chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Her lips went numb; Vomiting; Low grade fever; Nausea; Shakes; Weakness; Numbness; Tingling/sensation as when she go to the dentist or fall asleep on her arm; nerve pain; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself) via Medical Information Team. A 55-Year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0153) via an unspecified route of administration on 14Apr2021, as dose 1, single (at the age of 55-years-old) for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Immediately after the vaccine on 14Apr2021, patient lips went numb and had to be observed. She then experienced vomiting, low grade fever, nausea, shakes, and weakness which then resolved in 7 days. She called today (on an unspecified date in 2021) about numbness/tingling/nerve pain that started two weeks after the vaccine on the left side of the body, which was where the vaccine was administered. Her whole left upper quadrant was numb and tingling from her waist to the tip of her left ear lobe including her hand, arm, fingers, under her breast, back and left side of the neck. She described the sensation as when she went to the dentist or fall asleep on her arm. She had bloodwork on an unspecified date (Monday) and it all came back normal. She did not have a pinched nerve. She was scheduled for an MRI today. She was calling to see if these side effects of numbness, tingling and nerve pain have been reported and how to treat the side effects. The outcome of the events her lips went numb, vomiting, low grade fever, nausea, shakes, and weakness were resolved on 21Apr2021 and outcome for rest of the events was unknown.  No follow-up attempts are needed. No further information is expected.
11 lb weight gain; Nausea; Shortness of breath; Chest pain; vomiting; Severe menstrual cramps; Pain at her injection site Remodulin; This is a solicited report based on the information received from a contactable consumer (patient) via regulatory authority (MFR Control No: UNT-2021-017551).   A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization; treprostinil sodium (REMODULIN), intravenous from 26Aug2021 (Batch/Lot Number: 938633; Expiration Date: 28Feb2023) and ongoing, at 0.004 ug/kg for secondary pulmonary arterial hypertension. Patient medical history was unknown. Historical vaccine included BNT162B2 for COVID-19 vaccine. Concomitant medication included tadalafil taken for an unspecified indication, start and stop date were not reported. On 05Sep2021, the patient experienced the events of 11 lb weight gain and nausea. On an unreported date in 2021, after her second COVID shot she had chest pain, shortness of breath, couldn't hold anything down. The patient also had severe menstrual cramps and pain at her injection site for Remodulin. Her prescriber advised her to go to the emergency room but initially she chose not to go and then further reported to field nurse that she was feeling a little better. On 05Sep2021, 11 days after initiating IV Remodulin, the patient visited hospital emergency department and admitted to hospital with chief complaints of shortness of breath, 11 pounds weight gain, chest pain, vomiting and nausea. The action taken in response to the events for treprostinil sodium was unknown. The outcome of events weight increased, dyspnoea, chest pain, vomiting, and nausea was unknown and events dysmenorrhea and injection site pain was considered as resolving. The reporter did not provide causality for the events of weight increased, dyspnoea, chest pain, vomiting, dysmenorrhea, injection site pain and nausea.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded. 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.
Massive headache, probably the worst I've had in years and very painful. Aural migraine earlier in the day where I couldn't see. Extreme fatigue.
Pt complained this vaccine made his arm more sore than any flu shot he's ever had before.
Administration of an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) in a 44-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided.
Swelling to L thigh from hip to knee entire circumference enlarged, only tender and red @ injection site. 6cm x 6cm circle. Orapred 15mg ODT BID x5 BENADRYL 1 tsp every 6 hrs.
Administered both seasonal flu vaccine and H1N1 vaccine on 12-1-09 around 1500. At around 1900 developed chills, joint pain, all over body aches and muscle pain, headache. Seen in clinic 12-2-09. Pending recovery.
Bronchialitis coughing fit or episode lasting for minutes straight at a time, causing patient to be out of breath and wheezing. Otitis media or an ear ache that lasted over 3 weeks and was resistant to 2 different antibiotics and resolved itself with a third antibiotic. The cough lasted over 2 months and 3 weeks, would keep him up at night as well. Then a dermatitis or exzema rash developed on his right eye lid.
