chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain is unbearable/pain all the time; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of condition aggravated in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles 2 years ago). Previously administered products included Shingles vaccine. Concurrent medical conditions included pain.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced condition aggravated (Verbatim: Pain is unbearable/pain all the time). The outcome of the condition aggravated was not resolved.   It was unknown if the reporter considered the condition aggravated to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the condition aggravated to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 19-MAR-2023 The patient was being in labor, had shingles two years ago and had it all over his/her torso and around to his/her back and still had the pain all the time. The patient stated that yes, he/she also had the shot before he/she got shingles, did not thought that the rash was shingles until a day and a half later when he/she could no longer stand the pain, went to the physician and had to have two more shots because the old shots they said were outdated. The patient said that, the pain was unbearable even now with no rash or sores two years later. The follow-up could not be possible as no contact details were available. As per narrative, condition aggravated was captured as the adverse event was exaggerated at the time of reporting.
pt recvd vax passed out, pale, HR 40's, lost urine, eyes rolled &  ? greater than 1 min; prob sycopal sz;
Information has been received from a medical assistant(also reported as office manager) referring to a12 month old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 26-APR-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program(VFC) stock and the VFC status appointment was reported as 1. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received. ; Sender's Comments: US-009507513-1704USA014784:
Late evening of second   day left arm slightly painful at point of injection. Few hours later woke to an odd feeling; an extremely large swelling under left arm about 10? round.  No pain of swelling but scary and uncomfortable.  Upon examining?.Felt FULL  with Gel Like substance. Next morning ?.6:53 a.m.  area  significantly reduced?..almost normal ?.
Received immunization 3/9/04- has reaction to right thigh cellulitis (12 x 8 cm) of induration, red, painful.
Just like the flu,  chills, body and joint pain, nausea, extreme headache,  started to ease up today 3/13 but still feel sick. Also have weaknesses in arms and legs.
Patient said approximately 36 hours after shot...arm became hot and itchy and red.  APproximately 2x3 inch square. Attended urgent care, received keflex, didn't need to take.  Reaction only lasted 3 days in total
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date in 2013 (also reported as on an unspecified date in last winter), the patient was vaccinated with ZOSTAVAX (dose, frequency and route of administration was not provided), to prevent shingles. No concomitants were reported. The pharmacist reported that "within a week" of a patient receiving ZOSTAVAX, two sisters of the patient developed shingles. The pharmacist was unsure if the patient that received ZOSTAVAX developed any adverse reactions or if the two sisters came in contact with the patient after the patient received ZOSTAVAX. No product quality complaint (PQC) was involved. Action taken with respect to ZOSTAVAX was not applicable. Outcome of event was unknown. Causality was not provided. The pharmacist did not have any further information. No further information was provided. Additional information has been requested.
pt recvd vax & 4 days later pt exp nausea which subsided w/in 24hrs;
High fevers (103.5) for 5 days. Low energy, rash over body
On 2/15/00 the pt received her second dose of Infanrix. Subsequently she was sleepy for 24 hours, screamed for 4 hours and was flaccid, had a fever the next day and had a slightly red injection site. The pt was treated with Tylenol. Outcome resolved. The most recent information received on 3/27/00 reports the condition of the pt as resolved. Following the 1st dose, the pt was lethargic, but recovered.
Patient became lightheaded after receiving vaccine. She also experienced tinnitus. She became pale. She was provided with orange juice and stayed seated for 20 minutes. Client recovered from acute reaction in approximately 5 minutes post admin of vaccine.
SKIN HURTS; COULD NOT EAT; MISERABLE; LIGHTHEADEDNESS; SCREAMS; WEAKNESS; MUSCLE ACHE; TEMPERATURE 101.4; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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. The batch number was not reported. As per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced skin hurts, could not eat, miserable, lightheadedness, screams, weakness, muscle ache, and temperature 101.4. Laboratory data (dates unspecified) included: Body temperature increased (NR: not provided) 101.4 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temperature 101.4, skin hurts, muscle ache, weakness, could not eat, miserable, lightheadedness and screams was not reported. This report was non-serious.
Received 2nd dose of the vaccine that was expired; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received 2nd dose of the vaccine that was expired) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received 2nd dose of the vaccine that was expired). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Received 2nd dose of the vaccine that was expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.    This case was linked to MOD-2021-222874, MOD-2021-222826 (Patient Link).
Fever (99.0) post ASA; body ache, malaise red erythema area 3cm x 3cm at vaccination site. Induration area approximately 2cm around one cm size blister. (+) lymph nodes palpable to axilla and braphial 48 QTRS.
This spontaneous report as received from a nurse refers to a 2 month old patient. On an unknown date the patient was vaccinated with VAQTA (dose, route and lot# were not reported). The nurse reported VAQTA weren't supposed to get before 12 months of age. No adverse effects reported. Additional information is not expected.
