chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a non-contactable pharmacist. A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL9261) intramuscular in the right arm on 09Feb2021 (at the age of 73-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 09Feb2021, the patient experienced nausea, chills, and rigors. The patient was given water at 14:35. At 14:39, the patient experienced shaking. The patient's blood pressure (BP) was 180/74, and then when it was retaken at 14:40, it was 190/86. SpO2 was 98%, temperature was 36.8C. At 14:48, the BP was 187/83. At 14:54, the BP was 175/77, heart rate (HR) was 86, temperature was 98.8F. The patient was not treated for the events. The clinical outcome of "BP: 180/74, 190/86, 187/83, 175/77", nausea, chills and rigors, shaking was unknown. No Follow up attempts are possible. No further information expected.; Sender's Comments: Based on the temporal relationship, a causal association between BNT162B2 and the reported blood pressure increased cannot be 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.
Patient presented to the clinic with her husband to get a Moderna Bivalent vaccine and a flu shot. Reporting nurse realized she gave this patient both Moderna  vaccines in each deltoid instead of 1 Moderna and 1 flu. Patient notified right after the injection was complete. Patient observed for  15 minutes without reaction. Patient will notify the office if she has side effects.
Mother of child noted left arm swelling and redness where patient had immunizations given on 4/9/10. Mother of child called doctor on call, and was advised to apply ice and give Benadryl.  Mother of child understood plan, child did not improve so mom brought child to Emergency Room.  Patient was diagnosed with "Cellulitis" to left arm and treated with antibiotics.  Patient seen on 4/12/10 in office by provider for follow up.
This spontaneous report as received from a registered nurse refers to unspecified number of patients. On unknown dates, the patients were vaccinated with RECOMBIVAX HB (lot #, dose, route not reported), which were exposed to 31.5F during a period of 4.7 days in a physician's office. The reporter stated that the physician's office has twice told her that no vaccines were administered, but then told her that there were, however, she had not specified patient information or dates of administration. No adverse effect was reported at the time of report. This is one of several reports received from the same source. Additional information has been requested.
The patient has not reported any side effects; a patient received PROQUAD vaccine instead ofMMR2 today; This spontaneous report was received from a medical assistant referring to a female patient (age reported 47 (unit unknown)). Information regarding to the patient's medical history, drug reactions/ allergies and concomitant medication was unknown.  On 16-SEP-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status of rHA (recombinant human albumin))(PROQUAD) (lot # S038146, expiration date 25-MAY-2021; strength, dose and route were unknown) instead of  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, route, lot# and expiration date were unknown)for prophylaxis (wrong vaccine administered). The patient had not reported any side effects
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 lot # N020139 with expiration date 14-FEB-2020, for prophylaxis (dose and route of administration were not reported). No adverse effects were reported. At the time of reporting, the temperature excursion and the time frame were unknown. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1802USA013755: US-009507513-1803USA000351: US-009507513-1803USA000352: US-009507513-1803USA000354: US-009507513-1803USA000355: US-009507513-1803USA000356: US-009507513-1803USA000357: US-009507513-1803USA000358.
Acute intracranial venous thrombosis  Narrative: 60yo male presenting to the ED stating received his 2nd dose  of COVID vaccine on 3/29/21 and has had a headache with vomiting since. Labs,  EKG, head CT, and MRI/MRA head obtained. MRI/MRA showing an acute  intracranial venous thrombosis. Pt. approved for fee based transfer to community  facility. Neurointerventionist at Medical Center states that procedure pt. needs is not  performed at Medical Center. Pt. accepted in transfer by ED provider at other Medical  Center for further evaluation and treatment. Pt. transferred via EMS at 2020.
Pt received varivax on 4/9/1996 but contracted chicken pox disease on 5/29/2000.
pt recv vax 29APR96 & 9MAY96 pt devel a fine papular measles rash located mainly on neck, chest, & back;pt devel no Koplik's spots;one visit to MD was required;pt had recovered by the time of next office visit in JUL96;
A small itchy rash showed up 9 days after the injection.  The rash was at the injection site on my left arm.
