chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of chills in a 73-year-old female patient who received SHINGRIX for prophylaxis. On 25th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced chills, pain in arm and influenza-like symptoms. On an unknown date, the outcome of the chills, pain in arm and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the chills, pain in arm and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient's daughter. The patient received SHINGRIX in left arm. The patient experienced flu like symptoms and pain in the upper arm. The events lasted for couple days and she recovered. For tolerance after the 2nd dose of SHINGRIX, refer case US2018GSK152045.
Pt getting shot felt tingling 30 seconds after then nausea and lightheaded. He got stiff, gasped and passed out. Per pt, he had a "hallucination". Pt experienced LOC for approx 5 seconds, he "took a deep snort" and came back. Pt pale and diaphoretic, vomited and moved to med obs 1. VSS. Resolution of symptoms within 20 minutes, and released.
Arm tingling, more prevalent in right arm, face tingling R>L. Tingling started at 0030 1/8, only lasted a few hours. Intense body aches, chills, low grade temp, started at 00:30 and ended by 1800. Still experiencing intermittent chills, flushing, and sweating.
Patient reported localized skin erythema, warmth and pruritis since 5/29/2021  (received vaccine on 5/28/2021). Erythema has improved from "red" to "pink". Denies tenderness, fever. Pt was evaluated for the skin reaction through our clinic on 6/8/2021 (1st evaluation).
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a male patient who received SHINGRIX (batch number G45LN, expiry date unknown) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. After receiving 1st dose of SHINGRIX, the patient developed shingles. There was no further details reported regarding the event. The reporter did not give consent to follow up.
Friday, 3/19/21, stomach pains and diarrhea  Saturday, 3/20/21,  more severe stomach pains and diarrhea, unable to hold food or drink, became very dizzy  Sunday, 3/21/21, intractable dark stool, diarrhea, unable to ambulate due to severe dizziness, went to ED. At ED, bp 108/69, labs within normal limits. negative COVID-19 pcr, negative influenza a and b.  Monday, 3/22/21, dizziness slightly better and diarrhea desisted  Tuesday, 3/23/21, dizziness slightly better.
This spontaneous report as received from other health professional refers to a patient of unknown age and gender. Medical history was not reported. On 28-APR-2014 the patient was vaccinated with PROQUAD (Merck) (subcutaneous, dose number, frequency, anatomical locations, lot number was not reported). Concomitant medications were not reported. The reporter stated that the patient was administered PROQUAD which was out of range for 108 hours reaching -14 degree Celsius. The vaccines were supported. No adverse effects reported. This report is linked another MARRS # 1405USA011156 (Same reporter link). Additional information has been requested.
Nausea; Chills; Sweating; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old, non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151), via an unspecified route of administration in the left arm on 07Apr2021 at 08:45 (at the age of 43-years-old), as a single dose for COVID-19 immunisation. Medical history included graves, sjogren's, gluten intolerance and suspected ankylosing spondylitis. Concomitant medications included levothyroxine sodium (SYNTHROID), linaclotide (LINZESS), cevimeline hydrochloride (EVOXAC), cod-liver oil (FISH OIL) and vitamins; all from unknown dates for unspecified indications.  The patient previously took sulfamethoxazole; trimethoprim (BACTRIM) on unknown date for an unspecified indication and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration in the left arm on 17Mar2021 at 08:45 (at the age of 43-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 09:00, the patient experienced nausea, chills and sweating. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events nausea, chills and sweating were resolved on 13Apr2021 morning.    No follow-up attempts are needed. No further information is expected.
