chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient's concomitant medication included sterile diluent (lot #N021583 and expiration date: 18-NOV-2019). In October 2017 (reported as on 17-OCT-2017, 19-OCT-2017, 26-OCT-2017 or 27-OCT-2017, the patient was vaccinated with unspecified doses of improperly stored VARIVAX (dose, units, frequency and route not reported) (lot # N019133 and expiration date: 22-JUN-2019). Reporter informed that, there was multiple temperature excursions for the varicella virus vaccine live (oka/merck)(VARIVAX) as follows, on 02-OCT-2017, temperature excursion was at 14 F for the duration of 2 hours, on 03-OCT-2017, temperature excursion was at 16.7 F for the duration of 2 hours, on 04-OCT-2017, temperature excursion was at 16.7 F for the duration of 1 hour, on 05-OCT-2017, temperature excursion was at 16.7 F for the duration of 1 hour, on 10-OCT-2017, temperature excursion was at 17.1 F for the duration of 0.5 hours, on 11-OCT-2017, temperature excursion was at 18.1 F for the duration of 4 hours, on 16-OCT-2017, temperature excursion was at 19.2 F for the duration of 1 hour, on 17-OCT-2017, temperature excursion was at 19.40 F for the duration of 2 hours, on 18-OCT-2017, temperature excursion was at 17.40 F for the duration of 1 hour, on 19-OCT-2017, temperature excursion was at 21.90 F for the duration of 1 hour, on 20-OCT-2017, temperature excursion was at 17.10 F for the duration of 2 hours, on 24-OCT-2017, temperature excursion was at 5.80 F for the duration of 0.5 hours, On 25-OCT-2017, temperature excursion was at 8.20 F for the duration of 0.5 hours, on 26-OCT-2017, temperature excursion was at 17.80 F for the duration of 0.5 hours, on 27-OCT-2017, temperature excursion was at 14.40 F for the duration of 1 hour, On 30-OCT-2017, temperature excursion was at 16.90 F for the duration of 2 hours and on 31-OCT-2017, temperature excursion was at 14.40 F for the duration of 1 hour. It was reported that there was multiple previous excursions for the VARIVAX. Reporter did not state that sterile diluent was improperly stored. No adverse effects (no adverse event) reported. No product quality complaint was involved. No further information was provided.This is one of the 8 reports (Same reporter link). Sender's Comments: US-009507513-1802USA005090: US-009507513-1802USA005087: US-009507513-1802USA005088: US-009507513-1802USA005089: US-009507513-1802USA005085: US-009507513-1802USA003097: US-009507513-1802USA005086.
Redness at the injection site; Soreness at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of   in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        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.   Concomitant product use was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Postmenopausal bleeding; Migraine; Peripheral swelling; This is a solicited report based on the information received by Pfizer from AbbVie Inc. (Mfr. Control No.: 21K-163-4071912-00). This contactable consumer (patient) reported that a 55-year-old female patient received bnt162b2 (Batch/Lot number was not reported), second dose intramuscular on 25May2021 at the age of 55-year-old as single dose, first dose intramuscular on 04May2021 at the age of 55-year-old as single dose for covid-19 immunization; adalimumab (HUMIRA, Batch/Lot number was not reported, Solution for injection in pre-filled pen), subcutaneously from an unspecified date and ongoing, at unspecified dose for psoriatic arthropathy. The patient's medical history and concomitant medications were not reported. No known allergies. The patient experienced postmenopausal bleeding, migraine, peripheral swelling on an unspecified date in 2021. Solicited report by a consumer of a 55 years old female with events of non-serious post menopausal menses onset, migraine and swollen foot, toe and hand with adalimumab (HUMIRA). There was no reported medical history. In 2021, the patient experienced post-menopausal menses onset, migraine and swollen foot, toe and hand. Pfizer Biontech Covid-19 Vaccine (TOZINAMERAN) was also considered suspect.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 04May2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer. On 25May2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer. The action taken in response to the events for adalimumab was dose not changed. The outcome of events was not resolved.  The reporter's causality for the events of post-menopausal menses onset, migraine and swollen foot, toe and hand with adalimumab was not provided. The reporter's causality for the events of post-menopausal menses onset, migraine and swollen foot, toe and hand with bnt162b2 was possible.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on current available information, a possible contributory role of BNT162B2 cannot be completely excluded for events postmenopausal bleeding, migraine, peripheral swelling due to temporal relationship.  However, current information is limited and does not allow a full medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
FOUR WEEKS AFTER INITIAL FIRST DOSE, A "MODERNA RASH" SHOWED UP IN THE SAME LEFT ARM ONE DAY AFTER VACCINATION OF DOSE #2.  THE RASH STARTED AS FIRM ON THE DAY AFTER VACCINATION AND PROGRESSED OVER 3 DAYS TO A FULL RED RASH (CLASSIC MODERNA RASH), 6 INCH IN DIAMETER, FIRM TO TOUCH, SLIGHTLY WARM, SLIGHTLY ITCHY AT TIMES, RED BUT NOT ANGRY RED.  IMPORTANT NOTE: THIS IS THE EXACT SAME REACTION HIS SISTER GOT A MONTH AGO ON HER FIRST SHOT OF MODERNA.  A CLASSIC MODERNA RASH THAT WE HAVE SEEN IN OUR PATIENTS BEFORE.
