chrisvoncsefalvay/vaers-outcomes huggingface dataset:
15NOV cold/flu sx plus severe nausea & vomiting; treated @ ER w/antiemetics & IV fluids;
This spontaneous report was received from a pharmacy technician and refers to a 26 year old female patient. There was no information about the patient's concur en conditions, concomitant therapies or medical history provided. On 10-JAN-2017 the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis(dose, route of administration, lot# and expiration date were not reported. On 07-FEB-2017 the patient was vaccinated with the second dose of GARDASIL 9 for prophylaxis(dose, route of administration, lot# and expiration date were not reported. Not adverse effects were reported. Additional information has been requested.
A dose of Gardasil 9 was inadvertently administered to an 8 year old patient; This spontaneous report was received from a physician and refers to an 8-year-old of unknown gender patient. The patient's medical history, concurrent conditions and concomitant therpaies were not reported.   On 02-SEP-2020, the patient was inadvertently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # 1637651 and expiration date: 09-JUN-2022) (dose and route of administration were not reported) for prophylaxis (product administered to patient of inappropriate age). combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: 1637651; expirationdate: 09-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Nausea, vomiting and diarrhea reported by mother that statrted 2 days after vaccination an continued for 3 days.
CHILLS; BODY ACHE; FATIGUE; HEADACHE; WELTS ON LEFT ARM; SMALL COUGH; RASH ON LEFT ARM; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: cancer, no alcohol use, and non smoker, and other pre-existing medical conditions included: The patient was not pregnant at the time of reporting. The patient had no known allergies and no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 07-OCT-2021 for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported. On OCT-2021, the patient experienced small cough. On OCT-2021, the patient experienced rash on left arm. On OCT-2021, the patient experienced welts on left arm. On 07-OCT-2021, the patient experienced fatigue. On 07-OCT-2021, the patient experienced headache. On 08-OCT-2021, the patient experienced body ache. On 08-OCT-2021, the patient experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, small cough, chills, fatigue, headache, and welts on left arm on OCT-2021, and had not recovered from rash on left arm. This report was non-serious.
Information has been received from a 57 year old female registered nurse consumer who in 2000 was vaccinated with the 3 dose series of RECOMBIVAX HB (lot #s not reported) (manufacturer unknown). The consumer experienced another needle stick 10 years later and a titer was drawn. The titer was negative and she received another 3 dose series of RECOMBIVAX HB (lot #s not reported) (manufacturer unknown). Not titer was drawn after the series. The consumer sought medical attention. At the time of the report, the patient's outcome was unknown. No further information is available.
Mom reported an episode of apnea and turning blue during waiting time at ER. Mom took him for constipation one day after vaccines with no report of this in office visit. No abnormalities during a 48 hour observation in office. Discharge summary states infection. msv
Headache; Fatigue; all over joint and body pain; all over joint and body pain; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history included: "Cystic fibrosis" (unspecified if ongoing), notes: Cystic fibrosis Caller says this is genetic so report it as at birth. There were no concomitant medications. The following information was reported: HEADACHE (non-serious), outcome "not recovered"; FATIGUE (non-serious), outcome "not recovered"; ARTHRALGIA (non-serious), PAIN (non-serious), outcome "not recovered" and all described as "all over joint and body pain". Therapeutic measures were taken as a result of headache, fatigue, arthralgia, pain. Additional information: Patient got the Pfizer COVID-19 vaccine bivalent booster on the 06Oct and reported adverse reactions as she was now off work for being sick intermittently, but not intermittently, since vaccine. Now she was on steroids to suppress her immune system. She started on the same day as her doctor appointment on 18Oct2022. She was taking Prednisone 20mg once a day by mouth, and the reason for that was headaches, fatigue, all over joint and body pain since the vaccine was administered, with no other signs of being sick. She was not congested, no