chrisvoncsefalvay/vaers-outcomes huggingface dataset:
receiving the second dose after the 28 days; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (iving the second dose after the 28 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (iving the second dose after the 28 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (iving the second dose after the 28 days) had resolved. Not Provided      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 concomitant medication was reported. No treatment was reported.
Information has been received from a registered nurse concerning a child who was vaccianted with a dose of varicella virus vaccine live. Subsequently the child developed breakthrough varicella. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
This spontaneous report was received from a medical assistant refers to a 17 year old male patient. Concurrent conditions, medical history and allergies were not reported. On an unknown date in 2014, the patient was vaccinated with the first dose of GARDASIL, (strength, dose, lot number and expiration date were not reported), route reported as "injection". It was reported that immediately following each of the two first doses of GARDASIL on an unknown dates in 2014, the patient experienced fatigue and injection site hypoaesthesia for 24 hours. The patient sought medical attention through contacted the clinic and no treatment was given for the adverse events. On an unspecified date, the patient decided to discontinue the GARDASIL series after the second dose and decided not to receive the third dose. The outcome of fatigue and injection site hypoaesthesia after each of the first two doses of GARDASIL series was reported as recovered/resolved on an unknown dates in 2014 after 24 hours. Additional information has been requested.
rapid pulse; bloody nose; itchy around mouth and chin; very achy; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (rapid pulse), EPISTAXIS (bloody nose), PRURITUS (itchy around mouth and chin) and PAIN (very achy) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (rapid pulse), EPISTAXIS (bloody nose), PRURITUS (itchy around mouth and chin) and PAIN (very achy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (rapid pulse), EPISTAXIS (bloody nose), PRURITUS (itchy around mouth and chin) and PAIN (very achy) outcome was unknown.            Concomitant medications were not provided.
pt recvd vax 19JAN93 & 4PM & 22JAN had runny nose; 23JAN didn't eat well; 24JAN acting rather strangely; while in church passed alot of gas & screaming; loose & strange looking stools; restless; Would nap a short bit; up @ noc; SIDS;
This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 16-NOV-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L018501, expiry date-22-JUN-2017) (dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Vaccine that administered beyond use date after the thaw process/expired vaccine administered; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     It was unknown if patient ever been diagnosed with or tested positive for COVID-19. It was unknown if patient had acute illnesses at the time of vaccination and up to one month before. Unknown if patient had Chronic or long standing health conditions.     On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 32 years and 9 months.   It was unknown that prescriptions, over the counter medications, dietary supplements, or herbal remedies being taken at time of vaccination or at the time of the adverse event.  It was reported that vaccine was administered beyond use date to patient. There was no adverse reaction noted or reported regarding these administrations.  No treatment medications were reported.
1" X 1" indurated lump on upper left deltoid, warm and tender to touch.
Day 1 - Dizziness Day 2 - Left Arm sore, throat sore, headache, joints ache, body ache, high fever then only went down to 101.4 continual for over a day. Day 3 - Left Arm sore, throat sore headache, joints ache, fever controlled by Advil/Tylenol mix.,  ...Still in the process
Itchy red rash diagnosed as Dermatographism that appeared roughly 2 weeks after Moderna Covid-19 booster injection.  Rash appeared on torso, neck, groin, arms, and legs in response to touch.  No previous history.
Rash associated with shingles meds given Lidocaine Gel 2%, Acyclovir 200mg.
Case previously recorded as MA2009-6289. Initial case report received via MedCom from a physician on 25 NOV 2009: A 3year-old female child, was vaccinated with 0.5 ml of S-OIV FLUVIRIN (batch no. 102041P1) i.m. on 25 NOV 2009. No adverse event was reported. Rev. no.: NA09-008864.
Insomnia; Chills; This is a spontaneous report from a non-contactable healthcare professional, the patient. This 77-year-old male reported that he received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En5318) via an unspecified route of administration in the left arm on 05Feb2021 at 02:30 (as reported) (at the age of 77-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications were not specified. The patient experienced insomnia onset at day 8 then thru day 14 and chills day 10. The patient was not treated for insomnia and chills. The clinical outcome of insomnia and chills was recovering.   No follow-up attempts are possible. No further information is expected.
Mother called the health dept because  was to bring infant for accelerated schedule stated that child had a reaction form last vaccines a month ago. Stated child cried for more than 3 hours, but thought it was because the child was teething. Stated she finally took a bottle and fell asleep during the night, but when the child awaken she had a blank stare and did not respond to verbal stimuli and had jerky movements of hands and feet. Took infant to the emergency room and was given Motrin. Stay there and the child was better. The ER physician stated that the reaction was from the vaccines. Is to see own physician per request.
