chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swollen finger from left and right hand; hot to touch at site of injection; elevated temperature on the arm; redness; Fatigue; headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to touch at site of injection), FEELING HOT (elevated temperature on the arm), PERIPHERAL SWELLING (swollen finger from left and right hand), VACCINATION SITE PAIN (sore arm) and VACCINATION SITE ERYTHEMA (redness) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Prediabetes and Anemic. Concomitant products included IRON for Anemic, METFORMIN for Prediabetes.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 27-Feb-2021, the patient experienced VACCINATION SITE WARMTH (hot to touch at site of injection), FEELING HOT (elevated temperature on the arm), VACCINATION SITE ERYTHEMA (redness), FATIGUE (Fatigue) and HEADACHE (headache). On 28-Feb-2021, the patient experienced PERIPHERAL SWELLING (swollen finger from left and right hand). The patient was treated with PARACETAMOL (TYLENOL) at a dose of Extra Strength: 2 tablets and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 tablet. At the time of the report, VACCINATION SITE WARMTH (hot to touch at site of injection), FEELING HOT (elevated temperature on the arm), PERIPHERAL SWELLING (swollen finger from left and right hand), VACCINATION SITE PAIN (sore arm), VACCINATION SITE ERYTHEMA (redness), FATIGUE (Fatigue) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Body temperature: elevated (High) elevated temperature on the arm.         Action taken with mRNA-1273 in response to events was not applicable.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Pain at injection point and adjacent armpit. Pain throughout his arm and legs when picked up from school yesterday 8/22/2022, he also said his arms and legs hurt really bad all day whenever he moved. Pain throughout body is continuing today 8/23/2022. Loss of appetite. Pt. is normally the biggest eater in the family however, he is saying his stomach is bothering him and he is unable to eat. Nauseous: He woke up feeling nauseous and vomited. Decreased appetite for 1 week.
Soreness at injection site lasting  2+ days.  Mild headache lasting about 18-20 hrs.
Patient got PNEUMOVAX 11/16/2010 & came to the office 11/18/10 with cellulitis well below site.
This spontaneous report was received from a registered nurse referring to a multiple unspecified number of patients. The patients' concurrent conditions and medical histories were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Lot # L048463, expiration date 02-DEC-2017); (Lot # M008173, expiration date 16-FEB-2018) doses, routes and frequencies were not reported. There was no concomitant medication reported for any patient. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
pain & swelling rt side of neck-shoulder & arm;difficulty swallowing;had to remove necklace d/t tightness;MD gave DPH;
sx ST pharyngitis laryngitis HA high fever 102 + AG; sx ST pharyngitis laryngitis HA high fever 102 + AG; sx ST pharyngitis laryngitis HA high fever 102 + AG; exposed to COVID positive family member 12May2022; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 31-year-old female patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EL3247), on 22Mar2021 as dose 2, single (Lot number: EL3247) and on 07Dec2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 31 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. She exposed to COVID positive family member 12May2022, sx ST pharyngitis laryngitis HA high fever 102 plus AG 16May. was told by teledoc that she was too thin and too young to get paxlovid she would have rather had the therapy. The following information was reported: EXPOSURE TO SARS-COV-2 (medically significant) with onset 12May2022, outcome "unknown", described as "exposed to COVID positive family member 12May2022"; PHARYNGITIS (non-serious), LARYNGITIS (non-serious), PYREXIA (non-serious) all with onset 14May2022, outcome "unknown" and all described as "sx ST pharyngitis laryngitis HA high fever 102 + AG". The patient underwent the following laboratory tests and procedures: Body temperature: (16May2022) 102; SARS-CoV-2 test: (16May2022) Positive. It was unknown if therapeutic measures were taken as a result of exposure to sars-cov-2, pharyngitis, laryngitis, pyrexia.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information, the event EXPOSURE TO SARS-COV-2 was considered unrelated to suspect drug BNT162B2. 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.
Locked up for about 1-2 minutes then became diaphoretic Narrative: Employee was taken to the emergency department for further assessment. Came to after going into a state of "locked up" for about 1-2 minutes, then became diaphoretic. After 1-2 minutes, employee was able to speak, was alert and oriented and was transported for further evaluation to our ED. She was able to provide us with her personal information to submit this report.