Fully vaccinated against covid on 12/24/2020 and 1/13/21. tested positive on 6/24 and again on 6/26/2021 Narrative:
This case was reported by a lawyer and described the occurrence of nerve injury in a male subject of unspecified age who was vaccinated with Engerix B, Dtap, Hib, OPV, MMR II, Varivax for prophylaxis. The subject was vaccinated with Engerix-B on 09 July 1996, with hepatitis B vaccine (Manufacturer unspecified) on 13 August 1996, and with Engerix-B on 29 March 1997. According to information provided by the reporting attorney, on 29 March 1997 the subject received the third dose of Engerix B (unknown). In February 2000, the subject received the "first diagnosis" of pervasive developmental disorder. Other alleged injuries included autism and neurodevelopmental disorder. According to the legal complaint, the subject experienced" serious and permanent neurological injuries" which was "alleged to be caused by Thimerosal." The events of autism and pervasive developmental disorder were assessed as medically serious by manufacturer. Follow-up information was received on 30 March 2007 via medical records. The subject was born to a 44-year-old mother at 38 weeks gestation. Post delivery, the subject experienced skipped/irregular heartbeats and poor feedings. In 1999, he was enrolled in a special education program that included occupational and speech therapy. He underwent a developmental evaluation on 28 July 1999, which assessed his overall development to be "very significantly delayed". A pediatrician's notes dated 20 December 1999 indicated that the subject experienced progressed in speech, language, and motor skills. A neurological evaluation was performed on 25 February 2000 for encephalopathy. According to the subject's mother, concerns began at approximately one year of age, at which time the subject experienced episodes of stiffening "with excitement", without alteration of consciousness. He also experienced delayed walking at 16 months old, and delayed talking until "well after" two and a half years old. In addition to stiffening with excitement, stereotypes included staring, running back and forth, poor eye contact, and other problems with social interactions. The neurologist's impression was that the subject "fits within the spectrum of pervasive developmental disorder (PDD)". with problems including developmental dysphasia that was "disproportionate for his academic abilities which may also be significantly limited". The neurologist advised the mother that the disorder was unrelated to her pregnancy, labor and delivery, or subsequent home environment. On 28 November 2000, concerns including "still not talking, doses not follow directions", and a diagnosis of autism was noted. In February 2001, psychological testing revealed that the subject performed "significantly below his age expectation his intellectual abilities". According to the Childhood Autism Rating Scale, he fell into the severely autistic range. A subsequent developmental education profile in March 2001 indicated "some gains in the area of special education, although the gains have not been rapid, they have been steady". At the time of evaluation, he scored an age-equivalency of 23 months in the area of receptive language, and at 22 months in the area of fine motor skills.
Within thirty mins of having vaccine tongue started to go numb after about 1 hour after the vaccine face started to get tingling/numbness fast heart palpitaions felt like chest was getting pushed on then felt flusing of blood to my head this lasted for about 4-5 hours after vaccine administered. To date I still have numbness on the tip of my tongue that has not went away. I never had this numbness prior to the vaccine.
chills leg swelling. period arrived 4 days early and has been going heavy and over 7 days when its usually 3
death I21.4 - Non-ST elevation (NSTEMI) myocardial infarction N17.9 - Acute kidney failure, unspecified
No symptoms reported. No further AE details; HCP called to report an expired dose of PROQUAD was administered to Multiple patients. Patient Demographics provided for all patients, please see notes for additional case numbers. HCP gave permission to contact. No symptoms reported. No further AE d; Temperature: 70F Date of excursion: 3/2/2023; This spontaneous report was received from a pharmacist, referring to a 4-year-old patient. The patient's pertinent medical history, concomitant medications, previous drug reactions, or allergies were not reported.  On 14-JUN-2023, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (strength, vaccination scheme, anatomical site of vaccination and route of administration were not reported; lot number W028565, expiration date was reported as 02-JUN-2023, but upon internal validation was established as 06-MAR-2024 (conflicting information, reported as expired dose)) as prophylaxis, which also experienced a temperature excursion (expired product administered and product storage error).  The vaccine experienced a temperature excursion of 70 degrees Fahrenheit (F) for 9 minutes on 02-MAR-2023.  This is one of several reports received from the same reporter.
This spontaneous report as received from a consumer refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, frequency, route of administration, lot number and expiration date were unknown). There were no concomitant therapies reported. The reporter stated that, on an unknown date, the patient experienced rash, itchiness, eye issues and other side effects. When reviewing the product information (PI), it was suggested to contact the physician about any further concerns. The outcome of the aforementioned events was unknown. The causality between ZOSTAVAX and all the events was not provided. This case is one of two from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with two doses of ZOSTAVAX within the same 24 hour period (dose, dosage number, route of administration, expiration date and lot # were not reported). No concomitant medications were reported. No adverse event were reported.  Additional information has been requested.
This patient is 77 years old, and had a menstrual cycle that began 5/15/2021  and lasted until 5/18/2021. She has not menstruated in over 30 years. She experienced cramps, low back pain, and irritability.
Patient received the Zostavax vaccine on 7/8/14 and returned to pharmacy on 7/11/14 presenting with a localized, rectangular-shaped rash on the inside of his left arm.
