chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 at 09:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 24Jan2021 at 09:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 21Feb2021 at 10:00 as dose 2, single (Batch/Lot number: unknown), in right arm, on 28Feb2022 at 08:30 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 20Jun2022 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid on 22Nov2022 to 27Nov2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Headache, Fever, Chills, intermittent Sweating. Persisted throughout the night and started to fade around 6:30 am.
hest discomfort. Patient reports that she has been experiencing left sided chest discomfort for the past couple days and it has been occurring off and on. She states that the pain radiates to her left shoulder and all the way to her back. Patient reports an associated SOB and she can no longer walk without getting out of breath. She also reports that she has been nauseous and coughing up brown mucus.
2 hours after vaccines were administered baby had seizure at home last about 5 minutes with a 30-40 minute postictal period.
Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3248), via an unspecified route of administration on 14Jan2021 14:00 at single dose at left arm for covid-19 immunization. Medical history included thyroid disorder, irritable bowel syndrome diarrhea, colitis microscopic, low B12, low D, diarrhoea. Concomitant medication included levothyroxine for thyroid disorder, calcium, magnesium for colitis microscopic, cyanocobalamin (VIT B12) for low B12, vitamin d3 for low D, polycarbophil calcium (FIBERCON) for irritable bowel syndrome diarrhea, bifidobacterium infantis (ALIGN) for irritable bowel syndrome diarrhea, loperamide from May2020 for diarrhea, TRI Adrenopan for loss of adrenal function, multivitamin for losing vitamins; all ongoing. Right away after getting the vaccine, during the wee hours of the morning between 14Jan2021 and 15Jan2021 she got very severe diarrhea. Mentioned she previously had microscopic colitis so she was used to having some diarrhea so she didn't remember exactly the time in the night. Adds since that night she had been having six liquid stools a day. She was having to wear depends and can't go out of the house. Patient microscopic colitis was under control but now she had real bad diarrhea for seven days. Originally they thought she had IBSD, referring to irritable bowel syndrome diarrhea, but then they found out it was microscopic colitis. This condition predated treatment with Pfizer COVID 19 vaccine. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. The event required contacting the gastroenterologist and primary care by the portal. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of event was not recovered.
Coughing,Throwing up - 2 days; aching all over, Headache, Slightly dizzy - 4 days; eyes blury, nose running, no appetite, breath less - 9 days; fever 103 deg 1st day, Low grade 4 days; still somewhat breathless and Lethargic 2 wk Later but generally ok.
flu like symptoms; Very sore; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) and PAIN (Very sore) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) and PAIN (Very sore). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) and PAIN (Very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information provided. No treatment medication information provided
Flu shot caused nerve damage.  Lost feeling down left arm, left shoulder, left side of neck.  Lose of range of motion. Severe pain.
Swollen lip, fever up to 101, body pains & no appetite. This lasted for up to 3 days.
Started to noticed heart pounding in the night and it was rapid, and it was hard for me to sleep. I kept checking my heart rate and it was much higher than normal. With very little exertion I felt lightheaded. I never experienced that before. It was scary. It was in the 90's and 100's and normally I'm in the 80's. That happened for three weeks (the pounding) and then it started racing - and I was extra tired. I couldn't do very much. I contacted clinic. They ran some tests and by that time it seemed like things were starting to get better. I feel now like I use to before this.
This spontaneous report was received from a registered nurse refers to a patient of unknown age. On an unknown date, the patient was vaccinated with a dose of RECOMBIVAX HB, (lot number, expiry date and route was not reported). On an unknown date, the patient had titers drawn which showed no immunity. The outcome was unknown. Additional information is not expected.
13 Month old son was prescribed Prevnar 13 vaccine but was given Pneumovax 23. We were not notified until the next day when we called to report son having fever 104 after Tylenol and IBU. He had not voided in over 12 hours and would not eat or drink. The nurse took down our information to speak with PCP. The nurse called back 2 hours later to tell us our son had been given wrong vaccine and to take him to ER.
within 1-2 days after Abrysvo vaccination, pt developed pruritic rash over entire body. Exam today reveals a mostly follicular pattern of erythema with a handful of erythematous patches/plaques on her right antecubital area and left lower extremity.
