chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received pfizer vaccine on 1/26/21 and 2/16/21.Presented to ER on 4/17/22 and found to be COVID positive.  admitted from assisted living facility on account of generalized weakness falls and worsening confusion.  Patient tested positive for COVID-19.  Chest x-ray did not show evidence of pneumonia but did have mild CHF exacerbation. She was not hypoxic and did not require oxygen supplementation. She has already being vaccinated.  She was started on IV lasix, and did well. Regarding confusion,  Noncontrast CT of the head done on admission was unremarkable. This improved as well over few days. Discharged on 4/22/22
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) and DIZZINESS (Severe Dizziness) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). On 23-Apr-2021, the patient experienced DIZZINESS (Severe Dizziness). On 23-Apr-2021, PAIN IN EXTREMITY (Sore Arm) and DIZZINESS (Severe Dizziness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Heart rate: increased (High) Rapid Heart Rate which lasted only a few minutes.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment was provided by the reporter.  At the time of this report it was reported that second shot was scheduled for 19-May-2021.
Breakthrough COVID case; Breakthrough COVID case; Dose number=3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Oct2021 (Lot number: FF8841) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Patient had not received vaccine in four weeks. Patient had not received covid prior vaccination. Patient had covid tested post vaccination. Patient had not known allergies. Patient had not received Other medical History. Vaccination history included: Bnt162b2 (previous dose product=COVID 19, previous dose brand=Pfizer-BioNtech,, previous dose lot number=EN6199, previous dose administrator route=Intramuscular,, previous dose administration date=01Apr2021 , previous dose dose number=2, previous dose vaccine location=Right arm), administration date: 01Apr2021, when the patient was 43 years old, for COVID-19 immunization; Bnt162b2 (previous dose product=COVID 19, previous dose brand=Pfizer-BioNtech, previous dose brand unknown=False, previous dose lot number= EL3248, previous dose administrator route=Intramuscular, previous dose administration date=11Mar2021, previous dose dose number=1, previous dose vaccine location=Left arm), administration date: 11Mar2021, when the patient was 43 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 27Oct2021, outcome "unknown", described as "Dose number=3"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Jan2022, outcome "recovering" and all described as "Breakthrough COVID case". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Jan2022) positive, notes: Test name : FlowFlex. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Headache; This is a spontaneous report from a contactable Consumer. This Consumer reported for self that the patient of unknown age and gender who received bnt162b2 (BNT162B2) via unknown route of administration on 16Jan2021 21:30 at a single dose for covid-19 immunization. Medical history and concomitant medications were unknown. Consumer stated, "I got the Pfizer shot (Later clarified as Covid-19 Vaccine by Pfizer) yesterday about 09:30 at night and they told me not to take any Tylenol, if I can help it and how long I can actually take the Tylenol as I have the headache all night and all this morning, so when I can take Tylenol, do I have to wait like 2 days, 3 days, how long?" The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Hardness; Pain at injection site; Swelling 6x4 inches wide; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Hardness), VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE SWELLING (Swelling 6x4 inches wide) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Hardness), VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE SWELLING (Swelling 6x4 inches wide). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE INDURATION (Hardness), VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE SWELLING (Swelling 6x4 inches wide) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
On eve of 2/21/2019 at home begin feeling lightheaded, left arm begin to hurt real bad and had some chest tightness with stomach pain. Parent did give some ibuprofen and applied warm pack to arm. On Saturday noted to have a fine rash about arm and redness on left arm started getting bigger. No longer with chest tightness Saturday but continued to feel bad with lightheadness and pain in left arm and very weak. Came to Dr. office on Monday due to continues rash and still feeling a little weak.
I had difficulty to think all friday afternoon(2 days after injection). After going to bed around 9:30 PM and therefore lying down  I suddenly started to cough. It last for about 10 minutes, I could not stop. I also started to sweat. At this time I believed I got COVID-19 at the vaccination site and moved to another room to avoid to expose furthermore my wife. I did not cough anymore since then. Today after reading the news and symptoms of blood clot in the lung, I prefer to report this incident.
