chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had nose bleeds.  That was odd as never had a nose bleed.  I blew my nose and blood spewed out.; My ears feel funny, like pain; Flu like symptoms like 3 - 4 weeks after the vaccination; I had breast soreness; GI issues; her migraine syndrome was kicked into high gear. She had a migraine like when she was still ovulating; her migraine syndrome was kicked into high gear. She had a migraine like when she was still ovulating; I have migraines 2-3 times a week with auras, pain, dizziness disorientation, etc..; body pain; This is a spontaneous report from a contactable consumer (patient). A 62-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in the right arm on 13Mar2021 at 08:00 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. Medical history included known allergies: sulfa and tetra, some kind of autoimmune thing with no name and migraines (when she was still ovulating). The patient's concomitant medications were not reported. On 10Apr2021 at 04:00, the patient had nose bleeds which was odd as she never had a nosebleed. She blew her nose and blood spewed out. Her ears felt funny, like pain, body pain. The patient also had flu like symptoms like 3 - 4 weeks after the vaccination. She did hurt for about 2-3 weeks. Her body was feeling like 12years ago as far as hormones. She thought she was going to get a period. She was 62. She had breast soreness, GI issues, and her migraine syndrome was kicked into high gear. She had a migraine like when she was still ovulating. She had migraines 2-3 times a week with auras, pain, dizziness, disorientation, etc. It sounded like a stroke, but it is not a stroke. With regards to treatment, the patient mentioned none (really) as she just checked with the neurologist about them. The patient had no COVID prior vaccination and was not tested post vaccination. The events had not resolved.
He developed a small bowel to small bowel intussusception on June 25, 2022 which spontaneously reduced. This occurred in the midst of persistent diarrhea which started the week of his 2nd dose of Rotateq. The diarrhea continued to increase. By June 14, was having diarrhea every 10-15 minutes and vomiting. Seen in ER, no change in plan. Then within a few days developed blood in stool which became more intense and associated with pain and sent to ER where the US showed a small bowel to small bowel intussusception which reduced. Admitted overnight. Mom had been dairy free for months. Subsequenttly bloody stools resolved after elimination of soy from maternal diet as well
Approximately 6 hours after receiving the Moderna COVID-19 Vaccine EUA my arm became sore at the injection site, level of pain was 3-4. Approximately 9 hours after receiving the vaccine my pain level had increased to 8-9, had spread to include the entire shoulder as well as the armpit, and was accompanied by limited mobility of the left arm. I continued at that level of pain until roughly 36 hours after the injection, at which point the pain subsided to a 5-6. I continued at a 5-6 pain level for another 12 hours before the pain and mobility limits eventually subsided. I am now 76 hours post vaccination and the injection site is still mildly sore to the touch.
Accidental 3rd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Accidental 3rd dose) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (Accidental 3rd dose). On 03-Apr-2021, EXTRA DOSE ADMINISTERED (Accidental 3rd dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   No treatment information was provided.    Action taken with mRNA-1273 in response to the events was not applicable.
Pt presented with injection site reaction 10/15/14 (Given 10/13/14) Red, swollen, painful site Approx 5" x 2" and possible beginning of blisters.
I came down with COVID/ I tested positive on 27Sep2023; I came down with COVID/ I tested positive on 27Sep2023; I had Pfizer a long time ago the first one (COVID-19 Vaccine). The last one I had was Moderna (Clarified as Moderna COVID-19 Vaccine). Booster number three is Moderna."; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 71-year-old female patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 30Sep2022 as dose 3 (booster), single (Lot number: AS71642) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Sep2022, outcome "unknown", described as "I had Pfizer a long time ago the first one (COVID-19 Vaccine). The last one I had was Moderna (Clarified as Moderna COVID-19 Vaccine). Booster number three is Moderna.""; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Sep2023, outcome "unknown" and all described as "I came down with COVID/ I tested positive on 27Sep2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Sep2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient reported that he was a retired Pharmacist. His last COVID booster was on 30Sep2022. He called his Pharmacy and thought they knew he was on Paxlovid but they said do you want the COVID shot today? He wanted to know if one could get a COVID shot while taking Paxlovid. He stated that he took Pfizer a long time ago the first one (COVID-19 Vaccine). The last one he had was Moderna (Clarified as Moderna COVID-19 Vaccine). Booster number three was Moderna. Paxlovid came on Wednesday. That was the first day of his definite symptoms and he tested positive on Wednesday, 27Sep2023. He took Paxlovid (Batch/lot number: GG2270) for COVID-19.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202300316002 Same reporter/patient, different drug/event.;
Pfizer vaccine was administered  - reported by patient- ? NO LOT NUMBER WERE SUPPLIED ---------------------------------------------------------------------------------------------------------------------------- ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/29/2023 THORACIC VERTEBRAL OSTEOPOROTIC FX, INIT ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/29/2023 ABDOMINAL AORTIC ECTASIA ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/29/2023 THORACIC VERTEBRAL OSTEOPOROTIC FX, INIT
No adverse event; 14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) in an elderly 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. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD) 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 EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD).    Concomitant medication was not provided. Dosage text was reported as unknown. It was reported that 14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD between 15MAY-10JUN2023. Treatment information was not reported. This case contains information about 5th patient out of 14.   This case was linked to US-MODERNATX, INC.-MOD-2023-732456 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732456:Master case
Chills; High Blood Pressure at 180/60 first dose; This is a spontaneous report from a contactable consumer. This 87-year-old non pregnant female consumer reported for herself that she received first dose of bnt162b (BNT162B2, Solution for injection, Lot number: EH9899) on 06Jan2021 at 12:00 Right arm, as single dose for covid-19 immunisation. Medical history includes COPD (chronic obstructive pulmonary disease), High Blood Pressure, Pacemaker, Aortic stenosis, Liver Disease, Hip Replacement Surgery from an unknown date and unknown if ongoing. The patient had allergies of Pork and Shellfish. Concomitant medications includes Losartan, Eliquis, Montelukast, Amlodipine. No other vaccine in four weeks. No covid prior to vaccination. No covid post vaccination. The patient had Chills and high blood pressure at 180/60 first dose.  The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Per patient contact on 10/18/2021 patient had no adverse reactions related to vaccine.
