chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st SHINGRIX  dose in early 2020/has not received 2nd dose due to COVID19 Pandemic.; This case was reported by a consumer via call center representative and described the occurrence of social problem in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in early 2020, in pharmacy).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The reporter was the patient's wife. The age at vaccination was not applicable for this report. The reporter stated that, the patient had not received 2nd dose due to Covid 19 Pandemic, which led to social problem. The reporter was not able to provide exact details about month of 1st dose or shot administration details for the patient. The patient gave permission to follow up with his doctor.
where gall bladder was removed a lot of pain there; where gall bladder was removed a lot of pain there; arm still sore where they gave the shot; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number GLO142/ ELO142, reporter can't tell if it's an E or G), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. Medical history included blood cholesterol abnormal, thyroid disorder, blood pressure abnormal, gall bladder was removed, hospitalized with low potassium before. Concomitant medication included levothyroxine, liothyronine (NP THYROID) for thyroid, atorvastatin (LIPITOR) for cholesterol, atorvastatin for blood cholesterol, sodium hypochlorite (HYPOCHLORITE) (not clarified), potassium chloride for low potassium, indapamide water pill for blood pressure. The patient previously received her first dose of BNT162B2 on unknown date for COVID-19 immunization. The patient got the second shot yesterday and last night patient started getting like that......where patient's gall bladder was removed a lot of pain there and what she did it was like took the......she had this "brace" (not clarified) thing that she used for her lower back and she put that around her chest and that kind of helped a little bit but she didn't know if that was a side effect or is it the "fracture" (not clarified) in "your infection" (not clarified) this know what can she take for that. The patient's arm is still sore where they gave her the shot but her stomach was feeling better now. The patient worked in a hospital as a Nursing Assistant. She was a Certified Nursing Assistant. Actually the patient worked outside, she went to people houses to take care of patient in their houses. The outcome of events was unknown.  Information about Lot/Batch has been requested.
Large red swelling on left upper arm,  no fever, 2 days after injections. Parent took child to emergency dept, Dx cellulitis & treated with Trimethoprim sulfa.
Ot serum react d/t vacc on 2014-02-28. Clinician comment: Diarrhea, vomiting after ROTATEQ vaccine.
Injection arm red & swollen (R); didn't feel well for couple days - chills, fever, nausea, ache.
This spontaneous report was received from a physician concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions or allergies were not reported. On 13-SEP-2017, the patient was vaccinated with VARIVAX (dose, lot number and expiration date were not reported) and PROQUAD (dose, lot number and expiration date were not reported) both for prophylaxis. Other suspect vaccine included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid. The patient's concomitant therapies included sterile diluent (manufacturer unknown). No side effects were reported.
pt felt fine until ready to go  felt lightheaded and hot. pt placed on floor  began to shake for a few seconds and laid flat with feet elevated pt started to feel better and placed on stretcher to OBS for further evaluation.  pt in OBS feeling better  given water and crackers tolerating well.  denies further symtpoms.  vs as noted. dr at bedside  reviewed bp   pt sitting up then dangling then standing at side of bed   tolerated well   feeling better  pt okay to leave  ambulated to exit without difficulty at 1544 VS 1525 bp 132/80 hr 98 rr 14 o2 99, 1535 bp 149/84 hr 73 rr 16 o2 100  1540 bp 124/70 hr 75 rr 16 o2 100
Itchiness on arms and neck.; This is a spontaneous report from a non-contactable pharmacist. A 29-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via intramuscular route of administration in the right arm on 25Feb2021 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 25Feb2021, the patient experienced itchiness on arms and neck. It was reported that BENADRYL  and water was offered to the patient but was refused. Therapeutic measures were not taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event itchiness on arms and neck was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
As of this day 8/11/2022 i still feel occasional pain and itchiness at injection site. Is it possible for the side effects to last this long?  I have felt this since recieving this injection which was the booster shot. I asked my doctor a d she was not sure. Please email me about this. Thanks.
Administered Pfizer Boost dose and later discovered that first series that patient received was Moderna. No Reaction noted.
patient was given covid vaccine for 6 months - 4 years of age, instead of vaccine for ages 5-11 years of age
Incoherent, forgetful, didnt want to eat or drink stayed in bed . went to doctor 5/6/21, was sent to hospital ER and admitted .
Felt so debiliated; Fatigue; Chills; A spontaneous report was received from a consumer who received Moderna's COVID-19 vaccine and experienced felt so debilitated, fatigue and chills.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an Unknown date prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: Unknown) for prophylaxis of COVID-19 infection.   After receiving the vaccine, the patient experienced fatigue, chills, and felt debilitated. The treatment for the events are unknown.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the events, felt so debilitated, fatigue and chills were considered as unknown.; Reporter'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.
