chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Woke up in the morning with rash on parts of my body, included redness and swelling.  I went to an urgent care nearby but was told it was likely due to something I came in contact with since it only covered parts of my body, not vaccine related since it was roughly four days earlier.  I was advised by the PA/Dr. nothing can be given orally for this since I had the recent covid vaccine, only an ointment will be provided.   I went home and applied the ointment.  Less than 24 hours later the rash began spreading over my entire body.  Palms, bottom of my feet, my entire body.  My whole body was very red and swollen and extremely itchy.  I never had difficulty breathing or anything i felt was life threatening.  I did not return to the urgent care or seek additional medical assistance.  Approximately four days    later the pain, discomfort, rash and sleepless nights was over.
Had the booster flu shot 9/6/12. Next day couldn't move legs and arms were very heavy. Went back to bed and slept 24 hrs. Got up and felt lightheaded and started vomiting. Next day started feeling better. Have flu shots many years and never felt sick.
The day after the injection I started to experience symptoms of pleurisy. I am familiar with these symptoms as I had pleurisy in my youth. There was some difficulty breathing and chest pain. The chest pain continues to this day.
Trembling and teeth chattering like she had the chills. She reported not feeling cold, but couldn't stop trembling for approximately 10 minutes. Kept wrapped in a blanket to keep warm and eventually the shakes stopped. The trembling happened again about 30 minutes after the first episode, for approximately 5-10 minutes again after going back to bed. They stopped and did not reoccur. No other side effects noted other than a typical sore arm after a vaccine, along with a very small bruise around the injection site. The bruise is still present.
Pt. states that after receiving the 1st dose of Moderna 02/24/2021, started experiencing symptoms 03/15/2021 of extreme pain in the right leg. Urgent Care visit 03/15/2021 with Recommendation Emergency Room visit, diagnosed with a DBT in the right leg.
hives on hand that spread to rest of body; itching; The rash spread to the rest of her body; This spontaneous case was reported by a physician and describes the occurrence of URTICARIA (hives on hand that spread to rest of body), PRURITUS (itching) and RASH (The rash spread to the rest of her body) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced URTICARIA (hives on hand that spread to rest of body), PRURITUS (itching) and RASH (The rash spread to the rest of her body). On 19-Mar-2021, URTICARIA (hives on hand that spread to rest of body) had resolved. At the time of the report, PRURITUS (itching) outcome was unknown and RASH (The rash spread to the rest of her body) had resolved. 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 relevant concomitant medications were reported. No treatment information was provided.
Information has been received from a lawyer regarding a case in litigation concerning a male of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2013, the patient was administered the ZOSTAVAX by a health care provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a health care provider for the following injury resulting from his use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to himself, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Headache for ~48 hours (ibuprofen taken without relief) Sleeplessness  Fatigue
Within the first day of shot left arm was red, warm to touch, itchy. (First dose of Moderna received on 01-29-21 had a smaller reaction after 7 days)
Pain, erythema & swelling of left arm surrounding location of the pneumococcal vaccine. This resolved with local steroid cream and antihistamine.
A report was received from a health professional via medical representative concerning a 4 year old male patient. Medical history and concomitant medications were not reported. On 08-Oct-2013, patient received FLUMIST, (intranasal). On 18-Nov-2013, patient got the flu. On 20-Nov-2013, patient received TAMIFLU. At the time of reporting, the event was improving. The reporting health professional assessed the event to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune 25-Nov-2013 from health professional: patient's DOB, initials, start date, lot number for FLUMIST, event onset date and outcome were added.
This spontaneous report was received from a consumer refers to herself as a female patient of unknown age. The patient reported that on 18-APR-2013, she received the first dose of GARDASIL (dose, route and frequency were not reported). On 01-JUL-2013, the patient was vaccinated with a second dose of GARDASIL (dose, route and frequency were not reported). The patient stated that she had not received the third dose of GARDASIL yet because she thought that she was supposed to receive the third dose of GARDASIL six months after her second dose. No adverse effect reported. No further information was provided. Additional information has been requested.
