chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 24H had rash breakout on back, occasional nausea, fatigue, headache. Most resolved by 48 hours, but then had very swollen lymph nodes and sore joints. By 72 hours only fatigue remained.
First time seizure occurred 12 hr after injection; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9265), via an unspecified route of administration on left arm on 30Jan2021 13:30 at single dose for COVID-19 immunization. Medical history reported as none. There were no concomitant medications. First time seizure occurred 12 hr after injection (AE resulted in: Emergency room/department or urgent care, Hospitalization for 3 days) on 31Jan2021 02:00. Therapeutic measures (LEVETIRACETAM TABLETS - (KEPPRA)) were taken as a result of event. The outcome of event was recovering.
This is a spontaneous report from a contactable Pfizer Sales Representative who reported on behalf of a Physician for a patient. A 16-years-old female patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date in 2015 at single dose, on the same day the patient also received human papilloma vaccine, via an unspecified route of administration, and MENACTRA, via an unspecified route of administration. The patient medical history and concomitant medications were unknown. The patient went to the emergency room on an unknown date with nausea, body pain and neon red bloody urine which they diagnosed as hematuria which went away on its own within a day or two. The reporter did not believe that the patient has not taken any treatment for that, and at the emergency room they just monitored her for what the doctor said and then it just went away on its own. The patient underwent lab tests and procedures which included laboratory test with normal results. The outcome of the events nausea and body pain were unknown.
Body aches, headaches, tiredness, fatigue, injection site tenderness, lips/mouth swollen and very tender.
joint and muscle ache; pain is on neck; I can hardly walk; night chills; joint and muscle ache; pain is on neck and right side and up to my ear, radiates to shoulder and pulsates; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (night chills), MYALGIA (joint and muscle ache), PAIN (pain is on neck and right side and up to my ear, radiates to shoulder and pulsates), ARTHRALGIA (joint and muscle ache) and NECK PAIN (pain is on neck) in a 77-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062F22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Question:Was there parental vaccine exposure?Answer:No.  Previously administered products included for an unreported indication: COVID-19 VACCINE on 22-Jan-2021, COVID-19 VACCINE on 19-Feb-2021 and COVID-19 VACCINE on 08-Nov-2021.    On 16-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) Additional Booster. On 16-Dec-2022, the patient experienced CHILLS (night chills), MYALGIA (joint and muscle ache) and PAIN (pain is on neck and right side and up to my ear, radiates to shoulder and pulsates). On an unknown date, the patient experienced ARTHRALGIA (joint and muscle ache), NECK PAIN (pain is on neck) and GAIT DISTURBANCE (I can hardly walk). At the time of the report, CHILLS (night chills), MYALGIA (joint and muscle ache) and PAIN (pain is on neck and right side and up to my ear, radiates to shoulder and pulsates) had not resolved and ARTHRALGIA (joint and muscle ache), NECK PAIN (pain is on neck) and GAIT DISTURBANCE (I can hardly walk) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication was not reported. As per patient, Friday night chills, joint and muscle ache, pain is on neck and right side and up to patient ear, radiates to shoulder and pulsates. Patient was denying to take this vaccine again. No treatment medication was reported.
becoming incoherent and talking nonsense; This is a spontaneous report from a contactable physician (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Physician calling about whether or not she should receive the second dose of vaccine. She received dose on 23Dec2020. On 26Dec2020 she started experiencing several side effects including becoming incoherent and talking nonsense. Her daughter who is an EMT suggested that she go to the ER. While in the ER she received TPA but it was later decided she did not have a stroke. Her EKG, bloodwork and other testing came back negative. She otherwise healthy and has no comorbidities. She already spoke with agency. She has also already spoken with an infectious disease doctor and her neurologist. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the event incoherent is conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. 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 agencys, Ethics Committees, and Investigators, as appropriate.
Mom called Saturday stating that pt didn't feel well since getting the vaccines on Friday. It was found then that pt received her second Bexsero and duplicate Menveo. It was explained to mom that she can expect typical vaccine side effects over the weekend and to come in Monday if still not feeling well. Offered to come in Saturday but declined. Mom called after hours phone bc she was worried about the duplicate vaccine. Spoke to an NP friend who told her that Menveo and Bexsero should never be given given together and can be dangerous if done so. Also explained that patient felt so bad this morning she crawled into bed with her mom. Very fatigued and weak. Also concerned if this could cause meningitis. Consulted with Dr. who said: Bexsero and Menveo are safe to give together and indicated to do so. Also in other countries Menveo is given to infants and in a specific country in some instances. She is having an exaggerated immune response because it has seen the vaccine before and will actually give her a stronger immunity to meningitis. Treat symptomatically with rest, lots and lots of fluids and Motrin.