he (and his wife) only experience sore arm; This is a spontaneous report from a contactable consumer (reporter's wife).  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on 23Jan2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced he (and his wife) only experience sore arm on an unspecified date with. Reporter had antibody test done after 1st dose and results are negative.  He was asking for information about antibody testing and if he should be concerned the vaccine is not working properly since he read after 1st dose of vaccine, he should have approximately 50 percent protection. Caller mentions that his mother who is in her 70's received Moderna vaccine and experienced fatigue, achy all over the place. The outcome of event was unknown.  Information on the lot/batch number has been requested.  Follow-up (19Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
FEELS HORRIBLE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested. No concomitant medications were reported. On an unspecified date, the subject experienced feels horrible. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feels horrible was not reported. This report was non-serious.
Breakthrough case admission after 2 vaccines Moderna 2/9/21 Lot# 031L20A;  Moderna 3/9/21 Lot# 032M20A
Fever; Chills; severe body pain/ Couldn't sit still.; Couldn't sit still'; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever, chills, general body pain and restlessness. On an unknown date, the outcome of the fever, chills, general body pain and restlessness were recovered/resolved.   The reporter considered the fever, chills, general body pain and restlessness to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient had bad reaction to the shingles vaccine, fever, chills and severe body pain. The patient stated that he/she could not sit still, he/she was not prepared for that. The patient stated that the fever, chills, severe body pain and could not sit still gone by the next morning and he/she felt great. The patient stated he/she was so terrified to get the second shot after that, so patient waited till the last minute and got the shot prepared for worst and nothing happened, she/he thanks god so glad did it. The follow up would not possible as contact details was not available.
SkinRash, CoughWheeze, Syncope,  chills x3/day, rash (neck, face, forehead, chest), Narrative:  1/14 PCP VISIT ANTIBIOTIC CRREAM 1/19 DEMRATOLOGY -RASH CREAM
Area is quite red and she admits to a hard outline of swelling around red area. Pt denies pain, hives, or fever. She only noticed it upon taking off her shirt. Advised pt to use antipyretics, cool compresses, and topical anti-itch ointments. If she develops new or worsening sx, especially >48 hours after vaccination, she should present to UC.
Pt recv vax on 10/13/97; post vax pt exp local rxn from shoulder to wrist; vax was given SC rather than IM
UNUSUAL ODOR PRESENT IN URINE; UNUSUAL ODOR PRESENT IN STOOLS; UNUSUAL ODOR PRESENT EVEN ON THE SKIN WHEN SHOWERED; UNUSUAL ORDER PRESENT IN OCULAR TEARS; This spontaneous report received from a patient concerned a female of unspecified age. 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, and batch number were not reported) dose was not reported, administered on 11-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-SEP-2021, the patient experienced unusual odor present in urine. On 12-SEP-2021, the patient experienced unusual odor present in stools. On 12-SEP-2021, the patient experienced unusual odor present even on the skin when showered. On 12-SEP-2021, the patient experienced unusual order present in ocular tears. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the unusual odor present in urine, unusual odor present in stools, unusual odor present even on the skin when showered and unusual order present in ocular tears was not reported. This report was non-serious.
pt recv vax 22JUL98 & hives followed 23JUL98 on lower extremities particularly around inj site;more confluent erythema gen when seen by MD 27JUL98;
Arms and hands numb, muscle aches constant muscle "spasms" tremors.  Muscle constantly cramps up.  When trying to bowl, shooting numbness across shoulder blades.  Degenerative neck and extremities tingling, joint aches.
Patient felt fine after the first 15 minutes. Around 4PM, patient called the pharmacy and said that her arm had swollen up and was red and itchy. Patient's husband had her put on an ice pack (as previously spoken about) and said that the swelling in her arm had gone down.
