chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported to clinic at 1336 for influenza vaccine.  Influenza vaccine given at 1344.  At 1352 patient c/o itching at injection site, itchy throat, rash and SOB.  Provider assessed patient at 1358.  Patient given Benadryl 50mg IM at 1400.  Patient c/o some improvement.  Patient was given Solumedrol 125mg IM at 1430.  Patient observed in clinic until her husband arrived at 1530. Patient's condition improved, she ambulated from clinic in no acute distress.
pt to ED @ Hospital with hypoxia and positive for COVID; PMH: cervical CA, recurrent anemia, CKD4, DMT2; given dexamethasone, lasix, bronchodilators; no remdesivir given due to abnormal renal function; on BiPAP; transferred to Hospital to receive higher level of care; per death certificate, pt died at Hospital
Cellulitis of right and left upper limb pt treated with cephalexin, BENADRYL and Ibuprofen. ROCEPHIN inj. also given.
Pt received a dose of this, instead of Moderna, which she received the previous 2 doses
pt started flushing and her ears rang, then back spasm started. flushing and ears ringing passed in a minute or so, back spasm continued.
My nephew tested positive for Covid. He has received the Pfizer covid vaccine. I believe he has received 3 doses but I am not sure. I do not have any information about the date he received the vaccine; My nephew tested positive for Covid. He has received the Pfizer covid vaccine. I believe he has received 3 doses but I am not sure. I do not have any information about the date he received the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A child male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Jun2023, outcome "recovering" and all described as "My nephew tested positive for Covid. He has received the Pfizer covid vaccine. I believe he has received 3 doses but I am not sure. I do not have any information about the date he received the vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jun2023) Positive, notes: Type: Unknown. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300229460 same reporter/drug/ae, different patient.;
fever and weakness day after vaccine with increasing weakness at home /admitted to hospital 4 days later with weakness /progressive decline  with weakness  and paralysis of left arm / stroke  suspected but could not be confirmed on 2 magnetic resonance scans /inability  to speak and then swallow / treated for possible aspiration pneumonia /progressed to being obtunded   and respiratory distress / died 9/25/21
KNOT AT INJECTION SITE; VOMITING; DIARRHEA; LACK OF APPETITE; TINGLING; CHILLS; ARM TO FINGER THROBBING; HEADACHE; FEVER; INJECTION SITE THAT IS HOLDING  HEAT; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included morphine allergy, non-alcoholic, and non-smoker, and other pre-existing medical conditions included patient had no known drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 (Vaccinated on left deltoid) for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced knot at injection site. On 14-MAR-2021, the subject experienced vomiting. On 14-MAR-2021, the subject experienced diarrhea. On 14-MAR-2021, the subject experienced lack of appetite. On 14-MAR-2021, the subject experienced tingling. On 14-MAR-2021, the subject experienced chills. On 14-MAR-2021, the subject experienced arm to finger throbbing. On 14-MAR-2021, the subject experienced headache. On 14-MAR-2021, the subject experienced fever. On 14-MAR-2021, the subject experienced injection site that is holding heat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from knot at injection site, vomiting, diarrhea, chills, headache, and injection site that is holding heat, and the outcome of tingling, arm to finger throbbing, fever and lack of appetite was not reported. This report was non-serious.
Missed second dose; Heart attack; heart was racing; stomach bothering him; 101.4 degrees fever; chills; some headaches; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 22-year-old male patient who received mRNA-1273 (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Flu in February 2020. Concurrent medical conditions included Muscular dystrophy.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On 01-May-2021, the patient experienced TACHYCARDIA (heart was racing), ABDOMINAL DISCOMFORT (stomach bothering him), PYREXIA (101.4 degrees fever), CHILLS (chills) and HEADACHE (some headaches). On 16-May-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria death and medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. The patient died on 16-May-2021. The reported cause of death was Heart attack. It is unknown if an autopsy was performed. At the time of death, PRODUCT DOSE OMISSION ISSUE (Missed second dose), TACHYCARDIA (heart was racing), ABDOMINAL DISCOMFORT (stomach bothering him), PYREXIA (101.4 degrees fever), CHILLS (chills) and HEADACHE (some headaches) outcome was unknown.            No Concomitant product use was provided  This is a case of product dose omission issue. Very limited information regarding this patient's death has been provided at this time.  Based on the current available information and temporal association between the use of the product and the start date of the rest of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Significant follow up received :- Patient died, Reporter email and phone number added, patient's medical history added,events updated; Sender's Comments: This is a case of product dose omission issue. Very limited information regarding this patient's death has been provided at this time.  Based on the current available information and temporal association between the use of the product and the start date of the rest of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Heart Attack
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were each vaccinated with a dose of improperly stored PNEUMOVAX 23 (lot # L019836, expiration date 24-MAR-2017) (dose and route unknown). The vaccine was exposed to 35.3 degree Fahrenheit for 240 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent to contact physician.