Moderate to severe headache for 5 days.  Consulted PCP on 6th day.   Ibuprofen in beginning, then PCP indicated to switch to Tylenol (which I did)
pt started out staying in rehab facility for right hip fx, THA; had a positive COVID test on 9/8/21; DNR; pt's condition worsened and she was too weak for rehab; transferred to their hospice where she passed away; per death certificate, contributing factor to cause of death was COVID 19
Magnets are sticking to her arm/ started to get a little panicked when the magnet stuck to her arm; Magnets are sticking to her arm/ started to get a little panicked when the magnet stuck to her arm; This is a spontaneous report from a contactable consumer (Patient). A 42-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Right on 17May2021 (at the age of 42-year-old) as 2ND DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Family medical history relevant to AE and relevant tests was none. The patient did not emergency room and physician Office. The patient previously took first dose of BNT162B2 administered in Arm Right for COVID-19 immunization on 20Apr2021 and experienced headache. The patient experienced Magnets are sticking to her arm/ started to get a little panicked when the magnet stuck to her arm on 17May2021. It was reported that patient was received the second dose of the vaccine on 17May2021, and she reported that she experiences magnets are sticking to her arm on 17May2021, she also mentioned that a coworker has been experiencing the same thing. It was reported that the caller verified the information provided by the transferring agent. She would not believe it and saw videos of it online and tried it after she got it. She said that it physically happened to her and she said that she can feel the magnet pulling on her arm. She was concerned about something being in there that does not belong. She can feel the pull of the magnet. It was reported that She started to get a little panicked when the magnet stuck to her arm and it kept happening. It was reported by the caller it held a fairly heavy magnet. The seriousness of the events was reported as non-serious. The outcome for events was not recovered.  Information about batch/lot number has been requested.
Low grade fever, chills, sweats, headache, body ache, general malaise. Onset 2 hours and lasted 28 hours
1 day p/vax pt devel erythema multiforme resulting in dehydration & hosp;
Shortly after receiving the vaccine client had soreness, redness, and swelling on left arm near site of injection. Client instructed to see primary care physician if symptoms worsened or did not improve.
3 hours after receiving flu vaccine shot, noticed feeling itching and red bumps on bilateral hands. The next day bumps were more prominent and red, spreading to front of the hands. Applied OTC cortisone cream Saturday night, which alleviated and erythema on both hands. No SOB, or difficulty breathing. Had just completed Talicia 48 hours prior to receiving Flucelvax vaccine.
tested positive for Covid 19 on 1/17/2021 - fever, chills, slight cold - no problems after 5 days, returned to work after 10 days quarantine with no symptoms.  Hospital decline to give me second dose on 2/3/2021 as scheduled, stating I would have to start over in 90 days.
Rash all over body, body aches, teeth hurting  Right leg numbness tingling swelling  pain  From day one
This spontaneous report was received from a nurse via a company representative and refers to a patient of unknown age and gender. Medical history and concomitant medications were not provided.  On an unspecified date, the patient was given and expired GARDASIL injection (lot # and expiration date not provided). The outcome was unknown. Additional information is not expected as there was no contact information.
pt recvd vax & exp paresthesia of the face; No further details were provided;
This spontaneous information was received from a physician regarding 22 patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. This report refers to a patient who on 04-AUG-2014 was vaccinated with PROQUAD (Merck) lot # J015595, expiration date 05-JUN-2015, that were exposed to highest temperature of 5 Celsius degree for 5 months (also reported as exposed to refrigerator temperatures not greater than 46F), (strength, dose and dose schedule were not reported). No concomitant therapies were reported. No adverse effects reported. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Pt recv vax on 4/13/99; on 4/15/99 pt exp area of circular erythema on lt arm w/ swelling, warmth &induration, + around punctate, no discharge;
Received first dose of Moderna and second dose was Pfizer; A spontaneous report was received from a consumer who is a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and received first dose of Moderna and second dose was Pfizer/wrong product administered   The patient's medical history was not provided. No concomitant medications were reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient reported her first dose of the vaccine was from Moderna and her second dose was from Pfizer.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the event, received first dose of Moderna and second dose was Pfizer/wrong product administered, was considered resolved.; Reporter's Comments: This report refers to a case of wrong product administered with second dose with Pfizer vaccine and with no associated AEs reported.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Patient reported tongue swelling, whole body rash, heartburn, difficulty breathing, and a shingles-like rash all over the body
