chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccine administered  after it was stored beyond 12 hours at room temperature; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered  after it was stored beyond 12 hours at room temperature) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered  after it was stored beyond 12 hours at room temperature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine administered  after it was stored beyond 12 hours at room temperature) 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 medications were reported. No treatment medications were provided by the reporter.
cont itching lt upper arm @ site of shot; some tingling in lt hand, fingers some aching up into neck;
Nurse reported that the third dose ofROTATEQ was administered to an unspecified patient at 8 months and 12 days old on unspecified date; No adverse affects reported; This spontaneous report was received from a nurse referring to an 8 month and 12 days old patient of unknown gender. The patient's pertinent medical history, concomitant medication, concurrent condition and drug reactions/allergies were not provided.     On an unknown date the patient was vaccinated with the third dose rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (dose was not provided, lot #S000961, expiration date 19-OCT-2020) by oral for prophylaxis (product administered to patient of inappropriate age). No adverse event was reported.
Information has been received from a physician concerning a 15 year old female patient with sulfonamide allergy who on approximately 17-JUN-2009 (reported as "about 2 weeks ago") was vaccinated with the first dose of GARDASIL intramuscularly. Few hours after vaccination, the patient broke out in hives. The physician told the patient to take BENDARYL and the patient recovered after few days. Therapy with human papillomavirus vaccine was discontinued. Follow up information has been received from a physician concerning a 15 year old female who on 01-JUN-2009 at 11:30 AM, was vaccinated the the first dose of GARDASIL (Lot: 661953/1130X) intramuscularly. On 03-JUN-2009, 48 hours post vaccination at 11:00 AM, the patient developed hives that were itchy and slightly raised. Subsequently on 05-JUN-2009, the  patient recovered. Additional information is not expected.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 13-JUL-2017 the patient was vaccinated with an incorrect storage PNEUMOVAX 23 lot # M042324, expiration date on 10-JUN-2018; lot # N001007 expiration date on 09-SEP-2018; and lot # reported as M044564, expiration date on 22-OCT-2018, for prophylaxis. On an unknown date the patient experienced no adverse event. Sender's Comments: US-009507513-1708USA002800.
Okay so on July 4th 2021, he was fatigued and cranky and I did not realize he was sick. On July 5th 2021 he woke up with a sore throat and not feeling well, on that night he had a 102+ fever, congested and ill. This continued and on Tuesday morning when he woke up, nose red and could not breath out of it. The fever broke on Thursday and he had been treated with Tylenol, Ibuprofen, fluids, Flonase and rest. I tried to help him with steam, to steam out so he could breath better. We did a rapid Covid test on the 6th of July which was negative. On the 9th and 10th he was still tired and had congestion, but on late on the 8th of July the fever did break. He was just miserable, he slept most of that week. He did not have body aches, so I don't think that he had the flu.
no additionall AEs reported; expired dose of PNEUMOVAX 23 was administered; This spontaneous report was received from a nurse prescriber concerning an unspecified patient of unknown age and gender. No information regarding patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 22-JUN-2021, the patient was vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), expiration date reported as 10-JUN-2021 (lot number, dose, schedule, anatomical location, and route of administration were not reported) for prophylaxis. No additional adverse events (AEs) were reported.  This case was considered non-valid due to the lack of patient's identifiers.  Follow-up information was received from the nurse on 27-AUG-2021. The patient was a female patient of unknown age. It was stated that it was the only vaccine that the patient received that day and she had not received any vaccines in the four weeks prior. She also confirmed that no adverse events were reported.
Information has been received from a physician referring to a patient of unknown age and gender. The patient's medical history and drug reactions/allergies were not reported. On 03-MAR-2016 the patient was vaccinated with an expired dose of M-M-R II (rHA) (dose unknown, lot # K002816, expiration date 25-FEB-2016, subcutaneous) (expired product administered). No known adverse effects were reported. Additional information has been requested.
