chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age and ethnicity received second dose of PREVNAR 13 (batch number requested) via an unspecified route of administration on 25Oct2017 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) on 16Mar2015 and pneumococcal polysaccharide vaccine (PPV23) on 24Mar2016. The patient was vaccinated with pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) on 25Oct2017 and has not been feeling well since (unspecified date in 2017). After she received the vaccination, she went into her patient portal and realized that she had already received the pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) vaccine last 16Mar2015. The patient queried if there was any danger in double dosing. The outcome of the event was unknown. The following information on the batch number has been requested.
pt recvd vax;on 24nov,began to have burning itch over entire body;no hives/redness;some bumps;DPH & atarax for itch,lasted more than 1 wk;5dec94 sore throat w/ sinusitus, nasal congestion began 1 wk prior to sinusitus;
Within five minutes of my vaccination  I started to feel very dizzy and my eyesight became blurry. I told my husband who had also been vaccinated that I thought something was wrong and within a seconds I then passed out and he caught me. I vomited twice in the span of the next ten minutes and I was not alert for any of that time-no recollection of being able to see or hear. My husband stated my eyes were open and pupils very  dilated. He was able to get me to the ground with the help of the pharmacist who had administered the vaccine. 911 was called and by the time they arrived I became coherent enough to talk and interact. I declined a hospital visit because I had no interest in a ambulance ride but did follow up with my primary. No history of ever fainting or medical anxiety.
A report has been received from a Health Professional concerning a male subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 19-DEC-2014. The patient experienced administered expired FLUMIST Quadrivalent. The outcome of the event of patients have been administered expired FLUMIST Quadrivalent is unknown. The report was considered to be non-serious.
Dehydration; Headache; Cataract aggravated; This spontaneous case was reported by an other health care professional and describes the occurrence of CATARACT (Cataract aggravated), DEHYDRATION (Dehydration) and HEADACHE (Headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe Rheumatoid Arthritis), Hypertension, High cholesterol, Pre-diabetes (Pre diabetes type 2), Acid reflux (esophageal), Alcohol use (Wine user, 1 to 2 glasses at night, started in 1966), Tobacco user (10 cigarette per day started in 1968) and Dehydration since September 2019. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), BUPROPION and DULOXETINE HYDROCHLORIDE (CYMBALTA) for Antidepressant therapy, PRAVASTATIN for High cholesterol, HYDROCHLOROTHIAZIDE and LOSARTAN for Hypertension, METFORMIN for Prediabetes, HYDROXYCHLOROQUINE PHOSPHATE (PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE]) and PREDNISONE for Rheumatoid arthritis.   On 10-Oct-2019, the patient started ADALIMUMAB (HUMIRA) (unknown route) 40 milligram once a week. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced CATARACT (Cataract aggravated). On 27-Feb-2021, the patient experienced HEADACHE (Headache). On 01-Mar-2021, the patient experienced DEHYDRATION (Dehydration). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 01-Mar-2021, HEADACHE (Headache) had resolved. On 04-Mar-2021, DEHYDRATION (Dehydration) had resolved. In March 2021, CATARACT (Cataract aggravated) had resolved. Patient had cataract surgery on right eye on 10-Feb-2021 and 24-Feb-2021 for the left eye.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered CATARACT (Cataract aggravated), DEHYDRATION (Dehydration) and HEADACHE (Headache) to be not related.    The patient was treated with Tylenol.  Company comment Based on current available information and the temporal association between product use and the start date of the events cannot be excluded.   This case was linked to MOD-2021-108204 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow up received on 20 May 2021: Updated e mail of reporter.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events cannot be excluded.
received his booster (3rd dose) at 10:00am and had an ischemic stroke at 8:30pm same day.
