chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SORE LEFT ARM ON 2ND DOSE, FATIGUE, ITCHY LEFT & RIGHT ARMS AND HANDS, ITCHING NECK AND UPPER BACK. TOOK BENADRYL AND RESOLVED
Severe hives that got worse every day, started in the lower legs then spread up to the thighs, appeared on the neck , ears, arms, wherever there was friction . No notable rash by the injection site. Still no change after 1 week
No additional AE information was provided; the nurse reported she gave an unspecified patient an expired dose of PROQUAD; This spontaneous report was received from a nurse via a company representative, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.  On 29-JAN-2020, the patient was vaccinated with an expired dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live rHA (recombinant human albumin) (PROQUAD) (expired product administered) ,one dosage form as prophylaxis (lot number R011216 has been verified to be a valid lot number, expiration date reported and validated as 15-OCT-2019) (concentration, dose number, frequency of vaccination scheme, route and anatomical location of vaccination were not reported). Other suspect therapy included the sterile diluent (lot number and expiry date were not reported).   No additional adverse event was reported.  Follow-up information has been received from a nurse on 17-FEB-2020.  The nurse reported that the patient was a 4-year-old female patient.
Information has been received from a certified medical assistant (C.M.A) concerning a 23 year old female patient. The patient's obstetric history included 2 previous pregnancies with 2 full term deliveries without birth defects or infant complications in pregnancies. The patient's concurrent conditions, pertinent medical history, drug reactions and allergies were not reported. Concomitant medications included unspecified pregnancy vitamins. On 21-JUL-2016, the patient was vaccinated with the 3rd dose of GARDASIL 9 (lot number M005714) (strength, dose, route, anatomical location and expirati0on date were not reported). Other suspect medications were not provided. On unknown date, the patient became pregnant with an estimated date of last menstrual period (LMP) of 01-MAY-2016 and estimated delivery date (EDD) of 10-MAR-2017 determined by an ultrasound, which was performed on 03-AUG-2016. At the time of reporting, the pregnancy outcome was pending. Additional information has been requested.
Sore arm immediately; stomach ache 7 p.m.; headache upon rising the next day.
This spontaneous report was received from a 23-year-old female patient, who was reporting on herself. The patient's pertinent medical history, drug reactions and allergies were not reported. Concomitant therapies were not provided. On 02-APR-2018, the patient was vaccinated with the first dose of GARDASIL 9 for route vaccination (dose, route of administration and anatomical location, lot# and expiration date were not reported). On an unknown date, approximately in 2018, the patient got a bad cough from her contagious colleague. The outcome of the event was unknown. The relatedness between event and GARDASIL 9 was not reported.
None- vaccine given 16 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 16 days post expiry) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 16 days post expiry). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 16 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicines were reported No treatment medicines were reported   This case was linked to (Patient Link).
Shingles; Pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles) and pain (Verbatim: Pain). The outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 9-Mar-2023 The case was received from the patient via interactive digital media. The patient asked that anyone had pain or shingles after shot. The patient did it was awful.  The patient got the shot because, how did they really know if they had chicken pox, it could be a mild case.  The patient was suppose to get second shot, but was afraid. The follow-up could not be possible as no contact details were available.
Severe bruising on entire front side of upper Right arm (arm she received Zostavax vaccine.) Slight inflammation as well.
I received  My Two-dose Pfizer Covid Vaccines from Pharmacy. I had Normal symptoms at first, but Now as of Last Week, August 25th, 2021, I've started feeling Extremely sick: Nose leaking clear liquid like water, constant sneezing, a Hatd, Dry cough that shoots pain from My Lower Back all the way up to My Neck. I also have Extreme Back Pain & Pain in Both Legs. I was having so much Difficulty breathing, I kept pumping My Atrovent Inhaler every two hours. My Pain Pills had already stopped working by then &  on Saturday, August 28th, I called 911 because I was having even more Trouble breathing. I was taken to Hospital and given Tests & My Breathing Treatment and Now I have Covid for the First Time. Which I doubt Understand because I'm Fully Vaccinated for Covid as well as My other Vaccinations.
