chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chest pain; increase in PVC's; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious), outcome "unknown", described as "chest pain"; VENTRICULAR EXTRASYSTOLES (non-serious), outcome "unknown", described as "increase in PVC's".  Additional information: Subject: Patient Assistance. Customer Verbatim: Patient had over 10 days of chest pain and an increase in PVCs after receiving the first dose of Pfizer COVID-19 vaccination. Patient reached out to healthcare provider before pursuing the 2nd dose, to advise patient. He consulted with a cardiologist, and it was recommended that patient seek further testing (EKG, echocardiogram) before receiving 2nd dose. Patient was self-insured. Patient was inquiring if there were any funds or grants available (through Pfizer or other companies) to help off-set the costs of these tests.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (01Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Third trimester vaginal bleeding, intrauterine pregnancy at 35 weeks - hospital admission. Treated and released. Baby was delivered by C-section on 10/24/2021. Hospital admissions were within 6 weeks of receiving the CVOID vaccine.
Information has been received from a retired licensed practical nurse concerning herself, a 74 year old female patient. The patient's medical history included a fracture of the left knee. Her concurrent conditions included osteoporosis and cephalosporin allergy. Historical drugs included a vaccination with ZOSTAVAX on an unknown date 10 years ago, she had a local reaction described as "developed 1 inch by1 inch area red and swollen located above the elbow" (MARRS 1703USA008228). The patient did not take concomitant medications. On 01-MAR-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly, lot number M038359 with expiration date: 03-MAY-2018 (dose, dose number and anatomical location were not provided) for prophylaxis. On the same day, after receiving PNEUMOVAX 23, the patient developed a local reaction of "redness, swelling and itching located about 2 inches above the elbow", the area on her arm that was affected was not at the PNEUMOVAX 23 injection site and that the area of redness and swelling grew to a 3 inch by 2 inch area. She took BENADRYL, as treatment. On 03-MAR-2017 the patient experienced a "runny nose". Then, on 04-MAR-2017 the patient was recovered from the redness and swelling located area and experienced cough. In addition, on 05-MAR-2017, the patient developed laryngitis. The patient did not seek medical attention and there was not lab diagnostics studies performed. At the time of the report, the patient was not recovered from the runny nose, laryngitis and cough, and the outcome of the itching was unknown. The relatedness between the events and the PNEUMOVAX 23 was not reported. There was no product quality complaint involved. Additional information has been requested. Sender's Comments: US-009507513-1703USA008228.
pt states he developed itchy during the night in various locations on the body.   Next day pt also had mild headache and congestion.  Pt has not contacted his PCP at this time.
Large raised, redden area noted to back and (R) arm, warm to touch, spreading around arm and to lower arm. Client reports hx recurrent staph infections. Tympanic temp - 98.5, referred to PCP, walk-in clinic or to go to ER.
Guttate psoriasis/Her symptoms are still ongoing at the moment. It's horrible. It's itchy, all over her body, red, scaly; This spontaneous case was reported by a patient and describes the occurrence of GUTTATE PSORIASIS (Guttate psoriasis/Her symptoms are still ongoing at the moment. It's horrible. It's itchy, all over her body, red, scaly) in a 49-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (1st Pfizer dose) on 18-Mar-2021, PFIZER BIONTECH COVID-19 VACCINE (2nd Pfizer dose) on 08-Apr-2021 and PFIZER BIONTECH COVID-19 VACCINE (Pfizer booster dose) on 02-Dec-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 13-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 08-Jan-2023, the patient experienced GUTTATE PSORIASIS (Guttate psoriasis/Her symptoms are still ongoing at the moment. It's horrible. It's itchy, all over her body, red, scaly). At the time of the report, GUTTATE PSORIASIS (Guttate psoriasis/Her symptoms are still ongoing at the moment. It's horrible. It's itchy, all over her body, red, scaly) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant Medication use information was not provided by reporter.  The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient got the Moderna COVID bivalent booster on 13 December 2022. It was the first time she ever had a Moderna shot. On 8 January 2023, patient had guttate psoriasis. the symptoms were still ongoing at the moment. It was horrible and itchy, all over the body, red and scaly. The only parts of body that it was not on her face, both her hands, and both the feet.   It was really bad on her back and hips. It was on her ankles. It was really bad on the back of the legs. The patient dermatologist was not sure if it was due to the Moderna booster bivalent or the Strep A infection. She repeated that it was bad. Her doctor told her it would take 3 months to go away. She will be having UV light therapy and steroid ointment. The patient reported that she never had any reactions from her previous Pfizer shots.  Non drug treatment includes UV light therapy. Also on steroid ointment, drug name not specified. .
