chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She states 8 days later, she developed redness and swelling at the injection site (photographed and appeared urticarial) Several days after, her rash changed to a petechial rash. This was then followed by a sudden onset of fever, chills, then she developed severe joint pain in her back that radiated down to both legs. Back pain persisted and was "intense," but relieved with Tylenol and ibuprofen. The petechial rash later spread to her entire body including her feet. She had facial swelling as well. She began to take benadryl which did change the petechial rash which has subsequently resolved. The shooting leg pain was bilateral and severe. It has improved to a "pulling sensation" behind both of her knees which is intermittent and transient.
This spontaneous report was received from a physician referring to a 19 month old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 23-MAY-2017, the patient was vaccinated with improperly stored dose of PEDVAXHIB. On 25-AUG-2017, the patient was vaccinated with improperly stored dose of VAQTA (lot # N005274, expiration date 03-APR-2018) (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1709USA007325: US-009507513-1709USA012768.
nausea,h/a,chills 3hrs p/vax;APAP,IV-NaCl;
On 3/13/00, developed quarter-sized "lump" at injection site, immediately, post vax. Denies soreness, redness or warmth. She has remained fairly stable and was advised by her PMD to monitor and come in for evaluation if no improvement if symptoms of infection is present. Agreed to course of action. Symptoms are continuing on 4/10/00.
Pt had diarrhea, dark brown with "highlighter yellow" color streaks and streaks of blood. Odor, hard stomach. Also sees doctor for GI problems. 8/28/08-records received for DOS 7/14-7/17/08-DC DX: Abdominal distention. Guaiac-positive stools. Dehydration. Two days prior to admission abdomen distended, slightly looser stool and decreased urine output.
FAST HEART RATE; SHORTNESS OF BREATH; This spontaneous report received from a parent concerned a 20 year old female. 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 was not reported, administered on 02-JUN-2021 09:15 am for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 02-JUN-2021, the subject experienced fast heart rate. On 02-JUN-2021, the subject experienced shortness of breath. Laboratory data included: Heart rate (NR: not provided) 99. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fast heart rate, and shortness of breath. This report was non-serious.
Information has been received from a nurse practitioner concerning a 15 year old female patient, who on an unspecified date was vaccinated with a second dose of GARDASIL (Lot # not reported). On 02-NOV-2010 the patient experienced numbness in her left extremity which ran down both the patient's legs from therapy on GARDASIL. The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
rash began to appear later Pm on 18th on both hands;rash has spread to back, knees & rt arm;has a sl temp;pt has one blister (looks like chickenpox) on each thumb;pt has not been exposed to chickenpox to mom's knowledge;
neck stiffness on left side, since day after injection and continues as of todays date 18Feb; This is a spontaneous report from a contactable consumer (patient). A 66-year-old non pregnant female patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injec-tion, Lot Number: el3247) via an unspecified route of administration, administered in arm left on 27Jan2021 12:00 (age at vaccination 66 years) as dose number unknown, single for COVID-19 immun-ization. Medical history included chronic obstructive pulmonary disease (COPD) from an unknown date and unknown if ongoing. Concomitant medications included loratadine, pseudoephedrine sulfate (CLARITIND), fluticasone propionate, salmeterol xinafoate (ADVAIR), ascorbic acid, ergocalciferol, nic-otinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC ACID; ERGOCALCIFEROL; NICOTINAMIDE; RETINOL; RIBOFLAVIN; THIAMINE HYDROCHLORIDE]) all taken for an unspecified indication, start and stop date were not reported. Patient has not received other vaccine in four weeks. The patient previously took amoxicillin and experienced allergies. The patient experienced neck stiffness on left side, since day after injection and continues as of todays date 18feb on 28Jan2021. The patient was not received any treatment for the event. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has not been tested for covid post vaccination. The outcome of the event was not recovered.  Follow-up attempts completed. No further information expected.
Nurse from Doctor's office called 6/11/18 stated that patient had a reaction to SHINGRIX vaccine. She has redness and scabbing size of 2 inches by 1.5 inches on her left chest, not at the injection site. It started 2 weeks after vaccination and lasted more than 6 weeks. She still has some scabbing currently not resolved yet.
