chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Herpes simplex virus reactivation with every dose. Reactivation with in hours and up to 3 days following each dose. Upper lip; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Nov2021 at 15:30 as dose 3 (booster), single (Lot number: FE3592) at the age of 58 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, lot number: EP6955,), administration date: 17Mar2021, when the patient was 57-year-old, for Covid-19 immunization, reaction(s): "Herpes simplex virus reactivation with every dose. Reactivation within hours and up to 3 days following each dose. Upper lip"; BNT162b2 (DOSE 2, SINGLE, lot number: EP6955), administration date: 07Apr2021, when the patient was 57-year-old, for COVID-19 Immunization, reaction(s): "Herpes simplex virus reactivation with every dose. Reactivation within hours and up to 3 days following each dose. Upper lip". The following information was reported: ORAL HERPES (non-serious) with onset 30Nov2021, outcome "recovered" (02Dec2021), described as "Herpes simplex virus reactivation with every dose. Reactivation within hours and up to 3 days following each dose. Upper lip". Therapeutic measures were not taken as a result of oral herpes.  Additional information: Herpes simplex virus reactivation with every dose. Reactivation within hours and up to 3 days following each dose. Upper lip. Patient was not received any other vaccine four weeks prior vaccination and patient did not receive any medication two weeks prior vaccination. Patient not diagnosed with covid-19 prior to vaccination and since vaccination patient not tested for covid-19. The patient had no known allergies. Patient received DOSE 4 on 06Aug2022 (Batch/Lot: FJ6369) in Left arm and DOSE 5 on 17Nov2022 at 14:30 (Batch/Lot: GH9693) in the right arm both for COVID-19 immunization.
This spontaneous report as received from a physician via a representative refers to a 70 year old female patient. The patient's medical history included mild lupus disease. On 17-OCT-2012 the patient was vaccinated with ZOSTAVAX, subcutaneous. The physician reported to the representative that the patient went blind with "herpes zoster" in her eyes after being vaccinated with ZOSTAVAX. The patient had an office visit on an unspecified date for medical attention. At time of reporting, the outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
At approximately 1238 patient was noted to be on floor, experienced  fall from chair. 911 called. came to patient.  Pt placed in recumbent position. noted to be having seizure regained consciousness. Airway not obstructed no s/s if respiratory destress noted. Regain consciousness after 2 seconds. Vs  bp130/82, O298% on RA, HR 72, RR 28. Denies pain or discomfort. Pt alert and oriented able to state his name date location. Mae x34 l neurologically intact.  did not give Epi . No s/s of anaphylaxis noted. please patient and become a position. Ambulance and fire department on site at this time.
temp 102.7; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (temp 102.7) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (temp 102.7). At the time of the report, PYREXIA (temp 102.7) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.7 (High) 102.7.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications were reported.  No treatment medications were provided.
vaccine expired on 11/1/21. Dose administered on 11/5/21 (4 days past expiration date) She reported symptoms much like 1st dose, night of vaccine she was fatigued, day after vaccine developed headache, body aches. All symptoms were resolved by day 2 after vaccine
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 13:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 25Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 23Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. No known allergies. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. COVID 19 Treatment was Paxlovid from 01Nov2022 to 05Nov2022. On 10Nov2022, recurrence of covid symptoms (GI disruption, cold symptoms). No fever.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received an expired Intramuscular Vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired Intramuscular Vaccine) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired Intramuscular Vaccine). On 27-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired Intramuscular Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    The patient received vaccine from the vial which had past 12 hours since it had been punctured. Hence the patient received an invalid dose.    No other adverse reactions were reported.  The vial did not undergo any temperature excursions.  No concomitant and treatment medications were reported.
Headache, Fever, Chills, Body Aches, Nausea lasting Over 48 hours.
No appetite; Fatigue; Nauseous; A spontaneous report was received from a 33-year-old female consumer  with unknown race and ethnicity who received Moderna Covid-19 vaccine and experienced fatigue, nausea, and loss of appetite.  The patient's medical history was not provided. No concomitant medications were reported. No information on allergies.  On 08-JAN-2021, prior to the onset of events, patient received her first of two planned doses of Moderna Covid-19 vaccine. She started feeling nauseous, fatigue and loss of appetite since then. It is not known whether the patient received the treatment for the symptoms.   Action taken with 2nd dose of vaccine is not reported.  The outcome of the events fatigue, nausea, and loss of appetite is unknown at the time of report.; Reporter's Comments: This case concerns a 33-year-old female who experienced a NS unexpected event of Decreased appetite and NS expected events of Fatigue and Nausea.  The events occurred the same day as the first dose of mRNA-1273. Treatment not reported.  Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Passing Out, Loss Of Voice, Throat Closing Up, Can Not Breath, Chess and Body Pains, Headaches, Face Swelling, Face Red
22MAY96 pt recv vax & fever that noc;23MAY-24MAY nl;25MAY fever & sz (gen) to ER: 26MAY fever & sz (gen) to ER;
Narrative: Patient received the 1st dose of the Moderna COVID vaccine on 3/11/21 and reported headache x 3 days with fever up to 101F. He received the 2nd dose on 4/9/21 and reported vision changes - blurry with periodic light flashes and floater in left eye. Visual changes lasted 5-6 days then resolved. Patient has known catarats.
