chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via sales rep and described the occurrence of chills in a male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX with an associated reaction of allodynia (at least 5 years ago) and VALTREX (treatment for allodynia). On 19th April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced chills, myalgia, arthralgia, synovitis, allodynia, neuralgia and fatigue. On an unknown date, the outcome of the chills, myalgia, arthralgia, synovitis, allodynia, neuralgia and fatigue were recovered/resolved. It was unknown if the reporter considered the chills, myalgia, arthralgia, synovitis, allodynia, neuralgia and fatigue to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient previously received ZOSTAVAX at least 5 years ago. About 3 years after receiving ZOSTAVAX, he developed allodynia on the left side of his head that radiated to his ear. He felt it was zoster and was treated with VALTREX. The patient reports that after receiving SHINGRIX, he developed the same allodynia in the same location, with neuralgia lasting 1 day. It was relieved with rubbing the area (neuralgia pain would fatigue). In 2018, less than a month after receiving SHINGRIX vaccine the patient experienced chills, myalgia, and arthralgia which resolved in 36 hours. In 2018, less than a 5 month after receiving SHINGRIX vaccine the patient experienced allodynia, neuralgia and fatigue. Approximately 3 weeks after the injection, he developed synovitis in his MCP joint on his right hand, which has persisted for 4 months. The patient had never experienced that pain or inflammation previously. The patient saw rheumatologist. The patient was a physician and was somewhat hesitant to receive the 2nd dose for fear of additional joint issues.
This case was reported by a consumer via call center representative and described the occurrence of numbness of tongue in a 67-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included polymyalgia rheumatica. Concomitant products included DTPa (Reduced antigen). On 2nd August 2018, the patient received the 1st dose of SHINGRIX. In September 2018, less than a year after receiving SHINGRIX, the patient experienced numbness of tongue, speech disorder and tingling tongue. On an unknown date, the outcome of the numbness of tongue, speech disorder and tingling tongue were unchanged. It was unknown if the reporter considered the numbness of tongue, speech disorder and tingling tongue to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on left arm. In June 2018, the patient received Tdap vaccine. Around middle of September 2018, the patient experienced tongue numbness, tingling and speech problems. The tongue numbness and tingling only happens in the morning time of the day from 8:30 AM to 9:30 AM, and then it goes away for the rest of the day. The patient reported it was the worse a day before reporting. Due to the numbness and tingling the patient had speech problems and it was hard to pronounce words. The patient required a visit to her vascular surgeon and rheumatologist to follow up in regard to what she was experiencing. The patient was referred to follow up with her primary care physician. The patient denied permission to contact their physician. No further details were provided.
Severe nausea, vomiting, diarrhea. Onset within 24 hours of injection. Required IV fluids.
Feeling fatigued, drained, tired Pain in right side of back, and pain behind both knees, as if vaccine triggered an adverse arthritic reaction Tickle in throat Soreness in roof of my mouth Difficulty sleeping
23 Spots last PM more today, no fever, not bothersome.  Awake, alert, bilateral tm's normal.  Spots on trunk, arms 5-6, eryth with vsical anterior upper back.  Chest pain?  Vaccine related?  No treatment.
Case received from a health professional  and forwarded by Crucell ref. no. CVAE-003-2012. A spontaneous report was received on 11.Jan.2012 and concerns a 63-year-old female patient who received VIVOTIF (batch number 3002144). The patient's medical history and concomitant medications were not reported. On an unreported date, the patient took the first dose of VIVOTIF with a full glass of water, two hours after eating. Approximately one hour later, the patient "became achy" and experienced nausea and upset stomach. The patient decided not to take any more doses. The outcome was not reported. The case was considered non-serious.
