chrisvoncsefalvay/vaers-outcomes huggingface dataset:
mentally frustrating; stuffy ear and can't sleep at night/didn't sleep for days; interfered with my daily activities; pulsing sound and ringing in ear/tinnitus(ringing in the ears)and pulsing tinnitus about 9-10 days/Tinnitus got worse; experiencing in right stuffy ear; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (pulsing sound and ringing in ear/tinnitus(ringing in the ears)and pulsing tinnitus about 9-10 days/Tinnitus got worse), EAR CONGESTION (experiencing in right stuffy ear), FRUSTRATION TOLERANCE DECREASED (mentally frustrating), INSOMNIA (stuffy ear and can't sleep at night/didn't sleep for days) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (interfered with my daily activities) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism since 30-Oct-1997 and Tinnitus. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) from 30-Oct-1997 to an unknown date for Hypothyroidism, ATORVASTATIN for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced EAR CONGESTION (experiencing in right stuffy ear). On 09-Apr-2021, the patient experienced TINNITUS (pulsing sound and ringing in ear/tinnitus(ringing in the ears)and pulsing tinnitus about 9-10 days/Tinnitus got worse). On an unknown date, the patient experienced FRUSTRATION TOLERANCE DECREASED (mentally frustrating), INSOMNIA (stuffy ear and can't sleep at night/didn't sleep for days) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (interfered with my daily activities). At the time of the report, TINNITUS (pulsing sound and ringing in ear/tinnitus(ringing in the ears)and pulsing tinnitus about 9-10 days/Tinnitus got worse) was resolving, EAR CONGESTION (experiencing in right stuffy ear) and FRUSTRATION TOLERANCE DECREASED (mentally frustrating) outcome was unknown and INSOMNIA (stuffy ear and can't sleep at night/didn't sleep for days) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (interfered with my daily activities) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details were not reported.    Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Follow up received on 07-sep 2021 second event of ear congestion  and  action taken updated from unknown to no change. only one event of tinnitus aggravated coded with onset date of 09-Apr-2021a nd outcome recovering.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 23-Sep-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided
Developed headache, facial swelling, dizziness the morning after receiving vaccination on 4/30, seen in ER on 5/2 for progressing symptoms and prescribed steroid course, later developed hyperglycemia needing hospitalization
Patient mother called 12/12/02 stating child had a red spot on leg where vaccine was given and site was warm. She called again 12/13/02 stating red spot was getting bigger. When patient came to the office the site was measured 15x14cm and was hot to the touch. Doctor looked at the site advised mom it was non-life threatening and to give patient Tylenol and Zyrtec or Benadryl. To follow-up 12/16/02.
DVT and Pulmonary Embolism. I had a swollen left leg with reddness and hot to touch.
4:45PM received MMR inj lt upper arm subcutaneously. 5:05PM developed itching, urticaria, hives on face, neck and extremities. 5:10 Benadryl 25 mg given PO, T 97.6 BP 90 by palpation, P 100. Still itching. Benadryl 25 mg given at 5:25 PM. C/O tongue swelling. 911 called 5:30 PM vomited 5:45 EMT began O2 Epinephrine 0.3 CC IM given to hospital by amb.  Records received from an ER visit for c/o hypotension, diaphoresis, and hives/itching after MMR. Pt. used own epi-pen and was taken to ER via ambulance, where she was found to be feeling better. Treated with Solumedrol, IV Benadryl, and O2 and d/c'd when stable to continue benadryl and prednisone at home. DX: Allergic Reaction, Medicinal substance.
FATIGUE; Chills; felt something running down her arm and it was the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (felt something running down her arm and it was the vaccine), FATIGUE (FATIGUE) and CHILLS (Chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.).    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced UNDERDOSE (felt something running down her arm and it was the vaccine). On 03-Mar-2021, the patient experienced FATIGUE (FATIGUE) and CHILLS (Chills). On 02-Mar-2021, UNDERDOSE (felt something running down her arm and it was the vaccine) had resolved. At the time of the report, FATIGUE (FATIGUE) and CHILLS (Chills) outcome was unknown.        There was no concomitant medication provided   Reporter did not allow further contact; Sender's Comments: This report refers to a case of accidental underdose for mRNA-1273, lot # 013A21A with associated AEs fatigue and chills.
