chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a noncontactable other HCP. A 30-year-old male patient received the 2nd dose of BNT162B2 (Comirnaty, batch/lot# EL3247), at the age of 29, on Mar 16, 2021, and received the 1st dose of BNT162B2 (Comirnaty), on Feb 23, 2021; both single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced vaccination failure (medically significant), and COVID-19/nasal swab: positive (medically significant), onset Jan 19, 2022, with outcome of unknown. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan 19, 2022) positive; notes: nasal swab. Clinical course: It is not known whether the patient experienced COVID-19 prior to vaccination; or if patient received any other vaccines within 4 weeks. Also it is not known whether the patient received any treatment for adverse event. No follow-up attempts  possible. No further information expected. Sender's comments: Based on known drug safety profile, there is a reasonable possibility of causal association between the events vaccination failure (medically significant), and COVID-19 (medically significant). The suspect drug BNT162B2.
Extensive swelling, redness and induration of the entire leg (upper) in which vaccine was given, Right leg.
headache; This spontaneous case was reported by a physician and describes the occurrence of HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Immunosuppression. Concomitant products included TACROLIMUS (PROGRAF) and MYCOPHENOLATE MOFETIL HYDROCHLORIDE (CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]) for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown. Not Provided      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.
No additional AEs; Non-supported frozen vaccine was administered on two separate occasions during temperature excursion on 8/5/22 and 8/9/22.; This spontaneous report was received from a medical assistant and refers to a 30-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 09-AUG-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5ml/once, lot #W005208 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck) (VARIVAX) expiration date reported as 14-FEB-2023, but upon internal validation established as 14-FEB-2024, for prophylaxis (anatomical location and route of administration were not provided). The vaccine underwent temperature excursion (product storage error).  No additional adverse event (AE).  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA008336
Typical injection site/muscle soreness.  Myalgias, chills, swollen lymph node in injected arm, ftigue/weakness, nasal congestion
Quadracel administered to patient inadvertently on 10/16/2018 and 08/09/2019, no AE; Initial information received on 09-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 years old female patient who was inadvertently given 0.5 ml DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C5500CA, expiry date: 16-Aug-2020 via intramuscular route in the left deltoid) on 16-Oct-2018 and on 09-Aug-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation.  It was an actual medication error due to extra dose administered.  It was unknown if any adverse event occurred.  This suspected adverse reaction report is 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 is 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 has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
I went to the dermatologistto determine what was causing my extreme itching. He ran a complete blood panel that came showing that my white blood cells were extremely low. They were so low that he called me at 11pm at night asking if I was feeling alright because my blood work showed that I should be in the hospital.
throat started to close up/felt kind of like a burning slightly going up side of her neck; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (throat started to close up/felt kind of like a burning slightly going up side of her neck) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CITALOPRAM, LEVOTHYROXINE and ESTRADIOL for an unknown indication.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced THROAT IRRITATION (throat started to close up/felt kind of like a burning slightly going up side of her neck). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Throat irritation, at an unspecified dose and frequency. On 19-Apr-2021, THROAT IRRITATION (throat started to close up/felt kind of like a burning slightly going up side of her neck) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other treatment medications included an unspecified medicine taken in emergency room and patient was released once she was able to breath easier.
Vaccine administered on 6-24-14. Fever of 101.2 was reported the next day. Full body rash was noted on 6-26-14.
Patient's left arm started swelling up, it was hot to the touch. He had a rash/infection that was going around his arm. His arm had gotten big and painful. He received the vaccines on January 21st 2020, I, his mother noticed something different January 22nd 2020. January 23rd he was taking back to the doctor, who said it was from cold compresses. On January 24th 2020 I took patient to urgent care where he received antibiotics and pain medication.
Oral thrush with plaques in the back of throat and uvula. Difficult/painful swallowing. I have been treating myself empirically with Mylanta, Rolaids, gargling salty water alternating with diluted listerine, honey, and basically a soft diet. I experienced headaches, general fatigue, and diarrhea as well, no fever, cough,not even pain or swelling at site of injection. I must said that I am feeling better, but still have soreness when swallowing, and I have lost 4 lbs. I do not know if this is a common side effect,so I decided to report it, I am on Humira due to my AS.
