chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Back started hurting really bad; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back started hurting really bad) 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 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 BACK PAIN (Back started hurting really bad). At the time of the report, BACK PAIN (Back started hurting really bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provider by the reporter.  Treatment information was not provided.
Didn't eat a whole lot; It was just so hot; Couldn't keep anything down; Wasn't feeling all that great; Extreme nausea; Lot of stools; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Mar2021 09:30 (Lot number: ER8730, Expiration Date: 31Jul2021) at the age of 66 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, Administration time: 09:30, Lot number: EN6205, Expiration Date: 30Jun2021), administration date: 02Mar2021, when the patient was 66 years old, for COVID-19 immunisation. The following information was reported: NAUSEA (non-serious) with onset 26Mar2021, outcome "unknown", described as "Extreme nausea"; FAECAL VOLUME INCREASED (non-serious) with onset 26Mar2021, outcome "unknown", described as "Lot of stools"; DECREASED APPETITE (non-serious) with onset 27Mar2021, outcome "unknown", described as "Didn't eat a whole lot"; FEELING HOT (non-serious) with onset 27Mar2021, outcome "unknown", described as "It was just so hot"; VOMITING (non-serious) with onset 27Mar2021, outcome "unknown", described as "Couldn't keep anything down"; MALAISE (non-serious) with onset 27Mar2021, outcome "unknown", described as "Wasn't feeling all that great".  Additional information: The patient hasn't had any gagging. The patient had no additional vaccines administered on same date of BNT162B2. The patient had not received any other vaccines within 4 weeks prior vaccination. The events did not require a visit to ER or Physician office.   No follow-up attempts are possible. No further information is expected.
Throat burning; Nose and throat burning; Nose and throat burning and sore; Unable to poop but feel like stomach may have diarrhea; Warm no fever; Fingertips were tingly.; Stomach pains; Nose and throat burning and sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 24May2021 11:45 (Batch/Lot number: unknown) at the age of 36 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TRINTELLIX. The following information was reported: THROAT IRRITATION (non-serious) with onset 24May2021 14:30, outcome "not recovered", described as "Throat burning"; NASAL DISCOMFORT (non-serious) with onset 24May2021 14:30, outcome "not recovered", described as "Nose and throat burning"; RHINALGIA (non-serious), OROPHARYNGEAL PAIN (non-serious) all with onset 24May2021 14:30, outcome "not recovered" and all described as "Nose and throat burning and sore"; CONSTIPATION (non-serious) with onset 24May2021 14:30, outcome "not recovered", described as "Unable to poop but feel like stomach may have diarrhea"; FEELING HOT (non-serious) with onset 24May2021 14:30, outcome "not recovered", described as "Warm no fever"; PARAESTHESIA (non-serious) with onset 24May2021 14:30, outcome "not recovered", described as "Fingertips were tingly."; ABDOMINAL PAIN UPPER (non-serious) with onset 24May2021 14:30, outcome "not recovered", described as "Stomach pains". Therapeutic measures were not taken as a result of throat irritation, nasal discomfort, rhinalgia, constipation, feeling hot, paraesthesia, abdominal pain upper, oropharyngeal pain.  Additional information: On 24May2021 at 14:30, the patient experienced nose and throat burning and sore. Stomach pains. Unable to poop but felt like stomach may have diarrhea, warm no fever. Fingertips were tingly. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. 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.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
I started experiencing symptoms Left arm pain not at injection site.  It was on the under side of my arm through the collar bone area. Month after the vaccine I noticed that there was pain to these areas.  It still continues to hurt.  Pain feels like there's something there like a pinch or a pull. Saw the doctor a few times for these symptoms after my injection.
