chrisvoncsefalvay/vaers-outcomes huggingface dataset:
mild cough; mild sore throat; tested positive on at-home rapid test for Covid-19 on 05Jan2022; tested positive on at-home rapid test for Covid-19 on 05Jan2022; Comirnaty booster; This is a spontaneous report received from contactable reporters (Consumer or other non HCP). A 73-year-old male patient received BNT162B2 (COMIRNATY), administration date Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single; administration date 2021 (Batch/Lot number: unknown) as dose 2, single and administration date 2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. The patient had no relevant medical history (no underlying health conditions). The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset Nov2021, outcome "unknown", described as "Comirnaty booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jan2022, outcome "unknown" and all described as "tested positive on at-home rapid test for Covid-19 on 05Jan2022"; COUGH (non-serious), outcome "unknown", described as "mild cough" and OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "mild sore throat". It was reported that the event took place after the use of product. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Jan2022) positive, notes: at home.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
injection site had fever; swelled up with rough bumpy skin; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site had fever) and VACCINATION SITE SWELLING (swelled up with rough bumpy skin) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (injection site had fever) and VACCINATION SITE SWELLING (swelled up with rough bumpy skin). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (injection site had fever) and VACCINATION SITE SWELLING (swelled up with rough bumpy skin) outcome was unknown. Not Provided          The action taken with mRNA (Moderna COVID-19) (Unknown) was Not Applicable Concomitant medications were not provided.
He felt a little tired.; Mouth and nose felt tingly/itchy; Throat closing; Mouth and nose felt tingly/itchy; Fever; Chills; Flu-ish; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-ish), PRURITUS (Mouth and nose felt tingly/itchy), THROAT TIGHTNESS (Throat closing), PARAESTHESIA (Mouth and nose felt tingly/itchy) and PYREXIA (Fever) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Apr-2021 at 2:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-ish), PYREXIA (Fever) and CHILLS (Chills). On 14-Apr-2021, the patient experienced PRURITUS (Mouth and nose felt tingly/itchy), THROAT TIGHTNESS (Throat closing) and PARAESTHESIA (Mouth and nose felt tingly/itchy). On an unknown date, the patient experienced FATIGUE (He felt a little tired.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of UNK, tid. On 14-Apr-2021, INFLUENZA LIKE ILLNESS (Flu-ish), PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, PRURITUS (Mouth and nose felt tingly/itchy), THROAT TIGHTNESS (Throat closing), PARAESTHESIA (Mouth and nose felt tingly/itchy) and FATIGUE (He felt a little tired.) outcome was unknown.            No relevant concomitant medications were reported.
"Covid arm"--rash that appeared eight days after injection, spread the next day.    Still there two days later.
Patient developed a rash resembling measles few hours after vaccination. Seen today for rash/fussiness.
Red, swollen, bump, warm to touch, keeps getting worse, itches. On 04/18/2002 getting worse given Aumentin and Zyrtec.
Developed severe bilateral hip pain that is muscular, possibly skeletal, in nature. Trouble walking. Taking Tylonol for pain. 8/10 on the pain scale. Pain has decreased somewhat, but still taking Tylonol 3x daily to function. Has last going on 3 weeks
Patient returned to pharmacy approximately 6 days after vaccine to let me know she experienced the following syptoms starting 1 day after receiving her 2nd dose of vaccine and lasted for 2-3 days: fever of 100 degrees, body aches all over her body. Both symptoms resolved on its own after 3 days. She took OTC medications to help eleviate some of the body aches and to control the fever.
Patient experienced a hot flash, nausea/vomiting within 10 minutes of the injection - fast onset. Left facial numbness, left arm heaviness, chest heaviness, tongue burning sensation, slight hypertension then followed. Patient was sent to the ER and no medications administered. A CT was completed to rule out a stroke. At 12pm (4 hours later), the facial numbness and some left arm heaviness remain.
