chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt reported on 9/25/13 that they experienced a nicked tendon from flu vaccine. Went to Dr. and they said that it will heal in time and to use ice and anti-inflammatory.
arm was quite sore; arm was/ red; arm / had swelling; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included glaucoma and blood cholesterol increased. Additional patient notes included Ethnicity.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, erythema of extremities and swelling arm. On an unknown date, the outcome of the pain in arm, erythema of extremities and swelling arm were recovered/resolved.   It was unknown if the reporter considered the pain in arm, erythema of extremities and swelling arm to be related to Shingrix.  Additional details were provided as follows: The patient reported case for herself. The age at vaccination was not reported, however could be 69 or 70 years. The patient was taking statin, a blood pressure medication for high cholesterol and eye drops for glaucoma. The patient did not provide any product names. In 2018, the patient received 2 doses of Shingrix vaccine. After 1st Shingrix vaccination, the patient experienced that arm was quite sore, red, and had swelling. The patient stated that there was little more redness and swelling than the Covid vaccine. The reporter consented to follow up. No further information was reported. This case has been linked with US2021AMR116503, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR116503:2nd dose, same reporter same patient
Muscle twitching throughout body. Ongoing since dose 1. Followed up with provider who stated to increase water intake and stated it may be vaccine related. Have scheduled an upcoming appointment with a neurologist.
expired dose of acthib was administered with no reported adverse event; Initial information received on 15-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 years old female patient to whom expired dose of acthib was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 7V (CRM197) (Prevnar) and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine Toxoid (DTAP) for Prophylactic vaccination.  On 15-Aug-2023, the patient received 0.5 ml (dose 4) of suspect HIB (PRP/T) VACCINE, Powder and solvent for solution for injection lot UJ787AA, expiry date-11-Aug-2023 via intramuscular route in left quadricep for immunization (strength: unknown), expired dose of acthib was administered with no reported adverse event (expired product administered) (latency same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event expired product administered.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
Last two times got COVID were definitely less severe than the first three times; Patient got Pfizer, Moderna and JnJ; Patient got Pfizer, Moderna and JnJ; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Last two times got COVID were definitely less severe than the first three times), INTERCHANGE OF VACCINE PRODUCTS (Patient got Pfizer, Moderna and JnJ) and COVID-19 IMMUNISATION (Patient got Pfizer, Moderna and JnJ) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication and COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form, dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form and dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Last two times got COVID were definitely less severe than the first three times), INTERCHANGE OF VACCINE PRODUCTS (Patient got Pfizer, Moderna and JnJ) and COVID-19 IMMUNISATION (Patient got Pfizer, Moderna and JnJ). At the time of the report, COVID-19 (Last two times got COVID were definitely less severe than the first three times), INTERCHANGE OF VACCINE PRODUCTS (Patient got Pfizer, Moderna and JnJ) and COVID-19 IMMUNISATION (Patient got Pfizer, Moderna and JnJ) outcome was unknown.            No concomitant product was reported. No treatment information was reported. 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.
Approx 5 minutes after receiving vaccines which included Tdap, HPV#1 and Menactra, pt had syncopal episode, falling to the floor and hitting her head.  She was unconscious for approx 10-15 seconds, then groggy but oriented x 3.  She was unable to remember the day's events and kept asking the same questions repeatedly.  Was observed in outpatient clinic x 2 hours with no improvement.  Transported via ambulance to ER, CT of head was normal, was observed 2 more hours and discharged home.
No adverse effect. Administration error.  Mother brought child to clinic for HIB vaccine.  Child had received only 1 valid dose of Hep B in the past ( second dose was invalid)  Per registry, child has a documented immunity to Hep B Child received 2nd valid dose in series. Mother has agreed to vaccinate for HIB in 2 weeks.  Mother has also provided documented immunity to Hep A, Measles, Mumps, Rubella and Varicella
After 12 hours from the vaccine, I started lose body function. Felt terrible and after I woke up, I was then able to get some Tylenol and the next day my body just ached. After a few weeks of body aches, I went to my PCP and received bloodwork. Bloodwork was done however results have not come back yet from PCP. PCP examined thoroughly and could not find anything wrong and that my antibodies had begun attacking my body. I am also having pain in my right side starting from above my hips going into my right side.
Patient received 2nd dose 5 days early before the 28th day or the 4 days grace period. Patient had no side effects or adverse effects after vaccination. Patient received the 2nd dose on the 22nd day after the first dose. Patient was advised to return after the 28 days of the first dose or no earlier than 4 days before the 28th day.
Administration error, patient received first dose of Pfizer 02/16/2021. Patient did not develop any adverse reaction at the time of visit.
