chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse events were reported.; received one improperly stored dose of PNEUMOVAX 23 on an unspecified date.; This spontaneous report has been received from a pharmacist concerning to 1 of 19 patients, a 85-year-old male patient. The patients' historical condition, concomitant medications and drug reactions or allergies were not reported.   On 11-OCT-2019, the patient was vaccinated with an improperly stored dose (product storage error) of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route and frequency were not reported) lot # S012245, the expiration date: 09-FEB-2021 for prophylaxis.  The administered dose experienced a temperature excursion at lowest temperature below 36-degree Fahrenheit (32F) for 6 hours. Previous excursions were unknown by reporter. The temperature excursions were not detected by a data logger. No adverse events were reported.  This is one of several reports received from the same reporter. # 1909USA001561, 2003USA005392, 2003USA005393, 2003USA005394, 2003USA005395, 2003USA005396, 2003USA005397, 2003USA005398, 2003USA005399, 2003USA005400, 2003USA005401, 2003USA005402, 2003USA005403, 2003USA005404, 2003USA005405, 2003USA005406, 2003USA005408 and 2003USA005409. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: Unspecified; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S012245; expirationdate: 09-FEB-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information about the availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1909USA001561: US-009507513-2003USA005392: US-009507513-2003USA005393: US-009507513-2003USA005394: US-009507513-2003USA005395: US-009507513-2003USA005396: US-009507513-2003USA005397: US-009507513-2003USA005398: US-009507513-2003USA005399: US-009507513-2003USA005400: US-009507513-2003USA005401: US-009507513-2003USA005402: US-009507513-2003USA005403: US-009507513-2003USA005404: US-009507513-2003USA005405: US-009507513-2003USA005406: US-009507513-2003USA005408: US-009507513-2003USA005409:
Redness, swelling, tender area appx. 2 inch diameter around site of vaccine. Gave BENADRYL 1 1/2 tsp. still under observation.
Mother states "child had vomiting x2 on 2-2-17. On 2-2-17 child had hives on neck and cheeks. On Saturday had various hives on face and neck. "Reports "didn't take temp, didn't feel warm". mother called Dr's office was told to call HD since that was where vaccine was given. Mother called HD 2-6-17(pm).
Patient's husband stated patient's vaccinated upper arm was hot, sore/painful. The side effects started a couple hours after the vaccine and lasted >3 days. The husband couldn't remember how long the symptoms lasted, but he said the patient has since recovered.  The patient was not available for me to speak with per husband.
Strong injection site muscle pain, low grade fever, whole body joint & muscle aches: Lasted about 16 hours
PATIENT RECEIVED HER 2ND DOSE OF PFIZER ON 5/17/21 BUT RECEIVED HER BOOSTER SHOT ON 10/30/21, 17 DAYS TOO EARLY
arm hurts as normal; Initial information was received on 19-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age/gender patient who experienced arm hurts as normal while receiving vaccines COVID-19 VACCINE and INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot, formulation, strength, and expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date, the patient received a  dose of suspect COVID-19 VACCINE not produced by Sanofi Pasteur (dose,lot, formulation, strength, and expiry date: unknown) via unknown route in unknown administration site for Covid-19 immunization.  On an unknown date the patient developed a non-serious arm hurts as normal (pain in extremity) (unknown latency).  Action taken: not applicable for both suspects.  It was not reported if the patient received a corrective treatment for the event (arm hurts as normal).  At time of reporting, the outcome was Unknown for the event arm hurts as normal.
Rec'd vaccine Friday, Sunday body aches with mild vertigo. Monday same symptoms, still mild. Tues night into Wed exp. severe vertigo, nausea, sweating, went to Emergency Room. Given ANTIVERT & ZOFRAN. Discharged to home.
Patient admitted with complicated COVID-19 infection with resultant weakness due to critical illness myopathy and aphonia due to bilateral vocal cord paralysis. Upon arrival, due to severe respiratory distress, she was intubated. She was ultimately extubated 9/6/2021. Her treatment course included steroids, Remdesivir, antibiotics with Doxycycline, and proning. Her hospital course had been additionally complicated by DKA. Due to her prolonged hospital course, she now has LB>UB weakness. She also has aphonia due to bilateral vocal cord paralysis.  Patient was deemed medically stable and was transferred to Rehabilitation Center. This admission was within 6 weeks of receiving the COVID vaccine.