Patient developed swelling, pain in the right upper arm one day after immunizations.  When came to office 2 days after, had a 16 x 17 cm circumferenced band of erythema and swelling in the right upper arm.
within minutes of receiving the vaccine pat reported feeling faint and upon examination she was very flush with slightly elevated BP, she sat down and after about 10 minutes the reaction began to subside and blood pressure was returning to normal, she was fine in about 30 minutes, and I have checked on her after 3 hours which she reported being back to normal.
Pt states the site started swelling and a bruise was formed. Around 6 pm pt states the site felt like it was pulsating. Today 13July some redness, swelling, and a little tender to the touch.
1/9/22  Positive date: 1/9/22   EDD 3/17/22 Symptomatic date: 1/1/22 Current symptoms: no symptoms 1/3/22  HPI  24 year old female that presents to urgent care for cough and fever. Her symptoms started 2 days ago. She denies chest pain, shortness of breath, nausea, vomiting, diarrhea. She is currently 29 weeks pregnant. She has not been vaccinated for Covid. PMH significant for allergic rhinitis and vitamin D deficiency.   1/3/22 Physical Exam: Physical Exam Vitals and nursing note reviewed.  Constitutional:  Appearance: Normal appearance. She is normal weight.  HENT:  Head: Normocephalic and atraumatic.  Musculoskeletal:  General: Normal range of motion.  Cervical back: Normal range of motion and neck supple.   1/3/22  Skin: General: Skin is dry.  Neurological:  General: No focal deficit present.  Mental Status: She is alert and oriented to person, place, and time.  Psychiatric:  Mood and Affect: Mood normal.  Behavior: Behavior normal.  Thought Content: Thought content normal.
FEEL WORSE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not 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. As per procedure no follow-up will be requested for  this case. No concomitant medications were reported. On an unspecified date, the subject experienced feel worse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feel worse. This report was non-serious.
COVID 19 Treatment; COVID 19 Treatment; 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 33-year-old male patient received BNT162b2 (BNT162B2), on 14Nov2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 32 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 24May2022, outcome "unknown", COVID-19 (medically significant) with onset 24May2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24May2022) Positive, notes: First positive test and treatment began 24May; (30May2022) Negative, notes: Negative rapid tests on 30May; (31May2022) Negative, notes: Negative rapid tests on 30May and 31May; (01Jun2022) Positive, notes: Positive rapid test in 01Jun. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient had not received any other medication in 2weeks. Patient had no known allergies. Patient had received COVID 19 Treatment as Paxlovid from 24May2022 to 28May2022. This is a notification generated from the system.  As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the One and Done business process according to in Q1215 and/or Q1252. Refer to the below table for details. AE Ref No. (CC): 202200789582: 7237006. Product-Description: Compound BNT162B2 COVID-19 Vaccine suspension for intramuscular 2ML multiple dose vial X 1, Lot-: FG3527. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the Pfizer-Biontech Covid-19 Vaccine lot FG3527 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot FG3527, fill lot FG3512, and the formulated drug product lot FJ8500. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. ID of Previously Completed Inv: 6577183, Link (Previously Investigated): 6573465
Pericarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  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: PERICARDITIS (medically significant), outcome "unknown".  Clinical Couse: dancer develops Pericarditis after receiving Pfizer vaccine unable to dance for at least a year.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received
03/18/2021 Vaccine: one week later felt dizzy, light headed. Driving into work on 04/11/2011 (24 days after vaccine) I felt like I was going to pass out. That lasted 20 minutes. Continued to feel light headed for another two weeks.  11/17/2021 Booster: On 12/10/2021 (24 days after booster) 1:10pm I felt I was going to pass out. Went to lunch and drank a lot of water. Felt better but still light headed On 12/14/2021 (28 days after booster) at home kept feeling I was going to pass out. Paranoid, felt like I was drugged. Scared to go to sleep. Anxious, out-of-body feeling. experience lasted from 12:00pm to 6:00pm until I felt "normal". Still felt dizzy for the following week.