Patient states that she is having flu like symptoms, primarily on the left side. Lymph nodes swollen, sore muscles, headache, son states that she was somewhat slow with her thoughts for a day or two after the symptoms began.
Pt recvd 1st dose of vax on 02JUL91 & w/in several hrs of receiving vax, pt got hot, & tightness in chest & difficulty breathing;  Later got a h/a, nausea & weakness & then vomited; p/vomited undigested food, pt was fine;
patient received the vaccine after it was in the refrigerator for more than 30 days; Product storage error; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received the vaccine after it was in the refrigerator for more than 30 days), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received the vaccine after it was in the refrigerator for more than 30 days), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received the vaccine after it was in the refrigerator for more than 30 days), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient received the vaccine after it was in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (Product storage error).    No concomitant medication were reported.   A patient received the vaccine after it was in the refrigerator for more than 30 days. The Nurse did not wish to stay on the phone any longer to report the adverse event information.  No vaccine lot numbers or past vaccine history was provided. No treatment information was provided by the reporter.
I woke up dizzy; I still don't feel good; probably little weak; This is a spontaneous report was received from a contactable consumer or other non hcp. An 83-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3249; Expiration Date: 31May2021), via an unspecified route of administration, administered in left arm on 19Jan2021 as 1st dose, single dose for covid-19 immunisation. The patient medical history was not reported. The patient was taking unspecified concomitant medications. She was fine for the first few days on the 5th day, i.e., on 24Jan2021, she woke up dizzy and she still do not feel very good and still do not feel good. Well patient just don't feel good, nothing can pinpoint it and probably little weak, she did not know and have not been doing much, she don't feel good. Patient do take medications, going to have to go get the list and took Tylenol couple of times as treatment. Patient reported that they scheduled the second one and it is 4 weeks rather than the 3 weeks. The patient was not recovered from "I still don't feel good" and outcome of the other events was unknown.  Follow-up attempts are completed. No further information is expected.
Developed Covid arm 8 eights after 1st Moderna vaccine. It then disappeared after 2 days, but came back bigger and redder the very next week.
This is an instance of breakthrough COVID-19 disease after which death occurred.  The individual was vaccinated with the Moderna product on 01/21/2021 and 02/18/2021. They became symptomatic for COVID-19 disease on 08/24/2021. The individual tested positive for COVID-19 via PCR test on 08/25/2021. They presented to emergency department via ambulance on 08/26/2021 after a fall from bed. Household member reports the individual had been falling frequently as of late. They were admitted to hospital on 08/26/2021 and remained hospitalized until their death on 08/31/2021.
asthma; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient 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 (Manufacturer unknown), for Covid-19 immunization. The following information was reported: ASTHMA (non-serious), outcome "unknown", described as "asthma".  Additional information: Consumer says she is calling to ask questions about severe side effects, and she had reaction from the booster shot and wants information about them. Caller declines to complete a report and says she wants information first, information about severe side effects to the booster. Caller is unable to specify which Pfizer vaccine she got a booster too. Caller says she has asthma.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
led to a fall (possible faint) that caused a head injury (bone chip above her eye).; led to a fall (possible faint) that caused a head injury (bone chip above her eye); led to a fall (possible faint) that caused a head injury (bone chip above her eye); led to a fall (possible faint) that caused a head injury (bone chip above her eye); Nausea; shivers; fever; dehydration; This is a spontaneous report from a non-contactable consumer (patient) 71-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), (batch/lot number and expiry date not reported) via an unspecified route of administration, on 22Feb2021 (in the age of 71-years-old) at single dose for covid-19 immunization. Medical history included chronic headaches, high cholesterol, high blood pressure and minor heart condition. Patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medications included candesartan, rosuvastatin, gabapentin, topiramate, amitriptyline and erenumab aooe (AIMOVIG), all from an unspecified date for an unspecified indication.  