chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious spontaneous report of inadvertent administration of expired FLUMIST was received from a health professional concerning a male child. Neither medical history nor concomitant medication was reported for this patient. The product expired on 16-Jan-2011. On 26-Jan-2011, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing concomitment for the indicated population of 2 years to 59 months of age.
passed out briefly; a fruity taste in her mouth; turned "Beet red" on her neck/face; have an episode of hypertension; feeling hot; was "swaying"; had menstrual like cramps that radiated from her abdomen to her entire body; had menstrual like cramps that radiated from her abdomen to her entire body; This is a spontaneous report from a contactable pharmacist. A 33-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 13Jan2021 at the first single dose for covid-19 immunisation .  The patient medical history was not reported.  The patient's concomitant medications were not reported.  Within in minutes of receiving the vaccine on 13Jan2021, the patient reported a fruity taste in her mouth, turned "Beet red" on her neck/face, and passed out briefly. When she regained consciousness, she was given Benadryl, and also was reported to have an episode of hypertension. She reported feeling hot and was "swaying" and had menstrual like cramps that radiated from her abdomen to her entire body.  The outcome of events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the event "passed out briefly". The impacts of this report on the benefit/risk profile of the 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.,Linked Report(s) : US-PFIZER INC-2021027150 same reporter/drug, similar event, different patient
My heart is uncomfortable. It hurts a little bit and feels like drinking a lot very strong black coffee without any food. ?I didnt drink any after vaccine?I could not sleep for the whole night
I have been taking Metformin and 1 shot of Lantus (50 units PM) for the last 5 years.  A1C has been stable in the low 7s to upper 6s.  I have had 3 Moderna shots, the November 2021 being a booster.  On 12/10/2021 @ 6AM I got up from bed and collapased in bathroom.  Taken to hospital for emergency.  Blood sugar tested at 56.  I almost died!
Pfizer vaccines given 1/21/21 and 2/11/2021 both in left arm - on 4/7/2021 client noticed open area at site he remembers receiving the vaccine - approximately 0.5 cm circular shape - shallow - dark center with red edge - describes it as itchy - no streaks - base appears dry at this time.
In error, I administered Pfizer Bivalent vaccine for 5-11 year old to a 17 year old. It is the patients first bivalent vaccine. No reaction or symptoms after administration.
Was find 1st and 2nd day.  3rd day morning dizzy and loss of energy.   A little nausea caused me to lay down, stay home from work.  Rested.  Took Tylenol  and slept throughout the day.  Got up around 12:30pm, felt better, did decide to go for a jog to get body temperature  up.  Jogged for 60 minutes, returned, ate and rested again.  4th day, felt much better, no dizzyness, still a little tired but maybe 85% energy level.  5th day back to normal.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 30-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was provided. No Treatment medication was provided.    Reporter did not allow further contact
shingles; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient herself) reported that an unspecified aged female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 03Feb2021 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient sated that she received first dose 3Feb2021 second scheduled 14Feb2021, got shingles after first vaccine, wants to make sure its ok to still get second dose. Outcome of event was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Patient received vaccine midday and his blood pressure bottomed out that night to the point he got  very dizzy. He could not stand or swallow.
patient reports having a stroke many days after the vaccine.  Couldn't remember the exact timing.  Said he developed dizziness, and other stroke symptoms and friend had him go to hospital.  P
Patient came to the vaccine clinic with his mom to get his Pfizer Bivalent booster dose. He received the dose at 3:50, while waiting in the waiting area he started to not feel well and walked to a family friend who is a vaccinator at 3:55.  Patient was complaining of feel dizzy, warm, sweaty and pale. He started to fall to the ground and his mom lowered him. Mom does not believe there was LOC, he did not strike his head or any other body parts and has no additional complaints. At 3:59 patient was given water and a granola bar and advised he was feeling much better. Both he and his mom stayed with us for approximately 30 minutes to ensure he was feeling 100%.
