chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning an 11 year old female who on 15-APR-2008 was vaccinated with her first dose of GARDASIL (lot# not provided). Concomitant therapy included VARIVAX, (duration and dose not reported). Other concomitant therapy included MENACTRA and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 15-APR-2008 the patient fainted after receiving the first dose of GARDASIL. The patient was recovering from fainting. She sought medical attention in the clinic. Additional information has been requested.
COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a 28 year old male. 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: 204A21A, expiry: 21-SEP-2021) dose was not reported, administered on 28-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-DEC-2021, the patient experienced sars cov 2 test positive. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sars cov 2 test positive was not reported. This report was non-serious. This report was associated with product quality complaint :90000206786
I felt very tired not to much energy; I felt very tired not to much energy; Pain headach started on the right side of my face from my temple down to lower chin; more disconfort near my ear and sensitive when i stroke my face; Felt like muscle spasms; Felt like tension tightness ach; tingling in my ankle and feet but only on one side but mild.; more disconfort near my ear and sensitive when i stroke my face; Pain headach started on the right side of my face from my temple down to lower chin; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Apr2021 (Batch/Lot number: unknown) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High Cholestrole" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: FATIGUE (non-serious), ASTHENIA (non-serious) all with onset 23Apr2021, outcome "not recovered" and all described as "I felt very tired not to much energy"; FACIAL PAIN (non-serious), HEADACHE (non-serious) all with onset 23Apr2021, outcome "not recovered" and all described as "Pain headach started on the right side of my face from my temple down to lower chin"; EAR DISCOMFORT (non-serious), SENSITIVE SKIN (non-serious) all with onset 23Apr2021, outcome "not recovered" and all described as "more disconfort near my ear and sensitive when i stroke my face"; MUSCLE SPASMS (non-serious) with onset 23Apr2021, outcome "not recovered", described as "Felt like muscle spasms"; FEELING ABNORMAL (non-serious) with onset 23Apr2021, outcome "not recovered", described as "Felt like tension tightness ach"; PARAESTHESIA (non-serious) with onset 23Apr2021, outcome "not recovered", described as "tingling in my ankle and feet but only on one side but mild.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, asthenia, facial pain, muscle spasms, feeling abnormal, paraesthesia, sensitive skin, headache. Therapeutic measures were taken as a result of ear discomfort.  Additional information: No covid prior vaccination. The patient tested post vaccination. No other vaccine in four weeks. Other medications in two weeks was vitamins. No known allergies. Facility type vaccine was hospital and vitamins had taken within two weeks. The patient experienced muscle spasms and thought was coming from my mouth. Went to the dentist did not find anything wrong. The pain came in went everyday. Felt like tension tightness ache. Took Advil or Tylenol for the disconfort only helped a little. It was may and I still had this ache off and on.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report received from a healthcare worker refers to a unknown number of patients of unknown age and gender. Since 23-MAY-2014 the suspect vaccines were improperly stored and on unknown date (in approximately May 2014) the patients were vaccinated with PROQUAD, Lot #, dosage, anatomical localization and route of administration were not reported. Vaccines has been administered up to 8 patients. No adverse effects reported. This is one of several reports of the same source. Additional information has been requested.
I95.9 HYPOTENSION 6/11/2023 SIRS DUE TO NONINFECTIOUS PROCESS WO ACUTE ORGAN DYSFUNCTION J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 6/20/2023 SIRS DUE TO NONINFECTIOUS PROCESS WO ACUTE ORGAN DYSFUNCTION R09.02 HYPOXIA 6/12/2023 SIRS DUE TO NONINFECTIOUS PROCESS WO ACUTE ORGAN DYSFUNCTION
Presented at private MD with fever of 103F and an abscess at injection site on 11/2/00. Admitted to hospital and at 16:00 on 11/2/00 with fever of 101.8F then decreased with RX and IV Rocephin and normal saline. Given Tylenol for pain and went home with Keflex 500mg every 6 hours X 5 days.
Large swelling of Left deltoid muscle12" diameter, red and tender to touch, increased WBC 21.9, fever 99.1. Oct 7/04, rash at injection site.