Pain in upper left arm and shoulder next day, could not lift arm above shoulder for 2 days was very painful lifting arm above head x 4 weeks.
pt reports that she had muscle pain, joint pain, thrush and a rash on her bilateral arms
Severe headache, soreness at site of injection, dizziness, feeling of confusion, rapid heart rate, pain in chest radiating down arm to injection site
they come down with the flu; they don't always work; Initial information received on 16-Jan-2022 regarding an unsolicited valid Social Media serious case was received from the consumer/non-hcp (healthcare professional).  This case involves an unknown age male patient who come down with the flu, while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, dosage regimen, lot number not reported) via unknown route in unknown administration site for flu vaccine. Information on batch number was requested.   On an unknown date, (unknown latency) following the administration of influenza vaccine, the patient come down with the flu (influenza) so bad he was on a nebulizer and a z-pack. Reportedly, they thought it might have been covid but it wasn't. It was a bad case of the flu. Reportedly, the shots didn't always work (vaccination failure).   Seriousness criteria: The event was assessed as medically significant.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  The patient was treated with azithromycin (Z-PAK) and nebulizer for Influenza.  It was not reported if the patient received a corrective treatment for the event (they don't always work).  At time of reporting, the outcome was Unknown for the event.; Sender's Comments: Sanofi company comment dated 16-Jan-2022: This case involves an unknown age male patient who come down with the flu, while receiving vaccine influenza vaccine. Case will be reevaluated post further update on concomitant medications, concurrent condition during vaccination, underlying disease, laboratory investigations excluding alternative etiologies for the reported event which will preclude a comprehensive assessment of this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
pt recvd Engerix-B & 6AUG92 pts arm got red p/inject; resolved;
I received the flu vaccine yesterday at 3PM, by 6:30 PM, my throat felt completly shut. I could not swallow and I had a slight wheezing. I drank some juice and some warm tea, but it didn't help. I was so tired, I went to bed. Although I felt hot, I had the chills and my teeth begin to chatter. I woke up a couple of hours  later and my eyes were puffy, swollen and red, with phlegm in the corners.
Patient fainted after vaccine. and felt numbness in cheeks. 911 was called. Patient came to in 45-60 seconds and no longer complained of any breathing issues or of feeling faint. Vitals were WNL. 911 was cancelled and patient was advised to see primary physcian for follow up.
Information has been received from a consumer and a school nurse concerning 41 child patients who in approximately 1995 were each vaccinated with a dose of varicella virus vaccine live. In approximately 2003, the patients developed mild cases of chickenpox.  Most of the children were in the first grade and had been vaccinated at their private pediatrician's offices in the area. The reporter noted that her elementary school was the only one out of six in the area that has experienced a chickenpox outbreak. The reporter notified the elementary school parents of the outbreak. Follow up information from the nurse indicated that 13 of the reported 41 patients were not previously vaccinated with a dose of varicella virus vaccine live and all of the cases of chickenpox have recovered. One of the previously vaccinated patients was a 8 year old patient who on 04OCT1995 was vaccinated with a dose of varicella virus vaccine live. On 29MAR2003, the patient developed chickenpox. The previously vaccinated patients included two siblings in elementary school who were vaccinated by the same pediatrician and subsequently developed mild outbreaks of chickenpox. The other patients that developed chickenpox post vaccination with varicella virus vaccine live were also identified.  Additional information is not expected.
Patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    In April 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The reporter stated that she had 22 forms (from the CDC) about patients that were administered expired vaccines, she was asking if they should revaccinate those patients.  Number of doses/vials: 22  The date of vial initially stored in the refrigerator was unknown.  The patient received his second booster in his left arm.  The vial did not undergo any temperature excursions.  No treatment information was reported.
Patient had first dose of Pfizer vaccine 8/5/21 at 11:30am. Observed for 30 minutes. On car ride home, she complained of itchiness and tingling of mouth, lower lip swelling. Mom could visibly see swelling of her lower lip. Administered Zyrtec 10ml. Mom notes she had Zyrtec 10ml in the morning as well. No other symptoms noted. Mom reports symptoms improved within an hour.  Went to ED and was monitored for 4 hours. No additional treatment.   Patient safe for discharge to home. Discharged in improved condition. Written instructions reviewed with family.
First dose Moderna vaccine inadvertently given to 17 year old by vaccinator. Consent signed by parent.  Recipient monitored for 15 minutes. No adverse events noted. Recipient released to parent.