Pt recv vax on 1/13/99; on 1/14/99 pt fainted & dizzy; tx=IV hydration
Patient experienced injection site pain after COVID shot.  On Sunday arm swelled significantly and was red and hot.  The axilla swollen and hard to move.  Patient had fever, nausea and dizziness.  Symptoms resembled the flu and she was unable to eat
Information has been received on 09-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2007, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, at a clinic as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2011, the patient was treated at a clinic for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Localized redness, warmth, itching, low grade fever, body ache, myalgia.
Fatigue - enough that I needed to lie down.  Routine workout was completely exhausting. injection site ache
My left hand turned blue. I was diagnosed as a allergic reaction. I was experienced diarrhea, headache, fatigue.
Vaccine was a previously drawn vial from 7/6/2022 that was not properly discarded. Staff administered the vaccine to the patient under the impression that the vaccine had been drawn on 7/7/2022. The vaccine had been drawn and at room temperature for 27 hours at the point of administration.
a 40-year old male patient that was given the orange cap formulation Comirnaty vaccine as his booster dose; a 40-year old male patient that was given the orange cap formulation Comirnaty vaccine as his booster dose; a 40-year old male patient that was given the orange cap formulation Comirnaty vaccine as his booster dose; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 40 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), UNDERDOSE (non-serious) all with onset 2021, outcome "unknown" and all described as "a 40-year old male patient that was given the orange cap formulation Comirnaty vaccine as his booster dose".  Additional info- A patient, male, he is 40 years old and he received the booster dose of Pfizer COVID vaccine but instead of the adult dose he was given paediatric dose."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient reported being nauseated, lightheaded, dizzy, and felt that she needed to vomit. Patient stood and immediately collapsed to the floor. BP 117/81, R 18, HR 117, T 98.2, O2 sat 99%. Father stated that she had not eaten that morning; she was given crackers and water. , BP 110/76, R 16, HR 92, O2 sat 100%. Patient stated that she was feeling much better and was able to walk/stand without feeling lightheaded or dizzy and went home.
Inappropriate schedule of vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2 years prior to the reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Inappropriate schedule of vaccine).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 06-OCT-2023 It was reported that patient received the 1st dose of a shingles vaccine (she could not confirm if the vaccine was Shingrix-manufacturer unknown), might be 2 years prior to the reporting, and till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The patient went to her pharmacy, and they could not find her vaccination record. The patient has no further information to provide about this event, no lot/expiry, no route of administration, and cannot remember the location of administration. I have reported the adverse event as Shingrix based on the patient being told to call us by her pharmacy, that she knew she should have gotten a 2nd dose, and per content if GSK manufactures a vaccine for the reported disease state, enter product name as GSK brand name and list as manufacturer unknown in comments. Consent to follow up with HCP was obtained. The vaccine administration facility is same as primary reporter for 1st dose.
blood clots in left lung which turned into an infarction; blood clots in left lung which turned into an infarction; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3248) via an unspecified route of administration, administered on the left arm on 15Jan2021 (at the age of 40-year-old) at a single dose for COVID-19 immunisation. Medical history included lupus. Concomitant medication included hydroxychloroquine sulfate (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]). The patient had blood clots in left lung which turned into an infarction on 22Feb2021. The event resulted in a doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized for the events for 3 days. Therapeutic measures were taken as a result of the events which included blood thinners and anti-inflammatory meds. COVID test post vaccination on 03Mar2021 Nasal Swab: Negative. Patient was not pregnant. 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. Outcome of the events was recovering.; Sender's Comments: Drug causality would seem unlikely fo rBNT162B2 since there is no plausible mechanism implicating the subject drug to the events. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Pt was given the adult COVID 19  vaccine that was reconstituted with 1.3 of the diluent, was given 0.2 of the reconstituted purple cap vaccine.  no treatment given, no s/sx at this time
When I got the vaccine I had a metallic taste. I waited the 15 minutes and no problem. I went to work and after some minutes I had swelling in my throat and arm and I went to the ER. My airway was not fully shut but they gave me steroids and other stuff and then I was fine. I waited about 2 hours and I was fine later.
Mild headache.  malaise, extra "aching" is areas of known osteoarthritis.  Started about 12 hours after vaccine.  Resolved about 36 hours after vaccine.
Mother states child developed a red area with lump in left thigh (inject site) post receiving vax's. No other SXs reported.
his body seems to be swollen; patient also thinks that he had corona and has been suffering from the side effects of corona specifically; This is a spontaneous report from a contactable consumer (patient) A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: ER8733 and Expiration date: unknown) via an unspecified route of administration, administered on the right arm on 31Mar2021 (at the age of 32 years old) as dose 1, single for COVID-19 immunisation. The patient has no medical history and concomitant medications. There was no investigation assessment. On an unspecified date in 2021, patient reported that his body seems to be swollen after receiving his 1st shot yesterday (clarified as 31Mar2021) and was asking if it was normal. The patient also thinks that he had corona and has been suffering from the side effects of corona specifically but he was not taking any medication. The patient did not receive any treatment for the events. The outcome of the reported events was unknown.  No follow-up attempts are possible. No further information is expected.
