chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It was reported that a male pt received a Fluzone UNSP '99-'00 vaccination on 10/25/99. Reportedly, sometime post vax, the pt experienced intestinal problems consisting of diarrhea and cramps. The pt was evaluated by a physician and underwent a barium colon enema on 12/8/99.
Post covid vaccine, patient is feeling like her throat is "tight."  Denies any tongue swelling or difficulty breathing. Has allergies to RUM.   Vitals:   04/14/21 0936 Resp: 16 SpO2: 98%   Anterior and posterior lung fields clear without any respiratory distress. Benadryl 25 mg po given. monitored longer than over 1 hour.
I started developing a very itchy rash on my arms has since spread to my chest legs neck face and has gotten worse by the day; I started developing a very itchy rash on my arms has since spread to my chest legs neck face and has gotten worse by the day; I started developing a very itchy rash on my arms has since spread to my chest legs neck face and has gotten worse by the day; This is a spontaneous report from a contactable consumer (patient).   A 32-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0186), via an unspecified route of administration, administered in right arm on 03Jun2021 15:30 (at the age of 32 years) as dose number unknown, single for COVID-19 immunization. The patient's medical history included multiple sclerosis. The patient's concomitant medications included methadone (METHADONE). The patient previously took vancomycin, tramadol, Darvocet, Vicodin and had allergies. The patient did not take other vaccine in four weeks. The patient did not have COVID prior vaccination. The patient did not test for COVID post vaccination. Patient was not pregnant at the time of vaccination. On 07Jun2021 02:00 (about 4 days after vaccine) the patient developed a very itchy rash on her arms, has spread to her chest, legs, neck, face and has gotten worse by the day. The patient did not receive any treatment for the events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
COVID test Positive; COVID test Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, on 30Mar2021 at 15:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 27Apr2021 at 15:00 as dose 2, single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies penicillin" (unspecified if ongoing), notes: known allergies penicillin. Concomitant medication(s) included: SIMVASTATIN; OMEPRAZOLE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID test Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Nasal Swab.  Clinical Information: Patient received no other vaccine in four weeks. Other medications in two weeks included simvastatin, omeprazole and multivitamin. Patient had no COVID prior vaccination. The patient was COVID tested post vaccination.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
PATIENT COMPLAINED DURING HER FLU VACCINATION ON 10/13/2020 THAT AFTER HER VACCINATION LAST YEAR ON 10/11/2019 HER ARM BECAME TOO SORE TO MOVE.
Vaccine inadvertantly administered to patient less than 18 yrs of age; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine inadvertantly administered to patient less than 18 yrs of age) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine inadvertantly administered to patient less than 18 yrs of age). On 23-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine inadvertantly administered to patient less than 18 yrs of age) had resolved.        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 use was provided by the reporter.  No treatment of events was reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: ADR form was received and the following information was updated: Reporter information, patient Dose one lot number and vaccine date.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (15 year old male) for mRNA-1273 (lot number unknown) with no associated AEs reported.
a severe rash; This is a spontaneous report from a contactable consumer. A 74-year-old male consumer (patient himself) reported that he received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via an unspecified route of administration on an unspecified date, at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. Seven days after vaccine administration the patient developed a severe rash. He did not think it was an allergic reaction because it did not occur right away after receiving the vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Employee received second dose of the Hep B series today (02/08/2019) around 9:30 AM. Per employee, she felt nauseous, lightheaded, and felt her face hot after lunch, which was around 10:30AM. Upon assessment, employee's face was flushed. Vital signs: BP-110/71, Pulse-81, Resp-18 RA, Temp: 98.7. Vital signs taken at 11:55AM. BENADRYL 50MG by mouth given x 1. Health management services was contacted immediately and suggested to send employee to see doctor for further evaluation.
Muscle soreness; Headache; Diarrhea; Tiredness; Swollen lymph nodes in armpit; This case was reported by a consumer via call center representative and described the occurrence of muscle soreness in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number N3755, expiry date 26th June 2023) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose was received on Jun 2022, refer case US2022AMR142462).   On 3rd October 2022, the patient received the 2nd dose of Shingrix. On 4th October 2022, 1 days after receiving Shingrix, the patient experienced muscle soreness, headache, diarrhea, tiredness and axillary lymph nodes enlarged. On an unknown date, the outcome of the muscle soreness, headache, diarrhea, tiredness and axillary lymph nodes enlarged were not recovered/not resolved.   It was unknown if the reporter considered the muscle soreness, headache, diarrhea, tiredness and axillary lymph nodes enlarged to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR142462   Additional Information: GSK Receipt Date: 04-Oct-2022 Reporter's comment: The patient self-reported this case. The patient received the second dose of Shingrix and experienced muscle soreness, headache, diarrhea, tiredness, and swollen lymph nodes in armpit.  The reporter consent to follow-up.; Sender's Comments:  US-GSK-US2022AMR142462:Same reporter
Flare up of gout began about 32 hours post vaccination  No idea if this is related to the vaccine or not but thought I should report it.  I know that there have been reports of gout flares due to other vaccines such as shingrex
The patient came to clinic to receive his second Pfizer vaccine on 4/2, which was the date indicated on his hand written appointment card. His first dose was 3/19 and he was scheduled for 4/9, however his hand written card said 4/2. An appointment was made for him on 4/2 when he came in that day and the patient was vaccinated with his booster dose 2 weeks after his prime dose. This was one week early.
