chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headaches; Mild dull achy tenderness; Irregular heartbeat; Tingling of their extremities (wrists, hands, feets, chest); Heat on theirhttps://ilssafety1f.quintiles.com/img/tabs/tab_left_move.gif extremities; Inflammation on the extremities; Normal swelling; redness; Pain; A spontaneous report was received from a consumer concerning a female patient of 69-years-old, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events normal swelling, redness, pain, mild dull achy tenderness, tingling of their extremities (wrists, hands, feets, chest)/Paraesthesia, irregular heartbeat/palpitations, heat on their extremities/burning sensation of skin, inflammation on the extremities, headaches.  The patient's medical history was not provided. Concomitant medications reported were Depakote for PTSD, acid reflux medicine, blood pressure medication,used for unknown indication.  On 26 Feb 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (lot/batch: 025A21A)vaccine via unknown route for prophylaxis of COVID-19 infection.  On 26 Feb 2021,evening of the vaccination day, the patient had normal swelling and redness and pain for 2 and a half days,   On 27 Feb 2021,Within the first 24 hrs patient had tingling of the extremities (wrists, hands, feets, chest) along with an irregular heartbeat and it took a day to go away. Had heat and inflammation along with the pain on the extremities. This heat and inflammation lasted longer than the pain. Had the injection on the left side but all of this happened also in their right side. Had headaches too.  On 01 Mar 2021, the patient had a mild dull achy tenderness. The patient had it on a Friday afternoon and by Monday morning it was just mild.  Before getting the vaccine they tested borderline negative for rheumatoid factor (because their mother has it).the event irregular heart beat was also considered to be medically significant.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.   The events tingling of their extremities (wrists, hands, feets, chest) and irregular heart beat were considered resolved on 28 Feb 2021.  The events normal swelling,redness,pain were considered resolved on 01 Mar 2021.  The outcome of the events mild dull achy tenderness, heat on their extremities, inflammation on the extremities and headache was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
after pt recv vax developed swelling, redness, warmth & pain at inject site within 24 hrs. seen by m.d. & treated with tylenol & ice.
Patient was a participant at the Olympics and arrived at our community clinic located at the event. Patient stated he wanted a COVID vaccine, he was able to answer all questions, i.e. address, DOB, and medical screening questions. Patient consented to being vaccinated. The nurse vaccinated the patient. Thirty minutes later a very upset parent arrived and stated the patient was not his own guardian and should not have received a vaccine without the guardians consent.
red skin under bandage; patient said she is reacting to bandage, not the vaccine. she said she has a latex allergy
hives uncomfortable specially when it is swollen and appears randomly at random parts of the body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives uncomfortable specially when it is swollen and appears randomly at random parts of the body) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Fruit allergy (Kiwi), Allergy to nuts and Bee sting hypersensitivity.    On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives uncomfortable specially when it is swollen and appears randomly at random parts of the body). The patient was treated with EPINEPHRINE (EPIPEN) for Swollen tongue, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives uncomfortable specially when it is swollen and appears randomly at random parts of the body) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Allergy test: positive (Positive) An allergy test will be done once she weans from the antihistamine..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products included Liver support pills and Collagen powder drink Patient tried to stop taking the vaccine 2 days ago but this flared up her side effects.   This case was linked to MOD-2021-317631 (Patient Link).
Pt received second JEV around 09:00 on 2/16/01 and later on that morning, she developed a headache and nausea. Approx. 8 hours later, she noticed swollen feet, eyes, hands and whole body. 3rd dose not given secondary to above reaction.
On Friday 10/16/09 within 10 minutes of getting intranasal vax. pt. developed a headache which lasted a "couple of days"  On Sunday 10/18 she found a dried blood crust in her nose.  On Mon. 10/19 She began having intermittent dropping nose bleeds which ended on Wed 10/21.  No pain right after - vax - no bad taste.  Denied ever having nose bleed before.  Denied sinus problems.  This event was first reported by pt. on 10/10 follow up call to pt 10/27.  Call returned by pt on 11/5/09.  Details obtained.