March of 2023 noticed enlarged bilateral cervical lymph nodes and one enlarged supraclavicular node on right side. Watched it for 1 month with no noticeable change in size. Went to PCP who ordered round of Augmentin x 10 days-no significant change, then round of doxycycline for 10 days, also with no noticeable change. I requested a CT scan since I am a registered nurser and was very concerned. CT scan indicated increase in size of cervical, mediastinal, and supraclavicular nodes, as well as and nodes. Next step PET scan which showed same, fine needle biopsy, then surgical biopsy with diagnosis of sarcoidosis. had a series of 4 shots in trials becoming increasingly ill with each successive injection. (fever 104, arm swelling). No family history of this, no history of any autoimmune disorder. Al
Temperature excursion; No Adverse event; Patient received these vaccines post excursion; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received these vaccines post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Nov-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received these vaccines post excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) and NO ADVERSE EVENT (No Adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received these vaccines post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient received these vaccines post excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion).    No concomitant medications were reported. The nurse reported that, there was temperature excursion on 01-Nov-2022 in the refrigerator. At the time of excursion, the vials were in refrigerated storage. It was individual vials and vial size was unknown. The maximum or minimum temperatures reached at time of excursion was minimum 34.8 F (Fahrenheit) and maximum at 42.49 F for 14 Minutes duration. The vials were moved from freezer to refrigerator in less than 30 days. On visual inspection vials were in normal state. The patient received the vaccine post excursion and remaining vials were discarded.  The vial did not undergo any temperature excursions. No treatment medications were reported.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Left arm at the injection was sore), VACCINATION SITE SWELLING (Left shoulder near the injection site was swollen.), VACCINATION SITE ERYTHEMA (Developed a red rash at the injection site) and VACCINATION SITE RASH (Developed a red rash at the injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Nov-2021, the patient experienced VACCINATION SITE PAIN (Left arm at the injection was sore). On 19-Nov-2021, the patient experienced VACCINATION SITE SWELLING (Left shoulder near the injection site was swollen.), VACCINATION SITE ERYTHEMA (Developed a red rash at the injection site) and VACCINATION SITE RASH (Developed a red rash at the injection site). At the time of the report, VACCINATION SITE PAIN (Left arm at the injection was sore), VACCINATION SITE SWELLING (Left shoulder near the injection site was swollen.), VACCINATION SITE ERYTHEMA (Developed a red rash at the injection site) and VACCINATION SITE RASH (Developed a red rash at the injection site) outcome was unknown. No concomitant medication details were reported.No treatment medication details were reported.Most recent FOLLOW-UP information incorporated above includes:On 21-Nov-2021: Follow-up information received contains no new information.
Shortly after receiving Engerix-B vaccination, the patient was able to communicate she was experiencing mild vasovagal syncope, slight dizziness, and paleness. She indicated beforehand that this reaction might occur but still wanted the vaccination to complete the series. She refused smelling salts, remained talkative, stayed conscious, and drank water. This reaction lasted from 4:20pm until patient completely feeling better around 4:54pm and was able to walk without dizziness or paleness.
On July 13,2016 patient was administered expire dose of varicella. Vaccine expired 6/19/16.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The pharmacist reported that on 10-JUL-2014 the patient was administered a dose of VARIVAX (Merck) (lot #J013734 and expiration date 30-OCT-2015, dose, route not reported) that was stored improperly. Concomitant medications were not provided. No adverse effects were reported.  Additional information is not expected.
Bilateral arm rash within 15 minutes of giving Moderna Covid-19 vaccine. Patient was observed for 60 minutes . Patient given 25 mg of diphenhydramine and had no further events
grandma called states pt is having allergic react-sx swollen eyes & face, mouth drawing to one side & has a rash;
I am having problems with 'loose' bowels, going to the bathroom; This is a spontaneous report from a contactable consumer. A 81-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 3L3246), dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date as a single dose for covid-19 immunization. Medical history included diabetes mellitus. Concomitant medication(s) included metformin hydrochloride, sitagliptin (JANUMET [METFORMIN HYDROCHLORIDE;SITAGLIPTIN]) taken for diabetes mellitus. The patient experienced problems with 'loose' bowels, going to the bathroom on an unspecified date. The patient receive treatment with some Imodium and 'Pepto Bismol' and yet not visited to emergency room/ Physician Office. Outcome of the event was unknown.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
vomiting, diarrhea lasting approximately 12 hours; aches/pains lasting  for about 10 days
Stabbing Pain on her back; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Stabbing Pain on her back) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced BACK PAIN (Stabbing Pain on her back). At the time of the report, BACK PAIN (Stabbing Pain on her back) outcome was unknown.            No Concomitant and treatment medications were reported.
His urine retention is becoming worse; His urine retention is becoming worse; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A male patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL3247, on 21Jan2021 at single dose for COVID-19 immunization. Medical history included ongoing urinary retention and taking medication. Concomitant medication included medication for urinary retention. The patient had his first shot 9 days ago. He had urinary retention and taking medication before receiving the vaccine. After taking the first shot, he said that his urine retention was becoming worse. The outcome of the events was unknown.
