chrisvoncsefalvay/vaers-outcomes huggingface dataset:
light headed/dizziness.  Pt. became unconscious, not alter for approximately for 1 min Two person lift on Pt. to wheelchair and taken to the recovery room Placed in a supine position on a cot Assessment and vitals done. Pt. was alert after 5 mins Vitals were done every 10 mins for a half hour Pt. recovered to a normal status and left the facility
fever 102 for over four days  dehydration nauseous diahrea cough  chills fatigue
Around 5PM - arm hurting at site of injection - swelling red and itchy. Was getting fatigue, chills and fevers. I was talking in my sleep a lot which is something that I never do. The next morning severe migraine, nausea, my spine hurt, extreme fatigue, only spine was sore but it felt very hard to move my body - like I was moving in slow motion. I was back to having trouble forming sentences and finding correct words. These symptoms were far more severe than my actual COVID symptoms when I was sick with that. I had no appetite. That lasted all day. Tylenol - took that and did go to work to see two patients but should have stayed home. When I woke up the next morning (third day after the vaccine) I felt fine except for lingering fatigue. The fatigue was gone by the afternoon on Friday (the 29th).
Patient indicated he needed his second shot in the series--however he had already had a complete (2 shots) series -we did not know this per his registration information..he had misunderstood the process and got a third Pfizer vaccine --previous completed series was Pfizer
Early second dose / 1st: 12/02/2020  2nd: 01/13/2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 13th January 2021, the patient received the 2nd dose of Shingrix. On 13th January 2021, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional information was provided as follows:  The age at vaccination was not reported. The patient received 1st dose on 2nd December 2021. The patient received 2nd dose of Shingrix, less than the recommended interval, which led to shortening of vaccination schedule. The reporter did not consent to follow up.
Diffuse body aches, muscle tenderness and neuropathic pain beginning 1 day following injection.  No abnormal physical exam findings.
rash, feels like sandpaper; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.  Additional details were provided as follows: The patient received vaccine shot and developed rash.  The patient felt like sandpaper. This is one of the 3 cases, reported for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR237273:Same reporter US-GLAXOSMITHKLINE-US2021AMR237274:Same reporter
Patient was administered a vaccination of gardasil by accident instead of the scheduled comvax. It was administer on 1/25/06.  It has been only one and no symptoms have been observed. Gardasil is approved for patients of 9 years to 26 years.  No studies have been done for a patient of 15 months.
I had a little bit of sore arm, redness not same as Dose 1. The next morning I woke up felt sick around 2pm started exp low grade fever and loss of taste.I missed one day of work.
symptoms were numbness in his left arm and pain in the chest / Myocarditis; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (symptoms were numbness in his left arm and pain in the chest / Myocarditis) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050F21A and 045C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021, the patient experienced MYOCARDITIS (symptoms were numbness in his left arm and pain in the chest / Myocarditis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 17-Sep-2021 to 19-Sep-2021 due to MYOCARDITIS. The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 18-Nov-2021, MYOCARDITIS (symptoms were numbness in his left arm and pain in the chest / Myocarditis) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Troponin: high (High) Troponin elevated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. Treatment medications included unspecified blood thinner.  The patient called to report that he had myocarditis after getting the second dose of the Moderna Covid-19 vaccine. His symptoms were pain in the chest, numbness in his left arm.. Lab results included, troponin elevated. He was told that he has myocarditis when the lab results came in. Patient was hospitalized from 17-Sep-2021 to 19-Sep-2021.  Company Comment: This case refers to a 29-year-old male patient with no known medical history who experienced the expected event of Myocarditis approximately 4 days after the second dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case refers to a 29-year-old male patient with no known medical history who experienced the expected event of Myocarditis approximately 4 days after the second dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sore Throat, Headaches, Chills, Runny Nose, Mild Cough, Body Aches; Lasted 9+ days; Did not realize how sick I was or what was happening. Had significant difficulty locating test.