4 weeks after receiving meningitis vaccine, developed numbness on inside of cheek.  2 days later numbness progressed to 1 side of face.  5 days after numbness first started, one side of face as numb, headaches would "come and go".  MRI was done-WNL.  Patient also experienced some loss of taste.  History of sister developing tingling on 1 side of body, later diagnosed with MS.  Our MD thinks it may be Bells' Palsy with the palsey.
got COVID/ tested positive for COVID-19; got COVID/ tested positive for COVID-19; This is a spontaneous report from a contactable pharmacist. A female patient of unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route on 29Mar2021 as a single dose for COVID-19 immunization. The patient had no relevant medical history and no concomitant medications. The patient received the first dose on 29Mar2021 and then got COVID between doses. The patient tested positive for COVID-19 on 20Apr2021. She was supposed to get the second dose on 21Apr2021, which she missed; she was told she'd have to wait 90 days. The reported wanted to know if okay now to get the second dose since patient feels fine. She quarantined and feels better. The clinical outcome of got COVID/ tested positive for COVID-19 was recovered on unspecified date.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2  (PFIZER-BIONTECH COVID-19 mRNA VACCINE) cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity after the first vaccine dose.,Linked Report(s) : US-PFIZER INC-2021527897 same reporter/patient/drug, different event in separate dose
Received vaccines DPT, IPV, MMR, HIB on 08/01/2005 - broke out in a rash 08/03/2005 trunk to extremities.  No fever, no pruitis.
body feels numb and she describes hard to stand up - feels like fainting.  possible shortness of breath but said that might be because she is so nervous about how she is feeling
About an hour to two hours later. He noticed he is getting itchiness all over his body.; Left arm where he got the vaccine is a little sore; This is a spontaneous report from a contactable consumer. This male consumer (patient) reported for himself that:  A male patient of an unspecified age received first dose BNT162B2 (formulation solution for injection, Batch/Lot number was not reported) via unspecified route of administration in left arm, on 21Apr2021 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. About an hour to two hours later he noticed he was getting itchiness all over his body. The itchiness was on various spots on his body, it was random spots his left arm where he got the vaccine was little sore on an unspecified date. The patient had not massive itchiness, just slight itchiness. He will get a small spot where it will be slight reddish and it will start itching. After a while it goes away and is back to normal. Then, another part will start the same way. He has had no other concerns with it. The outcome for both the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Fever; spitting up phlegm; weak/no stamina; Short of breath; kidneys hurt a bit; mouth was so dry; appetitive was gone; bad taste in his mouth; This is a spontaneous report from a contactable consumer or other non-hcp (patient). A 74-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 27Jan2021 11:00 (at the age of 74 years), (Lot Number: EK4170) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD). There were no concomitant medications. Patient said he got a COVID-19 shot two weeks ago today on 27Jan2021 and was still having stuff. He said he had the regular little stuff like a fever and all that went away, he had a cold and was spitting up phlegm and stuff. He was supposed to get another shot a week from today, but he was not recovered enough from this to get another one, he was weak with no stamina, and was short of breath. Patient also reported his kidneys hurt a bit, which might go away for a little bit, but it came back because his mouth was so dry, he was drinking Gatorade along with water to combat that, his appetitive was gone, and if it did not pick up, he was going to be losing a lot of weight, he eats like a little girl right now. Patient reported to please excuse the expression, but had bad taste in his mouth, there was no way he was going to be recovered enough to take the second dose next week, he was afraid it would kill him. He said he has got COPD, but he regularly goes walking and dancing, and did yard work and all the other stuff. He said he was 74, but right now he feels 95 and ready for the nursing home. He was hoping it will wear off him, but there was no way he could get the shot next week. He had a fever for a little while, but that was gone now. It was just his breathing and stamina, he was not feeling as strong as he usually does. Therapeutic measures were taken as a result of mouth is so dry. The clinical outcome of the events fever was recovered on an unknown date in 2021 and was unknown for other events.   Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a consumer refers to a 60 year old female patient. The patient's concurrent condition included hypertension, fibromyalgia and allergic to tape, sulfa drug, nortriptyline and morphine. Historic condition included shingles twice. On 16-AUG-2014, the patient was vaccinated with ZOSTAVAX 1 injection (dose and lot # not reported) subcutaneous. Other suspect therapies included flu shot/influenza virus vaccine (name and manufacturer unspecified) on the same day by a pharmacist in same arm. Concomitant therapies included CYMBALTA, LYRICA, ampicillin sodium (reported as AMPOLINE), amlodipine besylate (reported as VESYLATE), benazepril hydrochloride, acetaminophen, PERCOCET, simvastatin (manufacturer unknown), PROTONIX and XANAX. The patient felt the shot was given in a strange location, very near her underarm; on the underside of her arm. On 16-AUG-2014, the patient started experiencing headache and got really hot, red and swollen at the injection site. The patient reported that the injection site had swollen to the size of an egg by the next night (17-AUG-2014) and the swelling migrated down her arm. She went to emergency room she was treated and send home. Her symptoms started to clear up. On AUG-2014, Saturday morning (date unspecified) she woke up feeling paralyzed on the right side of her face. She went back to hospital and was hospitalized overnight. She was diagnosed with Bell's Palsy. Patient was treated with valacyclovir hydrochloride for adverse events. No product quality complaint (PQC) was involved. The lab diagnostics tests included blood work which was reported to be normal. The outcome of events was unknown. The causality of was not reported. Additional information has been requested.
