chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Migraine aura / migraine; Severe abdominal pain; Diarrhea; Dry burning on cheeks; Skin rash on face; Vomiting; A spontaneous report was received from a consumer concerning herself, a 44-year-old patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe abdominal pain / abdominal pain, vomiting, diarrhea, skin rash on face / rash, dry burning on cheeks / skin burning sensation migraine and migraine aura.  The patient's medical history, as provided by the reporter, included Crohn's disease and irritable bowel syndrome. The patient even reports that she has migraine even before the vaccine administration. Concomitant medications reported included linaclotide daily for product use for unknown indication and the dose was unknown.  On 27 Feb 2021, approximately six hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 014M210A) intramuscularly in the right dominant arm for prophylaxis of COVID-19 infection.   On 27 Feb 2021, the patient experienced severe abdominal pain, vomiting, diarrhea, skin rash on face, dry burning on cheeks, migraine and migraine aura. The patient states that all the symptoms have improved but are still ongoing at the time of call.  Treatment information included acetaminophen of unknown dose.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), severe abdominal pain, vomiting, diarrhea, skin rash on face, dry burning on cheeks, migraine and migraine aura was not resolved at the time of report.; Sender's Comments:  MOD21-043998:Crosslinked
Information has been received from a physician and a practice manger referring to a patient of unknown age and gender. On 12-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 0.5 ml (lot # K011492, expiration date 22-JUN-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/ Celsius) and the type of excursion (R/F) for each time were 24, 34 and R. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree/Celsius_ and the type of excursion (R/F) for each time were 176, 48 and R. The storage criteria was refrigerator (R). This is one of several report received from the same source. Additional information has been requested.
Weakness on the left side of the body; Numbness on the left side of the body; This case was reported by a physician via call center representative and described the occurrence of hemiparesis (left) in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced hemiparesis (left) (serious criteria GSK medically significant) and body numbness. On an unknown date, the outcome of the hemiparesis (left) and body numbness were recovered/resolved.   It was unknown if the reporter considered the hemiparesis (left) and body numbness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient received 1st dose of Shingrix and experienced numbness and weakness on the left side of the body which lasted 2 weeks after receiving 1st dose of Shingrix. The physician (reporter) inquired about data on administration of second dose after 6 month window because the patient wants to receive second dose after 6 months. The physician also inquired about clinical data of use of one dose of Shingrix as well. The reporter declined consent for follow up.
Patient is sweating excessively.  It started after his dose and has continued 4 days later.
Headache, Diarrhea, NauseaVomiting, malaise Narrative:
I woke up two days after the vaccine with a lack of balance and stayed in bed most of the day as walking was difficult. A couple days later the feeling subsided but it just returned six days after the vaccine.
rash; fingers have swollen; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash) and PERIPHERAL SWELLING (fingers have swollen) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 017T21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jun-2021, the patient experienced RASH (rash) and PERIPHERAL SWELLING (fingers have swollen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL ALLERGY/COLD) at an unspecified dose and frequency. At the time of the report, RASH (rash) and PERIPHERAL SWELLING (fingers have swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information provided as Benadryl.
No adverse Event; Patients received 0.5 ml of a Moderna bivalent booster, However, the patients stated verbally that they had not received any COVID19 vaccine before,so that might have been their first dose; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patients received 0.5 ml of a Moderna bivalent booster, However, the patients stated verbally that they had not received any COVID19 vaccine before,so that might have been their first dose) and NO ADVERSE EVENT (No adverse Event) in a 70-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Oct-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 12-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patients received 0.5 ml of a Moderna bivalent booster, However, the patients stated verbally that they had not received any COVID19 vaccine before,so that might have been their first dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patients received 0.5 ml of a Moderna bivalent booster, However, the patients stated verbally that they had not received any COVID19 vaccine before,so that might have been their first dose) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patients received 0.5 ml of a Moderna bivalent booster, However, the patients stated verbally that they had not received any COVID19 vaccine before,so that might have been their first dose).    No concomitant drug was reported. The reporter admitted that patient had not actually confirmed in the system that was true. No treatment drug was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-658663 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-658663:same reporter
Pt admitted on 7/15 with CC of confusion and tested positive for CoVid-19 on 7/16/2021.Per guidelines all hospitalizations are reported.
Shortly after receiving his 2nd dose, he developed the expected fever, chills, and myalgias.  However, he also developed substernal chest pain that was persistent.
