chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu; Initial information was received on 04-Oct-2021 regarding an unsolicited valid non-serious case from social media via consumer/non-health care professional.  This case involves a patient (unknown demographics) who had flu (influenza) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   Medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Only time I ever had the flu was the one time I took a flu shot so no thanks but you go ahead!"  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.   It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of the event was unknown.  There will be no information available on the batch number for this case.
Meningitis; drug ineffective; High fever; Total hearing loss; This is a spontaneous report from a Pfizer sponsored program Prevnar 13. A Contactable Pediatric Nurse reported the niece.  A 15-18 month old female patient of an unspecified age received 2 doses of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) at single dose on an unspecified date for pneumococcal immunisation, not prescribed by the reporting nurse.  The patient medical history and concomitant medications were not reported.  The patient only had 2 doses of PREVNAR and she was in daycare; at age 15-18 months she got high fever and was taken to hospital and was in hospital for a length of time (1 or 2 weeks). She was diagnosed in hospital with meningitis and then later (2-3 months) 2-1 months with total hearing loss that was linked to the meningitis and high fever. The outcome of the events was unknown.  The reporting nurse was actually not sure if PREVNAR was 7 or 13.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded.
10/16- report of sudden onset of right sided facial and eye drooping, declined to go to ER for evaluation .  Symptoms persisted over the weekend, seen by physician this morning, prescribed  60 mg oral prednisone.
Information has been received from a healthcare worker concerning unspecified patients who might on unspecified dates have been administered with an unspecified number of unspecified doses of improperly stored ROTATEQ (lot # L027067, Expiration Date 06-APR-2017) orally. The ROTATEQ was stored at 30.4 F for 8 hours 30 minutes. There was no previous excursions. No data logger reported. This is one of several reports received from the same reporter. Additional information has been requested.
faster heart beats; This is a spontaneous report from the Pfizer-sponsored program Pfizer via a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (Pfizer Covid-19 Vaccine), via an unspecified route of administration on 31Mar2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was asking whether the second dose was supposed to be on 21Apr2021. She was also asking whether it was alright to receive the second dose of the vaccine after experiencing faster heart beats after being given the first dose of the vaccine. Outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
After receiving the shot my son stopped waving, talking and keeping eye contact. My son has been labeled as medially disabled now.
Headache - 7:00PM on day of vaccination (03/24/2021) Headache, chills, body aches, fever, nausea - 5:00AM day after vaccination (03/25/2021) Only lasted 24 hours, ended around 7:00PM on 03/25/2021.
VOMITING AND REDNESS AROUND INJECTION SITE. PATIENT FEELS WEAK AND HAS LOOSE STOOLS
Local reaction redness at the site 7 cm x 5 cm Rt thigh, and had urticaria face and extremities
Unknown outcome to receiving 3 COVID19 vaccines. Pt received 2 on time doses of Moderna COVID19 vaccine at one of our clinics after already receiving 1 dose of Pfizer COVID19 vaccine elsewhere.
Patient stated that he developed rashes after one week of receiving the covid-19 bivalent booster. Patient was advised to follow up with his PCP or seek medical care but he stated he would observe some more and see if it resolves on it's own.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Oct2022 at 12:30 as dose 1, single (Batch/Lot number: unknown) at the age of 78 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Chronic pain" (unspecified if ongoing); "Known Allergies: Penicillins" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Immediately following the injection, my son went cold and clammy.  His skin turned grey and his body was limp.
Systemic: pt had blister at injection site -Severe, Additional Details: pt had hard ball at injection site and then blister appear and blister popped
1415 Patient c/o Pain posterior left shoulder with beginning numbness.  No sensation from shoulder to fingers on left arm.  Initially, no s/s of vaccination reaction.  No sob, no rashes, no swelling, glascow 15.  We monitored for 10 min.  she decompensated to facial, tongue, and arm numbness.  BP 170/96 HR 98 O2 Sat 98 room air.  In 5 min. became dizzy, anxious, sweaty.  Placed in supine position, legs elevated.  O2 at 2L nasal cannula, EMS called.  BP 200/100 HR 108 98%, RR 15.  Suddenly reported vision loss, pulse was fleeting, loc dropped.  Epinephrine 0.3 mg (Epi Pen) Left lateral thigh. Quick return to baseline vitals. BP 150/90 98% and HR 101 RR 22.  EMS onsite at 256.  Care assumed by EMS at this time.  Attempted to reach husband at start of event using patient phone.  We reached him at 1456 ambulance left at 1510 to Hospital.  Vital signs stable, awake and aware.
