chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This study report as received from a principal investigator refers to an approximately 6 months male patient enrolled in a study for ROTATEQ (study name or protocol was not specified). On an unknown date the patient was vaccinated with ROTATEQ, dose 3 (route, indication and dates unspecified) (also reported as "the patient was in the control group"). On an unknown date in 2014 date the patient experienced a serious adverse event also reported as gastrointestinal problems. "The physician would not elaborate". The physician states the event was already listed in Prescribing Information and he was not sure if it is even reportable. He stated that he was in process of faxing the report to the company. Action take with study therapy was unknown. Patient's outcome was unknown. Upon internal review gastrointestinal problems was considered medically significant, since there was not sufficient information and the event was reported as a serious adverse event (SAE). Additional information has been requested.
Narrative: COVID infection following COVID vaccine series 06/23, Pfizer, dose #1 07/14, Pfizer, dose #2 12/28 COVID swab, result: detected 12/26 pt cc: chills, cough, fatigue, headache, myalgias, nausea, rhinorrhea, vomiting exposure: unknown 12/28 pt admit ED cc: "fever, cough, congestion, and body aches" dx: Covid 19, Covid 19 LOS: 1 day 12/28 CXR impression: No acute pulmonary finding. 1/5 clinically resolved
ARM SWELLING TRAVELED BELOW THE ELBOW AND MUSCLE PARALYSIS WITH TEMPERATURE OF 99.
Body aches, fever, chills, sweats, fatigue, dizzyness, loss of taste & smell (three days post vacinne)
This spontaneous prospective pregnancy report was received from a pharmacist refers to an unspecified number of female patients of unknown age. On an unknown date, the patients were vaccinated with a dose of PNEUMOVAX23, (lot number, expiry date and route was not reported) when pregnant. No symptoms reported and no adverse foetal outcomes reported. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
At the time of reaction, I was 10 weeks and 4 days pregnant, estimated deliver April 6, 2020.  Around 30 minutes after the shot, my arm became extremely swollen, red, itchy, and hard.  Around 6-7 hours later, my neck became extremely stiff and painful.  The pain was localized in my spine from between my shoulder blades up to the base of my head.  I could not move my neck or sit up because the pain and stiffness were so awful.  I continued to have these symptoms for two days.  On the third day (Monday September 18, 2019), the swelling mostly subsided and the redness disappeared.  The hardness on my arm was still present.  The stiffness in my neck went away at this point, but I am still currently experienced some pain in my neck.
Temp of 100.3, body chills, swollen injection site; received Tylenol
Information has been received from a registered nurse concerning a male patient, approximately 3 years old at the time of this report, who on 11/02/00 was vaccinated with a dose of MMR vaccine live (second generation) (lot number not given) and a dose of varicella virus vaccine live (lot # not given). On 12/3/99, 1/26/00 and 7/19/00, the patient was vaccinated with a first (lot #633792/1672J), second (lot #633793/1673J), and third (lot #636121/0497K) dose of hepatitis B vaccine recombinant (yeast). Concomitant therapy included diphtheria toxoid/ pertussis vaccine/teta (manufacturer unknown) and poliovirus vaccine (manufacturer unknown) given on unknown dates. The reporter stated that the patient had been vaccinated with several vaccines and developed autism. The reporter was questioning if thimerosal was in any of the vaccines given and when thimerosal free hepatitis B vaccine recombinant (yeast) was available in adolescent dosing. The reporter was uncomfortable giving any other information about the patient because the mother of the child is already upset. Unspecified medical attention was sought. Follow up information received from the registered nurse indicated that she had called the manufacturers for information on the thimerosal content contained in the normal childhood vaccines that children receive. The reporter further stated that regarding this case, they are not pinpointing the vaccines to be the cause of the child's autistic diagnosis. The patient's mother and physician were just curious to know the thimerosal content of the vaccines. The reporter did not feel comfortable releasing any further information on this child and stated that the mother of this child has enough to deal with at this time. Upon internal review, autism was determined to be an other important medical event. Additional information has been requested. Follow up info received from the registered nurse indicted that she had contacted the company only to "question thimerosal in vaccines." The reporter stated that the physician "does not want any further exploring of this matter." Additional info is not expected.
Pt received the Prevnar injection on 3/6/01. This is the only IZ she received. Tuesday night her left arm was bright red 3" X 2", warm to touch, hard and sore. After applying moist heat her arm began to look better on Saturday the 10th and on Monday the 12th, her arm just looked bruised.
This case was reported by a consumer and described the occurrence of autism in a male subject of unspecified age who was vaccinated with hepatitis B vaccine for prophylaxis. The reporter is the subject's mother. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Hepatitis B vaccine. At an unspecified time after vaccination with hepatitis B vaccine, the subject experienced autism. This case was assessed as medically serious (OMIC). At the time of reporting, the outcome of the event was unspecified.
