chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient under 18 years of age, got vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18 years of age, got vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18 years of age, got vaccine). On 10-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18 years of age, got vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported. No treatment information was provided.
Patient is a 7 yr female who received KINRIX on 7/29/11, had no adverse events or symptoms.
very, very dizzy; swelling at the area of the injection; redness at the area of the injection; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (very, very dizzy), VACCINATION SITE SWELLING (swelling at the area of the injection) and VACCINATION SITE ERYTHEMA (redness at the area of the injection) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE SWELLING (swelling at the area of the injection) and VACCINATION SITE ERYTHEMA (redness at the area of the injection). On 21-Feb-2021, the patient experienced DIZZINESS (very, very dizzy). On 21-Feb-2021, DIZZINESS (very, very dizzy) had resolved. On 22-Feb-2021, VACCINATION SITE SWELLING (swelling at the area of the injection) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (redness at the area of the injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications and treatment details were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow up received on 18th JUN 2021 contains no new information
metallic taste/After the 1st shot she had a metal taste in her mouth; This is a spontaneous report from Pfizer-sponsored program COVAX US Support two contactable consumers one of (patient) via Medical information team. A 65-year-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: EL1283), via intramuscular, administered in Arm Right on 08Jan2021 14:00 (age at the vaccination 64-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included ongoing fibromyalgia, reflex sympathetic dystrophy, Irregular heartbeat, ongoing hemangioma (In her brain), thyroid problems, low white blood cell counts (patient Was on Tegretol and her white count was down to 1 and she was sent to the hospital), ongoing Pinched nerves in her neck and back, migraines/weather migraines (that cause numbness in nose and foot as well as gastro-intestinal symptoms patient took AMITREX which usually takes for her migraines however it was less effective, and she felt the symptoms until 10PM that night. She has a history of migraines and they cause numbness in her face sometimes. She took migraine meds, and it did not help), numbness in nose and foot (weather migraines, that cause numbness in nose and foot as well as gastro-intestinal symptoms), gastro-intestinal symptoms, burst blood vessel in her eye, burst blood vessel in her eye, diastolic heart failure (She has diastolic heart failure she was diagnosed with about 5 years ago), abdominal pains and numbness in her face. The patient concomitant medications were not reported. The patient historical vaccine include flu shot on an unspecified date in Jul2020. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient experienced metallic taste/after the 1st shot, she had a metal taste in her mouth on 08Jan2021. The patient underwent lab tests and procedures which included white blood cell count low on, white blood cell count was down to 1 on unspecified date. The outcome of the event was recovered on 08Jan2021.  Follow-up (19MAY2021): Follow-up attempts completed. No further information expected.
Chickenpox 6/1/99. Fever 104 6/4/99. Prickly heat rash 6/7/99. Ear infection, staggered gait 6/5/99. 6/7/99 saw MD started rash & fever from MMR.
broke out w/3 areas on torso on 11/17/99 raised, sl fluid vesicular eruptions;11/18/99 stating areas w/small scabs w/new areas of eruptions/blisters present;
Information was received from a medical assistant concerning unspecified patients (demographics not provided). The medical assistant reported that an unspecified number of unspecified patients received doses of RECOMBIVAX HB on unspecified dates that underwent a supported temperature excursion. No adverse experiences reported. No further information provided. This is one three reports from the same reporter (see #1411USA012708 and 1412USA007342). Additional information has been requested.
