chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 14 year old female patient who 10 days ago, on 13-OCT-2009 was vaccinated with the third dose of GARDASIL (lot number not reported). Concomitant vaccine therapy on the same day included a dose of FLUZONE. On 22-OCT-2009 the patient developed an urticarial/vasculitis like rash only on her palms and soles of her feet, she also developed a headache and fever. Medical attention was sought, the patient visited the physician's office. It was unspecified if there were lab studies performed. The patient took ibuprofen for the fever and headache and BENADRYL for the rash with no response. At the time of the report, the patient had not recovered. Follow-up information has been received from the physician's medical records concerning the 14 year old female patient had no illness at the time of vaccination who on 13-OCT-2009 at 15:00 pm was vaccinated IM in the left arm with the third dose of GARDASIL (lot number 660393/0067X). The patient developed cervicalgia/vasculitis rash itchy and throbbing on her palms and soles. The patient had headache too. On 23-OCT-2009 the following labs were collected: ASO screen positive, titer 200 IU/ml (reference negative <200 IU/ml). The patient was treated with 500 mg amoxicillin twice a day for 10 days, Rheumatoid factor negative, ESR-Westergren results of 2 MM/HR (reference 0-20) interpreted as no serologic evidence of infection with B. burgdorferi (Lyme), complement CH50 52 U/mL (reference 30-75), antinuclear AB positive, For CBC, neutrophil count 79% (reference 35-65%) and lymphocyte count 15% (reference 25-45%), lymph absolute 1.09 K/uL (reference 1.3-2.9 K/uL), remaining CBC were within normal limits, total bilirubin 1.4 MG/DL (reference 0.2-1.2), IgM 288 MG/DL (reference 48-226); on 28-OCT-2009 the following lab results were negative: DNA DBL STR AB, SS-A/RO ABS, SS-B/LA ABS, SM antibodies, U1RNP antibody, SCL 70 ABS, JOI antibodies. On an unspecified date, the patient recovered. The physician considered the events non serious. Additional information is not expected.
Approx 1 wk post/vax, arm became achey, sometimes in shoulder joint & sometimes in muscle. After about 2 mos, seen by Dr & had x-rays which were neg. Noticed mostly when raised arm above head or lifting something heavy.
Arm pain; Nervousness; felt pressure in body; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm pain), NERVOUSNESS (Nervousness) and DISCOMFORT (felt pressure in body) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Allergy.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced VACCINATION SITE PAIN (Arm pain), NERVOUSNESS (Nervousness) and DISCOMFORT (felt pressure in body). On 21-Apr-2021, VACCINATION SITE PAIN (Arm pain), NERVOUSNESS (Nervousness) and DISCOMFORT (felt pressure in body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient took Natural Herbal Supplements  as concomitant medication. No treatment medication were reported.
Case number PHEH2014US024580 is an initial spontaneous report received from a consumer on 03 Dec 2014. This report refers to a female patient whose age was not reported. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 141301, expiry date: Jun 20150 multi-dose vial into her left deltoid muscle on 29 Oct 2014. It was reported that she contacted next day and stated that she experienced fever and pain on her arm. She required immediate medical attention and treatment. The events outcome, seriousness and causality were not reported.
pt exp numbness & coldness in hand of inj arm about 2min p/vax;
Initial report received on 28 August 2009 from a health professional.  A female patient, age not reported, received a first dose of ADACEL (lot number not reported) in the right deltoid on an unspecified date.  Medical history, concomitant medications, and illness at the time of vaccination were all unknown.  It was unknown if the patient had any vaccines within the four previous weeks and whether she had any previous adverse events following vaccination.  An unspecified amount of time after receiving ADACEL, the patient had fever and could not move her arm as high as usual.  The patient's recovery status was unknown.  No further information was available.  Follow-up information was received from a physician on 02 November 2009.  The patient received a left deltoid injection of ADACEL (Sanofi Pasteur Ltd lot number C3159, Sanofi Pasteur inc. lot number UF551AA), and within 24 hours of vaccination experienced pain and swelling.  She was treated with CELEBREX 200 mg for two weeks, and was then referred to an orthopedist on 15 October 2009.  Her prescription was changed to NAPROSYN 500 mg bid, and she began undergoing physical therapy.  An X-ray of the shoulder was normal, and she was diagnosed with a mild frozen shoulder.  At the time of the report, the patient still had persistent pain and limited range of motion.  Follow-up information received on 19 January 2010 from a physician.  The patient had received the vaccination on 24 August 2009.  The patient had a follow-up on 14 January 2010, and at that time the patient showed complete recovery of the left shoulder with no pain and full range of motion.  Per the reporter, the patient is considered to be recovered.  Documents held by sender:  None.