Patient had previously received Moderna vaccine on 3/11/21 as 1st dose.  Patient was administered on 3/11/22 Pfizer Covid-19 vaccine for 2nd dose.  Nurse administering the Pfizer vaccine failed to see that patient had received Moderna for 1st shot.  Pfizer vaccine was given in error.
Patient said that she start feeling something is not right about an hour after receiving the shot due to pain, by that night she start noticing rash. By the next morning she said her arm was very swollen and she start noticing blisters with clear fluid in it. She called to notify the pharmacy later that morning. I checked on her again around 7pm, she said her condition is better now--swelling has gone down and only a few blisters left on her arm.
Patient reports that she had a fever and "flu like" symptoms the second day after Covid vaccine dose # 2.  Four days after the second dose, she developed redness and bumps to upper arm where she received the vaccine.  The "rash" is very itchy.  Twelve days after the vaccine, patient reporting that the rash spread to stomach and legs, but is not certain if due to Prednisone that was prescribed for her rash.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 at 16:00 as dose 1, single (Lot number: EN6205), in right arm, on 30Mar2021 at 14:00 as dose 2, single (Lot number: ER8733), in right arm and on 19Nov2021 at 12:00 as dose 3 (booster), single (Lot number: FJ1611) at the age of 68 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "skin lupus" (unspecified if ongoing); "GERD" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing); "known allergies: Bactria" (unspecified if ongoing); "known allergies: shellfish" (unspecified if ongoing); "overweight" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the Pfizer BioNTech Covid-19 Vaccine lot EN6205, ER8733, FJ1611 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 and product type. The final scope included the reported finished goods lot EN6205, fill lot EN5337, formulated drug product lot EN5326; finished goods lot ER8733, fill lot EP8685, formulated drug product EP8572; finished goods lot FJ1611, fill lot FH4344 formulated drug product FJ8502. 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. All release testing performed prior to the release of the reported batch was within specifications.  No follow-up attempts are possible. No further information is expected.
came to COVID 19 vaccine clinic as an add on at the end of our day.  stated she had never received the vaccine through Spanish interpreter. Upon entering the vaccine data into MIIC,  was found to have had the COVID 19 vaccine in the past. She received Moderna on 3/15/21, 4/12/21 and now again on 7/8/21.
complete hearing loss in right ear and diminished hearing in the left; diagnosed with leukemia; very rare form of leukemia, CMML.; had issues with her hearing before, but it was completely gone after the doses of the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administration date 21Feb2021 (Lot number: EL9269) at the age of 71 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "issues with her hearing" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose, 31Jan2021, Lot-EN5318 or EM5318- states it is hard to tell), administration date: 31Jan2021, when the patient was 71 years old, for COVID-19 immunization. The following information was reported: CHRONIC MYELOMONOCYTIC LEUKAEMIA (medically significant) with onset Mar2021, outcome "not recovered", described as "diagnosed with leukemia; very rare form of leukemia, CMML."; DEAFNESS (medically significant) with onset Apr2021, outcome "not recovered", described as "complete hearing loss in right ear and diminished hearing in the left"; CONDITION AGGRAVATED (medically significant) with onset Feb2021, outcome "not recovered", described as "had issues with her hearing before, but it was completely gone after the doses of the vaccine". The events "diagnosed with leukemia; very rare form of leukemia, cmml.", "complete hearing loss in right ear and diminished hearing in the left" and "had issues with her hearing before, but it was completely gone after the doses of the vaccine" were evaluated at the physician office visit with ear specialists and the cancer doctor. Clinical course: she has a loss of hearing that occurred after she got the second shot in Feb2021. Complete hearing loss in her right ear occurred toward the end of Apr2021. Hearing was very diminished in her left ear. Follow-up attempts are completed. No further information is expected.
