chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got fully vaccinated for the Pfizer covid-19 vaccine in 2021. tested positive for covid-19.; got fully vaccinated for the Pfizer covid-19 vaccine in 2021. tested positive for covid-19.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administration date Jun2021 (Batch/Lot number: unknown) as dose 1, single and administration date Jul2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "got fully vaccinated for the Pfizer covid-19 vaccine in 2021. tested positive for covid-19.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2022) positive, notes: she tested positive for covid-19.  Clinical Information: Caller was a consumer who wanted to get her booster dose for the Pfizer COVID-19 vaccine. She got her primary series last year (2021) on June and July. She was diagnosed with COVID-19 this year (2022) and was told to wait at least 90 days to receive her booster dose. Caller wanted to know if this information was correct or when she could receive the booster dose.  The lot number for bnt162b2 was not provided and will be requested during follow up.
minor pains; I had a Fever of 101.3 degrees which lasted 1 day; minor aches; fatigue; minor headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (minor pains), PYREXIA (I had a Fever of 101.3 degrees which lasted 1 day), MYALGIA (minor aches), FATIGUE (fatigue) and HEADACHE (minor headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 006B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DIPHENHYDRAMINE for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced PAIN (minor pains), PYREXIA (I had a Fever of 101.3 degrees which lasted 1 day), MYALGIA (minor aches), FATIGUE (fatigue) and HEADACHE (minor headache). At the time of the report, PAIN (minor pains), PYREXIA (I had a Fever of 101.3 degrees which lasted 1 day), MYALGIA (minor aches), FATIGUE (fatigue) and HEADACHE (minor headache) outcome was unknown.            Treatment details was not reported by the reporter.   This case was linked to MOD-2021-342759 (Patient Link).
Dizziness/vertigo; nausea, sweats, abdominal/uterine cramping, rash on chest and neck
Pt w/ localized inflammatory reaction - 11 x 11 cm, & ecchymosis surrounding this.
I had a really bad headache, and I ached all over. It felt like the flu. I had terrible chills and couldn't get warm. This lasted about 12 hours.
Child received ROTATEQ at 6 mo visit - third vaccine 1/17/12 - next day - 1/18 (7:39 pm) bout with vomiting & 1/19 bloody stools. To hospital ER with US -> showing possible intussusception. Transferred to another hospital. Had reduction of intussusception & appendectomy noted dr.
On 02/23/2023, I felt weird in the morning.  I took a home COVID-19 test later that morning. It was positive. I developed a fever about 102, I got the shakes and went to bed. I called Dr who said to alternate Ibuprofen and Advil and he prescribed Paxlovid. I had a couple of good days and then my fever returned. I went to see my doctor.. They ran blood tests and white blood was elevated. He gave me a prescription with an antibiotic.  I have been fever free for 72 hours.
within 20 mins of injections, pain, stiffness, extreme fatigue, lethargic . Then experienced cont. pain and soreness, stiffness on and off for next week and 1/2 when became increasingly worse with joints locking up, severe pain and stiffness, fatigue, fever, swelling of joints. Small relief with pain meds.  4/29/009 Received PCP medical records of 8/25/08-4/8/2009. FINAL DX: polyarticular arthralgias Records reveal patient experienced good general health & was on OCP on 3/23/09 for HPV#1 & Menactra.  RTC 4/8 & reported malaise since day after vax & then developed progressively worsening joint pain, stiffness & swelling w/difficulty sleeping & generalized body aching x 1 wk. Tx w/NSAIDS & heat.  Patient still has pain in the joints and stiffness in the joints at times. We would not make the same decision, if we had it to do over again.
IMMEDIATE METALLIC TASTE IN MOUTH RIGHT AFTER VACCINE. THE FOLLOWING DAY WOKE UP STILL WITH TASTE BUT HAD A FAINTING SPELL AROUND 9AM THEN ANOTHER AROUND 530PM.  THE METALLIC TASTE LAST LIKE 5 DAYS BUT THE FAINTING SPELLS HAVE CONTINUED SINCE. HAVE DECIDED TO SET UP APPOINTMENT WITH A FAMILY DOCTOR DONT KNOW IF ITS NORMAL FOR THIS TO BE ONGOING.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with VARIVAX for prophylaxis. On an unknown date the patient experienced drug administered to patient of inappropriate age and no adverse event. This is one of two reports from the same source.; Sender's Comments: US-009507513-1708USA009469:
multiple excurion occured during shiping time  with no adverse event; Initial information received on 04-Oct-2021 regarding an unsolicited valid non-serious case received from a nurse and non-healthcare profession and non-healthcare professional via [Regulatory authority (reference -00797286].  This case involves a 59 years old male patient who vaccinated INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] which went on multiple temperature excursions (product storage error).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapy was given.  On 04-Oct-2021, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number QFAA2121 expiry date 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  It was reported "Nurse practitioner reports that she received a delivery of FLUBLOK today 04OCT2021; states it was shipped 01OCT2021, and she received a message from Sanofi stating that her product was in shipment for too long and it was not viable for use. Nurse practitioner states that when she received this message, she had already administered FLUBLOK to one patient; asks if there are any recommendations after FLUBLOK is administered post-excursion."  It was a case of actual medication error due to incorrect product storage (latency was on same day).  At the time of reporting, no adverse event reported.  Outcome of event was 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.
