chrisvoncsefalvay/vaers-outcomes huggingface dataset:
intermittent headaches; diarrhea; dizzy; This spontaneous report was received from a registered nurse and refers to a 60-year-old female patient. The patient's pertinent medical histories included Cushing's. The patient was allergic to levofloxacin (LEVAQUIN) and codeine. The patient had no concomitant therapies.  On 27-SEP-2019, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S020157 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 30-JUN-2021 (exact dose, dose number, route and site of administration were not reported) for immunization.  On 27-SEP-2019, reported as in 30 seconds after vaccine administration, the patient became dizzy. On 28-SEP-2019, reported as on the next day, the patient developed diarrhea and intermittent headaches. On an unknown date in 2019, the patient had basic lab work, electrocardiogram (EKG) and chest x-ray, the results were not provided. The patient sought medical attention, the patient had emergency room visit and office visit. The treatment was not given. On 29-SEP-2019, the patient recovered from diarrhea, it was reported that diarrhea lasted for one day. The dizziness and headaches had decreased at the reporting time. The causality assessment was not provided.
ANCA-associated vasculitis; ANCA-associated vasculitis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 13Nov2021 10:00 (Lot number: FH8030) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Sinusitis" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: MULTIVITAMIN [VITAMINS NOS]; INFLUENZA taken for immunisation, administration date 18Oct2021. Vaccination history included: Bnt162b2 (Dose 2, single, lot number: Ew0151, administration time: 02:00 hours, location: left arm), administration date: 12Apr2021, when the patient was 64 years old, for COVID-19 immunization; Bnt162b2 (Dose 1, single, lot number: E96955, time: 02:30 hours, location: Right arm), administration date: 22Mar2021, when the patient was 64 years old, for COVID-19 immunization. The following information was reported: ANTINEUTROPHIL CYTOPLASMIC ANTIBODY (prolonged hospitalization, disability, life threatening), VASCULITIS (prolonged hospitalization, disability, life threatening) all with onset 14Nov2021 08:00, outcome "not recovered" and all described as "ANCA-associated vasculitis". The patient prolonged hospitalization for antineutrophil cytoplasmic antibody, vasculitis (hospitalization duration: 4 day(s)). The event "anca-associated vasculitis" and "anca-associated vasculitis" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Dec2021) negative. Therapeutic measures were taken as a result of antineutrophil cytoplasmic antibody, vasculitis. The patient received treatment with high-dose Solumedrol. The patient did not have Covid prior vaccination, was Covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Between his first and second birthday my son developed allergies. He was and still is often congested. He suffers from constant runny nose, sneezing, coughing, and has trouble sleeping at night due to his coughing.
Vaccine: Use by date = 10/17/2022 8 wk after defrost Exp. date = 10/31/2024
Patient received the Pfizer COVID-19 vaccine on 4/11/21 and 5/2/21 so was fully vaccinated when they tested positive for COVID-19 on 8/31/21.
Had them on face even after shot/suspected vaccination failure; Shinles had on face; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had them on face even after shot/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shinles had on face). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received Shingles vaccine and experienced shingles on face. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Complaint, 6 days post vax, of erythema, swelling and itching to left upper arm. Pt presents at 9 days, post vax, with hot, red and itchy ridge at proximal end of reaction.
This spontaneous report as received from a pharmacist refers to two patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On an unknown date, the patients' were vaccinated with ZOSTAVAX (dose, route, lot # and expiry date unknown). No concomitant medication was reported. On an unknown date, the patients' experienced redness and swelling around injection site after receiving vaccination. No treatment was provided for the event and the patient did not seek any medical attention. The pharmacist reported that he had performed a lot of ZOSTAVAX vaccinations and he remembered these two patients complaining of swelling and redness around the injection site. Product quality complaint was not involved. The outcome of injection site redness and injection site swelling was unknown. Causality assessment was not provided by the reporter. Additional information has been requested.
