chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dime to nickel sized red blotches on both shoulders, chest, back and lower back 10-12 in all. They are not raised, not itchy. There are there just in color; His lower back on Saturday that look darker than the other ones; This is a spontaneous report from two contactable consumers (one is patient and other is patient's daughter) via medical information team. A 90-year-old male patient received the first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283, expiration date: unknown), via an unspecified route of administration, on left arm on 20Jan2021 at 11:30 AM at the age of 90 years old at a single dose to Prevent COVID (COVID-19 immunization). The patient medical history was none. Family medical history was none. Relevant tests was none. Concomitant medications were none. Patient's daughter stated, her father received the Pfizer vaccine on wednesday 20Jan2021 then on 22Jan2021 (Friday) patient noticed (but not sure exactly when the rashes appeared) a rash after the first dose. The rashes are described as "dime to nickel sized red blotches on both shoulders, chest, back and lower back 10-12 in all on 22Jan2021. They are not raised, not itchy. There are there just in color. No other side effects, no difficulty breathing. Should he receive the second dose? Would it be ok if they prescribed him a steroid to clear it up?" was asked. Patient's daughter says he is 90 and he received it 20Jan2021 and next week he is supposed to receive the second dose and he is not sure when they appeared but he knows that he noticed 3 days later, it could have been sooner but he just didn't look at him self in the mirror. He noticed some spots on him maybe like a nickel size on his shoulder, chest, arm and on his backside, they are a little bit red, they are flat, not raised they are not itchy. They are not causing him a problem at they are just there. But they are concerned because he has to get second dose so they are wondering should he get it still or could it cause any problems. He confirmed it was actually 2 days after the vaccine that he noticed the rash. It was Friday the 22Jan2021 when he noticed it. They are ongoing and the patient thinks the spots may be a little bit lighter now, just a little bit. Patient's daughter says she noticed a couple on his lower back on Saturday that look darker than the other ones. She says it is hard for him to see all of them. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior and Since to vaccination, the patient was not diagnosed with COVID-19. Patient had not recovered from the event rash and for other events it was unknown.
Pain in arm for 3 days, severe exhaustion and fatigue for 3-4 days, muscle pain and tenderness for 3-4 days, headache for 2 days
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. From 01-JUN-2016 to 23-AUG-2016 the patients were vaccinated with improperly stored GARDASIL 9 (lot # M007764, Exp 30-JAN-2018, dose and route unknown), which was exposed at 47 Fahrenheit for 2016 hours and 34 Fahrenheit for 2016 hours. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient was nervous and afraid of needles during the vaccine process. Patient was asked to sit and wait 15 minutes after vaccine administration but he apparently went to get a soda and fainted at the self-check out stand 1 minute after getting the vaccine. Patient returned to his seat and was okay afterwards. Patient's father was also present during the whole process as he got the vaccine at the same time also.
Seizure activity occurred 7-9 times per day starting on the 25th.  It had been at least once daily prior to that when awakening, but then became more severe and prolonged daytime events.
This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional was calling for a family member. The age at vaccination was not reported. The age group was not reported, but was selected as adult as per vaccine indication. The healthcare professional did not administer vaccine herself and did not provide patient information. The patient experienced a shingles outbreak following vaccination with SHINGRIX. This case was considered a suspected vaccination failure since the details regarding completion of vaccination schedule, exact time to onset and laboratory confirmation of shingles were unknown.
stinging at injection site; increase in allergies; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (stinging at injection site) and HYPERSENSITIVITY (increase in allergies) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Dyshidrosis.    Concurrent medical conditions included Dyshidrosis and Hypersensitivity.   On 04-Oct-2021, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram once a week. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (stinging at injection site) and HYPERSENSITIVITY (increase in allergies). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (stinging at injection site) had resolved and HYPERSENSITIVITY (increase in allergies) outcome was unknown.            No concomitant product reported by reporter.  The dupixent single dose pre-filled pen component of the combination product dupixent (Single-entity for initial use) has been identified with a device issue. It was unknown if the product was stored or used properly. The device was operated by the Patient. The product was not available for evaluation.  dupilumab was used for unapproved indication Dyshidrosis.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 30-Dec-2021: Significant follow up- patient age, suspect product information updated
I did not have a reaction after the first dose. After taking the second dose (08/07/2021) 12 hours later I got very sick, I had a fever, headache, joint pain and shortness of breath. On 08/10/2021 I improved a bit, days have passed and I am still very tired and out of breath if I do any physical exertion. I do not feel normal, this worries me, it's been more than 10 days and I do not feel well. What should I do?
Myalgia, Arthralgia, Fever, ErythemaMultiform, UrticariaPruritus, NauseaVomiting, Fatigue Narrative: Lost time of work
No adverse event. Vaccine was given past best use date. Received vaccines on 7/1/22 10 weeks would had been 9/9/22 and we administered on 9/15/22.