Patient received Covid 19 vaccine booster at the school clinic. About 12 minutes of the 15 minutes being monitored, patient complained of a scratchy throat. Patient stated she had this last time too. Patient was given 50mg of oral benedryl per standing order. Patient was monitored by school nurse for the next 30 minutes or until patient felt symptoms improved.
diarrhea; blood sugar went up to 340 when it is usually in the 100's; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) and BLOOD GLUCOSE INCREASED (blood sugar went up to 340 when it is usually in the 100's) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood sugar increased. Concomitant products included METFORMIN for Blood sugar increased.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced BLOOD GLUCOSE INCREASED (blood sugar went up to 340 when it is usually in the 100's). On an unknown date, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) and BLOOD GLUCOSE INCREASED (blood sugar went up to 340 when it is usually in the 100's) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Metformin was doubled in dosage to treat the event of Elevated blood pressure.
Coughing, difficulty swallowing, swollen eyes, gagging. Benadryl, Advil.
Flu vaccine given on 10/29/13. Patient became very ill in 11/13, but on 12/8/13, he woke up trembling, rash, said body was on fire...after 4 months of loss of weight and cognitive function and then psychosis, patient admitted to Hospital and diagnosed with Auto Immune Limbic Encephalitis. He cannot work and had additional treatments in May of 2015 to reduce infection, but hospitalized again in June 2015 for Low sodium/near comatose. In therapy still after 14 months at TIRR. Steroids, IVIG neuropsych and physical therapy. Still very, very sick. Limbic part of brain controls emotions and he is sometimes in panic mode over simple things. His cognitive function as per test in February was very, very, very low...especially executive function. He used to be a computer genius. Now he can barely comprehend some things that were easy to him before. He cannot INITIATE or think of things to do. He will say, MY MIND IS BLANK. It is heartbreaking. He has had suicidal thoughts and has lost his entire identity. Encephalitis is horrible, because it is sometimes a HIDDEN illness. His last lumbar puncture was May 8, 2015 and infection and auto immune limbic encephalitis still there.
Information has been received from a medical assistant concerning a 22 year old female with no medical history and AUGMENTIN, ibuprofen, penicillin and CECLOR allergies who on 07-DEC-2009 was vaccinated with the first dose of GARDASIL (lot# 663452/0671Y). There was no concomitant medication. The patient developed hives covering her whole body except at the injection site after vaccination with her first dose of vaccine. The patient had been prescribed BENADRYL. At the time of report the patient had not recovered. Additional information has been requested.
pt recvd vax 12NOV93 & hospital dx HIB meningitis; treated w/IV Cephalosporins; 1DEC in critical condition; has exp several sz; on anticonvulsants;
Rapid decline in ability to perform respiratory gas exchange and build up of carbon dioxide in the blood to life-threatening levels, ultimately leading to death. Rapid decline began about 2 weeks after receiving vaccine. Death would likely have occurred on  5/6/2021 or 5/7/2021 but for hospital intervention via use of a BiPAP machine. Patient had been exhibiting more mild, non-COVID respiratory distress for some time, back to at least late 2020, and likely at even lower levels for several years prior. Signs and symptoms included shallow breathing, extreme fatigue, difficulty or inability to lie down, occasional lightheadedness, etc. Oxygen saturation levels in April, as measured by a pulse oximeter, ranged from about 87%-96%. On May 6, it measured 65% just prior to ER visit.
