chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache, body aches, chills, fever, diarrhea - 24 hours
Fever 102; chills; headache; back pain; lymphadenopathy in cervical, axilla, and groin; This is a spontaneous report from a contactable other healthcare professional (hcp, reported for herself).  A 34-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 12Jan2021 15:30 at a single dose in the left arm for COVID-19 immunization. Medical history included allergies to penicillin. The patient was not pregnant at the time of the report. The patient had no covid prior to vaccination. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks. The patient had first dose of COVID-19 vaccine bnt162b2 on 23Dec2020 08:30 AM in the left arm (at the age of 34 years old). On 13Jan2021 12:00 PM, patient experienced fever 102, chills, headache, back pain, and lymphadenopathy in cervical, axilla, and groin. No treatments received in response to the events reported. The patient was not COVID tested post vaccination. The outcome of the events fever 102, chills, headache, back pain, and lymphadenopathy in cervical, axilla, and groin was recovering.   Information on batch/lot number was requested.
diarrhea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) and VOMITING (vomiting) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 096AZ1A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No prior medical history was reported).    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced DIARRHOEA (diarrhea) and VOMITING (vomiting). At the time of the report, DIARRHOEA (diarrhea) and VOMITING (vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment details was not provided.
I have memory problems. Have a hard time thinking and processing; Head feels swollen at times, no pain; Vaccine location: Left leg; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left leg on 25Apr2021 at 13:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included omeprazole (OMEPRAZOL) and unspecified birth control medication; both taken for unknown indications from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 04Apr2021 at 12:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient previously took amoxicillin; clavulanic acid (AUGMENTIN) for unknown indication and experienced drug allergy. On 26Apr2021 at 11:00, the patient had memory problems, had a hard time thinking and processing never had prior to shot and head felt swollen at times, no pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On an unknown date in 2021, the patient underwent SARS-COV-2 test (polymerase chain reaction (PCR)) by test type nasal swab and the result was negative. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events she had memory problems, had a hard time thinking and processing and head felt swollen at times, no pain was not resolved at the time of this report.
pt recv vax 6OCT97 & 7OCT97 pt exp a fever of 102;the following day pt presented to MD office w/a swollen red arm & elbow described as being like cellulitis;pt was treated w/APAP;
PATEINT WAS GIVEN DILUTED DOSE FOR PFIZER VACCINE. RPH HAD MIXED OLD USED PFIZER VACCINE LEFT IN TRAY WITH DILUENT. PT WAS INJECTED VERY DILUTED DOSE/ SALINE SOLUTION AT APPOINTMENT. WE FOUND ERROR IN THE LATE AFTERNOON. WE CALLED PATIENT AND SET UP APPOINTMENT FOR 3/21 TO GET RIGHT DOSE.WE ARE ALSO REPORTING THIS TO VAERS SITE.
Information has been received from a registered nurse concerning a 5 year old male who on 23-JUL-2008 was vaccinated with ZOSTAVAX (Oka/Merck) instead of the second dose of VARIVAX. No adverse reaction noted. Follow information received from the nurse indicated that she did not administer the vaccine. She indicated that this was human error as the nurse administering the vaccine did not read the label. Additional information is not expected.
Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore Arm) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore Arm). At the time of the report, VACCINATION SITE PAIN (Sore Arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information provided by Reporter.   This case was linked to MOD-2021-080080, MOD-2021-080342 (Patient Link).   Reporter did not allow further contact
No Adverse event Look A Like Pfizer vial resulted given Pfizer Biontech Covid 19 instead of PfizerBivalent  Patient was ok Offered to give Bivalent in 2 months
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 17-SEP-2014 the patient was vaccinated with an expired dose of M-M-R II (lot # was reported as 8014646, (lot number 8014646 is an invalid lot number for measles, mumps, and rubella virus vaccine), expire date 03-AUG-2014, dose, frequency and route unspecified). No adverse effect reported. Additional information has been requested.
