chrisvoncsefalvay/vaers-outcomes huggingface dataset:
RECEIVED VACCINE ON 11/8/21 1) 11/10/21: TWO KNOTS  CAME UP ON LEFT LEG ACCOMPANIED BY SEVERE ITCHING 2) 11/11/21: WHOLE BODY INFLICTED WITH SEVERE PAIN AND ITCHING 3) FINGERS BURNING AND ITCHING 4) 11/15/21: PAIN SO SEVERE I WENT TO E.R. A PRESCRIPTION FOR A MEDROL DOSE PACK WAS WRITTEN. 5) 11/16/21: PAIN STILL SEVERE SO I WENT TO MEDICAL. TORODOL AND DEPO MEDROL INJECTION WAS GIVEN WITH A PRESCRIPTION FOR PREDNISONE. 6) OUTCOME: BODY STILL IN SEVERE PAIN. TOES CAN'T STAND TO TOUCH A BED SHEET. FINGERS AND TOES BURNING LIKE FIRE. ALL JOINTS PAINFUL AT A LEVEL 10. CAN'T STAND TO WALK ON FEET.  7) TREATMENTS: USING ASPERCREAM, CORTIZONE CREAM,  BENADRYL, TYLENOL, IBUPROFEN, FLEXERIL, METHOCARBOMOL,  8) RESULTS: NOTHING IS BEING FIXED. BODY STILL IN SEVERE PAIN MINUS THE ITCHING. PAIN IS UNBEARABLE TO THE POINT I'VE CONSIDERED SUICIDE. PAIN IS NOT SUBSIDING AFTER 8 DAYS. STILL HURTING PRESENTLY.
Fever; chills; sweating; Light-headed; Unwell for 24 hours; This is a spontaneous report from a non-contactable consumer, the patient. A 25-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Er8737) via an unspecified route of administration in the left arm on 31Mar2021 at 18:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6208) via an unspecified route of administration in the left arm on 12Mar2021 at 02:45 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 01Apr2021, the patient experienced fever, chills, sweating, light-headed, and unwell for 24 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for events. The clinical outcome of the event fever, chills, sweating, and light-headedness was recovering. The clinical outcome of the event unwell for 24 hours was recovered on 02Apr2021.   No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: updated Patient Country, updated administration time of first dose of BNT162b2 from 12Mar2021 at 14:45 to 12Mar2021 at 02:45 in narrative.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 73-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at that time. No adverse event was reported. Treatment information was not provided.
warmth at the side of the injection site in her left arm; itching at the side of the injection site in her left arm; redness at the side of the injection site in her left arm; swelling at the side of the injection site in her left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warmth at the side of the injection site in her left arm), VACCINATION SITE PRURITUS (itching at the side of the injection site in her left arm), VACCINATION SITE ERYTHEMA (redness at the side of the injection site in her left arm) and VACCINATION SITE SWELLING (swelling at the side of the injection site in her left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced VACCINATION SITE WARMTH (warmth at the side of the injection site in her left arm), VACCINATION SITE PRURITUS (itching at the side of the injection site in her left arm), VACCINATION SITE ERYTHEMA (redness at the side of the injection site in her left arm) and VACCINATION SITE SWELLING (swelling at the side of the injection site in her left arm). At the time of the report, VACCINATION SITE WARMTH (warmth at the side of the injection site in her left arm), VACCINATION SITE PRURITUS (itching at the side of the injection site in her left arm), VACCINATION SITE ERYTHEMA (redness at the side of the injection site in her left arm) and VACCINATION SITE SWELLING (swelling at the side of the injection site in her left arm) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  No relevant concomitant medications were reported.   Treatment information was not provided.
Patient reports a 10/10 pain radiating from deltiod down entire length of left brachium. Patient also reports decreased range of motion of left arm.
Tdap (Boostrix) dose for ages 10 and up given to 6 y/o child. No signs, symptoms, or adverse events reported at this time.
post-herpetic neuralgia; herpes zoster; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or about 12-MAY-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, and lot # not provided) for long-term prevention of shingles and zoster-related conditions.         Subsequently, as a direct result of zoster vaccine live (ZOSTAVAX) use, the patient was treated for herpes zoster and post herpetic neuralgia. At the time of the report, the patient's outcome was unknown.
