chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cough; rash on both arms; rash was inflamed; it was red and burning; it was red and burning; 20 little red dots on each arm from his elbow to his hands; they were like welts; they were inflamed and the skin around the welts was swollen.; Fever; This is a spontaneous report from contactable consumers. A 59-year-old male consumer (patient) reported that he received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route at left arm on 13Jan2021 3pm at single dose for COVID-19 immunization. Medical history included blood pressure high diagnosed about 5 years ago and being in the hospital seeing patients every day, sometimes they were Covid patients. Concomitant drugs included losartan ongoing for blood pressure high. Patient had his 2nd vaccine on Wednesday 13Jan2021. On 14Jan2021 Thursday he had a fever, and on 15Jan2021 Friday he developed a cough and a rash on both arms that continued through the weekend. He stated that the rash was inflamed on 15Jan2021 Friday and Saturday; it was red and burning; he had about 20 little red dots on each arm from his elbow to his hands, but on 15Jan2021 Friday and Saturday they were like welts; they were inflamed and the skin around the welts was swollen, then on Sunday it started to subside, and today it's almost gone but still a little bit red. Outcome of event fever was recovered on 16Jan2021, cough was recovered on 18Jan2021, and the rest of events was recovering.    Information about Lot/batch number has been requested.
High blood pressure - 205/108 within 3 minutes of injection.  Passed out multiple times when BP continued to rise.  Transported to hospital when BP did not come down.  Came down in ambulance with laying down and elevated feet.  Standing or sitting raised it again and continued to pass out.  Hospital monitored me, did blood work and released me even though BP did not go below 190/100.  Would not allow me to lay down or do anything to try and get BP down.  Took a couple of days of rest to be back to normal.
Vial punctured for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial punctured for more than 12 hours) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial punctured for more than 12 hours). On 21-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Vial punctured for more than 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided.  Treatment information was not provided.  The patient received dose of Moderna vaccine (unknown if it is first or second dose) from a vial which was punctured for more than 12 hours.The pharmacist said the vial was punctured on Monday 20 -Sep-2021 at 12 pm, they left it in the fridge and would have expired by 12 AM on Tuesday 21-Sep-2021. It was administered then at 3.59 PM, 4.53 PM, 9.15 PM and 9.16 PM.
Vaccine screening questionnaire was given to pt which he responded "no" to all questions including the question regarding history of adverse reaction after a vaccination. Pt was administered 0.5 mL of FLULAVAL in the left deltoid at 12:34pm. Approximately 6 minutes after vaccine administration pt experienced a syncopal episode that was witnessed by his father and sister. Upon re-entering the room pt was found to be sitting on the floor. Medical provider was notified who examined the pt. No head injury or other injury noted. Pt stated "this has happened before and I pass out all the time." Pt improved quickly and was stable for discharge from the clinic.
Over the period of 12 hours, client had symptoms of increase pain, swelling of arm from shoulder to elbow of left arm, limited mobility following vaccination. On day 2 following vaccination, client received treatment per MD, diagnosed with cellulitis.
I had the typical reactions: fever, headache, chills, fatigue but then got cellulitis right below injection site.
24APR99 lt arm swollen, afeb, rash over trunk by 25APR99 spread to legs;called ER 25aAPR99 instructed to given DPH;
Severe intestinal issues; Daily cramping that makes it hard to function; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GASTROINTESTINAL DISORDER (Severe intestinal issues) and MUSCLE SPASMS (Daily cramping that makes it hard to function) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GASTROINTESTINAL DISORDER (Severe intestinal issues) and MUSCLE SPASMS (Daily cramping that makes it hard to function). At the time of the report, GASTROINTESTINAL DISORDER (Severe intestinal issues) and MUSCLE SPASMS (Daily cramping that makes it hard to function) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment medication were provided  No concomitant medication were provided   Reporter did not allow further contact
Extreme swelling of left shoulder, severe pain, swelling inside left eye. Loss of vision left eye.