Yes length of time for side effects; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION COMPLICATION (Yes length of time for side effects) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Yes length of time for side effects). At the time of the report, VACCINATION COMPLICATION (Yes length of time for side effects) 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.   No Concomitant medications were provided No treatment medications were provided.
muscular pain; hardness; swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscular pain), FEELING ABNORMAL (hardness) and VACCINATION SITE SWELLING (swelling at injection site) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced MYALGIA (muscular pain), FEELING ABNORMAL (hardness) and VACCINATION SITE SWELLING (swelling at injection site). At the time of the report, MYALGIA (muscular pain), FEELING ABNORMAL (hardness) and VACCINATION SITE SWELLING (swelling at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
A report has been received from a Pharmacist concerning a child, subject of unknown gender, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 16-Sep-2013. The patient received given full dose of FLUMIST into one nostril on 16-Sep-2013. The outcome of the event of given full dose of FLUMIST into one nostril is unknown. The report was considered to be non-serious.
pt c/o dizzy and lightheaded. bp 108/66. HR51. Had pt lie on cart to evaluate. Symptoms started approx 5min after shot pt has history of passing out after shots. next bp 108/66, HR 54. pt still c/o dizziness. Mother agreed to see ER doc after 20 min of unresolved symptoms.
Fever lasting 5-6 days; body aches; red, bumpy rash; nerve pain in arm beginning 1 week after vaccine and lasting to present.
The pt experienced an area around the injection site which was red the day after the injection. On 9/9/01 the child began with headache, by 9/11/01 the child was dizzy and confused, had a temp of 99.0, and then seizures began. The pt was life flighted to the hospital. The annual follow up states "spoke with mother 11/14/02. Pt continues on anti-seizure rx. Caigetrol 800mg/day and has had no more seizure activity. Saw neurologist today and will then be followed yearly. Doing well in school, personality ahs returned to pre-vaccine normal. The 60 day follow up received on 1/15/02 states pt is improving according to her mother. She continues to need seizure medication. Her last EEG was done 12/01, it remained abnormal. She sees the neurologist every 3 months. She's beginning to better in school and her personality is more like "the old self."
Had DTAP #5 Yesterday. Today has large swollen arm <5 inches. Area red, hot, hard and slightly painful.
arm pain; muscle/body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (arm pain) and MYALGIA (muscle/body aches) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hypertension (Constant for a while) in 2007 and Chest pain. Concurrent medical conditions included Drug allergy, Tension headache (Once a week usually, not recall last HA) since 28-Feb-2021, SLE nephritis (Knee pain, low energy (continued after vaccination and ondoing)) since 24-Jun-2021 and Depression. Concomitant products included FLUOXETINE for Depression, TRAZODONE for Tension headache, HYDROXYCHLOROQUINE, MYCOPHENOLATE MOFETIL (MYCOPHENOLATE), PREDNISONE, SPIRONOLACTONE, ARIPIPRAZOLE (ABILIFY), VITAMIN D NOS and FOLIC ACID for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain) and MYALGIA (muscle/body aches). At the time of the report, PAIN IN EXTREMITY (arm pain) and MYALGIA (muscle/body aches) had resolved. Not Provided      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 information was not provided.   This case was linked to MOD-2021-293783, MOD-2021-291097, MOD-2021-291097 (Patient Link).
This is a spontaneous report from a contactable Nurse via Pfizer sales representative. An 82-year-old male patient of an unspecified age and ethnicity received PREVNAR 13 via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced the area by injection site was hot to touch and swollen as well as painful. Cellulitis was also seen on arm. The outcome of the events was unknown. No follow up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available, it cannot be fully excluded that the vaccination with PREVNAR 13 may have contributed to the occurrence of the reported event Cellulitis on arm.  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.
I have never had an irregular period in my entire life. It has always been 28 days. Maybe 27 days or 29 days. My first month after the vaccine, my period was one week late. Then several days late, then again several days late, then a week early and now I'm going on two weeks late. It's egregious women's menstruation wasn't studied during the initial trial.
