chrisvoncsefalvay/vaers-outcomes huggingface dataset:
backache; feeling terrible; pain in left knee, excruciating and cannot bend the knee; Red hot lump at injection site; hard, red hot lump at injection site; Itching at injection site; Red hot lump at injection site; Swelling at injection site 2.5 inches; Throwing up; Feeling weak and tired; Low grade fever; head was hurting; Felt weak; Dizziness; Sleepy; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt weak), DIZZINESS (Dizziness), SOMNOLENCE (Sleepy), BACK PAIN (backache) and MALAISE (feeling terrible) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Allergy. Concomitant products included METOPROLOL SUCCINATE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), PREGABALIN, BIOTIN and VITAMINS NOS for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced ASTHENIA (Felt weak), DIZZINESS (Dizziness), SOMNOLENCE (Sleepy), VOMITING (Throwing up), FATIGUE (Feeling weak and tired), PYREXIA (Low grade fever) and HEADACHE (head was hurting). On 11-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Red hot lump at injection site), VACCINATION SITE MASS (hard, red hot lump at injection site), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE ERYTHEMA (Red hot lump at injection site) and VACCINATION SITE SWELLING (Swelling at injection site 2.5 inches). On 12-Mar-2021, the patient experienced BACK PAIN (backache), MALAISE (feeling terrible) and ARTHRALGIA (pain in left knee, excruciating and cannot bend the knee). On 10-Mar-2021, PYREXIA (Low grade fever) had resolved. At the time of the report, ASTHENIA (Felt weak), SOMNOLENCE (Sleepy), BACK PAIN (backache), MALAISE (feeling terrible), VACCINATION SITE WARMTH (Red hot lump at injection site), VACCINATION SITE MASS (hard, red hot lump at injection site), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE ERYTHEMA (Red hot lump at injection site), VACCINATION SITE SWELLING (Swelling at injection site 2.5 inches), VOMITING (Throwing up), FATIGUE (Feeling weak and tired) and ARTHRALGIA (pain in left knee, excruciating and cannot bend the knee) outcome was unknown and DIZZINESS (Dizziness) and HEADACHE (head was hurting) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, Ultrasound Doppler: normal (normal) To rule out blood clot.   Action taken with mRNA-1273 in response to the events was not applicable     no treatment medications provided   This case was linked to MOD-2021-044459 (Patient Link).
Rapid heartbeat,  shaking, swelling in mouth and throat. Resolved after 15 minutes. EMT assessment said everything was ok.
Experienced tingling, numbness and weakness in my left arm shortly after receiving injection. The numbness was throughout my entire arm but was especially pronounced along the outside down to the pinky finger. Within about 2hours the numbness also affected my left leg along the outside of the leg to the pinky toe and all around the lower thigh. Symptoms still present 8 hours after injection at time of writing this description.
The day after vaccination, the patient felt pain in her left shoulder and "couldn't move [her] shoulder" for a few days. Over time, she was able to elevate and abduct her arm to about 90 degrees, but not further. Now 3 months out, she has full ROM of her arm with only intermittent pain, but cannot sleep on her left side due to shoulder pain.
Patient reports fatigue, chills, fever and sweats that began 20 minutes after vaccination. Local reaction to injection site that began 2 days after vaccination. Complains of continued fatigue, chills, sweats and 'brain fog' since vaccination administered.
