chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 03-FEB-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 03-FEB-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 03-FEB-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 03-FEB-2022) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2022 at 3:56 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Feb-2022 at 3:56 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 03-FEB-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 03-FEB-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 03-FEB-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 03-FEB-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided.  Patient received Booster dose. The time of vaccine administration was reported as 15:56:31  No treatment drug information was received.
A report has been received from a Pharmacist concerning a 9 month old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced INADVERTENTLY ADMINISTERED FLUMIST TO A 9-MONTH OLD BABY GIRL. The outcome of the event of INADVERTENTLY ADMINISTERED FLUMIST TO A 9-MONTH OLD BABY GIRL is unknown. The report was considered to be non-serious.
30 hours after given Varivax and hib, developed Urticaria - legs, lower trunk - resolved in 12 hours with Atarax.  2 weeks later fever for 2 1/2 days up to 102 degrees, 3 red papulomacular spots - resolved spontaneously.  Red papular lump on left thigh at 2 weeks after shot.
first dose on May 2019 , second dose on August 14th (no data about year).; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in May 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 11-MAY-2022 Reporters comment: The patient received 1st dose of Shingrix in May 2019 and 2nd dose on 14th August, no data about year was provided. Permission for follow-up was not asked as well as no other information because member of public was looking only for an answer.  Additional supportive information: The patient received 2nd dose of Shingrix, later than the recommended schedule, which led to lengthening of vaccination schedule. This case had been linked with case US2022076977, reported by the same reporter for the patient's husband.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022076977:same reporter
High blood pressure of 188/98; High Blood sugar 283; Headache; A spontaneous report was received from a consumer concerning a 68 year old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced high blood pressure, high blood sugar level, headache and high heart rate.  The patient's medical history was not provided by the reporter. Concomitant product use was not reported.   On 11 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection. After receiving the mRNA-1273 vaccine, patient experienced high blood pressure, high blood sugar level, headache and high heart rate.  Treatment details for events were metoprolol and cavitrol and symptoms improved a little.  Action taken with the drug in response to the event is not provided.  The  outcome of the event, high blood pressure, high blood sugar level, headache and high heart rate was considered to be recovering/resolving at the time of this report.; Reporter's Comments: This case concerns a 68 Y/O M with a serious unexpected event of hypertension, and nonserious unexpected hyperglycemia, and expected headache.  Event onset on day 2 after first dose mRNA-1273. Events resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
He had a fever, nausea, and a cough. He was diagnosed with Flu A. He was prescribed BROMPHEN, and oseltamivir. He is feeling much better now. He still has a slight cough though.
Patient is a 38 y/o female physician with  ADHD and depression presenting with concern for involuntary choreiform movements that began 1/9.  Patient has never had this problem before.  She does not note any associated symptoms.  She denies extremity weakness, paresthesias, seizures, headache, chest pain, abdominal pain, nausea, vomiting, fevers, and other symptoms.  She cannot think of any inciting injury or event that led to this.  She did receive the second dose of the Pfizer COVID vaccine on 1/7, and is unsure if this is related.
