chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received my Influenza vaccine at work on 9/21/09 (free to employees at Cafeteria through Employee Health Services).Had nothing but mild arm pain until 8 days later, when  I woke up with severe neck and ear pain (on same side as injection. On 9/30, I felt extreme fatigue, headache and continued increase in pain in area noted above. On 10/1, went to PCP, who noted blister like sores behind my ear and in my scalp. She diagnosed me with shingles. The blisters have now progressed to the entire back of the left side of my scalp, my neck, my ear and my cheek. I was RX'd Valtrex, Levaquin for cellulitis prophylaxis and pain medication. I am now on D4 of these meds and continue to have new eruptions. I am an otherwise healthy 53 year old with no immune deficiencies. I will not be allowed to return to work untl my blisters have stopped erupting and have begun to dry.If they begin to erupt near my left eye, I will be hospitalized in order to prevent serious eye damage/blindness.
Pfizer\BioNTech vaccine incorrectly diluted. It was only diluted with 0.8mL of Sodium Chloride instead of 1.8mL Sodium Chloride. Pt given dose of the incorrectly diluted vaccine. After waiting her 15 mins post vaccine she did not have any adverse reaction.
pt admit w/inc liver size, elevated liver enzymes, PT/PTT; by hx , pt had recv 1st two hep B vax; hep B core antibody + p/numerous screening labs; increased liver enzymes; increased PT/PTT
Redness, firm lump size of quarter to 1/2 dollar at site of injection.
Headache, fever/chills x day 3 of dose, pain at site x day 4, headache, fatigue, swollen glands x day 5 of dose. Narrative:
LEFT FOOT BECAME ITCHY; FLUID FILLED SPOT ON LEFT FOOT; LEFT FOOT BECAME WARM; LEFT FOOT TINGLY WHEN WALKS; FEELS LIKE DISSIPATING; This spontaneous report received from a patient concerned a 35 year old female. 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: 1855194, and expiry: 09-APR-2022) dose was not reported, administered on 17-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-NOV-2021, the patient experienced left foot became itchy. On 19-NOV-2021, the patient experienced fluid filled spot on left foot. On 19-NOV-2021, the patient experienced left foot became warm. On 19-NOV-2021, the patient experienced left foot tingly when walks. On 19-NOV-2021, the patient experienced feels like dissipating. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left foot became itchy, fluid filled spot on left foot, left foot tingly when walks, left foot became warm, and feels like dissipating. This report was non-serious.
Information has been received from a physician concerning 4 year old male who on 18-MAY-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (lot # 656394/0162U) instead of Varivax (Oka/Merck). The physician reported that the practice ordered Varivax (Oka/Merck) and Zostavax (Oka/Merck) was sent by the pharmacy. The vaccine was put in the freezer where Varivax (Oka/Merck) is normally kept and the medical assistant administered the vaccine assuming it was Varivax (Oka/Merck). The medical assistants will now be double checking all medications prior to administration. As of 07-JUN-2007 the patient was fine, there was no fever or rash. There was no product quality complaint involved. This is one of several reports from the same reporter. Additional information has been requested.
Lupus anticoagulant positive/Tested positive to Lupus; This spontaneous case was reported by a consumer and describes the occurrence of ANTIPHOSPHOLIPID ANTIBODIES POSITIVE (Lupus anticoagulant positive/Tested positive to Lupus) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On an unknown date, the patient experienced ANTIPHOSPHOLIPID ANTIBODIES POSITIVE (Lupus anticoagulant positive/Tested positive to Lupus). At the time of the report, ANTIPHOSPHOLIPID ANTIBODIES POSITIVE (Lupus anticoagulant positive/Tested positive to Lupus) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antiphospholipid antibodies: positive (Positive) Positive.         No concomitant medication was provided by the reporter No treatment medication was provided by the reporter.
