chrisvoncsefalvay/vaers-outcomes huggingface dataset:
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient of unspecified age. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On or about 18-MAY-2010, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) as prescribed and/or administered by a healthcare provider for the long-term prevention of shingles and/or zoster-related conditions. The patient reported that she relied on the warning label affixed to zoster vaccine live(ZOSTAVAX), and the information relayed through patient's healthcare provider(s) 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 her to be vaccinated. On an unspecified date (reported as subsequent to zoster vaccine live(ZOSTAVAX) inoculation), the patient was treated by a healthcare provider for herpes zoster. As a direct and proximate result of zoster vaccine live(ZOSTAVAX) vaccine, patient had and would continue suffer 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 would continue to suffer such losses, and damages in the future. The outcome of herpes zoster was unknown. The reporter considered the event to be related to zoster vaccine live(ZOSTAVAX).
This spontaneous report as received from a Physician Assistant refers to a 3.5 years old patient. The patient was vaccinated with M-M-R II (0.5 ml dose at 12 to 15 months of age, route and lot # were unknown) approximately in April 2010 (reported as "2 1/2 years ago"). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient who had been vaccinated with M-M-R II presented with mumps at the emergency room. No treatment was given for adverse event. At the report time the outcome of event was unknown. The patient had sought unspecified medical attention. Lab diagnosis studies of "Titers for mumps" had been performed. Additional information is not expected.
pt recv vax & area on arm red & warm 3"-4" circle;1PM BP 128/78 c/o tingling in face & neck side only;no SOB, no swelling in neck area;1:10 tingling better-improving left w/2nd employee;
Information has been received from a nurse concerning an 82 year old female patient. The patient's concurrent conditions included allergy to bacitracin, naproxen, neomycin, penicillin, vitamin B and pramoxine hydrochloride. No pertinent medical history was reported. Concomitant therapies included FLONASE, unspecified vitamins and an unspecified thyroid medicine. On 10-OCT-2016, the patient was vaccinated with an unspecified dose of PNEUMOVAX 23 (lot # M032635 with an expiration date of 05-MAY-2018). Other suspect medications were not reported. On an unspecified date in 2016, after receiving PNEUMOVAX 23, the patient experienced redness and swelling around the injection site and was diagnosed with cellulitis. The patient sought medical attention by visiting the physician's office and he was treated with an unspecified antibiotic. No laboratory studies were performed nor product quality complaint was involved. On unknown date in 2016, the patient recovered from the cellulitis. The relatedness between the event and therapy with PNEUMOVAX 23 was not reported. Upon internal review, cellulitis was determined to be a medically significant event. This is one of several reports received from the same reporter. Additional information has been requested.
Narrative: PFIZER-BIONTECH COVID-19 VACCINE EUA 74 YEAR OLD PATIENT RECEIVED PFIZER COVID-19 DOSE #1 ON 2/6/2021 AND DOSE #2 3/8/2021. WAS ADMITTED TO A OUTSIDE HOSPITAL ON 4/17/2021 DUE TO COVID-19 INFECTION AND PNEUMONIA, DISCHARGED 4/21/2021. WIFE STATED THE ENTIRE FAMILY HAD COVID-19. PATIENT READMITTED ON 4/23/2021 TO ANOTHER HOSPITAL WITH WORSENING O2 SAT AND DIFICULTY BREATHING. ADMITTING DIAGNOSIS: ACUTE HYPOXIC REPIRATORY FAILURE, WORSENING COVID PNEUMONIA VS. BACTERIAL PNEUMONIA. TRANSFERRED TO ICU AND INTUBATED ON 4/28/21. TREATED WITH COVID-DIRECTED THERAPY WITH REMDESIVIR AND DEXAMETHASONE, PRESSOR SUPPORT, PRONE, ETC. CLINICAL STATUS CONTINUED TO WORSEN AND UNABLE TO BE WEANED OFF VENTILATOR. PALLIATIVE CARE TEAM MET WITH FAMILY AND PATIENT TRANSITIONED TO COMFORT CARE AND EXPIRED THE NEXT DAY.
pt recvd vax; elev T 3mar-11mar95; ear infect on 4mar95;on septra for 10-15 days;
Chronic left shoulder joint pain and weakness starting a few days after first injection and persisting today (3.5 months later). Thinking it is SIRVA.
