chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Was exposed (in close contact for more than 15 minutes) with two people on 4/23 and 4/24 who tested positive for COVID on 4/25 and 4/26. On 4/25 had a sore throat and runny nose. On 4/26 was very congested and had a slight fever and body aches.
3/24/21 ER C/o high blood pressure. States he got up to use the restroom this morning and "felt like my legs wouldn't hold me up & then I checked my blood pressure & it was high". Ambulates from waiting area to room without difficulty. Pt denies dizziness, shortness of breath or pain.
55 yo female honks the horn to report cc SOB and tightness in the throat. VSS HR 82 RR 18 airway was found to be clear and no s/s of respiratory distress.  She was monitored for an additional 30 min symptoms improved and sent home
2 1/2 x 2 1/2 area of induration and redness.  Minimal warmth, mild swelling in office on 10/21/2005, after ER visit.  Diagnosed with Cellulitis.  Treated with Cleocin.
breathing was heavy; increased heart rate; bruising; chills; arm pain was so intense; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain was so intense), DYSPNOEA (breathing was heavy), HEART RATE INCREASED (increased heart rate), CONTUSION (bruising) and CHILLS (chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04112OA) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Mold and Cedar).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm pain was so intense). On an unknown date, the patient experienced DYSPNOEA (breathing was heavy), HEART RATE INCREASED (increased heart rate), CONTUSION (bruising) and CHILLS (chills). At the time of the report, PAIN IN EXTREMITY (arm pain was so intense) was resolving and DYSPNOEA (breathing was heavy), HEART RATE INCREASED (increased heart rate), CONTUSION (bruising) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
pt recvd vax & had fever of 102 & whiny next day; had hives on body; took to pmd & told was allergic rxn to vax
RED, INFLAMED, LARGE BLISTER, BODY ACHES, FATIGUE.
Urticaria. 2 doses Pfizer vaccine.   2nd dose 4/14/21 Daily urticaria started 4/23/21 and continued, responding Poorly to medication. On 6/18/21 her hives were Noted to have bruising. Skin biopsy showed
felt "run down"; diarrhea; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP).  An 85-year-old male patient received tofacitinib citrate (XELJANZ XR), at 11 mg; BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Covid-19 vaccine for COVID-19 immunization, notes: Primary series of immunization completed manufacturer: Unknown. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "felt "run down""; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea". The action taken for tofacitinib citrate was unknown.  Additional Information: It was reported that, on 06Jun2022 [Xeljanz D/C Call] completed. Spoke with patient's wife. Reports getting COVID 4th dose 2 weeks ago, and patient felt "run down" for about a week after and experienced some diarrhea. Did not stop Xeljanz for that dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
patient tested positive for COVID 19 the same day; patient tested positive for COVID 19 the same day; This is a spontaneous report from a non-contactable Nurse. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The COVID 19 vaccine was administered to the patient and the patient tested positive for COVID 19 the same day. Patient did not have a fever and reported feeling tired. The nurse wanted to know if the immune response would be affected by having COVID 19 at the time of vaccination and will the symptoms be exacerbated because of receiving the vaccine. The outcome of the events was unknown.  No follow up attempts are possible. Information on Lot/Batch could not be requested. No further information is expected.; Sender's Comments: The patient tested positive for COVID-19 on the same day when receiving BNT162B2 vaccine.  And therefore there is not a reasonable possibility that reported "tested positive for COVID 19" is related to vaccine.
2 distinctly different rashes - maculopapular morbilliform rash on trunk and neck and 5 vesicles on face and arms.
He recieved the H1N1 vaccine and 6 hours later became fussy and ran a fever of 101. During the night it went up to 102. Parents gave Tylenol and Motrin and at 12:30 on 11/10/2009 to him to see Dr. Advised them to continue Tylenol at home. Also advised the to report to Health Dept. Mom called in 12/09/09 to report the reaction and to let us know she was not getting the 2nd dose for this child.
Patient was sitting in observation room 15 min following covid-19 vaccination,  she appeared anxious and complained of light headedness. noted with facial flushing and mild appearance of hives. H/O  shellfish allergy, hospitalized with anaphylactic reaction twice in the past after eating shrimp. Denies nausea, no vomiting  or difficulty breathing. No itching, tongue heaviness or throat swelling. Benadryl 50mg  PO administered immediately. vital signs as followed BP 134/86 pulse 101. repeated BP 126/77, pulse 92.  third BP reading 112/73, pulse 81. o2 sat 99% . respiratory rate 18. She was closely monitored for another hour, repeating vitals signs every 15 mins,  symptoms resolved, states she feels fine, left facility stable in uber. Instructed to follow up with PCP for further evaluation and discuss alternate setting for 2nd covid 19 vaccination. Instructed on when to seek medical assistance.
administrated with an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Infanrix) (batch number 49tm3, expiry date 28th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th June 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 13th June 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On 13th June 2022, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-JUN-2022 Reporter's Comments: The nurse reported that a dose of Infanrix was given to the patient and it was already expired.  The nurse reported that no adverse event was reported. The Vaccine Administration Facility was the same as primary reporter. No patient's identifiers provided. The reporter consented to follow up. Additional Supportive Information: The patient received Infanrix dose which was already expired on 28th May 2022, which led to expired vaccine used.
