chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 44-year-old female. Neither medical history nor concomitant medications were reported. On 09-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.
heavier, longer period - began a few days post-vaccine, lasted 2.5 weeks (until approx. April 2), and was much heavier than normal. Normal periods are 4 days and light, approximately 1x per year due to implant, which had already happened one month prior. Implant was in the same arm as the shot (non-dominant).
I did not have an adverse event with the vaccine. I tested positive for COVID-19 in 01/2023 with a severe cough and fever. I had a telehealth visit with a provider and I go a prescription for Molnupiravir. I tolerated the prescription with no limits. As of today, I feel better with no lingering symptoms.
Began running fever, began screaming. Inconsolable for 7 hours. Didn't eat for 8 hours. Has not been normal since vaccination. Constantly cries, doesn't want to eat or be held unless it's in the morning. Baby is completely different upon vaccinations.
COVID virus after COVID vaccines; COVID virus after COVID vaccines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 74-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 74 years intramuscular, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EM9810), in left arm, on 25Feb2021 as dose 2, single (Lot number: EN6198), in left arm, on 01Oct2021 as dose 3 (booster), single (Lot number: FC3184), in left arm and on 01Apr2022 as dose 4 (booster), single (Lot number: FP4554), in left arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN, stop date: 15Mar2023. No prior vaccinations (within 4 weeks). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Mar2023, outcome "unknown" and all described as "COVID virus after COVID vaccines". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Mar2023) Positive, notes: Tested positive at: 10AM. Therapeutic measures were taken as a result of vaccination failure, covid-19. Treatment included Paxlovid for Covid virus (Start of Drug: 16Mar2023, Stop: Ongoing, lot number: GF5570, Expiry Date: Apr2023) 3 tablets in morning and 3 tablets in evening. Also, Cepacol and Claritin D 12 hour for sore throat; and benzonatate from 16Mar2023 (Stop: Ongoing) for COVID and Cough (she asked her doctor for something for her cough; coughing like when she was six years old; also took Cepacol and felt much better) 200mg capsules three times a day). Clinical course: After all these vaccines, she still got the COVID virus. Just tested positive on 15Mar2023 (yesterday). While driving heard on the radio that if it had been two months since the last COVID vaccination that a person should get another vaccine. Would not give her another booster, after her last booster on 09Sep2022, because they had not received any specific guidance. Instructed by her doctor to stop taking atorvastatin (due to potential interaction with Paxlovid, stopping for 10 days). Clarified she did not take both Paxlovid and Atorvastatin together; took last dose of Atorvastatin 15Mar2023 (last night) and started Paxlovid 16Mar2023 (today). Tested positive at 10AM. Symptoms started on 14Mar2023 (a day before 14Mar2023), took Cepacol and Claritin D 12 hour for sore throat, and until she could call her physician, confirmed as over the counter. Adverse event required no emergency room no, and no physician office; spoke to her doctor.
Afebrile. Pt. received DTaP, PCV7, and Hepatitis A at health center on 8/13/08. That nght (L) anterior thigh erythema -> increase in size yesterday, increased today with warmth, redness-Dx with cellulitis (L) thigh 8/15/08
first dose on 1/8/2020, second dose on 8/26/2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 8th January 2020).   On 26th August 2021, the patient received the 2nd dose of Shingrix. On 26th August 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that, an unknown patient received shingrix vaccine doses later than the recommended interval, which led to lengthening of vaccination schedule. The reporter dd not consent to follow-up. The reporter did not want to provide any of the patient information.
Skin burning sensation started in arms at 2 weeks; electric shocks in left foot; cold lower legs; sweating on torso; tinnitus and numbness of ear all of which lessened over 24 hrs but continued for two weeks; tinnitus and numbness of ear all of which lessened over 24 hrs but continued for two weeks/numbness in left leg; buzzing in hands; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Aug2021 18:00 (Lot number: FC3180) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Scoliosis" (unspecified if ongoing); "Occasional hives" (unspecified if ongoing); "Premature atrial contraction" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYZINE HCL; CLARITIN ALLERGIC. Past drug history included: Toradol, reaction(s): "known allergies". The following information was reported: ELECTRIC SHOCK SENSATION (non-serious) with onset 24Aug2021 18:45, outcome "not recovered", described as "electric shocks in left foot"; PERIPHERAL COLDNESS (non-serious) with onset 24Aug2021 18:45, outcome "not recovered", described as "cold lower legs"; HYPERHIDROSIS (non-serious) with onset 24Aug2021 18:45, outcome "not recovered", described as "sweating on torso"; TINNITUS (non-serious) with onset 24Aug2021 18:45, outcome "not recovered", described as "tinnitus and numbness of ear all of which lessened over 24 hrs but continued for two weeks"; HYPOAESTHESIA (non-serious) with onset 24Aug2021 18:45, outcome "not recovered", described as "tinnitus and numbness of ear all of which lessened over 24 hrs but continued for two weeks/numbness in left leg"; PARAESTHESIA (non-serious) with onset 24Aug2021 18:45, outcome "not recovered", described as "buzzing in hands"; SKIN BURNING SENSATION (non-serious) with onset Sep2021, outcome "not recovered", described as "Skin burning sensation started in arms at 2 weeks". The events "electric shocks in left foot", "cold lower legs", "sweating on torso", "tinnitus and numbness of ear all of which lessened over 24 hrs but continued for two weeks", "tinnitus and numbness of ear all of which lessened over 24 hrs but continued for two weeks/numbness in left leg", "buzzing in hands" and "skin burning sensation started in arms at 2 weeks" were evaluated at the physician office visit. Therapeutic measures were taken as a result of hypoaesthesia.  