chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tingling in the hands; This is a spontaneous report from a contactable other healthcare professional (patient). A 51-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ED1283), intramuscularly on 15Jan2021 in the Right arm at single dose for COVID-19 immunization in hospital. Medical history included Celiac Disease, Dystonia, Hypothyroid, GERD (Gastrooesophageal reflux disease), Anemia, Ovarian cancer, Migraines, gastroparesis and known allergies with Penicillin. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took and had known allergies with prochlorperazine maleate (COMPAZINE), nicergoline, metoclopramide, dihydroergotamine, doxycycline, prochlorperazine, sulfamethoxazole and trimethoprim (SULFAMETHOXAZOLE-TRIMETHOPRIM). The patient experienced tingling in the hands on 18Jan2021. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the event. The outcome of the event was not recovered. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
This solicited report, was received from a 43 year old consumer, as part of Marketing Research Program, concerning to an unspecified number of patients (reported as "too many") whose concurrent conditions, medical history and concomitant medications were not provided. On unknown dates, the patients were vaccinated with doses of Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) (strength, dose schedule, route of administration, lot numbers or expiration dates were not provided). The patient stated that she did not get vaccinations shots since too many people she knows have gotten sick from them. She usually just took precautions to try and stay away from getting vaccines. Additional information is not expected as the reporter did not wish to be contacted.
She is reporting that her parents both received their first dose of the Pfizer-Biontech Covid19 vaccine on 06Apr2021 and contracted Covid illness shortly after; She is reporting that her parents both received their first dose of the Pfizer-Biontech Covid19 vaccine on 06Apr2021 and contracted Covid illness shortly after; This is a spontaneous report from a contactable consumer (patient daughter).  A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 06Apr2021 (Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received her first dose of the Pfizer-Biontech Covid19 vaccine on 06Apr2021 and contracted Covid illness shortly after. The patient was due for their second doses, tomorrow (on 30Apr2021), but her quarantine will not be over by her. Event outcome was unknown.    Information on the lot/batch number has been requested.
Hot, red, swollen area of LTR at site of VAR #2 administration 1 day ago. No fever.  Otherwise healthy.  Treatment:  Ice, Ibuprofen 400-600 mg PO TID.  If much worse in 2 more days go to Urgent Care Clinic.
Day of vaccine, quarter-sized red mark at site of vaccination - raised, hot, swollen. Each day size of mark increased to day four at 5 inches wide by 6 inches high. Continues to feel warm and painful. Seen in the ED - given Septra DS in case of cellulitis, and tramadol for pain.  Some nausea and vomiting day 3. (possibly from the pain)  Patient was positive for COVID19 the week prior to Thanksgiving.
Hiccups continuous non stop, nausea vomiting 1 today, 2 times yesterday, normal breathing, c/o warming, no report of rash 140/92, 74, 22R, No wheezing noted 1432 /2/21/09 1501 137/86 - 88- 20R - 98% Advised to go to hospital. Refused Medical Treatment.
Patient's wife described the injection as being very high on his arm.  The top of his shoulder became very sore and painful, and he developed an apple sized bump. He visited his doctor and received a pain medication and anti-inflammatory. His wife said that now he experiancing tingling down his arm and cannot even raise it.  He is scheduled for an MRI.  She is concerned that he may have nerve damage.
She tested positive for Covid 19 today; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. A 36-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/ Lot Number and expiry date were not reported), via intramuscular on 08Apr2021 (at the age of 36-years-old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 12Apr2021, patient was tested positive for Covid 19 today. Patient underwent Covid test on 12Apr2021 and result was positive. As reported, there was unaddressed medical questions referred or forwarded to Medical Information. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Patient was administered vaccine on 10/28/21. Vaccine was moved from Ultra Low Freezer to refrigerator on 9/24/21 and therefore was expired on 10/28/21 at time of administration.  No known adverse reactions have been reported by patient.
Woke w/headache..........after exercising started to feel very tired.......... spent the whole afternoon on the couch
Patient was approx 4 weeks pregnant when received vaccine and started to miscarry following day. 11/6/2009 and 11/9/2009 lab results and OB-GYN visit for 11/3/2009. Patient with c/o's intermittent bright red bleeding in first trimester. Pelvic exam noted a friable cervix. Tx: repeat labs ,rest
This spontaneous report as received from a medical assistant refers to a 2 month old patient of unknown age. The patient's medical history was not reported. On 16-AUG-2014 the patient was vaccinated with improperly stored ROTATEQ (dose and frequency were not reported, lot # J014981 and expiry date: 17-SEP-2015). No adverse symptoms were reported. The temperature excursion for the ROTATEQ was a supported excursion with in-house stability data. No product quality complaint (PQC) was reported for ROTATEQ. This case is linked to 1409USA010141, 1410USA009191, 1410USA009192, 1410USA009193 and 1410USA009195 (same reporter link). Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a 13 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 19-SEP-2017, the patient was vaccinated with improperly stored GARDASIL 9 (dosing details were not reported) (lot # N019923, expiry date: 28-APR-2019) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054: US-009507513-1709USA007012: US-009507513-1709USA007011: US-009507513-1709USA007014.
