chrisvoncsefalvay/vaers-outcomes huggingface dataset:
21 y/o female seen in ER 13 May with C/O it hand & lt. foot numbness approximately 1 month post GARDASIL vaccine. She also C/O of nausea, vomiting and diarrhea. A heat CT demonstrated bilateral basal ganglion infarcts and a MRI showed with similar results with no acute process. She was admitted 20 May with left hemiballsmus. On 22 May her mental status declined. She received many doses of HALDOL and ATIVAN for agitation and was intubated on 28 May. She was transferred to medical center 28 may for w/u for encephalitis and has since become comatose. Symptoms: Nausea w/vomiting, Diarrhea, Nausea w/o vomiting, Numbness.  7/11/08 Reviewed hospital medical records for 6/11-6/23/2008. FINAL DX: aseptic meningo-encephalitis; choreoathetosis r/t meningo-encephalitis; paroxysmal autonomic instability w/dystonia; e. coli UTI. Records reveal pt transferred from military hospital.  Military deployment 1-3/2008.  On leave 5/2008 developed n/v/d, abd pain & bifrontal HA which continued to worsen.  Sought medical help but no dx given.  Developed left side weakness, flaccidity & several falls.  Found 5/12 unable to ambulate & incontinent of urine.  Taken to ER where MRI revealed possible basalganglia infarct.  To ICU where subsequent MRIs were WNL.  Ventilated & remains in persistent vegetative state.  LPs done.  PICC , trach & PEG tubes.  Intermittently febrile, labile BP, asystole x2.   Tx in multiple hospitals w/multiple meds including steroids, IVIG, antibiotics & antivirals.  12/11/08 Reviewed additional medical records of 5/08-7/08. FINAL DX:  Records reveal patient experienced nausea/vomiting/diarrhea, dizziness & HA, left hand/foot numbness x 4-5 days.  Seen in ER on 5/13 where labs were WNL but CT of brain revealed lacunar infarcts, bilateral basal ganglia & cavum verge.  Numbness continued & developed involuntary jerking of LEs & difficulty walking.  Admitted to MICU 6/08 w/encephalitis.  Tx w/IVIG & steroids.  Transferred to higher level of care & then to inpatient rehab program.
per moc pt got vaccines on Tuesday and now has a lump, red, swollen and tender     Comments: left leg red raised bump after vaccines received MMRV vaccine at this location (was second vaccine received in this series)
6 hours after vaccine the patient had was burning, itching and tingling on palms. Mouth itchy and eyes also itchy. Patient went to the ER and they told her to take Benadryl.
cancer; This case was reported by a pharmacist via call center representative and described the occurrence of cancer in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced cancer (serious criteria GSK medically significant). On an unknown date, the outcome of the cancer was unknown.   It was unknown if the reporter considered the cancer to be related to Shingrix.  Additional information was reported as follows: The age at vaccination was not reported. The patient was diagnosed with cancer so the patient did not get 2nd dose of Shingrix. The reporter asked, should the patient start over or just get the second shot even though it had been over one year.
Persistent shoulder and upper arm pain. Ortho consult, currently doing PT to regain range of motion.
Information has been received from a physician concerning a female with a history of obesity who on 19-FEB-2008 was vaccinated with a first dose of GARDASIL (lot # not reported) and has not menstruated. Concomitant therapy included MENACTRA (lot # not reported). The parent placed a call to the physician's office on 28-APR-2008 the notify and inquire about the situation. Pregnancy has not been determined. Patient outcome was not reported. Additional information has been requested.
My arm is red and sore. Large area has developed under injection site in right arm that is swollen, red, hot to touch, and very painful. I developed flu like symptoms within 2 hours or receiving the vaccine which lasted for 48 hours, which included fever, body aches all over, tiredness and general malaise.
Sore arm; Low grade fever 99.3; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PYREXIA (Low grade fever 99.3) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001V21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and PYREXIA (Low grade fever 99.3). On 15-Mar-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, PYREXIA (Low grade fever 99.3) outcome was unknown.            No relevant concomitant medications were provided.  Reportedly, the arm was sore for 1.5 days. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow up received on 5-MAY-2021. no new information
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown ages and gender. On an unknown dates the patients were vaccinated with a dose of (Oka/Merck) VARIVAX (dose, route, and lot number not provided) that was improperly stored and exposed to temperatures outside the storage range in the prescribing information. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
I had COVID the first time, in January of 2022; I had COVID the first time, in January of 2022; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Jan2021 as dose 1, single (Lot number: EL0142), on 28Jan2021 as dose 2, single (Lot number: EN5318) and on 30Sep2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 49 years for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "I had COVID the first time, in January of 2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: treatment of COVID-19. Therapeutic measures were not taken as a result of vaccination failure, COVID-19.  Additional information: The patient had no known allegrgies.; Sender's Comments: Based on the available information in the case, the causal association between the events vaccination failure, COVID-19 and the suspect drug cannot be excluded.
