chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer and described the occurrence of arm hot at application site in a 56-year-old female subject who was vaccinated with Influenza vaccine (unspecified, GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included autoimmune disorder, Hashimoto's disease and mitral valve prolapse. Concurrent medications included LIPITOR, Multivitamin, Vitamin C, Biotin, Vitamin B12 and Vitamin D. In 2011 (either the last week in September or the first week in October) the subject received a dose of known GlaxoSmithKline Seasonal Influenza vaccine (unspecified) on the back, underside of her arm. In 2011, 1 day after vaccination with Seasonal Influenza vaccine, the subject experienced arm hot at application site. Two days after vaccination with Seasonal Influenza vaccine, the subject developed injection site pruritus, injection site pain, extensive swelling of vaccinated limb (underside of arm 3 to 4 inches (101.6 mm) long and half an inch swollen ("felt like skin stretching"). Also reported with no specific onset date was injection site discomfort. The subject was treated with Cold compress. At the time of reporting, the events were resolved with the exception of periodic itching (improved). The subject also reported reactions to previous flu vaccines (manufacturers unspecified). The subject stated that she has received flu vaccine very year for the last "8" years, prior to the report of this year (received at Pharmacy). The first "vaccine" she ever received, she reported feeling sick, like a "mini flu". Other times she reported a sore arm about a day or so after the injection, but nothing other than that.
No side effects were reported/No other additional AEs/no PQC.; HCP calling to report an adult received a pediatric dose of VAQTA inadvertently.; This spontaneous report was received from a Registered Nurse referring to a 71-year-old male patient. The patient's medical history, concurrent conditions and concomitant medications was not reported.  On 24-OCT-2023, the patient was vaccinated inadvertently with a pediatric dose (0.5 milliliters) of Hepatitis A Vaccine, Inactivated (VAQTA) (lot # W023937 has been verified to be a valid lot number, expiration date 06-DEC-2023) (Incorrect dose administered) (strength, dose number, route of administration and anatomical location were not provided) administered as prophylaxis. No side effects was reported.
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDIS vaccines were stored in improper temperatures were administered to overall number of 132 patients. This report refers to one of the patients involved, a patient of unspecified age and gender, who had administered dose of GARDASIL on 05-AUG-2013 (lot # H011350, Expiration Date: 21-FEB-2015). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Woke up with a headache on Tuesday morning at 0700 am (had vaccine Saturday evening)  Took Tylenol and went back to sleep.  Was still present 3 hours later but milder.  Headache completely resolved by 3:30 pm on Tuesday.  No further signs or symptoms.  No further intervention required.
Patient was in attendance at the JANSSEN vaccination clinic on 4/9/21.  After vaccination while he was in the observation area, PT experienced a syncopal episode and hit his head on the window sill next to where he was sitting.  Staff responded and assessed PT and decided to initiate a MET call.  There was concern that the patient may have experienced a seizure.  Patient was taken to the Emergency Department.  Patient was ultimately admitted on 4/9/21 with new onset of a. fib.  He was discharged on 4/11/21.  While hospitalized, the patient received IV cardizem
Menopaused and got period; This spontaneous case was reported by an other health care professional and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (Menopaused and got period) in a 7-decade-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Menopause.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (Menopaused and got period). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (Menopaused and got period) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  Company Comment: This spontaneous case concerns a 7-decade-old female patient, with relevant medical history of Menopause, who experienced the unexpected event of Postmenopausal haemorrhage. The event occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. This case is downgraded to non-serious due to the lack of evidence of seriousness from a clinical or regulatory standpoint.   This case was linked to MOD-2022-485039 (Patient Link).; Sender's Comments: This spontaneous case concerns a 7-decade-old female patient, with relevant medical history of Menopause, who experienced the unexpected event of Postmenopausal haemorrhage. The event occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. This case is downgraded to non-serious due to the lack of evidence of seriousness from a clinical or regulatory standpoint.
EMS called to a 34 y/o female limp in a chair with head titled back being held up by her husband with decreased level of consciousness after receiving first dose of Pfizer vaccine in left arm. Pt states she is having trouble breathing and she's gasping for air. Unknown past medical history, with known allergy to Novocaine Pt's eyes rolled back and she went unresponsive to verbal and painful stimuli Auvi-Q epinephrine auto-injector 0.3mg administered via IM to left lateral thigh and she was placed on Oxygen 15lpm via Non-Rebreather Pt was transferred to stretcher and removed from arena floor and taken to EMS room for further treatment and assessment. First set of vitals taken at 16:49 hours BP- 76/49,  HR-129 , SPO2-100% supplemental O2 , BGL-108 , RR-10 shallow and labored ,4-lead ECG-NSR 20G IV was established in left AC and 1L of NS KVO initiated at 16:51 hours, lung sounds are clear Pt and vitals reassessed after five minutes Pt's mental status has improved since initial pt interaction Second set of vitals taken at 16:55 hours BP- 159/82 , HR-116 , SPO2-100% supplemental O2 , BGL-108 , RR-12-normal and non-labored, 4-lead ECG- NSR Pt is alert at this time, BP has improved and pt is able to speak now but she still appears drowsy  Rescue arrived, pt was transferred over to their stretcher, care was transferred over to rescue personnel and she was transported to hospital
her menses started 12 days early, within 18 hours of the second shot; This is a spontaneous report from a contactable consumer (Pfizer Colleague). A 40-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's menses started 12 days early, within 18 hours of the second shot on an unspecified date. The outcome of the event was unknown. Information on the lot/batch number has been requested.