COVID Booster; Fever; Chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4466102.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer, dose number unknown.), for covid-19 immunisation. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "COVID Booster"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; CHILLS (non-serious), outcome "unknown", described as "Chills".  The lot number for bnt162b2 was not provided and will be requested during follow up.
The patient is a 12 month old male who presents with a possible food allergy. Note for "Food allergy": patient has egg allergy by skin testing. He is therefore receiving split dose flu vaccine today via routine protocol of 0.05cc PF vaccine, followed 30 min later by 0.20cc. He has not had any accidental egg ingestion. He is avoiding all nuts. He is able to eat oat w/o any reaction and has been for a few months. He was eating Cheerios in office today. Mom hasn't tried feeding him carrot yet - was thought to have hives around mouth w/ carrot several months ago. She wonders if she can retry it. His younger brother is allergic to raw carrots and raw apples but can eat them cooked (typical OAS). Has never had a flu vaccine, but has had his other routine vaccinations thus far w/o any trouble.
JB experienced tingling in the head region, states that he had a rash and had a blister on his lip.; rash; had a blister on his lip.; This case was reported by a pharmacist via sales rep and described the occurrence of tingling in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number AP257, expiry date 26th November 2021) for prophylaxis.   On 3rd September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced tingling, rash and lip blister. On an unknown date, the outcome of the tingling, rash and lip blister were unknown.   It was unknown if the reporter considered the tingling, rash and lip blister to be related to Shingrix.  Additional details were provided as follows: The patient experienced tingling in the head region, states that he had a rash and had a blister on his lip. The reporter agreed to follow up.
Mom called 2 days after child received DtaP in left thigh to report that child's left thigh was larger than right one. Reported that leg was swollen from his "knee up" and was about 1 1/4th to 1 1/2 times the size of the right one. Denies elevated temperature or any other involvement other than tenderness and redness. Mom was instructed to give Tylenol/Advil for tenderness, monitor for worsening of symptoms and to report event to physician at next ofice visit or sooner if does not resolve. Mom verbalized understanding and agreement.
pain at the site of injection on her left arm; swelling at the site of injection on her left arm; redness at the site of injection on her left arm; warmth at the site of injection on her left arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (pain at the site of injection on her left arm), VACCINATION SITE SWELLING (swelling at the site of injection on her left arm), VACCINATION SITE ERYTHEMA (redness at the site of injection on her left arm) and VACCINATION SITE WARMTH (warmth at the site of injection on her left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included PHENOBARBITAL and METHIMAZOLE for an unknown indication.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain at the site of injection on her left arm), VACCINATION SITE SWELLING (swelling at the site of injection on her left arm), VACCINATION SITE ERYTHEMA (redness at the site of injection on her left arm) and VACCINATION SITE WARMTH (warmth at the site of injection on her left arm). At the time of the report, VACCINATION SITE PAIN (pain at the site of injection on her left arm), VACCINATION SITE SWELLING (swelling at the site of injection on her left arm), VACCINATION SITE ERYTHEMA (redness at the site of injection on her left arm) and VACCINATION SITE WARMTH (warmth at the site of injection on her left arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided   Reporter did not allow further contact
Dr. diagnosed it as an allergic reaction; RASH ON THE ARM / covered her entire left arm; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 1st dose of Shingrix. In November 2020, 2 days after receiving Shingrix and an unknown time after starting Zyrtec, the patient experienced allergic reaction and rash. The patient was treated with cetirizine hydrochloride (Zyrtec). On an unknown date, the outcome of the allergic reaction was unknown and the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the allergic reaction and rash to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient received 1st dose of Shingrix in unknown arm. After receiving 1st dose of Shingrix, the patient experienced rash covered her entire left arm. The doctor diagnosed it as an allergic reaction. The rash disappeared after one week. The patient reported all possible side effects. The patient became frustrated with the collection of demographics and hung up the phone before transfer to the product team. The patient did not give permission to contact their doctor.    The reporter did not consent to follow up.
Information has been received from a 71 year old male physician who on 06-SEP-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  It was reported that after vaccination the patient developed 2 large red lesions.  One lesion was on the stomach area and the other was at the injection site.  The lesions then developed into smallpox.  At the time of report the patient had not recovered.  A product quality complaint was not involved.  Additional information has been requested.