3/31/2021-Arm soreness 4/1/2021- afternoon-large amount of swelling in lymph nodes in right arm and side. Very painful. Changed to lose fitting clothing, took Advil, used warm compress and took a nap 4/2/2021-  large amount of swelling in lymph nodes in right arm and side. Very painful. Wore lose fitting clothing, took Advil, used warm compress 4/3/2021-Swelling down considerably seemed to be almost back to normal.  4/4/2021-Fatigue started to set in but contributed to lots of activity on 4/3/2021 4/5/2021-Fatigue all day, difficulty concentrating ,itchiness in legs when resting even after lotion 4/6/2021-Fatigue all day, difficulty concentrating ,itchiness in legs when resting resting even after lotion 4/7/2021-Fatigue all day, difficulty concentrating ,itchiness in legs when resting resting even after lotion, napped in the afternoon still fatigued 4/8/2021-Still Fatigued, called nurse line and visited Dr.
Client received first dose COVID vaccine @10:45am, complained of feeling faint @ 10:48am.  Client was placed in zero gravity chair, and reported feeling better.  Vital signs stable, symptoms resolved and client left home @ 11:20am.
Tinnitus in both ears starting 12 days after first injection.  Continuous, has not subsided.
Pt sibling (WAES97110254) recv  vax 23Oct97 &. Pt devel chickenpox.
pt recvd vax 1MAY95 & 2MAY pt was spitting up material that had a chemical smell (no vomiting);that noc pt awoke drenched w/sweat;pt did not feel feverish; was more irritable than usual;
No symptoms noted with my 1st dose.  The 2nd dose injection was approximately on Thurs afternoon at 1:30 pm.  Arm and slight body ache noticed around 3:30 am the following Friday. Severe chills and body aches began around 11:45 am Friday morning followed with a 101.7 fever around 12:30 pm.  Took 1 aspirin and by around 3:30 or so chills subsided and the fever broke.  Soreness and redness began taking place the next day, Saturday, early morning.  Rash-like itching and swelling began the following Sunday morning around 6 am.  I rubbed my arm periodically with ice.  Redness and itching continued Monday, used more ice.  I took 2 Benadryl tablets around 9 am Monday. Redness and swelling are down but slight itching remains this morning and I've just taken 1 Benadryl tablet.
girl administering the shot went to high on his arm and appeared she injected into his bursa; pain; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 06Mar2021 (Lot number: EN9581) at the age of 74 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (dose 1, Batch/Lot number: unknown), for COVID-19 immunisation. The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 06Mar2021, outcome "unknown", described as "girl administering the shot went to high on his arm and appeared she injected into his bursa"; PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "pain".  Additional information: It was also reported that the second dose was received on 06Feb2021.  No follow-up attempts are possible. No further information is expected.
On the 13th, I had a low grade fever and it never actually broke past 100. I spent most of the day in bed. Fatigued - and general was exhausted and tired .After that day, everything was pretty good. I had minor discomfort in my arm (that first day.) On the Friday, the 16th- my left arm - a third of my upper arm was bright red, swollen and hot to the touch and it was very painful. I reached out to a doctor for a chat with a doctor. The dr had me take 600 mg of Motrin and a Claritin and I took those based on the dosages allowed on the box, consistently for about 24 hours and after that it started getting a lot better.  I'd say by Sunday the 18th, I was pretty much back to normal and everything resolved.  Doctor chat but not a regular doctor visit.
muscle constriction - entire body - jaw fever, chills, confusion, intense body pain, Loss of memory from 10pm - 3am, incoherent, bladder spasms took ibuprofen at the end of the event
Right arm swollen, 1 inch>circumference than left arm, area red, warm, slightly tender to touch.
Soreness of arm started 01/13/21 Runny nose started 01/14/21 Sinus infection developed 01/15/21 Went to doctor and started antibiotics on 01/18/21
Initial unsolicited report received from a physician, who is also the patient, on 12 March 2015.  A male patient self-administered FLUZONE QIV on an unspecified date "this past season". He subsequently experienced an adverse reaction, consisting of coughing, sneezing, post-nasal issues, wheezing, fever, chills, muscle pain, and joint pain. His kidneys shut down and he lost renal function, and had difficulty walking. He was hospitalized for these events. The patient's medical history was not reported. The reporter did not have the lot number. Outcome was not reported. Documents held by sender: None.
Pt was admitted to hospital on 4/13/09 for intussusception after receiving vaccines on 3/23.  7/7/09 Received vaccine & PCP records which include ER medical records of  4/13-14/2009. FINAL DX: Intussusception, enema reduced. REcords reveal patient experienced abdominal pain, constipation x 5 days, irritable, lethargic.  Seen in outlying ER & transferred to higher level of care.  Enema administered & successfully reduced IS.  Observed w/o complication s/p reduction & d/c to home w/PCP f/u.
