chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Took fourth dose of Vivotif a day late; Took bactrim while taking Vivotif doses; Spontaneous report received on 03MAR2020.   A male consumer reported that he "took bactrim while taking Vivotif doses" (PT: Labelled drug-drug interaction medication error) and "took fourth dose of Vivotif a day late" (PT: Inappropriate schedule of product administration). The consumer was receiving Vivotif for immunization and Bactrim (sulfamethoxazole and trimethoprim) for prophylaxis for cystoscopy. The consumer took three doses of Vivotif according to the schedule on 25FEB2020, 27FEB2020, and 29FEB2020 respectively. However, the consumer forgot to take the fourth dose of Viviotif on 02MAR2020 and took it on 03MAR2020 (01:00 AM). It was also reported that the consumer took the Bactrim on 02MAR2020 for prophylaxis for his cystoscopy. Action taken with Vivotif and Bactrim with respect to the reported events was not applicable. The outcome of the reported events was unknown.  Company Comment: A consumer took bactrim while taking Vivotif doses (Labelled drug-drug interaction medication error) and also took fourth dose of Vivotif a day late (Inappropriate schedule of product administration). Vivotif doses should be taken every other day and there should be a gap of at least three days between Vivotif and antibiotic doses. Considering the nature of the events, the causality of both the events is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took bactrim while taking Vivotif doses (Labelled drug-drug interaction medication error) and also took fourth dose of Vivotif a day late (Inappropriate schedule of product administration). Vivotif doses should be taken every other day and there should be a gap of at least three days between Vivotif and antibiotic doses. Considering the nature of the events, the causality of both the events is assessed as not applicable to Vivotif.
Information has been received from a physician concerning a 5 year old female with no allergies or medical history who on 04-JAN-2002 was vaccinated SC with a 0.5 mL dose of Varivax (lot # "MSD18931-1"). There was no concomitant medication. On 02-OCT-2006, the patient was found to have six lesions located on the face, torso, and back. The lesions were tested and verified that it was wild type varicella. Unspecified medical attention was sought. The patient was given Benadryl. A product quality complaint was not involved. Varicella was determined to be an other important medical event by the physician. Additional information has been requested.
8 hours after receiving the vaccine I could feel the effects of body aches coming on.  I went home from work, put warm clothing on and fell asleep.  Several hours later I woke up with severe chills.  Ibuprophen was my friend and I had body aches and exhaustion for the next full day.  A total of 48 hours of symptoms that kept me home.
Patient received IPV and meningitis vaccine in the left arm on 12/20/2005 developed marked swelling and itching at the injection site.
Td booster given 06/07/2004. Next day pt reported swelling, redness to site. Called 6/9. Local tenderness. Mild swelling. No redness.
Acute metabolic encephalopathy - after evaluation it appears this is a multifactorial chronic dementia or degenerative process with acute delirium. His a course did wax and wane there was no reversible cause. Treated for 8 days and discharged. ED visits and hospital admission within 6 weeks of receiving the COVID vaccine.
Headache; Fever; Chills; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Myalgia) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Myalgia). At the time of the report, HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Myalgia) outcome was unknown. Not Provided          The patient had symptoms post 3 weeks of having second dose of vaccine. He was worried if his wife can get the any of the symptoms from him. No concomitant or treatment information was provided by the reporter.
Fever; Achiness; This case was reported by a consumer via call center representative and described the occurrence of fever in a male 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 2 years after receiving Shingrix, the patient experienced fever and pain. On an unknown date, the outcome of the fever and pain were unknown.   It was unknown if the reporter considered the fever and pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced fever and achiness after first dose of Shingrix vaccine. The reporter denied to provide any additional information. The reporter did not want to provide his address. The reporter denied permission to follow up.
Awoke from nap on 01/21/2007 and was disoriented and confused.  Taken to the ER where multiple tests were performed.  This last several hours.  Psychiatry was consulted as well.  Patient states she felt funny the next day, but was ok by 01/23/2007.
