chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Negative, notes: Tested negative on day 9; (2023) Positive, notes: positive on day 10. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had no known allergies. The Patient had received the Paxlovid as a treatment of COVID-19 on 31Aug2023 to 05Sep2023.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300296468 Same reporter/patient,different drug/AE.;
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 16-MAY-2013, patient received improperly stored VARIVAX dose # not reported, from lot # 0610AE (expiry date unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous case reported by a consumer, describes the occurrence of injection site pruritus (itching), injection site induration (hardening) and injection site inflammation in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Jan 14, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 21, 2021, patient experienced injection site pruritus (itching), injection site induration (hardening) and injection site inflammation. At the time of the report, injection site pruritus (itching), injection site induration (hardening) and injection site inflammation outcome was unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Concomitant product use and treatment information not provided.
Patient developed hard lump on upper right thigh 2 days after Pediarix injection.
This is a spontaneous report from a contactable consumer reported for herself. A 63-year-old female patient received PREVNAR 13 for immunization at single dose on unknown date. Concomitant medications and medical conditions were unknown. The patient experienced vaccination site swelling. The patient was told to use ice, along with Ibuprofen, as treatment. The outcome of the event was reported as recovering.
Within 45 minutes of Pfizer vaccine dose #2, my head started feeling full / whoozy; my ears started ringing/I now have Tinnitus.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Apr2021 11:45 (Lot number: ER8734) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Mild asthma" (unspecified if ongoing); "Penicillin" (unspecified if ongoing); "Rash" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Sulfur, reaction(s): "Allergy: Sulfur". Vaccination history included: Bnt162b2 (ER8730, 10:45 am, left arm, dose 1), administration date: 23Mar2021, for COVID-19 immunisation. The following information was reported: HEAD DISCOMFORT (non-serious) with onset 15Apr2021 12:30, outcome "not recovered", described as "Within 45 minutes of Pfizer vaccine dose #2, my head started feeling full / whoozy"; TINNITUS (non-serious) with onset 15Apr2021 12:30, outcome "not recovered", described as "my ears started ringing/I now have Tinnitus.". The events "within 45 minutes of pfizer vaccine dose #2, my head started feeling full / whoozy" and "my ears started ringing/i now have tinnitus." were evaluated at the physician office visit. Therapeutic measures were taken as a result of head discomfort, tinnitus.  Additional information: Facility where the most recent COVID-19 vaccine administered was Hospital. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient had reported it to her doctor. She had also switched her Tylenol to Ibuprofen 800mg to help reduce the immune response. Also she was going to start on a dose of B12 to see if that helps.  No follow-up attempts are possible. No further information is expected.
PATIENT GRANDMOTHER CALLED TO INFORM THAT PHARMACY VACCINATED PATIENT WITH MODERNA. PATIENT IS 17 YEARS OLD AND NOT REQUIRED TO RECEIVE MODERNA
Skin reaction at injection sight, raised and itchy for the first week. Now it?s not raised or itchy but the discoloration seems to be permanently on my arm. Sometimes it aches in the exact a lot and it hasn?t gone away.  It seems to be a permanent reaction. Second dose has not been taken.
Breakthrough case admission after 2 vaccines  Moderna 5/6/21 NO LOT #;  Moderna 6/7/21 Lot# 041C21A
Patient came in to get his vaccines I accidently administer a Kinrix instead of just a Dtap and also gave him another polio vaccine. I called the CDC which inform me that we had it to do a report on the CDC website and notified the patient and parent. They also stated that this should not cause any harm to the patient and just to have patients' parent call us incase patient has any symptoms. I spoke to patient's father after patient was in the waiting room for 30 min and he stated that patient was fine and that he will call us if any symptoms. I will also place a note protocol.
I woke with horrible hives all over my body. I was very itchy all over my.
The patient had received the moderna vaccine and about four days later he started to develop persistent fevers and, within one week, had developed a diffuse, blotchy, erythematous rash. Bloodwork was obtained by PCP which had revealed eosinophilia (AEC peaked 4250) without evidence of end organ damage. He underwent skin biopsy which revealed:  Superficial and mid dermal perivascular infiltrate. Additionally, there are focal interface changes where lymphocytes approximate the dermal-epidermal junction and are associated with vacuolar alteration. A few eosinophils are noted in the infiltrate but they are not numerous. Vasculitis is not seen. These histologic features are not entirely specific, but are most suggestive of a hypersensitivity reaction.  Initially treated with topical steroids. When eosinophil count was noted to be above 4,000 the patient was started on 60 mg of prednisone daily (this was on 1/26/21) and repeat CBC with differential are pending. The rash is improving and fever curve is also improving (on tylenol q8H PRN).  He was referred to hematology/oncology for consideration of bone marrow biopsy, as hypereosinophilic syndrome is also on differential diagnosis.