After the vaccination, I started to feel headaches and body aches including fever that wouldn't stop. Two days later I went to the ER due to dehydration caused by the fever, received an IV and also leg cramping and pain began as well including migraine as well. The migraine caused great pain in my eyes as well to the point where I had light sensitivity. My fever went down while in the ER however the migraine continued including chills. After leaving the emergency room I took an additional Advil migraine and two days later the migraine went away.
This spontaneous report was received from a certified medical assistant referring to an unspecified number of patients of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. It was stated that doses of MMR II (lot # K000174, expiration date: 08-JAN-2016) (dose and route of administration were not reported), which had been exposed to a temperature excursion outside of the recommended storage temperature, had been administered to the patients on unspecified dates since the temperature excursion (incorrect product storage). Concomitant therapies were not reported. No adverse experiences had been reported. At the time of the report, no additional information was provided. This is one of two reports form the same source. Additional information has been requested.
A non-serious spontaneous report of 17 month old received H1N1 was reported by a medical assistant/health professional concerning a 17-month-old male. The patient had no medical history and no concomitant medication was taken by the patient. On 18-Nov-2009, the patient received H1N1, Intranasal at a MD's office. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. Additional information was received on 02-Dec-2009 and incorporated into the narrative: Information added for medical history and concomitant medication.
Narrative: 51yo mlae patient died outside facilities on 5/29/2021. Pt with medical history of obesity, smoker, htn, h/o multiple recurrent nephrolithiasis, right renal hematoma, chronic lbp, osa, erectile dysfunction, t2dm. No information provided regarding pt's death. Not able to assess if death related to covid vaccines or not.
VAGINAL BLEEDING MISCARRIAGE O20.9 - Vaginal bleeding in pregnancy, first trimester
second Shingrix vaccine on February 21, 2021/patient received both the first and second doses of Shingrix/ on June 21, 2021/ have an active shingles outbreak.; active shingles symptoms on her abdomen /have an active shingles outbreak; abdominal pain; This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 21st February 2021, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. On 12th June 2021, 111 days after receiving Shingrix and unknown after receiving Shingrix, the patient experienced abdominal pain. On 18th June 2021, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and abdominal pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and abdominal pain to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccionation was not reported. The reported confirm that, the patient received both the first and second doses of Shingrix, but unsure of the date of the first dose of vaccine. On the weekend of 12th June 2021, the patient was treated at the emergency department for abdominal pain. The patient began experiencing active shingles symptoms on her abdomen on 18th June 2021. The patient was evaluated by the doctor on 21st June 2021 and found to have an active shingles outbreak (Lack of effect). The field professional did not have information regarding the Lot number and physical location of the vaccines received. The reporter consented to follow up.
5 minutes following vaccination, patient became pale, sweaty, dizzy, and light headed. Vitals noted to be: Bp 88/60, P 100, R 16 no distress. Patient laid down on cot and given ice pack on neck. Patient also reported having nausea and abdominal cramps. Patient monitored for half hour. Color improved and Bp noted to improve to 110/66. Patient drove home by father.
Feeling sick; Abdominal pain; Generalized aching; Tiredness; Injection site pain; This spontaneous case was reported by a health care professional and describes the occurrence of MALAISE (Feeling sick), ABDOMINAL PAIN (Abdominal pain), PAIN (Generalized aching), FATIGUE (Tiredness) and INJECTION SITE PAIN (Injection site pain) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Spondylitis ankylosing.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced MALAISE (Feeling sick), ABDOMINAL PAIN (Abdominal pain), PAIN (Generalized aching), FATIGUE (Tiredness) and INJECTION SITE PAIN (Injection site pain). At the time of the report, MALAISE (Feeling sick), ABDOMINAL PAIN (Abdominal pain), PAIN (Generalized aching), FATIGUE (Tiredness) and INJECTION SITE PAIN (Injection site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Full body rash, especially prominent on face, chest, forearms, and lower legs and above knees. Red, raised, papular, and extremely itchy. Continues today. 4 days ago on the 20th, developed vaginal bleeding. I am post menopausal x 24 years. I have not had vaginal bleeding in 24 years. This vaginal bleeding continues today.
