chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 02-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On AUG-2021, the patient undergone laboratory test SARS-CoV-2 IgG (Immunoglobulin G) antibody (ARF COV-2 AB IGG SPIKE), semi quantitative which came negative (less than 1.00) (confirmed immunological vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority: 90000190792.; Sender's Comments: V0: 20210849914-COVID-19 VACCINE AD26.COV2.S-Confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Narrative: Pt received first dose of COVID-19 vaccine on 4/6/21, on 4/7/21 reports HA. Unclear if HA resolved on its own or if patient took APAP/IBU.
Bad sensitivity to light. Had to wear sunglasses indoors. Migraine headache for 7 straight days. Head felt like it was in fishbowl, sounds muffled, hard to concentrate, or give answers, brain felt disconnected. Felt cold a lot but did not have fever, generally weak and tired.  I?m starting to feel better but still have a couple times a day that this happens.
No reaction. Pt was supposed to get Pfizer vaccine due to age and new 23-24 requirements.
temperature Excursion on my gray visor at my Pharmacy; temperature Excursion on my gray visor at my Pharmacy; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, 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: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), outcome "unknown" and all described as "temperature Excursion on my gray visor at my Pharmacy".  Additional information: The patient had a temperature excursion on her gray visor at her Pharmacy and she wanted to know what to do with it or if it's still good.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Lost my sense of smell 9 days after taken first shot; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Lost my sense of smell 9 days after taken first shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANOSMIA (Lost my sense of smell 9 days after taken first shot). At the time of the report, ANOSMIA (Lost my sense of smell 9 days after taken first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication were provided.  The patient got the first shot of the vaccine after 7 month of Covid   Most recent FOLLOW-UP information incorporated above includes: On 15-Aug-2021: Follow-up information received contains no significant information
He developed febrile seizures / hospitalized many times at unspecified times due to seizures; Developed epilepsy at age of 4; This spontaneous report was received from a consumer (patient's mother) regarding a currently 5 years old male patient. Information on patient's current conditions, drug allergies/reactions were not reported.Concomitant medications included divalproex sodium (DEPAKOTE). On an unknown date, the patient was vaccinated with first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR), 1 regular injection, for prophylaxis (dose, route, lot# and expiry date was not reported).The consumer reported that the patient had received MMR (not  M-M-R II) vaccine around 12 to18 months of age. On an unknown date (reported as within 24 hours of vaccination), the patient developed febrile seizures (febrile convulsion). The consumer reported that her son had been hospitalized many times at unspecified hospitals at unspecified times due to seizures. On an unknown date (reported as at the age of 4), the patient developed epilepsy (also reported as pertinent medical history).The patient sought medical attention. The consumer stated that she was not anti-vaccine. She was against putting her son's life in danger. She also stated that she highly doubted her son would have had epilepsy if he had not gotten that first shot of MMR. The consumer stated that her son was up to date on all vaccines except MMR because he tolerated monovalent vaccines. The consumer wanted to speak to the person who made the decision to stop making MMR as a monovalent vaccine. There was no product quality complaint (PQC) was involved. The outcome of the event febrile seizures was reported as not recovered, however for epilepsy it was unknown.Causality of the events were not reported.   Upon internal review, the event febrile seizures and epilepsy were determined to be medically significant.
Pt received both smallpox and anthrax vaccines on 28Jan03 in AM.  The next evening (29Jan03), pt developed a pruritic, urticarial rash on arms and legs.  Presented to sick call 30Jan03 for treatment.  No SOB.  Wound site clean and intact except for skin reaction to adhesive tape.  Pt diagnosed with urticaria, given Zantac and Benadryl and epi-pen and released.  Pt presented to sick call again on 31Jan03 with c/o worsenng rash.  No SOB or other symptoms.  Increased # of lesions on upper arms and legs.  Photos taken.  Dose of Benadryl increased and Zantac was continued.  Pt instructed to proceed to ER if sx worsened over weekend.  Dx-  erythema multiform vs hives.
Patient described the following- Confusion, Shortness of Breath, Hard Time Standing Up, Chills(Shaking), Didn't feel himself (out of body experience)
Information has been received from a lawyer and a consumer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient was inoculated with ZOSTAVAX vaccine in 2016, at a medical center, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and subsequently the patient contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2017, the patient was treated at a medical center for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Tested covid + on 9/4 , travelled for testing per Return To Work policy 72hrs before arrival. Hx of Bronchitis with Sx onset 8/30: congested, cough, runny nose.  Will quarantine   and keep in touch with employer as far as return to work policy.  Advised to seek medical attention if symptoms worsen.