It was reported that 2 days after second dose (reported as 24Feb2021), the patient experienced nausea, shivers, fever and dehydration which led to a fall  (possible faint) that caused a head injury (bone chip above her eye). As a result, the patient had an ER visit and they provided her with fluids and stitches. The outcome of events was reported as 'recovering'.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Symptoms: - loss of sight (blackout) - weakness - cold sweats - ringing in both ears - comparable to low blood sugar reaction - pale skin  Time Course until symptoms dissipated  ~10 minutes  Course of action: - returned to pharmacy and notified staff - sat and placed head between legs - remained with pharmacist for approximately 5 minutes  - drank water and Poweraid - then moved to chair outside pharmacy and sat for 45 minutes continuing to drink poweraid - walked around store for about 15 minutes - notified staff that I was feeling better - left store
This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a male patient who received HAV (Havrix) (batch number E9G4E, expiry date 29th December 2021) for prophylaxis. Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 10th January 2022, the patient received the 2nd dose of Havrix and Havrix Pre-Filled Syringe Device. On 10th January 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The age at vaccination was not reported. The patient received expired dose of Havrix, which led to expired vaccine used. The reporter consented to follow up. This case was linked with case US2022005766, reported by same reporter for different patient.; Sender's Comments: US-GLAXOSMITHKLINE-US2022005766:same reporter.
Fever,  muscle pain. Onset around 21 hours after vaccine, resolved around 6 hours later without intervention.
Information has been received from a health professional concerning a 15 year old white female who on 16-NOV-2007 was vaccinated with the second dose of Gardasil (lot# 654535/0960F).  Subsequently the patient fainted after the second vaccination.  The patient was fine with the first dose.  Unknown medical attention was sought.  The patient's outcome is unknown.  No product quality complaint was involved.  This is one of the multiple reports from the same source.  Additional information has been requested.
No appetite; nauseous; tired; joints started aching; fever; chills; This spontaneous case was reported by a patient and describes the occurrence of DECREASED APPETITE (No appetite), NAUSEA (nauseous), FATIGUE (tired), ARTHRALGIA (joints started aching) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No historical conditions provided by the reporter.    On 13-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 13-May-2021, the patient experienced DECREASED APPETITE (No appetite), NAUSEA (nauseous), FATIGUE (tired), ARTHRALGIA (joints started aching), PYREXIA (fever) and CHILLS (chills). At the time of the report, DECREASED APPETITE (No appetite), NAUSEA (nauseous), FATIGUE (tired), ARTHRALGIA (joints started aching), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            No Concomitant medications were provided No Treatment information provided
Patient has low grade fever, aches/pains, cough and experienced severe chills/numbing of fingers/toes on 10/5/12, 10/7/12 and 10/11/12.
Left clavicular lymphadenopathy; This is a spontaneous report from a non-contactable nurse, the patient.  A 38-year-old non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 13Jan2021 at 09:00 AM (at the age of 38-year-old) as a single dose for COVID-19 immunization. Medical history was none.  The patient's concomitant medications were not reported. 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 20Jan2021 at 10:00 AM, the patient experienced left clavicular lymphadenopathy. No treatment was given for the event.  The clinical outcome of left clavicular lymphadenopathy was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot number cannot be obtained.
Myalgia, NauseaVomiting, Fatigue Narrative: I took my second shot yesterday around noon felt pretty tired around 10 PM and 2 o'clock was aching like crazy..i've been taking Tylenol and NSAIDS and tums. And I took twice tramadol 50 mg left over from five years ago. The only relief was a short gag throw up a few minutes ago. I i'm lucky I took the day off today and tomorrow. I think by early afternoon I'll be able to get back on the computer. But there was no way I could talk to anybody this morning. Even my hair hurts. Feel dehydrated.