Angioedema of bilateral breasts, labia, bilateral lower extremities, face, right upper extremity.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: mild itching and redness on arms and neck; mild tickle in throat.  Patient took 25mg diphenhydramine and drank water with improvement in symptoms.  Patient has history of anaphylaxis with penicillin but no other allergies.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 22Feb2022 as dose number unknown, single (Lot number: 033K21-2A) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HIV", start date: 1995 (ongoing), notes: HIV since 1995. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19".Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information:No Other medication in 2 weeks. Paxlovid was taken as COVID 19 Treatment.Treatment start date was 02Dec2022.Treatment stop date was 05Dec2022.
This spontaneous report as received from a pharmacist refers to a 62 year old male patient. The patient's medical history and current conditions were not provided. On 28-APR-2016 (reported as "8 days ago"), the patient was vaccinated with ZOSTAVAX (lot number, expiration date and dose were not reported), subcutaneous. Secondary suspects and concomitant therapies were not reported. On 28-APR-2016, immediately after the administration of ZOSTAVAX, the patient experienced redness, itching, swelling, and bruising at the injection site. There was no treatment given for adverse events. The outcome of adverse events was reported as not recovered. The patient sought medical attention via calling the pharmacist. The relatedness between adverse events and ZOSTAVAX was not reported. Additional information has been requested.
Fever, chills, body aches, extreme fatigue (lasting more than 3 days), nausea, rash on injection arm (appeared 2 days after vaccination.)
Patient was  mistakenly scheduled for, and received her second dose of the Moderna vaccine series 22 days following her first dose, earlier than the recommended 28 days and 4 day grace period per CDC. Called patient 9/9/21 immediately after mistake was realized and explained situation. Per CDC, patient does not need to repeat dose or series.
A fever of 102.5, chills, body aches, swelling, tenderness & redness on left arm- lymphedema
Days later developed cellulitis at and around the site of injection; This is a spontaneous report from a contactable physician received via Pfizer Sales Representative.  A male patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (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. Days later receiving the vaccine, patient developed cellulitis at and around the site of injection on an unspecified date with outcome of unknown.    The information on the lot number has been requested.
All over body hives with severe itchiness, medicated with Benadryl, took 2 doses of Benadryl and still feeling itchiness and hives. Symptoms started around 10 am and lasted all day
Moderna mRNA vaccine use for COVID-19 under Emergency Use Authorization (EUA): 2 years after taking Moderna vaccination series, I am now diagnosed as having CML.
Patient called today reporting next morning after the vaccine she had blood blisters on the right shoulder and down her arm. Her eyes were blood shot and her vision was blurry.  She also reported having pain in her whole body.
fever of 103.6 inability to move arm muscle spasms  extreme nausea and vomiting  cough and sore throat  inability to taste or smell  loss of appetite
1600 day after vaccine presented with N/V and chills.    Small bowel obstr-partial.  NG tube, fluids.  resolved.  Admit 3/3 DC 3/8
Child presented to our clinic September 11 (12 days after vaccine) with symptoms consistent with a mild case of Chicken Pox.  She states symptoms appeared 3 days ago.  Child is afebrile, reports no pain.  Presents with disperse pruritic erythemic rash at approximately half dozen sites, as well as an indurated angry looking patch 4x6 cm at injection site.  Child appeared to be 'weary'.
Information has been received from a female who on 30-JUN-1988 was vaccinated with MMR (second generation). She was 4 and a half months pregnant at the time. She gave birth to a male who blind in one eye, had a seizure disorder, experienced fevers "off and on", diarrhea, and had learning problems. The patient also developed a skin rash which "when it came it covered his body". She also indicated her son may be sterile. She indicated her son had other unspecified conditions as well. No further information is available. Follow up information has been received from a female consumer who refers to her now 26 year old son. The patient's mother stated, "on an unspecified date 26 years ago (previously reported as 30-JUN-1988), while she was pregnant (date not provided, previously reported as 4 and a half months), was given a dose of MMR" (also reported as M-M-R II INJ and previously reported was vaccinated with MMR, second generation). The patient's mother stated, "her son was born blind (previously reported as blind in one eye), extremely ill, has suffered physically and mentally all his life, mildly retarded and suffers from seizures." No further information was provided. Upon internal review born blind, mildly retarded and seizures were determined medically significant. The events of born blind and mildly retarded were considered both disabling and a congenital anomaly. The adverse events were previously reported within the maternal case (MARRS # 98032333). Additional information has been requested.
