chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received SHINGRIX. On 17th March 2018, the patient received the 1st dose of SHINGRIX. On 19th March 2018, 2 days after receiving SHINGRIX, the patient experienced fever. On 22nd March 2018, the patient experienced nausea, sweating, upper abdominal pain and lower abdominal pain. On an unknown date, the patient experienced pain in arm, pain, flu symptoms, gastrointestinal pain, tremor and appetite absent. The patient was treated with PRILOSEC, PEPTO-BISMOL and Probiotics. On an unknown date, the outcome of the pain in arm, flu symptoms and appetite absent were unknown and the outcome of the fever, pain and tremor were recovered/resolved and the outcome of the gastrointestinal pain, nausea, sweating, upper abdominal pain and lower abdominal pain were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, fever, pain, flu symptoms, gastrointestinal pain, tremor, nausea, sweating, upper abdominal pain, lower abdominal pain and appetite absent to be related to SHINGRIX. Additional details were provided as follows: The patient received vaccine on left arm. The consumer stated that she was still experiencing upper and lower gastrointestinal pain, and did not eat much because of this. She had a fever Monday to Wednesday. On an unknown date, less than a month after vaccination, the patient experienced pain in arm, pain, flu symptoms, gastrointestinal pain, tremor and appetite absent. She stated that she was going to see an internist in two days for lab tests to be done. She stated that she received no other vaccines within four weeks of SHINGRIX dose. She stated that she did not want to second dose of SHINGRIX. Consumer did not have address of her provider's office at time of call. She did not have lot number or expiration, and was not willing to provide other information. She stated ache, fever and shakes lasted 1 week then stopped. The nausea, abdominal pain upper and lower, sweats began on the Thursday, 22nd March 2018, 5 days after the vaccination. They had continued and progressively gotten worse. She stated she could not eat without it bothering her gastrointestinal. When she asked the pharmacist if there were any side effects she was told no, just a little arm pain was there. It was asked if she had allergy to eggs and then given the vaccine. The consumer stated she didn't go in asking for the vaccine, she stated the pharmacist approached her about getting it. She didn't ask lot number from pharmacist but did call back and request the name of the product she received and was told SHINGRIX. She was experiencing upper and lower gastrointestinal distress and hadn't eaten much with gastrointestinal pain. She had been taking PRILOSEC and took PEPTO-BISMOL but she threw it up. She was also taking Probiotics. She felt like her stomach is blown up and she woke up nauseous every morning.
Information has been received from a certified medical assistant concerning a patient who was vaccinated with a dose of ROTATEQ. The medical assistant reported the patient "spit up a dose of ROTATEQ". Additional information has been requested.
Severe tinnitus in both ears beginning shortly after first dose and continuing to this date.  difficulty sleeping and concentrating with this condition.  Prednisone burst has not affected the severity.  Able to sleep somewhat with 2  Gabapentin capsules.  Blood pressure under control with Ramipril.   Tried acupuncture with negative results.  I have seen many other reports of this side effect.
Information has been received from a physician concerning a patient (age and gender unknown), who, on an unspecified date was vaccinated with a dose of Gardasil. Subsequently, the patient fainted a few minutes after receiving the vaccination. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Noticed swelling/red "spot" around vaccine site on the night of 5/6; did not hurt or itch but was warm to the touch and about 2-3 inches diameter. By night of 5/7, "spot" was still swollen, slightly itchy (if shirt rubbed it too much), and still did not hurt but had spread to about 4 inches in diameter -- more ovular (longer horizontally than vertically).
This spontaneous report as received from a physician refers to a 15 months old female patient. On an unknown date the patient completed the oral ROTATEQ series in a timely fashion. There was no concomitant medication reported. On an unknown date the patient received a 4th dose of oral ROTATEQ at age 15 months. No adverse effect reported. The physician also reported that the patient also ate 1 bead of silica from a dessicant pack on the same date that she received the 4th dose. Additional information has been requested.
