chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist referring to a 59 year old patient of unknown gender. There were no concomitant medications, concurrent conditions and medical history reported. In September 2015 (reported as "between 10-SEP-2015 and 18-SEP-2015"), the patient was vaccinated with improperly stored dose of ZOSTAVAX (dose, frequency and route of vaccination were not reported, lot # L011533 with expiration date: 03-JUL-2016). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
shingles; This is a spontaneous report received from a non-contactable consumer or other non hcp. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient experienced shingles on unspecified date. Additional information reported as he refers to AE's he knows about or has heard about. He saw a report that an infant received the Pfizer BioNTech Covid-19 and is paralysed. He also saw a news report about a doctor that pulled out parasite linked to vaccine. The same doctor showed blood samples of people that have had blood clots from the vaccine. He himself had a relationship with a woman who got the vaccine, and she got both Covid and shingles (shingles presented as a rash all over his body that lasted 2 months). He knows an adult female who gets migraines every other day. The clinical outcome of the event shingles was recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
NEUROLOGICAL SYMPTOMS; This spontaneous report received from a consumer concerned a male of unspecified age. 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 was not reported, administered on APR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced neurological symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of neurological symptoms was not reported. This report was non-serious.
fever every night, of just over 100; body aches; massive joint pain; This is a spontaneous report from a contactable consumer (patient).   A 34-year-old male patient received second of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm on 13Apr2021, at the age of 34-years-old, (Lot Number: EW0153) as 2ND DOSE, SINGLE for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19.  Historical vaccine includes first dose of BNT162B2, on 23Mar2021 left arm (Lot number: EP7534). On 14Apr2021, the day after the second shot, the patient had fever every night, of just over 100, has body aches and massive joint pain for over 30days. The adverse event required doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events was assessed as serious, disability.  Since the vaccination, the patient been tested for COVID-19, test: Nasal Swab on 20May2021 with negative result.  The outcome of the events was recovering. Treatment received for the adverse event includes prednisone.
Immediately migraine, extreme fatigue and then within hours the  onset of pericardial type pain (pressure and stabbing pericardial pain) and has persisted since along with fever and chills on and off, skin crawling sensations in face as well.  I have gone back to taking colchicine again and am afraid to take second dose since I reacted so immediately to this one.  Understanding people?s reactions have been more severe on 2 Nd dose.
Patient called & stated he normally has a sore arm after a flu shot which goes away in 1-2 days - this time he has been very sore for over 1 week. (No lump, redness or swelling at injection site). Recommended pt should try Ibu.
COVID infection requiring hospitalization, intubation and mechanical ventilation with ARDS, pneumomediastinum, pneumothorax.
The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023; No adverse event; Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023) and PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. It was reported that no adverse reactions have been reported by any patients. The vial was initially stored in the refrigerator on 4-JUN-2023 and did not underwent any temperature excursions. No treatment medication was reported. This case is reported for patient 10 out of 50 patients.
patient reports feeling lightheaded and weakness, sees spots/blurry film, cheeks flushed,  patient began to report focal muscle tenderness under her left armpit.  Symptoms resolved about 40 mins after vaccination.
15 min S/P BEXSERO and PPD placement, while on toilet pt C/O nausea and feeling like she was going to pass out. Pt pale and eyes started to rolled back in head. Pt alert and oriented x 3. Helped into wheelchair. Pt then reported tingling. Clammy and reported "I just don't feel like I'm here". Noted rash on chest. (HX anxiety rash). This occurred in BR outside clinic office - 911 called and sent to ER for evaluation.
Patient presented to the pharmacy to receive the second dose in her primary vaccine series. Patient was given a Pfizer Bivalent Booster shot in lieu of the Pfizer Monovalent Booster that should have been administered due to the fact that she had not completed her primary series.
Soreness at time of injection followed by chronic inflammation and pain in my left upper arm, elbow, and shoulder.
Patient received Moderna Covid-19 vaccination at 10:50 AM on June 2, 2021. Within 10 minutes patient describes being shaky. Patient was given orange juice. After 2-3 minutes patient described chest tightness which progressed into left arm pain during our conversation and was not improving. 911 was called.  As paramedics arrived, approximately 11:30-11:40 AM, patient began to complain of trouble swallowing but no trouble breathing. Paramedic checked patients heart and patient started to develop hives. The paramedic gave the patient diphenhydramine and then was taken to the hospital for treatment.
Swelling and red rash to left arm (deltoid) where MMR and DTAP sites given.
3d after vaccine noted (L) clavicle area sore then spread to (L) anterior clavicle area. Pain 8/10. ADVIL helped total 7d with decreased ROM and pain 5/10.
