chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected vaccination failure/Got the vaccine / within two months had a nasty case of shingles and have had several bouts since; Had a nasty case of shingles and have had several bouts since; This case was reported by a consumer via media and described the occurrence of Suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 months after receiving Shingles vaccine and an unknown time after starting Valacyclovir, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient itself. The age at vaccination was not reported. The patient got a nasty case of Shingles after vaccination within 2 months and  had several bouts since. It was recommended by patient's doctor to get vaccinated for shingles for several reasons. The patient never personally had shingles but knew people who did. The patient had a standing prescription for Valacyclovir HCL 1gram tablet to take immediately after the shingles starting. If the patient had choice, the patient would never have gotten this vaccination. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting.
2 days following started headaches, fatigue. 4 days following have headache, nausea, fatigue, chills, sweats.
Shot given in Right upper arm. Bilateral urticaria and prurtus of arms developing after injection. Rhinorrhea. Itchy throat. No dyspnea or wheezing.
Anaphylactic reaction to neomycin in a flu vaccine; This spontaneous case was received on 29-Dec-2020 from pharmacist via agency (reference number: SEQW20-05972) and concerned a male patient of an unknown age.    The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified, dose, route of administration and anatomical location: not reported) for influenza prophylaxis. Batch number was not reported.   On an unspecified date, after receiving influenza virus vaccine polyvalent, the patient experienced anaphylactic reaction to neomycin in a flu vaccine.  On an unspecified date, the patient recovered from the event 'anaphylactic reaction to vaccine'.  The reporter assessed event as related to influenza virus vaccine polyvalent, as it was reported that the patient had anaphylactic reaction to neomycin in a flu vaccine.   The reporter assessed event as serious due to criterion of medical significance.  Company comment: A patient of unknown age was vaccinated with influenza virus vaccine polyvalent. On an unspecified date, after receiving influenza virus vaccine polyvalent, the patient experienced anaphylactic reaction to neomycin in a flu vaccine. Causality is assessed as possibly related. Brighton Collaboration criteria could not be assessed due to insufficient information.; Reporter's Comments: The patient had anaphylactic reaction to neomycin in a flu vaccine.; Sender's Comments: A patient of unknown age was vaccinated with influenza virus vaccine polyvalent. On an unspecified date, after receiving influenza virus vaccine polyvalent, the patient experienced anaphylactic reaction to neomycin in a flu vaccine. Causality is assessed as possibly related. Brighton Collaboration criteria could not be assessed due to insufficient information.
Pt states on 3/30 not feeling well, reports 104Temp, headache then on  3/31 L arm soreness and redness at injection site, increasing in size, warm to touch and tender
COVID Vaccine Breakthrough Case   Pfizer Dose 1 2/20/21 (EN6200) Pfizer Dose 2 3/13/21 (EN6204) COVID Positive 10/7/21  10/7/21: Patient is a 68 year old male with past history of obesity, diabetes, atrial fibrillation on warfarin, and hyperlipidemia was admitted with worsening shortness of breath secondary to COVID-19 pneumonia. History is obtained from chart review as well as discussion with the patient and the ED provider.  Patient has a history of atrial fibrillation for which he takes digoxin and metoprolol for rate control.  He is also on warfarin. Patient has been vaccinated for COVID-19 with the pfizer vaccine in approximately February.  Patient started feeling poorly about 1 week ago.  Start having fevers, chills, and cough.  His daughter-in-law tested positive for COVID-19 about 2 weeks ago.  He obtained a home test from the pharmacy which returned positive on Saturday.  Patient was monitoring his oxygen and was noted to be in the 80s so came to the ER today.  Oxygen saturations initially in the 70s and currently is on BiPAP at FiO2 50%.  Does desaturate with any activity.  He is not having any chest pain, nausea, vomiting, diarrhea.  Does have a poor appetite.  CT scan was performed which showed no PE but does have diffuse bilateral consolidations consistent with pneumonia.  Did have a lactic acidosis as well as elevated INR on arrival to the ER.  10/21/21:   68-year-old man who presented to the emergency department worsening shortness of breath and low oxygen saturation on pulse ox at home following recent diagnosis of COVID-19 infection.  He presented to the emergency department where his oxygen saturation was in the 70s requiring initiation of noninvasive positive pressure ventilation with BiPAP.  Chest x-ray and CT pulmonary angiogram confirmed bilateral infiltrates in keeping with COVID pneumonitis.  He was admitted to the hospital, treated with Actemra, antiviral therapy with IV remdesivir, IV steroids as well as empiric antibiotic therapy with Rocephin / azithromycin.  He continued to require high-flow oxygen and noninvasive positive pressure ventilation with BiPAP for a significant amount of time.  Gradual clinical improvement has been noted and has gradually been weaned down to supplemental oxygen at 3 liters/minute at rest.  Oxygen walk for home determination was done prior to discharge,  he was found to require no supplemental oxygen at rest per 3 liters/minutes via nasal cannula with activity.  He has been discharged in stable medical condition to continue outpatient follow-up.