27, Feb 2021  Received Pfizer vaccination #1 at center 11, Mar 2021  Took a friend to center for her Pfizer vaccination #2 - Noticed I was very winded walking to center, and climbing stairs in - Figured . . . out of shape 12, Mar 2021  Aspirated a grain of rice, coughed up after 30 minutes 16, Mar 2021 Saw my PCP, Dr.  Chest x-ray negative. Prednisone 70 mg, decreasing daily 20, Mar 2021 Received Pfizer Vaccination #2 at clinic - Knew I was having more difficulty breathing.  Rode in the golf cart to clinic, and then wheelchair into the clinic. 21, Mar 2021 Bought a Pulseox meter, low 90?s ? high 80?s 23, Mar 2021 Called Dr.  given samples of Trelegy.  Only used twice. 25, Mar 2021 Pulseox low 80?s ? high 70?s 26, Mar 2021 Woke up on kitchen floor.  Estimated 2-3 hours unconscious. - Called 911 - Taken to  Hospital  26, Mar-09 Apr  Diagnoses:        2021  - Multiple Subsegmental Pulmonary Emboli w/o Acute Cor Pulmonale    - Aspiration pneumonia of both Lower Lobes    - Acute Hypoxemic Respiratory Failure      - Acute eosinophilic pneumonia      - Ground glass opacities - Laceration to the head, 2 ½ inch, 11 staples - Developed an allergy to Heparin = Thrombocytopenia 09, Apr 2021  Readmitted to hospital; Diagnoses ? - Autoimmune hemolytic anemia - Hypoxia Heart Failure w/ Preserved Ejection Fraction  14, Apr 2021  Discharged 27, Apr 2021  Saw Dr., monitoring blood work q1wk 05, May 2021 Saw Dr. 20, May 2021 Pulmonary Test 24, May 2021 Saw Dr., Rheumatologist. Released from care. 01, June 2021 Saw Dr.  monitoring blood work q2wk 02, June 2021 Last dose of Prednisone and Atovaquone Oral Suspension 05, June 2021 Saw Dr.  Chest x-ray. Mid ? July 2021 Noticed I was not lightheaded, for 5-10 seconds, after getting up and did not get as winded after light/moderate exertion. 03, Aug 2021  Saw Dr.   Pleased with progress.  See in 3 months 12, Aug 2021  Saw Dr.   Pleased with progress.  See in 6 months  18-19, Aug 2021 Noticed trouble getting my breath; Pulseox low 90?s-high 80?s 20, Aug 2021  Called Dr.   Sent for out-patient chest x-ray and blood work - Told to go to hospital.  Both were not taking new admissions. 20, Aug 2021 Admitted to Hospital, Diagnoses:  Acute Hypoxemic Respiratory Failure PNA - Received: o Echocardiogram (talk of an additional ?bubble test?, did not have) o Bronchoscopy ? blood found in both lower lobes of the lungs o Viral and Bacterial pneumonia ruled out 27, Aug 2021  Discharged.  Medications added: - Prednisone 70 mg qd for 1 week, then decrease by 10 mg each week - Atovaquone Oral Suspension 10 mg daily while on Prednisone
Information has been received from a registered nurse concerning an unspecified number of patients. The patients' pertinent medical history or drug reactions/allergies were not reported. On unspecified dates from 11-FEB-2015 to 25-JUN-2015, the patients might have received one of the vaccinated with improperly exposed PROQUAD (Merck) (subcutaneous, lot: K018144; expiration: 10-APR-2016 and lot: K010210; expiration: 17-JAN-2016 and lot: K009470; expiration: 03-JAN-2016 and lot: K018142; expiration: 10-APR-2016). These vaccines were exposed to 17 Fahrenheit degree for an unspecified length of time. No adverse effects were reported. This is one of several reprots received from the same reporter. Additional information has been requested.
None we know of. Given Adult Hep A should have received Peds Hep A.
Baby latching on and well until time of hep B shot. Then slept virtually from ~ 2 1/2 hrs later until 14 1/2 hrs later since then screaming, won't nurse, lost wt. Mother w/excellent supply of milk, pumping for baby now. Baby regaining wt w/ syringe feeds 48 hrs after vax given.
