chrisvoncsefalvay/vaers-outcomes huggingface dataset:
loss of appetite; loss of appetite; Chills; body aches; Nausea; Fatigue; This is a spontaneous report received from a contactable consumer or other non hcp. A 54-years-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Batch/Lot Number: EL9265; Expiration Date: May2021), via an unspecified route of administration, administered in Arm Left on 31Jan2021 11:30 ,at the age of 54 years old,as dose 1, single for an unspecified indication. Medical history included blood cholesterol, migraine, dyspepsia and hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin, pantoprazole; fluticasone propionate (FLONASE ALLERGY RELIEF); and azelastine hydrochloride taken for hypersensitivity, start and stop date were not reported.The patient experienced chills, body aches, nausea and fatigue on 02Feb2021 and loss of appetite on 09Feb2021.The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 03Feb2021 and sars-cov-2 test: negative on 05Feb2021.The outcome of the event chills was Not recovered,body aches was recovering,nausea was not recovered,fatigue was recovering,and loss of appetite outcome was not recovering.The patient stated that she has been trying not to take any pain relievers because she read it could impact the effectiveness of the vaccine. However she did take ibuprofen on 04Feb2020 and the 05Feb2020 and did get some relief.The patient prior vaccination within 4 weeks included -DAP 21Dec2020; no product information to provide NDC, lot or expiration date; received at her primary care office.The patient family history included son was positive for COVID 19 02Feb2021.The patient was scheduled to receive her 2nd dose of Pfizer covid19 vaccine on 21Feb2021,but she was confused whether to get the second dose on that date or not.  Follow-up (10Feb2021): This is a follow-up spontaneous report received from a contactable Consumer. This 54-year-old Consumer reported loss of appetite was reported as worsened.Additional Information for Concomitant Products vitamin compound: Product is compounded and contains methyl B 12; Riboflavin; Co Q 10; Magnesium and B3.The adverse event didn't result in patient visit to emergency room.History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none.Vaccination Facility was reported to be education center.  Follow-up attempts are completed. No further information is expected.
she tested positive 5 days after taking the first COVID19 Vaccine dose; she tested positive 5 days after taking the first COVID19 Vaccine dose; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient tested positive 5 days after taking the first COVID-19 vaccine dose. Outcome of the events was unknown.  Information about lot/batch number has been requested.
leg pain; he has symptoms of Covid 19; Eyes are runny; pain throughout his body; eyes and ears bother him the most; eyes and ears bother him the most; Brain fog couple of times; chills; diziness; head itches; Stayed home; got hot, but not a fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (leg pain), SUSPECTED COVID-19 (he has symptoms of Covid 19), LACRIMATION INCREASED (Eyes are runny), PAIN (pain throughout his body) and EAR PAIN (eyes and ears bother him the most) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Flu shot. Past adverse reactions to the above products included Adverse drug reaction NOS with Flu shot. Concurrent medical conditions included Dyspepsia, Allergic reaction to antibiotics (Tetracycline) and Allergy to chemicals (sulfur). Concomitant products included FAMOTIDINE for Heartburn, VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced FEELING HOT (got hot, but not a fever) and IMPAIRED WORK ABILITY (Stayed home). On 07-Apr-2021, the patient experienced DIZZINESS (diziness) and PRURITUS (head itches). On an unknown date, the patient experienced PAIN IN EXTREMITY (leg pain), SUSPECTED COVID-19 (he has symptoms of Covid 19), LACRIMATION INCREASED (Eyes are runny), PAIN (pain throughout his body), EAR PAIN (eyes and ears bother him the most), EYE PAIN (eyes and ears bother him the most), FEELING ABNORMAL (Brain fog couple of times) and CHILLS (chills). At the time of the report, PAIN IN EXTREMITY (leg pain), SUSPECTED COVID-19 (he has symptoms of Covid 19), LACRIMATION INCREASED (Eyes are runny), PAIN (pain throughout his body), EAR PAIN (eyes and ears bother him the most), EYE PAIN (eyes and ears bother him the most), FEELING HOT (got hot, but not a fever), DIZZINESS (diziness), FEELING ABNORMAL (Brain fog couple of times), PRURITUS (head itches), IMPAIRED WORK ABILITY (Stayed home) and CHILLS (chills) outcome was unknown. Not Provided          No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to MOD-2021-071229 (Patient Link).
