chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Back & left shoulder muscle pain and immobility, left arm numbness, left hand fingers tingling; increase neck pains; increase arthritis pain throughout body; increased lower body weakness; increased loss of balance; difficulty sleeping; visited doctor MD (DO) 1/7/15 (diagnosed as "Inflamed Tendon, Bursa and Cartilage"; Blood test 4/28/15 relatively normal Vitamin B-12 low; DO 5/19/15 Regional Musculoskeletal Dyfunction; Skeletion Evaluation 5/11/15; pain medicines, exercise and referral to professional physical therapy.
At 8:30PM patient exhibited a cough and throat tightness. Symptoms continued through the night. Patient woke up with full body hives, lip swelling, swollen throat, and left arm swelling. Patient has had the flu shot vaccine in the past with no issues. The Shingrix is a new vaccine for this patient.
arm could hardly be raised in evening and had large lump at injection site, woke up around midnight with bad chills, felt feverish and dizzy.  Stayed in bed and slept pretty much until 2:30 when was woken up by wife.  around 11:00am on 03/05/2021 face looked swollen and still feverish and dizzy.  Wife called the hospital and spoke to a nurse who wanted him to be woken up to check facial swelling and advised going to a walk in clinic or emergency room.  face looked better so did not go, he went back to bed around 7:00 p.m and the next morning on 03/06 still felt light headed and not normal.  Today 03/10/2021 still doesn't feel right still some light headedness, just not normal at all.
He felt sick the following day.(Monday) On Tuesday he still felt sick. Wednesday he felt better, but began to wheeze. He started taking his Xopanex to help him breathe. By Saturday he had to have his xopanex every 4 hours and it would not work. We increased his dosage, but it still wore off. On Sunday he was prescribed a steroid. The steroid didn?t work completely. On Friday he was prescribed more steroids and a separate bronchodilator. He finally felt better the following week.
Severe abdominal cramps, nausea, vomiting, inability to eat, severe fatigue for two days now
Staff gave a low dose of Moderna vaccine to patient. She administered .25 ml as if the patient was getting a booster when he should have received the .5 ml Primary dose. The error was caught at the end of the patients observation time. My supervisor was notified and I was told to follow guidelines and administer another .25ml to acquire the equivalent  of .5ml which would be a primary dose.  The patient received the second half with no complications after observing him again for an additional 15 minutes.
22 year old patient received FLUZONE HD/ NO AE; 22 year old patient received FLUZONE HD/ NO AE; a patient received FLUZONE QUAD and FLUZONE HD on same day/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a Pharmacist via Agency(Reference number- 00438020) via call-center and transmitted to Sanofi on 20-Jan-2021.  This case involves a 22-years-old female patient who received 0.5 mL INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (batch number and expiry date not reported) in right deltoid and INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (batch number: UJ507AA and expiry date: 30-Jun-2021) in left deltoid on same day 20-Jan-2021 for prophylactic vaccination (extra dose administered, product administered to patient of inappropriate age and overdose).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to extra dose administered, overdose and inappropriate age at vaccine administration (latency: same day).  Patient received no other vaccines or medications.  At the time of reporting, no adverse event 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.  There will be no information available on the batch number for FLUZONE HIGH-DOSE QUADRIVALENT for this case.
Pt recv vax on 11/13/98; on 11/23/98 pt exp runny nose & chicken pox-like rash
Rash, swelling, muscle pain, heat and bruising at injection site, lethargic, itching
Pt was transferred from an outlying facility as a trauma patient after a ground level fall.  Pt had a left hip fracture.  Pt was found to be COVID positive.
Noticed swelling/edema in lower and upper extremities around 5:30 pm on 8/18/2021, eyes were delilated, increased heart rate, and called 911. Patient went unresponsive and was rushed to the ER. Gave numerous does of epinephrine and was intubated at the Hospital.  Was discharged on 8/20/2021.  Reports fever off and on, racing heart since receiving the vaccination
fever, slugglish, sore throat, started on Friday cont on Saturday; does feel a little better; sweating on Sunday does feel sl fever still;
Patient selected "no" that they had not previously had a covid vaccine on form, and disclosed this was their first vaccine despite previously having a Moderna series.