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID- 19 INFECTION; This spontaneous report received from a patient via other manufacturer Pfizer concerned a 65 year old female. Initial information was processed along with additional information received on 19-JUL-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: chronic kidney disease, hypothyroidism, high blood pressure, and drug allergy, and other pre-existing medical conditions included: The patient was not pregnant at the time of the report.  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered on 10-MAR-2021 in left arm for covid-19 prophylaxis. Age at time of vaccination 64 years old. The batch number was not reported and has been requested. Concomitant medications included levothyroxine, lisinopril and simvastatin.  On 18-JUN-2022, the patient was exposed to COVID which lead to confirmed clinical vaccination failure (dose number in series 1). The patient received additional two doses of Non-company suspect vaccine Moderna (elasomeran) (Dose number in series 2) (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered on 27-OCT-2021 in left arm (dose 2), and dose was not reported, administered on 23-APR-2022 (dose 3) in left arm for covid-19 prophylaxis.  On 18-JUN-2022, the patient experienced confirmed clinical vaccination failure (Dose number in series 2). On 22-JUN-2022, Laboratory data included: COVID-19 virus test Positive and received non company suspect paxlovid (form of administration and route of administration were not reported and batch number: unknown, expiry: unknown) dose was not reported, administered from 22-JUN-2022 to 27-JUN-2022 for covid-19 treatment. On 27-JUN-2022, 29-JUN-2022 and on 01-JUL-2022 patient tested negative. On 02-JUL-2022, at 11 hours, evening the patient experienced cold symptoms. On 03-JUL-2022, the patient tested positive. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable paxlovid was discontinued. The patient was recovering from confirmed covid- 19 infection, and the outcome of confirmed clinical vaccination failure was not reported.  This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000242796.; Sender's Comments: V0:20220731131-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
10 days after Moderna booster, I developed widespread hives over my head, neck and torso. The hives and hyper-reactivity of my skin have persisted now through at least 19 days after my booster (today, 11/24) despite a Prednisone taper and daily Zyrtec.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 03-SEP-2013 at 07:30, ZOSTAVAX lot # J003360 was exposed to an exact T not recorded but noted as equal to or >12C for an estimated total time out of range of 72.0 hours. On 10-SEP-2013 at 17:30, ZOSTAVAX lot # J003360 was exposed to -13C for an estimated total time out of range of 10 hours. On 16-SEP-2013 at 17:30. ZOSTAVAX lot # J003360 was exposed to -14C for an estimated total time out of range of 10 hours. On 25-SEP-2013 at 07:30, ZOSTAVAX lot # J003360 was exposed to 11C for an estimated total time out of range of 14 hours. On 07-OCT-2013 at 07:30, ZOSTAVAX lot # J003360 was exposed to an exact T not recorded but noted as equal to or <12C for an estimated total time out of range of 42.5 hours. On 10-OCT-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J003360, Exp. Date: 21-JUN-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Initial information received on 02-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 12 years old female patient who did not receive the full dose of menactra and needle broke off, while she received vaccine MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 02-Aug-2018, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5984AC via intramuscular route in left arm. It was a case of actual medication error due to vaccine underdose and syringe issue. (Other relevant tests included No lab data.) Final diagnosis was needle broke off and did not receive the full dose of MENACTRA. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Applicable for did not receive the full dose of menactra and as Not Applicable for needle broke off. 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.
ear infection 12SEP95; head cold treated by MD on Amoxicillin & Codimal
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Apr-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. 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.   Age of patient was reported as 55.87for dose administered on 27-APR-2021. No concomitant medications were reported.  Batch number 007C21A underwent temperature excursion on 27-APR-2021 with temperature 42 degrees Fahrenheit from 12:00 PM to 01:00 PM. This vial was moved to fridge on 19-APR-2021 and beyond use date for the vial was reported as 19-MAY-2021. Product moved to clinic on 27-APR-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
R arm swollen reported from mom possibly started yesterday didn't notice until this AM. In clini shoulder to elbow redness and warmth noted. One inch swelling all around. Uses arm. Denies pain or itching. Referred to take Motrin as needed and prescribed 7 1/4" bicep R compared 6 3/4".
No adverse effect reported.; some of the vaccine "sprayed back out" of the injection site and onto the patient's forearm, resulting in a partial dose of M-M-R II and topical exposure/he feels that she pulled the needle out too soon and got some on the dad; Information has been received from a medical assistant referring to a 22 month old male patient. Concomitant therapies included hepatitis a virus vaccine (unspecified) and pneumococcal conj vaccine (unspecified). The patient had no illness at the time of the vaccination and had no pre-existing physician-diagnosed allergies, birth defects or medical conditions. The patient had no adverse event following a prior vaccination.  On 06-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # R028002, expiration date was 01-OCT-2020, subcutaneous in the left thigh (LT); strength and dose were not reported) for prophylaxis. Other suspect therapies included sterile diluent (Merck manufactured) (lot # was reported as R032351, expiration date was 02-JUN-2021, subcutaneous in the left thigh; strength, dose and indication were not reported).  On the same day, the medical assistant reported that during administration of a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), some of the vaccine "sprayed back out" of the injection site and onto the patient's forearm, resulting in a partial dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and topical exposure (Accidental exposure to product). No adverse effect was reported. There has no temperature excursion occur as a result of a reading from a Digital Data Logger. The reporter reported according to the patient's dad, while the medical assistant was giving the shot he feels that she pulled the needle out too soon and got some on the dad. The doctor spoke with the dad and felt that he received enough of the medication and told him it was up to the parents if they want to revaccinate the child or wait. At the reporting time they were waiting.
Swelling, redness, and warmth at injection site. MOD= 5cm. Tx'd with ice pack.
?Pfizer-BioNTech COVID-19 Vaccine ?  Patient hospitalized after fall with UTI, hyponatremia, and C7 cervical fracture several months after receiving vaccine.