chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from two contactable consumers (husband and daughter of the patient). A 65-years-old female patient received PREVNAR 13, via an unspecified route of administration in Jun2016 at single dose for immunization at physician office. Medical history included ongoing thyroid disorder. The patient previously received a pneumococcal vaccine on unknown date for immunisation. Concomitant medication included ongoing levothyroxine (unknown manufacturer) at 150mg once a day, for thyroid, taking for probably 20 years. The patient experienced swelling/everything swelling in her body/swelling in her upper extremities got so bad/body started swelling within 3 days of getting the shot/everything in her body was swelling, both hands, feet, knees, elbows on unspecified date in Jun2016 with outcome of not recovered; knees hurt on an unspecified date with outcome of unknown; hardly gets out of bed/can't get out of bed/ has to lie flat because otherwise her knees hurt on an unspecified date with outcome of unknown; still sick in bed on an unspecified date with outcome of not recovered; has residual pain/had all of this pain on an unspecified date with outcome of unknown; neck surgery to fused neck on an unspecified date with outcome of unknown. The patient have gone to the emergency room three times, not admitted to hospital. The daughter of the patient said that her mother got pneumococcal 13-val conj vac and her body has decompensated. The consumer said that this product poisoned her mom and her mother was still sick in bed. Her mother couldn't get out of bed and had residual pain with no identifiers. The daughter reported also that body started swelling within 3 days of getting the shot. Everything in her body was swelling. Both hands, feet, knees, elbows. It has been worse every day since then. She regularly was getting worse, it was still bad. Her swelling in her upper extremities got so bad and her mother had all of this pain. She said that they have done all kinds of tests, X-rays, and seen chiropractors, and no one has an answer. Have had lots of treatments, everything can think of she has had. First started given X-rays of neck, lungs, and had MRIs. Have had blood work checking kidneys, liver, heart, brain and for lupus, results were all good. Ended up having neck surgery to fused neck, thinking that was the problem, risked her life again with no affect. Seen two Rheumatologists, a Neurologist, Hematologist, and Allergist. She has gone through pain management, she was on Morphine from Mar2017 to Aug2017 and was trying to get off of that. Had knees x-rayed a week before, orthopedic surgeon reviewed them and showed swelling.
ongoing, prolonged headache migraine started within 24 hours of vaccine, to date 19 days of headaches out of 20,  same spot on forehead between  eyes above,  requires multiple doses of pain medication to subside the pain and has required migraine ( headache) cocktail of Benadryl/ ibuprofen/ Compazine on occasion to relieve pressure and pain of headaches,  than it returns.  Extenuating headaches after Pfizer vaccine,  seems the vaccine has triggered a  prolonged immune response we have yet been able to stop.  Constant daily headache same area requiring more medication and lasting longer, some days after first does of tylenol he will need a 2nd dose of ibuprofen 4/5 hours later as the headache with first does of pain meds did not remove the headache. , achy pressure pain same with each headache, not sever pain but moderate and affects daily movements and activities as to not escalate the pain further,  drinking multiple bottles of water and trying to stay hydrated along with medications trying to remedy the prolonged headache from the vaccine . Drs have very limited information on how to treat or handle prolonged headaches from vaccination, information on these events or recommended treatments not easily found.
sore throat; joint pain; chills; severe headaches; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), ARTHRALGIA (joint pain), CHILLS (chills) and HEADACHE (severe headaches) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD and Hypertension.   On 11-Feb-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 OROPHARYNGEAL PAIN (sore throat), ARTHRALGIA (joint pain), CHILLS (chills) and HEADACHE (severe headaches). At the time of the report, OROPHARYNGEAL PAIN (sore throat), ARTHRALGIA (joint pain), CHILLS (chills) and HEADACHE (severe headaches) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  Treatment details included aspirin.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 13Jan2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing); "Allergy to NSAIDs" (unspecified if ongoing); "Seafood allergy" (unspecified if ongoing); "Partial thryrodectomy" (unspecified if ongoing); "pre-diabetes" (unspecified if ongoing). 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 "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19, Paxlovid was administered from 03Oct2023 to 05Oct2023. The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
The Tdap vaccine was administered instead of the correct vaccine Dtap. They have received a reduced dose. No reaction or side effect has been reported by parent or witnessed.
on 7/25 mom reported that patient had red knot to LAT day after inj of DTaP.  States patient doing fine now, no symptoms, fever, knot gone.
