chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative:  She reports having developed 4-5x wheals on anterior b/l thighs about 7-9 days post initial vaccination and took 2 evenings to resolve. These were described as ~dime sized, well circumscribed, erythematous, indurated, not fluid filled. She does not remember if they were warm to touch, but denies itchiness. She took an OTC benadryl the first evening, with resolution of the wheals by the next morning. However, they reappeared later that day. She took another benadryl that night and the issues did not reoccur afterwards. Patient has had a puritic rash over that area in the past when visiting hotels that may have used a different detergent. She denies any recent detergent changes, known new exposures (plant/environment or animal), and new OTC or prescription rx.
sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (that was miserable). Previously administered products included Shingrix with an associated reaction of illness (received 1st dose on an unknown date, refer link case US2023AMR060416 ).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced sickness (Verbatim: sick). Rechallenge with Shingrix was positive. The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Shingrix.     It was unknown if the company considered the sickness to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR060416   Additional Information: GSK receipt date: 22-APR-2023 This case was reported by a patient via interactive digital media. The reporter reported that he/she was sick after each dose of Shingrix shot but, he/she would take that over than having shingles again. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR060416:dose 1, same reporter
warm at the injection site; fever blister; rash at the injection site; red circle at the injection site,redness at the injection; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Mar-2021 and was forwarded to Moderna on 17-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (fever blister), VACCINATION SITE WARMTH (warm at the injection site), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE ERYTHEMA (red circle at the injection site,redness at the injection) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No reported medical history.  Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (HYDROCHLOROTHIAZIDE + LOSARTAN) and LEVOTHYROXINE for an unknown indication.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE ERYTHEMA (red circle at the injection site,redness at the injection). On 12-Mar-2021, the patient experienced ORAL HERPES (fever blister). On 15-Mar-2021, the patient experienced VACCINATION SITE WARMTH (warm at the injection site). At the time of the report, ORAL HERPES (fever blister), VACCINATION SITE WARMTH (warm at the injection site), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE ERYTHEMA (red circle at the injection site,redness at the injection) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information in response to events was not provided.
Information has been received from a registered nurse concerning a 19 year old female pt who on 09/07/1989 and on 04/06/1995 was vaccinated with a first and second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot # not reported). Subsequently the pt experienced failure to seroconvert to one or more of the components. Laboratory evaluation by 2 different labs revealed failure to seroconvert. The nurse also reported that 3 other pts (ages and genders not reported) received 2 doses of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot # not reported) and failed to seroconvert to one or more of the components. (WAES #0302USA01877). Additional info has been requested.
Rec. immunizations 2/17/04 mom came to clinic 2/19/04 at approximately 4pm for nurse to check L deltoid. RN checked arm L, found to be warm and red, area approx. size of an orange. Child states red area itches. Mom reports onset 2/19/04, no problems previously. Tx: ice packs, use Tylenol for pain and soreness. Benadryl prn for itching and see MD if not resolved.
Patient complaining of itchiness to right arm progressing to legs. Negative for hives or visible rash. Benadryl 25 mg administered at 0918. As per patient, rash appeared to face post first vaccine. Educated to follow up with PCP if symptoms continue or call 911 if symptoms worsen. VS-BP 158/98, pulse 91, oxygen 99%, temp 97.6. Additional 25 mg administered at 0923. 9:41 dr made aware. Ok to release. Mother with patient will drive her home. Left in no acute distress. Symptoms resolved, monitored for total 30 min.
got the flu shot, got so ill that would rather suffer through the flu; Initial information received on 30-Dec-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who got the flu shot, got so ill that would rather suffer through the flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported; formulation: unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "got the flu shot, got so ill that would rather suffer through the flu" (illness) (unknown latency).  There were no lab data/results available.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (got the flu shot, got so ill that would rather suffer through the flu).  At time of reporting, the outcome was Unknown for the event got the flu shot, got so ill that would rather suffer through the flu.