cough, it was like the reaction after her initial doses but it has not gone away. Her symptoms started on 06Oct2022, and her headaches stayed about the same since they started. She has treated those with Ibuprofen over the counter, she was taking 600mg PRN. Her fatigue treatment was taking time off work and sleeping, and it got worse over time. Her aches got worse over time as well. She says that she was going to have a recheck on Monday with her doctor about how long she was going to take the Prednisone. Pfizer COVID-19 vaccine bivalent booster: Caller does not see LOT/EXP on the receipt she got from # (facility name withheld), she does not have injection records, those would be on # (facility name withheld) site which she has not figured out how to access yet. She doesn't have a vaccine card to provide NDC/LOT/EXP from previous doses of Pfizer COVID-19 vaccine either, those are in her employee file.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201249184 same product, patient and different dose.;
fell on the floor; arm was really sore; felt weak; could not move; fever; This spontaneous case was reported by a patient and describes the occurrence of FALL (fell on the floor), PAIN IN EXTREMITY (arm was really sore), ASTHENIA (felt weak), MOBILITY DECREASED (could not move) and PYREXIA (fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21A) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis.    On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FALL (fell on the floor), PAIN IN EXTREMITY (arm was really sore), ASTHENIA (felt weak), MOBILITY DECREASED (could not move) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Fever, at a dose of unk dosage form. At the time of the report, FALL (fell on the floor), PAIN IN EXTREMITY (arm was really sore), ASTHENIA (felt weak), MOBILITY DECREASED (could not move) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was multiple sclerosis medication.
Shingles. Left anterior and posterior flank area. Several scattered crusted vesicular lesions. Treated with acyclovir 800mg PO 5 times daily for 7 days. Naproxen PRN for pain. Topical calamine lotion PRN.
Nausea; Fatigue; Chills; Diarrhoea; 6lb weight loss within 24 hours; Constant burping; Bloating; Food taste bland; Loss of appetite; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Er8732) via an unspecified route of administration in the left arm on 28Mar2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as no. The patient had allergies to lisinopril and losartan. Concomitant medications included vitamins (MANUFACTURER UNKNOWN) and liraglutide (SAXENDA) weight loss injection. The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 29Mar2021 at 18:30, the patient experienced nausea, fatigue, chills, diarrhea for at least 24 hours, 6lb weight loss within 24 hours, loss of appetite, food taste bland that normally the patient find good, constant burping and bloating. 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. No therapeutic treatment was taken for the reported events. The clinical outcome of the events diarrhea recovered on 30Mar2021. The clinical outcome of the events nausea, fatigue, chills, diarrhea, 6lb weight loss within 24 hours, loss of appetite, food taste bland that normally find good, constant burping and bloating were not resolved at the time of this report.   No follow-up attempts are needed. No further information expected.
Pt recv vax on 11/16/98; 3 hr post vax pt exp nausea, dizzy, headache
Information has been received from a registered nurse concerning a 20 year old female patient with allergy to amoxicillin and no pertinent medical history who on 30-DEC-2011, was vaccinated with the first dose of GARDASIL (lot # not reported) 0.5 mL IM. There was no concomitant medication. Nurse reported that at an unspecified time after receiving GARDASIL, the patient experienced a broken hip and was hospitalized. At the time of the report, the patient was recovering from broken hip. Additional information has been requested.
Patient reported a funny feeling of the tongue about 20 minutes after getting the shot. We offered to call the ambulance to come get her and she refused. Her husband transported her to the emergency room.
has been dealing with side effects from Shinglix vaccination; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. In August 2019, unknown after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was not recovered/not resolved.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The patients friend was the reporter.  The age at vaccination was not reported. The patient experienced side effects after receiving Shingrix.
