chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 05Apr2021 the COVID test result positive; On 05Apr2021 the COVID test result positive; muscle pain in my left arm; two days the pain radiated into my anterior chest wall which increased by activity; The pain then radiated to my elbow, forearm, and both of my lower extremities.; The pain then radiated to my elbow, forearm, and both of my lower extremities.; The pain then radiated to my elbow, forearm, and both of my lower extremities.; Dose 1 and dose 2 administered on 27Jan2021; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN5318 and expiry date was not reported), via an unspecified route of administration at the left arm, on 27Jan2021 at 03:15 PM (age at the time of vaccination was 52-year-old), as a dose 1, single for COVID-19 immunization and BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN5318 and expiry date was not reported), via an unspecified route of administration at the right arm, on 27Jan2021, as a dose 1, single for COVID-19 immunization. The patient's medical history was not reported. The patient concomitant medications include unspecified prescribed medication for diabatic and hypotension. It was reported that the patient did not have any allergies. Reportedly the patient tested for COVID post vaccination. On 27Jan2021, at 05:00 PM the patient experience muscle pain in his left arm and after two days the pain radiated into his anterior chest wall which increased by activity. Reportedly the patient visited his primary physician regarding the pain, he then referred him to a cardiologist, who conducted an EKG and echocardiogram. An X-Ray of his left shoulder was also taken, and his carotid ultrasounds were normal. The pain then radiated to his elbow, forearm, and both of his lower extremities. On 05Apr2021 the patient was tested for COVID-19 (drug ineffective). On 05Apr2021, the patient underwent lab tests and procedures which included SARS-CoV-2 (COVID19) (Nasal Swab) resulted positive. Outcome of the event was not recovered for muscle pain in my left arm, two days the pain radiated into my anterior chest wall which increased by activity, the pain then radiated to my elbow, forearm, and both of my lower extremities. Outcome was unknown for rest of the event.  Follow-up attempts are completed. No further information is expected.
nausea, vomiting, abdominal pain, cramping, diarrhea, body aches;
5/14/01 Prevnar given 11am, by 6pm mother reports slight fever (no temp taken tylenol given. 5/15 - ok today still slight fever & cranky. 5/16/01 woke with red, non raised diffused rash on chest, abd & back and fever continues. 5/17/01 rash spread to legs front & back - to Dr who examined throat & ears and told Mom was from shot 5/14/01. Given Rx benadryl. No rash by morning of 5/18/01.
About 24-48 hours after vaccine given developed fever (max 103 degrees F) and a large, hard, swollen and moderately tender area from her elbow to shoulder on the left arm where shot was given. Improved gradually over 4-5 days.
I began to feel a burning sensation in my left shoulder on 07/24/22 at around 11:30pm EST while laying in bed. The pain felt deep within the shoulder joint. I tried to stretch out the shoulder but began to feel increased pain so I stopped. Within a few minutes the pain dissipated. The pain returned in the middle of the night while I was sleeping on my right side; the pain woke me up. Once again, the pain returned today (07/25/22) at around 12:30pm. Onset is random and returns while I'm resting. The pain lasts for a few minutes (~10-15 minutes) and subsides on its own with no treatment. I have not undergone any strenuous physical activity nor have lifted anything heavy since receiving the vaccine.
Patient came in with family and was given a Pfizer booster dose  inadvertently on 12/8/2021.Her first 2 doses were given 4/16/2021,5/7/2021.Her age is 16 and was given booster dose 12/8/2021
Information regarding PREVNAR was received from a healthcare professional regarding a 5-year-old female patient who experienced pneumococcal bacteremia. The patient received a dose on an unspecified date. The patient experienced pneumococcal bacteremia on 16-Dec-2009. The patient was hospitalized and treated with unspecified IV antibiotics. The patient recovered. No additional information was available at the time of this report.