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In March 2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at physician's office (by an unspecified healthcare professional) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 09-JUL-2016, the patient was treated (by an unspecified health care professional) at a hospital for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
positive for covid; positive for covid; This is a spontaneous report from a contactable nurse (patient) via a Pfizer-sponsored program Pfizer First Connect. A 61-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at left arm, intramuscular on 31Dec2020 at 0.25 mL, single for preventative. Time the Vaccination was Given between 7:30 to 08:00 am. Medical history was none. There were no concomitant medications. The patient took the first dose of the covid vaccine on 31Dec2020. She took a rapid test on Tuesday 12Jan2021 and found out she was positive for covid, she did not know the name of the test specifically. She stated she was lucky that she had mild covid symptoms. The outcome of event was unknown.  No Follow Up attempts are Possible; Information on Lot/Batch Number cannot be obtained.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Tingling in fingertips, same side that I received my Covid vaccine. Had my shot at 9:30am and started feeling the tingling around 11:50pm that day. It lasted about 40 minutes but my hand still felt weak. Went to the ER and the doctor said it was likely due to inflammation of the injection site compressing on my nerves.  Had a low grade fever of 99.4°F and body aches.
Flushing of the face began five minutes post  2nd vaccination dose. His vitals were within normal limits. He was brought to the medical evaluation area and monitored for over 30 mins with no further incident. He denies any SOB, chest pain, dizziness, numbness or tingling of the tongue. Wife at bedside. Refused to be transported to nearby ER for further evaluation. Patient requested to follow up with PCP.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On an unspecified date in 2014 (reported as "vaccinations occurred between 13-OCT-2014 and 17-NOV-2014"), an unspecified number of patients received (Merck) VARIVAX (doses, routes of administration, lot # and expiration dates were not reported) stored at 8F for 3 hours. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient completed two shot series of Moderna COVID-19 vaccine 10 Feb and 10 March and tested positive for COVID-19 30 April.
After administration of vaccinations, it was found that patient received 2 doses of Gardasil.
Localized redness, warmth, tenderness, and "burning sensation" at injection site.
PATIENT RECEIVED FIRST DOSE COVID-19 MODERNA VACCINE ON 04/21/2021, THEN SUBSEQUENTLY RECEIVED A SECOND DOSE COVID-19 MODERNA VACCINE 7 DAYS LATER ON 04/29/2021. NO KNOWN ADVERSE REACTION TO THE PATIENT OCCURED.
pt developed shingles after receipt of both doses of Shingrix / Suspected Vaccination failure; Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional Information: GSK Receipt Date: 06-July-2022 Reporter's Comments: The reporter knew of one patient who had developed shingles after receipt of both doses of Shingrix. The reporter did not consent to follow-up. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation for shingles were unknown at the time of reporting. This case was linked with case US2022103217, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022103217:Same reporter
Patient received a second influenza vaccine on this date. Patient received influenza vaccine prior to today at her place of employment.
