chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 4/22/2021 and 5/13/2021. On 8/28/2021 patient presented to a outside facility with complaints of worsening shortness of breath and chest tightness with patient report of positive COVID test on August 20th. On 9/1/2021 patient presented to ED with chest pain and shortness of breath. VS stable; minimally tachycardia. Physical exam overall reassuring. The pt is well appearing, nontoxic, in NAD. Lungs CTAB, no respiratory distress. Labs overall reassuring.  No leukocytosis to concern for sepsis. Troponin negative. BNP normal. ECG w/o ST elevation;
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vial was initially stored in refrigerator on 14-Jul-2022 and was in refrigerator the entire time), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was in refrigerator the entire time) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056A22A) for COVID-19 prophylaxis. No Medical History information was reported. In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vial was initially stored in refrigerator on 14-Jul-2022 and was in refrigerator the entire time). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was in refrigerator the entire time) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vial was initially stored in refrigerator on 14-Jul-2022 and was in refrigerator the entire time), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was in refrigerator the entire time) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Vial was initially stored in refrigerator on 14-Jul-2022 and was in refrigerator the entire time) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was in refrigerator the entire time). No concomitant medications were reported. It was reported that the patient received expired booster dose of vaccine in between 22-Jul-2022 to 02-Aug-2022. Number of doses and vials that were affected were 8 doses from 2 vials. The vial was initially stored in the refrigerator on 14-Jul-2022. The vial did not undergo any temperature excursions. The vial was in refrigerator throughout the entire time and not kept at room temperature. No treatment details was reported.
The pt experienced diarrhea, autism and leaky gut syndrome. The 60 day follow-up states autism and diarrhea.
extreme muscle ache that she couldn't move; I couldn't take the pain/severe body ache severe like I couldn't walk; I couldn't take the pain/severe body ache severe like I couldn't walk; extreme muscle ache that she couldn't move; High fever; Lot of chills; Itchiness; Hives; she was crying; This is a spontaneous report from a contactable Nurse (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), intramuscular on an unspecified date at single dose for covid-19 immunization. Patient history was no and investigation assessment was no. There were no concomitant medications. The patient had hives and itchiness and then that was the first day that was after 8 minutes and then the next day the patient had severe body ache severe like I couldn't walk, she cried. The patient took Tylenol and Ibuprofen as she couldn't take the pain (further clarification was unknown). The patient had high fever 102.4 and was having a lot of chills. Start date of event was 24th, the 23rd she had the hives and the 24th she had the extreme muscle ache that she couldn't move and she was crying and she had the chills and the fever on the 24th. So it on started 23rd with the hives so then it started with the body aches and the fever on the 24th. Outcome of the events was recovered. The causality between the events and drug was considered as related by the reporter via Global Introspection.   Information on the batch/lot number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported body ache severe like I couldn't walk, extreme muscle ache that she couldn't move, and the administration of  BNT162B2, based on the reasonable temporal association.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
This case was reported by a nurse and described the occurrence of an injection site reaction in a 5 year old female patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix).  On an unspecified date in 2002, the patient received the fifth dose of Infanrix in the left arm (lot DTPA531A2).  At an unspecified time following the administration of the fifth dose of Infanrix, on 05/10/2002, the patient experienced an injection site reaction characterized as redness and swelling.  The outcome of the injection site reaction was not reported.  The nurse considered the injection site reaction to be related to vaccination with Infanrix.
Information has been received from a registered nurse concerning a 65 year old female who on 22-JUN-2007 was vaccinated subcutaneously with a 0.65 mL dose of ZOSTAVAX. On 24-JUN-2007 the patient experienced nerve pain on left side including her eye, left nostril and underarm after the ZOSTAVAX. The patient's eye was hurting so bad she could not put her contact in. The patient had sought unspecified medical attention. As of 25-JUN-2007 the patient was recovering. Additional information has been requested.
PATIENT GOT WEAK AND FAINTED AND HAD SEIZURE WITH EYES ROLLING BACK FOR ABOUT 10 SECONDS
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Vomiting-Severe, Additional Details: Patient noted no issues with vaccines prior to Moderna. After administration, patient felt nauseous, proceeded to vomit, felt very hot, then her ears were tingling. Water was brought for her to sip on. Dizziness proceeded to worsen and she requested to lie down. After about 10 minutes patient sat up and felt better. Patient was advised to stay for 30 minutes. Patient's father was present for this adverse event.