Chills, body aches, headache, fever, lightheadedness, fatigue.
Sore arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm at injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included Surgery (spinal). Concurrent medical conditions included Anxiety, Obsessive-compulsive disorder and Wheelchair user (semi-disabled). Concomitant products included PARACETAMOL (TYLENOL) for Pain.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore arm at injection site). At the time of the report, VACCINATION SITE PAIN (Sore arm at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications was not provided by the reporter
syncopal episode occurred after pediatric COVID vaccination. patient lying down on floor, pallor noted. chest rising  noted. no difficulty breathing.  raised his legs for some time, he open his eyes. He was nauseated but no emesis . Vital signs stable and  O2 was normal 100%.. Pt back to base line. No SOB noticed. No pallor noted. A &O x 3.  Verbally responsive and able to ambulate.
Pharmacist reporting an AE. Per caller, an adult employee received pediatric PROQUAD instead of MMRII. Caller did not have any details of administration, stating that information was not in the report he got. No additional AE. No PQC.  Caller stated; an adult employee received pediatric PROQUAD instead of MMRII.; No additional AE; This spontaneous report was received from a pharmacist and refers to an adult patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with a pediatric measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 0.5ml, administered for prophylaxis (strength, lot number, expiry date, and route of administration were not provided) instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, administered for prophylaxis (strength, dose description, lot number, expiry date, and route of administration were not provided) (wrong vaccine administered and product administered to patient of inappropriate age). No additional adverse events was reported.
feeling dizzy; unable to eat; feeling knocked out all day; dull headache; feeling so tired/not able to get out of bed; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (feeling knocked out all day), DIZZINESS (feeling dizzy), FEEDING DISORDER (unable to eat), FATIGUE (feeling so tired/not able to get out of bed) and HEADACHE (dull headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. WT012AZ1A) for COVID-19 vaccination.     The patient's past medical history was not reported .  Concomitant products included ROSUVASTATIN and TIZANIDINE for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-1900, the patient experienced FATIGUE (feeling so tired/not able to get out of bed). On 27-Feb-2021, the patient experienced ASTHENIA (feeling knocked out all day), FEEDING DISORDER (unable to eat) and HEADACHE (dull headache). On 01-Mar-2021, the patient experienced DIZZINESS (feeling dizzy). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. On 28-Feb-2021, FEEDING DISORDER (unable to eat) and FATIGUE (feeling so tired/not able to get out of bed) had resolved. At the time of the report, ASTHENIA (feeling knocked out all day), DIZZINESS (feeling dizzy) and HEADACHE (dull headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Severe and debilitating arm, shoulder and neck pain. Constant severe pain. Loss of motion. Loss of arm strenght. Could not sleep.  Severe impacts through 2nd week of January, slowly mitigating. At this time, I still only have less than 50% usage of left arm.
Not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 20Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: Dec2020 (unspecified if ongoing); "Headache", start date: Dec2020 (unspecified if ongoing); "Loss of appetite", start date: Dec2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "Not feeling well".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
VIAL INITIALLY PUNCTURED AND HAD BEEN MAINTAINED IN THE REFRIGERATOR FROM THE TIME OF INITIAL PUNCTURE; This spontaneous report received from a pharmacist concerned a 41 year old male. 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: 1816022, expiry: 15-AUG-2021) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUL-2021, the subject experienced vial initially punctured and had been maintained in the refrigerator from the time of initial puncture. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vial initially punctured and had been maintained in the refrigerator from the time of initial puncture was not reported. This report was non-serious. This case, from the same reporter is linked to 20210703146.
pt recv vax & the evening of vax was wound up, had a sl h/a & was irritable & exp a sleepiness noc; No further details were provided;
Pt experienced a fever of 100 & nausea on 13JUN90 3days post vax; 16JUN lump under the lt arm; rt arm (inject site) was swollen, red & pain extending to fingers; Tx Augmentin 500MG TID & Atarax;
Patient seemed very nervous before vaccine.  Within 5 mins of receiving vaccine, she began behaving a little dizzy.  Patient fainted and was placed in a chair.  She recovered within 30 seconds, but continued complaining that "she just wanted to go to sleep."  Patient was given 3 small cups of water and parents were consulted about us calling 911.  They preferred to take her to an urgent care if she did not recover.  Mother reported patient never have having a problem with a vaccine before.
Systemic: dry mouth-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: pt waited the required 15 minutes after receiving 2nd dose of vaccine. returned to pharmacy after 45 minutes later complaining of numbness and tingling in arm and face and dry mouth. pt did not complain of breathing difficulty or other signs of allergic reaction. told pt to go urgent care or emergency room and told her to follow up with us after.