Initial and follow up information has been received from a physician concerning a 72 year old female with an unknown history of chicken pox who on 07-SEP-2007 was vaccinated IM in the left deltoid with a 0.65 ml dose of Zostavax (Oka/Merck) (Lot#658083/0885U). On 21-SEP-2007 (also reported as 24-SEP-2007) the patient developed a papular rash with small vesicles on the right side of her chest with dermatone distribution, the patient was diagnosed with shingles. Unspecified medical attention was sought. No lab studies were performed. No further information was provided. There was no product quality complaint involved. Follow up information from the physician indicated that the patient had concomitant medications of amlodipine besylate (+) atorvastatin calcium (Caduet), zolpidem tartrate (Ambien), metoprolol succinate (Toprol XL), olmesartan medoxomil (Benicar), and venlafaxine hydrochloride (Effexor XR). The patient had a maximum temperature of 99.4 degrees F. Her pain was a 6 on a scale of 0 (least) to 10 (most). There were no other systemic symptoms. There was no recent exposure to chicken pox or herpes zoster. There was no DFA or PCR done. A photo was not taken. On an unspecified dose the patient recovered. Additional information is not expected.
Pt became convulsive for approx. 30 seconds, then had a loss of consciousness for approx. 1 minute. After regaining consciousness he was unable to walk for approx. 5 minutes and his speech seemed to be slurred. No treatment was administered.
pretty bad headaches/headache was consistent; disorientation; brain fog; dizziness; I can no longer concentrate; episodes of fainting; bad memory/memory issues; some hand tremor in both hands; She cannot drive. She had fainted a couple of time/I can no longer drive or exercise since that makes it more likely for me to black out; problems have been escalating more at the cognitive level; This is a spontaneous report from a contactable consumer (patient) and another contactable consumer (patient's mother). A 29-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration as a single dose, in her left arm, on 31Mar2021 11:00 (lot number ER8737), at age of 29-year-old of vaccination, for Covid-19 immunization, in a pharmacy or drug store. The patient had no medical history or known allergies. The patient did not have Covid-19 before vaccination and did not test post vaccination. The patient did not receive other vaccines in four weeks and she received vitamins in two weeks. Started with pretty bad headaches/ consistent headaches, and then the patient started to present memory issues, brain fog, disorientation, dizziness, and overall the problems had been escalating more at the cognitive level. She could no longer concentrate, she had episodes of fainting, bad memory, some hand tremor in both hands. She could no longer drive or exercise since that made it more likely for her to black out. Her family kept her under constant supervision to avoid any accidents from happening. After the vaccine not only the patient but her parents as well experienced some of these issues but in their case the side effects had been disappearing while in her case had been getting worse. The events occurred on 16Apr2021 08:00. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and Disability or permanent damage. Patient received doctors' appointments, tests, referrals to special (including neurologist), and received unspecified treatment. The patient did tests and everything but the doctors could not find anything wrong but the symptoms started worsening. The patient had her second dose of vaccine on 22Apr2021. The outcome of the events was not resolved at the time of reporting.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101289277 Same reporter/ drug, different patients/ events;US-PFIZER INC-202101289278 Same reporter/ drug, different patients/ events
high pitched shrill screaming for 2 hrs p/vax & also starring & unresponsive;
Bell's Palsy on RIGHT side of face. Half her face can't smile, can hardly close eye, lost sense of taste on 1/2 her face.
Pt had redness, warmth on arm radiating up neck on (R) side. Also had body aches. Unable to raise arm above shoulder. Patient was informed to ice area, take OTC pain med and call if not better. Spoke with pt 8/30/10 and sx were much better, almost gone.
