chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt appeared to have a change in level of consciousness post MMR inject w/eyes rolled back & muscle spasms that occur about 30 seconds; voided involuntary & hard to arouse;
It started as excruciating and severe abdominal pain when I eat. it does not happen during the day, just when I eat. Its an ulcerative colitis flare up. Its lasted about a week but now I seem to be getting better.
hives; Per mother of the patient he has rash break out all over his body (Rash and itching); Information has been received from a nurse, referring to 12 years old a male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 18-MAR-2021 early in the morning (discrepant information also reported as 08-MAR-2021), the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly (anatomical location, lot number and expiration date were not reported) for prophylaxis. Per nurse he had no issues with the first dose of the vaccine.      On the same date, the patient experienced a rash break out all over his body (rash and itching) and hives. The patient was not admitted to the hospital, just treated with predsione for 5 days by the emergency department and then was discharged.  The outcome of hives and rash pruritic was reported as resolved informed as "the patient is fine now".       The casuality assessment between the vaccination with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the aforementioned events was not provided.
Area around injection site red & bumpy on R/th where varicella given. BENADRYL prn.
have not received the second shot because of the pandemic; This case was reported by a consumer via call center representative and described the occurrence of social problem in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not applicable for this report. The age group was not reported but was captured as an adult as per vaccine indication. Till the time of reporting, patient did not received 2nd dos of Shingrix, due to pandemic. No further information was reported.
Didn't feel well; 1st shot 2 years ago, didn't feel well so didn't go back for 2nd; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient did not receive the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date,  unknown after receiving Shingrix, the patient experienced feeling unwell and incomplete course of vaccination. On an unknown date, the outcome of the feeling unwell and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.     Additional Information: GSK receipt date: 1-Feb-2023 Reporter's comment: The patient received 1st shot 2 years ago and did not felt well for several weeks afterward  the patient did not go back for the second shot. (Also, the COVID shots were coming out and was focused on getting those). The patient asked that he/she should get 2nd shot this long after the 1st one. Additional supportive information: Till the time of reporting, the patient did not receive 2nd shot of Shingrix, which led to incomplete course of vaccination. The follow-up could not be possible as no contact details were available.
pt recv vax 15AUG95 & became pregnant (LMP 22JUL95) & in SEP95, nine wk p/LMP, pt elected to terminate pregnancy;
Initial report received from a Healthcare professional on 06 February 2014. A 28-years-old female patient, whose medical history and concomitant medications were not reported, had received subcutaneous dose of YF-VAX (batch number: UH674AA) in right deltoid on 30 January 2014, had received VIVOTIF (manufacture: Other, batch number: 3000691) orally, on 30 January 2014. On 30 January 2014, the patient presented injection site soreness, redness and swelling. Corrective treatment and laboratory data were not reported. As of 06 February 2014, the patient had not recovered from the event. Documents held by sender: none. Follow up information was received on 03 April 2014: The patient received YF-VAX in to the right upper arm and not in to the deltoid right as reported as earlier. It was updated that the event was informed on a phone call. This case is linked with the case number 2014SA016136 and 2014SA016153.
Headache, Rash, body aches, chills Narrative:  Pt reported body aches, headache, chills, rash from chin to neck/bck/chest/legs onset two wks after 1st dose vaccination (redness at injection site on 2/1/2021), but worse effects occurred after 2nd dose given on 2/2/21 listed. Pt required medical intervention. Pt was prescribed antibiotic, antihistamine and steroids (oral & injectable). Pt recovered. Pt did not supply specific medications taken for treatment.    Other Relevant History:
patients received the vaccines after the beyond use date/10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13DEC2022-17DEC2022; No Adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received the vaccines after the beyond use date/10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13DEC2022-17DEC2022) 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)) (batch no. 024H22A) for COVID-19 prophylaxis.     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) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received the vaccines after the beyond use date/10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13DEC2022-17DEC2022) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients received the vaccines after the beyond use date/10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13DEC2022-17DEC2022) and NO ADVERSE EVENT (No Adverse event) outcome was unknown. Not Provided      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 EXPIRED PRODUCT ADMINISTERED (patients received the vaccines after the beyond use date/10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13DEC2022-17DEC2022).    Concomitant medications were not reported.  They reported their beyond use date was on 12Dec2022 but they discovered it on 17Dec2022. This case contains information for the patient 3 out of 10 adult patients. Treatment medications were not reported.