Patient with history of dementia and COPD. She was brought to the ED by EMS on 12/28/22 after having two syncopal episodes at home. In the ED, patient also reported a headache and cough along with newly developed shortness of breath while lying flat. A COVID PCR test performed in the ED resulted positive. Ultimately, she was admitted to the hospital 12/28/22 - 1/6/23. Patient was found to have bilateral PE. Discharge diagnoses include bilateral pulmonary embolism, COVID-19, demand ischemia, and AKI.
Treatment of COVID-19; Treatment of COVID-19; Pfizer / BioNTech - Dose Number: 4 ... Moderna - Dose Number: 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Jul2022 as dose 4 (booster), single (Lot number: FN2908) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Mar2021 as dose 1, single (Lot number: 030A21A), on 03Mar2021 as dose 2, single (Lot number: 019B21A) and on 09Nov2021 as dose 3 (booster), single (Lot number: 071F21) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies : Steroids" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN POTASSIUM; SIMVASTATIN; HYDROCHLOROTHIAZIDE. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 06Jul2022, outcome "unknown", described as "Pfizer / BioNTech - Dose Number: 4 ... Moderna - Dose Number: 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid from 06Oct2022 to 10Oct2022 as covid-19 treatment. Other medication in 2 weeks included losartan potassium, simvastatin and hydrochlorothiazide.
Patient had a spell of unusual movements with coincident apneic episode while asleep several hours after receiving the vaccination. Self-resolved and did not require any immediate medical care. No residual effects.
My arm is really sore from the shot / It's just sore from where they put the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (My arm is really sore from the shot / It's just sore from where they put the shot) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (My arm is really sore from the shot / It's just sore from where they put the shot). At the time of the report, VACCINATION SITE PAIN (My arm is really sore from the shot / It's just sore from where they put the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided.  No treatment medication were provided.
Sudden onset of hearing loss and tinnitus in the left ear.  Went through two courses of Prednisone treatment starting 4 days after the onset of symptoms.  Three hearing tests were done - one before the treatments and one after each treatment.  There was no significant improvement from the treatment.
Patient went for colonoscopy 2 days after receiving vaccine and was told that it was noticed that he was in afib while the colonoscopy was taking place. Patient went to the ER and was released and then followed up with his PCP for an EKG.
Excruciating pain in upper arm.  At times it radiates to lower arm.  I have difficulty sleeping and am not able to work my usual hours.  My PCP has ordered an MRI, but a CT scan would be better. I have applied warmth, 3x day, and taken ibuprofen 3 times a day.  I have also tried a lidocaine patch.  Nothing has helped. The area does not appear red or swollen and is not warm to the touch. I would really like to know what type of specialist I shoudl see.   PLEASE HELP!
I started having Arrhythmia and asI never had any kind of this episode in my life and this started being more and more I am doing all the check to see what s going on. I found everything very strange that it started in conjunction with the COVID vaccin.
Vomiting of dose; Vomitting of dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of regurgitation of medication in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 732L4, expiry date 25-APR-2025) for prophylaxis.   On 03-AUG-2023, the patient received the 1st dose of Rotarix lyophilized formulation (oral). On 03-AUG-2023, less than a day after receiving Rotarix lyophilized formulation, the patient experienced regurgitation of medication (Verbatim: Vomiting of dose) and underdose (Verbatim: Vomitting of dose). The outcome of the regurgitation of medication and underdose were unknown.   It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.     It was unknown if the company considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 3-Aug-2023 The nurse reported that the patient was administered a dose of Rotarix and afterwards vomited the dose back up. At the time of reporting, the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient received a dose and vomited the dose back up, which led to underdose.
Patient's arm was profusely red from top of shoulder down to elbow, started about 12 hours after vaccination, arm is swollen and hot to the touch. Patient said it has improved since last night. Advised he should seek treatment from a doctor; however, patient denied treatment and does not believe it is necessary.