At 19:24 client received dose 1 of the COVID19 Pfizer vaccine (Lot #EW0187 Exp 08/31/21).  Client?s adult daughter was accompanying him.  After receiving the vaccine, client and his daughter walked to the observation room and sat down.  At 19:57 client communicated to EMT1 that 2 of the fingers on his right hand (pointer & middle fingers) were tingling and felt a little numb.  EMT1 radioed Lead RN for notification purposes.  Lead RN arrived in the observation room at 19:59. Client informed Lead RN that he was not experiencing shortness of breath, chest pain, or trouble breathing, but his fingers were numb, and he felt a little dizzy.  AT 20:02, EMT2 took client?s vitals (BP:  148/102, HR: 88, RR: 14 SPO2 Sat: 99%) and confirmed that he was alert and oriented to person, place, time, and self.  Client stated to Lead RN that he has no known allergies, and his underlying conditions consist of diabetes and high blood pressure.  He also stated that he takes Metformin and another medication for his diabetes that he could not remember the name of.  Client could not provide the name of the high blood pressure medication he has previously taken.  Client also stated that since the COVID19 pandemic started, he hasn?t taken much of his blood pressure medication because he has not been able to see his doctor.  Client implied that if he still has high blood pressure, it is not being managed.  Client stated he was starting to gain feeling back and his fingers and that maybe his hand fell asleep because of the way he was sitting.  Lead RN asked client when he had last eaten and/or drank something.  Client stated he had not consumed anything since 12:00.  EMT1 gave client a granola bar and a bottle of water.  After eating the granola bar and drinking the water, client stated he was starting to feel better and was feeling very little, if any, dizziness.  At 20:18, EMT2 took client?s vitals (BP: 140/102, HR: 83, RR: 14, SPO2 Sat: 98%).  Client stated he felt totally fine and was ready to go.  At 20:20 Lead RN educated client on high blood pressure signs and symptoms, the importance of blood pressure management, and recommended client contact his medical provider for follow-up.  Lead RN also educated client on the side effects and adverse effects of the COVID19 Pfizer vaccine.  Lead RN instructed client to go to urgent care if he started to experience extreme side effects and/or dizziness again and to call 911 if he started to experience any difficulties breathing, shortness of breath, or chest pain.  Client stated he understood.  Client left with his daughter at 20:23 walking with a steady gait.
VACCINE WAS REFROZEN (INCORRECT PRODUCT STORAGE); ADMINISTRATION OF REFROZEN VACCINE (OUT OF SPECIFICATION PRODUCT USE); This spontaneous report received from a health care professional concerned a 66 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: 1821286, and  expiry: 20-MAR-2022) dose was not reported, administered on 07-JUL-2021 for prophylactic vaccination. Age at time of vaccination 66 years old. No concomitant medications were reported. On 07-JUL-2021, the patient experienced administration of refrozen vaccine (out of specification product use). On an unspecified date, the patient experienced vaccine was refrozen (incorrect product storage). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of refrozen vaccine (out of specification product use) and vaccine was refrozen (incorrect product storage) was not reported. This report was non-serious. This case, from the same reporter is linked to 20220540524, 20220537683, 20220540688, 20220540570, 20220540324, 20220540536, 20220540611, 20220540642, 20220540765, 20220540474, 20220540814, 20220540420, 20220540816 and 20220541085.
Tinnitus, nausea, muscle pain at injection site, metal taste in mouth, all occurring immediately and lasting at about 24 hours.
Pt developed Herpes Zoster 2 days after receiving H1N1 vaccination. Treated with VALTREX and VICODIN.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. 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, 1 total, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, a month after vaccination, the patient donated blood and found out he still did not have the antibodies (confirmed immunological vaccine failure), then after a month again he donated blood and did not have the antibody or antigen in blood. Laboratory data included: Antibody test (NR: not provided) Negative. On JUN-2021, Laboratory data included: Antibody test (NR: not provided) Negative.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210630149-COVID-19 VACCINE AD26.COV2.S-Confirmed Immunological Vaccine Failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Sore throat about 2 hours after vaccine was administered; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 10 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Nov2021 14:30 (Lot number: FK5127) at the age of 10 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 06Nov2021 16:30, outcome "not recovered", described as "Sore throat about 2 hours after vaccine was administered". Therapeutic measures were not taken as a result of oropharyngeal pain.  Additional information: The patient did not have any known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient been tested for COVID-19.
