverish after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-392136 (Patient Link).
Patient reported vaso-vagal response ~5 minutes post vaccination. He walked out to his car to wait after his vaccination and "felt unwell". He was able to walk to his car but immediately fainted. His wife reports he regained consciousness ~1 minute after.
Moderate-to-severe diarrhea starting 2 days after vaccination and now into 2nd day of condition.
fatigue; difficulty concentrating and with memory; difficulty concentrating and with memory; This is a spontaneous report from a contactable physician reporting for herself. A 37-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 04Jan2021 12:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history reported as none. There were no concomitant medications, no other medications was received in two weeks. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of BNT162B2 on an unknown date in Dec2020 at left arm for covid-19 immunization and had fatigue and myalgias for 3 days after the 1st dose. After the second dose the patient had had 3 weeks of fatigue and difficulty concentrating and with memory, events started on 04Jan2021 20:00. Adverse event resulted in: Doctor or other healthcare professional office/clinic visit. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
suspected vaccination failure; 15 people / experienced shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult 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 age group was not reported but was captured as an adult as per vaccine indication.  The patient received Shingles vaccine and experienced shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This case was 1 of the 16 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR088476: US-GLAXOSMITHKLINE-US2021AMR088498:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088500:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088499:
one of 3 pts vaxed from same vial who devel a red, swollen & hot arm four days p/vax; tx included Ancef & Keftab; dx cellulitis;
A non-serious spontaneous report of we gave 14 doses of expired FLUMIST was received from a health professional concerning a 10-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 22-Jan-2012. On 27-Jan-2012, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Person was given 0.3cc dose of Janssen Booster dose instead of standard 0.5 cc. DOH notified and Manufacturer (Janssen) notified and all persons reported to Janssen Manufacturer for their Pharmacy department, recommendations from the Manufacturer and with agreement from DOH are to notify all of the recipients that received an incorrect dose and submit a VAERS report for each.
Rash at injection site that showed up seven days after the shot. Currently on day four and the rash has spread every day. Currently covering about one third of upper left arm. Rash has been red, swollen, and hot, with occasionally itchiness. Rash is about four inches tall and wraps around most of the upper arm.
Headache, Sedation, Myalgia, Arthralgia, Fever & NauseaVomiting Narrative:
Patient received pfizer vaccine on 2/24/21, 3/17/21 and 8/27/21. COVID positive on 5/3/22. PResented to ER on 5/4/22 and admitted. Presented as transfer from OSH for acute hypoxic respiratory failure secondary to COVID 19. CT chest at OSH with emphysema and bronchitis. Vitals on admission remarkable for fever.    Started on steroids on admission. Remdesivir started after patient jumped from 2L NC to 5L NC overnight of admission. Completed 3/5 days of remdesivir and then d/c'ed as patient on room air. Not d/c'ed with steroids as on room air. Patient given instructions to resume home dose of prednisone. Patient is working with endocrinology on tapering prednisone.     ID consulted, not a candidate for tocilizumab or barictinib given being treated for superimposed CAP. Placed on ceftriaxone and doxycycline. D/c'ed with doxycyline and cefuroxime.    Patient given instructions to follow up in one week with PCP.  Discharged on 5/7/22
Following my 1sst dose of Moderna I developed a rash, that began on my hip but slowly traveled up my back.  However following my 2nd dose I experienced a delay in my menstrual cycle in June 2021 which cause a late ovulation and a subsequent miscarriage.
