chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender (First name could be female or male). No information was provided regarding concomitant medications, concurrent conditions or medical history. During 2013, the patient was inoculated with ZOSTAVAX at a clinic, as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. During 2013, the patient was treated at clinic /medical facility for the onset of a vesicular rash which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Cerebrovascular accident; Thrombosis; This case was received via FDA VAERS (Reference number: 1321745) on 08-Jun-2021 and was forwarded to Moderna on 08-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of CEREBROVASCULAR ACCIDENT (Cerebrovascular accident) and THROMBOSIS (Thrombosis) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-May-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 11-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Cerebrovascular accident) (seriousness criteria hospitalization, disability, medically significant and life threatening) and THROMBOSIS (Thrombosis) (seriousness criteria hospitalization, disability, medically significant and life threatening). At the time of the report, CEREBROVASCULAR ACCIDENT (Cerebrovascular accident) and THROMBOSIS (Thrombosis) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2021, Computerised tomogram: blood clot (abnormal) Blood clot.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient suffered a blot clot on may 11th and a stroke.  No treatment information were reported.  Action taken with the drug in response to events was not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.  Event terms, onset dates and outcomes captured per Health Authority reporting.  Events seriousness per overall case assessment by Authority and per IME list
This retrospective cohort study report has been received from the authors of a published literature, title as stated above. This paper described a 9.5-year cohort study evaluating the incidence of herpes zoster after concomitant administration of ZOSTAVAX (ZVL) and PNEUMOVAX 23 (PPSV 23). A retrospective cohort study was conducted from 01-JAN-2007 to 30-JUN-2016. The exposed cohort (concomitant vaccination group) consisted of 60 years of age and older who were vaccinated with ZVL and PPSV 23 on the same day from 01-JAN-2007 to 31-DEC-2014. The comparator cohort (prior vaccination group) consisted of 60 years of age and older who were vaccinated with ZVL during the same period as the exposed cohort but were previously vaccinated with a dose of PPSV 23 from 365 days to 30 days prior to receiving ZVL. Both groups had been continuous members in the year prior to date of ZVL vaccination, allowing for a 31-day gap in membership. The patients from both groups were followed from the date of ZVL vaccination until the date of herpes zoster occurrence, termination of membership (allowing for a 31-day gap), death, or 30-JUN-2016, whichever was earliest. This report refers to 604 elderly patients (age 65 years and older). On unknown dates the patients were previously vaccinated with a dose of PNEUMOVAX 23 (lot#, expiration date, dose, route and frequency unknown) from 365 days to 30 days prior to receiving ZOSTAVAX (lot#, expiration date, dose, route and frequency unknown) for prophylaxis. On unknown dates, the patients experienced incident severe herpes zoster. The outcome of the events was unknown. The reporter considered vaccination failure and herpes zoster to be related ZOSTAVAX. This is one of several reports received from the same literature (linked report MARRS #1804USA008699, 1804USA010349, 1804USA010350, 1804USA010352, 1804USA010377).
Red raised itchy area on arm. There was a small area the day after the shot and then today 8 days later it is larger and itches worse
About 4 hours after getting the vaccine, I experienced diarrhea. Overnight I had a headache, slight chills. The next morning I was tired, had muscle aches, had a headache, had a bit more diarrhea.   The diarrhea has gone away, but still feel aches and tiredness and headache 18 hours after the vaccine shot.
11/02/22 presents to EC ED for "dizziness" "cough, hoarse voice, she tested positive for COVID approximately 5 days ago". PMHx of "HTN, dyslipidemia, aortic valve stenosis, mitral valve prolapse"
Sharp, shooting pain in LEFT hip; Finds it difficult to walk; This case was reported by a consumer via call center representative and described the occurrence of pain in hip in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number 4KK43, expiry date 26th August 2023) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Zostavax.   On 22nd April 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In April 2022, less than a week after receiving Shingrix, the patient experienced walking difficulty. On 23rd April 2022, the patient experienced pain in hip. On an unknown date, the outcome of the pain in hip was not recovered/not resolved and the outcome of the walking difficulty was unknown.   It was unknown if the reporter considered the pain in hip and walking difficulty to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-APR-2022 Reporter's Comments: The patient received Shingrix in the left deltoid. The next morning, she began experiencing a shooting pain in left hip. This had not yet resolved. She described the pain as sharp, shooting, and then it went away. She finds it difficult to walk. Less than a week after vaccination, the patient experienced difficulty in walking. The reporter gave consent to follow up.
