chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left arm where vaccine was given hurt for 2 days; This is a spontaneous report from a non-contactable consumer (Patient herself). A 66-year-old non pregnant female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration administered in left arm on 12Feb2021 15:00 (at the age of 66-year-old) as single dose for COVID-19 immunization. No Medical history provided. Concomitant medications were not reported. Patient did not other vaccine in four weeks. Patient did not receive any treatment for AE. The patient did not have covid prior vaccination and did not test covid post vaccination. On 12Feb2021 15:00 patient experienced Left arm where vaccine was given hurt for 2 days; resolved thereafter. No other issues. The outcome of the event was recovered on unspecified date.  No follow-up attempts are possible. Information about lot/Batch number cannot be obtained. No further information is expected.
palpitations for about 5 minutes; This is a spontaneous report from a contactable consumer (patient's husband) via Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Not reported) via an unspecified route of administration on 29Mar2021 as first dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 29Mar2021, the patient experienced palpitations for about 5 minutes. Reporter wanted to know if that was okay or just normal. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
patient never got the third dose; first dose of Twinrix on Feb-27-2019 / second dose on Aug-28-2019 / received a late second dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received first dose on 27th February 2019).   On 28th August 2019, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 28th August 2019, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device and not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long and incomplete course of vaccination were 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 applicable for 3rd dose. The patient was vaccinated with 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule. Till the time of reporting, the patient did not receive 3rd dose of Twinrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with GARDASIL. Subsequently the physician reported that the patient had a reaction to the sulfate in the vaccine. The reaction manifested as a rash on different parts of the patient's body. The patient was seen by her physician. At the time of this report, the outcome of the event was unknown. Additional information has been requested.
Broke out in a generalized rash...with itching.  Beginning in left armpit.  The shot was given in the right arm.
Pain in injection area (worst 1-2 days after),  swelling at injection site (worst 1 day after), muscle/joint soreness (upper body only 1-2 days after),  limited arm movement (injected arm, severe pain when raising above 90 degrees, worst 1-2 days after), exhaustion (1 day after), headache (mild 1-2 days after, worsened when moving),
Last year patient had a reaction to the vaccine in his upper left arm. It was swollen, warm when palpating and minimal mobility at right elbow. He also had very itchy skin. Yesterday he was given a flu shot in his right thigh and is having the same reaction. Red, swelling, and guarding leg, except no itching this time.
Swollen glands under left armpit after a few days after first dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Apr2021 (Lot number: FR8734) at the age of 38 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Antibiotics, reaction(s): "Known Allergies", notes: antibiotics. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 04Apr2021, outcome "not recovered", described as "Swollen glands under left armpit after a few days after first dose". The event "swollen glands under left armpit after a few days after first dose" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: Swollen glands under left armpit after a few days after first dose have remained swollen for over a month. The patient did not had other vaccine in four weeks.The patient did not had COVID prior vaccination and was not tested for COIVD post vaccination.  No follow-up attempts are possible. No further information is expected.
On April 1st, I begin sneezing a lot and runny nose, also the left side of my face was swollen and a little red, by Sunday the 4th my left side was more red, I was still sneezing and had running nose.  I went to my Dr. on Monday, saw a PA, who diagnosed me with a sinus infection and gave me meds.  The next day I went to the dentist, because it was redder and swelling more, thinking it might be a tooth problem(none) On Thursday I returrned to the Dr. office,where I again saw PA. He called in another PA who immediatly said it was shingles(by now my whole upper side of my face to my hairline was red and puffy.  I was given meds, My face looks worse then even, red, puffy, blisters, and hur
Covid monitoring documentation. PT admitted 1/9/22 documented to have positive covid. PT received Pfizer 2/22/21 Lot EN6200 for dose 1. Dose 2 was Pfizer given on 3/15/21 Lot EN6204
Client states has never had varicella vaccine or chicken pox disease. Is attending nursing school and varicella vaccine required for clinical experiences. Received varicella vaccine on 3/6/15. Started slight fever and rash on face an generalized on body 3/28/2005 (21-22 days after vaccine). Presented at HD on 3/30/15 for cough. Fever has resolved . Rash is mild and drying. Out at school and at home until rash is crusted and dry.
I got my 1st vaccine in March and in May I felt a lump in my left breast. Got a mammogram done in August and it was abnormal. Biopsy in September confirmed triple negative brest cancer.
