chrisvoncsefalvay/vaers-outcomes huggingface dataset:
16 Year Old Patient Was Given Heplisav-B; Initial Report Received on 06- Oct-2022   This is a spontaneous report, received from a pharmacist in the regarding a female patient, aged 16 years, who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient.  Concomitant medications were not reported.  On an unknown date, a dose of HEPLISAV B (Lot # unknown, expiration date 24-Sep-2023, NDC # unknown), route and site not specified, was administered for hepatitis B immunization at an "off site clinic". No concomitant medications at the time of vaccination were reported.   The pharmacists reported that the 16-year-old patient had provided an incorrect date of birth. Reporter states that the vaccine was given at an "Off site Clinic." No adverse reactions were reported by the patient.  The reported stated that she had no other information about the event.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
The patient presented with redness, swelling, and heat several inches below the injection site 2 days following immunization with Fluzone HD. We told the patient to take Benadryl and referred her to her physician.  The physician diagnosed her with a local reaction to the flu shot and gave her a prescription for dexamethasone, which he stated should cause her symptoms to fully resolve.
Information has been received from a physician concerning a 2 or 4 month old patient who was vaccinated with a dose of ROTATEQ.  Concomitant vaccinations administered on that same day included all the other vaccines normally given at that time.  The next day the mother brought the baby back in to say the baby had an adverse experience which she thought was from the oral vaccine.  During the night the baby was colicky and had abdominal which she felt was from the oral vaccine.  When the doctor saw the baby the next day he/she was fine; the baby didn't seem to be suffering from any type of adverse reaction.  The baby will continue treatment.  Additional information has been requested.
Pt received PREVNAR 13 in office, reports developing N/V, chest pain 2-3 days later, then again 2 days after that. No arm pain or swelling. No fever.
I got them AFTER a shot/can be rash- free´/was the kind I suffered; This case was reported by a consumer and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details provided were as follows: Age at vaccination was not reported. Patient reported that the shots was not 100 percent effective. They also can be rash free and that was the kind patient had suffered. No further details provided.
petechiae again petechiae again on shins on the skin, not in the upper thigh, just the lower legs/ its on both legs; This spontaneous case was reported by a consumer and describes the occurrence of PETECHIAE (petechiae again petechiae again on shins on the skin, not in the upper thigh, just the lower legs/ its on both legs) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029H21B, 046821A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, the patient experienced PETECHIAE (petechiae again petechiae again on shins on the skin, not in the upper thigh, just the lower legs/ its on both legs). At the time of the report, PETECHIAE (petechiae again petechiae again on shins on the skin, not in the upper thigh, just the lower legs/ its on both legs) had not resolved.            Concomitant medications were not provided.  Treatment information was not provided.  Patient had petechiae on both legs.  Company Comment: This case concerns a 49-year-old female patient, with no medical history reported, who experienced the unexpected event of Petechiae. The event occurred on the same day after the third dose of mRNA-1273 Vaccine. At the time of the report the outcome of the event was not resolved. The rechallenge is positive since the same event recurred upon re-administration of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-407943 (Patient Link).; Sender's Comments: This case concerns a 49-year-old female patient, with no medical history reported, who experienced the unexpected event of Petechiae. The event occurred on the same day after the third dose of mRNA-1273 Vaccine. At the time of the report the outcome of the event was not resolved. The rechallenge is positive since the same event recurred upon re-administration of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
administered 7 booster doses of the Moderna COVID-19 Vaccine on 22Apr2022 from a vial expired on 16Apr2022 & had been initially refrigerated on 11Mar2022; they administered 7 booster doses of the Moderna Covid-19 Vaccine on 22Apr2022 from a vial expired on 16Apr2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they administered 7 booster doses of the Moderna Covid-19 Vaccine on 22Apr2022 from a vial expired on 16Apr2022) and PRODUCT STORAGE ERROR (administered 7 booster doses of the Moderna COVID-19 Vaccine on 22Apr2022 from a vial expired on 16Apr2022 & had been initially refrigerated on 11Mar2022) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (they administered 7 booster doses of the Moderna Covid-19 Vaccine on 22Apr2022 from a vial expired on 16Apr2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administered 7 booster doses of the Moderna COVID-19 Vaccine on 22Apr2022 from a vial expired on 16Apr2022 & had been initially refrigerated on 11Mar2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they administered 7 booster doses of the Moderna Covid-19 Vaccine on 22Apr2022 from a vial expired on 16Apr2022) and PRODUCT STORAGE ERROR (administered 7 booster doses of the Moderna COVID-19 Vaccine on 22Apr2022 from a vial expired on 16Apr2022 & had been initially refrigerated on 11Mar2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. Patient was administered with the booster dose of Moderna COVID-19 vaccine. The Date vial was initially stored in the refrigerator was reported as 11 Mar 2022. The vial did not undergo any temperature excursion. No treatment medication information provided.
