chrisvoncsefalvay/vaers-outcomes huggingface dataset:
VACCINE INDUCED IMMUNE THROMBOTIC THROMBOCYTOPENIA (VITT) SYMPTOMS; THROMBOCYTOPENIA; This spontaneous report received from a pharmacist concerned a 44 year old female of unknown race and ethnicity. The patient's height, and weight were not reported. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced vaccine induced immune thrombotic thrombocytopenia (VITT) symptoms, and thrombocytopenia, and was hospitalized (date unspecified). The duration of hospitalization was unspecified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine induced immune thrombotic thrombocytopenia (VITT) symptoms and thrombocytopenia was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210946732-covid-19 vaccine ad26.cov2.s-vaccine induced immune thrombotic thrombocytopenia (VITT) symptoms and thrombocytopenia. This event(s) is labeled per RA and is therefore considered potentially related.
This spontaneous report as received from a 65 year old female consumer reporting on herself. In 2008, the patient was vaccinated with a dose of ZOSTAVAX (route and lot# not reported). The consumer reported that she received the vaccine when she was 60 years old and on an unknown date, when she was 65 years old, she experienced shingles. The consumer stated that she had no rash at all and had very back pain. The outcome of shingles was unknown. Additional information is not expected.
Immediately after injection, the injection site swelled up. Pt did not experience any pain. Applied ice pack to area for 15 minutes.  Pt took 400mg ibuprofen. Swelling went down before leaving the pharmacy. ( 25 minutes after injectin)
Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Hyperlipidemia.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications were  included high blood pressure medication and cholesterol medication. Treatment medication was unknown   Reporter did not allow further contact
Patient began presenting with extreme psychological adverse reactions to the flu shot in November 2017. She has not recovered to date. Her symptoms are cyclical and are not improving. She presented at the height of this reaction with hallucinations, delusions, paranoid thoughts, lethargy, anxiety and depression. She was admitted to the hospital about November 27, 2017 and was discharged with unknown brain condition. She was then recalled to the hospital when doctors suggested she had autoimmune encephalitis. All tests resulted in negative outcomes. It was suggested she had dementia and depression; however doctors cannot agree as to the  correct diagnosis. She is once again in the hospital for indeterminate amount of time at psychiatric unit due to worsening conditions once again. I (daughter) have corresponded with at least two other individuals with similar conditions that appear to be related to flu shot. At least two doctors have expressed concern over flu shot and the timing of when patient's symptoms started coinciding with flu shot.
Patient stated that she got redness in her arm from her elbow up, pain and itchiness. It lasted a few days and is now not presenting with symptoms
Sore arm (1st dose); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm (1st dose)) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm (1st dose)). At the time of the report, PAIN IN EXTREMITY (Sore arm (1st dose)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was not provided by the reporter.    This case was linked to MOD-2021-293176 (Patient Link).
about 2 hrs following administration of vax pt devel a rash & was hospitalized overnoc for observation; d/c 26MAY93;
High fever, weakness, paleness, dizziness, aches from Thursday to Tuesday. Sought medical treatment and received prescription Z-Pak.
At 3/20/03 experienced chest discomfort lasting at 15-20 minutes while working in the garden. Since 3/20/03 had several recurrent episodes lasting at 5 minutes which improved after rest. Saw MD 4/1/03; sent to cardiologist 4/3/03. 4/7/03 triple cardiac bypass.
Sweling from elbow to shoulder that spread past the shoulder on the second day. Fever. Cephalexim was prescribed by doctor, which resulted in decrease of swelling.
This spontaneous report as received from a licensed nurse practitioner refers to a 63 years old female patient who on 31-AUG-2012, was vaccinated SQ in the left arm with a 0.5 ml dose of VARIVAX (Merck) (lot# 0973AA, exp 17-JUN-2013). It was reported that the patient was inadvertently vaccinated with VARIVAX (Merck) instead of ZOSTAVAX today "on 31-AUG-2012". No adverse effects were reported. This is one of several reports from the same source. Additional information is not expected.
- Swelling in right axillary lymph nodes 5 days after vaccine. - Redness and pain in right axilla same day as vaccine.
VESTIBULAR NEURITIS, TRANSPORTED TO ER AND SUBSEQUENTLY HOSPITALIZED FOR 7 DAYS. PATIENT HAS  REGAINED 80 % OF HER EQUILLIBRIUM. SHE IS HOME NOW.
Within a minute of getting vaccine, warm sensation all over my body. I broke out in hives, throat and mouth were itchy, irregular heartbeat, elevated BP, felt flutters in my chest. I went to emergency room. I was given Benadryl and steroids
Temp to 101.4 after imms. No swelling or redness at inj. sites. Day of imms. Temp down to 99.9 the following day.
Fatigue, chills, fever, body aches, headache, malaise.  I received booster on 1/21/22 and missed day of work on 1/24/22.