Case number PHEH2015US021775, is an initial spontaneous report from a consumer received on 26 Oct 2015. This report refers to a 59 years old female patient. Concurrent condition included celiac disease. Concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly on 22 Oct 2015. On the same day after vaccination the patient experienced runny nose in the night. On 23 Oct 2015 the patient experienced tongue swelling and "map" on her tongue. The patient states she only experiences this event when she receives gluten. Further the patient also experienced diarrhea and vomiting (severe). It was reported that the patient never had these reactions in the past after influenza vaccination. Outcome of swollen tongue was condition unchanged and outcome of other events were unknown. Seriousness and causality of the events were not reported. Seriousness assessment of swollen tongue was upgraded based on information in the source document. The case was lost to follow-up as the patient declined to provide HCP contact information.
Joint pain; Accident with dog; Broke in location where could not have surgery; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENT (Accident with dog), FRACTURE (Broke in location where could not have surgery) and ARTHRALGIA (Joint pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In November 2021, the patient experienced ACCIDENT (Accident with dog) and FRACTURE (Broke in location where could not have surgery). On an unknown date, the patient experienced ARTHRALGIA (Joint pain). At the time of the report, ACCIDENT (Accident with dog) and FRACTURE (Broke in location where could not have surgery) was resolving and ARTHRALGIA (Joint pain) had resolved.            No concomitant medication provided. No treatment information mentioned.  Patient took the booster dose of Moderna COVID vaccine. Experienced joint pain and in NOV2021, had an accident involving the dog and got a fracture in a location where they could not get surgery.  Reporters causality of events with Humira was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Vesicular rash at site of injection, appeared 6 days, post vax, about 2.5cm.
headache left side of my head, from the front to the back (every single day) since 5 days after my second dose, left eye with blurry vi sion at night time (since 2 weeks after) dizziness and nausea (like twice a week)
12/31/2021- Covid symptoms started with runny nose, sneezing, coughing, not much of an appetite, generally not feeling great, and maybe a headache but no fever or shortness of breath. Symptoms lasted about 5-7 days. Tested positive on 01/03/2022. I still have sinus issues but it's normal for me, and I took another test just incase and it was negative.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns an 85 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 15-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 15-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
PATIENT RECEIVED HIS BOOSTER THIRD DOSE OF PFIZER VACCINE AT 4:45 PM, HOWEVER THE VACCINE DOSE EXPIRED AT 4:05 PM. PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS WHILE IN HIS OBSERVATION PERIOD.  THE ERROR WAS NOTED AT 4:40PM.
-Employee arrived at work this morning and reported the following current symptoms: Dizzy, GI upset, fatigue, nausea, soreness at injection site - VS: 98.0-125/75-93 - Left arm assessed:  full range of motion, radial pulse present and  no redness, warmth or swelling noted - Employee was dismissed from duties today and instructed to seek medical care
Patient received the 2nd dose 12 days early; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 2nd dose 12 days early) in a 68-year-old male patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 2nd dose 12 days early). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 2nd dose 12 days early) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were provided.
Massive stomach cramping; Extreme nausea/dizziness; Extreme nausea/dizziness; Could not get out of bed; Chills; Major vomiting/diarrhea; Major vomiting/diarrhea; 102 fever; This is a spontaneous report from a contactable other hcp (patient).   A 54-years-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 29Sep2021 18:30 (vaccination age was 54 years old) (Lot Number: 30145BA) as DOSE 2, SINGLE for covid-19 immunisation. Facility type vaccine: Pharmacy or Drug Store. Medical history included breast cancer from 2018 and no information about if ongoing , HASHIMOTO from 2006 and no information about if ongoing, BARRETT'S ESOPHOGUS from 2019 and no information about if ongoing.  No known allergy.Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 08Sep2021 11:30 AM (Lot Number: Ff2587) as DOSE 1, SINGLE for covid-19 immunisation. No other other vaccine in four weeks.Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported; loratadine taken for an unspecified indication, start and stop date were not reported; tamoxifen taken for an unspecified indication, start and stop date were not reported; famotidine taken for an unspecified indication, start and stop date were not reported and unspecified Flut.  On 30Sep2021 07:00 PM, the patient experienced massive stomach cramping for over 48 hours and recovered in Oct2021 (medical significant), 102 fever and recovered in 2021, chills and recovered in 2021, major vomiting/diarrhea for 18 hours and recovered on 01Oct2021 13:00, could not get out of bed for over 18 hours and recovered on 01Oct2021 13:00, extreme nausea/dizziness for over 24 hours and recovered in Oct2021 (medical significant), could not keep water down for 18hours.  The patient underwent lab tests and procedures which included body temperature: 102 on 30Sep2021.  No covid tested post vaccination.Therapeutic measures were taken as a result of massive stomach cramping, extreme nausea/dizziness, 102 fever, chills, major vomiting, diarrhea, could not get out of bed, as receiving Zofran and advised to get plenty of rest/fluids.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events abdominal pain upper, nausea, dizziness, and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Client noticed "freckle-like rash on feet and ankles @ 8 am on 8-15-08. Denies itchiness,described as "too many to count".
