chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative:  Wrong formulation of COVID-19 vaccine administered 09/01 FDA removes authorization to use monovalent COVID-19 (pfizer) vaccine as booster  dose in individuals 12 and up, email communication sent to impacted staff 09/06 Pt administered COVID-19 (Pfizer) monovalent vaccine as booster dose instead  of FDA approved bivalent booster. No adverse effects.
This spontaneous report was received from a nurse practitioner concerning a female patient in her mid of 60's. On 19-OCT-2012, the patient was vaccinated subcutaneous or intramuscularly with a dose of 0.5 ml PNEUMOVAX 23 (lot not reported). No other co-suspects were reported. No concomitant medications were reported. The nurse practitioner reported that, the evening of 19-OCT-2012, the patient noticed redness and swelling. It was worse the next day. The patient was self-medicated and took some BENADRYL and the symptoms did go away. The relation between the events and PNEUMOVAX 23 was not related. Additional information has been requested.
1 day after receiving flu shot in right arm, patient developed large "welts" up to one inch in size all over right arm.  From wrist, up into right neck, with a few on the face. Welts went away, followed by right elbow joint pain that started 1 week after injection and continues.  Patient unable to completely straighten right arm as of today.  Advised office visit for recheck and documentation.
NO ADVERSE EVENT NOTED. VACCINE ADMINISTERED IN WRONG LOCATION. DONE SUBCUTANEOUS AND SHOULD HAVE BEEN INTRAMUSCULAR. THE VACCINE DOSE IS STILL VALID AND DOES NOT HAVE TO BE REDONE.
Bump at injection site that has not resolved, now up to 1 month. Pain only when touched. Patient was referred to see PCP.
The pt experienced a fever of 103 for 3 days, screaming, no sleep for 3 days, roseolla (rash on stomach) after four days. The pt developed autism, developmental delays with 9 month malabsorption.
I read that anecdotal evidence has appeared on social media about the vaccine affecting women?s menstruation cycles . After the second dose, my period was one day early and on the second month it was three days late.
blood pressure shot up; Diarrhea issue; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (blood pressure shot up) and DIARRHOEA (Diarrhea issue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (blood pressure shot up) and DIARRHOEA (Diarrhea issue). At the time of the report, BLOOD PRESSURE INCREASED (blood pressure shot up) and DIARRHOEA (Diarrhea issue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) blood pressure shot up.         No concomitant information was reported. Patient saw her doctor who gave her a medicine to bring her blood pressure down to normal.   This case was linked to MODERNATX, INC.-MOD-2021-434942 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-434942:Female patient (Hypertension, Diarrhoea) Same reporter
Patient called and reported having moderna 2nd dose on 3/12/21 . Patient reports fatigue the day after but reports having rash after two days . Patient reported rash that covered both arms, back and mid chest . Patient reports rash going away after 1 day .
Aching in chest, total body aches afebrile Local-deltoid area warm to touch, denies redness.
SYMPTOMS: vision difficulty, ears ringing, tingly feeling all over, nausea.  TIME: symptoms started 10 minutes after immunization and continued for 30 minutes.  TREATMENT: layed down to rest in cool room, applied ice to injection site.
bleeding ulcer; Unable to receive the second dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ULCER HAEMORRHAGE (bleeding ulcer) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K2VZA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history. ).    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ULCER HAEMORRHAGE (bleeding ulcer) (seriousness criterion hospitalization) and INCOMPLETE COURSE OF VACCINATION (Unable to receive the second dose). At the time of the report, ULCER HAEMORRHAGE (bleeding ulcer) outcome was unknown and INCOMPLETE COURSE OF VACCINATION (Unable to receive the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not provided. Treatment information included blood transfusion.  Very limited information regarding this event has been provided at this time.  Additionally, this report refers to a case of incomplete course of vaccination for mRNA-1273, lot not applicable. Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time.  Additionally, this report refers to a case of incomplete course of vaccination for mRNA-1273, lot not applicable. Further information has been requested.
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; Product storage error; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and PRODUCT STORAGE ERROR (Product storage error).    No concomitant medication reported. No treatment medication reported.  It was reported that 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion. The doses were administered before it was known if the vaccine was ok to use after the excursion.  This case belongs to 71st patient of the total 77 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. In January 2021, the patient received the 2nd dose of Shingles vaccine. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine and unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got both the Shingles vaccine doses and still got shingles. The patient stated that he/she never had shingles, and last week from reporting date it resulted in it on his/her left side. The patient enquired if the vaccine did not work. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the detail regarding laboratory test confirming shingles was unknown at the time of reporting.