OUT OF SPECIFICATION PRODUCT USE (VIAL WAS PUNCTURED APPROXIMATELY 28-DEC-2021 AT 9:00 AND THEN DOSE WAS ADMINISTERED TO THE PATIENT ON 30-DEC-2021 AT 9:00 IN THE MORNING); This spontaneous report received from a health care professional concerned a 25 year old male. 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 not reported, batch number: 1855191, expiry: UNKNOWN) dose was not reported, administered on 30-DEC-2021 09:00 for prophylactic vaccination. No concomitant medications were reported. On 30-DEC-2021, the patient experienced out of specification product use (vial was punctured approximately 28-dec-2021 at 9:00 and then dose was administered to the patient on 30-dec-2021 at 9:00 in the morning). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of out of specification product use (vial was punctured approximately 28-dec-2021 at 9:00 and then dose was administered to the patient on 30-dec-2021 at 9:00 in the morning) was not reported. This report was non-serious.
After my mother took the first vaccine shot on March 4th 2021, I noticed the changes 2 weeks later. Her handwriting became more disoriented in her checkbook. She said she had trouble remembering which week days to write in her checkbook. I noticed incomplete transaction lines. She forgot to take medications for the first time in years.  She used to be an early riser. She started to get up late in the mornings between 8 am and 9 am. She does not eat as much as she should. She drank coffee more frequently all day daily. She hardly drank enough water to avoid her chronic consciptation problem in the bathroom. She has not been herself lately since her first shot. So I have a good reason to be concerned. I think a 2nd vaccine shot is not really a good idea.
Patient began experiencing altered mental status, required admission to hospital. Overnight patient returned to baseline with no treatment.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 42-year-old female patient 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) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported. No adverse reactions were reported by patient.
WIthin a few hours of the Modern booster (I received the J&J one dose shot on 3/11/21 and was therefore eligible for a booster on Friday) a severe sore throat developed on right side, constant post nasal drip and runny nose, congestion, dull headache. Initially after injection felt a bit of a heart flutter and maybe woosy walking around, nothing serious but a little lightheaded. It could have been needle anxiety and hyper focus on the reactions, but sore throat and runny nose was already starting a couple hours later. It's now Monday night and the runny nose, sneeze has been pretty constant. The sore throat shifted to the left side a day later and now it's gone but I have just under a 101 fever, dull headache and eyes ache, very low energy, some chills on and off but not much. I noticed that my sense of smell was gone in the middle of the night last night, it was fine up til then. I haven't had a cold in the past year or the flu, this was the first time this happened and coincidentally it developed a couple hours after the vaccine. I took a rapid COVID test and negative on that. I have a cough that produces on a tiny bit of mucus, mainly an irrittion cough. My chest hurts a little - nothing serious, like when dealing with a mild respiratory infection.
11 days 13 hours after initial 1st dose, I experienced throbbing and pain at the injection site.  There was no rash or redness.  This is random and it is continual to this day - January 6, 2022.  Sometimes it is a quick throb, other times it lasts 15-20 seconds followed by a flash of pain.  Frequency 1-2x per day.  Often when driving or when I lay down to go to bed and I am relaxing.  On a few occassions, my heart may flutter after the throbbing subsides.  I will be seeing my doctor later this month about this.  This happens mostly in my left arm, my right arm of 2nd injection has only had a few minor throbs and in less frequent.
Pt complained of warm feeling about 10 minutes after receiving vaccination and requested some water, pt was given an ice pack to cool off. symptom resolved after 10 minutes. Pt was monitored for another 10 minutes before discharged.
NAUSEA; DIZZINESS; SLURRED SPEECH; DRY HEAVES; FEVER; BODY ACHES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no any medical history. The patient experienced drug allergy when treated with ibuprofen. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and batch number: 1805018 expiry: 25-MAY-2021) dose was not reported, administered on 09-MAR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced nausea. On 09-MAR-2021, the subject experienced dizziness. On 09-MAR-2021, the subject experienced slurred speech. On 09-MAR-2021, the subject experienced dry heaves. On 09-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, dizziness, slurred speech, dry heaves, fever and body aches was not reported. This report was non-serious.