HX OF MILD REACTION TO FIRST DOSE, GIVEN BENADRYL ON SITE AND THEN GIVEN PREDNISONE BY PCP.  FOR 2ND DOSE SHE DEVELOPED UTICARIA, FLUSHED EARS, C/O HOT. 50MG BENADRYL IM GIVEN AT 4:18 PM, BP 137/89, HR 89, OS SAT 100% ON RA,  4:25 PT STARTED FEELING DIZZY AND TONGUE BECAME TINGLY,  4:35 0.3MG EPI GIVEN IM, BP 159/90, HR 112,O2SAT 100% ON RA 4:40 PT C/O NAUSEA, GIVEN 4MG ZOFRAN IM AND PT TRANSORTED TO MEDICAL CENTER
so sleepy; tired; fatigue; not in the mood to talk to anyone; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SOMNOLENCE (non-serious), outcome "unknown", described as "so sleepy"; FATIGUE (non-serious), outcome "unknown", described as "tired"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; MOOD ALTERED (non-serious), outcome "unknown", described as "not in the mood to talk to anyone".  Additional information: Clinical course: It was reported that patient was so sleepy and tired after the first dose of the Pfizer. The patient cannot be falling asleep halfway through the day and want to confirm that she was calling about the covid vaccine. Wants to know why she is so sleepy, is this a known side effect. Has Pfizer heard a lot about fatigue after the vaccine. The patient was not in the mood to talk to anyone. She was going to get her lawyer after she gets off the phone. Patient concern was why (incomplete sentence) she get the shot, the Pfizer. She should have got the Moderna. Why she always sleepy, all the time now. Is that one of the side effect.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient experienced syncope about 2 minutes after administration of vaccine.  Consciousness regained within 15 seconds.  Patient has reported previous syncopal episodes with vaccines in the past.
Pt recvd 1st 2 doses of Hep B vax & a 3rd dose of Heptavax on 17APR90 & did not respond;
Reports rash on inner lower arms, inner lower legs that appeared 6/10. Rash became inflamed & red then, scars darker now, healing. Dermatologist - "Lichen Planus" - Autoimmune Disease Response. Seen 11/10 reported to us 3/29/11.
Pt. developed hard subcutaneous nodule approx. 1 cm diam. at site of MMR inj in Rt. post. upper arm. Non-tender, no redness. Pt. to f/u with infectious disease MD.
Fibromyalgia pain escalated after second dose; pain involving trigger points in lower neck; edge of upper breast; worse pain in hipbones,upper and outer shoulders; Trigger points that had not been affected before are now affected.; Sore Injection Site (After the first Shot); This spontaneous case was reported by a health care professional and describes the occurrence of FIBROMYALGIA (Fibromyalgia pain escalated after second dose), NECK PAIN (pain involving trigger points in lower neck), BREAST PAIN (edge of upper breast), BONE PAIN (worse pain in hipbones,upper and outer shoulders) and PAIN (Trigger points that had not been affected before are now affected.) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer. Concurrent medical conditions included Fibromyalgia (fibromyalgia for 40 years.). Concomitant products included CEFIXIME (FLEXERIL [CEFIXIME]) for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 26-Jan-2021, the patient experienced FIBROMYALGIA (Fibromyalgia pain escalated after second dose), NECK PAIN (pain involving trigger points in lower neck), BREAST PAIN (edge of upper breast), BONE PAIN (worse pain in hipbones,upper and outer shoulders), PAIN (Trigger points that had not been affected before are now affected.) and INJECTION SITE PAIN (Sore Injection Site (After the first Shot)). At the time of the report, FIBROMYALGIA (Fibromyalgia pain escalated after second dose), NECK PAIN (pain involving trigger points in lower neck), BREAST PAIN (edge of upper breast), BONE PAIN (worse pain in hipbones,upper and outer shoulders), PAIN (Trigger points that had not been affected before are now affected.) and INJECTION SITE PAIN (Sore Injection Site (After the first Shot)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant:  Suspect #1: Medication Flexeril 10 mg. Suspect #2: Medication NSAIDS as needed, not often. Treatment Flexeril, NSAIDS, myofacial release chiropractic adjustments.       Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: The follow up information document which received on 25-MAY-2021. Second dosage information is added . Events were added.
Tested positive for Covid with Rapid test after having possible exposure and feeling tired the day before with a dry cough.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (dose, lot #, expiration date and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
6AM day p/had shot pt had hives over face only & vomiting x 1; sl fever pt given APAP; hives seemed to go away p/APAP given;
Next day arm hurt  so bad I couldn?t lift it. I felt very tired and whole body aches. 3 days later I can lift my arm but not above my head. Extremely tired. Low grade fever 99.5. Whole  body hurts.  In general I feel horrible.
The patient and the vaccinator both observed that there were 0.2mL in the syringe.  The patient thinks that the vaccinator placed the low dose aside, picked up another syringe, and then gave her a syringe with the correct dose of vaccine.  The vaccinator is not sure whether he gave her the full dose or if he gave her the syringe with 0.2mL.