chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event.  Dose was drawn up and sent to nursing unit on 9/13/2022 around 1500.  Nurse did not realize dose was to be given immediately, so it was placed in the fridge.  The dose was pulled from the fridge and given on 9/14/2022 around 1200 prior to patient discharge.  Nurse did not know to request a new vaccine from pharmacy.  Pharmacy did not realize this happened until 9/15/2022 when looking at documentation in registry. Will contact patient.  Does patient need an additional booster at this time?
no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 17-FEB-2023, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.  This is one of several reports form the same reporter.
Awakened on 19NOV91 w/rash (red, flat, patches) on face & stomach; fussy & irritable 19NOV during night; awakened 20NOV91 w/rash spread to back; pt taken to ER & given DPH & Pediapred; Mom does not know dx; mom report pt "warm"  20NOV91;
p/vax pt devel a skin rash, not @ the inj site;pt condition is unk;
Wheezing short of breath for a duration of two hours. Generally not feeling good after for a few weeks and s breathing issues restarted a few weeks after the vaccine . Still not completely well months later.
Patient contracted COVID-19; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Patient contracted COVID-19) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced COVID-19 (Patient contracted COVID-19). At the time of the report, COVID-19 (Patient contracted COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications was reported.  Treatment information was not provided.
administered a dose of Pediarix on 30Aug2022; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 7L9PZ, expiry date 24th November 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th August 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 30th August 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date:08-Sep-2022 Reporters comment: The 8 years old patient received pediarix vaccine, patient was not previously received any vaccines, started getting vaccinated on 30th Aug2022. Clinic was trying to get her caught up on vaccines and administered a dose of Pediarix. The Vaccine Administration Facility is the same as Primary Reporter. Reporter gave permission for follow-up The reporter gave consent to follow-up. Additional Supportive information: 8 year patient received pediarix vaccine, which led to inappropriate age at vaccine administration. .
Shortly after receiving the vaccine patient felt light headed and removed mask. He then passed out falling forward in chair and hitting his head he then went into convulsions. Quickly came to and was able to walk out with EMS.
Severe hay fever the next several days. I haven't experienced hay fever in over 15 years.
flu; Initial information received on 06-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-helath care professional.  This case involves an Adult patient who had flu after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect  INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date, strength, formulation, route was unknown) in unknown administration site for prophylactic vaccination(immunization). Information regarding batch number details has been requested.  On an unknown date the patient had a non-serious event of flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported" To late. Got my flu shot last month, now have the flu. The worse I have felt in a long time".  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
About 3:30 in the morning I woke up and I was really cold. I started having chills. when I checked my temperature it was in the 99s (the highest my temperature 101.9. When I checked my heart rate in the morning and it was in the 90s, and that's higher than normal for first thing in the morning. My heart rate went high and I had achy muscles. I sat around all day, but I didn't feel that bad in the morning, I took an extra strength Tylenol and I didn't have much have an appetite. My heart rate stayed in the 90s-130, so I called my cardiologist and he recommended I alternate Tylenol and ibuprofen and drink lots of fluids. By dinner that night I had no appetite, and then I had nausea and dry heaves, so I took 25 mg of promethazine at about 8 and the dry heaves got better within an hour. I got the COVID tongue. I had a white coating on my tongue and I couldn't get it off and a weird metallic taste in my mouth, I had a mild headache. The next day I felt much better. I called my PCP and they didn't think it was necessary for me to come in for a cardiogram because I was feeling better.
Instant headache and instant feeling like i could go to sleep, hives under arms . Back of legs had hives and burning sensation. Was given Advil and a total of 50mg  of Benadryl
This spontaneous report was received from a consumer refers to nine patients of unknown ages and genders. The patients historical conditions, concomitant medications and drug reactions or allergies were not reported. In 2018 (reported as in the last 3 months), one patient was vaccinated with an improperly stored dose of VARIVAX for prophylaxis, lot # N020016 and an expiration date 17-JUL-2019; however, route, dosage schedule, anatomical location and dosage number were not reported. In 2018 (reported as in the last 3 months), eight patients were vaccinated with PROQUAD recombinant Human albumin (RHA) for prophylaxis, lot # N035172 and an expiration date 09-JUN-2019; however, route, dosage schedule, anatomical location and dosage number were not reported. On 29-JUN-2018, an unspecified number of patients were vaccinated with an improperly stored dose of PROQUAD (RHA) lot number N025718 with an expiration date of 17-MAR-2019, which experience excursion the following dates: on 28-JUN-2018, the excursion was 9.10°F for 0.5 hours; on 29-JUN-2018, the excursion was 9.50°F for 0.5 hours; and on 30-JUN-2018, the excursion was 8.80°F for 1.75 hours (conflicting information). On 31-JUL-2018, an unspecified number of patients were vaccinated with an improperly stored dose of PROQUAD (RHA) lot number N025718 with an expiration date of 17-MAR-2019, which experience excursion the following dates: on 30-JUL-2018, the excursion was 8.10°F for 0.25 hours; and on 31-JUL-2018, the excursion was 7.30°F for 0.25 hours. Additionally, on 31-AUG-2018, an unspecified number of patients were vaccinated with an improperly stored dose of PROQUAD(RHA) lot number N035172 with an expiration date of 09-JUN-2019, which experience excursion on 07-AUG-2018, the excursion was 17.10°F for 3.25 hours. The reporter stated there were previous temperature excursions. The call was placed because of a Digital Data logger.
