chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramps) and DIARRHEA (diarrhea) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 26-May-2021 at 1:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach cramps) and DIARRHEA (diarrhea). At the time of the report, ABDOMINAL PAIN UPPER (stomach cramps) and DIARRHEA (diarrhea) had not resolved. No concomitant medication was provided. No treatment medications was provided. Action taken with mRNA1273 Moderna vaccine was Not Applicable
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 13-NOV-2012 at 14:52, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 06-APR-2018 the patient was vaccinated with improperly stored dose of ROTATEQ (lot # N003984, expiry date: 19-NOV-2018), orally for prophylaxis (product storage error). The vaccine was stored at a temperature of 10 degree celsius for a time frame of 26 minutes. No previous temperature excursions reported. No adverse effects were reported. There was a digital data logger involved. No product quality complaint involved.
This spontaneous report as received from a nurse refers to multiple patients of unknown ages. The patients' medical history and concurrent conditions were not reported. On multiple unspecified dates the patients were vaccinated with improperly stored (temperature/time frame: to 32 F for 60 hours and a previous excursion of 33 F for 12 hours) ROTATEQ (lot number: K020182, expiry date: 25-JUN-2016) at unspecified doses. The nurse stated that it was unknown at the time and could not be denied or confirmed that doses were administered. No adverse effects reported. The outcome of the events was unknown. Additional information had been requested.
pt recvd vax;9:15am,pt reported itching & swelling at inject site;ice pack applied & dph given;2pm to hosp er; SOB; tx w/ epi,monitered & released;
Client received mcv and hpv immunizations at approximately 11:20 am-stated did not have breakfast nor anything to eat-during 15 minute waiting period both mother and client returned to vaccination room, stating client was nausaeous and feeling weak.  client was laid down to rest for approximately 20 minutes after which she stated she was feeling better-no injuries were noted.  Client left ambulating with mother and comfort measures were reinforced,to seek er attention if furthur episode.
This spontaneous report was received from a pharmacist and refers to a 49 year old female patient. No pertinent medical history, concurrent conditions or concomitant medications were reported. On an unknown date, the pharmacist vaccinated the patient with the last dose of GARDASIL in his pharmacy. The dates of administration for any previous doses of GARDASIL were unknown. The pharmacist did not provide any further explanation of the last dose administered to patient. No adverse events were reported. The outcome of the events were unknown. Additional information has been requested.
Patient received vaccination on 1/21/2021 @ 1511 and within 5 minutes of receiving reported to experiencing a tingling sensation through his body and feeling like he was not inside his body.
Information has been received from a literature article titled Invasive pneumococcal infections in pediatric cardiac transplant pt's (Pediatric Infectious Disease Journal; 20(10): 946-950,10/01 concerning an approximately 5 year old female pt with a history of a cardiac transplant who was vaccinated with one dose of pneumococcal vaccine 23 polyvalent at the age of 42 months (3.5 years). Concomitant therapy included an unspecified immunosuppressive medications at the time of infection. almost 2 yrs later the pt developed a bacteremia with serogroup 14. Upon internal review, pt's bacteremia was considered to be an other important medical event. It was noted that this information was rec'd from medical records of all cardiac transplant pt's receiving their care at a hospital from 3/90 to 11/00 that were reviewed for cases of invasive bacterial infections caused by S pneumoniae that occurred after transplantation. the pt's involved developed pneumococcal bacteremia. The risk factors for the development of invasive pneumococcal disease included African-American race, transplantation at age < 32 years and having idiopathic cardiomyopathy as the indication for transplantation. It was noted that the first infection occurred at median age of 20 months post transplant (range 3 to 48 months). Fever >101F was the presenting sign/ symptoms in 75% of cases. Other clinical presentations included pneumonia, otitis media and petechiae, purpura. In 25% of episodes pt's had received a course of oral anti microbial therapy within 30 days before their invasive disease. All patients were taking immunosuppressive medications at the time of infection including cyclosporin, azathioprine, systemic corticosteriods and mycophenolate mofetil. It was also noted that four other pt's were vaccinated with one dose of pneumococcal vaccine 23 polyvalent and developed similar events (WAES# 01104800, 01104801, 01104802, and 01104803) A copy of the published article is attached as further documentation of the pt's experience.