PATIENT STATED THAT APPROXIMATELY 6 HOURS AFTER RECEIVING HIS SECOND (IN THE SERIES) ANTHRAX VACCINATION OVER HIS RIGHT DELTOID, HE BEGAN TO EXPERIENCE HEADACHE, NAUSEA, MILD ABDOMINAL PAIN, LOW-GRADE FEVER, AND FATIGUE. HE SELF-MEDICATED WITH OVER-THE-COUNTER ALEVE, WHICH HE STATED DID HELP SOMEWHAT TO RELIEVE HIS SYMPTOMS. HE PRESENTED TO THIS CLINIC ON JANUARY 8TH, 2013, 2 DAYS POST-VACCINATION, WITH AN APPROXIMATELY 2" x 2.5" AREA OF ERYTHEMATOUS, DRY-APPEARING RASH THAT WAS NOT SOLID. PATIENT STATED HE WAS STILL EXPERIENCING THE OTHER SYMPTOMS AS WELL. HE STATED THAT THE RASH WAS NOT ITCHY, BUT WAS RATHER VERY PAINFUL TO TOUCH. PATIENT VITAL SIGNS WERE OBTAINED AND WERE AS FOLLOWS: BP 114/76, P52, R14, T98.0F ORALLY. PATIENT OTHERWISE STABLE WITH NO FURTHER COMPLAINTS. THIS CLINIC SENT PATIENT TO A LOCAL WALK-IN CLINIC FOR FURTHER EVALUATION BY A PHYSICIAN. MEDICAL DOCUMENTATION FROM VISIT WAS OBTAINED, AND PATIENT IS SCHEDULED TO FOLLOW-UP WITH ONE OF THIS CLINIC'S PHYSICIANS ON FEBRUARY 9TH, 2013. SINCE JANUARY 8, 2013, THREE ATTEMPTS TO CONTACT MEMBER FOR FOLLOW-UP BY PHONE HAVE BEEN UNSUCCESSFUL. MESSAGES LEFT FOR PATIENT TO RETURN CALLS THREE TIMES. WILL CONTINUE TO CALL AND LEAVE MESSAGES IF NECESSARY.
The patient had tightness of chest, rapid pulse, and tingling of the legs.  She was checked out by paramedics and released.
A consumer report has been received concerning a female patient.  Patient's concurrent diseases, concomitant medications and relevant history was not provided. On an unknown date, the patient received  FLUMIST QUADRIVALENT (intranasal), 0.2 mL. Patient reported that she was allergic to the flu shot (preferred term: allergy to vaccine). At the time of reporting, the outcome of the event of allergic to the flu shot was reported as unknown. Company physician assessed the event of allergic to the flu shot to be non-serious.
Nurse pulled vaccines to be given to patient after reviewing vaccines that were due. When she pulled them from the fridge she accidentally pulled HPV instead of IPV. Mistake was realized when she was charting vaccines that were given.  Nurse notified NP and state contact person was notified. Mother was called and notified of wrong vaccine given. Mother told to watch for adverse reactions.
Got abundant(6-8) cold sores in her mouth; Flu like symptoms; Sweating profusely; No appetite could only eat couple of bite; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), HYPERHIDROSIS (Sweating profusely), DECREASED APPETITE (No appetite could only eat couple of bite) and ORAL HERPES (Got abundant(6-8) cold sores in her mouth) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No medical history reported by the reporter.  Concomitant products included NAPROXEN for an unknown indication.   On 24-Apr-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) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), HYPERHIDROSIS (Sweating profusely) and DECREASED APPETITE (No appetite could only eat couple of bite). On 25-Apr-2021, the patient experienced ORAL HERPES (Got abundant(6-8) cold sores in her mouth). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), HYPERHIDROSIS (Sweating profusely), DECREASED APPETITE (No appetite could only eat couple of bite) and ORAL HERPES (Got abundant(6-8) cold sores in her mouth) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.
Nausea and vomiting 1 1/2 hours after receiving vaccines. Compazine 10mg stat and tid will follow injection site. Examined abdomen, lungs, heart.
