chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Nausea; Lethargy; This is a spontaneous report received from a non-contactable consumer (patient). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3248), via unspecified route of administration in left arm on 09Mar2021 02:00 PM (at the age of 54-year-old) as 2nd dose, single dose for COVID-19 immunisation. Vaccine facility type was reported as workplace clinic. The patient's medical history was not reported. No COVID prior vaccination was reported. The patient's concomitant medications within 2 weeks included atorvastatin (LIPITOR) 40 mg, from unspecified date at 40 mg, daily. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), on unspecified date for COVID-19 immunisation. The patient did not receive other vaccines in four weeks. On 10Mar2021 10:00 AM the patient experienced headache, nausea, and lethargy. No treatment was received due to the events. The patient was not tested for COVID post vaccination. The outcome of the events was resolving.  No follow-up attempts are possible. No further information is expected.
Vasovagal RXN. Pt HR decreased to 50 and BP decreased.
STEMI in young healthy male. Normal coronary arteries. Found to have acute arterial clot in coronary arteries.
Rapid Heartbeat and chest pain led me to the hospital. Doctors performed X-ray, echocardiogram, and eventually angiogram to rule out blockage. No immediate signs of inflammation, however DR though strong possibility of myocarditis, but at the tail end. I had been ignoring chest discomfort for a week or two before the event that led me into the hospital. Due to my self reported Covid precautions (we are not seeing anyone outside 2 immediate vaccinated family members, and 99% of shopping is contactless), DR thought that it was caused by vaccine.
Patient seemed very nervous about getting a vaccination.  Was sitting on a chair waiting for her 15 minutes. I walked by and asked her if she felt ok and she said no.  I helped her to the floor as she looked pale.  Other pharmacist sat with her and waited for ambulance to come.  She did go to the hospital to get checked out.
Severe flu like symptoms. Body aches, headache, chills, and fever of just over 102 for about 12 hours. Over 100 degrees for approximately 36 hours.
Within minutes of administered the MMR and Varicella vaccine reacted with welts to each of vac sites ice applied and BENADRYL given.
Severe migraine, I suffer from chronic migraines and this headache is worse than any I have ever had; Also having some shortness of breath.; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 16Apr2021 at 09:15(at the age of 64-years-old) as a single dose for COVID-19 immunisation. The medical history included multiple sclerosis(MS), chronic migraine, neck fusion, high BP and eye problems. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received other unspecified medications within two weeks of vaccination. The patient previously took pregabalin (LYRICA), Triiodothyronine (T3) on an unknown date and experienced allergy. On 16Apr2021 at 15:00, the patient experienced severe migraine, suffered from chronic migraines and this headache was worse than any he ever had. It was been three days straight now and was also having some shortness of breath. The adverse event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether the patient received any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe migraine, suffered from chronic migraines and this headache was worse than any it ever had and shortness of breath was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Patient PCR positive for COVID-19 on 07/10/2021, symptoms began 07/04/2021. Patient had completed both doses of Moderna series- first dose 01/06/2021 and second dose 02/05/2021
Information has been received from a consumer referring to her child, a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On an unknown date the patient was vaccinated with VARIVAX (dose, frequency, route, lot# and expiration date not reported). On an unknown date the patient experienced a mild case of Chicken Pox (diagnosed by an unspecified physician) after the vaccination. The outcome of the event was unknown. Causality assessment was not reported. Additional information is not expected due to lack of contact information.
pain primarily in the joints in his hips and legs; a lot of discomfort, mainly joint pain; This is a spontaneous report from a contactable consumer, the patient. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was not reported) via an unspecified route of administration on 04Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient developed pain primarily in the joints in his hips and legs and stated that he was going through a lot of discomfort, mainly joint pain. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
swollen right eye, vision was blurry, lost my voice and had difficulty swallowing: these started about 3 hours in  burning/itching across face, neck, head and chest: 10 minutes after injection in the first hour: continued itching, dizziness, limbs were very heavy, dry heaves  Benedryl 50 mg when swelling started, 25 mg Benedryl every 4 hours through Sunday 3/28
Client given COVID booster at 4 months after 2nd dose instead of 5 months after 2nd dose. According to mother, client threw up last night and was feeling warm with no fever in the morning. Still felt well enough to go to school.
Wiped out/no energy; Achy; Bad headache; More tired; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Wiped out/no energy), PAIN (Achy), HEADACHE (Bad headache) and FATIGUE (More tired) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced ASTHENIA (Wiped out/no energy), PAIN (Achy), HEADACHE (Bad headache) and FATIGUE (More tired). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, ASTHENIA (Wiped out/no energy), PAIN (Achy), HEADACHE (Bad headache) and FATIGUE (More tired) had resolved.            This case was linked to MOD-2021-033538 (Patient Link).