This is a spontaneous report from a contactable consumer reporting for herself. This 76 year-old female patient received the first dose of PREVNAR 13 intramuscular on 09Feb2015 at around 11:00 am at 0.5 ml single. Medical history included asthma and lung problems since she was 16 year-old, pneumothorax spontaneous from Jul1999 to an unknown date. The patient reported that before the vaccination she was in disgustingly good health and all the tests had normal results. Concomitant medications included ALBUTEROL, FLOVENT. On 09Feb2015 the patient experienced pain at injection site when the vaccine was injected, she had pain and soreness at the injection site, she had headache, tiredness, a terrible muscle pain all night and joint pain, the area where she got the vaccine was swollen, she did not sleep well in the night. The consumer stated that she has already called her doctor office and notified them of her side effects. She added that she has gotten the regular pneumonia vaccine in the past for immunisation and not had any issues with it. The patient was not recovered from pain, soreness and swelling at the injection site, muscle pain, joint pain, she was recovering from headache and tiredness, outcome of sleep difficulty and pain during the injection was unknown.
currently sick w/ sinus infection; I am sick; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (currently sick w/ sinus infection) and ILLNESS (I am sick) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Sinus infection.    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, the patient experienced SINUSITIS (currently sick w/ sinus infection) and ILLNESS (I am sick). At the time of the report, SINUSITIS (currently sick w/ sinus infection) and ILLNESS (I am sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications was not provided.  Concomitant medications was not provided.  Patient is sick and don't know if patient can take second dose or wait.  After first dose patient experienced currently sick w/ sinus infection.
Bloody stools starting first Typhoid pill on 5/11/03. Has BM qd however bloody stools occur only 12 hours after taking Typhoid pill. Feels "unwell". Low grade fever.
fever, chills, body aches, headache, fatigue, sore throat...ongoing for two days
PATIENT WAS GIVEN JANSSEN COVID 19 VACCINE  AT AROUND 12PM WHEN PATIENT WAS ACCOMPANIED BY HIS SON. HE WAS OBSERVED FOR 15 MINUTES AFTER THE VACCINATION AND LEFT PHARMACY WITHOUT ANY PROBLEM. PATIENT'S DAUGHTER CALLED AROUND 6PM AND REPORTED HER FATHER JUST DIED.  SHE REPORTED HER FATHER ALL OF SUDDEN WAS SHAKING AND DIED RIGHT AFTER.
Administered Pneumococcal vaccine which expired 06/04/2005. No adverse event.
BLURRY VISION; NERVOUSNESS; PAIN DURING SLEEP; WEAKNESS IN MUSCLES/ARM/CANNOT LIFT MILK JUG; PAIN IN ELBOW; PAIN IN ARM AND SHOULDER; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient had 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: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-MAY-2021, the subject experienced pain during sleep. On 04-MAY-2021, the subject experienced weakness in muscles/arm/cannot lift milk jug. On 04-MAY-2021, the subject experienced pain in elbow. On 04-MAY-2021, the subject experienced pain in arm and shoulder. On 09-MAY-2021, the subject experienced nervousness. On 09-JUN-2021, the subject experienced blurry vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nervousness, pain in arm and shoulder, weakness in muscles/arm/cannot lift milk jug, pain during sleep, blurry vision, and pain in elbow. This report was non-serious.