Upset stomach; Nausea; Vomitings; A spontaneous report was received from a nurse on 02DEC2022. It described a 14-years-old male patient (patient 2) who had "nausea" (PT: Nausea), "vomitings" (PT: Vomiting) and "upset stomach" (PT: Abdominal discomfort) following administration of Vivotif (Typhoid vaccine live oral Ty21A) (lot number: unknown), for immunisation. It was reported that the patient received Vivotif on an unknown date and following the two doses of Vivotif he had nausea, vomiting, and an upset stomach. The outcome of the reported events was unknown, at the time of this report.  Action taken with Vivotif with respect to the reported event was unknown.  The concurrent conditions, medical history, and concomitant medications of the patient were not reported.  No additional information was reported.  Based on the information available in the document two individual case safety reports 22000313 (patient 1) and 22000314 (patient 2) were created and cross-linked in the database.  Company comment: A 14-year-old male patient took Vivotif for immunisation, and developed nausea, vomiting, and upset stomach (abdominal discomfort). Further information regarding the events is limited. Considering a temporal association (between the onset of the events and Vivotif intake), the causality for the events nausea, vomiting, and abdominal discomfort is assessed as possibly related to Vivotif. The case is considered non-serious as per medical assessment.; Sender's Comments: A 14-year-old male patient took Vivotif for immunisation, and developed nausea, vomiting, and upset stomach (abdominal discomfort). Further information regarding the events is limited. Considering a temporal association (between the onset of the events and Vivotif intake), the causality for the events nausea, vomiting, and abdominal discomfort is assessed as possibly related to Vivotif. The case is considered non-serious as per medical assessment.
Bloating tummy; Reflux; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISTENSION (Bloating tummy), GASTROOESOPHAGEAL REFLUX DISEASE (Reflux) and NAUSEA (Nausea) 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 22-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISTENSION (Bloating tummy), GASTROOESOPHAGEAL REFLUX DISEASE (Reflux) and NAUSEA (Nausea). The patient was treated with ESOMEPRAZOLE for Adverse reaction, at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISTENSION (Bloating tummy), GASTROOESOPHAGEAL REFLUX DISEASE (Reflux) and NAUSEA (Nausea) outcome was unknown.            Patient consume only natural sugars (found in fruits etc) and  on a low sodium diet. No concomitant medication was provided.   This case was linked to MOD-2021-344140 (Patient Link).
Patient was given both the PCV 20 and PPSV 23 on the same day.  Did not need the PPSV 23.
anxiety; This is a spontaneous report from a contactable consumer via Pfizer Company Representative. A 33-year-old male patient received bnt162b2 (UNSPECIFIED TRADE NAME, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Lot Number: EL9265) at the age of 32 years old as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient began having anxiety the day after receiving his second dose of the Covid-19 vaccine. Event took place after use of product. The outcome of the event was unknown.  Information about the lot/batch number has been requested.
Moderate to severe allergic reaction - puffy face and lips; itching, skin burning all over; fever and chills
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2022 as dose 4, (booster), single (Lot number: FJ4991) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "psoriatic arthritis" (unspecified if ongoing); "known allergies: melons" (unspecified if ongoing), notes: known allergies: melons; "known allergies: airborne" (unspecified if ongoing), notes: known allergy: airborne; "Known Allergies: chemical sensitivity" (unspecified if ongoing), notes: Known Allergies: chemical sensitivity. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: I tested negative for 3 days; (unspecified date) Negative, notes: I tested negative for 3 days; (unspecified date) Negative, notes: I tested negative for 3 days; (unspecified date) Positive, notes: then have tested positive for 8 consecutive days including today; (unspecified date) Positive, notes: then have tested positive for 8 consecutive days including today; (unspecified date) Positive, notes: then have tested positive for 8 consecutive days including today; (unspecified date) Positive, notes: then have tested positive for 8 consecutive days including today; (unspecified date) Positive, notes: then have tested positive for 8 consecutive days including today; (unspecified date) Positive, notes: then have tested positive for 8 consecutive days including today; (unspecified date) Positive, notes: then have tested positive for 8 consecutive days including today; (unspecified date) Positive, notes: then have tested positive for 8 consecutive days including today; (06Sep2022) Positive, notes: then have tested positive for 8 consecutive days including today. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received treatment for COVID 19 as Paxlovid on 21Aug2022 and stopped on 26Aug2022.
started with like a vertigo event for hours, then violent headache and lights were making it worse? slept, woke up, confusion, headache, nausea and now diarrhea where i have nothing left but water coming out. general weakness and lack of motivation for anything
I have been throwing up for a few hours since midnight. Dry heaving, vommit, and extreme chills/shakes
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 23-year-old male. Neither medical history nor concomitant medications were reported. On 12-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events reported through the medical clinic associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009: product complaint investigation results.
