chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a register nurse refers to a 2 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 21-JAN-2014, the patient was vaccinated with dose 1 of ROTATEQ lot # J007283; expiration date: 27-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccines improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degree F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperature for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64/8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
POSSIBLE CELLULITIS WITH LARGE AREA OF REDNESS/WARMTH/TENDERNESS OVER ENTIRE AREA OF DELTOID MUSCLE. NO OPENING OR DRAINAGE SEEN. 2" LONG BRUISE AT BICEP NOTICED NOT LONG AFTER VACCINE PER PATIENT.
1/12/11 AM - pain on medial aspect of left arm PM - pain, tenderness, redness on medial aspect of left arm feverish, goose bump - warm compress done by patient slight chest tightness brief in duration 1/13/11 redness started to fade but a little itchy. 1/14/11 slight pain & tenderness on medial aspect of left arm.
approx 5hr p/vax pt started crying as if severe pain, pulling legs up to stomach-had fever of 104;got sore in mouth;crying lasted approx 5hr;fever & sores lasted a few days;
Severe chest pain, diagnosed as Pericarditis.  No prior history, no prior surgeries, no risk factors, no illnesses. In addition, patient is very healthy, has never had COVID, he is provided free COVID tests and work, has tested negative regularly for months, gets him temperature taken at work every day before entering.
Information has been received from a registered nurse concerning an 18 year old female with seasonal allergies to clindamycin and Penicillin, who on 11/15/06 was vaccinated SC in the back of her left arm with a second dose of MMR II (lot 654820/1027F). There was no concomitant medication. The pt went home, and 45 minutes after vaccination she experienced breathing difficulty. The pts parents immediately took her to the ER and she was treated with epinephrine, prednisone and oral Benadryl. The pt was given Epi Pen to take home with her. It was reported that the pt was in the ER for hours but was not hospitalized, and she was told to follow up with an allergist. The pt received her first dose of MMR II in 1989 and to the nurses knowledge, did not have nay adverse effects after that vaccination. Subsequently, the pt came in for an office visit and is better now and has recovered. There was no product quality complaint involved. The reporter considered the pts breathing difficulty to be an other important medical event (OMIC), disabling and life threatening. A lot check was requested.
Menquadfi was ordered for patient but pt received MMRV, parent's never reported any adverse events. This error was not know till now.
Pt recvd flu vax 15OCT92 & 16-18OCT pt had minor pain in legs; 19-20OCT pt in bed 18 hrs extreme fatigue, exhaustion, weakness, t98, muscle aching; 26OCT seen by MD had lung xray & EKG; 2NOV felt normal;
Doctor diagnosed potential pericarditis; This is a spontaneous report from a non-contactable consumer or other non hcp via a sales representative. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine concluded bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at dose 1, single for covid-19 immunization. Patient was diagnosed with potential pericarditis (medically significant) on an unspecified date. Patient went to emergency room about two weeks post second covid vaccine dose. Event took place after use of product. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
This spontaneous report was received from the office manager and refers to multiple unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medication were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ lot # M014544, expiration date 27-NOV-2017; lot # M007125, expiration date 06-OCT-2017; lot #M007301, expiration date 19-NOV-2017, administered orally (dose was not reported) for prophylaxis, which were exposed to temperature excursion, a total time in the range of 47°Fahrenheit (F) to 77°F (48F), for a time frame of 8 hours. There was a previous temperature excursion, the total time in the range 47°F to 77°F (55F) for 8 hours. There was no data logger. No adverse effects reported. No product quality complaint was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Dizziness, Headache, Myalgia, Arthralgia, Fever, SkinRash, UrticariaPruritus, Erythema, decreased appetite, paresthesia in gums and teeth Narrative:
suspected vaccination failure; pneumonia; shingles; exacerbation of asthma; This case was reported by a pharmacist via sales rep and described the occurrence of suspected vaccination failure in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st November 2019, the patient received Shingrix .5 ml. On an unknown date, 1 month after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), pneumonia (serious criteria GSK medically significant), shingles and asthma. The patient was treated with valaciclovir hydrochloride (Valtrex) and azithromycin (Z-Pak). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the pneumonia, shingles and asthma were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, pneumonia, shingles and asthma to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received shingrix and in end of November or December 2019, 1 month later developed shingles, pneumonia, exacebation of asthama. The patient was treated with Valtrex and z-pak. The reporter mentioned that events were resolved. This case was considered as suspected vaccination failure as details regarding vaccination schedule and laboratory confirmation were unknown at the time of reporting.