This case was reported by a healthcare professional and described the occurrence of dry heaves in a female subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). On 28 October 2011 the subject received a dose of FLUARIX (unknown route). On 28 October 2011 at 19:00, less than one day after vaccination with FLUARIX, the subject experienced dry heaves, chills, fever, weakness and intestinal problems. The events were resolved after a 12 hour period. On 29 October 2011 the events were resolved. Follow up information received from the healthcare professional (nurse) on 05 December 2011. The 55-year-old subject's concurrent medical conditions included codeine allergy, hypertension, increased triglycerides and social alcohol drinker. On 28 October 2011, subject received a dose of FLUARIX (0.5 ml intramuscular, left upper deltoid). Less than one day after vaccination with FLUARIX, the subject was diagnosed with nausea and chills. The healthcare professional identified FLUARIX as the suspect product, but causality assessment was listed as unknown. The healthcare professional indicated the events were not serious.
Transaminitis; AST 392; ALT 81 IU/l; Fevers; Nausea; Vomiting; abdominal pain; dose 2 on 05May2021 and first dose on 24Apr2021; dose 2 on 05May2021 and first dose on 24Apr2021; This is a spontaneous report from a contactable physician. A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) dose 2 intramuscular, administered in arm right on 05May2021 16:00 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. Medical history included bilateral cystic kidney disease, hypertension, allergies to amoxicillin, cephalexin, ceftriaxone. Concomitant medication received within 2 weeks of vaccination included propranolol 30 mg, 3x/day. The patient previously received first dose of BNT162B2 intramuscular in right arm on 24Apr2021 04:00 PM for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced transaminitis, AST 392 IU/l, ALT 81 IU/l; normal bilirubin 0.6 on 06May2021. Fevers starting on 06May2021 to 10May2021 and continued (current at time of reporting) with nausea, vomiting, abdominal pain. These events resulted in Emergency room/department or urgent care. Treatment received for the adverse events included ondansetron; IV bolus. The outcome of events transaminitis, AST 392 IU/l, ALT 81 IU/l, Fevers and abdominal pain was recovering and other events was unknown. Events were reported as non-serious and did not resulted in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating or congenital anomaly/birth defect.  Information on the batch/lot number has been requested.; Sender's Comments: Based on temporal association, a contributory role of BNT162B2  to the reported events cannot be totally excluded.  Case will be reassessed if additional information is received.   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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
PRODUCT STORAGE ERROR; THE JANSSEN COVID 19 VACCINE WAS REFROZEN AND ADMINISTERED TO PATIENT; This spontaneous report received from a health care professional concerned a 44 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: 20-MAR-2022) dose was not reported, administered on 09-AUG-2021 for prophylactic vaccination. Age at time of vaccination 44 years old. No concomitant medications were reported. On 09-AUG-2021, the patient experienced the janssen covid 19 vaccine was refrozen and administered to patient. On an unspecified date, the patient experienced product storage error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the janssen covid 19 vaccine was refrozen and administered to patient and product storage error was not reported. This report was non-serious. This case, from the same reporter is linked to 20220540611, 20220540524, 20220538292, 20220537341, 20220537356, 20220537444, 20220537683, 20220537688, 20220538146, 20220538149, 20220538210, 20220538238, 20220538297, 20220538316, 20220538411, 20220538425, 20220538428, 20220538437, 20220538627, 20220538666, 20220538758, 20220538890, 20220539045, 20220540324, 20220540420, 20220540435, 20220540536, 20220540570, 20220540642, 20220538480, 20220541180, 20220540765, 20220540814, 20220538693, 20220537507, 20220537532, 20220537548, 20220538347, 20220538573, 20220540688, 20220541401, 20220541506, 20220541085, 20220540765, 20220538379 and 20220540816.
Information has been received from a physician concerning a 2 month old patient who was vaccinated PO with the first dose of rotavirus reassortant vaccine live (human-bovine). The physician reported that, 48 hours after being vaccinated, the patient developed prolonged diarrhea. It was noted that 10-12 diapers per day were needed due to the diarrhea. Unspecified medical attention was sought. Subsequently, the patient recovered from the prolonged diarrhea. The physician also noted that the patient would receive the second dose of rotavirus reassortant vaccine live (human-bovine) at four months of age. Additional information has been requested.
Dizziness, hypertension. BP 184/77 (pulse 102), 99% O2 sat. F/u BP 168/85. Patient has a fear of needles.