2/5/03  @5:30pm developed rash from head to toe, fever of 102 degrees, loss of appetite and a little cough
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
BRUISING ON THIGHS AND BELOW GROIN AREA; This spontaneous report received from a patient concerned a 56 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced bruising on thighs and below groin area. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bruising on thighs and below groin area. This report was non-serious.; Sender's Comments: V0  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Intense face and neck flush; Skin was red, very warm and tingly; Skin was red, very warm and tingly; Began to have numbness in my lips and tongue; My BP was on the elevated side; skin very warm; This is a spontaneous report from a contactable Physician (patient). A 59-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ELI283 and expiration dates were not reported), via an unspecified route of administration in left arm on 09Feb2021 at 03:00 PM, as single dose for COVID-19 immunisation. The patient's medical history included hypothyroidism and hypertension. The concomitant medication included toprol, pravastatin, levothyroxine, fish oil, CoQ10. Patient did not take any other vaccine in four weeks. No COVID prior vaccination and no covid tested post vaccination. On 09Feb2021 at 15:15 At about 18 minutes after the vaccine was administered, patient had a sudden and intense face and neck flush, skin was red, very warm and tingly. Patient took benadryl 25 mg tablet and after about 5-10 minutes began to have numbness in lips and tongue. At this point, patient returned to the vaccination site to report this and wait for resolution. Patient was immediately seen by a nurse and EMS and her vitals were taken and was advised to take another 25mg of Benadryl. Patient underwent lab test and procedure which included BP was on the elevated side, O2 sat was normal. Her symptoms improved and by 45 mins after the vaccination she was comfortable returning to home no additional symptoms. The outcome of the patient's events was recovered.
I developed an abscess on my right shoulder about 2 or 3 weeks after my vaccine. I still have it since October. I went to my doctor about this. She is going to watch it to see if it grows. But right now there is nothing they can do about it.
I had an MRI with contrast on 11/22/2022 and afterwards I was nauseous, dizzy and had a headache. I have had this occur off and on for the last week and the dizziness will not let up, the doctor believes crystals were displaced during the MRI.
Redness, itching and soreness appeared 10 days after vaccine received. No issues encountered initially.
Patient described pain in extremities, difficulty breathing  consistent with GBS.  Patient was advised to wait to get 2nd dose until seen by his PCP.  Patient stated he just started feeling back to normal after 3 weeks
I received my third Pfizer booster for COVID-19 on 9/13/2022. On the morning of 9/22/2022 or 9/23/2022, I woke up with a bit of a scratchy throat and a runny nose. Over the next couple of days, it progressed into a productive cough, headache, and sore throat. My husband and I were on vacation at the time. When we came home on 9/30/2022, I did a home test for COVID-19, which yielded a negative result. On the morning of 10/1/2022, I retested and got a positive result. I went to an urgent care clinic that day and was prescribed Paxlovid, which I started taking the same day. The symptoms gradually improved. I just finished the Paxlovid on the morning of 10/6/2022. I took another test this morning (10/7/2022) and got a negative result. At the time of this writing, I feel much better, though I still have a bit of a cough and runny nose.
21-year-old male with no significant past medical history who received his second vaccine of the Pfizer COVID series on Wednesday, 16JUN21. Afterwards, he developed myalgia and chest pain that began on 17JUN21, which worsened prompting his arrival to ED. His troponin was found to be elevated and there were non-specific ST elevations on his electrocardiogram so he was admitted for observation while starting colchicine for myocarditis. His chest pain resolved in the emergency department prior to admission and did not return during his stay. His troponin peaked and down-trended. The findings on his electrocardiogram resolved. A formal echocardiogram was performed on 21JUN21 with no significant findings. He is to continue on colchicine 0.6mg PO BID for 3 months (END 8/11/21) and then follow up with cardiology for possible further workup if needed.
Erythema to face, tachycardia, mild throat tightness and SOB
knot developed behind left ear, swelling and redness in lower part of face; confusion and cognition issues; dizziness
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 1:53 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 1:53 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient age was reported as 68.11    Concomitant products were not provided.  On 15-Apr-2021, Excursion time were at 09 AM was 34, total doses given for the day was 188 , condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on  06-Apr-2021 , vial was moved to clinic on 15-Apr-2021. 18 vials was moved to clinic. Vaccine BUD date was 09-May-2021.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree F.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken by using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
Developed Bell?s Palsy to left side of face. Unable to blink left eye, numbness to left side lips/ mouth Being treated with Prednisone and Valacyclovir