Extreme headaches,  nausea, swelling , redness, warm to touch, pain at injection site
diagnosed with autism at the age of 18 months; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  An 18-month-old male patient received bnt162b2 (COMIRNATY) (Lot number: unknown) as dose number unknown (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Dpt (they got DPT MMR when they were 8-9 months old), for immunisation; Mmr (they got DPT MMR when they were 8-9 months old), for immunisation. The following information was reported: AUTISM SPECTRUM DISORDER (medically significant), outcome "unknown", described as "diagnosed with autism at the age of 18 months". Clinical course: Reporter wanted to provide her statement/feedback about the Pfizer covid vaccine for infant (6 months) to 5 years old. She stated there would be a lot of lawsuits in Pfizer's hand if they pushed to give Pfizer covid vaccine to this age group. She stated she and her kids and grandkids took the vaccine but not "extra ones". She stated you didn't know how this vaccine would affect the small children. Her grandchild (patient) was diagnosed with autism at the age of 18 months, he was ok before that, her older children received vaccine and they got sick "sicker than dog" (reporter did not clarify which vaccine). She stated that babies did not need injection. They just needed the regular vaccine MMR, polio, DPT injections, which are tested for long time. she told her granddaughter to not give her grandkids who are 7 and 9, "weird injection" (non-Pfizer injection). All they need was MMR polio, DPT vaccine. She stated she heard in the news about the Pfizer covid vaccine for babies and she got really upset about it. She stated it could cause kids to have autism and cerebral palsy, there was going to be lawsuit on Pfizer. She stated she got her Brand name thyroid medication from Pfizer (agent tried to clarify the name of the medication but reporter did not provide name) she stated she did not take generic levothyroxine as it made her hair fall/hair loss. Caller stated none of her children got Pfizer medication that she knew of, they got DPT MMR when they were 8-9 months old. She was 83-84 years old female was in a car accident that ruptured her spleen, they would not give her vaccine not even shingles vaccine. She was very concerned, was crying at times on the phone and upset about small children getting the Pfizer covid vaccine. She stated patient had autism and that was from a vaccine. Reporter asked if they could explain to her how this vaccine wouldn't be unsafe.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The consumer reported that 10 years ago, in 1999 her son had a very severe reaction. He experienced a seizure and a high fever. The consumer stated that most of her family members had this immune disorder that made them react to live vaccines that are given in combination with other live vaccines. Her son did recover and was fine. However, her physician suggested that none of her children get the combined vaccines but rather try and separate them. Upon internal review, seizure was determined to be another important medical event. This is one of several reports received from the same source. No further information is available.
Woke up a week later after vaccine and the injection site area is red swollen and itchy. It had a hard lump but I took a Zyrtec and it seems to be going down.  Still warma nd swollen but the Zyertec seems to be helping.
SORE ARM; PAIN; REDNESS AT INJECTION SITE; This spontaneous report received from a patient via a company representative concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) .5 ml, start therapy date was not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm, pain, and redness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm, pain and redness at injection site was not reported. This report was non-serious.; Reporter's Comments: This is a case of multiple patient.
The vial expired on 13-Jul-2022, vial was initially stored in refrigerator on 21-Jul-2022 and the vaccine was administered on 22-Jul-2022; 4 patients received expired Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 patients received expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (The vial expired on 13-Jul-2022, vial was initially stored in refrigerator on 21-Jul-2022 and the vaccine was administered on 22-Jul-2022) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 051F21A and 051F21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 16-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jul-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (4 patients received expired Moderna Covid-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expired on 13-Jul-2022, vial was initially stored in refrigerator on 21-Jul-2022 and the vaccine was administered on 22-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 patients received expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (The vial expired on 13-Jul-2022, vial was initially stored in refrigerator on 21-Jul-2022 and the vaccine was administered on 22-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the patient had not reported any adverse events after first and second dose and after second booster no other adverse reactions are known .  No treatment medications were reported.