Narrative:  Pt is a 40 y/o female with PMH significant for migraines and vestibular neuronitis who received the Jassen Covid vaccine on 4/10/2021. Provider contacted pt on 4/16/2021 regarding J&J vaccine pause. Pt reported she had the vaccine in her L arm and her LUE/LLE have been "numb" one hour after vaccine was administered. Numbness on left side was persistent and when trying to sleep, left side felt heavy but otherwise no motor symptoms, diplopia, or dysarthria. Pt was instructed to go to the ER and call medical facility after evaluation. Per Emergency Summary 4/20/2021, vital signs were completely stable and labs were normal at baseline. CT scans of the head revealed no intracranial abnormalities. Final diagnoses was motor restlessness. Pt was discharged home to f/u with PCP for further assessment and possible work-up. Upon chart review, no other noted s/sx or worsening of sxs related to COVID-19 vaccination.
"Not feeling well"; freezing (feeling cold); migraines; vertigo; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th November 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 20th November 2019, several hours after receiving Shingrix, the patient experienced feeling unwell, feeling cold, migraine and vertigo. On 26th October 2020, the outcome of the feeling unwell, feeling cold, migraine and vertigo were recovered/resolved.   The reporter considered the feeling unwell, feeling cold, migraine and vertigo to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. Patient herself reported that she received the shingrix vaccine on 20th November,2019 and within a matter of hours experienced events like "not feeling well," freezing (feeling cold), migraines and vertigo. She also stated that events lasted for many months but Symptoms are now resolved. The reporter consented to follow up.
Bell's palsy (R) side. 1/30/07-records received for DOS 11/23-11/30/07-C/O cough/congestion. Had dental appointment on 11/21/07 noticed face was not moving porperly. Left side Bell's Palsy. 11/30/07-face some improvement.
No additional adverse events reported; Caller confirmed that the improperly stored dose of VARIVAX was administrated; This spontaneous report was received from a nurse regarding a patient of unknown gender and age.    There was no information about the patient's drug reactions or allergies, medical history, concurrent conditions, nor concomitant medications.   On 15-NOV-2021, a temperature excursion occurred (until reporting time). On 17-FEB-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 mL (formulation, strength, route of administration, vaccination scheme, and anatomical site of vaccination were not reported, lot numbers U015678 which had been verified to be valid, expiration date reported and validated as 18-MAY-2023), as prophylaxis (Improper storage of product in use). The vaccine administered was stored at temperature of 51 degrees Fahrenheit (F) for an unknown time frame. There was no previous temperature excursion. It was unknown if a data logger was used. No additional AE details were reported.
Extremely painful arm where shot was give, 5 days. Tired for 5 days. Nauseated for 5 days.
A few days after the injection, the site of the shot started to itch. Then it became slightly swollen and red, and felt warm to the touch. It continued at this level for another 2 days or so, then it started to recede. I took Advil to reduce symptoms. It took about 5 days after the onset of these symptoms for it to clear up. I am reporting this only for research purposes. I'm fine.
He indicates he experiences shortness of breath following MRSA pneumonia.; He indicates he experiences shortness of breath following MRSA pneumonia.; Caller started coughing on the phone; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number and Expiry date: not reported), via an unspecified route of administration on 24Jun2021 as dose 2, single for covid-19 immunisation. Medical history included covid-19 (he thinks a few months ago he had SARs-COV-2), and had allergies from "heck" this year. The patient's concomitant medications were not reported. Previously patient received first dose of bnt162b2 (Lot number Not reported), on an unknown date for covid-19 immunization and he fell backwards and was intubated (tube in his throat) and stayed in the hospital for fourteen days. On an unknown date in Jun 2021, the patient experienced shortness of breath following MRSA pneumonia. And he started coughing on the phone. The patient wanted to know when the 95% efficacy starts and how to count the seven days. He states that he heard on the news that he should still wear a mask, so he will wait till the seven days and continue to wear a mask as he had been in hospital three times this year. The outcome of the events was unknown.  Information about lot/batch number is requested.
Information has been received from a nurse referring to unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored ROTATEQ (lot # L029615 with expiration date 0f 15-MAY-2017, lot# L025508 with expiration date of 12-MAY-2017, dose and strength unknown, oral). The ROTATEQ was stored at 9.9 Celsius for 1 hour and 23 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.