No adverse effects reported; VAQTA was given to an infant before he turned 12 months old; This spontaneous report was received from a registered nurse referring to a 10 month old male patient.  No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication.  On 05-APR-2019, the patient was vaccinated with 1 dose of hepatitis a vaccine, inactivated (VAQTA) VIAL 25/0.5, intramuscularly, in the right thigh, lot number R024007 and expiration date of 12-OCT-2019, for prophylaxis because he was traveling outside of the country. No adverse effects were reported
T105.6 23OCT91; broke out in red rash 27OCT91; Seen by MD dx poss viral infect/MMR rxn exanthem;
Pt. Having Symptoms of Guillain-Barre syndrome.  Physicians office notified because of pt. hx. of this disease and they did nothing about it just blew us off.  I them took her to see her neurologist and he said she should never have received this vaccine.  Clinic never gave pt. any info. on vaccine reactions until after vaccine was given  Clinic is pt.  primary care  physician so they are aware of her previous condition of GBS. Pt was having pain in arms and legs first c/o was seen in office by Dr. and told not to worry about it next day experienced weakness in legs and was examined bye her neurologist. 6/21/07-office record received for DOS 5/22/07-Assessment:myalgias, arthralgias, limb pain and fatigue. Suspect this is a vaccine related adverse reaction. Suspect that patient does not have Guillain Barre syndrome. Reflexes normal. No signs of sensory loss in examination. Complained of joint pains, muscle aches, feeling tired and also felt unsteady when she took her antihistamine mediction. Feeling pains very freuently on first few days after injection peaked on weekend subsided since Monday. Currently here for a follow up visit because there were concerns if she has a relapse of her GBS which was diagnosed in Frebruary 2006.
Patient first reported feeling lightheaded, feels like glands are swollen, pale facial color. After monitoring by nurse and visit with provider patient started to better 15 minutes later.
received their first / shot in March of 2020 / never got the second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 31st March 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. Till the tme of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up. This case was linked with case US2021168380, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021168380:Same reporter
pt recv vax & devel full-blown chicken pox;The MD reported 10 to 20 patients;
tingling and itchy session in the legs, torso. Hands tingling, hot and red. I took a benadryl and used my inhaler albuterol (1 puff) and that seems to be helping.
Chest pain 48 hours after vaccine.  I was at rest. Symptoms went away with Motrin 400 mg, but come back when the Motrin wears off.
The pediatric Pfizer vaccine was not diluted prior to administration, pt has not reported any additional side effects from the higher dose
After receiving the vaccine patient stated that felt warm and shot of Breath Her O2 Metered 100%. She self administered her antianxiety medication (She carry it with her) and went home with no further report of consequence. Today 2/3/21 She declined 2nd dose of Moderna COVID 19 vaccine
JANSSEN SARS COVID19 VACCINE INDUCED BRACHIAL NEURITIS; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date was not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient lost 90 percent function of left arm in 10 days and dianosed with janssen SARS (Severe acute respiratory syndrome) covid19 vaccine induced brachial neuritis. His left thumb remained wet noodle. It was reported as "Lost 90 percent function of left arm in 10 days. Diagnosed with Janssen sarscovid19 vaccine induced brachial neuritis. Left thumb remains wet noodle. Their Team won't call back. Is their vaccine even legal to inject anymore" and "Changed my life for the worse in a week. Absolutely toxic." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from janssen sars covid19 vaccine induced brachial neuritis. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221229031- Janssen sars covid19 vaccine induced Brachial neuritis. The event 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. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable
Associate reports she was administered the Pfizer booster on 03/30/2022 at 4:20 pm at the local Pharmacy. States she woke up this morning with dizziness ,weakness and pain on the injection site (Right Deltoid). Reports she took  400mg tab of Ibuprofen this morning at 0700.