Additional information: Patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination patient was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 77 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: Unknown, Manufacturer: Unknown), for Covid-19 immunization. The following information was reported: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "cancer"; SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown", described as "Inactive lupus"; INFLAMMATION (non-serious), outcome "not recovered", described as "inflammation in the body"; LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "the size of the lymph nodes was related to the vaccine/enlargement and inflammation of the lymph glands"; LYMPHADENITIS (non-serious), outcome "not recovered", described as "inflammation of the lymph glands". It was reported that she has had some reactions in relation to the fact that she had some inflammation in the body, enough to go to rheumatologist who said she has lupus and that's when the information on the papers stopped. Caller states since that time, the rheumatologist said she has inactive lupus. Caller states the size of the lymph nodes was related to the vaccine, but probably not the cancer. Caller states her oncologist said it was unusual problem but recommended her to contact Pfizer. Caller was asking have you had other people with activated lupus after receiving the Pfizer Covid-19 vaccine. The patient underwent the following laboratory tests and procedures: biopsy: cancer, notes: Caller states she spoke with an oncologist regarding the enlargement and inflammation of the lymph glands that happened after the booster that have not gone away, therefore they did a biopsy and as a result found cancer. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Follow-up (07Apr2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
07/29/2021 immediately after receiving the vaccination began feeling a pain in from Hip to ankle like and aching pain like a tooth ache. Pain was from the outside of the leg and he tried to massage to lesson the pain.  Walked around help lessen and lossen the pain. Heated seats. Though it was satticia but it felt different, and it usually knee would give out on left side and he would feel sharp pain like a ice pick to back, to shoulder blade to the lung and take his breath away , at same time knee would give out.  Not as frequent since off work, but schedule to go back after surgery.
10/22/08 Pruritis & pain at injection site.  Welts, Benadryl given po X 2. 10/28/08.  Awakened with swollen cheeks, right cheek red, given Benadryl Q4-6H.  Groggy 10/24/08, decreased swelling, nausea soreness, redness at injection site faded.  Resolved 10/24/08.
Seizure at home Friday, 11/3/00. Did have low-grade fever per grandmother in the afternoon of 11/2/00, which resolved. No URI/GI symptoms. Went to ED and PICU. Did have left OM and was given amoxicillin. At time of incident, had nml po, energy, eliminations and sleepy. Lives with guardian, parents unavailable. Follow-up information received states pt diagnosed with OM while in hospital and started on amoxicillin in hospital.
Information has been received from a nurse concerning female patients who was vaccinated with a dose of Gardasil. Subsequently the patients fainted. Subsequently, the patients recovered. Additional information has been requested.
Sore Arm; This case was reported by a consumer and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th January 2021, the patient received the 1st dose of Shingrix (intramuscular). On 17th January 2021, several hours after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information are as follows: The patient reported for herself. The patient received dose of shingrix  and experienced after few hours as she began to experience a sore arm. The reporter did not had  lot number or expiration date. The patient was still experiencing some soreness in her arm (unresolved). The reporter did not consented to follow up. No further information was available
Initial information and additional information received on 16-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer (Office manager) via phone. This case involves a 61 year old male patient who received a 0.5 ml dose of FLUZONE HIGH DOSE, [Suspension for injection in pre-filled syringe] (Batch number: UJ024AC, site of administration: left deltoid, expiration date and route was not reported) on 28-Sep-2018. The patient's past medical history, medical treatments, vaccinations and family history were not provided. Patient did not receive concomitant vaccination. It is an actual medication case error due to inappropriate age at vaccine administration. A 61 year old male received a FLUZONE HD. The patient had no adverse reactions. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Congestion, Cough, and runny nose lasting up until now.  Patient awaiting COVID-19 test results.
TIREDNESS; MUSCLE PAIN; 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. Per procedure no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced tiredness, and muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tiredness and muscle pain was not reported. This report was non-serious.
headache; fever; soreness; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (soreness), HEADACHE (headache) and PYREXIA (fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Blood pressure high and High cholesterol.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced ARTHRALGIA (soreness). On 20-Jan-2021, the patient experienced HEADACHE (headache) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) for Adverse event, at an unspecified dose and frequency. On 21-Jan-2021, ARTHRALGIA (soreness), HEADACHE (headache) and PYREXIA (fever) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included blood thinner medication, medication for diabetes, high blood pressure and high cholesterol medication.
