chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Noticed red patch near injection site around 1600,14 days after 1st dose. Not itchy, not painful. It was in the shape was long and irregular and was warm to the touch. Took naproxen 200mg soft gel before bed for a mild headache (most likely unrelated but can't confirm). On day 15 around 1100, the site is slightly pinker (not red) and a little warmer to the touch (no itching, not painful).
covid vaccine breakthrough event  dose 1 Moderna 2/13/21 015M20A dose 2 Moderna 3/13/21 002B21A
Loss/thinning of hair top of head from anterior to posterior (crown)=2 1/2 months after shot.
sore arm; super itchy and breaking out with hives; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of INJECTION SITE PAIN (sore arm) and URTICARIA (super itchy and breaking out with hives) 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 13-Jan-2021 at 6:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced URTICARIA (super itchy and breaking out with hives). On an unknown date, the patient experienced INJECTION SITE PAIN (sore arm). At the time of the report, INJECTION SITE PAIN (sore arm) and URTICARIA (super itchy and breaking out with hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered INJECTION SITE PAIN (sore arm) and URTICARIA (super itchy and breaking out with hives) to be possibly related.    Patient states she has not been exposed to any new food, soap, or solutions.   Treatment information not provided.
received a late second dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number KB97C, expiry date 13th November 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2 years ago from the date of reporting, the reporter did not know the exact date).   On 5th July 2021, the patient received the 2nd dose of Shingrix. On 5th July 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 reported as follows: Pharmacist reported that a patient who received 2nd dose of Shingrix later than recommended schedule which led to lengthening of vaccination schedule. The reporter did not consent to follow up.
pt recvd vax;came to hosp c/o sweating,shoulder pain & dizziness p/ recving vax 7dec94;noticed numbness in 4th & 5th fingers w/ severe pain & inc swelling of lt arm;pt c/o T 103 & chills;pt appeared septic 8dec & T 101.7, lt arm cellulitis;
Suspected vaccination failure; shingles; sick; tired; pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   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, sickness, tiredness and pain. On an unknown date, the outcome of the vaccination failure, shingles, sickness, tiredness and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, sickness, tiredness and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient taught that you only get shingles once but the patient keep getting them so his/her doctor started doing a biopsy to make sure they were shingles and not herpes, and sure enough they were shingles.  The patient was vaccinated but still experienced shingles. The patient was so sick and tired of getting shingles, and the pain was sometimes unbearable. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset of shingles were not provided. This case has been linked with case US2021AMR200635 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR200635:same repoter
Beginning in March began having more severe arthritis flare ups than usual (pain, swelling, hot joints)  may have no connection to vaccine.  Maybe it's an age thing.  Usually have minor flareups that do not affect working however have had 3+ since March.  I plan to get the booster as soon as possible
dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A214) 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) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (dizzy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizzy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported concomitant medication use of female hormones and cholesterol medication both for unknown indications since unknown start dates.     This case was linked to US-MODERNATX, INC.-MOD-2021-075286 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-075286:CROSSLINKED WITH DOSE 2
This case was reported by a healthcare professional and described the occurrence of arm tingling in a 54-year-old female subject who was vaccinated with Influenza vaccine unspecified (GlaxoSmithKline). Concurrent medications included PREMARIN, WELLBUTRIN, Allergy medication, PRILOSEC, Glucosamine chondroitin, Vitamin B Complex and Meloxicam. On an unspecified date in October 2009 the subject received 1st dose of Influenza vaccine unspecified (1 ml, unknown, left arm). On an unspecified date in October 2009, less than one day after vaccination with Influenza vaccine unspecified, the subject experienced arm tingling, arm pain and vaccine administered at inappropriate site. The subject, who is also the healthcare professional reported she received the flu vaccine very high up on her arm in her joint. The same afternoon, the subject experienced a tingling in her arm as well as increasing pain. She went to a physician who gave her cortisone shots in that joint but she is still have pain from it. The subject reported that "physician wants to do surgery and take the bursa sac out". The subject was treated with cortisone. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the arm tingling and arm pain was unspecified.
vaccine was administrated beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine was administrated beyond use date after the thaw process) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030h21b) for COVID-19 prophylaxis.     It was unknown if the patient had ever been diagnosed with or tested positive for COVID-19. It was unknown if the patient had any acute illness at the time of vaccination and up to one month before. It was also unknown if the patient had any chronic or long-standing health conditions.     On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine was administrated beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine was administrated beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Age of the patient was reported as 43 years and 2 months.  Race of the patient was reported as some other race.  Concomitant medication of the patient was not reported.  The patient did not experience any adverse reactions after the administration of vaccine.  No treatment information was provided by the reporter.
Initial 3 days: Tiredness, head ache. 7 days later: Itchy at injection site and redness/a hard-ish bump at injection site. Lymph node under left armpit feels tender for 3 days.