Death Narrative: Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient died of a drug overdose and had a UDS positive for fentanyl and alcohol on 3/8/21 patient tested positive for Chlamydia due to high risk sexual behavior and substance use disorder. Patient was admitted to facility on 2/26/21 to detox from alcohol.
10/29/2020: SOB, fever, chills, feels shaky, and her arm is swollen. Advised pt to go to ED  Patient admitted for cellulitis/ sepsis.
Welps on legs, arms, face, torso. Lips and cheeks swollen in early AM. Not swollen much at 2 PM on 11/7/03. May try Benadryl 1/2 tsp 4 times a day. Rash looked like erythema multiforme.
Left deltoid area indurated erythematous, apprx 4-6 hours after placement. No fever or demonstrate pain /disense of arm.
pt recv vax & devel pain, no erythema, fever, n/v;pt improved p/few days;
This spontaneous report as received from a pharmacy technician concerning a currently 42 years old patient. Gender was not reported. Medical history and concurrent conditions were not reported. On 18-MAR-2014, the patient was vaccinated with VARIVAX (Merck) lot #J005416; expiration date: 02-MAY-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
This spontaneous report was received from a consumer regarding her daughter of an unknown age. Information on the patient's pertinent medical history, concomitant medications and drug reactions/ allergies were not reported. On 17-AUG-2018, the patient inadvertently received an additional dose of RECOMBIVAX HB (strength, dose, frequency, route of administration were not reported) (lot # M040422, expiry date: not reported) for prophylaxis (extra dose administered). The patient experienced no adverse effects. No product quality complaint was involved.
Possible RLL pneumonia and cellulitis rt arm.  To ER 9/2/02-tx with Augmentin, motrin, benedryl. 9/03/05- To Dr. Dr. reports localized reaction.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 45-year-old male patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "psoriasis" (unspecified if ongoing); "complex regional pain syndrome type 1" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2021, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2021) Positive, notes: Patient tested positive for covid May2021; (09Jun2022) Negative, notes: Patient then recently had onset of symptoms on 09Jun2022, negative test; (20Jun2022) Positive, notes: Patient then tested positive 20Jun2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Anti-viral details: Product: COVID 19 Treatment. Patient has had first dose of Pfizer covid vaccine Apr2021. Patient tested positive for covid in May2021. Patient then recently had onset of symptoms on 09Jun2022, negative test. Patient received paxlovid. Patient then tested positive 20Jun2022. Adverse event start date: 08Jun2022. Patient was recovering form adverse event. If treatment adverse event: No.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The reported Covid 19 positive after both the doses of  COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Chills; Headache; Felt weak; Wanted to go to bed and sleep; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (Headache), ASTHENIA (Felt weak) and FATIGUE (Wanted to go to bed and sleep) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache), ASTHENIA (Felt weak) and FATIGUE (Wanted to go to bed and sleep). On 19-Mar-2021, CHILLS (Chills), HEADACHE (Headache), ASTHENIA (Felt weak) and FATIGUE (Wanted to go to bed and sleep) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.
Patient came in 6/12 and stated that after we administered the vaccines she went home and started feeling sick. Chief complaints were abdominal/body pain and nausea/vomiting.
pt recv vax & noted leg rash characterized by tiny red dots that appeared p/vax;
24 hrs after vaccination I began to have a speckled rash; itchy skin on chest, back,arms; This is a spontaneous report from a Non-contactable consumer.   A 75 year old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302) on 20Feb2021 at single dose via an unspecified route of administration  for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On 21Feb2021 24 hours after vaccination patient began to have a speckled rash and itchy skin on chest, back, arms. No treatment received. At the time of the reporting the patient had not yet recovered from the events.   No follow-up attempts are possible. No further information is expected
This spontaneous report as received from a Nurse refers to a 7 month old male patient. On 31-MAR-2014, the patient was vaccinated with expired oral Lot # H016262 (Expiry: 21-MAR-2014) ROTATEQ, 2 ml, oral. The reporter stated that the nurse who gave the vaccine did not look at the expiration date until after she had given it. No adverse effect was reported. No additional information available. Additional information has been requested.
Approximately 24 hours after receiving the Janssen COVID-19 vaccine, patient experienced central vision loss or "white out" vision as she described it. She could still see things in the periphery, but her central vision went completely blank. This lasted for four to five hours and over time her symptoms gradually improved. She still has some double vision and difficulty focusing. Of note, she saw the eye doctor last month and had her prescription updated but has not picked up her new glasses. She only wears her glasses for driving and occasionally at work. She has chronic headaches and has not had any new/different headaches than before. No weakness, but her right leg did feel heavier than normal after receiving the vaccine.