chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pfizer / BioNTech / Treatment of COVID-19 start date: 18Jul2022; Pfizer / BioNTech / Treatment of COVID-19 start date: 18Jul2022; Vaccine brand other=Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Dec2020 as dose 1, single (Lot number: EJ1685), in left arm, on 13Jan2021 as dose 2, single (Lot number: EL3249), in left arm and on 31Aug2021 as dose 3 (booster), single (Lot number: FC3183) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 24May2022 as dose 4 (booster), single (Lot number: 054A22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidaemia" (unspecified if ongoing). There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 24May2022, outcome "unknown", described as "Vaccine brand other=Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Pfizer / BioNTech / Treatment of COVID-19 start date: 18Jul2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The Patient had taken Paxlovid from 18July2022 to 23July2022 for the treatment of covid-19. The patient had no known allergies.
2 weeks after 2nd does of vaccine I had joint pain in finger and tows, most of them were gone after 2 weeks, 1 joint remained painful for 6 months. Beside, joint pain, 1 month after the 2nd does of vaccine, I had vision symptoms, which doctors evaluations concluded that it either comes from inflammation in sinus, or dryness of eye. Also MRI should there is a 8mm lesion formed in the brain, but vision symptoms was not related to this lesion. both vision symptoms and joint pain were improved using Prednisolone, but as I could not use it for long time, Dr (rheumatologist) decided to start CellCept. Using full doze (1440 mg) of Mycophenolic acid could resolve the symptoms, and as it was causing sore throat decreased to half (720 mg) and still symptoms were fine. Till in the last month I got Covid for 2 time with separation of 7 days, and vision symptoms started again but with lower intensity that I had from vaccine. After recovery increased the Mycophenolic acid dose to 1440 mg again. As summary, it seems vaccine (and covid itself but with lower intensity) flared up of immune system and causes inflammation in body.
This case was reported by a consumer via call center representative and described the occurrence of loose stools in a 65-year-old male patient who received SHINGRIX. The patient's past medical history included gastrointestinal disorder (bowel problems and suspected that the patient had irritable bowel disease). Previously administered products included ZOSTAVAX (received 2 to 3 years before the reporting date). Concomitant products included amlodipine, atenolol, Baby Aspirin, Losartan, simvastatin, JANTOVEN and hydrochlorothiazide. On 16th January 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 18th January 2018, 2 days after receiving SHINGRIX, the patient experienced loose stools and stool odor abnormal. On 23rd January 2018, the patient experienced upset stomach. On an unknown date, the outcome of the loose stools was not recovered/not resolved and the outcome of the stool odor abnormal and upset stomach were unknown. The reporter considered the loose stools, stool odor abnormal and upset stomach to be possibly related to SHINGRIX. Additional details were provided as follows: The reporter stated that her husband received SHINGRIX in the left deltoid. The patient started experiencing frequent, almost uncontrollable, loose stools. They occurred off and on over the next few days. They thought he was getting better, but the day before reporting date (7 days after vaccination), he had a bad bout and had been experiencing an upset stomach. The patient's loose stools also had a funny metallic or medicinal smell.
Pt received flu shot on 11-11-14, noticed hives on Wed, 11-12-14 at approx 4:00pm.  Hive were located on her vaginal area, buttock, trunk of body.  Denies any on limps, neck, or face.
This case was reported by a physician and described the occurrence of injection site cellulitis in a 21 month old male patient who received diphtheria toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. In 24 or 25 February 2004, the patient received the fourth dose of Infanrix in the left arm. Approximately twelve hours after Infanrix vaccination, on 25 February 2004, the patient experienced injection site cellulitis characterized by an 8 centimeter by 6 centimeter hard indurated mass on his left bicep, which required medical attention in the doctor's office. The mass appeared from below the shoulder, to above the elbow. The patient was treated with cephalexin. The events resolved on an unspecified date in March 2004. The reporting physician considered the events were probably related to vaccination with Infanrix.
Swollen red and hot arm, fever x 3 days, pain (excessive), nausea, light-headedness. Not resolved as of 10/20/17 from shots 10/16/17.
Strong taste/smell of nickels.  Pt reported she experienced this same sensation after 2nd Covid vaccine in the primary series and it went away in 1-2 days without any long effect.
Client c/o numbness of left arm after getting 1st dose of Moderna  Vaccine on left arm.at 10.47am,/Lot number #036A21A..Client denies any headache or any dizziness at this time. EMS on site called for further evaluation. Vital signs. B/P 124/62,HR79 and P99. No signs of any respiratory distress at this time.
