chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Physician states that a patient's mother (who was a nurse) reported that she had worked with a physician whose daughter ended up on a ventilator with paralysis after receiving GARDASIL-9; The patient ended up on a ventilator with paralysis; The patient ended up on a ventilator with paralysis; This spontaneous information has been received from a physician regarding a female patient of unknown age. Patient's pertinent medical history, drug reactions and allergies and concomitant medication were unknown by reporter.  On an unknown date, the patient was vaccinated with a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), injection, administered for prophylaxis, (strength, dose, route of administration, anatomical location, lot number, and expiration date were not provided).  On an unknown date in approximately 2019 (also reported as sometime "within the past 3 years but not within the past 6 months), the patient ended up on a ventilator (mechanical ventilation) with paralysis after receiving the suspect vaccine and it was suspected that the patient may have been Guillain-Barré syndrome (guillain-Barre syndrome). The reporter assessed the event with a hospitalization criteria. The outcome of the events was not provided.  The causal relationship regarding the suspect vaccine and the events was not provided.  Upon internal review the events mechanical ventilation, paralysis, and Guillain-Barré syndrome were considered as medically significant.
C/o dizziness and dark pigmentation around mouth s/p Hep A vaccine received 8/18/2018 AM; Epipen X 1 given on Left upper thigh as orderd by Dr.@ 3:43PM. VS @ 3:47PM - HR-81bpm; BP- 106/53 (L); O2 Sat -99%; RR -16. Pt toleared the procedure well and denied dizziness, palpitation, chest pain, sweating or weakness. @3:53PM: Pt started to c/o shakiness and nervousness. Dr. notified and ordered to have pt lie down to rest and continue to monitor. @4:15PM VS - HR:80bpm; O2 Sat -98%; Pt reports that she feels better - no more shakiness observed. @4:45PM VS- HR: 68bpm; O2Sat -98%; BP-110/74 (L);RR-20. Pt reports that she is doing much better and has no complaint now. Per Dr., pt can go home when asymptomatic. @5:30PM - VS- HR: 71bpm; O2 Sat- 99%; BP- 102/66(L); Pt currenrly A&O x3, self-ambulatory and denies dizziness, headahce, palpitation, SOB, nervousness, or weakness. Dr. came to speak to the family. Per Dr., pt can go home by car service. Car service contacted for pt. Pt left clinic accompanied by her mother @ 6:13PM. Pt left clinic accomapnied by her mom @ 6:13PM but returned c/o recurrence of shakiness and requests 911 called to go to hospital. Pt d/c from hospital  on 8/19/2018.
Pt received second dose of Moderna vaccine Friday AM, pt presented today stating that Saturday AM she awoke to a diffuse, maculopapular, erythematous rash over her entire body.  Pt states rash is very itchy and has not been relieved with OTC Zyrtec or Benadryl.  Pt given prescription today for 50mg Benadryl every 6-8 hours x 1 day and prescription for Prednisone taper x 12 days should rash continue despite treatment with Benadryl and Zyrtec.
Complaints of redness and swelling to left thigh. No fever, some tenderness noted, warmth also. Advised to apply cool compresses to site Benadryl po pm. Not resolved returned to clinic. Rx Amoxil 250mg / po bid x 7 days.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; SINUS INFECTION; This spontaneous report received from a patient concerned a 53 year old male with unspecified ethnicity. The patient's weight was 260 pounds, and height was 71 inches. The patient's concurrent conditions included: diabetic, non-smoker, and alcohol use 1 or 2 drinks a week, and other pre-existing medical conditions included: The patient has no known allergies. The patient has no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, expiry: UNKNOWN) 1 total, dose was not reported, administered on 16-JUL-2021 for prophylactic vaccination. Concomitant medications included empagliflozin for diabetes, metformin for diabetes, and metformin hydrochloride/pioglitazone hydrochloride for diabetes.  On OCT-2021, the patient experienced confirmed covid-19 infection. On OCT-2021, the patient experienced sinus infection. On an unspecified date, the patient experienced confirmed clinical vaccination failure. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) POSITIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection, confirmed clinical vaccination failure and sinus infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a regulatory authority.; Sender's Comments: V0 20211110640-COVID-19 VACCINE AD26.COV2.S-confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
1 week after vaccine, new onset of left-sided head tilt, left arm extension and left shoulder lifting, referred to neurology for further evaluation. EEG pending, no other dx given.