Expired Fluarix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 42-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2021-2022 season) (batch number HZ2JR, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   In October 2022, the patient received Fluarix Tetra 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. In October 2022, unknown after receiving Fluarix Tetra 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-NOV-2022 Reporter's Comment: The reporter wanted to know from the lot number if that was the accurate expiration date. So this expired vaccine was administered this month.  The reporter wanted to know was there a recommendation from GSK (GlaxoSmithKline) about revaccinating with a flu vaccine that was not expired for this flu season. The reporter did not have the exact date of administration, only that it was administered in October of this year.  The reporter consented to follow up via postal. Additional Supportive Information: The patient was administered with expired dose of Fluarix Quadrivalent 2021-2022 season, which led to expired vaccine used.
red rash began on R thoracic region about three weeks after administration of FLULAVAL QUAD flu vaccine. The rash became very extensive over my lateral R thoracic area, and spread up to mid chest and lower abdomen, consisting of closely spaced numerous red, raised, fluid-exuding papules. The rash was present for over a month before resolving. The FLULAVAL QUAD vaccinated was administered on the same day as my third Pfizer Covid-19 vaccination, in the opposite deltoid. However, I had no adverse reactions to either of the first two Pfizer vaccinations. Administered on Oct 5, 2021 Manufacturer: ID Biomedical Product: FLULAVAL QUAD 2021-2022 (PF) Lot #: 3A9ZG NDC: 19515-818-41 Dose: 0.5 mL Route: Intramuscular Site: Right deltoid Location: INTERNAL MEDICINE
This spontaneous report as received from a health care worker (office manager) refers to an unspecified amount of patients of unknown age. On unknown dates the patients were vaccinated with M-M-R II (lot # reported as J010158, expire date 06-SEP-2015) (dose and route not reported). The office manager stated this temperature excursion was supported and the vaccines were out of range for approximately 3 hours. This is one of several reports received from the same source. Additional information has been requested.
Patient states she had the following symptoms -throat swelling -rash neck/chin -fever -diarrhea  -swollen lymph node She said all this happened the day before and that she slept for the rest of the day. 4 days later she is much better and not showing any symptoms
Gross Hematuria that lasted 2 months.  Sudden onset of muscle passin and fatigue on 3rd day after vaccination.  No treatment. Told to drink a lot of water. When I said that the vaccine caused this condition it was ignored at the medical facilities that I went to for this issue.  It resolved itself after a full 2 months.
Patient fainted 5 minutes after receiving first dose of Moderna COVID-19 vaccine.  Experienced low heart rate (96/53 100) and shortness of breath.  Patient given water and monitored for an hour checking oxygen levels and blood pressure.  EKG given, showing slight abnormality.  Patient felt better, recommended to contact PCP and see cardiologist for follow up.
Case number PHEH2014US003827 is an initial spontaneous report received from a pharmacist on 24 Feb 2014: This report refers to an 84-year-old female patient who was inadvertently vaccinated with MENVEO (batch number: unknown) intramuscularly at a dose of 0.5 ml on 07 May 2013. No adverse event was reported following this administration error (inappropriate age at vaccine administration).
Pt received PNEUMOVAX on 12-01-08. came to the office on 12-04-08  with (R) arm red, swollen warm to touch and with fever of 101. Dr informed and recommends Benadryl, cold compress and fever reducer. F/U with Dr on 12-05-08 if no better.