No known adverse reactions. Reporting this due to the fact the clinical staff administered two vaccines on the same day that should not have been administered together.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.
Information has been received from a physician concerning female about 17 years old who on unspecified dates was vaccinated IM with all three dose 0.5 ml doses of GARDASIL (lot number not reported). Recently, during the last cervical smear (PAP) the physician discovered that the patient developed high grade cervical dysplasia. The outcome of the patient was not reported. This is one of several reports from the same source. Additional information has been requested.
This case was reported by a healthcare professional and described the occurrence of Hepatitis B antibody negative in a 23-year-old female patient who was vaccinated with ENGERIX B (GlaxoSmithKline). On 22 January 2001, the subject received the 3rd dose of ENGERIX B (unknown), to complete the three dose series. The 2nd dose of ENGERIX B (unknown) was given on 16 October 2000, and the 1st dose of ENGERIX B (unknown) was given on 14 September 2000. On 12 June 2007, approximately six  years after receiving the 3rd dose in the Hepatitis B antibody negative. At the time of reporting the outcome of the event was unspecified.
This patient had tightness in her chest, shortness of breath, light headedness; starting about 2 hours after her injection. The patient admits history of panic attacks and states the symptoms are consistent with those.
no additional adverse events; needle and syringe malfunctioned and disconnected from each other" while administering PROQUAD; uncertain how much vaccine was given to patient; This spontaneous report has been received from a licensed practical nurse referring to a 1-year-old patient of unspecified age. The patient's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies were not reported.   On 28-MAR-2022, the patient was vaccinated with 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) (dose, route of administration, vaccine scheme, and anatomical site of vaccination was not reported; lo number U029322 has been verified to be valid, expiration date reported and established as 19-MAR-2023) as prophylaxis.   The reporter stated that while administering measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD), the needle and syringe malfunctioned and disconnected from each other (device connection issue). It was uncertain how much vaccine was given to patient (incorrect dose administered) and if it should be repeated. No additional adverse event was reported (no adverse event).   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2203USA010353:
Pfizer scheduled immunization diluted improperly 0.8 not 1.8,
Had Moderna vaccine to the L deltoid at 1440. She sat down and started experiencing some warmth coming over her body and became diaphoretic.  She denied SOB, dizziness, nausea, rash. 1446 vs were 110/78, 86, 98%. After approximately 15 minutes her skins dried and she felt better. She at no time had any other symptoms.  1451 124/78, 93, 97%. 1458 130/78,96,98%. 1505 130/78, 95, 98%. At the end of 30 minutes she felt better without any complaints. She was released and advised to call 911 if she had any new symptoms.
Child became a diabetic 12 days after having the varivax vaccine. Child first had a throat infection the following week. then about 3 days later started throwing up; got shot of Pherghan; then changed antibiotic and got thrash. The about 3 days later, diagnosed with Diabetes. Pt was dignosed with Type I diabetes, she will not recover from this takes 2-3 shots per day. Sticks finger at least 4 times a day. If you find any connection between the shot and her having diabetes- would you please let me know.  Annual follow up on 04/14/04: "Pt has not recovered from adverse events.  She has diabetes and takes 3 shots every day and sticks her finger 4 times a day.  We have to buy 7 medications every month.  In small children a virus can attack the pancreas and it will no longer produce insulin.  The varicella shot is a live virus.  Yes, where do we get help from for this child. No one in our family has diabetes on either side-so what happened?  I just want help.  My medical insurance is $500.00 a month.  There is no cure for this side effect.  We still got the chickenpox also.
1.5-2 hrs after injection felt lightheaded & dizzy. 4-5 hrs later developed fever (101.2). Area at inj. site reddened & warm about 15 cm. Sx lessened next day.
I received my flu shot on Nov 14th and developed a bruise a little larger than a quarter at the injection site. I rolled up the sleeve on my dress to receive the shot in my left deltoid, but the sleeve was a bit tight and my failure to mention this to the nurse might have resulted in the bruise. The nurse did remark that I bled more than expected, which I suspect could have also been the result of the tight sleeve. I was not sure if this was of clinical significance but I thought it would be better to give more information than not at all.