Per mom pt exhibited "convulsions" that night.  (Exact time unknowns.)  Had to be physically carried to the car as she could not walk.  Taken to ED.
Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry) in a 71-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that the date vial initially stored in refrigerator was unknown. The vial did not undergo any temperature excursions. Total of 173 doses were given from LOT 070H21A.  Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non-significant live follow up was received
DTP/HIB recvd 8SEP92 & up all noc crying; t102.5 ax; only slept from 6AM-9AM; 1115 t99ax; shot area sl raised; pt fussy;
Shortness of breath, wheezing, received 2 doses of epi before reaching ED.
Right deltoid arm pain that spread down into forearm causing limitation in movement with pronation/supination
Pt said she developed a rash with pain a few hours after the injection. Rash is on left deltoid. Pt stated painful for several days. Pt saw MD today and nothing prescribed. MD stated rash will go away. Pt in less pain now as well.
Site: Pain at Injection Site-Mild, Systemic: see below -Medium, Additional Details: Patient states that 10 days after vacccination, started to get swollen legs and pain which went away a week later. She was concerned due to blood clot warning and I advised her to seek additional medical assistance which she said she would seek. She did state in addition, she experienced swollen lymph nodes and breast tenderness which occured right after vaccination and lasted 2 weeks.
The next day (3/27) I experienced sudden onset idiopathic hearing loss on right ear side only. Accompanied by tinnitus, headache, flu symptoms (no fever or vertigo though). Remained in bed, vomiting with flu-like sickness for about 3 days. Then, tinnitus, hearing loss, aural fullness and headache for last 6 months. Hearing loss is permanent (in lowest register, about 30%).  Tinnitus appears permanent. Headache is intermittent.
Information has been received from a physician concerning a 7 year old patient who on 06/18/1996 was vaccinated with a dose of varicella virus vaccine live.  On 11/10/2003 the patient experienced a case of breakthrough varicella.  There were less than 50 lesions.  Unspecified medical attention was sought, but there was no treatment and no hospitalization.  The patient recovered.  No product quality complaint was involved.  This is one patient out of 40 reported.  Thirty nine other cases experienced breakthrough varicella after vaccination with varicella virus vaccine live.  Additional information is not expected.
Right lateral thigh swelling 9cm x 9cm, warm to touch, red; ice, Motrin PO
Large swelling to lymph nodes under arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Apr2021 13:00 (Lot number: EP7534) at the age of 63 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLUOXETINE taken for depression (ongoing). Past drug history included: Codine, reaction(s): "Drug allergy", notes: known_allergies: codine. Vaccination history included: Bnt162b2 (Dose: 1, Lot: EP7534, Vaccination site: left Arm, Route: Intramuscular, Time: 13:00), administration date: 05Apr2021, when the patient was 63 years old, for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 27Apr2021, outcome "recovering", described as "Large swelling to lymph nodes under arm". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional Information: Serious: No. Seriousness criteria reported as NO for included: Results in death/Life threatening/Caused/prolonged hospitalization/Disabling/Incapacitating/Congenital anomaly/birth defect/Other medically important condition. Reported Event: Large swelling to lymph nodes under arm receiving the vaccination following second shot. If covid prior vaccination: No. If covid tested post vaccination: No. Known allergies: Codeine. Does Pfizer have permission to contact the reporter about this event: Yes. Does Pfizer have permission to contact your/the patient's healthcare provider about this report: No. Facility where the most recent COVID-19 vaccine was administered: Clinic/facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The did not received any other medications within 2 weeks of vaccination: Fluoxetine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Right sided facial weakness paralysis. Headache radiating from right base of skull to right ear to top of head.