ON 2/25 THE PATIENT CALLED AND REPORTED BEING SHORT OF BREATH OVERNIGHT. HE STATED THAT IT WAS SOMEWHAT BETTER ON THE MORNING OF 2/25. PT WAS REFERED TO HIS PCP FOR EVALUATION
Patient began with metallic taste several hours after vaccine administration and progressed to right sided facial droop with difficulty closing right eye and drooling when drinking due to right sided mouth numbness and droop. He was medically evaluated for symptoms 4 days after symptoms began and diagnosed with Bell's Palsy and treated with steroids. At this time he has had no improvement in symptoms. He is using eye drops for dry eyes and using an eye patch at night to keep his eye closed.
This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A male patient received BNT162b2 (BNT162B2), as dose 1, 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: TINNITUS (non-serious), outcome "unknown"; AGEUSIA (non-serious), ANOSMIA (non-serious), outcome "unknown" and all described as "Loss of taste and smell". Additional information: Patient stated that he developed tinnitus and loss of taste and smell after two doses of Pfizer Covid vaccine. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s) : PFIZER INC-PV202200042943 Same patient/drug/AE, different dose;
Missed heart beat.  Every 17 or 18th beat on Sunday following the Thursday dose.; This is a spontaneous report from a contactable consumer, the patient. A 65-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm left on 25Mar2021 at 14:30 (at the age of 65-years-old) (Batch/Lot Number: ER8733) as dose 2, single for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Other. Medical history included sleep problems, sleep apnea and large prostate all from an unknown date and unknown if ongoing. Patient had known allergies to drugs paclitaxel (PAXEL) and ketoconazole (KETOCONAZAL). Concomitant medication included alfuzosin (received within 2 weeks of vaccination) taken for an unspecified indication, start and stop date were not reported. Past drug events included known allergies to drugs paclitaxel (PAXEL) and ketoconazole (KETOCONAZAL). Historical vaccine included previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 04Mar2021 at 14:30 (at the age of 65-years-old) (Batch/Lot Number: En6204) as dose 1, single for covid-19 immunization and did not experience any adverse reaction. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination and since the vaccination, the patient had not been tested for COVID-19. The patient reported he experienced 'missed heartbeat, every 17 or 18th beat on Sunday following the Thursday dose' on 28Mar2021 at 10:00. The event did not result in emergency room/physician office visit. The patient was not treated for the event. The event was assessed as non-serious by reporter. The outcome of the event was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Pain in random places all over her body /Aches in random places all over her body; Swollen lymph node; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain in random places all over her body /Aches in random places all over her body) and LYMPHADENOPATHY (Swollen lymph node) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 025J20-2A) for COVID-19 vaccination.     Concomitant products included LORAZEPAM (ATIVAN) and LORAZEPAM for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Pain in random places all over her body /Aches in random places all over her body) and LYMPHADENOPATHY (Swollen lymph node). At the time of the report, PAIN (Pain in random places all over her body /Aches in random places all over her body) and LYMPHADENOPATHY (Swollen lymph node) outcome was unknown.            No treatment was provided. The action taken with mRNA-1273 in response to the event was not applicable.
The HCP stated that a husband and wife received their first doses of VAQTA on 24 FEB 2020, but then never received their booster dose 6 to 18 months later.; No other additional AEs.; This spontaneous report was received from the pharmacist and refers to currently 72-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 24-FEB-2020, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided), but then, never received booster dose (6 to 18 months later) (booster dose missed). No other adverse event was reported   This is one of the two reports from the same reporter.; Sender's Comments:  US-009507513-2206USA008817:
severe headache; neck pain/Speaking or eating hurts the neck; Any kind of movement such as swallowing; Any kind of movement such as swallowing and breathing is painful; A spontaneous report was received from a non-healthcare professional concerning a 48 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe headache, any kind of movement such as swallowing and any kind of movement such as swallowing and breathing is painful. No medical history was reported.  No concomitant medication was reported.  On 07-Jan-2021, prior to the onset of the events severe headache, any kind of movement such as swallowing and any kind of movement such as swallowing and breathing is painful, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via an intramuscular route in right arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced severe headache, any kind of movement such as swallowing and any kind of movement such as swallowing and breathing is painful.  Laboratory details was not provided.  Treatment medication included ibuprofen at an unknown dose and frequency via an unknown route.  Action taken with mRNA-1273 in response to the events severe headache, any kind of movement such as swallowing and any kind of movement such as swallowing and breathing is painful was not provided.  The outcome of the severe headache, any kind of movement such as swallowing and any kind of movement such as swallowing and breathing is painful was not provided.  The reporter did not provide the assessment of the events severe headache, any kind of movement such as swallowing and any kind of movement such as swallowing and breathing is painful to study drug.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
a little tired; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (a little tired) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 prophylaxis.     Concomitant products included FAMOTIDINE, ATORVASTATIN, ESCITALOPRAM and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced FATIGUE (a little tired). At the time of the report, FATIGUE (a little tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No Medical History information was reported.  No treatment drug was reported.   This case was linked to MOD-2022-648680, MOD-2022-648682 (Patient Link).