We opened bottle of Moderna Covid-19 vaccine yesterday (06Jun2022)and gave 1 shot; We opened bottle of Moderna Covid-19 vaccine yesterday (06Jun2022) & gave 1 shot at 10:20a. We gave 1 shot this morning.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We opened bottle of Moderna Covid-19 vaccine yesterday (06Jun2022) & gave 1 shot at 10:20a. We gave 1 shot this morning.) and PRODUCT STORAGE ERROR (We opened bottle of Moderna Covid-19 vaccine yesterday (06Jun2022)and gave 1 shot) in an 89-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jun-2022 at 10:20 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jun-2022 at 10:20 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (We opened bottle of Moderna Covid-19 vaccine yesterday (06Jun2022) & gave 1 shot at 10:20a. We gave 1 shot this morning.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (We opened bottle of Moderna Covid-19 vaccine yesterday (06Jun2022)and gave 1 shot). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We opened bottle of Moderna Covid-19 vaccine yesterday (06Jun2022) & gave 1 shot at 10:20a. We gave 1 shot this morning.) and PRODUCT STORAGE ERROR (We opened bottle of Moderna Covid-19 vaccine yesterday (06Jun2022)and gave 1 shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. It was unknown if patient had the ever been diagnosed with Covid-19. It was unknown if patient had acute illness at the time of vaccination as well as unknown  for chronic health conditions. It was unknown if patient experienced similar adverse event in the past. Treatment information was not provided.   This case was linked to MOD-2022-584257 (Patient Link).
FLUZONE QUAD was given in the tricep area instead of deltoid area with no AE; Initial information received on 02-Nov-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown demographic patient whom fluzone quad was given in the tricep area instead of deltoid area (product administered at inappropriate site), while the patient received vaccine influenza quadrival a-b vaccine [Fluzone quadrivalent].  Medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was unknown.  On an unknown date, the patient started to receive influenza quadrival a-b vaccine (with an unknown formulation, strength, dose, frequency, route, lot number and expiration date) for prophylactic vaccination.  On an unknown date, (latency unknown) after the initiation of suspect drug therapy, the patients fluzone quad was given in the tricep area instead of deltoid area (product administered at inappropriate site).  No laboratory tests were reported.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Case number PHEH2012US014996 is an initial spontaneous report received from a nurse on 30 Jul 2012. This case refers to two patients (patient identifiers not reported). These patients were vaccinated with MENVEO (batch number: M10126A) intramuscularly on unspecified dates between Jun 2012 and Jul 2012. It was reported that these patients were administered only MenCYW liquid conjugate component, instead of being reconstituted with MenA component of MENVEO. No adverse event had occurred since vaccination.