product COVID 19 Treatment; product COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 05Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 15Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing). Concomitant medication(s) included: STELARA. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "product COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: It was reported that COVID 19 Treatment was provided as Paxlovid with treatment start date as 20Apr2022 and treatment stop date as 24Apr2022. adverse event COVID recurrence positive test and symptoms) 6 days after completing Paxlovid. On final day of paxlovid treatment and for several days after, I tested negative for COVID and experienced no symptoms. adverse event start date 30Apr2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a health care professional concerning a 15 month old who on 2/16/00 was vaccinated with one dose of varicella vaccine. On 2/28/00, the pt developed a rash with over 100 lesions. She was afebrile. It was unknown whether the child had been exposed to the wild-type virus. The pt sought medical attention and a physician ruled out varicella. He confirmed a diagnosis of roseola. The pt had no papules, vesicles, or pustules. No further information is available.
30 + red papules sparsely dispersed with concentration in groin, neck, axilla and trunk; dx with varicella. Received varicella vaccines on 07/29/03 & 02/02/2007.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Mild, Additional Details: After injection was administered spoke with patient and mother about waiting the 15 minutes. Returned to pharmacist station, heard mother call out, patient was laying face first in floor, went to grab epi-pen. Mother said patient fainted, she said she thought it possibly could have been a seizure because her whole body shook before she fainted. Patient said she felt like she was going to vomit, grab a trash can and the patient dry heaved a few times. While this was going on tech called 911.
RN administered a Pfizer Booster Shot without diluting  it.  Patient was observed post booster administration without any reaction.  This morning when patient came in, was assessed without any adverse reaction and asked how he feels over the weekend and claimed that he feels fine.
This spontaneous report as received from a pharmacist refers to a patient of unknown demography. The patient's concurrent conditions and relevant medical history was not reported. On 03-APR-2015, the patient was vaccinated with expired dose of ZOSTAVAX (lot number: K003601 with expiration date of 19-MAR-2015) (dose, frequency and route unspecified). Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with ZOSTAVAX was not reported. Product quality issue was not involved. Additional information has been requested.
I had a very hard time breathing that woke me up. I thought I might be having an extreme Asthma attack. I only have a Asthma attack perhaps every other year. I couldn't call out for my daughter for help & barely made it to my inhalers. I've never been so scared & close to calling 911 for help before. I had back spasms from being so tense. It took a good 5 hours before I could breathe without my back & chest hurting. 2 days later I'm now coughing up some real nasty stuff I have no idea where it came from.  I'm healthy for the most part & I'll never get another flu shot.
Patient had a seizure which consisted of both her upper and lower body convulsing.  I started talking to her and I could see her face turning dark purple.  Her eyes were shaking. Seizure lasted a little over a minute.  She had not had a seizure for about a month and has never turned purple and couldn't breathe with one before. She has not had any other adverse signs since. Followed up with Dr. on Monday and was unable to make contact. He did leave message on answering machine.  Did discuss with school nurse too.
