chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After i got the vaccination my thyroid is higher; thought the palpitations where from an illness that had on the past, when got for the test from the thyroids and the doctor said the thyroids was high; Illness; This spontaneous case was reported by a patient and describes the occurrence of HYPERTHYROIDISM (After i got the vaccination my thyroid is higher) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE for Hypothyroidism, SIMVASTATIN (SIMVASTIN), VITAMIN D NOS and ASCORBIC ACID (VITAMIN C ACID) for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERTHYROIDISM (After i got the vaccination my thyroid is higher) (seriousness criterion medically significant), PALPITATIONS (thought the palpitations where from an illness that had on the past, when got for the test from the thyroids and the doctor said the thyroids was high) and ILLNESS (Illness). At the time of the report, HYPERTHYROIDISM (After i got the vaccination my thyroid is higher), PALPITATIONS (thought the palpitations where from an illness that had on the past, when got for the test from the thyroids and the doctor said the thyroids was high) and ILLNESS (Illness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood thyroid stimulating hormone: high (High) Thyroid level was High.         The patient stop taking the medication for a week . Treatment medication information was provided as "Decreased to 50 mcg from 75 mcg after the high thyroids".  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.  Further information is expected.; 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.  Further information is expected.
Severe diarrhea for 28 days now; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El0142, expiry date not reported), via an unspecified route of administration at the left arm on 31Dec2020 14:00 at single dose for COVID-19 immunization. Medical history included asthma. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a public health clinic/veterans administration facility. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included prednisone and amoxicillin (AMOXYCILLIN). The patient experienced severe diarrhea for 28 days now on 02Jan2021 10:00. The adverse event resulted to doctor or other healthcare professional office/clinic visit as well as emergency room/department or urgent care. No therapeutic measure was taken as a result of the events. Clinical outcome of the event was not recovered.
TUBERCULOSIS (TB); This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, frequency 1 total, start therapy date were not reported for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced tuberculosis (TB). The action taken with covid-19 vaccine  was not applicable. The outcome of tuberculosis (TB) was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211202026-covid-19 vaccine  -Tuberculosis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Left second toe acutely inflamed and swollen,no trauma or h/o gout looks like typical Covid toe
Patient was tired for two days; Had chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Had chills) and FATIGUE (Patient was tired for two days) in a 73-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 02-Feb-2022, the patient experienced CHILLS (Had chills). On 03-Feb-2022, the patient experienced FATIGUE (Patient was tired for two days). On 02-Feb-2022, CHILLS (Had chills) had resolved. In February 2022, FATIGUE (Patient was tired for two days) had resolved.        mRNA-1273 (Spikevax) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.  No treatment details were reported.   This case was linked to MOD-2022-507465 (Patient Link).
she took the band aid off and it is still itching; This is spontaneous report from contactable consumer (Patient). A unspecified age of female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: unknown), via an unspecified route of administration, administered on 06Apr2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date the patient experienced itching at injection site, patient states she has a minor side effect, she remembers the pharmacist said not to rub it and she took the band aid off and it is still itching. Patient asking if she can put hydrogen peroxide or hydrocortisone cream on it? States it does say there may be itching on the paper, but there is no redness. The patient lab data and other investigations not reported. The outcome of the event was unknown.  Communication: Advised patient her physician would be the best person to contact to make decisions about appropriate treatment options.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Expired vaccine used; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Caller mentioned that "the CDC had just approved extended expiration dates" and wanted to know if it was extended. When asked the caller stated that there were no remaining vials unused of that lot number and med info agent reminded the caller that no patients should receive doses from expired vials. Dose was administered after 30-day Use by Date or after manufacturer date of expiry. Vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. There were no pertinent medical history and concurrent conditions and concomitant medications reported. On 03-NOV-2015 the patient was vaccinated with expired dose of PROQUAD (Merck) lot # K006218, expired on 29-OCT-2015, dose 1 (route, dose not reported). No adverse effects reported. Additional information has been requested.