Headache, Sedation, TONGUE TINGLING SENSATION Narrative:  PRIVATE PCP RECOMMENDED TAKING 2CD VACCINE.
Symptoms started 12 hours after receiving vaccine. Pain at injection site, headache, body aches, swollen lymph nodes, stiff neck
It was a kidney stone on my right kidney. I found out on January 30th, 2023, I went to urgent care clinic. I had severe pain in my lower right back, I was prescribed tamsulosin and TYLENOL.
her vaccinated right arm hurt; slight headache; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (her vaccinated right arm hurt) and HEADACHE (slight headache) in an 8-decade-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.     The patient's past medical history included Cancer in 2019, Chemotherapy in 2019 and Radiotherapy in 2019. Concurrent medical conditions included Epilepsy (since teenage years). Concomitant products included PRIMIDONE (MYSOLINE) for Epilepsy, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 14-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (her vaccinated right arm hurt) and HEADACHE (slight headache). At the time of the report, VACCINATION SITE PAIN (her vaccinated right arm hurt) and HEADACHE (slight headache) outcome was unknown.            It was reported that because of the cancer treatment in 2019, sometimes she tried to say something, and it doesn't always come out the way she intended. She has had Epilepsy since teenage years & takes Mysoline. She stated that the Epilepsy medication makes her whole body slow. That was why she was slow to respond. Her whole system was like that, just in general without a vaccination, that's just from every day. She stated that part didn't change after vaccination. She takes Vit D3, and the doctor had asked her to monitor her High Blood Pressure. She mentioned that they are monitoring her blood pressure and have not prescribed any medication for it. No treatment information was provided.   This case was linked to MOD-2023-748129 (Patient Link).
large bruise on right breast; swollen lymph nodes under right arm; tenderness in her lymph nodes; Feels like she has been put through the ringer; sensitivity under right arm; Almost passed out; Dry-heaves; Became sweaty; Headaches; Nausea; 102 Fever; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Almost passed out), RETCHING (Dry-heaves), HYPERHIDROSIS (Became sweaty), FEELING ABNORMAL (Feels like she has been put through the ringer) and SENSITIVE SKIN (sensitivity under right arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism, High cholesterol and Contrast media allergy. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ROSUVASTATIN CALCIUM (CRESTOR), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) and ZINC for an unknown indication.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced PRESYNCOPE (Almost passed out) and HYPERHIDROSIS (Became sweaty). 20-Apr-2021, the patient experienced RETCHING (Dry-heaves), SENSITIVE SKIN (sensitivity under right arm), HEADACHE (Headaches), NAUSEA (Nausea) and PYREXIA (102 Fever). On 21-Apr-2021, the patient experienced FEELING ABNORMAL (Feels like she has been put through the ringer). On 22-Apr-2021, the patient experienced CONTUSION (large bruise on right breast) and LYMPHADENOPATHY (swollen lymph nodes under right arm). 22-Apr-2021, the patient experienced LYMPH NODE PAIN (tenderness in her lymph nodes). On 22-Apr-2021, PRESYNCOPE (Almost passed out), RETCHING (Dry-heaves), HYPERHIDROSIS (Became sweaty), SENSITIVE SKIN (sensitivity under right arm), NAUSEA (Nausea) and PYREXIA (102 Fever) had resolved. At the time of the report, FEELING ABNORMAL (Feels like she has been put through the ringer), CONTUSION (large bruise on right breast), LYMPHADENOPATHY (swollen lymph nodes under right arm), LYMPH NODE PAIN (tenderness in her lymph nodes) and HEADACHE (Headaches) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Ultrasound breast: Negative.         .   Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: Significant Follow-up appended.
Burning pain in back; This is a spontaneous report from a contactable consumer. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), first dose via an unspecified route of administration on unknown date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced Burning pain in back. The outcome of the event was Unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Covid arm rash; sore arm at vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Covid arm rash) and VACCINATION SITE PAIN (sore arm at vaccination site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Chronic fatigue syndrome in 1985, Acute gastritis (Intestinal gastritis) in 1993, Hypertension in 2019, Chronic back pain in March 2003 and Arthritis in 2007. Previously administered products included for an unreported indication: INFLUENZA VACCINE (Innfluenza fluad (0.5ml)) on 07-Oct-2021. Concomitant products included HYDROXYZINE for Cystitis interstitial, PARACETAMOL (TYLENOL [PARACETAMOL]) for Pain.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Covid arm rash) and VACCINATION SITE PAIN (sore arm at vaccination site). At the time of the report, RASH (Covid arm rash) and VACCINATION SITE PAIN (sore arm at vaccination site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient have many drug sensitivities, but not "allergies" that are life threatening.  No treatment medications were provided by reporter.   This case was linked to MOD-2021-374828, MOD-2021-368330 (Patient Link).