02/06/2021 Headache entire 01:00 to 22:30  fever at 01:00  101.6 Fever 03:16 102.4 dizziness/weakness Fever 06:30 102.2 Fever 09:00 103.2 Fever 12:30  102 Fever 14:20. 102.4 Fever 16:00 103.2 Fever 19:00 102.6 Fever 22:00 102.4 All while taking Motrin and Tylenol alternating and ice packs to core areas to break fevers
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 21Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 19Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Cholesterol managed with medication" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: Mar2022, stop date: May2022; EZETIMIBE, start date: Mar2022, stop date: May2022; DEPLIN [LEVOMEFOLIC ACID], start date: Mar2022, stop date: May2022; FISH OIL, start date: Mar2022, stop date: May2022; VITAMIN B COMPLEX, start date: Mar2022, stop date: May2022; COQ10 [UBIDECARENONE], start date: Mar2022, stop date: May2022; VITAMIN B 12 [CYANOCOBALAMIN], start date: Mar2022, stop date: May2022; VITAMIN D3, start date: Mar2022, stop date: May2022; MAGNESIUM, start date: Mar2022, stop date: May2022. Past drug history included: Levaquin, reaction(s): "Known allergies: Levaquin". The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 04May2022 at 14:30, outcome "unknown", described as "Paxlovid: Treatment of COVID-19"; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 188/104. Therapeutic measures were not taken as a result of drug ineffective. Therapeutic measures were taken as a result of Covid-19. Clinical course: Paxlovid was given for Covid-19 treatment on 01May2022 and stopped on 04May2022. Adverse event start date was 04May2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
chills; body aches; cold; fever; pain at injection site; This is a spontaneous report from a Pfizer-sponsored Program Pfizer First Connect. A contactable consumer (patient herself) reported that a 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL0140), via an unspecified route of administration on 06Jan2021 at single dose for covid-19 immunization. Patient had a history of COVID in Nov2020. Concomitant medication included levothyroxine sodium (SYNTHROID) (for twenty some years), bupropion hydrochloride (WELLBUTRIN) (for about a year), naltrexone (for about a year), all from an unspecified date and ongoing.  The patient got the vaccine yesterday (06Jan2021). Patient experienced chills, body aches, cold, fever, and pain at the injection site started at 10 am on 07Jan2021. The fever has went up a little since this morning, but everything else has stayed the same. Her fever was 100.6 degrees Fahrenheit now. Earlier this morning it was 99.3 degrees Fahrenheit. Outcome of events were not recovered.
something like a boil or a pimple began appearing in various places on her body: top of left breast, under her breast, right buttock, etc. Each of these was an inflamed (red) area about the size of a dime, with a small amount of pus under a blister in the middle of the inflamed area.
Called to waiting room, client not responsive to voice or touch. Sitting upright in chair eyes open glazed, fixed stare, clammy, pale, perspiring profusely. Unable to feel RP or hear RP. Lasted about 6-7 1/2 mins. Client stared, then responded appropriately to name, stating my head feels funny, C/O nausea wanting to void. Denied any throat itching, swelling, VS remained low, sent by rescue squad to local ER, Awake, responding app when she left. 7/18/06 TC to pt states I'm fine. They (ER) really didn't know what happened.
Pt mom reported that her daughter received 2nd dose of moderna and started having back and chest pain (no difficulty breathing) later that evening. Pt went to dr who deteremined it was an inflammation of her rib cage and sterum and a rare occurance due to the vaccine. Pt was at home resting.
Tripedia left thigh. Child develooped local reaction at site evening of vaccine. Red, warm to touch: redness increased to entire thigh per mom. Better next am 8/18/04, then seemed to get worse. Went to ER. Local reaction.
pt recvd vax & lost consciousness; resulted in MVA; was aprehensive about receiving inject;
Eyrothema , swelling, tenderness 4 "diameter x 6" long..extending to top of arm. Fatigue. Exercise intolerance. Nausea. Enlarged submandibular lymph glands. Feeling of "something in throat. Ibuprofen 200 mg. Rest. May add Benadryl 25 mg
tiredness; headache; shivers; terrible muscles aches and pains; This is a spontaneous report from a contactable other HCP (patient). 38-years-old male patient received second dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: EL3248), via an unknown route of administration in left arm on 15Feb2021 at 09:00 (at the age of 38-years-old) as single for COVID-19 immunisation at  clinic. The patient's medical history and known allergies were reported as none. Concomitant medication was not reported. No other vaccine in four weeks. The patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: EL3248), via an unknown route of administration in left arm on 25Jan2021 at 09:00 as single as historical vaccine for COVID-19 immunisation. On 16Feb2021 at 02:00, the patient woke up in middle of night with shivers. Had to get into shower just to keep warm. Muscles kept locking on whole body. Woke the next day with terrible muscles aches and pains. Along with great tiredness and headache. No COVID prior vaccination. No COVID tested post vaccination. No treatment received. The outcome of the event was not recovered.  Follow-up attempts completed. No further information expected.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 4 (booster), single (Lot number: GH9693), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive. The patient was treated with Paxlovid from 01Mar2023 to 05Mar2023.; Sender's Comments: The contributory role of BNT162b2, BNT162b2 omi ba.4-5 to the reported drug ineffective event cannot be excluded since a lack of effect can generally be expected for any medicinal product as a 100% success rate cannot be reasonably assumed in every patient treated.
