chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itching; headache; fatigue; redness; swelling; fever; chills; Bodu aches; Heart rate; injection site pain; This is a spontaneous report from a contactable consumer (patient) reported in response to non-HCP letter sent in cross-referenced case. A 51-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9264 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 05Feb2021 at 08:00 (age at vaccination: 51 years), as a single dose for COVID-19 immunization at hospital clinic. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EJ1485 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 21Dec2020 (age at vaccination: 51 years), as a single dose for COVID-19 immunization at hospital clinic. Vaccine was not administered at Facility. On 05Feb2021 at 08:00, the patient experienced injection site pain. At 10:45, the patient had fever, chills, bodu aches, and heart rate. On 07Feb2021, the patient experienced redness and swelling. On 08Feb2021, the patient experienced itching, headache, and fatigue. On 28Feb2021, the patient diagnosed with covid-19. The patient underwent lab test and procedure included covid test-24HR: negative on 30Dec2020, covid quick test #2: negative on 31Dce2020, covid quick test#3, and Covid quick test#4: both negative on 02Feb2021. Outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Local, red, swollen hot, tender 4x3 inch lesion at injection site x 4 days.
DX pneumonia due to COVID. 75y.o. male with history of colon cancer undergoing chemo prior but now switching to radiation who was admitted to the ICU from ED with a complaint of hypoxia due to COVID-19.Patient had elevated inflammatory markers, therefore he was started on Decadron and continued on it throughout his hospital stay. Patient was stable in ICU, therefore downgraded to the general medical floors. On the GMF, patient was given and completed a course of her Remdesivir, was baricitinib day 7 and Decadron day 7. He was also on full dose Lovenox. Patient was maintained on 5 L oxygen on the general medical floors. Per family, they requested that patient be discharged home, considering his prognosis given his extensive malignancy, shared decision making was utilized to send patient home on home oxygen, with possible hospice, palliative care consult in the future.
No adverse reaction.  This was a vaccine error. The vaccine was administered 9.5 hours after the 12 hour expiration mark. Vial punctured on 2/13/23 at 2:15pm with a 12-hr expiration of 2:15 AM the next morning. It was administered at 11:48 AM on 2/14/23.
Patient fainted within 2 minutes of vaccine administration. Patient obs x 45 minutes. BP checked after 10min. BS checked-88. Drank water. Walked out of office escorted
Patient experienced extreme headache and body pain, described as constant pain bringing him to tears.  Reported feeling like he was being stabbed in his whole body; muscles and joints.  No pain at the site of the immunization.  Pain started around 27 hours after immunization 10 AM - 1 PM next day).  Sought care at an Emergency Department,  Community Hospital at 6 PM next day and was given 1,000 mg Tylenol & 800 mg Ibuprofen; both mediations as pills & taken at the same time.  Advised to return to the ER if he experienced chest pain or worsening symptoms.  No additional medications prescribed or advised.
no adverse effects; received VAQTA that expired on 10/12/2019; This spontaneous report was received from a medical assistant referring to a 6 years old male patient. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.  On 21-OCT-2019, the patient was vaccinated with hepatitis a vaccine, inactivated(VAQTA) 25/0.5 (lot # R024007, expiration date was 12-OCT-2019)(exact dose was not reported)intramuscularly for prophylaxis(expired product administered). No adverse effects were reported.
This spontaneous report received from a patient, concerned a 74 year old female. Medical history, weight, height, concomitant medications and concurrent conditions not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number: not reported) dose: not reported, on Mar 5, 2021 for immunization. The batch/lot number requested. May 2021, patient felt better than what she felt for the past 18 years. She noticed a difference in energy. The vaccine changed something. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The outcome: not reported.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with ZOSTAVAX at a family health center (considered a physician's office) for routine adult health maintenance and the intended purpose for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. On or about 12-MAR-2016, the patient was treated at a hospital (not specified if admitted, therefore considered Emergency Room visit until follow-up received) by for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
dose 1 engerix-9/27/19 dose 2 engeix-12/01/19 (late); This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 31-year-old female patient who received HBV (Engerix B) (batch number MN7XR, expiry date 18th January 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (received 1st dose on 27th September 2019).   On 1st December 2019, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 1st December 2019, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received 2nd dose of Engerix B later than the recommended interval, which led to lengthening of vaccination schedule. On 27th January 2020, he patient received 3rd dose of Heplisav instead of Engerix B. No reactions were reported.
Pt developed achy muscle, flu-like symptoms, fever and weakness in arm and legs.  She was treated with Neurontin and vaslin and vitamin B6, Tylenol.