The vial was stored in the refrigerator on 04 JUN 2023 after expiration date 11 MAY 2023 and Dose administered to patient on 5 JUN 2023; No adverse event; Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04 JUN 2023 after expiration date 11 MAY 2023 and Dose administered to patient on 5 JUN 2023) 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)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04 JUN 2023 after expiration date 11 MAY 2023 and Dose administered to patient on 5 JUN 2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04 JUN 2023 after expiration date 11 MAY 2023 and Dose administered to patient on 5 JUN 2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023) and PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04 JUN 2023 after expiration date 11 MAY 2023 and Dose administered to patient on 5 JUN 2023).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. It was reported that no adverse reactions have been reported by any patients. The vial was initially stored in the refrigerator on 4-JUN-2023 and did not underwent any temperature excursions. No treatment medication was reported. This case was reported for patient 7 out of 50 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:Master case
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 02-SEP-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # L007720 Expiration date: 08-JUL-2016, 0.5 ml (route and anatomical location of administration were not reported). The sum of hours in excursion was 32 hours and the lowest recorded temperature was 34 Fahrenheit (F) (1.111111111 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
4/8/03 C/O CHEST PAIN STARTING ON 4/2/03, STATES SHOOTING PAIN DURING THE DAY TIMES 2-3 TIMES A DAY.  EASES AT NIGHT.  LAST PAIN WAS 4/6/03.  REFERRED TO PMD FOR F/U AND EVALUATION PER PHN.
Information has been received from a pharmacy intern referring to a patient of unknown age and gender. There was no information about medical history or concurrent condition. On 31-JUL-2017, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # M015926, expiration date 28-JUN-2017) (dose and route unknown), which was reconstituted with non-expired sterile diluent (manufacturer unknown) for prophylaxis. No adverse effects were reported.
Janssen COVID-19 Vaccine EAU started with a mild headache, to more severe by end of day. I?m on day 5 of headache and ringing in ear. Also sound is muffled. Left arm is extremely sore and swollen. Hurts to raise it. Slight tingling in left arm to wrist. Diarrhea a little.
diarrhea; Fever; Chills; Headache; Groggy; Body ache; This is a spontaneous report from a contactable other health care professional. A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 21Feb2021 11:30 (Batch/Lot Number: EN6200) as single dose for covid-19 immunisation. Medical history included spinal stenosis, rhinitis, Intermittent asthma and allergies to almonds, peanuts, and hazelnuts. Concomitant medication included estradiol (ESTROGEN), ibuprofen and levocetirizine dihydrochloride (XYZAL). The patient experienced fever, chills, headache, groggy and body ache on 22Feb2021 at 15:00 and diarrhea on 23Feb2021. Outcome of the events was recovered on an unspecified date.  No follow-up attempts are needed. No further information is expected.
Right arm swollen redness hot to touch- vesicular pimple. Cultured site, antihistimine, antibiotic given.
This spontaneous report as received from a certified medical assistant via a company representative who learned of this event refers to a female patient of unknown age who was a retired nurse. In 2014 (reported as a few week ago) the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose, frequency and route unspecified). The patient experienced an unspecified injection site reaction after receiving ZOSTAVAX a few week ago in 2014. The outcome of the event was unknown. Additional information has been requested.
Irregular sense of smell- most food smells like rotten meat, artificial scents smell sickly sweet (overripe pineapple smell)  Abnormal menstruation- menses cycle reduced to 21-22 days.  Prior to vaccine, menses were a predictable  27 days.
HIGHER BLOOD PRESSURE THAN NORMAL; LOWER HEART RATE THAN NORMAL; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced higher blood pressure than normal, and lower heart rate than normal. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 140s/90, and Heart rate (NR: not provided) 50s bpm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from higher blood pressure than normal, and lower heart rate than normal. This report was non-serious.