2 minutes after vaccines administered hive like rash note all over body and scalp. Appeared in no distress O2 Sat 100 Pulse 145 observed x 30 min hives cleared child comfortable. Will F/U with patient.
Info has been received from an RN concerning a female child who was vaccinated with the 2nd dose of MMRII. The RN reported that in early 11/05, the pt developed mumps. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. No further info is available.
4NOV97 1st report of swelling @ MMR inj site inc in pain, swelling & redness since given 28OCT97;6NOV97 lt arm becoming more difficult to use referred to MD;
Depleted milk supply for breastfeeding twins. Fatigue  Body aches Headaches
Pt recv vax on 1/20/99; on same day pt exp headache, rash w/ itch & palpitations
Rash was itchy; Hives; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the arm right on 08Apr2021 at 00:00 (at the age of 21-year-old) as a single dose for COVID-19 immunisation. Medical history included bee sting hypersensitivity. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 12:00, the patient experienced hives and rash was itchy. The patient received first vaccine from Pfizer and was completely fine. Arm did not hurt and did not feel sick at all. After second dose, felt fine as well. Until two days after got this rash/hives that would flare up. It's extremely itchy and can only guess it's from the vaccine because routine had not changed. It hives/rash comes and goes but was extremely uncomfortable and was not sure when it will cease. Therapeutic measures were not taken as a result of these events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event hives and rash was itchy was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Headache, body aches, nausea, fatigue, loose stools. Injection site red, hot, swollen, pain when using arm.
convulsive shivering/chills fever up to 102 F Excellerated heart rate, typically resting heart rate approx 75 bpm, during reaction BPM approx. 140, peaking at 190bpm. soreness body aches.
Fever of 102.2 degrees, nausea, vomiting, extremely swollen in the entire upper right arm. Required antibiotic and steroid, cream application
This spontaneous report was received from a other health professional (nurse) refers to a patient of unknown demographics. Patient's pertinent medical history and drug allergies were not reported. On 08-DEC-2014 the patient was vaccinated with one dose of RECOMBIVAX HB (dose, frequency, lot #, expiry date unspecified) that was exposed to a supported temperature excursion. No concomitant medications were reported. No adverse effect was reported. No product quality complaint (PQC) was reported. Causality was reported as not related to therapy with RECOMBIVAX HB. This is one of several reports received from the same source (MARRS # 1412USA004863). Additional information has been requested.
False positive HIV Elisa 4 test 3 weeks after vaccine followed by indeterminate differential assay despite high (100%) PREP adherence and no exposure. False positive confirmed by multiple negative ELISA 4 tests in weeks following and multiple negative hiv rna screenings in week following. No symptoms
Info has been received from a physician and an RN, through a mfr pregnancy registry, concerning a 36 year old white female with no previous pregnancies who on 8/31/04, was vaccinated with the 2nd dose of varicella virus vaccine live. There was no concomitant therapy. The RN reported that the pt was pregnant at the time of vaccination (LMP=8/27/04, EDD=6/3/2005). Unspecified medical attention was sought and it was noted that the pt did not have a local injection site reaction, varicella symptoms or herpes zoster symptoms post/vax. On 11/16/04, an ultrasound was within normal limits. The physician reported that during pregnancy, the pt developed mild oligohydramnios and in 5/05, at 37 weeks gestation, developed pregnancy induced hypertension. No other infections or illnesses were noted during the pregnancy. On 5/18/05, at 37 5/7 weeks gestation, the pt gave birth to a live born normal female, weighing 7 lbs 11 oz. No complications were noted during labor/delivery. The infant had no congenital anomalies or any features of congenital varicella zoster syndrome. No further info is available.
