chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Reduced general condition; Chills; Generalized aching; Fever; Unevaluable event; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of GENERAL PHYSICAL HEALTH DETERIORATION (Reduced general condition), CHILLS (Chills), PAIN (Generalized aching), PYREXIA (Fever) and PAIN IN EXTREMITY (Pain in arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   In March 2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. In April 2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) CF, Solution for injection in pre-filled pen. On 25-Mar-2022, the patient experienced PAIN IN EXTREMITY (Pain in arm). On an unknown date, the patient experienced GENERAL PHYSICAL HEALTH DETERIORATION (Reduced general condition), CHILLS (Chills), PAIN (Generalized aching), PYREXIA (Fever) and UNEVALUABLE EVENT (Unevaluable event). At the time of the report, GENERAL PHYSICAL HEALTH DETERIORATION (Reduced general condition) was resolving, CHILLS (Chills), PAIN (Generalized aching), PYREXIA (Fever) and UNEVALUABLE EVENT (Unevaluable event) outcome was unknown and PAIN IN EXTREMITY (Pain in arm) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: high (High) Markers were really high..         No Concomitant medication reported. No Treatment medication reported. It had been reported that Blood work showed that markers were really high.   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2022: Live follow up contain Significant information Patient demographics, event information updated.
pt recv vax 22MAY95 & 24MAY95 pt c/o severe nasal congestion,cough,diaphoresis & achiness in the upper arms;pt afeb;pt recovered;MD did not feel that the exp was related to vax but pt refused further inj
Our FDA contact checked with a VAERS person who said VAERS wants all of the SAE reports from our clinical trial. If you want to change that after seeing this report, please let us know. Subject in pneumococcal vaccine trial fell from wheelchair and was hospitalized for a few days. I don't know his age but all of our subjects are middle age or older.  10/29/07 Per direction of FDA, will initiate f/u.  10/30/07 Spoke w/reporters office who states patient definitely received pneumovax but no lot number available.  No medical recods available either, only the SAE report form from site.  Message left for FDA to see whether SAE report form is required.  11/1/07 Letter faxed to reporter to request SAE report per FDA request.  11/06/07 SAE report reviewed which reveals patient experienced fall 18 days s/p vaccination when trying to transfer from wheelchair to transport van & hit his head.  Resulted in 5 staples to back of head & admitted to hospital for observation 10/12-10/15/2007.
Information has been received from a registered nurse concerning her infant granddaughter who was recently vaccinated with a dose of ROTATEQ. Subsequently the patient experienced diarrhea. The patient sought unspecified medical attention. The outcome was unknown. There was no product quality complaint. Additional information has been requested.
Numbness and weakness in Left upper extremity, persistent with  motor weakness; same symptoms in RUE after second dose 28 JAN 2021 Narrative:  Persistent numbness and motor weakness, dropping objects, s/p Left deltoid injection  Other Relevant History:
Per phone note written on 7/15/11; About 3 days after my injection I had terrible stomach pains and diarrhea I could not control. I finally ended up taking IMMODIUM to control the diarrhea so that I could function through my daily routine.
Sore arm; Mild headache; Nausea; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199), via an unspecified route of administration on 11Mar2021 (age at vaccination 41-year-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis. The patient was allergic to macrobid. Patient's concomitant medications was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12Mar2021, the patient experienced sore arm, mild headache, nausea and fatigue. No therapeutic measures were taken as a result of sore arm, mild headache, nausea and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The outcome of sore arm, mild headache, nausea and fatigue was resolved on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient's first name's format updated, Vaccination Facility Country captured. Reaction of Past Drug Event updated as known allergies: Macrobid. Narrative updated from This is a spontaneous report from a contactable consumer to This is a spontaneous report from a non-contactable consumer.
Bloody diarrhea; Nausea with vomiting; Nausea with vomiting; Abdominal cramps; Fever; This case was reported by a pharmacist via call center representative and described the occurrence of bloody diarrhea in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number BA5GK, expiry date 4th November 2022) for prophylaxis.   On 6th June 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In June 2021, less than a day after receiving Shingrix, the patient experienced bloody diarrhea (serious criteria GSK medically significant), nausea, vomiting, abdominal cramp and fever. On an unknown date, the outcome of the bloody diarrhea, nausea, vomiting, abdominal cramp and fever were not recovered/not resolved.   It was unknown if the reporter considered the bloody diarrhea, nausea, vomiting, abdominal cramp and fever to be related to Shingrix.  Additional details were provided as follows: Health care professional called on behalf of patient.  A day before reporting, the patient received 1st dose of Shingrix and on the day of reporting, the side effects experienced were nausea with vomiting, abdominal cramps, fever and bloody diarrhea. Symptoms were started within 24 hours of receiving the vaccine and were not resolved. Call transferred to Medical Information for follow up. Instructed to have patients follow up with their Health care professional. The reporter did not consent to follow-up. This case had been linked with the case US2021AMR123236 (patient's husband), reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR123236:Same reporter. Husband's case.
