chrisvoncsefalvay/vaers-outcomes huggingface dataset:
eyes are blood shoot red; feel bad; high fever; right arm was swollen, red an feverish at the injection site; swollen at the injection site; red at the injection site; feverish at the injection site; Initial information was received on 13-Dec-2019 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case involves a 65 year old female patient who reported that her eyes are blood shoot red (ocular hyperaemia), she feel bad (feeling abnormal), had high fever and right arm  was swollen, was red and feverish at the injection site (vaccination site inflammation), (vaccination site swelling), (vaccination site erythema) and (vaccination site warmth), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past vaccination included influenza vaccine with sickness and flu. Medical history, medical treatment and family history were not provided.  On 11-Dec (year unknown), the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in the right arm.  On an unknown date, the patient developed a non-serious feel bad (feeling abnormal) 2 hours following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  On an unknown date, the patient developed a non-serious eyes are blood shoot red (ocular hyperaemia), high fever (pyrexia), right arm was swollen, red and feverish at the injection site (vaccination site inflammation), (vaccination site swelling), (vaccination site erythema) and (vaccination site warmth) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  (Other relevant tests included no laboratory data.)  Final diagnosis was right arm was swollen, red and feverish at the injection site, high fever, feel bad and eyes are blood shoot red.  The patient was treated with Paracetamol (Tylenol).  The patient was not recovered from ocular hyperaemia and outcome of other events were unknown.  Information on the batch number was requested.
Patient's mother reports that her right arm swelled up 2 days after receiving the vaccines. She has been using ice/heat throughout the day. I recommended benadryl and to continue ice, monitor arm for worsening changes and report to me.  Patient's mother stated she understood.
i had chest pain and i felt like my heart was racing. i went to the ER and the second time was in April of 2021 and I experienced the same chest pain as well as chest tightness. My heart rate was high i went to the ER again and another EK was done. it happened again towards the end of the month but did not go to the hospital. In July of 2021 I went through 2 days of this same adverse event and I went to the doctor and an EK was done
Pt received HIB and MMR immunizations in left thigh on 9/13/04. On 9/16/04 mom called clinic complaining that area was sore and had a lump which felt like a golf ball. The area also was warm to the touch. Mom and daughter came to clinic on 09/17/04 for follow up. Temp was 98 Lump was 4-5cm on left lateral thigh w/no discharge, slight erythema. Looked more like immune response than frank infection. The pt had full sensation down leg. Mom advised to use children's ibuprofen and RTC or ER if pt becomes febrile, stops eating, has N/V, or lump changes shape, color, or has discharge. As of 10/8/04, no further follow up has been needed.
Fever starting overnight that same Saturday at 11 pm into Sun; Subject also had body aches and chills, feeling very tired; Subject also had body aches and chills, feeling very tired; Subject also had body aches and chills, feeling very tired; Feeling still a little lightheaded and dizzy but overall better; This is a spontaneous report from a non-contactable consumer (patient). A 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 07Aug2021 10:15 as dose number unknown, single for COVID-19 immunization (at the age of 17-year-old). The patient medical history and concomitant medications were not reported. On 07Aug2021 23:00, the patient experienced fever starting overnight that same saturday at 11 pm into Sun. On an unspecified date in Aug2021, the patient also had body aches and chills, feeling very tired and feeling still a little lightheaded and dizzy but overall better. The patient underwent lab tests and procedures which included body temperature: 102 (Highest was at 04:30 am) on 08Aug2021 and 99.7 on 09Aug2021. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache, Myalgia, NauseaVomiting, wheezing, slight nausea, fatigue, body ache Narrative:
bilateral lower leg weakness/floppiness/poor proprioception in ?stocking? distribution, from knees down.  symmetrical. needed to lift knees high, for feet to clear the floor, as i walked to sit down. duration:  3 to 5 minutes.  sudden onset;  complete resolution of symptoms within 5 minutes. no other associated symptoms. no recurrence.
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced chickenpox with several lesions which cleared. Approximately 6 weeks later the pt broke out with chickenpox again.
