chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired vaccines that were administered to less than 10 patients; The pharmacist stated that they were pulled out on 27May2021 from the freezer and placed in the fridge until past weekend; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccines that were administered to less than 10 patients) and PRODUCT STORAGE ERROR (The pharmacist stated that they were pulled out on 27May2021 from the freezer and placed in the fridge until past weekend) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) 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 EXPIRED PRODUCT ADMINISTERED (expired vaccines that were administered to less than 10 patients) and PRODUCT STORAGE ERROR (The pharmacist stated that they were pulled out on 27May2021 from the freezer and placed in the fridge until past weekend). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccines that were administered to less than 10 patients) and PRODUCT STORAGE ERROR (The pharmacist stated that they were pulled out on 27May2021 from the freezer and placed in the fridge until past weekend) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable. No relevant concomitant medications were reported. No treatment information was provided.
Patient received 4 yr immunizations on 5/8/07. In right leg received Dtap and IPV. Next morning a 4AM had wheezing and when awoke had hives. Right leg swollen at injection site. Suspect reaction to Dtap. Able to treat with Benadryl. Responded to Xopenex inhale with no wheezing or hives.
A week later I am driving  on the highway and I started to feel shortness of breath, within 2-3 minutes I got out via an exit and park at a gas station, I palpated my chest and felt a weak but rapid heart beat. I ingested the carvedilol 6.25mg, I felt dizzy but walked in the gas station to got a granola bar and chocolate milk drink went back to the car. Twenty five minutes after taking the first carvedilol, I felt no changes in heart rate & shortness of breath and took an additional 6.25mg of carvedilol. I then called my wife and talk to her (and my children) about what was happening and where I was. I asked to call 911 if I loose consciousness. At about fity five-Sixty minutes went by and symptoms were unchanged  and I took third dose of 6.25 mg of cavedilol. At approximately 75-80 minutes after onset of symptoms my hear rate went down and shortness of breath improved to normal. I contacted my doctor the next day
Chief Complaint: Shortness Of Breath .  Tachypnea .COVID-19 virus RNA test result positive at limit of detection
Presented to hospital on 1/8/22 with a recent COVID infection 1/5/2022 and altered mental status. Head CT non-acute.  CXR demonstrated interstitial prominence, possible pulmonary vascular congestion vs pneumonia.
Pt feels like there is a knot at the vaccination site when he moves his arm back and up. Healed vaccine scar present. No palpable induration felt. No redness or swelling noted. Muscle mass appears symmetrical with R deltoid. Did not notice this until after receiving the influenza vaccination. Not sore to touch. Relates history of shoulder injury 7-8 yrs ago. Pt wonders if symptoms are from this.
Information has been received from a pharmacist referring to a female patient of unknown age. The patient's pertinent medical history included haemochromatosis. The patient had no concomitant medication or drug reactions/allergies. On 07-NOV-2018, the patient was vaccinated with PNEUMOVAX 23 (lot# R012550, expiration date was 20-JAN-2019; strength, dose and route were not reported) for prophylaxis. On 09-NOV-2018, the patient came into the pharmacy stating that her arm really hurt (Pain in arm) and she had a red rash at the injection site (Injection site rash). No treatment had been provided. The patient also stated that the red rash had grown in size from the day before the reporting time. No lab test was performed. The outcome of the events was reported as not recovered. The causality between the events and PNEUMOVAX 23 was not reported.
3in diameter, flat reddened area surrounding injection site, warm to touch and itchy-BENADRYL or CLARITIN recommended to take-states she will apply topical BENADRYL ointment.
Moderna booster was given to patient under 18. Patient didn't appear to have any symptoms or reactions. Patient's dad was told to monitor for any side effects
Sore arm, reddened site 4 cm square 2 days after. Redness continues 6 days after
suspected vaccination failure; Had the shot still had shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: Age at vaccination was not reported. The age group was selected as an adult as per vaccine indication. The patient had the shot still had shingles. The patient would not wish that on anyone. This case was considered as suspected vaccination failure since the details regarding dose number, time to onset and laboratory confirmation for shingles was not reported.