Temporal lobe epilepsy; I developed focal seizures; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2021 at 13:00 as dose 2, single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing), notes: High BP; "high cholesterol" (unspecified if ongoing), notes: high cholesterol; "hemochromatosis" (unspecified if ongoing), notes: hemochromatosis; "prediabetic" (unspecified if ongoing), notes: pre-diabetic. The patient's concomitant medications were not reported. Past drug history included: Known allergies: lisinopril, reaction(s): "Drug allergy", notes: Known allergies: Lisinopril. Vaccination history included: BNT162b2 (Dose 1, Lot no:  Er8733, Administration time: 13:00, Vaccine location:Left arm), administration date: 28Mar2021, when the patient was 36-year-old, for Covid-19 immunization. The following information was reported: PARTIAL SEIZURES (medically significant) with onset 01Mar2022, outcome "not recovered", described as "I developed focal seizures"; TEMPORAL LOBE EPILEPSY (medically significant) with onset 01Mar2022, outcome "not recovered". The events "temporal lobe epilepsy" and "i developed focal seizures" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of temporal lobe epilepsy, partial seizures. Clinical course: Facility type vaccine: Public Health Clinic/ Administration facility. No other vaccine in four weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; 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 the reported event PARTIAL SEIZURES, TEMPORAL LOBE EPILEPSY Cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Soreness at injection site Red, bumpy rash on chest, breast, stomach, sides, both legs front and back ( treated with Benadryl and hydrocortisone cream, after  8 days called back to dr and she prescribed triamcinolone acetonide cream because still itching badly)
This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 27Mar2021 (Batch/Lot Number: EN6207) as single dose for COVID-19 immunisation. Medical history included arthritis (He has had arthritis for maybe 10 years. He walked three times a week, and it seemed to improve it by walking or stretching. It especially helped the muscle part of it. His muscles get stiff. When he got up in the morning, it was very difficult moving. Right now, it was not as bad as at first. At first, he couldn't even sit on the toilet seat because it was so painful). Concomitant medication included steroids for arthritis. Historical vaccine included 1st dose of BNT162B2 (lot number: EN6198) on 06Mar2021 for COVID-19 immunisation and experienced chest pain. Ten days after his second dose of the Pfizer COVID vaccine (06Apr2021). He got pain like freight train that affected in his joints, muscles, hips, and pelvis. He even had pain in his hamstring. Also, the upper arm muscles hurt too.
First started feeling fatigued initially. Had severe headache and chills for about 30 hours after vaccination. Took Tylenol starting at 10P on 03/30/2021 every 4-6 hours and last took Tylenol evening on 03/31/2021. No symptoms since.
COVID-19 infection with pneumonia: Present on admission.  Patient was treated with remdesivir and convalescent plasma.
This spontaneous report as received from a physician refers to an unknown number of patients. The physician reported that improperly stored RECOMBIVAX HB might have been administered to an unknown number of patients for vaccination. Administration date and lot# was unspecified. No adverse event reported. Additional information has been requested.
First shot no problem just sore arm. 2nd shot extremely painful injection, then approx. 11:45 p.m. woke up with severe pain, tried to move right arm, could not raise arm had to use left to assist raising of arm, most comfortable when bent had elbow after left arm assisted with this, pain remained better slightly next day, then severe and lack of range of motion x 2 days, then  on 3/8/21 4days after injection could use arm but was limited pain remained but improved could raise arm with minor difficulty . Left VM for the nurse that i know at the health dept. on 3/8/21 sent email to the nurse at health dept. on 3/12/21 no response as yet...just felt this should be reported, i think the injection was too high and injected into my acromial process & could possibly cause permanent damage in the future, wanted to report as felt perhaps the administrator of the 2nd shot should have technique reviewed to prevent this from happening to someone else...my major concern.
pt recvd vax;devel few spots 2 days p/ vax;f/u:20sep95 devel chicken pox & recovered;
This is an 86-year-old white male with past medical history of diabetes insert fibrillation, hypothyroidism CKD coronary artery disease status post bypass who was brought in from Home where he had been staying since he had the hip surgery in July. Patient is not able to provide much of the history hence it is obtained from the brother over phone and ER staff. Patient brought in for altered mentation and hypoxia 87 percent to ER. Patient found to be covid positive, ct scan revealed pneumonia.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients' of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On unknown date, the patients were vaccinated with improperly stored doses of PEDVAXHIB injection (exact dose, route of administration, lot number and expiry date were not reported). There were no concomitant therapies reported. The administered doses of the vaccine were exposed to a temperature between 32 degrees Fahrenheit to 35 degrees Fahrenheit (35 degrees Fahrenheit) on an unspecified date, for a time frame of 6 hours. A digital data logger was not involved. There were no previous temperature excursions. No adverse experiences were reported. There was no product quality complaint involved.
Received 5 immunizations.  After receiving last immunization c/o not feeling well, passed out + hit head on floor.