Rash and pain bilateral LEs. Both progressively worsened prompting patient to be evaluated in the ER 11/28/2015. Patient was diagnosed with Henoch Schonlein purpura. No biopsy was done.
Herpes Zoster onset 9/29/08, diagnosed 10/3/08 V1 distribution.  Disseminated zoster diagnosed 10/6/08 requiring hospitalization for IV acyclovir 10/6/08 to 10/9/08 at Hospital.  Recovered. 10/20/2008 MR received for DOS 10/6-9/2008 with D/C DX: Disseminated zoster.  Asthma.  Hx of HTN. Hx of tubular adenoma. Pt presented with Shingles rash already Dx'd for antiviral tx. Itchy rash is on L side of face, and scalp as well as multiple small eruptions on trunk and R arm. Mild h/a for last week. Ophth r/o ophthalmic involvement. Tx with Acyclovir.
right hand wrist with second shoot/hand wrist swollen and painful with movement in fingers and hands; right hand wrist with second shoot/hand wrist swollen and painful with movement in fingers and hands; right hand wrist with second shoot/hand wrist swollen and painful with movement in fingers and hands; right hand wrist with second shoot/hand wrist swollen and painful with movement in fingers and hands; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old patient received BNT162b2 (BNT162B2), on 11Jul2021 at 10:00 as dose 2, single (Lot number: EW0198) at the age of 76 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hip Replacement-Left", start date: Jan2020 (unspecified if ongoing), notes: Jan2020; "Hip Replacement-Right", start date: Jul2020 (unspecified if ongoing), notes: Jul2020; "Blood Sugar" (ongoing); "Cholesterol" (ongoing); "TIA" (ongoing). Concomitant medication(s) included: ATORVASTATIN oral taken for blood cholesterol abnormal (ongoing); METFORMIN oral taken for blood glucose abnormal, start date: Apr2021 (ongoing); ASPIRINE oral taken for transient ischaemic attack (ongoing). Vaccination history included: BNT162b2 (Dose: 1st, Date: 20Jun2021, Time: 10:00, Anatomical Site of Injection: Left Arm, Route of Administration: Intramuscular, Batch/ Lot Number: EW0181), administration date: 20Jun2021, for COVID-19 immunization, reaction(s): "Left hand got very swollen", "Left wrist got very swollen", "Could barely move his fingers without any pain", "She give her husband an Aleve to ease some of the pain". The following information was reported: JOINT SWELLING (disability, medically significant), PERIPHERAL SWELLING (disability, medically significant) all with onset 12Jul2021, outcome "recovered" (2021) and all described as "right hand wrist with second shoot/hand wrist swollen and painful with movement in fingers and hands"; PAIN (non-serious), MOVEMENT DISORDER (non-serious), outcome "unknown" and all described as "right hand wrist with second shoot/hand wrist swollen and painful with movement in fingers and hands". The events "right hand wrist with second shoot/hand wrist swollen and painful with movement in fingers and hands" required emergency room visit. The patient underwent the following laboratory tests and procedures: X-ray: Unknown results. Therapeutic measures were taken as a result of joint swelling, peripheral swelling, pain, movement disorder.  Sender Comments/ Narrative: The patient hands and wrists was swollen and painful with movement in fingers + hands very limited. The patient went to ER and had X-rays and gave anti-inflammatory drips. Sent home next day with Pretazone and Octikoten. The patient received left hand & wrist with first shot and then right hand & wrist with second shot.  No follow-up attempts are possible. No further information is expected.  Follow-Up (19Apr2022): Follow-up attempts are completed. No further information is expected.
Patient fainted after receiving immunizations-recovered rapidly-pulse 62 BP 100/70 evaluated by physician.
Fatigue.  Slept for 3 hours.  Headache, decreased appetite starting 1 hour post injections.