Fatigue, loss of appetite, diarrhea, chills.  Began  20 hours after first vaccination  and lasted for 8 hours
This spontaneous report as received from an office manager refers to a 72 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 06-SEP-2016, the patient was vaccinated with the improperly stored dose of PNEUMOVAX 23 (lot # reported as M007769 with expiration date 27-JUN-2017; dose and route were not reported). No adverse effects were reported. The reporter also stated that the office was alerted on 16-SEP-2016, from Sanofi that shipment including PNEUMOVAX 23 vials were in transit too long. Additional information has been requested.
High pitched crying- required 1/2 hr to console repeated 11FEB91 & 13FEB91 1st convuls 19FEB91 w/o fever seen @ Hosp admitted 1MAR91 d/c 6MAR91 no conclusive test data for convuls;
fever to 106, stridor; probably a viral illness but onset of fever is w/in 24 hrs of immun;
Pt received 18 month shots  (DTap and Hep A) on 09/17/2018. On 09/18/2018 at 8pm, pt's father noticed swelling at the site of the shot accompanied with local redness. Swelling reached about the size of a palm. On 09/19/2018 pt's mother came in to have reaction checked.
No symptoms. Contacted by pediatrician 3 months later to Alert us to the wrong vaccine given.
This spontaneous report was received from a nurse (immunization official) concerning to an unspecified patients of unknown age and gender.  Medical history and concurrent conditions were not provided. On an unknown dates (from 01-MAR-2016 to an unspecified date), the patients were vaccinated with improperly stored doses (incorrect product storage ) of RECOMBIVAX HB lot # L025738, (the expiration date, dose and route were not reported) for prophylaxis. No adverse events reported at this time. The call was made by the data logger with a registered temperature of 10.3 °C during 107 hours and 30 minutes and there was no previous temperature excursion registered. This is one of three reports form the same reporter.   Additional information has been requested.; Sender's Comments:  US-009507513-1701USA004692: US-009507513-1612USA011665:
Severe reaction. Excessive vomiting and diarrhea, excessive body shaking and chills. Temp of 101. Extreme fatigue.
Pt vaccinated with DTP developed extreme irritability beginning about 8 hrs /p adm. of vaccine & lasting about 2 days.
After her vax, she had a little bit of bleeding. Then last night, on 12/23/20, my husband told me she had a large lump on her arm (size of a golf ball).  I can see the insert of where the needle was. It's like a big ring around the insert site. It's warm to touch as well.
Extreme dizziness. "Walking is dangerous" Started 2/13/2005, vaccinated on 2/11/2005. Instructed to seek medical attention. MD order for Yellow Fever Vaccination for travel overseas.
no adverse event reported by patient, no symptoms or signs. reporting that dose was given after 6 days after beyond use date and was stored in the refrigerator with average temperature of 38 degrees.
The evening of the received vaccination the patient developed tongue swelling and a low grade fever of 101F. The patient took Benadryl that night and felt better afterwards.
Immediately I got a headache. That night 101.5 temperature. I took Tylenol. Day 2 same thing except the headache was worse and nauseated Day 3 temperature down to 100.5 still headache and nausea Day 4 found a lump under my left arm and swelling by my underarm to my left breast. Temperature down to 99.5 , headache remained. Day 6  called my oncologist. Told me to change to 3 Advil?s three times daily.  Temperature leveled at 99.5 headache remained. I went for a COVID test on day 10 as per doctors suggestion.  I still had a headache and low grade fever.  The test was negative. On Day 12 all symptoms stopped
anaphylactic shock, causing choking on food, causing cardiac arrest, given three doses of epinephrine by paramedics, taken to hospital emergency and remains in a coma since 12/01/2022.
t101 ax, jerking & twitching lasted 15 min; wouldn't nurse; took to MD 29APR92; cried less than 3 hrs; pt given APAP;
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster) single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered", COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 and was treated with Paxlovid from 10Jul2022 and 14Jul2022. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache, fatigue, muscle pain, chills, joint pain, eyes irritation. The symptoms started yesterday night and I still have the symptoms.
Wheezing, couldn't breathe right. Lethargic - Finally went to ER. on 10/29/09. Developed pneumonia - Told Doc it was from flu shot - He didn't seem to care.
OUTSIDE THE RECOMMENDED 6 HOUR WINDOW PUNCTURED VACCINE WAS ADMINISTERED TO PATIENT (BUT VIAL WAS IN REFRIGERATOR); This spontaneous report received from a pharmacist concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-JUL-2021, the patient experienced outside the recommended 6 hour window punctured vaccine was administered to patient (but vial was in refrigerator). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of outside the recommended 6 hour window punctured vaccine was administered to patient (but vial was in refrigerator) was not reported. This report was non-serious.