Red area with small bumps that continuously itch around  injection site. Using Benadryl in attempt to relieve itching. No other treatment sought at this time.  I have never had an allergic reaction to any previous injection or medical treatment
This spontaneous report as received from a healthcare worker (medical assistant) refers to 16 patients of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were vaccinated with improperly stored doses of ROTATEQ oral liquid (lot# L008054, expiry date: 30-NOV-2016) (strength and dose unspecified). No concomitant medications were reported. No adverse effect were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
I received the vaccination on a Monday afternoon.  That night I started to feel achey.  I woke up early Tuesday morning with severe aches, severe chills and sweating.  I fell back asleep and when I woke up I felt fine.  Tuesday night I fell asleep and then woke up early Wednesday morning to severe aches, severe chills and sweating (my bedsheets were soaked.  I fell back asleep and woke up Wednesday morning and felt fine.  I went to work and felt fine.  I went to bed Wednesday night feeling fine and then woke up early Thursday morning with chest pain and my head felt like all the blood rushed to it.  I felt lethargic and my chest felt like there was pressure, not a stabbing pain.  More like my chest was swollen.  I went to work and took it easy.  The pressure/pain subsided by the time I went to bed and I thought I would feel fine in the morning.  Friday Morning I woke up to more chest pain/inflamation that was also in my head and also spread to my arms and throat.  I then went to the ER.
Severe swelling, redness, & bruising at injection site. Rash on both arms, legs, feet, back, stomach, & neck. Lots of itching, skin was crawling. Swelling with some blistering. The reaction continued to progress until 10/08/2014 when Benadryl was taken & a Kenalog shot was administered. Benadryl was taken through 10/10/2014 to control reaction.
Stroke like symptoms as an emergency case experienced approximately 6 hours post injection. Scans show no stroke. Patient in hospital with stroke like complications.
Fever; Weakness/Lack of energy; Fatigue; Muscle ache; Limited daily life activities; This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced fever, weakness, fatigue, muscle pain and activities of daily living impaired. On an unknown date, the outcome of the fever, weakness, fatigue, muscle pain and activities of daily living impaired were unknown.   It was unknown if the reporter considered the fever, weakness, fatigue, muscle pain and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced fever, weakness, fatigue, lack of energy and muscle aches. His daily life activities were limited for 3 to 4 days. Call  The caller did not want to provide any additional details in regards to the adverse event, therefore limited data was available.
pt recvd vax NOV93 & 2 to 3 months later devel arthritic type problems characterized by fatigue, muscle pain, & joint pain; pt was treated w/Relafen, Lodine & diclofenac; pt reports that pain started to subside as of JUL94;
1st dose Mar2019, 2nd not yet; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in March 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 26-OCT-2022 Reporter's comment: The pharmacy intern reported that the patient had not received a second dose of Shingrix yet. The health care professional wanted to be anonymous. The reporter consented to follow up by email. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
The patient stated he started feeling chest pain as soon as vaccine was injected but stated he believed it was anxiety. This was the patient's first dose of Pfizer.  The patient stated the chest pain continued on and off after he received the vaccine but he didn't contact his physician about it. He came in for his second dose and reported that this had occurred to pharmacy staff and was advised to speak to his physician before receiving his second dose.
Information has been received from a healthcare worker referring to unspecified number of patients of unknown age and gender. The patients' medical history was not reported. On an unknown date the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, strength, lot# and therapy type unknown). No concomitant medication was reported. No adverse effects reported. It was unknown if the patients had sought medical attention. No product quality issue (PQC) was involved. Action taken and outcome was not provided. This is one of several reports received from the same source. Additional information has been requested.
arm pain; body ache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm pain), MYALGIA (body ache) and PYREXIA (Fever) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm pain), MYALGIA (body ache) and PYREXIA (Fever). The patient was treated with EMU OIL, TROLAMINE SALICYLATE (BLUE EMU CONTINUOUS PAIN RELIEF) for Pain, at an unspecified dose and frequency; MENTHOL, METHYL SALICYLATE (BENGAY [MENTHOL;METHYL SALICYLATE]) for Pain, at an unspecified dose and frequency and LIDOCAINE for Pain, at an unspecified dose and frequency. On 20-Mar-2021, VACCINATION SITE PAIN (arm pain), MYALGIA (body ache) and PYREXIA (Fever) had resolved.            No concomitant medications reported.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-167601 (Patient Link).