Administered 1st Pfizer dose to patient.  Requested that patient wait 15-20 minutes in waiting area after vaccine.  After 10 min, Patient signled me (the pharmacist) that he wasn't feeling well.  As I approached, he stood up and started walking towards me.    I took his arm, we took two steps and he fainted.  I laid him to the ground while supporting his head.  He regained consciousness quickly, but was disoriented.   NP assisted by taking vitals/911 called.  Paramedics arrived and then took over evaluation.  Pt was taken to ambulance for further evaluation, as he still could not walk to diziness.
Had horrible pain in the arm/muscle in which I was given the injection several hours after the shot and the next day. It had me in tears. It continues to be sore today, two days later. The day after the shot I started having flu like symptoms. It started with chills, and then head ache, body aches and tired. Spent the day in bead. This is the second day and I am feeling better then yesterday but still not myself.
vertigo occurrences are much more frequent after receiving Moderna Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo occurrences are much more frequent after receiving Moderna Vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (vertigo occurrences are much more frequent after receiving Moderna Vaccine). At the time of the report, VERTIGO (vertigo occurrences are much more frequent after receiving Moderna Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication and treatment drug were not reported.
Tinnitus in left ear started within 24 hours since first shot. Has not stopped as of 05/25/2021. Not as loud as the first three weeks but it has not stopped.
Never pregnant. It was an Influenza Vaccine- I don't know the exact name or Lot #. Initially I was fine. Seven hours later, I got sick to my stomach, body aches, intense headache, chills. I don't know if I had a fever or not, I didn't take my temperature.  I took a hot shower, put hot compresses on my head and around my neck and rested. I was in pain the whole night. I was a little stiff the next morning. I felt bad for a few days. By the 10th I felt better.
3 days later - unable to move - sit/stand/get out of bed - agony, vomiting from pain.    Unable to get in touch with pharmacy.    5 weeks later I had someone take me to pharmacy to tell them what happened and report it.    Pharmacist only told me not to get the second vaccine!   No help with pain.    2 months later when I was able I went to my own dr - locally.  She also would not file a report and told me not to get the second vaccine.   IEight months later, I now have some range of motion and not in agony - but I now walk slowly and with a limp and am in discomfort.
pt returning home from clinic pt mom stated that pt felt warm & was given APAP 9PM t inc to 101, chills, & weak; MN t104 & MD was called who instructed cool bath & APAP; morning pt began to improve & now doing well;
w/in 2-3 min of getting vax;hive started to form @ site of vax & later @ site of MMR;p/ 20min the  vax rxn was z 35x22mm hive & erythema;the MMr rxn was 20mm of swelling (no hive) & erythema;
Severe mood swings, abdominal cramping (like period cramping), vaginal bleeding (spotting)
Pain in my heart.  Lasted 15 minutes.  Took zanax and it went away. Also very bad trembling in my hands. Worse than usual.
FEB: intense nerve pain neck down, heart palpitations, sweating, hypersensitive skin, changes in blood pressure; MAR: above plus nausea, diarrhea, unsteady gait, falling, lack of concentration, no stamina, tired;
Patient was given her 2nd dose of the covid vaccine today which was Pfizer.  Her previous 1st dose given was from Moderna.  Patient was monitored for the 15 minutes after given the dose and had no symptoms and no adverse reactions.
Shot given above deltoid muscle. immediate pain, swelling, hot to the touch. symptoms on day 4 with slight improvement still with swelling, pain in arm/neck, warm to the touch. taking ibuprofen every 6hrs with ice. went to work site clinic and was told vaccine administered in shoulder bursa.
none Sepsis (blood cultures + for grp A streptoccocus) added from autopsy report rec'd 11/10/2005/sr
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: pt was walking out and collapsed on the floor, pt regained consciousness after couple seconds, pt is alert and responsive, and he thinks he just got up too fast, pharmacy gave pt water and he was okay after sitting and resting
SWELLING REDNESS HEAT ON LEFT DELTOID AND PAIN ENDED UP CONTRACTING COVID
No nausea until day 2, sleepy and groggy, Day 2 slept all day ate, nothing. , drank water.  Day 3 slept another day away, ate very little. Day 4. sleepyness but less than previous days, began to eat again.  Day 5 seemed to be back to normal, a fatigue stayed and I took lots of naps . Woke up on day 6.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No medical history and concurrent conditions of the patient were reported. On 10-AUG-2015, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (lot number: L008269 and expiry date: 11-MAR-2017) (dose, frequency and route not reported). No concomitant medications were reported. No adverse experiences were reported. No product quality complaint (PQC) was filed. The outcome of incorrect product storage was unknown. This is one of the several reports of the same reporter. Additional information has been requested.
