chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had a vasovagal syncope response upon standing after injections (both given in left deltoid, +1 inch apart. Hep A was the first given in the upper deltoid, HPV second in the lower deltoid). Writer had patient sit down, and she then passed out for 5-10 seconds. RN and provider were called into the exam room to evaluate her. Writer took her blood pressure and it was 54/34. Writer elevated patients legs on provider's chair, as she was not able/willing to transfer to the exam table. Patient was given orange juice, water, and crackers as she reported she had not eaten since noon, nor had she had anything to drink all day. Blood sugar was 102. Second blood pressure reading was 64/36. Patient then went to the restroom  with her mother, had a BM, and went back into exam room. Her final blood pressure was 94/64 and she was feeling much better, less pale and clammy. She walked to check out with RN and was given permission to go from RN and provider.
The left ear is a little weird, less hearing than usual; I lost hearing on my right ear completely; A spontaneous report was received from a  consumer,concerning himself, a 63year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a new side effect.  That he lost hearing on right ear completely and the left ear is a little weird,less hearing than usual.  The patient's medical history was not reported. Concomitant drug Lipitor is ongoing.  On 27-Feb-2021, prior to the onset of event, the patient received their second of two planned doses of mRNA-1273 (Lot number: 022M20A) intramuscularly  in the left non-dominant arm for prophylaxis of COVID-19 infection.   On 28-Feb-2021, the  second day after receiving mRNA-1273, the patient  experienced hear loss on right ear completely, so far there is no change and his left ear is a little weird and less hearing than usual. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable. The outcome of events lost hearing on right ear completely and the left ear is a little weird, less hearing than usual was not resolved at the time of report.; Reporter'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.
Sore arm, extreme fatigue, fever 101.9 and loss of appetite for 2 days following vaccine. aching behind eyes, especially right eye which lingered until about day 7, headache on right side for about last 4 of the 7 days, some discomfort in right armpit and tenderness of right breast nipple. No treatment except fluids and bed rest for first 3 days. By day 6 I felt myself again.
This spontaneous report as received from a medical assistant refers to a 60 years old female patient. The patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot # not reported) in September 2012. No other co-suspects were reported. No concomitant medications were reported. The medical assistant reported that a patient had a mild allergic reaction to ZOSTAVAX and an exaggerated injection site reaction the day following vaccination in September 2012. The medical assistant thought the reaction was anaphylactic, but then clarified that it was only an allergic reaction. The patient had swelling from the injection site down to elbow. The patient went to the health care professional and was given unspecified treatment. The outcome of the events was unknown. The relatedness for exaggerated injection site reaction and swelling from the injection site down to elbow was not provided for ZOSTAVAX. Additional information has been requested.
Patient administered MENVEO vaccine, felt okay and left office. Pt fainted outside of office and brought back in to office to rest. Wasn't feeling well and said her throat felt funny; she was taken to emergency room by parent.
Information has been received from a physician concerning a female in her 60's with a history of local injection site sensitivity who was vaccinated with Zostavax (Oka/Merck).  Subsequently the patient developed a swollen hard know at the injection site.  Additional information has been requested. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Information has been received from a physician concerning a 61 year old female with a history of local injection site sensitivity after receiving tetanus toxoid who on 20-AUG-2007 was vaccinated with ZOSTAVAX in her R arm (Oka/Merck). On 21-AUG-2007 the patient developed a swollen hard knot at the injection site. The local reaction was erythemic, edematous and swollen (10cm x 10cm). Subsequently the patient recovered. Additional information is not available.
Sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (for 1st dose, refer case US2019AMR142228).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix 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 Shingrix.  Additional details were provided as follows: This case was reported by the patient's sister. Additional information was not available. The reporter did not consent to follow up.
approximately 10:00pm CDT on 6.1.19 pt was undressing for bed and discovered a red rash in the shape of a long oval on her left arm approximately 2 inches below the injection site.  There was pain and swelling at the injection site. She also had low grade fever and pain in her back from the neck to torso.  Pt did not manage symptoms with any medication and they resolved within 3 days.
no side effects reported, only pt got a first pfizer dose when shouldn't have. Pt came in on 8/26/21 requesting first pfizer dose and noting on consent form haven't had any covid-19 vaccines before. Pfizer was administered. FOund pt had prior J&J dose at a health department a few months prior.
