chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19 virus test positive; COVID-19 virus test positive; fatigue; Therapy Dates/Duration : 06Aug2021-06Aug2021 - 07Aug2021- 07Aug2021; This is a report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4494146-00.  A 57-year-old female patient received BNT162b2 (BNT162B2), on 06Aug2021 as dose 1, single (Batch/Lot number: unknown) and on 07Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 57 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1163895), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious) with onset 07Aug2021, outcome "unknown", described as "Therapy Dates/Duration : 06Aug2021-06Aug2021 - 07Aug2021- 07Aug2021"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19 virus test positive"; FATIGUE (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. The action taken for adalimumab was dosage permanently withdrawn.  The reporter considered "covid-19 virus test positive" and "fatigue" related to BNT162b2. The reporter's assessment of the causal relationship of "therapy dates/duration : 06aug2021-06aug2021 - 07aug2021- 07aug2021" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.   Clinical course: The reporter's causality for the event(s) of COVID Positive with Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of tired was not provided. It was unknown if the patient was enrolled in a COVID-19 Vaccine Trial.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Drug ineffective, covid 19, off label use and fatigue with the suspect product BNT162b2 cannot be excluded. The case will be reassessed once new information is available.
My Rheumatologist suggested I report this:: I had no side effects other than a sore arm and some tiredness up until approx 6 hours after the injection. At approx 8:30 PM, I was lying in bed and both of my legs from the hips down started to shake violently. It did not feel like the chills as I was not cold and the rest of my body was unaffected. The shakes felt completely involuntary as if my brain was short circuiting. My legs shook so violently that my hip joints began to really hurt. Shaking lasted less than 30 minutes total. I am not sure what stopped the shaking, but I had tried to put my body weight over my legs  (body folded in half) to try to stop the shaking and took 1 regular strength tylenol.  After the shaking ended, up until I went to sleep (maybe 3-4 hours later) I felt some numbness and tingling in my finger tips and feet.  The next day, I felt fine but emailed my Rheumatologist to report the shaking and she directed me to report it here.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE PERIPHERAL NEUROPATHY ACUTE PERICARDITIS, UNSPECIFIED
Pt left the clinic around 1230 after having a physical and vaccines. Pt received Varicella, Polio, Tdap, and MMR Vaccines. Nurses' station was called at 1238 from clerical stating pt was "not feeling right." As RNs were making their way to the lobby, a CODE was called on the intercom.  An interpreter was with the pt and her mother the entire time. APNs were present at 1239 along with 4 RNs. Vitals were taken at 1240. BP 97/65, Pulse 89, Respirations 21, and SpO2 98%.  Pt never lost consciousness. Pt was given water and juice to drink. Mother stated pt had only eating cereal that morning. By 1245, pt was feeling much better and was able to answer questions. Vitals taken again at 1250. BP 108/74, Pulse 96, SpO2 99%, and Respirations 18. Event was resolved at 1253. Pt instructed to wait 10  minutes in the lobby before standing up.
Information has been received from a pharmacist concerning an 82 year old male patient who on 07-MAR-2007 was vaccinated SC with a dose of ZOSTAVAX vaccine (Merck). On approximately 07-MAY-2007, two months after vaccination, the patient developed an outbreak of herpes zoster on his back. The patient was examined by his physician and was prescribed a course of VALTREX. At the time of report, the patient was not recovered. A product quality complaint was not involved. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 6/14/2007.  Additional information has been received from the pharmacist who stated that the outbreak of shingles was a normal occurrence to a live vaccine. No further information is expected.
Patient said she felt dizzy, slight trouble breathing, crying.  Did not turn into an allergic reaction.  ER said patient probably had symptoms triggered by anxiety - did not suspect an allergic reaction.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergic reaction to antibiotics (Azythromycin). Concomitant products included SPIRONOLACTONE for an unknown indication.   On 08-Apr-2021, the patient 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 received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.            The patient took COVID-19 Treatment with unknown product from 15-May-2022 to 19-May-2022. On 27-May-2022, the patient had body aches, fatigue, runny nose, congestion, sore throat, sinus pain and pressure. Device date :01-Jun-2022.  Company comment: This spontaneous case concerns a patient of unknown age and gender with no reported medical history who experienced the unexpected non serious AESI of COVID 19 which occurred unknown days after the administration of third dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received an unspecified drug as treatment for COVID 19 from 16-May to 19-May. Approximately 8 days later the patient had body aches, fatigue, runny nose, congestion, sore throat, sinus pain and pressure. Details regarding event outcome, investigations and further treatment are not available. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no reported medical history who experienced the unexpected non serious AESI of COVID 19 which occurred unknown days after the administration of third dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received an unspecified drug as treatment for COVID 19 from 16-May to 19-May. Approximately 8 days later the patient had body aches, fatigue, runny nose, congestion, sore throat, sinus pain and pressure. Details regarding event outcome, investigations and further treatment are not available. The benefit-risk relationship of mRNA-1273 is not affected by this report.