This spontaneous report has been received from a medical assistant, concerning to an unspecified patient of unknown age and gender. The patient's medical history, concurrent condition or concomitant medications were not reported. On 13-JUN-2017, the patient was vaccinated with an expired dose of GARDASIL 9 lot # M014929 and expiration date 27-MAY-2017 (dose and route of administration were not provided) for prophylaxis. No symptoms were reported. There was no product quality complaint involved.
Patient called stating that on 09/08/2023 he received a flu shot and the RSV shot (Arexvy) and over the next couple days, he developed very painful "sciatica" pain in his low back and hip.  He had never experienced this type of pain before.  He stated it lasted approximately 3 weeks and then resolved. He did not seek medical care, just managed at home.  Since he had never had the RSV vaccine before, and could not recall any other changes at the time, he thought it could have been an adverse reaction to the RSV shot and wanted to report to the pharmacy.
1/28/21 and 2/17/21:  Case received Pfizer vaccine  3/20:  Developed symptoms of COVID 3/23:  Tested positive -  SARS-CoV-2 RNA Resp Ql NAA+probe~SARS-COV-2 (COVID-19) As of 3/24: Case is isolating at home
Patient received flu vaccine on 11-10-14 at a community health flu clinic. After 3 days of soreness, pain worsened. By the middle of last week pain began to limit patient's ROM, has disrupted sleep, and has impacted ADLs. At rest pain described as dull ache (2-3) when moving pain described as 8-9. Seen by MD. Rx 600mg Ibuprofen, ice and tests ordered. MD and RN to check-in with patient to monitor for worsening/improvement.
PATIENT STATED SHE HAD EXTREME FATIGUE,  MIGRAINE, BODY ACHES AND EXTREME TIRENESS THAT LASTED FOR THREE DAYS.
Infant cried inconsolably first 24 hours. Low fever (99-101) first five days. Regression of development and social withdrawal noticed within 24 hours. Infantile spasms first observed 14 days after vaccines and resulted in permanent developmental disability. 60 day follow up: Pt was diagnosed with Moyamoya disease this January, and underwent bilateral neurosurgeries in March. Her Moyamoya disease is the likely underlying cause of her seizures and delays. Her vaccines probably did not affect her underlying disorder, but perhaps the underlying problem made pt more sensitive to the Dpat and other vaccines. Information from medical records states cerebral circulation impairement. msv
Lateral aspect of left upper arm reddened and raised. Area extends entire length and width of upper arm and is painful to the touch.
REDNESS ACROSS JOINTS, IT DECREASES RANGE OF MOTION IN THE JOINT BUT WITHOUT PAIN, FEELS TIGHT AND HOT. MAIN JOINTS THAT ARE AFFECTED ARE KNEES, ELBOWS, AND WRISTS, AND LESS COMMONLY ANKLES; BENDING AT THE WAIST IS DIFFICULT; DIFFICULTY BREATHING; FULL BODY HIVES; FLUSHING; EXTREME DRYNESS; This spontaneous report received from a patient via a company representative concerned a 25 year old male. The patient's weight was 185 kilograms, and height was 67 inches. The patient's concurrent conditions included: high blood pressure, chronic migraines, and non smoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. Non-company suspect drugs included: nortriptyline (form of admin unknown, oral, batch number was not reported) 25 mg, every 1 day, from 30-AUG-2021, frequency was not reported, 50 mg, every 1 day, frequency, and therapy dates were not reported, and 25 mg, every 1 day from 09-NOV-2021 to MAR-2022, frequency was not reported for an unspecified indication. Age at time of vaccination 25 years old. No concomitant medications were reported. On 09-NOV-2021, the patient experienced extreme dryness. On 13-NOV-2021, the patient experienced flushing, and full body hives. On an unspecified date, the patient experienced redness across joints, it decreases range of motion in the joint but without pain, feels tight and hot. main joints that are affected are knees, elbows, and wrists, and less commonly ankles, bending at the waist is difficult, and difficulty breathing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with nortriptyline was withdrawn on MAR-2022. The patient had not recovered from flushing, and full body hives, and the outcome of difficulty breathing, redness across joints, it decreases range of motion in the joint but without pain, feels tight and hot. main joints that are affected are knees, elbows, and wrists, and less commonly ankles, bending at the waist is difficult and extreme dryness was not reported. This report was non-serious.