pt recvd vax & devel a rash on the thigh & arm; pt evaluated by dermatologist;
Information has been received from a nurse concerning a 44 year old female patient with asthma and no drug reactions or allergies who on 13-DEC-2010, was vaccinated IM with a 0.5 ml dose of PNEUMOVAX 23 (Lot# 667914/1067Z). Concomitant therapy included WELLBUTRIN and albuterol. Subsequently, a couple of days after the patient had received the vaccines, the patient developed cellulitis. There were no lab diagnostics studies performed. At the time of the report, the patient was recovering. The patient did not seek medical attention. Information has been received from a nurse and medical records concerning a 44 year old female nurse practitioner with migraine headaches and a history of mild postpartum depression (1997) and infertility (status-post multiple IVF attempts) who was vaccinated with PNEUMOVAX 23 on 13-DEC-2010, (Lot# 667914/1067Z). Concurrent medications included TERAZOL 7 vaginal cream, fluoxetine, PEN-VEE K, and LEXAPRO. Office note from 15-DEC-10 showed patient's symptoms included left arm swelling, redness and swollen axilla lymph nodes. The patient was diagnosed with cellulitis of arm. The patient's treatment included ROCEPHIN 1 gram, given on left gluteus. The nurse reported that patient caught the cellulitis "early" and started on antibiotics right away. This is one of two reports from the same source. Additional information is not expected. All available medical records will be provided upon request.
Information has been received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of VAQTA (lot # J000366, expiration date: 22-AUG-2015, route, dose and frequency were unknown). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pain in shoulder while sleeping the night of 10/28/2018. Upon waking up, upper arm is swollen and tender. Throughout the day I began feeling run down and rested often at work. At home - around 5:10, still felt bad and not hungry. Fever of 100. Put ice on shoulder which helped the pain. Body is achy and joints are painful.
Pt called hospital call ceneter on 10/11/21. Pt is A/Ox4 and in no acute distress. Per pt, she received 3rd dose Pfizer on 10/7/2021 and for the first couple of days after the shot, felt generally ill (fatigue, IM site pain, some redness and swelling). Pt began to feel better but states IM site pain continues today and extends to the underarm and near the breast, with some limited arm movement. Pt feeling some anxiety. Pt denies treating the symptoms, states she wanted to observe her body naturally.  Pt prefers to go to private PCP. Pt educated on ED precautions.
pt recv vax 15SEP97 & on 17SEP97 pt exp rash @ the inj site around lt shoulder;
I work dialysis. My job offered Moderna Covid vaccines. Due to my biotoxin illness, it was not recommended that I do Pfiser or Moderna covid vaccine. I did the J/J vaccine one shot.  I have side effects every 4 weeks for the past six months. Body aches, no appetite, cramping (yet menopausal), SOB, fatigue and chest pains.  I felt like it was my body telling me the vaccine was viable yet the symptoms persists.  I felt that the vaccine was acting like the virus therefore working.  I am not sure that I can do a booster. I have not been the same since the vaccine.  I am a healthcare worker for 40 years and pro-vaccine. I felt that someone needed to forward the on-going long term side effects on the J/J covid vaccine.  I was formerly a State Surveyor for the Department of Health Bureau.  I know the need for vaccinations.  I am truly surprised that I have struggled with this one.  My 82 y/o mother has reported to me similar symptoms especially the no appetite.
she is having dental surgery a week after that and she will be on antibiotics; This is a spontaneous report from a contactable consumer (patient herself). A 87-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: F.L.9266), via an unspecified route of administration on 17Feb2021 (age at vaccination: 87 years) as DOSE 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient was having dental surgery a week after that and she will be on antibiotics (amoxicillin). She did not have a sore arm. The second dose was scheduled on 10Mar2021 (reported as this month). The outcome of the event was unknown.   No follow up attempts are possible. No further information is expected.
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Additional Details: has had redness and itching at injection site since approximately one week after injection.  Dermatologist prescribed topical steroid but patient only used prn.  after we spoke she will use bid x2 weeks as prescribed and follow up with derm if not resolved
Redness in injection site; Itchiness in injection site; Minor swelling in injection site; Severe body aches while on antiinflammatorymeds; fever of 101 while on meds; Skin hurt like needles stabbing; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: Er8735) via an unspecified route of administration in the left arm on 19Apr2021 at 09:15 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included allergic to walnuts and cough medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and budesonide (NASOCORT); both for an unknown indication from an unknown date and unknown if ongoing. The patient previously received some antifungal medications, miconazole nitrate (MONISTAT) and lidocaine (VAGISIL) for an unknown indication from an unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Er8732) via an unspecified route of administration in the left arm on 29Mar2021 at 09:15 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. On 19Apr2021, the patient experienced severe body aches while on anti-inflammatory medicines, fever of 101 while on medicines, skin hurt like needles stabbing all started about 3 hours after injection and lasted for about 36 hours. On 23Apr2021, 4 days after the injection, the patient experienced redness, itchiness and minor swelling in injection site. Swelling and redness lasted for about 24 hours. On 19Apr2021, the patient underwent lab tests and procedures which included body temperature test and the result was found to be 101 (unspecified units). The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures taken as a result of the reported events severe body aches included treatment with anti-inflammatory medicines and the treatment for fever included unspecified medicines. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe body aches, fever, skin hurt like needles stabbing were recovered on an unknown date in Apr2021 which lasted for about 36 hours, while the events minor swelling and redness in injection site were recovered on an unknown date in Apr2021 which lasted about 24 hours and the event itchiness at the injection site was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
TIREDNESS, HEADACHE, FEVER, SORE THROAT, PAIN IN RIGHT KIDNEY, DYSURIA, HEART PALPITATIONS FOR 2 DAYS
Patient presented to urgent care and then doctor with chest pain that awoke him rom sleep. ECG showed signs of pericarditis. Bloodwork showed very elevated troponin (up to 17.5 ng/ml).
