chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 20-FEB-2015, the patient received the ZOSTAVAX (lot number, dosage and route of administration not provided) for its intended purpose: the prevention of shingles. As a direct result of the ZOSTAVAX, the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of his body. The patient did not have a shingles outbreak until 20-FEB-2017. As a direct result of the ZOSTAVAX, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred medical expenses and other economic harm as a direct result of use of ZOSTAVAX.  The outcome of shingles outbreak was unknown. Shingles outbreak was considered to be disabling. Additional information has been requested.
PENTACEL was administered to a patient after the expiration date with no reported adverse event; Initial information received on 26-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves a 6 months old female patient who was administered Diphtheria/Tetanus/5 Hybrid AC Pertussis/Ipv(Vero)/HIB(PRP/T) Vaccine [Pentacel (Vero)] after the expiration date 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 Hepatitis B Vaccine (Hepatitis B [Hepatitis B Vaccine)]; Pneumococcal Vaccine Conj 13V (CRM197) (Prevnar 13) and Rotavirus Vaccine (Rotavirus Vaccine) for Immunisation.  On 25-Jul-2022, the patient received a 0.5 ml dose once total (dose 3) of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine (lot: UJ527AAA; expiry date: 22-Jul-2022) via intramuscular route in the left thigh for Immunisation.  On 25-JUL-2022 the patient was administered Diphtheria/Tetanus/5 Hybrid AC Pertussis/Ipv(Vero)/HIB(PRP/T) Vaccine after the expiration date with no reported adverse event (expired product administered) (latency: same day).  It was unknown if there were lab data/results available.  Action taken: Not applicable.  Outcome: Unknown.   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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Shortness of breath; heart palpitations; Muscle soreness (left arm); overall unwell feeling; This is a spontaneous report from a contactable consumer (patient). A 56-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL 9262 and expiration date: unknown), via an unspecified route of administration on the left arm on 27Jan2021 at 09:15 at a single dose for COVID-19 immunization. Medical history included systemic lupus and shrimp allergies. The patient had no other vaccine in four weeks and no other medications in two weeks. There were no concomitant medications. The patient had no COVID prior vaccination. The patient experienced muscle soreness (left arm), heart palpitations, shortness of breath and overall unwell feeling on 27Jan2021 at 10:00, which resulted in a doctor or other healthcare professional office/clinic visit. No treatment was administered for the events. The patient has not tested for COVID post vaccination. The events were resolving.
got the flu; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 06-Dec-2020.  This case involves a patient of unknown demographics who had got the flu (influenza), while the patient received Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was unknown.  On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site.   On an unknown date, unspecified time after receiving the vaccine, the patient stated that he/she had the flu shot 3 times and got the flu (influenza) 3 times.   It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.      The reporter assessed the causal relationship with suspect vaccine as related.
p/vax pt exp muscle aches & fatigue, felt bad & had a difficult time getting out of be;pt felt first few itchy bumps in hair & 10 maculopapular lesions;lesions vesicular only when scratched;
Information has been received from a pharmacist via agency concerning unspecified patients of unknown age and gender. The pharmacist heard about the new Advisory Committee On Immunization Practices (ACIP) recommendation and indicated that it might be possible that the unspecified patients were not given PREVNAR 13 (lot#, dose, route not reported) first or not given the PNEUMOVAX 23 (lot#, dose, route not reported) after 12+ months of PREVNAR 13 vaccination, which was considered to be inappropriate schedule of vaccine administered per new Advisory Committee On Immunization Practices (ACIP) recommendation. Additional information is not expected as the reporter was not willing to be contacted.
This spontaneous report was received from a physician and refers to four patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, those patients were vaccinated with improperly stored doses of VARIVAX lot# reported as M0402496, expiration date: 19-NOV-2017 (dose and route of administration were not reported). The vaccines were stored in the temperature of -4 degrees Celsius for 105 minutes. Digital Data Logger was involved. There was no previous temperature excursion. Vaccines were reconstituted with properly stored sterile diluent lot# N016122, expiration date: 05-OCT-2019. No adverse effects were reported. Additional information has been requested.