I learned I was pregnant on Monday 10/18/10. This was confirmed by midwives on 10/19/10 and it was estimated I was somewhere between 4 and 7 weeks pregnant. On 10/23/10 I miscarried. I miscarried 9 days after receiving the vaccine.
positive test for COVID-19; positive test for COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 75-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 74 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 24Apr2022 as dose 4 (booster), single (Lot number: FJ4989), in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 07Mar2021 as dose 1, single (Lot number: EN6206), in right arm and on 29Mar2021 at 14:30 as dose 2, single (Lot number: EN6201), in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL (Lupin Pharmaceutical), start date: 01Oct2013; LEVOTHYROXINE (Mylan), start date: 01Aug2014; ALENDRONATE SODIUM (Aurobindo), start date: 01Dec2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "recovered" (2023) and all described as "positive test for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) positive; (2023) negative, notes: after 5 days of Paxlovid; (2023) negative, notes: one day later to confirm. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Following a positive test for COVID, patient asked her doctor to prescribe Paxlovid based on her age. She took it on Tuesday and had reduced symptoms within a day after she finished the 5 days of Paxlovid, she tested again. She was negative for COVID. Then she tested one day later to confirm and was negative again.
About three weeks after receiving my first Moderna vaccine, I woke up on April 6th, and my entire body was twitching (head to toe),  My doctors tried many different medications to stop the twitching, but nothing helped.  I went through months of testing (spending thousands of dollars).  Every test has come back normal, with the exception of some spinal stenosis shown on my mri's, which I have had for some time.  It is now 7 months in, and I still have the twitching.  It had subsided somewhat, but it still happens about every three minutes or so.  I have also developed neuropathy symptoms which I never had before.
after pt recv vax 10/95 in 3/98 pt devel full blown varicella
This spontaneous report was received from a registered pharmacist via a company representative concerning a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. On an unknown date, the patient experienced redness at the injection site after the vaccination. The patient sought medical attention (called pharmacy). It was unspecified if any treatment was given or if any lab tests were performed. The outcome of redness at the injection site was unknown. The relatedness for redness at the injection site was unknown for ZOSTAVAX. Additional information has been requested.
Patient had erythematous papules at injection site and on abdomen area. Patient was given .3cc dex and 12.5mg of Diphenhydramine injection. Patient was given rx for Prapred 15/5cc 1tsp BID x 5 days. Patient is to RTC in 1 week.
pt recv vax  10MAY99 8PM running a fever of 103;mom called local hosp;told to alternate APAP & advil @ 3hr intervals;pt vomited @ 10PM & again 6AM;looks sick;discussed dehydration & fluid replacements;
Immediately, upon injection I felt a pain that went down my arm to my elbow.  About an hour later my arm stated to ache and it was hard to move it.  By 6PM I could not lift my arm, I could barely move it, and it was painful.  By 9PM I called the pharmacy and asked what to do - it was severely painful and uncomfortable even just hanging by my side or sitting in my lap.  They said to take Ibuprofen and use ice.  I did that.  I slept poorly but by morning, I could move my arm somewhat and the pain was subsiding.  I was able to use my arm some that day, though I could not raise it very high or hold it out to my side and by the next day I had complete movement and just a bit of soreness.  The shot was given by a Pharmacy trainee - it was his first Shingrix shot.  The Pharmacist watched but did not advise him at all.  I told them of the immediate pain down my arm and they said nothing.  I wondered then if he had hit a nerve.  It seems possible now.  I did not feel completely well the day after the shot, which I think is a normal reaction, as is the mild soreness I still feel.  The extreme pain and immobility of my arm the day of the shot does NOT seem at all normal.  I WILL call my doctor on Monday!
Approx 20-24 hrs p/immun pt devel t104 w/shrill, prolonged crying; mother of child states pt was fussy & irritable x 1 wk;
It started 16 hours after vaccination I woke up with a fever of 100.8 with body ache, Chills, Headache, had shortness of breath and by Tuesday evening my temp was 103.9 and Thursday i had fever still, cold and sore with chills, by Friday morning I still had fever and chills and cold throat all over my mouth, same over the weekend, Monday morning I had very mild swollen neck and low grade fever of 99.5 and my normal is 97.0 , I still have a headache and I feel cold sores coming out again.  Seen my doctor and Prescribed me Valtrex.
