chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Elevated temp of 100.8 at 1030pm on 1/25/2021 treated with alternating ibuprofen and acetaminophen.   Headache at 5pm on 1/25/21 until 8am 1/27/21 treated with ibuprofen and acetaminophen.  Nausea at 5pm on 1/25/21 until 8am 1/27/21. Treated with fluids.
Information has been received on 06-NOV-2017 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown), subcutaneous on or about 19-MAY-2009 at a pharmacy, 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 04-OCT-2015, the patient was treated at an urgency care facility for the onset of a severe vesicular rash accompanied by weakened immune symptoms which was diagnosed as severe herpes zoster or shingles. On or about 13-OCT-2015, the patient sought subsequent treatment by a physician for continued and ongoing symptoms of shingles causing exceptional pain and insomnia. On or about 22-OCT-2015, the patient was treated again by the same physician for new and worsening symptoms of shingles outbreaks in the L1 dermatome with persistent burning sensation radiating throughout the leg, thigh and buttock. On or about 16-NOV-2015, the patient received subsequent treatment from a physician for ongoing painful symptoms, at which time she was diagnosed with post-herpetic neuralgia, a chronic condition of nerve pain and damage caused secondary to zoster infections. The patient has been prescribed VALTREX, Prednisone, Tramadol, Gabapentin, and Nortriptyline for management of her persistent and painful condition. 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.
Patients states the next Am after receiving the vaccine that she awoke with body aches and 104 degree fever. This lasted throughout most of the day then stopped.
a pregnant patient was administered with expired FLUZONE QIV from last season with no adverse event; a pregnant patient was administered with expired FLUZONE QIV from last season with no adverse event; Initial information received on 02-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves pregnant patient of unknown age who was administered with expired influenza quadrival A-B vaccine [Fluzone QIV]from last season with no adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.   On 02-Oct-2023, the pregnant patient was administered with expired dose of suspect influenza quadrival A-B vaccine, Suspension for injection (dose, strength: not reported) (lot UT7716KA; Expiration Date : 30-Jun-2023) via unknown route in unknown administration site for Immunization from last season with no adverse event (expired product administered) (exposure during pregnancy) (latency on same day).  Relevant prenatal testing after exposure was not reported.  Action taken : not applicable.  Outcome :  Unknown.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.   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 the 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.
Lethargic; sore arm; fever; loss of taste; loss of smell; loss of hair; loss of memory; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Feb2021 14:00 (Batch/Lot number: unknown) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing). Concomitant medication(s) included: TRESIBA; VERAPAMIL. Past drug history included: Allergy: amlodopine, reaction(s): "Allergy: Amlodopine"; Allergy: lisinopril, reaction(s): "Allergy: lisinopril". The following information was reported: LETHARGY (non-serious) with onset 20Feb2021 04:00, outcome "not recovered", described as "Lethargic"; PAIN IN EXTREMITY (non-serious) with onset 20Feb2021 04:00, outcome "not recovered", described as "sore arm"; PYREXIA (non-serious) with onset 20Feb2021 04:00, outcome "not recovered", described as "fever"; AGEUSIA (non-serious) with onset 20Feb2021 04:00, outcome "not recovered", described as "loss of taste"; ANOSMIA (non-serious) with onset 20Feb2021 04:00, outcome "not recovered", described as "loss of smell"; ALOPECIA (non-serious) with onset 20Feb2021 04:00, outcome "not recovered", described as "loss of hair"; AMNESIA (non-serious) with onset 20Feb2021 04:00, outcome "not recovered", described as "loss of memory". Therapeutic measures were not taken as a result of lethargy, pain in extremity, pyrexia, ageusia, anosmia, alopecia, amnesia.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Monday - Sore throat, or possibly heart burn, I was not sure. Monday night (1:30 am Tuesday morning). - seriously sore throat, super hot and sweaty . Could not find a thermometer though. Tuesday morning - Throat so sore and swollen I could not swallow porridge or tea.  My epiglottis was about 4-5 times normal size.  Looked like it had been pumped up.  I can't see colors but it is not look normal. Tuesday mid morning.  Temp normal, sore throat declining (I have some spray that helps) and epiglottis back to normal. Tuesday rest of day flu symptoms and a brief flash of dizziness.