Pericarditis atrial fibrillation, thrombocytopenia, anemia reported in pt receiving Fluogen; Pt recd vax 27NOV89 & on 10DEC89 was admitted to hosp w/dx of viral pericarditis & new onset atrial fibrillation; dx paroysmal atrial fib & atelec
Sudden infant death; Child seemed well at 4AM feeding 13DEC90 was found dead in crib 8AM 13DEC90; Child had Bronchopulmonary Dysplasia;
Calcium went up to 10.8; Glucose was 107; phosphorus level is very low, it went up to 3.5; FBF 23 was 899; Parathyroid Hormone went down to 13; Creatinine/ it went down to 0.9 where it belongs.; Sodium: it went up; Creatinine went down to 0.9 where it belongs / shot did something good too; Arm was a little sore just where the shot was; This is a spontaneous report from a contactable consumer. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8729), via an unspecified route of administration on 06Apr2021 at around 09:15-09:30 (at the age of 66-year-old), as 2nd dose, single in left arm for COVID-19 immunization. The patient's medical history included ongoing Tumour Induced Osteomalacia from Jul2019 and had surgery in Feb2021. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6207), via an unspecified route of administration on 16Mar2021 around 09:15-09:30, as single in left arm for COVID-19 immunization and her arm was just a little sore. Patient did not receive any other vaccinations within 4 weeks prior to COVID vaccine. Concomitant medications included Calcitriol 0.5mcg every morning and every night by mouth and then reduced it to 0.25mcg every morning and every night, taken for calcium. Patient had been going for lab tests every 3 months since Jul2019. On 13Apr2021, after the second dose, the blood work came back all crazy. Patient could not figure out why it went so crazy and the only difference was that she had the vaccine. On 13Apr2021, her tumour marker FBF 23 (Fibroblast growth factor 23) was 899, which was supposed to be under 189, and hers was typically about 365, 348. Patient did not receive FBF 23 test result performed on 10May2021, and she assumed that this would be normal as all other results went back to normal. On 13Apr2021, calcium went up to 10.8, which concerned the doctors, and she went again to physician's office on 10May2021 to repeat the blood work and everything went back to normal: 9.9, it was usually 9.7 or 9.6. Patient's glucose was normally 85, 86. On 13Apr2021, glucose was 107 and on 10May2021, it was back to 96. Patient's phosphorus level was usually very low, but on 13Apr2021, it went up to 3.5, but it was in the normal range. On 13Apr2021, patient's parathyroid hormone went down and then reached back to 24. Creatine level was 1.1 on 13Apr2021, but on 10May2021, it went down to 0.9 where it belongs and the patient stated that the vaccine might have done something good too. On 13Apr2021, sodium went up to 146, but it was not bad. On 10May2021, it decreased to 144. On 06Apr2021, the patient's arm was a little sore just where the shot was taken and confirmed that she got this after both vaccines. It was not a whole sore arm, pain was present only on the vaccination spot and pained only on touching it. The clinical outcome of events fibroblast growth factor 23 increased, arm was a little sore just where the shot was, creatinine went down to 0.9 where it belongs / shot did something good too was unknown and clinical outcome of all other events was recovered.
The next day of the vaccine I had fever, felt really fatigued, I felt very low of energy, my head felt like I had brain freeze it felt was worse every time I stood up, I saw my doctor he ordered lab work & urine test my urine test comeback as I was a little dehydrated & lab work came back normal. This has not resolved as it right now I still feel very low of energy. My energy is still not the same.
