chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Upon arrival, patient was informed she was attending a Moderna booster clinic.  Patient acknowledged "that is okay."  Prior to immunizing patient, the nurse reviewed the patients name, DOB, vaccine, dosing and vaccine expiration date.  The nurse ask the patient if she had any questions, the patient stated "no."  The nurse administered the appropriate 0.25ml Moderna and reviewed the patients immunization card with her.  The patient then tells the nurse "Moderna, I wanted the Pfizer vaccine."  The Director of Nursing called the patient on Monday morning (11/1/2021) @ 11:52 to check on the patient's wellbeing post immunization.  There was no answer, so DON left voice message for patient to return the call.  The DON preceded to call the patient, leaving multiple messages and the patient has not return the call.  On 11/1/2021 the DON called the Provider Support Line to inquire if a VAERS reported needed to be filed.  DON was initially told no, but received an email later in the day to file a VAERS report.  This report is filed to report the incident.  Unable to make contact with the patient for any adverse side effects.
Something going on with the thyroid; High blood pressure; Out of breath/Was winded; Couldn't walk hardly; Severe muscle aches; Became exhausted/Extremely tired/No stamina; Severe chills; Severe headache; lethargic; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Out of breath/Was winded), HYPERTENSION (High blood pressure), THYROID DISORDER (Something going on with the thyroid), GAIT DISTURBANCE (Couldn't walk hardly) and LETHARGY (lethargic) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for an unknown indication.    On 20-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced LETHARGY (lethargic). On 21-Mar-2021, the patient experienced DYSPNOEA (Out of breath/Was winded), GAIT DISTURBANCE (Couldn't walk hardly), MYALGIA (Severe muscle aches), FATIGUE (Became exhausted/Extremely tired/No stamina), CHILLS (Severe chills) and HEADACHE (Severe headache). On 08-Apr-2021, the patient experienced HYPERTENSION (High blood pressure). On an unknown date, the patient experienced THYROID DISORDER (Something going on with the thyroid). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Out of breath/Was winded), GAIT DISTURBANCE (Couldn't walk hardly), LETHARGY (lethargic), MYALGIA (Severe muscle aches), CHILLS (Severe chills) and HEADACHE (Severe headache) outcome was unknown and HYPERTENSION (High blood pressure), THYROID DISORDER (Something going on with the thyroid) and FATIGUE (Became exhausted/Extremely tired/No stamina) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Blood pressure measurement (128-64): 168/86 (High) 168/86. On 19-May-2021, Chest X-ray: Inconclusive.         This case was linked to US-MODERNATX, INC.-MOD-2021-073911 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow-up received.ADR Form in which patient's demographic details , event details were updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073911:Dose 1
Tiredness - approximately 30 hour duration Body aches - approximately 30 hour duration Fever - approximately 12 hour duration Chills  - approximately 12 hour duration Headache - approximately 12 hour duration Nausea - approximately 3 hour duration Vomiting - occurred 4 times
Rashes with the Moderna Covid19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rashes with the Moderna Covid19 Vaccine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rashes with the Moderna Covid19 Vaccine). At the time of the report, RASH (Rashes with the Moderna Covid19 Vaccine) outcome was unknown.        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.   If the rashes did not resolve within 3 or 4 days patient was advised to take Benadryl by a pharmacist.
Information has been received from a 61 year old female consumer with no medical history or drug allergies who in July 2008, was vaccinated with a dose of ZOSTAVAX (Merck) (lot number not reported). Concomitant therapy included gabapentin, CARDIZEM LA, PREVACID and ACTONEL. In August 2009 (also reported as two months ago), the patient experienced shingles. The shingles caused hearing loss in her right ear. She was experiencing bad pain behind and on top of her ear because of shingles. Unspecified medical attention was sought. Laboratory diagnostics studies included brain scan and computed axial tomography (CT), but the results was not reported. At the time of the report, the patient had not recovered. Upon internal review, hearing loss in her right ear was considered an other important medical event. Additional information has been requested.