Pt started crying @ approx 6PM same day as immun & cried until approx 10PM; Crying started loud & turned to screaming-high pitched; Was seen in ER; dx: viral syndrome;
Not feeling good, feeling awful, after first vaccine; Passed out after first vaccine; Tested positive for Covid virus, after first vaccine; Tested positive for Covid virus, after first vaccine; This is a spontaneous report from a contactable consumer. A 69-year-old male patient (reporter's Brother) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route of administration on 03Aug2021 as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in Aug2021, after first vaccination, patient was not feeling good and was taken to the hospital by ambulance on 06Aug2021. Patient Passed out. And when he was in the emergency room, they tested him for COVID and he tested positive. It was reported that patient had an appointment last Friday (on an unspecified date), to see a primary doctor because he wasn't feeling good. Event malaise resulted in emergency room and physician office visit. The patient underwent lab tests and procedures which included sars-cov-2 test resulted positive on an unspecified date in Aug2021. Reporter wanted to know can the Pfizer shot, give patient COVID, and states that she got the shot the same week as patient and she was reading her information sheet that was provided about the side effects, her brother has all of them, and was feeling awful. Reporter asked, when can patient take another Covid test to see if he was still positive, should he get the second vaccine within the 21 days or wait. Report does not relate to a study or programme. The clinical outcome for events was unknown.  Information on the lot/batch number has been requested.
Got an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Got an expired dose) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Got an expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Got an expired dose) 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.
Pt received Moderna at 6:10. Pt then wished to receive flu shot, insisted on same arm. Received at 6:20. About 6:25 PT CALLED ME OVER TO SAY HE WASN'T FEELING WELL. FELT NAUSEOUS AND DIZZY. GAVE ICE PACK, PROPPED UP FEET. SXS PROGRESSED TO ALL OVER BODY SHAKES "FEELS LIKE IN MASSAGE CHAIR" THIS LASTED FOR 5-10 MINUTES. NAUSEA AND DIZZINESS WENT AWAY FIRST. THEN SHAKING ABOUT 5 MINUTES LATER.  No treatment or other invention was needed.
migraines might be getting worse since she took Ibuprofen; she experienced migraine; headache; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 18-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Lot Number: FA7485), dose 2 via an unspecified route of administration, administered in arm left (left shoulder) on 30Jul2021 at 14:00 or 15:00 (age at vaccination 18 years old) as DOSE 2, SINGLE for covid-19 immunisation at pharmacy. The patient medical history was not reported. The patient's concomitant medications included ethinylestradiol, norethisterone acetate (AUROVELA 1/20) via oral from an unspecified date and ongoing at 1x/day (taking for over a year, about a year and two or three months) for birth control. Historical vaccine included first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number EW0198) via an unspecified route of administration in left arm (shoulder) on 09Jul2021 at 10:00 as DOSE 1, SINGLE for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. This report was not related to a study or programme. On 30Jul2021 (then 1-2 hrs later after getting vaccinated), the patient experienced migraine, headache and migraines might be getting worse since she took ibuprofen. About an hour or two hours after the second dose her migraines started and have been consistent ever since. She had contacts and curly hair and her hair was tight and thrown in a bun, since that was usually why she gets headaches, she took her contacts and hair out of bun but she was still getting the migraines. She usually takes tylenol and usually it worked. She clarified that she took ibuprofen (Lot: 9KE3036A, Expiration: Jul2021) not tylenol. Reported her migraines might be getting worse since she took Ibuprofen around 9:30 this morning and still has a headache. She got her second shot of the pfizer covid vaccine on friday. The doctor told her that symptoms usually last about 24 hours or 48 hours at the longest. Reported it had been 4 days and she has constantly had migraines. Asked if this was normal. The adverse event did not result in physician's office visit or emergency room visit. Therapeutic measures were taken as a result of migraine, headache, migraines might be getting worse since she took ibuprofen. The outcome of all the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Rash all over chest-looked like sunburn or sun poisoning.  Last time I had a rash like that it was following surgery and Darvocet Rx.  I noticed the rash when I went to get ready for bed.  No fever or other symptoms.  I still have it today but appears less red, splotchy, bumpy.  I will answer no for recovered as I still have the rash the following day.  I called my doctor's office to notify them.  Not requested to be seen at this time.
Pt given immunizations.  Per mother, child seized at home (half-way house).  No medical care available until 01/07/04.  Child sent to ER for evaluation. Temperature 103 on 01/07/04.