12/9 Pt to ED  from home for increasing fatigue and black, looses stools. Pt is very pale with hypotension. Pt is A&O x 4 at this time. Patient states that for the last 2 weeks she has been having dark, black-colored stools. States that she has been feeling progressively more weak and fatigued, and that she feels dehydrated. No abdominal pain or vomiting. No fever or chills. No cough or URI symptoms. No chest pain shortness of breath. No acute focal neurologic complaint. Pt tested + for COVID 12/10 Currently seems to be asymptomatic for COVID. 12/11 The patient is currently maintained on room air saturating around 99%.  The patient's chest x-ray from admission showed mild cardiomegaly with no ... radiographic evidence of acute intrathoracic process. CT of abdomen and pelvis done, showed no evidence of acute process or cholelithiasis or renal cyst.  The patient is currently in the ER.  Her white blood cell count is elevated at 14.4, and she is on Remeron.   12/13 Esophagogastroduodenoscopy: Small gastric prepyloric ulcer without active bleeding.  Antral Biopsies were obtained. Proximal erosive duodenitis 12/15 The patient remains on room air.  The patient is stable.  So for now, doctor will continue watching patient off COVID treatment. Pt discharged.
Minimal redness, immediately following vaccine then increased swelling size erythema and warmth starting 7/3/18. Seen in ER on 7/4/18 prescribed Abx for ?cellulitis. Seen in office at PCP on 7/5/18 with cont. Sx and prescribed prednisone.
40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult 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)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    No Concomitant medication was reported.  Pharmacy intern reporting that correctional facility administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients. No patient information or product information available. Consent provided for safety follow-up.  No treatment medication was reported   This case was linked to MODERNATX, INC.-MOD-2023-698650 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-698650:Master case
Recvd imuun 13JAN92 started vomiting & diarrhea of 15JAN92, elevated temp 100.2 on 16JAN92; mom reported pt was not active, listless pale; took pt to MD on 16JAN92; MD told mom illness was delayed rxn to immun on 13JAN92;
severe shortness of breath, starting around 11:00 AM 8/30, lasted the whole day. She quotes "feeling like she ran a marathon." Some shortness of breath continued on 8/31, but less in severity. patient still has some shortness of breath now, 9/1, but seems to be improving with each day.
Rash on face started on 6/04/17, spread to chest and back. Itchy.  Feeling achy 1-2 days prior. Felt chilled 1 day before onset of rash.  Sore glands in neck/behind ear.
red welt area that is stiff  and warm to the touch, began as lighter red and changed shape to be more circular and slightly darker red. started turning red and painful approximately 8-9 hours after injection. got more swollen/raised, darker red, and warm overnight. remained about that size ~1.5 inches across as of right now (48 hours after injection).
Tested positive for COVID after receiving the vaccination.  Symptoms began on 9/25/2021
2/2/07 Vesicles near eyebrow, sty in eyelid - found to be possible herpes. Treated with Valtrex.
5-23-13 injection site redness, edema, tenderness measuring 2.5 x 1 inches. Given 1 tsp BENADRYL and Amoxicillin called to pharmacy. Mother instructed to give BENADRYL, TYLENOL, antibiotic and apply ice to area.
Mom returned to clinic with complaint of redness to injection site.  MD evaluated and was diagnosed with "Local vaccine reaction versus a possible early cellulitis." Was started on Keflex to treat.
an unspecified patient experienced swelling,redness and warmth from her shoulder to her elbow after receiving PNEUMOV AX 23 on an unspecified day.; an unspecified patient experienced swelling,redness and warmth from her shoulder to her elbow after receiving PNEUMOV AX 23 on an unspecified day.; an unspecified patient experienced swelling,redness and warmth from her shoulder to her elbow after receiving PNEUMOV AX 23 on an unspecified day.; This spontaneous report has been received from a physician via company representative referring to a 72-year-old female patient. Information about the patient's concurrent conditions, medical history, concomitant therapies and drug reaction or allergies were unknown.     On 23-JUL-2019, the patient was vaccinated with pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (dose, dose number, route, lot number and expiration date were not reported)) for prophylaxis.         On an unknown date in July 2019 (reported as after receiving pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) on an unspecified day), the patient experienced welling, redness and warmth from her shoulder to her elbow. The patient had sought medical attention (came back to office). The patient was treated with prednisone therapy pack and benadryl. It was unknown if the lab diagnostics or studies were performed. The outcome of the events was reported as recovered. No cancer and overdose were reported. No product quality complaint (PQC) was reported. The causality between the events and pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was not reported.