Information has been received from a licensed practical nurse (LPN) concerning a 4 months old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies or concurrent conditions were not reported. On 20-SEP-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ administered orally for prophylaxis (lot number M004508 with an expiration date of 29-JUN-2017) (dose was not reported). Other suspect and concomitant medications were not provided. There was no adverse effect reported. The temperature excursion reported was 1 degree Celsius (C) for 48 hours. A digital data logger was involved. There were no previous temperature excursions. This is one of several reports received from the same reporter. Additional information is not expected as all follow up information has been received. Sender's Comments: US-009507513-1610USA013756.
resident staying at assisted living as a respite case, had exposure from Grandson during his visit to her.
pain after Moderna Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (pain after Moderna Booster) 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (pain after Moderna Booster). At the time of the report, PAIN (pain after Moderna Booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Treatment medication was not provided by the reporter.
Presents to the emergency room with progressive shortness of breath for the last few days before admission. The pt was admitted to the hospital on  10/7/2021 because of COVID-19 pneumonia and hypoxia.  Patient was also seen by ID.IV Decadron and IV Remdesivir were continued.  The patient also received Actemra.  Oxygen was weaned.  Patient does not want to go to rehab.  Patient wants to go home.  Yesterday patient also had nonsustained V-tach episode.  Echocardiogram showed moderate to severe aortic stenosis. It was recommended that she discharge to SNF but patient refused and was discharged home with family support.
Erythemaous papular rash 2.5 by 1.5 cm lateral thigh.
?Covid toe? - wasn?t painful but slightly itchy in the beginning. Middle toe on each foot.
MATERNAL EXPOSURE DURING PREGNANCY; SORE ARM; CHILLS; FEELING UNWELL; FEVER 100.8 FAHRENHEIT (F); FATIGUE; HEADACHE; MUSCLE PAIN; NAUSEA; This solicited pregnancy report received from a health care professional concerned a 34 year old female. The patient was enrolled in a non-company sponsored study C-VIPER: COVID 19 Vaccines International Pregnancy Exposure Registryt number: C00060). The patient's weight was 52.15 kilograms, and height was not reported. The patient's past medical history included multigravida. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 14-MAR-2021 for prevention covid-19. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 14-MAR-2021, the patient experienced maternal exposure during pregnancy. On 14-MAR-2021, the patient experienced sore arm. On 14-MAR-2021, the patient experienced chills. On 14-MAR-2021, the patient experienced feeling unwell. On 14-MAR-2021, the patient experienced fever 100.8 fahrenheit (f). On 14-MAR-2021, the patient experienced fatigue. On 14-MAR-2021, the patient experienced headache. On 14-MAR-2021, the patient experienced muscle pain. On 14-MAR-2021, the patient experienced nausea. Laboratory data included: Body temperature (NR: not provided) 100.8 Fahrenheit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fatigue, feeling unwell, fever 100.8 fahrenheit (f), headache, muscle pain, nausea, sore arm and maternal exposure during pregnancy was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy was not related, and between covid-19 vaccine ad26.cov2.s, and sore arm, chills, feeling unwell, fever 100.8 fahrenheit (f), fatigue, headache, muscle pain, and nausea was related.  This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
sore arm with both shots; Caller stated that he had an antibody test on 05Feb2021 and the test was negative.; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable physician (patient). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 29Dec2020 (first dose, lot number: EK5730) and 19Jan2021 14:00 (second dose, lot number: EL3248) both in left shoulder at 0.3 mL, single for prevention. The patient medical history was not reported. There were no concomitant medications. He had 2 doses of covid vaccine with no side effect. 15 days later, he had antibody test on 05Feb2021 and the test of IgM and IgG basically were negative. He had no antibodies to the coronavirus. So he was not sure whether or not he got a vaccine that was too old, not taken care of properly, but he had no immune response 15 days after the second dose he should have developed a response, developed antibodies. He was inquiring if that was effective and wanted to know if he should get another antibody test and take another dose of the Pfizer vaccine or get the Moderna vaccine. The patient stated seriousness as it was serious, it did not require hospitalization, he was not ill at least and had been self-isolating very well, but he was thinking long term, he was feeling well, had no problems, no complications related to the vaccine, other than a sore arm with both shots, that's it, it went smoothly, it was serious, he hoped to have some protection, but was concerned he had none. The patient had sore arm with both shots. The outcome of event antibody test negative was not recovered and event sore arm was unknown.; Sender's Comments: It was noted that patient had antibody test and the test of IgM and IgG basically were negative. He had no antibodies to the coronavirus.  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.