Late second dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 75-year-old 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. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the drug dose administration interval too long to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had received a late second dose of Shingrix, which led to lengthening of vaccination schedule. The reporter did not know the date of the administration of the second dose, nor lot number or expiration date. The reporter did not consent nor declined consent to be contacted for follow up. No further events were reported.
08aug90 pt vax hepta B.23aug90 pt exp burning sensation from groin&buttocks down through lt thigh&vagina.Next day pt exp weakness of lt leg.27Aug90 pt exp fever, emesis, leg weakness, difficulty climbing stairs and nausea....see WORM
T104 & sz x 1 at home; Seen @ Hosp ER @ 230AM; Not admitted;
Heavy menstrual bleeding, lasting over 6 days. I have Mirena IUD. Sore throat.; Sore throat; This is a spontaneous report from a contactable consumer, the patient. An adult non-pregnant female patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 26Apr2021 as a single dose for COVID-19 immunisation. Medical history included embedded intra uterine device (Mirena IUD). The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Apr2021, the patient experienced heavy menstrual bleeding, lasting over 6 days and also experienced sore throat. Therapeutic measures included treatment with ibuprofen, taken as a result of the events, heavy menstrual bleeding and sore throat. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore throat and heavy menstrual bleeding were recovering at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax;no adverse rxn reported by PAR to hlth dept; pt died on 16jan95;COD undetermined at time of this report filing;
By 7 p.m. my face was as red as Rudoph's nose!  It was also very hot.   I took a Benadryl tablet, washed my face with cold water, and went to bed. The following morning, I had burst blood vessels on both cheeks. These are resolving.
Pinching/Stabbing pain in upper right clavicular area, lateral to coronal plane
Tenderness in Left underarm area with palpable lymph nodes in axilla and neck.
Information has been received from a 62 year old female nurse with penicillin and PREDNISONE allergy, hypercholesterolaemia and osteopenia and a history of shingles twice in the past who on 07-JAN-2009 was vaccinated with ZOSTAVAX (Oka/Merck).  Concomitant therapy included LIPITOR, EZETIMIBE (MSD), LEXAPRO and BONIVA.  On 08-JAN-2009 the patient developed a slight itch, redness and a lump on her arm at the injection site after receiving ZOSTAVAX (Oka/Merck).  The nurse also reported a headache after receiving ZOSTAVAX  (Oka/Merck).  The nurse had sought medical attention in the office.  Follow-up information has been received from the physician that the nurse was vaccinated with ZOSTAVAX (Oka/Merck) (lot number 663194/1415X) at 1:00 PM on 07-JAN-2009 and no reaction happened.  At 22:00 PM on 08-JAN-2009 the patient developed 1 inch X 1 inch red area at the injection site.  No rash happened.  On 10-JAN-2009 the red area had gone.  No further information is available.
Symptoms dissipated in half hour. If rash in your throat if it comes back or you get it in the next dose and have difficulty breathing please go to the emergency department, otherwise if no symptoms present your all set. If you present rashes on the next dose you could also apply a cold compress to the site to alleviate the pain
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: paramedics check patients vitals and transported to hospital for further evaluation - patient was alert and talking when transported to hospital
First injection was only saline; First injection was only saline; Administered it incorrectly; This case was reported by a consumer via call center representative and described the occurrence of inappropriate preparation of medication in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th August 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 20th August 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication, inappropriate dose of vaccine administered and drug administration error. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and drug administration error were unknown.  Additional details were provided are as follows: The case was reported by patient for himself. The patient reported that health care professional administered 2nd dose of Shingrix incorrectly which led to drug administration error. The patient stated that he was given 2 injections  and believed he was administered vaccine adjuvant without active component, which led to  inappropriate preparation of medication and inappropriate dose of vaccine administered.  Then the patient was given a second administration with the complete Shingrix vaccine. Registered pharmacist reviewed the stored video and stated the 1st injection was only saline. The patient stated he had an appointment to saw his primary care physician on Friday for a annual visit and would follow up with them on how to manage this event. Provided MI phone number for health care professional reference. The reporter consented to follow-up.
Patient received flu shot on 10/7/13. Came to store 11/6/13 to complain still experiencing soreness in injection arm. Went to MD, did MRI revealing nothing. Says MD may guess tendonitis if injected in tendon. Do not know at this time.