Myocarditis; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Myocarditis) in a 31-year-old male patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant). The patient was treated with METOPROLOL for Myocarditis, at an unspecified dose and frequency. At the time of the report, MYOCARDITIS (Myocarditis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, C-reactive protein: negative (Negative) Negative. On an unknown date, Echocardiogram: abnormal (abnormal) revealed an ejection fraction of 55% with no wall motion abnormalities.. On an unknown date, Ejection fraction: 55 percent 55 percent with no wall motion abnormalities. On an unknown date, Electrocardiogram: normal (normal) Normal. On an unknown date, Magnetic resonance imaging heart: abnormal (abnormal) showed an area of myocardial hyper-enhancement in the apical anterior segment suggesting the diagnosis of myocarditis. On an unknown date, Red blood cell sedimentation rate: negative (Negative) Negative. On an unknown date, Troponin: 1.7 (High) 1.7 Elevated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDITIS (Myocarditis) to be related.    No concomitant medications were reported.  The symptoms included burning chest pain associated with orthopnea and paroxysmal nocturnal dyspnea. Patient was discharged with Metoprolol and was instructed to refrain from strenuous exercise. Patient was seen outpatient, and endorsed to still experience intermittent burning substernal chest pain.  Company comment: This is a literature case concerning a 31-year-old male patient with no medical history reported, who experienced the expected serious AESI of Myocarditis two days after the second dose of mRNA-1273 vaccine. The patient was hospitalized and the diagnosis was established by cardiac magnetic resonance imaging. The outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a literature case concerning a 31-year-old male patient with no medical history reported, who experienced the expected serious AESI of Myocarditis two days after the second dose of mRNA-1273 vaccine. The patient was hospitalized and the diagnosis was established by cardiac magnetic resonance imaging. The outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
24 hours post immunization DTaP and IPV, left deltoid pt developed 2 x 4cm indurated area. No ROM limitation, good peripheral circulation. Possibly early cellulitis. Leaving for vacation. Will treat with Cefzil 250 mg/5ml 1 1/2 tsp bid for 7 days. OV or seek attention if not better.
Bivalent vaccines stored in freezer because thermometer was not a Digital data logger and not able to upload temperatures; Bivalent vaccines stored in freezer because thermometer was not a Digital data logger and not able to upload temperatures; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Bivalent vaccines stored in freezer because thermometer was not a Digital data logger and not able to upload temperatures), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Bivalent vaccines stored in freezer because thermometer was not a Digital data logger and not able to upload temperatures) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 053022A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Bivalent vaccines stored in freezer because thermometer was not a Digital data logger and not able to upload temperatures), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Bivalent vaccines stored in freezer because thermometer was not a Digital data logger and not able to upload temperatures) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT STORAGE ERROR (Bivalent vaccines stored in freezer because thermometer was not a Digital data logger and not able to upload temperatures), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Bivalent vaccines stored in freezer because thermometer was not a Digital data logger and not able to upload temperatures) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (Bivalent vaccines stored in freezer because thermometer was not a Digital data logger and not able to upload temperatures) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Bivalent vaccines stored in freezer because thermometer was not a Digital data logger and not able to upload temperatures).    No concomitant medications were reported. HCP stated that the vaccines were stored in the freezer, they keep a log of temperatures morning and evening, have had no prior or current temperature excursions, no alarm and no power outages. Treatment information was not provided.  This case contains information for the 13 of 20 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-687867 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-687867:Master
The patient is a 19-year-old female who presents for an allergic reaction s/p receiving her 1st COVID vaccination at 1640 today. About 15 minutes later, the patient developed a tingling sensation in her tongue, tight scratchy throat, and swelling in her upper lip. She denies any rash or shortness of breath. She denies having any drug allergies, but does note an allergy to macadamia nut in the past. She denies taking any anti-histamines or epinephrine prior to arrival. She reports a history of ADHD and took 30 mg of Vyvanse, which typically causes her heart rate to elevate in the low 100s. LNMP: 3-4 weeks ago. She denies any chance of pregnancy.