6Feb 1) febrile seizure-ear infection, antibiotic given, T 99.2 (R)
GOT SICK FOR A BIT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: immune compromised. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-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 an unspecified date, the patient experienced got sick for a bit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got sick for a bit was not reported. This report was non-serious.
This spontaneous report was received from a medical assistant referring to multiple patients of unknown age and gender. No information about the patients' medical history, concurrent conditions or concomitant medications was provided. On unknown dates, the patients were vaccinated with multiple improperly stored doses of PROQUAD (with lot # M038227, expiration date 06-MAR-2018; lot # M039447, expiration date 20-MAR-2018 and lot # M041084, expiration date 22-APR-2018), for prophylaxis (dose, frequency and route were not provided), the doses underwent a temperature excursion of 6 degrees Fahrenheit during 15 hours with no data logger involved and no previous temperature excursion. The vaccines were reconstituted with properly stored sterile diluent. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of two cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA004645.
2 days after the shot I woke up and I had a hard time moving my mouth and my bottom lip was completely swollen. Its still puffy and very very red.
Day after vaccine, woke up incredibly dizzy (room was spinning) and nauseated. Temperature was 99.3. Went away throughout the day. The following day (2 days after vaccine) no dizziness, no nausea, and temperature back to 98.6.
TWITCHING FACIAL; A spontaneous report has been received from the regulatory authority concerning a male patient of Unknown ethnic origin (age 11 years).    No medical history was reported. The following demography was reported for the patient's parent:   Sex: Unknown. Concomitant medication included clobazam for epilepsy.     On 30-Nov-2022, the patient received Live Influenza Virus (influenza vaccine live reassort 4v) (batch number PH3539), via nasal route, for flu vaccination.    No malfunction has been reported for LIVE INFLUENZA VIRUS.    On 30-Nov-2022, the patient experienced twitching facial (preferred term: Muscle twitching).     It is unknown if any action was taken with Live Influenza Virus.     At the time of reporting, the outcome of the event was unknown.    Reporter assessed the event was considered serious due to important medical event.     Device Information:     Combination Product Report: Yes    Product As Reported: LIVE INFLUENZA VIRUS  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect
Hgb low; Woozy; Headache; This is a spontaneous report from a contactable consumer (Patient). An 87-year-old male patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration in Feb2021 as dose 2, single for covid-19 immunization. Patient received ruxolitinib phosphate (JAKAFI), oral from 18Oct2019 (Batch/Lot number was not reported) and ongoing, at 10 mg, 2x/day for myelofibrosis. Medical history included ongoing essential thrombocythemia. Concomitant medications included furosemide (LASIX [FUROSEMIDE]), levothyroxine sodium (SYNTHROID), cyclosporine (CYCLOSPORINE) taken for an unspecified indication, start and stop date were not reported. The patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. On an unspecified date in 2021, the patient experienced Hgb low, woozy and headache. The patient underwent lab tests and procedures which included biopsy bone marrow result was unknown and haemoglobin was low on an unspecified date. The clinical outcome of the event Hgb low was not recovered and events woozy and headache was recovered in unspecified date in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pain in L shoulder joint began approx 3-4 hours after shot. Shot given very high on L arm at bottom of shoulder joint. Pain became severe that evening / night. Very limited range of shoulder movement. Took Aleve for a bit of relief. Pain next day Friday was not much diminished, shoulder range of motion very limited.  By Sat a.m. pain was diminishing. Range of motion a bit better but still could not elevate arm to 90 degrees. Sunday similar. Monday pain was down to manageable levels as long as arm remained down. Tuesday pain had subsided to dull throb, arm could come up to 90 degrees w/o pain. Wednesday, no pain unless arm went all the way up.
Blister rash; This case was reported by a pharmacist via call center representative and described the occurrence of blistery rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced blistery rash. On an unknown date, the outcome of the blistery rash was unknown.   It was unknown if the reporter considered the blistery rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The health care professional stated that the patient had a rash that was blister like on face and several other areas where it occurred in clusters. The health care professional thought it was possibly within a week of the Shingrix vaccination. The reporter consented to follow up.