diarrhea started 6/6/23. Progressed to bloody stool, pt. was evaluated in ED and diagnosed with intussusception 6/12/23
her husband had 4 doses Covid 19 vaccine/Husband has too many interactions with his drugs and was past his 5 days to start Paxlovid; her husband had 4 doses Covid 19 vaccine/Husband has too many interactions with his drugs and was past his 5 days to start Paxlovid; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Lot number: EL9266) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 included: "Drug interaction" (unspecified if ongoing), notes: Husband has too many interactions with his drugs. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "her husband had 4 doses Covid 19 vaccine/Husband has too many interactions with his drugs and was past his 5 days to start Paxlovid".  Clinical course: the patient's wife reported "it's funny because when she had her 1st Pfizer Covid shot she had the same metallic taste in her mouth and so did her husband. Husband has too many interactions with his drugs and was past his 5 days to start Paxlovid for treatment of covid-19." The reporter stated that her husband had 4 doses of the Covid 19 vaccine. Received vaccine at (withheld) hospital "for chronically ill."   Conclusion of Previously Completed Investigation: The complaint for lack of effect of COVID-19 VACCINE lot EL9266 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL9266, fill lot EL9257, and the formulated drug product lot EL9248. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  Therapeutic measures were taken as a result of drug ineffective, COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.  Follow-up (17Mar2023): This is a spontaneous follow-up report received from the product quality group. Updated information includes: product quality group investigation results.  ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300115993 Same Reporter/Patient/Drug, Different AE/Vaccine Dose;US-PFIZER INC-202300115780 Same Reporter/Patient/Drug, Different AE/Vaccine Dose;
9 days post vaccination patient reported fever, with periods of confusion, chest pain-#7 scale 1-10, center of chest described as pressure, inc with resp and leaning forward, pos diaphoresis, and nausea; headache-frontal behind eyes and neck pain.  Never had headache like this before.  Symptoms: Dyspnea, Rash, diffuse, Pain.  Myopericarditis. 12/1/08-records received-presented to clinic for follow-up on 9/30/08-Developed systemic symptoms starting on 9/25/08 with fever, chills, rash, nausea and headache. Admitted on 9/28/08 with chest pain and troponin of 0.1. DX: viral syndrome.
pt w/episode of chills & hypotension 30min p/vax;no rash or SOB, pt was hypotensive & required IV fluids;
Parent presented child at an age younger than 12 years old. Child received COVID-19 vaccine 5 months early.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 19-JUN-2015, the patient was vaccinated with improperly stored dose of VARIVAX (Merck) (lot number, dose and route were unknown). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
severe adverse reactions; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (severe adverse reactions) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (severe adverse reactions). At the time of the report, VACCINATION COMPLICATION (severe adverse reactions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications or treatment information was provided.
first dose of Gardasil 9 was administered on 02-JUL-2020, the second dose on 29-JAN-2021 and the third one was schedule for to months after the second (March 2021), This conflicts with the normal 0, 2, and 6 month dose schedule; No additional side effects to report.; This spontaneous report was received from a consumer (mother's patient) referring to a currently 19-year-old male patient. The patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not provided.  On 02-JUL-2020 and 29-JAN-2021, the patient was vaccinated with first and second dose respectively of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) by intramuscular route as routine vaccination (prophylaxis) (concentration, dosages, lot numbers and expiration dates were not reported), also the patient had the third dose scheduled for 2 months after the second (approximately on March 2021) (inappropriate schedule of product administration). No additional side effects to report.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were recovered/resolved. It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that she received the 1st dose of SHINGRIX on left arm approximately 5 months ago. The patient experienced severe pain in left arm after receiving vaccine and could not raise or move her arm for 5 days. The pain lasted for 5 days. The reporter consented to follow up and the patient did not provide the date of birth.
Sever Flu like symptoms that included high fever, head aches and body pains lasting for 48 hours.
Body aches, chills, shaking, headache, neck pain, fever, insomnia, rust colored spots on palms and fingers and finger tips
pt recvd vax;a few hrs p/ vax,devel fever of 104.2; swelling & erythema of thigh;2 days later cont fever,swollen leg;to er;WBC=36,000;IV ceftriaxone given;
Patient was given the normal dose of fluzone quadrivalent instead of the high dose for 65+
20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range; 20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) and PRODUCT TEMPERATURE EXCURSION ISSUE (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049l21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jun-2022 at 11:43 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2022 at 11:43 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) and PRODUCT TEMPERATURE EXCURSION ISSUE (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Patient received half dose. It was reported that no adverse event occurred at time of administration or were reported thereafter. Treatment medications were not reported.
Got the vaccine about 12:30 and an hour later she said she felt she felt she was having difficulty swallowing, but she does have history if anxiety but was given 1 Benadryl  by nurse Elissa  and observed for her for 20 min then pt. claimed to felt fine and went to, nurse instructed her to call if she had any problem.
