chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 03/04/2021 I woke up and it felt like I bit my bottom lip because it started to swell. I did not think much of it. By noon it was huge. I went to see the outpatient stat care and they gave me a shot of Benadryl and sent me home. The swelling went down but I developed a rash and some welts on my right shoulder, left hip, and left side. That lasted for about 4 days. One week to the day I woke up early my tongue was swelling and my throat was shutting off. I went to the ER. Benadryl did not help. Epinephrine did not help either. They put me on a ventilator for a short amount of time. Now I take 3 different medications The allergist that I have seen said that I need to take those medications at least for 6 months to make sure I do not have any other adverse events. It took me a long time to recover after being in the hospital. I am sure they did medical tests but I was under anesthesia so I do not remember. I was admitted to ICU for 2 days.
Both of my eyelids are swollen and sore from the lash lines to midway up the lids.
Eight days after administering smallpox vaccine, the patient developed a moderate flu-like illness with fatigue, malaise, muscle aches, dizziness and subjective fever.
Bells Palsy Acutely developed 5/31/2021 Went to ER and head ct / labs normal Started on doxycycline (we are lyme endemic) and prednisolone
febrile, sore throat, body aches, leg cramps, chest pain (hurts to breathe)
no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 21-MAY-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, lot # R034700, expiry date 16-JUN-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 Fahrenheit degrees for 4 hours and 54 minutes. Digital data logger was involved. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000926: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000927: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000928: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: US-009507513-1907USA000929: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000862: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000882: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925:
This spontaneous report as received from a registered nurse refers to unknown patients of unknown age and gender. Concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with an improperly stored doses of ROTATEQ (Lot # M007125, expiration date 06-OCT-2017; M004542, expiration date 07-OCT-2017) orally (Dose was not provided). Concomitant medications were not reported. The temperature excursion details were 9 degree C for 1 hour 24 minutes, with an additional excursion of 10 degree C for 2 hours for ROTATEQ (M007125 expiration date 06-OCT-2017). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Hair growth abnormal; Fatigue; one dose adminstered on 09-SEP-2021 and another on 20-SEP-2021; This spontaneous case was reported by a consumer and describes the occurrence of HAIR GROWTH ABNORMAL (Hair growth abnormal), FATIGUE (Fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (one dose adminstered on 09-SEP-2021 and another on 20-SEP-2021) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for an unknown indication.    No Medical History information was reported.   On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2022, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In September 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (one dose adminstered on 09-SEP-2021 and another on 20-SEP-2021). In 2022, the patient experienced HAIR GROWTH ABNORMAL (Hair growth abnormal) and FATIGUE (Fatigue). At the time of the report, HAIR GROWTH ABNORMAL (Hair growth abnormal) and FATIGUE (Fatigue) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (one dose adminstered on 09-SEP-2021 and another on 20-SEP-2021) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
At approx 11:00pm, on 10/29 the day I got the shot, I got the chills and shakes.  Sometime after 2am I developed a fever.  That lasted until after midnight the next day. During the day, of 10/30 I was lethargic, my joints ached, and I did not have an appetite.  I took a Tylenol around 10am, and another around 10pm.
pt recv vax 6NOV96 & on 9NOV96 mom noted red raised area on pt forehead;red raised areas have spread to face, neck, abd, back;MD prescribed med;
Patient had a small red spot where injection occurred with small blister and slight pain. Patient applied cold compresses and made appt. with dermatologist.
mom states pt had episode of losing color then lips turned blue;was taken to ER-kept approx 1hr;color returned;
COVID; had 4 Pfizer shots; COVID; had 4 Pfizer shots; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID; had 4 Pfizer shots". The patient underwent the following laboratory tests and procedures: COVID-19 test: Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19 with Paxlovid.  Additional information: patient took her last morning dose of Paxlovid on 12Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored GARDASIL lot # K001631 and lot # J011272 (dose was not reported). No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
About 30 minutes following the injection I was very nauseous and extremely tired.  The tiredness lasted for several days afterward and the nausea last for 2 and a half days.
