chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tinnitus; usual aches and pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Mar2021 09:00 (Lot number: EN6205, Expiration Date: 30Jun2021) at the age of 63 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: TINNITUS (non-serious) with onset 16Mar2021 16:00, outcome "not recovered", described as "Tinnitus"; PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "usual aches and pains". The event "tinnitus" was evaluated at the physician office visit.  Additional Information: patient has worked in the health care industry for many years. Patient visited to Physician Office.No Emergency Room visit. he has not received the second dose. History of all previous immunization with the Pfizer vaccine considered as suspect: None   No follow-up attempts are possible. No further information is expected.
side effects that have lasted ten days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects that have lasted ten days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects that have lasted ten days). At the time of the report, VACCINATION COMPLICATION (side effects that have lasted ten days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.   Treatment for the event included was not provided.
Nonstop Fever, chills, exhaustion, and nausea for 3 days.  Where shot was placed, right arm swelled and bruised for 3 weeks.
Patient was administered with an expired dose of Tenivac with no reported adverse events; Initial information was received on 30-Aug-2022 regarding an unsolicited valid non-serious case received from a pharmacist via call center.  This case involves an 80 years old female patient who was administered with an expired dose of Tenivac with no reported adverse events while receiving vaccine Diphtheria-2/Tetanus-5 adsorbed toxoids no preservative adult [Tenivac].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 29-Aug-2022, the patient was administered with an expired dose of Diphtheria-2/Tetanus-5 adsorbed toxoids no preservative adult [Tenivac] (batch/lot number: U6669AA; expiration date: 15-May-2022; formulation, strength, dose: unknown) via intramuscular route in unknown administration site (expired product administered) (latency: same day).  No adverse event was reported following expired product administered.  Seriousness criteria: non-serious  Action taken: not applicable  Outcome: Unknown    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 the guidelines. 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.
Thirteen hours after second does of Moderna Covid - 19 vaccine I experienced fever (low-grade 100.6),  chills, headache, body aches, joint pain, nausea with vomiting.  These symptoms lasted for approximately 7 hours.  Headache, body aches, fatigue and tightness in my chest (with some shortness of breath at times) continued for  48 hours after injection of the vaccine.  Of course, significant arm pain at injection site is present as well.
I started to black out minutes after waking up the morning after administration. In doing so I hit my head on the table resulting in a laceration and 8 staples in my head. I was diagnosed vasovagal syncope while my blood pressure remained low throughout testing at the clinic. That day (5/26) I had chills and a headache. I have had dizziness the past 2 days (5/28 and 5/29).
POTS; Information has been received from a lawyer referring to a 16-year-old female patient regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (strength, dose, lot# and route unknown) for prophylaxis. On an unknown date, the patient experienced postural orthostatic tachycardia syndrome (POTS). Reported date of injury was unspecified date in 2006. The outcome of the event was not reported. The causality assessment was considered as related by the lawyer.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
Temporary hearing loss, 1 ear. Tinnitus. Vertigo. Nausea
Case number PHEH2014US018171 is an initial spontaneous report received from a medical assistant on 08 Sep 2014 with a follow up information received from the medical assistant on 09 Sep 2014. This case was initially reported as a multiple patient case. Upon follow up information, identifiers were reported making this a valid single patient case. This report refers to a 16 years old male patient. His medical history and concomitant medications were not reported. It was reported that MENVEO vaccine had been at 47 F for 10 minutes on 29 Aug 2014. On 03 Sep 2014, the patient was vaccinated with 0.5 ml intramuscular MENVEO (batch number: not reported) which underwent temperature excursion. No adverse event was reported following this administration error. Follow up information received from the medical assistant on 09 Sep 2014: Updated report type, patient demographics (age, date of birth, gender, initials) and vaccination date.
11/07/21 presents to EC ED "w/ weakness and possible syncope earlier today". PMHx "rheumatic heart disease, adrenal insufficiency, presenting with nausea, dizziness"
Sore throat for 24 hours, then runny nose and sneezing for following 7 days, also coughing due to mucus in throat. Pressure in sinuses around eyes.
suspected vaccination failure; got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles anyway. The reporter stated that, it was terrible. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
The patient was bleeding more than usual and had a bump on the injection site. About 5 minutes later, she stated that she was feeling weak and dizzy. We called 911 and had her stay sitting down. EMT measured her vital and it was completely normal. (BP 135/85). About 10 minutes later, she was feeling better and walked out the store.