Febrile seizure, 2 minutes duration, with 3 associated vomiting episodes
p/vax parents reports temp spike 105 ax 1 1/2hr p/vax;temp ranging 100-105.2 over next 4 days;pt taken to hosp;
Patient experienced a red rash spreading from her chest down her arms. The rash is not itchy and just red.
Fever of 100.3F; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), FATIGUE (fatigue) and PYREXIA (Fever of 100.3F) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concomitant products included MONTELUKAST, ATORVASTATIN, ACETYLSALICYLIC ACID, DIPYRIDAMOLE (AGRENOX), METFORMIN, ALENDRONATE SODIUM, VITAMIN D3, CAFFEINE, CODEINE PHOSPHATE, PARACETAMOL (ACETAMINOPHEN WITH CODEINE), CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), CALCIUM CARBONATE (OSCAL [CALCIUM CARBONATE]) and OLMESARTAN for an unknown indication.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced CHILLS (chills) and FATIGUE (fatigue). On 26-Jan-2021, the patient experienced PYREXIA (Fever of 100.3F). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 27-Jan-2021, CHILLS (chills), FATIGUE (fatigue) and PYREXIA (Fever of 100.3F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, Body temperature increased: high (High) 100.3 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also included allergy shot every 3 weeks.
approx 2 hrs p/immun pt begin to have facial swelling & rash; no other sx except itching w/rash; referred to MD;
I contracted COVID-19. I had body aches all over my body, coughing, runny nose, nasal congestion, and a fever of 100.6 maximum. I also had an extreme sore throat. It was very hard to swallow and it was painful. I was prescribed Paxlovid and was given cough medication. The Paxlovid was very helpful and made me feel better. I'm not completely better though, but I'm feeling way better than the first three days.
pt recv flu vax in 1994; 3 days later pt devel bilateral lower extremity weakness & paresthesias; pt was hospitalized & MD dx transverse myelitis affecting the lower limbs; pt has improved but cont to have bilat weakness
Patient left arm around injection sites was hot to touch and was accompanied by redness for several inches induration from site...not much swelling & no pain.
day p/vax pt exp rash back, left side of face & bilat thighs & inject site
Information has been received from a health professional concerning a 9 year old male with a history of allergic rhinitis who on 12/21/1998 was vaccinated with a subcutaneous first dose in th right arm of varicella virus vaccine live (lot 627333/1244H). There was no illness at the time of vaccination and no adverse events following prior vaccinations. On 12/15/2004 the patient presented to the office with a rash, described as elongated vesicles in various stages that was diagnosed as varicella by the doctor. There were no laboratory or diagnostic tests performed. Follow up information from a health professional indicated that on 12/15/2004 the patient was examined by the physician at the office with a skin rash, described as itchy with elongated vesicles at various stages that the physician diagnosed as varicella. It was reported that the patient recovered in approximately 2 weeks, on 12/28/2004. Additional information is not expected.
Developed hives and dizziness with headache day after vaccine; took Benadryl ; no outcome yet as just medicated
Influenza type symptoms; Localized swelling; Redness at the injection site; Body aches; Nausea; This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms, swelling, injection site erythema, general body pain and nausea. On an unknown date, the outcome of the influenza-like symptoms, swelling, injection site erythema, general body pain and nausea were unknown.   It was unknown if the reporter considered the influenza-like symptoms, swelling, injection site erythema, general body pain and nausea to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the patient experienced localized swelling and redness at the injection site with severe all over body aches and influenza type symptoms, including nausea. The reporter consented to follow up.
Pt called and stated that he has had a severe headache since vaccine 2 days ago, one episode of nausea and vomiting.  Pt spoke to Dr. and provider recommended Tylenol 500 mg TID.  Also told pt he he can take ibuprofen, or benadryl sparingly. Report to ER if symptoms worsen. Call and make appt at clinic if symptoms persist for more than 7 days post vaccine.
Pt reports "frozen shoulder" about 2 weeks about vaccination on 10/17/21. Saw MD, had an MRI, which showed no damage per pt. Pt says arm still hurts and has limited range of motion. Submitting for documentation purposes.
broke out in a bad flare of BP; broke out in a bad flare of BP; Bad itch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 86-year-old female patient received BNT162b2 (BNT162B2), in Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 85 years for covid-19 immunisation. The patient's relevant medical history included: "Bullous pemphigoid" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single, lot number: EY0584, intramuscularly administered in the left arm (upper) at 12:00), administration date: 03Aug2021, when the patient was 85-year-old, for covid-19 immunisation, reaction(s): "Bullous pemphigoid flare", "Condition aggravated", "Rash". The following information was reported: CONDITION AGGRAVATED (medically significant), PEMPHIGOID (medically significant) all with onset 18Jul2022, outcome "unknown" and all described as "broke out in a bad flare of BP"; PRURITUS (non-serious) with onset 2022, outcome "unknown", described as "Bad itch". Therapeutic measures were taken as a result of pruritus. Course of events: The patient has been communicating over the past year regarding COVID and her autoimmune disease "Bullous Pemphigoid". This is the 8th year she had this auto immune disease. She had her 2 vaccines, the last Aug2021. After 2 weeks from 04Jul2022, she broke out in a bad flare of BP (above). She had bad itch and need Doxycycline every day. She was trying to avoid prednisone. She think that vaccines for COVID should not be given to people with BP.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
A high touch sensitivity of area of right hip & thigh w/ some muscle ache. First event occurrence.