20 min after receiving injection C/o dizzy nausea MA, R flank pain intermittent scale 1-10 3 chills, tired BP 120/60, 100/50 P 100x2, R 22x2, T 98.9. Called  home doctor where he is living. Advised they will pick up student + take him to MD.
very bad case of blister; itching; quite a few things on my skin; hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 73-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation.The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, I think its Pfizer, here is the Lot# EN6203, its the Lot# of Pfizer first one), for Covid-19 Immunization; Bnt162b2 (DOSE 2, Second dose is my Pfizer ER8730.), for Covid-19 Immunization. The following information was reported: BLISTER (non-serious), outcome "unknown", described as "very bad case of blister"; PRURITUS (non-serious), outcome "unknown", described as "itching"; SKIN DISORDER (non-serious), outcome "unknown", described as "quite a few things on my skin"; URTICARIA (non-serious), outcome "not recovered", described as "hives".   Additional information: She took the COVID-19 Vaccine and now she was having issues and its hives and she wanted to report this and she wanted to talk to someone, she wants to talk to someone about her experience. When paraphrased the concern Consumer stated, she was having a very serious problem. she was dealing with a dermatologist, a allergist, the doctors. she had a very bad case of blister, itching and quite a few things on her skin that she never had, she was 73 year old women and these things are happening. Consumer stated, she was experiencing now is it above 5 weeks now, she was 73 years old and her visiting doctors now, she still have the hives on her skin.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 05-APR-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # 0869AA expiry date, 26-JUL-2013) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
suspected vaccination failure; shingles; still gets nerve pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved and the outcome of the post herpetic neuralgia was not recovered/not resolved.   The reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient's friend. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles from it. The reporter stated that, it took a long time to go away. Till the time of reporting, the patient still got nerve pain. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; OFF LABEL USE; This spontaneous report received from a patient concerned a 63 year old White, not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's  concurrent conditions included: non alcohol user, non smoker, tinnitus from medication she was on, neuropathies, neuralgias, flu (every year), immunocompromised, upper respiratory issues with infusions, sulfa drugs don't do well, multiple drug allergies/ allergic to lot of rheumatoid drugs, and autoimmune rheumatoid inflammatory disease due to vaccine for lyme disease. The patient had a past medical history of covid-19 on DEC-2020 and was hospitalized for 10 days.On 18-JUN-2021, the patient was previously treated with covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1808982, expiry: unknown) dose was not reported, 1 total administered for prophylactic vaccination. The patient had no adverse events following vaccination with covid-19 vaccine ad26. cov2. s. (Dose number in series 1).On 02-NOV-2021, the patient was treated with covid-19 vaccine ad26. cov2. s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855194, expiry: unknown) dose was not reported, 1 total administered for prophylactic vaccination. The patient received third dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855194, expiry: 09-APR-2022) dose was not reported, 1 total administered to left arm on 24-JAN-2022 for prophylactic vaccination which was an off label use, and inappropriate schedule of vaccine administered. (Dose number in series 2). Concomitant medications included abatacept (Orencia) 750 mg intravenous a month. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.The outcome of the off label use and inappropriate schedule of vaccine administered was not reported.This report was non-serious.
A red band of skin formed approximately one inch wide and 3 inches across around the injection site.  The patient did not report any pain or itching.
Patient experienced low muscle tone (unable to walk, support himself, hold his head up,) lethargy, and fussiness after vaccines were administered on 10/14/19. He was seen in urgent care on 10/16, his pediatrician on 10/17, and admitted to hospital on the afternoon of 10/17.  He was discharged on 10/19 after all tests came back within normal limits and he began to improve.
Pain in shoulder/deltoid in left arm that persisted weeks after shot. Pain with movement and at rest. Did Active PT with physical therapist for 3 months. Now resolved.
patient received a vaccine that too low in the muscle and and may have been considered subcutaneous/ no AE; Initial information received on 02-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 55 years old female patient who received 0.5 ml INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] lot UJ257AD (Expiry date 30-Jun-2020) via subcutaneous route in the left arm.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to inappropriate route of vaccination.  It was reported that patient received a vaccine that was too low in the muscle and may have been considered subcutaneous.  At a time of reporting no adverse effect reported.  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 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.  List of documents held by sender: none.
Patient broke out in hives and got itchy rashes. Reaction started at the feet and worked it's way up.
Aside from aching vaccination site I felt OK until 9:00 am. Then I was struck with violent vertigo, which lasted about an hour. I practiced controlled breathing  for about 10 minutes and the vertigo gradually subsided. Then for the rest of the day I had chills and a low fever.   I also noticed that my thyroid was very swollen and remains so today, approximately 3 weeks later.  However, I have no pain in the thyroid.