chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist and from the patient refers to a 64 year old female patient reporting on herself. On 10-DEC-2014, the patient was vaccinated with a dose of ZOSTAVAX lot # K014834 exp. 14-DEC-2015, (route and dose were not provided). Consumer states she also has history of Mitral valve prolapse, and high cholesterol. Concomitant medications included simvastatin (manufacturer unknown) 20 mg once daily, one baby aspirin daily, one multi vitamin daily, INDERAL 20 mg a day. The pharmacist stated that the patient came into the pharmacy recently and stated that she developed shingles on an unspecified recent date. In addition, the patient reported that she had gone to the local emergency rook on 03-OCT-2015, because she was in such severe pain radiating from her "belly to her back". They performed 2 Computerised Axial Tomography (CAT) scans looking for kidney stones but none found. The patient stated she was sent home with muscle relaxer and pain pills. Two days later, she went to an urgent care clinic, because she had such severe pain. They took 3 CAT scans and a nuclear magnetic resonance imaging (MRI). They found a urinary tract infection. Finally on 07-OCT-2015, she went to the urgent care clinic and got a prescription for the shingles. The shingles were located on her right lower stomach to her right back. The patient stated the health care provider told her that the size of the shingles was a manageable size and that may had been due to the fact she got vaccinated with ZOSTAVAX. The patient was prescribed NEURONTIN 200 mg three times a day, ZOVIRAX 80 mg five tablets by mouth once a day, and FLEXERIL once a day as needed. The patient stated that her husband also had ZOSTAVAX vaccine in December 2014, but he was not experiencing any adverse effects. Additional information has been requested.
Chills; Fever; very lethargic; a lot of aches and pains; Exhaustion; This is a spontaneous report from a contactable consumer (patient's wife). A 75-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: EL1283, expiration date: Apr2021), intramuscularly on the right arm (also reported as upper right arm) on 11Jan2021 at 10:15 at a single dose for COVID-19 immunization administered at the hospital (medical center). The patient had no medical history. There were no concomitant medications. The patient had no history of previous immunization with the Pfizer vaccine. The patient had no prior vaccinations within 4 weeks. He had no adverse events following prior vaccinations. He had never had a flu shot. The patient had the shot on Monday, 11Jan2021 and that early evening, he got chills, fever, and since then he had been very lethargic and had a lot of aches and pain and exhaustion. He had difficulty getting up in the morning. He just felt exhausted. She had him go have a Covid test on 12Jan2021 in the late afternoon to make sure he did not have Covid; he took the test that was a 98% accurate Covid test, and it was negative. The reporter was asking if that was a common reaction or if the patient had some type of virus. The reporter was asking if the patient should get the second shot. The patient experienced the chills at night, the day he received the vaccine and by the next morning they were gone. The reporter stated that the patient was still exhausted and lethargic. He was normally a very active person and now he was down and out. The events did not require a visit to the emergency room or the physician office. The patient did not receive any treatment for the events. The patient recovered from the events "chills and fever" on 12Jan2021. The patient was not recovered from the events "very lethargic, a lot of aches and pains, and exhaustion."
PATIENT WANTED TO GET 1ST DOSE PIZER COVID VACCINE STATED THAT HE HASN'T RECEIVED ANY COVID VACCINE ON CONSENT FORM AND WE ADMINISTERED. HOWEVER, WHEN WE PROCESS VACCINE ON PHARMACY PROGRAM, IT SHOWS HE RECEIVED JANSSEN COVID VACCINE AT OTHER LOCATION. WE CALLED PT AND HE SAID HE DOESN'T REMEMBER THAT HE GOT VACCINE BEFORE BUT LATER HE FOUND THE VACCINE CARD AND REALIZED THAT HE RECEIVED IT. HE DOESN'T EXPERIENCE ANY SIDE EFFECT FROM VACCINE SO FAR.
After yesterday's vaccines patient cried almost non stop for 3-4 hrs. We tried cold compress but did not work. She kept crying a lot. Few times she was crying in a hoarse voice with face becoming very red. After we gave warm water bath she was better and stopped crying. Later she was smiling, cooing etc. She had fever at night and we gave her infant Tylenol and she was fine.
Fever of 100 F, Chills, Body aches lasting about 24 hours and then fatigue for next 24 hours.
pt recvd vax & a few minutes p/vax face & tongue felt tingly for a few mins;24MAY95 3:00 pt had a severe h/a which was treated w/APAP;pt felt very weak (fatigued) on 24MAY as if had a fever;head did not feel right & felt queasy;DPH given
Sore arm for a day and a half, soreness occured 1 wk later for 1 day. Nodule appeared after 2 days at injection site; 2" in diameter.