Left middle finger acutely became swollen  and discolored.  There was no injury to that hand or finger to have caused this Pernio-like lesion on that finger?   This was after receiving a booster dose of Pfizer covid vaccine.  2 days later swelling has improved but discoloration/bruising still present.
Spotted rash on both arms extending the full length of the arms appearing several days- 1 week after receiving vaccine.  Was prescribed prednisolone by doctor and was referred to dermatologist
None- vaccine given 17 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 17 days post expiry) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 17 days post expiry). On 23-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 17 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-395985 (Patient Link).
headache; chest pain; I received my 1st dose 29Jan. I tested positive 07Feb; This is a spontaneous report from a contactable unspecified age female Consumer communicated to a Pfizer colleague that the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 29Jan2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that she lives with her boyfriend and her16-year-old daughter. While she did quarantine after diagnosis, she spent a lot of time with her boyfriend prior to her diagnosis. He tested negative when they should have been positive. The patient's daughter also was with her, in very close quarters for several hours (a car for well over 3 hours) and her daughter also tested negative. The patient was 6 days post diagnosis and felt almost normal again. The patient chest pain and headache on an unknown date. On 07Feb2021, she tested positive.  The outcome of the events was unknown.  Information on the lot/batch number has been requested.
getting real bad headaches; She could not sleep last night since she was itching real bad, all over hair and body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (She could not sleep last night since she was itching real bad, all over hair and body) and HEADACHE (getting real bad headaches) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 933901) for COVID-19 prophylaxis.     The patient's past medical history included Leg pain.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced PRURITUS (She could not sleep last night since she was itching real bad, all over hair and body). On 03-Sep-2021, the patient experienced HEADACHE (getting real bad headaches). At the time of the report, PRURITUS (She could not sleep last night since she was itching real bad, all over hair and body) and HEADACHE (getting real bad headaches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   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
Patient presented 2 days fever, malaise, temperature was 101 degrees.  Patient was dehydrated.
received a third dose; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number Z42G4, expiry date 26th August 2023) for prophylaxis.   Previously administered products included Shingrix (the patient received 2nd dose of Shingrix in 2018).   On 6th April 2022, the patient received the 3rd dose of Shingrix. On 6th April 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 06-APR-2022 Additional Supportive Information: The patient received a third dose of Shingrix, which led to extra dose administered. The reporter consented to follow up.
titers levels were less than 25; This spontaneous report was received from a 51 year old male patient regarding himself. The patient had no pertinent medical history, no concurrent conditions, no concomitant medications and no drug reactions or allergies.      On 07-MAY-2019, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, (lot # R029513 with an expiration date in 14-OCT-2020), therapy type (rHA) 1 dose, for prophylaxis (strength, dose, frequency and route were not provided).         On 02-JUL-2019 ,the patient underwent a blood drawn for titer levels and the result showed that his titers levels were less than 25" after receiving the  dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (viral titre decreased). Moreover, it was also reported that the patient sought for medical attention, but no treatment was prescribed for the experienced event.     At the time of reporting, the outcome of viral titre decreased was reported as not resolved.    Causality assessment was not provided.
Patient was vaccinated with LOT FL8095 on 09/13/2022  that has expired on 08/31/22
Received Flucelvax Quadrivalent and has now developed Flu; This is spontaneous case initially reported by other health professional to agency (reference number: SEQ19-07513) on 18-Dec-2019, concerning 21-year-old male patient.  The patient's medical history and concomitant medications were not reported.  On 26-Sep-2019, the patient was administered Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent; batch number: 261204; expiry date: 26-Jun-2020; route of administration: intramuscular; anatomical location: left deltoid] for influenza prophylaxis.   On 17-Dec-2019, 81 days after vaccine administration, the patient was diagnosed with flu at Urgent Care and was treated with Tamiflu (oseltamivir phosphate).   At the time of initial reporting, the outcome of event was ongoing.  The event of flu was considered serious due to the criterion of medical significance per company.   The reporter did not provide causality assessment.  Company comment: The patient experienced influenza (reported as flu) associated with Flucelvax QIV. Reportedly, 81 days after vaccine administration, the patient was diagnosed with flu at Urgent Care and was treated with Tamiflu (oseltamivir phosphate). Chronology seems plausible. The patient's medical history and concomitant medications were not provided. With information provided, causality is assessed as possibly related.; Sender's Comments: The patient experienced influenza (reported as flu) associated with Flucelvax QIV. Reportedly, 81 days after vaccine administration, the patient was diagnosed with flu at Urgent Care and was treated with Tamiflu (oseltamivir phosphate). Chronology seems plausible. The patient's medical history and concomitant medications were not provided. With information provided, causality is assessed as possibly related.
Pt. states that after receiving the 1st dose of Shingrix 12/24/2021, started experiencing symptoms 12/26/2021 of loss of voice, decreased mobility in throat, muscle aches, itchiness at the injection site, and headache. Primary visit 12/27/2021 with recommendations of Prednisone and Antibiotic. Swelling appeared under the chin into facial are, Emergency Room visit 12/28/2021 treated with IV Dextrose with Follow-Up with Primary. Improvement with Prednisone use with loss of voice remaining. Diagnosed with Dysesthesia. 01/03/2022 Follow-Up appointment with Primary scheduled.