This spontaneous report was received from a consumer referring  to  himself, the patient age was not provided.  Information regarding the patient's medical history, concomitant medications, drug allergies or reactions was not provided. On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for prophylaxis (strength, dose, frequency, administration route, lot number and expiry were not provided). On 22-SEP-2020, the patient was vaccinated with Varicella zoster vaccine rge (cho)(SHINGRIX) and Influenza vaccine(FLU) (strength, dose, frequency, administration route, lot number and indication were not provided). On 28-JUL-2020 the patient experienced shingles (herpes zoster). The outcome of herpes zoster was unknown, and the reporter did not assess the causal relatedness between the event and the suspect therapies.
herpes zoster; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 23-JUN-2017, the patient was vaccinated with zoster vaccine live(ZOSTAVAX)(dose, route of administration, anatomical location, lot#, expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as "shortly after receiving zoster vaccine live(ZOSTAVAX)"), the patient suffered a severe and painful rash to the abdomen and back and was diagnosed with herpes zoster. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX). Patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live(ZOSTAVAX), patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event herpes zoster was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered the event herpes zoster to be disability.
getting COVID-19 infection; getting COVID-19 infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu vaccine (DOSE NUMBER UNKNOWN, SINGLE; UNKNOWN MANUFACTURER  feeling sick with flu symptoms for one month after getting the flu vaccine), for Flu vaccination, reaction(s): "flu/ feeling sick with flu symptoms". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "getting COVID-19 infection".  Clinical course: This female consumer reported receiving two injections for the primary series of the Pfizer covid-19 monovalent and then later a booster dose of the Pfizer covid-19 monovalent. She did not report on what dates. The consumer reported recently getting COVID-19 infection. The consumer stated she had been prescribed Zithromax 500 mg every other day to take by her doctor. She did not say why the Zithromax 500 mg was prescribed. The consumer stated her ex-husband and his girlfriend received the Pfizer covid-19 vaccines and later got COVID-19. The consumer did not report when and how many of the Pfizer covid-19 vaccinations her ex-husband or the girlfriend of her ex-husband received. The consumer mentioned she had a flu vaccine in the past (manufacturer not specified), after just getting over the flu, and she experienced feeling sick with flu symptoms for one month after getting the flu vaccine.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021152706 same patient, same product, different dose and event;US-PFIZER INC-2021329876 same patient, same product, different dose and event;US-PFIZER INC-202101587543 same patient, same product, different dose and event;
Stabbing chest pain 10 hours after vaccine. Pain worse when lying down and deep breathing.  Doctor believed that symptoms were pericarditis and gave antii-inflammatory and pain meds.   Also started menstrating. I am in menopause and have not had a period in 5 years and I started a period the day I got the vaccine.   Do not know outcome as I?ve just started meds and rest today and just left the ER
Headache; nausea; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Oct2023 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Latex allergy" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Thimerosol, reaction(s): "Known allergies: thimerosol". The following information was reported: HEADACHE (non-serious) with onset 27Oct2023 at 19:30, outcome "not recovered"; NAUSEA (non-serious) with onset 27Oct2023 at 19:30, outcome "not recovered". Therapeutic measures were not taken as a result of headache, nausea.  Additional information: Patient have not received any other vaccine in four weeks or any medications in two weeks, no covid prior to vaccination and was not tested for covid post vaccination.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Day after immunization patient experienced left sided numbness but no muscle weakness. Tested negative for stroke and Guillan Barre. Still experiencing numbness in alternating sites (hands, arms, feet, cheeks) but less severe. Symptoms were most severe the first seven days
Patient experience swelling/redness at injection site (covered approximately 3x3in square).  Patient also experience fever and overall malaise.  Patient sought treatment from her PCP and received an antibiotic and steroid dose pack. I advised patient to ice the spot and take either ibuprofen/APAP for pain/fever.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A, 027L20A and 015M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Non Significant follow up received
Lymphadenopathy in left axilla; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Depression" (unspecified if ongoing); "GERD" (unspecified if ongoing); "History of right breast cancer DCIS treated with radiation" (unspecified if ongoing), notes: History of right breast cancer DCIS treated with radiation; "History of right breast cancer DCIS treated with radiation" (unspecified if ongoing), notes: History of right breast cancer DCIS treated with radiation; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: METFORMIN; ACTOS; PROZAC; ABILIFY; TRAZODONE. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergies: Codeine; Gabapentin, reaction(s): "Known allergies: Gabapentin", notes: Known allergies: Gabapentin; Celebrex, reaction(s): "Known allergies: Celebrex", notes: Known allergies: Celebrex. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3, Manufacturer unknown), for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 31Dec2022, outcome "recovering", described as "Lymphadenopathy in left axilla". Therapeutic measures were not taken as a result of lymphadenopathy.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Soreness in left arm that went up my left arm, across my shoulder to my neck below my hairline. A few days later my neck became stiff and painful. When I look down, the pain radiates down my neck towards my back. I cannot turn my head very far to the left.  I can't lean my head back very far to look up without bracing my neck against my hand. It continues to get worse with each passing day. The bones in my neck crack and make grinding sounds when I turn my head or attempt to look up and down.
