chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. On or about 09-MAY-2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration unknown), as recommended for routine adult health maintenance and for the prevention of shingles. It was reported that the vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 21-JUN-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster. The patient was prescribed acyclovir for management of her painful and persistent symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
patient received vaccine and fainted about 5 minutes later. She hadn't eaten prior and believe event actually due to low blood sugar. Called patient later, she was fine
Headache; Lack of energy; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In FEB-2023, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced headache (Verbatim: Headache) and loss of energy (Verbatim: Lack of energy). The outcome of the headache and loss of energy were not recovered/not resolved.   It was unknown if the reporter considered the headache and loss of energy to be related to Shingles vaccine.     It was unknown if the company considered the headache and loss of energy to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 3-Mar-2023 The patient received second shingles vaccine one week ago and was continuing to have headache and lack of energy. He or she asked if it was normal. Follow-up was not possible, as no contact details were available.
Patient received COVID-19 vaccine on 6/12, she presented on 6/27 in septic shock but leading differential is toxic shock syndrome secondary to recent first time tampon use.
Swelling just below injection site, red itchy rash spreading/growing on arm. Tiny itchy bumps around swollen site.
nerve pain; painful outbreak of shingles on his back, upper extremities; shingles of eyes; scarring of the cornea; other vision problems; Information has been received from a lawyer regarding a case in litigation concerning a male patient(pt) of unknown age.The pt's medical history, concurrent conditions and concomitant medications were not provided.On or around 02-MAR-2016, the pt was inoculated with zoster vaccine live(ZOSTAVAX)(dose detail, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).As a result of receiving zoster vaccine live(ZOSTAVAX), pt suffered scarring of the cornea and other vision problems on or about June 2016. In December 2016, pt suffered a painful outbreak of shingles on his back, upper extremities and eyes. Pt had suffered numerous outbreaks since that date which had created extreme nerve pain, depression and had negatively affected his life. All of these issues were caused by zoster vaccine live(ZOSTAVAX).As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX). Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition and had suffered economic losses due to his inability to work. As a result of the zoster vaccine live(ZOSTAVAX), pt sustained severe and permanent personal injuries, emotional injuries and loss of consortium. Further, as a tragic consequence of zoster vaccine live(ZOSTAVAX),pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The events ophthalmic herpes zoster, herpes zoster, neuralgia, visual impairment and corneal scar were considered to be disability. Upon internal review, ophthalmic herpes zoster was determined to be medically significant.
Bright red painful at injection site. Started about 24 hrs after injection. Patient saw her Dr. just to be sure.
I feel like I have sinus infection kind of (booster); fuzzy headed; little bit of cough (booster); Body aches; real bad headache; arm still hurts a little bit (booster); itchy (booster); swollen a little bit at the site, when touches it hurts (booster); swollen a little bit at the site, when touches it hurts (booster); This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (I feel like I have sinus infection kind of (booster)), FEELING ABNORMAL (fuzzy headed), COUGH (little bit of cough (booster)), MYALGIA (Body aches) and HEADACHE (real bad headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported.On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced SINUSITIS (I feel like I have sinus infection kind of (booster)), FEELING ABNORMAL (fuzzy headed), COUGH (little bit of cough (booster)), MYALGIA (Body aches), HEADACHE (real bad headache), INJECTION SITE PAIN (arm still hurts a little bit (booster)), INJECTION SITE PRURITUS (itchy (booster)), VACCINATION SITE PAIN (swollen a little bit at the site, when touches it hurts (booster)) and VACCINATION SITE SWELLING (swollen a little bit at the site, when touches it hurts (booster)). The patient was treated with ACETAMINOPHEN for Adverse event, at a dose of 1-2 dose per day and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, SINUSITIS (I feel like I have sinus infection kind of (booster)) and VACCINATION SITE PAIN (swollen a little bit at the site, when touches it hurts (booster)) outcome was unknown, FEELING ABNORMAL (fuzzy headed), MYALGIA (Body aches), INJECTION SITE PRURITUS (itchy (booster)) and VACCINATION SITE SWELLING (swollen a little bit at the site, when touches it hurts (booster)) had resolved and COUGH (little bit of cough (booster)), HEADACHE (real bad headache) and INJECTION SITE PAIN (arm still hurts a little bit (booster)) had not resolved. No concomitant drug details were reported by the reporter.  This case was linked to MOD-2021-395755, MOD-2021-395756 (Patient Link).
Upon awaking around 8am on Oct 24, patient could not sit up or stand or walk. His speech was garbled for several hours. When doctor (nurse) returned call, he was sent by ambulance to local hospital. Spent 6 hrs in ER, then admitted to a room (for 7 days) and then to nursing home. (Still There). Still unable to stand or walk. 02/21/07-records received and reviewed for DOS 10/24-10/30/06.C DX: acute pneumonia possibly secondary to aspiration although the patient is a poor historian. Leukocytosis with white count 30,000. Abdominal aortic aneurysm. Alzheimer's dementia. Presented with acute mental status change, leukocytosis, fever. Per information received from annual follow up has weakness. Patient had Alzheimers and hard to determine that contribution to problem with recovery. (Pt ultimately dides in NH).