have been up all night with a fever; This is a spontaneous report from a non-contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 09Feb2021 (Batch/Lot number was not reported) as UNK, single for COVID-19 immunization. The patient medical history was not reported. The patient previously received the first dose of bnt162b2 (BNT162B2). The patient's concomitant medications were not reported. It was unknown if the patient had any other vaccines in four weeks. It was unknown if the patient had COVID prior to vaccination. It was unknown if COVID was tested post vaccination. On 09Feb2021, the patient experienced have been up all night with a fever (pyrexia). The clinical outcome of the event was unknown.  No follow-up attempts are possible. Information on lot/batch number could not be requested. No further information is expected.
Pt received #2 moderna vaccine. Pt had no problems with #1 other that fatigue for 1 day. Went to store and passed out in the parking lot after passing out and hit her head on the pavement. Pt was transported to hospital. Pt was transferred to different hospital. Pt died at Hospital ER. 3 weeks ago pt diagnosed with heart murmur. Echo showed aortic valve function at 65%. Dr states he will just watch pt. no meds given. Pt family stated pt has a heart attack while at store.
first dose/10th October, 2020. And hasn't received the second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 10th October 2020, with batch number CE4DE, expiry date 25th September 2022).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follow: The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. No further events was reported. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
day 1: small anxiety, easier bruising, heavy breathing. normal anxiety symptoms but more elevated day 2: rash, and hives. more anxiety but stomach issues and dizziness
Patient developed redness, heat, and swelling in the local area of vaccination on night of 2/17/17.
her heart rate is different, higher; It bothers her at night and during the day she feels pressure; This is a spontaneous report from a contactable consumer. This consumer (patient's son) reported for a 52-year-old female patient (reporter's mother) that: A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: ER2613 and Expiry date was not reported), dose 1 via an unspecified route of administration on 20Mar2021 (age at vaccination was 52-year-old) as DOSE 1, single dose for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medications were not reported. It was reported that she received the first dose of the Pfizer BioNTech Covid vaccine and she experienced some side effects and asking if it is safe for her to take the second dose. On an unspecified date, she feels like her heart rate is different, higher. It bothers her at night and during the day she feels pressure. No treatment received for the events. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Jan. 16, 2021 i started noticing redness on the injection site. Then Jan. 19, 2021 was when I noticed that the redness grew bigger, it felt itchy, sore, tender and warm to touch.  I took Benadryl and Tylenol for it. No changes
Patient received 2nd dose of shingrix on 8.20.19. Pt called us to report that he noticed he experienced numbness on his left tiny finger and it did not get better due to numbness.  He is concerned if this is Shingrix's adverse reactions.  We consulted him to see his doctor for follow-up with the numbness.  Patient has no reactions on first dose of shingrix.
booster; Pain around the injection site on the left arm, which was the site of administration.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Dec2021 11:00 (Lot number: FJ8762) at the age of 29 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0171), administration date: 26Apr2021, when the patient was 28 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0150), administration date: 05Apr2021, when the patient was 28 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 06Dec2021 11:00, outcome "unknown", described as "booster"; VACCINATION SITE PAIN (non-serious) with onset 06Dec2021 11:00, outcome "not recovered", described as "Pain around the injection site on the left arm, which was the site of administration.". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information:  No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and Since the vaccination, patient was not tested for COVID-19.   Follow-up attempts are completed. No further information is expected.
Rec'd injections 10/14/16; Seen in office 10/17/16 for c/o (R) arm injection site redness, edema and mild increased warmth. Area approximately 13 x 13 cm. Dx as mild local reaction to vaccine (KINRIX) tx with ibuprofen and ice packs. Advised to return if S/s increased.