Very swollen lymph nodes under right armpit. Felt like it was the size of a watermelon. Doctor checked it and said they did not feel swollen. Today is April 22 and it is still sore. Injection site in not painful though. Also experiencing fatigue
This spontaneous report as received from a licensed practical nurse refers to a 6 year old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was inadvertently vaccinated with VARIVAX injection, subcutaneously, lot # L049532, expiry date 08-DEC-2017 (dose and anatomical location were not specified) and ZOSTAVAX 19400 plaque-forming unit (PFU) injection, lot # L037790, expiry date 30-DEC-2016 (dose, route of administration and anatomical location were not provided), at the same office visit. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
sore arm; a little bit of chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and CHILLS (a little bit of chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis, High cholesterol and Blood pressure high.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, 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 PAIN IN EXTREMITY (sore arm) and CHILLS (a little bit of chills). At the time of the report, PAIN IN EXTREMITY (sore arm) and CHILLS (a little bit of chills) outcome was unknown.            Concomitant medication of the patient included medication for osteoporosis, medication for high cholesterol and medication for high blood pressure.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-328976 (Patient Link).   Reporter did not allow further contact
It was reported that a 40 year old female received Fluzone SV 98-99 USP on 10/19/98. Reportedly somtime after the vaccination the pt experienced redness and warmth at the site.
Patient was given the 12+ version of vaccine. Made to wait 30 min post vaccine. The health director was called. Expecting no abnormal outcomes.
Started my periods again 4 days after Pfizer bivalent booster dose.  After 7months no periods, hot flashes had subsided about 4 months ago.  Hot flashes have started up again, including during my periods.   After my 1st 2 Pfizer doses I had heavy bleeding during periods, had my 3rd dose which was Moderna which stopped my periods x3 months.
Pt experienced pain in the knee down to her calf. Redness around injections site that went away.
Approximately 1 day after injection.  Armpits on both arms being tender and sore. Lymph nodes could be felt with touch.
Lump and itchiness at vaccination site on day 1, took 10 mg Cetirizine Hydrochloride tablet Flu symptom like muscle and joint aches,  tiredness, headache, no appetite. on day 2, took 500 mg acetaminophen (2) caplets Severe vertigo, nausea, tiredness, and no appetite on day 3, took 12.5 mg of Meclizine caplet
nervous; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose number unknown (booster), single (Lot number: gj5342) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; Manufacturer unknown), for Covid-19 immunization. The following information was reported: NERVOUSNESS (non-serious) with onset Sep2022, outcome "unknown", described as "nervous".  No follow-up attempts are possible. No further information is expected.
swollen, redness 5 cm x 4 cm right arm, reaction to DTaP
Information has been received from an office manager concerning a 41 year old male who on 11/14/02 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. No lot number was available as it was not recorded in the patient's chart. There were no concomitant vaccinations. Several hours after being vaccinated the patient developed a fever, muscle aches, and chest pain. The patient was admitted to the hospital for overnight observation. The reporter was unaware of any treatment the patient may have received while hospitalized. The patient was discharged the following day as he developed no other symptoms and his events had resolved. No product quality complaint was involved. Additional information has been requested.
severe body aches,  muscle pain(injection site)  very tired.  dizzy spells,
pt recvd vax 7MAR96 called office on 11MAR96 asking about red area where shot was given;mom called again on 12MAR96 appt given;MD gave augmentin;
Rt arm swelling erythema tenderness from shoulder to just below elbow.  Subjective fever, no fever upon admission. Seen in ED 7/22/2004 within one day of vaccination. Admitted to hospital 7/23/2004 St Vincents Hospital; 7/24/04 Discharge summary states Rt upper extremity cellulitis and Clostridium difficile colitis as final diagnosis.  Confirms Dx that patient had previously been treated for GI S/S, was then vaccinated , treated in ER for focal cellulitis, pt returned with increased symptoms and was admitted.  Notes at discharge state that 'residual erythema remained in area of rt elbow and some swelling on the right forearm'
A registered nurse reported that an 18-month old male received Prevnar vaccine (pneumococcal 7-valent conjugate vaccine and subsequently developed fever, irritability, inconsolable  crying and was not eating. This is 1 of 4 patients from this facility who experienced these events following receipt of Prevnar lot # 483-166. One patient (not identified) developed a fever of 104.5 degrees. See Case ID HQ9924616JAN 2002, HQ9924716JAN 2002 and HQ989281JAN2002. No additional information was available as of the date of this request.
A cluster of 2 female patients who received FLUZONE (lot number U2853AB) and Pneumococcal vaccine, and developed injection site pain, redness, and swelling at an unknown time after vaccination. Initial report received on 20 November 2008 from a healthcare professional. A female patient, whose medical history and concomitant medications were unknown, received on 20 October 2008 an intramuscular injection of FLUZONE (lot number U2853AB) and and intramuscular injection of a Pneumococcal vaccine (Merck, lot number 0555EU). Both vaccines were administered in the same arm at the same site. The patient had no illness at the time of vaccination. After an unknown amount of time, the patient experienced pain, redness, swelling and blister formation at and around the injection site. The patient was evaluated by a physician and received treatment with oral antibiotics. The patient's outcome was not reported. Case 2008-03697 with the same reporter, same vaccines and same lot numbers was created for the other patient.
Pt developed neck/head turning with smacking of tongue. Started 2 days post vax.
J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 10/4/2022 PULMONARY HTN R09.02 HYPOXIA 5/21/2022 PULMONARY HTN
Moderna COVID-19 Vaccine EUA  August 11, 2021  Heart Attack Summary: This is a 67 y.o. female admitted 8/11/2021 (hospital day #0) as a transfer from a hospital with ongoing chest pain. Her serial ECGs at a local hospital demonstrated old anterior infarct with borderline anterior ST elevations not meeting STEMI criteria, but given continued symptoms she was transferred to a different Medical Center for coronary angiogram. She is now s/p coronary angiogram which showed occlusion of the LAD, s/p 2 drug eluting stents.
Arm very sore and tires; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Arm very sore and tires) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: TDAP on 26-Feb-2021. Concurrent medical conditions included Drug allergy (Tetracycline), Drug allergy (Imitrex), Drug allergy (Xanax), Drug allergy (Fentanyl Patch), Migraine since 2008 and Pain (Shingle Pain) since 2008. Concomitant products included AMITRIPTYLINE, VERAPAMIL, ACETYLSALICYLIC ACID (ASPRIN) and CAFFEINE for Migraine, GABAPENTIN for Pain.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced MYALGIA (Arm very sore and tires). On 21-Feb-2021, MYALGIA (Arm very sore and tires) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided Butaita 325mg  was taken as concomitant medication.. MRI results was awaiting and patient was scheduled for appointment.   This case was linked to MOD-2021-057843 (Patient Link).
Pt had two seizures on the day of vaccination, and subsequent to receiving diastat became apneic and was intubated. 8/8/07-records received -DC DX: Seizures. Neutropenia.presented to ER with prolonged seizure. Febrile 101.7. Tachycardic 140. Admitted overnight.
Case number PHEH2011US08486 is an initial spontaneous report received from a physician on 28 Oct 2011: This report refers to an adult female patient. She was bitten by a vampire bat on an undetermined date. Subsequently she was vaccinated with RABAVERT vaccine (batch number: unknown) intramuscularly and was also given immunoglobulin human anti-rabies (manufacturer and batch number: unknown) on 28 Oct 2011. After vaccination, she developed bilateral rash, malaise and receptive aphasia. She was admitted in to the hospital for monitoring and was having difficulty with higher cognitive focus. Outcome of the events was reported as unknown.
J&J Covid shot - full body rash, panic attacks, and my husband says he thinks I had a seizure - J&J "report" email rejecting messages, and COVID reactions gov site is not accepting anything, it keeps saying "error." My husband had a 104 fever that only lasted the first 24 hours and responded to Tylenol.
Profuse sweating, joint aches (specifically to neck/spine), significant headaches/brain fog for 48 hours. Redness/swelling/pain/itching to injection site that continues to worsen each day. Started as a small red area 24 hours post injection (about a pencil eraser size), now the area is notably more red, painful, swollen and itchy. Size is now larger than my palm (as wide as a coffee mug).
10/8/2015-patient was vaccinated at her place of work for the county.  Facility administed vaccine.  At 0300 10/7/2015 patient woke a large amount of redness around her injection site.  Area is reported to be raised and tender to touch.  10/9/2015 contacted patient and she reports that she has redness, warmth and tenderness in area.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Aug-2021 at 9:44 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 19-Aug-2021 at 9:44 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 19-Aug-2021 at 9:44 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided.
This spontaneous report as received from a 70 years old female Licensed Practical Nurse refers herself with diabetes. On 16-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J004268, expiry date: 12-JUL-2014) (dose, location unspecified) ("one single shot" as reported), route as injection as reported for the prevention of shingles. The nurse stated that she was also using many other "unspecified medications" (names/dosages/frequencies/manufacturers unknown). On an unspecified date she developed "rash like bumps all over her body" after the ZOSTAVAX vaccine, she stated that "it did not itch at first". She stated that the rash had become progressively worse, and it now itches. It had spread to cover almost her entire trunk, her lower extremities, and her buttocks. She stated that when the rash itches and she scratches it, it developed a "whitish scaly appearance", and occasionally the lesions ooze and crust-over. She had only consulted her physician about her rash one time, and biopsy results indicated that she might have lichenoid dermatitis. She also stated that her lips were very dry, and she put an unspecified ointment on her lips often throughout the day. She stated that she would be consulting her physician on 15-JAN-2014. She stated that no steroids or antivirals had bene prescribed, and she was agreeable to submitting to a VZVIP test. Routine blood work was performed and no result was performed. At the time of report, the outcome of the events was not recovered. Additional information has been requested.
Rash on face that looks like measles. It is not clearing up, seems to be getting worse. I stopped using Tretinoin the day the rash showed up, knew it was something other than the Tretinoin, because I've had no reactions to that and this rash was different than any skin problems I've had as an adult and reminds me of when I had measles as a child. I have not seen my family physician yet but calling today for an appointment.
We received via Vaccine Information Service in the USA the following information on 30 JUL 2007: A 46-year-old woman, born on 13 NOV 1960, was vaccinated with Fluvirin, batch-no 70740, into the left arm on 17 NOV 2006. Since then, she has experienced severe pain at the injection site, and limited range of motion in her left arm. This has subsided somewhat over time, yet she does still experience pain upon extension of her arm. There is nothing visible at the injection site and the patient feels that the muscle in that area has been affected. Company assessment: Seriousness criterion: permanent disability. Causality: Insufficient data. Expectedness assessment according to SPC: The reported symptoms, except for pain at injection site, are not expected after vaccination with Fluvirin (due to the long duration). No change in benefit-risk-ratio. No measures necessary.
Patient was administered a Pfizer Covid-19 vaccine that was exposed to a temperature excursion. (Vaccine was between 8-14.5 degrees C for 7hrs and 48 minutes). Pfizer was contacted and advised the clinic to consider the dose as invalid and to revaccinate. Patient was revaccinated on 03/19/21 and since had had dose 2 on 04/09/21
Pt Returned to pharmacy to report that the site of immunization was still sore from IMZ administered on 2/4/18. On examination skin was intact, the area was warm to touch, pain when pressure applied, No redness swelling or rash. She stated that it hurt when she elevated her arm or used arm to push down on lotion bottle at home.
This spontaneous report as received from a pharmacist refers to multiple patients of unknown age and gender. There were no concomitant medications concurrent conditions and medical history reported. On an unknown date, the patients were vaccinated with doses of improperly stored PNEUMOVAX23 lot # K021030, expiration date: 22-JUN-2016 (dose, route and site of administration were not reported). No adverse effects were reported. Follow up information has been received from the pharmacist on 09-NOV-2015. On 26-AUG-2015, the patient was vaccinated with dose of improperly stored PNEUMOVAX23. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.  Patient details: suspect therapy, event data and narrative were updated.
Moderate pain at injection site; Mild fatigue; Mild body aches; Initial information received on 09-Oct-2023 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 45 years old female patient who experienced moderate pain at injection site, mild fatigue and mild body aches after receiving vaccines Pfizer Biontech COVID-19 vaccine and Influenza Quadrival A-B vaccine [Fluzone Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 09-Oct-2023, the patient received an unknown dose of suspect Influenza Quadrival A-B vaccine suspension for injection of lot UT8155JA (strength and expiry: unknown) via intramuscular route in the left arm as annual flu vaccine (influenza immunization).On the same date, the patient received an unknown dose of suspect Pfizer Biontech COVID-19 vaccine not produced by Sanofi Pasteur of lot Fj1611 (formulation, strength and expiry: not reported) via intramuscular route in the left arm as prophylactic vaccination (immunization).  On 09-Oct-2023, the patient developed moderate pain at injection site (injection site pain) (latency: 5 mins) following the administration of Influenza Quadrival A-B vaccine and Pfizer Biontech COVID-19 vaccine.  On 09-Oct-2023, the patient developed mild fatigue (fatigue) and mild body aches (pain) (latency: 8 hours) following the administration of Influenza Quadrival A-B vaccine and Pfizer Biontech COVID-19 vaccine.  No lab data was reported.  Action taken was not applicable.  No corrective treatment was received for all events.  At time of reporting, the outcome was Recovering / Resolving for all events.