Skipped period 73 days after both doses. June1-got period and it was full of mucus and brown clots-lasted a little over a week. 7/26 period was normal again.
SORE ARM, HURTING FOR A COUPLE OF DAYS AFTER RECEIVING INITIAL DOSE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194, and expiry: UNKNOWN) dose was not reported, administered on 07-DEC-2021 for prophylactic vaccination.  No concomitant medications were reported.  On an unspecified date, the patient experienced sore arm, hurting for a couple of days after receiving initial dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, hurting for a couple of days after receiving initial dose. This report was non-serious.
3 PEOPLE I KNOW DIED FROM COVID; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer via a company representative concerned multiple patients (03) of unspecified race and ethnicity. No past medical history or concurrent conditions were reported. On an unspecified date, the patients previously received covid-19 vaccine ad26.cov2.s vaccination (unspecified manufacturer) (dose number in series: 1), (suspension for injection, route of admin not reported, batch number and expiry were unknown) dose was not reported, 1 total, administered for prophylactic vaccination. No adverse events were reported following administration of covid-19 vaccine ad26.cov2.s (dose number in series:1). The patients received covid-19 vaccine ad26.cov2.s (dose number in series 2), (suspension for injection, route of admin not reported, batch number and expiry were unknown) dose was not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, following administration of covid-19 vaccine ad26.cov2.s, the patients experienced coronavirus disease (Covid-19) although they were fully vaccinated and boostered (captured as: suspected covid-19 and suspected clinical vaccination failure) (dose number in series 2).  On an unspecified date, the patients died due to Covid-19. It was unknown if autopsy was performed or not (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome for 3 people died from Covid was fatal, and the outcome of the suspected clinical vaccination failure was unknown/not reported. This report was serious (Death, and Other Medically Important Condition) This report was associated with product quality complaint: 90000207716. This case, from the same reporter is linked to 20211243153.; Sender's Comments: V0: 20211240566-covid-19 vaccine ad26.cov2.s-3 people i know died from Covid. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20211240566-covid-19 vaccine ad26.cov2.s- suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: 3 PEOPLE I KNOW DIED FROM COVID
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender, who was admitted to an unspecified hospital, on an unspecified date for an unspecified reason. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (route of administration and lot number were not reported). No other concomitant medications were reported. Pharmacist noted that patient was administered PNEUMOVAX 23 twice in a short period of time. While in the hospital the patient was administered PNEUMOVAX 23 and then admitted to an unspecified nursing home on an unspecified date where PNEUMOVAX was administered again on an unspecified date. No adverse effect noted. The outcome of the patient at the moment of the report was unknown. The relationship between therapy with PNEUMOVAX 23 and the events was unknown. Additional information has been requested.
Moderna Booster (0.25ml) vaccine was drawn up after max 20 drawn doses allowed. Proper aseptic techniques were used during dose extraction and vaccine was inspected prior to administration. Patient was given correct dose (0.25ml) and was monitored for 15 minutes after vaccination. No adverse event occurred after administration.
stomachache shortly p/vax & rash;w/in 3 days rash covered entire body-felt flush-hot but not temp;stomach bothered pt for quite a few days & sleep was very very restless;rash on stomach & head;
Dizziness; Weakness; Trouble breathing; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ASTHENIA (Weakness) and DYSPNOEA (Trouble breathing) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.     On 24-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced DIZZINESS (Dizziness), ASTHENIA (Weakness) and DYSPNOEA (Trouble breathing). At the time of the report, DIZZINESS (Dizziness), ASTHENIA (Weakness) and DYSPNOEA (Trouble breathing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Aug-2021, Heart rate: fast (High) Fast.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient takes psychiatric medication. No treatment drug details was reported.
I woke up at 4 am and again with vertigo.  While it has subsided, the effects lasted through Wednesday, October 12.  I am seeking further medical attention but don't have an appointment yet.   I used the internet to try the exercises to relieve the vertigo.  It seemed to have helped some but I still have an occasional dizzy moment which is why I'm seeking further information about the condition and how to address is.
Sudden onset of severe headache and back pain. Pain increased throughout the evening and patient took Tramadol for the pain. Headache and back pain persisted at a lower level the next day. Fatigue symptoms started next day. Headache and back pain tapered off on Monday. Fatigue tapered on on Wednesday.
Information has been received from an adult female consumer who in her childhood was vaccinated with a dose MMR II. In approximately January 2009 she had low titers for rubella. Her mumps and Measles titers were normal. No adverse effects noted. This is one of two reports from the same source. No further information is available.
Angioedema and angioedema-swollen lips; mild tenderness at injection site. Diphenhydramine 25 mg BID.