This spontaneous report was received from a pharmacist and refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or concurrent conditions were reported. The pharmacist reported that multiple unknown patients were vaccinated on multiple unknown dates with improperly stored VARIVAX lot number M006157, expiration date 05-FEB-2018, lot number M003439, expiration date 19-JAN-2018 and lot number M010483, expiration date 01-FEB-2018, (dose, route and frequency not reported). No adverse effects were reported. The pharmacist reported that the temperature of the excursion was -14.4 C, and that the time frame was 12 hours and 15 minutes. There were no previous temperature excursions and the report was because of a data logger. No product quality complaint was reported. Lot numbers M006157, M003439 and M010483 have been verified to be valid lot numbers for VARIVAX. This is one of several reports from the same reporter. Additional information has been requested.
Unknown amount of 19 year old patients may have received adult doses; Unknown amount of 19 year old patients may have received adult doses; This case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in an unspecified number of patients who received HBV (Engerix B adult) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B adult and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The number of patients of 19 year of age received adult doses of Engerix-B, which led to adult product administered to child and overdose. The health care professional was not in the office at the time of repot and did not have any patient information. The reporter consented to follow up.
JANSSEN LOT# 202A21A SITE OCC ON 6/16/21
Information has been received from a registered nurse concerning an 11 year old male patient who on 11-JUN-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). The nurse reported that the patient received ZOSTAVAX instead of VARIVAX (Oka/Merck). There was no product confusion discovered, just a nurse error. No adverse event reported. Additional information has been requested.
Systemic: Allergic: Rash Generalized-Mild, Systemic: Dizziness / Lightheadness-Mild
10/03/05 flu left arm and pneumonia right arm shots at drug store clinic. By supper time both arms were terribly sore. The pneumonia arm was warm and achy in addition. It throbbed and itched all night and all the following day. I had aches with pains all over by body and I was either burning hot or so cold I shook all night long. There was no sleep. The next day I slept a little from time to time and took pain meds (Esgic plus). Rubbed the itching arm with Solorcaine ointment, stayed in bed and suffered. My bowels were runny and I felt lousy. I had a dry cough and a runny nose. It was hard to lift the pneumonia arm until Thursday when it finally eased up. It really felt like I had some type of flu, I had never had a reaction from either type of shot previously. This is Friday and I still feel lousy, but I kept my chiropractic appt. It is not the 14th and am just beginning to feel like maybe I am getting well.
Rash is only itchy in the area of his back; This then spread to his left back, around to his stomach area, and to his left leg; he first noticed a dark red, slightly raised rash on his right arm; Slightly raised rash on his right arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (he first noticed a dark red, slightly raised rash on his right arm), RASH PAPULAR (Slightly raised rash on his right arm), RASH PRURITIC (Rash is only itchy in the area of his back) and RASH (This then spread to his left back, around to his stomach area, and to his left leg) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jun-2021, the patient experienced RASH ERYTHEMATOUS (he first noticed a dark red, slightly raised rash on his right arm) and RASH PAPULAR (Slightly raised rash on his right arm). On an unknown date, the patient experienced RASH PRURITIC (Rash is only itchy in the area of his back) and RASH (This then spread to his left back, around to his stomach area, and to his left leg). The patient was treated with METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (he first noticed a dark red, slightly raised rash on his right arm), RASH PAPULAR (Slightly raised rash on his right arm), RASH PRURITIC (Rash is only itchy in the area of his back) and RASH (This then spread to his left back, around to his stomach area, and to his left leg) had not resolved.
75 y/o female w/ PMH significant for COPD, diabetes, GERD, HLD, HTN, CAD, CVA who presented to the hospital ED on 4/2/21 for fever, dyspnea. Pt reports being exposed to COVID 1 week ago, her entire family at home had it. She called her PCP and was placed on multivitamins and prednisone taper when she became symptomatic ~3/27/21. Throughout the week, pt had worsening dyspnea, worse with exertion, as well as dry cough, fevers and chills. Reports her temperature was 102 at home. Pulse ox was 85% at home and pt was instructed to come into the ED. On arrival, O2 82% on RA and pt having some respiratory distress. Patient was intubated and placed on full vent support, but could not be extubated. Patient's diabetes continued to be uncontrolled because of IV steroid. Patient's lactic acidosis improved with IV hydration. Patient continued to be difficult to extubate because of COVID pneumonia with ARDS. Family opted for the patient to be transitioned to hospice care and comfort care. Expired on 4/26/2021.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were inadvertently vaccinated with the improperly stored doses of M-M-R II (lot # L033589) with expiration date 02-SEP-2017; dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted.