Booster; Headache; Some arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2), administration date 13Dec2021 (Lot number: FH8030) 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: IMMUNISATION (non-serious) with onset 13Dec2021, outcome "unknown", described as "Booster"; HEADACHE (non-serious) with onset Dec2021, outcome "unknown", described as "Headache"; PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "unknown", described as "Some arm pain". Additional information: The patient received the Pfizer-BioNTech COVID-19 Vaccine booster dose on Monday and had headache now, 3 days later and asked for information how to treat this. Patient mentioned she would still need to contact her Doctor. E-transmitting potential AE for review (47 years old, Female). Response: Checked EUA, Revised: 16Dec2021. Spoke from attached documents and explained that Pfizer is unable to make treatment recommendations specific for individual patients, referred to HCP for further guidance. Follow-up received on 17Dec2021: This is a spontaneous follow-up report received from the same contactable consumer. This 47-year-old female consumer (patient) reported for herself that: Updated Information: New event added. Additional Information: This report is not related to a study or programme. Reporter seriousness for Severe headache and Arm pain: Unspecified. Reporter states that: She received the Pfizer vaccine, the booster on Monday and she had severe headache since then. Patient wanted to confirm whether she should go to the ER. Patient had queried if this Is major cause of concern and what should she do.   No follow-up attempts are possible. No further information is expected.
Cant make fist with left hand; Taste is off (food taste bad); This is a spontaneous report from a contactable consumer (patient). A 63-year-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 24May2021 09:00 (at the age of 63 years old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma, multiple allergies, diverticulosis and hashimoto's disease. The patient was allergic to antibiotics, cats and fish. The patient did not receive any other medications in two weeks of vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. There were no concomitant medications. On an unknown date in May2021, the patient was unable to make fist with left hand and taste was off (food taste bad). The outcome of events was unknown.  The lot number for the vaccine [BNT162b2], was not provided and will be requested during follow up
Client was vaccinated with Pfizer's 1st dose at 1020.  At 1025, the client stated he was light headed. RN on staff began taking his vitals: BP was 168/82 at 1030, 138/72 at 1039, 134/68 at 1051, and 128/72 at 1108. The PulseOx reading was 107 to 180 at 1035, 72 to 74 at 1042. Within this time, RN and client walked around the vaccination area. His mobility was good, as he described himself as a "runner." At 1110, he was cleared by RN and he stated he was feeling good.
This spontaneous report as received from a healthcare worker refers to a 18 year old male patient with penicillin allergy and not pertinent medical history. On 18-JUL-2000 and on 30-APR-2007, the patient was vaccinated with the first and second dose of VARIVAX (route, Lot # and dose not reported) due to he was exposed to a person that had shingles. No concomitant medications taken. On 27-DEC-2012, the patient showed "equivocal" titers. The healthcare worker mentioned the patient received an additional dose of VARIVAX (route, Lot # and dose not reported) on 02-JAN-2013. The patient did not receive treatment. No lab tests were performed. The patient sought medical attention (unspecified). Patient's outcome was unknown. Additional information has been requested.
Fever for two days; injection site pain - for two days. Body pain for about three days. Then after those I got COVID symptoms and was tested positive. After I had COVID - I had axilla lump pain; cough; fever; upper respiratory cough; body aches for about 10 days; I was off of work for about two weeks. I had to go through the Medical group through my doctor and was given a bronchial dilator prescription and that helped clear up the symptoms.  I still have discomfort in my lymph nodes - under my arms.