Received Varicella vaccination on 04/25/02.  Next day, vesicles noted around injection site.  1-2 days later, rash developed on back, trunk, legs, and scalp.  Itching noted.  Restless and irritability noted that evening and for approximately three days after injection.  Rash lasted approximately 10 days.  Follow uP: no report of reaction at Prevnar site.  No prescription. Seen by pediatrician 4 days after injection and was diagnosed with a possible allergic reaction to varicella vaccine.
Redness of left arm from shoulder to 1 inch above anticubital-swelling.
Given Pneumovax left deltoid 10/21/2005 noticed redness and swelling 10/22/2005 am. Seen 10/22/2005 14 53 size 9.5 x 17 cm tender to touch. Rx given for Keflex 500mg. Atarax 25g TID Q B. 10 days.
THROAT PAIN; EAR PAIN; COUGH; CHEST PAIN WHEN COUGHING; HEADACHE; This spontaneous report received from a patient concerned a 20 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: pollen allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A and expiry: UNKNOWN) dose was not reported, administered on 26-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-DEC-2021, the patient experienced throat pain. On 14-DEC-2021, the patient experienced ear pain. On 14-DEC-2021, the patient experienced cough. On 14-DEC-2021, the patient experienced chest pain when coughing. On 14-DEC-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from throat pain, ear pain, headache, cough, and chest pain when coughing. This report was non-serious.
patient received a 3rd dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 77-year-old male patient who received Herpes zoster (Shingrix) (batch number 9Y92A, expiry date 28th June 2023) for prophylaxis.   Previously administered products included Shingrix (2 doses received on an unknown dates).   On 28th June 2022, the patient received the 3rd dose of Shingrix. On 28th June 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 1st July 2022. Reporter's Comments: The patient received 3rd dose of Shingrix. The consent to follow up was granted. Additional supportive information: The patient received 3rd dose of Shingrix, which led to extra dose administered. This case was linked with US2022101099, reported by same reporter for patient's wife.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022101099:same report, other patient
Information has been received from a licensed practical nurse via pediatric medical records concerning a 10 weeks old male with a history of cough, dacryostenosis congenital, adverse event, dermatitis, dermatitis diaper, dyspnea, gastroenteritis, lacrimination increased, mass, rhinorrhea, pyrexia, upper respiratory infection, vomiting and wheezing after exposure to GARDASIL vaccine (MSD WAES# 0809USA00346) who on 15-MAY-2009 was vaccinated with RECOMBIVAX HB (manufacturer unknown). Concomitant therapy included PREVNAR vaccine and PENTACEL vaccine. On 01-JUN-2009 the patient developed thrush. The infant was prescribed DIFLUCAN 10mg/mL, 1.5mL, by mouth everyday for 14 days. On 05-JUN-2009, the infant was seen in the office to check his weight and to discuss his feeding. The examination revealed good weight gain and that the infant was doing well. On 09-JUL-2009, the infant had a well visit and was vaccinated with PENTACEL, ROTATEQ and PREVNAR. At the time of this report the patient had recovered. Additional information is not expected. All medical records are available upon request.
Patient relates onset of oral symptoms to include itching and throat tightness approximately 30 minutes after vaccine administration, progressive over course of day, evolving into dyspnea and single episode of nbnb emesis and loose stools. Eventually presented to ED that evening at approximately 2135. Treated with IV solumedrol, epinephrine, diphenhydramine, Pepcid, and albuterol inhaler with resolution of symptoms.
I had mild side effects after SHINGRIX #1 in August 18 but significantly stronger side effects after this 2nd dose. Within 8 hours I began having a headache and muscle soreness and fatigue. Within 12 hours after the injection I began having significant joint pain and chills/shivering. It was comparable to a BAD case of influenza. I took Ibuprofen (600mg q 6 hours) which provides some relief from the muscle aches and joint pain. Maximum oral temp was 100.2.
