chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expiration date of the box was different than the vials inside. Based on the expiration date on the box, it was not expired at the time, however the vials did; expiration date of the box was different than the vials inside. Based on the expiration date on the box, it was not expired at the time, however the vials did; received an expired dose / expired on Nov 30, 2020; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 59-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA207A, expiry date 30th November 2020) for prophylaxis. This case was associated with a product complaint.   On 16th May 2021, the patient received Menveo. On 16th May 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the patient experienced product packaging confusion and product expiration date issue. On an unknown date, the outcome of the expired vaccine used, product packaging confusion and product expiration date issue were unknown.  Additional details were provided as follows: The patient received expired dose of Menveo which expired on 30th November 2020 which led to expired vaccine used.  Healthcare professional mentioned that, the expiration date of the box was different than the vials inside which led to product packaging confusion.  Based on the expiration date on the box, it was not expired at the time, however the vials did which led to product expiration date issue. The reporter consented to follow up.  This was 1 of 3 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021152087:Same reporter US-GLAXOSMITHKLINE-US2021152084:Same reporter
Left thigh eryth swollen 3x5 inches at sight of DTaP injection. Arthr-like rxn.
Patient received Rotateq 6-12-09, on 06-15-09 mom called and state pt was unconsolable, crying, pushing away from mom and had vomited x 3.  Advised to take to Hospital.  That night he had surgery for intussusception and appendectomy.  7/27/09 Hospital records received DOS 6/15/09 to 6/16/09. Assessment: Ileocolic Intussusception. Patient presents with crampy abdominal pain. Vomiting. Rectum - blood on skin. Enema reduction unsuccessful. Exploratory Lap and appendectomy performed. 9/21/09-ICD-9 codes received-287.0.
T12 dermatome rash consistent with shingles on right side of body-painful, sensitive, erythema base with blistering on front & back of patient, not much on lateral side. Treated with MEDROL & VALTREX & CALADRYL.
This spontaneous report as received from a Registered Nurse refers to a 58 years old female patient of unknown age with high blood pressure and smoker. The patient's medical history included bilateral mastectomy. The patient had no known drug reactions/allergies. The patient also had a flu shot in 2011. The patient was not immune to rubella based on her titers so she was administered M-M-R II. The patient was administered M-M-R II on 20-FEB-2013 (lot number was reported as H011885; exp.was 25-JUN-2014) subcutaneously . Concomitant therapies included hydrochlorothiazide (manufacturer unknown). On 21-MAR-2013 the patient woke up and half of her bottom lip was swollen and she was having trouble drinking from a glass. The patient went to the emergency room on 22-MAR-2013. At that emergency room visit the patient had left-sided facial weakness which included her eyebrows, had reduced sensation to light touch on the left side of her face, there was no tongue or ovular deviation, and her pupils were equal and reactive to light; all else was normal on physical exam. Bell's Palsy was diagnosed in the emergency room based on physical exam. She was treated with LACRILUBE and prednisone (manufacturer unknown) (60mg daily for five days). The patient was not admitted to the hospital. As of 02-APR-2013, the patient was improving. Additional information has been requested.
1st dose  2-3 years ago, 2nd not yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date about 2 to 3 years ago prior to reporting).   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: 24-OCT-2022 Reporter's comment: The case was self-reported by the patient. The pharmacy where shot was administered indicated to patient that the record had been archived. Till the time of reporting, the patient did not receive the second dose of Shingrix. The reporter consented to follow up. The details given for first dose. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. This was 1 of 2 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2022153130:Same reporter
Shortly after injection patient was light headed, had blurry vision, was pale, and was having trouble hearing.
On Tuesday 11/29 I wasn't feeling good, next day I had shortness of breath, I did a COVID-test at home and came negative. I could not walk to the house; I had another test, and it was negative again. On Thursday I went to work and sent me home, I went to urgent care and had another test came negative, they sent me to ER and ordered a stress test for 12/29 and will see the Cardiologist on January 12th, 2023.