The patient received a dose from a vial more than 30 days on the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 014C21A) for COVID-19 vaccination.     The patient's past medical history included CVA (history of CVA) on 19-Nov-2020 and Chronic hepatitis C (started treatment with Harvoni x 12 weeks on 18-Aug-2021). Concurrent medical conditions included Major depression on 18-Jan-2018, Hypertension since 22-Apr-2021 and Osteoarthritis since 22-Apr-2021. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] from 19-Nov-2020 to an unknown date for CVA, AMLODIPINE from 22-Apr-2021 to an unknown date for Hypertension, QUETIAPINE from 19-Jan-2021 to an unknown date for Major depression, NAPROXEN from 19-Feb-2021 to an unknown date for Osteoarthritis.   On 16-Jun-2021 at 1:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021 at 1:16 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge). On 19-May-2021, EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Out of 14 patient that received vaccine from  affected lot, only 4 patient took dose 1 and 2 from  same lot. No adverse event was reported.   This case was linked to MOD-2021-373445 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2021: Include second dose date was updated. On 02-Nov-2021: Include patient demographics details, past medical history, first and second dose details, vaccine facility details,concomitants added. On 05-Nov-2021: Include no new information. Information from E-mail was added.
Rapid onset of redness, pain, swelling an pain with movement of RUE. Prescriptions of MOTRIN, PREDNISONE, DIPROSONE CREAM, DARVOCET  8/6/09.
right arm injection site was throbbing and swollen; right arm injection site was throbbing and swollen; lymph node under right arm is very swollen and painful and becoming red; General malaise, low grade fever, joint aches morning of 06Mar; General malaise, low grade fever, joint aches morning of 06Mar; dizziness; chills; drenching sweats; lymph node pain and swelling on right side; lymph node pain and swelling on right side; Low grade fever and painful injection site starting evening of 05Mar; Low grade fever and painful injection site starting evening of 05Mar; This is a spontaneous report from a contactable consumer. This 34-year-old female consumer (patient) reported for herself. A 34-year-old non pregnant female patient received bnt162b2 (PFIZER COVID-19 mRNA VACCINE Solution for injection Lot Number: EN6204) via an unspecified route of administration in arm right on 05Mar2021 as dose 2, single (age at vaccination: 34 years) for COVID-19 immunisation. Medical history included asthma, IBS, hypothyroidism, known allergies: penicillin, all from an unknown date and unknown if ongoing. Concomitant medications included venlafaxine hydrochloride (EFFEXOR); ergocalciferol (VITAMIN D [ERGOCALCIFEROL]); levothyroxine (LEVOTHYROXINE); hyoscyamine (HYOSCYAMINE), all taken for an unspecified indication, start and stop date were not reported. Historical vaccine includes bnt162b2 (PFIZER COVID-19 mRNA VACCINE Solution for injection Lot Number: EL9266) via an unspecified route of administration in arm right on 12Feb2021 as dose 1, single for COVID-19 immunisation. No other vaccine in four weeks. No COVID prior vaccination and did not tested COVID post vaccination. On 05Mar2021 04:00 PM, the patient experienced low grade fever and painful injection site starting in the evening. On 06Mar2021, general malaise, low grade fever, joint aches morning and by afternoon, fever rose to 103.5, experienced dizziness and chills, drenching sweats and lymph node pain and swelling on right side. On 07Mar2021, had fever of 101.2, but feeling better. On 08Mar2021, afternoon right arm injection site was throbbing and swollen, lymph node under right arm is very swollen and painful and becoming red. On 09Mar2021, seeking medical care. No treatment was received. The patient underwent lab tests and procedures which included fever resulted as 103.5 on 06Mar2021 and 101.2 on 07Mar2021. The clinical outcome of the events was not resolved.  No follow-up attempts are possible. No further information is expected.