Patient received typhoid (TYPHIM Vi) vaccine first she was fine. Although she was nervous to get vaccinated then received yellow fever (YF-VAX) and felt very dizzy and nausea.
Patient reports that she experienced muscle pain in the arm around the area where the vaccines were given later in the afternoon on 1-13-19. Later that evening she reports having a fever and chills, and by 3am the next morning woke with a high fever and sweating with redness and swelling in her arm. She went to see her PCP, the next day. She reports being diagnosed with cellulitis and given an injection and a course of oral clindamycin. The condition resolved completely by the time of reporting.
This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 57-year-old male patient who received SHINGRIX for prophylaxis. On 30th July 2018, the patient received the 1st dose of SHINGRIX .5 ml. In July 2018, less than a week after receiving SHINGRIX, the patient experienced muscle pain, body temperature increased, chills and fatigue. On an unknown date, the outcome of the muscle pain, body temperature increased, chills and fatigue were unknown. It was unknown if the reporter considered the muscle pain, body temperature increased, chills and fatigue to be related to SHINGRIX. Additional details were provided as follows: The patient experienced muscle aches, fatigue, elevated temperature and chills.
I am a 35yo G2P1, was 29 weeks pregnant at the time of vaccination (due 3/25/21), completely normal pregnancy so far. CDC Vsafe called and asked me to report as an adverse event though I wouldn't consider more serious than most. Had low grade fever (99-100) on tylenol, chills, rigors, myalgias and joint pains starting about 12 hours after vaccination.  Went to work the following day (I am an physician) and by about 10 am had a presyncopal event and was unable to stand/continue working. Was unable to stand without feeling faint for about the next 6 hours.  Was febrile until about 8pm 1/9, never over 100 while taking tylenol. Symptoms completely resolved by 1/10 AM except fatigue for the next 4 days or so, though I developed axillary lymphadenophathy on the side of vaccination starting 1/12 for about 5 days.  No effect whatsoever on the fetus.
About 30 minutes after the injection experienced a cough and itching in throat.  Denies shortness of breath.  BP  178/88, HR  82  97% pulse oximetry.  Given a bottle of water, states feels a little better. .  Given  Benadryl 50.mg. .  States feels better about 10 minutes after Benadryl.  Meeting with son after visit.   Patient refused Epinephrine dose earlier.
Next morning after shot developed fever, nausea, lack of energy. By end of evening on 16th fever was at 101.1, severe chills, headache,  nausea,  no appetite, no energy and elevated heart rate. At rest and no movement it was at 98-120 bpm. My heart rate usually around 60-65 at rest. Took some ibruprofen which helped fever go down. Heart rate is now around 80-85. Also developed large red spot, swollen sore arm at shot site.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history was not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD lot # reported as M001151, expiration date reported as 05-JUL-2017 (dose, route and site of administration were not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 8.8 degrees Fahrenheit for 7 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports from the same reporter. Additional information has been requested.
No adverse effects were reported; 3 patients were administered the vaccine on March 3, 2023 at the beginning of the excursion, 9 others were administered the vaccine after the full excursion; This spontaneous report was received from a health care professional (HCP) referring to a 72-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  On 03-MAR-2023, the patient was vaccinated with an improper stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) at a dose of 0.5 ml, lot #W027449, expiration date: 25-SEP-2024, administered for prophylaxis (strength, and route of administration were not provided) following a temperature excursion of 46.7F (47F) for 72 hours 0 minutes 0 seconds discovered upon looking at the data logs (product storage error). Data logger recorded a 46.7F temp on 03-MAR-2023, and did not record again until logging a 43F temperature on 06-MAR-2023, worst case scenario of 46.7F was used for the full 72 hours. No adverse effects were reported.   This is one from several cases from the same reporter. ; Sender's Comments:  US-009507513-2304USA002694: US-009507513-2304USA002650: US-009507513-2304USA002667: US-009507513-2304USA002675: US-009507513-2304USA002696: US-009507513-2304USA002746: US-009507513-2304USA002759: US-009507513-2304USA002776: US-009507513-2304USA002840: US-009507513-2304USA002932: US-009507513-2304USA002992:
The vaccine was the second dose of Shingrix. The first was uneventful other than a very sort left arm. The second resulted again in a very sore left arm and a low grade fever the next day. The other symptoms came about three weeks later and now, on September 21, have not subsided: on the inner thighs and the back of the thighs. Sensitive to clothes rubbing, even skin on skin, and sensitive when sitting. Symptoms have variously been burning, irritation, and what feels like heightened nerve endings. There has never been a rash. I was first prescribed a topical steroid which I took for about a week, and then a dermatologist told me to stop it because I did not have signs of a rash. It was triamcinolone acetonide 0.1%. . After around two weeks, I saw a neurologist who prescribed gabapentin - 100 mg twice a day which I could increase to the same dosage three times I day. I started that yesterday.