Pain / paralysis / stiffness. Went to ER to make sure would not stop breathing. Continued pain and paralysis for hours after shot. Same day. Side effect of shot started w/ in hours of getting shot - went to ER that same evening - kept for several hours.
eyes are watery, more on the right, top to bottom feels numb/paralyzed type feeling. Seems to be a Bell's palsy type symptom but no drooping; Right side of my face is numb; eyes are watery, more on the right, top to bottom feels numb/paralyzed type feeling.; eyes are watery, more on the right, top to bottom feels numb/paralyzed type feeling.; This is a spontaneous report from a contactable consumer (patient). A 39-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: Er8733), via an unspecified route of administration at age of 39-year-old at arm right on 14Apr2021 12:15 at single dose for COVID-19 immunization. Medical history included high blood pressure. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Concomitant medications included hydrochlorothiazide, clomifene citrate (CLOMID), men's multivitamin, gluco, received within 2 weeks of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Apr2021 10:00, right side of his face was numb, eyes are watery, more on the right, top to bottom feels numb/paralyzed type feeling. Seems to be a Bell's palsy type symptom but no drooping. The adverse events result in doctor or other healthcare professional office/clinic visit. The adverse events result in Emergency room/department or urgent care. The patient underwent lab tests included Curative testing (covid tested): negative on 19Apr2021. The patient was given allergy steroids for events. The outcome of events was recovering.
Syncopal episode about 5-10 minutes after receiving Menactra and Gardasil in L arm and TDaP in R.
Positive pruritus (general) persists without rash as of this report 10/12/11. Tx ZYRTEC - results unk.
Approximately 27 minutes after administration patient reports feeling itchy all over and had the sensation that her throat was closing up.  Epipen administered and within 5 minutes patient reports total improvement of symptoms.
Very nausea, pale, low BP (70/50), almost fainting - gave him water, sprite, and ice packs on neck - recovered in about 10 minutes
This spontaneous report has been received from a nurse practitioner refers to a female patient of unknown age. Medical history and current condition of the patient were not reported. The patient received her first dose of GARDASIL (lot#, expiry date unspecified), 0.5 ml, intramuscularly on 27-FEB-2012 and her second dose of GARDASIL on 15-JAN-2015 (Inappropriate schedule of vaccine administered). No adverse effect reported. The third dose had not been administered. No product quality complaint (PQC) involved. Additional information has been requested.
Arm pain, fatigue, chills, little fever, headache, swollen armpit 2nd day after shot
Information has been received through a Merck Pregnancy Registry and a 25 year old, female with no drug reactions/allergies and no medical history, who on 04-APR-2007 was vaccinated intramuscularly with the first, 0.5 mL dose of Gardasil. There was no concomitant medication. On 04-JUN-2007, the patient was vaccinated intramuscularly with the second, 0.5 mL dose of Gardasil. Since the vaccination the patient reported that she was eight weeks pregnant with an estimated date of delivery on 11-FEB-2008. The patient sought unspecified medical attention. The patient reported that she had a pregnancy test. The patient reported that she had not experienced any adverse reactions and could not provide the Gardasil lot numbers. In follow-up it was reported by the physician, that the date of the patient's last menstrual period was 08-MAY-2007 and estimated conception date was 21-MAY-2007. It was reported that on 05-JUN-2007, the patient was vaccinated intramuscularly with the second, 0.5 mL dose of Gardasil. Previously reported the patient was vaccinated with the second dose of Gardasil on 04-JUN-2007. The estimated delivery date was 12-FEB-2008. On 01-OCT-2007, the patient had prenatal testing, an ultrasound which revealed dilated bladder, posterior urethral valves. On 08-JAN-2008 the patient delivered a live born infant, male, 36 weeks from her last menstrual period (LMP). The infant was not normal. The infant had dilated bladder and ureters, posterior urethral valves. There was no complication during labor/delivery. At the time of the report, it was unknown if the infant recovered. Additional information has been requested.