Was operated on again; Twisted bowel; she was too sick; she was too sick to get the 2nd dose and had the operations which is reason for delay; Throwing up; Cramps; Peritonitis; Double pneumonia; This spontaneous case was reported by a consumer and describes the occurrence of VOLVULUS (Twisted bowel), SURGERY (Was operated on again), PERITONITIS (Peritonitis) and PNEUMONIA (Double pneumonia) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced MUSCLE SPASMS (Cramps) and VOMITING (Throwing up). On 05-Mar-2021, the patient experienced VOLVULUS (Twisted bowel) (seriousness criteria hospitalization and medically significant). In March 2021, the patient experienced PERITONITIS (Peritonitis) (seriousness criterion medically significant) and PNEUMONIA (Double pneumonia) (seriousness criterion medically significant). In June 2021, the patient experienced SURGERY (Was operated on again) (seriousness criterion hospitalization). On an unknown date, the patient experienced MALAISE (she was too sick) and PRODUCT DOSE OMISSION ISSUE (she was too sick to get the 2nd dose and had the operations which is reason for delay). The patient was hospitalized on 05-Mar-2021 due to VOLVULUS. At the time of the report, VOLVULUS (Twisted bowel), SURGERY (Was operated on again), PERITONITIS (Peritonitis), PNEUMONIA (Double pneumonia), MUSCLE SPASMS (Cramps), MALAISE (she was too sick) and VOMITING (Throwing up) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (she was too sick to get the 2nd dose and had the operations which is reason for delay) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.  Company Comment:  This case of a female patient who was too sick to get the 2nd dose and had the operations which is reason for delay (product dose omission). The event of volvulus and pneumonia are assessed as not related to product use based on biological implausibility. Peritonitis and vomiting are assessed as symptom of peritonitis and also unlikely related. The other reported events show temporal association with product use and a causal relationship cannot be excluded.  Product omission is not applicable.   Reporter did not allow further contact; Sender's Comments: This case of a female patient who was too sick to get the 2nd dose and had the operations which is reason for delay (product dose omission). The event of volvulus and pneumonia are assessed as not related to product use based on biological implausibility. Peritonitis and vomiting are assessed as symptom of peritonitis and also unlikely related. The other reported events show temporal association with product use and a causal relationship cannot be excluded.  Product omission is not applicable.
Looked like a white substance, like a floating piece of cotton. Reporter would shake and shake the syringe, but this substance wouldn't go away (NO PATIENT); The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 24Jan2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Nurse) from medical information team and product quality group. A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Lot number: FW0032, Expiration Date: Nov2024) for immunisation, Device Lot Number: FW0032, Device Expiration Date: Nov2024. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT CONTAMINATION (non-serious), outcome "unknown", described as "Looked like a white substance, like a floating piece of cotton. Reporter would shake and shake the syringe, but this substance wouldn't go away (NO PATIENT)".  Additional information: The sample of the product was not available to be returned.
Headache starting the morning after , 4/29/21. Lasted 36 hours. Fever starting 26 hours after injection ranging from 99 - 101.7. Lasted 14 hours. Took Advil.
Immediately after injection I had soreness and several notable  heart palpitations followed by mild dizziness and mild difficulty breathing accompanied with dry mouth. This subsided after a short while (within 15) minutes after I left the vaccine location. I arrived home and felt fatigue and a  slight headache develop.  The headache has since stopped. I also experienced some chills. No fever as of yet. Soreness at injection site is moderate.
collapsed and briefly lost consciousness; This is a spontaneous report from a contactable consumer. An 82-year-old female patient (reporter's mother) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN6205, expiration date was unknown), via an unspecified route of administration, administered in the left arm on 04Mar2021 at 14:00 as a single dose for COVID-19 immunization. The vaccination facility type was reported as the hospital. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EM9809, expiration date was unknown) at the age of 82 years on 11Feb2021 at 02:00 PM administered in the left arm for COVID-19 immunization. Relevant medical history included Alzheimer's, had lost consciousness before, and she had a pacemaker; all from an unknown date. The patient had other unspecified medications in two weeks. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. The patient was not tested for COVID post vaccination. On 05Mar2021, about 24 hours after the vaccine, the patient collapsed and briefly lost consciousness while taking a walk. This had happened with her before, but not for a number of months. The patient did not receive any treatment for the adverse event (AE). The patient recovered from the event on an unspecified date.