Left work early Friday (4pm) and went to bed. In bed for the following 5 days, including now. Muscle and bone aches through my spine and hips, nausea with some vomiting, chills, severe weakness, no recordable fever but felt feverish, skin hurt. Woke up Tuesday drenched in sweat but the bone pain had subsided. Still very weak, nauseous, continued in bed. Woke up today feeling on fire, eyes burning hot, skin no longer hurt but felt hot.  Injection site hurt through Sunday-no redness, no rash or swelling.  I took Tylenol and Advil throughout.  My previous trunk rash completely disappeared. I began taking the prednisone last night. 50mg BID. I have a 5 day supply.  Took a Covid test on Monday-results pending.  Tried to see my doctor today giving them the above information-there were no appts til Friday and I was referred to the ED.  I will not go to the ED where I could actually catch Covid. I was unable to get past phone triage with the doctors office.
Extreme fatigue, nausea, chills, headache, dizziness 18-20 hours after receiving the 2nd vaccine for about 10-12 hours, then lessening to feeling tired, bouts of vertigo and occasional headache.  Five days later on 1/25 I experienced blurry vision, nausea, confusion, dizziness, and impaired speech (to a co-worker).  This lasted about an hour.
Received shot on Fri left arm started to swell on Sat and turned red. Started out as small bump/big as thumb, now the size of baby's fist, sore and hard. Can't lay on arm.
After taking the first dose of the vaccine, within 3 hours he could feel the skipped heart beat; This is a spontaneous report from a contactable Consumer (patient, self-reported). A 86-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 13Jan2021, as a single dose for COVID-19 immunization. The patient's medical history included skipped heart beat for which took medication Pacerone 4 years ago. Concomitant medications were not reported. The patient reported that he got the COVID-19 virus shot on the 13Jan2021, and about 14 days ago he started having skipped heart beats. He said he had a condition, and took a medication for skipped heart beat that he started taking 4 years ago that when they gave it to him it cured the problem of the skipped heart beat for 4 years. He said after he took the first dose of the vaccine, within 3 hours he could felt the skipped heart beat on 13Jan2021, and he didn't know if it had to do with it or not, but he was calling to see if anyone else had reported this since the only thing on the paperwork he was given that references the heart was a fast heart beat. The patient reported that the skipped heart beat happened from time to time, every 3-4 hours it might happen, though sometimes it didn't happen. He said last night it did not happen any and that it was not serious, it was more of an irritating thing. He took medication, Pacerone, cured him in three days, and he only skipped one day of taking it in those 4 years. He already called his doctor and was gonna see him soon, but he wanted to get the second vaccine because he was an attorney and he was in meetings face to face with people, so he wanted to take the second dose which was scheduled on 02Feb2021, The patient said something about 14 days, and he was thinking he would go and take the second dose anyway and see what happens, then thought that might be stupid, but he wanted to take it so bad, but if it caused these heart beats not a good idea possibly. There was product complaint. The patient was unwilling to complete the report. and declined to complete a report. No further details captured, reported, or documented at this time. Outcome of the event was unknown.  Information on the lot/batch number has been requested. The lot/batch number is not available despite the follow-up attempts made.  Follow-up attempts have been completed and no further information is expected.
8/28 started with 3-4 vesicle & increased over next 24-48 hours - hand, axillary, waist, buttock & feet. Approx 20-30 lesions.
18 mo pt recvd DTP/OPV/MMR &  2 days later began a low grade fever; seen in office w/sore throat;
Vaccine was given in the gluteus muscle due to patient having bilateral lymphedema of upper extremities.
2 hours after shot felt nauseous.  6 hours after shot had vomiting and diarrhea.  Repetitive vomiting 14 hours and diarrhea and malaise for 36 hours.