Vaccine was administered 8/17/2010. On 8/19/10 patient reported rash, redness & swelling (about size of an apple) rash was warm to touch. Recommended ice & BENADRYL/hydrocortisone cream for itching, swelling. MD has appt w/her MD 8/21/10. Rash was much better on 8/22/10 per pt.
Area surrounding where PPSV 23 was administered is warm to touch, red, and painful. Pt's daughter s/s began in the evening after administration. Referred to PCP for treatment.
hives; This is a spontaneous report from a contactable physician via Pfizer sponsored program.     A 60-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation Solution for injection, Lot Number unknown, Expiry date: 31Jul2021) via an unspecified route of administration on 20Apr2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 20Apr2021 patient Stated that hives experienced almost immediately after receiving the first dose Pfizer Covid Vaccine. Outcome of the event was recovered.  Follow-up attempts are needed. Further information has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event, urticaria cannot be completely ruled out. The impact of this report on 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 Regulatory Authorities, Ethic committees, and Investigators, as appropriate.
body aches, Severe headache, sore throat, ear ache, was awaken in the night with what seemed like a convulsion, severe shakes, all my joints hurt so bad I couldn't walk, hard time breathing. 2 days later i still feel fatigue and have a headache
Patient was witnessed having a grand mal seizure in a classroom during her hospital orientation as a new employee. Seen in the ED where another seizure occurred, then admitted to the inpt unit. Keppra was started. Rec'd the flu shot 48 hrs prior to seizure...unknown if a precipitating factor. Treating doctors unaware of previous vaccination in Employee Health office.
This spontaneous report as received from a healthcare worker refers to an unknown number of patients of unknown age and gender. No information regarding patient's medical history, concurrent conditions nor concomitant therapies was provided. On an unspecified date in approximately 2015 (reported as between 08-SEP-2015 through 02-OCT-2015), the patient was vaccinated with a dose of improperly stored GARDASIL or GARDASIL 9 (dose, frequency, route of administration, lot # and expiration date were not reported). No adverse symptoms were reported. The reporter was not able to provided any further details at the time of reporting. This is one of several reports received from the same reporter. Additional information has been requested.
Received my positive test; Received my positive test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: Unknown) at the age of 46 years for covid-19 immunisation, Covid-19 manufacturer unknown (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 relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Received my positive test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: started taking Paxlovid the day I received my positive test; (2022) Negative, notes: took it for 5 days and tested negative (antigen) on day 6. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient have not received any other medication in 2 weeks. Adverse event: Paxlovid Rebound! I started taking Paxlovid the day I received my positive test. I took it for 5 days and tested negative (antigen) on day 6. On day 11 I started feeling very tired, then a runny nose on day 14. I'm on Day 15 and still congested and tired, achy. start date of events was 13May2022 at 03:30 PM. The patient was treated with paxlovid from 04May2022 to 08May2022 for treatment of covid-19.  The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received.
This spontaneous report was received from a medical assistant regarding unknown number of patients of unknown demographics. There was no information about concurrent condition and historical medication. Since 22-JAN-2015, the patients were vaccinated with GARDASIL, lot # J012212 (expiration date-18-FEB-2016), lot # J006236 (expiration date- 25-FEB-2016) and lot # K005881 (expiration date- 14-JAN-2017), intramuscularly which had underwent unsupported temperature excursions (incorrect product storage). No adverse effect was reported. No product quality complaint was involved. No concomitant medication was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Patient received routine, CDC recommended, vaccines for 12 month old child. Immediately after injections, a red flat rash developed at each injection site. BENADRYL given. Pt observed. Discharge condition.
