chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The days following the vaccine I began experiencing tingling in my cheeks and some eye blurriness.It bothered me but did not think too much of it. It was a special week so I was excited about all the week events I was going to do with family. Then finally, on Thursday September 30th around 1 pm I felt the tingling return to my cheeks, then to my nose and forehead. I was also At around 3:30 pm, my face had gone numb. The entirety of it. I would touch my face and lightly slap it and I still couldn't feel. I immediately called the doctors office to schedule an appointment asap. I had done some research into the vaccine and this had been a side effect reported by people. The feeling came back to my face around 5:30 ish. My right cheek lost feeling the next morning around 8:30 am.l but was back around 12 pm. Today is sunday and I have not experienced any more numbness since friday.
felt chilled; temp was 100.3. The highest it got was 101.7; felt lethargic; achey; sore arm; fatigue; This is a spontaneous report from a contactable consumer (patient). A 71-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9267) (at the age 71-year-old), via an unspecified route of administration, administered in arm right on 17Feb2021 16:00 as dose 2, single for covid-19 immunization. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9261), dose 1, on 27Jan2021 04.15 PM on right arm for covid-19 immunization. Patient known allergies includes daypro and morphine. The patient relevant medical history includes HTN, GERD, fibromyalgia, arthritis, history of Breast Cancer. The patient concomitant medications were not reported in two weeks. The patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that about 22-23 hrs after her 2nd dose, (on 18Feb2021 at 14:30) the patient felt chilled and temperature was 100.3 and the highest it got was 101.7. The patient felt lethargic and achey. Except for a sore arm and fatigue the side effects was gone when the patient woke up the following morning. The patient underwent lab test on 18Feb2021: body temperature: 100.3 and 101.7 Fahrenheit. The patient did not received treatment for adverse event. The patient did not had prior vaccination for covid. The patient did not tested for covid post vaccination. The outcome of feeling cold, pyrexia, lethargic and pain was recovered on an unspecified date in 2021. The outcome of pin in extremity and fatigue was not recovered.  No follow-up attempts are possible. No further information is expected.
My arm hurt for a week after each vaccination shot; This case was reported by a consumer via  interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on an unknown date, refer case US2021AMR149439).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient reported that after every Shingle shot, his/her arm hurts for a week. The patient stated that he/she could not imagine how painful shingles were. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR149439:Same reporter.
Systemic: Fainting/Unresponsive-Severe. Additional Details: Patient had a syncope episode post vaccine administration. Unresponsive for about 5 minutes. Paramedics were called, patient had recovered from his episode quickly.
Pt received PNEUMOVAX vaccine on 8/10/10. Started with (L) arm pain/purplish discoloration at injection site, next morning, felt left arm pain, "hot feeling" and left palm tingling. Pt was to f/u to recheck in 2 d but did not f/u. Also pt FTKA on 8/27 and pt. did not f/u.
Swollen lymph nodes under both arms, swollen breasts and severe pelvic pain started in the evening after the booster was given.  Stayed in bed with heating pad for over 2 weeks now.  Still experiencing severe pelvic pain.
a 9 year old patient received a dose of Fluzone MDV from a vial stored at 18.6 degrees celsius for 6.5 hours; Initial information received on 22-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA143997, 2019SA144003, 2019SA144004, 2019SA144008, 2019SA144007 and 2019SA144005 (same reporter).  This case involves a 9 years old female patient who received a 0.5ml first dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] multi dose vial that was at 18.6 degrees Celsius for 6.5 hours lot UJ005AE, expiration date: 30-Jun-2019 via intramuscular route in the right deltoid on 17-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to incorrect product storage.  It was unknown if any adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
fever of 102; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 102) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PYREXIA (fever of 102) and CHILLS (chills). At the time of the report, PYREXIA (fever of 102) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Sore arm; This is a spontaneous report from a non-contactable consumer (patient's friend) from Regulatory Authority. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced sore arm on an unspecified date. The outcome of event was unknown. The patient also received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number was not reported) on an unspecified date for COVID-19 immunisation and experienced knocked them down for 4 or 5 days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Started having a sore throat, congestion, fatigue and cough. Took home COVID-19 test and it was positive. Currently taking PAXLOVID.
death- SADDLE PULMONARY EMBOLISM Narrative:  Patient was at home with his family when he suddenly collapsed to the ground, was unconscious for only a few moments then came back around. His wife called EMS. They showed up and checked him out, he said he felt fine, unsure why he suddenly collapsed. They convinced him to get checked out at the ER. They were doing a CT scan and saw that his pulmonary artery was obscured on both sides. An embolectomy was attempted, but the PE was too extensive. He coded and eventually died.
