chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received the Pfizer Covid vaccine on 22Apr2021, and 02May2021; Arthritis; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 22Apr2021 and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 02May2021 as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced inappropriate schedule of product administration on 02May2021 and arthritis on an unspecified date in 2021. She stated she taking Leflunomide 10mg daily for arthritis. She wanted to know if " A third "booster shot was necessary since she was on immunosuppressants?  The use of a 3rd or booster dose was not recommended or authorized and Pfizer does not suggest the use of the vaccine in any manner other than as described in the authorized EUA Prescribing Information. Therapeutic measures were taken as a result of arthritis with Leflunomide. The outcome of events was unknown.  The lot number for the vaccine was not provided and will be requested during follow up.
Fever,  chills,  aches,  pains,  very swollen hot arm for two days so far ?. This happened after the 3rd booster vaccine  for four days ?  so now I know it?s the vaccine and not me being sick or ill .
24 hrs after injection, feeling achy, tired. 48 hrs temp 100.2-continuous feeling tired and achy small knot with slight redness at site of injection.
1st vaccine given 3/10/21, 2nd given 3/19/21. No adverse reaction known.
Client did not exhibit any adverse reactions following administration.  Client was seated in exam room with provider and parent after injection for 15 minutes. No symptoms exhibited.
Right sided sudden hearing loss, no vertigo.   Woke up and noticed I wasn't hearing low frequencies.  Everything sounds tinny, my own voice doesn't sound the same, cannot hear people talking, all sound muffled but can hear higher pitched sounds.
Received vaccine at 1500 on Wednesday 2/3. General body aches started at 2200. At 0000 on a Thursday 2/4 upper back pain like someone hit me with a baseball bat. By 0400 chills, flushed face, temperature 101.2. By 0900 chest pain for 30 minutes. The rest of Thursday and Friday chills, bone pain in pubic area and both legs and then fever would start 101 or higher took Tylenol for every fever. Saturday headaches began with nasa congestion, nasal dryness and nose bleeds. Sunday night diarrhea. Monday morning headaches continue took 1 Tylenol with hangover feeling along with nausea all day and NO I did not drink alcohol, COVID TEST DONE as per work requirement. Tuesday runny nose, headache, nausea, took temperature 99.8. Today Wednesday woke up with headache congestion and more nausea and headache, COVID Test results negative , went to primary physician and did lab work and urine test . I have missed 2 weeks of work. As per  work still symptomatic after the vaccine and can not return to work after 10 days, today Wednesday is day #7
Vaccine that had temperature excursion administered to 69 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine that had temperature excursion administered to 69 patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 026B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine that had temperature excursion administered to 69 patients). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine that had temperature excursion administered to 69 patients) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported   No treatment medication reported
pt recv vax 26FEB96 & 7MAR96 pt devel large nodules on lower leg, pt seen in ER on 9MAR96 & nodules were dx as cellulitis;pt was also noted to have a pericardial effusion lab eval revealed ESR of 29;not hosp;dx nodule as erythema nodosum
Resident is fully vaccinated for COVID-19. Pfizer on 3/25/21 and 4/15/2021. Resident had a positive antigen test result for COVID-19 on 11/1/2021. Sx: Fever (T>100), increasing O2 dependence. PCR confirmed COVID-19.
Approximately 3 months later, I had extreme back head pain as if someone was beating me in the head with a hammer.  It was almost paralyzing.  So much pain that i could not do anything except sleep and not move. I finally went to the neurologist and had an MRI which showed i was diagnosed with occipital neuralgia which is inflamed nerves that travel to the skull.  Never had so much pain in my life.  The doctor was able to give me two injections in the back of my head to ease the pain.  It did not work right away and at the same time the pain traveled to the right side of my neck with also practically crippled me.  I could not turn my head at all.  Went to an occupational therapist who took another MRi and said it could be a pinched nerve or arthritis.  Never was so sick in my life.  This condition required me to take pain medication which did not really help much.  I spent most of the day crying in pain and not knowing what else to do.  Then maybe two or three weeks later I woke up and all the pain disappeared.  Have no idea what happened but I cannot say for sure if the Moderna shots had any impact of this since I have never been sick in my life. I have lead a pretty healthy life before.