CHILLS; arm became sore; This case was reported by a consumer via call center representative and described the occurrence of chills in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced chills and pain in arm. On an unknown date, the outcome of the chills and pain in arm were recovered/resolved.   It was unknown if the reporter considered the chills and pain in arm to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient was either 63 or 64 years old. The patient's arm became sore the day after the injections and lasted a day. The patient also experienced chills the morning after receiving the shot. The reporter did not consent to follow up.
I felt like I got hit by a bus. I felt very off the next day and light headed. I know Covid is serious and I did the vaccine to protect others, but at my age I think Covid symptoms would have been easier to deal with. The extreme, and I am saying extreme, symptoms lasted for roughly 24 hours. They started 24 hours after the vaccine. I  am significantly better now (8:24 am 6 minutes from the 48hr mark).
Chest pain; Labored breathing; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWA73) via an unspecified route of administration in the right arm on 19May2021 at 15:30 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient had no known allergies. Concomitant medications included ethinylestradiol, norethisterone acetate (MICROGESTIN) for unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Era735) via an unspecified route of administration in the right arm on 28Apr2021 at 14:00  (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23May2021 at 14:00 the patient experienced chest pain and labored breathing. No therapeutic measures were taken as a result of the events. The events resulted in emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the event chest pain and labored breathing was recovering at the time of report.  No follow-up attempts are possible. No further information is expected.
I had a sore arm and I was tired after receiving the vaccine for about a day. One day I fainted, and I was transported to the emergency room. I was diagnosed with lung cancer on 12/09/2022. I was admitted for two days to the hospital. I had part of my lung removed in 03/2023 and waiting to see what the treatment will be.
pt was admitted to the hospital for s/s consistent with COVID 19.  Tested positive on admission
24 hours ache & bruise. 72 hours redness, pruritis, "lump the size of an egg". On exam (6 days post) only SQ nodule <1 cm. No erythema.
COVID pos on 9/18/2022. Symptoms; body aches, cough; low grade fever and debilitating fatigue. I was prescribed a 5-day course of Paxlovid. However, I contracted COVID a second time on 10/04/2022. It was a very mild case so there are no symptoms to report. Tested COVID neg on 10/10/2022
Information has been received from a physician through a Merck Pregnancy Registry concerning a female with asthma, back pain and depression who on 05-FEB-2007 was vaccinated intramuscularly with the first 0.5 mL dose of Gardasil (Lot # 654535/0960F). The date of the patient's last menstrual period (LMP) was 14-MAR-2007. On 18-APR-2007, the patient was vaccinated, intramuscularly with the second 0.5 mL dose of Gardasil, (Lot # 654510/0962F). Concomitant therapy included PERCOCET, prednisone, MOTRIN and albuterol. It was reported that the patient was pregnant and had gestational hypertension. The patient sought unspecified medical attention. It was reported that the patient had laboratory evaluation of "prenatal ops". The estimated date of delivery was 19-DEC-2007. Additional information has been requested. Follow up information was received from the physician on 10-APR-2008 via telephone call. The physician reported that the patient had initiated her prenatal care with them, but then switched to another hospital for care. Additional information has been requested.
Patient claimed she has intense local pain redness swelling superficial pealing a rough surgical pattern rash redness difficult breathing weakness dizziness. After 2 weeks still have nausea when push or roll on it cause severe pain. MD. saw the patient on 9/5/12 gave her BENADRYL & told patient to apply Hydrocortisone MD said Pt still have reaction of redness more swelling on 9/11/12.