Redness and itchiness down the lateral and mediolateral aspect of the right upper arm and bruising with firm induration at injection site.
Within a month of receiving the vaccines, the pt became a very extreme toe walker and began to exhibit impulsive behavior. There were no illnesses or medications given during this time. We are now attempting to treat behavior and toe walking with physical therapy, occupational therapy, and braces, but so far there has been no improvement. A follow up report received 8/1/2000 adds: (5/25/00) Call back from mother of pt - child has not improved as yet with PT, OT and speech therapy - no definite diagnosis except "Hypotenia".
I first noticed that I was extremely cold and could not get warm at about 11 pm on the evening of my vaccine. I then realized it was getting worse, and I was shivering uncontrollably despite sitting in front of a space heater in warm clothing and wrapped in a blanket. I checked for a fever, but my temp was only 99. I fell asleep around 1 am, and woke up at 5 am (3/8/21) to a splitting headache, extreme thirst, slight nasal congestion, muscle soreness, fatigue, and nausea. These symptoms feel almost identical to the symptoms I experienced when I contracted COVID-19 in September 2020 at my university.
Blotchy red facial rash x a few hrs, itching, t97.7, 96, 20, BP200/120 (pt is quadriplegic & has inc autonomic reflexes; indurated area @ inject site still present;
FEELING LIGHTHEADED WHEN SHE STANDS. REPORTS NEAR SYNCOPE UPON STANDING AND GUIDED HERSELF DOWN WHILE HOLDING A PLATE THAT DID NOT BREAK. REPORTS SLIGHT RIGHT SIDED HEADACHE DESCIRBED AS ELECTRICTY ONLY. NO CONFUSION. NO SPEECH CHANGES. WAS READING WSJ OUTLOUD TO DETERMINE. I ADVISED HER TO GO TO THE NEAREST EMERGENCY ROOM FOR EVALUATION AS I COULD NOT ATTRIBUTE HER SYMPTOMS TO VACCINE ADR. RESTING IN BED TO HELP ALEVIATE SYMPTOMS. NO MEDICATIONS. 5/2-Called the home and there was no answer, 2nd attempt. Message was left to call the Covid hotline for further follow up.
Patients received 0.25ml of Bivalent Moderna COVID-19 vaccine instead of 0.5 ml; No Adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Patients received 0.25ml of Bivalent Moderna COVID-19 vaccine instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination. No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patients received 0.25ml of Bivalent Moderna COVID-19 vaccine instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patients received 0.25ml of Bivalent Moderna COVID-19 vaccine instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.    For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patients received 0.25ml of Bivalent Moderna COVID-19 vaccine instead of 0.5 ml).    No concomitant medications were reported. It was reported that none of the patients were pregnant. Vaccination date was reported as 01-SEP-2022 to 26-OCT-2022. No treatment drug details were reported. This case is reported for 4th patient out of 20 patients.
This is a spontaneous report received from a contactable reporter(s) (Nurse). A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jul2021 as dose 1, single (Batch/Lot number: unknown) and on 26Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "COPD" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "HTN" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "Depression" (unspecified if ongoing); "IBS" (unspecified if ongoing); "OSA" (unspecified if ongoing). The patient had no known allergies. Concomitant medication(s) included: Albuterol [Salbutamol]; Buspirone; Diazepam; Duloxetine; Gabapentin; Hydroxyzine; Levothyroxine; Mirabegron; Modafinil; Tribenzor; Omeprazole; Crestor; Zolpidem. The patient received other medication in two weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid from 24Aug2022 to 29Aug2022 via oral route of administration for the treatment of COVID-19. Clinical course: The patient states she started Paxlovid the night of 24Aug2022 and took her last dose the morning of 29Aug2022. The night of 29Aug2022 she turned pale, had 1 episode of vomiting, felt extremely lightheaded, and was disoriented. By disoriented, patient reports that she was talking but could not hear herself. The patient's Husband reported that she kept repeating statements. The patient's Husband reports that it took a couple of hours before her color returned, clamminess resolved, and she stopped repeating herself. The reporter stated that the patient was seen by me on 30Aug2022 with persistent lightheadedness and nausea that were improving. The adverse event start date reported as 29Aug2022 18:00. Adverse event was not resulted in physician office or emergency room visit. The patient was recovering. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and the suspect drug BNT162B2.
Pt recvd 2nd dose of vax 16APR92 & inject site became sl swollen & itchy; prescription med was not neccessary because the exp was considered to be mild in nature;
Injection site was red, painful, edematous, hot to the touch in a circle approximately three inches in diameter approximately 24 hours after administration.