Report 20010092611 described lethargy and pallor in a two month old male who adsorbed (Infanrix) for prophylaxis of diphtheria, tetanus and pertussis. Reportedly, the vaccinee had no allergies or medical history. Reportedly, he took no concomitant medications. On 04/11/2001 11:00, the pt received his first 0.5 ml left thigh dose of Infanrix. "Within minutes" post-vaccination, the vaccinee became lethargic and very pale. There was no loss of consciousness. Within 15 minutes, the vaccinee's color had had returned. After an additional fifteen minutes, the vaccinee was mroe alert and took some of his bottle. The vaccinee stayed in the physician's office for "a while" to be observed. As of 04/11/2001, the adverse events were resolving.
Pt recvd vax & exp pain in arm & back, earache, h/a, arthraglia, rash, myalgia & insomnia; various lab tests done; MD do not know what to do;
My husband and I both went to another family's house for holiday. I was not feeling 100% but had been getting drainage and a little allery-asthma in my chest...which had been fairly steady, so figured it was allergy-type stuff and went.  I was tired that evening, to be sure, but started tanking the following day. Figured I'd caught some upper respiratory thing. Was eventually tested for covid and flu, both coming back negative. -My husband came down with it on Sunday (2-3 days later). (Report for him will be separate and coming your way.) -The symptoms of the upper respiratory thing haveostly subsided, and we have both been left with fatigue...seemingly unending fatigue. I went into the doctor for on-going virus or fatigue, where she tested for a variety of things. I asked her to check for Mono, tho' I'd had a long case of that starting March of 2020. This fatigue feels reminiscent of that, tho' not as heavy as it was for a time.  Those scores seemed signficant, and she mentioned possibly CMV, since there had been no fever (now or even during what we think was an upper respiratory virus.)  -A coworker mentioned the timing of the bivalent vaccine,  and I've looked up a little now myself trying to understand things and how to hopefully avoid what seems to be a relapse or re-emergence of CMV or some other mono-like, normally latent virus.  Since my husband and I are both dealing with this, and he has a very different immune system, I thought it worth bringing to your attention.
Pt reported very anxious re 6 hr certification test for work today. Approx 10:30 had nausea, stomach cramps, euphoria, metallic taste in mouth, profuse sweating, then chills. Mild itching at injection site. Sx resolved at 12:00. Lightheadedness started 14:30-15:00. Pt feels better when in fresh air. Denies vomiting swelling or redness of arm, room spinning dizziness.
About 2.5 weeks after the covid bivalent booster, Patient developed generalized hives for a few days which did not respond to benedryl.   About a 3-4 days later it calmed down (no longer generalized hives) but then developed into dermatographism where any friction on his skin he would develop localized hives.  He saw a dermatologist Nov 17 who was not aware of a relationship between the vaccine and dermatographism but recommended zyrtec BID which he has been taking religiously ever since.  He did do labs (CBC with diff, CMP, TSH, sed rate) but there was no abnormalities.  He saw the dermatologist again who prescribed Xyzal and he has required BID dosing as well with no resolution of the dermatographism.  He has never had any skin pathologies.  Interestingly, he did develop significant ear swelling (cauliflower ear) which then progressed down his neck to his ipsilateral arm after his 2nd dose of the primary moderna series one day after the vaccine.  It resolved in about a week with only a few doses of anti-histamines.  He has no issues with the 3rd dose (the first booster).  Prior to this Patient had no medical problems and was only taking Flonase as needed in the summer for seasonal allergies.  This dermatographism has become very debilitating as anything that touches his skin (dress pants, socks, watch) cause significant pruritis and any friction (playing with his kids) will cause significant marks on his body.
Pt couldn't walk that night. I had to carry her around for a several days. I reported this to the doctor's office who said that they must have nicked a muscle. We had numerous problems from then on.
This spontaneous report as received from a health care worker refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL lot # K006117, expiry date 14-JAN-2017, dose, route and site of administration were not reported. No adverse effects were reported. Additional information has been requested.
Patient with pain on injection site, feeling weak, BP down 104/62, received DEPO-MEDROL injection. Nausea, vomiting, hypotension and pain.