She got the vaccine, was fine within the 15 minutes and while driving home within 10 minutes her neck, arm and chest got extremely red.  She went numb around the mouth and lips and her throat felt like it was closing up and itchy.  She was able to breath ok and took Benadryl for a couple of days and then had a really bad rash, small that covered her entire chest, stomach and back, but they were little prickly-heat looking rash.  The rash cleared after 5 days of taking the Benadryl.  She was also taking a steroid cream at that time that she had been given by a dermatologist in the past.   She called her doctor and informed him of the reaction and he informed her that she should not take the 2nd vaccine due to her reaction unless she felt that maybe something else triggered the reaction.
PFIZER COVID VACCINE GIVEN TO PATIENT UNDER 12 YEARS OLD BECAUSE PARENT AND PATIENT GAVE FALSE INFORMATION
Patient had received one dose of the Janssen COVID-19 vaccine. patient states that the injection site was sore, red, and hot to the touch after a few days after receiving the vaccine. patient's husband called on 09/11/2021 stating that there was bruising and redness around the site of injection. initially, the use of ibuprofen and benadryl was suggested, but after further investigation, the patient stated that the condition looks like it was worsening and/or spreading. upon hearing this, it was suggested that the patient may want to consider going to urgent care just in case. called the patient 09/13/2021 as a follow-up. at urgent care, the provider stated that it may possibly be an allergic reaction or an infection. patient was prescribed bactrim, had been taking for 2 days and the patient reports feeling a bit better.
Pain, hotness to touch, red splotchy rash and itching in the injectio  arm from the top of shoulder to midway to the elbow. Lasted for 7 days and then the following 3 days the itching decreased along with the pain when touched and the redness.
Headache; Muscle pain in armpits; muscle pain ~4 inches from injection site; Loss of smell for 2 hrs; loss of  taste for 2 hrs; Body aches; Malaise; Approx 30 minutes after vaccine got intense wave ofnausea; Approx 30 minutes after vaccine got intense wave oflightheadedness; Almost passed out; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 17Apr2021 at 14:30 (at the age of 33-year-old), as a single dose for COVID-19 immunisation. Medical history included asthma and COVID-19 and known allergy to penicillin. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included levocetirizine dihydrochloride (XYZAL), bupropion hydrochloride (WELLBUTRIN), montelukast sodium (SINGULAIR), salbutamol (VENTOLIN), fluticasone propionate, salmeterol xinafoate (WIXELA INHUB) and sp (as reported); all for unknown indication from an unknown date and unknown if ongoing. The patient previously received amoxicillin (MANUFACTURER UNKNOWN), levofloxacin (LEVOQUIN), doxycycline (MANUFACTURER UNKNOWN) and paracetamol; oxycodone hydrochloride (PERCOCET); all for unknown indication from an unknown date and experienced drug allergy. On 17Apr2021 at 15:15, the patient experienced headache, muscle pain in armpits, muscle pain approximately 4 inches from injection site (felt like muscle tearing), loss of smell and taste for 2 hours, body aches, malaise. Approximately 30 minutes after vaccine, the patient got intense wave of nausea, light-headedness and almost passed out. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events loss of smell and loss of taste was resolved on 17Apr2021, after the duration of approximately 2 hours. The clinical outcome of the events headache, muscle pain in armpits, muscle pain 4 inches from injection site, body aches, malaise, intense wave of nausea, lightheadedness and almost passed out was resolved on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
The pt started getting rashes in 1/99. The first rash was on the outside of her right arm, above the elbow. That lasted in that spot for about 1 week. It then spread to my other arm, shins, chest, and back. Occasionally, she gets a small spot on her right cheek. It has never been on her hands, feet, knees, elbows, or privates. It iches horribly and no cream, pill seems to help. Per doc 204219, patient still gets an itchy/blotchy rash on arms and legs. He occasionaly gets it on face. The creams and pills that the doctors tried with patient still do not work. The rash and the itch usually last one week than go away. 21y/o AD female w 2 wk Hx of very prurutic rash that initially presented on her arms and now has affected her legs as well. Rash sxs occurred initially while home on leave. She doesn't think it is an allergic reaction to soap she uses as the soap at home is the same she has been using for her laundry here. No new cosmetic problems, creams or foods. No exposure to situations that might result in poison oak or poison ivy contact. No truncal involvement. No involvement of the groin or axillae. Rash is intensely pruritic and occasionally has wakened her in the middle of the night due to itching. She was seen in the ER and given Hydroxyzine tabs that made her sleepy but did not eliminate the itch. Rash consists of 1-2 mm papules, occasionally in clusters that are somewhat erythematous, present on arms and legs. Evidence of some excoriation's present, especially on the legs.