2nd dose in December 2020. Got shingles in July 2021; Got shingles; rash; This case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In December 2020, the patient received the 2nd dose of Shingrix. In October 2020, the patient received the 1st dose of Shingrix. In July 2021, between 6 and 8 months after receiving Shingrix and between 8 and 10 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced rash. On an unknown date, the outcome of the vaccination failure and rash were unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix and Shingrix.  Additional case details were provided as follows: The reporter was physician assistant. The age at vaccination was not reported. The patient was vaccinated with 1st dose and 2nd dose of Shingrix and got shingles. The patient noticed rash and after three days contacted with physician who treated her with regular shingles medication and symptoms diminished after 5 days. less than 9 months after receiving 1st dose of Shingrix and less than a year after receiving 2nd dose of Shingrix the patient experienced vaccination rash. The reporter consented to follow up.
PER PT - FAINTED, PER RPH SEEMS LIKE A SMALL SEIZURE FOR 3-5 MINUTES.  CLIENT DID NOT RESPOND BUT WAS BREATHING THE WHOLE TIME - UNRESPONSIVE ON THE COUCH LAYING DOWN. RPH CONTINUE TO MONITOR BREATHING  AND AFTER A FEW MINUTES THE PATIENT GAIN CONSCIOUSNESS.  THE PATIENT BECAME FULLY AWARE OF LOCATION AND WHAT HAPPENED.  STAFF CALLED 911 BUT WHEN THEY ARRIVED PATIENT REFUSED HELP.
My son had a high fever (over 104 degree fever) for 6 straight days, hives on his legs, rash on his upper body, fast heart beat, dizziness, lethargic, no appetite.  He was admitted into the ER on the evening of Friday Jan. 14th, 2011 for all the conditions listed above.
Patient fully vaccinated with Pfizer vaccine on 1/28/2021 and 2/24/2021.  Patient diagnosed with Covid19 on May 25, 2021 with a rapid PCR test after a known exposure to a Covid positive person
Patient states that she woke up the next morning with hives around her waist and ankles. States the symptoms lasted about 1 week.
Vertigo; Tinnitus located in one ear; This is a spontaneous report from a contactable other healthcare professional, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Feb2021 at 10:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were reported as none. The patient had no known allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 06Jan2021 at 09:30 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 26Feb2021 at 07:00, the patient experienced vertigo and tinnitus located in one ear. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the events vertigo and tinnitus located in one ear were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt recvd vax 16MAY90 & was found to be pregnant w/a conception date on or about the date of vax; LMP 1MAY90; on 3AUG90 spontaneously aborted approx 12-13 gestation; autopsy showed that fetus was thoroughly infarcted;
I have a black bump on my arm where COVID vaccine was administered; Bump on arm still present; This is a spontaneous report from a contactable consumer (patient herself). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9269, Expiry date: unknown, age at vaccination of 59-years), dose 1 intramuscular, administered in arm right on 09Mar2021 14:00 as single and dose 2 intramuscular, administered in arm left on 30Mar2021 14:00 (Batch/Lot Number: ER2613, Expiry date: unknown) as single for covid-19 immunisation. The vaccination facility type was others. Medical history included blood cholesterol and A Fib (atrial fibrillation). Concomitant medications included pravastatin for cholesterol, propafenone hydrochloride (RYTHMOL (PROPAFENONE HYDROCHLORIDE)) for A Fib, metoprolol (METOPROLOL) for A Fib and the medications were ongoing. The patient stated that bump on arm still present on 10Mar2021, I have a black bump on my arm where covid vaccine was administered on an unspecified date. No treatment medication was received for the event bump on arm still present. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected
Received vaccine 12 noon 8/3/2004. At 10:30PM had generalized itching of body. In morning 8/4/04 noted swelling of lips and balls of feet. Did not surface. 8/6/2004 lips slightly swollen. Felt returned to normal.