patient also received covid states normal side effects from when she receives covid(fever, aches, fatigue) believes to be from covid not from flucelvax which was  incorrect formulation given 2022-2023 flucelvax given expired 6/30/23
BLACKED OUT; CHILLS; HIGH FEVER; NAUSEA; WORSENING MIGRAINE; This spontaneous report received from a consumer concerned a 19 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included skull fracture. The patient's concurrent conditions were concussion and migraine and it was happened for couple of weeks. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: unknown) dose was not reported, 01 in total, administered on left arm on 05-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  After receiving vaccine on 05-AUG-2021, the patient had chills, high fever, nausea and blacked out for 8 to 12 hours after the vaccine and lasted for couple of hours. On unspecified date in AUG-2021, after vaccination she got more migraines (worsening migraine) than prior to the vaccination. Laboratory data included: Body temperature resulted 103.9 (unit unspecified) high fever. The patient received Tylenol (paracetamol) as treatment medication. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blacked out, chills, high fever, and nausea on 06-AUG-2021, and had not recovered from worsening migraine. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220224825-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Blacked out. 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). Therefore, this event(s) is considered unassessable.
chills, sinus congestion Narrative: Patient contacted telephone triage nurse today requesting to let provider know she feels she is having a reaction to her covid vaccine. Patient states she had her second covid vaccine on 5/15/2021. Later that night, she developed chills, body aches, sinus congestion, "just felt horrible." HIghes temperature was 102.4 (5/15/2021). Temperature this AM is 101.3. Body aches and clamminess at onset, gone today. States she continues to have sinus congestion (clear drainage, no sinus pain or pressure), and "my ears keep popping - when I put q-tips in the ears, they are coming out wet." (No ear pain). States ears feel "plugged up." No ear pain.
Generalized aches; persistent nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Generalized aches) and NAUSEA (persistent nausea) in a  patient of an unknown age and gender 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 PAIN (Generalized aches) and NAUSEA (persistent nausea). At the time of the report, PAIN (Generalized aches) and NAUSEA (persistent nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information was unknown.   Reporter did not allow further contact
Severe, painful leg cramps- entire leg, but more intense in the upper thighs  - lasting the night into morning/ time ( now 12:30 pm and still have mild cramps)- disrupted sleep. During evening took quick-dissolving tables of Hylands Leg Cramps PM. Fell asleep about 7:30 am till 11:30 am. Last night also  early evening mildly nauseated. Either the 26th or 27th felt slightly nauseated, had some diarrhea and mild stomach cramps.
positive pcr test; positive pcr test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 15Jan2021 as dose 1, single (Lot number: EL3248), in left arm, on 05Feb2021 as dose 2, single (Lot number: EL9264), in left arm, on 28Sep2021 as dose 3 (booster), single (Lot number: FF2589), in left arm and on 31Mar2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 78 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "peripheral neuropathy" (unspecified if ongoing); "insomnia" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN, start date: 31Dec2004; AMITRIPTYLINE, start date: 31Dec2004; ALPRAZOLAM, start date: 31Dec2004; PRAVASTATIN, start date: 31Dec2004. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Jun2022, outcome "not recovered" and all described as "positive pcr test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jun2022) Positive, notes: positive pcr test on day 1; (15Jun2022) Positive, notes: rapid binax test has been positive from day 2 through day 14 (today); (27Jun2022) Positive, notes: rapid binax test has been positive from day 2 through day 14 (today). Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course reported as follows: Patient had no known allergies. Patient received other medication in 2weeks. Patient received treatment anti viral details product: COVID 19 Treatment, brand: Paxlovid. Treatment start date: 15Jun2022 and Treatment stop date: 20Jun2022. Indication: Treatment of COVID-19. Adverse event: Mild cold symptoms (headache, temp, sore throat) on day 0; positive pcr test on day 1; I started 5-day paxlovid course on day 2; rapid binax test has been positive from day 2 through day 14 (today); test showed weak band on days 9 and 10 but on day 11 through today, binax test band is strong. Cold symptoms have persisted: hoarse throat, dry coughing, temp fluctuating above basal state. Oxygen has been at 98% throughout. Very concerned that test remains positive at 14 days and mild cold symptoms persist though less than onset symptoms.