Case number PHEH2011US02193 is an initial spontaneous report received from a health care professional on 19 Aug 2011. This report refers to a female patient. The patient received only the Men A lyophilized conjugate vaccine component of MENVEO (batch no: 10C58) and did not receive MenCYW liquid component of MENVEO on 12 Aug 2011. No adverse reaction has occurred.
I had numb lips, tongue and arms itchy all over within about 15 minutes of the shot. 10 days later I am still very itchy and cannot get relief
Patient received vaccination of PCV 13 on 7/22/2015, then had dizziness, left arm erythema and getting bigger. Minimal pain, no fever.
This spontaneous report was received from a registered nurse concerning a 1 day (reported as 0 months) old male patient. On 11-JUL-2014 at 14:32, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (lot # J012520, Expiration date:30-JAN-2016), dose 1, intramuscular (dose was not reported). It was reported that the vaccine storage temperature dropped to 0-1 degree (units not reported) for 18 different episodes according to minimum/maximum. All recorded temperatures were within 2-8 degrees (units were not reported). No adverse symptoms were reported. Thi sis one of several reports received from the same source. Additional information is not expected due to all follow ups requested to complete the case were received.
Fist dose on: 12/21/2020. Second dose on: 01/12/2021.  Diagnosed/Tested POSITIVE with COVID-19 on: 04/20/2021.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 21-JUN-2013, the patient was inoculated with ZOSTAVAX vaccine (lot number, dosage and route of administration not provided) at a healthcare facility/medical clinic (by an unspecified healthcare professional) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 27-OCT-2014, the patient was treated by a healthcare facility/medical clinic (unspecified healthcare professional) for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
States soreness in left arm was felt the night of vaccination, uncomfortable while lying in bed.  By 12/08/2022 states area of vaccination swollen, warm to touch and reddened.  Used ices packs to site which seemed to improve swelling by 12/9/2022. States currently the area of redness is 2 x 3 in and slightly itchy.
PATIENT C/O FEVER LAS NIGHT OF 101. COME IN TO OFFICE WITH FEVER OF 103.6 AND CRANKINESS. APPETITE DECREASED.TYMPANIC MEMBRANES REDDENED,NASAL REDNESS,LUNGS CLEAR.
Woke next day with swelling. Warm to touch and tender to touch.  Continued to swell down to elbow. Not above shoulder. On 6/20/17 started to resolve and get better. Fever of 101. Raised goose bumps in area and itchy.
I experienced on 06/04/21; I went to the doctors; they prescribed steroid pack and steroids. I went back on the following Monday and I still felt awful. I had cough prior two weeks, felt miserable.  I had a covid test which was negative and prescribed another antibiotic and by the end of the week I went to the doctors again. I saw nurse practitioner on 06-14-2021, they did all kinds of tests, lab work. I ended up having RSV. I had also gotten a pimple on the palm of my hand, red was there for about three weeks. Looked like a cyst. I popped it and it went away a little of bit. Then I got another cyst on my stomach and below my bra.  They did a biopsy and they told me it was cyst and it was benign.  I also had a slight headache after my vaccine.
Case number PHEH2012US006813 is an initial spontaneous report received from a pharmacist on 15 Mar 2012. This case refers to a patient (age and gender not reported). The reporter stated that a patient received only MenA lyophilized conjugate component of MENVEO (batch number: unknown) reconstituted with a sterile diluent on an unspecified date; patient did not receive the MenCYW-135 liquid conjugate vaccine component of MENVEO. The reporter stated that the error was discovered because they had an extra MenCYW-135 liquid conjugate component of MENVEO vial. It was also reported that no patient identifying information was available at the time of this report, because they do not know which patient received a partial dose. No adverse reaction had occurred following this vaccination error.
experienced lots of gas - indigestion -  bloating feeling.  Vaccine on Tuesday, March 9th, and other symptoms started Friday, March 12, so not sure if related.  Lasted 3 days.
Bilateral deep vein thrombosis in both legs.; This is a spontaneous report from a non-contactable consumer (patient). An 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 03Apr2021 10:00 AM (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. Medical history included hypothyroid, high bp, urinary bladder cancer, lung cancer, covid-19. No Known allergies. Patient is not pregnant. The patient's concomitant medications were not reported. No other vaccine in four weeks. Patient previously received the first dose of BNT162B2 on 13Mar2021 10:00 AM (at 86 years old) into left arm for Covid-19 immunisation. The patient experienced bilateral deep vein thrombosis in both legs (hospitalization) on 14Apr2021. The patient was hospitalized for 2 days. Event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. covid was not tested post vaccination. Treatment received for the event included Xarelto. Outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
dispensed 28 doses of expired Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dispensed 28 doses of expired Moderna Covid-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     Patient had no known allergy. It was reported that patient had never been diagnosed/ tested positive for COVID-19. Patient had no chronic or long-standing health conditions. Patient had no acute illness at the time of vaccination and up to one month before.     On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dispensed 28 doses of expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dispensed 28 doses of expired Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  It was reported that patient had no adverse event from the vaccine on 6 Apr 2022.  The vial did not undergo any temperature excursions. On unknown date the vial was initially stored in the refrigerator.  No treatment medication information was provided.   This case was linked to MOD-2022-541343 (Patient Link).