Fatigue, malaise, elevated heart rate, difficulty taking deep breaths, feel like I'm fighting the flu.  Crashed in bed a few weeks after receiving the booster.
no other AE; Caller is a pharmacist who reports a temperature excursion involving VARIVAX. He does not know whether any doses were administered following the temperature excursion.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies were not reported.  On an unknown date, varicella virus vaccine live (oka/merck) (VARIVAX) (lot #W011623, expiration date: 06-APR-2024) underwent a temperature excursion at minus 10 degrees Celsius for 1400 hours. There was no previous temperature excursion.  On 19-AUG-2022, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (strength, dose, and route of administration were not provided; lot #W011623, expiration date: 06-APR-2024), administered for prophylaxis (Product storage error). There was no other AE (No adverse event).  This is one of 13 reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA010264: US-009507513-2209USA010265: US-009507513-2209USA010266: US-009507513-2209USA010267: US-009507513-2209USA010268: US-009507513-2209USA010269: US-009507513-2209USA010270: US-009507513-2209USA005873: US-009507513-2209USA010272: US-009507513-2209USA010273: US-009507513-2209USA010274: US-009507513-2209USA010275:
Breakthrough case admission after 3 vaccines Moderna 01/30/2021 LOt# 007M20A;  Moderna 02/27/2021 Lot# 031L20A;  Moderna 11/9/21 LOt# 017F21A
Had what was diagnosed as non specific urticaria.  Later biopsied and determined to be spongiatic excema.  Suffered sleepless nights and unbearable itching.  Still have occasional flares.  Have been treated with dupixent and now rinvoq
I got the Pfizer booster; he is having a very bad fever;  I have high fever really bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 20Nov2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1 (Primary Immunization series complete but unknown manufacturer)), for COVID-19 immunization; Covid-19 vaccine (Dose 2 (Primary Immunization series complete but unknown manufacturer)), for COVID-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 20Nov2021, outcome "unknown", described as "I got the Pfizer booster"; PYREXIA (non-serious) with onset 20Nov2021, outcome "unknown", described as "he is having a very bad fever; I have high fever really bad".  Additional information:Transferring agent stated, I have a caller on the other line. He said he got the booster shot (Captured as unspecified shot) and he is having a very bad fever. So, he also wanted to know if he can take allergy tablets (Unspecified medications). So, I already provided him the number of Pfizer Medical Information department as well." Call was transferred. Consumer stated, Yesterday I got the Pfizer booster. I have high fever bad. The guy who gave it to me said I could not get an allergy shot. I just need to know if I can take allergy pills (unspecified medications), you know, like Benadryl or any of them. Is there any problem there?". Proprietary medicinal product name: Benadryl.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Increased heart rate, facial tightness, muscles around mouth affected, and dizziness. This same thing happened with my first dose and I just thought it was a panic attack at the time.
felt he lost some equilibrium; sometimes felt like he was spinning; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (felt he lost some equilibrium) and VERTIGO (sometimes felt like he was spinning) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BALANCE DISORDER (felt he lost some equilibrium) and VERTIGO (sometimes felt like he was spinning). At the time of the report, BALANCE DISORDER (felt he lost some equilibrium) and VERTIGO (sometimes felt like he was spinning) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative.         No concomitant medications were reported.  No treatment information was provided.  Onset of event was about 2 days after the mRNA-1273 booster dose. Symptoms had persisted for 10 days and are ongoing.
A little over two weeks after the vaccine my body became very sensitive.  My feet started aching and, over a couple of days, the aches moved up my body. I kept needing to sleep during the day and was having a hard time completing my work.  Mid week I felt like I had a fever, which I didn't. A few days later my body started to feel better but I just had a general blah feeling.  During the next two weeks, I was having harder time doing things I would normally do - cook dinner, go shopping.  I lost my appetite but just kept going.  On 5/28,  I went for my 3 month blood test to check on my liver.  Numbers were very and I have done nothing else new to cause this change
PATIENT REPORTED IMMEDIATE ITCHING AROUND THE ARM AND CHEST. SPORADICALLY CHANGED TO DIFFERENT BODY AREAS. 24 HOURS AFTERWARDS PATIENT REPORTED "COVID ARM" RED, ITCHY, LIGHTLY RAISED INJECTION SITE AREA.
Patient came in with her mother. Mother reported to nurse that her daughter was 12 years and older. Pfizer 12+ vaccine was given. When entering patient into Immunization Registry age field stated patient was only 10 years old. Mother and Public Health Manager notified of incident.
Seizures, RespDepression, HYPERtension & HYPERglycemia  Narrative: 15 minutes after the vaccine she had a seizure that lasted about 2 minutes. She has a hx of seizure, we called a code and she was taken to ED, Her BP 180 /127 pulse 87 temp 36.5, spo2 80% on RA. Repeat Vs 181/97 hr 87 spo2 95% on 4L n/c Blood glucose 318.