chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I am 28 weeks pregnant and received the Covid-19 vaccine yesterday; NICU for Tachycardia; This is a spontaneous report from a contactable consumer (patient). This consumer or other non hcp reported information for both mother and foetus/baby.   A 38-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9269), via an unspecified route of administration on 17Feb2021 as single dose and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6200), via an unspecified route of administration on 11Mar2021 as single dose for covid-19 immunization. Medical history included gestational diabetes, hypertension, self-carrier for cerebral palsy all from an unknown date and unknown if ongoing. Concomitant medication included metformin (METFORMIN) taken for gestational diabetes, start and stop date were not reported, loratadine (CLARITINE), bupropion hydrochloride (WELLBUTRIN), escitalopram oxalate (EXIPRO), omeprazole (OMEPRAZOLE), paracetamol (TYLENOL) all taken for an unspecified indication, start and stop date were not reported. It was reported that the patient is 28 weeks pregnant and received the covid-19 vaccine. The baby was delivered full-term. The baby weighed 3174.5grams. Full time live birth. Date of outcome of pregnancy: 23Apr2021 Gestation age at birth in weeks: 37 weeks Tachycardia treated for 3 days in NICU Infant Details: Gender: Male Length at birth: 18 in Head circumference at birth: Unknown. Upon follow-up received on 25Jun2021 included First Day of last menstrual period was 07Aug2020. Estimated date of conception was 24Aug2020-28Aug2020. Estimated delivery date was 14May2021. Gestational period at the time of initial exposure: 27 weeks 6 days 31 weeks. Mother did not smoke, drink alcohol, use illicit drugs during this pregnancy. Previous pregnancies was reported as 2 and other children was 1. Outcome of previous pregnancies was reported as 1(Elective termination), 2 (Live birth C- section), no any problems during deliver. Yes problems before delivery (Gestational Diabetes/ Hypertension. Delivery by C-section at 37 weeks). The outcome for the events was unknown.   Follow-up (25Jun2021): New information received from a contactable consumer. This consumer (patient) reported in response to EDP letter sent via follow-up letter which included that: concomitant medications added, relevant medical history added, pregnancy details added, baby details added. First dose and second dose details added.   Follow-up attempts are completed. No further information is expected.  Follow-up (05Jul2021): Follow-up attempts completed. No further information expected.
pt devel an inj site rxn p/vax;this is 1 of 4 pt from this facility to exp this rxn;
Fever, /headache, Chills, Sore, itchy  Arm, body aches, Tired
breaking hip; Consumer put pressure on the leg and it collapsed; right leg feel asleep; Patient missed his second dose because he had to get a surgery; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HIP FRACTURE (breaking hip) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic and Overweight.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HIP FRACTURE (breaking hip) (seriousness criteria hospitalization and medically significant), FALL (Consumer put pressure on the leg and it collapsed), HYPOAESTHESIA (right leg feel asleep) and PRODUCT DOSE OMISSION ISSUE (Patient missed his second dose because he had to get a surgery). The patient was treated with Surgery for Hip fracture. At the time of the report, HIP FRACTURE (breaking hip) had not resolved, FALL (Consumer put pressure on the leg and it collapsed) and PRODUCT DOSE OMISSION ISSUE (Patient missed his second dose because he had to get a surgery) had resolved and HYPOAESTHESIA (right leg feel asleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment reported was surgery for breaking his hip. No concomitant medication information was provided.  Caregiver states the fall was not related to vaccine. Caregiver did not provided information whether consumer was hospitalized and what kind of care he got afterwards. He did not have much information since he was calling with a medical inquiry.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Severe Pain in hand, wrist, thumb, and fingers for 4 months, moderate pain until now.
Fussiness x 2 nights after vaccine given. Inappropriate dose given, 0.5 ml instead of 0.25 ml
Tinnitus began within a week of first Pfizer injection.  Seemed a bit better,  comes and  gets a bit better, never leaves  after 2nd injection, both ears affected...
COVID-19 mRNA LNP-S, bivalent PF 6mos-5yrs (Moderna), 10 mcg/0.2 mL - Wrong dose received. (underdosed)
Patient reported sore arm below elbow to pharmacy on 09/23/16.  Advised to try cold packs and anti-inflammatories. Patient had a follow-up appointment with primary care provider on 09/29/16.  Arm was still red and tender.  Provider scheduled ultrasound for am of 10/03/2016.  Ultrasound revealed multiple blod clots in left arm.  Patient was prescribed warfarin.
arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is sore) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm is sore). At the time of the report, PAIN IN EXTREMITY (arm is sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment medication included Motrin.