Information has been received from a literature article concerning a 27 year old female patient developed uveitis and papillitis, following administration of GARDASIL. The patient had as a pre-existing conditions sarcoidosis and vasculitis. A total of 24 cases of uveitis occurred following administration of GARDASIL; the gender in all cases was female. The median age was 17 (range 12 - 29). The median time from vaccination to onset of ADRs was 30 days (range 0 - 476); time to onset was unknown in 1 case; the time to onset in this case was of 9 days from vaccination. There was one reported rechallenge of the GARDASIL vaccine. In 13 of the 24 cases other ocular side effects were noted including 3 case reports of papillitis, 2 case reports of retinitis and 1 case report of papilledema. Systemic side effects were noted in 9 of the 24 case and included 3 cases of arthralgia. In 2 case reports multiple vaccines were administered simultaneously. The ocular findings of papilledema may be confounded by pre-existing conditions (sarcoidosis, cat scratch disease and Behcet's disease) known to affect the optic nerve in 3 case reports. According to World Health Organization Causality Assessment Guide of Suspected Adverse Reactions, the relationship between human papilloma virus vaccination and uveitis was "possible". Causality assessments are based on the time relationship of drug administration, uveitis development and rechallenge data. This is one of several reports from the same literature source. Additional information has been requested.
I had nasal congestion, cough, and felt bad. I tested myself for COVID-19 and, I was positive. I call my doctor and they didn't want to see me because my symptoms were not bad. I tested negative for COVID-19 on 10/30/2022.
10/11 hives following DaPT & VARIVAX. 7/11 hives following HIB & IPV.
Hive all over her body/generalised pruritic urticaria and continued to have intermittent urticaria; Generalised Itching/pruritus; This spontaneous case was reported by a physician and describes the occurrence of URTICARIA (Hive all over her body/generalised pruritic urticaria and continued to have intermittent urticaria) and PRURITUS (Generalised Itching/pruritus) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer in 2009 and GERD. Concurrent medical conditions included Hives, Blood cholesterol, Heart disorder, Blood pressure high, AFib, Anxiety, Diabetes and Drug allergy (Allopurinol). Concomitant products included LOSARTAN POTASSIUM, FLECAINIDE ACETATE, FAMOTIDINE, FUROSEMIDE, APIXABAN (ELIQUIS), ROSUVASTATIN CALCIUM, DILTIAZEM (CARDIZEM [DILTIAZEM]), PRAMIPEXOLE DIHYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE (CARDIZEM CD) from 06-Aug-2020 to an unknown date, ROSUVASTATIN CALCIUM (CRESTOR), POTASSIUM CHLORIDE and VITAMIN D3 for an unknown indication.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced URTICARIA (Hive all over her body/generalised pruritic urticaria and continued to have intermittent urticaria) and PRURITUS (Generalised Itching/pruritus). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) (oral) on 04-Mar-2021 at an unspecified dose and frequency. On 27-Apr-2021, URTICARIA (Hive all over her body/generalised pruritic urticaria and continued to have intermittent urticaria) and PRURITUS (Generalised Itching/pruritus) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported developing generalized pruritic urticaria 4 hours after the administration of dose 1 . She continued to have intermittent urticaria for the next 4 weeks.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Follow-up received on 30-JUL-2021 contains significant information. The primary reporter details added. The patient demographics were added. The patient medical history were added. The concomitant and treatment medication were added. The start date of suspect drug was updated. The new event was added. The event outcome was updated from unknown to recovered/resolved.
receiving dose more than 12 hours after of its beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving dose more than 12 hours after of its beyond use date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028k21a) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2022 at 7:59 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2022 at 7:59 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving dose more than 12 hours after of its beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receiving dose more than 12 hours after of its beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter stated that the patient received a booster dose of the Moderna vaccine lot more than 12 hours after of its beyond use date. The dose administered was administered more than 12/24 hours post puncture. The date the vial was initially stored in the refrigerator was 27-Apr-2022. The date and time, the vial first punctured was 28-Apr-2022 at 7:35 am. The vial was stored at room temperature post puncture. Reportedly, the vial didn't undergo any temperature excursions. The total amount of time the vial exposed to room temperature range (8° to 25°C= 46° to 77°F) was from 7:35 am 28-Apr-2022 to 8:00 am 29-Apr-2022.  No treatment information was reported.
Patient presented this time with new onset confusion and generalized body weakness.  He reportedly pulled out his suprapubic Foley catheter. In the ER, stroke code was called and CT head showed small hypodense area in the left occipital lobe. Dual antiplatelet therapy was recommended by stroke team.  Aspirin and Plavix. He was discharged back to SNF. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Hospitalization for COVID. Treated with dexamethasone 6 mg IV daily and Remdesivir
This spontaneous report as received from a patient's mother refers to a 13 year old female patient. The patient's drug allergies were none and pertinent medical history included asthma. Approximately in 2013 (reported as a year ago), the patient was vaccinated with first dose of GARDASIL (dose and frequency unknown, route: in the arm) for vaccination. Concomitant medications included unspecified breathing treatments. Approximately on an unknown date in 2013 (reported as after first dose), the patient experienced hair loss. The patient was vaccinated with second dose on an unspecified date and on 15-DEC-2014, the patient was vaccinated with third dose of GARDASIL.  The patient's hair loss gotten progressively worse since her last vaccination on 15-DEC-2014. The mother of the patient also reported that the patient was receiving unspecified steroid treatments to treat the adverse experience. The patient sought medical attention with a dermatologist. It was also reported that the therapy with GARDASIL was continued. The outcome of hair loss has gotten progressively worse since her last vaccination was reported as not recovered/not resolved. No product complaint was repotted for GARDASIL. Additional information is not expected as the reporter did not wish to contact.
