chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shortness of breath; Headache; Tinnitus; This is a spontaneous report from a contactable Physician.  A 55-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Dec2020 at single dose for covid-19 immunisation.  Medical history included type 2 diabetes mellitus, hypertension, gastroesophageal reflux disease and asthma, all from an unknown date and unknown if ongoing. Known allergies reported: drug intolerances with nausea/vomiting to Opiates, TRULICITY, sulfa antibiotics. The patient's concomitant medications were not reported.  The vaccine was administered at Hospital Facility.  It was unknown If other vaccine were administered in four weeks. The patient did not experience COVID prior vaccination. The patient was tested for COVID post vaccination on 01Jan2021 and was negative. On 31Dec2020 within minutes of vaccination the patient experienced shortness of breath, headache and tinnitus. The events required visit to Physician Office and Emergency Room. The patient was admitted to hospital for 7 days. Therapeutic measures taken as a result of the events included epinephrine without benefit, prednisone course but tinnitus remained about 12 days since vaccination, corticosteroids, and H1 and H2 antagonists.  The patient underwent lab tests and procedures which included COVID test post vaccination (Nasal Swab) on 01Jan2021 with negative result. The outcome of the events was recovered with sequelae. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events dyspnea, headache and tinnitus cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Vaccine was taken was taken from a vial that had been opened and prepared 8 days prior on 6/21/2021. So the vaccine viability had already past.
Vaccine @ 644, c/o feeling flushed @ 652 BP 130/76 O2Sat 98% RA HR 84 653 c/o HA & heart palpitations, shaking 659 drank H2O feeling better 704 HR 64 BP 124/80 O2 Sat 99% RA 711 light headed, shaking, 713 O2 Sat 100% 721 anxious, nausea, face numb HR 66 726 BP 120/78 HR 80, O2 Sat 100% RA ED via w/c
Intestinal cramps (mainly lower left side), loose bowels, weak appetite from the day after the injection continuing through the time of this report (five days later).
In March 2022 after receiving the Pfizer booster in Jan 2022 I noticed intermittent tinnitus symptoms. By August the tinnitus was constant. I still have tinnitus today. I have seen two ENTs. The first diagnosed the follow codes Sensorineural hearing loss and Tinnitus. The second said I have little to no hearing loss and saw no signs of autoimmune inflammation.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 22Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 32 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 21Nov2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history and no known allergies. Concomitant medication(s) included: CETIRIZINE HCL; MAGNESIUM L-THREONATE. (Other medications in two weeks). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25May2022) Positive, notes: first tested positive for covid on 25May2022; (02Jun2022) Negative, notes: First tested negative on 02Jun2022; (05Jun2022) Negative, notes: tested negative again on 05Jun2022; (07Jun2022) Positive, notes: Tested positive again on 07Jun2022. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course includes covid 19 rebound. She first tested positive for covid on 25May2022. First tested negative on 02Jun2022, tested negative again on 05Jun2022. Tested positive again on 07Jun2022. Am experiencing nasal congestion, sneezing, and very mild fatigue. The patient had anti-viral details includes COVID 19 treatment started from 26May202 to 31May2022, Lot number (GC0466)  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
On 11/25/21, 6 days after receiving the Moderna COVID Booster shot, Patient had a massive heart attach and died.
Lightheaded, dizziness, along with a headache.  She was transported via ambulance to the local ER and reports that once she was lying down and had something to eat along with Tylenol she started feeling better.  She was told that it was a vasal vagal response.
Expired vaccine administered to 5 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 5 patients) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 5 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 5 patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided.  The vial did not undergo any temperature excursions. The patient experienced no adverse events after all three doses. The patient received her booster dose on right arm shoulder deltoid muscle.   No treatment medication information provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Mar-2022: Follow up received included product quality compliant number, added in reference section. On 11-Mar-2022: Follow up received contains additional Reporter.
Red, swollen, itchy, and hot at site of vaccination.. Still red and hot 12 hours later, but not as red and swollen.