Got Covid; Got Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 79-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 as dose 5 (booster), single (Lot number: GJ6796) at the age of 78 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL3302), in left arm, on 16Feb2021 as dose 2, single (Lot number: EN5318), in left arm, on 08Sep2021 as dose 3 (booster), single (Lot number: 30130BA), in left arm and on 21May2022 as dose 4 (booster), single (Lot number: FM9992), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Got Covid". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 128; 153; 149/56. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient got 5 of the Pfizer shots for Covid. She got Covid after being on a plane while out of town and was prescribed Paxlovid on Apr2023.
About 5-6 days after the vaccine, neuralgia around my rib cage mirroring that of shingles (which I have previously had in the same place) became active. No rash or outbreak, but the neuralgia was present, with burning and pain for a couple days. It subsided, then returned a week later and has remained painful for 4 days.
tinnitus; They make me nervous everyday; I can't live like normal/Im not gonna live a normal life like before this vaccine; I can't focus; I did the third shot/I did the vaccine July; I did the third shot/I did the vaccine July; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 40 year-old female patient received bnt162b2 (COMIRNATY), administration date Jul2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), for Covid-19 Immunization; Bnt162b2 (dose:2), for Covid-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset Jul2021, outcome "unknown" and all described as "I did the third shot/I did the vaccine July"; TINNITUS (non-serious), outcome "unknown", described as "tinnitus"; NERVOUSNESS (non-serious), outcome "unknown", described as "They make me nervous everyday"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "I can't live like normal/Im not gonna live a normal life like before this vaccine"; DISTURBANCE IN ATTENTION (non-serious), outcome "unknown", described as "I can't focus".  Additional information: Patient was visited neurology doctor, so he's pretty sure he checked her up her hearing everything. he said, you don't have nothing. but this reaction comes the next day when she did the third shot." Doctor gave her some 3 kind of medication. And she was doing it for a healthy life. Caller added, "that was come from the vaccine. she never heard before this problem. Her husband has the same problem. The last step today is MRI. But my neurologist professor, he's pretty sure that my brain is ok but I don't see get out, the last step is MRI. Patient was feeling sorry she did this vaccine and she would not recommend it to nobody okay. Because you see some people got the vaccine they could be disabled. So this noise could not disappear for life. If the people get disabled with the vaccine they never get back the normal life.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (21Dec2021). Follow-up attempts have been completed and no further information is expected.
Radial nerve damage to left arm and hand; This is a spontaneous report from a contactable healthcare professional (patient). A non-pregnant 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0158), via an unspecified route of administration in left arm, on an unspecified date, as second dose, single, for COVID-19 immunization. The patient's medical history included diabetes, irritable bowel syndrome (IBS), high cholesterol, and allergies to sulfur or sulfa. The patient had unspecified concomitant medications. The patient previously took the first dose of BNT162B2 (Lot Number: EN6208) in Mar2021 (reported as 22Mar2021; pending clarification) at the age of 48 years for COVID-19 immunization (left arm). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The most recent COVID-19 vaccine was administered in a public health clinic or Veterans administration facility. On 08Apr2021, the patient experienced radial nerve damage to left arm and hand and was hospitalized in 2021 for 3 days; event caused disability. The adverse event resulted in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the event.; Sender's Comments: Based on limited information and temporal association a contributory role of  BNT162B2  to the reported radial nerve damage  cannot be totally  excluded.  Case will be reassessed if additional information is received.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Local reaction on the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Local reaction on the arm) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, LEVOTHYROXINE, PROPRANOLOL HYDROCHLORIDE (PROPRANOLOL [PROPRANOLOL HYDROCHLORIDE]), MORNIFLUMATE (FLOMAX [MORNIFLUMATE]), LORAZEPAM (ATIVAN) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE REACTION (Local reaction on the arm). At the time of the report, VACCINATION SITE REACTION (Local reaction on the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment details were reported.   This case was linked to MOD-2021-354362 (Patient Link).