6-8x vomiting and diarrhea with increased irritability every time received immunizations (within 24-48 hours).
no longer wanted cigarettes, quit smoking; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (no longer wanted cigarettes, quit smoking) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059E21A and 061E21A) for COVID-19 vaccination.     The patient's past medical history included Smoker (smoking for 40 years).   On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (no longer wanted cigarettes, quit smoking). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (no longer wanted cigarettes, quit smoking) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment informations were reported.
fever of 104 F; dizzy; my arm was so sore I could not lift it/ My body ached mostly in my legs and lower back; felt soreness at the injection site; felt extremely nauseated; My body ached mostly in my legs and lower back; Body aches/extreme tiredness; headache; This is a spontaneous report from a non-contactable consumer (patient).  A 30-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 07Jan2021 at 09:45 at single dose in left arm for COVID-19 immunisation at the age of 30-year-old. Lot number was EJ1686. Medical history and concomitant medications were unknown. Historical vaccination included flu vaccine for immunization (vaccination site pain). About 6 hrs after vaccine on 07Jan2121, the patient felt soreness at the injection site, very similar to the flu vaccine. About 12Hours post vaccine on 07Jan2021, arm was so sore that the patient could not lift it. That night the patient took two Tylenol and had to wrap arm in a heating pad. The patient woke up around at 03:00 on 08Jan2021 with a fever of 104 F; the patient was so dizzy from the high fever. The patient felt extremely nauseated on 07Jan2021. Body ached mostly in my legs and lower back on 07Jan2021. It hurt to sit on the toilet, to put on clothes. On 07Jan2021, the patient experienced body aches/extreme tiredness. On 07Jan2021, the patient experienced headache 8as reported). Fevers happened at night-time ranging from 102-104F for 4 days. Injection site soreness lasted for 7 days. Body aches/extreme tiredness lasted around 2-3 days. Dizziness subsided after fever broke, but it was replaced with a severe headache lasting 2 days (as reported). The patient was not COVID tested post vaccination. The patient recovered from the events. No follow-up attempts are possible. No further information is expected.
Booster dose was given 3 months after series completion when should have been given at 5 months.
In April, 1999, the pt received her first injection of Lymerix, with no side effects. In May, 1999, she received the second dose and the frequency of her arthralgias seemed to lessen. Approximately 5 months later, October, 1999, he arthralgias increased, and she went to a rheumatologist. She was found to have an elevated erythrocyte sedimentation rate, and on 10/25/1999 was diagnosed with Waldenstroms macroglobulinomia. She was hospitalized in late November 1999 and received chemotherapy for one week. She again was hospitalized on 1/7/00 and received another week of chemotherapy.  The information received on 4/27/00 provides no further information.
O2 saturations is getting low; Fever; Chills; Muscle aches and pain; Nausea; Fatigue; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced saturations was getting low, fever, chills, muscle aches and pain, nausea, fatigue.  The patient's medical history included COVID-19, eight months ago. No relevant concomitant medications were reported.  On 04 Mar 2021, at 10:30 am and 10-11 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot: 029A21A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 04 Mar 2021, the patient started covid-19 like symptoms fatigue, muscle aches and pain, chills, nausea, fever, and his oxygen saturations was getting low at 93 percent. No treatment information was provided.  The seriousness criterion for the event his oxygen saturations was getting low was medically significant.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events, saturations was getting low, fever, chills, muscle aches and pain, nausea, fatigue was unknown.  The reporter did not provide an assessment for the events saturations is getting low, fever, chills, muscle aches and pain, nausea, fatigue; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events 10-11 hours after vaccination, a causal relationship cannot be excluded. Further information has been requested
Received Hep B #1 of series on 09/12/2005. RTC 09/14/2005 with rash and itch.
ADVERSE EVENT; This spontaneous report received from a patient via a company representative 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 admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified adverse event was not reported. This report was non-serious.
pt reports became ill 4NOV96 w/body aches, neck, shoulder pain, unable to walk unaided, double vision, watery, puffy eyes;
fever, tachycardia, PACs. Tachycardia to 160s. Fever to 39C.
This spontaneous case reported by a consumer, describes the occurrence of rosacea (purplish spots on face) and fatigue (extreme fatigue) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. It was reported the patient declined providing information on pre-existing condition and allergy. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced rosacea (purplish spots on face) and fatigue (extreme fatigue). At the time of the report, rosacea (purplish spots on face) and fatigue (extreme fatigue) outcome: unknown. No concomitant medication or treatment information provided. The patient received a booster dose.  The caller declined to provide contact information when agent tried to clarify few times. She said she was angry with her current side effects. No further contact allowed.
headache; neck pain; blurry vision; This case was reported by a pharmacist via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced headache, neck pain and blurred vision. On an unknown date, the outcome of the headache, neck pain and blurred vision were recovered/resolved.   It was unknown if the reporter considered the headache, neck pain and blurred vision to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had first dose of Shingrix on an unknown date and experienced headache, neck pain and blurry vision all of which had resolved.   No further details were available. It was reported that the patient had first dose at a different pharmacy.
her arm is red; arm started itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (arm started itching) and ERYTHEMA (her arm is red) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PRURITUS (arm started itching). On an unknown date, the patient experienced ERYTHEMA (her arm is red). At the time of the report, PRURITUS (arm started itching) and ERYTHEMA (her arm is red) outcome was unknown.            treatment medication include calamine lotion, Benadryl no concomitant medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: contact  information was updated
approx 7 hrs p/vax pt exp t104, irritable, screaming, swollen, tender, ecchymosis area where shot was administered;
rt arm swollen, hot, red shoulder to below elbow;no fever;started small mild rxn-gradually spread;
Pt. c/o of feeling Lightheaded, Pt. vitals as follows: @ 12:41 pm B/P  130/70 HR   100 R        17 02      99%  @ 12:56 pm Pt. was re- accessed , vitals as follows: B/P    120/68 HR      98 R          16 02       98% on RA Pt. stated she felt better , left with her mom in stable condition. Pt's mom was advised to call Pcp if any new or worsening symptoms occur.