48 hrs after shots she had fever between 99.7-100.7 that lasted 8 days (off and on) She had rash break out on neck, chest, belly and back on day 8. Day 10 she had "facial swelling".  She has had previous Tdap with no rxn and Varicella with no rxn.
Within 5-10 minutes, post vax, pt developed raised area (pencil eraser sized), redness and warmth at site of MMR. Pt's physician was called and received orders to give Epinephrine if redness got larger than 1/2 dollar size. This was the case and Epinephrine was given SC in left thigh. No further reaction was noted for approx. 15-20 minutes following Epinephrine (Monarch/02709/SC/LL/0 previously). Phoned daycare the following day, 8/15/00, and personnel stated she was doing well and symptoms better.
on 02/01/2021 when I woke up in the morning I noticed a rash on my left arm in the area of the COVID 19 vaccination injection.  Slight warm to the touch, slight swelling, slightly itchy, no pain.
Started to feel dizzy with ringing in my ears and trouble focusing on work around 10am around 10:45 my face started to feel numb and I felt like I was going to pass out. Laid my head down for a bit and then called my PCP's office. While talking to the nurse, my speech was slurred and my tongue and the roof of my mouth started to feel numb. she advised me to take Benadryl and call 911. I took Benadryl called 911 they sent out EMS and they advised me that I was just injected with a live virus and this was the side effect of having COVID. That made no sense to me, she then instructed me to take DayQuil for the effects of having COVID. I told the EMT that I was not feeling like I had the flu I felt out of it and numb. She checked my vitals and lungs and said everything was good and that they could transport me to the Hospital ED but they were full and I would just be sitting there and it would be best to rest in my home. That if the Benadryl wore off or if things got worse, to go to urgent care. I slept and when I woke up the facial numbness was less and my tongue and mouth no longer felt numb. I was dizzy and my ears were still ringing and disoriented the entire day. The next day I was extremely tired and started to having coughing with chest pain when I would cough and by that evening I was having joint pain everywhere. Today I feel better, still have the coughing with chest pain. Following up with my PCP at 9:20am 11/04/21.
Myalgia, CoughWheeze, Short of breath Narrative: Per nursing report: "called to report that she received her 2nd dose of the COVID 19 vaccine on 6/2/21 and reported SOB, productive  cough, and body aches starting last night [6/2]. "
the nurse had asked a question regarding administration of GARDASIL 9 in a 6 year old wilh HPV on his vocal cords; the nurse had asked a question regarding administration of GARDASIL 9 in a 6 year old wilh HPV on his vocal cords; the nurse had asked a question regarding administration of GARDASIL 9 in a 6 year old wilh HPV on his vocal cords; This spontaneous report was received from a nurse concerning a 6-year-old male patient. The patient's pertinent medical history, concomitant medications, concurrent conditions and drug allergies or reactions were not reported.      The nurse had asked a question regarding the administration of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) in a 6-year-old with human papilloma virus (HPV) on his vocal cords (circumstance or information capable of leading to medication error, product administered to patient of inappropriate age and product prescribing issue). The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was recommended by the surgeon for treatment, but bas not been given yet.  Also, the nurse mentioned that the surgeon had said that they had treated another patient with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for HPV that was non-genital warts, and it had slowed the process down a little bit.
According  to his wife, his symptoms include lightheadness, severe dizziness, body aches, headaches, extreme tiredness, "whooshing in his head," light sensitivity. All effects started within hours of recieving the vaccine and have persisted over the last 3-4 days without letting up. His primary physician, Dr is evaluating.
Abnormal menstruation. Heavy clotting without normal flow.  If in resting state,  clots build up and once released there is no flow in between.
This spontaneous report as received from a registered nurse refers to an unspecified number of adults. The patients were vaccinated with a dose of improperly stored RECOMBIVAX HB (dose, route and lot number not provided) on unknown dates "within the past 13 months". No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. It was unspecified if the patients had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a medical assistant referring to an 18 years old patient of unknown gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On unknown dates in 2015 and 2016, the patient respectively received the first and second dose of GARDASIL 9 (strength, dose, frequency, lot#, expiration date and route were unknown), both for prophylaxis (inappropriate schedule of drug administered). No adverse effects were reported. No product quality complaint (PQC) was involved in this case.