Child received Td in left deltoid. Next day noted to have redness and swelling 2 days later came to clinic for PPD reading and noted to have 4cmx6cm red, warm, swollen area.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting,   Chills, Fatigue, Injection site reaction  Narrative:   Other Relevant History:
Patient was hospitalized and diagnosed with COVID-19 on 4/26/2021 post receiving two doses of his Pfizer COVID-19 vaccine on 3/31/21 and 4/21/21
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2011, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date in 2016, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the 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. Additional information has been requested.
rash on her chest that looks more like a "measles" rash; This case was reported by a physician via call center representative and described the occurrence of measles-like rash in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included eczema. Previously administered products included Shingrix with an associated reaction of erythema (1st dose received on an unknown date (refer case US2019232438)).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced measles-like rash. On an unknown date, the outcome of the measles-like rash was unknown.   It was unknown if the reporter considered the measles-like rash to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication.  The patient received 2nd dose of Shingrix and experienced more pronounced rash on her chest that looks more like a measles rash. The physician was not convinced that this was related to Shingrix as the patient has a history of eczema and did not wish to report this as an adverse event. The reporter submitted limited information as did not wish to report the event and disconnected the call. The reporter did not consent to follow up.
One hour later I felt I was going to pass out. Blood pressure and oxygen levels were read at the time of the event. Oxygen levels were good, but blood pressure/pulse was high but gradually went down. No fever reported after arriving home but area on arm was hot. Upon arriving home I had to go straight to sleep. Next few days I had tiredness. Week 2 I had an allergic reaction at the injection site.
Sudden onset of severe myclonus in R shoulder, constant, has had 3 hospital visits with 2 admissions, 3 dr visits, 2 MRI, EEG, EMG, and full assessments by multiple healthcare providers, with normal results, Meds- Sinemet was tried, did not work, currently on Clonidine 0.1mg BID, with lessening in severity of twitching, but not a cure.
I suffered mental confusion that lasted approximately 2 1/2 hours (from 6pm to approx 8:30pm). Initially I thought it might be exercise-related (I had just completed a 35-minute bike ride in temperatures in the high 80's), but I have never experienced confusion like this after any type of short exercise. My husband provided water, sports drink (with electrolytes), and some crackers, but after an hour the symptoms hadn't lessened so he took me to the ER, where doctors performed a range of tests -- all of which indicated I didn't have any noticeable blood, heart, or neurological issues. On reflection, the feeling I had was very similar to a bout of mental confusion I had a few days after my FIRST Pfizer/BioNTech vaccination (on April 2, 2021, at the same location noted above). I had attributed that first incident to the vaccine, because I had heard that some people experienced mental confusion following their vaccination. I don't KNOW that this second episode was related to the vaccine, but the symptoms were similar to those I experienced in April.
Wheezing, throat tingling and anaphylaxis, dizzy, mostly the breathing. I was coughing nonstop
Abrupt onset of freight train sound in head with headache, dizziness, unsteady gait, brain fog/confusion, tongue numbness, altered smell/taste, fatigue.  Now three months later with persistent/chronic/fairly debilitating symptoms, but particularly unrelenting, incredibly distressing, 24/7 loud noise in head.
Dx chicken pox 2/12/03. Broke out 2/11/03. Child received varicella vaccine 11/22/00.
very high frequency of tinnitus and totally constant, exactly same; arm stiffness and pain at the injection site; stiffness and pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (very high frequency of tinnitus and totally constant, exactly same), MUSCULOSKELETAL STIFFNESS (arm stiffness and pain at the injection site) and VACCINATION SITE PAIN (stiffness and pain at the injection site) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-May-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 TINNITUS (very high frequency of tinnitus and totally constant, exactly same), MUSCULOSKELETAL STIFFNESS (arm stiffness and pain at the injection site) and VACCINATION SITE PAIN (stiffness and pain at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, TINNITUS (very high frequency of tinnitus and totally constant, exactly same), MUSCULOSKELETAL STIFFNESS (arm stiffness and pain at the injection site) and VACCINATION SITE PAIN (stiffness and pain at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Information has been received from a RN concerning an 8 year old female child who on 01/09/97 was vaccinated with a dose of varicella virus vaccine live. Subsequently, between the dates of 10/06/03 to 12/04/03, the pt developed a "mild case of chickenpox break thru". It was noted that this case was part of 16 cases of chickenpox reported at a school, 4 of which had been previously vaccinated with varicella virus vaccine live.  The reporter also mentioned three other children who experienced similar reactions (WAES # 0312USA00810, 0312USA01001 & 0312USA01002), two of which were siblings respectively. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Anti viral treatment (Paxlovid) from 03Feb2023 to 07Feb2022 for COVID-19. Patient did not other medications in 2 weeks. Patient did not have known allergies. Patient did not have any other medical history.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received first dose of Moderna on 4/15/2021.  Patient tested positive on 4/19/2021 for Covid.  Patient admitted to hospital on 4/25/2021.  Patient expired 5/14/2021
Patient states that he had a 4x5 inch area of redness around the injection site along with myalgia and limb pain.