Patient indicated history of egg allergy prior to receiving a flu vaccine. No contraindication to receiving flu vaccine could be identified. Patient was given flu vaccine. Afterwards Patient was monitored for more than 30 min. During this time patient admitted to not feeling well. Patient was continuously monitored but showed no serious signs of adverse reaction at that time. Patient left with the rest of her group. Later in the day she indicated a need to seek medical attention to her Instructor who released her for medical care. She sought help at the Urgent Care Clinic at which time her symptoms had developed into what appeared to be a delayed allergic response.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, the patient was inoculated at a pharmacy with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2015, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
The day after receiving the moderna Covid vaccine, i came with extreme tightening of the chest, wheezing, and a heavy cough.  I received the shout in 4/23 and on 4/26, which is today, I still have tightness of my he shear and wheezing.
Received 1st Covid vaccine injection to left deltoid and arm became sore immediately. Shortly after my arm continued to hurt along with my shoulder. Difficulty raising my arm because of pain to shoulder and deltoid area Received 2nd Covid vaccine injection 3 weeks later. Immediately arm became sore and pain to shoulder and deltoid area continues to present. Difficulty with raising and moving  my left arm with shoulder and deltoid pain
Patient had pain in lower legs, upper arms, and right wrist. Patient was diagnosed on 10/10/14 with polymyalgia rheumatica.
tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I was tested positive for COVID, I had my boosters (Pfizer COVID-19 Vaccine). Therapeutic measures were taken as a result of drug ineffective, covid-19.Paxlovid was used as a treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was in the 15 minute post immunization time period.  About 10 minutes later he wasn't feeling well.  He was very hot, sweating and thirsty.  He passed out while sitting in a chair.  He fell out of the chair and hit his head on the floor, which caused it to bleed.  He took about 20 minutes to fully recover.  He drank some water and lay on the floor.
After the vaccination I developed a non productive cough, had creepy crawly feeling skin and felt as if my eyes were burning but no fever develop. I got tested for COVID via rapid/PCR test on12/25 which was neg but got retested on 12/28 via the rapid COVID test and was positive then.
This was a booster.  On Monday 29th - Day of vaccination - 10am Onset of headache, nausea at 2:30pm Chills, Aches and Pain at 6pm Fever starting at 9pm, along with aches and pains Fever until 6pm the following day, along with aches and pains Rash over legs and stomach visible at 10pm Aches and Pains continuing  On 3rd day: aches, pain (less than the day before); rash spreading to stomach, and lightly on arms; still exhausted  Onset of chills, headache
More than 36 days after the first dose without receiving the second dose/her 1st and 2nd doses of the Moderna Covid-19 vaccines on 14Jul2021 and 29Sep2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose without receiving the second dose/her 1st and 2nd doses of the Moderna Covid-19 vaccines on 14Jul2021 and 29Sep2021) 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 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose without receiving the second dose/her 1st and 2nd doses of the Moderna Covid-19 vaccines on 14Jul2021 and 29Sep2021). On 29-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose without receiving the second dose/her 1st and 2nd doses of the Moderna Covid-19 vaccines on 14Jul2021 and 29Sep2021) had resolved.            The  concomitant medications on use were not provided. No treatment information was provided.  Patient was scheduled for her booster dose of Moderna COVID-19 vaccine on 29-Mar-2022 but she wanted to reset it on 28-Mar-2022 because clinic was open only on Mondays, Wednesdays, and Fridays.
more than 42 days for administration of second dose/ patient has not gotten second dose yet; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (more than 42 days for administration of second dose/ patient has not gotten second dose yet) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (more than 42 days for administration of second dose/ patient has not gotten second dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (more than 42 days for administration of second dose/ patient has not gotten second dose yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.  No Treatment information was provided by the reporter.
(R) deltoid swelling, tenderness/erythema extending to entire arm and fingers day after vaccinations given the 3rd day (day seen in clinic) swelling only in deltoid area.