collapse/rapid progression of symptoms; hypotension/rapid progression of symptoms; respiratory distress with stridor; respiratory distress with stridor; dizziness/rapid progression of symptoms; not limited to abdominal pain/rapid progression of symptoms; blood pressure abnormality/rapid progression of symptoms; chest pain/rapid progression of symptoms; drooling/rapid progression of symptoms; increased swelling/rapid progression of symptoms; wheezing; dyspnea and increased work of breathing; skin changes; tongue swelling and vomiting; tongue swelling and vomiting; This is a spontaneous report from a non-contactable other health professional. A 35-year-old female patient (Age at vaccination: 35) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. During her 15 minute waiting period after the injection, the patient began to experience dizziness. Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality, chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress with stridor, wheezing, dyspnea and increased work of breathing, skin changes, tongue swelling and vomiting. Treatment included: no therapy. The outcome of the events was unknown.  No follow up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the collapse, hypotension, respiratory distress and other reported events due to temporal relationship.  There is very limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including BP measurements, chest x-ray, EKG and chemistry panel, counteractive treatment measures and concomitant medications.   This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
impinged nerve (pinched nerve?) in one of his muscles; general malaise; left arm pain; Soreness/Normal pain/Pain never went away; This case was reported by a pharmacist via call center representative and described the occurrence of pinched nerve in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number 24KZ7, expiry date 15th May 2022) for prophylaxis.   On 8th January 2020, the patient received the 1st dose of Shingrix. In January 2020, less than 3 weeks after receiving Shingrix, the patient experienced pinched nerve, general malaise, pain in arm and pain. On an unknown date, the outcome of the pinched nerve, pain in arm and pain were not recovered/not resolved and the outcome of the general malaise was unknown.   It was unknown if the reporter considered the pinched nerve, general malaise, pain in arm and pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had general malaise and left arm pain and soreness, but attributed it to normal pain after an injection.  The reporter stated that from January until 16th March 2020, the patient continued his normal activity, which also included playing tennis, but the pain never went away.  The patient had a doctor's appointment and was then referred to physical therapy, where it was discovered that he had an impinged nerve in one of his muscles. They were unable to definitively provide a cause and could not say if it was related to the vaccine as it was not listed as a common adverse effect listed with the vaccine. The reporter consented to follow up and also provided the patient's name and telephone number as well for follow up with patient.
RASH, REDNESS INNECK AREA,  STARTED AT 7PM ON DATE OF VACCINE. C/O PAIN IN LEFT EAR, REDNESS THAT LASTED 5 DAYS,  EAR PAIN LASTED 24 HOURS
Vaccine give L upper arm - that evening it became red and hard. Entire upper outer arm involved. Temp up to 102 x one week.
This spontaneous report was received from a nurse refers to a 01-year-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 20-SEP-2017, the patient was vaccinated with improperly stored M-M-R II (dosing details were not reported) (lot # M045401, expiry date: 14-NOV-2018) for prophylaxis. The lot of M-M-R II were reconstituted with properly stored sterile diluent (MRK). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054: Original Case: 1709USA000054.
Dose 1 was given at 9 am on Friday morning Feb 26, 2021.  I was fine until mid afternoon the next day when I started experiencing a bad headache.  The headache was severe from Saturday Feb 27, 2021 evening until Monday morning February 28, 2021.  After that I was fatigued and very tired until Wednesday, March 3, 2021.  Dose 2 was given this morning, March 19, 2021 at about 9:30 am.  On the drive home at 10 am, I started feeling the heaviness again.. as if a large heavy blanket is draped over my shoulders.  This feeling comes in waves and I often experience hot flashes with the heavy feeling.  No headache yet (fingers crossed!)
Moderna COVID-19 Vaccine EUA  Had Covid in September 2020. The first shot had me experiencing covid symptoms all over again for almost 48 hours. Nausea, thirst, headache, chills, body aches, 102° fever, exhaustion, and not being able to move arm where shot was. Also experiencing ear issues again which took almost 3 months to dissipate when I actually had covid. Shot was administered around 1700 on a Wednesday. Felt fine going to bed. Woke up to the headache that quickly progressed to everything else.
was fatigued but usually pretty low energy; was fatigued but usually pretty low energy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (173415).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "was fatigued but usually pretty low energy".  Additional information: Reporter's Mother-in-law also received the Pfizer C19 vaccine: was fatigued but "usually pretty low energy"  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
6AUG92 recvd Engerix-B & deel back pain w/in 8 hrs of vax;