Fatigue, vomiting,  swollen left eye and then turned to a black eye for 10+ days
Neuropathy left cheek, radiating up and down my face. It started in the late afternoon after I received the vaccination.  It would get more intense throughout the day. I thought I was having a stroke. After sleeping it wasn't as intense, the more active I was it would intensify. I went to clinic on 1-07-2021 because I still have neuropathy on my left side of my face. The Provider tested me to see if I had Bells Palsy. He said I didn't, he recommended I see a Dentist, he thought I probably had a tooth infection. I went to the Dentist at 3 p.m. on 1-07-21. They took a panoramic x-ray of my teeth. The dentist adivsed me that I did not have a infected tooth. I limited my activity for the jrest of the day on 1-7-21. I still have the neuropathy.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 08-APR-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) injection, lot # L044058, expiration date 02-MAY-2017 (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 9.9 degrees Fahrenheit for 163 hours and 30 minutes. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Injec. site became red and indurated. Patents' mother describes purulent blisters approx. 1wk after administration
fatigue; sore arm; headache; This is a spontaneous report from a contactable Nurse (patient). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Dec2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. Patient had fatigue, a sore arm, and a headache following the first shot on unknown date. The outcome of the events was unknown. Information on the lot/Batch number has been requested.
This spontaneous report as received from a pharmacy technician refers to a 4 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 15-MAR-2018, the patient was vaccinated with improperly stored dose of Oka/Merck VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The Oka/Merck VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
Adverse rxn to ZOSTAVAX right arm. Patient developed redness at site of injection w/ a 4-5 inches in diameter w/ a few tiny blisters in the center. The affected site was itching and was tender to touch. No other symptoms were reported.
Full body itching at bed time. Woke up with full body rash & itching. Took systemic antihistamine (generic Allegra).
Loss of appetite lasting 14+ days Weight loss of 10 pounds in less than one month Excessive sweating at night starting first night lasting 21+ CONSECUTIVE  days  (I am not close to menopause) Excessively heavy and painful period after absence of period for 1 calendar year  Exhaustion lasting from day of injection for 3+ days after  Severe acne break out localized to neck
It did bring my periods on 10 days early; it started my period back up again; Have allergic reaction to Penicillin and to other drugs (Unspecified Medications); Have allergic reaction to Penicillin and to other drugs (Unspecified Medications); It did bring my periods on 10 days early; it started my period back up again; Stomach start hurting and it start cramping; cramping sensation; Stomach start hurting and it start cramping; cramping sensation; This is a spontaneous report from a contactable consumer. A 45-Year-old female consumer (patient) reported that patient received Bnt162b2 (BNT162B2; Formulation: Solution for injection; LOT#: Consumer stated, "I don't have my card it's in the other room." expiry date of COVID-19 vaccine: unknown) Intramuscularly from 08Jun2021 1st dose (13:00) on left arm for COVID-19 immunization. Patient's medical history includes bleeding disorder. No family medical history reported. Concomitant medications include Penicillin G Benzathine,Penicillin G Procaine (PENICILLIN G BENZATHINE,PENICILLIN G PROCAINE; Formulation: unknown). Additional Questions includes time of Administration which consumer stated, "It was around I want to say 1 o'clock in the afternoon." Anatomical Site of administration includes consumer stated, "It's my left arm and it was in the upper muscle." About route of administration consumer stated, "It was intramuscular, in the muscle, must be at the 'bottom of the side'. I asked them, at the administer that it did concern me and they told me that they had changed a little bit of where the site had to be at instead of where it normally could be at so, she said it was at the top and that is where the muscle area is." (Further clarification was unknown). Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. About other medical conditions consumer stated, "Just the Bleeding disorder I have in the (incomprehensible voice) that is all." And treatment in response to adverse event consumer stated, "No I didn't. I just ate cucumber that's all. I ate cucumber." It was reported that "I just want to let somebody know because I got the shot yesterday. I was slightly okay until we drove to the other side to wait when we need our card and my stomach start hurting and it start cramping and then when we were sitting there, I do have allergic reaction to 'berries' and Penicillin and to other drugs (Unspecified Medications) and we were sitting there and all of the sudden, my stomach was cramping and it was the cramping sensation and I tried to put it out of my mind because I said I hope it doesn't bring my period up and it did bring my periods on 10 days early. I am 10 days early on my period and I just got off my period not too long ago and it started my period back up again from the drug (Intent: COVID-19 Vaccine) so and I am supposed to take it again the second dosage in 2 weeks probably 29th or so I don't want it to occur again for me to start my period again because I do have a bleeding disorder (Later clarified as medical history) it cause my period to come early, 10 days early." The outcome of the events was unknown. Information on Lot/Batch number has been requested.
pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD; Date the vial was initially stored in the refrigerator 23-DEC-2022,some pediatric 6m-5y recived the dose after the BUD; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator 23-DEC-2022,some pediatric 6m-5y recived the dose after the BUD) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator 23-DEC-2022,some pediatric 6m-5y recived the dose after the BUD) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator 23-DEC-2022,some pediatric 6m-5y recived the dose after the BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator 23-DEC-2022,some pediatric 6m-5y recived the dose after the BUD).    No concomitant medication was reported.    Date the vial was initially stored in the refrigerator on 23-DEC-2022.The vial did not undergo any temperature excursions. No treatment information was reported.  This case contains information for Patient no-24 out of 42 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-718298 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718298:Master case
This spontaneous case, initially received on 02-Nov-2017, from other health professional (nurse) and concerning a patient of unspecified age and gender. The patient's medical history and concomitant medications were not reported. On 01-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left or right deltoid (as reported), batch number: 195128, expiry date: 30-Apr-2018). It was reported that, a dose from a leaking FLUCELVAX Quadrivalent multi-dose vial was administered to a patient (explicitly coded as product leakage and drug administration error). The reporter (nurse) stated that, the vial had been used once but when she was about to administer the second dose from that MDV, she discovered it was leaking and did not give it to the patient. The metal rim around the stopper was slightly lifted in a spot and was very thin. It was reported that, 25-gauze syringe of 1-inch needle was used and packaging was not damaged. No adverse event was reported after the vaccination. As per PTC (product technical complaint) (PTC reference number: 1025735) investigation performed, it was concluded that FLUCELVAX Batch 195128 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process. However, a known trend was identified for the FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for vials leaking at the stopper during dosing due to air being added to the vial. The most likely root cause could be attributed to improper handling by the user. The report was considered as non-serious. Follow up received on 15-Dec-2017: The PTC investigation results were updated. It was reported that, the metal rim around the stopper was slightly lifted in a spot and was very thin, 25-gauze syringe of 1-inch needle was used and packaging was not damaged. The narrative was amended accordingly. Follow up received on 28-Dec-2017. The vaccination date (01-Nov-2017) was updated. The reporter confirmed that, the 0.5 ml dose was administered to the patient. The narrative was amended accordingly.
Sore arm; hurts to touch it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; HYPERAESTHESIA (non-serious), outcome "unknown", described as "hurts to touch it".  Additional information:  2 booster dose of Covid vaccine. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient given undiluted Pfizer vaccine (1 vial full = equiv 5 doses)  NO ADR reported, patient feels fine.
A report has been received from a Physician concerning an 8 year old, female subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on an unknown date. The reporter stated that the patient experienced paleness and weakness. The patient recovered from the event of paleness and weakness on an unspecified date. The report was considered to be non-serious.
On 2/6/01 the pt's right thigh developed swelling and redness, an area of bruising and some itching. No apparent discomfort, bruising, rash or reddened area is raised right thigh swelling. Mom states also hx of eczema. Advised to try cool compresses to right thigh. Also advised to consult with physician.
Patient developed a rash within 24 hours of vaccine administration.  It gradually spread from abdomen to the rest of her trunk, arms, and thighs.  It spared her face and neck, hands and feet.  I made the clinical diagnosis of pityriasis rosea.  Treatment is topical anti-itch medications only.