Developed a migraine headache shortly afterwards; Information has been received from a pharmacist via a company representative concerning to a male patient (age not reported). No medical history, concurrent condition nor concomitant medications were reported. On an unknown date, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, lot number and expiration date not reported), intramuscular for prophylaxis. On an unknown date, the patient developed a migraine headache shortly afterwards. The patient was offered an aspirin to treat the migraine , but he declined treatment. The patient sought medical attention (called physician). The outcome of migraine was unknown.  The causal relationship between migraine and therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Low grade fever, muscle fatigue: 1 week Continued muscle fatigue, improving but still present @ 4 weeks (28 days) Significant nose bleed (woke up choking on blood, pillow soaked in blood, took 20 minutes to stop): day 16 after vaccine
Patient vaccinated at Nursing home. Transferred to ER the following day when patient developed fever and altered mental status. Found to have acute kidney injury on chronic kidney disease, hyperkalemia. Required emergent hemodialysis for hyperkalemia with ECG findings of peaked T waves.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 01-OCT-2013 the patient was administered expired MMR II (lot# 1373AA, expiry date: 26-AUG-2013 as reported) route, dose and location unspecified. No adverse effects reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same reported. Additional information has been requested.
Returned to clinic 4 hrs after flu shot. Hot, red, swollen L arm with cramping. Also L shoulder muscle burning.
FEVER, MALAISE, FATIGUE, HEADACHE, NAUSEA, CHILLS, DECREASED APPETITE.
Headache, body aches, complained about not being able to get out of bed, couldn't talk, suffered heart attack.
newly immunocompromised patient; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "newly immunocompromised patient".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Severe Inflammation in left arm which began on 08/06 in the afternoon.  On 8/10 I finally began to get relief after I started taking Naprosen that I was prescribed by an Orthopedic dr.  The excruciating pain was not completely relieved until about 8 days later.  My arm was frozen to my side.  I was in excruciating pain even when I didn't move my arm.  Went to my dr on 8/9 and on 8/9 went to the ER and on 8/10 went to an orthopaedic dr.
Patient stated that she gets dizzy from sight of needles and passed out once at a younger age.  After immunizing tech administered both shots the patient removed her mask  and then passed out and rolled to the ground.  Patient was light headed and dizzy for about 15 minutes.  We applied ice packs and cold clothes to her face/neck and she began to  feel better.  She stayed in pharmacy area for about 30 minutes for observation before leaving with her husband.  I will call her later this evening to follow up on her.
I woke up 2/6/21 with swelling, tenderness of my entire left arm well below injection site. Down to elbow. With hives also. No trouble breathing. Low grade temp 100.0. Body aches. Headache. Took Zyrtec 10mg. Ate some toast and took ibuprofen 800mg.
Lymphadenopathy, fatigue, malaise, reactivation of latent Epstein-barr infection; Extreme GI pain
A red swollen mark on my arm that was tender to the touch, pins-and-needles feeling in my shoulder and fingers, cold hand. Started about a week after the vaccine and lasted for eight days.
Rash all over body, fever, runny nose, cough. Friday the 8th he got 2 shots in his left arm. KINRIX and MMRV. He ended up getting a rash Friday (the 8th) night. I noticed it....called the on call doctor, she's was like ohhh it's probably just a reaction to the shots, keep an eye on him, look for swelling and whatnot. Ok....so I did. Monday the 11th rolls around.... he still has the rash and he tells me Monday night that his neck hurts. I go into full blown panic thinking meningitis or something awful, rush him to the peds urgent care, they say it's scarlet fever and give him amoxicillin. No strep swab, he was only examined. He's was done the antibiotic on the Thursday the 21st and the rash is back, full force as of Thursday (before the last dose of antibiotics) So, I called the nurse at his office, sent pics and they diagnosed it as a 'Non-Specific Viral Rash' she said since they didn't do a strep swab at urgent care she can't be sure that's what he had, but if he was on antibiotics it should have gone away if it was. So she basically said keep an eye on it and bring him in tomorrow or Saturday if it gets worse or if he gets a fever... I'm bringing him back to the doctor tomorrow, Saturday the 23rd. He has a runny nose, a cough and a rash now.