A profoundly loud Tinnitus in my left ear and minor tinnitus in my right ear, it has grown in intensity; Now the ringing noise is almost deafening; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Aug2021 11:00 (Lot number: AFA7485) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: in February, testing positive on 11Feb and 20Feb. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FA7485, Location of injection: Arm Left, Vaccine Administration Time: 12:30 AM), administration date: 31Jul2021, when the patient was 56 years old, for Covid-19 immunization, reaction(s): "sore in my left arm", "fatigued", "pain radiated across my shoulder blades toward my right shoulder", "a profoundly loud Tinnitus in his left ear and minor tinnitus in his right ear", "sick", "muscle or tendon connecting to the left arm across his shoulders had not returned to normal". The following information was reported: TINNITUS (disability) with onset 2021, outcome "not recovered", described as "A profoundly loud Tinnitus in my left ear and minor tinnitus in my right ear, it has grown in intensity"; HYPOACUSIS (disability) with onset 2021, outcome "not recovered", described as "Now the ringing noise is almost deafening". The events "a profoundly loud tinnitus in my left ear and minor tinnitus in my right ear, it has grown in intensity" and "now the ringing noise is almost deafening" were evaluated at the physician office visit. Clinical course: patient had a profoundly loud Tinnitus in his left ear and minor tinnitus in his right ear. Patient first noticed it in mid August just and it has grown in intensity. Patient had never experienced Tinnitus before and it took awhile for him to understand what was going on. Now the ringing noise was almost deafening. Since the vaccination, the patient had been tested for COVID-19. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (unspecified date) positive, notes: on 11Feb; (unspecified date) positive, notes: on 20Feb; (06Sep2021) negative.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101698205 Same reporter/SD, Different AE/dose
(L) facial droop 2/2/2014. Dry (L) eye. Resolved within 7 days. No treatment.
drained; bad headache; This is a spontaneous report from a contactable consumer (patient). A 53-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 23Feb2021 at 14:00 (at the age of 53-years) as dose 2, single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 02Feb2021 at 14:00 as dose 1, single for covid-19 immunization. On an unspecified date, the patient had experienced bad headache and drained. The patient did not receive any treatment for the events. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The outcome of the events was recovering at the time of report.   No follow-up attempts possible. No further information expected. Information on lot number cannot be obtained.
LMP 8/14/2021 positive pregnancy test 10/2021 patient concerned with brownish vaginal discharge on 10/9/2021 patient states heavy vaginal bleeding consist with miscarriage on 10/16/2021
3/26 vaccination  3/28 slight swelling in both ankles. Over time, It started to spread into feet and heels 4/13 called PCM.  Swollen to the size of softballs, hurt like crazy.  4/14 Ultra sound; no blood clots 4/19 Went to PCM. I wear compression socks and steroid pack per PCM.  * dr stated it was 'more like swelling in the joints'.
My 12 mo received the MMR+V on 10/14/19 and developed an awful rash on his buttocks on 10/15/19. Red, raw, and very painful.
On 10/3/06 received both Flu and Pneumococcal vaccine both were injected in the same arm. 2nd injection hurt very bad. Spoke out in pain and the administrator rubbed area vigorously. Injections less than 1/2" apart. approx 6 hours later arm was very warm touch, hurt, had fever, and chills. Next day 10/04/06 woke up in pain and red mark on arm (4"x2"). Took Tylenol and Motrin. 10/05/06 had linear line on arm and seen Dr was cellulitis was in my lymph glands and arm pit. Prescribed antibiotics. Seen Dr again on 10/10 changed antibiotic, some pain.
Rash started on back, spread to stomach, chest, down arms 10 days after shot.  Went to dermatologist and was given Triamcinlone 0.1% cream 454 gm to apply 2x/day. Appearance of rash has been reduced but is still present. Was told by IVIG nurse to report symptoms.
Several hours after vaccination patient noted numbness & paresthesias involving the right medial scapula and entire right arm. Vaccination received in distal right posterior deltoid. No systemic symptoms. Seen in Emergency department 5/24/04 with weariness of right hand and numbness.
Information has been received from a physician concerning a 21 years old female with a history of cold sores, sulfonamide allergy and allergic reaction to CIPRO who on 19-OCT-2009 and 19-NOV-2009 was vaccinated intramuscularly with the first 0.5 mL and second 0.5 mL dose of GARDASIL (dose 1 LOT# 659054/0311Y and dose 2 LOT# 659054/0311Y), respectively. Concomitant therapy included ADDERALL TABLETS, YAZ and cyclobenzaprine HCl (MSD) and TWINRIX (with the second dose of GARDASIL). The physician reported that the patient experienced cold sores on her mouth each time after receiving GARDASIL doses. Unspecified medical attention was sought. There was no lab diagnostics study performed. The patient recovered approximately 1 and 1/2 weeks after getting cold sores. Additional information has been requested.