Severe extremity joint pain since second Pfizer COVID vaccine dose 1/15/2021
Very sore lump at site, chills, fever 101,  slight body aches, extreme exhaustion. Fully recovered within less than 48 hrs. 5 days after injection began a difficult menstrual cycle 8 days early (never early in my life.) Feel as though the vaccine severely disrupted my hormones.
This is a spontaneous report from a contactable Nurse via Pfizer sales representative. This Nurse reported similar events for 3 patients. This report is for 2nd of 3 patients. An elderly female patient of an unspecified ethnicity received PREVNAR 13 (Lot# R33240, expiring date Mar2018, NDC # 0005197101) via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, 1-2 days post injection, the patient experienced redness at injection site/large area of redness at site, itching to the site, heat to the site, swelling. The outcome was unknown. Staff found this very unusual and concerning and pulled the lot from their stock. The nurse considered there was a reasonable possibility that the events were related to the suspect product. There was a product complaint to report filed. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017063635 same reporter/drug/event, different patient; US-PFIZER INC-2017063627 same reporter/drug, similar events/patient.
Narrative: 78yo male died on 6/11/2021. No information about pt's health or death provided. Pt did receive covid vaccine from facility on 1/21/21 & 2/19/21. No able to determine if vaccinations were related to death given lack of information; given 4 months apart, not likely vaccines were related to pt's death.
COVID test, which yielded a positive result (03Aug2021 10AM); COVID test, which yielded a positive result (03Aug2021 10AM); Fainted; Unresponsive for 20 minutes; Hit his head while falling; Hit his head/ received 7 staples in head; This is a spontaneous report from a contactable consumer.A 71-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was unknown), via intramuscular on 13Mar2021 (at the age of 71-year-old) as dose 2, single for covid-19 immunization.Medical history included heart bypass (5 years ago), prostate removed (2-3 years ago), lower lumbar surgery (10 years ago) and cholesterol.Concomitant medications within 2 weeks of vaccination included acetylsalicylic acid (BABY ASPIRIN) QD, blood thinner QD taken for an unspecified indication and cholesterol medication QD taken for cholesterol. There was no known allergies.The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was unknown), via intramuscular on 20Feb2021 (at the age of 71-year-old) as dose 1, single for covid-19 immunization.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient diagnosed with COVID-19 and since the vaccination, had the patient been tested for COVID-19 was mentioned as no.It was reported that the patient attended a conference from 26Jul2021 to 30Jul2021 and returned home on 30Jul2021 where he presented with fever and dizziness. Fever self-reported at 101 degrees, symptoms persisted through 02Aug2021. On the morning of 02Aug2021, while preparing coffee at home he fainted and hit his head while falling resulting in being unresponsive for 20 minutes. Ambulance called and withheld taken to hospital. Woke up on his own after 20 min. Received 7 staples in head and hospital performed EKG, BP, chest X-ray, CAT scan, bloodwork and urinalysis. All tests were clean except for the COVID test, which yielded a positive result (03Aug2021, 10AM). Sample sent for variant confirmation. The patient was placed on fluids, antibiotics, steroids and was quarantined at the hospital. Also stated between 6 and 9 other conference attendees tested positive for COVID. As of 04Aug2021 (10AM), withheld reports fever has broken, no longer dizzy, feels better. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization. The patient was hospitalized for 3 days. The patient received treatment with regard to events. On 02Aug2021, patient recovered from loss of consciousness whereas patient was recovering  from events syncope, fall, head injury and covid-19.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were Reported. No Treatments were Reported.
Erythema, swelling over right leg, papular urticaria over entire body.  Atarax given for itching.
This spontaneous report as received from a pharmacist refers to a 73 year old female patient. The patient's historical drug included PREVNAR 13 administered in approximately November 2015 (reported as "about a year ago") with no reaction. The patient was pretty active, healthy and tough. The patient's concomitant medications, drug reactions, allergies and pertinent medical history was not reported. On 14-NOV-2016, the patient was vaccinated intramuscularly with a dose of PNEUMOVAX 23 in arm, lot # M032635 and expiry date: 05-MAY-2018. On the same day, in the same arm as the PNEUMOVAX 23, the patient received a dose of unspecified high-dose influenza vaccine. Later, on the same day, the patient began to experience excessive chills and tremors, and when she went to bed that night was up every two hours urinating and experienced severe nightmares what really laid her out for about two days. On an unknown date in November 2016, the patient also experienced soreness in the injection arm and a severe allergic response in her arm, which involved swelling, redness, warmth to the touch on the top of her arm, and it "looked like there were worms in the top of her arm." The patient returned to the pharmacy on 16-NOV-2016, and stated that she was experiencing less soreness in her arm and the swelling had gone down, but it was now also swollen underneath her arm. The only treatment that was given was BENADRYL on 15-NOV-2016 (reported as "last night"). No lab diagnostic studies were performed. On 16-NOV-2016, the patient recovered from the event of laying out. The outcome of the other events was reported as recovering. The relatedness between the events and PNEUMOVAX 23 was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Extreme Dizzyness, vertigo feeling, fainting, migraines. Lasted for over a week.