chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Gradual onset of raised red papilate lesions, eventually covering entire body from neck to ankles.  Currently on 5th day of treatment with prednisone. Biopsy reveals eosinophile invasion.
17MAY91 Parents reports pt had fever-unk degree, was irritable, had swelling inject site MMR, had reddened raised rash on face & neck;
appendicitis; This is a spontaneous report from a contactable consumer (patient).   A 66-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 66-year-old via an unspecified route of administration, administered in Arm Right on 10Mar2021 15:15 (Lot Number: EN6199) as single dose for covid-19 immunisation.  Medical history included High blood pressure, asthma. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No COVID prior vaccination. No known allergies. Concomitant medication included lisinopril received within 2 weeks of vaccination. The patient previous received first dose of BNT162B2 (Lot Number: EL9267) in Right arm on 17Feb2021 15:15 as single dose for covid-19 immunisation. The patient experienced appendicitis on 13Mar2021, resulted in Emergency room/department or urgent care.  The patient was hospitalized for appendicitis for 2 days. The patient had an appendectomy. The patient underwent lab tests and procedures which included covid-19 (Nasal Swab): negative on 16Mar2021.  The outcome was recovering.
Severe muscle aches and body/joint pain which led the patient to see his physician, physician immediately sent him to the ER to stabilize his blood pressure.
Alk phos raised; AST increased; ALT increased; This is a spontaneous report received from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in right arm on 23Dec2020 (Batch/Lot Number: EL9899) (at the age of 64 years old) as 1st dose, single for COVID-19 immunisation. Medical history included gastroesophageal reflux, fatty liver disease, obesity, ocular hypertension, coronary artery disease, osteoporosis, gallbladder removed, lumbar spinal stenosis grade II, sciatica, facet degenerative joint disease, disk degeneration, right ovary removal, radioiodine removal thyroid, Graves' disease, Han (as reported), hyperlipidemia, hypothyroidism, obstructive sleep apnea and osteopenia. The patient had allergies to penicillin, sulfa and lactose . Prior to vaccination, the patient was not diagnosed with COVID-19.  There  were no concomitant medications. The patient was not pregnant at the time of vaccination. The Vaccination Facility Type was Hospital and vaccine was not administered at Military Facility. No vaccines administered on same date of the Pfizer Suspect. No prior vaccinations (within 4 weeks). On 04Jan2021, the patient experienced alkaline phosphatase (Alk Phos) raised, aspartate aminotransferase (AST) increased, alanine aminotransferase increased (ALT). The patient underwent lab tests and procedures in Oct2020 which included alanine aminotransferase: 29, aspartate aminotransferase: 23 and blood alkaline phosphatase: 130. On 04Jan2021, alanine aminotransferase: 123, aspartate aminotransferase: 75 and blood alkaline phosphatase: 163. On 19Jan2021, alanine aminotransferase: 198, aspartate aminotransferase: 124 and blood alkaline phosphatase: 171. Her liver specialist told her that her liver enzymes increased after each Pfizer COVID-19 Vaccine shot she received. She said her liver specialist told her she should report her liver enzymes increasing to Pfizer. Events did require a visit to Physician Office. She went to a liver specialist on 04Feb2021. No treatment received for the adverse events.  On 22Feb2021, Nasal Swab was negative. The outcome of the events was not recovered.
Pt was given the full 0.5 ml dose vs. the 0.25 ml dose for the booster.  Pt did not report any side effects and was not overly concerned
Patient developed hives distal to injection site shortly after immunization noted itchiness given BENADRYL 50 mg.
On 1/28/22, I woke up in the middle of the night to intense vertigo. Shortly after I developed tinnitus to my right ear, ear pressure and muffled hearing. I have gone to ER and had CT scan done and blood work. I have seen an ENT and neurologist and had MRI done of the brain which also came back normal. I have been on 2 courses of antibiotics and steroid therapy with no relief. I am now getting acupuncture and vestibular therapy. I have been on medical leave and had to apply for disability due to having loss of balance and constantly feeling dizzy.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 82 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient received Paxlovid for COVID-19 treatment indication for COVID-19. Other medication received in 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Mother states patient awoke at 1 am 8/8/07 with a severe headache, fever greater then 102 and abdominal pain.  He also reported that his arms and legs felt heavy and sore.  Tylenol was given at 1 am 8/8/07 with no decrease in temperature.  His mother called the Hospital, who told her to try to get his temp down.  Tepid bath and Motrin was given at 4:30 am 8/8/07.  At 11:30 am 8/8/07 patient's mother reports that his temperature is at 99.7, still has a headache (but it's better), arms and legs feel better but remain sore, and adbominal pain is gone.
heart rate elevated; This is a spontaneous report from a contactable pharmacist. A 37-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284/expiration date unknown), dose number 1 intramuscularly on 07Jan2021 12:00 at a single dose on the right arm for COVID-19 immunization. The vaccine was administered at a nursing home/senior living facility. There was no relevant medical history. The patient had no concomitant medications. No other vaccines were received within 4 weeks prior vaccination and no medications were taken within 2 weeks of vaccination. The patient experienced heart rate elevated on 07Jan2021 12:00. The patient went to the emergency room/sought urgent care for the event. No treatment was received for the event. The patient was not diagnosed with COVID-19 prior vaccination and was not tested for COVID-19 since vaccination. The outcome of the event was unknown.