Pt recvd vax 17MAY94 in lt thigh; approx 24 hrs later devel redness & pain @ site; mom applied cool compress & gave APAP; seen by MD 19MAY94; local react noted @ site of lt thigh; 8-10cm erythema w/sl induration;no lumps, no mass, no infect
Client received the first dose of Moderna on 5?11?21 and was due for his second dose today 06/08/21. Mother is present and consent and the dose must be given per the CDC (Administration and error documentation deviation and error) Recommended as off label use,. Per Dr. (Chief Health Officer of the Health Department). Client denies any adverse reaction to the first dose.
CHILLS; BODY TWITCHING; ACHY BODY; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070, and batch number: 1802070 expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 11:40 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 98 F. On 06-MAR-2021 18:30, the subject experienced chills. On 06-MAR-2021 18:30, the subject experienced body twitching. On 06-MAR-2021 18:30, the subject experienced achy body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, and body twitching, and had not recovered from achy body. This report was non-serious.
While waiting for 2nd dose, contracted COVID; incomplete course of vaccination; This case was reported by a pharmacist via call center representative and described the occurrence of covid-19 in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 25th August 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced covid-19 and incomplete course of vaccination. On an unknown date, the outcome of the covid-19 and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.     Additional Information: GSK Receipt Date: 22-AUG-2022 Reporter's comment: Pharmacist reported that a patient received her first dose of Shingrix 2 years ago. While the patient was waiting for the 2nd dose, she contracted COVID and forgot about getting the 2nd dose. The reporter did not have any details of when the patient had COVID and was unable to provide a lot number and expiration date for the 1st vaccine. The reporter consented to follow-up via postal. Additional Supportive Information: Till the time of reporting the patient did not received the 2nd dose of Shingrix, which led to Incomplete course of vaccination.
Client noticed 2 1/2" x 1 1/2" red raised area with fever on left arm on 9/19/02. Shot administered on 9/17/02. No medications taken or ointments applied to area. 9/20/02 area silver dollar size now, warm to touch. No red streaks noted.
Presentation of expiration date on box was confusing for immunizer. They did not believe product was expired when administered.
staff member administered an expired daptacel to a patient with no reorted adverse event; Initial information received on 06-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 31 months old female patient and staff member administered an expired diphtheria-15/tetanus/5 AC Pertussis Vaccine [Daptacel] to a patient with no reorted adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 27-Jun-2023, the patient received a dose 4 at a dose of 0.5 ml of suspect diphtheria-15/tetanus/5 AC Pertussis Vaccine Suspension for injection (strength: standard, expiry date: 21-Jun-2023 and lot C5893AA) via intramuscular route in unknown administration site for immunization and staff member administered an expired daptacel to a patient with no reorted adverse event (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
antibody test came back at 0.4 and she was told it should be at 0.8 or higher(received results on 11/May/2021).; This spontaneous case was reported by a consumer and describes the occurrence of ANTIBODY TEST ABNORMAL (antibody test came back at 0.4 and she was told it should be at 0.8 or higher(received results on 11/May/2021).) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 002C21A) for COVID-19 vaccination.     Concurrent medical conditions included Lupus syndrome. Concomitant products included HYDROXYCHLOROQUINE SULFATE (PLAQUENIL S), MYCOPHENOLATE MOFETIL (CELLCEPT [MYCOPHENOLATE MOFETIL]), VITAMIN D NOS and PREDNISONE for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced ANTIBODY TEST ABNORMAL (antibody test came back at 0.4 and she was told it should be at 0.8 or higher(received results on 11/May/2021).). At the time of the report, ANTIBODY TEST ABNORMAL (antibody test came back at 0.4 and she was told it should be at 0.8 or higher(received results on 11/May/2021).) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-May-2021, Antibody test: 0.4 (abnormal) Result should be 0.8 or higher..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.  Patient was using 12 other unspecified concomitant medications.  Treatment information was not provided.
Mother states, 4 days, post vax, infant had greenish diarrhea stools; 6 days, post vax, had a fever of 104F (ax) during the day and treated with infant Tylenol. That night infant had episode of body stiffness with hands clinched, temp was 100.9F at this time. Mother did not take infant to the doctor. States infant was okay, the next day. New to area, does not have local doctor. Encouraged to obtain doctor. Update, has local doctor now.
After receiving injection pt. fainted upon leaving the exam room. Face pale, skin warm and clammy to touch.