It's still confusing for us.   I had no side effect from the first shot of Moderna, my husband just had a sore arm.  But after the second shot of Moderna, which was made one month after the first shot (I had thought these were booster shots) we both became very dizzy.  My husband felt horrible for a few days and even now notices some instability.   My side effect - after the first Moderna shot - was my becoming extremely dizzy and I fell backwards on a concrete floor, falling like a board.  My husband said he has never seen anyone fall in such a bizarre way, so straight.   Then yesterday I tripped and had a bad fall on a concrete floor and hit the other side of my head.   Although when I was young, I had a problem with falling and breaking a bone, my proprioception improved dramatically after exercises and Strontium (an inert substance),  It had been years since I fell for real and this represented two serious falls in 2 or 3 months.
Vaccine given 10/29/12. Started with redness at site & feeling achy, cold & shaking chills evening of 10/30/12. Flushed face, achy AM of 10/31/12 increased redness to (R) deltoid area 430PM 10/31/12 - seen by provider. Red & indurated area (R) deltoid measures: 11cm x 7.5 cm. Increased BP & pulse noted, no fever. 10/31/12 - Treated with antibiotics, f/u in 2 days. Sooner if increasing problems.
Red bump (L) arm. Dx R/O IMZ reaction. C/O itchy and pain. 8/3/14 1:24 PM. 8/1/14 Dx (L) arm lesion Rx ATARAX 25 mg TID PRN itching, BACTRIM DS BID x 10 days.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 4 (booster), single (batch/lot number: unknown) at the age of 46 years, in right arm for covid-19 immunization; BNT162b2 (BNT162B2), on 18Apr2021 as dose 1, single (batch/lot number: unknown), in left arm, on 09May2021 as dose 2, single (batch/lot number: unknown), in left arm and on 19Nov2021 as dose 3 (booster), single (batch/lot number: unknown), in left arm for covid-19 immunization. The patient's relevant medical history included: "cholesterol" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Dec2022, outcome "recovered" (09Dec2022) and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: Covid-19 Test: (unspecified date) positive, notes: treatment of COVID-19; (11Dec2022) negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient reported that he had anti-viral COVID 19 Treatment Paxlovid with treatment start date on 05Dec2022 and stop date on 09Dec2022.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5/ BNT162B2] has been requested and will be submitted if and when received.
administered expired Infanrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 2-month-old male patient who received DTPa (Infanrix) (batch number NG5GF, expiry date 26th November 2021) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th November 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 29th November 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The medical assiatant stated that, the patient inadvertently administered an expired Infanrix in left thigh, which led to expired vaccine used. The reporter consented to follow up.
On 3/3/03, Rabavert given at 08:30 and at 09:00, pt became pale, cold, teeth chattering uncontrollably, crying uncontrollably, body hurt all over, slight nausea and  slight difficulty breathing. Symptoms lasted approx. 1 hour per mother.
On 3/20 this patient started exhibiting right sided facial droop and paralysis of right arm and leg, dysphagia.  On 3/25 he was discharged from the hospital on hospice.
Arm hurts; This non-serious 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.   On 22-MAR-2023, the patient received the 1st dose of Shingles vaccine. On 22-MAR-2023, less than a day after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Arm hurts). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 22-MAR-2023 This case was reported by a patient via interactive digital media. The patient just got his/her first round and arm hurts but small price to pay he/she think. The follow-up could not be possible as no contact details were available. This report was one of several cases received as part of a line-listing, each containing minimal information.