red; warm; splotchy; itchy; sorenes; raised; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red), INJECTION SITE WARMTH (warm), VACCINATION SITE RASH (splotchy), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE PAIN (sorenes) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN, LUTEIN [XANTOFYL] and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 15-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 VACCINATION SITE ERYTHEMA (red), INJECTION SITE WARMTH (warm), VACCINATION SITE RASH (splotchy), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE PAIN (sorenes) and VACCINATION SITE INDURATION (raised). At the time of the report, VACCINATION SITE ERYTHEMA (red), INJECTION SITE WARMTH (warm), VACCINATION SITE RASH (splotchy), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE PAIN (sorenes) and VACCINATION SITE INDURATION (raised) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
not feeling well; Cough; My lungs feel like fine ,I can hold my breath for a long time .It is a kind of irrritation there.; Could not drink or eat anything; Vomited; when I close my eyes I was seeing weird stuff (people, monsters), it felt like I was hallucinating; Fever; Headache; Little of nausea; dry cough; feeling washed out; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (when I close my eyes I was seeing weird stuff (people, monsters), it felt like I was hallucinating) in a 54-year-old female patient who received mRNA-1273  for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 13-Mar-2021, the patient received first dose of mRNA-1273  (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced CHILLS (Chills). On 16-Mar-2021, the patient experienced HALLUCINATION (when I close my eyes I was seeing weird stuff (people, monsters), it felt like I was hallucinating) (seriousness criterion medically significant), COUGH (dry cough), ASTHENIA (feeling washed out), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Little of nausea). On 17-Mar-2021, the patient experienced DECREASED APPETITE (Could not drink or eat anything) and VOMITING (Vomited). On 19-Mar-2021, the patient experienced COUGH (Cough) and RESPIRATORY TRACT IRRITATION (My lungs feel like fine ,I can hold my breath for a long time .It is a kind of irrritation there.). On an unknown date, the patient experienced MALAISE (not feeling well). On 18-Mar-2021, VOMITING (Vomited) had not resolved. On 23-Mar-2021, CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Little of nausea) had resolved. At the time of the report, HALLUCINATION (when I close my eyes I was seeing weird stuff (people, monsters), it felt like I was hallucinating), MALAISE (not feeling well), DECREASED APPETITE (Could not drink or eat anything) and ASTHENIA (feeling washed out) outcome was unknown and COUGH (Cough), RESPIRATORY TRACT IRRITATION (My lungs feel like fine ,I can hold my breath for a long time .It is a kind of irrritation there.) and COUGH (dry cough) had not resolved.        The action taken with mRNA-1273 (Intramuscular) was unknown.       Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: Outcome of the events included nausea, headache, fever, chills were updated as recovered on 23-Mar-2021. Dry cough was added as new event.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
fever up to 104 for 24 hours and swelling in axilla on side where vaccine was administered
sick for 3 days after dose 2; days 1 and 2 fever of 102 degree F after dose 2; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick for 3 days after dose 2) and PYREXIA (days 1 and 2 fever of 102 degree F after dose 2) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 045B21A) for COVID-19 vaccination.     Concurrent medical conditions included Constipation (in October it was very serious and she started taking Miralax.). Concomitant products included MACROGOL 3350 (MIRALAX) for Constipation.   On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ILLNESS (sick for 3 days after dose 2) and PYREXIA (days 1 and 2 fever of 102 degree F after dose 2). In 2021, ILLNESS (sick for 3 days after dose 2) and PYREXIA (days 1 and 2 fever of 102 degree F after dose 2) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 102 degree fahrenheit (High) 102 degree Fahrenheit.         it was reported that the second dose was the worst. No concomitant medication details was provided.   This case was linked to MOD-2021-418177, MOD-2021-418186 (Patient Link).   Reporter did not allow further contact
Client c/o nausea immediately following the shot, headache 2 1/2 hrs after and dizziness 3 1/2 hrs after, felt fast heart rate which lasted for 15 mins, numbness (L) breast, had on 3 pillows last night. Did not take any meds. Is still c/o slight dizziness today. Patient recovering still c/o slight nausea and dizziness.
after getting vaccine in 10 days minor symptoms light eacthy rednees after 15 days getting severe allergyic reaction whole body spot eacthy readness when i each swelling whole body all body is severe eacthy    last time also happen same thing when i took second doose coming same allergic reaction its stay 6 month i am taken everyday medicine hardly after 6 month gone
vaccinated with a 2 dose series of Pfizer and reported he received an accidental 3rd dose of Moderna COVID-19; accidental, inadvertent administration of a dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (vaccinated with a 2 dose series of Pfizer and reported he received an accidental 3rd dose of Moderna COVID-19) and EXTRA DOSE ADMINISTERED (accidental, inadvertent administration of a dose of Moderna COVID-19 vaccine) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for Flu vaccination.    Previously administered products included for COVID-19 vaccination: Pfizer vaccine (Second dose) and Pfizer vaccine (First dose).   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (vaccinated with a 2 dose series of Pfizer and reported he received an accidental 3rd dose of Moderna COVID-19) and EXTRA DOSE ADMINISTERED (accidental, inadvertent administration of a dose of Moderna COVID-19 vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (vaccinated with a 2 dose series of Pfizer and reported he received an accidental 3rd dose of Moderna COVID-19) and EXTRA DOSE ADMINISTERED (accidental, inadvertent administration of a dose of Moderna COVID-19 vaccine) had resolved. Not Provided          Patient received an accidental third dose of Moderna COVID-19 vaccine when he was to receive Flu shot from his  pharmacy.he pharmacist realized the mistake aer administering the dose and proceeded to administer the Flu vaccine. No concomitant medications were reported. No treatment medications were mentioned.
