chrisvoncsefalvay/vaers-outcomes huggingface dataset:
POTENTIALLY FATAL SIDE EFFECTS; THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME; GUILLAIN-BARRE SYNDROME; This spontaneous report was received from literature: Parents are not so sure THERE'S NO HARM IN COVID-19 [VACCINE] TRYING. This report concerned multiple patients. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin were not reported, batch number: Unknown and expiry: UNKNOWN) dose, start therapy date were not reported,1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. It was reported that there were 47 patients experienced blood clots - thrombosis with thrombocytopenia syndrome (TTS), a rare and serious adverse event, after the administration of the JANSSEN COVID VACCINE. It also reported that some people who received the JANSSEN COVID VACCINE had Guillain-Barre Syndrome (GBS), a rare disorder where the body's immune system damages nerve cells, causing muscle weakness and sometimes paralysis. Most people recovered completely from GBS (Guillain-Barre Syndrome), but some had permanent nerve damage. A former journalist, started looking for vaccine studies after her appointment to receive the J&J/Janssen dose was cancelled in the spring when reports about potentially fatal side effects appeared (that suspension was eventually lifted by the healthcare authorities). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of potentially fatal side effects on an unspecified date, and the outcome of thrombosis with thrombocytopenia syndrome and guillain-barre syndrome was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0 : 20211154358-COVID-19 VACCINE AD26.COV2.S -thrombosis with thrombocytopenia syndrome and guillain-barre syndrome. This event(s) is labeled per Regulatory Authority and is therefore considered potentially related.  20211154358-COVID-19 VACCINE AD26.COV2.S -potentially fatal side effects. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Pt had onset of weakness in lower legs and forearms immediately following the vaccine and is very fatigued since receiving the vaccine.
He woke up with his left side of his mouth and face, the lips, the cheeks of the left side are very swollen; He woke up with his left side of his mouth and face, the lips, the cheeks of the left side are very swollen; He woke up with his left side of his mouth and face, the lips, the cheeks of the left side are very swollen; This is a spontaneous report from a contactable consumer reporting on behalf of the husband. A 78-year-old male patient received the first dose of BNT162B2 (PFIZER VACCINE, lot number: EL9262), via an unspecified route of administration on 20Jan2021 at about 9am at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received a first Pfizer vaccine on Wednesday (20Jan2021) morning at about 9am. And he woke up this morning everything was fine until this morning, Saturday morning (23Jan2021) and he woke up with his left side of his mouth and face, the lips, the cheeks of the left side are very swollen. They didn't do any lab work or blood. The patient did not receive any treatment. The only other question was whether he should go to the emergency room. He could breathe, he could swallow. The event outcome was unknown.
This spontaneous report as received from a physician via company representative refers to himself. The age of the patient was unknown. Pertinent medical history was unknown. On an unknown date the patient was vaccinated with ZOSTAVAX (1 shot, parenteral (reported as injection). lot# was unknown). Concomitant medications were unspecified by reporter. On an unknown date the patient developed shingles after getting ZOSTAVAX. The outcome of shingles was unknown. The causal relationship between the event and ZOSTAVAX was not reported. No further adverse event information was provided. Additional information has been requested.
rash and raised skin around injection site, itchy, red on 2/20 at 10pm; took some bennedryl allergy orally, lessend symptoms, but did not eliminate. 2/21 - more red, hot around area, itchy, but not as bad as the day before. 2/22 - still slightly itchy, a little less red, still pretty raised and warm.
This patient had shaking chills and temperature of 100.4 five hours after Tdap and High dose influenza. This patient also reports a pink to red band around her right upper arm 6 inches below the injection site for the high dose flu vaccine.  The band is 4 inches wide and goes around but does not completely encircle the arm.  Patient will observe this, it is not painful.   Patient's primary provider is notified.
lips numb, tingly, swollen DYSPNEA headache diaphoresis mild abd paini
LIP NUMPNESS, STOMACH CRAMPING, DIARRHEA, NAUSEA.
After recieving the vaccines at his 4 month appointment, my son demonstrated some jerking/shaking of his head while sleeping.  This lasted for about two weeks.
myalgia; fatigue; rash; This spontaneous case was reported by a health care professional and describes the occurrence of MYALGIA (myalgia), FATIGUE (fatigue) and RASH (rash) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heartburn, Optic neuritis and Multiple sclerosis. Concurrent medical conditions included Allergy to antibiotic (Levaquin), Allergy to antibiotic (Bactrim Allergy), Allergy to antibiotic (Zithromax Allergy), Allergy to antibiotic (Ceclor Allergy) and Relapsing-remitting multiple sclerosis. Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.    On 12-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Dec-2020, the patient experienced MYALGIA (myalgia), FATIGUE (fatigue) and RASH (rash). At the time of the report, MYALGIA (myalgia), FATIGUE (fatigue) and RASH (rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 12-Dec-2020 and Aug-2021, it was reported that patient experienced myalgia and fatigue and rash.   No treatment drug details was reported.
