chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist via a field representative referring to a male patient of unknown age. Information about medical history, concurrent condition and concomitant medication was unspecified. On an unknown date the patient was vaccinated with ZOSTAVAX (19400 PFU, 0.65 ml, he got the shot once; lot#, strength and route unspecified). On an unknown date, 2 days after vaccination, the patient went back to the pharmacy and his arm looked extremely red. Then, the patient came back to see the pharmacist again "a week later" complaining of muscle spasms in and around the injection area. Representative mentioned that the Pharmacist advised the patient to go see his primary care physician but it was unknown if the patient actually did contact or see their doctor at the time of the report. The outcome of the events was unknown. Additional information has been requested.
Patient was given a 0.3ml dose of the bivalent vaccine instead of the adult bivalent. Patient reported no issues.
Flu like symptoms: chills, headache, body aches (all within 12 hours, most symptoms decreased after 24 hours but still lingered for 2 days)  Rash on arm where shot was given - 2 days after injection
COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 included: "Heart failure" (unspecified if ongoing), notes: Heart failure with reduced ejection fraction; "Reduced ejection fraction" (unspecified if ongoing), notes: Heart failure with reduced ejection fraction; "Chronic kidney disease" (unspecified if ongoing); "Chronic obstructive pulmonary disease" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Peripheral artery disease" (unspecified if ongoing); "Coronary artery disease" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Morphine, reaction(s): "Known allergies: Morphine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "COVID-19 treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Therapeutic measures included Anti-viral details: Product: COVID-19 Treatment, treatment started on 05Nov2022 and stopped on 06Nov2022 via oral route, Indication: Treatment of COVID-19. The device date was on 09Nov2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Drug ineffective and COVID-19 cannot be ruled out.
gave patient her 1st booster of moderna, initially was fine, then arm turned red, swollen, and itching and burning....gave 50mg po benadryl, she sat for about 10 min when I checked on her again her throat was feeling itchy...offered 911 she refused and husband took her to er
Fever / 6 week following his first dose / continues to have a fever; This case was reported by a physician via sales rep and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details provided were as follows: Age at vaccination was not reported. The physician reported that, the patient received his first dose of Shingrix in 2021, about 6 weeks ago of reporting date. He received the dose of Shingrix from another physician at another clinic, so knew very little other information about the administration of the Shingrix dose. Shortly after receiving his first dose of Shingrix, he experienced a fever over the 6 weeks following his first dose of Shingrix, the fever continued, and did not resolve. The physician was unsure of the initial fever, but it had been varying between 101 degrees Fahrenheit and 99 degrees Fahrenheit over the 6 week period. The patient was reluctant to receive his second dose of Shingrix due to the fever that he experienced. As of 6th August 2021, the patient continues to have a fever.  No further information were provided.
This spontaneous report as received from a physician via company representative refers to a 20 year old female patient. Current conditions and other relevant medical history were not reported. On 12-AUG-2014 the patient was vaccinated with the first dose of VARIVAX (Merck) (Subcutaneous injection, dose 1, 0.5 ml; route, anatomical location, batch/lot # and expiration date not reported). Concomitant therapies were not reported. The physician informed that after the first dose of VARIVAX (Merck), on an unspecified date in 2014, the patient experienced extended local reaction with redness. The physician also stated that after the blood work test, performed on an unspecified date in 2014, the patient's titer showed no response to VARIVAX (Merck). The patient sought medical attention. The outcome of the events was not reported. Causality assessment was not provided by the reporter. Additional information is not expected because the physician did not consent to be contacted for further follow-up.
pt recv vax 24MAR94 & 3AUG95 pt lab results revealed the presence of meningitis;pt is part of a post marketing surveillance program;
Fatigue, Headaches, Fever, Neck pain, Back pain, Abdominal pain, Nausea, Diarrhea, Arm swelling, Arm tingling, Face tingling, Chest pain
Large redenning and swelling of skin at injection site. Significant soreness of upper arm. Fever. Significant aches and pains, Chills.