Pain on left side-arm/back. Can't breathe, muscle spasm. Got 3 shots-took pain away-went home. Pt took ADVIL every 6 hours. Rectal bleeding due to ADVIL.
Pharmacist was diluting doses of vaccine for vaccination clinic in hospital.  After dilution of 3 vials, the compounding pharmacist passed off to the on coming pharmacist.  The on coming pharmacist grabbed one of the empty vials of vaccine and added diluent to the empty vial.  6 doses were drawn up and delivered to the vaccine clinic with only diluent in the syringe.  The pharmacist in the clinic noted the number of syringe doses exceeded the number possible from the amount of vials used and sequestered all vaccine doses in clinic.  It is possible some of the patients in the first hour received diluent instead of vaccine but is not known for certain.  The pharmacist at the clinic kept the record of all the patients in the morning clinic.  Would you recommend any actions prior to the second dose for these patients?  Is there any utility in antibody testing the identified patients prior to administering the second dose?  Have parameters been established for titter?  Please provide direction.
arm pain; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899 and expiry date: unknown), via an unspecified route of administration on 04Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got her first vaccine back and everything went great. She had that usual arm pain on Jan2021. There was no treatment for the event. Outcome of the event was unknown.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient) for a Pfizer sponsored program (159558). A male patient received the 1st dose of BNT162B2 (Comirnaty, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient developed malaise/not feeling well, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Severe chest pain and difficulty breathing, Thought I was having a heart attack. Happened 5 or 6 times over several weeks after the vaccine. Don?t know if I have permanent heart damage (checking none of the above for item 21 since I don?t know)
Exposed to a low temperature of 31.5 degrees Fahrenheit; Patient born on Jun-2023 and received vaccine between 15 to 21st jun 2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a neonate male patient who received HAV (Havrix) (batch number PB5JA, expiry date 14-FEB-2025) for prophylaxis.   In JUN-2023, the patient received Havrix. On 15-JUN-2023, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: Exposed to a low temperature of 31.5 degrees Fahrenheit). In JUN-2023, the patient experienced inappropriate age at vaccine administration (Verbatim: Patient born on Jun-2023 and received vaccine between 15 to 21st jun 2023). The outcome of the incorrect storage of drug and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 03-AUG-2023 The reporter reported that the Havrix vaccine was exposed to a low temperature of 31.5 degrees Fahrenheit on 15th June 2023 and administered to the patient between 15th June 2023 and 21st June 2023. The reporter did not had specific date of administration. The reporter stated that at the time of reporting, the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The Havrix vaccine temperature was exposed to 31.5 degrees Fahrenheit, which led to incorrect storage of drug. The patient received Havrix who was younger than the indicated age which led to inappropriate age at vaccine administration. The reporter did consent to follow up. This case was 1 of 9 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2023105921:same reporter US-GSK-US2023105918:same reporter US-GSK-US2023105928:same reporter US-GSK-US2023105926:same reporter US-GSK-US2023105925:same reporter US-GSK-US2023105927:same reporter
Thighs felt achy and starting to have pain. Elevated feet. Hot and cold sensation through body. Legs started feeling shaky and unable to bear weight coming down stairs. By 12/15/13 pm could not walk.
Patient experienced a stroke 8 days after receiving GARDASIL 9.; This spontaneous report was received from a physician via company representative and refers to an adult patient ("in early 40s") of unknown gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, strength, lot #, expiration date, site and route of administration were not provided) for prophylaxis.  On an unknown date, 8 days after receiving hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patient experienced a stroke. On an unknown date, the patient recovered from the event. It was unknown whether the patient received any treatment for the event.  The causal relationship between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, the event of stroke was determined to be medically significant.
A report has been received from a literature source concerning an adult subject of unknown gender, who had been receiving nasal FLUMIST started on an unknown date. The patient experienced gastrointestinal symptoms. The outcome of the event of gastrointestinal symptoms is unknown. The report was considered to be non-serious.