This spontaneous report as received from a nurse. She states that doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients. The patients were vaccinated with MMR II. Other suspect therapies included ROTATEQ. No concomitant medications were reported. On an unknown date the patient experienced doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients. No treatment information was reported. Doses of MMR II and ROTATEQ that were exposed to 50 F for 48 hours were administered to patients is not related to MMR II and ROTATEQ. At the time of the call, she does not known who received the doses of improperly stored vaccine, but she would like to know if they should be revaccinated. She will call to provide the details when she is able to retrieve the information. SR # provided. It is not known at this time if there have been any adverse effects. Rotavirus vaccine Date given 03Nov2012. Medical records # 140652. Lot # 0057AE. Additional information has been requested.
left side has been hurting; This case was reported by a consumer via other manufacturer and described the occurrence of pain in a 60-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included sarilumab (Kevzara) for product used for unknown indication.   Concurrent medical conditions included peripheral swelling and feeling hot.   On 16th February 2022, the patient received Boostrix. On an unknown date, the patient started Kevzara at an unknown dose and frequency. On an unknown date, less than 2 months after receiving Boostrix, the patient experienced pain. The action taken with Kevzara was unknown. On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Boostrix.     Additional Information: GSK Receipt Date: 7-APR-2022 Reporter's Comment: 07-APR-2022. The patient self-reported this case. The patient developed fishhook got stuck in the heel of her foot, she then had swelling of her leg and heat started coming up her leg (feeling hot, peripheral swelling) (unknown latency) following the first dose intake of Kevzara. Since receiving Boostrix, her entire left side has been hurting following the first dose intake of Kevzara and Boostrix. The reporter asked if there was any problem with taking Kevzara dose on 23rd February 2022 when she had to have a tetanus shot this past Wednesday? The caller takes KEVZARA, as prescribed by her rheumatologist. She stepped on a fish hook in the parking lot of her condominiums. The fish hook got stuck in the heel of her foot. She then had swelling of her leg and "heat started coming up" her leg. She had to get a tetanus shot due to the fish hook on Wednesday (16Feb2022). She checked her paperwork and reports that she received Boostrix. She mentioned that since receiving Boostrix, her entire left side has been hurting. She was due for her Kevzara dose 23rd February 2022. No further information provided by the reporter. It was not reported if the patient received a corrective treatment for the events (fishhook got stuck in the heel of her foot, she then had swelling of her leg and heat started coming up her leg, fishhook got stuck in the heel of her foot, she then had swelling of her leg and heat started coming up her leg, since receiving Boostrix, her entire left side has been hurting). At time of reporting, the outcome was not recovered for peripheral swelling, feeling hot and pain. It was unknown if the reporter considered the pain to be related to Kevzera.
Within 2 hours of vaccine - numbness of pt hand, arm. On 8-15-08 by exam - glove numbness of rt hand, not of arm. Good color, movement of arm/hand. 3 cm warm redness of rt arm at vzv site.
States three weeks later on 4/23/2021 at 7pm radiating pain began from right shoulder to just above right elbow, severe pain, weakness, periods of paralysis. Self treated with plant based steroids and began to improve 5/1/2021.  States on 5/4/2021 pain back up to shoulder, milder pain, still sore today, 5/7/2021.  Has not and does not plan to see doctor for pain or discomfort.  Receiving #2 Moderna COVID-19 vaccine today.
Patient awoke in the middle of the night with fever, headache,  "thrashing around",  and felt very ill.   Patient took Excedrin for the headache.  Reaction was resolved by the time the patient woke up the next morning.   ***This was second vaccine in series. Patient reports she did NOT have reaction to first vaccine***
Approximately 2 hours after vaccines administered patient complained of being dizzy and light-headed. Over next 30 min. pt. was asleep and 'twitching', long deep breathing. Went to ER. Was told reaction from vaccine. Patient discharged around midnight.
Low-grade fever, persistent exhaustion, generalized aches esp. joints, cough; called and spoke with ARNP who said to come in if symptoms worsened, which they didn't. No treatment received.
Heavy sweating: immediately for 3 days, sporadically for 3 months. Spontaneous sweat returned with booster but not as dramatically Fever: first two days Fatigue: for about 10 days after the shot Elevated heart rate: for approximately the first three days after shot