Four patients were administered only 0.125mL (25mcg) as their booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Four patients were administered only 0.125mL (25mcg) as their booster dose) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .125 milliliter. On an unknown date, the patient experienced UNDERDOSE (Four patients were administered only 0.125mL (25mcg) as their booster dose). At the time of the report, UNDERDOSE (Four patients were administered only 0.125mL (25mcg) as their booster dose) had resolved.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  The four patients received 0.125mL of the Moderna COVID-19 Vaccine (25mcg) for their booster dose. All four patients were intended to receive 50mcg (0.25mL) of the booster dose. No concomitant and treatment information were reported by the reporter.
I had a sore throat and a runny nose the day before. I had in addition right ear pain my lymph  nodes and felt like they were swollen and congestion in my head.  A tele visit was done the next day and Pacxlovid was prescribed which I completed.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021 at 9:51 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Apr-2021 at 9:51 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 20.84.  Concomitant products were not provided.  On 27-APR-2021, Excursion time was 09 AM, temperature was 35, total doses given for the day was 42, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 19-APR-2021, vial was moved to clinic on 27-APR-2021. 8 vials were sent to clinic. Vaccine BUD date was 19-MAY-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
2 episodes febrile seizure, brought by EMS to local ER, received Ativan with 2nd seizure, transferred to second hospital PICU for observation and work-up.
Headaches for two days; Neck pain on right side for 2 days and then neck pain on left side for 2 days; This is a spontaneous report from a contactable consumer (patient). A non-pregnant female patient of unknown age (Age: 70; Unit: Unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 27Jan2021 10:30 AM at left arm as a single dose for COVID-19 immunisation. The patients medical history included cancer. No Known allergies were reported. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient had not been tested for COVID 19. Concomitant medications included losartan, atenolol and metformin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Jan2021 at 07:00 AM, the patient experienced Headaches for two days, neck pain on right side for 2 days and then neck pain on left side for 2 days. No therapeutic measures were received for the events. The outcome of the events were recovering. Information on the Lot/Batch Number has been requested.  Follow-up attempts are completed. No further information is expected.
Fatigue dizziness on site. Month later constant lymph node swelling feels like needles, abdominal swelling/constipation, abdominal pain. No other health issues at the time or prior to getting vaccination
Adjuvant only administered.; Adjuvant only administered.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 73PP9) for prophylaxis.   On 08-MAR-2023, the patient received the 2nd dose of Shingrix. On 08-MAR-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Adjuvant only administered.) and inappropriate dose of vaccine administered (Verbatim: Adjuvant only administered.). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 09-Mar-2023 The pharmacist called to inform that on 8th March 2023 a patient was supposed to receive the 2nd dose of Shingrix but received only the adjuvant portion of it. HCP asked to remain anonymous. The reporter consented to follow up. The patient had received only the adjuvant of shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Brief episode of lightheaded dizziness and nausea, drank some juice, and wife drove patient home
Five minutes post administration of DTaP and MMR, patient's arm began to swell at injection site.  Patient also developed a hive like rash, redness and swelling from shoulder to elbow.  Patient was given Benadryl 12.5 mg oraly.  No respiratory distress noted.
Swelling and tenderness at the site of injection. Patient stated that she started working out again the day before lifting six pound weights for the first time since injection. She stated that she has taken Ibuprofen for pain but hasn't noticed a decrease in symptoms since 12/01/2009. She stated that she is going to call her doctor.
Information has been received from a physician's assistant concerning a 13 year old male student with attention deficit/ hypersensitivity disorder and a "sulfa" allergy who on 02JUN1995 was vaccinated with a 0.5ml dose of varicella virus vaccine live. Concomitant therapy included methlyphenidate HCl (RITALIN) 10mg q AM and q noon. There was no history of chickenpox and no recent exposure to chickenpox or herpes zoster. On 22MAR2003, the patient developed herpes zoster, which was noted to be on his right thigh. The patient was seen in the physician's office The rash did not occur at the site of injection or elsewhere within 42 days of the vaccination. It was noted that the child had no fever, quantified his pain at a 5-6 (0 being the least; 10 being the most), and complained of itching. The patient was placed on famciclovir (FAMVIR) for seven days. After one month, the patient recovered from the herpes zoster. Results of PCR analysis revealed that the zoster lesion contained the WT varicella zoster virus. Additional information is not expected.
vaccine that was given,  it was expired after 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine that was given,  it was expired after 12 hours) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine that was given,  it was expired after 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine that was given,  it was expired after 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided. No concomitant medication was provided.