Petechiae with swelling dorsum left hand.  Nontender.  Non-cellulitic appearance
Inappropriate route of vaccination; Uveitis flare up; Flare-Up; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4360985-00 (AbbVie).  A 13-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk, cf, subcutaneous. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CONDITION AGGRAVATED (non-serious) with onset 04Mar2022, outcome "recovered" (2022), described as "Flare-Up"; UVEITIS (medically significant) with onset 04Mar2022, outcome "recovering", described as "Uveitis flare up"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Inappropriate route of vaccination". The action taken for adalimumab was unknown.  The reporter considered "uveitis flare up" and "flare-up" related to BNT162b2. The reporter's assessment of the causal relationship of "inappropriate route of vaccination" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Uveitis Flare Up (Uveitis): Causality as per reporter (Drug/Vaccine): Possible The reporter's causality for the event(s) of Uveitis flare up with HUMIRA (ADALIMUMAB) was a reasonable possibility.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (20May2022): This is a solicited follow-up report based on the information received by Pfizer from AbbVie (Mfr Control No.: 22K-163-4360985-00). A contactable 13-year-old female patient reported for herself that: Updated Information included: New adverse event and additional information updated.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the inappropriate route of vaccination" ,uveitis Flare-up and condition aggravated and the suspect drug. 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.
Patient and mother came into pharmacy for a covid shot. Mother gave us patient's date of birth as 11/21/2008, and he was a new patient so we assumed this was correct. Patient was given the shot and did not experience any adverse effects at the time of the shot. We were contacted by the  immunization services on  Monday 8/2/21 and they informed us the patient's date of birth was actually 11/21/2009, we called the mother to confirm and she stated that it was supposed to be 2008, but did not want to provide a birth certificate to prove this, so we are left to believe that the  Immunization Services are correct and that patient was too young to have received the shot.
Physician reported that patient received Prevnar, Hib-Titer, and DPT (manufacturer unknown) on 8/19/2000. The next day the patient developed a fever of greater than 102 deg. F. This is 1 of 5 patients from this facility who experienced this event following receipt of 3 different lots of Prevnar.
Patient came to the vaccine clinic to receive his second dose of Moderna and was accidentally given a dose of Pfizer instead.
Tested negative for SARS-CoV-2 antibodies after receiving two doses of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST NEGATIVE (Tested negative for SARS-CoV-2 antibodies after receiving two doses of the vaccine) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST NEGATIVE (Tested negative for SARS-CoV-2 antibodies after receiving two doses of the vaccine). At the time of the report, SARS-COV-2 TEST NEGATIVE (Tested negative for SARS-CoV-2 antibodies after receiving two doses of the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported by reporter.  No treatment medication reported by reporter.