This case was reported by a healthcare professional and described the occurrence of the use of expired vaccine in a 13-month old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). Concurrent vaccination included varicella virus vaccine (non-GSK) (manufacturer unspecified) and PREVNAR (manufacturer unspecified) both given on 14 April 2011. There were no concurrent medications. On 14 April 2011 the subject inadvertently received an expired dose of INFANRIX in the left thigh. On an unspecified date, the same month after vaccination with INFANRIX, the subject experienced a rash on her left lower leg. The outcome of the event was not known. No additional information was provided. This event occurred in four subjects. Linked cases include A925197A, A0925203A and A0925204A. Follow-up received on 03 October 2011 from the healthcare professional: The healthcare professional also considered the varicella virus vaccine, which was administered in the same leg as INFANRIX (left thigh), to be a suspect vaccine. The event of leg rash resolved on an unspecified date. The healthcare professional considered that the event was not associated with medical history or a concurrent illness, lack of efficacy, erroneous administration, nor suspected transmission of an infectious agent via a medicinal product. The healthcare professional reported that the event may have been associated with the outdated vaccine.
On 11/21/00 the pt received vaccines and when went home soon after the baby wouldn't wake up. Was taken to the ER and diagnosed with probably febrile seizure. Mother gave Tylenol when got home for pain. On 12/20/00 received vaccines and the pt cried for hours afterwards.
Caused hard changes in my period also in both my daughters periods age 12 and 13; Caused hard changes in my period also in both my daughters periods age 12 and 13; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Jan2021 (Lot number: El9261) at the age of 38 years as dose 2, single and administered in arm left, administration date 15Jan2021 (Lot number: Ek4176) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Latex" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MENSTRUATION IRREGULAR (non-serious), MENSTRUAL DISORDER (non-serious), outcome "not recovered" and all described as "Caused hard changes in my period also in both my daughters periods age 12 and 13". Therapeutic measures were not taken as a result of menstruation irregular, menstrual disorder.  Additional information: The patient had no other vaccine in four weeks and no other medications in two weeks. The patient had no Covid prior vaccination and not tested covid post vaccination.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101110603 Same reporter/, Different patient
This is a Solicited report based on the information received by Pfizer from a contactable female consumer reported for herself.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation and risankizumab (SKYRIZI), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, 1x/day for psoriasis.  The patient medical history and the patient's concomitant medications were not reported. On unknown dates, the patient had diabetes and neuropathy, she had a lot of neck issues from previous car wrecks,  her arm sore for the first day of vaccination, she had sinus issues, eyes watery and a cough a day or two after. The outcome of the events was unknown.   The reporter's causality for the events of diabetes, pain/ neck issues from car wrecks unknown onset and neuropathy with Skyrizi(Risankizumab) was no reasonable possibility.   The reporter's assessment of the causal relationship of the events with bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events diabetes, neuropathy, Pain, Sinus disorder, Lacrimation increased, Cough, Musculoskeletal disorder, Road traffic accident and Pain in extremity  cannot be totally excluded/assessed.  The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
This is a spontaneous report obtained from a non-contactable consumer (patient). A male patient of an unspecified age and rare received PREVNAR 13 single dose, on an unknown date, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced fatigue, joint and muscle pain. Clinical outcome was unknown at time of this report. No follow-up attempts possible. No further information expected.
Flu like symptoms; Rash; Chills; Fever; Bad hives all over the body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Bad hives all over the body), INFLUENZA LIKE ILLNESS (Flu like symptoms), RASH (Rash), CHILLS (Chills) and PYREXIA (Fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced URTICARIA (Bad hives all over the body), RASH (Rash), CHILLS (Chills) and PYREXIA (Fever). On 04-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, URTICARIA (Bad hives all over the body), INFLUENZA LIKE ILLNESS (Flu like symptoms), RASH (Rash), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   Treatment  medication included antihistamines.   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: Follow up was received on 7-Apr-2021, additional event of bad hives all over body was reported, treatment information of antihistamines was reported, start date of event chills was changed from 4 Apr 2021 to 3 Apr 2021.
This spontaneous report as received from a market research agency researcher refers to a 14 years old female patient. The patient had non pertinent medical history. In 2006 the patient was vaccinated with GARDASIL (lot # not reported). Concomitant medications were reported as none. On an unknown date the patient was fainting from anxiety and had "low" pain. It was unspecified whether the patient sought for medical attention. The adverse event stopped "soon". The outcome was reported as recovered/resolved with sequelae. The reporter considered the adverse event to be non serious. Additional information has been requested.