Runny nose started on the same day of vaccination then developed a bark like cough and now has a low-grade fever.
tiredness; sore arm at the injection site; loss of appetite; diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 20-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 28Feb2021 at 17:45 (20-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and dairy allergy.  Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included birth control. The patient previously received amoxicillin and clavulanic acid (AUGMENTIN) and experienced allergy. On 01Mar2021 at 08:00, the day after having the first dose of vaccine, the patient experienced tiredness, a sore arm at the injection site, loss of appetite and diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. On 22Feb2021, the patient underwent COVID-19 virus test (it was reported that the patient submits a saliva sample every week for pooled testing at her university) and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events tiredness, a sore arm at the injection site, loss of appetite and diarrhea was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
tingly sensation in my chin area; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL1284), via an unspecified route of administration on 15Jan2021 15:30 on left arm at single dose for covid-19 immunization. The facility type vaccine was hospital. Patient was not pregnant. Medical history included type 1 diabetes mellitus from an unknown date, Raynaud's from an unknown date. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included insulin glargine (LANTUS), insulin lispro (HUMALOG), lansoprazole. The patient experienced tingly sensation in chin area in Jan2021 with outcome of unknown.
nausea, vomiting, diarrhea, vitals: 155/94, 97, 112, pulse oximeter- 98%. Repeat B/P- 142/93. Client seen by EMS,  refused hospital transfer as recommended by EMS
Developed acute respiratory illness after receiving vaccine. Also experienced worsening of asthma symptoms. Asymptomatic prior to vaccine administration.
BROKE OUT WITH ROSACE; This spontaneous case was reported by a consumer and describes the occurrence of ROSACEA (BROKE OUT WITH ROSACE) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis and Psoriatic arthritis.    The patient's past medical history included Psoriasis.   On 01-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Dec-2021, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 01-May-2022, the patient experienced ROSACEA (BROKE OUT WITH ROSACE). At the time of the report, ROSACEA (BROKE OUT WITH ROSACE) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported. The patient had broke out with Rosacea. He had never had rosacea. He was perfect until received the Moderna vaccine where he received Moderna vaccine at work. The physician informed the vaccine must had ignited immune system. SKYRIZI was really working on Psoriasis. The patient was perfectly healthy until received Moderna. It was unknown if the patient was enrolled in a COVID-19 vaccine trial. No treatment drug details was reported.
Patient was given vaccine at 10:45am - Patient reported scratchy throat at 10:48am - at 10:50am we gave 50mg of Diphenhydramine orally, patient condition worsened, she described her throat starting to swell up, and had noticeable difficulty breathing and shortness of breath. We administered Epinephrine at 10:55am and within 5 seconds patient reported improvement. Patient remained stable until EMS arrived about 5-10 minutes later. Patient was advised to be taken to the hospital for monitoring and agreed. She remained stable and reported an "itchy back" upon exit.
This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced fatigue, drowsiness, headache and muscle pain. On an unknown date, the outcome of the fatigue, drowsiness, headache and muscle pain were recovered/resolved. It was unknown if the reporter considered the fatigue, drowsiness, headache and muscle pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not provided. The event fatigue, drowsiness, headache and muscle aches lasted 36 hours. The patient feels better now.
Information had been received on 20-APR-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient (age not reported) was inoculated with ZOSTAVAX (dosage and lot#/expiration not reported) on or about 31-AUG-2013 at a physician's office as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused patient to contract a persistent strain of herpes zoster (onset not reported). On or about 06-DEC-2016, patient was treated at the same facility for an ongoing painful rash which was diagnosed as shingles with post herpetic neuralgia. Post herpetic neuralgia is a chronic condition involving nerve damage caused as the residual effect of severe shingles. Although shingles is an incurable viral condition, patient was prescribed gabapentin and hydrocodone for management of her symptoms. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
3RD DOSE OF PFIZER COVID VACCINE GIVEN 12/2/21, LOT #FG3527 Pt brought to ED via EMS; has been in bed without food and little water because she's felt dizzy; pt passed out when EMS went to stand her up; nausea and vomiting; developed PEA arrest in CT scan department x 3; ICU; tx for hypotension and given TPA; large saddle PE; pt positive for COVID; Pt passed away in the hospital
2 days after vaccinations were given, Dad reports that patient developed a rash ("heat bumps") from neck down to groin. No trouble breathing or other symptoms noted. Dad gave BENADRYL and used hydrocortisone cream to skin per the advice of a family member who is an MD. He did not take the child to a physician or ER. Rash resolved in 3 days. This was reported on 4/5/18 when returning to the health department for additional vaccines. Client was referred to pediatrician for an evaluation before receiving further vaccinations.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 25-Oct-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The delivery occurred on an unknown date. For neonate 1, The outcome was reported as Unknown. At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications and treatment details was not provided.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 30-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2016) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 720 hours, the lowest recorded temperature was 20F (-6.667 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
extreme dizziness; vertigo (room was spinning); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2 NOS), in Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE, Lot No: Unknown), for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset Sep2022, outcome "recovered", described as "extreme dizziness"; VERTIGO (non-serious) with onset Sep2022, outcome "recovered", described as "vertigo (room was spinning)". Therapeutic measures were not taken as a result of dizziness, vertigo.  Additional Information: It was reported that the events occurred in the first 24 hours after receiving his second Pfizer covid booster. It was not known if this was a monovalent or bivalent booster. It was also reported that the events resolved on its own.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
7 days rash size of dime & got bigger (hives)-used constarch, caladryl & DPH; 9 days turning blue-took pt to ER; MD stated pt may be allergic to HIB;
Pain in Muscular Arch in upper left arm (Between elbow and shoulder) in vicinity where flu shot was given hurts when I move my arm in different position.