Enlarged or inflamed heart, lungs full of fluid, myocarditis, vomiting, dehydration
Patient received an extra dose of vaccine, her first dose was 1/24/20, second dose 1/14/21 and booster on 9/27/21.  She forgot she had her booster and received a fourth dose on 11/16/21
HCP called for temperature stability evaluation of vaccines and reported that 10 pediatric patients received PROQUAD vaccine since excursion date on 7/14/2022. See additional AEs filed under interaction 02221034.  No PQCs reported at this time.; This spontaneous report has been received from a medical assistant, referring to a 3-year-old female patient.   The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not provided.  On an unspecified date, the patient was vaccinated with an improperly stored 1st dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) subcutaneous injection, 0.5 milliliter, 1st dose (vaccination scheme, frequency, route of administration and anatomical site of injection were not provided), lot number W002781 has been verified to be a valid lot number with expiration date on 24-JUL-2023, administered as prophylaxis (product storage error). The vaccine temperature excursion occurred on 14-JUL-2022.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA004105: US-009507513-2208USA003812: US-009507513-2208USA004086: US-009507513-2208USA003988: US-009507513-2208USA004011: US-009507513-2208USA004135: US-009507513-2208USA003812:
Vaccine given approximately 11:00 am on 10/18/07.  Tingling in right arm.  Complained of arm very sore but no redness or swelling - did apply ice when soreness started on 10/19/07 around 8:00 pm.  Fever high with chills, but had no thermometer to take temperature.  Fever broke around 11:00 pm 10/20/07 but appetite is down, feels sluggish, has aches (like pressure) across eyes.  No headache.  Soreness in arm resolving but has scheduled appointment with primary doctor on 10/25/07.
Weakness/ Lethargic  Seen by EMS on site  PR 52 SPO2 100%  BP 88/35  BP at 10:20am 101/57
I am 42 and have had a regular cycle for years. Was on my cycle the day of the vaccine. Since getting vaccine in March I have only had 1 cycle and that was in September. I do get the bloating, irrability, fatigue and all other period symptoms just no period. The symptoms are worse then before when I was having periods. I am trying to get an appointment with my women's doctor to speak with her on the issue.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information on patient's medical history or concurrent condition was provided. From 02-DEC-2015 to the time of this report, unspecified number of improperly stored doses of ROTATEQ (dose, lot # and expiration date were not provided) were orally administered to unspecified number of patients. No adverse  effects were reported. This is one of the several reports from the same reporter source. Additional information has been requested.
This spontaneous report as received from an 81 year old female patient refers to herself. The patient's medical history included shingles 10 years ago (in August 2004). The patient's drug reactions/allergies included penicillin (dosage/frequency/manufacture unknown). On an unspecified date earlier in 2014 the patient was vaccinated with a dose of ZOSTAVAX, one single shot, subcutaneous, (lot#, dose# unspecified) for the prevention of shingles. No concomitant medication was taken. In May 2014 the patient was diagnosed with shingles. No lab diagnostics studies were performed. The patient sought medical attention. The outcome of shingles was reported as recovered in 2014. Additional information has been requested.
Developed a headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported. The patient received the first dose of Shingrix and developed a headache. She did not want to provide any other details or information and did not want to be contacted following call. No further information was available. The reporter did not consent to follow up.
24 hours after Hep A on 7/1/10 child had fever of 103 degrees lethargy, fatigue, insomnia, did not want to eat Mom gave TYLENOL and MOTRIN but it would not work fever and other symptoms went away after about 3 days. Mom reported this after we contacted her to bring child in for 2nd dose of Hep A.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 10-OCT-2018, the patient was vaccinated with an improperly stored dose of PROQUAD lot # N016993, expiration date 29-NOV-2018, subcutaneously for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of -14 to -10 degrees Celsius for 28 minutes. There was previous excursion reported of -14 to -10 degrees Celsius for 44 minutes. Data logger was involved.
Patient said he "was not feeling well", night before and in the morning. Went to work at 8:30 am and collapsed while on the phone at work at 11:10 am. Had heavy breathing and retrieved a pulse while on ambulance but then lost pulse at arrival of hospital.
