chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient said he was feeling unwell. Started to feel dizzy and felt like he could possible faint. Had slight trouble breathing. Had patient lay down and elevate legs. Patient started to feel better. Sat back down on chair but started to feel faint. Laid back down until EMS arrived. No loss of conscience. Patient was able to communicate without issue. EMS checked patient out and there was no issues found. Patient called and said he is feeling well.
Patient was dishonest on her prevaccination checklist and had received a Pfizer dose on December 30, 2020.  She should not have received the Moderna vaccine, but instead a 2nd Pfizer dose.
li[p swelling, throat tightness, general body itching. started 3 hours after Vaccine was given  treated with  benadrly
Soreness at injection site both times, fatigue, mild chills, and mild headache. Took no medications for symptoms. All had passed  by next morning after a night of rest.
The patient is a healthy 27 yo female who received anthrax #1 10/27/20 (lot # 300070A) while 23 weeks pregnant . No specific AE other than inappropriate administration. Provider visits for education and counseling.
Extreme swelling, painful, vruised, very red on his arm. I have pictures if necessary
2nd shot too early; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 28-JUN-2022 Reporter's Comments: This case was received via interactive digital media. The patient received 2nd shot too early. Additional supportive Information: The patient received 2nd early than recommended interval, which led to shortening of vaccination schedule. The follow-up would not possible as no contact details were available.
The vial was initially stored in the refrigerator on 02-May-2022, expired on 25-Mar-2022 and administered on 13-May-2022; 5 doses administered to patients after Moderna vaccine expired/vaccine was administered after published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 doses administered to patients after Moderna vaccine expired/vaccine was administered after published expiry date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-May-2022, expired on 25-Mar-2022 and administered on 13-May-2022) in an 88-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 doses administered to patients after Moderna vaccine expired/vaccine was administered after published expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-May-2022, expired on 25-Mar-2022 and administered on 13-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 doses administered to patients after Moderna vaccine expired/vaccine was administered after published expiry date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-May-2022, expired on 25-Mar-2022 and administered on 13-May-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. HCP stated that their facility had an error where 5 doses of the Moderna COVID-19 vaccine was administered after the expiration date of 25-Mar-2022. The administration occurred on 13-May-2022. None of the 5 patients had reported any adverse reactions to this dose. Number of doses/vials: 5 doses, 1 vial. The vial was initially stored in the refrigerator on 02-May-2022 The vial did not undergo any temperature excursions. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2022: Follow-up received contains no new information. On 16-May-2022: Live significant follow up: Patient information and dose number were added.
Bone/muscle aches, nausea, 102.2°, fatigue, diarrhea, no appetite.
CHILLS; FEVER; FATIGUE; WEAKNESS GENERALIZED; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and sulfa allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced weakness generalized. On 07-APR-2021, the subject experienced injection site pain. On 07-APR-2021, the subject experienced fatigue. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from injection site pain, and chills, and had not recovered from fever, weakness generalized, and fatigue. This report was non-serious.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of improperly stored VAQTA (lot number, strength, dose and route were not reported). No adverse effects were reported. The outcome of the patients event was not reported. This is one of several reports from the same source. Additional information has been requested.
very bad cold; loses sense of smell; shortness of breath; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program Support. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration on 21Apr2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration on 03Apr2021 as DOSE 1, SINGLE for COVID-19 immunisation. On an unspecified date the patient experienced very bad cold, loses sense of smell and shortness of breath. She was asking if these was related to covid 19 vaccine. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
I have a gastric band. After my perfectly ordinary flu like symptoms cleared up, I found myself unable to eat or drink, even clear fluids. It seemed as though I was more inflamed due to the vaccine at areas where there are medical devices implanted - such as my gums around a crown. I was unable to drink or eat for a total of six days.
Started with headache and nausea. The next day chest pain and shortness of breath. Diagnosed with myocarditis. Now has dystopia and severe pain /muscle spasms.
p/vax pt adm to hosp w/a meningitis picture;spinal tap & CT scan were consistent w/sterile meningitis;pt recovered p/2 days & was disch from hosp;s/sx mostly resolved x/ some residual h/a;vax was discontinued;pt condition resolved
Patient states that "almost instantaneously" she began feeling something "strange" in her cheeks and below her eyes.  She could not move her facial muscles as usual.  She then felt a pressure-like feeling at top of her neck and her left arm became weak and insensitive to touch.  States both legs were "jelly-like and wobbly".  She denied any shortness of breath, diaphoresis at that time.  She was taken to the ER at that time.  Vital signs were stable (slightly tachycardic).
This is a spontaneous report from a contactable pharmacist, via a Pfizer sales representative. A patient of an unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. After the use of the product, on 02Aug2016, the patient complained of injection site being really tender and the skin around the injection site was dry and peeling. The outcome of the events was unknown.
pt recv vax; had 10 sec of sz; pale & clammy; T=80; BP=104/68;R=80; pt had held his breath & was scared;cool cloth to forehead immed; laid on floor feet elevated;
Intense pruritic episode 4 hours post vaccine. Slight swelling in face. Lasted approx 24 hours per patient.