Around the injection spot is red, swollen, sore, and itching. Also, it feels hard to the touch.
TEMPERATURE EXCURSION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the patient experienced temperature excursion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of temperature excursion was not reported. This report was non-serious.
light headiness; feel tightness around my chest; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via unspecified route of administration on 15Jan2021 11:15 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated "I already reported the side effects to Pfizer before calling you. I received the vaccine today (15Jan2021) at 11:15 am. I felt light headiness for 5 to 19 minutes. I attributed this to the fact that I was fasting. I felt better after drinking water and a little walk. When I got home I started to feel tightness around my chest, no difficult breathing, no high pulse and no fever." The patient wasnted to know if this was considered a severe allergic reaction that may require hospitalization. The outcome of the event light headiness was recovering, while feel tightness around my chest was unknown.  Follow-up activities are possible, information on the batch number has been requested.
Pt recvd 2nd DTP/HIB/OPV on 11SEP91 & immediately had a fever of 100-101; 38 hrs p/immun temp 105; Seen in office on 13SEP tx included APAP & Pediaprofen; fever resolved 2PM that day; no other sx reported;
Patient reports swelling, redness at isolated site distal to left deltoid injection site on inner aspect left arm.  Area is 2x2inch with possible punctate center.  Using NSAIDS, ice.  Area tender but no decreased range of motion, no evidence of cellulitis.
"Blister" at site of injection, Red as "a coke can", Blister burst "spontaneously" Size of  a nickel per mother's statement
This spontaneous report was received from a pharmacist via company representative and refers to herself, about 59 years old female patient. It was stated that the patient's pertinent medical history included "fever blisters". The patient had previously received measles and mumps vaccines on an unspecified date (reported as "prior to receiving ZOSTAVAX"). On an unknown date in approximately 2015 (reported as "3-4 months ago"), the patient was vaccinated with a dose of ZOSTAVAX, injection, dose 0.65 ml, subcutaneously, (injection site, lot number and expiration date were not provided). There were no concomitant medications reported. On an unknown date, after receiving ZOSTAVAX, the patient developed soreness at the injection site when touched. The patient did not seek medical attention. No laboratory diagnostic studies were performed. No treatment was given for the event. The outcome of the event was reported as recovered on an unknown date. The relatedness between the event and ZOSTAVAX was not provided. Additional information has been requested.
Event reported by R.N. Left deltoid IM injection Influenza vaccine afluria 0.5ml Seqirus exp date 6/30/2017 lot # WT55507 Vaccination occurred 9/19/16 symptoms began approx. 1 week later with increasing tenderness at injection site and increasing ROM limitation due to pain Localized erythemia, edema, warmth & tenderness, ROM limitation due to pain, localized erythema, edema, warmth
1st day in pre-school, found on floor with eyes apparently twitching, and unresponsive for 1-2 min. Then rose up and became normal.
Light-headed; Dizzy; Not able to take deep breath, she can only take shallow breathing; Had an anxiety reaction; Body was shaking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 16 year-old female patient received bnt162b2 (BNT162B2), administration date 23Jul2021 (Lot number: FA6780) at the age of 16 years as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 23Jul2021, outcome "not recovered", described as "Light-headed"; DIZZINESS (non-serious) with onset 23Jul2021, outcome "unknown", described as "Dizzy"; HYPOPNOEA (non-serious) with onset 23Jul2021, outcome "not recovered", described as "Not able to take deep breath, she can only take shallow breathing"; ANXIETY (non-serious) with onset 23Jul2021, outcome "unknown", described as "Had an anxiety reaction"; TREMOR (non-serious) with onset 23Jul2021, outcome "unknown", described as "Body was shaking". The events "light-headed", "dizzy", "not able to take deep breath, she can only take shallow breathing", "had an anxiety reaction" and "body was shaking" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of dizziness, dizziness, hypopnoea, anxiety, tremor.  Additional information: Reporter Reported that Reporter  daughter experienced after having COVID vaccine. After she had the vaccine, starting about 15 minutes later, she was feeling light-headed and dizzy and that lasted for about six hours, when reporter finally found, she was also not able to take deep breath, she could only take shallow breathing and Reporter end up taking her to emergency room and doctor there, they said, she had an anxiety reaction and they had to gave her medication to get her body, to stop, her body was shaking. So, they gave her medication (treatment) to make her body stop shaking and help her calm, get her breathing. They said that was something they didn't hear of very often. There were no any prior vaccination. They gave her she believed Benadryl and Valium for the treatment. Reporter didn't have Dose of treatment medications.  Follow-up attempts are completed. No further information is expected.