PAIN IN KNEE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. 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 patient experienced pain in knee. Treatment medications (dates unspecified) included: alpha-d galactosidase/amylase/bromelains/cellulase/glucoamylase/lipase/minerals nos/nattokinase/protease nos. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in knee. This report was non-serious.
Case number PHEH2014US024631 is a combined initial and follow-up spontaneous report from a nurse received on 04 Dec 2014 and 09 Dec 2014. This report refers to an 84-year old female patient (previously reported as incomplete case). Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 16 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
According to Medical Center's report,  patient was brought to ED deceased upon arrival via EMS on 03/12/2021 at 8:57am.  Patient had been seen on 3/11/2021 at same ED complaining of a heavy type of chest pain in the mid chest, also noting body aches, headache, and nausea.
Patient received 3 doses of Moderna vaccine. Patient received his first dose at Hospital on 07JAN2021. Patient presented to Clinic for his second dose on 09FEB2021 without a vaccination card. The patient was given a new vaccination card only notating the 09FEB2021 dose and not a complete series. Patient returned Hospital on 01APR2021, presenting his vaccination card that noted only one dose given which resulted in a third dose given. During screening, he reported only receiving one dose and not two doses. The patient was contacted and interviewed, he reports no adverse reactions
Information has been received from a 65 year old female with allergy to sulfonamide and "gluten" who on 17-OCT-2008 was vaccinated with PNEUMOVAX 23 (lot # 660685/0619X). Concomitant therapy included CLARITIN, FLONASE, FLOVENT, "PROVELGEL", ACTONEL, SYNTHROID, estradiol and dietary supplement (unspecified). On 17-OCT-2008 the patient experienced severe pain, neurological pain and difficulty in focusing after getting PNEUMOVAX 23 vaccine. At the time of this report, the patient was not recovered. The reporter also mentioned she had allergic reaction to ezetimibe (WAES# 0810USA05059), PRAVACHOL and ALTACE. Additional information has been requested.
Tingling in fingers on left hand. Slight tingling no numbness. Hasnt gotten worse or better almost 3 weeks after shot
After receiving PPD test and Hepatitis A vaccine, client fainted, falling back onto the exam table.  He woke up within 30 seconds asking what happened, color was a little pale.  He rested for a few minutes, was then given MENACTRA vaccine, and walked out to waiting room.  He did faint again about 10 minutes later waking up moments later.  He was sent to emergency room for observation normal recovery.
RASH ON LEFT ARM WITH A SMALL HARD NODULE FEELING FOR 3 DAYS
Information has been received from a medical assistant concerning a 67 year old male patient with no pertinent medical history or no drug reactions or allergy who on 02-JUN-2010 was vaccinated SC with a dose of ZOSTAVAX (Merck). Concomitant therapy included ibuprofen (manufacturer unknown). On 03-JUN-2010 the patient experienced shingles after receiving ZOSTAVAX (Merck). The patient developed rash from left buttock and radiating down to the bottom of his left foot. It was reported that the patient said his foot was in pain like it was on the fire. The patient sought unspecified medical attention. No laboratory diagnostics studies were performed. At the time of the report, the patient was recovering. Follow-up information has been received from the medical assistant and a doctor concerning a patient with no allergies and no previous health problems who worked at a department store. On 01-JUN-2010, the patient was also seen in the office for left knee pain and took ibuprofen for it. It was reported that the patient was given the second dose of ZOSTAVAX (Merck) on 02-JUN-2010 and broke out with left leg shingles the next day. On 23-JUN-2010, photos were taken (result unspecified). At the time of the report, the patient was still off work due to pain. Left leg shingles was considered to be disabling by the reporter. Additional information has been requested.