Bumps; Lump; This spontaneous case was reported by a patient and describes the occurrence of GINGIVAL DISORDER (Bumps) and SENSATION OF FOREIGN BODY (Lump) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042LL20A) for an unknown indication.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced GINGIVAL DISORDER (Bumps) and SENSATION OF FOREIGN BODY (Lump). At the time of the report, GINGIVAL DISORDER (Bumps) and SENSATION OF FOREIGN BODY (Lump) outcome was unknown.            Reporter did not allow further contact
3JUN92 devel severe stomach ache, nausea, sore neck, itchy rash, swollen ears, eyes & face; seen in ER; given DPH which was limited in relieving sx; seen inclinic 9JUN92 for f/u face reddish confluent rash w/peeling ears; dx poss allergic r
Information has been received from a physician concerning a female patient who on unknown date was vaccinated with the second dose of GARDASIL.  It was reported that after the appointment, possibly on the same day, the patient developed seizures.  She went to the emergency room but was not admitted.  The physician stated that the patient had no problems with the first dose of GARDASIL.  At the time of reporting the patient has completely recovered.  Upon internal review, seizure was considered to be an other important medical event.  Additional information has been requested. 3/16/09-records received-vaccine administered on 8/16/08-. On 12/1/08 sudden onset of seizures-Neurolgoy consultation 1/13/09-PE WNL. Impression seizure episode.   9/11/09 Hospital records received DOS 8/27/09 to 8/29/09. Assessment: Epilepsy.  Patient presents with recent tonic/clonic seizures, decreased school performance. Foggy and distracted. c/o R/L temporal pain. Left frontal lobe lesion / schizencephaly. 10/12/09 Record received for ER date 11/30/08. DX: seizure.  Presenting symptoms: caregiver states pt had episode of generalized tonic/clonic shaking of the arms and legs associated with loss of consciousness for 2 to 3 minutes. Prior to episode, pt felt spinning sensation, fell to the floor and hitting head. Pt states felt normal prior to episode.
I woke up Wednesday and I felt like I was hit by a train. I felt like a wet dish rag hanging on the sink. Everything hurt, even taking a step, I just felt bad, tired like the flu but no respiratory issues. By the 14th I started getting short of breath, couldn't walk without SOB, my legs started to swell, joints were sore, I felt tired. Went to the doctor and my blood pressure was high, I was prescribed medication for my blood pressure and fluid pills. It hurt just to brush against the skin on my calf. An ultrasound revealed 4 blood clots in my left calf. Went to the ER at .  Hospital in  and sent to hematologist Dr.  and there were no findings.
low grade, fever, feel shaky, neck and shoulder discomfort, sister with similar sx.
Child received Pediarix Hib vaccines. Child was irritable, almost immediately after receivign the shots. The childs right thig was moderately red and swolled for several hours/ He was unconsolable for about 5 hours despite Tylenol, and cool compresses. Better about 7 hours after shots were received. >? was for the Hib.
No adverse event reported. Vaccine was reconstituted with bacteriostatic sodium chloride contrary to manufacturer's instructions.
She got her vaccine, afterwards she started to studdard about 1 1/2 months after the vaccine.  When she try to talk sometimes it is very difficult, she has to calm herself down and try to talk slower but she never in her lifetime had trouble talking.  She went to her doctor and went to several doctors and has an appointment now with a Neurologist in April of 2024.  When she went to her PCP she told her that she had a minor stroke, and she asked her when and she said that nothing occurred recently.  She didn't know the timeframe of it.  She said that if she had a stroke why wasn't she studdaring then, and she did not know.  She had an MRI and possibly a CAT scan and several other tests, and that's when her PCP determined she had a stroke.  She saw a cardiologist, an orthopedist, and many other tests.  She is on Meloxicam for inflammation for her knee pain which they said was due to arthritis.    Her skin is also very dry, and has never had skin that dry before.