Patient felt dizzy and fainted. According to his mother, patient has anxiety problems, which has  caused fainting before. Patient never had problem with flu shot. Patient received soda from his mom and felt better afterwards.
Eleven hours after injection I developed all-over body aches and chills--intense shivering for about an hour. Extreme fatigue the following day wherein I slept for four hours in the afternoon. About 55 hours after injection I developed hives on my neck and chest which lasted about 15 hours.
This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date it was reported that the patient experienced pain in the arm after the 1st dose of vaccine. Outcome of the event was unknown.  Information on Lot/Batch number has been requested.
Hives appeared on upper body, arms, face, shoulders & chest 9 days after injection. I put Benadryl lotion for itching. Hives gone the next morning but reappeared 2days later, although not nearly as severe.
Pt recv vax on 10/22/98; on 10/24/98 pt exp joint aches (elbow, shoulder, hip)
Menstrual cycle arrived a week early (2 days after booster) with very heavy bleeding.
Headaches; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headaches) in a male patient of an unknown age 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 17-May-2021, the patient experienced HEADACHE (Headaches). At the time of the report, HEADACHE (Headaches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported.  No treatment information provided.
This male subject was enrolled in the prophylactic study. On 5/15/2006, he received the 1st dose of combined haemophilus influenzae type B vaccine and meningitis C and Y vaccine conjugated on tetanus toxoid (Hib MenCY TT, IM R upper thigh, combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated polio vaccine Pediarix, IM L upper thigh, and pneumococcal vaccine Prevnar, IM L lower thigh. This subject received lot DMEHA010A of Hib MenCY TT. On 5/15/2006 the day he received the 1st dose of Hib MenCY TT, the 1st dose of Pediarix and the 1st dose of Prevnar, this two month subject developed pyrexia. On 5/16/2006, lat test showed increased white blood cells 21,500 and the subject was hospitalized. Urine analysis was normal. The subject was treated with ceftriaxone. The events resolved on 5/17/2006 and the subject was discharged. The investigator considered that there was a reasonable possibility that the fever and increased white blood cells may have been caused by Hib MenCY TT, Pediarix and pneumococcal vaccines.
Pfizer-BioNTech COVID-19 Vaccine EUA Fever up to 101.0 degrees Fahrenheit for several hours, which reduced with Tylenol and ibuprofen.
This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. On 12-MAY-2015 the patient was vaccinated with (Oka/Merck) VARIVAX (lot # K016131 with expiration date: 23-SEP-2016, dose 0.5 ml, administered subcutaneously) which had undergone supported excursion. No adverse effects were noted. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 12-NOV-2013, the patient was vaccinated with PROQUAD (Merck) (dose strength and route was not reported) (lot # J004319 and expiry date: 17-OCT-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting PROQUAD (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for PROQUAD (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Feeling very heavy dizziness; wave in my head like dizziness in vision; light headed; Affects diabetes; my sugar is high; This is a spontaneous report from a contactable consumer (patient). A 59-year-old patient of an unspecified gender received bnt162b2 (manufacture: unspecified, formulation: solution for injection; Batch/Lot Number: FA6780; NDC number, UPC number and Expiry Date: unknown), dose 1 via an unspecified route of administration on 01Jul2021 as dose 1, single for covid-19 immunisation. Medical history included thyroid (when probed for any concomitant medication, consumer stated, "Thyroid medication") from an unknown date and unknown if ongoing and ongoing diabetes from an unknown date. The patient's concomitant medications were not reported. The patient got the first shot yesterday on 01Jul2021 and after that patient felt very heavy dizziness today and the sugar was high, high that affected diabetes and patient had lightheaded. They told to know at the Pharmacy, wave in the head like dizziness in vision. This shot affects diabetes like and said the sugar was high. Patient was all set, this was too much will call the doctor. The patient underwent lab test blood glucose which was increased on 01Jul2021. The outcome of the events was unknown. When asked for any treatment for the event, consumer stated, no the only I had done with, my insulin for my blood sugar. The outcome of the events was unknown.
