chrisvoncsefalvay/vaers-outcomes huggingface dataset:
NOT FEELING RIGHT; HIGH BLOOD PRESSURE; DIZZINESS,  LIGHTHEADEDNESS; MILD CONFUSION; SEVERE MIGRAINE, HEADACHE; HEART POUNDING; NOT FEELING WELL; DELIRIOUS; This spontaneous report received from a patient concerned a 42 year old female of an unspecified ethnic origin. The patient's weight was 173 pounds, and height was 67 inches. The patient's past medical history included: car accident, and concurrent conditions included: traumatic brain injury approximately 2 years due to the car accident, non smoker, and non alcohol user. The patient had no prior cardiac history and had no known allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: unknown) dose was not reported, 1 total administered at right deltoid on 23-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-AUG-2021, Since she had taken vaccination the patient experienced not feeling well ( for 3 weeks now), on the same day she experienced light headedness and it kept getting worst with other developing symptoms included dizziness, mild confusion, severe migraine, headache, delirious and heart pounding. On 25-AUG-2021, the patient experienced episode of high blood pressure (1.5 days after the vaccination). It was also reported that she was driving and she was not feeling well, an ambulance was called and took blood pressure which read 176/100 mmHg. On 13-SEP-2021, she experienced that she was not feeling well and her customer, who was a nurse, took her blood pressure and read 165/92 mmHg at 14:00. During her physical therapy session at 18:00, she mentioned that she was not feeling right, and her blood pressure read 165/100 mmHg. On 14-Sep-2021, patient also reported that she was having her first appointment with her primary health care provider (PHCP) regarding this concern. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from high blood pressure, dizziness, lightheadedness, mild confusion, severe migraine, headache, delirious, heart pounding, not feeling well, and not feeling right. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210926256-JANSSEN COVID-19 VACCINE Ad26.COV2.S-  delirious -This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Rash & UrticariaPruritus Narrative:  developed ~3x3 inch circular rash around area of injection. Started the same day and persisted for about 10 days. Described as indurated, erythematous, pruritic. Mild topical steroid was applied without very much reported relief. No associated hives, sloughing, or other adverse effects noted.
I thank I got Bell?s Palsy. I got the shot at about 9:00am on May 3 2021, in my left arm. Who I woke up the next morning and tried to drank water it came back out on the left side of my face. I went to look in the mirror and tried to smile and only the right side of my  mouth would go up. The rest of my left side is fine it?s just the left side of my face.
pt recvd vax 930AM screaming & temp elevation began 1130 pt screamed till 600 to 630PM w/only short periods of quiet; t102.8 R; took 2 hrs for APAP to bring temp down; called MD APAP given again;
8 days after receiving vaccine my left arm heat, redness and itching returned, this time with a very minor and very transient chills Xs 2.
On 7-12-14, child awoke from nap mom noticed (L) eye turned in. Didn't think much about it. But she woke up next AM (L) eye worse. Took child to ER. Was admitted 7-13-14. MRI - 7-14-14. Normal per mom. Dx with 5th nerve palsy. Uses cyclopentolate 1% eye drops qd to strength muscle. Cause unknown Dr. told her possible SE vaccine, or virus. Had f/u with office 10-2-14. Remains in follow up.
patient received the 1st dose of Bexsero on 26Jun2023 and was given Trumemba; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of interchange of vaccine products in a male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On 26-JUN-2023, the patient received the 1st dose of Bexsero. On 26-JUL-2023, the patient received TRUMENBA. On an unknown date, an unknown time after receiving Bexsero, the patient experienced interchange of vaccine products (Verbatim: patient received the 1st dose of Bexsero on 26Jun2023 and was given Trumemba). The outcome of the interchange of vaccine products was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 27-Jul-2023 The pharmacist did not had patient initials or date of birth at the time of report. The Bexsero was given at a different clinic. The reporter consented to follow-up via email. The patient received 1st dose of Bexsero and then Trumenba, which led to interchange of vaccine products.
some liquid leaked from the syringe; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.  Additional details were provided as follows:  The age at vaccination was not reported. The pharmacist reported that a patient who was anxious prior to the receipt of a dose of Shingrix moved and some liquid leaked from the syringe during administration, which led to incomplete dose administered. Pharmacist did not clarify if this was dose 1 or 2 dose of Shingrix.  No more information was provided.