Herpes zoster; This spontaneous report as received from a lawyer regarding a case in litigation refers to a female patient (pt) of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On approximately 23-OCT-2013, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  As a direct result of zoster vaccine live (ZOSTAVAX), on an unknown date shortly after vaccination, the pt experienced abdominal pain and was diagnosed with herpes zoster (shingles). As a direct result of the zoster vaccine live (ZOSTAVAX), the pt suffered mental and emotional distress resulting in physical limitations and the seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the event was considered to be not recovered.      Herpes zoster (shingles) was considered to be disabling.
Swelling of arm redness itching like when getting stung by a wasp and I am allergic.  Numbness and tingling in extremities mainly pinky and ring finger of both hands
The vaccine was given past it?s refrigeration expiration date, the date on the vial was still within date.   Another covid vaccine given to patient.
On April 23, 2022 started having shortness of breath and fatigue. By the 25th chest pain and tachycardia throughout week. Being followed by PCP who ordered cardiac monitor. Symptoms became emergent on April 30, 2022. Severe shortness of breath led to calling EMS. From April 23rd to April 30th all symptoms included shortness of breath, chest pain, tachycardia, fatigue, and trouble speaking sentences due to shortness of breath.
Intermittent pain/itch on left side of shoulder above injection arm. Chronic irritation that has not subsided in 18 months.
Patient said put she had an adverse reaction to vaccine on her consent form. When I consulted her, she said she gets nervous and a little dizzy. Approximately 30 seconds after receiving her shot, patient fainted. It looked as if she may seize so I and her mother lay her on the floor on her left side. Patient never totally lost consciousness and about 10 seconds later she was responsive and after a few minutes she said she felt better. She sat up and received medical attention from EMS. She refused hospitalization. Her mother said she has not fainted before after a flu shot.
Started heavy period within 4 hours of vaccination.  Period isn?t due for 3 more week.
have been diagnosed with Covid19 illness; have been diagnosed with Covid19 illness; This is a spontaneous report from a contactable consumer. This consumer reported for an 85-year-old male patient (Reporter's father) that the patient has received his first dose of BNT162B2 (Formulation: Solution for injection, Lot number: EK4175) on an unspecified date and second dose on 15Feb2020 (Lot number: EM9810) through an unspecified route, both doses received as single doses (Age at vaccination: unknown) for covid 19 immunization. patient's medical history and concomitant medication was not reported. It was reported that the patient has been diagnosed with Covid19 illness and patient is in hospital now, fighting for his life and not on a ventilator yet, but patient was close. Reporter also mentioned his father is on 10L of oxygen, heparin, and other bad drugs.The caller is trying to figure out how this happened as his parents were fully vaccinated, and very safe (following mask wearing guidelines, etc.). He concerned as his entire family has been vaccinated with the Pfizer product.Have there been reports of bad batches. The reporter also enquired that if Pfizer is evaluating booster doses, Is the product effective against variants of the Sars-CoV-2 virus. The outcome of the event vaccination failure and COVID-19 was unknown
pt recv vax 4FEB98 & 25FEB98 pt exp six erythematous skin lesion (three on back, tow on the chest one on the neck) & a sl fever of 99.1;
Narrative: 74yo M with medical history of GERD, CAD status post CABG, OSA, hearing loss, anemia, BPH, Crohn's hypertension, diverticulosis, & most recent Relapsed refractory "B-cell lymphoma" after had been treated with chemo in 2018-2019. Pt in hospice care since 5/2020. Pt died on 7/26/2021 at home in home hospice care. Pt received covid vaccinations on 1/26/2021 & 2/23/2021. Pt's death unrelated to covid vaccinations.