Immuz 6/4/14, 6/5/13 fever 103 deg, 6/6/14 rash on legs-saw MD told sinus infection but no nasal symptoms, ordered med but mom didn't get. Sat 6/7- tongue ache and swollen- gave BENADRYL every 4 hours and went down. No appetite x 3-4 days-Rash now fading.
lips started to tingle and turn numb , then my face, heaviness in my chest then started having difficulty breathing and getting air in
Low grade fever - yesterday afternoon. Swelling, redness and hot to the touch. Given Tylenol at home (5/6/19 - 7:00 PM) Given Benadryl 5mL (5/7/19 - in the clinic)
Pt. was given first dose of Rotateq vaccine @ 18 weeks of age instead of it being given between 6 and 12 weeks of age. No adverse event noted.
Chronic Guillain-Barre syndrome - unknown diagnosis date. Patient undergoing ongoing treatment.
got sick; flu like symptom; got a fever of 102°F; was up all night; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY SLEEP (was up all night), ILLNESS (got sick), INFLUENZA LIKE ILLNESS (flu like symptom) and PYREXIA (got a fever of 102°F) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056m21a, 027l20a, 015m20a and 017e21a) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Keflex).   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2022, the patient experienced POOR QUALITY SLEEP (was up all night) and PYREXIA (got a fever of 102°F). On an unknown date, the patient experienced ILLNESS (got sick) and INFLUENZA LIKE ILLNESS (flu like symptom). At the time of the report, POOR QUALITY SLEEP (was up all night), ILLNESS (got sick), INFLUENZA LIKE ILLNESS (flu like symptom) and PYREXIA (got a fever of 102°F) outcome was unknown.            Concomitant medication included Blood pressure medicines and cholesterol medicine. No treatment medication information provided.  Adverse events did not cause patient to seek medical attention. Patient has never had tested positive for COVID and never has been diagnosed. No historical condition related to adverse events and both acute and chronic illness at the time of vaccination was reported. No other vaccination given within 1 month prior to COVID-19 vaccination.
no AE reported; expired vaccine administered; This initial spontaneous report has been received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, and drug reactions or allergies was provided.  On 05-JAN-2022, the patient was administered an expired measles, mumps, and rubella virus vaccine, live (recombinant human albumin, rHA) (M-M-R II), 0.5 milliliter subcutaneously (SQ), lot # S015961, expiration date 23-MAY-2021 (anatomical location was not reported) for prophylaxis (expired product administered). No other information provided. No additional adverse events (AEs) or product quality complaint (PQC) reported.
Chills at night; Muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergy to penicillin" (unspecified if ongoing), notes: allergy to penicillin; "Strong Anesthesia" (unspecified if ongoing), notes: Gives her tachycardia when she receives very strong anesthesia.; "tachycardia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Iron, reaction(s): "allergy to iron", notes: allergy to iron. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Chills at night"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain".  Additional information: It was reported as caller wanted to get their fourth dose of the Pfizer COVID-19 vaccine and wants to know if the formulation has changed. The reporter assessed the events as non-serious. She wanted to know if she could receive her 4th dose and if are ingredients still the same to receive the forth dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a nurse refers to unspecified patients of unknown demographics. No information about medical history, drug reactions and allergies were specified. On an unknown date in September 2014 over the past 3 to 4 weeks, the patients were vaccinated with RECOMBIVAX HB (lot#, dose, route not reported). No concomitant medications were reported. No symptoms reported. There was no product quality complaint. The outcome is unknown. This is one of the three reports received from the same reporter (MARRS # 1410USA004187 and MARRS1410USA005091). Additional information has been requested.
started with itchy arm at site, then moved to blotches all over chest, throat and face tingling
pt recv vax & p/about a min pt was lightheaded, looking straight ahead, not understanding what nurses were saying;BP & pulse OK, did not pass out entirely;w/in approx 2min was OK again;
This case was reported by a consumer via call center representative and described the occurrence of feels awful in a 58-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced feels awful. On an unknown date, the outcome of the feels awful was unknown. It was unknown if the reporter considered the feels awful to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received the SHINGRIX and felt awful afterwards. The reporter did not consent to follow-up. The reporter was unable to provide any additional information.