The patient stated over the phone that she started having redness, soreness, swelling and itchiness starting the day of 9/18/17.
Sensory neuro and hearing loss in left ear. 2nd dose on 10/00 and 3rd dose on 4/00. per doc 213821, 60-day follow up, patient experiences occasional hearing loss and dizziness. *F/UP report on 3/20/03: PT has had month recurrences of tinnitus and sensory nounal hearing loss. She has received intense steroid tx and has had a trans? - tympanic wick paced for aural steroid administration.* A follow up report received 9/23/2002 adds: Corrections: 2nd dose Lymerix was given 3/1/2000. 3rd dose Lymerix was given 9/1/2000. Additional info: Dose #1 Lymerix given 2/1/1000. Lot #LY128B2. Same lot for dose #2.
This case was reported by a consumer and described the occurrence of fever in a 2-month-old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Infanrix, GlaxoSmithKline) for prophylaxis. A physician or other health care professional has not verified this report. Subject was born 4 weeks premature.  On 21 April 2003 the subject received 1st dose of Infanrix. On an unspecified date, the subject experienced fever of approximately 100 degrees Fahrenheit. Within 12 hours fever resolved. Further information was not reported.
First dose 68 days ago; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose 68 days ago) and PYREXIA (Fever) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (First dose 68 days ago) and PYREXIA (Fever). On 07-Feb-2021, PRODUCT DOSE OMISSION ISSUE (First dose 68 days ago) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 07 Feb 2021, the patient had fever due to which patient could not get second dose of vaccine. the patient also stated that fever is not related to first dose of vaccination  No concomitant medications was reported by the reporter No treatment medications was  provided by the reporter.
Swelling in right armpit; Tenderness; Symptoms lasted 4 days and felt better with each additional day; no treatment
Unexpected death; found unresponsive 04/20/21 morning and pronounced dead after unsuccessful resuscitative efforts
Menorrhagia following both the first and the second shot. After the second shot the menstrual bleeding lasted from September 26 until October 13.  Currently I'm suffering stronger bleeding than usual.
Information has been received from a lawyer regarding a case in litigation concerning a male 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 2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-JUL-2016, the patient was treated at a clinic for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome is unknown. Additional information has been requested.
Allergic rash in lower back/n both legs; Allergic reaction in right wrist; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS ALLERGIC (Allergic rash in lower back/n both legs), HYPERSENSITIVITY (Allergic reaction in right wrist) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LISINOPRIL and METOPROLOL for Blood pressure.   On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Oct-2021, the patient experienced DERMATITIS ALLERGIC (Allergic rash in lower back/n both legs), HYPERSENSITIVITY (Allergic reaction in right wrist) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency and HYDROXYZINE for Adverse event, at an unspecified dose and frequency. On 10-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, DERMATITIS ALLERGIC (Allergic rash in lower back/n both legs) and HYPERSENSITIVITY (Allergic reaction in right wrist) outcome was unknown.
Patient said that her arm has been hurting over a month since she received the flu vaccine. She went to a doctor about 3 wks after shot and got a steroid shot. It only helped a little bit.
Patient had hypotension resulting in 94/ 58mmGh, pulse 91, nausea and headache. After 8 minutes he obtained a pressure of 115/69 pulse 97 and severe headache
Patient has history of food allergies & eczema - received DTaP, Prevnar, Hib, hep B, Varivax in office.  ~6 hrs later had swelling of hands & itching.  Seen at urgent care after Benadryl given - no wheeze, no SOB.  On Solumedrol.