Patient experienced some patches on upper and lower legs; COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4237019-00.  A 64 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 14Jan2021 (Batch/Lot number: unknown) as dose 1, single, administration date 31Jan2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 27Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 07Jan2022, outcome "recovering" and all described as "COVID-19"; SKIN DISORDER (non-serious) with onset 14Jan2022, outcome "not recovered", described as "Patient experienced some patches on upper and lower legs". The action taken for adalimumab was unknown. Clinical course: The patient experienced some patches on upper and lower legs and covid-19 with Humira (Adalimumab). It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Did event abate after stopping drug: NA. Concomitant drugs and dates of administration (exclude those used to treat event): Concomitant drugs not reported. Other relevant history: Not reported.  The reporter's causality for the event(s) with (HUMIRA) Adalimumab of 'some patches on upper and lower legs' was reasonable possibility and of 'covid-19' was no reasonable possibility.  The reporter's causality for the event(s) with PFIZER BIONTECH COVID-19 VACCINE of 'some patches on upper and lower legs' was not reported and of 'covid-19' was possible.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events  and suspect drug BNT162B2 cannot be excluded.
Information has been received from a nurse via a company representative, referring to an unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with the first dose of GARDASIL 9 (strength, dose, lot number, expiration date, anatomical location and administration route were not reported) for prophylaxis; and on unspecified dates more than 12 months after the first dose the patients received the second dose of GARDASIL 9 (strength, dose, lot number, expiration date, anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected because there was no consent to contact for follow-up. Sender's Comments: US-009507513-1702USA002433.
Excessive nose bleeding from both sides. Non-stop dripping 1+drops per second for 30 minutes +/-, 3-4 episodes per day for three days. Started from day 2 after second dose.; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 08Mar2021 at 16:45 and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 31Mar2021 at 16:45 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history included lower back pain and allergy to sulfonamide and pollens. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and multivitamins, all from unknown date for unknown indication taken within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021, the patient experienced excessive nose bleeding from both sides. The patient reported that it was non-stop dripping more than 1 drop per second for 30 minutes or so for 3-4 times per day for three days. This event started from day 2 after second dose. there was no irritation or any touching to trigger. The patient experienced one such episode after 1st dose and before 2nd dose and he had more than 10 episodes after the 2nd dose. No therapeutic measures were taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/ department or urgent care. The clinical outcome of the event nose bleeding was resolving at the time of the report.   No follow-up attempts are needed. No further information is expected.
Arm hurt badly about 10 hours after shot.  Felt super weak and tired too the whole day and the next day. A rash started on my neck and traveled down to my collar bone area by day 4
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 20220554543(0). A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization; Janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE INJURY (non-serious), outcome "unknown", described as "vaccine injury". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
"51 yo male reports that he received 1st dose of moderna covid vaccine injection on 2/11/2021 and he developed runny nose, fever, cold feelings and dizziness, headache and muscle ache/weakness. As of today, symptoms are on and off. Still experiencing pain to the left arm which is the injection site."
After second dose I have really bad headaches; Lips tingling/Tongue tingling; My eye starts drifting up or twitching when I try to chew,; Jaw pain; Have pain in my chest; Dysphasia; Can't eat food gets stuck; Tingling feet and hands; Burning in legs; Pain in neck and back; Pain in neck and back; Shortness of breath; Fatigue; Weakness in body; Stomach pain; Trouble sleeping; Brain fog; Dizziness; Depersonalization; Feels like spasms; Feels like whole in my chest; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 27-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 07May2021 08:00 (Batch/Lot number was not reported) as dose 2, single (age at vaccination 27-year-old) for covid-19 immunisation. Medical history included, known allergies: Codeine, cinnamon, latex from an unknown date. Concomitant medication(s) included probiotics (PROBIOTICS) taken for an unspecified indication, start and stop date were not reported. Historical vaccine information included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) 1st dose on 10Apr2021, administration site (right arm), administered at 10:00 AM (age at vaccination 27-year-old) for COVID-19 immunization experienced Leg pain, Fatigue and Weakness. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 12May2021 12:00, the patient experienced after second dose i have really bad headaches, lips tingling/tongue tingling, my eye starts drifting up or twitching when i try to chew, jaw pain, have pain in my chest, dysphasia, can't eat food gets stuck, tingling feet and hands, burning in legs, pain in neck and back, pain in neck and back, shortness of breath, fatigue, weakness in body, stomach pain, trouble sleeping, brain fog, dizziness, depersonalization, feels like spasms. The patient underwent lab tests and procedures which included sars-cov-2 test negative: negative on 04Jun2021. The patient not received treatment for events. The patient visited to emergency room visit/ physician's office for the events. The outcome for all events was not recovered.   Information about batch/lot number has been requested.