This case was reported by a physician via call center representative and described the occurrence of fever in a 59-year-old male patient who received SHINGRIX for prophylaxis. On 25th June 2018, the patient received the 1st dose of SHINGRIX. On 29th June 2018, 4 days after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. The reporter considered the fever to be possibly related to SHINGRIX. Additional details were provided as follows: The patient's body temperature was found as 103 degree F. The call transferred to MI (medical information).
Patient was a 65yr old Male, received 1st dose of Pfizer 01/25/2021. Tested positive for Covid on 03-04-2021. Passed away on 03/21/2021
5 min after vaccine pt became diaphoretic, altered mental status, loud breathing, pallor, lasting about 5 min.  no seizure activity noted.
This case was reported by a consumer and described the occurrence of injection site pain in an adult female pt who received Lyme disease vaccine recombinant (LYMErix) for prophylaxis. A physician or other health care professional has not verified this report. The pt received her second injection of LYMErix on 4/9/99. The initial injection of LYMErix was administered on an unknown date. After receiving LYMErix, the pt experienced arm pain at injection site and entire upper arm which resolved after a few days.
illness and very very sick; Death; A spontaneous report was received from a lawyer concerning a 70 or 71-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who died following illness.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on an unspecified date. On an unknown date, approximately 24 hours prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) via an unknown route for prophylaxis of COVID-19 infection.  Within 24 hours, of vaccination the patient got very ill and sick and on the 4th day patient went to have a shower and found dead by patient's husband. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the event, illness and very sick was unknown. The patient died on 13 Mar 2021. The cause of death was unknown.  Plans for an autopsy were denied due to COVID-19 relation and are reporting to Moderna.  Autopsy was not performed.; Reporter's Comments: This is a case of death in an 70/71-year-old male subject with unknown medical history,  who was sick from day 1 and died on  day 4 after receiving first dose of vaccine. Very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
numbness in right fingers along with tingling.  moved to back of neck and side of face.  right side of face was completely numb.  began with tingling and then moved to numbness. right eye was blurred; numbness in right fingers along with tingling.  moved to back of neck and side of face.  right side of face was completely numb.  began with tingling and then moved to numbness. right eye was blurred; numbness in right fingers along with tingling.  moved to back of neck and side of face.  right side of face was completely numb.  began with tingling and then moved to numbness. right eye was blurred; This is a spontaneous report from a contactable healthcare professional. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL01284, expiry date not reported), via an unspecified route of administration in the right arm on 31Dec2020 10:15 at single dose for COVID-19 immunisation. Medical history included pituitary tumor/prolactinoma. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Patient was not pregnant at the time of vaccination. Concomitant medications were none. On 31Dec2020 at 10:45, the patient experienced numbness in right fingers along with tingling. The patient moved to back of neck and side of face. The right side of face was completely numb. It began with tingling and then moved to numbness. Her right eye was blurred for short period. No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovered on an unspecified date.
Severe, sharp abdominal pain, nausea, fainting, extreme low blood pressure.
Approximately 2 am on 01-26-02, pt reported swelling, redness and heat at injection site. also reported large knot at injection site, c/o pain from shoulder to fingers and difficulty moving arm, these symptoms involved (R) arm. pt saw ER physician 1-28-2 and prescibed keflex due to "infection at injection site", saw PMD 1-30-02 and advised no more pneumonia shots.
This spontaneous report as received from a registered nurse refers to her daughter: a 11 year old female patient. The patient's medical history included adenotonsillectomy and respiratory syncytial virus. No drug reactions/allergies. On 23-MAY-2013 the patient was vaccinated with her first dose of GARDASIL, in right deltoid (lot number not provided). Other suspect therapies included VARIVAX (Merck) in right deltoid, Tdap in left deltoid and an unspecified meningitis vaccine (manufacturer unknown) in left deltoid (lot numbers not provided). There were no concomitant medication. On 23-MAY-2013, the patient received her first dose of GARDASIL and immediately developed tonic clonic movements and passed out for ten seconds. Right before the patient received the 3 other vaccines. The physician recommended for the patient to get something to eat and drink after the patient passed out. The nurse reports her daughter is better and went to school afterwards. The outcome of passed out for 10 seconds and tonic clonic movements was reported as recovered on 23-MAY-2013. Passed out for 10 seconds was determined medically significant upon internal review. The relatedness for passed out for 10 seconds and tonic clonic movements was not reported for the suspect therapies. Additional information has been requested.
Developed indigestion symptoms (stomach aches, vomiting) over night, hospitalized with small bowel obstruction on March 20,  2021,  ended up having  bowel resection surgery March 29th.    No previous history of bowel obstructions or digestive issues.