Per client states she had pain and was unable to move her left arm after receiving the vaccine. She need to go to the Chiropractor for an adjustment. Client still having some pain in left shoulder.
experienced a sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient's domestic partner reported that they experienced a sore arm after receiving the 1st dose of the Shingrix vaccine. The reporter did not consent to follow-up. This case was linked with US2020229497, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020229497:same reporter
headache; neckache; chest discomfort; BP was still elvated; elavated my Creatine Kinase CK Level; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 69-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 25Feb2021 09:30 (Batch/Lot Number: EN6198, Expiry date was not reported) (at the age of 69-years-old) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient did not have covid prior to vaccination and covid was not tested post vaccination. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 28Jan2021 09:30 (Batch/Lot Number: EN5318, Expiry date was not reported) covid-19 immunisation and experienced headache, sneezing and nosebleed. On an unspecified date, the patient experienced headache, neckache, chest discomfort, bp was still elevated and elevated my creatine kinase (ck) level (on 28Jan2021 09:45). Laboratory tests on an unspecified date included blood pressure measurement: 170/83 and blood creatinine was elevated. It was reported that 20 mins after shot felt diff and headache started, neck, my left shoulder and arm. At home she took 650mg of Tylenol, 2:15pm a 15 min sneezing fit, stopped up nosebleed, Head and neck became worse and foggy in judgement. 10pm laughing and crying fit for over 60 mins until I fell asleep. nose Headache continued for 25 days 24/7 Pain levels 6 & 7. 2 headache and feeling different, neckache, shoulder arm, backache, chest discomfort less than 15 mins they took my BP at 10am 170/83 they had me take 650 Tylenol I had the Bp would not come down was sent to urgent care the pain as much worse and BP was still elevated. Was sent home to rest and drink lots of H2O. The BP came down by night. The headache continued for 17 days 24/7 and the pain continued and still going 2 mos 2 days It elevated my Creatine Kinase CK Level, had a reaction too Gabapentin to help with pain it stops working at level 6 and that's where we are until the enzyme level come down it as at a level 9 and no narcotics were given. The clinical outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
No ?, seen in employee services at 1530, reports numbness and coldness in L arm and hand 3 1/2 hrs post immun. but sx's mostly gone by 4 1/2 hrs post of both hands observed to be equally cold. No swelling or redness at site. Hands both pale.
Rash described as looking like heat rash that started about 1.5-2 hours, post vax. Rash located on torso and slightly itchy. No other complaints. No fever. Rash spread to upper legs by AM of 4/17/02. Rash lasted 3 days. Client was advised to see MD.
The spontaneous information was received from a physician regarding 22 patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. This report refers to a patient who on 26-JUN-2014 was vaccinated with (Oka/Merck) PROQUAD lot # J015595, expiration date 05-JUN-2015, that were exposed to highest temperature of 5 Celsius degree for 5 months (also reported as exposed to refrigerator temperatures not greater than 46F) (strength, dose and does schedule were not reported). No concomitant therapies were reported. No adverse effects reported. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
given an vaccine that expired a month ago/ no AE; Initial information was received on 17-Jun-2021 regarding an unsolicited valid non-serious case received from a Other health care professional via regulatory authority (Reference number- 00646123) and transmitted to Sanofi on 17-Jun-2021.  This case involves a 20-year-old patient (unknown gender) who was vaccinated with 0.5 mL dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (total) (lot number U6575AA, expiry date 08-May-2021) via intramuscular route in left deltoid on 17-Jun-2021 for prophylactic vaccination (expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
varied from 13 to 18 months since their first dose / Second dose had not been given at time of report; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix (unknown). On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up. This case was linked with cases US2021136326, US2021136325, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021136326:Same reporter US-GLAXOSMITHKLINE-US2021136325:Same reporter
Initial information received on 14-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse via phone. This case involves a 69 years old female patient who experienced nausea, vomiting, fever and body ache, while she received vaccines PNEUMOVAX and FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had had the same flu shot last year without issues. On 12-Sep-2018, the patient received 0.5 mL dose of suspect FLUZONE HIGH DOSE lot U1995AA, expiry date 01-04-2019 via intramuscular route in the right deltoid. On 12-Sep-2018, the patient received a dose of suspect PNEUMOVAX not produced by Sanofi Pasteur (batch number, expiry date, route and site of administration were unknown). On an unspecified date, next day post-vaccination patient developed a non-serious nausea, vomiting, fever and body ache following the administration of FLUZONE HIGH DOSE. Relevant tests were not reported. Final diagnosis was body ache, fever, vomiting and nausea.  The patient was treated with TYLENOL for Product used for unknown indication. The outcome of the events reported as unknown. Documents held by sender: none.
Reported bilateral numbness and tingling to lower extremities, concern for Guillain Barre.