alopecia universalis; itching and tingling of skin on my abdomen, arms, chest and legs; tingling of skin on my abdomen, arms, chest and legs; This is a spontaneous report from a contactable nurse (patient). A 64-year-old non-pregnant female received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot Number: ep6955) via an intramuscular route of administration, administered on left arm on 19Mar2021 09:00 am (at the age of 64-year-old) as dose 2, single for COVID-19 immunisation. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EN6202) via an intramuscular route of administration on 26Feb2021 as dose 1, single for COVID-19 immunisation and experienced ongoing alopecia universalis, hair sloughed/slick bald head, alopecia areata which had been in remission for 5months. The patient's medical history includes alopecia arreata, auto immune disease and thyroid disease. Facility type of vaccine is Hospital. The patient's concomitant medications were not reported. Patient stated she has alopecia arreata which had been in remission for 5 months. She had a full head of hair growing very well. After the first injection, 7-10 days later her hair sloughed on 06Mar2021. It took only 2-3 days to fall out completely to a slick bald head. After the 2nd dose, she noticed hair loss of eyebrows, eyelashes, nose hair, and all body hair. Also, profound itching and tingling of skin on her abdomen, arms, chest and legs. Her diagnosis has been upgraded to alopecia universalis. Patient received therapeutic medications and steroid scalp injections. The outcome of events was not recovered.      No follow-up attempts are possible. No further information is expected.
Very sore, stiff neck hot to the touch; Very sore, stiff neck hot to the touch; Very sore, stiff neck hot to the touch; Body twitches; Tremors; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 10Mar2021 at 14:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included protein S deficiency. The patient had latex allergy and shellfish allergy. 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. Concomitant medications included AMLODIPINE, ASPIRIN, FLONASE, and PANTOPRAZOLE, all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received iodine and had drug allergy. On 11Mar2021 at 15:45, the patient experienced very sore, stiff neck hot to the touch, body twitches and tremors. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether the therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events very sore, stiff neck hot to the touch, body twitches and tremors was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
injection arm red; Injection arm swollen; arm has been itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (arm has been itching), VACCINATION SITE ERYTHEMA (injection arm red) and VACCINATION SITE SWELLING (Injection arm swollen) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (arm has been itching). On 04-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection arm red) and VACCINATION SITE SWELLING (Injection arm swollen). At the time of the report, VACCINATION SITE PRURITUS (arm has been itching), VACCINATION SITE ERYTHEMA (injection arm red) and VACCINATION SITE SWELLING (Injection arm swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
PATIENT CAME INTO PHARMACY TWO DAYS AFTER SECOND SHINGRIX VACCINATION. PATIENT HAS 10-12 CM RED AREA AROUND INJECTION SITE; SLIGHTLY RAISED BUT NOT WARM TO TOUCH. PATIENT COMPLAINED OF EXCESSIVE LETHARGY THE DAY FOLLOWING INJECTION - UNABLE TO LEAVE BED. PATIENT ALSO COMPLAINED OF UNUSUALLY BAD NIGHTMARES THE NIGHT OF INJECTION. REACTIONS SEEMED TO BE LESS AS OF TWO DAYS POST INJECTION, SO PATIENT WAS NOT GOING TO SEE PHYSICIAN BUT ENCOURAGED VISIT IF SYMPTOMS BECAME WORSE. NOTIFIED PCP AFTER PATIENT REPORTED.
loss of hair; skin rashes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 85 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Mar2021 13:00 (Lot number: EN6198) at the age of 84 years as dose 1, 0.3ml single, intramuscular, administered in arm left, administration date 23Mar2021 13:00 (Lot number: EN6207) as dose 2, 0.3 ml single and intramuscular, administered in arm left, administration date 19Oct2021 13:00 (Lot number: EW0185) as dose 3 (booster), 0.3ml single for covid-19 immunisation. Relevant medical history included: "Lowering blood pressure" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: COZAAR taken for hypertension (ongoing); CALCIUM taken for osteoporosis (ongoing); VITAMIN A [RETINOL] taken for supplementation therapy (ongoing); VITAMIN B COMPLEX taken for supplementation therapy (ongoing); VITAMIN C [ASCORBIC ACID] taken for supplementation therapy (ongoing); VITAMIN D [COLECALCIFEROL] taken for supplementation therapy (ongoing); VITAMIN E [TOCOPHEROL] taken for supplementation therapy (ongoing). The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "loss of hair"; RASH (non-serious), outcome "unknown", described as "skin rashes". No follow-up attempts are possible. No further information is expected.