12/15/09 received shot, 1st wk of Jan. became ill, vomiting constantly, diarrhea, high fever - Dr. prescribed only COMPAZINE, sick for 3 wks, couldn't eat, or drink - constant vomiting. Lost 44lbs.
1 of 2 pts who were vaxed during wk of 12AUG91 w/in 24 hrs, pt reported swelling & redness @ inject site, generalized aches & fever, tx w/ASA & DPH; pt improved; sx not completely resolved; pts vaxed from same vial;
Nine days after the Injection I am now developing redness hardness and itchiness at the site
arm  swelling, rash at site of injecion , treatment _ tylenol and cold compress
Time line: February 25, 2021 ... First vaccine Injection             No side effects March 1, 2021 ... Total Shoulder Replacement March 26, 2021 ... Second vaccine injection March 28, 2021 ... Severe pain at location of surgery.                                           I took pain medicine for relief.                                           In time I noticed the place of incision was getting red. April 20, 2021 ...      The incision point had swollen and was red. I took pictures and sent them to my surgeon.                                           He requested that I come see him that day. April 21, 2021 ...      I was brought to the Operating room for surgery. The incision was cleaned and stitched back up. April 23, 2021 ...     I was brought to the Operating room for surgery. The incision was cleaned and stitched back up. April 26, 2021 ...     I was discharged from the hospital but required to have daily antibiotic infusions for 30 days June 2, 2021 ...        I will finish my infusions today but will be on an antibiotic for 6 months My surgeon and an infectious disease doctor believe the second vaccine attacked the healing process. The extent is somewhat unknown. The infection may have migrated due to the second vaccine
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 4:44 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 4:44 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 26.51  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM, temperature was 34. Total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 PM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
shooting pain, burning immediately p/shot; nausea & vomiting w/in 30 mins (yellow fever inject to lt tricep); swollen erythematous & painful lt arm; body aches, fever, h/a, lt arm pain, redness & swelling p/receiving immun on 9SEP93;
Itching immediately after injection and that same night, first noticed hives surrounding injection site the next morning (documented with photograph), and swelling around both eyes noted next morning. Resolved with 1 dose of benadryl (12.5mg).
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 03-MAR-2014, the patient was vaccinated with ROTATEQ, lot #J007283; expiration date: 27-SEP-2014 (dose and strength 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 vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside 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 degrees 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 temperatures 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 reported. Additional information has been requested.
Erythema, induration (4x5cm) on LT arm, cellulitis, treatment with Keflex 500mg qid given.
localized, red, swollen left arm extending from injection site to elbow. recommended ice pack + ibuprofen for swelling.
Eyes Ached; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (Eyes Ached) and FATIGUE (Fatigue) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced EYE PAIN (Eyes Ached) and FATIGUE (Fatigue). On 04-Feb-2021, EYE PAIN (Eyes Ached) and FATIGUE (Fatigue) 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.   Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021
2 episodes of staring, unresponsive spells, lasting 10-15 minutes, 15 minutes apart. Occurred about 12 hours, post vax. Had otitis externa. Also had a fever of 101.7F at home and 102F in ER
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with improperly stored GARDASIL 9 (lot# L045711, expiration date 07-MAY-2017, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient had a vasovagal syncopal episode with seizure seconds after receiving the vaccine. Checked blood sugar and BP and EKG and everything looked normal. Observed patient in clinic and no problems after.
Fever, large local reaction, orthostatic hypotension, nausea, vomiting, facial swelling.