FEVER, MYALGIA, NAUSEA, HEADACHE  Narrative: SYMPTOMS BEGAN APPROX 12 HRS AFTER VACCINE WAS RECEIVED; FEVER 10; PATIENT MISSED ONE DAY OF WORK
SEVERE BODY SHAKES; VOMITING; CHILLS; NAUSEA; FEVER; FEELING HOT; This spontaneous report received from a consumer concerned a 22 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 to left arm for prophylactic vaccination. Concomitant medications included ibuprofen. On 06-APR-2021, the subject experienced feeling hot. On 06-APR-2021, the subject experienced fever. On 06-APR-2021 23:00, the subject experienced severe body shakes. On 06-APR-2021 23:00, the subject experienced vomiting. On 06-APR-2021 23:00, the subject experienced chills. On 06-APR-2021 23:00, the subject experienced nausea. On 07-APR-2021, Laboratory data included: Body temperature (NR: not provided) 103 F. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe body shakes, and chills on 07-APR-2021 02:00, and had not recovered from fever, nausea, feeling hot, and vomiting. This report was non-serious.
VERY SWEATY; LOW GRADE FEVER; FELT TIRED; AMENORRHEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: drug addiction (The patient had been 4 and half years clean from drug addiction), and other pre-existing medical conditions included: The patient had no known allergies. The patient was not pregnant at the time of vaccination and was healthy before vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 250A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for covid-19 prophylaxis. No concomitant medications were reported. On 2021, the patient experienced amenorrhea. On 09-APR-2021, the patient experienced felt tired. On 10-APR-2021, the patient experienced very sweaty, and low grade fever. Laboratory data included: Body temperature Low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very sweaty, low grade fever, and felt tired, and was recovering from amenorrhea. This report was non-serious.
t102, redness size of soft ball-applied cool wash cloth & temp dec, gave APAP, swelling subsided by 4th day;
POTS (postural orthostatic tachycardia syndrome).  Cough, DOE and elevated HR at rest.  (pt's usual HR is in the 60s; it is now in the 90s to 100s after the vaccine).  Pt's HR increased from 79 lying to 106 standing (orthostatics done in urgent care)
While seeing a retinal specialist for a recent symptom of flashes and floaters, he discovered evidence of a retinal vasculitis. I was sent to a second medical retina specialist, MD, who sent me to Rheumatology MD. My PCP also completed blood work. No specific symptoms from the vasculitis other than photopsia and floater due to a recently diagnosed posterior vitreous detachment. Vasculitis found coincidentally during retinal exam. Not previously noted in previous eye exams.
Covid symptoms started on 06/06/22; tested positive on 06/08/22. I had a little cough, fatigue, runny nose, and yellow phlegm. Symptoms lasted another 2 days. I called my doctor to inform of a positive Covid test and I had a telemed appointment and he prescribed me PAXLOVID since I have asthma and I started that day and my symptoms never got any worse than that. Symptoms wise, it was pretty light I stayed home and drank fluids and it never progressed any deeper and my wife had it week earlier and I think that's where I got it from. I took another test on 06/13 and it was negative.
Fever, cold sweat, pain and swelling in left arm, fatigue , body ache, dizziness, nausea.
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Unable to Sleep-Medium, Systemic: Weakness-Severe
Very heavy menstrual cycle, extreme PMS, period went from light 3 to 5 days to very heavy 7+ days
a 17 year old / received an adult dose of Engerix-B; a 17 year old / received an adult dose of Engerix-B; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 17-year-old female patient who received HBV (Engerix B adult) (batch number N4GA4, expiry date 2nd January 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (1st dose received on an unknown date).   On 8th June 2021, the patient received the 2nd dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. On 8th June 2021, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the overdose and inappropriate age at vaccine administration 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:  Nurse reported that a 17 year old patient who received an adult dose of Engerix-B, it was administered on the same day as reported it which led to overdose and inappropriate age at vaccine administration. The reporter consented to follow up.
Low grade fever continues five days after injection; skin is red in a rectangular shape diagonally from the injection site (site was upper left arm near the shoulder and the shape is down and on the inner arm towards the body
Pre vaccine anxiety. Post vaccine pt developed some visual changes and then muffled hearing. Pt was assisted to the ground by staff and legs elevated on chair. Transported to obs at 1652 via stretcher and accompanied by mother. Vitals obtained and monitored. No other symptoms developed and previous symptoms resolved. Pt was released to home with mother at 1710. Vitals as follows: 1655 LYING BP 115/82 HR 73 RR 18 SPO2 97 1700 LYING BP 117/76 HR 81 RR 18 SPO2 97 1705 SITTING BP 123/79 HR 66 RR 18 SPO2 98 1708 STANDING BP 105/71 HR 79 RR 16 SPO2 98
OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. No adverse events reported after primary vaccination (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination which was an off label use as inappropriate schedule of vaccine administered (dose number in series 2). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient received JNJ booster dose 14 days earlier than on-label interval after JNJ primary dose (off label use, and inappropriate schedule of vaccine administered) (dose number in series 2). Reporter stated that the event occurred 4 to 5 months ago in a long-term care facility. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious.