I was very tired for 2 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administration date 27Mar2021 09:00 (Lot number: ER8733, Expiration Date: 31Jul2021) at the age of 64 years as dose 1, single for covid-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "I was very tired for 2 days". Therapeutic measures were not taken as a result of fatigue.  Additional information: The patient stated that With First dose I was very tired for 2 days. With Second dose I felt in a fog or hangover for a week. My hot flashes returned for couple months. They did stop. With booster, had fever 100.4 and chills for 3 days. Hot flashes came back and still have then today arm was sore.   No follow-up attempts are possible. No further information is expected.
Single large urticarial hive extending around deltoid and to medial part of upper extremity. Diffuse swelling. 10/10 pain.
The patient reported no current adverse event or any effect requiring medical attention.  The patient instructed to contact the pharmacy if any adverse events occur.
On 02/20/2023 I was not feeling well. I reached out to my Physician via Telehealth and was prescribed Antibiotics for 1 week afterwards I was still feeling sick and was sent to get a CT scan which confirmed that it was Pneumonia I was put on a course of Prednisone and a Nebulizer. I am feeling a lot better now.
hurts to eat; hurts to eat; twinges on the right side of neck in the lymph nodes which is now a knot; twinges on the right side of neck in the lymph nodes which is now a knot; extreme fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 67-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Mar2021 (Lot number: EN6203, Expiration Date: 01Jun2021) at the age of 67 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing); "left kidney donation", start date: 2001 (unspecified if ongoing), notes: Verbatim: left kidney donation; "flu season/preventative for colds and flu" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN taken for blood cholesterol increased (ongoing); VITAMIN C [ASCORBIC ACID] taken for influenza, start date: Sep2020 (ongoing); ZINC taken for hypersensitivity, start date: Sep2020 (ongoing); VITAMIN D3, start date: 2015 (ongoing). The following information was reported: FATIGUE (non-serious) with onset 08Mar2021, outcome "recovered" (09Mar2021), described as "extreme fatigue"; LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious) all with onset 09Mar2021, outcome "not recovered" and all described as "twinges on the right side of neck in the lymph nodes which is now a knot"; EATING DISORDER (non-serious) with onset 10Mar2021, outcome "not recovered", DYSPHAGIA (non-serious) with onset 10Mar2021, outcome "unknown" and all described as "hurts to eat".  Additional information: Patient received the Covid-19 vaccine on 08Mar2021. She donated her left kidney in 2014. The recipient was doing good. Later that day she was extremely fatigued. It went away about 12 hours later. She had twinges on the right side of her neck in the lymph nodes which was now a knot was reported as worsened. Event: hurts to eat was reported as worsened. The Concomitant Products Simvastatin, patient started taking at age 32 or 34. As patient experienced hurt to eat, which was not a bad thing because she needed to lose some weight.  No follow-up attempts are possible. No further information is expected.
Patient has severe swelling of the arm.  Patient wanted both Afluria and Pneumovax injected in same arm.  She didn't have any issues with either vaccine in the past.
a little bit of fatigue after first dose; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (a little bit of fatigue after first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (she is usually allergic to everything).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (a little bit of fatigue after first dose). At the time of the report, FATIGUE (a little bit of fatigue after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated that  the Moderna COVID-19 vaccine is "safe" because she is usually allergic to everything . No concomitant medications were reported   No treatment information was provided   This case was linked to MOD-2021-406505 (Patient Link).
Patient under 18 years of age had Moderna vaccine; A spontaneous report was received from a consumer concerning a 16-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, patient under 18 years of age had Moderna vaccine/ product administered to patient of inappropriate age.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On 17 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 026a21a) intramuscularly for prophylaxis of COVID-19 infection.   On 17 Mar 2021, the Moderna COVID vaccine was given to a 16- year old patient. No adverse event was reported by the patient after being given the vaccine. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event, product administered to patient of inappropriate age, was considered resolved on 17 Mar 2021.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old female) for mRNA-1273 (lot number 026A21A) with no associated AEs reported.
herpes zoster ophthalmicus; loss of vision; postherpetic neuralgia; serious other neurological issues; herpes zoster; Information has been received from a lawyer concerning a case in litigation and refers to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving zoster vaccine live (ZOSTAVAX) vaccine, patient suffered herpes zoster, herpes zoster ophthalmicus, postherpetic neuralgia, loss of vision and serious other neurological issues. As a result of these symptoms, patient was seen and treated by medical providers and is still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, patient's symptoms have physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Patient also experience mental and emotional distresscdue to resulting physical limitations and seriousness of patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of company's wrongful conduct, patient 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. As a direct and proximate result of company's conduct, patient have suffering incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was unknown. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).     Upon internal revie events of herpes zoster ophthalmicus, loss of vision and serious other neurological issues were determined to be medically significant. All events were determined to be disabling.