The patient was vaccinated with PNEUMOVAX 23 on 30-DEC-2014 and 12-NOV-2017; This spontaneous report has been received from a other health care professional via medical records from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 1906USA007914), concerning to a 62-year-old female patient.  On 30-DEC-2014 and 12-NOV-2017, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX 23)  (strength, dose, route, lot number and expiration date were unknown) for prophylaxis respectively without adverse reaction or side effects (inappropriate schedule of vaccine administered).  This is one of two reports from the same patient.; Sender's Comments:  US-009507513-1906USA007914:
Monovalent mRNA vaccine administered for a bivalent mRNA dose.   Had not been notified (as of date of this vaccine  administration)  that monovalent vaccine had been discontinued). Notice wasn't released from Department of Health and Human Services until 05-01-2023, sent via e-mail to my supervisor on 05-02-2023,  forwarded to me, where I read it the morning of  05-03-2023 at which time, then all remaining doses of monovalent mRNA vaccine was destroyed.  This patient had no adverse effects or events as result of this dose of vaccine given.  Had already received earlier dose of  mRNA vaccine prior to his incarceration with us. Patient refused the Updated Pfizer Bivalent vaccine when he was offered on 06/ 07/2023 but said he would let us know if he changes his mind. Patient remains incarcerated.
Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no concurrent condition or medical history reported. On an unknown date the patient was vaccinated with a dose of improperly stored VARIVAX (lot # L034370, expiration date 08-SEP-2017) (dosage, strength and route unknown) (temperature: 42 degree F, time frame: 36 days). No adverse effect was reported. Additional information has been requested.
I woke up in the night and I was coughing. I had a headache and body ache and congestion. They gave me Paxlovid.
Information has been received from a nurse practitioner concerning her daughter, a 16 year old female who on 02-SEP-2007 was vaccinated with HPV rL1 6 11 16 18  VLP vaccine (yeast). The patient was vaccinated concomitantly with varicella virus vaccine live (MMD), meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA), pertussis vaccine (unspecified), tetanus toxoid and influenza virus vaccine (unspecified). The nurse practitioner reported that the patient started her menstrual period on 29-SEP-2007 and the period never stopped following the vaccination with HPV rL1 6 11 16 18 VLP vaccine (yeast). It was reported that the patient was not a patient of the nurse practitioner, but the daughter of the nurse practitioner. The nurse practitioner did not have further information at the time of the report. Additional information has been requested.
UPPER CHEST WAS BLACK AND BLUE; CHEST TENDER TO THE TOUCH; CHEST HAD LIKE BROKEN BLOOD VESSELS; CHEST WAS TIGHT; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included veins burning, vomiting, redness, burning sensation, swelling, sick, faint, and anaphylactic reaction, and concurrent conditions included multiple sclerosis, non alcoholic, non smoker, sulfa allergy, and steroid allergy, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. Patient was not pregnant at the time of vaccination. Patient had red light therapy as well. The patient experienced drug allergy when treated with teriflunomide, influenza vaccine, interferon, prednisone, cimetidine, and glatiramer acetate. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. Concomitant medications included atorvastatin for drug used for unknown indication, losartan for drug used for unknown indication, and ibuprofen. On 28-APR-2021, the subject experienced chest was tight. On 14-MAY-2021, the subject experienced upper chest was black and blue. On 14-MAY-2021, the subject experienced chest tender to the touch. On 14-MAY-2021, the subject experienced chest had like broken blood vessels. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from upper chest was black and blue, chest was tight, chest tender to the touch, and chest had like broken blood vessels. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
That same test suggested he use BCG VACCINE as a treatment for fibromyalgia; patients wife states she knows the HCP will write the prescription for him.; unable to find BCG VACCINE anywhere; This spontaneous report was received from a patient's wife and refers to a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.      On an unknown date, the patient had a test done (name of test was not provided) for fibromyalgia and he was "unequivocally positive for fibromyalgia". That same test suggested that he use bcg live (BCG VACCINE USP) (dose, route of administration, anatomical location, lot # and expiration date were not reported) as a treatment for fibromyalgia (product use in unapproved indication). The reporter stated she knew the healthcare professional (HCP) would write the prescription for him (circumstance or information capable of leading to medication error). It was also reported that the patient was unable to find bcg live (BCG VACCINE USP) anywhere (product availability issue). combinationproductreport: Yes; brandname: BCG VACCINE USP PUNCTURE DEVICE (DEVICE); commondevicename: BCG live; productcode: LDH; devicetype: SYSTEM, DELIVERY, ALLERGEN AND VACCINE (LDH); manufacturername: Organon Teknika Corporation LLC; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
10NOV98 temp 100.4, aching, dizzy, h/a, congestion, ear pain;12NOV98 still has fever, ear pain, sore throat & h/a mom encouraged to consult MD;
tested + 1/26/22 , admitted 3/10/22 and was placed on hydration , antibiotics.  Worsening resp status and continued to deteriorate and due to very grim prognosis was placed on comfort measures and passed 3/14/22.  DX were post covid condition, acute and chronic resp failure, pneumonia and sepsis
Patient reported nausea, headache, "weird" sensation within 15 minutes of vaccination.  Had dry heaves; IV started, BP 173/101; given Zofran and transported to ER by EMS.
Healthy 2nd pregnancy, 09/15/2021, also breastfeeding a 5 month old.
Patient is a 83-year-old male being admitted to telemetry from ED.  Patient states that his sons have been visiting him in the last few weeks and are not Covid vaccinated.  Patient states that all 3 of them developed similar symptoms approximately 10 days ago.  Patient describes the symptoms as shortness of breath and cough with sputum production.  Patient states that sputum production is a pink-tinged color that is thin in consistency.  Patient states that he is Vaccinated with receiving both shots for COVID-19 with the last one being in March.  Patient states he received the Pfizer vaccination.  Patient states that when he lost his sense of smell he proceeded to a store nearby x5 days ago.  Patient states at that time he tested positive for Covid. Patient states that he presented to the emergency department today when his shortness of breath worsened.  Patient reports that it worsened with him only being able to take a few steps before developing dyspnea.  Patient states that he does have a history of congestive heart failure and hypertension.  Patient denies chest pain, nausea vomiting, diarrhea, headache, or dizziness.  Patient had troponin levels drawn in the emergency department with both the initial and 1 hour troponin being elevated at 75 then 78.  Patient's BNP is 922.  Patient's chest x-ray shows a more extensive infiltrate in the inferior hilar right chest and right lung base.  Also signifies a right pleural effusion that is described as small.  The patient is hemodynamically stable during exam.  CODE STATUS is full code.  Prognosis is guarded.  Discharge 8/12/21 83 year old who tested pos for COVID, and was dyspneic. He was admitted, treated with COVID meds, and seen by CARDIO and PULM. He has baseline reduced LVEF and his issue was mostly fatigue and dyspnea, not hypoxia. He was ambulated in the hall on date of dc home without oxygen and did well. Sent home with HH care
Pt called complaining of pain on left shoulder joint, 2 days, post vax and at present time. Pt stated that she took ibuprofen tablets for pain and helps minimal for pain. Pt stated no history of pain on shoulder and joints.
Patient received the Moderna series. She came in to get an additional dose because she has cancer and was inadvertently given Pfizer as the additional dose instead of Moderna.
Macular degeneration; This spontaneous case was reported by a consumer and describes the occurrence of MACULAR DEGENERATION (Macular degeneration) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to Severe) and Macular degeneration (had low vision due to inherited macular degeneration.).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced MACULAR DEGENERATION (Macular degeneration) (seriousness criterion medically significant). At the time of the report, MACULAR DEGENERATION (Macular degeneration) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  On an unknown date, the patient experienced Inherited macular degeneration. MODERNA COVID-19 VACCINE (ELASOMERAN) was also considered as suspect.  The patient had low vision due to inherited macular degeneration. Patient  stated that it had nothing to do with Humira. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   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.  Company  Comment: This is a Spontaneous case reported by a consumer, concerning an elderly female patient, with relevant medical condition of inherited macular degeneration, who experienced the unexpected and serious (due to medically significant) event of Macular degeneration, which occurred related to an unspecified dose of mRNA-1273 vaccine. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. Co-suspect product included non-company product Adalimumab for rheumatoid arthritis. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had not resolved. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning an elderly female patient, with relevant medical condition of inherited macular degeneration, who experienced the unexpected and serious (due to medically significant) event of Macular degeneration, which occurred related to an unspecified dose of mRNA-1273 vaccine. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. Co-suspect product included non-company product Adalimumab for rheumatoid arthritis. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had not resolved. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.
Within 15 minutes of getting the vaccine my left arm felt fuzzy down to elbow.  Then the dizziness started.  Dizziness continued until going to bed.  Within the next week I started getting occasional dizziness.  I went to my doctor who said I had vertigo.  Did blood work and now I have to have a MRI.  Strange thing is my wife started with Vertigo 5 days after getting the vaccine at the same time I had the vaccine.  She is still having issues with dizziness and under doctors care.
She got her vaccine and her arm did not hurt like the first one.  Then she did not have any issues until about 3 weeks ago when she noticed itching down at the lower part of her neck, adjacent to her collarbone.  Not up into the throat area, just the itching.  It looked like a pinkish red rash and she has had a few little raised places which went away.  She now still has the itching, and has a dry ashen looking area.  There is no redness there but still itching.  She has been putting calamine lotion on it and started to use moisturizes on it, and said if it continues she will go to the dermatologist.    She took the polish on her nails and when she removed it she had some white areas/lines going across them.  Her daughter said that it looked like COVID nails, a couple cm from the cuticle which has only affected 2 fingernails.
This spontaneous report as received from a physician via company representative refers to a 21 years old female patient. It was reported that the patient was not pregnant. Sometime in 2007 the patient was vaccinated with first dose of GARDASIL (dose, frequency, lot# and expiration date were not reported). Subsequently, on unknown dates, the patient was vaccinated with the second and third dose of GARDASIL three-dose series at 15 years of age and on unknown date the patient tested positive for HPV. It was reported that smear cervix (pap test) was performed (unknown date). The patient sought medical attention. The outcome of HPV infection was not reported. The relatedness between GARDASIL and HPV infection was not reported. Additional information has been requested.
flu like symptoms; This is a spontaneous report from a contactable consumer (patient).   A 72-year-old male patient received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunizations. The patient past medical history and concomitant medication was not reported. The patients previous vaccine was a flu shot 4-5 months before for immunization and he took some herbs. The patient also took 1st dose of BNT162B2 and experienced adverse events. He was doing his own investigation as well and need to know if there's a virus in the vaccine after the 2nd dose he experienced flu like symptoms on an unspecified date. first dose of the Pfizer vaccine and right after experienced lower right side back pain and joint pain, but it subsided. The event outcome is unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Initially after immunization, he had local site pain. It fully resolved. Seven days later he developed an erythematous indurated region ~10cm x 10cm distal to the injection site on the left arm. No systemic symptoms.
Requested booster shot but received 3rd dose by mistake. I called the cdc to be sure receiving the 3rd dose was ok. They suggested I submit an adverse event report.
CURRENT CONCERNS: Feet hurt. Walking if painful. Hands & arms tingle and hands, fingers, and wrist are painful and fingers and hands change color, cold effects them. Lack of hand strength. Twitching in neck and eyes. Neck pain. Low pressure in both eyes and Retina of right eye has changed shape. Curve in upper back and right side rib cage. Back cramps. Fluctuating hearing loss. Irregular heartbeat PVC's (wearing 30 day Cardiac Event Monitor until 5/18/2022. Dilated Aortic Root. TREATMENT: Currently not on anything. Have been treated with Prednisone prescribed by Primary Doctor. Prednisone did help with joint pain.
Within  first hour had redness, swelling and soreness. Each day after for next 4 days had more pain in left arm, swelling of left hand. Pain became intense. On Saturday 11/24/2018 was seen by MD at Urgent Care facility. He diagnosed cellulitis of left arm. Was given injection of antibiotic and put on KEFLEX 500 mg. every 8 hours x 7 days. Left arm and hand are healed now.
Nausea; Vomiting; Chills; Headache; Fatigue; "I just don't feel right, it comes in waves"; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), VOMITING (Vomiting), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M2-20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced NAUSEA (Nausea), VOMITING (Vomiting), CHILLS (Chills), HEADACHE (Headache), FATIGUE (Fatigue) and MALAISE ("I just don't feel right, it comes in waves"). At the time of the report, NAUSEA (Nausea), VOMITING (Vomiting), CHILLS (Chills), HEADACHE (Headache), FATIGUE (Fatigue) and MALAISE ("I just don't feel right, it comes in waves") outcome was unknown.
About 2 hours after receiving immunizations my son became fussy which built up to crying which then progressed to nonstop screaming that lasted approx 3-4 hours. Administered Triaminic acetaminophen.
Within 24 hrs reported-acting "zonedout" quiet with Tylenol given 48 hrs after went to ER with hives (Lasting 4 hours given Atarax) Specific onset unknown
Develop rash on left deltoid today and it is red and itchy, swollen and tender.
Patient describes bad pain in both arms that started in December after receiving the vaccines, and still hasn't resolved as of 3-6-2019. She squeezes her biceps and the place where the pain is located, not up on her deltoid muscle where the shots were given at.