On 1/19/23, at 11:54 am, a 66yrs old woman came into the clinic to get a booster shot of Moderna COVID-19 Vaccine.   Upon getting to administer the vaccine in database, reconciliation was done, no Bivalent booster was seen. later when I tried to correct my documentation in the Chart with the assistance of medical staff., reconciliation again was done and no Bivalent booster appeared in the chart as she witnessed in the database by staff. I used a new card to document the vaccine, Moderna Bivalent (Lot# 030G22B) and patient sent to post-vac for observation. After 15mins in observation patient showed no sign of adverse reaction. However, after the patient left, I was told by my supervisor that patient had previous Moderna Bivalent from another agency. When the patient?s chart was reviewed again it was found that the patient had already received Moderna Bivalent before. At 3pm patient was called to check on her condition for any adverse reaction, but she said that she is feeling great, and not to worry as was interpreted by the nurse.
administered expired doses; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number G3Z3N, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 30th September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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 was provided as follows: The age at vaccination was not reported. The patient received vaccine which was already expired on 30th June 2021. This is 1 of the 5 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021206979:same reporter US-GLAXOSMITHKLINE-US2021AMR207379:same reporter US-GLAXOSMITHKLINE-US2021AMR207377:same reporter US-GLAXOSMITHKLINE-US2021AMR207378:same reporter
PATIENT WAS ADMINISTERED THE VACCINE WITHOUT ANY ISSUES. PATIENT LEFT IMMUNIZATION ROOM TO SIT ON A BENCH NEXT TO HIS OLDER BROTHER. MOMENTS LATER, PATIENT FAINTED/ FELL STRAIGHT FORWARD ON HIS HEAD WHILE SITTING. PATIENT AWOKE IMMEDIATELY AFTER FALLING AND WAS SITTING UP CRYING. PATIENT WAS GIVEN AN ICE PACK. PATIENT ALSO ATE SOME SNACKS. PATIENT MOM DECLINED EMERGENCY SERVICES. PATIENT WAS ABLE TO GET UP AND WALK AWAY AFTER APPROXIMATELY 30 MINUTES.
Two minutes after receiving her 11 year vaccines patient stated she was very hot, dizzy, which led to throwing up in the lobby; patient was brought back to treatment room (walked on her own), given ice packs, water, and monitored 30+ minutes for any further symptoms to develop; patient did not throw up again nor developed any new symptoms during evaluation; was looked over by PCM where patient was given the good to go evaluation; MOP v/u of what symptoms to look for for anaphylaxis and patient walked out of facility on her own.
sore throat; mild difficulty breathing; mild fever (99.1); fatigue; throbbing headache(6/10 pain); This is a spontaneous report from a contactable healthcare professional.  A non-pregnant 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EH 9899), via an unspecified route of administration in the left arm on 18Dec2020 16:00 at a single dose for COVID-19 immunization.  Medical history included gastrooesophageal reflux disease (GERD), irritable bowel syndrome (IBS), gastritis, asthma, anxiety/depression, allergies: penicillin.  Concomitant medication included salbutamol (ALBUTEROL HFA), pantoprazole (MANUFACTURER UNKNOWN), fluoxetine (MANUFACTURER UNKNOWN), cholestyramine (MANUFACTURER UNKNOWN).  The patient previously took cefalexin monohydrate (KEFLEX) and lactose (MANUFACTURER UNKNOWN) and experienced allergies.  On 18Dec2020, the patient experienced a sore throat, mild difficulty breathing, mild fever (99.1), fatigue and throbbing headache (6/10 pain).  Clinical details were reported as follows: On 18Dec2020, the patient had a sore throat and mild difficulty breathing. The patient took albuterol, which helped a little. The patient had a mild fever (99.1) for two days after the shot, as well as fatigue, and a throbbing headache (6/10 pain) for a week and a half. Acetaminophen (TYLENOL) helped manage the pain, and sleep helped the pain get better. The patient underwent lab tests and procedures on 18Dec2020 which included pain: 6/10 and body temperature: 99.1.  The clinical outcome of the events was recovering.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021 at 9:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 21.02.  Batch number 031L20A underwent temperature excursion on 14-Feb-2021 with temperature  35, 32 degrees Fahrenheit from 09:00 AM- 03:00 PM. This vial was moved to fridge on 9-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 13-Jan-2021  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.  No concomitant medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
This spontaneous report as received from the patient's mother concerning her daughter of unknown age. Concurrent or medical conditions were not reported. On an unknown date, the patient was vaccinated with the second dose of GARDASIL (dose, strength, frequency, route and lot number were not reported). Secondary suspects and concomitant therapies were not reported. On an unknown date, after receiving GARDASIL the patient experienced muscle pain and ache, elevated keratoconus (KC) levels and antinuclear antibody (ANA) levels. The outcome of the events was not reported. The reporter did not confirm if the patient would discontinued the product. No product quality complain was reported. Additional information is not expected there is no contact details.
Patient developed swelling of hands and then face.  Her skin became red and blotchy.  Hives developed.  The vaccine was given around 11am and symptoms began about 1 hour later.  She continues to have hives 2 days later.  She was seen in the emergency room on the same afternoon as the vaccination.  The physician is questioning a latex allergy.
Within 10-15 minutes of getting the vax I was having chest pain but I assumed it was maybe anxiety or dysautonomia from anxiety. Within another 10 minutes I was dizzy. I wasn't having any trouble breathing or swelling so I just told them I was ok at the 30 minute monitoring end. My sister and I sat in the hall a few more minutes and my chest hurt a little more but I assured her I was fine. I should backtrack that I pre-medicated with Zyrtec, Pepcid, Singulair, Luteolin, & Vit. D an hour before as some research I found about Mastocytosis & MCAD suggested could be helpful for people who have had severe reactions in the past.  Angioedema continued for several days and eventually resolved.