It started 15 hours after shot I was really tired. Not sleepy just tired, then 7 more hours I felt flu like symptoms with a low grade fever of 100 for 8 hours.  Then 60 hours after shot still a little weak with a small grade headache. Getting better
This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 08-JUN-2017, the patient was inadvertently vaccinated with an expired dose of GARDASIL injection, lot number M014929, expiration date: 27-MAY-2017 (strength, dose and route of administration were not reported) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Information has been received from a pharmacist concerning a 78 year old male who on 21-SEP-2007 was vaccinated SC with a dose of ZOSTAVAX (Lot # 656395/0290U). Concomitant therapy included 10 mg HYTRIN and 100 mcg SYNTHROID. In October 2007, the patient developed pruritis on left side and his back. The patient was examined by his physician and was told treat symptoms with ibuprofen. A product quality complaint was not involved. Additional information has been requested.
12 hours post injection developed fever and chills and nausea, headache. Also body aches. Lasted until approximately 36 hours. Extremely painful arm. 48 hour noticed red hot rash below injection site.
When I got home from my hike the next day of vaccination I felt my heart going crazy I had high blood pressure 160/100 it stayed like that for the next 3 days but the next day I felt my whole body pounding I was shaky I had to go to urgent care. Then for the next week I was feeling very fatigue & short of breath lasted for about a week.
sudden bone pain; This spontaneous case was reported by a physician and describes the occurrence of BONE PAIN (sudden bone pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDRALAZINE for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced BONE PAIN (sudden bone pain). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, BONE PAIN (sudden bone pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported sudden bone pain began a few days after the first dose.   This case was linked to MOD-2021-019183 (Patient Link).
Dose number: 3; Fever; Nausea; This is a spontaneous report received from a non-contactable reporter (other healthcare professional).  A 40-year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 12Jan2022 (Lot number: FD7218) at the age of 40 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN, Lot number: UNKNOWN, Route of administration: unspecified), for COVID-19 immunisation and Covid-19 vaccine (DOSE 2, MANUFCATURER UNKNOWN, Lot number: UNKNOWN, Route of administration: unspecified), for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 12Jan2022, outcome "unknown", described as "Dose number: 3"; PYREXIA (non-serious) with onset an unknown date in Jan2022, outcome "unknown", described as "Fever"; NAUSEA (non-serious) with onset an unknown date in Jan2022, outcome "unknown", described as "Nausea".  No follow-up attempts are possible. No further information is expected.
After the 1st dose I had an extremely severe headache within 4 hours, light sensitivity and eye pain  . For the next 72 hours I had severe body aches, chills, intense joint pain (starting at ankles, knees, femurs and then hips. Radiating pain in each section about 30 minutes at a time). Sweating at night. I was light headed and had extreme fatigue. The first 4 nights I had extreme stomach pain all over from under my rib cage felt it moving through my entire stomach track. Even my uterus hurt and I had intense diarrhea, always occurring after 1am but no later than 5am. For a week after the first dose i continued to experience side effects, but not as intensely. Mostly severe fatigue, headache, sensitivity to light, eye pain, muscle stiffness and diarrhea. Yesterday i received my 2nd dose and initially only experienced a slight headache and moderate fatigue. But at 2am I awoke with EXTREMELY INTENSE pain in my kidney area and lower back. It felt very similar to my stomach pain in that there was a throbbing and a sensation of squeezing  of the kidneys and surrounding muscles. The pain was so acute that it affected my breathing patttern and now the morning after my lower back muscles are very sore, indicating there was a physical component to the 2am incident that affected the lower back and kidney area.
Severe muscle pain, arthritis, stiffness, and autoimmune reactions related to my underlying medical condition. This persisted for approximately one month.  I also developed dry eye symptoms that eventually resulted in a case of Iritis and damage to my left eye.