Narrative:  Patient received 2 doses of Moderna COVID 19 vaccine. Patient reported vomiting and weakness in July 2021, then reported COVID-19 exposure, then was diagnosed with COVID and hospitalized at community hospital. Records for that hospitalization not available to this author. Patient was then in rehab facility and returned home 10/19/21. He was in a weakened state and hypotensive and medications were adjusted. On 10/16/21 he was again taken to local hospital due to weakness and syncope. His hgb was 7 mg/dL and he received a transfusion. Hospital records not currently available to this author. Patient was discharged home with hospice services and expired on 11/19/21.
Reaction where they broke out in pustules; Got sick; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 06Apr2021 as dose 2, single (Lot number: ER8737) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose number: 01, Lot number: EN6207, Manufacturer: Pfizer), administration date: 16Mar2021, for Covid-19 immunization. The following information was reported: PUSTULE (non-serious), outcome "unknown", described as "Reaction where they broke out in pustules"; ILLNESS (non-serious), outcome "unknown", described as "Got sick".  Additional information: Expiry Date and NDC number of Pfizer Covid Shot was Not Provided. This Nurse was also the patient who called about Pfizer Covid Shot. When caller got their second dose of Pfizer Covid Shot they had a reaction where they broke out in pustules and got sick but got over those events. Caller did not had any reaction to the first dose. Caller wanted to be protected from COVID and wants to get another dose of Pfizer Covid Shot but is scared to. Wanted to find out what to do next, what they should do next about getting additional dose. Caller asked if there was a pill now instead of a shot. How long will the immunity from those prior 2 doses last. Reporter Fax/Email was Unknown.   No follow-up attempts are possible. No further information is expected.
Nausea; Her left arm is very sore and swollen; Her left arm is very sore and swollen; A red mark in her injection site; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 88-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FF2588), via an unspecified route of administration, administered in Arm Left on 30Sep2021 (at the age of 88-years old) as dose 3 (booster), single for covid-19 immunisation. Medical history included cardiac pacemaker insertion from 02Aug2013 and ongoing she has had pacemaker quite a few years. Concomitant medication included warfarin taken for anticoagulant therapy from 2013 and ongoing; metoprolol taken for heart rate from an unspecified start date and ongoing; amiodarone taken for heart rate from an unspecified start date and ongoing. The patient previously received dose 1 and dose2 bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: not reported) via an unspecified route of administration, for COVID-19 immunisation and did not have any reactions from the first two shots. Patient states she had her Pfizer Booster shot on Thursday, 30Sep2021, she did not have any reactions from the first two shots, caller states this one she has experienced dizziness, on 01Oct2021 her left arm is very sore and swollen. her arm is swelling, has a red mark on arm and today when she got up she was so dizzy the room was spinning. On 04Oct2021, States she is also nauseous today. Patient states she treated the swelling and sore arm with ice and it has improved. The outcome of the events dizziness and nausea was not recovered and for vaccination site erythema was recovering and for all other events recovered on unspecified date.  Follow up attempts are completed. No further information is expected.
I had a Ectopic pregnancy yesterday. I had severe abdominal pain with nausea and vomiting and so I went to the ER. I had to have my left fallopian tube taken out. I've had 3 pregnancies, 2 termed deliveries 2019 and 2017, and 1 ectopic pregnancy. The estimated date of delivery was to be June 27, 2023. I was 6 weeks pregnant.
Patient have history of CAD, ICD placement in 2014, ischemic cardiomyopathy, diabetes mellitus, metastatic non-small cell lung cancer, COPD. Admitted for SOB. Patient treated with dexamethasone and remdesivir.