Patient developed a knot at the site of injection that turned into itching around injections site and spread to her back. it lasted for about a week, then self resolved.
Passed out while checking out/paying at counter - nurses had me sit in chair and gave me ginger ale and crackers until I regained strength.
11/14/02 19:30 Client had a fever and seizure. Temperature 103. Parents called 911 and took her to ER. She was given an IV medicine to reduce fever. Client was discharged 3 hours later at 22:30.
Initial unsolicited report received from the literature on 18-Apr-2016.  This case involves 31-year-old male patient who was vaccinated with intramuscular injection of Influenza vaccine quadrivalent (batch number, dose, dose in series and site of administration were not reported) on an unspecified date. The patient had no significant medical history, no known risk factors and concomitant medications were not reported. On an unspecified date, 12 weeks after the vaccination, the patient experienced severe myalgia, low grade fever, headache, cough and on an unspecified date, patient also experienced abdominal cramps, right lower quadrant abdominal pain and moderate bloody diarrhea. It was a case of vaccination failure. On an unspecified date, the patient was hospitalized. Laboratory investigations included hemoglobin 11.5 g/dL, leukocyte count 10,500 /mm3 and borderline low potassium level 3.7 mmol/L. Abdominopelvic CT scan showed moderately severe right sided colitis. Bacterial cultures of stool, stool examination for ova and parasites and polymerase chain reaction assay for C. difficile toxin did not reveal enteric pathogens. A rapid diagnostic test showed positive influenza A. patient had received oseltamivir 75 mg orally twice daily for influenza A as a corrective treatment. On an unspecified date, patient recovered from the events with conservative therapy including discontinuation of oseltamivir at the onset of abdominal symptoms, IV hydration and electrolyte repletion. On an unknown date, patient was discharged 5 days after the hospitalization. Documents held by sender: Yes. Sender's Comments: As with any vaccine, vaccination with INFLUENZA QUADRIVAL A-B VACCINE may not protect all recipients. A 31 years old patient experienced influenza type A, 12 weeks after vaccination with INFLUENZA QUADRIVAL A-B VACCINE. Patient was treated with oseltamivir and two days later patient experienced ischemic colitis. In this particular case, Vaccination Failure for INFLUENZA QUADRIVAL A-B VACCINE leading to the event influenza type A cannot be ruled out, whereas, the causality for Ischemic colitis can be ruled out, because Ischemic colitis is more likely due to treatment with oseltamivir. As the symptoms of Ischemic colitis improved rapidly on discontinuation of Oseltamivir along with conservative therapy.
Within 24 hours after the 2nd dose, I developed chills, fever and fatigue. For the next two weeks I experienced severe heart palpitation. I had an eye exam and the doctor noticed the vision in my right eye had decreased so they took my BP which had become very high. They suggested I go to the ER. I went to my PCP who also took so test and they confirmed my BP was extremely high.
Evening  Feb. 15,  chills, fever,  muscle aches, and headache and exhaustion.  Night sweats with temp.  up  to  101.8.   Day temps 99 to 100.  Have lasted  to the present time.   Treatment fluids and aspirin.  Chest x-ray and urinalysis clear.  Covid nasal test yesterday, Feb.23.  The second Pfizer vaccine scheduled for today, Feb. 24, was cancelled.
This spontaneous report as received from a consumer refers to a patient of unknown age and gender. Information regarding the patient medical history, concomitant medications, drug allergies or reactions  was not provided.  In August 2021 the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) 1 dosage form for prophylaxis (strength, frequency, administration route, lot number and expiry date were not provided.  On an unknown date, the patient missed her/his second dose (product dose omission issue). The patient would speak of the event with the physician.
I95.9 HYPOTENSION 4/26/2023 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 17-JUL-2013 the patient was vaccinated with ZOSTAVAX (lot # J001700, expiration date 08-MAY-2014) injection, subcutaneous. On an unknown date the patient experienced injection site reaction after receiving ZOSTAVAX that was described to be like a "big welt or target" that itched but was not reported to have been a rash. The pharmacist stated that three patients experienced similar reactions. The outcome of injection site reaction and injection site itching was unknown. The causality was unknown. This is one of several reports from the same source (MARRS 1308USA010306, 1308USA010307 and 1308USA010308). Additional information has been requested.