right arm went numb and fingers and right foot and leg burning.  tongue swelled.  then the next day i had chest pain and rib pain for a long time-5 hours
Within 1 and 1/2 hours, I experienced intense nausea, abdominal pain, and cramping. I lost my appetite for about 2 and 1/2 weeks. I experience tinnitus, beginning the day after receiving the vaccine which continued for about 1 week. My lymph nodes became painful and swollen for about 2 weeks. I had shooting nerve pain from my armpit to my chest the day, starting the day after the vaccination and continuing for 1 day.
At 11 days after immunization, pt seen in ER for cellulitus L arm from axilla to mid-upper arm. Received antibiotics x 48 hrs. Since receiving smallpox immunization on the arm, noticed local redness, bump, blister, pus-filled blister, sore under arm (redness from site down arm then under armpit), muscle aches-under arm, restricted activity, took medication (antibiotics), visited clinic, hospitalized (2 days) and pain at site at day 9. Pt reported redness and swelling in day 11 of vaccination. Reported to ED and hospitalized for IV ABX. Erythema to axillary surrounding site and along tricep muscle. Erythema resolved post 48 hrs ABX and d/c home. F/U 2 days post discharge.
pt was only 16hr old whe was given vax had 1st sz;became sz free for 2mo when 2nd vax;started having sz (uncontrolled) cont until 1996 when had brain surgery;looked purple;dusky, pale;fussy-crying;60 day follow-up / no additional data.
can't walk; can't eat; the arm of the injection is hurting and can't raise it up; chills; severe headache; fever; pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), GAIT DISTURBANCE (can't walk), FEEDING DISORDER (can't eat), PAIN IN EXTREMITY (the arm of the injection is hurting and can't raise it up) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-2021, the patient experienced PAIN (pain), CHILLS (chills), HEADACHE (severe headache) and PYREXIA (fever). On an unknown date, the patient experienced GAIT DISTURBANCE (can't walk), FEEDING DISORDER (can't eat) and PAIN IN EXTREMITY (the arm of the injection is hurting and can't raise it up). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (pain), GAIT DISTURBANCE (can't walk), FEEDING DISORDER (can't eat), PAIN IN EXTREMITY (the arm of the injection is hurting and can't raise it up), CHILLS (chills), HEADACHE (severe headache) and PYREXIA (fever) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications are provided.  The patient reported feeling better after taking paracetamol (Tylenol).   Reporter did not allow further contact
Temperature of 102 which started the day of the vax. Blotchy rash, fussy with screaming also.