Pt arrived to facility for 2nd dose of COVID vaccine. Noted by Dr, data entry position, that patient is 11 yrs old. COVID vaccine currently approved for ages 12 and up only. System documentation, administered the Pfizer vaccine to patient. RN team lead, RN program coordinator, and Dr, program medical director notified. Per Dr. order, pt. parent informed of above. Pt parent instructed to bring pt. back for 2nd dose when she turns 12. Reassurance offered no harm will come to pt. RN notified, Administered vaccine to minor child not eligible for vaccine. Incident report reviewed will be pulled from administering vaccine at Health site.
pt stated that about an hour after she got the vax she had severe headache, extremely tired and pain in right leg muscle.  On 2/20/21 all symptoms were gone except the pain the the right leg between her hip and knee on the outside of the leg.   On 2/26/2021 she went to the ER.  They did Covid Test, EKG, Chest X-ray and blood work. All test were negative.  She was released to go home.  On 3/4/2021 she woke up and her right leg had turned black and blue.  She call 911 and taken to the ER where they did blood test, EKG, Chest Xray, CT, Spine Xray and US to see if she had any blood clots.  She did not have any blood clots and all test were negative.  Pt was released to FU w/ her PCP on 3/12/21.  He took more blood work.  Pt was told to drink water take more vitamin D. Pt still has some pain.
Moderna COVID-19 Vaccine EUA About 30 minutes after receiving the vaccine she felt dizzy and lightheaded and felt like she was going to pass out.  She is a type II diabetic but they did not have any ability to check her blood sugar at employee health.  Therefore, rapid response team was called and patient was brought here to the emergency department.  Patient notes that she has had a couple of syncopal episodes in the past in her life and has had several near syncopal episodes.  Upon arrival to the ED her blood sugar was noted to be 99.  She is feeling little bit better but still just a little bit dizzy.  She was completely and entirely asymptomatic prior to getting the vaccine shot.  She has not been ill lately.  BP 116/68  | Pulse 62  | Temp 36.7 °C (98.1 °F) (Oral)  | Resp 15  | Ht 1.524 m (5')  | Wt 229 lb 8 oz (104 kg)  | SpO2 100%  | BMI 44.82 kg/m² 69-year-old female presented to the emergency department following a near syncopal episode after getting her COVID-19 vaccine.  She is normotensive, not tachycardic, tachypneic or hypoxic.  She has a normal physical exam and normal cardiopulmonary exam.  Lab work-up shows a mild chronic anemia with a hemoglobin of 9.9.  BMP, chest pain panel normal.  EKG was normal.  Patient was kept on cardiac monitoring and given oral fluids.  We then got her up and she was ambulatory without symptoms and without difficulty. Therefore, this appears to be a vasovagal near syncopal episode that has resolved.  Work-up here is negative.  No further work-up is indicated.  Will discharge home, rest, fluids, cautioned her that she might feel poorly for a day or 2.  Follow-up with primary care as needed.  Return for worsening symptoms.
Immediate and persisting pain in (R) shoulder at FLUVAX site followed by diffuse severe polyarthralgia.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 13-MAR-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 13-MAR-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 13-MAR-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 13-MAR-2022) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2022 at 12:08 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-Mar-2022 at 12:08 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 13-MAR-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 13-MAR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 13-MAR-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 13-MAR-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not reported. It was reported that a series of patients approximately 540 patients received vaccine of lot number 066H71A past its 30 days expired date. Vaccines went into 2-8 degree Celsius thaw state on or above 24-Dec-2021. This vaccine was administered up until its Mfg Exp date of 04-Apr-2022. Patient received booster on 13-Mar-2022 at 12:08:59. Treatment information was not provided.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    Concurrent medical conditions included Ulcerative colitis and Plaque psoriasis. Concomitant products included MESALAMINE for Ulcerative colitis.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate Free. In February 2021, the patient experienced COVID-19 (COVID-19). In 2021, COVID-19 (COVID-19) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Humira causality as per reporter was reasonable possibility for event COVID-19. No treatment medications were reported.  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.  Company comment: This is a spontaneous case concerning a 63-year-old male patient with Plaque psoriasis and ulcerative colitis on treatment with Adalimumab, who experienced the non-serious unexpected AESI COVID-19, on the same month after the first dose of mRNA-1273.  Clinical course, diagnostic tests and treatment details were not provided. Adalimumab was reported as a co-suspect product. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: Company comment: This is a spontaneous case concerning a 63-year-old male patient with Plaque psoriasis and ulcerative colitis on treatment with Adalimumab, who experienced the non-serious unexpected AESI COVID-19, on the same month after the first dose of mRNA-1273.  Clinical course, diagnostic tests and treatment details were not provided. Adalimumab was reported as a co-suspect product. The benefit-risk relationship of mRNA-1273 is not affected by this report.