2 doses of the Moderna COVID-19 vaccine and got COVID; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (2 doses of the Moderna COVID-19 vaccine and got COVID) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (2 doses of the Moderna COVID-19 vaccine and got COVID). At the time of the report, COVID-19 (2 doses of the Moderna COVID-19 vaccine and got COVID) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported by the reporter.  Company Comment: This spontaneous case concerns a male patient, of unknown age, with no medical history reported, who experienced the unexpected, non-serious AESI of COVID-19 after administration of the second dose of the Moderna mRNA-1273 vaccine on an unspecified date. The start date of the event was not provided. No further details were provided. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.   This case was linked to MOD-2021-414601 (Patient Link).; Sender's Comments: This spontaneous case concerns a male patient, of unknown age, with no medical history reported, who experienced the unexpected, non-serious AESI of COVID-19 after administration of the second dose of the Moderna mRNA-1273 vaccine on an unspecified date. The start date of the event was not provided. No further details were provided. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.
Cornea transplant rejection; inflammation/subepithelial infilatrates noted 1 week after the first vaccine; This is a spontaneous report from a contactable Physician (patient). A 62-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number EK9231, via an unspecified route of administration on 28Dec2020 14:30 at single dose in Left arm for COVID-19 immunization, vaccinated in Hospital. Medical history included diabetes; Graft is 2.5 years old. Partial thickness transplant (deep anterior lamellar keratoplasty) for treatment of keratoconus. The patient didn't have COVID prior vaccination. Concomitant medications included trazodone, rosuvastatin calcium (CRESTOR), zolpidem tartrate (AMBIEN), gabapentin, metformin. The were no other vaccines in four weeks. The patient previously took buspar and experienced drug allergy. The patient experienced cornea transplant rejection. Signs of inflammation noted one week after vaccine on 04Jan2021 02:00 PM. Subepithelial infilatrates noted 1 week after the first vaccine. Resolved with Pred Forte. The patient didn't have COVID test post vaccination. The outcome of the events was recovered. The temporal relationship with the COVID vaccine was reconstructed by the patient afterwards after thinking about it in retrospect.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
I had the first two COVID shots and the first booster, all made by Pfizer. I had ZERO symptoms from those shots. I decided to get the second booster and pharmacy told me to take the Moderna Bivalent.   In six hours I was feeling pain in my arm and back. It progressed down my spine and neck, both arm, and hips.  I could barely move, even my hands.  My legs could move, but I could not trun my body and it was agonizing.  I had a fever, chills, and was soaked in sweat.  I was literally thinking this was the end for me.  I am a strong person and kept telling myself this will pass. The pain lasted two days and today is the fouth day and the pain is completely gone, but I am exhausted as I did not sleep and could not move.    This was the worst suffering I ever had and will never take another vaccine.
This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 58-year-old male patient who received SHINGRIX (batch number EK279, expiry date 31st March 2020). On 2nd March 2018, the patient received SHINGRIX (intramuscular) .5 ml. In February 2018, several days after receiving SHINGRIX, the patient experienced muscle pain, influenza-like symptoms and pain. On an unknown date, the outcome of the muscle pain, influenza-like symptoms and pain were recovered/resolved. It was unknown if the reporter considered the muscle pain, influenza-like symptoms and pain to be related to SHINGRIX. Additional details were provided as follows: Few days after receiving SHINGRIX, the patient experienced flu like symptoms, muscle aches and pain. The events lasted for 3 days.
suspected vaccination failure; got the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 8 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. 8 months after receiving Shingles vaccine, the patient got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization and laboratory confirmation of shingles were not provided.
PATIENT REPORTS THAT HE DEVELOPED CERVICAL ADENOPATHY WITHIN 24-48 HOURS FOLLOWING RECEIVING ANTHRAX#1. LYMPHADENOPATHY CONTINUED FOR SEVERAL MONTHS.
Fever = up to 101 began AM 10/12/07 through 10/14/07 red rash began evening of 10/12/07 covering entire body, with red blotchy areas on face rash persists on 10/15/2007. Dx 10/16/07 = chickenpox = by physician
Information has been received from a registered nurse, via a company representative, concerning the nurse's daughter (age not specified), who was vaccinated (date not specified) with the first dose, 0.5 ml, of GARDASIL (lot # not provided). Following the vaccination, her daughter fainted. At the time of this report. The outcome of the event was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Reporting a vaccine administration error. The vaccine given was past it's Beyond Use Date by 20 days. Spoke with both Pfizer and CDC and recommendation was made that child be re-vaccinated. No wait period needed. Patient's father stated no adverse reaction was noticed.
About 7 to 8 days after receiving first dose patient started breaking out in rash in armpit area towards breast then to her back. She did follow-up with primary care and was diagnosed with shingles. She is recovering although delaying 2nd dose.
About 45 minutes after the vaccine was given I developed numbness and tingling on the left side of my face, from my lower cheek to my eyebrow, including half of my nose. The  symptoms started improving slowly a day later and were gone about 2-3 days later.