Food poisoning; This spontaneous case was reported by a consumer and describes the occurrence of FOOD POISONING (Food poisoning) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FOOD POISONING (Food poisoning). At the time of the report, FOOD POISONING (Food poisoning) outcome was unknown.            No concomitant medications were provided by the reporter.   Patient was able to get the second shot within the recommend time frame.Treatment information was not provided.  Company comment: Based on current available information and the temporal association between product use and the start date of the event a causal relationship is unlikely.   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: Product dose omission event deleted. Hospitalization was added.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested. However based on know profile of the vaccine and common source of food poisoning; it is unlikely related to vaccine.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the event a causal relationship is unlikely.
ADMINISTERED PFIZER BIVAL 30MCG/0.3ML INSTEAD OF THE CORRECT DOSE OF PFIZER BIVAL 10MCG/0.2ML  FATHER HAS NOT NOTED ANY ADVERSE EVENTS TO THIS POINT IN TIME
Moderna Covid-19 Vaccine 7 days after(Jan 21)  receiving 1st vaccine injection (Jan 14) I developed a line of red itchy bumps from the injection site. Went from injection point downward and then curved around it in a letter "C" shaped line.
she got pediatric dose 0.2 ml but they didn''t dilute it; she got pediatric dose 0.2 ml but they didn''t dilute it; severe headache; This is a spontaneous report received from a contactable reporter (Physician).  A 11 year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19), intramuscular (Batch/Lot number: unknown) at the age of 11 years as dose number unknown (tris), 0.2 ml single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: OVERDOSE (non-serious), PRODUCT PREPARATION ISSUE (non-serious), outcome "unknown" and all described as "she got pediatric dose 0.2 ml but they didn''t dilute it"; HEADACHE (non-serious), outcome "recovered", described as "severe headache". Additional information: Patient age is 11 years and 5 months of event (vaccination). The patient had not received any other vaccine within 4 weeks. Patient received pediatric dose but the pharmacist forgot to dilute it. Patient had severe headache for 5 to 6 days but right nowshe is doing okay and no other symptom.  The lot number for bnt162b2 was not provided and will be requested during follow up.
pt recvd vax & exp paresthesia, pain & stiffness p/each dose; pt seen by MD for the sx; No further details were provided;
pregnant at time of vaccination O13.9 - Gestational hypertension affecting first pregnancy O14.13 - Severe pre-eclampsia, third trimester
burning; very uncomfortable arm.; wheezing; whenever she blow nose is bloody; itching at the site of injection; redness at the site which is spreading and looks like hives; area of arm at injection site is hard to touch; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (burning), LIMB DISCOMFORT (very uncomfortable arm.), WHEEZING (wheezing), EPISTAXIS (whenever she blow nose is bloody) and INJECTION SITE PRURITUS (itching at the site of injection) in a 33-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE PAIN (burning), LIMB DISCOMFORT (very uncomfortable arm.), WHEEZING (wheezing), EPISTAXIS (whenever she blow nose is bloody), INJECTION SITE PRURITUS (itching at the site of injection), INJECTION SITE ERYTHEMA (redness at the site which is spreading and looks like hives) and VACCINATION SITE INDURATION (area of arm at injection site is hard to touch). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (burning), LIMB DISCOMFORT (very uncomfortable arm.), WHEEZING (wheezing), EPISTAXIS (whenever she blow nose is bloody), INJECTION SITE PRURITUS (itching at the site of injection), INJECTION SITE ERYTHEMA (redness at the site which is spreading and looks like hives) and VACCINATION SITE INDURATION (area of arm at injection site is hard to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.    Reporter did not allow further contact
This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 06-AUG-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB "10Pk 10 mcg/1mL SD LLok Cap AD", lot # L001441  with expiration date 17-AUG-2017 (route of administration and anatomical location were not reported). There were no concomitant therapies and adverse effects reported. No product quality complain was involved. On an unspecified date, the RECOMBIVAX HB had four temperature excursion of 31 F (-0.5 Celsius Degrees) for 152 hours, 34 F (1.1 Celsius Degrees) for 88 hours, 33 F (0.5 Celsius Degrees) for 40 hours and 32 F (0 Celsius Degrees) for 152 hours, respectively. The vaccine status was reported "in excursion". The vaccine storage criteria and type of excursion were reported as "Refrigerator (R)". This is one of several cases from the same reporter. Additional information has been requested.
This individual died the evening he received the Moderna Booster on 12/6/21.  Staff at his Group Home report he had a decreased appetite and fluid intake for the last week or longer.  He has had Dementia for a few  years. He had difficulty breathing on 12/6/21 around lunch time. 911 was contacted. The paramedics arrived and he was transported to Hospital. The group home staff received a call from Hospital staff on 12/6/21 stating that he had passed away at 8:15 p.m. His case worker, sister, and the Group Home Program Manager met the same day and agreed to pursue end of life care.
10.00 H1N1 administered. Approximately 10.30 began to have "Bugs crawling on me". Shot was in left arm. Began to have severe itching in L lower back. Felt like insects biting. Reported to clinic injection of benadryl at 10.35. Denies tenderness of shot, SOB, visual problems, head aches...... symptoms resolved after injection of Diphenhydramine 25mg IM.