Fever 100.7 F, joint achiness, myalgias, headache on 06/04/2017, developed chickenpox lesions on face, scalp, chest and body on 06/06/2017.
injection site pain,  subsiding as of 3 days later; upper arm tenderness, continuing ; entire arm noticeably swollen down into hand,  still present.
Pt had a red circular area that became painful the day following the immunization and eventually the site became firm. Pt no longer has pain and no firmness but she still has a red circle. Pt did not seek any treatment.
Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild
Vaccine administration staff did not follow Moderna vaccine instructions for handling leftover vaccine doses. Specifically, Moderna handling instructions state that vaccines should be used within 6 hours of the first puncture or be discarded after 6 hours. We administered this patient Moderna dose that was from punctured of longer than 6 hours. Of note, although the vials have been out of the fridge past 6 hours, they were stored in the fridge at the recommended storage temperature of 2-8 degrees Celsius.
Hospitalization for COVID, ARF 1/6/22-1/9-22. Treated with dexamethasone 6 mg PO daily , zinc 50 mg daily, vitamin D3 50 mcg daily and vitamin C 1,000 mg daily
What I believe may have triggered this reaction is that in October I had a carpal and ulnar tunnel release in the same extremity/affected the nerves; my entire upper arm began aching-pain from my trapezius down to my elbow; my index and middle finger began tingling; I am noting pain in each of the major joints of my arm-shoulder, elbow and wrist; I am noting pain in each of the major joints of my arm-shoulder, elbow and wrist.; I am noting pain in each of the major joints of my arm-shoulder, elbow and wrist.; This is a spontaneous report from a contactable nurse (patient).  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on the arm on 19Dec2020 as single dose for covid-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced the following:  " my entire upper arm began aching-pain from my trapezius down to my elbow " in Dec2020 with outcome of unknown;  "my index and middle finger began tingling "  in Dec2020 with outcome of unknown;  " I am noting pain in each of the major joints of my arm-shoulder, elbow and wrist " in Dec2020 with outcome of unknown; " what I believe may have triggered this reaction is that in October I had a carpal and ulnar tunnel release in the same extremity " in Dec2020 with outcome of unknown.  Therapeutic measures were taken as a result of the events. Details were as follows: The injection itself was without any issues. However, 6-7 hours later, the patient described the following: patients entire upper arm began aching-pain from trapezius down to the elbow. This continued throughout the weekend and then Monday, patients index and middle finger began tingling (as if asleep). This symptom never subsided. The patient noted pain in each of the major joints of the arm shoulder, elbow and wrist. The patient tried trigger injections in the trapezius, ibuprofen, muscle relaxers, heat, exercises, and a steroid burst-all without relief of symptoms. Patient was able to move arm and had strength in the extremity. Patient saw a specialist in physical medicine and rehabilitation. The patient believed that what triggered this reaction is that in October the patient had a carpal and ulnar tunnel release in the same extremity. The patient wondered whether the medication affected the nerves that had been manipulated during surgery. The events outcome was unknown.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up .; Sender's Comments: Based on the time association, the possible contribution of suspect BNT 162B2 injection to the event Neuropathy peripheral cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Pt was administered Fluzone that was affected by refrigerator  excursion this morning. Excursion lasted   for 7 minutes. with   cooler  temperature.   Called Sanofi Pasteur and recommended repeat influenza vaccine in the next 28 days. Pt notified and will come in next week for repeat Flu vaccine. Per pt no  side effect. Per pt doing well no fever, no SOB, chest pain and numbness.