Body ache; Headaches; Muscle aches; This case was reported by a pharmacist via call center representative and described the occurrence of general body pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th February 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced general body pain, headache and myalgia. Shingrix was discontinued. On an unknown date, the outcome of the general body pain, headache and myalgia were unknown.   It was unknown if the reporter considered the general body pain, headache and myalgia to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and had experienced body ache, muscle aches and headaches so patient would prefer not to get the second dose of Shingrix if that's possible.  The patient did not get the first dose at pharmacist's site and pharmacist had limited information for the first dose administered and patient could not provide date of birth.  The reporter consented to follow up.
Approximately one hour following vaccine administration patient developed  lightheadedness, clamy, sweating reaction, mild nausea no vomiting. symptoms completely resolved < 4 hours
all died within the 5 weeks after there first shot; This is spontaneous report from a contactable consumer. This the fifth case out of six cases.   An elderly patient of unspecified age received first dose of 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 of 2021 as single dose for covid-19 immunisation. The patient medical history and the patient's concomitant medications were not reported. On unknown date the patient died within the 5 weeks after the first vaccination. It was not reported if an autopsy was performed. The patient was in a residential home with 5 other elderly residents. He/she died in sleep.  Information related Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021617030 same reporter, same vaccine, same adverse event, different patient.; Reported Cause(s) of Death: all died within the 5 weeks after there first shot
Right deltoid - local reaction, swelling approx 2" diameter warm to touch, erythema tx with ice and ibuprofen for discomfort.
Pfizer-BioNTech COVID-19 Vaccine EUA - 1st day severe arm pain on left side - Took 800 Mg Ibuprofren. 2nd day - severe chills, trouble breathing, intense dry heaves, could not keep down water without vomiting, intense muscle pain, intense fatigue, fever. Took 250 mg of tylenol later in the evening after able to hold down water. Left side of body still sore and face swelling on left side. 3rd day - nausea, severe headache - took 250 mg Tylenol and 800 Mg Ibuprofren throughout day with no relief.  Still have pain and swelling on left side of face. Injection site is bruised with redness around and very sensitive to touch. Today (Day 4) - still have headache, face swelling on left side, fever blisters on lower lip, nausea, left side soreness and left arm still sore.
Narrative: Patient reported occasional heart palpitations and increased heart rate with episode of sweating for 4 days after second covid moderna vaccine.
My following cycle was then about a week late (still not on birth control); My cycle started the day after receiving my second dose of the Pfizer vaccine, which was a little over a week ahead of when it was supposed to start.; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via an unspecified route of administration in the right arm on 22Jun2021 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. 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. Concomitant medications included sertraline (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received sulfamethoxazole/trimethoprim (BACTRIM) on an unknown date and experienced drug allergy. The COVID vaccine seemed to effect her menstrual cycle (while not on birth control). On 23Jun2021, her cycle started the day after receiving her second dose of the Pfizer vaccine, which was a little over a week ahead of when it was supposed to start. On 02Aug2021, her following cycle was then about a week late (still not on birth control). Her cycle was typically very regular when not on birth control. On 15Aug2021, the patient underwent lab test and procedures which included nasal swab test and the result was negative. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events her cycle started the day after receiving her second dose of the Pfizer vaccine, which was a little over a week ahead of when it was supposed to start and her following cycle was then about a week late (still not on birth control) was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. No treatment medication was reported by reporter.