Home tested positive for Covid after being vaccinated x2 and boosted x2.; Home tested positive for Covid after being vaccinated x2 and boosted x2.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 28May2022 as dose 4 (booster), single (Lot number: FX9895) at the age of 74 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing); "GERD" (unspecified if ongoing); "AFib" (unspecified if ongoing); "BPH" (unspecified if ongoing); "Naproxen, Ibuprofen causes anaphylaxis" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Naproxen, reaction(s): "Known allergies: Naproxen causes anaphylaxis", notes: NSAIDS (Naproxen) causes anaphylaxis; Ibuprofen, reaction(s): "Known allergies: Ibuprofen causes anaphylaxis", notes: NSAIDS (Ibuprofen) causes anaphylaxis. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Home tested positive for Covid after being vaccinated x2 and boosted x2.". The patient underwent the following laboratory tests and procedures: Body temperature: (20Jun2022) 98.9, notes: low grade fever 98.9 (I am generally 97.5); SARS-CoV-2 test: (unspecified date) Positive, notes: Home tested positive for Covid; (unspecified date) Negative, notes: I tested negative; (unspecified date) Negative, notes: I continue to test negative w/home tests; (unspecified date) Unknown results, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: It was reported that, Adverse event: home tested positive for Covid after being vaccinated x2 and boosted x2. Virtually asymptomatic, slight scratch throat, clear nasal drainage (sinus allergy?). 4 days after testing positive I was prescribed Paxlovid which I completed. I tested negative x2 and never had fever. On 19062022 I began to exhibit symptoms, drippy nose and raspy throat. This time symptoms were much worse. I took expectorant to work on non-productive cough. Cough is persistent. On 20Jun2022 I ran a low-grade fever 98.9 (I am generally 97.5) Similar to serious allergy symptoms. Runny nose, chest congestion, cough and itchy eyes are persistent. I continue to test negative w/home tests.
Vaccine was frozen rather than refrigerated. Dose administered. Offered revaccination. Revax unwanted.
My patient received the first dose of the Pfizer COVID-19 vaccine on 22Jan2021. The patient was tested positive for COVID-19 last Friday; My patient received the first dose of the Pfizer COVID-19 vaccine on 22Jan2021. The patient was tested positive for COVID-19 last Friday; This is a spontaneous report received from a contactable Pharmacist. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not reported), via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient was tested positive for COVID-19 last Friday and feeling better now. Outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Considering a plausible temporal relationship and known product safety profile, a possible contributory role of suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE  to the reported 'COVID 19' cannot be excluded. However, more information is needed regarding the date of COVID19 test done.Once the information is received the case can be further reassessed
Redness, swelling at immunization injection site. Hot to the touch. Itchy.
Around 1:30 PM, my right arm started burning at the injection site. Then my right bicep became very sore. Within an hour, I couldn't lift my arm, it was stiff and sore. By 7:00 PM, the stiffness and pain had spread to my neck and right shoulder blade. The stiffness reached all the way down to my lower back. I had a fever of 100 degrees. The pain got worse, a deep ache in my arm and shoulder blade. Even my collarbone hurt. At 6:30 AM on 1/27/15, the pain and stiffness had left my neck and back. At 10:00 AM, some of the pain and stiffness had subsided in my right arm. I can raise my right arm slowly now. The right bicep is still sore and stiff, at 1:00 PM.
Redness & swelling & induration of 1 cm x 1 cm & 0.5 cm x 1 cm noted in R thigh (site of Hib & Prevnar).  Fever 102 degrees associated.  Seen at clinic 1/10/08 & office 1/11/08.
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 74-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 07Dec2021 as dose 3 (booster), single (Lot number: EJ8727), in left arm and on 05Jul2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 72 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "heart disease" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 02Oct2023 to 06Oct2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300328846 Same reporter/patient, different drug/AE.;
swollen r thigh with fever >101.  thigh also red and tender to touch.  difficulty walking on leg.