Total fatigue. Played pickleball, one game and rested a half hour. Couldn't play another. Dizzy, lightheaded. Fine if I just laid around the house. Symptoms remained the same for close to a month, slowly improving. Took 3 months for symptoms to completely go away.
A non-serious spontaneous report of administration of expired product was received from A non-serious spontaneous report of administration of expired product and administration of FLUMIST was received from a clinic administrator concerning a 24-month-old female subsequent to the administration of FLUMIST. This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's medical history and concomitant medications were not reported. On 23-Feb-2010, the patient was administered FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. 6/18/10 Additional information was received on 13-May-2010 and incorporated into the narrative: information on late occurring adverse events.
Information has been received from medical records through the Merck pregnancy registry concerning a 2 month old female with no known drug allergies, who on 18-JUN-2008 and 18-AUG-2008 was vaccinated by mouth with a first and second dose of ROTATEQ (Lot # 660845/0289X). Concomitant administered on 18-JUN-2008 and 18-AUG-2008 included PEDIARIX (AC21B156EA) and (AC21B182AA) both administered in the left upper thigh, ACTHIB (UF263AA) administered in the left upper thigh and (UF401AB) administered in the right upper thigh, and PREVNAR (C54766) administered in the right lower thigh and (C45721F) administered in the left lower thigh. On 22-APR-2008, the patient was seen and was reported to be feeding well and was advised to return to the clinic in one week. On 08-MAY-2008, the patient was seen and complained of projectile vomiting within the last 12 hours. The patient was fussy, was breastfeeding, and spit up yellow, watery mucous on the exam table. The patient did not have a fever and it was reported that the patient's father had pyloric stenosis when he was a baby. An upper GI was scheduled for the patient. the patient was not on any medications at the time of the visit. On 19-MAY-2008, the patient was seen at the office for follow-up to a urinary tract infection which was diagnosed the previous week. The patient was currently taking OMNICEF and ZANTAC. The patient experienced a low grade fever four days before the visit. On 05-JUN-2008, the patient was seen and was fussy. The patient was currently taking ZANTAC. It was reported the patient had been pulling on her ear, her appetite decreased, and her sleep increased. On 26-JUN-2008, the patient was seen at the office for her ears. The patient was currently taking ZANTAC and TYLENOL. The patient was fussy, slightly congested, and an earache was in question. Two days prior to the visit a clear to yellow discharge was noticed. On 04-AUG-2008, the patient was seen for congestion. The patient had experienced nasal congestion for the past five days. The patient was more irritable within the last 24 hours. The patient's runny nose was clear. The patient's appetite was reported to be "ok" and her sleep decreased. The patient was not taking any medications at the time of the visit. On 11-AUG-2008, the patient had complaint about the neck and ears. The patient was pulling at ear, was cranky, and had a temperature of 99 the day before. The patient was prescribed BACTRIM for 1 week. At the time of this visit the patient's parents were also reported to be congested. On 29-SEP-2008, the patient was seen and was experiencing a fever, nasal congestion, and a slight cough. The patient's appetite was decreased. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
This case was reported by a healthcare professional and described the occurrence of possible psoriasis in a 38-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 20 October 2011 the subject received a dose of FLULAVAL (.5 ml, unknown route, left arm). On 7 November 2011, 18 days after vaccination with FLULAVAL, the subject experienced a delayed rash on both deltoids (rash on both upper arms). A biopsy was performed on one lesion which resulted possible for psoriasis. The subject's "blood tests" also demonstrated possible psoriasis or possible drug reaction. This case was assessed as medically serious by GSK. The subject was treated with prednisone and miconazole. At the time of reporting the outcome of the events were unspecified.
This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with FLUARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included diphtheria and tetanus toxoids and acellular pertussis vaccine; manufacturer unspecified given on 9 December 2007, hepatitis B vaccine recombinant ; manufacturer unspecified given on 9 December 2007; hepatitis A vaccine inactivated; manufacturer unspecified given on 9 December 2007. On 9 December 2007 the subject received unspecified dose of FLUARIX (.5 ml, unknown) intranasally (intramuscular formulation administered by other route) and experienced a funny taste. The same day, the subject was later vaccinated with FLUARIX and experienced accidental overdose. No other adverse events were reported. In December 2007, the events were resolved. Outcome of accidental overdose was not specified. The healthcare professional considered the events were probably related to vaccination with FLUARIX (causality not provided for accidental overdose). Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as "FLUMIST" and administered intranasally. There were no other adverse events other than "bad taste."
