chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: En6198), in left arm, on 22Mar2021 as dose 2, single (Lot number: En6208), in left arm and on 22Oct2021 as dose 3 (booster), single (Lot number: PF1ZCCFF2528) at the age of 65 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 11Apr2022 as dose 4 (booster), single (Lot number: 001M21A) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "migraines" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing); "Thyroid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for thyroid disorder; AIMOVIG taken for migraine. Past drug history included: Neosporin, reaction(s): "Known allergies: Neosporin". The following information was reported: VACCINATION FAILURE (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 antibody test: Positive, notes: Took paxlovid one day into testing positive. 3 days later symptoms reoccur with positive test again; Negative, notes: tested negative 2x within 3 days. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had Covid rebound. Took paxlovid one day into testing positive. 7days after positive, tested negative 2x within 3 days. 3 days later symptoms reoccur with positive test again. Adverse event start date was 30May2022 at 11: 30 am. No treatment was taken for Adverse event. The patient was recovering from the event.  No follow-up attempts are possible. No further information is expected.
She got the vaccine and now she has Covid, she is tested positive; She got the vaccine and now she has Covid, she is tested positive; This is a spontaneous report from a contactable nurse (patient's husband). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0142, expiry date not reported) on 07Jan2021 intramuscularly in left deltoid muscle at single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included levothyroxine sodium (SYNTHROID), amlodipine besilate/ atorvastatin calcium (CADUET). The patient received the vaccine and then had COVID. On 07Jan2021 Thursday, the patient received the vaccine, and on Tuesday (12Jan2021) she said she was not feeling good. On Thursday (14Jan2021) she went to work and because she was not feeling good, she was tested and she was tested positive. The patient worked in a nursing home where she had been tested almost everyday. She was tested negative before she got the vaccine. She was at home, not receiving treatment for COVID. The reporter didn't understand why the patient (reporter's wife) got the vaccine and then had COVID. The outcome of the event was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event tested positive based on the known safety profile. However the short duration of 7 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
HEART RATE SLOWED; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. 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: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced heart rate slowed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart rate slowed. This report was non-serious.
Pfizer 3/28/21, 4/25/21, 10/22/21. Positive on 1/20/22
bit of a headache; little achy; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (bit of a headache) and PAIN (little achy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.     On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced HEADACHE (bit of a headache) and PAIN (little achy). In February 2021, HEADACHE (bit of a headache) and PAIN (little achy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: TCR Form appended on 15 JUL 2021: Reporter said that patient is doing fine. And declined for a follow-up.
Day after vaccine developed large red indurated area approximately 7 x 8 cm. Seen in office 2 days later, area fading.
small knot on her arm; This spontaneous case was reported by a consumer and describes the occurrence of NODULE (small knot on her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 NODULE (small knot on her arm). At the time of the report, NODULE (small knot on her arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided.  No treatment information provided.   This case was linked to MOD-2021-094499 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: FU: husband's case info given
felt sick and achy after 3 weeks; achy; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (felt sick and achy after 3 weeks) and PAIN (achy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (felt sick and achy after 3 weeks) and PAIN (achy). At the time of the report, ILLNESS (felt sick and achy after 3 weeks) and PAIN (achy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details were not provided.
Localized erythema, induration, and mild tenderness, 6 x6 cm. area, at injection site over left deltoid muscle.
patient received  expired dose of Engerix B; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 41-year-old male patient who received HBV (Engerix B) (batch number F73DG, expiry date 03-JUL-2023) for prophylaxis.   On 29-SEP-2023, the patient received Engerix B. On 29-SEP-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: patient received  expired dose of Engerix B).  The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-SEP-2023 The pharmacist reported that a patient received an expired dose of Engerix B which led to expired vaccine used. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter.
This spontaneous report has been received from a physician concerning a male patient of unknown age. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. The reporter stated that in another unspecified country on an unknown date, when the patient was one year of age, he was vaccinated with an unspecified monovalent dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) for prophylaxis. Other suspect therapies included measles, mumps, rubella and varicella (oka-merck) virus vaccine live (manufacturer unknown). Information regarding doses, dose numbers, routes of administration, anatomical locations, lot numbers and expiration dates of the vaccines was not provided. On an unknown date, the patient developed mumps. At the time of reporting, the patient's outcome for mumps and the causal relationship between the event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (manufacturer unknown) were unknown.