Information has been received from through the Merck Pregnancy Registry via a nurse, concerning a 19 year old female with a history of asthma, and no reported concomitant medications or allergies, who on 07-SEP-2007 was vaccinated with the first dose of GARDASIL 0.5ml, IM (Lot # 653736/0868F).  The second dose of GARDASIL (Lot # 658563/1063U) was administered on 09-JAN-2008.  It was reported that the patient was eight months pregnant and had sought medical attention on an unspecified date.  Unspecified pregnancy lab work has been completed through the obstetrician.  The expected date of delivery was calculated to be 12-JUN-2008.  No outcome information has been provided.  No product quality complaint was involved.  Follow-up information has been received from the nurse practitioner concerning the patient.  She stated that the patient has not been seen in the office since June 2008.  Follow-up information has been received from a nurse practitioner concerning the patient.  It was reported that she had a normal, vaginal delivery at 39 +3/7 weeks on 21-JUN-2008.  The baby who's gender was not specified, weighted 6 lb and 1 oz, and had APGAR scores of 9 and 9.  The baby appeared normal on exam and on her postpartum exam the patient stated that everything was fine for her and her baby.  However, the patient is not bringing her baby to the pediatric clinic that she went to, so there is no newborn exam notes on the baby.  The nurse also reported prenatal information.  The patient's LMP was 15-SEP-2007 and her estimated delivery date was 25-JUN-2008.  On 17-Oct-2007, early in the first trimester, the patient was treated with BACTRIM for a urinary tract infection.  She had routine prenatal screening test, a QUAD screen and MID-trimester anatomy survey ultrasound, which were both within limits.  She was prescribed several other medications for use during her pregnancy.  On 07-NOV-2007 she was orally treated with PHENERGAN, 25 mg, as needed every 6 hours for the treatment of nausea until DECEMBER 2007.  From 04-JAN-2008 to February 2008 she was treated for heartburn with PRILOSEC (dose and frequency not reported).  In February 2008 she was also orally treated for a bacterial vaginosis with an unspecified medication, 500 mg, twice a day for 7 days.  Additional information has been requested.
WEAKNESS; FELT TIRED; HEADACHE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced weakness, felt tired, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the weakness, felt tired and headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210842894.
Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart disease, unspecified. Concomitant products included ROSUVASTATIN for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Fever, chills and vomiting for 2-3 days following each vaccine. Additionally, patient experienced  waxing and waning fatigue, fever, dizziness and light sensitivity.
PHARMACIST DID NOT DILUTE WITH THE DILUENT BEFORE WITH DRAWING THE 0.2ML DOSE FOR INJECTION. ON 8/1/22, PATIENT'S AUNT WAS CONTACTED AND PER AUNT, PATIENT HAD FEVER, BODY ACHE, AND TIRED DURING THE NIGHT, BUT AS OF THIS MORNING SHE  IS  FINE AND OUT SHOPPING. AUNT WAS ADVISED TO MONITOR PATIENT AND IF ANY CHANGES TO LET THE PHARMACY KNOW.
This is a spontaneous report from a contactable consumer who reported for her mother. An 80-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration at single dose on 27Oct2015 or 28Oct2015 and influenza vaccine, via an unspecified route of administration on an unspecified date. The patient medical history and concomitant medications were not reported. The next day after vaccination (Oct2015), the patient was still very sick, dizziness/lightheadedness, loss of appetite, fatigue, listlessness, body aches, sweats, chills, fever, bedridden, lethargic, unable to stand. No treatment received. These symptoms started out the next day and increased plus multiplied within the time of her death. The patient died on 06Nov2015. It was not reported if an autopsy was performed. Follow-up (13Nov2015): New information reported from a contactable consumer includes: primary reporter's information. Follow-up (08Jan2016): Follow-up attempts completed. No further information expected. Follow-up (04Apr2016): New information obtained from the same contactable consumer includes: additional events, additional suspect drug, date of administration of PREVNAR 13.
COVID TWICE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced covid twice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid twice was not reported. This report was non-serious. The report was associated with product quality complaint number: 90000209172.
I've been totally vaccinated and all kinds of boosters and everything and still got it.; I've been totally vaccinated and all kinds of boosters and everything and still got it.; 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 patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "I've been totally vaccinated and all kinds of boosters and everything and still got it.". Clinical course: Patient stated "I forgot I have so much stuff going on and Covid this last year left me clueless...I actually didn't experience it until the summer which was bad because I've always managed to keep myself fine and than I got the 5, 4/5 variant and than I felt better after I initially got sick for like 4 or 5 days and than I stayed feeling bad for like a whole month. So it kind of ruined my whole summer but at least I didn't end up in the hospital or anything and I've been totally vaccinated and all kinds of boosters and everything and still got it. Its fine I'm alive...   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.