Initial Report Received: 27-Feb-2019. Non-significant Follow-up Report Received on 06-Mar-2019 included duplicative data that was already received for this report. A nurse reported that patient, a 52-year-old male patient (race not provided) was administered with HEPLISAV-B for hepatitis B immunization that was reported to be stored at the wrong temperature. Relevant medical history and concomitant medications were reported as unknown. Allergies were reported as unknown. On an unknown date, the patient received the first injection of HEPLISAV-B (lot #1036463, expiration date 28-Jul-2019, NDC #43528-002-05) by a physician. On 27-Feb-2019, a nurse reported that she received a call from a customer service representative at the distributor on this day. The nurse was instructed to remove all vaccines that were received because they were stored at the wrong temperature on distributor's end. The nurse was instructed to return it to the distributor and contact Dynavax. The nurse reported that six patients received HEPLISAV-B from the same lot number. The nurse also reported that all six patients were contacted on this day. No adverse events were reported. The reporter did not provide a seriousness assessment for the event. Company comment: The company assessed the event of product storage error as non-serious. The event of product storage error is unlisted per HEPLISAV-B USPI. Sender's Comments: The company assessed the event of product storage error as non-serious. The event of product storage error is unlisted per HEPLISAV-B USPI.
54-year-old female received the vaccine on 8/27/21. 3 days later she began experiencing tingling and muscle twitching in her arms and hands. One week post-jab, muscles in her legs also began to periodically spasm. Beginning 8/28/21, she reports developing chest congestion and coughing which resolved after 3 weeks but returned 9/27/21 along with pain, numbness and fatigue in her legs, especially after exercise. The cough improved again after about a week but the leg symptoms have not. She was an avid walker but hasn?t been able to manage even short walks now without significant discomfort. 10/15/21 she awoke in the night with a racing heart and arrhythmia. She suspected this was due to dehydration and taking too much magnesium in attempt to alleviate her other symptoms but it has happened a couple more times since after decreasing the dose.  In the latter half of October, the muscle spasms spread to her head and neck, particularly while lying down which has made sleep difficult at times. Massages and lifestyle advice from a physical therapist brought some temporary relief but symptoms keep resurfacing and increasingly interfering with daily life.
Fever or Chills  Cough  Fatigue  Muscle or body aches  Headache
patient reported feeling a sudden onset of pressure all over her body. She was able to communicate and had no difficulty speaking and was able to walk to EMT station. She denied any dizziness or nausea. She had water and was assessed for an additional 30mins. She said she felt better after assessment.
7 hours after receiving vaccine was more sore than expected and next day it was worse. By 10/5 pain settled in shoulder and it was worsening. 10/6 went back to doctor, he was no sure what was wrong. TYLENOL did not help. 10/14 orthopedic doctor is not sure what is going on got an x-ray. Sent her to physical therapy.
Patient tested positive for COVID-19 and experienced COVID-19 symptoms after being exposed to an individual that was COVID positive.; Patient tested positive for COVID-19 and experienced COVID-19 symptoms after being exposed to an individual that was COVID positive; This is a spontaneous report from two contactable consumers. A 24-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) dose 1, single and dose 2 single; both given via an unspecified route of administration, on an unspecified date, for covid-19 immunization. The patient's medical history included the patient was exposed to an individual that was COVID positive. Concomitant medications were not reported. The patient was not pregnant during the time of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. The patient tested positive for covid-19 on 01Aug2021 and experienced covid-19 symptoms after being exposed to an individual that was covid positive. The reporter assessed the case as non-serious. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 01Aug2021. No treatment was administered for the event. The outcome of the event was recovering.  Information on the lot/batch number has been requested.
Received vaccination at 11am on 5/26/2010.  At 5AM on 5/27/2010, woke up with temperature of 103.5F, achy all over, especially head, neck and back. C/O heart racing, irregular heart rate. States left arm swollen and sore at injection site,  Was seen at a clinic.  States was told to take Tylenol and Advil intermittently. States was told she was experiencing reactions from immunization received on 5/26/2010.  Was also told to take Benadryl.  States the evening of 5/27/2010 Went to ER because HA and Back pain, and fever of 103.5 continued.  On 5/28/2010 C/O of rash approx. 7" long on arm near injection site and "wraps around arm."  "Rash blotchy, dark and light red, purple, raised and hot to touch."
Patient had had an HPV vaccine and after the vaccine was waiting the 15 minutes and had a syncopal episode.
Patient given expired Covid Vaccine. Dose expired 10/9/21 dose give 10/29/21
Chest pain, feeling warm, throat scratchy, tired. Flu shot given at 2 PM. Started feeling warm, tired, chest pain around 5 PM. Went to hospital about 11 PM.
a furious reaction that does not itch at all; big hives; two large rashes repeatedly; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (a furious reaction that does not itch at all), URTICARIA (big hives) and RASH (two large rashes repeatedly) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Flu: Flu shot; for Shingles: Shingles vaccine (also experienced big hives with Shingles vaccine); for Product used for unknown indication: PENICILLIN NOS (also experienced big hives) and Cipro (also experienced big hives). Past adverse reactions to the above products included No adverse event with Flu shot; and Rash with Cipro, PENICILLIN NOS and Shingles vaccine. Concurrent medical conditions included Penicillin allergy.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first 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 COMPLICATION (a furious reaction that does not itch at all), URTICARIA (big hives) and RASH (two large rashes repeatedly). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (a furious reaction that does not itch at all) and URTICARIA (big hives) outcome was unknown and RASH (two large rashes repeatedly) had resolved.            No concomitant medications were reported.  It was reported that 2 days after receiving the booster dose, the patient started to experience the adverse events.  The patient believed that the patient had a problem with the binder.  The rashes went away on taking Benadryl and the patient had been treating them with Benadryl every time whenever the rash appeared.   This case was linked to MOD-2022-533441, MOD-2022-533436 (Patient Link).