Pt developed petechial rash on the left ankle, spotty rash on his right hand and around his mouth.  Itching all over.
a few minutes after vaccine administration patient informed her mother that she felt like she couldn't hear and had some visual disturbance as she couldn't see out of her left eye. Patient then vomited once. She was evaluated by staff RN and MD and a full set of vitals were taken. She was observed for an extra 15 minutes and was told to rest for the remainder of the day and mom was instructed to call our office with any questions.
Gradually increasing pain in right deltoid and upper arm area starting 1 hour after injection. By the time I went to sleep, I couldn't put any pressure on my arm, or move it away from my body much at all. The pain was so bad I hardly slept that night. I took 2 Aleve the next morning (and more in the following days), and eventually the pain began to subside, lasting for a total of ~3 days before feeling back to normal.
12/19-12/20/02 Fever. 12/21-12/14/02 Rash. Rash did not have fluid in it and did not break open and scab over.
The same day as the injection pt c/o pain-she stated "arm hurt real bad like the needle hit the bone and when she got home, it hurt up to her neck. The next day, she woke up, the right arm "hurt like the dickens.
Information has been received from a registered nurse concerning a female pt in the 6th grade who was vaccinated with a dose of hep B virus vaccine. The pt was vaccinated as a young child with "other vaccines" that had mercury in them. Subsequently, the pt developed autism or autistic behaviors. Unspecified medical attention was sought. It was noted that product quality complaint was not involved. Upon internal review, autism or autistic behaviors was considered to be an other important medical event (OMIC). Additional info is not expected.
rash on the chest; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on the chest) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced RASH (rash on the chest). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH (rash on the chest) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Injected site pain; mobility impariment; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2018, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain and mobility decreased. On an unknown date, the outcome of the injection site pain and mobility decreased were unknown.   It was unknown if the reporter considered the injection site pain and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of Shingrix in the left arm. The patient experienced severe sharp pain in the site since. The patient had some mobility impairment as well. Especially painful at night. The patient asked for further suggestions.
Missed miscarriage at 11 weeks on 8/26/2021. Had to have a D&C procedure
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Vaccine received post its 30 days Expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine received post its 30 days Expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 36-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2022 at 3:45 PM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 01-Feb-2022 at 3:45 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine received post its 30 days Expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine received post its 30 days Expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Vaccine administration time was given as 01-Feb-2022 at 15:45:11.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-542869 (Patient Link).
Arm soreness at injection site Neck pain Chills Low-grade fever Shivers Fatigue
Symptoms began around 10 hrs after administration of shot, first a racing heartbeat for a few moments followed by an intense ringing in the ears and legs felt wobbly, quickly progressed to chills feverish for 9 hours. Headache then began for several hours. Tylenol administered by parent/guardian. General malaise and bed rest followed by congestion. Malaise and some nasal congestion lasted for additional 24 hrs.  Thirst treated with electrolyte based-drink and water.
visible red skin in areas of last sunburn; This is a spontaneous report from a non-contactable consumer, the patient. A 30-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 on an unknown date in 2021 (30-year-old ) as a single dose for COVID-19immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. On an unknown date in 2021, the patient drank glass of wine two weeks post the second shot and experienced visible red skin in areas of last sun burn, no ability to know except in the mirror. There were no other symptoms. On an unknown date the patient underwent lab tests and procedures which included body temperature and vitals measurement which had no abnormalities. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event visible red skin in areas of last sun burn was unknown at the time of this report.   No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; Dose Number: 1 J&J; Dose Number: 2 Pfizer / BioNTech; Dose Number: 3 Pfizer / BioNTech; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 36-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 as dose 3 (booster), single (Lot number: GJ3277) at the age of 35 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 09Sep2021 as dose 2, single (Lot number: FF2587) for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 09Apr2021 as dose 1, single (Lot number: 1808979) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Sep2021, outcome "unknown", described as "Dose Number: 1 J&J; Dose Number: 2 Pfizer / BioNTech; Dose Number: 3 Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Product Quality Group provided investigational results on 20Mar2023. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the Pfizer BioNTech Covid-19 Vaccine lot GJ3277 was investigated. The investigation included a review of manufacturing and packaging records, deviations, and the complaint history for in scope lots. The final scope was determined to be the finished goods lot GJ3277, bulk and fill lots, GJ2421, and GJ2427. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. No corrective or preventative actions were identified because it was determined that the controls in place were sufficient at preventing and removing defects that could cause a complaint of this nature. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the Pfizer BioNTech Covid-19 Vaccine lot FF2587 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot FF2587, fill lot FF2556, and the formulated drug product lot FE5315. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  Follow-up (20Mar2023): This is a follow-up report from Product Quality Complaint Group providing investigation results.
Received vaccine 4/18/2019 (2nd Shingrix Dose) was seen in Doctors 4/22/19 for increased swelling and redness. Numbing lips, nerve pain on vaccinated arm.