Bexsero exposed to 29.8 F and  administered; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number 459MC, expiry date 31st March 2024) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th September 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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: 13-SEP-2022 Reporter's Comment: The CMA (Certified Medical Assistant) reported that the patient received Bexsero vaccine which was exposed to 29.8 degree F. The reporter consented to follow-up via mail. Additional supportive information: The Bexsero vaccine was exposed to temperature 29.8 degree F, which led to incorrect storage of drug. This was one of the 5 cases reported by same reporter.; Sender's Comments:  US-GSK-US2022132077:Same reporter. US-GSK-US2022132076:Same reporter. US-GSK-US2022132079:Same reporter. US-GSK-US2022132078:Same reporter.
Pt received first dose of Pfizer vaccine on 11/8 at the pharmacy. Four hours later, she developed severe neck stiffness, severe headache, chills, body aches, severe fatigue and injection site arm pain (right). She notified her PCP of symptoms and was prescribed a medrol dose pak. Pt has pmh hashimoto, thyroid nodule, rare antibodies, chronic anemia, mvp and gene mutation. Pt reports that was allergy tested on 11/4/21 with an allergist (local Dr.) and tested positive for J & J vaccine, but was informed that the Pfizer vaccine should be okay. She is feeling better after taking the steroids and headache and fatigue has improved. She called OOW for three days but plan to return tomorrow 11/19.
Covid Positive on 11Jan2022; Covid Positive on 11Jan2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), administration date 15Mar2021 (Lot number: EL3247) as dose 2, single and administration date 22Feb2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 11Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 11Jan2022, outcome "recovering" and all described as "Covid Positive on 11Jan2022". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Jan2022) positive. Therapeutic measures were not taken as a result of covid-19. Clinical course:   Prior to vaccination, patient was not diagnosed with COVID-19. No prolonged hospitalization reported.   No follow-up attempts are possible. No further information is expected.
My arms starting feeling sensitive 1/27/21, like it felt the 1st day kinda sore, later in the day when I look at my arm there were a lot of bumps near the site of the shot and still sore. Today 1/28/21the bumps are gone but it's still a little sore to the touch.
Irregular and early and messy period since the vaccination, most recent last period in second week of sept is so heavy bleeding , more bleeding than delivery baby,
Onset of multiple seizures (new) requiring hospitalization. Still hospitalized with difficult to control seizures. 60 day follow-up dated 9/22/00 provided no additional data.
red itchy knot in lt leg since DTAP inj 5/11/99;no fever;tx w/DPh;
June 27, 2022 tested positive for COVID-19. PCR test at a Clinic. Sinus infection developed on July 8, 2022.. I do not believe it this was a reaction to vaccine.
Rash at injection site. Per pt developed itching all over chest and back, starting on face. Took 3 doses of BENADRYL. Contacted PCP. Pt seeing MD today.
Nausea; vomiting; abdominal pain; I felt light-headed. I had extreme fatigue - it felt like I had to feel asleep for a year. I woke up and would feel like I hadn't slept.  Those symptoms continued for over  hours. I called the Dr on the 15th and she said didn't want to give me to Zofran; she wanted me to take Ginger but I didn't feel good enough to go out and get ginger. I was really feeling awful going to bathroom to bed.  My fiancé gave me one of his Zofran and I took Tylenol too. After eight or nine hours the symptoms subsided. Except the fatigue - and that resolved about the 21st or so.
itchy lumps on body, swelling over eyes & lt eye redness; dx urticaria ? cause;
Woke at 1 am 06-25-03 with temp of 101 continued for 1 1/2 days with motrin given every 6 hours. 1 dose motrin given prior to injections.