This study case was received from the investigator on 27 August 2012. A male subject (date of birth not reported) with a past medical history that included chest pain, shortness of breath, cigar smoking and chewing tobacco use had received a ACAM2000 (lot number, route, site and date of administration not reported) and an unspecified amount of time later was found to have on 22 May 2010 an elevated Troponin, central laboratory level of 0.11 ng/ml (drawn date of 20 May 2010). The subject had a rapid Troponin I level on 20 May 2010 that was within normal limits (negative). On 24 May 2010, the subject has an ECG that was normal. A repeat Troponin on 24 May 2010 was <0.10 ng/mL, per investigator was normal. The subject reported that he had a sore throat, headache and congestion from 13 to 20 May 2010. Concomitant medication included OTC cold medicine. No further information was available at the time of the report. The subject's outcome was recovered on 27 May 2010. According to the investigator, the event of elevated Troponin was considered an other important event and possibly related to vaccination. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: none.
ACUTE MYOCARDIAL INFARCTION; This spontaneous report received from a consumer concerned a 70 year old male. The patient's height, and weight were not reported. On 26-MAY-2021, the nurse had made a home visit. The patient was checked by physician on 10-JUN-2021 and blood sample was taken. The patient's labs showed that he had very low levels of haemoglobulin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, 1 total, administered on 10-JUN-2021 11:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  At 11:00 PM on 10-JUN-2021, the patient started throwing up, grabbed his chest, and fell over. He received immediate medical attention and time of death was announced at 12:10 AM on 11-JUN-2021. The physicians said cause of death was due to acute myocardial infarction. After the patient's death, reporter had received a phone call from doctor asking to take patient right away to the hospital as his labs showed that he had very low levels of hemoglobulin. It was unspecified if an autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died from acute myocardial infarction on 11-JUN-2021. This report was serious (Death).; Sender's Comments: V0:20210815166-COVID-19 VACCINE AD26.COV2.S-Acute myocardial infaraction. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: ACUTE MYOCARDIAL INFARCTION
Patient was very nervous before and during her flu shot. After giving the patient the shot, she seemed fine, so I had her move to a chair a few feet away so I could give her family member their shot. After administering the family member's shot, I saw the patient messing with her hair and looking upward oddly and slumping over a bit. Her eyes rolled back in her head, and she went rigid in the chair. Both the family member and I rushed over to her. She was breathing the whole time, but her skin and lips were very pale. I ran out of the room and called 911. We stood by her whilst waiting for the medics, and I made sure she was still breathing. The ambulance arrived and took her blood pressure. After checking her out, the medics pushed her out to her car in a wheelchair.
Erythematous wheal extending down to elbow; This case was reported by a physician via sales rep and described the occurrence of erythema urticarial in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced erythema urticarial. On an unknown date, the outcome of the erythema urticarial was unknown.   It was unknown if the reporter considered the erythema urticarial to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced erythematous wheal extending down to elbow.
popping jags in my throat swollen lymph node on my larynx  Treatment: albuterol inhaler
No adverse reaction noted.  Pt changed his DOB to register and received the dose despite being 16 years old.  Pt will return in 28 days for dose 2 per CDC guidelines.
body aches; My swallow glands swollen; she did not feel well; sore throat; she has something in her thyroid; inflammation in the tonsils, which were very large; This is a spontaneous report from a contactable consumer or other non hcp.A 70-years-old female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 23Feb2021 (age at vaccination:70 Years) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced inflammation in the tonsils, which were very large on 07Mar2021, she did not feel well on 15Mar2021, sore throat on 12Mar2021, she has something in her thyroid on 12Mar2021, body aches on an unspecified date, my swallow glands swollen on an unspecified date. Limited information was provided by the caller The outcome of the events tonsillar inflammation, malaise, thyroid disorder, pain, lymphadenopathy was unknown  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
shingles; other zoster related injuries; Information has been received from a lawyer and an elderly patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 08-OCT-2016 (at 71 years old), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by a physician and other healthcare providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX): shingles and other zoster related injuries. The outcome of these events was unknown.