This spontaneous report as received from a physician refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 21-MAR-2016, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot# L042846 and expiry date: 15-SEP-2017). The physician reported that it was unspecified which of the three dose series that this administration was. No adverse effects were reported. Temperature was reported as low of 33F to 35F for time frame of cumulative 48 hours. There was no previous excursion or no data logger. It was also reported that VAQTA was in the products tab and experienced a temperature excursion as well, but was not administered to a patient. MMR II was in the products tab and did not experience a temperature excursion, this was due to a general storage question. Additional information has been requested.
A non-serious spontaneous report of herpes simplex (cutaneous and may be conjunctivitis) has been received from a physician concerning adult, subsequent to H1N1, Intranasal. Neither medical history nor concomitant medications have been reported for this patient. The patient received H1N1, Intranasal for an unknown indication in 2009. On an unknown date the patient experienced herpes simplex (cutaneous and may be conjunctivitis). The outcome of the event was unknown.
Patient fainted in chair approximately 5 minutes after vaccination; did not fall. Was monitored by staff nurse until first responders arrived. BP was dropping and 02 sat was 90. ECG showed some abnormalities and condition did not improve. Patient transported to ER at approximately 4:30pm.
1 week post injection, swelling upper arm and top of shoulder, itchiness anterior upper arm, redness to elbow medial upper arm
First dose to muscle of left arm left muscle superbly sore; This is a spontaneous report from a contactable physician (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 21Dec2020 11:00 at single dose injection to muscle of left arm for Vaccination. There were no medication history and no concomitant medications. The patient had her first dose of Pfizer COVID-19 Vaccine she thought on 21Dec2020. She reported first dose of Pfizer COVID19 Vaccine to muscle of left arm, and out 1 hour after dose administered the patient experienced left muscle superbly sore probably onset about 12:00 noon on 21Dec2020 for about 3 days, when she recovered completely. The outcome of event was recovered on 24Dec2020. The physician considered Pfizer COVID19 Vaccine was related to the even.t First dose to muscle of left arm left muscle superbly sore.  Information on Lot/Batch number has been requested.
Patients COVID vaccine Card stated he had Moderna as his first dose in the series on 09/16/2021.  Patients EMR stated he had Pfizer #1 instead on 9/16/2021.  Patient returned 21 days later on 10/7/2021 and received Pfizer as his second dose.  Patient feels like wrong vaccine was given as dose #2 because his original card was hand written to say he had Moderna as his #1 dose.   Patient did not experience any signs or symptoms from receiving Pfizer on 10/7/2021. Cheif Medical Officer, was immediately notified of incident and spoke to patient via telephone regarding incidient. APRN was present at time of patient's vaccination and also assessed patient and educated him on side effects.
Patient c/o hoarseness, cough and nausea. Patient prescribed ZOFRAN 4 mg every 8 hrs PRN for the nausea. Vital signs within normal limits.
DIARRHEA X8 DAYS, MILD LOWER ABDOMINAL PAIN, WEAKNESS, LOSS OF APPETITE, SLIGHT COUGH
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 27-MAR-2019 the patient was vaccinated with VAQTA lot # R010369 for prophylaxis. On 27-MAR-2019, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date the patient experienced no adverse event.