it was rpt p/pt recv vax subsequently devel vomiting and diarrhea;
Arrival to ED:  9/23/21 @ 1:45pm  Patient arrived to ED via EMS with chief complaint of altered mental status and emesis.  His nephew was at his side. Patient's nephew and EMS stated patient received COVID-19 vaccine the day before and became progressively more weak and lethargic.  Patient's baseline is AA0x4 and he takes care of himself. Pt is non verbal and vomited x1 prior to arrival. Upon presentation in the ED, the patient was obtunded and unresponsive. Patient was seen immediately on arrival. The patient's history was provided by the EMS personnel and a relative (nephew).  Medical staff were unable to obtain history from patient due to his condition.   Physical Exam findings: Constitutional: Obtunded Eyes: Pinpoint pupils bilaterally, minimally reactive Neck: JVD Pulmonary: Breath sounds with rhonchi present bilaterally (R>L); spontaneous respirations Musculoskeletal: Edema to Right Lower Leg and Left Lower Leg; bilateral edema pitting to mid tibia Neurological: Unresponsive to painful stimuli; No posturing noted  Vitals on presentation to ED:  BP 145/86; HR 88; Resp 21; SpO2 83%  Patient seen by critical are provider at 2:15pm Patient placed on nonrebreather oxygen mask with improvement to oxygen saturation (to low 90s). Discussed plan of care with nephew (living will states patient wanted to be DNR/DNI) Stat Imaging ordered and results interpreted Infectious workup initiated & IV antibiotics ordered Discussed case with inpatient admitted MD ED diagnosis: Pneumonia of both lungs due to infectious organism   Medication Administration Zosyn 4.5gram IV @ 3:05pm Vancomycin 1,000 mg IV @ 3:05pm  Patient expired while in the ED. Time of death, 7:13pm.
pt exp extreme local react w/erythema, swelling & painful induration, & had elevated WBC count of 16,00; pt was adm to hosp; 2NOV94 had been discharged from hosp & was doing alright; addtl details are being requested;
After receiving nasal H1N1 FLUMIST pt c/o headache, dizziness and tingling head. S/S began 5-10 min post-vaccination and resolved 5-10 min after onset.
Patient received vaccine on 11/10/15 stating that she had a shoulder pain that wouldn't go away and thinks that it is due to the vaccine being administered too high up on her shoulder.
Warm to touch, redness, slight welling, blister-like bumps, all at injection site, fever also noted.
Patient stated airway was closing off, this patient has had adverse reaction to prior medication.  Epi pen was used and patient was transported via  ambulance to Hospital less than 0.5 miles from vaccine clinic.
Miscarriage  determined at 19 weeks gestation on 3/10/2021.
received pentacel, daptacel and act-hib so the dtap and hib portion is doubled with no reported adverse event; Initial information received on 25-Aug-2023 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 2-year-old female patient received pentacel, daptacel and HIB (PRP/T) vaccine [ACT-HIB] so the dtap and hib portion is doubled with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, HIB vaccine CONJ (TET TOX), pertussis vaccine acellular 5-component, polio vaccine INACT 3V (MRC 5), tetanus vaccine toxoid (Pentacel) for Prophylactic vaccination; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel) for Prophylactic vaccination; and hepatitis A vaccine INACT (HEP A IN VAC) for Prophylactic vaccination.  On 22-Aug-2023, the patient received a 0.5 ml dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (strength: unknown) (lot: UJ837AAA, expiry date: 30-Oct-2023) via intramuscular route in unknown administration site for Immunization and patient received pentacel, daptacel and act-hib so the dtap and hib portion is doubled with no reported adverse event (extra dose administered) (latency: same day).  It was unknown if any lab data/test results available.  Action taken with haemophilus type B (HIB) vaccine (ACT-HIB) was not applicable.  Outcome: Unknown  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 the Directive. 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.
Headache of shooting pain in her head; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache of shooting pain in her head) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced HEADACHE (Headache of shooting pain in her head). The patient was treated with PARACETAMOL (TYLENOL) for Headache aggravated, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Headache aggravated, at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache of shooting pain in her head) had not resolved.            Concomitant medications were not reported.
About 6-7 minutes after pt was given PREVNAR-13, pt was being instructed on how to use glucometer when she became very anxious, shaky, pale and diaphoretic. Pulse O2 was placed which registered oximetry of 89% and pulse of 30. Pt then lost consiousness and no pulse registered on pulse O2. Pt was unconscious for 1-2 minute with a weak thready pulse. EMS was called. Pt did regain consciousness and transferred to ER.