Neuropathy got worse; Neuropathy got worse; This case was reported by a consumer via call center representative and described the occurrence of neuropathy in a 90-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of erythema (1st dose received on end of August 2021,for tolerance of first dose refer case US2022AMR121991). Concurrent medical conditions included neuropathy and celiac disease.   In October 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a year after receiving Shingrix, the patient experienced neuropathy (serious criteria GSK medically significant) and condition aggravated. On an unknown date, the outcome of the neuropathy and condition aggravated were not recovered/not resolved.   It was unknown if the reporter considered the neuropathy and condition aggravated to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR121991   Additional Information: GSK Receipt Date: 19-AUG-2022 Reporter's Comment: The reporter was a patient. The reporter reported that the patient received Shingrix vaccine. The reporter stated after received Shingrix vaccine patient experienced her neuropathy got worse and this is still an ongoing problem. The reporter was unsure if it was related to the vaccine. The patient did not had any further information about the vaccine. Additional Supportive Information: This case had been linked with US2022AMR121991 reported by same reporter for same patient. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2022AMR121991:Same patient
She received an HPV vaccine 10 years ago and received recently the first dose of Gardasil 9; no adverse event; She received an HPV vaccine 10 years ago and received recently the first dose of Gardasil 9; This spontaneous report has been received from a consumer regarding to herself a female patient of unknown age.  The patient's concurrent conditions, medical history, concomitant therapies, drug allergies and reaction were not reported.   In 2012 also reported as 10 years ago, the patient was vaccinated with a dose of unspecified hpv vaccine for prophylaxis. In 2022, the patient has recently vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiration date, dose, route of administration and anatomical location of vaccine were not reported) for prophylaxis by recommendation of her Obstetrics and Gynecology (OBGYN) . The reported said that she was on schedule for the second and third dose.
MOTHER, CALLED AND REPORTED A SEVERE RASH ALL OVER PATIENT'S BODY, SHE TOOK CHILD TO SEE DR ON 10-16-19 AND DR TOLD MOTHER THAT RASH WAS FROM  HEP A VACCINE GIVEN ON 10-15-19
feels like a cramp; fell and broke her left arm; stiffness that comes and goes and rotates from her right arm, shoulders, hips, legs and feet; pain; fell and broke her left arm; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Medical Information (Reference number- 00792710) and transmitted to Sanofi on 30-Sep-2021. This case involves a 65 years old female patient who fell (fall) and broke her left arm (upper limb fracture), feels like a cramp (muscle spasms), pain and stiffness (musculoskeletal stiffness), while received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Medical history, concomitant medication, past medical treatment, vaccination and family history were not provided. Patient had ongoing metal allergy like cobalt, thimerosal and knows it was probably the aluminum and 2-phenoxethanol that is causing her the issues with the vaccine.  On an unknown date, the patient received a 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [oral solution, lot number: LU6922AA, expiry date: 22-Jan-2023], via an intramuscular route in right deltoid for prophylactic vaccination.  On 26-Sep-2021, the patient fell (fall) and broke her left arm (upper limb fracture) and went to the emergency room (suggested that she had the vaccine), pain and stiffness (musculoskeletal stiffness) that comes and goes and rotates from her right arm, shoulders, hips, legs and feet bu she wouldn't know about her left arm since it is casted and broken same day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  On an unknown date the patient developed a non-serious doesn't have cramps but feels like a cramp (muscle spasms) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was reported ''Paperwork states Adacel doesn't have a preservative but the list is incorrect because those are preservatives.''  Other relevant laboratory test were not provided.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the patient was recovering from all the reported events.