Redness and swelling on large area 2 days after vaccine covering his entire left shoulder. Mom advised to give BENADRLY and stated it greatly helped reduce swelling/redness.
if the patient move her arm in wrong direction or lift something then her arm would her. it started around 30 minutes after the vaccine. it would stop hurting for a bit and then resume if arm is lifted or move.
Information has been received from a licensed practical nurse concerning a 70 year old female patient with hypertension, oesophageal reflux, osteoporosis and allergies to acetaminophen with codeine and rofecoxib who on 4/19/05 was vaccinated IM with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot # 649695/0512P). Concomitant therapies included alendronate sodium, hydrochlorothiazide, cephalexin, pantoprazole sodium, metoprolol succinate, vitamin D, calcium carbonate and ibuprofen. Subsequently, (later), the patient developed cellulitis at injection site. It was unknown if treatment was required for cellulitis. The patient sought unspecified medical attention. The patient was reported to be recovering. It was also reported that at the time of the report, it was not known if the patient received a prior dose of pneumococcal 23v polysaccharide vaccine. There was no product quality complaint involved. Additional information has been requested.
adult patient who is going to be having surgery, and the doctor wrote a prescription for the patient to get one 0.5 mL dose of acthib prior to the surgery,with no reported adverse event; adult patient who is going to be having surgery, and the doctor wrote a prescription for the patient to get one 0.5 mL dose of acthib prior to the surgery,with no reported adverse event; Initial information received on 27-Jul-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 62 years old female patient who experienced adult patient who is going to be having surgery, and the doctor wrote a prescription for the patient to get one 0.5 ml dose of acthib prior to the surgery,with no reported adverse event and adult patient who is going to be having surgery, and the doctor wrote a prescription for the patient to get one 0.5 ml dose of acthib prior to the surgery,with no reported adverse event while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a 0.5ml dose of suspect HIB (PRP/T) VACCINE  (0.5 mL 1X) (strength, formulation, route,lot number not reported) in unknown administration site for prophylactic vaccination.  On an unknown date the patient reported adult patient who is going to be having surgery, and the doctor wrote a prescription for the patient to get one 0.5 ml dose of acthib prior to the surgery,with no reported adverse event (product prescribing issue) and  (off label use)(unknown latency) following the administration of HIB (PRP/T) VACCINE.  Action taken: not applicable.   At time of reporting, the outcome was Unknown for the events,    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.
Fever (+2 degrees above normal); very strong headache, body aches, chills, fatigue, hot flashes, some chest congestion, could not sleep due to aforementioned. Symptoms began about 12 hours after second dose. Symptoms subsided about 24 hours after second dose.
Moderna Covid-19 Vaccine EUA Injection SITE ROUND 6" INFLAMMATION , Hot and Raised.  painful, itching, some skin peeling. Reaction started within 24 hours and  side effects lasted 5-7 days. Other side effects not severe, fever 101 lasting 24 hours, treated with APAP. HA on and off for 7 days treated also with APAP slight runny nose and sore throat
local reaction; a little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (local reaction) and VACCINATION SITE PAIN (a little sore arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder. Concomitant products included CELECOXIB (CELEBREX), CORTISONE, BIMATOPROST (LUMIGAN) and GABAPENTIN for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE REACTION (local reaction) and VACCINATION SITE PAIN (a little sore arm). At the time of the report, VACCINATION SITE REACTION (local reaction) and VACCINATION SITE PAIN (a little sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication also include thyroid medication 75 mg once a day. No treatment drug details was reported.  Patient had no history of myocarditis/pericarditis and Previous COVID19 infection   This case was linked to MOD-2021-354510, MOD-2021-354564 (Patient Link).
This case was reported by a pharmacist via call center representative and described the occurrence of shoulder pain in a patient who received FLUARIX QUADRIVALENT (batch number 7994K, expiry date 16th June 2016). On 7th October 2015, the patient received FLUARIX QUADRIVALENT .5 ml. In October 2015, 7 days after receiving FLUARIX QUADRIVALENT, the patient experienced shoulder pain. On an unknown date, the patient experienced neuritis and bursitis. On an unknown date, the outcome of the shoulder pain, neuritis and bursitis were unknown. It was unknown if the reporter considered the shoulder pain, neuritis and bursitis to be related to FLUARIX QUADRIVALENT. Additional details were received as follows: This case was reported by a nurse to a pharmacist. There were 5 employees who received FLUARIX QUADRIVALENT, and experienced increasing pain at the shoulder, one week later after vaccination. Among the 5 employees 2 patients were female and the genders of the other 3 patients were unknown. One of the patients was treated at the emergency room. Other patients were seen by their primary care physician and diagnosed with possible bursitis or neuritis. The patients were underwent Nuclear magnetic resonance, but it was unknown that, who amongst 5 patients underwent had the test and what are the outcomes. It was reported that, according to one physician the cause of the event was maladministration, but the nature of maladministration was not certain. The reporter stated that, she provided all the information she had available.