Information has been received from a healthcare worker concerning a female patient who on unspecified dates was vaccinated with a first and second dose of GARDASIL (doses, routes and Lots# not reported). The healthcare worker stated that after received GARDASIL doses, on unspecified date the patient had to be treated for lyme disease (medication unknown). At the time of the report the patient's outcome was unknown. The patient sought medical attention by office visit. Follow-up information was received from the healthcare worker who reported that the patient was awaiting the third dose of GARDASIL and the patient was diagnosed with lyme disease before the third dose of GARDASIL was "administered". There were no adverse reaction after GARDASIL. The healthcare worker stated that they were just concerned as to any data that might be able to lacking . The healthcare worker reported that an immunization was given as a treatment for lyme disease. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Made him incredibly sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 83-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Unspecified types of Non-Hodgkin Lymphoma" (ongoing). Concomitant medication(s) included: IMBRUVICA taken for non-hodgkin's lymphoma (ongoing). Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: ILLNESS (hospitalization), outcome "recovered", described as "Made him incredibly sick". Therapeutic measures were taken as a result of illness. Clinical course: Reporter (patient care coordinator) reported as adverse event based on a conversation he had with his patient. Caller called regarding Imbruvica shipment but patient mentioned that he had Pfizer COVID-19 Booster shot and that made him incredibly sick, and he would not like to take any more Booster shots from Pfizer. Patient was discharged on an unknown date from hospital.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
covid vaccine breakthrough case  dose 1 Moderna  3/9/21  044A21A dose 2 Moderna  4/6/21  040B21A dose 3 Moderna  11/4/21  076C21A
Having pain and burning sensation to skin at injection site of left shoulder. It radiates to the base of the head, posterior left shoulder and upper arm. Took one dose of Excedrin with temporary relief.
One of our pharmacists gave a "booster" dose to this patient before booster doses were actually approved by the FDA/CDC.
Dose 1: 1/22/2021; Moderna Covid-19 Vaccine; Lot #028L20A Dose 2: 4/26/2021; Pfizer Covid-19 Vaccine; Lot #ER8736  Patient received Dose 2 of Covid-19 Vaccine series outside of 42 day window and received dose of Pfizer instead of Moderna.  Patient did not exhibit any adverse event, side effects or obvious reactions during required 15 minute observation. Patient was contacted after departure from clinic and self-reports stable condition.
popped blood vessels in both eyes after the vaccination; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of OCULAR DISCOMFORT (popped blood vessels in both eyes after the vaccination) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 002C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient experienced OCULAR DISCOMFORT (popped blood vessels in both eyes after the vaccination). At the time of the report, OCULAR DISCOMFORT (popped blood vessels in both eyes after the vaccination) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
IT DIAGNOSED AFTER THE COVID SHOT (ADVERSE EVENT UNSPECIFIED); This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced it diagnosed after the covid shot (adverse event unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of it diagnosed after the covid shot (adverse event unspecified) was not reported. This report was non-serious.
Left arm  redness, swelling and pain  Fever 9.99 Fon 1/5/2021 at 9 pm I took  2 Tylenol 500 mg tab  102 F on 1/6/2021 at 6:30 am  I took Tylenol again around 7:30 am 2 tab of 500 mg .  Fever returned around 4 pm for which I took Tylenol again and later in the evening I took total of 600 mg of Advil  200 mg . On 1/7 /2021 no fever but arm swelling and redness is much larger with  induration 4-5 cm diameter  Arm swelling still has not resolved as of today therefore I answered unknown to the following question.
This spontaneous report as received from a pharmacist refers to a 61 years old female patient with no known reactions or allergies. The patient was subcutaneously vaccinated with ZOSTAVAX (lot # 671901/0421AE, Exp date: 21-MAR-2013, dose/frequency unspecified) on 26-AUG-2012. It was reported that the patient experienced immediate tingling of the lower lip after administration of ZOSTAVAX on 26-AUG-2012. The patient declined the suggestion that she went to a local emergency room for evaluation. The patient took oral BENADRYL and left the pharmacy. The pharmacist contacted the patient for follow-up later in the day and she had fully recovered without additional symptoms. Additional information is not expected.
Fever(highest 103.8); Chills; body aches; Muscle soreness; Headache; extreme fatigue; This is a spontaneous report from a contactable nurse reporting for herself. A 35-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 08Jan2021 at 11:00 at single dose in left arm for COVID-19 immunisation. Age at vaccination was 35 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient was vaccinated at hospital. Historical vaccine included first dose of BNT162B2 administered on 18Dec2020 at 10:00 at single dose in left arm. Medical history included autoimmune thyroiditis (Hashimotos hypothyroidism), migraine, tachycardia/ palpitations. The patient has known allergies to tioconazole. Concomitant medications included sumatriptan succinate (IMITREX), propranolol (PROPANOLOL), levothyroxine sodium (SYNTHROID) and birth control. On 08Jan2021 at 07:00 PM, the patient experienced fever (highest 103.8), chills, body aches, muscle soreness, headache and extreme fatigue. No treatment was received for the events. The patient did not have COVID prior to vaccination and was not tested positive post vaccination. The events resolved on an unspecified date in Jan2021.  Information on the lot/batch number has been requested.