From 8/00 to 5/01 the pt experienced fatigue, followed by extreme joint and muscle pain, flu symptoms, headaches, problems walking, and working because of pain and fatigue. 5/01 the pt started antibiotic treatment and felt a slight improvement, may be related to treatment and weather change.
Adverse event began about 3 to 4 after the 3rd dose of Moderna. I started having hives on various parts of my body, It was more prevalent when anything touched my skin. One day it flared up to almost 60% to 70% of my torso. It was where ever I scratched, it was very itchy. There were red raised welts where ever I scratched or had something touched my skin. It went on, after the first day my PCP had given me Pridinol, I went back in a week and was given prednisone. He was also having me taking Benadryl at night, which really did not help diminish the effects really. After a while he suggested that I take Zyrtec twice per day and that calmed it down quite a bit, that actually helped me sleep. That did not stop the flair up, but made it less itchy. I have been taking Zyrtec 10mg since about February. I have tried to stop taking the allergy medication, but it has flared up today. I would prefer to not have to take any medication any more. I saw a dermatologist confirmed that this was happening with Moderna boosters. The diagnosis was skin dermatographias.
Menquadfi administered after the excursion with no reported event; Initial information received on 10-Mar-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2023SA082363 and 2023SA082367.  This case involves a 14-year-old female patient to whom meningococcal A-C-Y-W135 (T CONJ) Vaccine [Menquadfi] administered after the excursion with no reported event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 16-Dec-2022, the patient received suspect meningococcal A-C-Y-W135 (T CONJ) Vaccine solution for injection at a dose of 0.5 ml total (lot U7449AB, expiry date: 23-Sep-2024) via intramuscular route in unknown administration site for immunization.  On 16-Dec-2022, menquadfi administered after the excursion with no reported event (poor quality product administered, latency: same day).  Action taken: Not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2023SA082418:
covid test and came out positive; covid test and came out positive; allergy symptoms; she started feeling a little bad having pain in his hands; dizziness; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number and expiry date: unknown), via an unspecified route of administration on 11Feb2021 as a single dose for COVID-19 immunization. The patient's previously received first dose of bnt162b2 (lot number and expiry date were not provided), via an unspecified route of administration on 21Jan2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 13Apr2021 at night, the patient experienced she started feeling a little bad having pain in his hands, dizziness and allergy symptoms. On 14Apr2021, she took the COVID test and came out positive. Now, the patient had a lot of pain in her hands and legs and dizziness. She also infected a 4-month-old baby even when she wears face mask. Therapeutic measures as a result of allergic symptoms included Claritin. The reporter classified the events as non-serious. Outcome of the events was unknown.  Information about lot/batch has been requested.
Pain at injection site, nausea, headache, aching in muscles and joints, fever, chills, sweats. Time course 36 hours, home remedy and sleep treatment.
4 days post shot, got tingling in upper lip? Exactly 6 weeks later on December 9 21 I developed a droopy right eye? That was later deemed to be myasthenia gravis through a blood test , after visiting an optometrist, ophthalmologist, and neuro ophthalmologist
I was in the bathroom all night; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age (Age: 73; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported by the patient that she was about to go in about an hour for her second shot and stated that last night on 15Mar2021 she did not know if it was because she ate something, but she was in the bathroom all night. She mentioned that feel a little better today. She wanted to ask if it will affect her getting second shot. She thought she just ate too much fruit yesterday and it had to come out. As a treatment she took Pepto-Bismol and drinking electrolyte water. The patient was recovering from the event at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Covid vaccine administered in right deltoid on Dec 28. On Jan 9, 2021, client noticed  a rash and warmth at the injection site. Does not itch, but has some discomfort with pressure.
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium
I started noticing swelling and altered sensation in my right lower arm about 10 minutes after injection. The swelling subsided but numbness lingered. Then around 10am I started feeling numbness in my right neck, jaw and ear. Numbness improved after taking half tab of benadryl.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 29-JUN-2009, the patient received improperly stored VARIVAX dose 2, from lot # 663710/0219Y, expiry date 13-FEB-2011 (dose, vaccination site, route unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
I was staying in my home for 2 months or more at a time because of my sickle cell disease since March 2020 when COVID came out last year. August 11 is when I got out of the house because had to help my aunt because she had a a car accident. That is where I got the COVID-19 virus from because someone from my relatives that was at the hospital as well gave it to some of the rest of my family. I had got infected, but I didn't know at the time. I started to have a sore throat and it felt weird. I had a small fever. I though it was something related to a cold. I never though it was COVID until my other aunts called me and said that they had got COVID. I got a COVID test and it was positive so I started my quarantine. I quarantined for about 24 or 25 days to make sure I did not spread it to my intermediate family. Sometimes I have headaches and a little bit of breathing problems. I felt like I was under water and couldn't breath well. A week after my symptoms started I had lost my taste and smell.