pt recv vax 2JAN95 & either that day or the following day pt exp diarrhea & intermittent fever;diarrhea persisted for 3 wk;a stool culture was neg;pt recovered from sx;
Admitted on 2/6 for covid pneumonia. Noted to have an intermediate risk VQ scan and a DVT so started therapeutic lovenox. Followed by nephrology, pulmonology, transplant, vascular services. On 2/15 patient found in asystole and code blue called with several rounds of CPR recovering with bradycardia and pacing was undertaken. Epinephrine drip was started with transfer to ICU were he was stablized on a ventilator. Transitioned to  levophed and vasopressin drips. Noted to have myoclonic jerks and neurology was consulted. EEG showed no electrocerebral activity and no brainstem reflexes. CT showed anoxic brain injusry. Family requested comfort care.
TRAVELING TO AN ENDEMIC AREA ONE DAY AFTER COMPLETING VIVOTIF; This spontaneous case (PVX2019-1499) was received from a pharmacist on 10-Jun-2019. It describes a 74-year-old male consumer who was "traveling to an endemic area one day after completing Vivotif". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer last dose was due on Sunday. He had a planned trip to an endemic area on Monday.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "traveling to an endemic area one day after completing Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "traveling to an endemic area one day after completing Vivotif" was considered as not applicable.
Sharp Pains in chest.  Had chills and body aches that lasted  Passed put after waking up from pain in chest
This spontaneous report as received from a healthcare worker/medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown date an unspecified number of patients were vaccinated with GARDASIL (dose, frequency, lot#, expiry date and indication were not reported), which was stored improperly for a period of 25 days. No adverse effect was reported. This is one of three linked reports from the same reporter. Additional information has been reported.
Day after i had sore arm, sore neck and headache on right side. A week later (today and yesterday)  golf sized welt that is hot to touch and rash.
feeling a lump in her throat; clammy hands; lightheadedness/lightheaded; tingling of her lips and face; tingling of her lips and face; Each time patient would sit up, she would feel jittery and lightheaded; This is a spontaneous report from a contactable pharmacist. An adult female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EL1283) intramuscularly on 04Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. No known allergies. There were no concomitant medications. Patient received her COVID vaccine. During the observation period, the patient reported feeling a lump in her throat, clammy hands, lightheadedness, and tingling of her lips and face. Patient was taken back to an exam room. Orange juice provided, patient laid down. Each time patient would sit up, she would feel jittery and lightheaded. After having the patient stay in the patient exam room for 45 minutes with clinical staff monitoring her status, the patient did not report any improvement in symptoms, therefore, she was transported to the ED. Patient discharged from ED after evaluation. Events started from 04Jan2021. No treatment received. No other vaccine in four weeks. It was unknown if patient had covid prior vaccination. It was unknown if covid tested post vaccination. The outcome of the events was recovered on an unspecified date.
malaise; diarrhea; Tightness; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (malaise), DIARRHOEA (diarrhea) and MUSCLE TIGHTNESS (Tightness) 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 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (malaise), DIARRHOEA (diarrhea) and MUSCLE TIGHTNESS (Tightness). At the time of the report, MALAISE (malaise), DIARRHOEA (diarrhea) and MUSCLE TIGHTNESS (Tightness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No relevant concomitant medications were reported  Treatment details includes none.
Breakthrough case admission after 2 vaccines  Pfizer 4/14/21 lot# Ew0162;  Pfizer 5/6/21 lot# EW0164;
Patient reported having nausea and felt like fainting. Her blood pressure was low at 80/40. We raised her feet and gave her some water. Her blood pressure rose back up to normal after about 5 minutes. She had a lot of nausea. Patient stated she has anxiety issues.