Temperature 104.3 approx 5 hrs after immunizations. Lethargic, vomited x 2 and jerking movements. Fever went down to 101 post two hours of Motrin doses (doubled) x 2 jerking movements lasted until 8am 06/20/2002. Mother called family physician to report.
Fever to 102F, local redness, warmth, swelling, tenderness right upper arm, headache
Information has been received from a physician and a nurse concerning an 83 year old male patient with diabetes and on dialysis who in 2007 was vaccinated with 0.65ml dose of ZOSTER vaccine. The physician stated that the patient developed shingles this year after receiving ZOSTAVAX last year. At the time of this report it is unknown if the patient recovered. The patient sought unspecified medical attention. Additional information has been requested.
SORE ARM; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
My staff missed seeing that this individual was not old enough for the Moderna vaccine. Her mom works at the same facility and has been notified.
Patient reports having localized reaction , redness,  lump at site. Patient went to see her PVT MD who suspects it was given  subcutaneous instead of IM.
Patient complained of rash, redness, warm, hard, swelling and painful at injection site. The rash is is 3 & 1/2 inch diameter big.
Infection and hospitalization. 2/13/2021 admission with discharge on 2/22/2021. Worsening SOB and epistaxis upon admission requiring intubation and admission to ICU. Extubated on 2/17/2021. Dx during visit include hypoxia, sepsis, hypotension, anemia, aspiration into airway, creatinine elevation, epistaxis, atrial fibrillation, essential hypertension, diastolic heart failure
On day 2 after vaccine she developed a fever of 103 degrees & this lasted 3 days.  On day 3 after vaccine she was seen at PMD by FNP.  Treated with antibiotics for a sore throat.
shoulder is painful; shoulder is painful/cannot use it except maybe like 20 or 30 percent of the power of his hand; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient. A 75-year-old male patient received pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 20), in Jun2023 as dose number unknown, single (lot number unknown) for immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing). Concomitant medications included: METFORMIN oral taken for diabetes mellitus; METOPROLOL; ATORVASTATIN; AMLODIPINE. The following information was reported: ARTHRALGIA (non-serious) with onset Jun2023, outcome "not recovered", described as "shoulder is painful"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset Jun2023, outcome "not recovered", described as "shoulder is painful/cannot use it except maybe like 20 or 30 percent of the power of his hand". The events "shoulder is painful" and "shoulder is painful/cannot use it except maybe like 20 or 30 percent of the power of his hand" required physician office visit. Therapeutic measures were not taken as a result of arthralgia, joint range of motion decreased.  Additional Information: The patient informed that 4 months ago, a nurse gave him a shot for pneumonia, it's Prevnar 20 which is made by Pfizer. Since that time from that day till now his shoulder is painful, he cannot use it except maybe like 20 or 30 percent of the power of his hand. He does not know what's going on. The doctor did not give him an answer, so he called a pharmacy "that makes the vaccination" and maybe they have an idea what's going on. The patient stated that it's painful until today and every day; maybe tomorrow it will get better, but nothing gets better and it's 4 months now. It's not getting better. He wanted to know exactly what the problem was. He asked for help and asked if the same problem was identified with other people. The patient did not know the lot, expiry, UPC and NDC as the nurse gave him the shot and she went home so she did not give him anything to keep. The patient had lab work done earlier than 4 weeks. The patient was still experiencing the event and stated, "It's persisting maybe getting worse." There was no treatment. He was given a slip to get an X-ray. The patient informed that he talked to a lawyer about the situation, and he was told that they are not sure of anything. The patient needs an MRI, so he is going to take an MRI to see what is going on. The patient added that he had been taking vaccination all his life and he has never had any problem, except this time.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein), pneumococcal 20-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.
Bump at injection site, tingling, minor pain, fatigue, redness, raised welt, itching, warm to hot, blisters, oozing. Present to urgent care 11/19/2014 with worsening symptoms,  Diagnosed by MD with severe allergic reaction.  Given prednisone 20mg tabs, 2 tabs daily for 5 days.
This spontaneous report as received from a pharmacist refers to a 64 year old female patient. Patient had no pertinent medical history or drug allergic reactions. On 17-FEB-2014 the patient was vaccinated with ZOSTAVAX, 1 standard package vial of 1, 0.65 ml, subcutaneously. Other suspect therapies included PNEUMOVAX23 (strength, dose number, dose unit, lot# and expiry date unknown) was administered to the patient on same day. On 17-FEB-2014, in the morning after receiving ZOSTAVAX, patient developed injection site rash that was bright red, itching and painful. Patient contacted pharmacist and was received treatment for the events with over the counter topical hydrocortisone cream. No laboratory test was performed. The pharmacist reported that rash was less red. The outcome of injection site rash that was bright red, itching and painful was reported as recovering/resolving. The outcome of ZOSTAVAX and PNEUMOVAX23 was given on same day was unknown. Additional information has been requested.