Chills; Dose number 3/Booster dose; This is a spontaneous report received from a contactable consumer (patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: FF8841 and expiry date was not reported) via intramuscular, administered into the arm left, on 15Nov2021 9:30, at the age of 47-year-old, as dose 3 (Booster), single for COVID-19 immunization in workplace clinic. The patient medical history was not reported. Historical vaccine included BNT162B2 (PFIER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EP6955 and expiry date were not reported) via intramuscular, administered into the arm left, on 18Mar2021 14:00, at the age of 46-year-old, as dose 1, single and then second dose of BNT162B2 (PFIER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EP6955 and expiry date were not reported) via intramuscular, administered into the arm left, on 08Apr2021 09:30, at the age of 46-year-old, as dose 2, single both for COVID-19 immunization. The patient other medications within two weeks included Atorvastatin 40 mg and Escitalopram 10 mg. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Nov2021 12:30 AM, the patient experienced chills. The patient didn't receive any treatment in response to the event. The outcome of the event was recovered on an unspecified date in Nov2021.  No follow-up attempts are needed. No further information is expected.
vaginal bleeding; abdominal pain; This is a spontaneous report from a contactable consumer. A 21-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: 8733) via an unspecified route of administration in the left arm on 25Mar2021 at 09:00 (at an age of 21 years) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had seasonal allergies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 6205) via unspecified route of administration in the left arm on 04Mar2021 at 09:00 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medications within two weeks of vaccination include medication for birth control. Prior to vaccination, the patient was not diagnosed for 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 COVID-19 vaccine. On 27Mar2021 at 09:00, after two days of the second dose of vaccine, the patient experienced spotting with light vaginal bleeding. The patient reported that she had been on birth control for almost three years and had never spotted, and the patient always had period on the same exact day (which was not supposed to happen for another 10 days). The patient also experienced abdominal pain while it was happening. The patient did not receive any treatment for adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events light vaginal bleeding and abdominal pain were unknown.   No follow-up attempts possible. No further information expected.
Developed golf-ball sized lump under arm in which flu vaccine was administered approx. 3 days after vaccine. PMD thought it was due to vaccine. (enlarged lymph node)
Pt developed redness, warmth, erythema and pain 1-2 days after injection.
fever, vomit, h/a, irritability, drowsiness, no appetite, crying, redness more than 2 inches around;lymph glands enlarged lt groin;
PREGNANT FOR ALMOST TWO WEEKS WHEN VACCINATED; This spontaneous pregnancy report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. It was not reported whether the patient had been pregnant before. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On AUG-2021, the patient experienced pregnant for almost two weeks when vaccinated. The date of the patient's last menstrual period and expected delivery date were not reported. The pregnancy was continuing. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from pregnant for almost two weeks when vaccinated. This report was non-serious.
Patient developed a red, itchy rash on the upper torso which then spread to her arms and her upper thighs.  At the time of her second shot she still had the rash and decided not to be vaccinated at this time with the second shot.  When she reported the issue to me she had not yet followed up with her provider or a dermatologist.  She admits to having sensitivities to many things.
numbness in the arms and hands, this happened to a moderate degree after the first dose of vaccine, and then improved. It came back to a severe degree after the second dose of the shingrix June 2020.
Within days of receiving vaccines in the right upper arm patient has developed redness warmth and tenderness and does not want to move her right arm. She feels a little sick but has not had a fever.
PATIENT REFERS DEVELOPING SWELLING ON THE LIPS, STRONG HEADACHE AND DIZZINES  AFTER THE ADMINSITRATION OF COVID-19 VACCINE.  PATIENT WAS ADMITED TO ER AND TREATED WITH BENDARYL, SOLU-MEDROL AND POSTERIORLY DISCHARGED HOME WITH ORAL PREDNISONE PRESCRIPTION.
Severe chills/tremors.....my entire body was shaking/spasming. It shook my bed and woke me up. Severe sore arm at injection site.
Heavy Heart palpitations a few days following the shot, everyday following any stimulating activity such as eating, laughing, laying down,  walking. It happens when I am doing nothing as well. heart palpitations occur every 5 seconds on average at least
This spontaneous report was received from physician assistant regarding a 23 year old female patient. The patient's concurrent condition included asthma, allergic rhinitis and attention deficit disorder. The patient has a medical history of dysmenorrhea. On 20-MAR-2015, the patient was vaccinated with PROQUAD (Merck) lot # K005883, expiry date 24-OCT-2015, 0.5 ml, once, subcutaneously. Concomitant therapies included PROAIR, SPRINTEC, tramadol hydrochloride and MOBIC. On 23-MAR-2015, the patient experienced fever 104.8 F, sore throat, congestion and general malaise. The patient sought medical attention (visited office). The patient was treated with amoxicillin. On an unknown date in March 2015, the patient underwent strep culture which showed negative result. The physician assistant considered the events to be significant disability/incapacity to the patient since she received PROQUAD (Merck) as a required vaccination in order to become a camp counselor, but due to the reaction, she had to return home and miss a week of camp. The outcome of the events was reported as recovering. The reporter did not provide the causality between the events and the suspect therapy. Additional information has been requested.