Information has been received from a consumer concerning her approximately 61 year old mother with lung disease, heart problems, iodine allergy, penicillin allergy, MSG allergy, sulfa allergy and morphine allergy who was vaccinated on an unspecified date with a dose of pneumococcal 23v polysaccharide vaccine (lot # not reported). The reporter stated that the patient was on other medications but she could not recall the names. In 2000 the patient became extremely ill for at least one week. Unspecified medical attention was sought. The patient's outcome was not reported. Extremely ill was considered to be disabling. Additional information has been requested.
red raised have like rash starting on arm of inject w/in 1/2; rash has spread all over body;  itching & very uncomfortable; sent to see MD;
Flu like symptoms; intense body aches; felt very worn down; ache; could not get comfortable; nor sleep solidly; Slight fever for 3-4 days; Joint pain was pretty intense; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Dec-2021 and was forwarded to Moderna on 14-Dec-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (intense body aches), MALAISE (felt very worn down), PAIN (ache) and DISCOMFORT (could not get comfortable) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Codeine allergy).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (intense body aches), MALAISE (felt very worn down), PAIN (ache), DISCOMFORT (could not get comfortable), SLEEP DISORDER (nor sleep solidly), PYREXIA (Slight fever for 3-4 days) and ARTHRALGIA (Joint pain was pretty intense). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (intense body aches), MALAISE (felt very worn down), PAIN (ache), DISCOMFORT (could not get comfortable), SLEEP DISORDER (nor sleep solidly), PYREXIA (Slight fever for 3-4 days) and ARTHRALGIA (Joint pain was pretty intense) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It lasted for about 2 days intensely and then another 2 of milder symptoms. No concomitant medication information provided by the reporter. No treatment information provided.   This case was linked to MOD-2021-395635, MOD-2021-413020 (Patient Link).
No additional AE reported.; Caller is a medical assistant calling to report an adverse event for M-M-R II, VAQTA, and VARIVAX. Caller reports that the patient was administered all three vaccines on 13JUL2022, after they were exposed to a temperautre excursion.; This spontaneous report has been received from a medical assistant and refers to a patient of unknown gender and age.  The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 13-JUL-2022, the patient was vaccinated with improperly storage dose of measles, mumps, and rubella (Wistar RA 27-3) Virus Vaccine, Live (rHA) (M-M-R II) injection (lot number U022983 which has been verified to be valid, expiration date reported and validated as 22-JUL-2023), hepatitis A vaccine, inactivated (VAQTA) injection (lot number U038841 which has been verified to be valid, expiration date reported and validated as 06-MAR-2023), and varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot number W002599 which has been verified to be valid, expiration date reported and validated as 24-JAN-2024). All of the vaccines were administered at a dose of 0.5 milliliters (ml) as prophylaxis (strengths, routes of administration, and anatomical sites of injection were not reported). The administered dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (rHA) (M-M-R II) and hepatitis A vaccine, inactivated (VAQTA) were stored at a temperature of 65 degrees Fahrenheit (F), during a time frame of 17 hours; the dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) was stored at a temperature of 67 degrees F, during a time frame of 17 hours (product storage error). There was no previous temperature excursion No additional adverse events were reported in the patient.
Approx 18 hours after the vaccine: Cold and hot flashes with chills (no fever) weakness, fatigue, slight left arm ache, loss of appetite, insomnia, body/joint aches.  I took a couple of Aleve tabs 24 hours after the vaccine and then switched to 500 mg Tylenol 30 hours after the vaccine, with no relief of symptoms from either meds.  I've been sleeping (taking 2 hour naps) and called off of work (I work in home health).   Today, 1.27.21 I feel better, still having 'hot flashes' and some chills (again, without fever).  I feel tired, slept last night for 12 hours (no further insomnia).  I am eating, but really have no appetite.
Fever of 101.7- normal 96.8, extreme body aches,  arm pain, redness at injection site all lasted 2 days, chest pain and pressure
This spontaneous case, initially received on 19-Dec-2016, was reported by a health professional and concerns a(n) 59-year-old female patient. Weight: not provided; Height: not provided. Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): The patient received AFLURIA from 21-NOV-2016 to 21-NOV-2016. Dose regimen: 0.5 ml, Route of administration: Intramuscular, Batch number: WT57008. No additional suspect drugs. Between 20-Nov-2016 and 21-Nov-2016, the AFLURIA vaccine underwent first excursion. The vaccine was stored at 35.78 degree F for about 2 hours. The pharmacist stated that the thermometer was fluctuating in the previous location in the refrigerator and was moved to the top shelf. On 21-Nov-2016, the patient received the vaccine that underwent temperature excursion. Special circumstances: Incorrect product storage without adverse event. Drug administration error without adverse event.