Information has been received from a medical assistant concerning an 18 year old female with no pertinent medical history and no allergies who on 19-JAN-2008 was vaccinated with the first dose of GARDASIL IM 0.5 ml (lot # 659439/1267U) well tolerated.  On 29-MAR-2008 the patient was vaccinated with the second dose of GARDASIL IM 0.5 ml (lot # 655604/0052X) well tolerated.  On 04-AUG-2008 the patient was vaccinated with the third dose of GARDASIL IM 0.5 ml (lot # 659184/0843X).  There was no concomitant medication.  On 04-AUG-2008 the patient experienced body chills and tingling in both legs several hours after receiving her third dose.  The patient was examined in the local emergency room.  The patient was rehydrated with an unspecified intravenous fluid and released to home.  The patient's mother contacted the office by phone, on 05-AUG-2008, to relay the adverse event.  The current status of the patient was unknown.  The reporter considered the body chills and tingling in both legs to be other important events (IV hydration).  This is one of several reports from the same source.  Additional information has been requested.  9/23/08 Reviewed ER medical records of 8/4/08. FINAL DX: none provided Records reveal patient experienced numbness & pain in both legs, achy joints, pins & needles feeling in legs, temporal HA, felt feverish & chills.  Tx w/IVF & pain meds.  Improved & d/c to home.
extreme lethargy; Elevated temperature; chills; total body aches; booster dose; This is a spontaneous report from a contactable consumer or other non hcp. A 37-year-old male patient received bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: FF8841; Expiration date was not reported), dose 3 intramuscular, administered in Arm Right (age at vaccination 37-year-old) on 15Nov2021 01:15 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. Patient had historical vaccine of first dose of bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EL3247; Expiration date was not reported) via an unspecified route of administration on 11Mar2021 as DOSE 1, SINGLE and second dose of bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EP6955; Expiration date was not reported) via an unspecified route of administration in right arm on 30Mar2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history was not reported. Facility type vaccine: Workplace clinic. There were no treatment for ae. There were no covid prior vaccination. There were no covid tested post vaccination. There were no known allergies. There were no other medical history. There were no concomitant medications. On 15Nov2021 01:15 the patient experienced booster dose, on 15Nov2021 18:00 experienced extreme lethargy, elevated temperature, chills, total body aches. The patient underwent lab tests and procedures which included body temperature: elevated temperature on 15Nov2021. The outcome of events were recovered on Nov2021.  Follow-up attempts are completed. No further information is expected.
both eyes feel dry; both eyes feel irritated; While getting the YF vaccine ready to administer the orange clasp broke off while pressing the middle part to get the air out and sprayed in eye; while getting the YF vaccine ready to administer the orange clasp broke off while pressing the middle part to get the air out and sprayed in eye; Initial information was received on 24-Jun-2021 regarding an unsolicited valid non-serious case from an other-health care professional  (Inquiry number: 00654896).  This case involves a 23-years-old female health professional whose eye got sprayed with 0.5 ml YELLOW FEVER VACCINE - [YF-VAX] (lot number: UJ372AA, expiration date: 22-Jul-2022) while administration, as the orange clasp broke off while pressing the middle part to get the air out (Occupational exposure to product and Device breakage) on 23-Jun-2021.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  It was a case of an actual medication error due to occupational exposure to product via eye and device breakage (latency same day).  On 24-Jun-2021, the patient developed a non-serious event of both eyes dry and feel irritated (Dry eye and Eye irritation) (1 day) following the administration of YELLOW FEVER VACCINE - [YF-VAX].  The caller reported that while she was getting the YF VACCINE ready to administer, "the orange clasp broke off and while pressing the middle part to get the air out it broke off and sprayed in callers eye." The caller wanted to know if there was something she should do for her eye. There is no noticeable irritation, but it feels irritated. Yesterday (23 Jun 2021) at about 4 pm, the HCP was preparing a YF-VAX dose, and had it in a syringe, and the orange part that you turn on the syringe, which is supposed to be tight, was loose, and the YF-VAX sprayed out from the middle of the syringe, not from the needle, and sprayed into both of her eyes. HCP stated that she flushed her eyes out with water after this happened. HCP stated that she did not experience any symptoms yesterday for a few hours, but today (24 Jun 2021) both eyes feel dry and irritated. HCP had a doctor there look at her eyes, and they are not red. Patient stated that she is not currently experiencing any systemic side effects, just the dryness and irritation of both eyes.  No relevant laboratory data was reported. It was unknown if patient received a corrective treatment for the events. The patient had not recovered from the reported events dry eye and eye irritation.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error