Began with hot flash and numbness through entire right side of body about 20 minutes after shot. Quickly escalated to difficult swallowing, body tingling, and extreme anxiety that almost caused a full blown panic attack. Luckily it subsided after about 20 mins of duress. Unfortunately around 12 hours after the injection at 3 AM I began experiencing quite severe flu like symptoms including nausea, extreme fatigue\weakness, occasional gagging, pain and diarrhea. Lasted until I awoke on the 12th (today) at approximately 8 am. Spent entire time in an on\off sleep also tried treating with tylenol and flu medication to no avail. Temperatures were checked twice both times results were in the high 99's.
Vaccine was administered to the left deltoid at approximately 1:00PM or shortly after. Patient was monitored for 15 minutes following injection and returned to work. At approximately 2:55PM patient noticed a feeling of flushing at neck, face, and ears. Shortly after 3:00PM patient?s coworkers noticed hives and redness on neck. Patient?s temperature at the time was 99.4 (usual baseline is around 97). Patient was taken to ED. Redness and flushing was noted all over skin, hives on trunk, neck and back, along with a sensation of itching/burning all over. No respiratory symptoms or issues. Patient received oral prednisone, Prilosec, and Benadryl around 3:45PM. Flushing, redness, and hives began to slowly improve. Sensation of skin irritation remained. Patient discharged with 4 day course of prednisone around 6:30PM.
4 cm erythema with mild induration at injection site.  Improvement over 24 hours.
Given aged 5-11 years Pfizer dose to a 12 year old who should have received 12+ Pfizer dose.
got shingles on right back; still have major post herpetic pain; major aching in that spot; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) (batch number UNK, expiry date unknown) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced shingles, post herpetic neuralgia and pain. On an unknown date, the outcome of the shingles, post herpetic neuralgia and pain were unknown.   It was unknown if the reporter considered the shingles, post herpetic neuralgia and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported,however captured as adult as per vaccine indication The patient got Shingrix shot in January, 2 days later got shingles on right back. At the time of reporting the patient still had have major post herpetic pain, no blisters, but major aching in that spot.  The patient asked if he/she should get the second shot. No contact details were provided
Covid monitoring documentation. PT admitted 1/9/22 documented to have positive covid. PT received Moderna 5/21/21 Lot 033C21A for dose 1. Dose 2 was Moderna given on 6/18/21 Lot 036C21A.
No additional AE; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received from an other and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in May 2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, unk, lot #W001518, expiration date: 13-JAN-2024, administered for prophylaxis (strength, and route of administration were not provided); varicella virus vaccine live (oka/merck) (VARIVAX) injection, unk, lot #W008712, expiration date: 14-MAR-2024, administered for prophylaxis (strength, and route of administration were not provided); and  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, unk, lot #W026315, expiration date: 18-FEB-2024, administered for prophylaxis (strength, and route of administration were not provided). Those vaccines underwent temperature excursion in 58.65 Farenheit (F) (47 Farenheit to 77 Farenheit) for 25 hours 45 minutes (Product storage error). No additional adverse events were reported.  This is non-valid case due to lack of multiple patients identifiers.  Follow-up was received on on 17-AUG-2023: The patient identifiers was updated such as name and date of birth. On 12-MAY-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, unk, lot #W026315, expiration date: 18-FEB-2024, administered for prophylaxis (strength, and route of administration were not provided).
After receiving booster, I developed Afib 11 days after.  I have been under medical surveillance for 10 years, with two EKGs per year, I have always had a regular heart beat. Only 11 days after receiving the booster I developed Afib.
At 21:00 felt hot, had tachycardia and tachypnea. Later/very restless, talking incoherent. Hosp 11/24/99 for acute rad. On nebulizers x3 in ER to stabilize,then every 3 hrs. for 1st 24 hrs. Wheezing, rales.