Immediately developed severe headache lasting 24hrs through night prevent sleep Developed significant body aches and some tingling in extremities x 24hrs Chills x24hrs
On 3/5/00, awoke with swollen digits in left hand (shot was left arm). Also noted paresthesias in all fingertips left hand. Symptoms resolved spontaneously within 2 hours. No other vaccine given in left arm.
Headache; fatigue; pain from my left side into my stomach that lasted about 3 days; Severe joint pain that is going on 9 days; This is a spontaneous report from a non-contactable consumer or other non hcp. A 42-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6202), via an unspecified route of administration, administered in Arm Left on 06Mar2021 (age at vaccination:42-Years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Patient didn't had COVID-19 prior to vaccination, patient didn't receive other vaccines within 4 weeks prior to vaccination, patient had received other medications was Victoza, Jardiance, Naproxen and Fenofibrate within 2 weeks of vaccination. The patient medical history was not reported. Concomitant medications included liraglutide (VICTOZA) taken for an unspecified indication, start and stop date were not reported; empagliflozin (JARDIANCE) taken for an unspecified indication, start and stop date were not reported; naproxen (NAPROXEN) taken for an unspecified indication, start and stop date were not reported; fenofibrate (FENOFIBRATE) taken for an unspecified indication, start and stop date were not reported. On 06Mar2021 the patient experienced headache, fatigue, pain from my left side into my stomach that lasted about 3 days, severe joint pain that is going on 9 days. Patient had Emergency room visit for the events. No Therapeutic measures were taken for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 13Mar2021. The outcome of the events headache, fatigue, pain, arthralgia was not recovered.  No follow-up attempts are possible. No further information is expected.
Pt had edema of the eyes, clear rhinorrhea, itchy skin with no rash, sneezing.
pt received  3rd booster shot of Pfizer on 10/28/21. She wad admitted inpatient on 11/3/21 for acute respiratory distress secondary to angioedema and aspiration pneumonia. She was also taking Benazepril which could cause angioedema and had been on it for years w/o issues. however concern as it was a few days prior to her receiving booster.
Achy; Don't feel good; Chills; Body aches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), FEELING ABNORMAL (Don't feel good), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (Headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21B) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Achy), FEELING ABNORMAL (Don't feel good), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (Headache). At the time of the report, PAIN (Achy), FEELING ABNORMAL (Don't feel good), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (Headache) outcome was unknown.            Treatment information not provided.  Concomitant medications not provided   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2022: Follow-up document received contains No new information.
family reported while on couch drinking soda p/fight w/relative, fell back eyes rolled up in head & had poor color;aunt slapped pt back, gave a couple of rescue breaths  limp & didn't seem to have effective breathing, choked, gasped & crie
Patient called on 09/27/09 and said swelling on arm, face and allergic reaction since 09/26/09. Pt was given BENADRYL AND TYLENOL and the symptoms cured.
Initial information received on 18 February 2009 from a health care professional. A 49 year old male patient received FLUZONE (lot number U2761AA) intramuscularly in the left deltoid in August 2008. Two days post vaccination the patient's two index fingers, whole hand, and arm "went dead". He was unable to grasp and complained of numbness and pain. He was seen by a neurologist, details not provided. The patient was not recovered at the time of the report. List of Documents held by Sender: none.
Information has been received from a 67 year old male surgeon with asthma and hypertension who on 12/4/98 was vaccinated in the deltoid with the first dose of hep A virus vaccine inactivated (626422/0603M). On 7/11/99 the surgeon was vaccinated in the deltoid with the second dose of hep A virus vaccine inactivated (627357/0888H). There were no illnesses at the time of the vaccinations. On 9/25/01 a hep A IgM antibody test yielded negative results. On that same day, high lab values were also yielded for cholesterol 312 and triglycerides 1191. The surgeon reported that he had no apparent immunity and no hep A antibodies. Subsequently, the surgeon recovered. The pt also experienced a similar event after vaccination with hep B vaccine (WAES0204USA02495) and also reported that other members of his family also had no measurable antibodies after vaccination with hep A virus vaccine (WAES0207USA01064). This is a consolidation of two reports concerning the same pt. No further info is available.
Patient received ZOSTAVAX (6/21/12. (Thur.). Following week on Wed., she noticed rash on right buttock. Her dermatologist said it was herpes rash. Patient said it was a rough patch and didn't have it in another place. It took about week for rash to go away (Pusy at first, but no pain).
On 07/09/2021, My blood work was taken and my ALT, my AST, my alkaline phosphatafe, my SED rate, my C-reactive protein all my numbers skyrocket and I haven't changed anything for them to go up so high. On 07/15/2021 I saw Doctor and he gave me an injection of prednisone. On 07/22/2021, I saw my liver specialist, Doctor, because my number from my liver were really bad. He switched you from Azathioprine to Cellcept also known as Mycophenolate. He was trying to get my numbers lowered.  I went to the hospital, Middlesex Hospital, last night, 09/07/2021, because I have been sleeping for more than 12 hours at a time and my whole body was hurting. They did a COVID test and it was negative. And they put me on prednisone, because my SED rates had increased really high since my last blood work.  As of today, 09/08/2021, all my bloodwork is still high. I will see my doctor tomorrow. They are still trying to lower my high numbers.
Patient states had fever of 101.5 and sore arm evening of 2-27-07 and 2-28-07 off from work. Returned to work 02-29-07 and no further problems. Doctor reported advised Tylenol 500mg 2 tabs every 4-6 hours for 24 hours and cold compress.
3 days of severe abdominal and pelvic pain that was debilitating.  Patient was hardly able to walk - she had extreme pain with urination and defecation.  She also had headache, fatigue, arm pain, fever and rash - hives, with pruritus of scalp.
Patient stated, during recent visit with MD, that when she returned home at night she began experiencing generalized rashes and itchiness.
Approximately 8 hours after injection- headache and soreness at the injection site, fatigue, very mild sore throat. Headache and fatigue progressively got worse. About 24 hours after the injection noticed small red rash to the abdomen, progressively spread throughout the abdomen to to the truck. Rash looks similar to the chicken pox and is itchy at times.
pt recv vax 22AUG96 & it was reported that that same day pt exp n/v, severe h/a, myalgia & inj site discomfort;pt was seen @ ER & treated;
Fever peak 104.1 average 103 lasting 30 hours. Extreme muscle aches and weakness starting about 9 hours after vaccine
Extreme fatigue, general malaise and long lasting reoccurring fever. The fever let up a little bit after the first dose, but came back after the second. It's 99.5 -100.4, lasts for 20 minutes to several hours and goes away. It happens 0- 4 times a day with a mode of 2
Mild rash at injection site followed by itchy spots on back of left and right shoulders. a few days after the booster injection.
a. Starting 3-4 days after employer mandated Vaccine on 11NOV2021, began having the following symptoms: i. Day3, loss of balance, brain fog, pain in upper left thigh, migraines. ii. Day4, painful headaches, top of skull and temple/side of skull, ringing in ears increasing. 3. Patient reported on initial visit that he continued to have pain in thigh (inner and outer left thigh) near groin and down to femoral, and deep fascia.  a. Pain would last approximately 1-5 minutes and would require patient to massage with great pressure (even stated that he was required to resort to striking his own leg with a closed fist on several occasions to alleviate the pain/pressure). 4. For the next 30+ days, Patient continued to experience pain in thighs and calves.  a. Primarily pain was on left side, but also occurred on right side. b. This daily pain has lessened to approximately once a week  5. Ringing (tinnitus) in both ears was reported to have not subsided.  a. Patient did not recall ever experiencing tinnitus prior to DEC 2021. This ringing has gradually gotten more disturbing  6. In first week of March 2022, the pain was so great in the thigh (while driving) that patient had to pull over on the side of the highway and walk it off. 7. Ringing has persisted since the last office visit (as of 18APR2022) and is impacting sleep and concentration. Ringing is noticeably louder and higher pitch. a. Patient has purchased a machine to sleep. Patient can not be in complete silence, and electricity signals from lights or electronic devices that emit buzz or whine are very disturbing to patient. 8. Upon initial visit: Patient notified physician ( Medical Associates) (ATN: Dr.) , physician stated that a follow up in a few months would be required. Subsequent follow up with missed due to work commitment. And patient made a new appointment (earliest possible to get in) with another physician slated for NOV2022.