Mother reports on 06/17/2020 around 1240 p.m. she got a call that her daughter was passing out, was pale,  had chills, and had a headache. Daughter was getting her nails done at the time. This was about 2 hours after the vaccine was administered.
body ache; bone ache; chills; headache; high temperature; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache), BONE PAIN (bone ache), CHILLS (chills), HEADACHE (headache) and PYREXIA (high temperature) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN (body ache), BONE PAIN (bone ache), CHILLS (chills), HEADACHE (headache) and PYREXIA (high temperature). At the time of the report, PAIN (body ache), BONE PAIN (bone ache), CHILLS (chills), HEADACHE (headache) and PYREXIA (high temperature) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Treatment information was not provided.
Patient fainted, his skin turned very pale and he urinated on himself.  Paramedics were called, they took vitals and said he was fine now but should take it easy for the next few hours.
red, itchy, area around the injection site. started 1 week after firs shot. started on 1/9/21 and has gotten a little bigger but isn't itchy anymore. still there as of 1/12/21
rectal bleeding; colitis; abdominal pain; UTI; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 01Apr2021 10:30 at the age of 55-years-old (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history included known allergies. There were concomitant medications in two weeks. The historical vaccine included 1st of BNT162B2 on 10Mar2021 09:30 am at left arm for COVID-19 Immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe abdominal pain and rectal bleeding 4 days after the shot (05Apr2021 00:30) and on the 4th day went to emergency room had multiple tests done including but not limited to bloodwork and urine work up and CT scan, finding colitis, rectal bleeding and urinary tract infection (UTI). Therapeutic measures were taken as a result of events. The events outcome was unknown. No COVID 19 diagnosed prior vaccination, since the vaccination the patient hadn't been tested for COVID-19.  Information about the Lot/batch number has been requested.
Fever (low grade, sweats, lasted 24 hours on and off, treated with tylenol), chills (lasted roughly 4 hours), nausea (not severe, no medicine taken), headaches (severe and throbbing, ibuprofen), sore arm around injection site (lasted 1 day), swollen lymph node in armpit on same side as vaccine (right) (appeared night following vaccine, ongoing, armpit area is swollen and tender), bruising at injection site
w/in 24hr devel high fever & pain in chest under rt ribs;fever died down as pain in ribs decreased;fever 1001 did not go away until 20OCT98 14days p/vax;
After three days, I have nausea, dizziness, sever headache, fever and chills, nightmares and fatigue. Today is the fifth day after my first shut and Ive not got better. I am pale and very tired. I would like to know these side effects are normal? and how long might last?
The area is warm to the touch, area is the size of her whole hand almost touches her elbow, area is pink, itchy, hard in the center. Stiff, only painful if touch. PT. later went to walk-in clinic and was diagnosed with cellulitis. Antibiotic prescribed. (cephalexin).
Sore in the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain 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, less than 3 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Three months before the time of reporting, the patient received Shingrix and still experienced sore in the injection site. The reporter did not consent to follow up.
Respond to patient in observation area at COVID Pod vaccination site for nausea. Patient came to the vaccination site to receive her first vaccination of the Pfizer vaccine. Approximately 10 minutes after receiving the vaccine she began to feel nauseous and alerted EMS at the Covid Pod for evaluation. Patient states that she doesn't like to be around needles but denied feeling nervous about receiving the vaccine. . During patient assessment patient stated that all her symptoms had resolved and she felt normal, she adamantly denied any further treatment and denied transport to the hopital and signed
Patient had soreness in injection arm from the night after vaccine until now. Patient still has soreness now after 2 months.
Developed sores and lesions on the tips of my toes, along with, severve tinnitus and headaches.