Entire body ached in muscles; Did not feel well at all; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9267, expiration date not reported), via an unspecified route of administration in left arm on 23Feb2021 at 13:30 (age at the time of vaccination 60-year-old) as a single dose for COVID-19 immunization. COVID-19 vaccine was administered in hospital. Patient had a medical history of bronchitis and Raynaud. The patient received thyroid medications within 2 weeks of vaccination. Patient did not receive other vaccine in four weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior vaccination. The patient did not undergo COVID-19 test post vaccination. The patient had no known allergies to medications, food other products to his knowledge. On 23Feb2021 (the same day of vaccination) at 20:00, the patients entire body ached in muscles and did not felt well. Reportedly, for three full days my entire body ached in my muscles. Did not feel well at all. The patient did not receive any treatment for the events. The case was assessed as non-serious as per reporter with no seriousness criteria like results in death/life threatening/cause/prolonged hospitalization/Disabling/Incapacitating/Congenital anomaly/birth defect. The outcome of the events was recovering.
Started with a headache followed by joint pain in shoulder, knee and hip. Next morning woke up with a headache and the injection area was sore, swollen and red.
This is a spontaneous report from a contactable medical assistant communicated to a Pfizer sales representative. A 16 or 17 years old male patient of an unspecified age and race received TRUMENBA, intramuscular at 0.5 ml single and MENACTRA MCV4, via an unspecified route of administration at 1 DF single, both on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, after the patient receiving the vaccines, he fainted, had a vassal vagal response to them with outcome of unknown.
This case was reported by a pharmacist via call center representative and described the occurrence of burning tongue in a 74-year-old male patient who received BOOSTRIX (batch number TX34X, expiry date 14th May 2017). Concomitant products included ZOSTAVAX. On 2nd August 2016, the patient received BOOSTRIX (intramuscular) .5 ml. In August 2016, 2 days after receiving BOOSTRIX, the patient experienced burning tongue (serious criteria GSK medically significant), lip swelling, taste altered and lip redness. In August 2016, the outcome of the lip redness was recovered/resolved. On an unknown date, the outcome of the burning tongue and taste altered were unchanged and the outcome of the lip swelling was recovering/resolving. It was unknown if the reporter considered the burning tongue, lip swelling, taste altered and lip redness to be related to BOOSTRIX. Additional details were provided as follows: The patient received BOOSTRIX on the right deltoid. The patient received concomitant medication ZOSTAVAX (batch number M010486 expiry date 25th May 2017) subcutaneously on the left arm. The patient received ZOSTAVAX vaccine same time as BOOSTRIX. The reporting pharmacist administered the BOOSTRIX vaccine to the patient. On 18th August 2016, in the morning, the reporter came into the  pharmacy and reported that two days after receiving the BOOSTRIX, the patient's lips became swollen and red, tongue feels scorched, and food does not taste the same as it did prior to the vaccination. It was also reported that the patient's taste buds were affected. The upper lip was still swollen in the left corner. The reporter commented that the manufacturer of the ZOSTAVAX was Merck. This was the first time this was reported to the response center.
Itchy rash, excoriated papules on scalp, neck, trunk, extremities.
Full body muscle pain/weakness for six weeks, surgical removal of three masses from top right hand/pointer finger that developed the same time as the full body muscle pain. Two weeks after first Pfizer Covid 19 dose.
Swelling of lymph nodes in right neck and axilla within one week of vaccine, rash on right arm and neck 2-3 weeks after vaccine
Went to ER with SOB. Was admitted on September 23, 2021, then transferred to another Hospital on October 12, 2021. Pt succumbed to her illness on November 5, 2021.
The shots appear to have triggered an autoimmune resonse which is still present. Shortly after I received the shots I develped mononucleosis and strep throat. I have been experiencing chronic recurring viral infections since. I have been unable to exercise or perform strenous physical activity, when I do a viral infection manifests. I have had to sleep at least 10 hours each night just to be able to function and get through the day. I have had a difficult time interacting with others and now have a low stress tolerance. I was healthy before the shots and I have felt terrible ever recieving the shots.