No adverse side effects but was given past the BUD and product was considered "expired". Per BUD expired on 1/13/2023,  given on 1/14/2023. Per Pfizer they do have additional stability info that did say it was still a stable product and the CDC states the dose does not need to be repeated
Flu-like symptoms the next day  - lethargic, achy and tired. I took Tylenol and sleep and hydrating up to 48 hours. I did seek my provider as I had a scheduled appt. I think I had a sore throat, too. The lymph nodes were slightly enlarged. I am having some spinal issues; back pain; leg issues; bladder issues and leg fatigue. I'm currently off work and have been off work since mid April. I have seen my doctor multiples times. I had had many tests. Nothing has helped with the pain so far (getting physical therapy) and I'm having spinal injections tomorrow.
This spontaneous case reported by a consumer, describes the occurrence of impaired work ability (muscular problems kept him from working), muscle discomfort (muscular problems) and pyrexia (high fever) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced impaired work ability (muscular problems kept him from working), muscle discomfort (muscular problems) and pyrexia (high fever). At the time of the report, impaired work ability (muscular problems kept him from working): resolved; muscle discomfort (muscular problems) and pyrexia (high fever) outcome: unknown. No concomitant medication or treatment information provided. This case linked to MOD-2021-283049 (patient link).
Pfizer-BioNTech COVID 19 Vaccine EUA Fatigue the day after my vaccine.   Felt like I was "in a fog".   Went to bed at 8pm,  coughed for an hour  (not my asthma cough), chills, woke up at 8am    Felt fine the 2nd day after my vaccine.
Information has been received from a 77 year old male patient with no pertinent medical history or drug reaction or allergies who in May 2008, was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included TOPROL XL TABLETS, AVAPRO, LANOXIN and COUMADIN. In approximately February 2009, "about a month ago", the patient came down with shingles. He had lesions on his right shoulder and some breaking out on his right side of his neck. There was some pain on top of his head down to his neck, shoulder and going under his armpit. The patient was not severe. He was prescribed some antiviral medication and pain medication (unspecified which ones). The patient stated that he was almost fully recovered from the shingles. No lab tests were done. Unspecified medical attention was sought. Additional information has been requested.
This spontaneous report was received from a nurse regarding unspecified patients of unknown age and gender. Pertinent medical histories, drug reactions or allergies and concomitant therapies of the patients' were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # L027067, expiration date 06-APR-2017 (dose and route of administration were not reported). The administered doses experienced a temperature excursion of 0.0 degree Celsius for 9 hours. Previous excursions were 1.4 degree Celsius for 14 minutes, 0.0 C for 11 hours and 43 minutes,0.7 degree Celsius for 12 hours and 53 minutes 0.0 C for 10 hours and 36 minutes 0.6 degree Celsius for 46 minutes and 32 degree Fahrenheit for 4 hour and 20 minutes. The temperature excursions were detected by a data logger. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of three reports received from the same reporter. Additional information has been requested.
Needle used in vaccination did not auto-retract. Upon pulling needle out, caused fluid to splash back at provider. No harm to patient, just the provider.
DRUG ADMINISTERED VIA INAPPROPRIATE ROUTE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: Unknown) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced drug administered via inappropriate route, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the drug administered via inappropriate route and off label use was not reported. This report was non-serious.
Information has been received from an office manager (health professional) referring to multiple unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored GARDASIL 9 (lot # L004014, expiration date 04-MAR-2017, strength, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient was administered vaccine beyond the published expiration date. Per Moderna Manufacturer, re-vaccination is not required, the vaccine was determined to still maintain the activity necessary to protect against Covid-19.
Red, swollen joints starting 1 day after shot urticarial lesions & fever pale, decreased BP, sweaty episode in office today.
both ear swollen, red like acute perichondritis on day of 2nd oral typhoid vax;T99-99.9 given astemizele & DPH po, dipiztene topically;
About 36 hrs after injection, arm is red, warm to touch, swollen on inside of elbow. Nurse suggested he take Tylenol or Advil for pain, Benadryl for itching or allergic reaction he's having and to ice his arm for swelling.
Shortness of breath, diarrhea, vomiting (intractable), shock, hypotension required ICU stay and IV steroid therapy and pressors.
second dose later than 42 days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (second dose later than 42 days) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (second dose later than 42 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (second dose later than 42 days) had resolved.            No concomitant medications were provided. No treatment medications were provided.
Extreme fatigue; Cold sweats; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Aug2021 at 11:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and high cholesterol. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received codeine (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and experienced drug allergy. On 10Aug2021 at 06:00, the patient experienced extreme fatigue and cold sweats. The 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme fatigue and cold sweats was recovered on unknown date in 2021. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Sep2021 at 11:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider, a pharmacist at a pharmacy recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2012, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 28-MAR-2016, the patient was treated by a physician assistant at a medical office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.