23 yo F with h/o POTS who was feeling fine until about 25 minutes after the vaccine at which time she developed shortness of breath, chest tightness, flushing sensation, lightheadedness with sense of impending doom and abdominal cramping.  Reported she felt similar to when her POTS flares up, but that only occurs with standing which she hadn't done.  HR 126 and BP 174/93 and repeat was 132 and 152/113.  Oropharynx appeared normal but she appeared pale and very weak, and slumped over in the seat of the car.  911 called and EpiPen and IM Benadryl given with some improvement of symptoms.  BP continued to be hypertensive and HR tachycardic.  O2 sats remained stable at 99%.  With her overall symptoms, concern for anaphylaxis, although her symptoms were likely multifactorial - POTS, anxiety.
pt recvd vax 3MAR93 states had fever of 105; no sz, no inconsolable crying; advised mom to take pt to ER; mom took pt to ER; pt had acute OM, placed on Augmentin;
Patient was 11 weeks pregnant with no reported adverse event; Adacel was given to the wrong patient with no reported adverse event; Initial information received on 04-Feb-2022 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 23 years old female patient who was exposed diphtheria-2/tetanus/5 ac pertussis vaccine (Adacel) was given to the wrong patient with no reported adverse event and patient was 11 weeks pregnant with no reported adverse event occurred at unknown gestation period; the gestation period at onset and gestation period at exposure data needs to be populated, if available.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The date of last menstrual period was not reported. The estimated due date was not reported. The patient had previous pregnancy/ies was not reported.   On 02-Feb-2022, the patient received suspension for injection of suspect diphtheria-2/tetanus/5 ac pertussis vaccine at a dose of 0.5ml once (1x) with lot U7184AA via intramuscular route in the right deltoid for prophylactic vaccination (Immunization).  On 02-Feb-2022 the patient developed a non-serious "adacel was given to the wrong patient with no reported adverse event (wrong patient received product)" (latency: same day) following the administration of diphtheria-2/tetanus/5 ac pertussis vaccine. On an unknown date the patient developed a non-serious "patient was 11 weeks pregnant with no reported adverse event (exposure during pregnancy) (latency: unknown)" following the administration of diphtheria-2/tetanus/5 ac pertussis vaccine.  It was reported that "the incorrect patient received a ADACEL vaccine. The Medical Information agent confirmed the spelling of demographics with the caller for accuracy. Caller states that she is calling to report an incident that happened on 02feb2022. Adacel was given to the wrong patient. She received it 2 weeks early. Patient was 11 weeks pregnant at the time".   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (Adacel was given to the wrong patient with no reported adverse event, Patient was 11 weeks pregnant with no reported adverse event).  At time of reporting, the outcome was Unknown for the event adacel was given to the wrong patient with no reported adverse event and was Unknown for the event patient was 11 weeks pregnant with no reported adverse event. Additionally, at time of reporting, the outcome of the pregnancy is 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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information has been received from a physician concerning a female between 15 and 16 years old who was vaccinated with a 0.5 ml dose of HPV vaccine (yeast). After receiving the vaccine, the patient fainted.  Unspecified medical attention was sought.  At the time of this report, the patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
started with chills Thursday 3/11 evening 10 PM, progressed to diarrhea, vomiting, nausea, headache, body aches, sore arms and shoulders, stiff neck, hives on face, fever of 100.7 exhaustion  FRIDAY SATURDAY AND SUNDAY  3-12 thru  3/-14 dehydration, elevated blood pressure 148/92  diagnosed on 3-15 &  prescribed medicine for nausea to keep down liquids  diarrhea continued 3-16 still have body aches exhaustion and nausea have not had diarrhea yet
I feel under the weather, like I have a cold with sore throat, cold symptoms and kinda feverish; This spontaneous report has been received from a 43-year-old female patient (also a company representative) concerning herself with seasonal allergy. The patient's medical history included thyroid disorder. Concomitant therapies included escitalopram and levothyroxine sodium (SYNTHROID).     On 15-MAY-2019 (also reported as "yesterday afternoon"), the patient was administrated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot # and expiration date were not reported) for vaccine. The first dose of the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) series was administrated 2 months ago and the patient had no adverse effects.        In the evening on 15-MAY-2019 and 16-MAY-2019(reported as last evening and today), the patient felt under the weather, like he had a cold with sore throat, cold symptoms and kinda feverish. The patient did have a sore throat on Monday evening. The patient did not seek medical attention. No treatment was given for the event.    The outcome of cold was reported as not recovered. The causality between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Received a Moderna coronavirus vaccine "1st dose" today exactly 4 months after completing a Pfizer coronavirus vaccine regimen; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Received a Moderna coronavirus vaccine "1st dose" today exactly 4 months after completing a Pfizer coronavirus vaccine regimen) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Asthma, Hypertension, Hypercholesterolemia and Obesity (BMI 30.5).   On 26-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Received a Moderna coronavirus vaccine "1st dose" today exactly 4 months after completing a Pfizer coronavirus vaccine regimen). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Received a Moderna coronavirus vaccine "1st dose" today exactly 4 months after completing a Pfizer coronavirus vaccine regimen) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) tested negative for coronavirus antibodies immediately prior to the first Pfizer dose.         No concomitant medications provided. No treatment medications provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Follow up contains no new information.