from the start - I periodically STILL feel the injection sites (both arms) left arm more often.  but that sensation does not last very long.  probably about 1 1/2 years ago, I started feeling very very slight muscle discomfort in left arm first, then right arm followed.   Recently, either June or July, the pain has gotten a lot worse.  pain seems to move throughout my arm(s).  Left arm is much worse than right arm. It is very difficult to lift anything heavy (or with some weight) & very hard to sleep (since I sleep on my side)
This case was reported by a consumer via call center representative and described the occurrence of pericarditis in a male patient who received 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 pericarditis (serious criteria GSK medically significant). On an unknown date, the outcome of the pericarditis was unknown. It was unknown if the reporter considered the pericarditis to be related to SHINGRIX. Additional details were provided as follows: This case is reported by the consumer who was inquiring about getting vaccinated her husband with SHINGRIX 2nd dose. While doing inquiry the reporter had provided an information about 2 patients who had experienced pericarditis after receiving SHINGRIX. The patient age at vaccination was not reported. On an unknown date the patient got pericarditis after the vaccination. The patient had already filed the report with centers for disease control and prevention (CDC). The reporters husband has underwent stem cell transplant and they wanted him to get shingles vaccine at 2 months. This case has been linked to the case US2018GSK224232, reported by the same reporter.
high pitched screaming for3-4 hrs non-stop w/sl swelling @ lt inject site & redness the size of a dime, then remained fussy;
Developed facial shingles one week later, with a prodrone starting 3-4 days after vaccination
Faint; Migraine; Dizzy; Disoriented; Joint pain; Fatigue; Muscle pain; Nausea; Slight fever; A spontaneous report  was received from a consumer concerning a 23 year old, male patient, who experienced faint (syncope), migraine, dizziness, fatigue, disoriented (disorientation), joint pain (arthralgia), muscle pain (myalgia), nausea, and slight fever (pyrexia).   The patient's medical history was not provided. Concomitant products known to have been used by the patient, within two weeks prior to the events, included allergy medication unspecified.  On unspecified date, the patient received their first of two planned doses of mRNA-1273  for prophylaxis of COVID-19 infection.   On 10-FEB-2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 10-FEB-2021, after vaccination, the patient experienced faint, migraine, dizzy, fatigue, disoriented, joint pain, muscle pain, nausea and slight fever. Treatment  for the event included Ibuprofen and Excedrin.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The event of faint was considered recovered. The outcome for the events of migraine, dizziness, fatigue, disoriented (disorientation), joint pain (arthralgia), muscle pain (myalgia), nausea, and slight fever (pyrexia) was considered unknown.; Reporter'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.
Both arms from her elbows down to the hands like a golden color/different spots in both arms/As the days went by (spots) appeared on her chest and legs/little brown spots that sometimes are darker and shaped like a state/scattered all over; Sometimes a little bit of itching, but they are not painful; This spontaneous case was reported by a patient and describes the occurrence of SKIN DISCOLOURATION (Both arms from her elbows down to the hands like a golden color/different spots in both arms/As the days went by (spots) appeared on her chest and legs/little brown spots that sometimes are darker and shaped like a state/scattered all over) and PRURITUS (Sometimes a little bit of itching, but they are not painful) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A and 011F21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022, the patient experienced SKIN DISCOLOURATION (Both arms from her elbows down to the hands like a golden color/different spots in both arms/As the days went by (spots) appeared on her chest and legs/little brown spots that sometimes are darker and shaped like a state/scattered all over). In May 2022, the patient experienced PRURITUS (Sometimes a little bit of itching, but they are not painful). At the time of the report, SKIN DISCOLOURATION (Both arms from her elbows down to the hands like a golden color/different spots in both arms/As the days went by (spots) appeared on her chest and legs/little brown spots that sometimes are darker and shaped like a state/scattered all over) and PRURITUS (Sometimes a little bit of itching, but they are not painful) had not resolved.            Patient had chronic medication but declined to provide the list. No treatment information were provided.
Injection site sore to touch can't lift w/left arm hurts to lean on arm.
Initially the injection stung, followed my intense itching. 10/13/2016 woke up to my arm being swollen, itching terribly, and there is a hard, tender, red area approximately 1.5" in diameter around the injection site. Take benadryl for the itch and Motrin for the swelling.