Full body numbness; Lack of coordination; Extreme exhaustion; Inability to focus; feel a faint generalized numbness but it is fading; This is a spontaneous report from a contactable consumer (patient).A 43-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6208),via an unspecified route of administration on 12Mar2021 at 08:15 (at the age of 43-years-old) as a dose 1, single for COVID-19 immunization. Medical history included HEDS (Hypermobile type Ehlers-Danlos syndrome) and scoliosis. The patient was not allergic, but sensitive to eggs, dairy, steroids, aspirin, ibuprofen. Concomitant medication(s) included cyanocobalamin (B12 [CYANOCOBALAMIN]); vitamin d [vitamin d nos] and ascorbic acid (VIT C). The patient previously took aspirin [acetylsalicylic acid] and ibuprofen and experienced drug hypersensitivity. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior to vaccination. The patient was not tested for COVID post vaccination. On 12Mar2021 at 20:00, the patient experienced lack of coordination, extreme exhaustion, inability to focus, on 13Mar2021, around 2pm the patient experienced full body numbness and on an unspecified date in Mar2021, she experienced feel a faint generalized numbness, but it was fading. The patient reported that she experienced full body numbness climaxing around 2pm on 13Mar2021, the day after the injection. Also, lack of coordination, extreme exhaustion, inability to focus. It was 14Mar2021 and she still feel a faint generalized numbness, but it was fading, thankfully. The patient did not receive any treatment for adverse events. The patient was recovering.  No follow-up attempts are possible. No further information is expected.
Headache; Fever of 99 Degrees.; Pain Lump in Injection Arm Left Armpit; Pain Lump in Injection Arm (Left) Armpit; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever of 99 Degrees.), VACCINATION SITE MASS (Pain Lump in Injection Arm Left Armpit) and AXILLARY PAIN (Pain Lump in Injection Arm (Left) Armpit) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Hypertension. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced HEADACHE (Headache), PYREXIA (Fever of 99 Degrees.), VACCINATION SITE MASS (Pain Lump in Injection Arm Left Armpit) and AXILLARY PAIN (Pain Lump in Injection Arm (Left) Armpit). At the time of the report, HEADACHE (Headache) and PYREXIA (Fever of 99 Degrees.) outcome was unknown and VACCINATION SITE MASS (Pain Lump in Injection Arm Left Armpit) and AXILLARY PAIN (Pain Lump in Injection Arm (Left) Armpit) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient with hx of needle phobia and seizures unrelated to vaccine was vaccinated at 10:30 am in preparation to travel. He had his last T-dap in 2006  and had not had a prior Typhoid vaccine. Patient was vaccinated in the supine position and observed for 20 minutes after vaccination. He reported a tingling sensation in both hands immediately following vaccination, which was attributed to anxiety at the time. I subsided within a few minutes. Bp=128/75 P=87 pre and Bp=118/74, P=76 post. He left the medical office to have lunch and returned to his work station. At 1:25 pm he felt an intense headache and dizziness followed by "fainting", striking his Left frontal/Templar area on his disk on the way down. Medical staff responded within 5 minutes and the patient was found face down with body tremors, holding his head but not initially responding to verbal commands. Bp=106/64, P=90 in the supine position. 911 was called. He was able to turn over and sit with assistance and became more alert while waiting for EMS to arrive, but tremors remained until transport to the local hospital. Apparent seizure possibly related to vaccination.
Headache, severe and repeated diarrhea, vomiting, burning sinuses clogging the nose making it difficult to breathe.