Narrative:  COVID infections following completion of COVID vaccine series 02/02/21 COVID vaccine dose #1 02/23/21 COVID vaccine dose #2 05/03/21 Pt reports worsening tinnitus; audiologist recommends nonpharmacologic lifestyle changes to reduce symptoms and tinnitus education class 07/26/21 Pt reports COVID positive test from urgent care; symptoms of loss of taste, sore throat, headache, cough, runny nose that started 07/21; rx given for acetaminophen, ondansetron, DM/guaifenesin, throat lozenges, 07/28/21 Pt reports very little dry cough, diarrhea, improved fatigue, and improved loss of taste/smell 07/30/21 Pt calls into CCC reporting elevated blood pressure 190/96 and has been taking OTC dayquil and nyquil; primarily asymptomatic and advised to d/c OTC medications 08/02/21 Pt reports bad headaches and acid reflux 08/12/21 Pt reports continued cough, sore throat; rx given for benzonatate, zinc, famotidine, albuterol
Sure arm at injection site, body aches all over, chills, fever, headache, dizziness
Client presented to the immunization clinic for second dose of Moderna COVID-19 vaccine. Administered 0.25 ml booster dose instead of 0.5 ml full dose. After administration error was identified and while client was still in clinic he was notified of the error. After consulting nurse manager a second 0.25 ml dose of Moderna COVID-19 vaccine was administered.
patient was administered a first dose of Boostrix in August 2022 and then today May-11-2023 a second dose was administered by mistake.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 60-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number DH3A2, expiry date 29-SEP-2025) for prophylaxis.   Previously administered products included Boostrix (administered a first dose of Boostrix in 06 August  2022).   On 11-MAY-2023, the patient received Boostrix. On 11-MAY-2023, an unknown time after receiving Boostrix, the patient experienced extra dose administered (Verbatim: patient was administered a first dose of Boostrix in August 2022 and then today May-11-2023 a second dose was administered by mistake.). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date 11-MAY-2023 The medical assistant called to report that a patient received Boostrix and then again on the day of reporting was administered with another dose by mistake. The reporter did not consent to follow up. The patient received Boostrix and the second dose was administered, which led to extra dose administered.
This case was reported by a healthcare professional (also the subject) and described the occurrence of sore arm (injection site) in an adult female subject who was vaccinated with Flulaval (GlaxoSmithKline).  Concurrent medical conditions included back pain and high blood pressure.  Concurrent medications included Diovan, Ultram and naproxen.  In 2006 the subject inadvertently received a dose of Flulaval at 1.0 ml.  This was considered to be an accidental asymptomatic overdose.  Flulaval is indicated for use at a dose of 0.5 ml.  No adverse events were reported.  On 3 October 2007, the subject again inadvertently received a dose of Flulaval at 1.0 ml (dose given with one-half inch needle).  This was considered a medication error.  Immediately after vaccination with Flulaval, the subject developed a sore arm at the injection site.  This too was considered to be an accidental asymptomatic overdose.  The subject should have received a 0.5 ml dose of Flulaval.  At the time of reporting the outcome of the sore arm at injection site was unresolved and in the reporter's opinion, the event was possibly related to treatment with Flulaval.
First Dose  Monday Jan 18th -@ 8:15am - received first vaccine dose - Severe sore arm for 3 days  Second Dose Monday Feb. 15 @ 5:35pm received second vaccine dose  - Sore Arm Tuesday 16th - Morning - whole body soreness, severe sore arm - Noon - Chills and headache.  Took 1 Sudafed cold and flu tablet - 4:30pm - Chills, fever, increase body soreness and sensitivity, lethargy - 6:00pm - took 2 advil - 8:00 pm - took liquid Nyquil went to bed Wednesday 19th - 6:00am - no chills and or fever, still lethargic, sore arm -7:30am - headache returns, 2 advil no symptoms the rest of the day or next day
Sore arm, shortness of breath, swollen lymph nodes, anxiousness, and tiredness.
Fever, aches and pains, chills, dizziness, diarrhea, PODS.
Approximately 500 doses were administered from vaccine stored in Household freezer.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Approximately 500 doses were administered from vaccine stored in Household freezer.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Approximately 500 doses were administered from vaccine stored in Household freezer.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (Approximately 500 doses were administered from vaccine stored in Household freezer.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Reporter stated that they had been giving moderna vaccines exclusively 1.5years ago, starting the beginning of 2021. No treatment medications were reported.  On 16-Aug-2022, case MOD-2022-628739 became invalid as it was confirmed that no patient identifier was reported.
Patient reports arm pain following administration, reports worsening in pain over the first 48 hours including bruising, pain at injection site and tingling or numbness in her hand.   Patient called her primary care office, PCP recommended patient call 911.  Patient called 911 but ultimately did not go the emergency department.  PCP's office was notified 8/28/23 and will follow up with patient.