Vial was initially stored in refrigerator on 04-Jun-2022 and administered on 06-Jul-2022; No adverse event; Administered the vaccine to patient after the 30 day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day use by date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 04-Jun-2022 and administered on 06-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 04-Jun-2022 and administered on 06-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day use by date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 04-Jun-2022 and administered on 06-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day use by date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 04-Jun-2022 and administered on 06-Jul-2022).    Concomitant medication information was not provided by the reporter.  Patient received half dose.  Vial was initially stored in refrigerator on 4-Jun-2022 and did not undergo any temperature excursion.  Treatment information was not provided by the reporter.
Initial information received on 18-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional. This case involves a 63 years old female patient who received an expired dose of vaccine FLUZONE QUADRIVALENT (lot UI815AA, exp date: 30 June 2018) via unknown route on an unknown date 2 days ago. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was a case of actual medication error due to expired vaccine used. No specific adverse event was experienced. 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.
She feels uncomfortable.; discomfort under her arms/hard to lift her arms; hard to lift her arms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Apr2021 (Lot number: EW0162) at the age of 54 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: LIMB DISCOMFORT (non-serious) with onset May2021, outcome "not recovered", described as "discomfort under her arms/hard to lift her arms"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset May2021, outcome "not recovered", described as "hard to lift her arms"; DISCOMFORT (non-serious), outcome "unknown", described as "She feels uncomfortable.". Therapeutic measures were taken as a result of limb discomfort, joint range of motion decreased, discomfort.  Additional information: Patient was going to receive the second dose of the covid vaccine today 10May2021 at 5:00PM. Within her head, she is concerned. She has been having discomfort under her arms. Certain days, it is both of her arms, and others it is just one arm. She has been taking Tylenol, and it takes the discomfort away. She is asking would that have anything thing to do with the covid vaccine. Patient received first dose on 19Apr2021 between 5:00-5:30PM. Patient did not receive any vaccination within 4 weeks. Patient took vitamins.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a physician regarding an unspecified number patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with GARDASIL 9. On an unknown date the patient experienced syncope. The outcome of syncope was unknown. Causality was unknown. Additional information has been requested.
1/5/21: coughing, hoarse voice  1/6/21: increased anxiety, nausea, episode of dizziness, coughing, later in the day itching . Severe itching in the evening.  1/7/21: Redness on skin / hives, increased anxiety, tightness in throat, coughing - went to ER 1/8/21: Previous symptoms continued, along with tongue swelling. Went back to the ER.  1/9/21 + days symptoms continued.
Per our investigation at the Public Health Dept., the above vial of Novavax  had been opened on Wed. 12 /21/ 2022 and used to administer a vaccine.   It was immediately returned to the refrigerator that day.    Today, 12/27,2022, same vial was used to give a subsequent vaccine to the patient listed above.    The above patient was notified to watch for inappropriate redness or soreness to the area and to report to our office.   Efficacy is considered unharmed as the vial was kept in the main refrigerator between usages and no temperature excursions occurred.     Novavax was also contacted for follow up.
Sore scratchy throat, chills, slight body aches, slight fever 99.5. There was of 6 of us that all got COVID-19, my wife and i were the last 2 to show signs. We picked this up traveling, we were wearing our mask and test negative the Friday before we left. And after visiting, the oldest member test positive Tuesday the following week and then everyone else got sick. My symptoms game back June 11 and last 3 days and my fever went to 100.
Cough, fever, and poor oral intake for a few days prior to ER visit on 7/4/22. Admitted to Medical unit 7/4/22 with hypoxic respiratory failure likely due to COVID 19 pneumonia with probable bacterial component (per admission).
4x4 inch area of erythema and increased warmth, slt induration. Client c/o pain of "8" on 0-10 pain. Also c/o headache, chills & body aches. Occ nausea. Relates c/o began the day after injection. Pain, redness, heat at injection site persist to present (6 days post injection) but are improved. Rates pain as a 1-2 on 0-10 scale. Other c/o resolved by day 3 post injection. Also noted night sweats either night of the injection or night after.
This spontaneous report was received from a pharmacy student concerning a female patient of unknown age. On 31-MAY-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. Approximately on an unknown date in June 2013 (reported as within a few days after receiving ZOSTAVAX, the patient developed a mildly, painful rash on her flank about the size of a fist. The patient sought medical attention (called to pharmacy). No treatment was given. No lab tests were performed. The patient was not recovered from the event at the time of report. The relatedness for the event was unknown for ZOSTAVAX. Additional information is not expected.
PSORIASIS SYMPTOMS; This spontaneous report received from a patient concerned a 67 year old male. 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced psoriasis symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of psoriasis symptoms was not reported. This report was non-serious.