Case number PHHY2012US076889 is an initial spontaneous report received from vaccine adverse event reporting system website (VAERS reference number: 457438) on 05 Sep 2012. This case refers to a 11-year-old male patient. He was vaccinated with MENVEO (batch number: A10132) intramuscularly into his left arm on 11 jun 2012. On the same day he was also vaccinated with ADACEL vaccine (batch number: AC52B075BA, other manufacturer) intramuscularly into his left arm and VAQTA (batch number, batch number: 1441AA, other manufacturer) intramuscularly into his right arm. On 13 Jun 2012, the patient developed swollen red left arm. It was reported that there was a concern for cellulitis but was not confirmed. The final outcome was reported as completely recovered on an unspecified date. No other information was available.
24hrs following vax infant exp sz;spontaneous onset 7 resolution of stiffening of arms & inattention, lasting 5 to 10sec; Also vomiting, diarrhea, dehydration, lethargy, wgt loss, & t100.6F;
Sore throat, cough, slight fever; followed the next morning (01/06/2013) by fever, body aches, headache, fatigue which persisted 72 hours.  By 01/10/2013 no fever, but congestion, cough, fatigue.
(L) arm red, swollen, hot to touch 2 days s/p vaccine admin, antibiotics Rxed.
solid cramps on both her legs to the point of not being able to walk; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (solid cramps on both her legs to the point of not being able to walk) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 27-Feb-2021, the patient experienced MUSCLE SPASMS (solid cramps on both her legs to the point of not being able to walk). At the time of the report, MUSCLE SPASMS (solid cramps on both her legs to the point of not being able to walk) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
11 yr old male received 0.2cc of vaccine from Purple vial, essentially 20mcg. No adverse reactions noted during time in clinic.
patient called stating she went to her doctor and her dentist and they diagnosed her with shingles of the mouth. pt believes may be due to vaccine. she was diagnosed 1 week following immunization
Pt developed chest tightness shortly after vaccination. She believes that her chest symptoms are consistent with anxiety. She notes anxiety with injections and vaccines in the past. BP 160/90, HR 82, SP02 99%. R: 16. EMS services was recommended but the pt declined and elected to drive home. She is aware of the risks of a potentially serious undiagnosed medical issue.
first dose administered subcutaneously.; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 54-year-old male patient who received Herpes zoster (Shingrix) (batch number EZ4TD, expiry date 4th November 2022) for prophylaxis.   On 16th September 2021, the patient received the 1st dose of Shingrix (subcutaneous). On 16th September 2021, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix subcutaneously, which led to intramuscular formulation administered by other route. The reporter consented to follow up.
This spontaneous report as received from a 61 year old female patient refers to herself. On 17-FEB-2014 the patient was supposed to receive a dose of ZOSTAVAX injection but was inadvertently vaccinated with a dose of VARIVAX (Merck), 0.5 ml, subcutaneous (lot number not provided). The patient experienced no adverse effects. Additional information has been requested.
Patient experienced a warm sensation passing through her body for a couple of minutes after the injection. Also noted pain at injection site (minor pink swelling) & feeling of lightheadedness.
Acute muscle fatigue and pain below waist, lasting ~24 hours; self-treated with tylenol
pt recvd vax & exp a high fever 2-3 days p/vax & hematuria requirin hospitalization; treated w/ATB; urine culture neg; hematuria resolved; poss viral illness;
Get shingles after the shot/Suspected vaccination failure; Shingles; Painful; This case was reported by a consumer 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), shingles and pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The patient get shingles after the shot, however it was mild case but it was still painful. This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were not provided.
Covid vaccine given, 15 minutes later, pt Blood Pressure went up, some chest tightness observed by EMS for an hour and BP came down to normal & chest tightness went away
Information has been received from a nurse, referring to an adult  patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 12-SEP-2018, the patient was vaccinated with a pediatric dose instead of an adult dose of VAQTA, 25/0.5 (units not provided) intramuscularly (anatomical location, lot number and expiration date were not reported) for prophylaxis. No adverse effects were reported.
The same night as my second injection I woke up drenched in sweat. The following day (Sunday)I felt very rough but by Monday was feeling well apart from having very sore gums that hurt when I brushed my teeth.  By the following day (Tuesday) my lips, and tip of the tongue had become numb and tingly as if I had returned from the dentist and had novocaine administered the effects of which had not fully worn off. The front of my mouth has stopped producing saliva so I get cotton mouth a lot and my teeth stick to the inside of my gums at the front if I do not constantly move my tongue around.
This was the second dose in the series. Patient reported that the first dose in the series, she had no adverse events, but had normal muscle soreness associated with receiving a vaccine. The symptoms of the second dose began the morning after receiving the vaccine. She stated that the previous night, she noted muscle soreness, but the following morning (12/31/2019), her arm became slightly swollen and a rash around the injection site that spread down to the elbow. She also noted increased heat in the left arm and significant pain. She applied ice packs, but found little relief. She saw her primary care provider on 01/03/2020 due to these symptoms and was prescribed prednisone, hydrocodone/acetaminophen, and azithromycin. Per patient, the pain lingered until 01/12/2020.