Potentially got their doses from vials punctured longer than 12 hours ago; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.  HCP reported that while doing quality assurance on 19Nov2021, it was discovered an open vial in the refrigerator. Staff had been drawing doses from opened vials without taking in consideration the hours after the first punctured.   This case was linked to MOD-2021-395804 (E2B Linked Report).; Sender's Comments:  MOD-2021-395804:First patient case
Excruciating pain all over my body. Flu-like symptoms with sinus pain. Could not even wear glasses because the weight of the frames hurt my face that bad. The second day the pain migrated into my teeth, though I had been to the dentist about a month earlier and had no dental issues. Even xrays were taken.  Joint pain.  Loss of appetite.  The pain eventually disappeared by the morning of February 22, 2021.
Vaccine administered to 16 year old.  No adverse effects reported.  Per recommendations, it is considered off-label and 2nd dose in series should be administered in 28 days from 1st dose.
Acky Bones; temperature of 103.4; body ackes; mass headache; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Acky Bones), PYREXIA (temperature of 103.4), MYALGIA (body ackes) and HEADACHE (mass headache) 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 BONE PAIN (Acky Bones), PYREXIA (temperature of 103.4), MYALGIA (body ackes) and HEADACHE (mass headache). At the time of the report, BONE PAIN (Acky Bones), PYREXIA (temperature of 103.4), MYALGIA (body ackes) and HEADACHE (mass headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.4 (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.  The patient also stated he/she Felt like got run over by a Truck.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: follow up received contains significant information-Event added like Acky Bones. On 02-Sep-2021: Follow-up received contains NNI
Breakthrough case admission after three vaccines Moderna 1/11/21 Lot# 012L20A;  Moderna 11/12/21 Lot# 033F21A;  Moderan 5/2/22 Lot# 057M21A
nose dripping; cough after receiving the Moderna vaccine; headache; fatigue; fever 101.9; chills; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (nose dripping), COUGH (cough after receiving the Moderna vaccine), HEADACHE (headache), FATIGUE (fatigue) and PYREXIA (fever 101.9) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced RHINORRHOEA (nose dripping), COUGH (cough after receiving the Moderna vaccine), HEADACHE (headache), FATIGUE (fatigue), PYREXIA (fever 101.9) and CHILLS (chills). At the time of the report, RHINORRHOEA (nose dripping), COUGH (cough after receiving the Moderna vaccine), HEADACHE (headache), FATIGUE (fatigue), PYREXIA (fever 101.9) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-052012 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-052012:patient case
Itching on my head and back; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 68-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was unknown.   It was unknown if the reporter considered the pruritus to be related to Shingrix.  Additional details were provided as follows:  It was reported that the patient had shingles shot on last friday and the patient experienced itching on head and back.
I started having pain in my chest. It felt like it was behind my heart. I went to the doctor, and they ran some tests. The x-ray came back showing a slight enlargement of my heart. They went back and pulled an x-ray done in October and it was normal size, but the one they took in April is showing slightly enlarged. I am still going through this at this time.
Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.   On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown.            No treatment information was provided.
fever, chills, headache, etc.; fever, chills, headache, etc.; fever, chills, headache, etc.; This is a spontaneous report from a contactable other healthcare professional (patient).  A female patient of unspecified age started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), unspecified route of administration on 30Dec2020 as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  In Dec2020, the patient experienced fever, chills, headache, etc. The reporter inquired is it ok to take ibuprofen (MOTRIN) Motrin or  acetaminophen (TYLENOL). Outcome of the events fever, chills and headache were unknown. Information on lot/batch number has been requested.
Shortness of breath; Acute hypoxemic respiratory failure due to COVID-19 (CMS/HCC).