Pityriasis rosea; rash all over upper from neck to waist; COVID arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PITYRIASIS ROSEA (Pityriasis rosea), TYPE IV HYPERSENSITIVITY REACTION (COVID arm at the injection site) and RASH (rash all over upper from neck to waist) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     Concomitant products included PANTOPRAZOLE for Reflux gastritis, COLECALCIFEROL (VITAMIN D 3) for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (COVID arm at the injection site). On 24-Apr-2021, the patient experienced RASH (rash all over upper from neck to waist). On 03-May-2021, the patient experienced PITYRIASIS ROSEA (Pityriasis rosea). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 10 mg once a day and TRIAMCINOLONE ACETONIDE at an unspecified dose and frequency. At the time of the report, PITYRIASIS ROSEA (Pityriasis rosea) and RASH (rash all over upper from neck to waist) outcome was unknown and TYPE IV HYPERSENSITIVITY REACTION (COVID arm at the injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       laboratory test details include Strep throat test was negative On 28Apr2021,
Breakthrough covid infection; Breakthrough covid infection; Stuffy nose; Fatigue; Headache; This is a spontaneous report was received from a contactable nurse reporting same event under the same suspect product for 11 patients. This is 8th one of 11 reports. A 29-year-old female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, lot number: EH9899, Expiration date: not reported), on 07Jan2021 at 2nd dose, single administered via intramuscular route, administered in deltoid left for covid-19 immunisation. The patient had no medical history and concomitant medications were not reported. On 17Dec2020, the patient had received 1st dose of vaccination. On 31Mar2021, the patient experienced breakthrough covid infection, stuffy nose, low grade fever 100.6, fatigue and headache. The patient was not hospitalized and was not admitted to an Intensive care unit. The patient underwent lab tests and procedures which included Low grade fever 100.6, Nasal swab PCR: positive (Comments: 1st test nasal PCR) on 31Mar2021, SARS CoV2 by PCR: positive on 04Feb2021, Nasophx: positive on 02Apr2021. Patient did not have any medication prior vaccination within 4weeks. The patient had no multiorgan failure, no cardiovascular symptoms and no gastrointestinal/hepatic symptoms. It was unknown whether the patient have SARS CoV2 antibodies at diagnosis. The patient did not display clinical signs at rest indicative of severe systemic illness, the patient did not require supplemental oxygen or receive mechanic ventilation. The event did not require the initiation of new medication or other treatment or procedure. The information about the patient was taking any medications routinely prior to the event was not reported. Patient did not have any pre-existing diseases worsened during the SARS-CoV2 infection. Patient had not been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. On 14Apr2021, the patient was recovered from all the events.   Vaccine facility information is available. Follow-up attempts are needed. Further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however,lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded.
Had H1N1 administered on 10-29-09, developed Bell's Palsy on 11-07-09, states had a bad cold the previous week. before developing the Bell Palsy. Scheduled for MRIN 11-19-09 is taking prednisone presently being  seen by hospital. 12/11/2009 PCP records patient with c/o's rt sided facial numbness and uneven smile. Dx'd with Bell's palsy, rx'd prednisone
Became extremely ILL, very weak hard to stand up, Poor appetite lost of taste and a horrible hacking Cough, productive and sometimes blood tinged.
Muscle pain, redness the day of, worse the next day and pain subsided in a few days. 1 week later, It was noted with redness (5 1/2?x 3?), swelling, warm to touch, and itchiness. The next day, the size expanded to 8? x 3? with swelling, itchiness and heat to touch.  MD prescribed steroid ointment and Keflex.  Today redness subsiding.  Itchiness subsided.
Red swollen knot at site of injection. Is a perfect circle and warm to the touch compared to surrounding skin. Slightly Sore site of injection.
My wife mixed/mixing vaccines series; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (My wife mixed/mixing vaccines series) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (My wife mixed/mixing vaccines series). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (My wife mixed/mixing vaccines series) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was not reported. No treatment medication was not reported
Patient had limited mobility of arm and arm pain. Patient said that he had greatly improved over 2 to 3 weeks but some discomfort is still present.
Migraine Headaches has heighten in strength and pain level.  A centralized area of pain that moved down my right down, the next day down my right leg, up my left leg, and then on the 4th day it subsided. Muscle tremors all over my body.  Spontaneous spasms in various areas of the body.  Stiffening in my body all over similiar to "charlie horse" muscle cramps.   Alopecia and hair thinning has increased exponentially and a cramp pain in the upper left side of my chest.
No additional AE information provided; Nurse reported the patient was administered an improperly stored dose of VAQTA on 5/26/2020; Information has been received from a registered nurse regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 26-MAY-2020, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA)  injection, for prophylaxis (lot number S020241 with expiration date in 23-AUG-2020 (strength, route of administration and anatomical location not reported).  The hepatitis a vaccine, inactivated (VAQTA) was stored at a temperature range of 12.1 degrees Celsius (°C) for the time frame of 16 hours and 11 minutes. There was no previous temperature excursion and the call was because of a data logger.   No adverse effects reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent