chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hospitalized with covid after first dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Apr-2021 and was forwarded to Moderna on 09-Apr-2021.    This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of COVID-19 (hospitalized with covid after first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported).    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (hospitalized with covid after first dose) (seriousness criterion hospitalization). At the time of the report, COVID-19 (hospitalized with covid after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
4-9-13 830 (L) arm swollen, red & warm to touch. 10cm indurated in center with erythema/tenderness. Rec to use cool compresses to arm & TYLENOL . 4-10-13 2 pm mom called & said child had 4 1/2 min seizure this morning at school. Has concern could be due to meds vaccine.
Taken to ER where had EKG, blood tests and low blood pressure; Vaccine Poisoning; Fainted 2 times; Sweating; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 03-Mar-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYNCOPE (Fainted 2 times) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No adverse event reported.).    On 13-Feb-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced SYNCOPE (Fainted 2 times) (seriousness criterion medically significant) and HYPERHIDROSIS (Sweating). On an unknown date, the patient experienced HYPOTENSION (Taken to ER where had EKG, blood tests and low blood pressure) and TOXICITY TO VARIOUS AGENTS (Vaccine Poisoning). At the time of the report, SYNCOPE (Fainted 2 times), HYPERHIDROSIS (Sweating), HYPOTENSION (Taken to ER where had EKG, blood tests and low blood pressure) and TOXICITY TO VARIOUS AGENTS (Vaccine Poisoning) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: low (Low) low. On an unknown date, Blood test: unknoiwn unknown. On an unknown date, Electrocardiogram: unknoiwn unknown.         Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to (patient link). Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This case was reported by a consumer and described the occurrence of adverse event in a adult patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that the patient received shingles shot, and experienced severe side effects and said that no one in the pharmacy told him /her about. The patient want to talk someone. The patient received severe side effects after the both doses for tolerance of 2nd dose refer case US2018GSK194783.
This spontaneous report has been received from a registered nurse via a company representative, referring a 19 months patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of M-M-R II (strength, dose, frequency, anatomical site of injection, lot # and expiration date were not reported) for prophylaxis. On an unknown date, reported as "10 days later", the patient experienced fever of 104 Fahrenheit (pyrexia), the patient sought for medical attention; however the event was not resolved with unspecified treatment. On an unknown date, the patient was hospitalized with a diagnosis of leukocytosis. At the time of this report the patient had not recovered from the adverse events. The causality assessment between M-M-R II was not provided.
Patient contacted PCP to report c/o "lip swelling" This nurse contacted patient, per patient, the only sx was lip swelling. Sx only lasted for a few hours.
vasovagal event, "feeling sick to her stomach", emesis x1 episode, tingling in fingers, hypotensive with  blood pressure 88/62, anxiety, transported to EC, resolved spontaneously
Given ZOSTAVAX 6/10/13. 1 day later developed itching and redness at injection site. Used OTC HC cream - Area responding to OTC cream.
No additional AE; a patient was administered VARIVAX by intramuscular route; This spontaneous report was received from registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and drug reactions/allergies were not reported.  On 03-MAR-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 mL by intramuscular route (lot #U025205, expiration date 13-AUG-2023; anatomical location not reported) for prophylaxis (incorrect route of product administration). The administered vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) 0.5 mL (lot# and expiration date were not provided). No additional adverse event (AE).
Tdap 0.1 given Interdermal Rt fore arm. Slight redness at injection site without pain or redness. No treatment given.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On an unspecified date in December 2015 the patient was inadvertently administered with an expired dose of RECOMBIVAX HB (dose and lot# unspecified, exp unspecified date in October 2015) (expired product administered). No adverse effect was reported. No product quality complaint was involved. Additional information has been requested.
A non-serious spontaneous report of administration of product exposed to temperature way outside allowance was received from a non-health professional concerning 60 adult patients. Neither the patients' past medical history nor the concomitant medications were reported. The patients received FLUMIST on 22-Nov-2010. FLUMIST was administered to the patients even though their TempTale was alarmed and the product was exposed to temperatures outside of the allowance. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
This spontaneous report was received from medical assistant refers to a patient of unknown age and gender. Medical history was not reported. The patient was vaccinated with the first, second and third dose of GARDASIL (route, dosage, lot number and expiration dates were not reported), on 12-SEP-2013, 06-MAY-2014 and 30-JUN-2014 respectively. No adverse reactions were reported. Additional information is not expected.