boil to left ear; small boils to crotch area; stated that chicken cooked a certain way does not taste right; stated that his penis has gotten somewhat bigger; stated that he is getting more hair on his legs than what he has had; has not had smoothies in 3 months because he has not had the desire; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0150, Expiry date: unknown), via an unspecified route of administration on 31Mar2021 (at the age of 62 years old) as dose 1, single for covid-19 immunisation. No relevant medical history reported. There were no concomitant medications. On 11Aug2021 patient had boil to left ear, small boils to crotch area. On Jun2021 patient states getting more hair on his legs than what he had/ not really hairy and on Jul2021 patient states that chicken cooked a certain way does not taste right and penis has gotten somewhat bigger (Stated that when he gets hard, he gets hard). While unspecified date in 2021 had smoothies in 3 months because he has not had the desire. He went to get antibody and was told that he had COVID-19 in 2021. Patient went to dermatologist treatment for getting boils. The outcome of the events boil to left ear, penis has gotten somewhat bigger was recovering, of small boils to crotch area, getting more hair on his legs than what he had, chicken cooked a certain way did not taste right was not recovered, of he did not have the desire was unknown.  Follow-up attempts are completed. No further information is expected.
Employee states Sat PM 8/30/08 experienced swelling and pain in R elbow.  States elbow was reddened and tender to touch.  Denied any numbness or tingling.  States he did apply ice to area and took Tylenol.  Swelling decreased Sunday AM, but still tender to touch.  Had worked in yard and changed oil in truck on 8/30.
VARICELLA RASH FROM HEAD TO TOE STARTED ON 5/28/2007
Felt uncomfortable; headache; This is a spontaneous report from a non-contactable consumer (patient) from a Pfizer Sponsored Program. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 29Jan2021 15:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the patient got Covid-19 2nd vaccination yesterday (29Jan2021) at 3 o clock in the afternoon. After, she felt uncomfortable, not that severe headache but she took Tylenol. She researched online for 2 hours and read that they shouldn't be taking Tylenol after the vaccine. The patient wanted to know if this will affect the efficacy of the vaccine. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt recvd vax & exp a serum sickness type react consisting of joint pain, weakness &/or diarrhea; workup has included numerous tests for collagen vascular disease; has been non-diagnostic;
Contacted by patient's wife 8 days post vaccination, 2nd rabies. First vaccine given 11-6-2017, 2nd 11-13-17. Wife of patient stated on 11-17-17 patient woke up with hives, went to ED, had difficulty breathing and was given several medications and sent home. "A while later" after leaving the ED the patient's wife stated he started having the same type of reaction with weakness and difficulty walking and patient was taken back to the ED. Since patient does still have "hives off and on and puffy eyes."
On the 11th I was sore and assumed it was the work out and pulled a glut muscle. That evening I was hit with all symptoms and have been in bed the last three days Muscle aches, fever, chills, headache. Been taking Advil and hydrocodone Acetaminophen. Have had to stay in bed or the servers chills will cramp up my rib muscles
Pt received 1st dose Moderna vaccine on 2/2/21. Pt missed his 2nd dose apt on 3/2/21 and was rescheduled for 3/18/21. Vaccinator erroneously administered 2nd dose Pfizer vaccine instead of Moderna.
ATRIAL FIBRILLATION; HARDLY WALK ANYMORE; LEGS ARE SO HEAVY; This spontaneous report received from a patient via social media via a company representative concerned a patient of unspecified age, and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination. (Dose Number In Series 1). 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 an unspecified date, the patient stated that "My goodness is all this stuff everyone has really related to the vaccine? I have AFIB (atrial fibrillation) all of a sudden and my legs are so heavy I can hardly walk anymore! I couldn't figure out where all that came from!!". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the atrial fibrillation, heavy legs and can hardly walk anymore was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211222396-covid-19 vaccine ad26.cov2.s-atrial fibrillation. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Father of child woke to child jerking, unresponsive, didn't respond to father's attempts to wake - shaking continued < 1 min., child was then limp, incontinent of stool, urine. Child taken immediately to ED. Child awoke approx. 1-1 1/2 min after dad awoke to shaking but did not return to normal for approx 2 min.