4-19-16 4PM (R) arm wrist to bicep. About 100 red raised "dots", itchy. Took BENADRYL and TYLENOL. 4-21-16 AM (L) arm wrist to bicep about 50 red raised "dots" itchy. Took BENADRYL and TYLENOL. (R) arm unchanged. 4-25-16 telecall to patient. Rash unchanged. Stats "always was itchy."
I received my Moderna booster on the afternoon of 11/15. The morning of 11/16 I `noticed pain when I would take a deep breath on the left side of my chest. I went to the Emergency Room and was diagnosed with Myocarditis or Pericarditis.
area was hot; Red spot that is getting larger; area was itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (area was hot), VACCINATION SITE SWELLING (Red spot that is getting larger) and VACCINATION SITE PRURITUS (area was itchy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE WARMTH (area was hot), VACCINATION SITE SWELLING (Red spot that is getting larger) and VACCINATION SITE PRURITUS (area was itchy). In January 2021, VACCINATION SITE PRURITUS (area was itchy) had resolved. At the time of the report, VACCINATION SITE WARMTH (area was hot) and VACCINATION SITE SWELLING (Red spot that is getting larger) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication and treatment information was not provided.
PATIENT HAS NOTICABLE REDNESS AND SWELLING ABOUT 4-6 INCHES BELOW INJECTION SITE, NO REPORT OF PAIN OR DISCOMFORT. PT INSTRUCTED TO ICE AREA, WATCH FOR AND REPORT ANY CHANGES.  SPOKE WITH PT AGAIN 11/8/13, SYMPTOMS HAVE SLIGHTLY IMPROVED BUT REDNESS AND SWELLING STILL PRESENT.
The next morning I could not feel my entire right arm, it was all numb, I lost strength for a few hours, could not hold anything, had injection site pain for several days. The numbness/loss of feeling lasted for about 8-10 hours. After 3 to 4 hours I called my PCP for advice and they advised me to go to the ER or UC.  I also had diarrhea and fatigue
Symptoms began with sore shoulder 1-2 days after injection the sore elbow around 10 days after injection burning and numbness in left hand. 10/27 was seen in clinic to follow up with neurology. 10/28 had new burning in both legs to the thigh. Seen in ER , had LP and neurology consult. Given Neurontin follow up out-patient. Had AMA and NCS 11/9: normal. Per neurologist's: autoimmune inflammatory polyneuropathy vs early Guillian Barre. 10/28: CBC, Chemistry Panel normal. 11/4: C3 C4 CRP RF ANLA: normal.   Follow up 03/07/05: Summary of nerve conduction studies: The left sural, posterior tibial and right peroneal respones are normal. the upper extermities, the left median and right radial sensor responses are normal. Motor conduction in the left media and ulnar nerves are normal. The left median CMAP amplitude proximall is larger thatn that distally. While stimulating over the median nerve in the antecubital fossa and recording over the abductor dititi minimi, a small response was obtained, consisent with median to ulnar (Martin-Gruber) anastomosis. Conclustions: This electrophysiologic study is normal. Specifically, there is no evidence for a large fiber polyneuropathy. The normal F-waves argue against acute inflammatory demeylinating polyradiculoneuropathy with symptoms presnet for two weeks. Clinical correlation is recommended. Incidently noted is a left median to ulnar forearm (Martin-Gruber) anastomosis, a normal variant seen in 15-30% of the population.  1/7/05 Information form patient:  She was hospitalized for 2 days and then followed up by a neurologit at the hospital.  At first they thought she had GBS, but now it has been diagnosed as chronic demyelating polyneuropathy.   03/07/05 From Medical Center Clinic Records; 03/07/05 Neurology Consult done in ER gives detailed exam findings and provides list of possible Dx; Auto-immune Inflamatory polyneuropathy named first and remains the finding.  Notes mention improvement on Neuronton.    03/08/2005 Neuro Clinic records reveal patient was diagnosed with auto immune inflammatory polyneuropathy.  Main symptoms were numbness, tingling, and pain.  These symptoms occurred 2 days after vaccination.