6:30 pm coughing, sneezing-p 88 res no redness swelling warmth 6:45 pm P 88R, Reg unlabored breathing. No change 25 mg po Benadryl po given 7:10 pm 82/58, 90R, unlabored resp-started sneezing, rubbing eyes, eyes puffy and blood shot. 2.5 ml Epinephrine SC (L) arm. Improvement with redness in minutes. Paramedics arrived no further meds given at health department
itching, hives, coughing;DPH given;rxn lasted approx 2-2 1/2hr;
Pt lost consciousness and became incontinent -wife reported pt had a seizure but I was not present at the onset of symptoms within minutes of administration.
Patient is a 74 y.o. female patient of local MD with history of DM2, GERD, gout, HLD, HTN, kidney stones. Presented with fevers, body aches and was found to be positive for COVID-19. Initially required 2L O2 via NC, weaned to RA on discharge. PT/OT evaluated Patient and noted that she is appropriate for HH PT. Medically stable for DC.   COVID-19 Acute hypoxic respiratory failure, resolved  COVID positive, Flu negative, Strep negative CXR non-acute S/p dexamethasone, remdesevir Weaned to RA prior to discharge PT and CM following, discharged with home health care Reviewed masking recommendations around family until 3/17 Recommend Covid-19 vaccination 3 months after recovery   Elevated CK and lactate on presentation Likely secondary to COVID-19   Elevated troponin 46>42 EKG non-ischemic Likely demand ischemia secondary to COVID-19   HTN Hypertensive on admission, now improved following medication adherence  Continue home coreg, losartan, amlodpine, ASA on discharge   DM2 1/2023 A1c 7.2 Discontinued home glipizide 2/2 good control Continue Metformin on discharge   Gout Not in acute flare Continue allopurinol   HLD 11/2022 total cholesterol 179, LDL 93 Continue statin
just got sick; sore throat; sinus pain; tight cough; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (just got sick), OROPHARYNGEAL PAIN (sore throat), SINUS PAIN (sinus pain) and COUGH (tight cough) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (just got sick), OROPHARYNGEAL PAIN (sore throat), SINUS PAIN (sinus pain) and COUGH (tight cough). At the time of the report, ILLNESS (just got sick), OROPHARYNGEAL PAIN (sore throat), SINUS PAIN (sinus pain) and COUGH (tight cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.  Concomitant information was not provided.  Action taken with mRNA-1273 in response to events was not applicable.
right arm is red, swollen, sore, itchy, extends from top of shoulder to forearm x 2 days, redness is traveling
Red blotches and hives on face. Was given Benadryl 5ml by mouth per Dr. orders.
Muscle Aches, Fatigue, Diarrhea, Abdominal Pain, Headache.
Brain bleed; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender (physician) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at an unspecified age) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The consumer reported that a perfectly healthy physician who died after receiving the vaccine actually dying from a brain bleed. The outcome of the event was fatal. The patient died on an unspecified date. It was unknown if an autopsy was performed.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Brain bleed
Multiple symptoms at various times for 10 days from vaccines.  Fatigue & symptoms of cold virus such as little appetite and food having poor flavor for several days. 06/26, severe sore muscles & tendons in neck (left side) and left wrist. Fatigue seemed to be compounding through 06/28. 06/29 - 06/30, uncontrollable chills & shivering & low grade fever (100 degrees).  Per advice of Dr., visited another doctor on 06/30 to get a vitals report and blood tests.
Presents with mild cough, generalized weakness, shortness of breath x 2 weeks. Admit for acute respiratory failure with hypoxia secondary to COVID-19 pneumonia with sepsis. Tx: IV Decadron, IV Remdesivir, Baricitinib, Vit C and Zinc, O2 via NC. DC home w/O2 & steroid taper.
Patients states his arm is still sore 2 months post vaccination.  States arm aches from shoulder to elbow.  Patient did see MD but didn't give patient and information.  Instructed patient to continue to move arm, place heat on it and may take ibuprofen or tylenol, whichever is safe for him to take, OTC
not experienced any symptoms; 71 years old has received two doses of the GARDASIL 9 vaccine.; This spontaneous report was received from a 71-year-old male patient referring to himself. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.       On 08-APR-2022, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age). On 15-JUN-2022, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis. The patient had not experienced any symptoms.