Younger than 18 patient received the shot; A spontaneous report was received from a pharmacist concerning a patient who experienced the following: younger than 18 patient received the shot.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On an unknown date, prior to the onset of the event, the patient received a dose of mRNA-1273 (Batch number not provided, not specified if 1st or 2nd dose) for prophylaxis of COVID-19 infection.    On an unknown date, the patient was younger than 18 and received vaccination. Treatment information was not provided.    Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event younger than 18 patient received the shot was resolved.; Reporter's Comments: This report refers to a case of inappropriate age at vaccine administration for mRNA-1273 (Batch number not provided, not specified if 1st or 2nd dose)  with no associated AEs.; Sender's Comments:  MOD21-032350:Same reporter
chronic persistent coughing; strong headache; chills; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EL9266, Expiration Date: not reported), via an unspecified route of administration, administered in right arm on 03Mar2021 at 13:45 (reported as 01:45 PM) (at the age of 62 years old) as first dose, single for COVID-19 immunisation in a Health Clinic. Medical history included lobectomy on 31Aug2020 and COVID-19 from an unknown date. Patient was not pregnant at the time of vaccination and has no known allergies. Concomitant medication included bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines in 4 weeks. On 04Mar2021 at 14:00 (reported as 02:00PM), the patient experienced chronic persistent coughing, strong headache, and chills. No treatment was received for the adverse event. Since vaccination, the patient has not been tested for COVID-19. Outcome of all of the events was recovering  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 83-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On 11th February 2019, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could be 82 or 83 years old. The patient received a dose of SHINGRIX several months before the date of reporting and the pharmacist told the patient that she needed a second dose. In the interval, the patient developed shingles. The patient was diagnosed with wire shingles. The patient was due for the 2nd dose of SHINGRIX. The patient was heard that, the patient should wait a period of time before getting a second shot because of shingles. The patient wanted to know, how long was the waiting period.
sore throat; discharge/drainage from nose; really tired; couldn't stay awake 4 hours after, she went to bed and slept for 12 hours; muscle aches; nose was crusty; discharge from her nose, bloody/it was a little bloody; inflammation; cold; Cough; This is a spontaneous report from a non-contactable consumer (patient). A 70-year-old female patient received the first dose of  bnt162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration in left arm on 15Jan2021 at single dose for covid-19 immunization. There were no concomitant medications and medical history. She had still has a sore throat, it has been a week since her first injection, and she immediately like got a sore throat straightaway, then drainage, and she was really tired and had to go to bed in about 4 hours. She couldn't stay awake 4 hours after, she went to bed and slept for 12 hours after the first shot. There was discharge from her nose, bloody, crusty like a cold, and she seldom ever has a cold and that continued, she didn't feel good until about maybe 4 or 5 days later. Sore throat was immediately after she thinks, it was certainly the next day (16Jan2021), and her date of vaccine was 15Jan2021. Now states and cough developed not until later. On 15Jan2021, she had the shot, she was really tired, muscle aches, the kind of things on the sheet, if not that evening, but the next day (16Jan2021), then drainage, it was white at first, it didn't turn yellow until a few days later, had a yellowish tinge, so she is sure there was inflammation, and her nose was crusty, in the morning it was a little bloody, and she had a sore throat, and probably by the Wednesday or Thursday, so 20 or 21Jan2021, there was a little cough, in the evening, and she is not experiencing that today. The outcome of the event sore throat was not recovered, cough was recovered on 22Jan2021, cold was recovering, other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
lymphadenopathy in the ipsilateral axillary region; This is a spontaneous report from a contactable consumer (patient). A 57-years-old male patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EL3247 and Expiration date was not reported) via an unspecified route of administration, administered in right arm on 23Feb2021 at 12:30 hours as dose 2, single (at the age of 57-years-old) for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) within 2 weeks of vaccination included acetylsalicylic acid (Aspirin) taken for an unspecified indication, start and stop date were not reported. Patient had no allergies to medications, food, or other products. Historical vaccine included patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EL3247 and Expiration date was not reported) via an unspecified route of administration, administered in right arm on 02Feb2021 at 14:00 hours as dose 1, single (at the age of 57-years-old) for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for COVID-19, since the vaccination. On 24Feb2021, the day after receiving the second dose, patient developed lymphadenopathy in the ipsilateral axillary region.  The size of the enlarged lymph node was approximately the size of a tennis ball. Also had lymphadenopathy in the right side of the neck region and currently, the axillary lymphadenopathy has decreased slightly in size and neck lymphadenopathy also slightly decreased. Patient had doctor or other healthcare professional office/clinic visit for the event. Patient received no treatment for the event. The outcome of the event was recovering.   No follow-up attempts are needed. No further information is expected.
Information has been received from a licensed practical nurse referring to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients received improperly stored GARDASIL 9 (lot # L019297, expiration date 18-AUG-2017; dose and route were unknown). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.