chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE OBSTRUCTIVE SLEEP APNEA 5/23/2022 -- RECURRENCE OF SAME SYMPTOMS
wrong with my blood work; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD DISORDER (non-serious), outcome "unknown", described as "wrong with my blood work". The patient underwent the following laboratory tests and procedures: Blood test: Unknown results. Additional information: the patient received an injection for the COVID-19 virus and afterwards there was a "thing wrong with my blood work."  The information on the batch/lot number for bnt162b2 omi xbb.1.5, has been requested and will be submitted if and when received.
Four of the Rotavirus vaccines foil outerpacking was not sealed all the way on one of the sides. The medication's seal still looks in tact.
No adverse effects; improperly stored vaccines since 3/29/2019; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, previous drug reactions, allergies or medical history.  On 29-MAR-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot numbers: R024024 and R024023, expiration date for both lot numbers on: 22-AUG-2020; and with (rHA) Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot # R030794 and R017801, expiration dates on: 22-APR-2020 and 19-DEC-2019 respectively, (dosage schedule, route, anatomical location and indication were not reported for the vaccines). The vaccines were reconstituted with properly stored diluent.   The administered doses of vaccines were exposed to a temperature of multiples excursions of 6 degrees Fahrenheit to 14 degrees Fahrenheit (minus 14 degrees Celsius to minus 10 degrees Celsius) for 100 minutes cumulative. There was no previous temperature excursion reported. The call was placed because of a Digital Data logger report. No adverse effects were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA002283:
24 hours after the shot I got a horrible nosebleed and headache, felt flu like and ran a fever. The fever broke within 6 hours but I felt horrible for 5 days. I began getting red bumps on my chest that pop up really red and then take weeks to heal. I have had 5 nosebleeds low energy and on again off again times of extremely low energy
Flu-like symptoms (fever, aches, fatigue, chills, sweats, lymph nodes in throat sore), plus arm pain at site of vaccine. Second day began having acute chest and abdominal pain which primary care doctor wanted to see me for. Did EKG which was normal. Pain (including chest and abdominal pain) lasted several days, along with fatigue. 11 days later I still have intermittent pain down my arm all the way to hand on arm that got the shot.
A report has been received from a Health Professional concerning a 33 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT, 2 doses. FLUMIST QUADRIVALENT started on 17-Sep-2013. The reporter stated that the patient had two full doses of FLUMIST QUADRIVALENT, one in each nostril. The outcome of the event of TWO FULL DOSES OF FLUMIST QUADRIVALENT, ONE IN EACH NOSTRIL is unknown. The report was considered to be non-serious.
About a month after my second Pfizer Covid-19 vaccine I experienced an episode of hives.  Since then, I have had four other hives events.  My skin turns very red, my skin feels hot internally, and it is somewhat itchy.  It resolves itself after 45-75 minutes.  It does happen after I eat something.   But, I have not been able to determine which if any food is the cause.  And all of the foods that I'm consuming I have for quite some time.  For example, I have been eating dark chocolate almost daily for many years without a problem.  Last week, I hadn't eaten for several hours.  When I returned to my car , I ate a small piece of dark chocolate, and soon after I experienced a hives event.  I have never ever had hives in my life so I am assuming that it is an immune response resulting from the vaccine.
Initial information received on 18-Dec-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 24 months old patient of an unknown gender who received ActHib portion of PENTACEL without the diluent of the DTap/IPV (lot number, expiry date, dose, dose in series, route and site of administration not reported) on 12-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided. It was a case of actual medication error due to inappropriate reconstitution technique. Caller stated that one of the nurses gave the ACTHIB portion of PENTACEL and did not give the IPV portion of it. It was not reported if any adverse event occurred or not following the 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.
Dizziness; Nausea; This is a spontaneous report from a contactable other health care professional (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number- EN6206), via an unspecified route of administration on 11Mar2021 (at the age of 43-years-old) at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has no known allergies. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number- EN6200), via an unspecified route of administration on 18Feb2021 at a single dose for COVID-19 immunization. The patient was not pregnant. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient experienced dizziness and nausea on 11Mar2021 and lasted for two weeks after the second dose of the vaccine. The events were reported as non-serious. No treatment was given for the events. The outcome of the events was recovered in Mar2021.  No follow-up attempts are needed. No further information is expected.