05/14/21 I woke up with typical heart attack symptoms ( pressure on chest, pain in left arm, nausea, dizzyness). I went to the ER where they found elevated  troponin levels. They admitted me to the hospital where more test were done (see below). On 05/17/21 they discharged me after troponin levels lowered and no cause was found for the heart attack. The official diagnosis was NSTEMI (non-ST elevation myocardial infarction) The second week of June I was able to do everything as I did before except exercise. 08/05/21 I did a cardiac MRI to check whether  Myocarditis was the cause, this came out positive. I decided not to take the 2nd Pfizer dose.
PATIENT WAS GIVEN COVID VACCINE AFTER BEYOND USE DATE OF 12/17/2022.
Indigestion for days in a row.  Throws up undigested food (from lunch time/dinner time)  in bed while asleep.  None of the food had been broken down.
RIGHT ARM WEAKNESS; RIGHT ARM PAIN; MUSCLE ACHES; HOT AND COLD; FLU-LIKE SYMPTOMS; FREEZING; This spontaneous report received from a patient concerned a 79 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, no alcohol consume, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and batch number: 206A21A expiry: 23-JUN-2021) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-MAY-2021, the subject experienced hot and cold. On 06-MAY-2021, the subject experienced flu-like symptoms. On 06-MAY-2021, the subject experienced freezing. On 06-MAY-2021, the subject experienced muscle aches. On 12-MAY-2021, the subject experienced right arm pain. On 14-MAY-2021, the subject experienced right arm weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot and cold, flu-like symptoms, freezing, and muscle aches on 07-MAY-2021, and was recovering from right arm pain, and right arm weakness. This report was non-serious.
I passed-out the morning after receiving the booster vaccine. The exact same thing happened after receiving my 2nd dose of the Moderna vaccine. This was a very sudden loss of consciousness that caused me to land face first. My face, head and neck still hurt.
Hives, shortness of breath, dizziness, blurred vision, ear ringing (like after a rock concert), headache all started 15-20 min after injection. I took Benadryl and applied clay to the hives. This allowed me to breathe and the hives stop spreading but came back every 4 hrs when the Benadryl wore off.   I reported all symptoms to my dr. She said the rest were not signs of allergic reaction to vaccine, but that I did have an allergic reaction. It is noted in my file.  List of other symptoms: within 12 hrs - projectile vomit/diarrhea - I had not ate before work so this was not food poisoning or disagreeable stomach, tingling in hands and feet, light headed Vaccine +1 day: cramps in legs/feet, tingles in legs & hands, stomach pain, blurred vision, shortness of breath, extreme fatigue (these have all continued as of 6 weeks after  Vaccine +3 days: very heavy, thick pudding consistency period, never had anything like this. OBGYN said abnormalities happen after vaccine not to be concerned  Scheduled Covid test because some symptoms aligned with Covid and had positive exposure at work. Tested Negative. Vaccine +8 days: hair started falling out in clumps,  Had phone appt with dr she requested in person and ordered follow up lab work to my lab work taken 1 week prior to vaccine.  Vaccine +26 days still having symptoms plus 6 day long period (mine are always 4)
Hives; Itching all over body in random spots; Occasional stinging sensation mainly on arms; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 16:00 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. Medical history included Wolff-Parkinson-white syndrome (WPW) and neurocardiogenic syncope. The patient previously took paracetamol; oxycodone hydrochloride (PERCOCET) on an unknown date and experienced drug allergy.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cetirizine hydrochloride (ZYRTEC), butalbital, caffeine, paracetamol (FIORICET), fludrocortisone (MANUFACTURER UNKNOWN) and desogestrel, ethinylestradiol (APRI) all started from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 17:00, the patient experienced hives, itching all over body in random spots and occasional stinging sensation mainly on arms. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events hives, itching all over body in random spots and occasional stinging sensation mainly on arms were recovered on an unknown date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Itchy, warm rash. Very swollen and sometimes painful lymph nodes under armpit. Same side as injection.
Rash on face, hands shaking, can't hold anything, feels dizzy when stands up;
Diffuse hyperkeratotic rash on arm : legs - minor : without urticaria. improving.
Chills; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.            No concomitant medication was reported by the reporter. No treatment was reported by the reporter.   This case was linked to MOD-2021-340950, MOD-2021-340922 (Patient Link).