PAIN IN  ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced pain in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pain in arm was not reported. This report was non-serious.
Shortness of breath/ woke up at 3am with shortness of breath; felt like he was having an angina attach; chest pain; chest pain and tightness; allergic like reaction; an aching pain; heart disease; This is a spontaneous report received from a contactable consumer (patient). A 57-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14May2021 as single dose for Covid-19 immunization.  Medical history included heart disease (patient had a history of heart disease and he had heart surgery in 2008. Patient did not take heart disease medications). The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 for Covid-19 immunization and was observed for 15 minutes and he felt fine and when he got home then he started feeling light headed and tired. Patient had the second dose on 14May2021 and patient woke up at 3am on 17May2021 with shortness of breath and he felt like he was having an angina attach which he had had before. Patient had chest pain and tightness, like an allergic like reaction. His chest was still having mild pain but not as severe. He woke up at about 03:00 this morning, on 17May2021 and started feeling shortness of breath. After the Pfizer BioNTech Coronavirus Vaccine shot on 14May2021 he was feeling great, fine. This morning the shortness of breath just hit him, an aching pain. He had heart disease for one thing; and he consulted with the nurse, informed her that he had heart disease; and she mentioned this won't affect anything to do with your heart disease. When he was feeling shortness of breath it was kind of like an allergic reaction so he wanted some more information on this, to see if that had anything to do with the Pfizer BioNTech Coronavirus Vaccine. Patient clarified he was not having the shortness of breath at time of the call, but had ongoing tightness of chest. Outcome of events shortness of breath was recovered and tightness of chest was not recovered and the other events was unknown. Information on the lot/batch number has been requested.
approx 3yrs p/vax pt devel chickenpox rash that consisted of approx 30 lesions on various areas of body. also had ear infect. addl info requested
(Lt) upper arm with area of edema and redness about 4"x4 1/2"; increased warmth; c/o tenderness with movement, mildly TTP; slight induration - afebrile. (S/S at injection site). Tx = warm compress, rest; Ibuprofen PRN; Consider Abx if not better 24-48 hours (BENADRYL-PRN).
Within a day or so if getting the injection.  Patient began to experience numerous abnormal symptoms.  These included, dizziness, body aches, joint pain, headache, fatigue, brain fog, trouble sleeping, weakness especially in legs, ongoing sinus and upper respiratory problems.
Pt states taking Johnson at Johnson vaccine at 1000 with headache x5 hours with chills/sweating, with N and being light headed starting 1600. Denies taking medication.
Racing heart and difficulity breathing. Started within a few minutes, never got real severe, stayed the same and better a few hours later. Just went home. Would have seen a DR if got worse.
left arm with edema erythema, tenderness and increased warmth x 1 day. No fever-subjective Rx: Motrin and Hydroxyzine
Side effects reported from the first dose were "Minimal at most"; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION COMPLICATION (Side effects reported from the first dose were "Minimal at most") in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K2019 and 032L20A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL and VITAMINS NOS (DAILY VITAMINS) for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects reported from the first dose were "Minimal at most"). At the time of the report, VACCINATION COMPLICATION (Side effects reported from the first dose were "Minimal at most") outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were provided.   This case was linked to MOD-2021-294545.