diarrhea; ache; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 50 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Feb2021 (Batch/Lot number: unknown) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "Asthma" (ongoing); "hypertension" (ongoing); "thyroid cancer" (unspecified if ongoing), notes: Pertinent details: s/p thyroidectomy; "thyroidectomy" (unspecified if ongoing), notes: Pertinent details: s/p thyroidectomy. Concomitant medication(s) included: BUPROPION taken for depression (ongoing); SERTRALINE taken for depression (ongoing); SYNTHROID taken for hypothyroidism (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Anatomical Site of injection : left, Route of administration : Intramuscular), administration date: 15Jan2021, when the patient was 50 years old, for COVID-19 immunization, reaction(s): "Diarrhea", "Ache". The following information was reported: DIARRHOEA (non-serious) with onset 05Feb2021, outcome "recovered" (07Feb2021), described as "diarrhea"; PAIN (non-serious) with onset 05Feb2021, outcome "recovered" (07Feb2021), described as "ache". Therapeutic measures were not taken as a result of diarrhoea, pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
itch all over the body; palpitations; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itch all over the body) and PALPITATIONS (palpitations) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028a21a and 043b21a) for COVID-19 vaccination.     Concurrent medical conditions included Psoriatic arthritis since 1987, Drug allergy (cefdinir) and Hashimoto's disease since 2010. Concomitant products included CETIRIZINE HYDROCHLORIDE (CETRIZINE) for Allergy, LEVOTHYROXINE SODIUM (SYNTHROID), LEVOTHYROXINE, CIPROFLOXACIN HYDROCHLORIDE;DEXAMETHASONE from 01-Apr-2021 to an unknown date and MULTIVITAMIN [VITAMINS NOS] 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 an unknown date, the patient experienced PRURITUS (itch all over the body) and PALPITATIONS (palpitations). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (itch all over the body) and PALPITATIONS (palpitations) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 109 (Inconclusive) unknown.         Patient also took steroid shots  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable. ? Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-091092.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Initial Addiitonal-1 : VAERS On 28-May-2021: NNI FOLLOW UP -Translated document : VAERS translated WHERE no new information regarding dose 1possible NNI as all information given for dose 2
Fever for days(102 to 103F); Headache which lasted about 72 hours; Rash on face (Intermittent); This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever for days(102 to 103F)), HEADACHE (Headache which lasted about 72 hours) and RASH (Rash on face (Intermittent)) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PYREXIA (Fever for days(102 to 103F)), HEADACHE (Headache which lasted about 72 hours) and RASH (Rash on face (Intermittent)). On 14-Mar-2021, PYREXIA (Fever for days(102 to 103F)) and HEADACHE (Headache which lasted about 72 hours) had resolved. At the time of the report, RASH (Rash on face (Intermittent)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Body temperature: 102-103 (High) 102 to 103F. On an unknown date, Antinuclear antibody: positive (Positive) ANA positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Non Significant F/U Case Email ID Add.
This spontaneous report as received from a medical assistant via a filed employee refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown dates, the patient was vaccinated with two doses of GARDISAL intramuscularly in the right arm (dose, lot number and expiration date were not reported). On an unknown date and unspecified time after vaccination, a "bump" appeared at the injection site, which appeared after she took a shower. No treatment was given for the event. The patient sought medical attention by office visit. The outcome of the event was not reported. Product quality complaint was not involved. The relatedness between the event and GARDASIL was not reported. Additional information has been requested.
shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider at a medial group for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was not reported. Causality was related.
within 2 days of the first vaccine, occasional back pain from arthritis became chronic and limited mobility. OTC pain meds do not work. Steroids gave only temporary relief. Physical therapy gives some relief, but it never completely eliminates the pain. Pain is not now just limited to the back but effects most joints - shoulder, elbow, hips, knees-
This spontaneous report was received from a physician refers to a 22 year old male patient. On an unknown date, the patient received their scheduled doses of M-M-R II (lot#, expiry not reported). On an unknown date, recently the patient had titers drawn and the patient did not seroconvert for measles and rubella. No treatment was received. It was unspecified if the patient sought medical attention. The outcome of patient did not seroconvert for measles and rubella was unknown. The relatedness of the event with M-M-R II was unknown. Additional information has been requested.
Mom stated red lips 24 hours post injection.  Mom stated fever blisters around lips 48 hours post injection. Mom called md today; Doctor, who stated not to give second vaccine.
injection was given via subcutaneous route, no AE; Initial information received on 13-Nov-2020 regarding an unsolicited valid non-serious case received from a nurse via Information (Reference number- 00358374).  This case involves a 48 year old female patient for whom vaccination was given via subcutaneous route (incorrect route of product administration) with influenza quadrival a-b vaccine [Fluzone quadrivalent] suspension for injection 0.5 ml once (lot number and expiry date unknown) in unknown administration site for prophylactic vaccination.  Medical history, medical treatments, vaccinations, family history and concomitant medications were not provided.  This was a case of an actual medication error case due to the event inappropriate route of vaccination (latency: unknown). The needle was short and was less than an inch and probably about 2 cm long.   No adverse event was reported.  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 directive 2001/83/ec and module VI of the good Pharmacovigilance practices. 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.  There will be no information available on batch number for this case.