AE(s) following prior vaccinations: No, just tiredness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications.  The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "AE(s) following prior vaccinations: No, just tiredness".  Additional information: Route, Anatomical Location: Shoulders, left and right she would rotate. Concomitant Medications: No, she just takes her normal medications. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): none.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
squeamish p/1st shot-asked to be seated to recv inj-dizzy c/o faint-BP /pulse WNL became agitated;paranoia dilated pupils;pt fearful of dying;in ER 203 hr d/c no tx;
no symptomatic side effects/No additional AE; administration of improperly stored PROQUAD; This spontaneous report was received from a nurse and refers to a 4-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 31-MAY-2023, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection, 1 dose, 0.5 ml, lot # X011437, expiration date: 18-JUL-2024, administered for prophylaxis (route of administration was not provided) (product storage error).   No Previous temperature excursions. No additional adverse events (AEs) were provided.
Patient with 2 Pfizer vaccinations who died in ED with positive COVID test on same day as death.  Patient presented with fatigue, shortness of breath, and a ground level fall without loss of consciousness.  He was hypoxic in the 80's and in afib with RVR.  He became unresponsive and had chest compressions which were stopped after 30 seconds due to return of pulses.  Patient did not return to consciousness and family requested DNR with no escalation of care.  Patient died shortly after on 12/15/21.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a infant patient who received Hib (Hiberix) (batch number 242A7) for prophylaxis.   On 30-JAN-2023, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
within 24 hours - chills, body tremors, fatigue, malaise within 36 hours -  right eye tearing within 48 hours - prodromal skin burning and itching around right eye and face day 3 - vesicular rash from inferior right eye to lateral right eye including lower eyelid and upper cheek. facial edema and redness from right cheek to lower eyelid and to right jaw, up to right lateral head(lateral to R eye) day 4 - diagnosed with shingles at urgent care, prescribed valacyclovir.  increased facial and periorbital edema. day 5-6 - peak of symptoms so far day 7 - Ophthalmologist confirms infection, appears to be on skin only.  edema is reducing, sores are crusting.
This spontaneous has been received from a medical assistant, concerning 3 patients' of unknown age and gender. The patients' concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported. On an unknown date, 3 patients received unspecified dose of ROTATEQ (lot # N030996 and expiration date 08-SEP-2019), taken orally as prophylaxis. Those vaccines were improperly stored after initial excursion in September 2018 (Product storage error). The temperature excursion was 48.4 Fahrenheit (F), time frame: 25 minutes; and previous temperature excursion was 33.8 F for 61 minutes. The excursion call was made by a data logger. No adverse effects reported. This is a non-valid case due to the lack of a patient identifier.
Soreness at the injection site; Her arm was red; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On 9th November 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced injection site pain and erythema of extremities. On an unknown date, the outcome of the injection site pain and erythema of extremities were unknown.   It was unknown if the reporter considered the injection site pain and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of shingrix and experienced Injection site soreness and next day arm redness. No other information was available. The reporter did not consent to follow up.
12 months 7 days male, here for his 1 year vaccines. I mistakenly administer patient Tdap (BOOSTRIX) instead of his 4th Dtap. Patient tolerated vaccines well, patient kept for 10 to 15 minutes after administration of vaccines for observation of any allergic reactions or side effects. Patient discharged with father awake and alert.
7 days after initial varicella injection developed rash on left arm (encircling upper arm)- Rash consistent on varicella and zoster- Also reports zoster on left chest in dermatome distribution. Now has residual scarring.
Hives and intense itching for hours I took Zyrtec and Benadryl for 48 hrs as I continued to itch and will still have random itching.
Physician discharge summary: Admit date: 7/12/2022. Discharge date: 7/16/2022. Hospital course: Patient came in with chest pain. EKG confirmed inferior lateral MI. Patient taken emergently to the cath lab for LHC with left groin access where she received PCI to RCA with plans for staged PCI to LAD as an outpatient. Will require aspirin and Brilinta at discharge. Also started on statin, BB, ACEI. Of note, patient was already positive for COVID-19 when she came in. Pulmonology consulted for management. During her stay, she developed ventricular tachycardia requiring amiodarone. She also developed superficial thrombosis to right forearm requiring Lovenox. Patient is going home on Eliquis for this. Nursing staff confirmed with pharmacy and insurance that Eliquis will be covered 100%. Patient is now stable and cleared for discharge by hospitalist, as well as, pulmonology. Patient consult with doctor in 2 weeks for follow-up on medications and plans for future PCI of LAD. Discharge condition: Good.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date beyond the recommended date in the vaccination schedule, the patient was vaccinated with the second dose of GARDASIL (dose, route of administration, lot # and expiration date were not reported). There was no adverse effect reported. The nurse practitioner asked when should the patient receive the third dose of GARDASIL. Additional information has been requested.
This spontaneous report as received from a licensed vocational nurse (L.V.N) refers to an unspecified number of patients of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dose, route, lot# and expiration date unknown). On an unknown date the patients received a second or third dose GARDASIL late, due to patients not showing up for appointments. No adverse effect reported. Additional information has been requested.
Patient texted a friend on 2/7/2021 c/o arm pain and feeling tired. I don't know if he was taken to a hospital.  Autopsy today.