gen urticaria, pedal edema discoloration began 24hr p/vax;pt ingested mushroom 15min prior to urticaria;
1 hour after vaccine given when in office she vomited twice and cried and was unresponsive. This was around 4:45 PM. Arrived back here 10 minutes later and was unresponsive with eyes deviated to the right with fine subtle twitching of the fingers of the left hand and possibly also on the right but less obvious. The eye deviation and twitching stopped while receiving 0.1 mg/kg of ATIVAN IV and then was post-ictal. After 30 minutes she started looking around a little but remained only minimally responsive with occasional vocalizations. At 6:15 PM she was looking and reaching for her parents more and sucking on a pacifier but still significantly post-ictal. She cried during urine catheter placement right after the ATIVAN. Glucose 147 during the seizure. Patient afebrile after vaccine and during event.
Patient's wife called to report that patient "sick all last night with chills, feels very warm with high fever, no appetite, body aches and cannot work today from feeling so bad." Patient told to schedule OV for 5-14-10 but refused stating feeling better, no fever, no hives, no swelling.
Pt called clinic on 12/14/00 at 11:30 and states she received flu shot on 12/13/00 at 08:00 and about 1/2 hour, post vax, she developed pain across the middle of her back. She denied shortness of breath, itching, rash or difficulty breathing; denied fever or chills. States no other problem and the pain continues today, 12/14/00; no other signs or symptoms; no treatment.
pain in the forehead and the bone of the nose; pain in the forehead and the bone of the nose; This spontaneous case was reported by a consumer and describes the occurrence of RHINALGIA (pain in the forehead and the bone of the nose) and HEADACHE (pain in the forehead and the bone of the nose) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 19-Mar-2021, the patient experienced RHINALGIA (pain in the forehead and the bone of the nose) and HEADACHE (pain in the forehead and the bone of the nose). At the time of the report, RHINALGIA (pain in the forehead and the bone of the nose) and HEADACHE (pain in the forehead and the bone of the nose) outcome was unknown. Not Provided
I did experience with both doses, I had some swollen lymph node; having blood in her urine; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6201), via an unspecified route of administration on 22Feb2021 (at the age of 45-years-old) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported) on an unspecified date as dose 1, single for covid-19 immunisation, and experienced swollen lymph nodes. On 24Feb2021, the patient experienced having blood in her urine. On an unspecified date, she had some swollen lymph node. The outcome of blood in urine was not recovered; outcome of swollen lymph nodes was unknown.   No follow-up attempts are possible. No further information is expected.
NO ADVERSE EVENTS REPORTED. PARENT PROVIDED WRONG DATE OF BIRTH, RESULTING IN WRONG VACCINE ADMINISTERED FOR AGE (GRAY CAP FOR AGES 12+ WAS ADMINISTERED INSTEAD OF ORANGE CAP FOR AGES 5-11)
I was Breaking out in Hives Mainly Around my Stomach and genital Area. Two days Later I was having trouble Swallowing and breathing and was Admitted to the hospital. To this Very Day I still Break out with rashes and sometimes Hives. I'm Continuously on benadryl to help keep the rashes down.
Increased plaques in the body; Reaction to Covid 19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SKIN PLAQUE (Increased plaques in the body) and IMMUNISATION REACTION (Reaction to Covid 19 vaccine) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriasis.    Patient had no known allergies.  Concurrent medical conditions included Psoriasis. Concomitant products included BACLOFEN from 17-May-2023 to an unknown date and SULINDAC from 07-May-2023 to an unknown date for an unknown indication.   On 31-Dec-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2023, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40MG/0.4ML Every 2 week. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN PLAQUE (Increased plaques in the body) and IMMUNISATION REACTION (Reaction to Covid 19 vaccine). At the time of the report, SKIN PLAQUE (Increased plaques in the body) and IMMUNISATION REACTION (Reaction to Covid 19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2023, Weight: weight gain.         The number was reported. In Jun-2023, patient had weight gain. Treatment medication was not reported. Reporter causality for weight gain with Moderna vaccine was given s not provided. Reporter causality for Humira for vaccination adverse reaction and skin plaque was reported as not provided and for weight gain was possible.
patient mentioned that she had COVID-19 a few weeks ago; patient mentioned that she had COVID-19 a few weeks ago; This is a spontaneous report from a contactable consumer (patient, self-reported).   A 24-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. On an unknown date, the patient mentioned that she had COVID-19 a few weeks ago. Outcome of event was unknown.  Information about lot/batch number has been requested.