sunburn sensation (no rash); had two small mouth ulcers; had a small appetite; Heartburn; nausea; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8730, Expiry date, NDC number: unknown), via an unspecified route of administration, administered in left arm on 21Apr2021 at 10:30 (at the age of 54 years) as DOSE 2, SINGLE for covid-19 immunisation. Vaccination facility type was reported as pharmacy/drug store. Medical history included ongoing genetic diabetes. Concomitant medication includes insulin and other diabetes medications for diabetes. Prior vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine included first dose of BNT162B2 (Lot Number: ER6207) in left arm on 24Mar2021 for covid-19 immunisation and no adverse events following prior vaccinations. On 22Apr2021 at 06:00, the patient experienced nausea; on 25Apr2021 at 12:00 experienced heartburn; on 26Apr2021 at 12:00 had a small appetite; on 27Apr2021 at 06:00 had two small mouth ulcers; on 29Apr2021 at 09:00 experienced sunburn sensation (no rash). the patient was having side effects from the Covid 19 second shot. On 21Apr2021, the patient had his second shot. On the next four days after 21Apr2021 that patient had nausea and it was severe the first two days and lighter the next two days. The patient had heartburn and took Pecid AC, patient had a small appetite that has not come back totally. The patient got two ulcers in his mouth that lasted until this past Thursday. Clarified that the one in front subsided Thursday and one in the back subsided Friday. The patient had called his dentist and was told to gargle with warm salty water. On 29Apr2021, they were going away and had sunburn sensation on waist on 29Apr2021 around his belt but no rash, it has intensified since Thursday. Is like it is all over the patient body. Is like under patient skin was like needles being poked into patient skin. Stated that the patient took Aleve and Benadryl. It was irritating. Stated Saturday and last night that the water from the shower hitting his skin feels like sunburn. A soft towel feels like a rough towel. Is not intense during the day but at night it intensifies. The doctor told him she could give him a steroid but does not want to do that. Was told to take Aleve and rotate with Tylenol. Wanted to know what to do to eliminate the sunburn. Wanted to know if this was reported. Stated that patient was like the poster child. Is getting side effects in stages. Is a genetic diabetic before the vaccine. Therapeutic measures were taken as a result of all events. The patient visited physician office for sunburn. Outcome of the event sunburn sensation (no rash) was not recovered, event nausea was recovered on 26Apr2021, event heartburn was recovered on 27Apr2021, event had two small mouth ulcers was recovered on 29Apr2021 and event had a small appetite was recovered on 30Apr2021.  Follow up attempts are needed; Further information is expected.
Had the 2nd Pfizer shot on 4/9/21 -- 4/10/21 Diarrhea in a.m.   4/11/21 Diarrhea, extreme fatigue during the day, during the evening developing tenderness in right side of right breast (top to bottom) 4/12/21 Diarrhea, minimal fatigue, very tender in right side of right breast  4/13/21 No diarrhea, continuing tenderness in right side of right breast (no better or worse than 4/12/21).
Systemic: Chills-Medium, Systemic: felt very tired-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Additional Details: patient felt very tired, nauseas, sweaty and chills within 1 minute of receiving pfizer second dose.  sat with head down and felt better within 30 minutes.  Spoke to father 4 hours later and he stated he felt much better.
Headache, muscle aches, fever of 100F, pain in injection site, nausea, fatigue
Arm pain immediately, all other symptoms started about 12 hours after injection: chills, headache, nausea, dizziness, extreme vertigo and brain zaps
Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with a dose of Gardasil.  Subsequently the patient experienced muscle atrophy.  The patient was referred to an orthopedic physician who stated that the patient's muscle atrophy was related to therapy with Gardasil.  At the time of this report, the outcome was unknown.  Additional information has been requested.
Soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Soreness of arm) 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 10-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Soreness of arm). At the time of the report, MYALGIA (Soreness of arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Based on the available information and the temporal association between the use of the product and the event occurrence, a causal relationship cannot be excluded.
Irregular menstrual bleeding for 6 weeks+ and counting that does not respond to progesterone and has progressively gotten heavier and heavier.  Intrauterine ultra sound, endometrial biopsy, and blood work are all normal.
Patient called her left arm (injection site) is swollen, red and hot when felt. She also said her arm is itchy and sore. I advised her to go to ER for evaluation.
mom called 4:30 on 4SEP96 stated pt face was swelling & c/o rash & redness to face also informed mom to take pt to Er immed;
Hardness at injection site; Very painful arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Hardness at injection site) and VACCINATION SITE PAIN (Very painful arm) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE INDURATION (Hardness at injection site) and VACCINATION SITE PAIN (Very painful arm). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) ongoing from 27-Jan-2021 for Adverse event, at an unspecified dose and frequency. On 28-Jan-2021, VACCINATION SITE INDURATION (Hardness at injection site) and VACCINATION SITE PAIN (Very painful arm) had resolved.            No concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Significant FU-: Second dose added, Outcome of the event updated to Recovered/Resolved; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,  a causal relationship cannot be excluded.
pt recv vax 12JAN94 & 13JAN94 24 hr p/vax pt devel urticarial rash over entire body; presented to ER or MD ofc for treatment; MD felt pts rash was most consistent w/roseola & pt had a clinical history consistent w/that dx;
Legally blind in both eyes; In pain; Had double & triple vision; Extreme light sensitivity; Multiple diseases on multiple layers of his eyes; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (Legally blind in both eyes), PAIN (In pain), DIPLOPIA (Had double & triple vision), PHOTOPHOBIA (Extreme light sensitivity) and EYE DISORDER (Multiple diseases on multiple layers of his eyes) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A, 038K20A and 052E21A) for COVID-19 vaccination.     The patient's past medical history included Eye discomfort (Patient has history of eye problems dating back 30years) in 1991, Blepharoconjunctivitis, unspecified and Uveitis. Concurrent medical conditions included Immunocompromised. Concomitant products included PREDNISONE for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLINDNESS (Legally blind in both eyes) (seriousness criteria hospitalization and medically significant), PAIN (In pain) (seriousness criterion hospitalization), DIPLOPIA (Had double & triple vision) (seriousness criterion hospitalization), PHOTOPHOBIA (Extreme light sensitivity) (seriousness criterion hospitalization) and EYE DISORDER (Multiple diseases on multiple layers of his eyes) (seriousness criterion hospitalization). At the time of the report, BLINDNESS (Legally blind in both eyes), PAIN (In pain), DIPLOPIA (Had double & triple vision), PHOTOPHOBIA (Extreme light sensitivity) and EYE DISORDER (Multiple diseases on multiple layers of his eyes) was resolving.            Patient went to Clinic, Hospital, and a another major eye clinic for treatment after the 2nd shot & they never connected it with the vaccine.  They found multiple diseases on multiple layers of his eyes.    No treatment information was provided.  It was reported that within 24hrs of receiving the 3rd dose patient was bedridden  Company comment- Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-292150 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient brought to the local Medical Center via EMS for a code stroke.  Patient had a hx of recently being diagnosed with Covid-19 with poor oral intake and fatigue.  EMS intubated patient.  CT scan did not show acute stroke, no stroke per neurology.  Patient's EKG was performed had ST elevations in leads V23 and V4 with some reciprocal changes in the inferior leads.  Patients troponin came back significantly elevated.  Patient was hypotensive.  Central line was placed.  Patient was admitted to ICU for NSTEMI, hypotension, AMS, acute renal failure, acute resp failure.  Patient showed profound hypotension, concern for having blood loss, 4 units PRBC provided, another 1 L bolus IV fluid given, and patient was maxed on Levophed, and then started vasopressin and epinephrine.  Arterial line placed which demonstrated a value of 34/20.  Patient expired on 09/17/2021.
Fever, body aches, HA, fatigue, dizzy, weak, symptoms resolved by 1/10.