had an increase in Multiple sclerosis symptoms- numbness, weakness, tingling, and loss of strength in my left arm, hand and leg.; This is a spontaneous report from a contactable consumer, the patient herself. An adult non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: Unknown) via an unspecified route of administration in left arm on 26Jun2021 at 11:00 as single dose for Covid-19 immunization. The patient's medical history included ongoing multiple sclerosis. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated that, after receiving the first dose, since an unknown date in 2021, she had an increase in her Multiple sclerosis symptoms: numbness, weakness, tingling, and loss of strength in her left arm, hand and leg. Reportedly, there was no hospitalization due to the event (Hospitalization Prolonged: No). The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. There was corrective treatment for the event and symptoms. Outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Severe vertigo, nausea and vomiting started 7/29/21 around 7:00 a.m.   Severe vomiting lasted 36 hours.  Severe vertigo lasted 48 hours gradually getting better and completed resolved by 8/3/21.  Vertigo persisted with any movement of my head resulting in severe nausea and severe vomiting.  Unable to keep food or liquids down for at least 36  hours and was resolved by July 31.  I was unable to get out of bed for 36 hours due to vertigo.    Intense chills, sweating, fatigue, headache and irritability lasted through August 2, but gradually is getting better since August 2.  Today, August 3, 2021, vertigo has subsided.   As of today, August 3, 2021, nausea, fatigue, and headache is still present but continues to get better.   Item 20 has been answered as "yes" because major adverse issues have resolved.    Due to the severity of vertigo, nausea and vomiting, I am extremely concerned about adverse reactions to the 2nd dose of the vaccine.  I am interested in receiving input on whether to continue forward with the next dose given the issues with the first dose.    Background information on cat allergy:  I have a history of anaphylaxis with direct exposure to the presence of cats.  I have also had anaphylaxis with exposure to a cat owner as well as exposure to items such as paperwork that has been in an environment where a cat has been present.
Information has been received from a licensed practical nurse referring to multiple unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with doses of PEDVAXHIB (lot # L035880, expiration date: 11-AUG-2018; route not reported) that were improperly stored (0.6 degree C for 11 hours and 10 minutes and 12.3 degree C for 50 minutes; data logger). No adverse effects were reported. This is the several reports from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a female who was vaccinated intramuscularly with her first dose of Gardasil (lot number unspecified). Subsequently the patient experienced severe joint pain. The physician does not have any information about the patient as he only saw her for the joint pain. The patient sought unspecified medical treatment. The physician does not want to be contacted. No further information is available.
Immediately following vax pt fainted & fell to the floor w/brief 10-12sec sz; following sx seemed oriented but was hospitalized for observation; Tx Epinephrine & unspecified IV fluids; Additional details have been requested;
One day following vax, pt devel inject site rxn of "mild cellulitis", which was resolving 3 days later.
This spontaneous report was received from a medical assistant concerning an unknown number of patients of an unknown gender and age. On an unknown date, the patients were vaccinated with VAQTA (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The medical assistant reported doses of VAQTA that were exposed to a supported temperature excursion have been administered to unspecified patients on unspecified dates. No adverse effects have been observed or reported. This is one (1) of five (5) reports from the same source. Additional information has been requested.
Day following the vaccine: temp of 100.4, nauseated, headache, extreme tiredness, red/swollen/hot upper arm (5" in diameter). Lasted for three days.
RECEIVED PFIZER COVID VACCINE ON 02/13/21 02/18/21 CALLED SURGERY OFFICE AND REPORTED A SWOLLEN LEFT LEG TO AN NP. SHE HAD AN EMG PRIOR TO CALL AND TOLD THEM ABOUT VACCINE FROM 02/13.  02/20/21 CALLED AFTER HOURS REP ABOUT COVID VACCINE REACTION 0 DESCRIBED ITCHING CERVICAL LYMPHADENOPATHY, AND WEAKNESS IN LEFT ARM, AND GENERALIZED FATIGUE. INSTRUCTE DTO GO TO THE ER. 02/20/21 REPORTED TO AND DISCHARGED TO HOME/SELF CARE WITH DIAGNOSIS OF SHORTNESS OF BREATH AND ITCHING.