Painful, fluid-filled vesicles appeared on the patient's left forehand and between the fingers of the left and right hand on May 1, eight days after the second dose. By May 10, the blisters disappeared leaving deep red, purple, and brown discoloration on the affected areas. The discoloration remained for two months and gradually faded. Upon contracting COVID in September 2021, the discoloration reappeared and remained for over a week after infection. During these events, over-the-counter allergy medications (loratadine, diphenhydramine) proved ineffective.
had vax 11SEP95; 19SEP95 lt arm @ inj site feel warm & swollen; poss delayed rxn;
C/O HTN, low grade fever, increased confusion and lethargy.  Pt discharged 5/13/2021.
Information has been received from a nurse concerning a female patient of unknown age. The patient's concurrent conditions, medical histories and concomitant therapies were not provided. On 20-SEP-2016, the patient was vaccinated with a dose of M-M-R II (lot #, expiration date and dose were unknown), intramuscularly (rather than the recommended subcutaneous route). No apparent adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
ITCHING ALL OVER, SCRATCHY THROAT, ANAPHYLAXIS PT PREMEDICATED WITH BENADRYL 50MG PO AT HOME PRIOR TO COMMING FOR SECOND VACCINATION AT 1125 12:57 PT STATES S/S OF ANAPHYLACTIC REACTION, SCRATCHY THROAT, TONGUE SWELLING, HIVES, ITCHING VS TAKEN: HR 120,RR 20,BP 150/78, SPO2 100% RA 1258: EPI PEN GIVEN X 1 IM TO LEFT VASTUS LATERALIS, PT TOLERATED WELL. 1259: SQUAD AND ER NOTIFIED FOR NEED OF TRANSPORT TO CPH. 1301:DEXAMETHASONE10 MG IM IN RT LETOID GIVEN X 1, PT TOLERATED WELL. 1305: 20 GUAGE SL PLACED TO RT WRIST. PT TOLERATED WELL.  1315: REPEAT VS TAKEN AND STABLE HR 95, RR 20, BP 140/74, SPO2 100% RA. 1315 RESCUE ARRIVED AND TRANSFERED TO CPH
Initial report was received from a health care professional on 23 March 2012. A 15-year-old male patient had received an injection of MENACTRA (lot number, route, site and date of administration unknown) and an unspecified amount of time later experienced headache, congestion, cough, wheezing, nausea and joint aches. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: None.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain radiated from the shoulder to the bottom), PERIPHERAL SWELLING (Extreme swelling) and PAIN IN EXTREMITY (Extreme Pain) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  Concurrent medical conditions included Rheumatoid arthritis and Hypertension. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN (Pain radiated from the shoulder to the bottom), PERIPHERAL SWELLING (Extreme swelling) and PAIN IN EXTREMITY (Extreme Pain). At the time of the report, PAIN (Pain radiated from the shoulder to the bottom), PERIPHERAL SWELLING (Extreme swelling) and PAIN IN EXTREMITY (Extreme Pain) was resolving.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication not reported. Treatment medication not reported.
big itchy rash; This case was reported by a consumer via interactive digital media and described the occurrence of itchy 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 itchy rash. On an unknown date, the outcome of the itchy rash was unknown.   It was unknown if the reporter considered the itchy rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-JUL-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient got 1 shot and had a big itchy rash reaction from the shot. The nurse said it was normal. The patient heard there was a 2 shot series and asked if he/she would need to get another one and when. Follow-up would not possible as no contact details were available.