Her neck on the left side is swollen; Her neck on the left side is swollen and she is having severe pain; whole body aches; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6201; Expiration Date: 24Feb2021), via an unspecified route of administration on 23Feb2021 (at the age of 77 years old) as dose 1, single for COVID-19 immunisation. Medical history included diabetic for 5-6 years, a heart patient and has a pacemaker - all from an unknown date. The patient's concomitant medications were not reported. On an unspecified date in Mar2021, the patient reported that her neck on the left side was swollen and she was having severe pain. The patient was having severe pain on that side, the left side and it was swollen. The pain, the severe pain was ongoing and it was severe and has stayed about the same intensity the whole time. The patient was also having whole body aches on an unspecified date in Mar2021. All of this began around the same time, and the patient confirmed around the same time as the swelling. The patient's whole body aches are off and on but the one in her neck on the left side where the swelling was, it stayed there. The patient was asking if should she go to nearest clinic or go to the doctor, her primary care. The next dosage of the patient was reported to be on 16Mar2021. Outcome of all events was not recovered.  No follow-up attempts are needed. No further information is expected.
feeling hot and cold; nosebleed; she was brushing her teeth, she noticed blood in her saliva; This case was reported by a pharmacist via call center representative and described the occurrence of epistaxis in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number HB2B2, expiry date 13th April 2020) for prophylaxis.   On 30th April 2019, the patient received Shingrix (intramuscular) .5 ml. On 2nd May 2019, 2 days after receiving Shingrix, the patient experienced epistaxis and mouth hemorrhage. On an unknown date, the patient experienced feeling hot and cold. On an unknown date, the outcome of the epistaxis, mouth hemorrhage and feeling hot and cold were unknown.   It was unknown if the reporter considered the epistaxis, mouth hemorrhage and feeling hot and cold to be related to Shingrix.  Additional case details were provided as follows: The patient received dose of Shingrix in the left deltoid and was feeling hot and cold, nosebleed and while she was brushing her teeth, she noticed blood in her saliva.
Dizziness and tachycardia day after vaccine and other episode 2 weeks later
Approximately 8 hours after vaccine I was having a seizure in bed. Within hour of that at the hospital. Missing some memory of the events after the seizure
Blood clot; Swelling in lower leg; A spontaneous report  was received from a consumer concerning a male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swelling in lower leg and blood clot .   The patient's medical history was not provided.Concomitant medications reported included  blood thinners Xarelto.  On 21 Feb 2021  prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   Treatment for the events  was unknown.  Action taken with mRNA-1273 in response to the events was not reported.   The  outcome of the events, swelling in lower leg and blood clot was 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.
heart arrhythmia; heart pounding; felt like speeding up; This is a spontaneous report from a contactable consumer. This is a spontaneous report from a contactable consumer or other non hcp.   A 48-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EW0187) via an unspecified route of administration, administered in Arm Left on 20May2021 as single dose (at the age of 48-year-old) for COVID-19 immunization. Patient received second dose of vaccine on 10Jun2021 (lot number: EW0191). The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 21May2021, the patient experienced heart arrhythmia, heart pounding, felt like speeding up. No treatment was received. The outcome of the events was resolved in unspecified date in 2021.
patient received an expired MMR II; This spontaneous report was received from a nurse referring to a patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.   On 20-AUG-2021, the patient received 1 dose of an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rha) (M-M-R II) lot # S025155 for prophylaxis (vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported). The vaccine had expired on 13-AUG-2021.
About 3 hours after getting COVID 19 vaccine, the injected areas of my left arm started to have soreness. Second day?s morning, I walked at 8am and found that I had fever, chill, cough, body aches and tiredness and increased soreness of my left arm. The body aches increased on the next day with decreased soreness of my left arm.
