chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain in arm/injection site; Headache; weakness; fatigue; This is a spontaneous report from a contactable pharmacist reporting for himself. A 46-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose in arm for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  After his first dose, the patient experienced Headache, weakness, fatigue, pain in arm/injection site on an unspecified date.  The event outcome was unknown.  Information about Batch/Lot number has been requested.
Pt's wife called stating her husband had a reaction to pneumonia shot. He received pneumonia shot on 10/14 am. She stated it was painful more at ? illness not to site of injection-achy painful to raise arm up. Recommended warm compresses. Told pt wife I would ? When I spoke to her ?-stated pain continues and was taking Tylenol taken for pain. Spoke again to pt's wife before leaving 7:30pm offering our support. Told her to call their physician if pain continues. 10/15 called and spoke with Mr. inquired how he was doing. He stated pain was much less, but still has pain when raising arm sideways. He stated the pneumonia injection "hurt bad" when nurse putting it in and felt the fluid going in his arm. Recommended again to call his doctor and was ? call on 10/16 and see how he was doing. He appreciated the follow up. 10/16  placed phone call to pt and left message-checking how he was doing. 10/18/03 3pm wife of pt called and thanked us for our follow-up on her husband. Stated he was much better. They did see the doctor for follow-up. Seen by Dr. Dr stated injection given too high on arm (site near shoulder). Pt to continue warm compresses, again, wife stated pt much better and thanked me again.
about 8 hours after receiving flu vaccine in right arm (11/30/21) and Moderna Covid Vaccine (11/30/21) in left noted severe bilateral forearm pain.  Went to ER, dcd with Norco, took daily for 4 days and pain resolved
1st 3 days: very sore, red and swollen  4th day: red, swollen and itchy
chills; fatigue; She is feeling miserable; body aches all over her body; This is a spontaneous report from a Pfizer-sponsored program, by a contactable consumer (patient).   This female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on 19Jan2021 for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously the patient received the first dose of BNT162B2 on an unspecified date for covid-19 immunisation. On an unspecified date, the patient experienced chills, fatigue, she is feeling miserable, body aches all over her body. The patient was treated with Tylenol but did not feel any improvement. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
This spontaneous report received from a nurse regarding multiple unspecified patients of unknown demographics. No medical history was reported. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored PROQUAD (Merck) lot # L030586, expiry date: 10-FEB-2017 (dose, route and frequency: unknown). No adverse effects were reported. There was no product quality complaints (PQC). This is one of the several reports from the same reporter. Follow up information was received on 30-DEC-2015. Lot number L030586 has been verified to be a valid lot number for PROQUAD (Merck). Albumin status was verified to rHA. Follow up information was received on 12-FEB-2016 from a healthcare worker regarding a 4 year old female patient. On 10-NOV-2015, the patient was vaccinated with PROQUAD (Merck). This is one of the several reports from the same source. Additional information has been requested. Patient, product, event and narrative were updated.
Headache, left Brest( by armpit) tender/ sore. Seems a little swollen.
pain at the site; itching; pinkish area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the site), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (pinkish area) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 19-Jan-2021, the patient experienced VACCINATION SITE PAIN (pain at the site), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (pinkish area). At the time of the report, VACCINATION SITE PAIN (pain at the site) and VACCINATION SITE PRURITUS (itching) outcome was unknown and VACCINATION SITE ERYTHEMA (pinkish area) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Patient presents with severe left thigh pain with deformity after injury at home. She was admitted with left femur fracture. She underwent surgical repair of the fracture during this admission and was discharged home in stable condition after 37 days.
t101 under arm-crying says jaws hurt, mom says pt appears to have swelling like w/mumps-fever for 24hrs; 4hr APAP
Patient was standing in line and started to feel light-headed and fainted. Patient fell to the ground that caused a cut above her eye. Patient was still conscious and aware. Ambulance was called for assistance.  Patient received stitches and taken by ambulance to hospital.