1658 Patient reports feeling lightheaded after receiving COVID vaccine.  VS obtained, BP & HR are elevated.   1700 PA called 1702 PA arrived Patient remains lightheaded with some palpitations but denies any trouble breathing. 1711 VS are improving 1716 Patient states she starts feeling better but then gets a new wave of lightheadedness with "fogginess".  Monitoring continued. 1741 Patient starting to feel "extra lightheaded" 1742 Benadryl given per PA 1748 Patient verbalized a headache 1818 Medic called because BP & HR have not improved after 1 hour of monitoring. 1825 Medic team transported patient to the ER
ON NOVEMBER 5 2021 I WAS ADMITTED INTO MEDICAL CENTER FOR APPENDICITIS THAT REQUIRED AN APENDECTOMY. DURING THE V SAFE CHECK IN IT ASKED IF I'VE BEEN HOSPITALIZED OR UNABLE TO WORK AT ANY TIME AFTER THE VACCINATION (BY NOVEMBER 5TH I HAD 2 DOSES) AND TECHNICALLY YES.
Covid arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007b21a and 0001a21a) for COVID-19 vaccination.     Concomitant products included TRAZODONE for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-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 VACCINATION SITE REACTION (Covid arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. In April 2021, VACCINATION SITE REACTION (Covid arm) had resolved.            Height of the patient was mentioned as 411 and 3/4.  It was reported that the patient experienced Covid arm eight days after the first and second dose and it lasted for two weeks.   This case was linked to MOD-2022-477285, MOD-2022-477308 (Patient Link).
COVID Pfizer bivalent 6 mo-4 y/o immunization given instead of COVID Pfizer primary 6mo-4 y/o for 2nd dose of series
Severe brain fog to the point of forgetting simple things like what day it was, how to turn on a computer or walking into a room and forgetting what I went into the room, plus very hard to concentrate. It hit late Wednesday and lasted through Sunday of that week.
16-year-old patient erroneously received expired dose of Menactra vaccine with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a physician via global medical information (GMI) (Reference number- 00493927) and transmitted to Sanofi on 25-Feb-2021.  This case involved a 16 year old female patient who erroneously received expired 0.5 mL dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] [second dose, lot number: U6486AD, expiry date: 10-Jan-2021] via an intramuscular route at the left deltoid for prophylactic vaccination on 25-Feb-2021 (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE B (MENB).  It was a case of actual medication error due to expired vaccine use. It was reported that after the vaccination it was discovered that the MENACTRA had expired hence reporter would like to know how to move forward in caring for the patient.  At the time of report, no adverse event was reported.  This suspected adverse reaction report was submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error was in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party had contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report was received from a pharmacist referring to a male patient of unknown age. The patient's concurrent conditions and medical history included diabetes mellitus and drug reaction/allergy to FARXIGA. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (Lot # M027552, expiration date 04-FEB-2018) 0.5 ml, intramuscular, in the right arm. The patient received an unspecified flu vaccine in the left arm concomitantly with the PNEUMOVAX 23. The patient was also on concomitant medications but they were unknown. On an unknown date, within 24 hours after receiving the PNEUMOVAX 23 the patient experienced soreness at the injection site where the vaccine was administered, within the past 24 hours the patient developed an unspecified rash at the injection site that spread to his chest. The patient was scheduled to see his physician on 21-SEP-2016, regarding this adverse events. At the time of the report, the outcome of injection site pain, rash and injection site rash was reported as not recovered/not resolved. The reporter did not assess the causal relationship between the adverse events and the vaccination with PNEUMOVAX 23. This is one of several cases received from the same source. Additional information has been requested.
patient received her first dose at age of seventeen; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient received her first dose at age of seventeen) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient received her first dose at age of seventeen). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient received her first dose at age of seventeen) outcome was unknown. 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.   Patient filled her birthday incorrect when she received her first dose of Moderna COVID 19 Vaccine. no concomitant medications were reported. Treatment medicines were not included Action taken with mRNA-1273 in response to the event was unknown   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: NNI
Had the second vaccine shot SHINGRIX on Friday, 12/7 at 1:30pm On Saturday I was extremely lethargic and my arm was tender and sore where the shot was given. On Sunday 12/9 my left hand started a tingling sensation under my ring, I removed my ring, washed my hands really good thinking that the juice from a jalapeno pepper, not the case! The burning sensation continue through the night and covered my whole hand. To relieve the tingling I took two ALEVE and used an ice pack all night. This morning the sensation has dissipated to the palm and seems to slowly getting better.
Developed seizure disorder (trembling, shaking in upper half of body, in a "daze" during seizure).  Has had 3 seizures (12/01, 12/13, 12/28), has been taking anti-convulsants. No seizures since taking anti-convulsants.   Private provider did not think due to immunizations.  We obtained okay to give immunizations from our medical director as well as the private provider.