Sunday evening started to not feel good went to Urgent Care at 7:15pm they advised her to report ER. At the ER patient was experiencing fast heart beat and high blood pressure. Monitored patient (labs, x rays) for 3-4 hours and then was discharged. They told patient to report to PCP after if any side effects continuing. 11/17/21 patient has followed up with PCP and is have shortness of breath and high heart rate, jittery and tired.
Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; 42 Patients received bivalent booster with 38 having improvement of symptoms; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure systolic: 200.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms).    No concomitant medications were reported.  Reporter stated she has been administering the 65 plus bivalent dose to her patients who have symptoms of long-haul COVID and has seen 88-90% success rate in resolving the symptoms of long-haul COVID.  It was reported that, vaccine was given to patients for long COVID between 21-Mar-2023 and 01-Aug-2023. 42 Patients received bivalent booster with 38 having improvement of symptoms and 50s or more. Patient was treated skin lesions, scary brain, body aches. No adverse reactions occurred.  No treatment medications were reported.  This case contains information about patient 04 out of 42 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:Master case
Soreness and red rash on left arm around the injection site lasting 5 days. Dizziness lasting 4 days and still continuing.
broke out 29MAY98 no illness-no fussiness #80 pox-some itching;scabbed over by 5JUN98;confirmed by MD;no known exposure;
Patient's mother noticed hives only on RD area. Pt had no other symptoms on 10-20-18 or around 10:00 am. Gave pt CLARITIN 10 minutes after she noticed the hives. Hives went away. Had nothing the following day.
Patient made an appointment to received 1st COVID-19 vaccine, requested Pfizer. Upon processing the Pfizer vaccine later, received a third party block that patient already received other vaccine. Per online patient received Janssen vaccine on 3/22/21. PT VERIFIED VERBALLY AND IN WRITING THAT HAD NEVER RECEIVED A COVID-19 VACCINE prior to being administered the Pfizer vaccine. Pharmacist attempted to contact patient to discuss but kept being forwarded to voice mail. Canceled return vaccine appointment that patient made for 2nd Pfizer vaccine via email in scheduling system since additional vaccination does not meet current protocol guidelines.
Interruption of mensural cycle. Patient states she has very very regular periods.  Patient experienced a regular period April 17-23.  Patient received 1st vaccination on April 23rd.  Patient experienced severe motion sickness post vaccination.  On April 28th her period restarted and continued until May 9th.  Patient stated that she had never had a period last that long.    Patient received second vaccination on 5/14 Pfizer Lot#EP7533
Initial physician report received on 04 Feb 2011: This patient with an unknown medical history was vaccinated with RABAVERT (batch number: 465011A) pre-exposure series day 0 dose on 27 Jan 2011 and day 7 dose on 03 Feb 2011. The patient did not experience any reaction after day 0 dose. However, after day 7 dose, on 04 Feb 2011 he experienced purpuric discoloration of the skin from the elbow down to the hand on the same arm where day 7 dose was administered. He also experienced a lot of angioedema distally, particularly on the fingers. The outcome was not reported.
Redness at right upper arm 2 days after vaccine. Redness measured 8cm x 9cm and was warm to touch. She was placed on Augmentin ES 600/5 1 1/4 tsp bid x10d.
his wife experianced fatigue after the injection but that was it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 70 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing), notes: Takes methotrexate(stopped for 2 weeks prior to vaccine),Advil for rheumatoid arthritis in joints. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "his wife experianced fatigue after the injection but that was it".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
the patient was administered an improperly stored dose of PROQUAD on 25-NOV-2019; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about patient's concurrent condition, medical history, drug allergy/reaction was not reported.  On 25-NOV-2019, the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) therapy type: rHA, lot # S013715, expiration date: 01-NOV-2020 (strength, dose number, route, anatomical location was not reported) for prophylaxis (product storage error). The sterile diluent used to reconstitute was properly stored. Multiple temperature excursions were involved. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint was involved.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. In September 2012, the patient was vaccinated with the first dose of GARDASIL (injection) (lot#, dose and route not reported). On 20-FEB-2012, the patient presented to the office to get the second dose of GARDASIL. No adverse event reported. Additional information has been requested.