This case was reported by a healthcare professional (also the subject) via a sales representative and described the occurrence of a cut thumb in a 38-year-old female subject of who was vaccinated with BOOSTRIX, GlaxoSmithKline. On 18 March 2009 the subject picked up a BOOSTRIX vial and it shattered and she cut herself on the glass fragment. A co-worker (nurse) cleaned and bandaged the wound. The wound is healing, but she still has the bandage. A product complaint was associated with this report. At the time of reporting the event was improved. The healthcare professional considered the events were probably related to vaccination with BOOSTRIX. Follow-up information was received from the healthcare professional (subject) in April 2009. On 18 March 2009, the BOOSTRIX shattered in the subject's hand and cut her left thumb. The event resolved on 01 April 2009. The cut thumb was considered related to treatment with BOOSTRIX. The subject's physician was not contacted regarding this event.
Mild discomfort the day after at the injection site; Nausea; extreme fatigue; Muscle ache/ Muscle pain; Cough; Sore throat; Headache; All of joints were painful; This is a spontaneous report from a contactable physician reported for self. This 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular in left arm (IM in left shoulder) on 22Dec2020 at single dose for COVID-19 immunization. None medical history nor concomitant medications. Three hours after the vaccine (on 22Dec2020) patient started developing nausea that was pretty much and it was enough that patient had to stay at home instead of going out to shoot golf balls, it was so significant nausea. Then he had some extreme fatigue, muscle ache/muscle pain, started developing cough, sore throat and headache. Then all of his joints were painful. Patient had a mild discomfort the day after at the injection site. The next day (on 23Dec2020) when he woke up nausea was gone. Patient might just have some general labs at the family practitioner just to check cholesterol. The outcome of "nausea" was recovered on 23Dec2020, of "mild discomfort at the injection site" was unknown, outcome of else events was not recovered. The reporting physician considered all events "related" to the Covid 19 Vaccine, Physician stated 100 percent it is from the vaccine.
Patient refused to get 2nd dose; Sore around the injection site; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain and incomplete course of vaccination. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 23-SEP-2022 Reporter's Comments: The patient was sore for week around the injection site.  The reporter said it was the 1st dose not sure if other vaccines was given. The reporter stated patient refused to get 2nd dose. The reporter did not consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2022137220:Same reporter
Started to experience symptoms 3 days after my second dose.  Went to Urgent Care with what felt like a viral infection, it was treated as such.  Soon after, started having increased heart rate with chest pain, increased blood pressure, sensitivity to heat and lack of energy.  I have had EKG's, ultrasounds, X-Ray's, blood work and stress tests with no findings.  Symptoms have not gone away but have steadily increased.  Was seen in ER for tachycardia
inconsolable crying for 48hr p/vax;crying began about 8hr p/vax & lasted 48hr;exam was nl;no signs encephalitis;no fever;no tx given other than APAP/motrin;
1st dose no symptoms 2nd dose arm sore couldn't move it, headache, chills, fatigue, no appetite
1 hour after injection, pt passed out in class x 15 seconds.  Felt "sick and exhausted" rest of the day. Coordination was off.  Has experienced night sweats since injection and feels hair is thinning.
pt recv vax 7NOV96 & then had flu like sx;13NOV96 got nausea, vomiting, diarrhea 11NOV, 12NOV epigastric pain;sx resolved approx 18NOV96 p/Pepcid, Flagyl, Vibramycin;
I had chills, an ache in the roof of my mouth, a nuisance cough, low-grade fever. I used a home COVID-19 test that came back positive. I called my doctor to let him know I was positive and discuss my symptoms. He prescribed a Trilogy Inhaler, a Medrol dose pack, Paxlovid, hydro/oxy pills; azithromycin. Once I started taking the medications, I started feeling better in seven days. By day ten I felt so much better with the exception of a lingering cough that hung around for a couple of weeks. At the onset of getting COVID-19, I feel it may have helped contribute to my now losing two of my teeth.
About 10 hours after receiving the vaccine I started having major chills and my temperature rose to 103.7. I had to be taken to the emergency room of my local hospital.
1 day post immunization with redness at injection site.  Pruitic, followed by fever.  Fever persisted for 3-4 days.  Right thigh with 8x11cm red, warm, but nontender swelling.  Full range of motion right leg.  Jumps with pain.