Nickel-size, hard, red lump at site of immunization. Alternate cool and warm compress. Tylenol as needed. Gentle massage. Left thigh (DTaP and IPV).
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 09-DEC-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # K011004 and expiry date: 07-NOV-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Red bruise looking across forehead; Red bruise looking across forehead / Red bruise looking down the side of the face; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Red bruise looking across forehead) and ERYTHEMA (Red bruise looking across forehead / Red bruise looking down the side of the face) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     Concomitant products included PROBIOTIC FOR 60+ YEARS, APIXABAN (ELIQUIS), LIOTHYRONINE, IBRUTINIB (IMBRUVICA), GABAPENTIN, AMIODARONE and MAGNESIUM OXIDE for an unknown indication.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced CONTUSION (Red bruise looking across forehead) and ERYTHEMA (Red bruise looking across forehead / Red bruise looking down the side of the face). At the time of the report, CONTUSION (Red bruise looking across forehead) and ERYTHEMA (Red bruise looking across forehead / Red bruise looking down the side of the face) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was reported by the reporter
Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 56 years old male patient who received 0.5 mL dose of vaccine FLUZONE HIGH DOSE, lot UI994AB, expiry date: 09-APR-2019 via intramuscular route in the left deltoid on 01-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to Inappropriate age at vaccine administration and overdose. It was reported that 3 patients under the age of 65 had been given FLUZONE HD. It was unknown whether patient experienced any adverse reaction after vaccination. 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. Documents held by sender: none.
FLU LIKE SYMPTOMS; INJECTION SITE PAIN; STAYED IN BED FOR FEW DAYS; HEADACHE; This spontaneous report received from a patient concerned a 56 year old male. The patient's weight was 181 pounds, and height was 71 inches. The patient's past medical history included: covid, and concurrent conditions included: hypertension well controlled, and allergy to most opioids. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: 23-AUG-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination (dose number in series 1). No concomitant medications were reported. On SEP-2020, Laboratory data included: COVID-19 virus test (NR: not provided) Positive.  On 10-APR-2021, the patient experienced stayed in bed for few days, and headache. On an unspecified date, the patient experienced flu like symptoms with general body aches, and injection site pain (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, stayed in bed for few days, headache, and injection site pain. This report was non-serious. This case, involving the same patient is linked to 20211264309.
Pt states he awoke with headache, pain in arm with difficulty raising his arm 11/4/05. NKDA allergy to white/red beans, spaghetti sauce and tomatoes. Pt afebrile. Pt has 41/2" X 6 1/2" erythema induration. Tx: Solu-Medrol 20mg IM and Rocephin 15 IM. Rx for Zyrtec 10mg and cephallxin 250mg.
Mom reports inc sleepiness is awakened easily but is dec active & has refused feeding; temp elevated but not taken;
administered expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to patients, after the manufacture date of expiration) in a 60-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 173 doses of lot number 070H21A.  The vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to MOD-2022-581986 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live follow up received included non significant information of secondary reporter was added.
suffered a persistent, papulovesicular rash on Plaintiff's dermatomes and was diagnosed with herpes zoster.; Information has been received from a lawyer and the patient (pt) regarding a case in litigation involving a male patient (pt) of unknown age. No information about the pt's pertinent medical history, concomitant medications and drug reactions or allergies was provided.     In or around 25-sep-2017, the pt was inoculated with a dose of zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, route, frequency, lot/batch # and expiration date were not reported).     On an unknown date, reported as "shortly after receiving zoster vaccine live (ZOSTAVAX)", the pt suffered a persistent, papulovesicular rash on pt dermatomes and was diagnosed with herpes zoster.  As a direct and proximate result of zoster vaccine live (ZOSTAVAX), pt symptoms had resulted in physical limitations not present prior to using it. Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition.  As a result of the manufacture, marketing, advertising, promotion, distribution, and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained serious, progressive, incurable and permanent personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.    The reporter considered the event to be related to zoster Vaccine Live (ZOSTAVAX).  Herpes zoster was considered as disabling event, due to the pt's permanent and incurable injuries.
Information has been received from a physician, via a company representative, concerning the physician's daughter (age not reported), who was vaccinated IM on unspecified dates with the first dose and the second dose of Gardasil (Lot # not provided).  Following both the first vaccination and the second vaccination, his daughter experienced nausea, and dizziness that lasted for "about a day afterwards."  The physician indicated he was planning to proceed with the third vaccination for his daughter.  The patient sought unspecified medical attention.  Additional information has been requested.