upper gastric pain/terrible stomach pain; continuous diarrhea; experienced cramping; This is a spontaneous report from a contactable Nurse, the patient.   A 71-year-old female patient received the first dose of bnt162b2 (BNT162B2, Lot number unknown), via an unspecified route of administration on 18Feb2021 as a single dose in the arm (reported as "deltoid") for COVID-19 immunization. Medical history included multiple sclerosis from an unknown date. The patient responded "yes" when asked if she had been diagnosed with COVID-19 prior to the vaccination but also provided no details about this. The patient's concomitant medications were not reported. The patient experienced upper gastric pain/terrible stomach pain on an unspecified date with outcome of unknown, continuous diarrhea on an unspecified date with outcome of unknown and cramping on an unspecified date with outcome of unknown. The patient provided further details in that she reported that she woke the following morning after receiving the COVID-19 vaccine feeling as if she was having a heart attack, which was determined to be a result of upper gastric pain. She reported that she has experienced cramping and continuous diarrhea and she has been unable to leave the house except to receive medical treatment. She stated that she had had lab work (blood and stool samples) and everything has returned negative. She believes that the gastric pain and other symptoms are a result of her receiving the vaccine.  She remarked that she works in healthcare and has been tested every week for COVID-19 prior to receiving the vaccine, and has not had any gastric pain issues prior to receiving the vaccine, never had any problem with her stomach, pain, diarrhea or anything related to diarrhea and stomach pain. The patient underwent lab tests and procedures which included stool culture negative on an unspecified date and "BMP, CMP and Hemoglobin - things like that" on an unspecified date the results of which were reported as "good" and SARS COV 2 test: negative on an unspecified date prior to this vaccine. Unspecified therapeutic measures were taken as a result of the events. Treatment for the events was reported as  "just Tylenol."
PATIENT DID NOT EXPERIENCE ANY SIDE EFFECTS.  REPORT IS  NOT FOR ADVERSE EVENT.
pt recv vax JUN96;2-3 days post vax exp itching, widespread maculopapular rash, & urticaria;MD visit was required;pt was treated w/DPH & topical steroids;sx resolved 2 wk p/they started;
On Sunday 2/21/21, I noticed a rash had formed on the right side of my lower stomach/hip.  I applied lotion and when I got home from work at 7 p.m., the rash was more painful and prominent.  I took Benadryl and applied Cortizone cream.  This morning when I woke up, the rash was still there.  All day I have periodically applied Cortizone cream to keep the itching and slight pain at bay.  The rash consists of small red bumps over a 3 inch by 3 inch area.
Within 4 hours, rapid heart rate, nausea, dizzy, achy, chills, fever of 101 degrees, arm extremely sore. Patient took TYLENOL and EMETROL. was better within 24 hours.
blood pressue 96/42. patient sweating. feeling dizzie like he was about to pass out. provided food/water and constant monitoring until symptoms resolved
J96.10 CHRONIC RESPIRATORY FAILURE 12/31/2021 CHRONIC RESPIRATORY FAILURE J96.10 CHRONIC RESPIRATORY FAILURE 12/31/2021 DYSPHAGIA FOLLOWING CEREBROVASCULAR DISEASE
Heart Attack; most likely a blood clot; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer (patient).   A 62-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Right on 13Aug2021 13:00 at 62-years-old (Batch/Lot Number: FA7485) as DOSE 1, SINGLE; via an unspecified route of administration, administered in Arm Right on 08Oct2021 13:00 at 62-years-old as DOSE 2, SINGLE for covid-19 immunisation. Medical history included No - Healthy. Facility type Vaccine: Pharmacy or Drug Store. No covid prior to vaccination, was covid tested post vaccination. Concomitant medication included trazodone. The patient previously took demerol and experienced Allergy. The patient experienced heart attack most likely a blood clot (hospitalization, life threatening) on 16Sep2021 01:00 with outcome of recovered with sequelae, inappropriate schedule of vaccine administered on 08Oct2021 13:00 with outcome of unknown. The patient was hospitalized for 2 days. AE resulted in: Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Treatment included Angioplasty, medicine. The patient underwent lab tests and procedures which included Nasal Swab: negative on 17Sep2021.
