chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 9 year old male who on 10/23/1997 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). On 11/12/2005, the patient started erupting in an itchy rash. On 11/14/2005, he was seen in the physician's office and he still had an itchy rash that was red, scabbing and spreading on his left axilla, chest and both arms that was vesicular and papular. The physician diagnosed the rash as chickenpox. Treatment included diphenhydramine hydrochloride (Benadryl) and Avena (Aveeno Bath). At the time of the report the patient's out come was unknown. There was no product quality complaint involved. Additional information has been requested.
Facial swelling and slight lip swelling and redness to skin which began about 90 minutes after the vaccination.  He was seen in an emergency room and treated with diphenhydramine, famotidine and prednisone and discharged on the same. He improved in the ER but reports that he had recurrent facial swelling over the next few days when antihistamine wore off.  Resolved after a few days.  Seen in the office on 3/18/21 and doing fine off medication.
after her last dose of the vaccine she had "severe flu like symptoms" worse than she's ever had in her life; psoriasis; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (psoriasis) and INFLUENZA LIKE ILLNESS (after her last dose of the vaccine she had "severe flu like symptoms" worse than she's ever had in her life) in a 7-decade-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A, 027L20A and 002M21A) for COVID-19 prophylaxis.     Concomitant products included GUSELKUMAB (TREMFYA) for Psoriasis.   On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2020, the patient experienced PSORIASIS (psoriasis). In April 2022, the patient experienced INFLUENZA LIKE ILLNESS (after her last dose of the vaccine she had "severe flu like symptoms" worse than she's ever had in her life). At the time of the report, PSORIASIS (psoriasis) had not resolved and INFLUENZA LIKE ILLNESS (after her last dose of the vaccine she had "severe flu like symptoms" worse than she's ever had in her life) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2023-748136 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748136:Same Reporter
My doctor saw that I had a swollen left lymph node. Doctor wants to keep an eye on it. I felt run down, with a headache, aches and pains. Around 12/19/21 I started having sharp pains on my left side that spread to my upper abdomen which causing me much pain to bend down. I went to the doctor again on 12/23/21 because I have not been able to eat much because I am having such bad abdominal pain. Also now having issues with constipation so the doctor wants to do an ultrasound to see what is going on with that now. All of this began after receiving the booster.
FATIGUE; FEVER; This spontaneous report received from a patient concerned a 30 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) once a total dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F. On 27-MAR-2021, the subject experienced fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 27-MAR-2021, and fatigue on 29-MAR-2021. This report was non-serious.
hearing loss; ZOSTAVAX was not effective for long-term or permanent shingles prevention; Information has been received from a lawyer regarding a case in litigation concerning to apatient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On 20-JAN-2013, the patient was administered the zoster vaccine live (ZOSTAVAX) by a pharmacist (lot number, expiry date, dosage, anatomical location and route of administration were not provided). On an unknown date, the patient was treated at a hospital for the following injury resulting from her use of zoster vaccine live (ZOSTAVAX): hearing loss. Plaintiff claimeed had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. Additionally, it was considered that zoster vaccine live (ZOSTAVAX) was not effective for long-term or permanent shingles prevention. The outcome of the hearing loss was not recovered. The outcome of vaccination failure was unknown. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review the event hearing loss was determined to be medically significant.
Shingles; Blister; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 74A7L, expiry date 22nd October 2021) for prophylaxis.   On 17th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 26th July 2019, 9 days after receiving Shingrix, the patient experienced shingles and blister. On an unknown date, the outcome of the shingles and blister were not recovered/not resolved.   It was unknown if the reporter considered the shingles and blister to be related to Shingrix.  Additional information received were as follows: The reporter reported that the patient came to the pharmacy to report that she was diagnosed by her physician with Shingles on the reporting date. The patient had one shingles blister on her back. The reporter was unable to provide any additional details.  The call was transferred to medical information.
Initial report received from a consumer on 13 Aug 2010: This patient with unknown medical history was vaccinated with H1N1 vaccine (manufacturer and batch number unknown) on 18 Nov 2009. Ten days after the vaccination, the patient was paralyzed from breast to toes and suffered from permanent disability and continual pain. The patient was hospitalized. A diagnosis of acute transverse myelitis was made. The patient was treated with rehabilitation and physical therapy. Final outcome of the events was not reported.
broke out in hives; when my left side of my neck began itching; This is a spontaneous report from a contactable consumer (Patient). A 68-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EM9809) via an unspecified route of administration in Left Arm on 11Feb2021 11:00 am as 1st dose, SINGLE for COVID-19 immunization. Medical history included high blood pressure, hypothyroid, known allergies: penicillin, other allergies to unknown substances (known allergies: penicillin, other allergies to unknown substances). Patient's concomitant medications were not reported. Facility type vaccine: Other. On 11Feb2021 21:00, the patient experienced broke out in hives and when my left side of my neck began itching. Patient reported: I received the vaccination at 11:15 a.m. All went well, until 9:00 p.m. that night, when my left side of my neck began itching, I broke out in hives. I have a photo of the hives. Took two benedryl, hives eventually went away that night. AE resulted in: [Doctor or other healthcare professional office/clinic visit. If treatment AE: Yes, AE treatment: took benedryl followed up with office visit. if covid prior vaccination: No. If covid tested post vaccination: No. The clinical outcome of event broke out in hives was recovered on an unspecified date and for another event outcome was unknown.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Night fever; chest congestion; Chill; Getting a little bit mucus/mucus is thick; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 03Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included 20 years ago she had a walking pneumonia. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (BNT162B2) via an unspecified route of administration as SINGLE DOSE for covid-19 immunisation. It was reported that the patient got the second dose 6 days ago (03Feb2021) and currently experiencing Night fever and Chill and Getting a little bit mucus. The patient was asking if pneumonia or symptoms of pneumonia have been reported after gettting the second covid vaccination and if not how long with her congestion, mucous chills and fever last. She reported that 20 years ago she had a walking pneumonia that felt similar to this and was worried that the vaccine could cause her to have it again. She took her second shot on the third (03Feb2021). For the last two nights (Feb2021) she has had chills and a little fever. She is concerned if this can give pneumonia. She wanted to know has anyone reported pneumonia from it. She has chest congestion and her mucus is thick. It was six days ago. She knew it was something to expect, but she didn't know for how long. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Had injection Thursday afternoon.  Was home next few days, so no physical exertion.  Monday 4.3.21 morning went down flight of stairs on way out, noticed heavy breathing/out of breath.   Usual day out activities, Walk in Park and Zoo.   Same breathing issues through out day. Repeated for next two days out.  Accompanied by air-y cough.  Chest ache after.  Home four days, no exertion.  Out again next week Monday 4.10.21-Thursday, same symptoms.  Weekend same as previous, slight ache from cough, no breathing issues since no exertion.  Monday 4.17.21 Breathing and ache so bad, changed routine for week and did not take any walks.  Did errands with rest periods between.  Thought was getting better by Thurs as went up stairs with little issue.  Weekend same as prior.  Monday 4.24.21-Wed - Resumed regular walking activity, breathing, coughing, chest ache  presented.  Weekend, consistent cough and chest ache through out.  Today, Sunday 5.30.21 is day 31.
Kidney pain; can barely move; This case was reported by a consumer via patient support programs and described the occurrence of renal pain in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th April 2019, the patient received Shingrix .5 ml. On an unknown date, less than a week after receiving Shingrix, the patient experienced renal pain and mobility decreased. On an unknown date, the outcome of the renal pain and mobility decreased were unknown.   It was unknown if the reporter considered the renal pain and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The patient experienced kidney pain and barely move after receiving the Shingrix. The case did not have any product complaint. The reporter gave consent to contact the safety physician and provided contact details for the same. The case has been linked with the case US2019AMR089167, reported by same reporter.
liver enzymes being elevated; This spontaneous case was reported by a consumer and describes the occurrence of HEPATIC ENZYME INCREASED (liver enzymes being elevated) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Rheumatoid arthritis (Rheumatoid arthritis with rheumatoid factor of multiple sites without organ or systems involvement), Penicillin allergy, Sulfonamide allergy (Allergy to Sulfa) and Allergy to NSAIDs (Allergy to Aspirin). Concomitant products included OMEPRAZOLE, PARACETAMOL (TYLENOL), METHYLPREDNISOLONE, COLECALCIFEROL, MENAQUINONE (D3 +K2) and CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]) for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEPATIC ENZYME INCREASED (liver enzymes being elevated). At the time of the report, HEPATIC ENZYME INCREASED (liver enzymes being elevated) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Hepatic enzyme: elevated.         It was reported that the patient would not take another booster of Moderna, due to uncertainty about liver enzymes being elevated caused by taking the Moderna COVID vaccine.  No treatment information was reported.
The day before the first vaccine she was up and acting normal, laundry, housework and knew what to do.   She has severe dementia but was doing OK and knew where she was.  She got the first vaccine on 1/29/21, and the 3rd and 4th day they noticed she was having hallucinations and saying things that weren't there.  She could hear baby's crying but there were no baby's present.   Within 7 days she had what the son described as a stroke. He said that she was watching television and he was on a conference call and he noticed she walked into a wall and he asked if she was okay and starting stumbling across the room and when he touched her she felt very heavy and said that one side of her face was drooping.  He got her back into the chair and called 9-1-1.  She was so agitated at the hospital that the husband does not know what they gave her and they kept her for a week.    They finally got her under control.  They discharged her from there and she that was all that they could do with her.  They brought her home with nurses assistance and her paranoia was evident, hallucinations were very evident. They said that they tried to do a CAT Scan and an MRI and they said that she did not have a stroke.   Restless was very adamant, talking strange things and wanting to go to her son's house when she was there.  Before that vaccination she knew where she was and after that she did not know where she was thinking she was at one location and just confusion.     She then got her 2nd vaccine and then her husband went out of town and took her back home on 2/24/21 as he was able to get her in a car and travel and able to eat and knew somewhat what was going on.  On 2/25/21 when he brought her home to  a long term care facility.  She was chanting constantly, had irritability, anger, cognition completely eroded.  She was very agitated, very combative.  Drugs would not calm her down, and tried to get CAT scans or MRI's but were unsuccessful due to her combativeness.  She was screaming and yelling 24 hours a day to the top of her lungs and gave her Ativan which had the adverse effects of what they were supposed to do.  Had biting, hallucinations, paranoia.   She had a couple of falls, they had her in a wheelchair and tried to feed her and she would fall down.  They took her to the hospital a few times and she progressively got worse.  On 4/19/21 she shut down and quit eating, quit drinking, closed her eyes, and lasted a week like that and then she died on 4/24/21 @ 2:30 AM.   None of her doctors could figure out what had happened.  They were finally able to get a CAT scan and felt that she may have a stroke.      Finally they memory care facility told them to come a take her to the hospital and they had moved their hospice patient's as she was screaming and disruptive and they could not handle her anymore.     They thought she was suffering from Lewy body dementia at one point.  They were going to have her tested for that and they could not do it on Saturday when she passed for genetics and missed those timelines and could not do it.
Patient felt like she was going to faint, so we helped her move from the chair to the floor, bp was normal, 02 sat was 100, normal pulse, patient.  Called 911 to have patient evaluated at the ER.  Mother called after leaving the ER to say patient had a panic attack.  According to mother ER physician advised the patient that she did not have a reaction to the Vaccine but had a panic attack.  Mom stated that she thought she had grown out of having anxiety around needles etc.
Pt experienced lip swelling, total body rash and aphthous ulcers and tooth and mouth pain.
Intraparenchymal hematoma of brain; neurosurgery following neurosurgery felt there was no need for intervention. Patient treated and released. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
This case was reported by a healthcare professional and described the occurrence of eyes crossing in a 2-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), haemophilus influenzae type b vaccine (non-GSK), PREVENAR (non-GSK) and rotavirus vaccine (non-GSK). The subject's medical history included jaundice as a newborn. On 12 May 2014, the subject received 1st dose of PEDIARIX route unknown, right thigh), 1st dose of Haemophilus influenzae type b vaccine (Non-GSK) (unknown), 1st dose of PREVENAR (unknown) and 1st dose of Rotavirus vaccine (Non-GSK) (unknown). On 12 May 2014, 3 hours after vaccination with Haemophilus influenzae type b vaccine (Non-GSK), PEDIARIX, PREVENAR, and Rotavirus vaccine (Non-GSK), the subject experienced eyes crossing. He had about 5 to 6 episodes of eye crossing that lasted about 15 to 20 seconds each. No other episodes. On 12 May 2014, the event was resolved. According to EMS, it could be an allergic reaction to the pertussis component of PEDIARIX. Follow-up information received on 13 June 2014: On 13 May 2014, the event was resolved with sequelae (unspecified which).
Patient returned with a red, warm rash on the left arm near injection site that extended 5 inches downward towards the elbow. No itching or pain, no sores.
04/27/2006 fever reported by mother 104.5. Seen in clinic sent home. Returned later in the day due to decreased oral intake, tachypnea. Admitted to hospital increased WBC 20,700, temp 102, tachypnea. Given 16M Rocephin IM. Discharged 4/28/06 tachypnea resolved, active, afebrile, oral intake improved. Diagnosis viral syndrome with fever tachypnea. 6/12/06-18 page hospital record received-H&P, DC summary, lab and CXR included. DC principal DX viral syndrome with fever and tachypnea. Admission temp 102 and tachypneic but lungs clear,  Remaining labs noncontributory.  Past medical history significant for respiratory distress at birth with transfer to another hospital. No problems since. RX Rocephin IM. Parents refused IV. During course of hospitalization vitals stable and tachypnea resolved. H&P documented negative strep screen. HX of tachypneic on one other visit to the office, March visit respiratory rate in low 60s and noted to have otitis media and nasal congestions. Seen in office several other times recently treated for thrush currently RX with Nystatin, also seen for diarrhea that was felt to be secondary to possibly rotavirus.
vial first expired then stored in refrigerator on same date of administration; doses were administered after the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were administered after the expiration date) and PRODUCT STORAGE ERROR (vial first expired then stored in refrigerator on same date of administration) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were administered after the expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial first expired then stored in refrigerator on same date of administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were administered after the expiration date) and PRODUCT STORAGE ERROR (vial first expired then stored in refrigerator on same date of administration) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. The patient had received booster 1. The patient had no known reactions. The vial did not undergo any temperature excursions. It was stated that the vial was thawed on the same day of administration. Treatment medications were not provided.
burning sensation; rash spreading on left low in calf muscle area then right lower left calf; itching; redness; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning sensation), DERMATITIS CONTACT (rash spreading on left low in calf muscle area then right lower left calf), PRURITUS (itching) and ERYTHEMA (redness) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included SALBUTAMOL (PROVENTIL [SALBUTAMOL]) for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced BURNING SENSATION (burning sensation), DERMATITIS CONTACT (rash spreading on left low in calf muscle area then right lower left calf), PRURITUS (itching) and ERYTHEMA (redness). The patient was treated with TRIAMCINOLONE at a dose of 1 dosage form and CLOBETASOL ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, BURNING SENSATION (burning sensation), DERMATITIS CONTACT (rash spreading on left low in calf muscle area then right lower left calf), PRURITUS (itching) and ERYTHEMA (redness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: negative Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Benthemethasone was also used for treatment
GI tract issues including diarrhea. I took IMODIUM AD and MAALOX ADVANCED.