Evening 10/31/12 felt "getting flu", upper arm sore/bothersome. Body achiness/arm throbbing. 10/15/12 upper arm still sore. Felt run down past week; joints ache more than usual.
Individual received first dose of Pfizer at another clinic. Arrived to the site on 4/9/2021 and received a second dose of  Modern
Pt received the 3rd Covid vaccine on 9/8 and on 9/10 started having shortness of breath and chest tightness. She continued to have these symptoms and presented to our emergency department on 9/14 and was found to have an acute, large saddle pulmonary embolism.
The pediatrician had patient sit on the table for a few minutes after the vaccine was given to make sure she didn?t get dizzy. She was fine after that time was up, she jumped off the table and walked down the hall fine. We went to check out and she collapsed. She passed out, she was stiff and gargling. At her mouth so I tried to roll her over in case she vomited or anything but she was stiff so it was difficult to do so. She was twitching a bit as well. She was monitored and released from the pediatrician afterwards.
A report has been received from a Health Professional concerning a patient, Male subject, who had been receiving Nasal (INTRANASAL), 0.1 mL into each nostril for VACCINATION. FLUMIST (INTRANASAL) started on 06-Nov-2014 for VACCINATION. It was reported that patient had experiencing wrongful administration. The outcome of the event was WRONGFUL ADMINISTRATION is unknown. The report was considered to be non-serious. The reporter considered that there was no causal relationship between WRONGFUL ADMINISTRATION and QLAIV. The reporter and company physician considered the event of wrongful administration with the suspect drug of QLAIV to be unrelated.
Severe headache, muscle cramping, aches and general body pain.  Started 12 hours after receiving vaccine and lasted for about 36 hours.
Flublok QIV administer to 17 years old female patient / no AE; Initial information received on 24-Jan-2020 regarding an unsolicited valid non-serious case received from a non-hcp (other).  This case involves a 17 years old female patient who received 0.5 ml vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number-QFFAA and Expiry date unknown) via unknown route in the left deltoid on 21-Nov-2019 for Prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to inappropriate age at vaccine administration.  At the time of reporting no adverse reaction was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  The batch number information was requested.
Swollen, red and painful to touch area (upper arm). Hives on my upper right arm. This lasted for 2-3 days.
A  rash appeared on right arm starting just below the injection site. Rash was very red and slightly raised. Hot to the touch, not itchy but sensitive when touched. Rash faded and spread slightly over the next week. Rash appears to be more noticeable after being exposed to heat, like after a shower.
This spontaneous report was received from a medical assistant and refers to multiple unspecified number of patients of an unknown age and gender. There was no information about the patients pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. The reporter stated that improperly stored doses of RECOMBIVAX HB lot number L029631, expiration date 14-AUG-2017; and lot number L000717, expiration date 14-APR-2017(strength, dose, frequency, route of administration, and anatomical location were not provided) were administered to a multiple unspecified number of patients for prophylaxis. The vaccine was exposed to a temperature of 67 Fahrenheit degrees for 16 hours. There was no previous temperature excursion, and the call was not because of a data logger. No adverse effects reported. There was no product quality complaint involved. This is one of several reports received from the same soured. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA004337: US-009507513-1706USA004336: US-009507513-1706USA004338:
Patient says he experienced cob web/spider web feeling all along the left side of his face/head. Its not constant but it came up the day after he received his vaccinations. It doesn't prohibit his daily activities but its a nuisance.
Pain in arm; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) and VACCINATION SITE PAIN (Injection site pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No medical history provided by the reporter.  Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in arm) and VACCINATION SITE PAIN (Injection site pain). At the time of the report, PAIN IN EXTREMITY (Pain in arm) and VACCINATION SITE PAIN (Injection site pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient didn't take any treatment.   Reporter did not allow further contact
Chicken pox like rash with low grade fever, cough, irritability-mild. Tow bacterial conjunctivitis treated with no smoking and opthalmic solution and Zithromax for bronchitis.
Injection site pain, tiredness, headache, muscle pain, joint pain, nausea, feeling unwell, swollen lymph nodes.
Patient stated he had food allergies and was starting to feel itchy (face/mouth) after 15 minute wait period.  Advised to wait 15 more minutes. After another 15 minutes, his lips were feeling numb. Was administered Benadryl
mild pain in left breast which was on and off; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (mild pain in left breast which was on and off) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concomitant products included METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET), SIMVASTATIN, RAMIPRIL, MINERALS NOS, VITAMINS NOS (CENTRUM), UBIDECARENONE (COQ 10), CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B-12), FISH OIL, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D3) and CINNAMOMUM CASSIA BARK, THIOCTIC ACID (CINNAMON) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced BREAST PAIN (mild pain in left breast which was on and off). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, BREAST PAIN (mild pain in left breast which was on and off) outcome was unknown. Not Provided      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.   The patient's concomitant medications also included Curalin for an unknown indication.   This case was linked to MOD-2021-067496.