Vial was first punctured on 14-JUL-2022 at 12:09 pm and administered on 15-JUL-2022 at 11:15 am; 1 patient that was administered a Moderna Covid-19 more than 12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 patient that was administered a Moderna Covid-19 more than 12 hours post puncture) and PRODUCT STORAGE ERROR (Vial was first punctured on 14-JUL-2022 at 12:09 pm and administered on 15-JUL-2022 at 11:15 am) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051B22A) for COVID-19 vaccination.     No allergies were reported. No medical history relating to mentioned AE and both acute and chronic illnesses at the time of vaccination.  Previously administered products included for Product used for unknown indication: Pfizer (1st dose, Dose 0.3ml) on 24-Apr-2021, Pfizer (2nd dose, Dose 0.3ml) on 24-Apr-2021, Pfizer (3rd dose and Dose 0.3ml) on 09-Dec-2021. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer.    On 15-Jul-2022 at 11:15 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Jul-2022 at 11:15 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 patient that was administered a Moderna Covid-19 more than 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 14-JUL-2022 at 12:09 pm and administered on 15-JUL-2022 at 11:15 am). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 patient that was administered a Moderna Covid-19 more than 12(US) hours post puncture) and PRODUCT STORAGE ERROR (Vial was first punctured on 14-JUL-2022 at 12:09 pm and administered on 15-JUL-2022 at 11:15 am) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. It was reported that number of dose/vials is 1 dose. On 11-JUL-2022 vial was initially stored in the refrigerator. Vial did not undergone any temperature excursions. Post puncture vial was stored in room temperature for about 23 hours. No side effects from patient have been reported yet. Treatment medication was not provided by the reporter.
Patient called pharmacist on Saturday October 6th. Patient developed "triangle" rash around the area of the injection. Rash was about 3 inches long by 4 inches wide. Her arm was extremely painful and could not move it. Pharmacist recommended ice and naproxen OTC. Patient returned to the pharmacy on Wednesday October 24, 2018 - rash was resolved, but when pharmacist palpated the patients arm - it was lumpy. Patient still has pain at the area of the injection.
Developed rash and welts on all four extremities > 24 hours after receiving immunizations. Seen in local ER, given Solumedrol and Benadryl, rash and welts resolved. Given Rx for oral prednisolone to take at home.
Elevated high pressure, nauseas, dizziness and strong headaches. Couldn't sleep well.
Is sleepy; chills; muscle aches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Is sleepy), CHILLS (chills), MYALGIA (muscle aches) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced SOMNOLENCE (Is sleepy), CHILLS (chills), MYALGIA (muscle aches) and FATIGUE (fatigue). At the time of the report, SOMNOLENCE (Is sleepy), CHILLS (chills), MYALGIA (muscle aches) and FATIGUE (fatigue) outcome was unknown.            No treatment information was reported. Action taken with mRNA-1273 in response to the event was not applicable.
vomiting, fever, and mental status changes and was diagnosed with Herpes Simplex encephalitis; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or around 02-NOV-2013 the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster)(dose, route of administration, lot number and expiration date were not reported).  On an unknown date, the pt. experienced vomiting, fever, and mental status changes and was diagnosed with herpes simplex encephalitis.  As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations do not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered not recovered/not resolved. The event was considered related to zoster vaccine live (ZOSTAVAX).  Upon internal review herpes simplex encephalitis was considered to be medically significant event.  Upon internal review the herpes simplex encephalitis was considered to be disabling.
Fever, body ache, chills.  I received the flu shot at 10:00 AM and the fever began at 9:30 PM.
vaccine expired on 9/30/22, vaccine was given to pt on 10/2, no adverse reaction
Not able to lift arm, large rough knot at shot site, red solid ring that grew daily.
the patient received a dose of Gardasil ten years ago, when she was eleven years old, without completing the vaccine series for coverage; a patient approach her about receiving a Gardasil 9; no additional AE; This spontaneous report was received from a pharmacist via company representative and refers to a female patient of unknown age. Her pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On an unknown date in 2011, reported as 10 years ago, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) for prophylaxis (exact dose, dose #, route, anatomical location, lot # and expiration date were not reported). She did not completing the vaccine series for coverage. No adverse events were reported.
Patient presented to the ED on 4/22/21 and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnoses were: Severe sepsis (HCC) due to pneumonia causing acute on chronic hypoxic respiratory failure and hypotension that resolved with fluids. He also presented to the ED on 5/13/21 and was subsequently hospitalized for sepsis secondary to UTI.