Patient received a dose of Pfizer COVID-19Vaccine  formulation (5-11yr) that may have been reconstituted with a single use vial of 0.9%NS that was entered into multiple times to reconstitute other vials of Pfizer vaccine. Staff did not realize the 10mL vial  was for single use only (to take out 1.3mL then discard). Each time the vial was used it was swabbed with alcohol and a new syringe was used to enter the vial then to add the diluent to the Pfizer vaccine for reconstitution. The 10mL ,  0.9%NS vial was disposed of at the end of each day. The patient did not experience any adverse reaction. At the recommendation of Pfizer and the CDC, due to lack of stability data, it was advised to revaccinate the patient.
Information has been received from a health professional concerning a female patient, with lupus, who may have been vaccinated with a dose of MMR. In 2000 titers were drawn and the patient had not developed antibodies. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Fever of 102F; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 102F) and HEADACHE (Headache) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever of 102F) and HEADACHE (Headache). At the time of the report, PYREXIA (Fever of 102F) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Nov2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 62 years, in left arm 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. 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 "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient had no known allergies. Patient received treatment with paxlovid from 24Feb2023 till 01Mar2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300099645 Same patient, different product, different event;
Itchy throat (internal), weakness/dizziness 10 minutes following vaccine. I was given 50 mg of Benadryl which stopped these side effects.  Four hours later (around 3 PM) I experienced numbness in my left arm and hand. I am still experiencing this side effect.
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: Patient came to the pharmacy due to an injection site reaction. Patient just noticed the reaction today on February the 28th due to bandaid falling of while taking a shower. Patient expressed concern and was very worrisome and asked if it was normal. Injection site reaction was small, very red and had the resemblance of a rash but it looked like a minor skin infection. Advised patient to monitor and call us if it gets worse, develops other symptoms, does not go away/heal or if it starts oozing.
pt recvd vax 31JAN94 & 28FEB in AM pt had poss sz (well baby visit same day-PE nl);4MAR had sz confirmed by EEG;neurologist dx infantile spasms;rx anticonvulsants/ACTH;hosp;szs are not under control;mom has h/o grand mal szs
Patient suffered a hemorrhagic stroke (brain bleed) in the right deep brain structures with significant brain swelling and build up of cerebral spinal fluid requiring drainage. Patient's confusion and motor function have been improving and the bleeding has not worsened.
24 hrs following, swelling, itchiness and pain at site of injection increasing to giant hives on neck, trunk and arm. Considerable pain, throbbing and itching increasing until the ingesting of prednisone 20mg, (perscribed for fire ant allergy but available to me on a Sunday)improvement after 3 pills, telephoned doctor but was only allowed to speak to a nurse who said this was an unusual reaction did I want to make an appointment to see the doctor. As this is a 140 mile roundtrip by car and my arm hurt I declined and continued self medicating with prednisone and benadryl. While hives ceased within 24 hours, the pain, swelling and magenta coloring surrounding the injection site took about one week to go away. I also developed a fever sore in the corner of my mouth within 48 hours of the vaccine which took about 5 days to go away using Abreva. As of April 26th I have developed an annoying tingling in the arm where the shot was administered, it is intermittent but appears to be increasing in frequency.
2 days after getting the vaccine, I woke up with ringing in my ear/tinnitus. It's been constant since then.  I used to get mild tinnitus every now and then but they go away within seconds. It's been constant every since I woke up this morning.
patient stated that approximately 36 hours after receiving vaccine that  she broke out all over her body with hives and is experiencing extreme urticaria. she has been taking benadryl by mouth every 4 to 6 hours and has contacted her primary care provider for further treatment
Headache and shooting kidney pain two hours after injection.  By that evening, I had severe chills and shivered all night.  The next day, the kidney pain turned into a constant ache.  Headache worsened.  Severe joint pain.  Arm/injection site was horribly sore.  By 5:00PM I had a 101.2 fever.  That (Thursday/next night) evening, I felt much better.  Friday morning, I woke up feeling completely normal with only minor pain at injection site.
TDAP administered IM at 4:55 PM left deltoid.  30 minutes later c/o feeling "floaty", chest tightness and tingling in the cheeks.  Vital signs were stable.  Brought to ED dept.  Pulse O2 sat level & EKG normal also - c/o fatigue and nausea.  Felt tired.
DAMAGED FOR LIFE; This spontaneous report received from a consumer via social media via a company representative concerned a male of unspecified age, race and ethnic origin. 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, expiry date: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced damaged for life. Reporter stated that "your covid vaccine nearly killed my brother who is now damaged for life. Anything with your name on it stays on the store shelf. Murders" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of damaged for life was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20220545174-covid-19 vaccine ad26.cov2.s -Damaged for life. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.