Parasyncope the following morning, left shoulder pain 1 day, low grade (101 deg F) fever 1 day
sleeplessness; dizziness; shakiness; body aches; headaches; nauseous; stomach ache; temperature of 102.1; had to leave work; This case was reported by a nurse and described the occurrence of sleeplessness in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site erythema (received 1st dose on 31st August 2020 and experienced injection site erythema and injection site pain. For the tolerance of 1st dose, refer case US2020AMR261059).   On 15th December 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 15th December 2020, less than a day after receiving Shingrix, the patient experienced sleeplessness, dizziness, tremor, general body pain, headache, nausea, stomach pain, fever and feeling unwell. On an unknown date, the outcome of the sleeplessness, dizziness, tremor, general body pain, headache, nausea, stomach pain, fever and feeling unwell were unknown.   It was unknown if the reporter considered the sleeplessness, dizziness, tremor, general body pain, headache, nausea, stomach pain, fever and feeling unwell to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient experienced sleeplessness, dizziness, shakiness, body aches, headaches, temperature of 102.1-degree Celsius, stomachache and was nauseous. The patient was an operating room nurse and had to leave work. The reporter consented to follow up; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR261059:1st dose
pt  received her second dose of Pfizer COVID that was expired. This vial was prepared more than 12 hrs and its window of stability was already passed when pt received this vaccine. When contacted pt once this error was identified, she did not experience any side effect from the dose. Pt will come back to pharmacy to get re-vaccinated.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 50 year old female. The patient's weight was 178 pounds, and height was 64 inches. The patient's concurrent conditions included high blood pressure, non-alcohol user, non-smoker, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number, 043A21A, and expiry, unknown) dose was not reported, 1 total, administered on 02-APR-2021 for prophylactic vaccination. Patient was unsure about the anatomical site of vaccination, but thinks it was the left arm. Patient was 49 years at the time of vaccination. No concomitant medications were reported.  On 16-JUL-2021, the patient's physician performed the IgG antibody test (SARs COV2 Ab. IgG Spike-S Semi initial QN) which came back negative (confirmed immunological vaccine failure). Physician recommended that she gets vaccinated again but the patient was not sure if she should get another shot. Laboratory data included, SARS-CoV-2 IgG antibody test (NR, not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210755788-COVID-19 VACCINE AD26.COV2.S-confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Information has been received from a physician concerning an 81 year old female patient who in approximately 2007 was vaccinated with a dose of ZOSTAVAX. On 23-OCT-2008 the patient experienced sore throat and went to an urgent care facility then the ER the next day. The patient then developed shingles. She had a rash on her face (cheek) and lesions in her mouth, exactly on half the mouth. At the time of this report, the patient was recovering. Additional information has been requested.
Initial unsolicited report received from a pharmacist on 20 November 2015. This case involves a patient (age and gender was not reported) who was vaccinated with a dose of INFLUENZA VACCINE (flu shot) (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient's arm was hurting and sore when opening door. Lab data and corrective treatments were not reported. Outcome of event was unknown. List of documents held by sender: none.
AIDP/Guillain-Barré in the setting of recent COVID 19 infection  admitted 2/3/22, IVIG, intubation, placed on comfort measures 2/22/22
Patient received Moderna COVID vaccine on 2/11/21 and 3/11/21. On 7/27/22, patient was admitted to our inpatient facility (med/surg unit) for for acute hypoxic respiratory failure secondary to COVID-19 infection. During hospitalization, patient have episodes of hypertension with blood pressure in the 190s that was resolved with IV hydralazine and resumption of home dose of hydrochlorothiazide/lisinopril. Patient was discharged home on 7/30/22.
Change to mensural cycle - spotting 1-2 days immediately following vaccine. Also occurred day right after my 2nd shot of Pfeizer.
suspected vaccination failure; shingles; left with nerve damage; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for an unknown indication.   On an unknown date, the patient received Shingles vaccine at an unknown dose. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and nerve damage. On an unknown date, the outcome of the vaccination failure, shingles and nerve damage were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and nerve damage to be related to Shingles vaccine.  Additional details were provided as follows: The case reported by the patient's neighbor. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles and was left with nerve damage. The reporter stated that, Shingles vaccine did not prevent you from having shingles. Like the Covid vaccine, the hope was if you got shingles, it would not be as bad if you got the vaccine. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.    This case had been linked with case US2021AMR195120, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR195120:Same reporter
I received the J&J vaccine on 3/16/2021 and then flew to watch over my dads house while he went through cancer treatment. I began to have pain in my chest that was getting progressively worse, yesterday I had a very sharp pain when taking a shallow breath.  I went to the hospital they thought I had pneumonia, but then saw a blood clot in right upper side, I've had a prior event but that was attached to an injury in 2012. I've not had any other issues.
This case was reported by a healthcare professional and described the occurrence of a subject of unspecified age and gender not responding to therapy following vaccination with ENGERIX B. On an unspecified date the subject completed the ENGERIX B series. The subject was found at an unspecified amount of time later to have a negative titer  for HEP B. The subject had not responded to therapy. No other events were reported.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (Jun2022) Positive; (Jun2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: No known allergies. No other medication in 2 weeks. Return of covid symptoms and a positive test exactly one week after finishing treatment (5 day supply). Patient previously tested negative for covid 19 after finishing course of treatment last week. Paxlovid given from 02Jun2022 till 06Jun2022 for the treatment of COVID-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
In first 10-15 min after : upset, slight cough,crying and rubbing eyes became lethargic. 20 min after : lips, ears, around eyes, face in general swelled up/red. 25 min. after : tongue swollen, wheezing heard with stethoscope. No cyanosis or change in vital signs during observation after Diphenhydramine (20ml) given 20 min. after injection). 25-50 min. after: facial and tongue swelling slowly decreased, no wheezing. 75 min. after: Dad took her to ER.