a little sore arm; This is a spontaneous report from a Pfizer-Sponsored Program Pfizer reported from a contactable consumer (patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 14Apr2021 at single dose for COVID-19 immunization. The patient had a dental appointment on 10Apr2021 and took premedication named Clindamycin. Concomitant medication included clindamycin hcl (CLINDAMYCIN HCL) taken for premedication on an unspecified date in Apr2021. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 24Mar2021 at single dose for COVID-19 immunization. The patient was  wondering if Clindamycin interfere with the vaccine. The patient experienced a little sore arm on an unspecified date in Apr2021. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
My face swelled; Face turned bit red; Hard to breath through my left nostril; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 08Apr2021 at 15:15 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient had known allergies to penicillin (MANUFACTURER UNKNOWN), fish, seafood and kiwi. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified high blood pressure medication within two weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 09Apr2021 at 02:00, after more than 48 hours, the patient experienced face swelled and turned a bit red. It was hard to breathe through by left nostril, could not tell if the tongue swelled. Since the vaccination, the patient had been tested for COVID-19. On 24Apr2021, the patient underwent lab tests and procedures, which included COVID-19 virus test (nasal swab) and the result was negative. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of events face swelled and turned a bit red and hard to breathe through by left nostril were recovered on unknown date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Fever around 101 for 24 hours, body aches, extreme fatigue, chills, migraines, extreme dizziness, vertigo
On 4/15 at 2:18 AM, I had uncontrolled full body shaking till 5:40 AM. All I could do was lay in bed a shake. I was fully aware of the what was happening and did not lose consciousness.  I was very scared since I was alone and did not know what was happening.
macular degenration; ear ache on the right side; eye throbbing; vision problem/ can not fpocus vision/ jumping visionv; Bulge on the retina; Bloodshot eyes; vision issues in both eyes; headache on right side; This spontaneous case was reported by a consumer and describes the occurrence of MACULAR DEGENERATION (macular degenration) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high since 2018 and Heart valve disorders since 01-Jan-2020. Concomitant products included HYDRALAZINE, LOSARTAN, CHLORTHALIDONE and AMLODIPINE for Blood pressure abnormal.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2. On an unknown date, the patient experienced MACULAR DEGENERATION (macular degenration) (seriousness criterion medically significant), EAR PAIN (ear ache on the right side), EYE PAIN (eye throbbing), VISUAL IMPAIRMENT (vision problem/ can not fpocus vision/ jumping visionv), RETINAL DISORDER (Bulge on the retina), OCULAR HYPERAEMIA (Bloodshot eyes), VISUAL IMPAIRMENT (vision issues in both eyes) and HEADACHE (headache on right side). The patient was treated with GABAPENTIN ongoing since an unknown date at a dose of 300 mg once a day; PREDNISOLONE ACETATE for Earache and Headache, at an unspecified dose and frequency and LOTEPREDNOL ETABONATE (INVELTYS) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MACULAR DEGENERATION (macular degenration), EYE PAIN (eye throbbing), VISUAL IMPAIRMENT (vision problem/ can not fpocus vision/ jumping visionv), RETINAL DISORDER (Bulge on the retina), OCULAR HYPERAEMIA (Bloodshot eyes) and VISUAL IMPAIRMENT (vision issues in both eyes) outcome was unknown and EAR PAIN (ear ache on the right side) and HEADACHE (headache on right side) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: normal normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Patient laboratory data was include ultrasoung on neck result was not given. The patient two eye doctors, one ear doctor and Neurologist.  Patient treatment information was received steroid shot.   This case was linked to MOD-2021-169315 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: followup received on 25-may-2021 non significant information was reported. On 26-Jul-2021: Patient Information, Events Added, Medical history was updated, treatment drug and outcome for headache and ear pain.; 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.
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 36-year-old female 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 4:03 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 4:03 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). In 2021, 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.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 36.84. Concomitant products were not provided. On 15-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. Vaccine BUD date was 09-May-2021. On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 32, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 44 and 5 PM: 42. The vials were only punctured right before administration and the dose were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a  traceable temperature monitor at every hour .After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was 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 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
I have Burning at Site of Injection, near Pacemaker, Heart, and Shoulder Feel shortness of Breath
Narrative:  Patient reported itching throat after administration of 1st dose of Pfizer covid vaccine. Patient stated this improved with drinking water. Patient denied respiratory symptoms or rashes. Patient was observed and released without any intervention.
expired Moderna vaccine administered to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Reporter reported that the administration of vaccine occurred from 06-Apr-2022 to 09-Apr-2022. Date the vial was initially stored in the refrigerator*: 05-Apr-2022 Patients have not reported any adverse reaction after the vaccination.   This case was linked to MOD-2022-538688, MOD-2022-538614, MOD-2022-538698, MOD-2022-538689 (Patient Link).