who had both doses of the Pfizer BioNTech Covid 19 vaccine in March, and has now been diagnosed with Covid.; who had both doses of the Pfizer BioNTech Covid 19 vaccine in March, and has now been diagnosed with Covid.; throwing up; ill; fever; Flu; This is a spontaneous report. A 80-year-old female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as dose 1, single and BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Formulation: solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as dose 2, single both for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller reported on behalf of a female relative in her early 80s who had both doses of the Pfizer BioNTech COVID-19 vaccine in March and had now been diagnosed with COVID. He did not complete a safety report. He was asking how long, with the positive diagnosis, she had to wait to get the booster dose. He reports that she became ill with the flu and mild fever, throwing up and Tested positive for COVID   . They asked another relative, an RN, to check on her, and she talked her into getting COVID test. The relative who was an RN checked on this relative because she had been ill with the fever, and flu. She talked her into getting tested for COVID and found out she was COVID positive. He looked everywhere to see if he could find the answer. On an unspecified date, the patient underwent lab test and procedure which includes SARS-CoV-2 antibody test which was found to be positive. Outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Tested positive for COVID with a home test kit; Tested positive for COVID with a home test kit/runny nose for 24 hours; had difficulty sleeping last night; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group.  A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Dec2022 as dose 4 (booster), single (Lot number: GJ3274) intramuscular for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "low thyroid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for hypothyroidism.  The following information was reported: INSOMNIA (non-serious) with onset 19Jul2023, outcome "not recovered", described as "had difficulty sleeping last night"; DRUG INEFFECTIVE (medically significant) with onset 20Jul2023, outcome "not recovered", described as "Tested positive for COVID with a home test kit"; COVID-19 (medically significant) with onset 20Jul2023, outcome "not recovered", described as "Tested positive for COVID with a home test kit/runny nose for 24 hours". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Tested positive for COVID with a home test kit; (20Jul2023) Positive, notes: Nasal Swab. Clinical course: Patient complained of runny nose for 24 hours, had difficulty sleeping last night. Tested positive for COVID with a home test kit. No Covid prior vaccination and Covid was tested post vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between the events drug ineffective, covid-19 and suspect drug BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-202300255944 same patient, different vaccine dose number, different event;
lt arm sore, swollen, itchy became progressively worse from 14JAN93-16JAN93;
Case previously recorded as MA2009-5701. We received the following information from a consumer via LAREB, and Novartis Pharma on the 20 NOV 2009. This patient was vaccinated with 1 DF S-OIV FLUVIRIN (batch number 10127801) on an unknown date. Ref no. NA09-008676.
High fever of 102. 5 at 4:07 am 11/21/2021 increased from 101.7 at around 8:30 pm 11/20/2021 Muscle aches Chest congestion and strained breathing due to excess mucus
VACCINE ALMOST KILLED ME; 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 (suspension for injection, route of admin not reported, batch number: Unk) 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 numbers. No concomitant medications were reported. On an unspecified date, the subject experienced vaccine almost killed me. The action taken with covid-19 vaccine  was not applicable. The outcome of vaccine almost killed me was not reported. This report was non-serious.
Pt. received Tdap booster during well ck on 12/04/12. It was the only vaccine given. Pt. reported to parent evening of 12/06/12 of "welt, size of softball on left arm". Dx with cellulitis on 12-7-12 - treated with Clindamycin HCl 300mg and instructed to return to clinic in 24 hrs for f/u./
tested positive for Covid and put on Paxlovid; tested positive for Covid and put on Paxlovid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group.  An 81-year-old female patient received bnt162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN6200) and on 17Mar2021 as dose 2, single (Lot number: EN6207) at the age of 79 years for covid-19 immunisation. The patient's relevant medical history included: "kidney disease", start date: 2018 (ongoing); "thyroid" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing); "heart burn acid reflux" (unspecified if ongoing). Concomitant medication(s) included: PANTOPRAZOLE taken for gastrooesophageal reflux disease; LOSARTAN taken for blood pressure measurement (ongoing); LEVOTHYROXINE taken for thyroid disorder (ongoing); NEBIVOLOL taken for palpitations; DULOXETINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "tested positive for Covid and put on Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19, patient took Paxlovid from 21Oct2023 to 25Oct2023 .