This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 63-year-old male patient who received Influenza vaccine Quadrivalent. Concurrent medical conditions included blood cholesterol increased and arthritis. Concomitant products included biotin, Rosuvastatin, Turmeric and zinc. In October 2015, the patient received influenza vaccine Quadrivalent (intramuscular). On 15th December 2015, 61 days after receiving Influenza vaccine Quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant), sickness and influenza. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the sickness and influenza were recovered/resolved. It was unknown if the reporter considered the vaccination failure, sickness and influenza to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: The patient reported that around end of October 2015, he received 4 strain flu shot. The reporter did not know what brand it was. On 15 December 2015, approximately 2 months after vaccination, the patient got sick, possibly with the flu (suspected vaccination failure), but might be something else. The patient felt sick for several days, but did not have the full flu symptoms. The patient was a professional Santa, so he was exposed to many germs in the fall leading up to Christmas, so he always got sick with something. This case was considered as suspected vaccination failure as the target disease of flu was not confirmed and also no laboratory confirmation was provided.
I started to notice that my runs were getting harder. I run for exercise and enjoyment. What used to be achieved at one pace would now be achievable at a slower pace. I have an smart watch and saw my resting heartbeat was up 20 beats per minute. I went to the doctor and got blood work done. They found that my thyroid levels were high. The initial testing indicated that it was not permanent and may note the side effect of a virus. I did a round of prednisone that was finished last week. Also, on a beta blocker to reduce heart rate. I have more tests coming up in the next few weeks to make sure that the levels continue to reduce and normalize. And just to confirm that it's not permanent. Maybe in relation to a recent virus but not entirely sure. No in the mean time of recovery, but in the process.
Tested positive  for covid 19; Tested positive  for covid 19; It lowers the immune system; This is a non-interventional study report from the marketing program received from a contactable 44-year-old female consumer (patient) based on information received by Pfizer from Sanofi (manufacturer control number: 2021SA264459). This is a non-serious case received from a consumer. A 44-year-old female patient received bnt162b2 (Pfizer Biontech Covid-19 Vaccine, Batch/Lot number was not reported), via an unspecified route of administration in Dec2020 and Jan2021 respectively, as dose number unknown, single for COVID-19 immunization; teriflunomide (AUBAGIO, coated tablet), via oral from 17Mar2021 and ongoing, at 14 mg, once daily for multiple sclerosis (MS). The patient's medical history and concomitant medications were not reported. Teriflunomide may be the cause of it because it lowered the immune system following the first dose intake. The patient tested positive for Covid19 on 30Aug2021 since Monday this week while being treated with teriflunomide and bnt162b2. The patient received Pfizer Covid-19 vaccination on Dec2020 and Jan2021, nothing else changed, and asked if teriflunomide may be the cause of it because it lowers the immune system. No treatment reported. The action taken in response to the events for bnt162b2 was not applicable, for teriflunomide was dose not changed. It was not reported if the patient received a corrective treatment for events. SARS-COV-2 test on 15Jun2021: Positive. At time of reporting, the outcome of events was not recovered.  Aubagio may be the cause of it lowers the immune system is considered to be causality not reported to TERIFLUNOMIDE by the reporter and reportable by the company based on company causality assessment. Patient Tested positive for Covid19 Since Monday this Week is considered to be causality not reported to TERFLUNOMIDE by the reporter and reportable by the company based on company causality assessment.   The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report, causal relationship between the event Drug ineffective, COVID-19, Immune system disorder (NOS) and suspect drug BNT162B2 can be excluded.
Hearing loss; Information has been received from a lawyer and a consumer (reported as spouse) referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not reported.  On or about 22-OCT-2016, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for long-term prevention of shingles and zoster-related conditions.   On an unknown date, the patient experienced hearing loss. The patient did not recover from the events. As per the reporter, the patient has and will continue suffer significant medical and related expenses as result of the injury which costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies. The patient was hospitalized due to the event on an unknown date.   The reporter considered the event were related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the event of hearing loss was determined to be medically significant.
Bell's palsy symptoms.  Droopy eye (right) and tingling in the ears.
Sore arm; Stiff arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Feb2021 (Lot number: EL9267) at the age of 70 years as dose 1, single and administered in arm left, administration date 09Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood cholesterol increased", start date: 2021 (ongoing), notes: Verbatim: High cholesterol. The patient took concomitant medications. Vaccination history included: Flu shot (Had a sniffle that was gone after 24 hours), reaction(s): "sniffle". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 15Feb2021, outcome "recovered" (2021), described as "Sore arm"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset Feb2021, outcome "not recovered", described as "Stiff arm". Therapeutic measures were taken as a result of pain in extremity.  Additional Information: Concomitant medications included Unspecified statin, 1/2 tablet at night for Cholesterol since 15Feb2021. It was reported that Caller reported that he began taking a statin about a month ago, but he is not sure of the name or dosage.  Caller reported that he keeps forgetting to take the cholesterol medication. Caller reported that he was diagnosed with high cholesterol about a month ago. Sore arm: Caller reported that his arm started hurting an hour or so after getting home on 15Feb2021 after getting the first dose of the Covid-19 vaccine. Caller reported that the pain was not so much on the surface of his arm, but was closer to the bone. Caller later reported that the pain in his arm went away after 2-3 days.  Caller reported that he put a heating pad on his arm to help it.  Caller reported that he recovered completely in 3-4 days.Caller reported that he is still experiencing stiffness in his arm.  Caller reported that he has a fellow friend that is experiencing the same stiffness. Stiff arm: Caller reported that his arm feels tight.  Caller reported that the stiffness is still ongoing.  Caller reported that he doesn't know what's going on but that he can still move his arm. Second dose: Date: 09Mar2021; Lot Number: EN6198 or EN6148. Additional Administered Vaccines was no. The adverse events has not resulted in Emergency Room or Physician Office visit. Prior Vaccinations (within 4 weeks) was no. Caller reported that when he got his flu shot last year, he had a sniffle that was gone after 24 hours.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
She was immediately nauseus as soon as she stood up from receiving the vaccine. Medics assessed her on scene and administered zofran.
Patient had swelling on side of left thigh measuring 2.5 inches x 2.5 inches. It was swollen and tender to palpation. Mom advised to use warm compresses to the area to reduce swelling.
11/16/2021 received Engerix-B first dose, has not received dose 2; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 41-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (received 1st dose on 16th November 2021 for batch no 9AXEP and expiry date 23rd November 2023).   On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 09-JUN-2022  Reporter's comment: The pharmacist reported that a female patient received Engerix-B first dose and had not received dose 2. The reporter consented to follow up by email please. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Engerix-B, which led to incomplete course of vaccination.
Within 1 minute of receiving vaccine, pt. felt dizzy. Proceeded to vomit. Pt. laid down for 1/2hr. Upon sitting up pt. vomited again.
#5 vax given 27DEC93 & 30DEC93 rash around neck;
dizzy, achy, fever, sick to stomach w/in 24 hrs lasted x 3 days;
Patient's sister came over to get RN and said patients throat was closing up.  RN Grabbed doctor on site to assess.  MD and RN auscultated with stethoscope; good air movement and color.  Alert, oriented, speaking full sentences.  The patient had a potential reaction to COVID-19 vaccine.  Many co-morbidities and previous reaction noted.  Rn and MD evaluated.  Despite good air flow, patient reports throat closing up.  Patient self-dosed Benadryl (50mg) with no improvement.  911 called.  Mom Called.  RN gave report to EMS, EMS took over care and consulted mom who denied transport and with patient.  Patient's blood glucose also read "high" on meter x2 times.
Carpal tunnel swelling and pain in right hand (of right handed patient).  Sharp pain in both hands, between ring finger and middle finger (mostly in right hand).  Pain and swelling continuing to subside after second dose.
Severe Anxiety after second; feeling of eyes dilated; nausea; worse confusion; head crawling; head pain; havent been able to sneeze after second; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0153) dose 2 via an unspecified route of administration in right arm on 07Apr2021 at 10:00 (at the age of 58-year-old) as single dose for COVID-19 immunization. Medical history included Hepatitis B inactive, Hepatitis C cured, Genital Herpes, gastroparesis, IBS/ Irritable bowel syndrome, arthritis, allergies to steroids, Codene. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included atenolol, omeprazole, alprazolam (XANAX), macrogol 3350 (PEG3350), all in two weeks. No other vaccine received in four weeks. The patient previously took ciprofloxacin and had allergy. Historical Vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8732) dose 1 in right arm on an unspecified date as single dose for Covid-19 immunization and experienced anxiety week after first, confusion, sweat. On 13Apr2021 at 07:00AM, the patient had severe anxiety after second, feeling of eyes dilated, nausea, worse confusion, head crawling, head pain, still having side effects. It always started a week later. She was having MRI and MRA done this Friday. Didn't realize till after second shot, it was all from vaccine, thought she was having other problems, but now know it was from vaccine after second wave of side effects, hit her like a freight train all at once. Also haven't been able to sneeze after second, had to several times, but was not able to do it anymore. Since the vaccination, the patient had not been tested for COVID-19. It was unknown if received treatment for events. The outcome of events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
administration of a pediatric Engerix-B dose to an adult patient; administration of a pediatric Engerix-B dose to an adult patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 22-year-old male patient who received HBV (Engerix B pediatric) (batch number 9PG49, expiry date 28-DEC-2024) for prophylaxis.   On 05-SEP-2023, the patient received Engerix B pediatric. On 05-SEP-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: administration of a pediatric Engerix-B dose to an adult patient) and adult use of a child product (Verbatim: administration of a pediatric Engerix-B dose to an adult patient).The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 05-SEP-2023 The reporter was a medical assistant. The reporter reported that the administration of a pediatric Engerix-B dose to an adult patient, which led to underdose and adult use of a child product. The reporter consented to follow up.
Patient immediately started feeling diaphoretic, ringing in his ears and unable to understand questions that were asked. He then started to close his eyes at which his mother and myself got him to open his eyes again. He repeated this a couple times becoming very limp. We got him up to the exam table and applied some cold compresses. Once he became alert, gave him some apple and orange juice. Blood pressure was taking twice during this time, which both were normal. Report given to Dr. who said once feeling well can go home.
Sore arm and achy for a day; Initial information was received on 31-Oct-2021 regarding an unsolicited valid non-serious case from a Social Media via a consumer/non-health care professional.  This case involves a patient (unknown demographics) who had sore arm and achy for a day (pain in extremity) after receiving vaccines INFLUENZA VACCINE and corona virus disease of 2019 (COVID-19) VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry not reported) via unknown route in the arm Not Otherwise Specified (NOS) for prophylactic vaccination.  On an unknown date, the patient received a Booster dose of suspect COVID-19 VACCINE not produced by pharmaceutical company (batch number and expiry not reported) via unknown route in the arm NOS for prophylactic vaccination.  On an unknown date the patient developed a non-serious sore arm and achy for a day (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE and COVID-19 VACCINE.  It was reported "Flu shot in one arm and covid booster in the other. Sore arm and achy for a day."  It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, outcome of the event was unknown.  The reporter did not report the causality of event with INFLUENZA VACCINE.  There will be no information available on the batch number for this case.
This spontaneous report as received from a registered nurse refers to an adult patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The registered nurse stated that on two separate dates, the patient was inadvertently with the pediatric doses of RECOMBIVAX HB (dose, route of administration, lot # and expiration date were not reported) and with one adult dose of RECOMBIVAX HB (dose, route of administration, lot # and expiration date were not reported) on a third unspecified date. No adverse effects were reported. Follow up information has been received from the nurse on 18-FEB-2016, concerning to a 56 year old female patient, other patient's demographics and vaccination information were updated. The patient's concurrent conditions included allergy to adhesives, type 2 diabetes mellitus (DM II), osteoarthritis, peripheral vascular disorder (PVD), hyperlipidaemia, obesity, hypertension (HTN), thrombocytopenia, hepatic cirrhosis, splenomegaly, varices esophageal and peptic ulcer. On 18-JUN-2015 at 3:57 pm, the patient received the first pediatric dose of RECOMBIVAX HB and on 11-AUG-2015 at 11:16 am she received the second pediatric dose of RECOMBIVAX HB (Lot # J005078, expiration date was not reported). Laboratory tests included Hepatitis B surface antibody (also reported as Hb sab) which results was reported as non reactive and Hepatitis B core antibody (also reported as HBC) which results was reported as non reactive, the patient experienced Anti-HBs Antibody Negative. There was no life threatening illness, the patient did not require emergency room or doctor visit, did not require hospitalization, did not result in persistent or significant disability/incapacity and did not require medical or surgical intervention. At the time of the report the outcome of Ant-HBs Antibody Negative was unknown. Additional information is not expected because all correspondence was received. Patient, product, Events and narrative were updated.