Shingrix vaccines were placed in the freezer; This case was reported by a nurse via call center representative and described the occurrence of intercepted product storage error in an unspecified number of patients who received Herpes zoster (Shingrix) (batch number L4RD3, expiry date 8th October 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted product storage error. On an unknown date, the outcome of the intercepted product storage error was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. Nurse reported that Shingrix vaccines was exposed to a minimum temperature of minus 8.1 degree Fahrenheit since 28th July, 2021, which led to intercepted product storage error. The nurse realized they had made a mistake, and that the PI said that the vaccines should not be placed in the freezer. Vaccines was not given to patients, the health care professional  wanted to know if they were still viable or not. No further details was provided at the time of the call. The reporter consented to follow up.
Fever onset a few hours after administration MOTRIN given. Next morning eyes rolled back, arms shaking, foaming at mouth, incontinent. EMS to ED. Episode last about 5 minutes. Post-ictal about 2 hours. Discharged home from ED same day.
48 days post first vaccine and no second shot; Felt Very Sick; Very Weak like having a Flu; Shaky Legs /  could not hold her up; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MALAISE (Felt Very Sick), ASTHENIA (Very Weak like having a Flu), TREMOR (Shaky Legs /  could not hold her up) and PRODUCT DOSE OMISSION ISSUE (48 days post first vaccine and no second shot) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced MALAISE (Felt Very Sick), ASTHENIA (Very Weak like having a Flu) and TREMOR (Shaky Legs /  could not hold her up). On 07-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (48 days post first vaccine and no second shot). On 26-Mar-2021, ASTHENIA (Very Weak like having a Flu) had resolved. On 20-Apr-2021, MALAISE (Felt Very Sick) and TREMOR (Shaky Legs /  could not hold her up) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (48 days post first vaccine and no second shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant treatment medications were reported.
On 03/16/2021 I was having a hard time breathing for about a week. I went to walk in clinic took COVID test but it was negative. The doctor did x-ray and found pneumonia they gave me steroid, inhaler, and an antibiotic. I was on those for 10 days. I started to feel better after 3 or 4 days. I did a follow up x-ray 4 weeks later and the pneumonia was clear.
Information has been received from a physician concerning a patient (age and gender not reported) who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient experienced an injection site reaction. The patient sought unspecified medical attention. The patient's status was reported as "improved after a couple of days". There was no product quality complaint involved. Attempts are being made to obtain additional identifying information to distinguish the individual patient mentioned in this report. Additional information will be provided if available. This is one of several reports received from the same source. Additional information has been requested.
Hot rash; Red rash; rash on the arm where she received the vaccine.; Swollen rash; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE WARMTH (Hot rash), RASH ERYTHEMATOUS (Red rash), VACCINATION SITE RASH (rash on the arm where she received the vaccine.) and VACCINATION SITE SWELLING (Swollen rash) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT RAPIHALER) and CALCIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM CHLORIDE (FLO NASAL MIST) for Asthma, MONTELUKAST SODIUM (SINGULAIR), ROSUVASTATIN CALCIUM (CRESTOR), VITAMIN B12 [VITAMIN B12 NOS], VITAMIN D3 and L-LYSINE [LYSINE] for an unknown indication.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot rash), RASH ERYTHEMATOUS (Red rash), VACCINATION SITE RASH (rash on the arm where she received the vaccine.) and VACCINATION SITE SWELLING (Swollen rash). On 10-Feb-2021, VACCINATION SITE WARMTH (Hot rash), RASH ERYTHEMATOUS (Red rash), VACCINATION SITE RASH (rash on the arm where she received the vaccine.) and VACCINATION SITE SWELLING (Swollen rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details was not reported by the reporter.
This case was reported by a physician via call center representative and described the occurrence of injection site cellulitis in a child patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced injection site cellulitis, injection site erythema, injection site abscess and injection site swelling. On an unknown date, the outcome of the injection site cellulitis, injection site erythema, injection site abscess and injection site swelling were recovering/resolving. The reporter considered the injection site cellulitis, injection site erythema, injection site abscess and injection site swelling to be possibly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of FLUARIX QUADRIVALENT in an unknown deltoid. The injection site was red, swollen and appeared as a cellulitis with an abscess. The physician did not have the charts at the time of reporting.  The physician denied any serious criteria concerns. The physician had limited information, but would have nurse call back with more details. This case was linked to case, US2016155828 as reported by the same reporter.
PATIENT WENT UNCONSCIOUS FOR APPROXIMATELY 30 TO 60 SECONDS. WE CALLED AMBULANCE. THEY EVALUATED HER AND SAID SHE WAS OKAY.