Irresistible sleepiness generally culminating in a first ever episode of narcolepsy as I was in my car
neurological symptoms/ She went to her doctor and a neurologist who thought she had Parkinson's; wobbly when walking; aphasia; she had a headache which came on immediately and lasted for 2 weeks like a migraine.; This spontaneous case was reported by a consumer and describes the occurrence of PARKINSON'S DISEASE (neurological symptoms/ She went to her doctor and a neurologist who thought she had Parkinson's) and GAIT DISTURBANCE (wobbly when walking) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 006M20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced MIGRAINE (she had a headache which came on immediately and lasted for 2 weeks like a migraine.). On an unknown date, the patient experienced PARKINSON'S DISEASE (neurological symptoms/ She went to her doctor and a neurologist who thought she had Parkinson's) (seriousness criterion medically significant), GAIT DISTURBANCE (wobbly when walking) (seriousness criterion medically significant) and APHASIA (aphasia). The patient was treated with DOPAMINE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PARKINSON'S DISEASE (neurological symptoms/ She went to her doctor and a neurologist who thought she had Parkinson's), GAIT DISTURBANCE (wobbly when walking) and APHASIA (aphasia) was resolving and MIGRAINE (she had a headache which came on immediately and lasted for 2 weeks like a migraine.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient had Migraine for 2 weeks after the first dose. Following her symptoms after second dose, she consulted a neurologist who thought she had Parkinson's. Her doctor recommended she not receive an additional dose of the COVID-19 vaccines. She regularly takes dopamine. Her symptoms following the second dose have started to improve, but are not resolved.  Company comment: This spontaneous case concerns a 79-year-old female patient with no medical history reported who experienced the serious (medically significant) unexpected event of Parkinson's disease and Gait disturbance which occurred about unknown days after receiving second dose of mRNA-1273 vaccine. She received dopamine for treatment. Events were resolving at the time of the report. The events had resolved with sequelae at time of the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Mom called office on 7-9-2010, child (L) deltoid, swollen - Mom denied redness, fever or pain - Advice given for care to (L) deltoid and to watch closely for any change - In ER on 7-10-2010 - At hospital - admitted for 23 hrs for cellulitis to (L) arm - placed on antibiotics for redness and swelling at (L) arm injection site.
59 yr old female feeling nauseous and dizzy after receiving her first covid 19 vaccine. pt tried to vomit in the bathroom but didn't. pt was able to walk and was walked over to private treatment room for an assessment.  pt level of consciousness was normal. pt was a/ox4. pt vs were taken and pt bp was 114/76, hr 86, rest 18, spo2 was 98% room air. pt ls were clear bil. pt felt better sitting down and does not feel nauseous or dizzy anymore. pt feels her symptoms may have been the result of being nervous about the vaccine and wearing her mask all day. pt doesn't want to be seen at hospital and wants to go home. pt left after assessment was complete.
It was reported post vaccine pt experienced redness and knot under the skin at the injection site. The pt had no illness at the time of vaccination. On approx 10/24/2000, the pt's injection site became swollen, hot, red, and was very tender. The area was approx 3 inches in diameter. The pt had a knot under the skin at the injection site. Medical attention was sought. The nurse reported that "it appeared to be a grade 3 allergic reaction." The injection site remained tender and sore for several days. The nurse reported that the pt had not received the third dose of Hep B vaccine recombinant and probably would  not. No further info was available.
Janssen COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Janssen Vaccine on 5/22/2021. Patient was diagnosed with COVID-19 on 8/25/2021 with symptoms of nausea, vomiting, diarrhea starting on 8/24/2021. Per patient reoprt, she was admitted to a different facility for COVID-19 Pneumonia for two days. Patient did not require oxygen at that time. On 9/4/2021 patient presented to ED via EMS with complaints of shortness of breath. When EMS arrived patient was 55-70% on room air, was placed on a non-rebreather and came up to 88%, and was then placed on CPAP en route. Patient was admitted and started on dexamethasone and empiric ceftriaxone. On 9/10/2021, respiratory status
DX: Myocarditis S/S: Dyspnea on exertion onset  02/19/2021
Swollen, red pink bumps on skin. Symptoms very similar to Hives. Appears all over the body with itching. It disappears in 15-20 minutes and then again comes back in some other part of body.