PATIENT SAID THE AREA FELT HOT, RED AND RAISED. SHE NOTICED IT ON MONDAY BUT DID NOT CONTACT US UNTIL FRIDAY. I RECOMMENDED SHE SEE MD, HOWEVER HER MD WAS OUT. RECOMMENDED GOING TO URGENT CARE. SHE DIDN'T WANT TO. SHE BOUGHT BENADRYL. SHE DID DECIDE TO GO TO URGENT CARE THE NEXT MORNING AFTER SHE SPOKE TO THE RPH ON DUTY. URGENT CARE FELT IT WAS AN ALLERGIC RXN TO SOMETHING IN THE IMZ BUT NOT THE ACTUAL ANTIGEN. SHE CONTINUED TO TAKE BENADRYL AND SHE IS MUCH BETTER TODAY.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In 2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. 16-AUG-2016, the patient was treated at a physician's office for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
no adverse affects reported; HCP calling to report that PROQUAD was administered after undergoing a TE. No adverse affects reported. Caller stated this occurred in February 2023.          ?    Names of vaccines involved (including lot/exp): PROQUAD (Lot: W019631, Expiration: 1; This spontaneous report was received from a nurse, concerning to a patient of unknown gender or age.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unspecified date in February 2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 0.5 milliliter, (lot #W019631 has been verified to be valid, expiration date: 19-DEC-2023) (strength, and route of administration were not administered) for prophylaxis, after vaccine underwent to temperature excursion at 13.5 Fahrenheit grade during 3 hours and 5 minutes (product storage error). There was not previous temperature excursion. No additional adverse events.
Administered past expiration date. Expiration  date; 03/11/2023; administration date 03/13/2023  Called patient to inform her N/A will continue to reach out.
Right ear got suddenly congested.  Tried Sudafed for a few days, saw primary care doctor, who advised continue with coricidin to see if it cleared.  Ten days later, I requested steroids to see if that would help.  After a further five days, I sought out an ENT specialist, who urged me to report as possible vaccine side effect.  To be on safe side, she urged me to report to CDC.
Disclaimer: I was diagnosed with COVID in December 2020. This may be the reason why my symptoms were out of the ordinary.  The first shot gave me a mild chills and pretty bad body pain, however, the second shot gave me a sore throat, nasal congestion, chest congestion,  wet cough, body pain, and shortness of breath. In order to tally out a second exposure to Coronavirus, I got tested twice and was negative. These adverse symptoms started 4 hours after the 2nd vaccine and are still the same intensity. I?m taking mucinex and anti histamines but nothing has been helping much. I?m on my 6th day now.
Patient received a dose of Pfizer Monovalent 12+, after having already received two doses of the Pfizer Monovalent 12+.  The patient was supposed to receive Pfizer Bivalent 12+.  The error was caught by pharmacist while the patient was still in the pharmacy, and the patient received her dose of Pfizer Bivalent 12+.  The patient experienced no serious reactions to prior COVID vaccine doses, and was assured that it would be safe to receive the Pfizer Bivalent 12+ dose on the same day of the incorrectly administered Pfizer Monovalent 12+.
This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), VOMITING (Vomiting) and CHILLS (Chilling) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart attack and Stent placement.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced NAUSEA (nausea), VOMITING (Vomiting) and CHILLS (Chilling). At the time of the report, NAUSEA (nausea), VOMITING (Vomiting) and CHILLS (Chilling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Covid-19; Covid-19; depressed; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  An adult female patient received bnt162b2 (BNT162B2), intramuscular, administration date 30Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 07Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous, administration date 13Apr2014 (ongoing) (Batch/Lot number: unknown) as 40 mg (1 in 2 wk) for rheumatoid arthritis. Relevant medical history included: "Rheumatoid Arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Aug2021, outcome "recovered" (2021) and all described as "Covid-19"; DEPRESSION (non-serious) with onset 2021, outcome "not recovered", described as "depressed". The action taken for adalimumab was dosage not changed. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for HUMIRA 40MG/0.8ML (Adalimumab): The reporter's causality for the event(s), depressed, covid 19 with Humira 40mg/0.8ml(Adalimumab) was no Reasonable possibility. Causality for BNT162B2: The reporter's causality for the event(s) depressed, covid 19 with 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.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the currently available information the possibility of causal association between the reported events and the suspect drug BNT162B2  cannot be ruled out. 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,Linked Report(s) : 21K-131-4185304-00
Hot; Itchiness around injection site; Red; worse when touched; A spontaneous report was received from a nurse concerning a 87-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Injection site warmth, Pruritus, erythema and Pruritus aggravated.  The patient's medical history, as provided by the reporter, included breast cancer. Concomitant medications reported included levothyroxine 50mcg, gabapentin 300mg, tylenol 500mg TID, osteo bi-flex, lidocaine cream 4%, Magnesium 250mg BID, multivitamin, prolia Q6M, fresh optic BID, Vitc + Vit. D3.  On 12 Feb 2021, approximately eight days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the upper left arm for prophylaxis of COVID-19 infection. Patient cannot get vaccination on her right arm due to the medical history of breast cancer.  On 19 Feb 2021, prior to receiving mRNA-1273, the patient felt itchiness,heat on and around the injection site. Also patient still has itchiness and got worsened when touched. Treatment taken for the event itchiness was included as Cortisone Cream. Action taken with mRNA-1273 in response to the events was not reported.   No laboratory report was provided.  All the events were considered as unresolved.
Swollen, painful right neck lymph node 8 hours after injection.  Heart palpitations/arrhythmia 3 days after injection. Ongoing as of 3/26/221
Initial information received on 02 February 2009 from a health care professional. A 14 year old male patient with no reported past medical history received a first time dose of MENACTRA (lot number U238BA) administered in the right arm and VARIVAX (manufacturer Merck, lot number I025U) administered in the left arm on 24 August 2007 at 09:15. On 21 August 2007 the patient received a first time dose of Tdap (manufacturer GSK, lot number AC52B015AA) administered in the right arm. A few hours post vaccination on 24 August 2007, the family reported that the patient developed a migraine headache, vomiting and visual disturbances. The family stated that the patient was treated at that time, details not provided. MRI of the brain was pending. The date of MRI was not provided. The patient complaints of occasional migraines, however the patient was reported as recovered. List of Documents held by Sender: none.  2/20/09 MR received from PCP. Seen 2/2/09 with c/o Migraines. Exam WNL. Impression:  Migraines.
Sx onset 7-7-22  admitted 7-11-22    given broad spectrum antibiotics initially and IV steroids and then  remdesivir stareted and IV antibiotics were d/c.  Had left sided thoracentesis due to effusion, had pneumonia.  admitted to ICU 7-12 due to shortness of breath .   was feeling better but on 7-14-22 developed chest pain and code blue was called when he became unresponsive.  He expired on 7-14-22.
"I got shaking chills 11 hours after vaccine and then severe headache and fatigue, and had some nausea. I missed work 1/11 and 1/12."
Case number PHEH2014US018964, is an initial spontaneous report from a health care professional received on 19 SEP 2014. This report refers to a patient of unknown identifiers. Past medical history and concomitant medication was not reported. On 19 SEP 2014 the patient was vaccinated an intramuscular dose of FLUVIRIN 2014/2015 (batch number: unknown) from a multidose vial that was out of range at 18 degrees Celsius for 14 hours. No adverse event reported following this medication error (incorrect storage of drug).
Around 11:00 a.m. the day following receipt of the 2nd dose vaccine, I experienced horrible body aches and fatigue.  I went to bed but couldn't get any sleep because of muscle cramps and charley horses.  Around 4:00 p.m. I experienced chills and had to wrap myself in a blanket over my clothes.  At that point I took my temperature and it was 100.4.  I took it again a few minutes later and it was 99.4.  I went back to bed and slept until 3:00 a.m. when I woke up to get some water.  I got up today at 7:30 a.m. and all symptoms were gone.
Muscle pain at injection site; This is a spontaneous report from a non-contactable consumer (patient). A 25-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3248) via an unspecified route of administration on 04Mar2021 09:45 am (at the age of 25-year-old) as unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no known allergy. COVID prior vaccination was none. Since the vaccination, patient had not been tested for COVID-19. COVID tested post vaccination was none. On 04Mar2021, the patient experienced muscle pain at the injection site. The patient did not receive any treatment for the event. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Low grade fever for 22 days; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever for 22 days) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Low grade fever for 22 days). At the time of the report, PYREXIA (Low grade fever for 22 days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.