I received the first  shot on March 16th and on March 20th around 4:00 pm I was feeling like my speech was a little slurry.  I got home and about 5:30 pm I was resting against my boat cause I was feeling nausea and a headache.  Also it felt like my food tasted different...I had ate some chips the day after the shot on March 17th and I had told my wife that they tasted different.  Anyway, on  March 20th around 8:30 pm I went to spit and realized I could only spit from the right side of my mouth. I called my daughter, who is an ICU RN, asked me to do a series of tests over facetime with her and she told me I should go in cause when I smiled it wasn't symmetrical.  She came and picked me up and took me to hospital in.  Immediately there they asked me to smile and to raise my eyebrows and they treated for "possible" stroke.
This spontaneous report as received from a Physician's Assistant via Field Representative refers to a female patient of unknown age. On an unknown date a mother stated that "one of her seven daughters" received the full series of GARDASIL (lot number, strength, dose, frequency were not reported). On an unknown date the patient died. According to the mother, her daughter had a type of gynecological cancer that was caused by the GARDASIL. Upon internal review the event of "a type of gynecological cancer" was determined to be medically significant. Additional information has been requested.  ***03/24/2014: Merck rep misunderstood report. Provider told story about someone else (not pt. in office) and death not involved".
PATIENT CLAIMS THAT A FEW HOURS AFTER VACCINATION SHE HAD FEVER, CHILLS AND BODY ACHES. AFTER SLEEPING FOR A FEW HOURS SHE WOKE UP TO TERRIBLE TACHYCARDIA. SHE FELT THAT HER HEART WOULD STOP AND START BEATING ALL OVER AGAIN. SHE WAS VERY SCARED AND THOUGHT "SHE WAS GOING TO DIE" (VERBATIM).
Shaking, shivering, at start, developed into twitching, muscle tremors, aches, pains weakness, head drops rolls, hallucinations, insomnia, muscle lock ups, exhaustion, severe sleep apnea, headaches, diarrhea, bloody stool on a regular basis, head drops, rolls, uncontrollable spasms.
Pain; aching all over the body; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) and PAIN (aching all over the body) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included IBUPROFEN (MOTRIN [IBUPROFEN]) for Arthritis, OMEPRAZOLE, FAMOTIDINE and COLECALCIFEROL, MENAQUINONE-7, PHYTOMENADIONE, RETINOL PALMITATE, TOCOPHEROL, TOCOTRIENOLS NOS (VITAMIN D COMPLEX) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN (Pain) and PAIN (aching all over the body). On 18-Mar-2021, PAIN (Pain) and PAIN (aching all over the body) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.
Day after vaccination, large red, slightly swollen area. Slight headache 2nd/3rd day. Slight itchy feeling.
Information has been received from a 77 year old female consumer with hypertension, depression and drug hypersensitivity to a lot of medications who on approximately 11-MAY-2010, "one month ago" was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included NARDIL and losartan-potassium-HCTZ. On approximately 11-MAY-2010, 2 hours after receiving ZOSTAVAX (Merck), the patient experienced a change in mental status. The reporting consumer stated that she "felt drunk and said inappropriate things". The patient sought unspecified medical attention. No laboratory tests were performed. The adverse symptoms resolved after one hour. The patient had a history of "flu-like" symptoms while on prior therapy with PNEUMOVAX 23 (WAES#1006USA02019). No further information is available.
Fever FEVER AND CHILLS STARTING APPROX 15 HOURS AFTER VACCINATION, IMPROVED AFTER ABOUT 8 HOURS. SORE ARM  X 2 DAYS AFTER VACCINATION Narrative: