chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had a fever of 100.4 degrees for about 8 hrs this was my second dose.; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 75-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6202), via an unspecified route of administration (at the age of 75-years), administered in arm left on 13Mar2021 at 11:45 as dose 2, single for COVID-19 immunization. Medical history included high blood pressure (treated) from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration (at the age of 75-years), on 20Feb2021 as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccine in four weeks. Patient does not have covid prior vaccination and has not been tested for covid post vaccination. The facility type vaccine was reported as doctor's office/urgent care. On 14Mar2021 at 18:00, the patient experienced i had a fever of 100.4 degrees for about 8 hrs. This was my second dose. First dose 20Feb2021. The treatment was not received for the adverse event. The clinical outcome for the events was reported as recovered on an unspecified date in 2021.  No follow up attempts are possible. No further information is expected.
Patient's mother called to report an adverse event following receiving the ADACEL and PNEUMOVAX 23 on 7/2/17. All events reported via the mother, who was informed by the patient. The patient, a 23 year old type 1 diabetic, left for another state the evening after getting the vaccinations. After a day or so of being there he spiked a fever and his blood sugars were out of normal range. Once at the hospital, he was found to have an infection and was admitted. The mother wanted us to know this happened following the vaccinations and was concerned that he received the incorrect shots. I explained that he did qualify for the vaccines he received. She asked if we use a new needle for each patient and I informed her that we use a new sterile needle for each vaccination even for the same patient.
I received my second shot on Monday, April 5. 12 hours after my second shot I began to have body aches, fevers and chills, which were all to be expected. Those symptoms continued to get worse and my fever did not break until 48 hours later. On Wednesday, three days after my second shot, two or three bumps appeared on my posterior vulva. On Thursday, I was in terrible pain and the bumps got larger and turned white. I called NP and asked to be seen that day because something was very wrong. I was seen by NP and the gynecologist she worked with. Both mistakenly thought I had herpes and ran multiple tests and cultured the ulcers but they all came back negative.  They prescribed me antivirals, which I stopped taking once the test results came back negative for herpes and they prescribed a lidocaine gel which made things worse. I came back a few days later for a follow up exam. I was still in excruciating pain. I told them about acute genital ulcers related to Epstein-Barr and they ran those tests also. After two weeks things progressively got better and I followed up with my gynecologist and all doctors/nurses I saw or spoke to had no idea what happened. It was absolutely related to the vaccine. I have received a third dose and switched to Pfizer and had no adverse reactions to it.
Diagnosed with bilateral pulmonary embolism 16 days after second Pfizer covid dose.
Information has been received from a nurse concerning a 9 month old patient who was vaccinated with a third dose of ROTATEQ.  A product quality complaint was not involved.  No further information was given.  Additional information has been requested.
Ten days post vax pt developed a varicella like rash, a fever, decreased appetite, and was cranky. Three days post onset, the fever resolved. The pt was diagnosed with varicella and treated with Benadryl and Tylenol.
diagnosed as ocular shingles; rash occur in her right eye; remaining irritation in her right eye; This case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included ophthalmic herpes zoster (had a long history of ocular shingles over the last 7 years.).   In September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), rash and eye irritation. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the ophthalmic herpes zoster was unknown and the outcome of the rash and eye irritation were not recovered/not resolved.   It was unknown if the reporter considered the ophthalmic herpes zoster, rash and eye irritation to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 66 or 67 years. The patient received 1st dose of shingrix in September 2020 and had rash in eye which was diagnosed as ocular shingles. The patient was treated with Valtrex and rash was resolved and reappeared after stopping Valtrex. The patient had some remaining irritation in eye, which she mentioned as better than that she had rash, shingles after first shingrix vaccine. The reporter consented to follow up.
My arms was very sore immediately after the shot and the pain traveled up my neck within 10 minutes.  I also got an odd semi-metallic taste in my mouth within a few minutes after vaccine.  I went to bed with the pain in my arm and neck and woke up around 7:30am extremely nauseated.  I have been nauseous all day and have no appetite to eat or drink.  I also have a low-grade fever 99.5F, and am very tired.  I have taken Zofran, so that I do not vomit and Tylenol for the pain and fever.
Chills; fever; aches; This is a spontaneous report from a contactable other hcp (patient). A 62-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6200), via an unspecified route of administration, administered in Arm Left on 06Mar2021 11:15 (at the age of 62-year-old) as dose number unknown, single for covid-19 immunisation. Medical history included hypercholesterolaemia from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing, obesity from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing, allergy to arthropod sting from an unknown date and unknown if ongoing. Concomitant medications included esomeprazole magnesium (NEXIUM) taken for an unspecified indication, start and stop date were not reported; colecalciferol (VIT D3) taken for an unspecified indication, start and stop date were not reported; metoprolol taken for an unspecified indication, start and stop date were not reported; enalapril taken for an unspecified indication, start and stop date were not reported; simvastatin taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 07Mar2021 04:00, the patient experienced chills, fever, aches. No treatment was taken as a result of events. The outcome of the events was recovered on an unspecified date in Mar2021.  No follow-up attempts are possible. No further information is expected.
Had facial parenthesis and weakness on right side with mouth and eye.  Diagnosed as Bells Palsy.  Given steroids and anti viral.
Patient c/o headrush within 5minutes post vaccine, no acute distress notes, patient was diaphoretic with clammy skin and had warm sensation feeling.  after 2 minutes of siting and given water, patient stated he feels better. V/S obtained and within normal range.
H. fluenzae meniningitis-Claforan IV was given for 10 days; elevated temp noted throughout hospital stay; devel viral meningitis p/bacterial;
1 of 2 pts vaxed from the same lot# exp inject site react w/in 24 hrs of vax; pt recvd vax 22JAN93 & 23JAN devel erythema, tenderness & swelling; not resolved @ the time of this report 25JAN; not seen by MD;
This case was reported by a pharmacist via call center representative and described the occurrence of blood sugar increased in a 65-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included diabetes mellitus. On 9th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In October 2018, 7 days after receiving SHINGRIX, the patient experienced rash. On an unknown date, the patient experienced blood sugar increased (serious criteria hospitalization). On an unknown date, the outcome of the blood sugar increased and rash were recovered/resolved. It was unknown if the reporter considered the blood sugar increased and rash to be related to SHINGRIX. Additional details were provided as follows: A week after vaccination, the patient developed some spots on her hands, arms and abdominal region. The patient believed that, she had chicken pox, but the pharmacist had not heard any official diagnosis from the patient's physicians. Sometime after getting the SHINGRIX, the patient also ended up in the hospital due to very high blood sugar. Lab Comments: On an unknown date, the patient's blood sugar was increased.
The mother was lactating; had an upset stomach; had trouble sleeping; spit up a few times which is abnormal for her; This is a spontaneous report from a contactable other health professional (mother). This other health professional reported information for both mother and baby. This is a baby report. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), transmammary (parent route: intramuscular) on 16Dec2020 10:00 at single dose for COVID-19 immunization.  The patient medical history was not reported.  Concomitant medication included minerals nos, vitamins nos (PRENATAL VITAMINS), colecalciferol (VITAMIN D) and calcium. The patient's mother was vaccinated in hospital. On 18Dec2020, the mother was lactating and her baby seemed to have had an upset stomach.  She had trouble sleeping and spit up a few times which is abnormal for her.  This occurred two days after the vaccination. The mother took her to her pediatrician for this. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020509869 mother case
No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 12-month-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 13-DEC-2022, the patient was vaccinated with a first dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, in left thigh, lot #W023937, expiration date: 06-DEC-2023, administered intramuscularly for prophylaxis (strength was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Digital data logger was involved.  No adverse event was reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009024: US-009507513-2301USA009110: US-009507513-2301USA009088: US-009507513-2301USA009112: US-009507513-2301USA009927:
bells palsy; stroked out; Initial information was received on 27-Oct-2021 regarding an unsolicited valid serious case from a non-healthcare professional via Global Media Information (GMI) (under reference: 00830629).  This case involves a 61 years old male patient who experienced bell's palsy, stroked out (cerebrovascular accident) when received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Patient reported he had two Pfizer vaccines and multiple vaccines and never had an issue.  The patient's medical history, past medical treatment, concomitant medication and family history were not provided.  On an unknown date, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (total, lot number: U7328DA and expiry date: 30-JUN-2022) via an unknown route in the left deltoid for prophylactic vaccination.  On an unknown date the patient developed a serious bell's palsy, stroked out (cerebrovascular accident) (one day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. These events were assessed as medically significant.  Patient having the effects on the left side of his face.  Patient who on Sunday had vaccine and Monday awoke with stroked out symptoms diagnosed as bell's Palsy. Confirmed by Magnetic resonance imaging (MRI). He asks if there is any information regarding how long it will last.  He reported he received a dose of FLUZONE QIV from a single-dose vials (SDV) earlier this week and woke up the next morning with adverse effects. The effects were still lingering and has multiple doctor appointments. He was looking for any medical guidance that could possibly help.  Relevant laboratory test results included: (MRI) Magnetic resonance imaging - On an unknown date: Positive  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was unknown for the events.  He reported good physical health and he worked as a pipe fitter for air conditioning units in large building.; Sender's Comments: This case concerns a 61 years old male patient who experienced bell's palsy, stroked out (cerebrovascular accident) (one day) after vaccination with FLUZONE QUADRIVALENT. The time to onset is compatible. Past vaccination included Pfizer vaccines and multiple vaccines. Laboratory test included Magnetic resonance imaging positive. There is no further information regarding patient's medical condition at the time of vaccination and ruling out other alternate etiologies were not reported. Based upon the reported information, the role of the suspect individual vaccine cannot be assessed.
1:40 pm  Complaints of feeling flushed and lips tingling, but quickly relieved. Also states throat feels dry, but was also relieved very quickly.  Verbalizes she experiences anxiety at times, but denies feeling like this is her anxiety.   1:52 pm States no symptoms.   2:39 pm Secretary received a Skype message from patient, stating lips are tingling and throat feels funny.  Suggested Benadryl, 25mg, PO. 4:15 Denies any symptoms and states she is feeling fine.
Symptoms started at around 3AM. Pt couldn't sleep because of headache, neck pain, chills, slight fever, nausea, moderate chest tightness. Pt took TYLENOL. As of 830am pt had only mild headache and neck pain. Other symptoms subsided. Blood sugar was 159 and blood pressure were normal.
Information has been received from a registered nurse concerning a 24 year old female with no drug reaction allergies, obesity, goiter and a history of sexually transmitted diseases who on 12-AUG-2009 was vaccinated with her first dose of GARDASIL in her right thigh. Subsequently the patient experienced swelling and pain at the injection site. The patient also had palpable lymph nodes. Ibuprofen had been recommend as a treatment. No labs were performed. The patient's swelling and pain at the injection site and palpable lymph nodes persisted. The patient sought medical attention (came into office). Additional information has been requested.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown demographics. Patients' pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. Since 01-JUN-2017, on unspecified dates, these patients were vaccinated with improperly stored doses of ROTATEQ lot # M040268, expiry date 14-MAY-2018, orally (strength, dosing details, anatomical location were unknown) for prophylaxis. The vaccine was exposed to the temperature of 47 F to 77 F, for a time frame of 10 hours and 42 minutes. Data logger was involved. The vaccines had previous temperature excursion. No adverse effects were reported. No PQC was involved. This is one of the several reports reported by the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA003783.
This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age. The medical assistant reported that an unknown number of patients may have been vaccinated with VARIVAX (Merck) (lot # and exp date were unspecified) (dose, route frequency of administration were unspecified) stored in the refrigerator for a unknown period of time. No adverse event was reported. Additional information has been requested.
This spontaneous report was received from a Medical Assistant and refers to a patient of unknown age and gender. Medical history and concomitant medications were not provided. On 19-JUN-2017, the patient was vaccinated with an improperly stored PEDVAXHIB (lot # M032149; expiration 18-APR-2019). Temperature: 47 degrees F to 77 degrees F. Time frame: one hour. Previous temperature excursion: yes, 47-77 degrees F for two hours. Call was because of a data logger. There were no adverse effects. Additional information has been requested.
5JUN91 allergic rxn, t105.6, screaming episode > 3 hrs persistent crying; was told had allergic rxn to immun 29MAY91;
LEFT DELTOID SLIGHTLY RED,  3CM INDURATION. KEFLEX GIVEN FOR 10 DAYS.
This spontaneous case, initially received from other health professional on 20-Sep-2018, concerns a 29-year-old adult pregnant patient. The patient's historical drug included penicillin (taken prior pregnancy) for an unknown indication. The patient's maternal medical history included hypertension. This was the second pregnancy of the patient. The concomitant medications included aspirin, COLACE, Vit B6, REGLAN, ZOFRAN and Prenatal vitamins for unknown indications. On an unspecified date, FLUCELVAX QIVc was stored at a maximum temperature of 34.3F for 58 minutes for the first time. It was reported that, patient was 6 weeks and 5 days on her first appointment and the patient's last menstrual period date (LMP) was on 23-May-2018 (reported as unsure). On 20-Sep-2018, at gestational age of 23-weeks (second trimester of pregnancy) the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252656 and expiry date: 31-May-2019) which underwent a temperature excursion. At the time of this report, the patient and foetus had no adverse events. The patient's estimated date of delivery was reported as 11-Jan-2019. The reporter assessed this case as non-serious. Follow-up received from other health professional on 29-Oct-2018: It was reported that, the patient was 6 weeks and 5 days on her first appointment and last menstrual period date (LMP) was on 23-May-2018 (reported as unsure). The patient's week of exposure was 23 weeks (second trimester of pregnancy) was updated in the patient tab. The narrative was amended accordingly.
Fainting, shivering about 5 minutes after vaccination. EMS evaluated her and released her to go home.
Nausea, vomiting, diarrhea, body aches, moderate swelling and redness at injection site, headaches, fever, chills, symptoms have persisted for 48-72 hours, Motrin 800mg TID, Tylenol 325mg QID.
I started my period 8 days early and had cramping. I normally do not have cramping and my cycles are like clockwork. I have an app I use to track my period to show consistent. After this episode my periods returned to normal cycle length. I have had lower abdominal pain for months which has led to a pelvic sonogram  where they did not find anything. The pelvic pain lasted for about 6 weeks in august and now comes and goes. I?m not sure if it?s related or not.
I received the vaccine on 10/01/2021, I waited 15 minutes after receiving the first does. After driving home, I became tired ( sleepy). The following day 10/02/2021 I woke up with a massive headache, blurred vision, sensitivity to light, dizzy and some weakness during ambulating. I took two Tylenols and one Ibuprofen. symptoms were alleviated.
Patient claimed to have "ached all over the body for about 2 days, and has a rash+swelling+hot to the touch reaction at the injection site." Aching subsided but patient still has the rash and swelling at the injection site.
Sore arm on days 1,2,3.  On day 5 I noticed a scab or almost lesion where the shot was given  Today on day 6 I am achy on my left side only. Mostly my neck, arm and also my left side thigh.
pt. vax'd w/ 2nd dose of hepatitis B vac on 20Oct90 & exp. heartburn,nausea & diarrhea w/ yellow stools, sore throat. 3rd dose withheld  for further testing and vitamin therapy.
Severe Headache, muscle aches, chills, loss of appetite, pain at injection site. Headache etc not relieved by 1000 mg of Tylenol
Resident was on hospice care, terminal prognosis, end of life prior to vaccination. 11/2/21 residents O2 was decreased and resident declined shortly after.
Pt was working as EMT at site; had dose 2 Moderna in am and returned to NP approx 5.5 hours later reporting change in voice to high pitched voice and then hoarseness; BP  148/88; pt declined hospitalization and continued to be in clinic but was monitored by EMT colleagues. On 3/6/21, NP contacted pt who said she took benadryl tab po at home and felt better but now with hoarse voice. On 3/7/21, pt contacted NP to report her usual voice had returned and she felt much better.
severe lymphadenopathy of upper body (armpits, shoulders, neck, inner elbows), lymph masses approximately the size of golf balls painful joints (neck, shoulders, wrists, fingers)  ADEs have not resolved or been treated since onset
I gave 4 yr. old immunizations to this child that were meant for her brother by mistake. She had already had them July 31, 2012 at another clinic but I had no record of them.
Patient reported:  Paralyzed left vocal cord, occurring 36 hours later and still a problem today,  some 6 weeks later.
Pt.'s Mother states that after receiving the 1st dose of Moderna 07/21/2021, started experiencing symptoms 08/04/2021 of hives throughout the body (chest-legs), itchiness lasting 2 weeks still continuing through the feet. Urgent Care visit 08/07/2021 prescribed Prednisone.
COPD on 2L BL O2 requirement, hypothyroidism, cachexia, GERD with similar presentation earlier this month post-covid vaccine # 1, who presetned for feeling sick and SOB. Patient received her second dose of the covid vaccine on 2/19/21, 3 days prior to presentation. The following day, she started having "breathing issues" so she was given a dose of prednisone. 1 day prior to presentation, her breathing had improved but she was feeling generally sick, so she was given tylenol but not pred. Then, today, day of admission, patient was having bodyaches, weakness, headache, and breathing issues again. She took prednisone this morning, but still had to turn up her O2 because her work of breathing kept fluctuating. Admitted 2/22/21 ? 2/24/21.