Patient presented to the ED and was subsequently hospitalized for TIA, hypertension within 6 weeks of receiving covid vaccination.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. Pertinent medical history was unknown. On 30-JAN-2015 unspecified number of patients were vaccinated with doses of GARDASIL (dose, route of administration, anatomical location and lot# was unknown) which were improperly stored (Incorrect product storage). Concomitant medications were unspecified by reporter. No adverse effects reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information is not expected as reporter is not willing to be contacted.
This case was reported by a physician and described the occurrence of facial edema in a 7-month-old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. On 27 July 2005 the subject received the 3rd dose of Pediarix (lot AC21A019AA)/ On 27 July 2005, the subject was also vaccinated with th 2nd dose of 7-valent pneumococcal conjugate vaccine (Prevnar) and Haemophilus influenzae type B conjugate vaccine (PedvaxHib dose number not provided).On 29 July 2005, 2 days after vaccination with Pediarix, the subject experienced facial edema and a rash described a "a diffuse rash which covered the body and was red and circular." The subject was seen by the reporting physician on 02 August 2005. The rash was diagnosed as a "hypersensitivity rash." The subject was prescribed oral diphenhydramine hydrochloride (Benadryl). The facial edema and hypersensitivity rash resolved on 05 August 2005. The physician considered the events to possibly be related to vaccination with Pediarix. This case was initially received from the physician on 04 August 2005. On 06 September 2005 this report was received from research.
Headache, Myalgia, "I couldn't even get out of bed, my whole body hurt" Narrative:
PHARMACIST RECONSTITUTED GRAY CAP PFIZER VACCINE WITH 1.8 ML OF 0.9% NACL.  AND ADMINISTERED 0.3 ML IM TO PATIENT.  GIVING SUB A THERAPUETIC DOSE.
This case was reported by a consumer and described the occurrence of Lyme disease in a 18-year-old female patient who received MENVEO (batch number M15099, expiry date 31st March 2017). Concomitant products included ZOLOFT and Multivitamin. On 18th April 2016, the patient received MENVEO. In June 2016, 61 days after receiving MENVEO, the patient experienced joint pain. On an unknown date, the patient experienced Lyme disease (serious criteria GSK medically significant), walking difficulty, fibromyalgia, mycoplasma infection and general body pain. The patient was treated with Antibiotic and Pain Medication. On an unknown date, the outcome of the Lyme disease, joint pain, walking difficulty, fibromyalgia, mycoplasma infection and general body pain were unknown. It was unknown if the reporter considered the Lyme disease, joint pain, walking difficulty, fibromyalgia, mycoplasma infection and general body pain to be related to MENVEO. Additional details were provided as follows: At the time of the vaccination, the patient was taking ZOLOFT 50 mg and a multivitamin. In June 2016, approximately 2 months after vaccination, the started having pains in her joints and within one week she was bedridden in pain. The patient went to many doctors and still had no answer as to what was wrong with her. Doctors had suggested Lyme, fibromyalgia and mycoplasma disease. They had tried every pain medication and nothing touches the pain. They tried viral meds and antibiotics for Lyme as well. The patient had all tests done including a spinal tap, EMF, blood, urine, and test comes back normal. The patient has been in pain 24 by 7. She could barely walk. The pain was in total body.
CHILD BROKE OUT WITH SHINGLES APPROXIMATELY 12-12-2003.  CHILD WAS SEEN IN OFFICE ON 2-17-2004 BECAUSE SHINGLES WERE NOT IMPROVING AND SPREADING. SPOKE WITH MOM ON 02-27-2003 STATES SHINGLES IMPROVING.  USING BENADRYL AND CALOMINE LOTION AS NEEDED. CHILD DOES HAVE DIAGNOSIS OF AUTISM.
Patient experienced an allergic reaction approximately 10 minutes after receiving her second dose of the moderna vaccine.  The individual presented with labored breathing, complaining of a feeling of "her throat closing" and had a decreased level of consciousness, she was lowered to the ground by 2 nurses then became responsive only to painful stimuli. The individuals personal epinephrine was administered in her right thigh with minimal response, vitals were obtained and an albuterol nebulizer was then administered with marked improvement in her breathing. After about five minutes a second dose .33ml epinephrine was administered in her right deltoid. After approximately one minute she began answering questions.