After a few hours my arm had pain. I thought it was the normal ache I usually get after the injections. After a month I felt it was more than the usual pain. It hurt more as the days went by it hurt more I am now unable to use the arm without horrible pain. Pain wakes me during the night. If I turn or move it, it hurts. It's been 7 months now and the pain is still unbearable. I have seen my doctor due to the pain. I had flu vaccine and Tdap. I get the flu vaccine yearly but this time it is unbearable and has lasted past a week. For the last 7 months I have had to take pain medicine daily to help control the pain to work and function daily. Heating pad ice pack everything that will help ease the pain.
Info has been received from a physician concerning a 41 year old male pt with no known allergies and a medical history of non-hodgkins lymphoma who on 12/05/2002 at 14:00 was vaccinated intramuscularly in the left deltoid area with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #642722/0165M). On 12/05/2002, the pt was concomitantly vaccinated with influenza virus vaccine. On 12/05/2002 at 5:00 PM. "3 hours post vaccination", the pt developed erythema, tenderness and edema at the injection site (left deltoid area) of the pneumococcal vaccine 23 polyvalent. Erythema and edema progressed to the elbow over the next 48 hours. There was no relevant diagnostic laboratory data. The pt was treated in the ER with antibiotics (unspecified therapy) for possible cellulitis and diphenhydramine HCl (Benadryl) and steroids (unspecified therapy) for an allergic reaction. There were no sensory or muscle damage reported and the pt did not develop fever or chills at any time. Subsequently, the pt recovered. No further info is expected.
I thought I had the flu and went and got tested; the test was negative then I traveled and when I got back I wasn't getting better and went back to get tested again and I was positive for covid-19.
PATIENT HAD COVID VACCINE  Dose 1 date: 07/16/2021,   Dose 2 date: 08/14/2021, AND TESTED POSITIVE TO COVID.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 05-OCT-2016, the patient was vaccinated with an expired dose of VARIVAX, lot number K007786, expiration date 28-MAY-2016, (dose, route and anatomical location were not reported) (product use issue). There was no concomitant medication reported. The patient had not experienced any adverse effects. Additional information has been requested.
Patient developed a pulmonary embolism on 30 July 2021, 5 months following his 2nd dose of COVID-19 vaccine.  He did have mild COVID-19 infection on 12 August 2020.
Arm is little bit sore where I got the shot; pain in my arm where they give me the shot and it was sore; I noticed like a lump, not at the injection site where I got the shot. It is more like on my collar bone area, my shoulder collar bone area; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FC3181), via an unspecified route of administration in right arm, on 23Aug2021 (at the age of 42-year old) as dose 1, single for COVID-19 immunisation. Medical history included High Blood Pressure from an unknown date. Concomitant medication included enalapril maleate (ENALPRIN) taken for hypertension. On 23Aug2021, after vaccination, he experienced little bit sore where he got the shot, in his right arm and also he noticed something like a lump, not at the injection site where he got the shot. It was more likely on his shoulder collar bone area. No treatment was given in response to the events. The patient was not sure if the events was related to the shot. The outcome of the events was unknown.