Redness over the entire shoulder; The injection site was hot; Injection site had swelling; This spontaneous case was received on 03-Sep-2020 from other non-health professional via agency (reference number: SEQW20-01221) and concerned a 33-year-old, female patient.   The patient's medical history and concomitant medications were not reported.   The patient received multiple vaccines of all types in the past, and no adverse events were reported.  On 27-Aug-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 mg (as reported), route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number reported was 279827 and expiry date was 18-Jun-2021.   On 28-Aug-2020, 24 hours after receiving Flucelvax QIV, the patient's injection site had swelling. The patient experienced redness over the entire shoulder and the injection site was hot.   The patient was treated with Medrol Dosepak (methylprednisolone).   On an unspecified date in Aug-2020, the patient recovered from the events.  The reporter assessed the events to be related to Flucelvax QIV.  The reporter assessed the events as non-serious.  Company comment: The patient developed erythema, vaccination site warmth and vaccination site swelling one day after vaccination with the suspect product, Flucelvax QIV. Chronology is plausible. No information regarding concomitant medication and medical history was provided. Based on provided information, causal relationship between the suspect product and all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed erythema, vaccination site warmth and vaccination site swelling one day after vaccination with the suspect product, Flucelvax QIV. Chronology is plausible. No information regarding concomitant medication and medical history was provided. Based on provided information, causal relationship between the suspect product and all events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).
Two weeks after the second dose was administered, I started having constant headaches every day. Until being hospitalized from April 16, 2021 to April 30, 2021 with symptoms of headache, stiff neck, loss of mobility in lower and upper extremities with unexplained seizures. I was treated with a diagnosis of aseptic meningitis but with negative results. I was discharged with physical therapy treatment as I lost mobility and muscle function in my legs and arms. Right now today 7/12/2021 I am currently still in physical therapy.
every bone of the body was hurting; the arm hurt pretty much all day; slept all day; started not to feel good; muscle ache everywhere; 99°F fever; all the joints hurt bad/hurt real bad on the joints; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (every bone of the body was hurting), PAIN IN EXTREMITY (the arm hurt pretty much all day), SOMNOLENCE (slept all day), FEELING ABNORMAL (started not to feel good) and MYALGIA (muscle ache everywhere) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052F21A, 007M20A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL and AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3) for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced BONE PAIN (every bone of the body was hurting), PAIN IN EXTREMITY (the arm hurt pretty much all day), SOMNOLENCE (slept all day), FEELING ABNORMAL (started not to feel good), MYALGIA (muscle ache everywhere), PYREXIA (99°F fever) and ARTHRALGIA (all the joints hurt bad/hurt real bad on the joints). The patient was treated with PARACETAMOL (TYLENOL) for Joint pain, at an unspecified dose and frequency. At the time of the report, BONE PAIN (every bone of the body was hurting), PAIN IN EXTREMITY (the arm hurt pretty much all day), SOMNOLENCE (slept all day), FEELING ABNORMAL (started not to feel good), MYALGIA (muscle ache everywhere), PYREXIA (99°F fever) and ARTHRALGIA (all the joints hurt bad/hurt real bad on the joints) had resolved.
Flushing, tremor, feeling hot 10 minutes after administration. Given Benadryl 25mg orally and Loratadine 10mg orally transferred to ED.  Received Dexamethasone 10mg IV, Benadryl 12.5mg IV, Famotodine 20mg IV, and Normal Saline 1000mL bolus. Discharged home.
Headache, Myalgia, Fatigue Narrative: Slight fatigue, soreness at injection site, slight headache
Lower left side of lip numb for 1/2 hour after leaving facility. Next day 4x3 inch area around site red, hard, swollen and hot to touch.  Extremely itchy.
Mother called to report child had "pimple" on left side and diarrhea 8/1/06.  8/2/06 had rash on abdomen, side and back.  ER diagnosed "chickenpox shingles".