Body aches; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) and PYREXIA (Low grade fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced MYALGIA (Body aches) and PYREXIA (Low grade fever). At the time of the report, MYALGIA (Body aches) and PYREXIA (Low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No information of treatment medication was given. Laboratory details was not provided.  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.; 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.
aches, fever, headaches, heart palpitations, chills, UTI, fatigue, diarrhea, prayed for death. was sicker than i was when i had covid
Patient was diagnosed with Bells Palsy today. On 5/10 in the evening she noticed an odd sensation in/around her mouth.  It continued to worsen, she saw her primary MD who didn't seem concerned. She stated the symptoms worsended the next day, Today she awoke to her eye not being able to blink,  and one side of her face drooping.  She called the pharmacy and I told her to seek medical attn. as soon as possible. She went to the Urgent Care. This dr. prescribed Prednisone, Valtrex, and lubricant eye drops.
Fever 101dg.  Eyes Hurt, Sore and swollen throat, airway almost blocked, heavy coughing and runny nose. Symptoms lasted about 6 hours. completely gone by 8am.
At location of injection (rt arm) fluid filled 'bubble' formed and broke open on day of injection followed by redness surrounding ulcerated area. Applied topical OTC antibiotic, presently less red and drying ulcer.
Aches at injection site as well as joints, particularly in shoulders.; Aches at injection site as well as joints, particularly in shoulders.; Warm almost burning sensation left foot; Dizziness; Diarrhea; Headaches; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left  arm on 24Apr2021 at 14:30 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. 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. The concomitant medications were not reported. On an unknown date in Apr2021, the patient experienced aches at injection site as well as joints, particularly in shoulders, warm almost burning sensation left foot that subsided after about an hour of walking around, dizziness, diarrhea and headaches persisting through the following day. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events aches at injection site as well as joints particularly in shoulders were unknown, while the clinical outcome of the event warm almost burning sensation left foot was resolved on an unknown date in Apr2021. The clinical outcome of the events dizziness, diarrhea and headaches were not resolved at the time of this report.    No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a healthcare worker refers to an unspecified patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patients were vaccinated with improperly stored doses of Oral, ROTATEQ (lot # L000569, dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Night Sweats; Body aches; Chills; Fever of 102; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night Sweats), MYALGIA (Body aches), CHILLS (Chills), PYREXIA (Fever of 102) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hypertension.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced NIGHT SWEATS (Night Sweats), MYALGIA (Body aches), CHILLS (Chills), PYREXIA (Fever of 102) and HEADACHE (Headache). At the time of the report, NIGHT SWEATS (Night Sweats), MYALGIA (Body aches), CHILLS (Chills), PYREXIA (Fever of 102) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided/unknown by the reporter. Treatment for the event included Paracetamol.
Throat pain; Swollen tonsils; Swollen neck lymph nodes (opposite side of the injection0; Fever; Vertigo; Headache; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), OROPHARYNGEAL PAIN (Throat pain), TONSILLAR HYPERTROPHY (Swollen tonsils), HEADACHE (Headache) and NAUSEA (Nauseous) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced VERTIGO (Vertigo), HEADACHE (Headache), NAUSEA (Nauseous) and PYREXIA (Fever). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Throat pain), TONSILLAR HYPERTROPHY (Swollen tonsils) and LYMPHADENOPATHY (Swollen neck lymph nodes (opposite side of the injection0). On 16-Jan-2021, NAUSEA (Nauseous) had resolved. On 18-Jan-2021, VERTIGO (Vertigo), HEADACHE (Headache) and PYREXIA (Fever) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Throat pain), TONSILLAR HYPERTROPHY (Swollen tonsils) and LYMPHADENOPATHY (Swollen neck lymph nodes (opposite side of the injection0) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant drugs included no treatment drugs included   Most recent FOLLOW-UP information incorporated above includes: On 03-Feb-2021: follow up received contain no significant information