3 inch circle of pain. Intense pain for 4 days. Moving arm was very painful and warm. Relief after 1 week.
This case was reported by a consumer and described the occurrence of abnormal hair mercury level in a female subject born on 3/30/2004 who was vaccinated with hepatitis B vaccine Engerix B for prophylaxis. The subject received two doses of Engerix B vaccine, given on 04/08/2004 and 05/11/2004 respectively. At an unspecified time after vaccination with Engerix B, the subjects hair mercury level was abnormal. No one else in the subjects family had an elevated mercury level.
her arm is still hurting/it would hurt when she would move her arm up and down, to the point where she would need her other arm to lift it; her arm is still hurting/it would hurt when she would move her arm up and down, to the point where she would need her other arm to lift it; a muscle and joint pain; a muscle and joint pain; This is a spontaneous report from a contactable consumer.  A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 23Mar2021 16:00 (Batch/Lot Number: ER8730) as dose 2, single (at the age of 45 years old) for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 1, via an unspecified route of administration on 02Mar2021 17:00 (Batch/Lot Number: EN6200) as dose 1, single on left arm and experienced it was a muscle and joint pain and it was the same type of pain she experienced with the 1st dose. The patient experienced on 24Mar2021, her arm is still hurting. She mentioned that it is not hurt to touch, she had no rash, but it would hurt when she would move her arm up and down, to the point where she would need her other arm to lift it. She clarified that it was a muscle and joint pain and it was the same type of pain she experienced with the 1st dose but the only difference is that this lasts longer (Mar2021). The outcome of "her arm is still hurting/it would hurt when she would move her arm up and down, to the point where she would need her other arm to lift it" was not recovered and other events were unknown.   No follow-up attempts are needed. No further information is expected.
Tested positive for COVID-19 7/31/21.  cough, fever, loss of taste, fatigue
2/8/21 -10:00am patient noticed tingling in all ten fingers. Pt. denies taking anything for it. Pt. states that symptoms are improving.
pt came to pharmacy on 6/12/2023 complaining of muscle pain in the arm
Develop Tonsillitis after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of TONSILLITIS (Develop Tonsillitis after receiving the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 TONSILLITIS (Develop Tonsillitis after receiving the vaccine). At the time of the report, TONSILLITIS (Develop Tonsillitis after receiving the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Antibiotics used as a Treatment medication.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 05-Jun-2021: Follow-up received on 05-JUN-2021, patient denied conset to Followup and does not contain any new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information is requested.
Chills; fever; Sore joints; Headache; Diarrhea; Nausea; Fatigue; Runny nose; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 22Apr2021 at 13:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patient had no known medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The concomitant medications included unspecified hair skin and nails supplement and women's multivitamin. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 01Apr2021 at 13:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021 at 01:00, the patient experienced chills, fever, sore joints, headache, diarrhea, nausea, fatigue and runny nose. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, fever, sore joints, headache, diarrhea, nausea, fatigue and runny nose were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a consumer of unknown age and gender referring to an unconfirmed number of patients. Information about the patient's pertinent medical history and drug reactions/allergies was not reported. The reporter informed that all about shingles was good. But, poor people and low income can not afford it and a security social program does not cover vaccinations for much of anything other than flu and pneumonia (manufacturer unknown) which also do not work. Information about dose, frequency, route of administration, lot # and expiration date were not provided. At the time of reporting, the outcome of the vaccination failure and its relatedness with pneumococcal vaccine, were unknown. Additional information is not expected as no reporter details were provided.
Pins and needles and tingling in her face and both her hands; Bad headache; Tired; Dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 35 year-old female patient received bnt162b2 (BNT162B2), administration date 26Apr2021 (Lot number: EW0171) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: Nov2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious), outcome "unknown", described as "Pins and needles and tingling in her face and both her hands"; HEADACHE (non-serious), outcome "recovered", described as "Bad headache"; FATIGUE (non-serious), outcome "unknown", described as "Tired"; DIZZINESS (non-serious), outcome "unknown", described as "Dizzy". Therapeutic measures were taken as a result of paraesthesia, headache, fatigue, dizziness.  Additional information: The reporter stated that after couple about 2 or 3 hours after she had her shot she had pins and needles and tingling in her face and both her hands. She said she called she called her PCP and local helpline from the hospital she got it from and it in a way after two hours. She said she had an appointment to talk to her doctor tomorrow and to discuss whether not she should get the second shot. She wanted to know if this was something that was common or that has happened and was concerned about getting a second shot. She said she's been fine since. She did said she has been having other symptoms for about a week. She said normal stuff, really bad headache, she was dizzy, tired and she stated that dizziness started almost after she took Advil and Tylenol for first 3 days for her headache and after the headache went away that's when she noticed the dizziness. She said her dizziness would just come and go. She says that is something made her feel more dizzy than others and she also wanted to mentioned that she actually had the Covid virus back in November 2020.  No follow-up attempts are possible. No further information is expected.