Mom took child to bed, child c/o underarm hurting L arm where shots were given was blotchy red and swollen. Mom states it looked like a "water balloon." Approx 1/2 size tennis ball. Mom took child to MD, who suggested Benadryl prn and follow up if symptoms persist. States he still has a fever "better" (2/19/04).
Felt fine the night before. Woke up at 6:00 a.m. with fever, chills, puffy bottom eye lid, watering, irritated eyes, redness and swelling on upper cheeks, swollen at site of vaccination, slight redness at vaccination site, headache, and my body felt heavy and slow. Towards the Evening, I still had symptoms such as redness in eyes, slightly swollen bottom eyelids, redness and swelling in upper cheeks, fever, chills, watering, irritated eyes, headaches, and my body feels slow, but not as slow as in the morning.
Head ache and fatigue started shortly after vaccine but at 2am on 3/14, I woke up with body aches (torso and back only), headache, fatigue, coughing, fever of 102.1, chills and shaking all which lasted for about 3 hours. Then at 5 am I started sweating it all out, woke up and checked fever again and it went down to 101. I went back to sleep at woke up at 9 am (3/14/21) and all symptoms had gone away with the exception of severe fatigue for about another 24 hours.  Then I was completely fine, back to normal.
31 year old male started the anthrax series while deployed.  While deployed he experienced nasal congestion that was unusual for him.  On return from deployment, he continued to experience chronic nasal congestion and noticed that his senses of smell and taste were diminished.  Flonase has been prescribed, but has not relieved any of the symptoms.  Within 24 hours of receipt of the fifth anthrax vaccine, he had completely lost his sense of taste and smell, had maxillary sinus pressure, bilateral cervical lymphadenopathy and preauricular adenopathy on the right.  He completed a 14 day course of Septra DS during which time the lymphadenopathy resolved.  One week after he completed the antibiotics, his sense of taste and smell returned for two days.  The nasal congestion and sinus pressure have not resolved despite continued use of Flonase.  On 19 April he was started on a 7 day course of Tequin and Entex.  He was able to taste and smell for a few days, but has lost those senses again since completing the medications.  He has also noted recurrent sore throat recently.  He is scheduled for a MRI of the brain 17 May 2004.  He has not had an ENT consult at this point.
Fever 103 degree and rigor 12 hours after injection - Resolved 12 hours later without treatment.
Pain at the injection site within hours of the vaccine given. Stiff swelling the size of a golf ball 24 hours later. Redness and pain accompanied the swelling. After 36 hours, pain, swelling, stiffness, and redness lessened, with less distinct outline bordering the swelling. Every additional 24 hours, every symptom has been lessening.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of (Oka-Merck) PROQUAD lot # L044058, expiration date 02-MAY-2017 lot # L009207, expiration date 17-OCT-2016; lot # L023111, expiration date 24-DEC-2016 (exact dose, route of administration and anatomical location were not reported). There was no adverse effect reported. This is one of several reports received form the same reporter. Additional information has been requested.
Pain in arm could not lift above head. Severe chills. Was checking and teeth chatting. Headache for two days straight.
I taste salt; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and Lot Number: EP7533) dose 1 via an unspecified route of administration in Arm Right on 24Mar2021 11:45 as single dose for COVID-19 immunization. Medical history included Degenerative disc disease and moderate arthritis. Concomitant medications included pregabalin (LYRICA), celecoxib (CELEBREX) estradiol and omeprazole magnesium (PRILOSEC) and calcium pantothenate, folic acid, vitamins nos (MULTI-VITAMINS VITAFIT). On 24Mar2021 17:00 it was reported as the patient experienced i taste salt. Seriousness was reported as non-serious. Outcome of event was not recovered.
Information has been received from a registered nurse concerning a 78 year old female patient with chronic obstructive pulmonary disease and hypertension who on 01-SEP-2009 was vaccinated with a dose of PNEUMOVAX 23, 0.5 ml by intramuscular route. The nurse reported that the patient developed local reaction after receiving the dose of PNEUMOVAX 23 and it was believed to be the first dose of PNEUMOVAX 23 for the patient. The nurse reported that on 01-SEP-2009 the injection site was very swollen, red and hot to touch. The nurse also reported that the patient had headache and he was restlessness all night. At the time of this report the patient had not recovered. On 02-SEP-2009 the patient sought medical attention in the physician's office, the nurse reported that the physician started patient on unspecified antibiotic during office visit. Additional information had been requested.
29JUN92 pt recvd 1st dose of Engerix-B & approx 2 wks later had swollen nodes in neck; 18AUG92 still had sx; multiple swollen glands on rt side of neck; pain in rt shoulder, numbness & pain in rt buttocks extending down to rt leg;
Developed itchy hands, neck and head, then all over. Dyspnea and SOB; red rash on arms, neck, face. Tongue red and swollen, throat red and swollen. B.P. and P. high. Had flu shot at 820AM. Took BENADRYL at 1:20PM. Seen in flu clinic at 1:30PM - given BENADRYL and called 911.