104* fever, chills, headache for two full weeks after vaccination. Had to take two weeks off work just due to vaccine side effects
2 week after the pfizer vaccine had a big MS relapse.  5 new lesions.  5 days of steroids.  Only 2nd relapse in 20 + years, and has been off meds since 5/2016. Episode started Sunday the 8th.  Sudden restless legs, complete new.  Then lips became numb, problems speaking.  By Tuesday afternoon had numbness and tingling in the right hand.  Still numb the next day, then weakness of the whole arm and fine motor off.  MRI 8/12/21.  No steroids until 8/18.  Severe MS flare up following vaccination #1. Not recommended to receive second vaccine to complete series. Was given steroids for MS flare, but dosing and duration unknown. Was not on any MS medications prior to vaccine. Per office notes- Flu vaccine seemed to trigger optic neuritis, Td vaccine gave a fever of 104 x  4 d
Really fussy last night. Cried intensely 10-15 minutes. Last time he cried for 2 hours, today he was back to normal.
pt states itching began 5-10 mins p/inj put DPH cream & oral dDPH @ home; swelling & itching cont; today arm rt deltoid from 2x2" warm to touch & red/pink less itching;
headache; chills; tiredness; nausea; feeling unwell; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 40-year-old female patient received the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176, expiry date: unknown), intramuscular in left arm, on 11Jan2021 00:00 (reported as 12:00AM), at single dose, for COVID-19 immunization, in workplace clinic. There was no medical history. Concomitant medication was not reported. The patient has no known allergies. The patient did not have COVID-19 prior to vaccination. The patient did not receive other vaccines in four weeks. The patient is not pregnant. The patient experienced headache, chills, tiredness, nausea and was feeling unwell all on 11Jan2021 14:30. The patient was not tested for COVID-19 post vaccination. No treatment was given for the events. The outcome of the events was recovering.
FluBlok given to 14 yo patient.  Vaccine intended for 18 and up only.
24hrs after shot pt had swollen, painful area at site, 1" red circle at site with rash around it. Syncopal episode on 4/1. Transported to hospital by ambulance. Admitted with diagnosis of cellulitis. Discharged 4/5/2009.  4/8/09 Received hospital medical records of 4/1-4/5/2009. FINAL DX: cellulitis right arm secondary to vaccination Records reveal patient experienced fever, chills, syncope w/LOC, twitching of right extremities & right arm injection site pain & redness x 2 days.  Tx w/IVF & IV antibiotics.  Markedly improved & d/c to home on continued oral antibiotics.
MMRV given in Rt upper arm SQ. Site reaction developed 24 hours later. 3x3 area was red, hot, swollen and painful. 48 Hrs after large water blisters developed.
child broke out with red hives all over body, starting day after vaccines and continued to get worse into the night and next morning.  Was seen at Local PHC, and referred to local urgent care. Received oral steroids and Benadryl from that office. had already an appointment for follow-up for low birth weight that Saturday and was also seen there. Dr. is planning visit with allergist before next doses of vaccine.
ALTERED TASTE, TASTED EVERYTHING FISHY; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 41 year old female. 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: 1805025 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 09:30 for prophylactic vaccination. No concomitant medications were reported.  On 24-MAR-2021, the patient experienced chills. On 24-MAR-2021, the patient experienced fever. On 24-MAR-2021, the patient experienced headache. Laboratory data included: Body temperature (NR: not provided) 101.8 Max. On 25-MAR-2021, the patient experienced altered taste, tasted everything fishy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from altered taste, tasted everything fishy on 26-MAR-2021, and chills, fever, and headache on 25-MAR-2021. This report was non-serious.
Flu like symptoms for two days once those subsided then shortness of breath and heart palpitations began and have not subsided.
felt a little tired; numbness of arm traveling up neck; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt a little tired) and HYPOAESTHESIA (numbness of arm traveling up neck) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) 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 28-Apr-2021, the patient experienced HYPOAESTHESIA (numbness of arm traveling up neck). On an unknown date, the patient experienced FATIGUE (felt a little tired). At the time of the report, FATIGUE (felt a little tired) and HYPOAESTHESIA (numbness of arm traveling up neck) outcome was unknown. Not Provided      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.   This case was linked to MOD-2021-094856 (Patient Link).
PATIENT FEELING FAINT, CLAMMY, SWEATY, SAID SHE WAS HAVING TROUBLE BREATHING-ADMINISTERED EPIPEN AND CALLED 911.