All of the hair on my head fell out .; My auto immune Response Was insanely intense; This is a spontaneous report from a contactable Other HCP (patient). An elderly non pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration in arm right on 26Feb2021 14:00 as dose 2, single (age at vaccination: 67 years) for COVID-19 immunisation. Medical history included Hashimoto disease, seborrheic dermatitis, known allergies penicillin, all from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. Historical vaccine includes bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration in arm right on an unspecified date as dose 1, single for COVID-19 immunisation. No other vaccine in four weeks. It was unknown if covid prior and vaccination covid tested post vaccination. On 08Mar2021 at 01:00 AM, it was reported that the patient experienced all of the hair on my head fell out. My auto immune Response was insanely intense for one month and I am still dealing with the side affects 2 months later. The adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment was received. The patient underwent lab tests and procedures which included nasal swab resulted as negative on 14Apr2021 nasal swab. The clinical outcome of the events was not resolved.  No follow up attempts are needed. No further information is expected.
After 1 day post imm. started hives at face, puffiness of eyes-redness of sclera, body ache, rocking problems. Mother gave BENADRYL and symptoms resolved.
Myalgia Narrative: 4/28/2021 noticed left shoulder tenderness. Rom is somewhat painful with forward abduction, with painful arc from 90-180 degrees, clicking with overhead abduction to left shoulder
dizziness started after vaccine and has continued for 3 days now; heart rate has been elevated periodically. Patient advised to contact his primary care physician.
body aches; feeling hot; sleepy; tired; nauseous; headache; arm started to feel more sore; This spontaneous case was reported by a nurse and describes the occurrence of SOMNOLENCE (sleepy), FATIGUE (tired), NAUSEA (nauseous), HEADACHE (headache) and VACCINATION SITE SWELLING (arm started to feel more sore) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse reaction. Concomitant products included MULTI VITAMIN & MINERAL, FISH OIL and WITHANIA SOMNIFERA ROOT (ASHWAGANDHA [WITHANIA SOMNIFERA ROOT]) for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced SOMNOLENCE (sleepy), FATIGUE (tired), NAUSEA (nauseous), HEADACHE (headache) and VACCINATION SITE SWELLING (arm started to feel more sore). On 16-Feb-2021, the patient experienced MYALGIA (body aches) and FEELING HOT (feeling hot). At the time of the report, SOMNOLENCE (sleepy), FATIGUE (tired), NAUSEA (nauseous), HEADACHE (headache), VACCINATION SITE SWELLING (arm started to feel more sore), MYALGIA (body aches) and FEELING HOT (feeling hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment and concomitant medications were not provided by reporter.
I have increase in tinnitus; This is a spontaneous report received from a contactable consumer (Patient) via Medical Information Team. A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot# unknown), via an unspecified route of administration on 31Mar2021 (at the age of 63-years), as a single dose for COVID-19 immunisation. Medical history included tinnitus, stroke years before and her math skills are off. Concomitant medications were not reported. On an unspecified date in 2021 (after first dose), the patient experienced increase in tinnitus. It was reported that, patient developed tinnitus a year ago, and calmed down a bit, but has come back a bit after the vaccine. Patient was not sure if she need to have second dose as she read all of forums that say that either have or seen increase in tinnitus. Upon questioning, patient received details about administration of second dose. The patient appreciated the response she received. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Vaccine received post its 30 days Expiry date; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine received post its 30 days Expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2022 at 12:13 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Jan-2022 at 12:13 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine received post its 30 days Expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine received post its 30 days Expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient ethnicity was reported. Concomitant medication of the patient was not reported. Vaccine administration time was given as 28-Jan-2022 at 12:13:58 No treatment information was provided by the reporter.   This case was linked to MOD-2022-542869 (Patient Link).
mother states, child got white, lost control of body & limp stopped breathing, taken to local hospital then transferred childrens then transferred childresn hosp. was released /p exam to go home. Admit to hosp. 18Jul90
Sudden onset severe 8-9/10 pain left shoulder/brachial plexus area radiating down to left elbow associated with sudden loss of motor function in left shoulder and muscle fasciculations.  Seen within 3 hours at Orthopedics.   Acute severe pain and motor loss has now become persistent.  Within a week diagnosed as Parsonage Turner Syndrome (Acute left brachial neuritis/neuralgia/amyotrophy.)   Rare (approx 3/100,000) condition thought to be an auto-immune disease.  Surgery, VACCINATIONS, and viral infections may be causal.