Initial report received from a physician on 21 Oct 2010: This patient was vaccinated with FLUVIRIN (batch number 111784P1) subcutaneously on 18 October 2010. The patient was 7 months pregnant. On 18 October 2010, the patient presented red circle of size 3 inches in diameter at injection site and also had pain at injection site and at the fatty area of the arm. The outcomes of the events were reported as unknown. Follow up report received from a physician on 06 Mar 2012. The patient had an ultrasound performed at her fifth month. It was reported that the patient has possible pre-eclampsia in the eight month. On an unspecified date, the patient gave birth to a female neonate with weight 5 lbs 3 ozs (see case PHHY2012US021185), The APGAR score for the child was unknown for the first, fifth and tenth minutes. The delivery was reported to be normal but with unspecified placental complications. The event's outcome and causality were not reported.
Received the Pfizer 2nd dose on 9th April. Following day (04/10), I had body ache, fatigue, mild temperature 99.8, back neck and upper arm/shoulder pain. While I recovered from the ache and fatigue the next day (04/11), the neck pain continued for a couple of weeks. On 23rd April, the pain aggravated and I took a 2 Advil's (2 tablets of 200mg each) which made the overall pain extremely critical. The pain was mainly in the neck, upper arm, tingling in the fingers, grinding jaw pain, all symptomatic to a cardiac pain.  I visited the Urgent care and they suggested I rush to Emergency care. See the notes attached. I was detected with Myocardial infraction or Heart Inflammation (as there was an increasing Troponin). They did an Angiogram to detect any blockages but was cleared of all blockages or major heart conditions. Was hospitalized for 2 days and was on observation for any new pains, repeat or increase in symptoms. Heart inflammation continues to be there and I am unable to take any anti inflammatory as that aggravates the cardiac/ MI pain. No prior history of heart disease etc. Will be visiting for repeat tests with the Cardiologist in coming weeks. Since there were no prior heart condition and since this initiated day after the 2nd vaccine, i strongly believe this is a side effect from the vaccine dose.
Redness, pain and inflammation at injection site. Patient will go to MD and was given BENADRYL. Vaccine given 2/8; SX noticed 2/11; has gotten worse since then.
Information has been received from a nurse practitioner concerning a 65 year old female with a history of breast cancer in 1998 and an allergy to sulfa who on 06-NOV-2008 was vaccinated with ZOSTAVAX (Merck) (route and site not reported).  Concomitant therapy included estrogens, PREMARIN, ZYRTEC and therapy unspecified CERAX.  On approximately 10-NOV-2008, "a week ago" the patient developed neuraliga and blisters on her left buttock and left thigh. The patient's neuraliga and blisters on her buttock and left thigh persisted.  Additional information has been requested.
injection site itched really bad; a little bit of a rash appeared; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (injection site itched really bad) and RASH (a little bit of a rash appeared) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concomitant products included APIXABAN, LISINOPRIL, HYDROCHLOROTHIAZIDE, OMEPRAZOLE and CITRULLINE for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced INJECTION SITE PRURITUS (injection site itched really bad) and RASH (a little bit of a rash appeared). At the time of the report, INJECTION SITE PRURITUS (injection site itched really bad) and RASH (a little bit of a rash appeared) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided.
Information has been received from a physician concerning a 60 year old female with hypothyroidism, hyperlipidaemia, sciatica and back problems who on 15-JAN-2009 was vaccinated with ZOSTER vaccine live (Oka/Merck) (Lot # not reported).  After receiving ZOSTER vaccine live (Oka/Merck), the patient began to experience myalgia and elevated CPK levels.  The patient went to her chiropractor (who had previously been treating her for sciatica and back problems) then referred to a rheumatologist who ordered blood tests.  She went back to her primary physician for her symptoms.  On 30-JAN-2009, the patient had myalgia and nausea that was better with rest and worsens with activity.  At the time she developed the significant body aches and her CPK level was over 1000.  The patient had been stable on an unspecified statin for a long time with no problems.  The statin was recently discontinued due to the CPK.  There was no improvement in patient's condition.  It was reported that the patient sought medical attention.  Additional information has been requested.