booster; dizziness; dehydrated; couldnt speak; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 07Oct2021 14:00 (Lot number: FF2590) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Pancreatis", start date: 2015 (ongoing), notes: No symptoms doing good; "Skin Cancer" (ongoing), notes: Onset date: At least 30 years, Doing good; "BP" (ongoing), notes: Onset date: Last 20 years, Normal losartan; "Cholesterol" (ongoing), notes: Onset date: 20 years, Normal, Pravastatin. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1st, Date: 06Jan2021, Time (24 hrs): 2 PM, Site and Route of Injection: Right Arm, Batch/Lot Number: EK4176, DOSE 1, SINGLE), administration date: 06Jan2021, when the patient was 63 years old, for COVID-19 Immunization; Bnt162b2 (Dose: 2nd, Date: 21Jan2021, Time (24 hrs): 1-2 PM, Site and Route of Injection: Right Arm, Batch/Lot Number: 8N5318, DOSE 2, SINGLE), administration date: 21Jan2021, when the patient was 63 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 07Oct2021 14:00, outcome "unknown", described as "booster"; DIZZINESS (non-serious) with onset 07Oct2021, outcome "recovering", described as "dizziness"; DEHYDRATION (non-serious) with onset 07Oct2021, outcome "recovering", described as "dehydrated"; SPEECH DISORDER (non-serious) with onset 07Oct2021, outcome "recovering", described as "couldnt speak". The event "dizziness" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: No prior Vaccination. On 28Jan2021, the lab tests CT, Blood and BP were normal. It was reported that vaccine in middle of day but work requires. That night dizzy, dehydrated and couldn't speak. Sent home 3 hours later, doing good. Test Normal. Dehydrated, better.   Follow-up attempts are completed. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergy: amoxicillin", notes: Known allergy: amoxicillin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) negative, notes: 2 days of negative tests; (Jun2022) positive, notes: Third positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This solicited report as received from a pharmacist, as part of a marketing research program, refers to a 65 years old male patient. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date in 2013 (when the patient was approximately 62 years old), the patient was vaccinated with 1 dose of ZOSTAVAX, one time injection (route of administration, lot# and expiry date were not reported). On an unknown date in 2016, the patient experienced mild case of shingles. The patient recovered/resolved with sequelae from the event on an unknown date, in 2016. Causality assessment was not provided. This is one of two reports received from the same reporter. Additional information is not expected, as there was no consent for further contact.
p/vax pt exp blotchy rash starting on face progressing over neck; posterior anterior upper torso; tx tylenol & benadryl; pt fussy; poor appetite; low grade fever;
Fever  99.9 at 8:00 am next day, And also at 8:00 pm  99.4 Fatigue/ SOB around noon and for the rest of the day. Leg cramps at night for the next two nights
No additional information or AE's reported; one expired dose of PNEUMOVAX 23 (syringes) was administered to a patient on 3/23/23 and vaccine expired on 1/28/23.; This spontaneous report was received from a nurse and referred to a 66-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 23-MAR-2023, the patient was vaccinated with one dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), 0.5 ml injection, 1 quantity, lot #U026796, expiration date: 28-JAN-2023, administered intramuscularly for prophylaxis (expired product administered). There was no previous temperature excursion reported. No additional adverse event (AE) was reported.
potential symptom of being tired; potential symptom of spent a day in bed having fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (potential symptom of being tired) and PYREXIA (potential symptom of spent a day in bed having fever) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (potential symptom of being tired) and PYREXIA (potential symptom of spent a day in bed having fever). The patient was treated with IBUPROFEN (MOTRIN) at an unspecified dose and frequency. At the time of the report, FATIGUE (potential symptom of being tired) and PYREXIA (potential symptom of spent a day in bed having fever) outcome was unknown.            Relevant concomitant medications were not reported.  The action taken with mRNA-1273 in response to event was not applicable.   This case was linked to MOD-2021-186701, MOD-2021-187222, MOD-2021-186668 (Patient Link).
7 days post injection. Swelling, itchy, firm spot approx 1.5? at injection site.
Two-week delay, after receiving the vaccination, a flare up of allergy Asma, call out to allergy specialist told them about what was going on and the nurse gave the vaccination told wait 14 days before taking the allergy medication because it could make her immune to the Covid shot. Allergist (nurse practitonare) told her to wait    was not able to take medicinal for Asma 21 day dizzy off balance fatigue and also diabetics and the steroids   days.  At 21 set day she went to the office to the nurse auctioneer at her Primary office, he prescribed, musnex antibodies and steroids by that Friday, stated to feel bad, dizzy, fatigue, could not taste or smell anything and blood sugar was high, loss taste and smell and had type A flu and was not able to work.  Primary Dr. prescribed, put on flu medication with quarantine for three days and Covid and flu and another test. At st urgent care. ID  Testing
Patient' left arm (the arm in which she got the vaccine)started swelling and progressively got worse. It was swollen, red, and hot to the touch from the shoulder to the elbow. She called her family doctor two days later and was instructed to go to the ER. She went to the ER on 09/11/14 and was told it was a "severe allergic reaction" and was given Benadryl, Solu-medrol, and Pepcid in the ER and was given a prescription for antibiotics.