Maculopapular lesions noted on:  right arm (vaccine given on left side), one lesion at injection site, 3 small lesions on back, 2 on neck.  Maliase, fatigue, muscle aches. Occasional itch from lesions.
pt recvd flu vax & exp vomiting which lasted 2 days; 3OCT92 pt devel hives over the thighs, back & arms, which persisted for over 2 1/2 wks; also had a lump in the rt axilla; 8DEC92, rash persists;
This event is reported because patient received the wrong 2nd dose COVID-19 vaccine. Patient received 1st dose Moderna at another facility on 3/24/21. On 4/19/21, patient came to our facility intending to receive 2nd dose Moderna, but was inadvertently given Pfizer instead. There was no adverse event, this is reported since an error was made.
local rxn-day of inject 30min p/day p/inject fever, malaise;
DIVERTICULITIS ATTACKS; FLU- LIKE SYMPTOMS; FREQUENT URINATION; NOT SLEEPING WELL; DIARRHEA; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 95.5 kilograms, and height was not reported. The patient's concurrent conditions included primary pulmonary hypertension.  The patient received Selexipag (form of admin and route of admin were not reported, batch number: UNKNOWN expiry: UNKNOWN) dose, frequency, and therapy dates were not reported for drug used for unknown indication; and Macitentan (tablet, route of admin not reported, batch number: ZE019B0101 expiry: 31-JUL-2024) 10 mg, 1 time every 1 day, therapy dates were not reported for primary pulmonary hypertension. 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 MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in 2021, the patient had diarrhea, flu- like symptoms, body aches, nausea, fatigue, short of breath frequent urination and was not sleeping well. She was unsure if this was due to the vaccine or a combination of the Uptravi and the vaccine. The patient also had short of breath when she took her garbage out and that she had occasional diverticulitis attacks.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the diverticulitis attacks, diarrhea, flu- like symptoms, frequent urination and not sleeping well was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210414881-Covid-19 vaccine ad26.cov2.s-Diverticulitis . This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. V0:20210414881-UPTRAVI-Diverticulitis. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. V0:20210414881-OPSUMIT-Diverticulitis. This event is considered unassessable. The event 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.
Experiencing lot of pain in her left arm; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program. The reporter is the patient.  A female patient received BNT162B2 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 14Mar2021, outcome "unknown", described as "Experiencing lot of pain in her left arm". Therapeutic measures were taken as a result of pain in extremity.  Additional information: The patient reported that she was experiencing a lot of pain in her left arm so she took two Extra Strength Tylenol at 11 pm the night before. At the time of report, she was scheduled to have her second vaccine at 11:40 am and remembered that she was not supposed to take any Tylenol 24 hours before the vaccine. So it would be 12 hours later that she would be due to have the shot and asked if that was okay.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Shortened periods, ovarian degeneration, uterine fibroids, extreme mood changes.
dizziness; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Batch/Lot Number: EN6201), via an unspecified route of administration, administered in Arm Right on 09Feb2021 (at the age of 76-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included atrial fibrillation from an unknown date and unknown if ongoing. Concomitant medication(s) included apixaban 5 mg tablet twice a day mouth (ELIQUIS) taken for Atrial fibrillation (started taking over a year ago) from an unspecified start date and ongoing. The caller reported that he normally has some dizziness but what he was experiencing now was more than normal in Feb2021. The outcome of event was not recovered.   No follow up attempts are possible. No further information is expected.
Persistent Diarrhea, nausea, vomiting, chills less after 2 days, fatigue (unable to work), Rash on side of scalp (related?), GERD, rare mild periodic pain over heart (not midline of chest). I keep burping with acid reflux and sometimes vomit. Cannot eat without getting nauseous.
This spontaneous report as received from a healthcare worker concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 15-MAY-2014, the patient was vaccinated with one dose of RECOMBIVAX HB (dose, strength, lot number and expiration date were not reported) intramuscular route. Co-suspect and concomitant therapies were not reported. The healthcare worker reports that an improperly stored RECOMBIVAX HB was administered on 15-MAY-2014. The reporter stated that RECOMBIVAX HB was exposed to a temperature of 34F for 30 minutes on 05-MAY-2014. No adverse effect reported. Additional information has been requested. These cases is one (1) of ten (10) reports from the same reporter. (MARRS 1405USA011237, 1405USA0136601, 1405USA013602, 1405USA013603, 1405USA013604, 1405USA013605, 1405USA013606, 1405USA013607, 1405USA013508 and 1405USA013609).