About 4 hours after the vaccine I started to feel feverish and very thirsty. I took my own temperature and it was normal. About 5 days after vaccine I started to feel a few random heart jabs in the heart area. This occurred randomly during the day and now, 14 days later, seems to have slowed down in frequency. On 8/16 & 17 I also felt very strong jabs on the left side of my head, internally. On 8/18, I woke up with my entire face swollen especially my left side. There was no other swelling on my body.
2 month old given standard 2 month vaccines 3/30/06, developed a rash over face, neck and thighs with temps to 99-100 within 24 hrs of vaccination. Prescribed Tylenol, infant Benadryl. At 48 hrs, rash was worse urticarial, generalized and fevers up to 103. Prescribed Motrin, which improved rash/fevers. Continued to interact to feed well throughout the course of rash/fevers. Had complete blood count at 48 hrs post vaccination in ER. Labs normal except for viral shift. Infant discharged from ER 4/1/06 with instructions to use Tylenol/Motrin to keep fevers down. Per mothers verbal request 4/3/06 infant completely recovered by 72 hrs post vaccination with resolution of rash/fevers and normal activity.
Patient felt dizzy and lightheaded, was pale and diaphoretic per observer and MD report
Almost immediately felt warm sensation in left forearm near the elbow that started to become itchy. Then, a day later I noticed my arm was swelling about 3-5 inches from the injection site. Where it was swelling it became red, hard, and warm to the touch. My arm continued to itch in the said area and the size and symptoms persisted for about 2 weeks. I started doing cold compresses and taking Tylenol after week 2, the symptoms seemed to slowly subside over about 3-4 days. I total it took about 2 and a half weeks to rid of the side effects.
This spontaneous report as received from a pharmacist refers to multiple, unspecified patients of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. The Pharmacist reported that multiple unspecified patients were administered improperly stored varicella VARIVAX (dose, route were not reported) and PROQUAD.  Information regarding vaccines involved as follows:  PROQUAD (lot# M002055, expiration date 7/11/2017) or VARIVAX (lot#L048463, expiration date 12/2/2017).  Temperature/Time frame: -2 degrees Celsius for 1 hour 36 minutes, 2.9 degrees Celsius for 3 hours 42 minutes, -8.l degrees Celsius for 1 hour 36 minutes, -11.5 degrees Celsius 30 minutes, -7.4 degrees Celsius 2 hours 12 minutes, -7.5 degrees Celsius 48 minutes.  Names of vaccines involved: PROQUAD (lot # M007965, expiration date 15-AUG-2017) or VARIVAX (lot#M004663, expiration date 27-JAN-2018). Temperature/Time frame:  -2 degrees Celsius 1 hour 36 minutes, 2.9 degrees Celsius 3 hours 42 minutes, -8.1 degrees Celsius 1 hour 36 minutes, -7.5 degrees Celsius 48 minutes, -13.4 for 18 minutes, -13.7 12 for minutes.  No adverse effects were reported.  No additional information was available. Follow-up information has been received on 28-NOV-2016 from the pharmacist via phone call providing new stability data and an additional lot number to add to the case.  Names of vaccines involved:  VARIVAX (lot # L048463, expiration date 02-DEC-2017, lot #M004663, expiration date 27-JAN-2018).  Temperature 2.9 degrees Celsius:  time frame: 1 hour; cumulative time frame: 11 hours 54 minutes.  PROQUAD, (lot# M007961, expiration date 15-MAY-2017), temperature: 2.9 Celsius, time frame: 1 hour; cumulative timeframe: 11 hours 24 minutes.  The time frames and temperatures were double checked with the pharmacist.  No adverse effects were reported by patients.  No further information provided. Additional information is not expected.
Customer is 62 years old. He received the High Dose Fluzone that is for over age 65 years old.
Low grade fever, body aches, sorethroat, headache, and nausea.