Severe flare up or osteoarthritis. Pain and limited movement in 5 joint locations. Never had this before and it came up suddenly after my last vaccination on 04/02/2020. Still on going with pain and limited movement in different locations each day.
shots worsened the prolonged symptoms, he experienced from a previous COVID-19 infection; This spontaneous case was reported by a patient and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (shots worsened the prolonged symptoms, he experienced from a previous COVID-19 infection) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Long COVID-19.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced POST-ACUTE COVID-19 SYNDROME (shots worsened the prolonged symptoms, he experienced from a previous COVID-19 infection). At the time of the report, POST-ACUTE COVID-19 SYNDROME (shots worsened the prolonged symptoms, he experienced from a previous COVID-19 infection) had not resolved.            No concomitant drug reported. No treatment information was provided by the reporter.
Pt recvd Hep B vax OCT87 & recvd 2nd dose of vax NOV87 & pt exp achiness in NOV87; MAY88 recvd 3rd dose & felt achy & devel low grade temp 100-101; exp nausea w/o vomiting x 24 hrs;
approx 2mo p/vax pt devel vertigo & elevated liver enzymes, which persisted @ date of this report;
experiencing trouble breathing; chills; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 72-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, Primary immunization complete, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, Primary immunization complete, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3, Manufacturer unknown), for Covid-19 immunization.  The following information was reported: CHILLS (non-serious) with onset 20Apr2022, outcome "unknown"; DYSPNOEA (non-serious) with onset 20Apr2022, outcome "unknown", described as "experiencing trouble breathing"; PYREXIA (non-serious) with onset 20Apr2022, outcome "unknown", described as "fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Agent stated that caller was calling on behalf of his wife. Agent stated that caller stated yesterday his wife received her second booster dose of the Pfizer Covid Vaccine and today she was experiencing trouble breathing, chills and a fever. Agent stated caller wants to know have these symptoms been reported with use of the vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
A few days after the booster was received both ears began to ring.  Tinnitus has not stopped or reduced.  It is consistent 24 hours a day.
This spontaneous report was received from a healthcare worker and refers to an 8 year old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On 13-AUG-32015, the patient was vaccinated with improperly stored dose of VARIVAX (Merck) (exact dose and route of administration were not reported), lot # J009987, expiration date: 12-AUG-2015. The dose of VARIVAX (Merck) was expired. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Red and raised at injection site and redness wrapped around arm 6 inches. Tried BENADRYL and ice then went to UC and was rx'ed KEFLEX and started getting better right away.
Narrative: Pt received an expired COVID Pfizer vaccine. The expiration date and time is unclear as the date on the syringe could not be visualized as it was already in the sharps container.
Immunizations were given at approximately 10:00 am on 05/17/2004.  Mother called at 5:05 pm and said infant had just awakened and was fussy.  He had a fever (mother stated was burning up).  Infant had a rash on body and redness on legs.  Had not been given any Tylenol following shots.  Infant had slept all day off and on in infant carrier.  Did not yet have a private MD since had only been living in the area for 2 weeks.  Mother advised to go to ER, which she did.  Caseworker visited on 05/21/2004.
Patient presenting with complaint of roof of mouth and tongue tingling. Provider assessed patient Ordered Benadryl 25mg PO at 10:23 Vital Signs at 10:22 BP: 136/80 HR:78 RR:18 02:98%  Provider notes state anxiety related, no cranial nerve, sensory motor deficit. Patient monitored for 30 min. Symptoms improved advised to go to ER if symptoms worsen.
1st vaccine 01/15/2021; 2nd dose 02/05/2021; seen at care center 12/12/2021 for new onset jaw pain and swelling onset 12/12/2021.
Fatigue, dizziness, chills, back/neck/muscle pain, fever 100F, headache, night sweats, starting after 6-8 hours, lasting 36 hours; still some lingering headache
This case was reported by a nurse via call center representative and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown. It was unknown if the reporter considered the shingles and rash to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The health care professional reported that patient received the SHINGRIX in the office and before leaving the office the physician saw a rash and diagnosed her with Shingles. No additional information provided.