Swollen left arm and very itchy.  Provider seen patient today in clinic. Provider wants patient to do the following:  Diphenhydramine (Benadryl) 12.5 mg/5ml 6.5 ml every 6 hours for 3 days. Ice 3-4 x a day. Recheck if the redness gets more than 15 mm past the edges of the marked border today or if she has troubles breathing or swallowing.
PT DEVELPD FEVER, LUMP(/W/OUT ABSCESS), SHAKING AND CYANOSIS-LOWER BODY, TAKEN TO ER:OK ON EXAM
Swelling at injection, hard knot, sleepiness, irritability 2/11/2015.
approx 33days p/vax pt devel a rash. it was rpt 3x, 2wks apart, pt has had a rash lasting for as long as 5-6days. MD said it was poss chickenpox. addl info req
This case was reported by a nurse via call center representative and described the occurrence of tingling in a 18-year-old male patient who received BEXSERO. Concomitant products included HAVRIX. On 20th June 2016, the patient received the 2nd dose of BEXSERO .5 ml. On 20th June 2016, 2 hrs after receiving BEXSERO, the patient experienced tingling (serious criteria disability), muscle spasm (serious criteria disability), chills (serious criteria disability), vomiting (serious criteria disability), headache (serious criteria disability), pallor (serious criteria disability), cold (serious criteria disability) and injection site pain (serious criteria disability). On an unknown date, the outcome of the tingling was recovering/resolving and the outcome of the muscle spasm was recovered/resolved and the outcome of the chills, vomiting, headache, pallor, cold and injection site pain were unchanged. The reporter considered the tingling, muscle spasm, chills, vomiting, headache, pallor, cold and injection site pain to be related to BEXSERO. Additional details were received as follows: This case was reported by the patient's mother. The reporter did not have access to the lot number and expiration dates as she was not in the office. The reporter would call back to provide that information.
Pt came into store and complained of a pimply-like rash on left side of body with associated itching all over rash area. Stated it started on left shoulder and then spread over chest and started on left side of body. Treated by Dr. with a MEDROL dose pack. Pt. stated rash started on Sat 9/19. Presented Rx on 9/24
Left arm became swollen, tender and  hot in a 3  inch diameter around shot site.   The swelling and redness around shot lasted for 6 days and began to get smaller each day after day 3.  Around day 5 became itchy. The night of the shot and next day, I was fatigued, achy and slight headache.
This spontaneous report was received from the Vaccine Coordinator referring to a 5 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 28-SEP-2017, the patient was vaccinated with an improperly stored dose of VARIVAX with one of these lot #'s reported M017292, expiration date on 07-APR-2018; lot # N017701, expiration date on 09-JUN-2019 or with lot # N019127, expiration date on 22-JUN-2019 (Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis. There was no adverse effect reported.The administered dose of vaccine experienced the temperature excursion of 7.52 F degrees Fahrenheit for 24 hour, and had a previous temperature excursion of 5.5 F degrees Fahrenheit for 1 hour. There was a digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008693.
3 hrs after shot developed severe left shoulder pain & used Ibuprofen lasted 20-30 min site ok - used ice pack.
extreme weakness; lightheaded; This is a spontaneous report from a non-contactable consumer, the patient. A 40-years-old adult non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Mar2021 at 14:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Concomitant medications included ethinylestradiol, etonogestrel (NOVARING), escitalopram (MANUFACTURER UNKNOWN) and valaciclovir (VALACYCLOVIR); all for an unknown indication and from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021, the patient experienced extreme weakness and lightheaded. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events extreme weakness and lightheadedness were resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Received flu shot as an outpatient 12/12. Came to ER at 21:26 with SOB, wheezing, severe hypoxia. Received 6 respiratory treatments with albuterol, solumedrol, and Alocort. Almost required intubation. Severe hypoxia with asthma attack. Felt dizzy, fainting/no seizure disorder. Wheezing. Continue corticosteroids at high dosage for treatment.
Fever starting roughly 12 - 16 hours after injection, lasting at least three days. Soreness and fatigue. Occasional nausea