developed rashes, looked like "ring worm" rashes; dryness of mouth; This spontaneous case was reported by a consumer and describes the occurrence of RASH (developed rashes, looked like "ring worm" rashes) and DRY MOUTH (dryness of mouth) in a male 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (developed rashes, looked like "ring worm" rashes) and DRY MOUTH (dryness of mouth). At the time of the report, RASH (developed rashes, looked like "ring worm" rashes) and DRY MOUTH (dryness of mouth) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-103423, MOD21-086119, US-MODERNATX, INC.-MOD-2021-103531 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-103423: MOD21-086119: US-MODERNATX, INC.-MOD-2021-103531:
Pt recvd 3 doses of Engerix-B & was determined to be a non-responder;  both titer results were neg;
Pt. given hydrocortisone cream 1% and 25 mg BENADRYL PO. Rash, urticarial pruritus and patient has a round 5 cm in diameter red welt  left bicep with itching.
Patient started becoming feverish and had decrease in activity and appetite (mom did not have thermometer to take temp). Saturday am 11/12/05 Still feverish, decreased appetite and extreme decrease in activity. Seen in office temp 100.8 ax Rt arm swollen w/some tenderness no noted redness. Parents advised to contact in am unless becomes worse before then. Also told to increase fluids. Pt that evening had increase in temp per mom (no reading taken) and had a febrile seizure seen in ER.
Narrative:  60yr patient direct admit from hospital to ICU for COVID-19+ and lethargic. PMH:HTN, DM-II on lispro BID, MDD, hx of LLE DVT Hemorrhagic CVA x2 with baseline R hemiparesis and expressive aphasia, chronic G-J Tube, and recent R subdural hematoma. Per hospital lethargy was at baseline and arrived on RA satting at 100%, Patient stay in the ICU was 1 day (8/22 to 8/23), no oxygen requirements (100% on RA), no lab abnormalities noted, and no COVID medications including steroids were administered. Received 2 doses of Moderna (12/30/2020 and 1/27/2021) locally.
Patient was given the vaccine, she felt the sting very strong; itching; big welt at the vaccination site; swollen; red  spot; inflamed; sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Patient was given the vaccine, she felt the sting very strong), PRURITUS (itching), VACCINATION SITE RASH (big welt at the vaccination site), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE ERYTHEMA (red  spot) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 042B21A.) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included ASCORBIC ACID, CALCIUM CARBONATE (CALCIUM VITAMIN C [ASCORBIC ACID;CALCIUM CARBONATE]), ATORVASTATIN, fluxetine and VITAMIN D3 for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 19-Apr-2021, the patient experienced VACCINATION SITE PAIN (Patient was given the vaccine, she felt the sting very strong), PRURITUS (itching), VACCINATION SITE RASH (big welt at the vaccination site), VACCINATION SITE SWELLING (swollen), VACCINATION SITE ERYTHEMA (red  spot), VACCINATION SITE PAIN (inflamed) and MYALGIA (sore). At the time of the report, VACCINATION SITE PAIN (Patient was given the vaccine, she felt the sting very strong), PRURITUS (itching), VACCINATION SITE RASH (big welt at the vaccination site), VACCINATION SITE SWELLING (swollen), VACCINATION SITE ERYTHEMA (red  spot), VACCINATION SITE PAIN (inflamed) and MYALGIA (sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Consent given. They preferred to be contacted by telephone.   This case was linked to MOD21-079205 (E2B Linked Report).; Sender's Comments:  MOD21-079205:husband
headaches; resting heart rate is 106; nauseous; low grade fever; A spontaneous report was received from a consumer concerning a Drug Start Date-1963-1-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Headache, Heart rate increased ( resting heart rate is 106), Nausea (nauseous) and Pyrexia (lowgrade fever).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 043L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On unknown date, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 030M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced Low grade fever, Nauseous, Headaches and Resting heart rate is 106.  Treatment details included Excedrin PM.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was unknown.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Additional Details: Pt was sitting for observation after vaccine and fainted. She fell off the chair onto the floor. when she regained consciousness she was light headed and remained on the floor for 5 min. After that the pharmacist moverd her to immunication room for additional observation and gave her some water. She left after another 5 min. The Mom did not want an ambulance called.
I just want to report that I felt some pretty bad symptoms from the first shot:    First 24 hours:  Bad headache from 10am-8pm day of dose #1  Fatigue  Body aches  Cold sweats / fever during night  Fast HR (almost 100 bpm resting HR at 2am)  Shortness of breath    48 hours:  Fatigue  Body aches  Periodic headaches