No adverse event; Received 0.25 ml instead of 0.5 ml of the Bivalent Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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. AS7140C) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 11-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster).    Concomitant medications were not reported.  27 adult patients received pediatric dose of Bivalent  COVID-19 vaccine 0.25 ml instead of 0.5 ml.                                  No treatment information was provided by the reporter.  This case contains information for the 24 of 27 adult patients described by the reporter.
Pt. states that after receiving the 1st dose of J&J 05/07/2021, started experiencing symptoms 05/09/2021 of sharp pains throughout the left legs, ER visit 05/25/2021 . 05/25/2021 suffered a Brainstem Left Ponds Stroke. Hospitalized 2 weeks, In-Patient for PT. Out-Patient Neuro Therapy for 6 Weeks.
Headache, Myalgia, Arthralgia, Severe stomach cramping, no diarrhea Narrative: employee reported at 3 am she woke up with severe body aches, everything hurt. H.A. She was unable to sleep. She developed severe abdominal cramping on 1/29/21, cramping was constant. She did not have diarrhea with this. She needed to miss two days of work to recover.
sick; pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick"; PAIN (non-serious), outcome "unknown". The events "sick" and "pain" required emergency room visit.  Additional Information: Event: She received the Pfizer shot two days later, she got sick had pain went to the ER.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient received booster shot. No Concomitant information was reported. Date of placed in refrigerator was on 29-Oct-2021. Vaccine did not undergone any temperature excursion. No other events were reported for patient. No Treatment information was reported. This case was linked to MOD-2022-491837 (Patient Link).
Patient received two doses of vaccine during vaccine clinic. No additional treatments or outcomes to report at time of writing this report.
Patient became unresponsive around 5 minutes after receiving the shot. Patient was with her father at the moment .  Patient was not responsive and presented with shallow breathing, pale skin, dilated pupils. CPR was not started because patient was breathing and had a pulse. 911 rescue services was contacted right away and instructions were given over the phone. Rescue was at the store within 10-15 min. A short time after, patient gained some grade of responsiveness and was taken to the hospital by the paramedics for further reassessment and/or treatment.
pain expanded to the fingers of his left arm; "horrible pain" in arm; "horrible pain" going to the jaw; experienced chills; body aches; fever at night time; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW ("horrible pain" going to the jaw), CHILLS (experienced chills), MYALGIA (body aches), PYREXIA (fever at night time) and VACCINATION SITE PAIN ("horrible pain" in arm) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032N20A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced CHILLS (experienced chills), MYALGIA (body aches) and PYREXIA (fever at night time). On 10-Mar-2021, the patient experienced PAIN IN JAW ("horrible pain" going to the jaw) and VACCINATION SITE PAIN ("horrible pain" in arm). On 11-Mar-2021, the patient experienced ARTHRALGIA (pain expanded to the fingers of his left arm). At the time of the report, PAIN IN JAW ("horrible pain" going to the jaw), CHILLS (experienced chills), MYALGIA (body aches), PYREXIA (fever at night time), VACCINATION SITE PAIN ("horrible pain" in arm) and ARTHRALGIA (pain expanded to the fingers of his left arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Blood pressure measurement: 166/112 (High) blood pressure increased.         Concomitant product use was not provided by the reporter.   ? No treatment information was provided. ? 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.
five minutes after receiving Typhin Vi, client c/o tongue feeling "itchy, like when I get a bee sting." Chest flushed and she began to shake. B/P and respirations normal. Stated "tickling getting worse". Given one ml Epinephrine in rt. thigh and called 911.Taken to ER.Tx with solu-medrol,epi and Benadryl. D/C at 4pm. 2/23/04
Family reported patient had COVID vaccine around 10am. Pt came home at 11am, and was extremely lethargic.They helped her get undressed and in bed, but then patient became very rigid and flailed her arms as if she was having a seizure, only lasted about a minute, she was very lethargic after barely arousable, then again became very lethargic and arms flailed for about one minute.  Pt then projectile vomited.   Advised calling 911 and patient was taken and admitted into hospital.