Body aches; Weakness; Painful to move; Light headed when standing; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730), via an unspecified route of administration in the left arm, on 27Mar2021 at 12:00 (at the age 25-years-old) as a single dose for COVID-19 immunisation. Medical history included allergies to shellfish and peanuts. Concomitant medication included ethinylestradiol;norgestimate (ESTARYLLA) from unknown date for birth control. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via unspecified route of administration in the left arm, on 25Feb2021 at 16:00 (at the age 25-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 27Mar2021 at 22:45, the patient experienced body aches, weakness, painful to move and light headed when standing. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome of the events general body pain, weakness, painful to move and light headed when standing were recovering at the time of this report.   No follow-up attempts are needed. No further information expected.
flu feel like symptoms; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received first dose of bnt162b2 (unspecified trade name), via an unspecified route of administration on 11Feb2021 17:00 (Batch/Lot number was not reported) at 57-year-old as single dose for covid-19 immunization. Medical history included iodine allergy, "Iodine"(without other specified information), covid-19 prior vaccination, blood pressure abnormal and thyroid disorder. Concomitant medications included insulin for an unspecified indication, blood pressure meds, thyroid medicine. No other vaccine in four weeks. The patient had 24 hour flu feel like symptoms on the first vaccine on 12Feb2021 10:00 with outcome of recovered on 13Feb2021 10:00. The event was life threatening illness (immediate risk of death from the event). No treatment received. The patient did not tested for COVID post vaccination.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.; Sender's Comments: Linked Report(s) : 2021316565 Same patient, same drug, different dose number/event
Extreme fever, 104.1 Temporel thermometer, nausea vomiting, malice fatigue, lightheaded dizziness, hallucinations with the fever, Vasoconstriction that included numbness of hands and extremities. Fever exceeds the 48 hour mark only brought down by ibuprofen and acetaminophen alternating Q3 hours then bringing the fever down to 100.1 on average between doses
allergic reaction to vaccine; Initial information regarding an unsolicited valid non-serious courtesy case received from a physician assistant on behalf of healthcare professional in the United States of America (USA) via Merck on 03-Nov-2020.  This case involved a patient of an unknown age and gender who experienced allergic reaction to vaccine (Allergy to vaccine), after receiving DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (ADACEL).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date were not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (unknown latency), it was asked by reporter if vaccine contains any allergens and further it was reported that patient had an allergic reaction to ADACEL vaccine (Allergy to vaccine).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown.  There will be no information available on the batch number for this case.
This case was reported by a other health professional via sales rep and described the occurrence of erythema in a 18-year-old female patient who received BEXSERO for prophylaxis. Previously administered products included BEXSERO with an associated reaction of induration (received 1st dose on 18th July 2018 and experienced induration, refer case US2018GSK158625). On 24th August 2018, the patient received the 2nd dose of BEXSERO .5 ml. In August 2018, less than a week after receiving BEXSERO, the patient experienced erythema. On an unknown date, the outcome of the erythema was unknown. It was unknown if the reporter considered the erythema to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was nor reported but it could be 17 or 18 years. The patient received the BEXSERO in an unknown arm. The patient experienced redness of 3 inches and 1 and half inches in height. The reporter believed this to be related to the product. The reporter agreed to follow up. This case has linked to case US2018GSK158625, reported by the same reporter for same patient.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown demographics. Information about the patients' pertinent medical history, concurrent conditions and drug reactions/allergies was not reported. On unspecified dates, since 03-AUG-2015, the patients were vaccinated with improperly stored doses of GARDASIL, lot # J013324 with expiration date 12-FEB-2016 and lot # K007264 with expiration date 02-MAR-2017, (dose and route of administration were not provided); that were supported by prescribing information. Concomitant medication was not reported. No adverse effect were reported. The GARDASIL was also exposed to 68F for 19 hours. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a mother concerning her 20 month old daughter with no medical history or allergy who "a few months ago", was vaccinated with ATTENUVAX (lot# not reported). There was no concomitant medication. "Soon after getting the vaccine", the patient developed  a fever of 105F. The patient was evaluated at a local emergency room but was not hospitalized. The fever resolved in 4 days and the patient fully recovered. This is one of several reports from the same source. Additional information is not expected.
68-year-old female evaluated for painful movement of her extremities. Patient reports that her symptoms started the day after receiving the Pfizer COVID-19 vaccine at pharmacy. Patient was admitted. Patient has been evaluated by Neurology, Rheumatology and the Ortho-Spine Service. Symptoms improved with prednisone. Although unclear, a diagnosis of polymyalgia rheumatica was being considered due to elevated CRP (inflammatory marker). Relationship to vaccine administration is also unclear. Pt with Hx of arthritis, COPD, CAD, CHF, and HTN received first dose of Pfizer COVID-19 Vaccine. Within 24 hours of vaccine administration, pt went to hospital c/o of painful movement of extremities. Pt was treated with prednisone and symptoms improved. She was evaluated by multiple specialties including neurology, rheumatology and orthopedics without a clear diagnosis. Her CRP was elevated to 17.2 mg/dL and Sed Rate to greater than 130 mm/hr and reactive ANA titer. Total CK was normal at 23 IU/L. Rheumatology wrote this is highly suggestive of COVID-19 vaccine induced polymyalgia rheumatica which has been reported with other vaccines but not with COVID-19 vaccines.