Pt developed significant arm swelling overnight and said area felt hot and was nauseous. advised to seek acute care
Patient was given MMR vaccination 1/21/04.  History of reaction to aspirin and unknown injection.  Fifteen minutes after vaccine was given, patient complained of dizziness.  BP 200/120.  Patient given Nitro and was then transported to ER by paramedics.
Chills; This is a spontaneous report from a contactable consumer (patient) reported in response to Non-HCP letter via follow-up letter. This case was split to capture events after first and second dose of vaccine. This is the first of two reports, reflecting events after the 2nd dose.  A 62-years-old patient of an unspecified gender received BNT162b2 (PFIZER/BIONTECH COVID-19 VACCINE, Solution for injection, Lot No: FA7845), via intramuscular, administered in Arm Left on 25Jul2021, 12:08 as 2nddose, single for covid-19 immunisation (Age at vaccination was 62 years). Historical vaccine was a 62-years-old patient of an unspecified gender received BNT162b2 (PFIZER/BIONTECH COVID-19 VACCINE, Solution for injection, Lot No: EW0198), via intramuscular, administered in Arm Left on 04Jul2021, 11:40 AM as 1stdose, single for covid-19 immunisation with events of muscle pain in the raise arm, vaccine received within 4 weeks PRIOR: AstraZeneca. Medical history included hyperlipidaemia from 2005 and ongoing, hypertension from 2005 and ongoing. Concomitant medication(s) included amlodipine besilate, hydrochlorothiazide, valsartan (EXFORGE HCT) taken for hypertension from an unspecified start date and ongoing; pitavastatin (PITAVASTATIN) taken for hyperlipidaemia from an unspecified start date and ongoing. The patient experienced chills on 28Jul2021 10:00. Relevant tests where no. Treatment was received. Upon follow-Up on 01Sep2021Follow-up attempts are completed. No further information is expected. Outcome of the event was recovered on same day.  Follow-Up (01Sep2021): Follow-up attempts are completed. No further information is expected.
19AUG93 temp went to 104.2 p/giving APAP didn't come down @ all until p/a dose of advil; 20AUG93 temp still running 102-103;
Giant hives to face bilateral arms, chest, and trunk after injection. No SOB. VSS. Given Benedryl 50mg PO. Information given to DOH for allergist consult for 2nd dose.
Chronic Spontaneous Urticaria and Dermatographia all over body after COVID-19 1st  Booster Vaccine. Have been taking Allegra everyday (1-1.5 doses) everyday since it started with no progress in symptoms decreasing. On a low histamine diet. Still get breakthrough hives even when on Allegra. Also have stomach pain, lightheadedness, deep pauses in breathing (feeling like my heart stops for a second), fatigue, headaches.
Scheduled c-Section delivery on 10/7/2021. Hospital admission within 6 weeks of receiving the COVID vaccine.
This initial spontaneous case, was received on 02-Oct-2017, from a pharmacist, concerning a 70-year-old elderly female patient. The patient's current conditions included: CVA (cerebrovascular accident), memory changes, diabetes, hypertension, hypothyroidism, osteoarthritis, dementia and Urge Incontinence. Concomitant medications included: acetaminophen, albuterol sulfate nebulize solution, PROAIR inhaler, amlodipine, ASA, atorvastatin, citalopram, vitamin B 12, VOLTAREN Gel, donepezil, fexofenadine, fluticasone, levothyroxine, TRADJENTA, losartan, meclizine, NAMENDA, MYRBETRIQ, multivitamin, Vision Plus Lutein vitamin, ALEVE, Omeprazole, Promethazine with codeine, OCUVITE and vitamin B complex for unknown indications. On 02-Oct-2017, the patient was administered with the FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 178701, expiry date: Apr-2018). It was reported that the patient was administered with the PFS vaccine that was stored in 54 F up to 120 hours excursion time (explicitly coded as incorrect product storage and drug administration error). No adverse events were reported. The reporter assessed the event as non-serious. Non-significant case correction received 02-OCT-2017: The verbatim of the event drug administration error "Up to 120 hour excursion time, max temp reached of 54F. 2 doses administered" was corrected.
Feeling hot; Headache; Body aches; Low grade fever; Chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Feeling hot), HEADACHE (Headache), MYALGIA (Body aches), PYREXIA (Low grade fever) and CHILLS (Chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Feeling hot), HEADACHE (Headache), MYALGIA (Body aches), PYREXIA (Low grade fever) and CHILLS (Chills). At the time of the report, FEELING HOT (Feeling hot), HEADACHE (Headache), MYALGIA (Body aches), PYREXIA (Low grade fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.; Reporter's Comments: N/A; Sender's Comments: N/A