Passing out and falling; vomiting; Feeling strange; A spontaneous report ( was received from a consumer concerning a 84-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events loss of consciousness, vomiting, feeling  abnormal.    The patient's medical history included thyroid disorder and hypertension. Concomitant medications used by the patient were thyroid medication and blood pressure medication.  On 12 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 015M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 13 Feb 2021, the patient experienced passing out and falling, vomiting and feeling strange. She was taken to the emergency room and was administered IV and had some tests done. The patient was not admitted. The event passing out and falling (loss of consciousness) was considered as medically significant . No Laboratory details were provided.   Action taken with mRNA-1273 in response to the events was not reported.   On 13 Feb 2021, the outcome of the events, loss of consciousness, vomiting, feeling abnormal were considered as recovered.; 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.
tinnitus/so much noise in his left ear/sounds like buzzing in his ear; cannot sleep; screwed up his life; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (tinnitus/so much noise in his left ear/sounds like buzzing in his ear), INSOMNIA (cannot sleep) and IMPAIRED QUALITY OF LIFE (screwed up his life) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B214) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu vaccine in October 2022. Past adverse reactions to the above products included No adverse event with Flu vaccine.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced TINNITUS (tinnitus/so much noise in his left ear/sounds like buzzing in his ear), INSOMNIA (cannot sleep) and IMPAIRED QUALITY OF LIFE (screwed up his life). The patient was treated with QUETIAPINE FUMARATE (SEROQUEL) at a dose of 100 milligram at bedtime. At the time of the report, TINNITUS (tinnitus/so much noise in his left ear/sounds like buzzing in his ear) and INSOMNIA (cannot sleep) had not resolved and IMPAIRED QUALITY OF LIFE (screwed up his life) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       2nd dose - 01-Jun-2021, lot number - 035C21A 3rd dose - 02-Nov-2022, lot number - 051D22A No concomitant medications was reported. 1-2 weeks after the 1st dose of Moderna the patient experienced tinnitus. Patient states that he never had tinnitus in his life nor is it in his family until he got the vaccine. Patient states that he has so much noise in his left ear and it screwed up his life. Patient cannot sleep as it sounds like buzzing in his ear. Patient was taking Seroquel (Quetiapine) 100mg at night so he can sleep. Patient was seen by his primary care physician, an ENT and another specialist who all said that patient is okay.
Red, swollen, itchy, painful arm from shot site to elbow and under arm. Started evening of shot, became worse, hindered sleep, etc. Called Nurse Line on Sunday (injection was Friday) and given information about icing area. Continued icing 4 or 5 times a day until symptoms eased on day 6 (Wednesday).
Rashes developed over large areas of arms, legs, back, chest, and buttocks.  Went back to see Dr., who administered the Shingles Shot, and she said it was eczema.  Sent me to Dermatology for review. Worked with them for 10 months doing blood tests, using ointments, testing for scabies, had a biopsy of 2 sores, and all to no avail.  Am now seeing a holistic doctor, who is treating me with hydrogen peroxide body cleanings.  Still after 3 of these treatments there is no change.
05/17/2015 Nausea, Vomiting, Diarrhea started at approximately 5:50 pm and continued, with no resolution through 5/22/2015. 05/18/2015 Fever accompanied by muscle and joint pain with swelling to hands and lower extremities, developed ~5pm.  Temps ranging from 100 F Orally to 102.5 F Orally on 05/19/2015.  Fever and pain not responsive to Tylenol or Ibuprofen Q. 4-6 hr PRN.  Subsided 05/19/2015 after 11:00 pm. 5/20/2015 - Dizziness and malaise prompted employer to send home at 9:00 am.  Nausea and diarrhea continued. 5/21/205 04:35 am, woke to cardiac arrhythmia and shortness of breath.  Reported to Emergency Dept.  EKG with PVCs, Potassium at 3.8 mmol/L.  Dosed with 40 meq Potassium Chloride and fluids. Lomotil 2.5mg PRN.  Intermittent PVCs continued at home for another 8hrs. 5/22/2015 Malaise continued.  Diarrhea responsive to Lomotil 2.5 MG 1-2 QID PRN.