Granuloma Annulare; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 2, single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Acne" (unspecified if ongoing), notes: Never had problem with skin except, slight amount of acne when younger. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Anatomical Location: Left arm), administration date: 07Jan2021, for COVID-19 immunization. The following information was reported: GRANULOMA ANNULARE (medically significant) with onset 2021, outcome "not recovered". The event "granuloma annulare" required physician office visit. Therapeutic measures were taken as a result of granuloma annulare. Therapeutic measures were taken as a result of granuloma annulare which included Corticosteroid injection (Hydrocortisone injections), Cortisone cream USP 2.5%, Betamethasone cream .05%, Triamcinolone 0.025% cream. Clinical Course: Patient believed that about 6 months or less after, can't be sure but, didn't start reporting to doctor until then. Started having effects of auto immune disease, later diagnosed as granuloma annulare, an auto immune disease of the skin. Clarified, it was 3 to 6 months after second Covid vaccine that the symptoms started. They tried treating with several products, cortisone injections, several different types of creams. It spread on body in several places, nothing has been effective. They are going to try something else in about 8 days. They will be putting him on another product. Patient Visited to different doctor for this and was getting no results. Now going to be seeing a different dermatologist. Never had problem with skin except, slight amount of acne when younger.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on temporal association and known drug profile, a contributory role of suspect drug cannot be completely excluded for the reported event, GRANULOMA ANNULARE.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-202300266222 same reporter/patient,different drug/Event;
Patient did not feel well for 2 days after first shot; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Patient did not feel well for 2 days after first shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced MALAISE (Patient did not feel well for 2 days after first shot). On 10-Feb-2021, MALAISE (Patient did not feel well for 2 days after first shot) had resolved.            No concomitant medications reported.  No treatment information was provided.   This case was linked to MOD-2021-381277 (Patient Link).   Reporter did not allow further contact
Onset 20 hours after administered of vaccine. C/O headache and dizziness - ataxic
Body pain from legs to arms to shoulders and neck, Nausea beginning two days after vaccination. Fever starting three days after vaccination reaching 102. Profusely sweating combined with inability to sleep. Painful headaches with persistent sinus pressure.
Consumer reports that daughter devel hives approx 5 days p/recvd 1st dose of ORIMUNE;
Case number PHEH2012US010640 is an initial spontaneous report received from a pharmacist on 22 May 2012 with a follow up information received on 31 May 2012 with the follow-up on 11 Jun 2012: This case refers to 23-years-old male patient. It was reported that he received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: M10047 and expiry date: Dec 2012), in the left arm, intramuscularly without reconstituting with Men A component on 28 Apr 2012. He was fine so far. No adverse reaction occurred following this administration error. Follow up received on 31 May 2012: Reporter details and vaccination date updated. Follow-up received on 11 Jun 2012: Updated date of birth, age (23), vaccination date (28 Apr 2012), site (left arm), route (intramuscular).
The patient received her first dose of the Pfizer vaccine on 12/26/2020. Following the second dose of the Pfizer vaccine, the patient became lightheaded, dizzy, and wheezed 20-30 minutes after the injection.  25 mg Benadryl administered, along with Epi-Pen. The patient was transported to the ED.
Case number PHEH2016US023589 is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a patient of unknown demographics. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1516501, expiry date: Jun 2016) at a dose of 0.5 ml intramuscularly on 13 Sep 2016. It was reported that the vaccine administered was expired. No adverse events were reported following this maladministration.
Sudden onset of memory loss while paying for gasoline. Had been driving and stopped for gas. Paid and then couldn't recall where he was or what he was doing. EMS responded and transported to Hospital.