Ischemic stroke; This is a spontaneous report from a contactable consumer (patient).   A 73-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 16Mar2021 13:30 (at age of 73 years old)(Lot Number: EP7534) as single dose for covid-19 immunisation. Medical history included low grade prostate cancer, No known allergies, The patient was diagnosed with COVID-19 prior to vaccination. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) administered in Arm Left on 23Feb2021 13:30 (at age of 73 years old) (Lot Number: en6201) as single dose for covid-19 immunisation. The patient's concomitant medications received within 2 weeks of vaccination was No.  The patient experienced ischemic stroke on 02May2021 06:00 with outcome of recovering. The event resulted in Emergency room/department or urgent care. The patient was hospitalized for ischemic stroke from May2021 to May2021(reported as 4 days).  Medication received as treatment for event. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   No follow-up attempts possible. No further information expected.
drug ineffective; Covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 10Sep2020 at 12:15 as dose 1, single (Batch/Lot number: unknown), in left arm, on 10Apr2021 at 12:15 as dose 2, single (Batch/Lot number: unknown), in left arm, on 20Oct2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 29Apr2022 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "BMI = 30" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19. Additional information: There was no other medications in two weeks. Still l testing positive on rapid assay as of 14May Diarrhea, bad taste in mouth.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Within 6 hours I began having excruciating body pain from head to toe.  To treat, I tried laying in a hot shower, laying on multiple heating pads, and taking Advil/Ibuprofen.  None of which took the edge off the pain.  I also was nauseous, lethargic, and cold sweats.  After 24 hours, for the next 3-4 weeks I suffered from localized pain to the injection site (left arm), my lower back, and my left ankle which i broke approximately 17 years ago and never had an issue since the time of breaking it.  I also had daily migraines which were severe, causing light sensitivity, pain in my eyes and down my neck.  I have had irregular menstrual cycles since to include a period a week after the vaccine and lasting an entire month (daily bleeding, cramps etc).  I didn't get my next period for nearly 2 months and the last 2 periods I have had have included severely painful cramping and lower back pain lasting anywhere from 2 -12 days.  I am still getting migraines although not daily and have had a daily intermittent sharp pain on the left side of my chest near the lower ribs (not sure if its the spleen or kidney).   It should be noted that nearly 24 hours after my J&J vaccine, I saw the news about women suffering blood clots so I immediately stopped the use of my birth control and have not been on it since April due to this vaccine.
Patient developed a pericardial effusion and PE within 2-3 days of vaccine. Unclear if related.; Patient developed a pericardial effusion and PE within 2-3 days of vaccine. Unclear if related.; This is a spontaneous report from a non-contactable physician. A 72-year-old male patient received bnt162b2 (COVID-19, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concurrent medications were not reported. The patient was unclear if related. The patient experienced pericardial effusion and PE (Pulmonary embolism) within 2-3 days of vaccine on an unspecified date. The outcome of event was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events pericardial effusion and pulmonary embolism 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.
vomiting profusely and missed work; vomiting profusely and missed work; Nausea; stomach pain/ stomach hurt; fatigue; sore arm; This is a spontaneous report from a contactable consumer.  A 57-year-old female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number and Expiration Date: Unknown), via an unspecified route of administration on 23Dec2020 at 11:00 at a single dose for COVID-19 immunization. The patient's medical history was reported as none. There were no concomitant medications. On 23Dec2020, the patient experienced: sore arm (non-serious). On 25Dec2020 at 05:00, the patient experienced: vomiting profusely and missed work (non-serious), nausea (non-serious), stomach pain/ stomach hurt (non-serious), and fatigue (non-serious). The clinical course was reported as follows: The consumer called on behalf of the patient (his wife). The 57-year-old patient had a reaction to the COVID-19 vaccine and was reported to the Pfizer Drug Safety Unit. The patient received her vaccine on 23Dec2020 at 11:00. The patient initially had no symptoms other than a sore arm (for 40 hours as reported). Then, 41 hours later, at 05:00 on 25Dec2020, the patient began vomiting profusely and missed work. It lasted several hours with nausea, stomach pain, and fatigue. At the time of the report, the patient seemed fine. The consumer further reported: "I have a question, I looked at the data of the original participants and looked at the side effects and I'm a little confused as to my wife had the vaccine the other day she is an ICU nurse." The consumer reported that the patient was fine; she had a sore arm for 40 hours and she woke up in the morning "at 41 hours" vomiting profusely. The patient had to miss work and her stomach hurt. The clinical outcome of the event was recovered on 26Dec2020.  The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.
Patient received vaccinations as above (unsure about specific manufactures, would need access to clinic records). Patient seemed more tired, went to bed. Mom awoke on 12/3 to patient having a generalized tonic clonic seizure. He was taken to an outside hospital where he was febrile to 103, received ativan, tylenol, versed, keppra, fosphenytoin and phenobarbital then required intubation for respiratory failure.