TIREDNESS; FLU LIKE SYMPTOMS; BODY ACHES / PAINS; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (TIREDNESS), VACCINATION SITE PAIN (BODY ACHES / PAINS) and INFLUENZA LIKE ILLNESS (FLU LIKE SYMPTOMS) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN (BODY ACHES / PAINS). On an unknown date, the patient experienced FATIGUE (TIREDNESS) and INFLUENZA LIKE ILLNESS (FLU LIKE SYMPTOMS). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, FATIGUE (TIREDNESS), VACCINATION SITE PAIN (BODY ACHES / PAINS) and INFLUENZA LIKE ILLNESS (FLU LIKE SYMPTOMS) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided by the reporter.  Upon internal review on 05-AUG-2021, age was corrected to 76 years as a discrepancy was noted where the narrative in the source document reported patient DOB with one date;  however in the patient identifier section the patient DOB was reported as a different date. Thus, considered the year (in the patient identifier section) as a typing error and corrected patient DOB with the year as reported in the narrative of the source document.
Rash-raised red rash limited to her L arm, red and blotchy (hot to the touch), fever the next day (low grade) and aches in her upper trunk. She said movement and ice helped.
Nausea,  aches and pains, fever over 100, dizziness and chills.
pain in left knee; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (pain in left knee) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced ARTHRALGIA (pain in left knee). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, ARTHRALGIA (pain in left knee) 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.
Approximately 12 hours after vaccination the patient developed a rash consistent with erythema multiforme. It completely resolved in 24 hours. An urticaria lesion surrounded the vaccine site. (+) fever. 02/02/07-records received and reviewed for DOS 01/06-01/09/07 DC DX: Viral lower respiratory tract infection Fever resolved Seizures ruled out History of CHARGE syndrome history of 36 week prematurity ventriculary septal defect. Club foot, intestinal malrotation PMH:club foot atrial septal defect ventricular septal defect delayed nitration of nerves cataracts choanal atresia Presented to ER after several days of fever , history of vesicoureteral reflux takes amoxicillin prophylaxis. Seizure noted in ER
The pt had an enlarging redness, initially on left thigh on 3/12/02 and had increased redness. Then on 3/13/02, had increased redness and itching began.
getting the vaccine being 10 weeks pregnant; local reaction had appeared very close to the vaccine spot; it also was itching as an allergic side-effect; Little tired; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (getting the vaccine being 10 weeks pregnant), VACCINATION SITE REACTION (local reaction had appeared very close to the vaccine spot), VACCINATION SITE PRURITUS (it also was itching as an allergic side-effect) and FATIGUE (Little tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Nausea in pregnancy. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (UNISOM [DIPHENHYDRAMINE HYDROCHLORIDE]) and VITAMIN B6 for Nausea in pregnancy.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 05-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (getting the vaccine being 10 weeks pregnant). In April 2021, the patient experienced VACCINATION SITE REACTION (local reaction had appeared very close to the vaccine spot), VACCINATION SITE PRURITUS (it also was itching as an allergic side-effect) and FATIGUE (Little tired). On 05-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (getting the vaccine being 10 weeks pregnant) had resolved. In April 2021, VACCINATION SITE REACTION (local reaction had appeared very close to the vaccine spot), VACCINATION SITE PRURITUS (it also was itching as an allergic side-effect) and FATIGUE (Little tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was 10 weeks pregnant. One week ago she was 10 weeks pregnant and decided to get vaccinated, it was a personal choice as doctors and CDC have recommended. After 4-5 days a local reaction had appeared very close to the vaccine spot, it also was itching as an allergic side-effect. She was not sure but she was taking anti-histaminic (Unissom) and vitamin B6 as part of my nausea healing, it may contribute to heal more quickly. Fortunately, It went away after 2 days. Patient said it was important to mention that I did not have any other symptoms, just a little tired the day after, no fever though. She might have allergy to some ingredient and as it is local and went away. She was looking forward to having her second dose in April 30th.  No treatment medications were reported
Pt called very concerned about large lump, swelling and pain in whole arm at injection site.  She is also complaining of fever and chills.  Discussed that it sounded like a possible side effect.  She thinks it is more than that.  She has been icing the area for 3 days and it is getting worse.  Recommended she check with her doctor on 5/2.