Within a minute of receiving the shot, I became extremely weak, dizzy, and couldn't stand up.  Whole-body felt cold and clammy, hot to the touch, and underarms and neck became very sweaty. Had to lie down on the floor and elevate my feet on a chair for 20 minutes until I could stand up safely again.  Four hours after receiving the shot, I felt extreme fatigue and soreness all over my body. This lasted for three days.
slight headache; fever; chill; rash on right arm of the injection site; spreading and itching a lot; right arm with the rash 98.7; not relieving the itchiness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (slight headache), PYREXIA (fever), CHILLS (chill), VACCINATION SITE RASH (rash on right arm of the injection site) and PRURITUS (spreading and itching a lot) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced HEADACHE (slight headache), PYREXIA (fever), CHILLS (chill), VACCINATION SITE RASH (rash on right arm of the injection site), PRURITUS (spreading and itching a lot), RASH (right arm with the rash 98.7) and PRURITUS (not relieving the itchiness). At the time of the report, HEADACHE (slight headache), PYREXIA (fever), CHILLS (chill), VACCINATION SITE RASH (rash on right arm of the injection site), PRURITUS (spreading and itching a lot), RASH (right arm with the rash 98.7) and PRURITUS (not relieving the itchiness) outcome was unknown.            He undergoes immunosuppressant therapy for treatment of non Hopkins lymphoma and has also been diagnosed with renal cell carcinoma. His PCP approved the vaccine.
This spontaneous report as received from a registered nurse via company representative refers to a 14 months old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 14-SEP-2016, the patient was vaccinated with improperly stored dose of PEDVAXHIB, lot # L042836 (strength, dosing details, anatomical location and expiration date were unknown) for prophylaxis. The vaccine was purchased via public fund (Medicaid-VFC). On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter source. Additional information has been requested. Sender's Comments: US-009507513-1612USA003706.
First 36 hours after shot: Persistent headache, difficulty swallowing and difficulty breathing,  prickly heat, chills, joint pain, muscle aches, dizziness, Brain fog and disorientation.  Woke up the next day 11/18/2021 and I my whole body was swollen. As of 11/23/2021 joint & muscle pain has abated to my normal level, still have a constant headache, dizziness, difficulty concentrating and focusing.
after 18 days I am still having night sweats, muscle aches, disturbed sleep, chills, headaches, low grade fever, nausea & fatigue.
she had threw up for 3 to 4 times; have went to the washroom twice; Initial information received on 12-Sep-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (healthcare professional).  This case involves a 81 years old female patient who had threw up for 3 to 4 times and have went to the washroom twice after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Food allergy.   On 11-Sep-2023, the patient received 0.5 ml dose of suspect influenza vaccine produced by unknown manufacturer via unknown route in unknown administration site for immunization (strength, formulation, batch number and expiry date: unknown). Information on the batch number was requested  On an unknown date the patient had she had threw up for 3 to 4 times (vomiting) and have went to the washroom twice (diarrhoea) (unknown latency).  Reportedly, Patient was suspecting that the FLU VACCINE had pork that may have caused her symptoms, but after knowing that the FLU VACCINE does not have any pork component, patient told staff that maybe she ate a lot of chocolates that caused the vomiting and diarrhoea staff confirmed that the patient is not allergic to chocolate.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (vomiting, diarrhoea).  Outcome was Unknown for the event vomiting and diarrhoea.
Right after the shot I had flu like symptoms. I came in contact with someone who tested positive for COVID on 08/25/2021. I was put in quarantine and I felt like I was having pneumonia. I went to the doctor, and they tested me for COVID. The rapid test came back negative but the PCR came back positive.
Pain in the armpit on side of the injection. Most severe pain (6/10) on days 2 and 3 with pain slowly subsiding on the days thereafter. Still experiencing mild paid on day 7. Some swelling of the armpit was visible during more painful days.  Additionally, red blotchy rash about 2x4 inches at injection site developed 5 days after the shot. The rash is itchy, painful, and swollen. The rash is continuing to grow on its 4th day.
Right foot fell asleep; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on 31Mar2021(at the age of 39-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included birth control pills (MANUFACTURER UNKNOWN) for unspecified indication from unknown date. Prior to the vaccination, the patient was not 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 31Mar2021, on date of injection, the patient right foot "fell asleep" throughout the day, it was relieved when the patient got up and walked around but reoccurred when seated for an extended period of time. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event paraesthesia foot was unknown at the time of reporting.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
PATIENT STARTED HAVING NECK PAIN THE NEXT DAY AFTER GETTING THE VACCINE.  TWO DAYS LATER, THE PAIN MOVED TO HER LOWER BACK AND LEFT SHOULDER.  THE NECK PAIN CONTINOUED FOR ABOUT 10 DAYS WITH LIMITED NECK MOVEMENT