Stinging on administration; Arm pain lasting ~5 days; This case was reported by a physician via sales rep and described the occurrence of pain in extremity in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in extremity and injection site stinging. On an unknown date, the outcome of the pain in extremity was recovered/resolved and the outcome of the injection site stinging was unknown.   It was unknown if the reporter considered the pain in extremity and injection site stinging to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccine on and experienced stinging on administration and arm pain. The reporter did not consent to follow up.
Tested + for covid(home test)28Sep started Paxlovid 30Sep; Tested + for covid(home test) 28Sep started Paxlovid 30Sep; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 03Jan2021 at 10:00 as dose 1, single (Lot number: EL0142), in left arm, on 24Jan2021 at 10:00 as dose 2, single (Lot number: EL3248), in right arm and on 12Oct2021 at 10:00 as dose 3 (booster), single (Lot number: 30145BA) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "psoriasis" (unspecified if ongoing); "HTN" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA, start date: 01Sep2015; NUVIGIL, start date: 01Sep2015; ATENOLOL, start date: 01Sep2015; PROTONIX [OMEPRAZOLE], start date: 01Sep2015. The following information was reported: COVID-19 (medically significant) with onset 28Sep2022, outcome "not recovered", described as "Tested + for covid (home test) 28Sep started Paxlovid 30Sep"; VACCINATION FAILURE (medically significant) with onset 28Sep2022, outcome "not recovered", described as "Tested + for covid (home test)28Sep started Paxlovid 30Sep". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Sep2022) Positive, notes: Tested + for covid (home test) 28Sep; (05Oct2022) Negative, notes: Tested negative 05Oct with no symptoms; (13Oct2022) Positive, notes: Tested +again 13Oct. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Paxlovid treatment start date 30Sep2022, stop date 05Oct2022. Tested negative 5Oct with no symptoms. Started getting sore throat and runny nose 09Oct. Tested positive again 13Oct with bad non productive cough and bad nasal congestion. The known allergies were none.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events vaccination failure, COVID-19 and the use of suspect product cannot be fully excluded.
Pt has complained of intermittent burning sensation in ankles and wrist x 2 months since injection.
1007a  c/o headache, lightheaded,  BP 143/89 P 80 1022a BP 134/78 P 75  1024a placed in recliner 1033a Bp 142/87 P 74 pt reports feels like this when he gets a  migraine 1035a ambulated to Exit with (Security)
1 week after administration found dead at home. History of COPD and squamous cell lung cancer RUL with obstruction of airway and s/p palliative treatment. Daughter felt he became more lethargic 24 hours after vaccination and requested we report this. No autopsy performed by medical examiner and death certificate pending.  11/27/07 Reviewed death certificate which states COD as right lung pancoast tumor due to chronic obstructive pulmonary disease. 1/4/08 Reviewed medical records which reveal patient experienced cough, recurrent RUL infections which responded to antibiotic tx, RUE pain s/p brachial plexus involvement, poor appetite on 10/18/07.  Dx w/RUL lung Pancoast squamous cell carcinoma, stage B & tx w/chemo & radiation tx.
Migraine attack; Pain; Headache; Was in bed for two days; This case was reported by a consumer via interactive digital media and described the occurrence of migraine in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles twice in 40s).   In September 2022, the patient received the 1st dose of Shingrix. In September 2022, less than 2 weeks after receiving Shingrix, the patient experienced migraine, pain, headache and bedridden. On an unknown date, the outcome of the migraine, pain and headache were unknown and the outcome of the bedridden was recovered/resolved.   The reporter considered the migraine, pain, headache and bedridden to be possibly related to Shingrix.     Additional Information: GSK Receipt Date: 27-Sep-2022 Reporter's comment: This case was reported by the patient via interactive digital media. Some folks had poor reaction to the shot.  The patient age was now 57 years and got 1st shot last week.  The patient was in bed for two days with pain and headache etc. and then it triggered a bad migraine attack.  The patient did not had one in a decade that was bad.  The patient guesses that she would go back for shot 2 but she was scared of losing another week like this would like to be seen more studies about the link between migraine attaches and shingrix. Additional supportive information: The follow-up would not be possible, as no contact details were available. This case was linked with US2022AMR139468 reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR139468:Same reporter