Constant menstrual bleeding/spotting since April 24 2021. Goes between spotting and extreme bleeding.; Pelvic pain; Lower back pain; Fatigue; Cramping; some Lightheadedness; This is a spontaneous report from a contactable consumer (patient herself). A 44-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: ER8729), via an unspecified route of administration at left arm on 09Apr2021 as single dose for covid-19 immunisation. The patient's medical history included Hashimotos, Migraine, anxiety and Sleep apnea. Concomitant medications included levothyroxine sodium; gabapentin; topiramate and cefalexin monohydrate (LEXIPRON). The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm (at the age of 44-year-old) on 19Mar2021 as single dose for covid-19 immunisation. There were no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested for COVID-19 since the vaccination. On 24Apr2021, the patient experienced constant menstrual bleeding/spotting, goes between spotting and extreme bleeding, pelvic pain, lower back pain, fatigue, cramping, some light-headedness. The patient visits to the clinic for the event. The outcome of all the events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Post vax, in the parking lot getting ready to leave, the pt became dizzy, had spotty vision, and sweating. Returned to building, his skin was cool and he was diaphoretic and  pale. Pt states this has happened before when he has given blood.
Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Slight headache) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (Slight headache). At the time of the report, HEADACHE (Slight headache) outcome was unknown.            Patient experienced mild Headache in May 2021, even 3 weeks after receiving the second dose of vaccine. No concomitant and treatment medication information was reported.
Distortion of smell and taste; Distortion of smell and taste; Problems with remembering things , like "fogs" in the memory; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (Distortion of smell and taste), PAROSMIA (Distortion of smell and taste) and FEELING ABNORMAL (Problems with remembering things , like "fogs" in the memory) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 09-Oct-2020.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced TASTE DISORDER (Distortion of smell and taste), PAROSMIA (Distortion of smell and taste) and FEELING ABNORMAL (Problems with remembering things , like "fogs" in the memory). At the time of the report, TASTE DISORDER (Distortion of smell and taste), PAROSMIA (Distortion of smell and taste) and FEELING ABNORMAL (Problems with remembering things , like "fogs" in the memory) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Oct-2020, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
On 06/04/2022, I was diagnosed with atrial flutter. I've had it before, but this time it felt like my heart rate was quite high. My wife and I went to the emergency room where they were concerned, I was having a heart attack. I was not, but they wanted to monitor me, so I was admitted for 5 days. They added a blood thinner to my daily medications, Eliquis, to reduce the chances of a stroke. I'm told the blood thinner markedly reduces the chance of a stroke. I have had atrial flutter even before COVID-19 began.
Patient presented to the ED on 5/5/2021 for dizziness and double vision. Patient was subsequently hospitalized with vertebrobasilar insufficiency. These visits are within 6 weeks of receiving COVID vaccination.
No appetite; tries to swallow food the food does not go all the way down; flu symptoms 7 hours after he received the booster dose.; This spontaneous case was reported by a patient and describes the occurrence of DECREASED APPETITE (No appetite), DYSPHAGIA (tries to swallow food the food does not go all the way down) and INFLUENZA (flu symptoms 7 hours after he received the booster dose.) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Johnson and Johnson (The patient received Johnson and Johnson for his Primary Series and his first booster dose.). Past adverse reactions to the above products included No adverse event with Johnson and Johnson.    On 16-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced DECREASED APPETITE (No appetite), DYSPHAGIA (tries to swallow food the food does not go all the way down) and INFLUENZA (flu symptoms 7 hours after he received the booster dose.). At the time of the report, DECREASED APPETITE (No appetite), DYSPHAGIA (tries to swallow food the food does not go all the way down) and INFLUENZA (flu symptoms 7 hours after he received the booster dose.) outcome was unknown.            Patient took primary series and first booster of Johnson and Johnson vaccine and second Covid-19 vaccine booster dose as the Moderna vaccine. The patient had received second booster dose of Moderna vaccine on 16-May-2022. No concomitant information were reported by the reporter. No treatment information were reported by the reporter.
arthritic pain in his hands (which he has had for many months) has improved; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 69-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration as a single dose on 15Apr2021 for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was stated that the patient received his first dose of the Pfizer Covid vaccine on 15Apr2021. On 17Apr2021, he noticed arthritic pain in his hands (which he has had for many months) has improved. Patient wants to know if this a reported side effect. The outcome of the event was recovering.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Bell's palsy. Valacyclovir, Prednisone. Acupuncture.
Low grade temp, chills, headache and body ache.  Started early morning and were resolved within 12 hours of onset
HIVES RASH TO NECK, TRUNK, EXTREMITIES  SWELLING TO HANDS AND FEET