Patient presented for Varivax vaccine 01/17/2022 at local clinic.  Returned to different clinic 01/18/2022 reporting she needed MMR and not Varivax vaccine.  Had MMR  vaccine administered 01/18/2022 and both are live vaccines so should have either been administered same day or wait 28 days prior to receiving second live vaccine.
sought medical eval to determine source of skeletal pain; Endocrinologist eval thyroid function adrenal, onocologist ordered bone scan; endocrinologist suspected lupus (ruled out); concluded that rapid onset of symetric arthritis in all jo;
injection site it was red; injection site it was swollen; injection site it was hard; injection site it was itchy; pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), VACCINATION SITE ERYTHEMA (injection site it was red), VACCINATION SITE SWELLING (injection site it was swollen), VACCINATION SITE INDURATION (injection site it was hard) and VACCINATION SITE PRURITUS (injection site it was itchy) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included Lupus syndrome. Concurrent medical conditions included Penicillin allergy and Hypertension.    On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PAIN (pain). On 13-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site it was red), VACCINATION SITE SWELLING (injection site it was swollen), VACCINATION SITE INDURATION (injection site it was hard) and VACCINATION SITE PRURITUS (injection site it was itchy). At the time of the report, PAIN (pain), VACCINATION SITE ERYTHEMA (injection site it was red), VACCINATION SITE SWELLING (injection site it was swollen), VACCINATION SITE INDURATION (injection site it was hard) and VACCINATION SITE PRURITUS (injection site it was itchy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications was reported.  Treatment drugs was not reported.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Child here with mother today for vaccinations. Received MMR, HPAC, and DHI in left anterior thigh. Received VZV, PCV13, and HIB in right anterior thigh. Immediately after receiving vaccines, noted local site reaction, erythematous flat rash, to right thigh. No other reactions noted at this time. Nurse manager notified. Mother opted to take child to local emergency room via personal vehicle. Attempted to contact mother twice x 2 attempts.
Pt presented with sirs r/t covid +. Pt in Afib rvr treated with cardizem.  Dexamethasone and remdesivir given and supplemental oxygen. pt discharged home
he got the first dose of the Pfizer Covid vaccine on 03Mar2021 and tested positive for Covid a week later on 09Mar2021; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient (age: 37; unit: unknown; as reported) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route of administration on 03Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced he got the first dose of the pfizer covid vaccine on 03mar2021 and tested positive for covid a week later on 09mar2021. The patient underwent lab tests and procedures which included covid-19 virus test: positive on 09Mar2021. Outcome of the event was unknown.  Information about lot/batch number has been requested.
Patient was given shot a little high on arm - think may have nerve damage was stuck twice by pharmacist. First syr. did not dispense vaccine. Patient arm very sore 2 days after.
Discomfort at the injection site [up to neck muscles]; Discomfort [at the injection site] up to neck muscles; This spontaneous case, initially received from a pharmacist on 17-Oct-2018, concerns a 41-year-old, adult female patient.  The patient's current condition included diabetes (since an unspecified date). The patient's concomitant medications included Metformin (metformin hydrochloride), glimepiride and Depo-provera (medroxyprogesterone acetate) for unknown indications.  On 10-Oct-2018, the patient was administered Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: YF40908 and expiry date: 30-Jun-2019) for influenza prophylaxis.  On the same day, two hours after vaccination, the patient experienced discomfort at the injection site up to neck muscles. There was no swelling or redness. The patient did not take any treatment measure. It was reported that, the patient would try analgesics and contact physician if no improvement.  On an unspecified date in Oct-2018 (12 to 14 days after administration of the vaccine), the patient had recovered from the events.  The reporter assessed the case as non-serious.  Follow-up report received from a pharmacist on 20-Nov-2018: The reporter confirmed that, the patient had recovered from events, 12 to 14 days after administration of the vaccine. The outcome of the events was changed from not recovered' to recovered'. The narrative was amended accordingly.; Reporter's Comments: A 41-year-old, female patient experienced discomfort at the injection site up to neck muscles, two hours after the administration of Afluria Quadrivalent. The causality of the event injection site discomfort and muscle discomfort as related to the suspect vaccine due to the plausible temporal relationship and site-specific reactions.