Neck pain after #1 covax on 12/2; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 62 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date Dec2020 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NECK PAIN (non-serious), outcome "not recovered", described as "Neck pain after #1 covax on 12/2". The event "neck pain after #1 covax on 12/2" was evaluated at the physician office visit. Therapeutic measures were taken as a result of neck pain.  Additional information: The patient reported that Chiropractor more than 10 mins, endocrinologist and there was no improvement, had be on medication and cream.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Started running fever about 1hr p/shot got shaky temp 106R child was taken to MD child given med for fever & antibiotic prophyllactically; Mom states MD felt child had rxn to DTP;
severe cramps; Abdominal pain; Diarrhea; Dizziness; voice is weak; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (severe cramps), ABDOMINAL PAIN (Abdominal pain), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness) and DYSPHONIA (voice is weak) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced MUSCLE SPASMS (severe cramps), ABDOMINAL PAIN (Abdominal pain), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness) and DYSPHONIA (voice is weak). At the time of the report, MUSCLE SPASMS (severe cramps), ABDOMINAL PAIN (Abdominal pain), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness) and DYSPHONIA (voice is weak) outcome was unknown. Not Provided
This spontaneous report was received from a Registered Nurse and refers to a multiple patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, multiple unspecified patients received doses of improperly stored GARDASIL (dose, route of administration, injection site, lot# and expiration date were not reported). Administered doses of GARDASIL underwent temperature excursions at 47 Fahrenheit degrees, for unknown time frames. Information about the previous temperature excursions was not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient received 2nd dose of Pfizer covid vaccine. The vial had been mixed with 1.8 sterile diluent (sterile water) instead of 1.8 normal saline
After she received the H1N1 shot within 48 hours at 5:20 Am early she woke husband up. He seen her leg and arm twitch and she was not responding to her name. We took her to the emergency room because she looked like she was dying. They diagnosed her as having a seizure she was out 2 hrs at least. 11/24/2009 ED records for 10/26/2009, Dx seizure  patient with seizure activity. 12/1/2009 records from Pediatric neurologist for date 11/12/2009, Dx epilepsy patient with seizure activity, unresponsive to touch, eyes rolling back. Neuro exam noted mild weakness on the rt and increased tone RU and RL extremity. Tx placed on Keppra then changed to Lamictal
Patient received pneumovax and flu vaccine in left deltoid on 12/3/02. (Hx received flu vaccine in past without reaction). Within 8 hours of vaccines reported fever 104. Left arm swollen, hot, painful and unable to use arm. 12/6/02 exam. Afebrile slight swelling deltoid. No warmth. Quite painful with minimal movement of shoulder.
This case was reported by a consumer (subject's mother) via a sales representative and described the occurrence of seizure in a neonate female subject who was vaccinated with ENGERIX B pediatric (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date, the subject received unspecified dose of ENGERIX B pediatric (unknown route and injection site; lot number not provided). At an unspecified time after vaccination with ENGERIX B pediatric, the subject experienced seizure. The physician was informed or consulted regarding the reported event. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified. Follow-up information received on 17 April 2014: The newborn subject, experienced seizures after each administration and that she received them at/from Hospital. Follow-up information received on 29 April 2014: A week or so after the 1st vaccination week after the 1st vaccination with ENGERIX B pediatric, the subject started having seizures and was still experienced then, as she was 3 years old at the time of reporting. The subject's mother contacted the hospital in order to obtain the lot numbers of the vaccines as three different types of Hepatitis B vaccines were administered. At the time of reporting the information was not available. The subject's mother contacted her physicians and they were not sure if the seizures were caused by the vaccine. She wondered if her child was the "10% of kids that are sensitive to vaccines and can't get them". At the time of reporting the event was unresolved. The consumer was unsure if she wanted to pursue this any further and declined to provide her address for authorization to contact healthcare professional.
Developed abd pain 2-3 weeks after first Moderna shot.  Diagnosed with a mesenteric vein thrombosis--no prior personal or family history of blood clotting issues. Hospitalized for this.
rashes itch; rashes on her stomach and back,rash sting; This spontaneous case was reported by a consumer and describes the occurrence of   in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Drug allergy.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     NO Treatment drug reported.  Patient reported she stayed in the observation room for 30 minutes &  she did not experience any reaction that time.  Patient is allergic to a lot of over the counter drugs, penicillin, sulfur.