Within hour left arm began to hurt, redness to site, itchiness to site, and swelling set in.
not feeling well; hit by a truck; opposite side ear and scapula pain; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well), ROAD TRAFFIC ACCIDENT (hit by a truck) and ARTHRALGIA (opposite side ear and scapula pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced MALAISE (not feeling well), ROAD TRAFFIC ACCIDENT (hit by a truck) and ARTHRALGIA (opposite side ear and scapula pain). At the time of the report, MALAISE (not feeling well), ROAD TRAFFIC ACCIDENT (hit by a truck) and ARTHRALGIA (opposite side ear and scapula pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant included mild anxiety meds unsure of name Treatment included Tylenol
No additional AE reported; administered ROTATEQ and RECOMBIVAX HB after temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.     On 29-DEC-2021, hepatitis b vaccine (recombinant) (RECOMBIVAX HB) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced a temperature excursion with 35.9 Fahrenheit degrees for 0 hours 20 minutes 0 seconds. There was no previous temperature excursion.  On 03-JAN-2022, the patient was vaccinated with the improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (once, lot # 1742430, expiration date 16-SEP-2022; strength was not reported) orally and hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (once, lot # T032918, expiration date 12-NOV-2022; strength was not reported), both for prophylaxis (product storage error). No other adverse event (AE) or product quality complaint (PQC) was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2202USA007167: US-009507513-2202USA007118: US-009507513-2202USA006998: US-009507513-2202USA007028: US-009507513-2202USA007032:
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1805031, expiry: 26-MAY-2021) frequency one total, dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  The consumer reported that on 25-MAR-2021, the patient did antibody test to find out if he/she was immunized and the antibodies were not created. The patient then did antibody test again on 16-APR-2021 and was informed through the result that the patient did not create antibodies for Covid 19. On 25-MAR-2021, Laboratory data included: Antibody test (NR: not provided) No antibodies created, On 16-APR-2021, Laboratory data included: Antibody test (NR: not provided) No antibodies created.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210435716.; Sender's Comments: V0: 20210436395-covid-19 vaccine ad26.cov2.s-Confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Moderna vaccine.   Normal site soreness hours 1-20 post injection.  No treatment needed Injection site rash appeared day 6 post injection.  Very itchy.  Rash and itchiness continues into Day 7 post injection and into time of this reporting.  (Photo taken and can be submitted upon request)
10 minutes after flu shot: Dizzy, cold sweats, pale, sweating, numbness in fingers and face, nausea, blood pressure 227/95. All subsided after an hour except nausea.  Next day I still couldn't eat, had extreme fatigue (slept 17 hours per day), sore throat, chills, aches, and mild runny nose.  These flu symptoms were more than "mild" and lasted for 5 days.  Several coworkers had similar reactions to mine on the day of the shots (which were given at work). A couple fainted, and other got what seemed to be the flu. I've never had a problem w/ the flu shot before; this was the first time I had H1N1, though.  Still have sore throat but appetite and energy are returning. I was perfectly well up to the time of the injection.
COVID; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (COVID) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID) (seriousness criterion hospitalization). At the time of the report, COVID-19 (COVID) outcome was unknown.            The patient's concomitant medications included blood pressure and diabetes medicines.  It was reported that, patient had Covid after the first dose, and patient was admitted in hospital for 2 days because of Covid.  Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, this event is assessed as unlikely related to mRNA-1273.  No corrective treatment was provided.; Sender's Comments: Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, this event is assessed as unlikely related to mRNA-1273.
Morning following the event, large bruise surrounding vaccination site.  The following day, developed an fine, itchy, blistering rash across the back and upper chest and involving both upper arms, which persisted for two days, then has continued intermittently from mid-February until I see him today 4/25/23.
Patient presented to the ED and was subsequently hospitalized for severe sepsis with septic shock on 5/10/2021; this is within 6 weeks of receiving COVID vaccination.