I went to the ER on 3/9 and was diagnosed with Diverticulitis.  I was given some IV antibiotics and then at home antibiotics treatment for 10 days.  I developed further complications 3/24 and spent three nights in the hospital receiving IV antibiotics and fluids.  I'm back at home on another week long regimen of antibiotics.
Initially presented to emergency room with complaints of itching and burning of skin.  Was treated in the Emergency Room and released.  Patient then presented to the Emergency Room again in the early morning hours of 4/9/15 with complaints of malaise, shortness of breath and epigastric pain.
Immunocompromised patient got only a half shot (0.25ML); This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised patient got only a half shot (0.25ML)) 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.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. In August 2021, the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised patient got only a half shot (0.25ML)). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromised patient got only a half shot (0.25ML)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
Redness and swelling extending 4-6 inches around the injection site; hot to touch
Left arm became swollen, sore to touch pm of injection, next day swollen to elbow, red and more painful. Treated with Augmentin
Our patient had a flu shot on 10/25/02. On Sunday night, 10/27/02 she went out to eat for her meal. She ordered chili and a double cheeseburger. Later that evening she started throwing up. Patient said she vomited so much and so many times, patient felt she lost 8 pounds from all her vomiting. Our patient also developed some nasal congestion and a raspy sounding voice. She went to work on Monday, developed a fever which lasted for 24 hours. Tuesday patient felt better and returned to work. Patient wonders if this was allergic reaction or some type of reaction or if she is allergic to virus.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # L035510, expiry date: 13-MAY-2017, dose and site of administration not reported. Concomitant medications were not mentioned by the reporter. The ROTATEQ was stored at 33F for a time frame of 1 week. This temperature excursion was latter back in range. There was no previous temperature excursion reported. The call was a result of a data logger. No adverse effects reported. No additional information was provided. Product quality complaint was not filed. Additional information has been requested.
Pt. requested second series Maderna vaccination. Pt was given Pfizer as second dose. During the 15 minute observation period, the did not display and signs of discomfort or adverse reactions. Lead nurse notified pt. there are no contraindications if given both brands of vaccinations and to come back to get booster of her choice in 6 months.
No other AE was reported; A 7-month-old patient was mistakenly vaccinated with GARDASIL 9; This spontaneous report was received from an office manager concerning a 7-month-old male patient. The patient had no concurrent conditions and medical history, as well as concomitant medications.  On 29-JUL-2020, the patient was mistakenly vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (Lot No. R027946, expiration date 27-APR-2021) intramuscularly, once for prophylaxis (strength and dose were not provided).  combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R027946; expirationdate: 27-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Patient admitted as observation on 1/31/22 due to a closed compression fracture of body of L1 vertebra. Patient was tested for COVID-19 and was positive on 1/31/22.
This spontaneous report as received from a consumer refers to a currently 17-year-old female, who was the reporter's cousin in law's daughter. The patient's medical history and concurrent conditions were not reported. On an unknown dates, the patient was vaccinated with 3 doses of GARDASIL (doses, routes of administration, anatomical locations, lot# and exp. dates were not reported). Concomitant therapies were not reported. On an unknown date, reported as "several years ago", the patient was diagnosed with Postural Orthostatic Tachycardia Syndrome (POTS). History and details of the diagnosis were not specified. It was reported that the patient was athletic and was playing sports at the time her symptoms started. Since diagnosis the patient was unable to play sports and her activities were limited. The patient was visiting acupuncturist to help her with the symptoms. The outcome of the events was unknown. The relatedness between vaccination with GARDASIL and the events was unknown. Upon internal review, the event of being unable to play sports and limited activities was considered to be disabling. Additional information has been requested.