Almost immediately after receiving both vaccinations, patient stayed seated and put his head in his hands. He said he was feeling dizzy. I told him to stay seated. About 30 seconds later he fell back against the wall. He woke up after about 10 seconds and I had him lie down. He was gray looking and very sweaty. I gave  him water and put a cold towel on his head. He started feeling better after about 10 minutes.
AFTER I GOT THE SECOND SHOT I FELT A MODERATE PAIN  LIKE THE FIRST DOSE THEN AFTER A WHILE  THE PAIN CONTINUE  TO THE POINT THAT I CAN'T EXTEND MY ARM.  I FEEL A TERRIBLE PAIN IN MY JOINTS, I CAN'T SHAVE, PUT MY HAND IN THE BACK TO REMOVE MY BRA. I FELT TERRIBLE, I WANT MY ARM TO WORK LIKE BEFORE, I AM USING MY ARM LIKE 60%. I FEEL PAIN WHEN IS COLD .. THIS IS TERRIBLE
HEARING A NOISE FROM THE BONES WHEN MOVING HER LEGS WHILE GETTING UP FROM A LYING DOWN OR SEATED POSITION FOR A PERIOD OF TIME; COUGH; PAIN IN THE BONES; PAIN ALL OVER THE BODY; FEVER; PAIN IN THE MUSCLES; FEELING REALLY TIRED; NO ENERGY TO DO ANYTHING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191, expiry: UNKNOWN) dose was not reported, administered on 04-FEB-2022 10:00 for prophylactic vaccination. No concomitant medications were reported. On JUL-2020, Laboratory data included: COVID-19 virus test (NR: not provided) positive. On 14-JAN-2022, Laboratory data included: Physical examination (NR: not provided) doing very well. On 04-FEB-2022, the patient experienced pain in the bones, pain all over the body, fever, pain in the muscles, feeling really tired, and no energy to do anything. On 10-FEB-2022, the patient experienced cough. On an unspecified date, the patient experienced hearing a noise from the bones when moving her legs while getting up from a lying down or seated position for a period of time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 06-FEB-2022, and had not recovered from cough, hearing a noise from the bones when moving her legs while getting up from a lying down or seated position for a period of time, pain in the muscles, feeling really tired, pain in the bones, pain all over the body, and no energy to do anything. This report was non-serious.
Neuropathy; Paraesthesia; Electrical sensations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history included: "Heartburn" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE taken for dyspepsia. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: ELECTRIC SHOCK SENSATION (non-serious) with onset 05Oct2022, outcome "unknown", described as "Electrical sensations"; NEUROPATHY PERIPHERAL (medically significant) with onset 05Oct2022, outcome "unknown", described as "Neuropathy"; PARAESTHESIA (non-serious) with onset 05Oct2022, outcome "unknown". The events "neuropathy", "paraesthesia" and "electrical sensations" required emergency room visit. Therapeutic measures were not taken as a result of neuropathy peripheral, paraesthesia, electric shock sensation.  Clinical course: The patient reported that she believed she had an adverse reaction to the Bivalent Vaccine, it was a neurological reaction. The patient stated that paraesthesia, neuropathy and electrical sensations. She ended up in the ER which they did not pay any attention to her. They said that paraesthesia and neuropathy was addressed through the Neurologist.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Developed rash approx 3 weeks after vaccination on bilateral arms. Very pruritic, provided ATARAX for treatment.
Pt was seen on 22JAN92 for routine well pt exam; In good hlth recvd MMR/HIB vax; Had 3 generalized afebrile grand mal seizures next morning-hospitalized; suffered another 3 seizures until stabilized;
Received flu shot and PPSV approx 6:30PM. 10:30PM - Severe chills, body aches, headache, rapid heart beat followed by nausea. 1:00AM - vomiting 6:00AM aches - fatigue fully recover.
Severe whole body pain- I couldn?t move my body without pain for about 18 hours. Severe left arm pain/armpit/left breast), fever (100.5), sweating
Afebrile isolated seizure within 36 hrs after vaccine. Normal medical w/u for other etiology at ER and nml f/u EEG
Large _ in left deltoid, moderate warmth to touch. Swelling down to elbow top.