Patient fainted after receiving her vaccine.  EMTs came and found very low blood pressure, and took her to the hospital.
a red lump on the injection site and that is warm to the touch; warm to the touch; felling that their arm is killing them; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (a red lump on the injection site and that is warm to the touch), VACCINATION SITE WARMTH (warm to the touch) and VACCINATION SITE PAIN (felling that their arm is killing them) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048121A and 020f21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and HYDROCHLOROTHIAZIDE for an unknown indication.   On 28-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2021, the patient experienced VACCINATION SITE MASS (a red lump on the injection site and that is warm to the touch), VACCINATION SITE WARMTH (warm to the touch) and VACCINATION SITE PAIN (felling that their arm is killing them). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (a red lump on the injection site and that is warm to the touch), VACCINATION SITE WARMTH (warm to the touch) and VACCINATION SITE PAIN (felling that their arm is killing them) outcome was unknown.
This spontaneous report was received from a Registered Nurse referring to an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB, (lot # K007263, expiration date 09-JUN-2016), doses, routes and anatomical locations were not provided. No concomitant medications were reported. No adverse effects reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided. On 23-JAN-2019 the patient was vaccinated with a dose of GARDASIL 9 (strength, dose and frequency were not reported) lot # R025155 expiration date 23-MAY-2021, intramuscularly for prophylaxis in the (right ventrogluteal region" (Vaccine administered at inappropriate site). No adverse effects were reported.
Mother reported diarrhea started on 12/17/06. Stated infant had up to 8 stools a day for 2 weeks. Mother stated infant required a visit to her MD and MD was unsure if it was vaccine related or not. MD put infant on a formula that helps with diarrhea. Mother presents on 2/17/07 for 4 month immunizations and declines Rota-teq dose 2. D. Heyer RN.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a 55-year-old female patient who received SHINGRIX (batch number XC534, expiry date 4th July 2020). On 23rd March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 23rd March 2018, immediately after receiving SHINGRIX, the patient experienced injection site lump, injection site itching, injection site discoloration, injection site erythema and swelling. On an unknown date, the outcome of the injection site lump, injection site itching and swelling were recovered/resolved and the outcome of the injection site discoloration and injection site erythema were not recovered/not resolved. The reporter considered the injection site lump, injection site itching, injection site discoloration, injection site erythema and swelling to be related to SHINGRIX. Additional details were provided as follows: The reporter was the pharmacist who administered the product. The patient called to notify her that almost immediately after having been administered the vaccine, she had a red lump at the site of the injection which was raised about one half inch and was itching. It was described as a localized reaction on her right upper arm at the injection site which was a little smaller than the size of the palm of her hand. The itching and lump lasted about 10 to 12 days and had resolved at the time of reporting, but there was a discoloration in the area where the lump had been. Within a couple of days after receiving the SHINGRIX, the patient went to an urgent clinic care and was given BENADRYL and told that it would make the reaction resolve. The call was transferred to the GlaxoSmithKline regarding the reporters inquiry as to whether or not this patient should receive a 2nd future dose in the series. When asked twice what dose was administered of the SHINGRIX vaccine, she responded twice 50 mcg. The patient granted permission to be contacted with further related questions. The reporter was called back, and she clarified that the dose administered was 0.5 mL.
UrticariaPruritus, Eight days post injection, developed redness, swelling, warmth, and itching at the injection site. Narrative: Employee advised to follow up with PCP.
Headache began morning after vaccine was received.  Improves with tylenol.  Still having intermittent headaches.  Has followed up with her PCP.
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; joint pain hips and back; arm pain at the injection site; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142) on 08Jan2021 at 12:30 PM (that is 09Jan2021 00:30 AM) in the left arm at single dose for COVID-19 immunization. None Medical History. Concomitant product includes ongoing ethinylestradiol, ferrous fumarate, norethisterone (KAITLIB FE) for oral contraceptive taking for a long time. No Prior Vaccinations within 4 weeks. Patient received the first dose of the vaccine on 08Jan2021 at 12:30 PM and then COVID-19 PCR test positive the following 12Jan2021. Clinical course as: On 09Jan2021, some arm pain at the injection site. On 10Jan2021, she had some joint pain hips and back; chills. On 10Jan2021 night into 11Jan2021 she had some nasal congestion. On 12Jan2021, she lost her sense of taste and smell. All of these effects have resolved except for the loss of taste and smell. She is planning to get the next dose on 29Jan2021. Patient was asking about getting the second dose of the vaccine since she tested positive. She tested negative prior on 04Jan2021; 06Jan2021 and 08Jan2021, until 12Jan2021 when she was tested positive. No events require a visit to physician or ER. The outcome of arm pain and joint pain was recovered on 10Jan2021, of other event was not recovered.