patient was administered an expired vaccine/ no AE; patient was administered vaccine during pregnent/ no AE; Initial information was received on 14-Sep-2021 regarding an unsolicited valid non-serious case received from a Physician via Regulatory Authority (Reference number- 00768515) and transmitted to Sanofi on 14-Sep-2021. This case involves a 31-year-old female patient who administered an expired INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] with no adverse event (expired product administered) during her pregnancy (Maternal exposure during pregnancy).  Gestation period at onset was 45 weeks.  Data regarding this pregnancy were received prospectively for example before pregnancy outcome was unknown.   The date of last menstrual period was 12-Oct-2020  The estimated due date is 29-Sep-2021.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 14-Sep-2021 patient received a 0.5 ml (total) of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot UJ702AA and expiry date 30-Jun-2021] via intramuscular route in right deltoid for prophylactic vaccination.  It was reported,"4 patients in her office on 14SEP2021 received vaccinations of FLUZONE QIV NP that expired on 30JUN2021. Caller asked for information on how to proceed and whether or not these doses should be re-administered".  It was a case of actual medication error due to Expired vaccine used and Maternal exposure during pregnancy (latency was on same day).  Relevant prenatal testing after exposure was not reported.  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
6 cm area of warmth, moderate swelling, mild erythema lateral aspect (R) deltoid.
Information has been received from a Registered Nurse concerning a 25 year old female who in 2006 ("3 years ago") was vaccinated with her first and only dose of GARDASIL IM. There was no concomitant medication. On the same day after the vaccination, the patient experienced nausea along with hot and cold flashes. No lab diagnostic study was performed. The patient didn't seek medical attention. On an unspecified date the patient recovered from the above events. Additional information has been requested.
Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 10:02 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 10:02 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 61.39.  Concomitant products were not provided.  On 03-Apr-2021, excursion time was 09 AM, temperature was 34, total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.  On 03-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 38,9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40 and 5 PM: 41.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Patient scheduled appointment for pediatric pfizer, which was administered. After administration, it was noticed that patient should have received adult dose given ag greater than 11.
Shot given in left deltoid at 520pm. L. Inner forearm hives noted 540pm. Continued to monitor.  Feeling of needing to cough noted at 600pm. Lung sounds clear. Resolved Increased redness + itchiness on L. Arm. Patient took her own 25mg benydral at 605. Called on call Dr. who instructed to notify EMS. Continued to monitor patient. VS. pt refused to go to ED. Symptoms improved by 1930. PT able to go home per Dr.
Received Tetramune & OPV @ 11AM 19MAY94; @ 200PM child "cried loud & rolled eyes up, turned blue & was unresponsive" for 5 minutes according to grandmother; infant brought to ER & admitted 300PM 29MAY94;
Next day-arm swollen, vomiting, 101F temperature.  Resolved by following day.
29JUL92 extreme tenderness & pain of lt arm; pain & numbness of lt arm; burning sensation traveling from the area of inject down arm to wrist; difficulty in lifting the arm; numbness; abscess; tingling & numbness in arm;nerve irritation;
10FEB92 lt sided face swollen & sore sl fever; Pt seen by MD in the AM; r/o parotitis vs mumps; on Suprax for OM & Ventolin (Proventil) for cough & asthma;
I woke up 6 hours after the vaccine with significant swelling in my face; This is a spontaneous report from a contactable nurse, the patient.  A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL0140, via an unspecified route of administration on 29Dec2020 at 07:30 (at the age of 54 years old) as a single dose in the left arm for COVID-19 vaccination.  Medical history included allergies to azithromycin and compazine.  The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 29Dec2020, the patient stated she woke up 6 hours after the vaccine with significant swelling in her face. It did not affect her breathing. She took 50 mg Benadryl . The swelling was gone 4 hours later. The clinical outcome of swelling in her face was recovered on 29Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Vaccine given 04/01/2005 and on 04/06/2005 at 1:00 AM the pt felt like she was burning up. Fever, hot and cold chills, weak, at 6 AM it was over she just felt weak and a little foggy. Went to work that day, fine now.
PETECHIAE THEN PLATELET COUNT DROPPED TO 9,000 and  WHITE COUNT 1,400; ANC 320.
Severe inconsolable irritability for 2 day following Dtap shot. Irritability relieved briefly with Lumbar puncture. Persisting symptoms thinks less severe for 8-9 days. Discharge summary states urinary tract infection. msv Medical records state temperature elevation. msv