Pt noticed redness, lump, to injection site about 3 inches wide. No respiratory distress or fever. Pt received injection on 10/22/04 at 3:00PM. Pt noticed reaction the next day 10/23/04 at about 8 AM. Advised to take Benadryl 25m every 6 hrs. Treatment started today. (Benadryl)
Pt had excessive irritability, cried until vomiting regularly. Three weeks after, tremors and shaking entire body. Lost walk, crawl, self feed. Inability to focus, loss or balance constantly, speech impaired. When hospitalized under went nuclear-med tests. EKG, EEG, sleep study, spinal tap, MRI, CT Scan. Tremors decreased in March 2001.OT/PT/speech. Mild chicken pox while in hosital for tremors. Per follow up pt has not recovered. Persistent language delay.
FLARE/SYMPTOMS WERE WORSENING/EXPERIENCING NEUROLOGICAL SYMPTOMS; COVID-vaccine issue / felt like Hangover; This spontaneous case was reported by a consumer and describes the occurrence of NEUROLOGICAL SYMPTOM (FLARE/SYMPTOMS WERE WORSENING/EXPERIENCING NEUROLOGICAL SYMPTOMS) and HANGOVER (COVID-vaccine issue / felt like Hangover) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, citrate free. On an unknown date, the patient experienced NEUROLOGICAL SYMPTOM (FLARE/SYMPTOMS WERE WORSENING/EXPERIENCING NEUROLOGICAL SYMPTOMS) and HANGOVER (COVID-vaccine issue / felt like Hangover). At the time of the report, NEUROLOGICAL SYMPTOM (FLARE/SYMPTOMS WERE WORSENING/EXPERIENCING NEUROLOGICAL SYMPTOMS) and HANGOVER (COVID-vaccine issue / felt like Hangover) outcome was unknown.            No concomitant medications were provided by the reporter. It was unknown if the patient was enrolled in a COVID-19 vaccination trial. It was mentioned that primary reporter contact for lot number information was not available. No treatment information was provided by the reporter.
no adverse event; expired Moderna that was administered to two patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna that was administered to two patients) and NO ADVERSE EVENT (no adverse event) in a 71-year-old 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. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 13-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna that was administered to two patients). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna that was administered to two patients) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (expired Moderna that was administered to two patients).    Concomitant product use was not provided by the reporter.  Expiry date of suspect vaccine was reported as 12-Jun-2023.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-731728 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731728:Patient 2
Patient developed cough, loss of taste or smell, shortness of breath, headache, and nasal congestion on 07/16.  She was tested for COVID on 07/19 and found to be positive.
This is a spontaneous report from a contactable consumer (patient's husband) from a Pfizer-sponsored Regulatory Authority Support. A 79-years-old female patient (reporter's wife) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date: Unknown), via an unspecified route of administration on 05Feb2021 as dose 1, single, and received second dose of BNT162B2 (Batch/Lot number and Expiration date: Unknown),via an unspecified route of administration on 26Feb2021 as dose 2, single; both for COVID-19 immunization. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. Concomitant medications included infliximab (REMICADE) taken for rheumatoid arthritis, start and stop date were not reported. On an unspecified date, Patient started taking Remicade infusion because of her rheumatoid arthritis every 8 weeks, she took this after she received the second dose vaccine. The reporter asked if the booster dose is available and where they can get it because their immune system is low. Therapeutic measures were taken as a result of rheumatoid arthritis. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B], was not provided and will be requested during follow up.
This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite) and FATIGUE (Extreme fatigue) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Bladder cancer.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (Loss of appetite) and FATIGUE (Extreme fatigue). At the time of the report, DECREASED APPETITE (Loss of appetite) and FATIGUE (Extreme fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood creatinine increased: 4 (High) high. On an unknown date, Blood urea: high (High) high.         Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.