low iron; Haemoglobin: 5.9; tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 21Feb2021 as dose 2, single (Lot number: EN6200) at the age of 64 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (first dose was 31Jan2021 of LOT: EL9261, NDC/EXP: not provided), administration date: 31Jan2021, when the patient was 64-year-old, for Covid-19 Immunization. The following information was reported: BLOOD IRON DECREASED (hospitalization, medically significant) with onset Mar2021, outcome "not recovered", described as "low iron"; HAEMOGLOBIN DECREASED (medically significant), outcome "unknown", described as "Hemoglobin 5.9". FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "tired". The patient underwent the following laboratory tests and procedures: Blood iron: low iron; Haemoglobin: 5.9, notes: Result: 5.9, Unit: Not provided; 10.5, notes: Dropped to 10.5 initially; Low, notes: It was so low; 5, notes: hemoglobin drops to 5. Therapeutic measures were taken as a result of blood iron decreased.  Follow up information has been requested.
Patient's mother reports experiencing rash on legs and arms.  Patient contacts doctor office and recommended to take 2 pills of Benadryl.  The next day, patient's mother reports the rash is gone and he is fine.
The patient was vaccinated with a booster shot before the six month period.  The patient also received 3 Moderna injections prior to the number giving the booster shot (04/20/21; 04/22/21;05/18/2021; 11/05/2021)
sensation of numbness in one part of the roof of her mouth; She is also now complaining that her nose is suddenly stuffy; she is now complaining of odd taste in her mouth; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPOAESTHESIA ORAL (sensation of numbness in one part of the roof of her mouth), NASAL CONGESTION (She is also now complaining that her nose is suddenly stuffy) and TASTE DISORDER (she is now complaining of odd taste in her mouth) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 2) and Pfizer (the patient was given Pfizer for their primary series :Dose 1). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.  On 14-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jun-2022, the patient experienced HYPOAESTHESIA ORAL (sensation of numbness in one part of the roof of her mouth) and TASTE DISORDER (she is now complaining of odd taste in her mouth). 14-Jun-2022, the patient experienced NASAL CONGESTION (She is also now complaining that her nose is suddenly stuffy). At the time of the report, HYPOAESTHESIA ORAL (sensation of numbness in one part of the roof of her mouth), NASAL CONGESTION (She is also now complaining that her nose is suddenly stuffy) and TASTE DISORDER (she is now complaining of odd taste in her mouth) had not resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient complained of odd taste in her mouth and sensation of numbness in one part of the roof of her mouth just after 30 minutes after administration of booster of Moderna COVID-19 vaccine. No treatment details were reported.
Uneasiness, tightness in throat, nausea.  Administered Epi Pen
I had an anembryonic pregnancy. The miscarriage didn't progress on its own and required medical intervention to get going.
This is a spontaneous report from a contactable nurse via a Company representative reported for two patients. This report is the second of two. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced arm got swollen and it was sore, excessive itching. The outcome of the events was unknown.
For the first several days I had loud ringing in my ears and pressure in my chest. Then, I experienced a full-blown flare of my encephalitis symptoms:  constant nausea, dread/doom/anxiety/panic, memory loss, loss of balance, extreme fatigue, weakness, sleep disturbance, GERD, depersonalization, bizarre ideation.
As the injection was being administered, my daughter cried, and she is a very strong, stoic child, who normally does little more than wince. She said it hurt, burned like fire and just felt odd going in.
no actual adverse effect at time of submission. administration error. patient was wanting a covid booster but received a flu shot when she had already received one for this flu season. per database she got previous dose 9/16/21
it cleared up patient's asthma, after getting the shot, half hour later patient's lungs opened way up and patient could finally breathe really good and haven't breathe that good in years; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "it cleared up patient's asthma, after getting the shot, half hour later patient's lungs opened way up and patient could finally breathe really good and haven't breathe that good in years". Additional Information: Patient's friend had a cloudy mind for years and he told the patient it cleared up his mind as well.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021373341 same reporter and drug; similar event, different patient
Localized cellulitic response: 5 cm area of raised erythema, warmth & pain w/ 2 cm halo.  Enlarging 8 days after vaccination.