Starting around 12 hours after injection- Severe, sharp joint pain all over and muscle aches, muscle contractions/twitching, 12 hour fever, mild-moderate stomach cramping and nausea, extreme fatigue and discomfort from body pain. Approximately 24 hours after vaccine, moderate facial dermal fillers (hyaluronic acid) swelling and pain/tenderness upon palpation. Most of the body pain and fever/sweats stopped after about 16-20 hours after vaccine. Took two Benadryl and an antihistamine (I'm 110lbs) at bedtime day 2 for facial swelling and it did not continue to worsen after that. Day 3 today and the facial swelling is still going down and almost gone, with no more pain. Fatigued and worn out from the 12 hour night of no sleep with bad body pains and fever that first night, but otherwise feeling good besides slight migraine. Menstrual cycle just started today (day 3) so I believe the migraine is from that (common for me).
arm soreness; This is a Spontaneous report based on the information received by Pfizer from AbbVie (Manufacturer Control No: 20K-163-3609696-00) from a contactable consumer. This consumer reported events with both dose of vaccine. This case refers to first dose. A 72-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 21Jan2021 (Batch/Lot Number: EL8982) as single dose for covid-19 immunisation.  Medical history included cataract from 2011 to 2020 , upper limb fracture from 03Jan2011 to 16Feb2011 , upper limb fracture from 03Jan2011 to 16Feb2011 , cardiac failure congestive from 2017 and ongoing , pneumonia from 2017 to 2017 , ongoing constipation , coeliac disease from 2008 to an unknown date , lumbar spinal stenosis from 2017 to an unknown date , weight increased from 2020 to an unknown date , joint range of motion decreased from an unknown date and unknown if ongoing, crohn's disease. Concomitant medication(s) included adalimumab (HUMIRA), subcutaneous from 2006 (Batch/Lot Number: 1132579) and ongoing, at 40 mg, weekly (Humira 40 mg/0.4 ml/40 mg,1 in 1 wk), subcutaneous from an unspecified date (Batch/Lot Number: 1135601) to an unspecified date, at unspecified dose, subcutaneous from an unspecified date (Batch/Lot Number: 1137002) to an unspecified date, at unspecified dose for crohn's disease, amlodipine (AMLODIPINE) taken for blood pressure abnormal, start and stop date were not reported; atorvastatin (ATORVASTATIN) taken for blood cholesterol increased, start and stop date were not reported; calcium (CALCIUM) taken for osteoporosis, start and stop date were not reported; carvedilol (CARVEDILOL) taken for cardiac failure congestive, start and stop date were not reported; duloxetine hydrochloride (CYMBALTA) taken for depression, start and stop date were not reported; hydrocortisone (HYDROCORTISONE) taken for adrenal insufficiency, start and stop date were not reported; furosemide (LASIX [FUROSEMIDE]) taken for cardiac failure congestive, start and stop date were not reported; lisinopril (LISINOPRIL) taken for blood pressure abnormal, start and stop date were not reported; mirtazapine (MIRTAZAPINE) taken for depression, start and stop date were not reported; omeprazole (OMEPRAZOLE) taken for gastrooesophageal reflux disease, start and stop date were not reported; tramadol (TRAMADOL) taken for an unspecified indication, start and stop date were not reported; vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) taken for vitamin d deficiency, start and stop date were not reported; bupropion hydrochloride (WELLBUTRIN) taken for depression, start and stop date were not reported.  The patient experienced arm soreness on 21Jan2021 with outcome of recovered on 23Jan2021.    No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021287078 same patient/ vaccine, different dose/ AE
20 mins p/inject sitffness in lower jaw (intermittent); 2-4 hrs dizziness (intermittent for 5 /12 wks); next day inc pressure in head lasting 5 1/2 wks; 2 wks p/inject arthritic pain in ankles/wrists lasting 1 wk; 5 wks p/inject MD examine;
BREAKTHROUGH COVID: FULLY VACCINATED /BOOSTED AND COVID POSITIVE. PT FOUND TO BE COVID POSITIVE TO HAVE A SORE THROAT AND NAUSEA DURING ADMISSION. PT WAS ADMITTED FOR INTRACTABLE ABDOMINAL, SUSPEC D/T DIABETIC KETOACIDOSIS. NO TX MEDICATION NOTED FOR COVID 19.