Itchiness at vaccine site beginning 9 days after injection. Continuing itchiness on day 12.
Onset of shaking chills, dysasthesia, and myalgias lasting ~20 hours.
Caller also reports that her nurse at the clinic died because of the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Caller also reports that her nurse at the clinic died because of the vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300178092 same reporter, same product, different patient/event;; Reported Cause(s) of Death: Caller also reports that her nurse at the clinic died because of the vaccine.
Nausea with vomiting x 4 from 1800 11/17 to 11/18 1500. C/o fatigue with light sensitivity. 97.9 - 84 - 16 - 108/75 98% O2 c/o increased stress & anxiety - college student concerned about grades. Meused present Injection site WNL
Hemolytic anemia; Cold agglutinin disease; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Nov2021 (Lot number: FH8030) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine.Prior to vaccination, the patient wasn't diagnosed with COVID-19. Concomitant medication(s) included: SERTRALINE, within 2 weeks of vaccination. Vaccination history included: Moderna (Dose Number: 2, Batch/Lot No: Unknown. 016B21A, Location of injection: Arm Left), administration date: 16Apr2021, when the patient was 42 years old, for COVID-19 immunization; Moderna (Dose Number: 1, Batch/Lot No: 029A21A, Location of injection: Arm Left), administration date: 22Mar2021, when the patient was 42 years old, for COVID-19 immunization. The following information was reported: HAEMOLYTIC ANAEMIA (hospitalization, medically significant) with onset 05Dec2021, outcome "not recovered", described as "Hemolytic anemia"; COLD TYPE HAEMOLYTIC ANAEMIA (hospitalization, medically significant) with onset 05Dec2021, outcome "not recovered", described as "Cold agglutinin disease". The patient was hospitalized for haemolytic anaemia, cold type haemolytic anaemia (hospitalization duration: 14 day(s)). The events "hemolytic anemia" and "cold agglutinin disease" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Since the vaccination, the patient has been tested for COVID-19, sars-cov-2 test: (22Dec2021) negative. Therapeutic measures were taken as a result of haemolytic anaemia, cold type haemolytic anaemia included Blood transfusion, IVIG.   Reported Event: After the 3rd booster COVID vaccine with Pfizer, I developed haemolytic anaemia, cold agglutinin disease. I am still suffering from this illness and doctors have no much information about it. The patient did not diagnosed with COVID-19 Prior to vaccination and not tested for COVID-19 Since the vaccination.  No follow-up attempts are possible. No further information is expected.
Suspected Guillain Barre Syndrome.  BLE weakness with multiple falls prior to hospital admission on 4/1/2020.  Treated with IVIG x 6 doses, last dose reported on 3/30.  Reported having "shingles shot" about a week prior to symptoms.  Unable to locate exact information.
Beginning on the evening of Monday, May 10th, I began to feel a dull soreness in my chest, directly over the heart. I took an antacid believing it may be heartburn, but symptoms did not resolve. I scheduled a doctor's appointment for the next day as I felt something was definitely "off".  The next afternoon I walked about 30 minutes to the clinic throughout relatively hilly terrain and did notice that I seemed a bit more tired than usual and felt my heart was working a bit harder, but it was hard to tell if it was just mental anxiety about the whole thing. I met with Dr. and an EKG was performed. The results indicated possible LAE and possible RV conduction delay.  Both him and a colleague didn't see much reason for concern, however. I scheduled an upcoming video visit with a cardiologist. The feeling continued, varying in intensity for the next week. On Wednesday, May 19th (2wks post 2nd dose, 9 days post symptom onset), I returned home from a motorcycle ride (something I mention as it often results in stress?still learning) and walked up to my third floor apartment. I noticed I was particularly stressed from the climb and my heart felt like it was working harder than usual, and consequently I felt the strongest pain since the initial onset. That pain lasted for a few hours until subsiding somewhat that evening, but was consistently present. The following day the pain had reduced significantly. It is now May 22nd and it's felt mostly normal all day, but is still definitely there. Feels worse when I get anxious or stressed. Heart rate as measured by my Apple Watch appears consistently normal aside from aforementioned stress or anxiety.