Injection site reaction and vertigo.; Injection site reaction and vertigo.; This is a spontaneous report from a contactable pharmacist. A 63-year-old patient of an unspecified gender received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot EH9899), intramuscular on 17Dec2020 10:30 at single dose (left arm) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products. On 17Dec2020, at 10:30, the patient experienced injection site reaction and vertigo. The patient was administered at the hospital. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no treatment received for the events. It was unknown if the patient was diagnosed with Covid-10 prior to vaccination and it was unknown if the patient had been tested for Covid-19 since the vaccination. Outcome of events was recovered on an unspecified date.
My husband passed away June 3, 2021 resulting from complications which began a few hours after receiving his 2nd Moderna shot on April 29, 2021. He never tested positive for Covid19, however his first symptoms were the typical fever, muscle aches, rash. He declined daily from a host of mysterious symptoms including full body rash, blood clots, muscle spasms, atrial fibrillation, ulcers lining his esophagus and colon, and exorbitant WBC (157K) with extremely high eosinophils (90%). He was treated with a host of drugs including antibiotics, steroids, blood thinners, ivermectin and finally chemotherpay (Campath). His ICU team  included hematology, pulmonology, ... oncology and infectious disease. After an incredible amount of diagnostic testing ( daily routine blood work, EKGs, chest x-rays, CT scans, MRI, bone marrow biopsy, endoscopy, colonoscopy, skin biopsy, genetic testing) no definitive diagnosis could be made, however, he was given the possible diagnosis of chronic eosinophilia leukemia in late May. The big question among the medical staff was, "Did the shot trigger something?" He was eventually treated with the chemotherapy drug Campath, which reduced the WBC and EOs some, but his organs, especially, lungs had been very compromised by the high WBC and eosinophils. Several days after being placed on a ventilator and given a feeding tube at the end of May, a CT scan and MRI confirmed patient had suffered multiple strokes. He passed away a half hour after being taken off the ventilator the morning of June 3, 2021. His death certificate read:  A. cardiopulmonary arrest  B. acute hypoxic respiratory failure  C.  hypereosinophila
This initial non-serious spontaneous case, was received from other health professional (pharmacist) on 18-Nov-2017, concerns a 44-year-old female patient. The patient's medical history was not reported, concomitant medications included ibuprofen for pain. The patient's historical vaccine included flu vaccine on an unspecified date. On 26-Oct-2017, the patient was administered with FLUCELVAX QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch no: 195248 and expiry date: Jun-2018). On 26-Oct-2017, the patient had soreness. On 28-Oct-2017, 3 days after vaccination, the patient had pain and muscle weakness in the arm, which lasted for about 3 weeks. On the day of vaccination, the patient did not have localized pain while administering injection but later had less pain than usual when receiving injection, no localized rash. She was on ibuprofen at the time of vaccination and was continuing with it, but she couldn't sleep at night due to pain. It was reported, that she had pain in her whole arm. It was hard for her to discern exactly the pain. On 18-Nov-2017, pharmacist stated that she had no sign of injection site reaction, no redness or swelling at the injection site on that day, no redness or swelling down the arm, no rash noted when visually observed by pharmacist. The outcome of the events was not recovered. Non-significant case correction received with IRD 18-Nov-2017 and CRD 04-Dec-2017: IRD and CRD was corrected for the initial version. Non-significant case correction received with IRD 18-Nov-2017: 'Expiry date of the product changed from 'Jun-2018 to 30-Jun-2018'. The "description to be coded" term was changed from insomnia to Sleep difficult.
chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills). At the time of the report, CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-263697, MOD-2021-263735 (Patient Link).