Case was received from the Health Authorities on 27-JUN-2012 (reference number PEI2012020019). Case was medically confirmed. A 13 year old female patient, received a first dose of GARDASIL (lot number NN08930 batch G004210) IM into the upper arm who on 01-JUN-2012. Immediately after vaccination she developed a syncope for 30 seconds. After elevating legs and oral administration of fluids, the patient recovered. Unspecified time later, she presented with herpes simplex infection. Duration and outcome was not reported. Case was assessed as serious by Health Authorities, as other important medical event. Other business partner numbers include E2012-04192. No further information is available.
About two weeks after the booster rash under both breast and neck  treating with over the counter cream but it does not work  have to schedule a doctor appointment.
Chest tightness, SOB, feeling hot. Advised technician to call 911 and gave EPIPEN 0.3mg and patient symptoms began to improve w/in 5 mins. She then received treatment at Hospital.
A report was received from a health care professional on 5 November 2003 concerning a 65-year-old male vaccine who received expired Fluvirin on 1 October 2003.  On 1October 2003 the vaccine received expired Fluvirin.  There was insufficient information to determine the reporter's causality assessment.  Update 1, 16 February 2004.  A follow-up report was received from a health care professional indicating that the vaccine received Fluvirin on 02 October 2003.  No adverse event had occurred at the time of reporting.  No follow-up pending.  All information received.
1 minute after receiving vaccine, patient was seated in a chair.  Large sigh, then head went back.  Staff immediately by her side, full grand mal seizure lasting 90 seconds.  During this time assist of two to floor.  After seizure assisted to side for rescue position.  Public health attached to hospital and MD and PA arrived quickly.  Patient transported to ER for further follow up.  When patient regained consciousness she stated she had "passed out several times before and has felt more stress in this past year."
Saturday April 1st in the evening I felt congested with some hoarseness when I spoke.  I also felt a bit lightheaded and weak.  I tested positive on the same day.  About 12 hours later I tested positive again.  I felt much weaker and more congested.  I had a sore throat and uncomfortable sensation in my ears.  Later that day I got chilled and running a fever.  By the end of that day, I had a strong headache similar to a migraine, but it was unresponsive to migraine medication or ibuprofen.  This headache lasted for 3 days.  Also, I became less lucid and extremely tired.  I was having difficulty getting out of bed, mentally and physically.  Any physical activity left me out of breath.  I had body aches in my back, hands, legs, arms.  I had difficulty concentrating, "brain fogged", throughout.  I felt like I was in a waking nightmare and unable to focus on anything.  My fever peaked at 100.9.  My ears were clogged, and my throat was sore, and it was painful to swallow that ensued a stabbing pain in my ears.  Monday night I was prescribed Paxlovid but had to wait 24 hours for the first dose.  12 hours after that for the next 24 hours my symptoms lessened, (Tuesday-Wednesday).  Over the next several days the pain in my ears and my throat became less.  During the worst, Sunday, Monday and Tuesday, the pain in my ears was constant and the stabbing pain only happened when I swallowed.   My body aches were gone by Wednesday and pain in ears as well.  As of today, day 12, I feel essentially 100% with a bit brain fog and a tickle in my throat when I talk and need to cough.
Pt. states that after receiving the 3rd dose of Phizer Booster 09/30/2021, started experiencing symptoms 10/01/2021 01:15am of chills, muscle aches, muscle spasms, and passed out x1. Self-treated with Tylenol for pain. 10/03/2021 still feeling fatigued and nausea. No noted Primary visit.
BILATERAL SWOLLEN ARMPITS/BILATERAL LYMPH ADENOPATHY; This spontaneous report received from a physician concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, once a total administered, start therapy date not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced bilateral swollen armpits/bilateral lymph adenopathy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bilateral swollen armpits/bilateral lymph adenopathy was not reported. This report was non-serious.
Mixed Dose series. Cl previously vaccinated with Moderna on 3/25/21 and 4/22/21
severe arm pain; was very tired day after; sore throat; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 55 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "severe arm pain"; FATIGUE (non-serious), outcome "unknown", described as "was very tired day after"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat".  Additional information: The patient experienced severe arm pain, was very tired day after, sore throat felt like she got run over by a truck. She has no underlying conditions, she did have a sore throat the week before, but it came back after getting the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Acute pain and swelling around injection site, Redness and bruising around the injection site, reaching 3-4 inches diameter for 4 days, diarrhea for 4 days.
Multiple swollen lymph nodes in supraclavicular and axillary region. Pain has worsened over post two days, and patient is starting to lose active mobility of arm.