Patient reported continued soreness in Left arm after receiving a flu shot. Pain was still persisting over a month after receiving the shot. Patient states the pharmacist injection technique not the vaccine itself gave him the pain in his arm.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients was vaccinated with a dose of GARDASIL (strength reported as 120 microgram, dose, lot# and expiry date not reported) that was exposed to 20 F for an unspecified period of time, which was excursion that was unsupported by in-house stability data. No adverse symptoms were reported. Additional information has been requested.
pt admitted to hosp with c/o productive cough, SOB, moderate dyspnea on exertion, wheezing, weakness, myalgias x approximately 2 wks; positive COVID test in ED; O2 sats at 74% on 4 L/min O2; treated with Decadron, antibiotics, nebulizer treatments; during hospitalization, pt c/o chest pain and went into cardiac arrest; unable to be resuscitated; passed away in the hospital of COVID pneumonia
At about 7:30 AM I started experiencing minor abdominal pain. As the day went on the pain got much worse. By 11:30 AM I could not get out of bed. I developed a fever on top of the abdominal pain and my joints began to ache all right around 11:30 AM. At about 2:00 PM I got very nauseous and had been experiencing cold sweats. I threw up twice and then things slowly calmed down. The fever subsided by 8:00 PM as did the joint pain however on 02/19/2016 at 4:54 PM I am still experiencing minor abdominal pain.
FEELING OFF; This spontaneous report received from a patient via a company representative concerned a 32 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received tylenol unspecified (form of admin and route of admin were not reported, batch number: Unk) dose, frequency, and therapy dates were not reported for an unspecified indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number is not reported. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced feeling off. The action taken with covid-19 vaccine ad26.cov2.s, and tylenol unspecified was not applicable. The outcome of feeling off was not reported. This report was non-serious.
Shortly after injection of first dose, I experienced a "vaccine-like" or "metal like" taste in my mouth; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7534) via an unspecified route of administration in the arm left on 10Apr2021 at 13:15(at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history were reported as no. Concomitant medications included ascorbic acid (VITAMIN C), tocopheryl acetate (VITAMIN E) and colecalciferol (VITAMIN D3) all taken for unknown indication from unknown date. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccines within four weeks prior to COVID-19 vaccine. On 10Apr2021 at 13:15 shortly after injection of first dose, the patient experienced a "vaccine-like" or "metal like" taste in her mouth. It was reported that the event lasted very long maybe less than two hours and she did not really look at the clock. The patient did not receive any treatment for the reported event. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event "vaccine-like" or "metal like" taste in mouth was resolved on 10Apr2021.  No follow-up attempts are needed. No further information is expected.
Patient in observation area, covid vaccine clinic. patient got vaccine at 1316. at 1330, girlfriend alerted staff patient wasn't feeling good. patient looked pale. Nurse next to patient. Lost consciousness for about 30secs. regained consciousness after stimulation. patient then started vomiting, x2. transferred to gurney. vital signs checked. normal. monitored every5 min x3 then every 15min. Observed for about 30min. patient refused to have nurse call 911. refused to go to ER or urgent care. vital signs remained stable. check BP while sitting and standing. no change in BP. patient did feel dizzy. started vomiting again.  Advised patient to go to ER or urgent care but patient and girlfriend refused D/C home stable
From her knees down it felt like ice, she could not warm them up; She is very cold; Feels sick; Head is warm, she thinks she has a fever but didnt check; Body aches all over/ her whole body, legs, muscles, feels like she got beat up; On her left arm where she got the shot, swelled up; On her left arm where she got the shot, it kind of hurts; Fatigued; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS (From her knees down it felt like ice, she could not warm them up), NASOPHARYNGITIS (She is very cold), ILLNESS (Feels sick), PYREXIA (Head is warm, she thinks she has a fever but didnt check) and MYALGIA (Body aches all over/ her whole body, legs, muscles, feels like she got beat up) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H218) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer and Pfizer. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concomitant products included VITAMINS NOS and PANTOPRAZOLE for an unknown indication.    On 08-Dec-2021 at 3:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL COLDNESS (From her knees down it felt like ice, she could not warm them up), NASOPHARYNGITIS (She is very cold), ILLNESS (Feels sick), PYREXIA (Head is warm, she thinks she has a fever but didnt check), MYALGIA (Body aches all over/ her whole body, legs, muscles, feels like she got beat up), VACCINATION SITE SWELLING (On her left arm where she got the shot, swelled up), VACCINATION SITE PAIN (On her left arm where she got the shot, it kind of hurts) and FATIGUE (Fatigued). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at a dose of 650 mg. At the time of the report, PERIPHERAL COLDNESS (From her knees down it felt like ice, she could not warm them up), NASOPHARYNGITIS (She is very cold), ILLNESS (Feels sick), PYREXIA (Head is warm, she thinks she has a fever but didnt check), MYALGIA (Body aches all over/ her whole body, legs, muscles, feels like she got beat up), VACCINATION SITE SWELLING (On her left arm where she got the shot, swelled up), VACCINATION SITE PAIN (On her left arm where she got the shot, it kind of hurts) and FATIGUE (Fatigued) outcome was unknown.            Concomitant products used included Pantoprazole for Stomach acid. Treatment medication included the patient's husband got her some bottles of warm water for her feet and she slept for like 6 hours.