headache; sneezy; itchy nose with no mucus; sweating; weird sinus pressure that leads to increased light sensitivity; weird sinus pressure that leads to increased light sensitivity; feeling of itchiness in the back of the throat that goes away; fever of 100.5; cold sweat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP) from medical information team. The reporter is the patient.  A 37 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 13Sep2021 13:00 (Lot number: FE3592) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "RA", start date: 2009 (ongoing), notes: stopped methotrex in 2012. There were no concomitant medications. Past drug history included: Methotrexate, stop date: 2012, notes: stopped methotrex in 2012. The following information was reported: HEADACHE (non-serious) with onset Sep2021, outcome "not recovered", described as "headache"; SNEEZING (non-serious) with onset Sep2021, outcome "recovered" (2021), described as "sneezy"; NASAL PRURITUS (non-serious) with onset Sep2021, outcome "recovered" (2021), described as "itchy nose with no mucus"; HYPERHIDROSIS (non-serious) with onset Sep2021, outcome "recovered" (2021), described as "sweating"; PARANASAL SINUS DISCOMFORT (non-serious), PHOTOPHOBIA (non-serious) all with onset Sep2021, outcome "recovered" (2021) and all described as "weird sinus pressure that leads to increased light sensitivity"; THROAT IRRITATION (non-serious) with onset Sep2021, outcome "recovered" (2021), described as "feeling of itchiness in the back of the throat that goes away"; PYREXIA (non-serious) with onset Sep2021, outcome "recovered" (2021), described as "fever of 100.5"; COLD SWEAT (non-serious) with onset Sep2021, outcome "recovered" (2021), described as "cold sweat". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: When probing medical history and concomitant medications she reported at one time doctors were testing her for arthritis or rheumatoid arthritis. She was taking medication at that time which was about 10 years ago. She decided to try a more preventative, natural treatment instead. She was never diagnosed with arthritis or rheumatoid arthritis but she definitely has some inflammation or maybe an autoimmune disorder. She also had a skin reaction on her left arm, top of her hands and upper arm right by her elbow. She had a weird itchy rash. She experienced headache, sneezy/itchy nose with no mucus/no runny nose, sweating, weird sinus pressure that leads to increased light sensitivity, a feeling of itchiness in the back of the throat that goes away, a fever of 100.5, sweating (has a pre-existing condition of hyperhidrosis), and broke a cold sweat in the middle of the night. Overall, she described was as feeling sick without actually being sick and that the AEs she experience comes in a wave (repeating side effects that comes and goes).  No follow-up attempts are possible. No further information is expected.
On the 1st day, I had a migraine. 2nd day (29th) fever, chills, nausea, vomiting - woke up with it and that lasted about four or five days And I had meds to treat it.. Went to work but had to leave work - acutely ill. When I went home, I had a rash across my abdomen. On the 30th I went to urgent care, I had a rash across my neck when I woke up. Rash kept spreading. They gave me a prescription for steroids and a cocktail of meds to reduce spread of rash. Watched me for 30 min to make sure I wasn't having airway restrictions and they sent me home. Had it for a week and a half. Went to PCP and came up with an action plan to get my next shot.
Patient recieved flu mist vaccine earlier in the day. At 2:45pm patient was unresponsive for 10+ minutes in the school yard. Ambulance called and taken to Emergency room
Caller who was administered 1st GARDASIL 9 Dose on 12/28/2022 was administered 2nd GARDASIL 9 Dose on 03/23/2023; No additional AE reported; This spontaneous report has been received from the patient referring to themself as a patient of unknown age and gender.  The patient's medical history, past drug reactions or allergies, concurrent conditions, and concomitant medications were not reported.  On 28-DEC-2022, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection and the second dose was administered on 23-MAR-2023 (strength, doses, route of administration, anatomical location, lot numbers, and expiry dates were not provided) administered as prophylaxis (Inappropriate schedule of product administration).The reporter requested HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) prescribing information specific to alternative schedule.  No further information provided. No additional adverse event was reported. In addition, the patient did not wish for physician to be contacted in future.
Feeling glooomy snd a little foggy in the head since day one. Tightness in my leggs  thighs. Feeling warm not fever.  Not as much on day 7
Patient recieved pneumonia and flu vaccines on 11/2/10, started feeling flu like symptoms (body aches and fatigue) also left arm soreness, erythema and swelling patient told to rest ice the arm and take ibuprofen as needed.
This spontaneous report was received from a nurse and refers to multiple unspecified patients. There was no information regarding the patients' pertinent medical history, concomitant medications, drug reactions or allergies provided. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M036059, expiration date 03-JUN-2019 for prophylaxis. The vaccines were stored in temperature from 9°C to 25°C for 4 hours and 30 minutes. There was no previous temperature excursion. The call was because of digital data logger. No adverse effects were reported. There was no product quality complaint involved in this case. Additional information has been requested.