Shortly after injection during the 15 minute wait period patient began to have excessive sweating, started to shake, and became pale. Neighboring patient alerted the pharmacist and 911 was called. An associate sat with and monitored patient until EMS arrived. Patient's vitals were checked and was cleared to return home. Patient was driven home without incident.
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy was not provided. On 20-JUL-2016, the patient was received an unknown dose of improperly stored ZOSTAVAX (lot # M013377, expiration date 25-MAY-2017, subcutaneous; dose was unknown). The vaccine was stored under 32F for 16 days. There was no previous temperature excursion. Data logger was not involved. No adverse effects was reported. Additional information has been requested.
bumps on arms; Atypical Pneumonia; elevated heart rate; Headache; Sleepy; tired; This is a spontaneous report from a contactable consumer (reported on herself). A 70-year-old female patient received first dose of BNT162B2 (solution for injection, Lot number: EN6202 expiry date: unknown) via an unspecified route of administration in left arm on 02Mar2021, as a single dose of COVID-19 immunization. Medical history included COPD, Asthma: She had a cough for two years and had acid reflux which was when they diagnosed her with asthma, Coughing started 1-2 hours after that flu vaccine which she received in 2019, she did not have the NDC number, lot number, or expiration. The caller had not received a flu vaccine since. She was diagnosed with Lichen sclerosus 3 months prior to this report, pneumonia diagnosed 4 years prior to this report, and she believed it was autoimmune. Concomitant medication included FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (Trelegy) inhaler dosage text: 1 inhalation a day, 200mcg been taking it a couple of months for asthma and COPD. On 02Mar2021, she had her vaccine in the morning and by the afternoon her heart rate was high at the appointment with her asthma doctor and her heart rate had been elevated ever since. She then noticed bumps on both of her arms when she was getting out of the bath. Her heart rate was still elevated so she went to the Emergency Room a day prior to this report and was diagnosed with atypical pneumonia. She had a headache, she took a Tylenol, and little bumps on both of her arms. The bumps did not itch, but they were still there. Her doctor put her on antibiotics (unspecified). The patient was she was tired and sleepy from the vaccine but did not feel quite so groggy. She did not feel good a week prior to this report, she thought it was something she ate, she was going to reschedule vaccine because of it. She had blood tests (unspecified) done a day prior to this report, in the Emergency Room and they all came out okay, she guessed. She did not have history of previous immunization with the Pfizer vaccine and was not administered additional vaccines on same date of the Pfizer Suspect. She did not have a family medical History relevant to events. The outcome of the events of atypical pneumonia, elevated heart rate, bumps on arms, and headache was not recovered, however the outcome of the events tired and sleepy was unknown.   No further information was available.
Left arm became  swollen, red and warm to touch from shoulder to within 3 inches of elbow on 1/16/21. It is also tender to touch. Treatment has included: ice pack for 15 minutes on for the first 24 hours, then alternated with heat and Benadryl. Then, went to doctor(1/18/21) because of increased swelling. Doctor prescribed Cephalexin to prevent infection.
This spontaneous case, initially received on 28-Feb-2018 combinedly processed with the source document received on 05-Mar-2018, reported by other health professional and concerns a 41-year-old adult female patient. The patient's medical history and concomitant medications were not reported. On 09-Feb-2018, the patient was administered with AFLURIA in which particles were floating (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: XT33908, expiry date: 30-Jun-2018) (explicitly coded as particle present in liquid product and drug administration error). The PTC (product technical complaint) number was PR493672. The product was stored properly without any temperature excursion or leakage. The reporter assessed this case as non-serious. Follow-up received on 23-Mar-2018 for other health professional: The reporter confirmed that, the product was stored properly, and no temperature excursion had occurred. Product leakage was also not reported prior to administration. Narrative was amended accordingly. Case correction received 28-Feb-2018: The LLT of the event "Particles floating in all of the AFLURIA TRIVALENT prefilled syringes' was changed from 'Product contamination particulate matter' to 'Particle present in liquid product' in the event tab. The narrative was amended accordingly.