Swelling and soreness of infraricular lymphnode; Moderate soreness at injection site; This spontaneous case was reported by a patient and describes the occurrence of LYMPHADENOPATHY (Swelling and soreness of infraricular lymphnode) and VACCINATION SITE PAIN (Moderate soreness at injection site) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 immunization.     Previously administered products included for COVID-19 immunisation: pfizer COVID-19 VACCINE (Dose 1, Batch no: EL9262) on 28-Jan-2021, pfizer COVID-19 VACCINE (Dose 1, Batch no: EL9262) on 28-Jan-2021, pfizer COVID-19 VACCINE (Dose 2, Batch no: EN6200) on 17-Feb-2021, pfizer COVID-19 VACCINE (Dose 2, Batch no: EN6200) on 17-Feb-2021, pfizer COVID-19 VACCINE (Dose 3, Batch no: FC3181) on 21-Aug-2021, pfizer COVID-19 VACCINE (Dose 3 and Batch no: FC3181) on 21-Aug-2021. Past adverse reactions to the above products included Painful lymphadenopathy with pfizer COVID-19 VACCINE, pfizer COVID-19 VACCINE and pfizer COVID-19 VACCINE; and Vaccination site pain with pfizer COVID-19 VACCINE, pfizer COVID-19 VACCINE and pfizer COVID-19 VACCINE.    On 04-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced LYMPHADENOPATHY (Swelling and soreness of infraricular lymphnode) and VACCINATION SITE PAIN (Moderate soreness at injection site). At the time of the report, LYMPHADENOPATHY (Swelling and soreness of infraricular lymphnode) and VACCINATION SITE PAIN (Moderate soreness at injection site) outcome was unknown.            No concomitant medication was reported. On 09-Sep-2022, Merck vaccine (Dose 5 and Batch no: GH9694) was administered. On 22-Apr-2023, Pfizer COVID-19 VACCINE BIVALENT (Dose 6 and Batch no: GL0087) was administered. It was reported that the product was prescribed by a healthcare professional.  Patient experienced Moderate soreness at injection site, Swelling and soreness of infraricular lymph node with each COVID-19 vaccine. After 24hrs of last injection patient had low grade fever(101 degree), Joint aching which resolved with out treatment. Patient tested with covid positive on 17-May-2023. Treatment with Paxlovid. Patient experienced fever, lethargy, aching for 24hrs  then symptoms resolved. Negative test of COVID on 22-May-2023.
Fever of 99.1F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 99.1F) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced PYREXIA (Fever of 99.1F). At the time of the report, PYREXIA (Fever of 99.1F) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Felt sick; This case was reported by a consumer via call center representative and described the occurrence of sickness in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The reporter reported that her neighbor received Shingrix. The patient was in her 60s. The patient was fine after the 1st dose, but felt sick for one day after the 2nd dose.
This case involves a patient (unknown age and gender) who was sick (illness), after receiving INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.   Medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "The last flu shot I got made me sick. I had to go back to the doctor (Dr.) twice before I got better. It seems when you reach a certain age they double your shot because they THINK you have a weak immune system."  It was unknown if the patient experienced any additional symptoms/events.   There were no laboratory data/results available.  It was not reported if the patient received a corrective treatment.  The patient was recovering from the reported event.  There will be no information available on the batch number for this case.
High fever, aches, pains - started 16 Jun. Severe HA 18 Jun. Loss of feeling (R) arm and weakness - started 22 Jun and has continued again flu symptoms 1-2 Jul.
Left shoulder cellulitis, warm to touch, extremely swollen, difficulty moving arm, couldn't sleep on it. Was given antibiotic.
One hour got very stuffy with running nose 8 hours later chills through the night and fever Fever, body aches, nausea, chills, aches, pain, extremely tired throughout.
I had severe abdominal pain that started about 1.5 hr after the 2nd dose of the vaccine.  I was doubled over in pain and I can tolerate alot of pain. Within 12 hours, I had developed diarrhea,  migraines and a significant facial rash, across my nose and cheeks, my malar rash, and across  my forehead. I had no itching, no throat swelling, no shortness of breath. I was in touch with both my GP and Rheumatologist. Because of the vaccine, we felt it cause a significant flare of my SLE, but opted to defer steroid treatment due to not being on them daily already. If I had more significant issues we would have likely started steroids. The diarrhea lasted for 2 weeks, but was more of an inconvenience issue. The face rash was uncomfortable and lasted about 10 days. I'm only sharing this for information sharing as it relates to my chronic immunosuppressive disease, Lupus.
Running fever for couple of days; Soreness and redness at injection site; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Running fever for couple of days), VACCINATION SITE PAIN (Soreness and redness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-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 an unknown date, the patient experienced PYREXIA (Running fever for couple of days), VACCINATION SITE PAIN (Soreness and redness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (Running fever for couple of days), VACCINATION SITE PAIN (Soreness and redness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) outcome was unknown. Not Provided          This case was linked to MOD-2021-021532 (Patient Link).