Left eyelid puffy and sensitive following Pfizer booster shot 8 months after receiving Johnson and Johnson dose
Patient received the Covid-19 vaccine. She reports symptoms of Other: difficulty swallowing similar to shell fish reaction, but no difficulty breathing. No Hx of anaphylaxis and does not have epi pen I have observed at 1350 P ox 97%, HR 85, B/P 150/82, RR 24 At 1400 Pox 97% HR 77, B/P 132/78, RR 16 Treatment/intervention Benadryl oral 25mg at 1353 VAERS report submitted: Yes NO
no AE; an expired dose of PROQUAD that was administered; This spontaneous report has been received from a consumer referring to herself or himself with unknown gender and age. The patient's pertinent medical history, concomitant therapies and drug allergy or reactions were not provided.  On 02-DEC-2020, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (therapy type: recombinant human albumin (rHA) strength, dose, frequency and route not provided, lot number S017251 has been verified to be a valid lot number, expiration date was 01-DEC-2020) (expired product administered) for prophylaxis. No adverse event reported (no adverse event). The outcome of both events were unknown.
Information has been received from a registered nurse concerning an elderly patient who on an unspecified date was vaccinated with a second dose of PNEUMOVAX 23 (lot#, route and site of administration not reported). The first and second doses were reported to be given "approximately 6 months apart". On an unspecified date, the patient died but many months after receiving the second vaccination. The nurse stated that the patient was administered PNEUMOVAX 23 vaccine prior to discharge from a local hospital. The reporting nurse insisted that it had nothing to do with PNEUMOVAX 23 vaccine and death was from old "age". This is one of several reports from the same source. Additional information has been requested.
Pt states she began to experience minor cold symptoms starting on 7/9 but denies fever.  Pt took J&J vaccine on 7/14. Beginning on 7/14, pt notes she developed a fever and acute worsening in cold symptoms. Pt reports congestion, sore throat, and dry cough. Highest home temp was 101.2.   Pt reports that these symptoms lasted from 7/14 to 7/17 and have since resolved. Pt denies swelling or abscess at injection site. Denies chest pain, SOB, rash, itching, swelling, anaphylaxis, LOC, syncope, chills, body aches, fatigue.
adm 9/9/99 for intuss;reduced surgically, and inflamed appendix-removed;discharged 2 days 9/12/99;
Death by suicide sometime between late evening Wednesday, April 21st, 2021 and early morning April 22nd, 2021.  He was found at about 8am that morning.
This spontaneous report as received from a pharmacist refers to a 53 year old female patient with penicillin allergy. On 08-NOV-2013 the patient was vaccinated with ZOSTAVAX lot # J006155, expiration date: 30-AUG-2014, one injection in the left arm. On 09-NOV-2013 the patient began to develop redness, swelling, warmth, and blistering 1 inch by 3 inches, at the injection site. She took an unknown non-drowsy antihistamine and ibuprofen during the day and BENADRYL during the night. On the morning of 10-NOV-2013 the red, warm, reaction area around the blister had increased in size to 5 inches by 6 inches, the entire back of her arm, and is hot to touch. The area has a blistery cellulitis appearance. It is unknown if there is any relevant laboratory data. As of 10-NOV-2013 it is unknown if she will receive another injection of ZOSTAVAX. At the time of this report the patient did not recover from the events of blisters, redness, warmth and a blistering cellulitis appearance around the injection site. The relatedness between the patient's adverse events and the vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Within 24 hours after receiving my 2nd Pfizer booster vaccine, my right foot became swollen, red, and extremely painful.  I can't walk on it.  It has been like this for 1 day now.; Within 24 hours after receiving my 2nd Pfizer booster vaccine, my right foot became swollen, red, and extremely painful.  I can't walk on it.  It has been like this for 1 day now.; Within 24 hours after receiving my 2nd Pfizer booster vaccine, my right foot became swollen, red, and extremely painful.  I can't walk on it.  It has been like this for 1 day now.; Within 24 hours after receiving my 2nd Pfizer booster vaccine, my right foot became swollen, red, and extremely painful.  I can't walk on it.  It has been like this for 1 day now.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 21Apr2022 at 18:00 as dose 4 (booster), single (Lot number: Fp4554) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: En6208, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 16Mar2021, when the patient was 54-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: Er8733, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 06Apr2021, when the patient was 54-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 3, Batch/Lot No: 301258a, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 21Oct2021, when the patient was 55-year-old, for COVID-19 Immunization. The following information was reported: PERIPHERAL SWELLING (disability), ERYTHEMA (disability), PAIN IN EXTREMITY (disability), GAIT INABILITY (disability) all with onset 22Apr2022 at 18:00, outcome "not recovered" and all described as "Within 24 hours after receiving my 2nd Pfizer booster vaccine, my right foot became swollen, red, and extremely painful. I can't walk on it. It has been like this for 1 day now.". Therapeutic measures were not taken as a result of peripheral swelling, erythema, pain in extremity, gait inability.  Clinical course: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No hospitalization Prolonged. AE resulted in Disability or permanent damage. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Reported Event: Within 24 hours after receiving his 2nd Pfizer booster vaccine, his right foot became swollen, red, and extremely painful. He couldn't walk on it. It has been like this for 1 day now.  No follow-up attempts are possible. No further information is expected.