pt recv vax 1APR97 & 15APR97 devel approx 6 chickenpox, one of which was fluid-filled;no fever or itching were noted;18APR97 pt recovered;
Felt her heart was racing; Felt dizzy; Cold to the bone; Started to sweat; Could not sleep; A little pain in the arm; Went to bed achy and thought her meninges were inflamed everywhere; This spontaneous case was reported by a nurse and describes the occurrence of PALPITATIONS (Felt her heart was racing), DIZZINESS (Felt dizzy), FEELING COLD (Cold to the bone), HYPERHIDROSIS (Started to sweat) and INSOMNIA (Could not sleep) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PALPITATIONS (Felt her heart was racing), DIZZINESS (Felt dizzy), FEELING COLD (Cold to the bone), HYPERHIDROSIS (Started to sweat), INSOMNIA (Could not sleep), PAIN IN EXTREMITY (A little pain in the arm) and MYALGIA (Went to bed achy and thought her meninges were inflamed everywhere). At the time of the report, PALPITATIONS (Felt her heart was racing), DIZZINESS (Felt dizzy), FEELING COLD (Cold to the bone), HYPERHIDROSIS (Started to sweat), INSOMNIA (Could not sleep), PAIN IN EXTREMITY (A little pain in the arm) and MYALGIA (Went to bed achy and thought her meninges were inflamed everywhere) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-377121, MOD-2021-377122 (Patient Link).
No symptoms or adverse effects reported; Nurse reports 8 patients received unspecified dose of PROQUAD that was improperly stored; This spontaneous report was received from a registered nurse, referring to patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and previous drugs reactions or allergies were not provided.  On 23-SEP-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (concentration, number of administered dose, vaccination scheme frequency, route and anatomical location of vaccination were not reported; reported lot number S012530 and expiration date 20-OCT-2020) as prophylaxis. The sterile diluent (manufacturer unknown) used was properly stored.  According to the reporter, the temperature excursion was -12.8 degrees Celsius for a time frame of two hours and 38 minutes on an unspecified date (product storage error), with multiple previous temperature excursion of, the worst temperature/ was -9.8 degrees Celsius for about 112 minutes; which was detected by a digital data logger.  This is one of eight reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA009891:
Even though patient has epilepsy she had not suffered a seizure in 6 years prior to receiving the GARDASIL vaccine. She had a seizure the next morning after receiving the vaccine.
Fainted; Feeling very light-headed; Slightly nauseous; This is a spontaneous report from a non-contactable consumer (patient). A 50-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EW0179, expiration date unknown) via unspecified route of administration on left arm on 15May2021 at 12:00 PM at age of 50-year-old at single dose for COVID-19 immunization. Patient was not pregnant at time of vaccination and events onset. Medical history included back pain. Patient had no known allergies. Patient previously received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EW0171, expiration date unknown) on 24Apr2021 at 12:00 PM at age of 50-year-old via unspecified route of administration on left arm for COVID-19 immunisation. Concomitant medications included cyclobenzaprine, gabapentin, both administered within 2 weeks of vaccination. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, patient hasn't been tested for COVID-19. In the morning after the injection on 16May2021 at 09:30 AM, patient was in the kitchen and started feeling very light-headed and slightly nauseous. Patient sat in a chair but still felt the same. She got up to go lie down and fainted. After crawling to the couch and lying down for a few minutes, she felt better. The events didn't result in emergency room visit or physician office visit. Outcome of the events was recovered. No treatment received for the events.  No follow-up attempts are possible. No further information is expected.
A patient had received an injection of Menactra, on an unspecified date.  Route and site of injection were not specified.  At an unspecified amount of time after receiving the vaccination, the patient experienced extreme sleepiness and pain.  The pain was in the patient's side, down the back and into the arm.  Per the reporter, the event required medical attention.  Recovery status or additional medical information were not provided.
This spontaneous report was received from a licensed practical nurse and refers to unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M000442, expiry date: 31-MAR-2018, dose and route of administration were not reported). No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. Follow up information has been received from the nurse on 08-MAY-2017. This case refers to 21 month old patient, who was vaccinated with improperly stored doses of RECOMBIVAX HB on 16-AUG-2016. Reporting nurse did know why the temperature excursions occurred but there were no further excursions.  This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1608USA012908: US-009507513-1608USA012794: US-009507513-1608USA012794: US-009507513-1705USA004965: US-009507513-1608USA012908: Original case: 1608USA012916 US-009507513-1705USA004960: US-009507513-1705USA004973: US-009507513-1705USA004953: Original Case: 1608USA012916 US-009507513-1705USA004952: Original case 1608USA012916 US-009507513-1705USA004967: US-009507513-1705USA004954: