chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The afternoon of 12/17 I started with a mild itch and rash under the armpit on my side of injection. That evening I had a rash break out along my waist line, upper thighs and goin. The following 4 days and counting I have been dealing with striation like rash breakouts on all over my body, upper and lower. After eating an apple I began to experience swelling in my lip a reaction I have never had.
This spontaneous report was received from nurse refers to a 47 year old patient of an unknown gender. Medical history was not reported. On 08-SEP-2014 the patient was vaccinated with the third dose of RECOMBIVAX HB injection (10/1.0 mcrg/ml) 1 ml, intramuscular, lot # J008505 dose, expiration date: 07-FEB-2016, which was improperly stored. No adverse effects reported. Additional information has been requested.
Received PPSV23 on 11/3.  The next day she had mild arm soreness.  On 11/5 her arm hurt quite a bit and the redness at the site was spreading.  On 11/7 she felt malaise, dizziness, floaters in supine position, could eat/drink very little. Her arm was red and hot from the shoulder nearly to the elbow and was hot.  Went to ED and admitted to ICU for hypotension, elevated WBC and Acute Renal Failure.  She was in ICU for 2 days, general unit for 1 day and discharged.  Cause of illness not known, but immunization is suspect.  Much better today (11/21), but not all the way back to normal.
Surgery was done at on 5/19/21 to replace her aortic valve. While other complications came up, all of the fixes worked. Everything was repaired. My Mother?s blood would not clot. They were unable to close her following surgery. They tried again over night to stop the bleeding but her blood would still not clot.  She had stopped all of her blood thinning medications days earlier than suggested prior to surgery.  She died the next morning.   Had her blood clotted I believe  she would be here today.  I believe her blood did not clot because of her two doses of this vaccine.
itched; rash all over stomach/it was bad; rash all over stomach and legs/it was bad; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itched), RASH (rash all over stomach/it was bad) and RASH (rash all over stomach and legs/it was bad) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 031M20A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced RASH PRURITIC (itched), RASH (rash all over stomach/it was bad) and RASH (rash all over stomach and legs/it was bad). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and CORTISONE (topical) for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (itched), RASH (rash all over stomach/it was bad) and RASH (rash all over stomach and legs/it was bad) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the rash was not painful.   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Follow up was received on 22-NOV-2021: No new information.
Fatigue; Vertigo; Arm pain; This is a spontaneous report from a contactable other HCP (patient). A 43-year-old male patient received the first dose of BNT162b2 (Lot/batch number and Expiration date were not provided), intramuscular at left arm on 22Dec2020 13:00 at single dose for covid-19 immunization. There were no medical history and concomitant medications. The patient experienced fatigue and vertigo, arm pain on 22Dec2020 20:00. It was unknown if treatment received for the adverse event. The outcome of the events was recovered on unspecified date.  Information on the lot/batch number has been requested.
Arm swollen and red with red blotches extending to axilla. Axilla painful; no fever. Doctor felt it was infected and placed on antibiotics. Improved.
The pt experienced painful, soft tissue swelling to the left arm at the injection site / deltoid muscle with redness of skin which was 5cm. No fever.
Patient slept for 13 hours and when she awoke Mom noticed papular rash on body.
Individual tested positive for COVID-19 on 06/23/2021 and was sent to hospital.  Chest x-rays were abnormal and she was diagnosed with COVID pneumonia in both lungs.  Was discharged on 06/27/2021 and is currently on 3L of O2
Pt got the flu shot on 11/2/01. "A couple of days later", he felt joint aches and was "feeling bad". On 11/13/01 at 14:00, he began to feel numbness and tingling in his feet and hands. Also was losing coordination. GBS? Still in ICU. 60 day follow-up information states on 1/21/03 T.V. with medical RN and client.l Under care of neurologist for GBS which occurred 2 weeks after flu vaccine 11/2/01. On Soc Sec because uncalbe to return to job as machinist. Able to ambulate now without care. Very fatigued/no stamina, feet hypersensitive and sore; numbness and tingling in fingers and left side of face and forehead. Discharge summary states GBS, sepsis, and URI. Follow up on 11/04/2003: "Vaccine recipient did not recover from the adverse event.  See attached updated report based on 10/30/2003.  Telephoned client regarding her present health states and treatment."
After about 20 minutes left leg became numb. Like it fell asleep, but not that bad. Persisted about 1 hour.  Then OK.
This case was reported by a consumer via call center representative and described the occurrence of vesicular rash in a 92-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX and SHINGRIX with an associated reaction of fatigue (1st dose received on 26th June 2018, refer case US2018166447). On 30th August 2018 13:00, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than 2 weeks after receiving SHINGRIX, the patient experienced vesicular rash, bone pain, pain, blister, erythematous rash, scab and induration. On an unknown date, the outcome of the vesicular rash, blister, erythematous rash, scab and induration were recovering/resolving and the outcome of the bone pain and pain were recovered/resolved. It was unknown if the reporter considered the vesicular rash, bone pain, pain, blister, erythematous rash, scab and induration to be related to SHINGRIX. Additional information received as follows: The case was reported by the patient's daughter. The reporter reported that the patient received SHINGRIX on the left deltoid. The patient experienced feeling achy and her bones hurt like arthritis. The patient also experienced a big rash on her right buttock cheek. The daughter (reporter) thought that the rash looked like a shingles rash. She stated that the buttock was uncomfortable for her mother to sit on. It was blisters at first, red, angry-looking, hard little bumps. At the time of reporting, as these events were seemed to be getting better, the blisters were crusted over and scabby and so the patient did not visit the physician regarding this. The reporter noted that the area did not itch or hurt. The contact details of the physician were provided.
The patient received a dose of VARIVAX and a dose o PROQUAD during the same office visit; This spontaneous report has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. No information was provided regarding patient's medical history, concurrent conditions, drug and allergy history.    On 30-SEP-2019, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, route of administration and frequency were not provided) lot # R002057, expiration date 22-JAN-2020 and during the same office visit, the patient also received a dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (strength, dose, route of administration and frequency were not provided) lot #S003326, expiration date 02-AUG-2020 both for prophylaxis (overdose). An sterile diluent (MRK DILUENT) was used in the vaccination process.
Patient came in two days after vaccine to report erythema and tenderness spreading down arm from injection site/
hardness on the site of injection; sorenes on the site of injection; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (hardness on the site of injection), VACCINATION SITE PAIN (sorenes on the site of injection) and FATIGUE (fatigue) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (hardness on the site of injection), VACCINATION SITE PAIN (sorenes on the site of injection) and FATIGUE (fatigue). At the time of the report, VACCINATION SITE INDURATION (hardness on the site of injection), VACCINATION SITE PAIN (sorenes on the site of injection) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was not reported.
Patient called today (2/2/22) to state that she has very swollen lymph nodes in her right arm after getting her vaccine on 1/29/22. She states that she experienced a very sore armpit in her right arm the evening of the 29th and then the next morning experienced "a lot" of swelling in her lymph nodes. She states that the swelling is still present today and has not gone down since then.
Severe Nausea, vomiting, diarrhea, fever, severe chills with sweating, extreme exhaustion, headache, extremely sore at injection site, body aches, muscle pain
Pt developed a low-grade fever, post vax, and began losing skills after 18 month DTAP. He lost all skills of language, cognitive and pragmatic. He formed major sensory issues by the age of 27 months. Now has severe autistic disorder.
pt recvd vax; exp numbness in arms/legs p/ vax;joint pain; as per MD,had sxs for 6 wks;
This spontaneous report as received from a certified registered nurse practitioner (CRNP) referred to a 65 year old male patient Rheumatoid arthritis (RA), vitamin D deficiency and with drug reactions/allergies to Penicillin, prednisone, SEROMYCIN and sulfa. On 28-FEB-2013 at 11:10 AM, the patient was vaccinated with a dose of ZOSTAVAX (lot # H013943, subcutaneous in the left upper arm, dose unspecified). On 28-FEB-2013 at PM the patient experienced burning on injection, which continued with the rest day. Bright red area 5cm X 4cm raised and hard area, felt like a major bruise. Itching and stinging. Chills started through night and continued to last presently. "Can't get washed." Taking BENADRYL for itching and reaction symptom since Friday. The outcome of all events were unknown. Causality were not provided. All the events were considered as other significant medical events (required medical intervention) by reporter. Additional information has been requested.
Telephone call from patient. Patient stated her upper arm, about 4-5 inches below injection site, became red and hot the day after the injection, then became itchy; it remained so for a day, then on the following day (10/12/17) symptoms began to resolve. She states on 10/13/17 that "I can barely see that area, it is not firm or warm, but it is tender if I push on it."
She had a little sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (She had a little sore arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L201A) for COVID-19 vaccination.     Concomitant products included METFORMIN, AMLODIPINE, MELOXICAM, SIMVASTATIN, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), MECOBALAMIN (VITAMIN B12 [MECOBALAMIN]) and ELDERBERRY [SAMBUCUS NIGRA] for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (She had a little sore arm). At the time of the report, PAIN IN EXTREMITY (She had a little sore arm) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided   This case was linked to MOD-2021-261717 (Patient Link).
Patient developed cryoglobulinemic vasculitis within few days of vaccination. Workup does not suggest any other underlying autoimmune or infectious process
Patient developed tingling  on the tongue 7 days after vaccine and developed unilateral facial weakness 9 days later diagnosed as bell's palsy and started on Prednisone, Valcyclovir and ophthalmic Lubricants.
Information has been received from a physician concerning a 16 week old twin (sex not reported) who on 06-MAR-2007 was vaccinated orally with the first dose Rotateq. At four months of age the child received the first dose of Rotateq. No further information is available.  Additional information has been requested.
LARGE BRUISE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced large bruise. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from large bruise. This report was non-serious.
Patient had syncopal event within 1 minute of vaccination. He was actively talking and fell back in his chair, hitting his head on the way down. He had full body trembling without involvement of his head and a pause in breathing for approximately 30 seconds. He came too with a quick extension of all extremities and return of breathing within 30 seconds. He took approximately 1 more minute to open his eyes. He was provided nourishment with food and fluids and acting normally immediately after with some pale appearance and sluggish reactions. He felt fully recovered within one hour.
Wife states that his arm was so sore that he could not lift it up, then it became numb. The patient went to the hospital where some tests were run (wife did not know what tests) and the outcome was that he had a bacterial infection.
SWELLING IN LEFT ARMPIT ALONG WITH LIGHT REDNESS AND THE AREA FEELS HOT TO A TOUCH; SWELLING IN LEFT ARMPIT ALONG WITH LIGHT REDNESS AND THE AREA FEELS HOT TO A TOUCH; ITCHING ALONG THE LEFT ARM; AREA FEELS HOT TO A TOUCH; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 11Apr2021 at 14:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure (fine under medication). Patient received unspecified other medication within 2 weeks of vaccination. The patient previously took lisinopril (MANUFACTURER UNKNOWN) and experienced allergic reaction. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 13Apr2021, the patient experienced swelling in left armpit along with light redness and the area feels hot to a touch and itching along the left arm. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events swelling in left armpit along with light redness and the area feels hot to a touch and itching along the left arm was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
10 minutes after patient received vaccine he felt lightheaded and fell out of his chair and hit his head.
This spontaneous report was received from a vaccine coordinator and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of one of the following incorrectly stored vaccines: VARIVAX lot # M045205 with expiration date 11-NOV-2017, lot# N014632 with expiration date 11-MAY-2019 and lot# N014632 (dose, route and anatomical location were not reported), or ZOSTAVAX lot# M041511 with expiration date 01-OCT-2018 (dose, route and anatomical location were not reported), or PROQUAD lot# N010866 with expiration date 01-OCT-2018, lot# N013864 with expiration date 31-OCT-2018, or lot# N015621 with expiration date 15-NOV-2018 (dose, route and anatomical location were not reported). The doses were stored in the range from 15 degrees Fahrenheit to 46 degrees Fahrenheit for 49 minutes. There was no previous temperature excursion reported. No adverse event was reported. Digital data logger was involved.
No treatment. Patient experienced nausea, diarrhea, severe headache, convulsions, spasms, & shaking. She also had a slight fever. Pt said she had a ball of phlegm in her throat too, she was also dizzy.
Was being treated for possible Lyme disease before 12 mo well check. Rash had resolved and pt was afebrile when shots given but also on AMOXIL shots on 7/11/14. 7/18/14 went to urgent care b/c of rash on face and body and also had fever of 101 that day. Stopped AMOXIL 7/15. Took one dose of cefuroxime 7/19. No abx since 7/19. Was seen by Pedi ID for possible tick borne dz. Also tested for enterovirus which was (+).
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 75 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Nov2021 (Lot number: FG3527) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose, Lot: EN5318, Site: right arm), administration date: 02Feb2021, when the patient was 74 years old, for COVID-19 immunization; Bnt162b2 (Second Dose, Lot: EN6200, Site: right arm), administration date: 01Mar2021, when the patient was 74 years old, for COVID-19 immunization.The following information was reported: IMMUNISATION (non-serious) with onset 18Nov2021, outcome "unknown", described as "Booster"; PSORIASIS (non-serious) with onset Nov2021, outcome "not recovered", described as "Body was covered from head to my feet with psoriasis and it is bad; Whole body was covered from top of my head I even got it on the bottom of my feet"; FEELING ABNORMAL (non-serious) with onset 20Nov2021, outcome "unknown", described as "Have been through hell and back since the 20Nov and it is caused from your stupid booster shot"; EMOTIONAL DISTRESS (non-serious) with onset Nov2021, outcome "unknown", described as "Pain and suffering"; NAIL DISORDER (non-serious) with onset Nov2021, outcome "unknown", described as "I got my booster shot on the 18Nov and 2 days later I noticed these 'things' on my finger nails"; RASH (non-serious) with onset Nov2021, outcome "not recovered", described as "she got the booster vaccine and 2 days later developed an ugly rash around her fingernails of her right hand, and then progressed to her whole body from head to toe"; SCAB (non-serious), ULCER (non-serious) all with onset Nov2021, outcome "unknown" and all described as "crusty sores"; RASH ERYTHEMATOUS (non-serious) with onset Nov2021, outcome "unknown", described as "Rash as bloody". The event "she got the booster vaccine and 2 days later developed an ugly rash around her fingernails of her right hand, and then progressed to her whole body from head to toe" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash. Additional information: The patient had not received any other vaccine within 4 weeks of covid-19 vaccine. After two days of booster dose, the patient developed an ugly rash around her fingernails of her right hand, and then progressed to her whole body from head to toe. The reporter described the rash as bloody, and crusty sores. The reporter stated that her doctor sent photos to the dermatologist confirmed it was psoriasis. The reporter stated that she had taken Prednisone as treatment since that Friday and that had dried up some of the rash. The reporter stated that she would see a dermatologist in Feb2022.
3 DAYS AFTER RECEIVING HER FLU VACCINE THE PATIENT DEVELOPED BODY WIDE HIVE AND FACIAL SWELLING. NO LIP OR TONGUE SWELLING. NO COUGH OR RESPIRATORY DISTRESS. NO OTHER IDENTIFIABLE CAUSE FOR THESE SYMPTOMS. MOTHER OF PATIENT GAVE ONE DOSE OF ORAL BENADRYL WHICH RELIEVED SYMPTOMS. SYMPTOMS DID NOT RETURN.
she gave a D.M. a DTaP/IPV from a vial instead of reconstituting with the HIB/no AE; Initial information received on 12-Aug-2019 regarding an unsolicited non-valid non-serious case received from a consumer.  This case involves a 7 months old male patient who received only 0.5 ml third dose of DTaP-IPV liquid portion of DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) (lot: U6218AA) without the HiB component on 09-Aug-2019 during a Well Check Up. (given Intramuscular in the Left thigh) HIB Lot-UJ015AA, Expiry Date: 26Oct2020, Box- Lot UJ124AAA, Expiry Date: 29Sep2020  Patient's medical history was not reported.  Concomitant therapies were Hepatitis B, Prevnar 13 and Rotavirus given on 09-Aug-2019.  It was of actual medication error due to inappropriate reconstitution technique.   It was reported that no adverse event was experienced.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Report body aches, fever, chills, GI upset.  Treatment: Ibuprofen,  Outcome:  Mild improvement does not interfere with ADLs.
patient developed symptoms of severe dizziness with nausea which started at 4pm and lasted 4 hours. patient got a flu shot at 11 am that day.
Pt inadvertently given Hep A 1 mL adult dose.  Called CDC, informed no adverse effects other than redness to site.
Hives; Paleness; Weak; Lethargic; Wouldn't eat or Drink; Spoke to Pediatrician put him on Benadryl Four Times a Day.