sore arm; headache little bit; FLU LIKE SYMPTOMS; WEAKNESS; stayed in the whole day; tired,weakness; FEVER OF 101.1; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (FLU LIKE SYMPTOMS), ASTHENIA (WEAKNESS), PAIN IN EXTREMITY (sore arm), BED REST (stayed in the whole day) and FATIGUE (tired,weakness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included AZITHROMYCIN, ETHAMBUTOL and AMIKACIN SULFATE (ARIKAYCE) for an unknown indication.   On 14-Feb-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (FLU LIKE SYMPTOMS), ASTHENIA (WEAKNESS), BED REST (stayed in the whole day), FATIGUE (tired,weakness) and PYREXIA (FEVER OF 101.1). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and HEADACHE (headache little bit). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (FLU LIKE SYMPTOMS), ASTHENIA (WEAKNESS), PAIN IN EXTREMITY (sore arm), BED REST (stayed in the whole day), FATIGUE (tired,weakness), PYREXIA (FEVER OF 101.1) and HEADACHE (headache little bit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 101.1 101.1.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
PATIENT REPORTED TO THE PHARMACY ON 7/11/22 THAT HER ARM WAS HOT RED AND SWOLLEN FOLLOWING VACCINATION ON 7/8/22. SHE STATED SHE DID NOT FEEL WELL AND WAS IN BED ALL DAY SATURDAY. SHE FELT BETTER SUNDAY AND WENT TO CHURCH AND HAD LOSS OF APETITE DURING THIS TIME. SHE SHOWED ME HER LEFT ARM STILL HAS SIGNS OF ERYTHEMA BUT IS IMPROVING. SHE IS FEELING BETTER TODAY BUT WANTED TO NOTIFY US OF THIS REACTION. SHE RECEIVED MODERNA COVID19 BOOSTER IN LEFT DELTOID AND PREVNAR20 IN RIGHT DELTOID. THE ERYTHEMA WAS IN LEFT DELTOID.
Soreness in the arm at shot area; Fatigue; feverish; This is a spontaneous report from a contactable consumer, the patient. An 67-year-old male patient of unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the right arm on 08Mar2021 at 13:15 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient no known allergies. The patient did not receive any medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Mar2021, day after the shot in the morning, the patient felt symptoms of soreness in the arm at shot area, fatigue and feverish, one day after shot was administered. The patient was fine till the symptoms started. The clinical outcome of the event soreness in the arm at shot area, fatigue and feverish were resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
4/13/2021 dose (left arm); 5/11/2021 dose (right arm) EYES: 4/13/2021: Within first 15 minutes of injection during wait time, odd sensation around rims of eyes (more heat than burning); continued into next day  and evening. 5/11/2021: Same eye issue and similar course after second vaccination. By the weekend, eyes hurt from waking and throughout the day.  Visited eye doctor in June and was given EYESUVIS (Used for 2 week course, 2-4 x/day). Rested eyes when able. Some improvement.  Second visit to eye doctor, following up with hot compresses, OTC lubricant eye drops SYSTANE, and adapted contact care routine. 4/13/2021: Felt hoarse for a brief time following vaccination and resolved quickly (within about an hour) 4/14/2021: Slightly tired and achy on arm upon waking around 7AM. 4/14/2021 and 5/12/2021: Around 10:30 AM, realized I was "weepy", and throughout day, continued to feel weepy, and at times, tears would roll down my cheeks for no reason (was not mentally sad). 4/14/2021 and 5/12/2021: Around 10:30/11AM, freezing from the inside out from head to toe (multiple layers of clothing, blankets, heating pad, 5/12/2021 gloves). Tired. Achy joints; hurt to stand up. No headache, but "heavy" head. Temperature increased as day progressed, and when reached 101.5 (around 5:15 on 4/14; time on 5/12 not recorded), took Tylenol Extra Strength. Sharp head pains consistent with pains I typically get when I have a fever). 4/14/2021: 10:20PM - Stuffy nose, feel like getting a sore throat.  Other: I have a long history of tinnitus that I have learned to manage/"tune out". My tinnitus has been amplified since receiving the vaccinations and has become noticeable every day. While I had hot flashes associated with menopause, I had not had hot flashes in what I believe was about a year. Hot flashes have returned since receiving the vaccines. My sleep was disrupted following the vaccines; however, that appears to have normalized. Late June/Early July: Unknown if associated with vaccine; however, with numerous other issues following vaccine, this additional odd symptom is being shared: Burning pain outer left thigh; 1st time awoke from sleep due to severe pain, and one more episode of nighttime severe pain in July. Other times, mild or unnoticeable, but continues today. Question below asks if there is disability or permanent damage: I do not know.
swelling at the injection site; redness at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles (patient had an active case of shingles (rash) at the time of vaccination) and rash.   On 11-OCT-2023, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid). On 11-OCT-2023, less than a day after receiving Shingrix, the patient experienced injection site swelling (Verbatim: swelling at the injection site) and injection site erythema (Verbatim: redness at the injection site). The outcome of the injection site swelling and injection site erythema were resolved.   It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to Shingrix.     It was unknown if the company considered the injection site swelling and injection site erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-OCT-2023 The reporter was the patient. The patient received first dose of Shingrix and experienced redness and swelling at the injection site. The patient mentioned she had an active case of shingles (rash) at the time of vaccination and the shingles rash appeared about 3 or 4 days prior to Shingrix. Nothing else was reported. The reporter did not consent to follow-up.