bilateral pulmonary emboli; This is a spontaneous report from a contactable consumer. This patient (consumer reported for self):  A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: Unknown), via an unspecified route of administration, on 07Oct2021 as a dose 3 (booster), single for COVID-19 immunization. The patient medical history included DVT (Deep vein thrombosis) in 2019 and PE (Pulmonary embolism) in 1989. The concomitant medication of the patient was not reported. The patient previously received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: Unknown), both via unspecified route of administration, on an unspecified date as a dose 1 and dose 2, single for COVID-19 immunization. On 09Oct2021 the patient experienced bilateral pulmonary emboli so large the interventional radiologists were used. Patient stated that they do not have a family clotting history. The outcome of the reported event was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Went into a trance. Could not hear, speak, or talk for about 5-10 min. Acted strange and did not know who his family were. Transported to the ER where the doctor said he had seen it before and it had lead to death. Advised parents to watch him for a week.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions (strength, dose, route of administration, anatomical location, lot#, and expiration date were not reported). At the time of vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through the patient's healthcare provider that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced the patient to be vaccinated. Alternatively, in 2015, the patient's healthcare providers included but not limited to a healthcare provider, relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine, believed that it was effective in preventing shingles on a long-term or permanent basis that it did not carry any significant risks of adverse effects. On an unknown date, reported as subsequent to the vaccination, the patient was treated for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffered ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was not recovered. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).
Information has been received from a health professional concerning a 9 year old male with no medical history and no allergies who on 29-APR-1999 was vaccinated with a first subcutaneous dose of varicella virus vaccine live (Oka/Merck) (lot # 628695/1671H) in the left thigh. The father of the patient stated that the patient developed chickenpox and did not have a fever, per the father. No other information was available at the time of this report. No product quality complaint was involved. Medical attention was not sought. There were no laboratory or diagnostic tests performed. The outcome is unknown. Additional information has been requested.
fever, cough, SOB, chills, fatigue, headache, muscle aches, nausea and runny nose.
no additional AEs; it was reported multiple temperature excursion 16-NOV-2022 and 09-DEC-2022 and were administered PEDVAXHIB, ROTATEQ and VAQTA; This spontaneous report was received from a medical assistant and refers to an unspecified group of patients of unknown age and gender. Their medical history, concurrent conditions and concomitant therapies were not reported.  On 16-NOV-2022 and 09-DEC-2022, the patients were vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot number: U029144 and expiration date: 31-MAR-2024; with Hepatitis A Vaccine, Inactivated (VAQTA) lot number: W015191 and expiration date: 27-OCT-2023; and with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot number: U038854 and expiration date: 20-APR-2023. The vaccines were administered only once for prophylaxis, but dosage regimens, route of administrations and anatomical locations were not reported.  It was reported that the vaccines were administered after multiple temperature excursions (product storage error). Temperature was above 47 Fahrenheit (F) degree (50.0 F) for 0 hours 12 minutes and 0 seconds on 16-NOV-2022 and above 47 F (47.6F) for 0 hours 15 minutes and 0 seconds. Time frame was total 27 minutes. Additionally, no previous temperature excursion was reported. No other adverse event was reported (no adverse event).  Follow-up information was received from the medical assistant on 28-DEC-2022. This report refers to a 19 month old patient who was vaccinated on 01-DEC-2022 with Hepatitis A Vaccine, Inactivated (VAQTA) lot number: W015191 and expiration date: 27-OCT-2023, intramuscular (IM). The primary thermometer displayed out of range temperature for less than 15 minutes. The back-up thermometer did not display max. that was out of range. Log was ran and the temperatures were within range. The primary thermometer was re-calibrated.  Patients' identifiers were missing in the previous report but have now been provided.
At time of first does I didn?t realize I was pregnant.  I was 5 weeks pregnant at the time of 1st dose. I miscarried on 2/9/21 which the baby was suppose to be 10 weeks but I was told the baby looked was 6 weeks of age therefore the baby passed away/stopped developing a week after I got the first dose
This spontaneous report as received from a nurse refers to a unknown number of patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patients were inadvertently vaccinated with improperly stored with M-M-R II (strength, dose, frequency and route were not reported). No concomitant medication were reported. No adverse effects were reported. There was no product quality complaint. This is one of the two reports received from the same reporter (Case # 1512USA002869). Additional information is not expected as the reporter did not wish further contact.
01/25/05 Immunization, 01/26/05 well baby exam at Dr, large, red, swollen left leg on side, RX antibiotic Cephalexin 10 days. 01/29/05 no longer red mother reported. Dr stated infection, hard, size of fist mom states.