Client registered for a Moderna Covid-19 vaccine booster nine months after completing the Pfizer Covid-19 vaccine series (doses 1 and 2). He received a Pfizer Covid-19 vaccine booster instead of the Moderna booster which was not his preference. No adverse reactions to our knowledge
This spontaneous report was received from a Registered nurse regarding a 18 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 21-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly female 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 recovered/resolved.   The reporter considered the pain in arm to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR137884   Additional Information: GSK receipt date: 23-SEP-2022 Reporters comment: This case was reported by patient. The patient got the shots when first available in 2018. The patient got sore arm from first Shingirx. But felt no soreness at all after the second and was afraid she might not be fully protected. Wonder if she repeats the shots. The patient stated that it was so unusual for her not to had sore arm, that she wonders if the second shot was effective. Additional Supportive information: For tolerance of Flu vaccine refer case US2022AMR137884, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR137884:Same reporter
Patient reported receiving x3 doses of COVID vaccine.   Patient unable to provide date of 3rd dose  Patient admitted to hospital on 11/27/21, required surveillance testing for behavioral health placement.   Patient is asymptomatic. Surveillance testing only,  no symptoms, not admitted for COVID.  Tested positive for COVID 11/28/2021
PT STATES THAT HIS ARM FELT WEAK AND HE COULD NOT WORK OUT LIKE HE NORMALLY DOES. HE CAN BARELY BENCH PRESS OR DO PULL UPS WITH HIS LEFT ARM WHERE HE GOT THE SHOT. IT HAS BEEN A WEEK SINCE HE GOT THE VACCINE AND IT DID NOT GO AWAY. WE RECOMMENDED HE GETS HIS ARM CHECK OUT BY THE DOCTOR.
This spontaneous report has been received from a medical assistant and an administrator and refers to an unspecified number of patients of unknown ages and genders. The patients' medical histories, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. The reporters stated that on unspecified dates, an unspecified number of patients were vaccinated with improperly stored doses of PNEUMOVAX23 (lot # M036728, expiration date 20-MAY-2018; dose, route of administration, and frequency were not reported), for prophylaxis. The vaccine data logger measure on 24-JAN-2017 a temperature range from 32°F to 35°F (0°C to 1°C) for a total time frame of 1 hours (1 cycle), on 25-JAN-2017, the same temperature frame for 3 hours (3 cycles), on 26-JAN-2017, for 4 hours (4 cycles) at the same temperature frame for a total of 8 hours. The medical assistant mentioned that the vaccine were exposed only for 1 hour and 30 minutes at a temperature as low as 33.1 °F, the other cumulative hours were at 34°F.  There was no previous temperature excursion. No adverse effects were reported, and product quality complaint (PQC) was not involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA001785: US-009507513-1703USA008107: US-009507513-1704USA001784:
No adverse event; Dose-1 (19-Mar-2021) and Dose-2 (06-Apr-2021); This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1 (19-Mar-2021) and Dose-2 (06-Apr-2021)) and NO ADVERSE EVENT (No adverse event) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0048A21A and 007B21A) for COVID-19 vaccination.     Concurrent medical conditions included Lupus erythematosus.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1 (19-Mar-2021) and Dose-2 (06-Apr-2021)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1 (19-Mar-2021) and Dose-2 (06-Apr-2021)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.
Broke out in hives on her ankles, knee caps, hands, and elbows.
Flu shot about 11:30 am. About 2:30 pm started coughing followed by headache, sore throat. By 4:30 "severe" chills with shaking, "skin hurt". Subsided about 8 pm. Woke up this AM "fine" T. 98.5 P 83 BP 106/66 O2 97%.
PT RECEIVE A DOSE THAT HAD BEEN AT ROOM TEMP FOR MORE THAN 12 HOURS - WAS OUT FOR ABOUT 23.45 HRS
no additional AE; the pharmacist that injected her did not do it properly and "a large drip came down the syringe after the injection".; Caller is unsure if she got the full recommended dosage of the vaccine; This spontaneous report was received from a female patient of unknown age reporting on herself. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 23-APR-2021, the patient was vaccinated with her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) as it was recommended by gynecologists. The patient reported that the pharmacist that injected her the vaccine did not do it properly and a large drip came down the syringe after the injection. The patient was unsure if she got the full recommended dosage of the vaccine. The patient did not seek medical attention. No additional adverse event was reported.