arm twice its nl size, rash around arm & down back, shoulder swollen, t100, diarrhea;
passed out; high fever; horrible headache; aches; This case was reported by a consumer via interactive digital media and described the occurrence of passed out in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date).   In June 2022, the patient received the 2nd dose of Shingrix. In 2022, 4 days after receiving Shingrix, the patient experienced passed out (serious criteria GSK medically significant). In June 2022, the patient experienced fever, headache and ache. On an unknown date, the outcome of the passed out was unknown and the outcome of the fever, headache and ache were recovered/resolved.   It was unknown if the reporter considered the passed out, fever, headache and ache to be related to Shingrix.     Additional Information: GSK Receipt Date: 01-JUL-2022 Reporter's comments: This case was reported by consumer via interactive digital media. This case was reported by the patient's family member. The patient received his 2nd inoculation, 3 days before the date of reporting.  The patient had high fever, horrible headache, aches, and on the 4th day seemed fine, then passed out. The reporter asked how long before someone are back to normal health. In June 2022, less than a week after receiving Synflorix, the patient experienced fever, headache and ache. Additional supportive information: Follow-up would not possible, as no contact details were available.
I didn't experience severe AE after the shots (except for sore arm, mild cold symptom). However, my period started to be irregular since Oct-- it is way more blood volume and duration than my usual period, which I have never experienced before (lasted almost three weeks). I didn't think if much, since I know period regulatiion can be complicated. However, in Nov (end of Oct), after my last heavy period stopped for only a little over a month, my period came again, with unusual amount and now it has lasted over a week, no sign of stopping
Scheduled to receive a booster dose due to Compromised immune system; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNE SYSTEM DISORDER (Scheduled to receive a booster dose due to Compromised immune system) 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 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 IMMUNE SYSTEM DISORDER (Scheduled to receive a booster dose due to Compromised immune system). At the time of the report, IMMUNE SYSTEM DISORDER (Scheduled to receive a booster dose due to Compromised immune system) outcome was unknown.            No concomitant medications were reported. No treatment information was provided by the reporter.   Reporter did not allow further contact
severe shaking all over & severe aches & pains from waist down;temp nl;treated w/DPH;well a/vaccine;prior flu vax w/o problem;
I didn't have any adverse reactions to the vaccination, but my partner who has also received his COVID vaccines was exposed to COVID at work. I was then tested for COVID on 11/15/2021 and the results came back as positive. I had a cold and fatigue on 11/17/2021. I was out of work for 14 days. I received the Monoclonal Antibodies on 11/19/2021.
weakness; nasal pack hurts; soreness in the arm; headache; tiredness; A spontaneous report was received from a Non-Health Professional concerning a female patient, of 67-year-old, who was administered Moderna COVID-19 vaccine and experienced soreness in the arm, headache, nasal pack hurts, tiredness and weakness  The patient's medical history was not reported. No relevant concomitant medications were reported.  On 12-JAN-2021, The patient received her first of two planned doses of mRNA-1273 (Batch number: 041L20A) through intramuscular route in her right arm for prophylaxis of COVID-19 infection. On 13-JAN-2021, The patient experienced soreness in the arm, headache, nasal pack hurts, tiredness and weakness.  The patient took Aleve as a treatment medication for the events, soreness in the arm, headache, nasal pack hurts, tiredness and weakness. The patient was also about to had Tylenol as a treatment medication.  The action taken for Moderna COVID-19 vaccine was unknown.  The outcome of the events, soreness in the arm, headache, nasal pack hurts, tiredness and weakness were unknown.  The Non-Health Professional did not declared any relatedness between the events, soreness in the arm, headache, nasal pack hurts, tiredness and weakness and Moderna COVID-19 vaccine.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
When I awoke on 02/07/2021 I had a severe headache, fever, sore throat and fatigue to the point of not being able to move.  I lost all appetite and did not take in anything PO for >24 hours.  My stomach cramped up as well and my joints were so inflamed the pain was almost unbearable.  Anytime I crossed my legs or put any pressure anywhere that limb fell asleep immediately (which is a phenomenon I've never had happen before).  Carrying my small purse on my shoulder for example made my arm fall asleep.  I was able to go into work on 02/08/2021 but unable to complete my shift due to the pain and lethargy.