Hives on chest starting at 12pm day after Hives and swelling on face starting at 6pm day after  General fatigue and not interested in food
The syringe separated from the needle and leaked out on my skin, it appears as i wasn't clear if i got the full dose; The syringe separated from the needle and leaked out on my skin; The pharmacist who administered the vaccine tried twice in giving the dose and same thing happen both times; don't know how much I got; I had a little tenderness, no pain; A spontaneous report was received from a physician, a 70-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced "PT had a little tenderness, no pain," "the syringe separated from the needle and leaked out on my skin," and "the pharmacist who administered the vaccine tried twice in giving the dose and same thing happen both times; don't know how much I  got."  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 01 Feb 2021, at 13:30, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012MZ0A/012M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 01 Feb 2021, during vaccine administration, the syringe separated from the needle and leaked onto the patient's skin. It wasn't clear if the full dose was given. The pharmacist administering the vaccine then tried to give a second dose and the same thing happened both times. The patient was not sure how much he received. No treatment was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The events of "the syringe separated from the needle and leaked out on my skin", and "the pharmacist who administered the vaccine tried twice in giving the dose and same thing happen both times; don't know how much I  got", were considered resolved on 01 Feb 2021. The event outcome of "I had a little tenderness, no pain" was considered 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 events, a causal relationship cannot be excluded.  Very limited information regarding these event/s has been provided at this time
Initial report was received from a healthcare professional on 07 October 2013. A 15-month-old male patient had received an injection of FLUZONE, lot number reported as U469CA (not a valid lot number) (route and site not reported) on 05 October 2013 at around 11:30 AM. Within a few hours on 05 October 2013, the patient developed a fever and subsequently a febrile seizure at around 7:00 PM. The patient was seen in the emergency room and dismissed without any tests needed. The patient had no previous neuro history or seizures. Outcome was not reported. Documents held by sender: None. Follow-up information received on 18 October 2013. Lot number was updated as U4697CA. Follow-up information received on 12 November 2013: The patient's name, birth weight, number of siblings (3 bros) and date of birth were provided. He had no illness at time of vaccination; no adverse event following prior vaccination; personal history of mild seasonal allergic rhinitis. The patient did not receive any other vaccination within 4 weeks prior to 05 October 2013 and no other medications. He had received his dose of FLUZONE in the right leg/thigh (0.25 mL). No relevant diagnostic tests/laboratory data were done at ER visit. The patient recovered on an unspecified date.
This is 78 years old male with past medical history of hyperlipidemia, BPH, hypothyroidism, and vitamin-D deficiency who presented to the emergency department with shortness of breath for 1 day duration. As per the patient he was recently diagnosed with COPD approximately 2 months ago , he underwent a pulmonary function test at that time, patient was put into inhalers that he does not recall the names and he stopped using them after he did not feel any improvement with using them. As per the patient has baseline is usually feels shortness of breath while walking, since last night he started feeling shortness of breath associated with wheezes, chills, nonproductive cough but he denies fever, chest pain, abdominal pain, nausea, headache, vomiting or contact with sick people.
PT complained of lump in her throat, she then denied any assistance with breathing. PT was monitored for 30mins. She then started to feel better. She was advised to seek medical attention if the problem returns or worsens.
Stroke.  I was hospitalized had to miss work and now recovering with PT and speech therapy.
Initial information received on 19-Nov-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 78 years old male patient who received vaccines FLUZONE HIGH DOSE and FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines was given. On 19-Nov-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ069AB via unknown route instead of PNEUMOCOCCAL VACCINE. On 16-Nov-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ048AB via unknown route in unknown administration site. It was a case of actual medication error due to wrong vaccine administered and extra dose administered. It was not reported if adverse event was experienced or not. 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.
Fever, Chills, Headache and joint and muscle pain. Fatigue.  48 hours. Resolved.
arthralgias in her knuckles, hands, hips, and all major joints in her body; Information has been received from a lawyer, regarding a case in litigation, and refers to female patient (pt) of unknown age. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or around 19-NOV-2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered and was diagnosed with arthralgias in her knuckles, hands, hips, and all major joints in her body. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered to be not recovered/not resolved. The reporter considered the event of shingles (herpes zoster) to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered the event of herpes zoster to be disabling.
I had nausea that lasted about a week and had fatigue and body aches and brain fog. I had a hip ache which got really bad after the vaccination.