We had given the first Moderna dose in July, with her being over 16, and we were given instruction to provide the second dose of the series for the patient. Today she was given the second dose of the Moderna series.
local swelling, redness, pain to shoulder w/in 24 hrs, diarrhea, fever;
3 days after shot My mother has tenderness and redness the size of a cookie at the Injection site possibly warm to touch.
THROAT HAS BEEN HURTING; RUNNY NOSE; FEELS WEAK; This spontaneous report received from a patient concerned a 58 year old female. 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 not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-APR-2021, the subject experienced throat pain. On 24-APR-2021, the subject experienced runny nose. On 24-APR-2021, the subject experienced feeling weak. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the throat pain, runny nose and feeling weak was not reported. This report was non-serious.
I experienced mild muscle soreness at the injection site. I do not have my lot # to provide. I do not have the date of vaccine.
Caller states they are experiencing "flu like" symptoms including fever, chills, fatigue one day after second dose of Pfizer vaccine
Redness on the site increasing slight swelling. ice applied observed Benadryl p.o. given
Moderna vaccine was administered - reported by patient  ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/12/2022 ATHEROSCLEROSIS OF AORTA CARDIOGENIC SHOCK 10/12/2022 ATHEROSCLEROSIS OF AORTA ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/12/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED CARDIOGENIC SHOCK 10/12/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/12/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIF CARDIOGENIC SHOCK 10/12/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED
Developed hive like rash covering R arm, R upper back, chest and spreading.  Throat began to tighten.  Given 50 mg of Benadry and sent to ER
D69.6 - Thrombocytopenia, unspecified E87.1 - Hypo-osmolality and hyponatremia
diarrhea again following vax;diarrhea 5x/days x 10 days;sx resolved w/o treatment
Felt lump and heaviness in throat. No resp. distress. Followed by dry cough. S/S improved by 3:00 pm, As 3:00 had increased fatigue and dry, eyes w/ blurry vision, f/b headache and chills and generalized joint pain and fatigue. Fever 101.3 at 5:30 - 6:00/p. Has cont'd fatigue and headache.
Missed dose of Varivax; no adverse events; This spontaneous report as received from a physician refers to a 11 year old patient of unknown gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.  On 27-OCT-2009, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose, route, lot number and expiration date were not reported) for prophylaxis. The patient did not receive the second dose of varicella virus vaccine live (oka/merck) (VARIVAX).
I got the shot and woke up the next day with the feeling that shingles was coming back. It came back right where I got the shot as well as in my arm pit.  It lasted a little over a week maybe 9 days in total.
I had extremely severe flu symptoms for the first 36 hours (cough, runny nose, sore throat, headache, body ache, exhaustion, chills, etc.). The second 36 hours I had the same symptoms but nausea was added to the mix. I wasn't able to keep a sip of water down, a bite of food or any meds for 36+ hours before I was finally hospitalized for almost a day. I was vomiting every 30 minutes even when there was nothing left in my stomach, I was dry heaving. Once I was admitted to the hospital and got anti-nausea meds and fluids via a drip, I started to slowly feel better but I was unwell for ~8 days total.
Heat rash on their leg after taking the Moderna COVID vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of MILIARIA (Heat rash on their leg after taking the Moderna COVID vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient do not have a history of reactions to any medications/vaccines prior to this.  Previously administered products included for Product used for unknown indication: J&J (Dose 1). Past adverse reactions to the above products included No adverse event with J&J.    In January 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MILIARIA (Heat rash on their leg after taking the Moderna COVID vaccine). At the time of the report, MILIARIA (Heat rash on their leg after taking the Moderna COVID vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment medication was not reported.
This spontaneous report as received from a healthcare professional refers to a patient of unknown age and gender. On 27-AUG-2014 the patient ws vaccinated with an expired vaccine of M-M-R II lot #H011907, expiration date 03-JUL-2014 (strength and route not reported). No adverse effects reported. Additional information is not expected because the reporter refused additional contact.
Strong Sciatica. Three neighbors having the vaccines reported similar issues. Three additional neighbors who contracted the infection also reported similar issues. We have encouraged them to report here. No previous issues before vaccination, ever.  Treatment: Nonsteroidal anti-inflammatory drug including naproxen Sodium, stretching exercises, additional attempts at physical therapy including walking. Use of rubbing pain inhibators including menthol and CBD ointments and oil ingestion. Temporary relief but pain returns. Pain seems to be in "waves," sometimes harsh, sometimes less harsh, but mostly physically inhibitive.