Initial information received on 01-Sep-2018 regarding an unsolicited valid non-serious case received from a physician. This case is linked to 2018SA248513 (Same reporter). This case involves a 16 years old patient (gender not reported) who was vaccinated with 0.5 ml dose of FLUBLOK QIV (batch number QFAA1801, frequency once) expiration date and route of administration not reported) in the right deltoid on 01-Sep-2018 instead of FLUZONE QUADRIVALENT. The patients medical history and concomitant medications were not reported. It was an actual medication error due to wrong drug administered and drug administered to patient of inappropriate age. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
Patient states he has numbness in last 2 fingers, ring finger and more in the little finger. Also has pain radiating down his left arm.  It started the day of his vaccination and has continued. He states the pain has remained about the same this entire week.
I woke up the next morning feeling run down. Tired, sore, aches and pains. It?s gotten progressively worse everyday since then. Start 4/11 I woke up with horrible hip pain, it?s only gotten worse since then. It?s very painful and the worse of all my symptoms
arm pain follwed by shortness of breath 2 weeks later and pulmonary embolism
Next day had soreness at injection site and shoulder. Swollen gland under arm (left). Soreness lasted about 3 days. Itchiness on side od body started a week ago. At same time had night sweats on 2 consecutive days and went away. On 2nd/3rd day stiffness on neck and pressure on back of head. Headache is very uncomfortable. Have to take TYLENOL/ADVIL (600mg) every day. Feels better to a degree but not sure if it is just because of the medicine. Had doctor visit on 12/27 and blood work was done. Spoke to nurse who was not sure problems were vax related and pt might be developing cranial disease. Today doctor called back and said to wait for symptoms to go away. Today feels a little better but pt taking so much ADVIL so not sure how much pain/soreness still is there.
Arm swollen around the vaccine injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Arm swollen around the vaccine injection) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Arm swollen around the vaccine injection). At the time of the report, VACCINATION SITE SWELLING (Arm swollen around the vaccine injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Treatment information was not provided.
Pt was administered COVID booster at appointment. after patient left, it was noticed that the vial used to draw up vaccine had expired. Supervisor was notified, who reached out to Pfizer company, who recommended pt receive an additional dose with no interval in between. Pt was notified and came to receive additional dose.
-Chills and fatigue 3 days after the 2nd dose -Early heavy menses, arrived 14 days early -Headaches and fatigue that come and go ever since -Constant major depression (anxiety, difficulty breathing, insomnia, bouts of crying, difficulty concentrating, difficulty going about normal daily activities)
Information has been received from a medical assistant concerning a 31 year old female patient who on 25-FEB-2010, 04-MAY-2010 and 10-SEP-2010 was vaccinated with the first, second and third dose of GARDASIL (third dose lot# 666596/0414Z, expiration: October 2012) respectively (dose, strength and therapy route were unspecified). The medical assistant reported that on 07-FEB-2011 the patient who was performed the lab diagnostics with Pap test and HPV screening tested positive for high risk HPV on a routine HPV DNA screening test performed. At time of report, the patient's status was unknown. The patient did not seek medical attention. Follow up information has been received from a health professional who said no reactions noted so far. Additional information has been requested.
Mild localized erythema on the cheek, denies itching, sob, chest pain, sore throat. Seen and cleared by EMS
This spontaneous report as received from a pharmacist refers to a 64-year-old female patient. The patient did not have any pertinent medical history or drug allergies. On 31-OCT-2017, the patient was vaccinated with ZOSTAVAX subcutaneous, lot number N003697, expiration date 13-MAR-2018 (also reported as 01-MAR-2018) (dose and injection site were not provided) for prophylaxis. Other suspect therapies included sterile diluent (STERILE DILUENT) lot number N015478, expiration date 28-SEP-2019.  On 01-NOV-2017, the patient experienced a red and itchy rash at the injection site. On 03-NOV-2017, the patient reported that the rash was travelling down to her elbow. The patient did not receive any treatment. The outcome of the events was reported as not recovered. The relatedness between ZOSTAVAX and the events was not provided.