Pt recv vax on 2/16/99; on 2/17/99 pt exp restless sleeping, fever (101.4), irritable,shallow breathing/ pauses, rash;dx=Roseola, possible vax rxn; tx=Tylenol &Motrin, oxygen x 1.5 hr; 2/18/99-pt imp
it "did hurt for 45 seconds" when he was "stabbed by the needle"; This spontaneous report was received from a male consumer of unknown age referring to himself. The patient's current condition included sinus issues such as a "deviated septum" and "drainage not wide enough". The patient had sinus surgery scheduled to realign the deviated septum but had not had it yet. No information regarding the patient's drug reactions or allergies and concomitant therapies was provided. On approximately 07-JUN-2019 (reported as "3 or 4 days ago"), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) first dose (strength, dose, route of administration, indication, lot # and expiration date were not reported) for prophylaxis. It was reported that when the patient was "stabbed by the needle" it "did hurt for 45 seconds". The outcome of the event was reported as recovered on the same date. The patient did not seek medical attention. The relatedness between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Within 3 hours of receiving the Moderna Booster vaccine, my left deltoid felt strained. When I woke up the next morning by 7:00am, I had pain with movement of my arm. My husband had to help me get out of bed. I had limited range of motion in my left shoulder. I could not raise my arm without the assistance of using my other arm to raise it. Over a 3 day period, there was limitation in shoulder movement. At present(9 days after injection), I still have a "straining" feeling in my upper left arm with movement.  I am able to rotate and move my shoulder. With the first 2 Moderna injections, I had discomfort at the injection site but have never had limited movement of my shoulder with any other vaccines.  I am hopeful that that I have not sustained an injury but wanted to report my experience.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 12-SEP-2013 the patient was vaccinated with ZOSTAVAX (lot number, dose, route and injection site were not reported). An unspecified physician reported to the pharmacist that on an unknown date the patient developed polymyalgia rheumatic after receiving ZOSTAVAX. The action taken was not provided. The outcome of polymyalgia rheumatica was unknown. It was unspecified if the patient sought medical attention. There was no product quality complaint. Additional information has been requested.
Sore arm after his first dose.; This is a spontaneous report from a contactable other healthcare professional (patient). A male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced a sore arm after his first dose of BNT162B2 on an unspecified date. Outcome of the event was unknown.   Information on the Batch/Lot number has been requested.
Can not lift anything; Swollen right arm; Pain in right arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can not lift anything), PERIPHERAL SWELLING (Swollen right arm), PAIN IN EXTREMITY (Pain in right arm) and HEADACHE (Headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0G1W21A, 039K20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Dapsone).   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Oct-2021, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can not lift anything), PERIPHERAL SWELLING (Swollen right arm), PAIN IN EXTREMITY (Pain in right arm) and HEADACHE (Headache). At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can not lift anything), PERIPHERAL SWELLING (Swollen right arm), PAIN IN EXTREMITY (Pain in right arm) and HEADACHE (Headache) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Forty-two hours post vax, broke out in hives, complained of respiratory problem, i.e. coughing, with significant mucous production. Took Benadryl and hot shower. Hives on trunk to groin. History of hives in past. Complained of swelling of extremities.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Medium, Systemic: Seizure-Severe, Additional Details: Pt looked like a seizure and was unresponsive for about 2 minutes. Pt walked out of own accord against medical advice to stay for an ambulance. EMS was called and patient left before they arrived.
Patient developed a fever up to 103 the morning following his vaccinations. Physical exam was normal at that time. Influenza test was negative. Fever resolved within 48 hours.
Pediarix given to 7 year old; This case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a child patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was 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: GSK Receipt Date: 27-JUN-2022 Reporter's Comment: The reporter wanted to know that, if a dose of Pediarix was inadvertently given to a patient 7 years of age or older, would the Hepatitis B and IPV components count as a dose of Hepatitis B and IPV or would it have to be repeated. Additional Supportive Information: The dose of Pediarix was inadvertently given to a patient 7 years of age or older, which led to inappropriate age at vaccine administration.
pt recv vax 30APR97 & 29APR97 exp a flu-like synd (myalgia, nausea, fever 100.8) & a sl inc in liver function tests;SGOT went from 19 to 49 & then returned to 20 three wk later;also had a sl inc of the LDH up to 174;
Within a minute of administering the vaccine the patient developed swelling at the site about one inch in diameter. There is a visible lump at the injection site. Patient had no other symptoms. Gave patient 50mg of diphenhydramine and monitored blood pressure and pulse. Both were normal.
Pt became fussy on the night of 12/28/02. In the morning, mother noticed rash on face and trunk. Rash was diffuse, mostly macular, slightly papular. No fever, no vesicles, no open areas or large urticarial regions.
3 days after she tested positive with Covid-19; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient). A female patient of an unspecified age received the first dose BNT162B2 (PFIZER COVID-19 VACCINE, lot no. and expiry date was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included bamlanivimab. The patient received the first dose and 3 days after she tested positive with Covid-19. She is also due or the second dose on 25Mar2021, and she is asking if she should get it. The outcome of the event was unknown.  Information on lot/batch number has been requested.