DIZZINESS; HEADACHE; This spontaneous report received from a consumer concerned a 68 year old female. 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 (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 29-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced dizziness, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and the outcome of dizziness was not reported. This report was non-serious. This case, from the same reporter is linked to 20210701429 and 20210701921.
Got COVID-19 after getting the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Got COVID-19 after getting the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Got COVID-19 after getting the vaccine). At the time of the report, COVID-19 (Got COVID-19 after getting the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter.  No treatment medication was provided.   This case was linked to MOD-2021-253201 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Updated reporter information,  causality for COVID-19 event and added a new event infection.
Pt received Immunization for PPV 23, Tdap and Influenza on 10/30/17, returned to clinic on 10/31/17 with c/o rash to (L) upper arm assessed by provider and given Loratadine 10mg.
My daughter received GARDASIL on 10/04/2007 and was diagnosed within 6 months with vasovagal syncope and Multiple Sclerosis. She was 16yrs old at her diagnosis and many doctors have commented on how young she was to be diagnosed. After researching the H1N1v vax and its possible side effects, it sparked conversations of other vaccines and side effects. I spoke with my sister who is a dr of pharm and she suggested reporting our situation to the FDA. I also did some further looking into reports of GARDASIL and MS and instances have been reported. I this this could be a valid concern.
Migraine; chills. Migraine treated with NSAIDs painkiller. 2 tablets did not help over the course of 2 hours.
fever like feeling with only a 1 degree rise in temperature, severe chills, headache, upset stomach, flush feeling in face, stiffness in knee and ankle joints, very drowsy.  Drowsiness started 20-24 hours after the shot and lasted for 36-48 hours.  More severe side effects lasted 6-8 hours.  Ibuprofen and tylenol together were very effective.
SUPERFICIAL BLOOD CLOT IN RIGHT LEG, UPPER THIGH AND VARICOSE VEINS; This spontaneous report was received from a 68-year-old female patient. The patient's height, and weight were not reported. The patient's past medical history included headache, and asthma. Concurrent conditions included high blood pressure (under control with medicines), diabetes (diagnosed 2 years ago; under control with medicines), tetracycline allergy (caused headache), and allergy to cats, dogs, horses, tree (caused asthma). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 1800031 or 1805031, and expiry: unknown) dose was not reported, 1 total, administered on left arm on 03-MAR-2021 for prophylactic vaccination. The patient was on unspecified medications for high blood pressure and diabetes. On 25-MAY-2021 (two and half month after vaccination), the patient noticed tenderness, warmth on touch, redness, and red lines in the upper inner thigh (above the knee) of the right leg. On 31-MAY-2021, the patient went to the immediate care, and the doctor diagnosed her leg as a superficial blood clot in the leg, thigh and varicose vein. Ultrasound was not available so healthcare professional (HCP) recommended the patient to see her primary HCP the next day. On 01-JUN-2021 (Tuesday), the patient went to her primary HCP (internist). The internist looked at patient's leg and confirmed the diagnosis as a superficial blood clot. On 02-JUN-2021 (Wednesday), at 08:45, she went to the vein specialist and the first ultrasound was performed. Once again, a diagnosis of superficial blood clot in varicose vein was confirmed. On 09-JUN-2021 (one week later), the patient returned for a second ultrasound to make sure the clot did not get any bigger and no improvement was noted. The patient was prescribed oral Aspirin 325 mg, 1 tablet, twice a day (BID) by the doctor. On 29-JUN-2021, the patient stated that she felt better. However, on the same day, a third ultrasound was performed by the ultrasound technician who noticed no improvement. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from superficial blood clot in right leg, upper thigh and varicose veins. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210666967-covid-19 vaccine ad26.cov2.s -Superficial blood clot in right leg, upper thigh and varicose veins. This event(s) is considered unassessable. The event(s) 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(s).