Patient got dizzy after vaccine administration. Had no breakfast. Patient has Hx  of hypertension Exam was normal Patient was given juice and crackers Patient discharged to home
Pt c/o slight redness around her lip area and also slight redness at  inner corner of bother eyes,denies itching or any discharge at affected area. Pt concerned as stated she got her 2nd dose Moderna on 5/21/2021 and noticed these sx after that more this morning. Pt speech clear, comfortable. AO X3. Also denies emergency sx at this time. Advised pt to monitor her sx . Pt  Scheduled an appt with  urgent care provider telephone f/u 5/24/21.
12 months vaccines 6/10/20, 24 hours after with fussiness--99 temp, Friday with tmax 103 with rash about 48 hours post vaccines-red.  Treated with Benadryl.  Saturday with rash swelling and red (not urticarial-not itchy per mom.  +eye swelling.   No joint swelling with mild swelling hands/feet. Taken to ER with CBCd, CRP, and CMP.  Mild leukopenia and thrombocytopenia.  CRP 1.2.  Otherwise normal. Home Saturday and fever lasted x5 days.    Rash resolved in 2 weeks.  No fevers in interim.  No school.
This spontaneous report was received from a registered nurse refers to an unspecified number of unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, patient were vaccinated with improperly stored doses of VAQTA, lot # L002717, expiry date 02-JUN-2017; lot # K018181, expiry date 04-JUN-2017; lot # L015460, expiry date 20-JUL-2017; lot # L015460, expiry date 20-JUL-2017; lot # L045713, expiry date 14-JAN-2017; lot # K018181, expiry date 04-JUN-2017; and lot # L034381, expiry date 21-DEC-2016, (dose and frequency not reported). No adverse effects reported. No previous excursions were reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
NauseaVomiting FATIGUE,SORENESS/TIGHTNESS ON INJECTION SITE, SWELLING/REDNESS/NODULE ON THE INJECTION SITE-NODULE IS MOVING Narrative:
Hospital course was dominated by his hypoxic respiratory failure due to his pre-existing pulmonary fibrosis and presumed underlying COPD.  He also suffered a spontaneous pneumothorax in the left chest early in his hospitalization that required chest tube placement. He was never able to significantly wean his oxygen requirements at best was able to tolerate brief periods on 85% Vapotherm.  He alternated this with noninvasive ventilation.   Attempts w ere made with diuresis and corticosteroids but none of these made a significant impact on his underlying chronic lung disease. Due to the progressive nature of his respiratory failure he and his family had multiple discussions with myself and our nurse practitioners.  They eventually were in consensus for palliative care with management of air hunger and pain.  They understood that this would result in his death but the goal was to keep him comfortable throughout the process.  They were able to be at his bedside when he died on July 7th
Patient called pharmacy 8/25/14 complaining of swelling, redness and heat at injection site. Also, developing a rash on the wrist. She was advised to see her family physician.
Information has been received from a physician concerning a 20 year old female with seizures and a history of brain surgery within the past few months who on about 1 & 1/2 month ago (approximately 09-Sep-2008) was vaccinated intramuscularly with the first dose of GARDASIL (0.5 mL, lot# and injection site not reported). The patient informed office that she had an increased frequency of seizures post-GARDASIL. No information is available about any single occurrences. The patient informed the office of the seizures during a follow-up visit, when she may have received the 2nd dose of GARDASIL. Physician believes that the seizures are not related to GARDASIL. At the time of the report (24-Oct-2008) the symptom of seizures is stable. Upon internal review, seizures determined to be other important medical events. Additional information has been requested.
After giving Varicella vaccine, Tdap, then HPV, child's eyes rolled back, body slumped to right side, b/l arms and legs waved/flapped side to side.  No jerking motions.  No rigidity of child's body noted.  No pallor or cyanosis.  Immediately requested mother to notify MD.  Laid child down flat on exam table.  Within seconds, child opened her eyes and asked what was the matter.  I asked her if she remembered what happened.  She remembered feeling light-headed.  Then felt like she "had a dream".  Child A,A,Ox3.  Child c/o tingling feeling in arms and lips.  BP done (refer to vitals section).  Had child lay flat until feeling of dizziness passed.  Water given.  Had child sit with feet dangling.  Then had child stand.  When initially stood up, child c/o unsteady feeling.  Sat child in chair for 15-20min.  Child reported that she felt fine, was able to walk steadily, no feeling of dizziness.  Dr okayed that child go home.  Left with mother and sibling.  Father was driving family home.
pt recv vax & later that day devel vertigo, described as a feeling of unbalance, dizziness & lightheadedness, nausea & vomiting, weakness in legs, tightness in throat; pt recovered the following day;
Red, tender bump at injection site started approx one week after vaccination. Circular, measures 4cmx4.5cm.