I experienced lightheadedness a couple of hours after receiving the vaccine along with arm swelling (currently breastfeeding and my daughter experienced a nosebleed and had to be taken to the pediatrician the very next day). We were fatigued and had a loss of appetite; then on the third day, my daughter continued to experience fatigue, had soft stool, vomiting, and only wanted breast milk and then the hives appeared on my neck, right breast and my private area. I called my Endocrinologist and PCP who was unable to see me said to go to the ER since she could not see me because I had just taken the vaccine. First, I wanted to see if it was vaccine related before going to the ER and took a Benadryl and took a nap (one at 4:30pm and 9:30PM). I woke up with hives all over my body and drove to the ER around 09:30PM (blood pressure was around 116) they prescribed me a 6-day steroid plan and Pepcid (2x per day) and before I left, they gave me steroid medication and two Pepcid. The next two days, I was off from work and all the hives on my body were gone and I continued with the regiment. On Friday, I had hives on my right leg near my knee that were very itchy and the next day the hives moved to my feet and ankles. I continued with the regiments and did not have any more symptoms. On the next day, I experienced heart palpitations and then the next day they subsided. I have been drinking a lot of water to try to flush my system and recover.
hives on face, refused ER visit, Benadryl 25 mg po given per order for allergic reaction. Patient stayed another 30 minutes with relief. Left without further issues. Advised to contact Primary before  receiving next vaccine
Started having seizures an hour after vaccines. Had EEG'S MRI and long term monitoring and started medicine called Keppra. A couple months later switched to Trileptal.
Pericarditis; This is a spontaneous report from a contactable consumer (patient) via Pfizer RXPathways. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on Feb2021 (Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on Jan2021 (Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient stated that over the past 4-5 weeks from the time of reporting, the patient has been having chest pain with breathing and movement. The patient thought of having some heart issues, so the patient went to PCP (primary care physician), then sent the patient to ER (emergency room), then referred to cardiologist. The cardiologist scheduled the patient for an Echo and Stress Test. Then on 24Aug2021, the pain was worse, so the patient went back to cardiologist. The patient was sent back to ER again and finally the ER diagnosed the patient with pericarditis. The patient had no past cardiac issues or heart related conditions. The outcome of the event was unknown.  The lot number for BNT162B2 was not provided and will be requested during follow-up.
Information has been received from a healthcare worker concerning a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of GARDASIL (lot number: K004204 and expiry date: 12-JAN-2017), which was improperly stored by exposing to 52F for 12 hours on 06-SEP-2014, 33.5F for 2 hours on 19-JAN-2015 and 31.5F for 29 hours (date unspecified). No adverse effects were reported from the time of administration of the vaccine. This is one of several reports received from the same reporter. Additional information has been requested.
Pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Ciprofloxacin with an associated reaction of hypoaesthesia. Concurrent medical conditions included numbness, hypersensitivity and arthritis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient experienced injection site pain. The reporter consented to follow up. For the tolerance of 2nd dose, refer linked case US2020138133, reported for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020138133:same patient, 2nd dose
On day 2 after vaccine I had moderate nausea On day 3, I vomited twice and had moderate diarrhea Day 4,5,6 and 7 mild diarrhea and nausea. Imodium-D and Dramamine seem to keep the symptoms in check if I take them every morning.
I had some issues with my vision being obscured. 10 minutes later I had numbness in my right hand and arm and went to the ER where they initiated stroke protocol. MRI EKG Cat Scan were performed. I was admitted to the hospital for observation for 24 after the test results did not show anything negative. Took me off birth control permanently and had me add a baby aspirin (81) to my daily. Everything was fine after the numbness went away. I have had a follow up with a Neurologist and Neuro-Ophthalmologist as well as primary care.