The patient is doing fine as far as we know/ No additional AEs; patient received less than the recommended dose; Some of the product got on the patient's skin and on the bed; the needle was not screwed on appropriately; This spontaneous report as received from a Medical Assistant refers to a 1 year old male patient. The patient's medical history included premature at 36 weeks.  Concomitant therapies included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and pneumococcal vaccine conj 7v (crm197)(PREVNAR).    On 29-JUN-2021 the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated(VAQTA) (lot # T035721 has been verified to be a valid lot number, expiration date reported and confirm upon internal validation as 15-APR-2022), via intramuscular route for prophylaxis (anatomical location was not reported). When giving the vaccine, the needle was not screwed on appropriately (device connection issue) and some of the vaccinated with hepatitis a vaccine, inactivated(VAQTA) got on the patients skin (exposure via skin contact) and on the bed, therefore the patient received less than the recommended dose (incorrect dose administered by product). No additional Adverse events were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T035721; expirationdate: 15-APR-2022; deviceage and unit: 0 ; serialnumber: 100880435798; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 3/19/2022 ELEVATED TROPONIN I
Tendinopathy beginning within a few days after 2nd dose of Pfizer COVID vaccine, ultimately leading to full avulsion of all 3 hamstring tendons, requiring surgical repair
Covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Drugs Not Reported. The patient received first Moderna vaccine on 04-Feb-2021 and was scheduled for second on 02-Mar-2021. Patient was diagnosed with Covid on 26-Feb-2021 and was in isolation until 06-Mar-2021. No Treatment information was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment:  This spontaneous case concerns a patient of an unknown age and gender with no reported medical history, who experienced the unexpected, non-serious  adverse event of special interest COVID-19, that occurred  22 days after receiving the first dose of mRNA-1273 vaccine.  SARS-CoV-2 test, and treatment were not reported. No information on any other doses of COVID-19 vaccination was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender with no reported medical history, who experienced the unexpected, non-serious  adverse event of special interest COVID-19, that occurred  22 days after receiving the first dose of mRNA-1273 vaccine.  SARS-CoV-2 test, and treatment were not reported. No information on any other doses of COVID-19 vaccination was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Flu like symptoms....headache, chills, aches, fatigue, malaise. Began day after vaccine and subsided by the 3rd day.
Slight chill and fatigue; Slight chill and fatigue; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 02May2021 (Batch/Lot number: unknown) at the age of 33 years as dose 2,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), administration date: 11Apr2021, when the patient was 33 years old, for COVID-19 Immunization. The following information was reported: CHILLS (non-serious), FATIGUE (non-serious) all with onset 03May2021, outcome "unknown" and all described as "Slight chill and fatigue".  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was unknown. Device Date : 04May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
tingling; lightheadedness; cold feet; numb; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 24Feb2021 as a 2nd dose single for COVID-19 immunization. Patient had historical vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on unknown date as a 1st dose single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient reported that, the reaction he has had is not totally sure it's related to the vaccine. On Sunday, 4 days later (as reported) patient's right leg started going numb and went down to his foot. Everything started tingling but then moved to his left leg. It had been persistent since then. On 29Feb2021 it had kind of gone into his hands and face tingles and numbness, his tongue. Patient went to his physician the next day and it checked his hands and his pulse and said everything seemed normal. Patient's feet also went really cold. He has had a little lightheadedness too. Outcome of all the events were Unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient got 2nd Pfizer Covid19 vaccine yesterday in the afternoon and experienced cramping (worse than period cramps) on lower abdomen starting that evening.  Patient called at about 4:45pm today saying that she still had the cramping at pain scale of 4 to 6 out of 10. She had been drinking warm water and ate her chicken and rice and she did not have any issue with nausea/diarrhea.  I suggested her to take Tylenol/ibuprofen if she would like and I followed up with her at 8:15pm and she said she still had the cramping at a 3 to 4 out of 10 but she took two 200mg ibuprofen...  I reminded her to report side affect on V-safe and continue with fluid and ibuprofen and I would fill out FORMS... I also reminded her to call us/her primary doctor if she has any further questions.
2 days post vaccination patient developed an indent in the injection site and shooting pain in right arm from shoulder blade and down to tips of fingers. Due to pain patient did not sleep for 3 months with 10/10 pain. Patient still has right arm and hand pain and was diagnosed by a neurologist as having right arm nerve palsey/neuropathy and Parsonage Turner Syndrome due to vaccination. Patient cannot move fingers, cannot move his right thumb and has constant pain fluctuating from 5/10-10/10. Patient now takes Gabapentin 600 mg PO TID and Tramadol HCL ER 100 mg PO PRN for pain on a regular basis and has a poor quality of life with chronic "shooting debilitating pain."
Headache chills, arm soreness, itchy, arm once soreness dissipated, lymph node tenderness underarm, fatigue Narrative:
Main symptom: Shortness of Breath Treatment: Diagnostic tests and IV fluids-No breathing treatments Outcome: Felt better
1st dose 11 Nov 2020, 2nd dose did not received yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 11th November 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose 11 Nov 2020, 2nd dose did not received yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 23-MAR-2023 The pharmacist was the reporter who called and reported that a patient had not received a second dose administered yet. Lot number and expiration date for the vaccine were asked but declined because administration happened at a different facility. The reporter did not consent to follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.