got sick to their stomach; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (got sick to their stomach) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (got sick to their stomach). At the time of the report, ABDOMINAL DISCOMFORT (got sick to their stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided. List of concomitant medication were not given.   This case was linked to MOD-2021-031835, MOD-2021-031857, MOD-2021-031928 (Linked Report).; Sender's Comments:  MOD-2021-031835: MOD-2021-031857: MOD-2021-031928:
patient came in the morning after vaccine was given complaining of pain at the injection site. he said his upper arm felt hard but there was no redness or sign of cellulitis. He was advised to apply ice and take ibuprofen for any swelling and if it does not get better to contact his prescriber.
Within 3 mins of injections, the left thigh developed a rough, raised red rash with areas of blanching. Within 10 mins a less severe rash appeared on the right thigh. No respiratory or other symptoms. The baby was kept for 30 mins for observation during which time the rash lessened considerably and no other symptoms developed.
Pregnant. Due august 2, 2021  Having fever (up to 100  F), headache, nausea, vomiting, aches
DRUG ADMINISTERED TOO HIGH UP IN ARM,BARELY TWO FINGERS DOWN; This spontaneous report received from a patient concerned a patient of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) .5 ml, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAR-2021, the patient experienced drug administered too high up in arm, barely two fingers down. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of drug administered too high up in arm,barely two fingers down was not reported. This report was non-serious.
Pt had redness and swelling about 2" in area. Treated with cool packs.
1st dose Pfizer administered at 0940 at clinic. patient experienced no reactions or symptoms during observation period at the clinic. Patient had been home for approximately 2 hours when he started experiencing some chest pain prior to his seizures around 1210. He does have a history of seizures which are uncontrolled ranging from having them twice a week to twice a month. patient reports the seizures were no worse than any other seizure he has had in the past. The seizures lasted periodically for approximately 20 minutes.   patient reports he didn't consult with his PCP or neurologist prior to the vaccine. The patient was encouraged to seek medical treatment if symptoms persist or worsen over the next hours. He was also encouraged to reach out to his neurologists prior to the second dose.
Tested positive for COVID 19 11/9/21 - Symptoms started 11/3/21
Syncope event; Typical arm pain; could not stand or walk; could not stand or walk/slid down to the floor; Received a full booster dose of 0.5 mL; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Syncope event), GAIT INABILITY (could not stand or walk), DYSSTASIA (could not stand or walk/slid down to the floor), VACCINATION SITE PAIN (Typical arm pain) and INCORRECT DOSE ADMINISTERED (Received a full booster dose of 0.5 mL) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 05-Apr-2022, the patient experienced INCORRECT DOSE ADMINISTERED (Received a full booster dose of 0.5 mL). On 06-Apr-2022, the patient experienced GAIT INABILITY (could not stand or walk) and DYSSTASIA (could not stand or walk/slid down to the floor). On an unknown date, the patient experienced SYNCOPE (Syncope event) and VACCINATION SITE PAIN (Typical arm pain). At the time of the report, SYNCOPE (Syncope event), GAIT INABILITY (could not stand or walk), DYSSTASIA (could not stand or walk/slid down to the floor), VACCINATION SITE PAIN (Typical arm pain) and INCORRECT DOSE ADMINISTERED (Received a full booster dose of 0.5 mL) outcome was unknown.            Concomitant and Treatment product use was not provided by the reporter.  Details of the initial doses of COVID-19 vaccination was reported by the reporter. It was stated as, the patient received second booster dose of the Moderna COVID-19 vaccine on 05 Apr 2022 in her right arm and experienced a severe reaction. On next day of vaccination, the patient could not stand or walk. It was a syncope event, she slid down to the floor. She also reported typical arm pain. Patient had to call the EMT because reporter was not sure what was happening. The reporter stated that patient received a full booster dose of 0.5 mL, and was unsure if that was okay.
One week after 1st  vaccine, woke up with 3 blisters on inside of upper lip. No other side affects.  After 2nd shot, I did have a slight headache, but not any different than the headache I get with seasonal allergies. No medicines required. Then 51 hours after the 2nd shot, I started having swelling on left side of the face (cheek area).  Took Benadryl and iced it, swelling subsided slightly. Approximately  6 hours later, swelling return and is not more swollen than before. Taking additional Benadryl and Zyrtec and following up with an ENT doctor in AM if symptoms do no subside.
Cellulitis, swelling of thigh that started a little more than 24 hours after vaccine was given but increased by a lot at around 26 hours after vaccine was given. Some limp/change in gait.