Symptoms developed within several hours of receiving vaccine - fever (101.2) lasting 2.5 days, weakness, achiness, dizziness, arm swelling & redness at injection site, pain in arm down through fingertips, nausea/vomiting, migraine like headache. Doctor visit resulting in prescriptions for methylpred 4mg and Ondansetron 4mg.  Lost 5 days of work due to symptoms severe enough could not work, 7 days total reaction.
ache all over; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (a few years ago patient had a slight occurrence of shingles on one arm). Previously administered products included Shingles vaccine (got the old vaccine about 10 years ago).   On 1st June 2022, the patient received Shingles vaccine. In June 2022, less than a week after receiving Shingles vaccine, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was unknown.   It was unknown if the reporter considered the general body pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 02-JUN-2022 Reporter's Comments: The patient self-reported this case via interactive digital media. The patient got the old vaccine about 10 years ago and a few years ago he/she had a slight occurrence of shingles on one arm. Doctor recommended getting the newer vaccine so on 1st June 2022 patient received Shingles vaccine, and he/she had ache all over.
No additonal AE details available; vaccine was admnistered after experiencing temperature excursion; This spontaneous report was received from a medical assistance and refers to a 13 month old patient of unknown gender. The patient's concurrent conditions,  pertinent medical history, drug reactions or allergies, or concomitant medication were not reported.  On 14-SEP-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot number T032317 with expiration date 22-SEP-2022 (dosage, route of administration and anatomical location were not reported) for prophylaxis, after experiencing a temperature excursion at a temperature 6°F to 14°F (8.5F) for 0 hours, 18 minutes and 0 seconds; and a temperature 6°F to 14°F (11.9°F) for 1 hour, 0 minutes and 0 seconds; for a cumulative timeframe of 1 hour and 18 minutes (product storage error). There no previous temperature excursion. No additional adverse events (AE) details were available.
pt in hospice in nursing home; DNR/DNI; worsening dementia and HTN; positive for COVID and passed away in hospice
Information had been received on 26-MAY-2017 from a lawyer regarding a case in litigation. The patient's medical history, concurrent conditions and concomitant medication were not provided. It was alleged in litigation that a male patient of unknown age was inoculated with ZOSTAVAX (dose, route, site of administration, lot # and expiration date were not provided) on or about 03-MAR-2014 at a health care facility, as recommended for routine adult health maintenance for the prevention of shingles. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of Herpes Zoster. On or about 13-SEP-2016, the male patient was treated in the emergency department (ED) of a health care system for a vesicular outbreak that was diagnosed as severe shingles. On or about 22-SEP-2016 the male patient was treated by a certified nurse practitioner, at the Hospital for ongoing and worsening symptoms of shingles outbreaks. The male patient was prescribed valcyclovir (as reported) for management of his painful symptoms. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
About one week after vaccination, patient had acute onset of severe multiple joint pains and calf pain to the point of inability to walk and was found to have ESR above 140. He does have history of chronic severe gout and rheumatoid arthritis, is not on immunosuppression, and reported he had not had similar episodes in the past. He was admitted to the hospital overnight and given IV solumedrol with marked improvement.
Red rash from belly button up to neck; Was very tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Was very tired) and RASH ERYTHEMATOUS (Red rash from belly button up to neck) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016C21A and 06C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hay fever, Allergy to antibiotic (Clindamycin which causes rash), COPD and Cholesterol. Concomitant products included ATORVASTATIN, VITAMIN D3 and CALCIUM for an unknown indication.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Was very tired). On 10-Jun-2021, the patient experienced RASH ERYTHEMATOUS (Red rash from belly button up to neck). On 12-Jun-2021, RASH ERYTHEMATOUS (Red rash from belly button up to neck) had resolved. At the time of the report, FATIGUE (Was very tired) outcome was unknown.            No treatment information was provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow up received on 02-JUL-2021 contains information about patient demographics and allergies of patient.Updated information on doses of vaccination,and concomitant medications were added.event outcome was updated and newevent added.