HR to 104; Chills; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 44 years intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer unknown), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset Oct2022, outcome "recovered"; HEART RATE INCREASED (non-serious) with onset Oct2022, outcome "recovered", described as "HR to 104". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased, chills.  Additional information: The patient had no other vaccine in four weeks; no other medication in two weeks. The patient had no COVID prior vaccination. COVID was not tested post vaccination. Adverse events did not result in physician office visit or emergency room visit.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
CLIENT RECEIVED FULL DOSE (0.5ML) MODERNA INSTEAD OF BOOSTER DOSE (0.25ML). CONSENT PAGE WAS FOR SECOND DOSE MODERNA BUT THERE WAS A BOOSTER CONSENT PAGE STAPLED TO IT THAT WAS NOT RECOGNIZED BY VACCINATOR.
Td was given instead of KINRIX. Supervisor and Doctor were notified. Family was notified as well.
local pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (local pain at the injection site) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Latex allergy.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE PAIN (local pain at the injection site). On 08-Mar-2021, VACCINATION SITE PAIN (local pain at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided   This case was linked to MOD-2021-073118 (Patient Link).
Redness, heat, swelling, pain at the injection site, approximately 9 x 4 inches in diameter. Treatment: AUGMENTIN 875-125 mg 1 tab twice a day with meals.
Syncope, nausea  Duration of approximately 20 to 30 minutes in total Loss of consciousness was only 30 seconds or less
This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. There was no pertinent medical history, current conditions reported. It was unknown the patient was vaccinated with ROTATEQ, (dose, frequency, lot#, route not reported). No concomitant medications reported. On an unknown date medication error was reported were doses of ROTATEQ were exposed to highest temperature of 53F for 21 hours. The healthcare worker does not know whether or not any of these improperly stored doses were administered to any patients since these excursions occurred. This case is linked to 1403USA012857, 1403USA012858, 1403USA012859, 1403USA012860, 1403USA005464 (same reporter link) Additional information has been requested.
Approx. 3-4hrs. after vaccines given, baby had 20-30 seconds of apnea (without cyanosis), then "wide-eyed" expression and body "tensed" briefly. Entire episode lasted perhaps 1-2 minutes baby normal afterwards. Neg. Exam in ER, and in our office the following day.
significant autoinnoculation of left arm at elbow and left lower extremity at knee.  No evidence of generalized vaccinia.  Patient nearly recovered.  No loss of duty.  No secondary infection
developed ITP (Idiopathic thrombocytopenic purpura); platelet count dropped; This is a spontaneous report from a contactable HCP. A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were unknown. The patient developed ITP (Idiopathic thrombocytopenic purpura) on 07May2021 after receiving her first dose of the Pfizer-Biontech Covid19 vaccine. The patients platelet count dropped to 3,000 on 07May2021. The reporter was looking for information regarding this AE and guidance on how to proceed with the second dose. Outcome of the events was unknown.   information about lot/batch number has been requested.; Sender's Comments: A contributory role of BNT162B2 to reported events cannot be fully excluded based on implied temporal relationship. However, information provided is very limited and does not allow for a complete medical assessment. 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 Committees, and Investigators, as appropriate.
Bad case of diarrhea for one day; Sore arm; This is a spontaneous report from a contactable consumer (patient). An 87-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not reported, expiry date: not reported) via an unspecified route of administration on 19Jul2021 as dose 1, single for COVID-19 immunization. The patient's medical history included COVID from Dec2020, constipation. He has taken medicine before and after but he has never had that happen before. One of the medications that he is taking causes constipation and he has to usually take prunes or something to keep going, but this was the opposite. Concomitant medications were not reported. On 23Jul2021, patient experienced a bad case of diarrhea for one day and on 20Jul2021, experienced, sore arm. Patient also stated he experienced a bad case of diarrhea for one day that occurred two days after receiving the vaccine. Caller states he did not experience anything else with the first dose other than a sore arm. Sore arm wasn't severe, it was just sore. He could use it but it was just sore. It wasn't bad, it was just there. But two days later he had a severe case of diarrhea that lasted one day and then it was gone. He had the COVID vaccine on 19Jul2021 and he had a sore arm for about 2 1/2 to 3 days and then it was gone and he had diarrhea on the second day afterwards. His arm was sore starting on 20Jul2021 and it was gone by 23Jul2021 probably. The diarrhea started on 23Jul2021 and lasted all day and then it was gone. He confirms he has recovered completely from both side effects. He had to drink a lot of water to stay hydrated.  Lab test included antibody test: had antibodies on an unspecified date in Jun2021, Covid test: negative on an unspecified date. The outcome of events was recovered on 23Jul2021.  Follow up (04Aug2021): New follow-up information received from a contactable consumer (patient) included: event information, vaccine information, outcome of event added.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.