Administration of booster shot which was more than 18 hr in fridge; Administration of booster shot which was more than 18 hr in fridge; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of booster shot which was more than 18 hr in fridge) and PRODUCT STORAGE ERROR (Administration of booster shot which was more than 18 hr in fridge) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21B) for COVID-19 vaccination. No Medical History information was reported.On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first 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. On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of booster shot which was more than 18 hr in fridge) and PRODUCT STORAGE ERROR (Administration of booster shot which was more than 18 hr in fridge). On 04-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of booster shot which was more than 18 hr in fridge) and PRODUCT STORAGE ERROR (Administration of booster shot which was more than 18 hr in fridge) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medications were reported.No treatment medications were reported. This case was linked to MOD-2021-388723, MOD-2021-385958 (Patient Link).
Headache, Myalgia, Fever, Rash, UrticariaPruritus, inj site red/swollen, warm, itchy day 2-4; muscle weakness, fever, chills, headache day 2-3 Narrative:
Information has been received on 04-JAN-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous on or about 06-JAN-2012, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 30-APR-2015, the patient was treated at a health clinic for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed valacyclovir hydrochloride (VALTREX) and acetaminophen (TYLENOL) for management of his painful and persistent symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Intense fatigue lasted for approx 72 hours post injection and still semi fatigued 5 days post vaccine; Dizzy within 10-15 mins of vaccine; 8-10 hours later skin became severely sensitive and sensation of being scraped or peeled with anything brushing against or touching it.; 10-12 hours after vaccine low grade fever began and remained for 48 hours; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 14Sep2021 at 10:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included flu (The patient had never experienced in her life even with various rounds of flu) and possible penicillin allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 24Aug2021 at 10:15 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On 14Sep2021, the patient experienced dizzy within 10-15 mins of vaccine. On 14Sep2021, 8-10 hours later. skin became severely sensitive and sensation of being scraped or peeled with anything brushing against or touching it. This lasted approximately 12 hours. On 14Sep2021, 10-12 hours after vaccine, low grade fever began and remained for 48 hours. Intense fatigue lasted for approximately 72 hours post injection and still semi fatigued 5 days post vaccine. Still the patient was noticing skin sensory type sensitivity, but not as intense as it was week of vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events skin became severely sensitive and sensation, fatigue was not resolved, low grade fever was resolved on 16Sep2021 and dizzy was unknown at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Large local reaction to (R) deltoid with itching. Redness 3.5 x 5 inches. Spoke to pt by phone. Dr advise eval and dose of BENADRYL.
After one week from the immunization, anaphylaxis response-itchy skin on legs and arms resulting in hives when scratched; this lasted 8 weeks and was moderate to severe; antihistamines (Allegra) had little effect. After 4 months symptoms are reduced but not gone entirely.
Pt developed widespread macular papular rash on her extremities and torso the next day after vaccination. Rash gets more pronounced when child gets hot or after bath. No sx of URI. No treatment advised.
The bivalent vaccine (booster) was given as the 1st dose in the primary series
Covid-19 treatment; Covid-19 treatment; This is a spontaneous report received from a non-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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Lot number: GJ3277), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Past drug history included: Azithromycin, reaction(s): "Known allergies: azithromycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19 treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Vaccine received and other medication in 2weeks was Yes. It was reported that patient received treatment with Paxlovid from 29Nov to 03Dec.  No follow-up attempts are possible. No further information is expected.
Initially had headache, sore arm, chills, but on 4/1/21 had to go to ER with a stroke, and then on 4/5/21 had a TIA
The next day, had chills and fever, muscle and joint pain. Next day, I woke up and felt pain on left side of my neck and could not turn my head towards; The next day, had chills and fever, muscle and joint pain.; The next day, had chills and fever, muscle and joint pain.; The next day, had chills and fever, muscle and joint pain.; 2 hrs after 2nd dose, I was dizzy and nauseous.; 2 hrs after 2nd dose, I was dizzy and nauseous.; Noticeable swelling in the area between left neck and shoulder towards left half of nape/ swelling on back of nape feels like a pinched nerve; felt pain on left side of my neck; Two lymph nodes swollen and painful to touch; could not turn my head towards the left; feels like a pinched nerve giving me headache; This is a spontaneous report from a contactable consumer (patient). A 53 years old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route, administrated in left arm on 23Apr2021 at 15:15 (at age of 53-years-old) as Dose 2, Single for Covid-19 immunization in Pharmacy or Drug Store. The patient was non-pregnant at time of vaccination. The patient's medical history included ongoing migraine, kidney stones, known allergies to Avocado, Almonds and Walnuts. The patient's concomitant medication(s) included propranolol; omeprazole; erenumab aooe (AIMOVIG); frovatriptan within 2 weeks of vaccination. The patient's past drug included clindamycin and experienced drug allergy. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously received first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number: EN6207, Expiration Date: Not reported), via an unspecified route of administration in left arm on 02Apr2021 at 15:45 (at age of 53-years-old) as Dose 1, Single for Covid-19 immunization. On 23Apr2021 at 17:30 (approximately 2 hrs after second dose of vaccination), the patient was dizzy and nauseous. On 24Apr2021 (the next day), the patient had experienced had chills and fever, muscle and joint pain. (Next day on unspecified date in Apr2021), she woke up and felt pain on left side of her neck and could not turn her head towards the left. On an unspecified date in Apr2021, the patient experienced noticeable swelling in the area between left neck and shoulder towards left half of nape, two lymph nodes swollen and painful to touch, swelling on back of nape feels like a pinched nerve giving her headache. Since the vaccination, the patient was not tested for COVID-19. No treatment received for resulted events. Device date was reported as 26Ap2021. The outcome of the events was not recovered.   No Follow-up attempts are needed. No further information was expected.
Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date in 2014, the patient was vaccinated with a dose of ZOSTAVAX, (dose, route of administration, anatomical location, lot # and expiration date were not reported) for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster (onset date was not provided). On an unknown date in 2015, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter determined the events to be related to the ZOSTAVAX.
I was exhausted and fatigue. I have a fever and chills with a cough. I came down with an ear infection and a sinus infection and the cough continues.
PT RECEIVED THE VACCINATION AT ABOUT 7:30PM AND STATES SHE STARTED HAVING SEVERE SHOULDER PAIN AROUND 12AM-1AM AFTER RECEIVING VACCINATION. STATES THE PAIN IS CENTRALLY LOCATED IN THE SOCKET AREA AND PAIN IS LEVEL 10.
Information has been received from an unspecified health care professional, referring to multiple unspecified patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown dates, the multiple unspecified patients were vaccinated with an improperly stored doses of ZOSTAVAX lot # M032638 and expiration date 04-OCT-2017 (dose, administration route and anatomical location were not reported) for prophylaxis. No adverse effects were reported. The vaccine had one temperature excursion of 7.1 Fahrenheit (F) for 1 hour and a previous excursion of 6.4 (F) for 3 hours; with a data logger involved. This is one of several reports received from the same source. Additional information is not expected because the reporter did not want to be contacted.; Sender's Comments: US-009507513-1701USA001224: US-009507513-1612USA010151:
broke his nose; car accident; He has not received his 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL BONES FRACTURE (broke his nose) in a 20-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.     The patient's past medical history included Surgery (Nose surgery).    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FACIAL BONES FRACTURE (broke his nose) (seriousness criterion medically significant), ROAD TRAFFIC ACCIDENT (car accident) and PRODUCT DOSE OMISSION ISSUE (He has not received his 2nd dose). At the time of the report, FACIAL BONES FRACTURE (broke his nose) and ROAD TRAFFIC ACCIDENT (car accident) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (He has not received his 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication information has been provided by the reporter. No concomitant medication information has been provided by the reporter. No lab data has been provided by the reporter.  This report refers to a case of Product dose omission issue for mRNA-1273,  with associated adverse events of Road traffic accident and Facial bones fracture. Very limited information regarding these events has been provided at this time.  Further information has been requested.; Sender's Comments: This report refers to a case of Product dose omission issue for mRNA-1273,  with associated adverse events of Road traffic accident and Facial bones fracture. Very limited information regarding these events has been provided at this time.  Further information has been requested.
Weird non stop ringing in his ears; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (Weird non stop ringing in his ears) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TINNITUS (Weird non stop ringing in his ears). The patient was treated with AMOXICILLIN TRIHYDRATE, CLAVULANATE POTASSIUM (AMOXCLA) on 06-Apr-2021 at an unspecified dose and frequency. At the time of the report, TINNITUS (Weird non stop ringing in his ears) outcome was unknown. Not Provided          No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.
This spontaneous report as received from a healthcare worker who is an office manager refers to unspecified patients of unknown ages and genders. On an unknown dates the patients were vaccinated with a dose GARDASIL (dose, lot #, expiration date and route were not reported). The doses of the vaccine were exposed to temperatures outside of the recommended range since October 2014. No adverse effects have been reported. It was unknown if the patients sought medical attention. This is one of several reports from the same source. Additional information has been requested.