The patient had Pneumonia vaccine (Pneumovax 23) administered, then she developed a fever of 104, sore arm (entire arm), with a lump at the injection site.
BLOOD CLOTS IN BOTH LOWER LEGS; LEG CRAMPS; This spontaneous report received from a patient concerned a 58 year old white non-Hispanic or Latino female. The patients weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, expiry: 25-MAY-2021) dose was not reported, frequency 1 total, administered on 18-MAR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the patient started experienced leg cramps.  On 22-MAR-2021, the patient diagnosed with blood clots in both lower legs by ultrasound. Patient was put on unspecified  blood thinner and started RX on 23-Mar-2021 Laboratory data included: Diagnostic ultrasound (NR: not provided) Positive for bilateral blood clots in lower legs. On 04-Apr-2021 patient went to ER for severe leg cramps, Patient got RX for Soma and started taking on 05-Apr-2021. Treatment medications (dates unspecified) included: carisoprodol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots, lower extremities, and leg cramps. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210506805 - Covid-19 vaccine ad26.cov2.s-Blood clots in both lower legs. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Subject reports that she experienced injection site swelling extending into her neck that the injection site was purple and hot to the touch. She reports redness of face, pressure from the swelling into her chest, chest pain, SOB, and blue nail beds. She was seen at sick call and given a shot of Thorazine and Benadryl. She was also given Benadryl cream and pills. Symptoms lasted 4 days and resolved. Since that time her pre-existing nausea nd joint pain have increased. In Dec 04 she experienced anaphylactic shock. She was treated in the ER with Epinephrine and Benadryl. In Jan 05 she saw an allergist who said she had developed many allergies. The subject reports that she did not have allergies to anything prior to Dec 04. In Jan 05 she experienced weight loss from 150 lbs. to 124 lbs. despite a high calorie diet. She developed and continues to experience frequent episodes of low-grade fever. She was diagnosed by an allergist with asthma, chronic urticaria and angioedema in Jan 05. The urticaria usually develop over her arms, legs and neck. She has frequent episodes of face, eye, hands and feet swelling - hence the angioedema diagnosis. She has experienced occasional headaches and fatigue. In April 05 she was diagnosed with a hiatal hernia and reflux (GERD). In May 05 she experienced painful dilating of the veins in her legs, arms and forehead, and her fingers turned blue. She has now received the diagnosis of Raynaud's phenomenon. A rheumatology work-up was reported as negative. She will be seeing a vascular surgeon for this condition.
Excessive local reaction of redness heat and swelling at injection site measuring 4 x 8cm.
Pt says " I feel dizzy." Vasovagal syncope . B/ p 62/45. Pt drank half bottle of water and placed in Trendelenburg position. After 2 minutes Blood Pressure 112/ 70 HR 89 left vaccination site accompanied with family member.
Received HEPLISAV-B 1st Dose then Engerix as 2nd Dose; Initial Report Received on 02-Sep-2022  An advanced nurse practitioner reported that a female patient (age, race, and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as the first dose and Engerix as the second dose.  Medical history, concomitant medications, and allergies at the time of vaccination were unknown.  On 21-Jul-2022, the patient received the first dose with HEPLISAV-B (Lot #, expiration date, NDC #, route, and injection site unknown).   On 20-Aug-2022, 31 days after having been vaccinated with HEPLISAV-B, the patient received Engerix as the second dose (no details provided).   No further information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
TDaP injection site swelling measuring 3 x 2 1/2 inches, pain/tenderness, redness, and warmth.
pt recv vax 11JAN97 & 20JAN97 pt devel a rash on abd, stomach, chest, torso, & neck;the rash was described as raised bumps but no heads;21JAN97 pt recovered;
fine red rash back & neck beginning 5MAY96;hives over upper & lower extremities erupted beginning 8MAY96;very itchy;to Er on 12MAY96 prescription for pedipred;no temp throughout the course of illness;t98.6;
The pt experienced swelling of the throat and difficulty swallowing within 2 hours of flu shot. The pt was treated with epinephrine and Benadryl.
Severe right lower abdominal pain that started approximately 2-3 days after vaccine administered.  Over a month after the vaccine, she continues to have dull lower right abdominal pain that was not present prior to having the vaccine.