11/17/17 6pm face burning and red. 11/18/17 morning arm hurting, swollen.  11/17/17 by evening: BP 164/104 pulse over 100. 11/17/17 evening went to hospital ER--given "big dose" of Benadryl, then went home, improving. 11/19/17 saw PCP, arm still red and swollen to elbow, no further treatment.
Myalgia Chills Narrative: Sore arm with swelling persisted for several days post-injection. Chills improved quickly.
Using all the diluent to reconstitute the lyophilized powder and not just 0.6mL.; Using all the diluent to reconstitute the lyophilized powder and not just 0.6mL.; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in an unknown number of patients who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 22-JUN-2022 Reporter's comment: The reporter stated that there was not a specific patient, but general population at department of health. The reporter stated that when reconstituting Hiberix, site had been using all the diluent to reconstitute the lyophilized powder and not just 0.6mL. They had been doing this for a long time. They recently caught this error and had corrected it. Additional Supportive Information: when reconstituting Hiberix, site had been using all the diluent to reconstitute the lyophilized powder and not just 0.6mL which led to inappropriate preparation of medication and inappropriate dose of vaccine administered
Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On unspecified date, the patients were vaccinated with improperly stored PEDVAXHIB (dose and route unknown, lot # K011078, expiration date: 31-MAR-2017). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Local: Upper arm, swelling, redness, warmth, itchy 48 hours after injection. System: Cough/wheeze starting 4 hours after shot.   Gave Benadryl/albuterol aerosol.
patient experience Grade 1 body ache; Grade 1 nausea; Grade 1 pain at site of injection; Grade 1 headache; Fatigue G1; Received COMINARTI booster shot on 19Nov2021. Flu shot was also administered on the same day; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 19Nov2021 (Lot number: FH8030) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administration date 19Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. Relevant medical history included: "Asthma", start date: 1978 (ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Single, Intramuscular, left arm, Lot number: EL3248), administration date: 04Mar2021, for COVID-19 immunization; Bnt162b2 (Dose 1, Single, Intramuscular, Left arm, Lot number: EL3248, Lot number: EP655), administration date: 25Mar2021, for COVID-19 immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 19Nov2021, outcome "unknown", described as "Received COMINARTI booster shot on 19Nov2021. Flu shot was also administered on the same day"; IMMUNISATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "Booster"; PAIN (non-serious) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "patient experience Grade 1 body ache"; NAUSEA (non-serious) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "Grade 1 nausea"; VACCINATION SITE PAIN (non-serious) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "Grade 1 pain at site of injection"; HEADACHE (non-serious) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "Grade 1 headache"; FATIGUE (non-serious) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "Fatigue G1". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, vaccination site pain, headache. Therapeutic measures were not taken as a result of nausea, fatigue.  Addition information: The patient took 400mg Ibuprofen on 19Nov2021 orally for Grade 1 body ache, Grade 1 headache, and on morning of 20Nov2021. It was unknown if the patient had received any other vaccine within 4 weeks of Covid-19 vaccine. No relevant test was performed for thromboembolic events with thrombocytopenia.  Follow-up attempts are completed. No further information is expected.
Pt reported vaccine arm became erythematous, tender and swollen to her wrist beginning approximately 4 hours after the injection. Symptoms relieved with PO diphenhydramine. No systemic symptoms. No rash, itching, shortness of breath, perioral swelling or fever. Pt declined clinic appointment but came to the ED 6/22 complaining of continued erythema. She was given PO KEFLEX for possible cellulitis. Pt reported resolution of symptoms on 6/26.