15 year old came in to get Varicella and MMR vaccines and was given PROQUAD.; This spontaneous report was received from a nurse who was reporting on 15-year-old female patient. There was no information about the patients concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 08-APR-2021, the patient came in to get Varicella and MMR vaccines and was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), 0.5 milliliter (strength, route of administration, anatomical location, lot number and expiration date were not reported)  for prophylaxis. It was considered as product administration to patient of inappropriate age.
Immediately after receiving vaccine pt developed sensations of throat closing and pruritus. Pt has previous alergic rx to flu vaccine. RN at clinic administered epinephrine 0.3 mg IM into R thigh and was given benadryl 50 mg. Patient then went to ED via EMS. Patient was discarhed from ED.
Pt seen by doctor on 7/27 for 4 yea old check up. Complained of increased swelling later that day. Flu 7/29 with large 6x8 cm circular warm area on leg where MMR received. Flu 7/30.
Breakthrough case admission after 3 vaccines ; Moderna 3/29/21 Lot# 002B21A;  MOderna 4/26/21; Lot# 048B21A;  Moderna 1/29/22 Lot# 027L21A
Redness at injection site, Approximately softball size; swelling at injection site, Approximately softball size; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of injection site erythema in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22-MAR-2023, the patient received the 2nd dose of Shingrix .5 ml. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site erythema (Verbatim: Redness at injection site, Approximately softball size) and injection site swelling (Verbatim: swelling at injection site, Approximately softball size). The outcome of the injection site erythema and injection site swelling were resolved (duration 2 days).   The reporter considered the injection site erythema and injection site swelling to be possibly related to Shingrix.     The company considered the injection site erythema and injection site swelling to be possibly related to Shingrix.   Additional Information: GSK Receipt Date: 11-MAY-2023 The patient was 52-53 years old. Duration of adverse event was approximately 2 days.  Reporter believed that adverse events were related to immunization with Shingrix.  The reporter did not consent to follow up.
Patient had a positive COVID PCR test on 10/04/2021 after receiving both vaccines
Patient felt dizzy and appeared to have a mild seizure 10 minutes after receiving vaccine. was evaluated by emt and then went home. Patient was doing well the next day when I followed up with her
1st Shot: The right side of my face felt like someone punched me and knocked my teeth out. Every joint in my body hurt terribly  (ie: neck, fingers, wrists, shoulders, elbows, hips knees, ankles toes). I had an excruciating pain that started from the top of the right side of my head continued on down my jaw thru my neck down to my chest just below my right breast. This pain was intense and would follow thru to my back. It literally put me on the floor when it hit. I had a fever of 99.7 despite talking Tylenol. I was is bed for 34 hour starting about 10 hrs after injection, lights out, no phone, no TV. I was unable to eat, all the water I was able to drink I threw up immediately. 72 hrs after injection I returned to work still achy and nauseous. 2nd Shot: Almost identical results.
Headache, Myalgia, Fever, fever h/a body aches chills Narrative:
Dehydration  Vertigo  Headache Weakness  Extreme tiredness  Loss of appetite  Blurry vision  Bruise at injection site 2-weeks now Lethargic  Stomach pain
Pfizer 3/8/21, 3/29/21, 10/5/21. Positive on 8/19/22
Gave an Adult dose HAVRIX to an 18 year old patient at an off site clinic. No adverse events reported.