Symptom onset of 2/28, including fever (40c), cough, vomiting, diarrhea, rash, headache, conjunctival injection, and elevated BNP/d-dimers. Confirmed MIS-C. SARS-COV2 IgG positive on 3/8/22
Patient described what she experienced as bug bites that started on her lower legs the evening after she received the vaccine.  What later turned into hives, began to pop up all over her body.  She showed pictures of them to myself, and they were big raised whelps that were all over her body.  She is experiencing chills and headaches with them as well.  She also complains of extreme heartburn which she had to take TUMS for.  She said it still feels like her feet, toes, side of her fit are itching or bugs are biting her.  She even got whelps in her scalp.  Thankfully, it didn't interfere with her breathing or respiratory functions and she didn't have to go to the ER.  She called me today, 6/2/21 and told me all of this and I made her an appointment with her PCP for today at 3:15pm.  I called to check on her and what the Dr said.  She said he just told her to take Benadryl for the whelps, and to premedicate with Benadryl before she takes the 2nd dosage.??  I wasn't sure what the information on the Moderna shot recommended about a patient who had a severe allergic reaction after the first dosage receiving the second dosage?
Still experiencing severe muscle pain in right leg and left arm (arm was vax site); Severe migraine; Flu-like symptoms; Diarrhea; Nausea; Temperature regulation issues; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP 7533) via an unspecified route of administration in the left arm on 04Apr2021 at 17:15 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Information on medical history and known allergies was not available. Information on whether the patient had received any other medications in two weeks was not available. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6203) via an unspecified route of administration in the left arm on 13Mar2021 at 13:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 08:00 the patient was still experiencing severe muscle pain in his right leg and left arm (arm was vax site), severe migraine, flu-like symptoms, diarrhea, nausea, and temperature regulation issues. The patient did not receive any treatment for the adverse events. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events severe muscle pain in right leg and left arm (arm was vax site), severe migraine, flu-like symptoms, diarrhea, nausea, and temperature regulation issues was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
hive on her neck"; she feels so bad; significant muscle pain; stiffness; achiness, body aches and pains; chills; fatigue; just wants to get into bed"; significant nausea; headache; A spontaneous report () was received from a consumer concerning a 70-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events significant nausea, headache, hive on her neck?, felt like it moved to her left eye, she feels so bad, significant muscle pain, stiffness, achiness, chills, body aches, pains, fatigue, just wants to get into bed.  The patient's medical history include Allergies include ibuprofen. PMH includes hypertension.  Concomitant medications reported were amlodipine, atorvastatin, D3, multi vitamins for drug use for unknown indication.  On 17 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013L20A) in the left arm for prophylaxis of COVID-19 infection. On 14 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 031L20A) in the left arm for prophylaxis of COVID-19 infection.  On 14 Feb 2021, the patient experienced the events significant nausea and headache . On 15 Feb 2021, the patient experienced the events hive on her neck?, felt like it moved to her left eye, she feels so bad, significant muscle pain, stiffness, achiness, chills, body aches, pains, fatigue, just wants to get into bed.  Treatment details included Aleve.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, significant nausea, headache, hive on her neck?, felt like it moved to her left eye, she feels so bad, significant muscle pain, stiffness, achiness, chills, body aches, pains, fatigue, just wants to get into bed was unknown.
Client states she was covered in a rash from head to toe. States her hands and face were swollen. felt heaviness in chest also c/o headache.