chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning an 8 year old female patient with no allergies and no medical history who on 13-MAY-2009 was vaccinated SQ with a 0.5 mL second dose of VARIVAX (Merck). On 13-MAY-2009 the patient developed redness, pain and swelling of her arm, at the injection site. Medical attention was sought via telephone call. At the time of reporting the patient had not recovered. Additional information has been requested.
General joint inflammation: ankles; elbows, wrists.  Knee has become chronic and severe. Other symptoms include heart palpitations, headaches, difficulty breathing, nausea.
The vial was initially stored in the refrigerator on 31-May-2023 and administered to patient on 17-JUL-2023; No Adverse event; Bivalent Moderna vaccine was administered after date of expiry to adult patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to adult patient), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-May-2023 and administered to patient on 17-JUL-2023) and NO ADVERSE EVENT (No Adverse event) in an adult 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. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jul-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 17-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to adult patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-May-2023 and administered to patient on 17-JUL-2023) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to adult patient), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-May-2023 and administered to patient on 17-JUL-2023) 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 (Bivalent Moderna vaccine was administered after date of expiry to adult patient) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-May-2023 and administered to patient on 17-JUL-2023).    It was unknown patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine No concomitant medication was reported.  Date the vial was initially stored in the refrigerator on 31-May-2023. The vial did not undergo any temperature excursions. No treatment information was reported.  This case contains information for patient 13 out of 19.   This case was linked to US-MODERNATX, INC.-MOD-2023-733761 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733761:
sCD40L levels increased 116, 880.2 Vegf level 64.l    CCL5 14,224   CCL4 dropped  1.2 CCL3 dropped 2.4  IL10 rose to 1.4, IL rose to 4.4, IL4 rose to 18.5
Student recieved VZV and Menactra in right arm, TDAP in left at the school clinic on 8/12/08. Mother complained on 8/14/08 that student has swelling and a "hard lump" with itching on right upper arm where she recieved the two vaccines. Has been applying ice.
Approximately 3 hours post vax, noted hives on face, arms and swelling around both eyes. Noted no swelling around lips. Denies shortness of breath, or nausea and vomiting. Took 50mg Benadryl immediately on noting reaction with effect by 09:00 PM. Took another dose of Benadryl 25mg in morning of 02/01. Currently presents with patch of hives approximately 1" across cheek below right eye and complained of mild itching to chest and eyes. Injection site is clear.
This spontaneous report was given from a Nurse Practitioner concerning her 4 year old granddaughter with no pertinent medical history or drug reactions/allergies who on 13-MAY-2009 was vaccinated with the first dose of VARIVAX (Merck) (dose and route not provided) (lot# 663819/0336Y, expiration date on 13-MAR-2011) and on 12-AUG-2009 received the second dose of VARIVAX (Merck) (dose and route not provided) (VARIVAX) (lot # 0803Y). There were no concomitant medications. The nurse reported that "early last week" on approximately 25-JUN-2012 her granddaughter was diagnosed with severe widespread chickenpox. The patient developed a fever of 102. The nurse indicated that the chickenpox rashes were "everywhere" on her granddaughter, including between toes and around genitalia. She was treated with CALADRYL lotion to the lesions and a topical mixture of MYLANTA and BENADRYL to the oral lesions. No laboratory test were performed. At the time of the report, the patient had not recovered from the event. The patient sought medical attention at the physician's office. Additional information received from the nurse practitioner revealed that her granddaughter was tested and it turns out that she had "coxsackie virus". The patient's outcome for "coxsackie virus" was not provided. It was noted that the nurse practitioner daughter also developed lesions and was tested and it turns out that she had "coxsackie virus" too. This is one of several reports received from the same source. Additional information has been requested.
They were dosing Bexsero like Trumenba; This non-serious case was reported by a physician via sales rep and described the occurrence of interchange of vaccine products in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On an unknown date, the patient received Bexsero and TRUMENBA. On an unknown date, an unknown time after receiving Bexsero, the patient experienced interchange of vaccine products (Verbatim: They were dosing Bexsero like Trumenba). The outcome of the interchange of vaccine products was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-JUL-2023 It was reported that they were dosing Bexsero like Trumenba which led to interchange of vaccine products.
COVID Vaccine Breakthrough Case  Moderna Dose 1 2/18/21 (031L20A) Moderna Dose 2 3/18/21 (013A21A) COVID Positive 12/5/21  12/5/21: Patient is an 80-year-old male with history of chronic obstructive pulmonary disease, recovered COVID-19 pneumonia, history of CAD, hypertension and hyperlipidemia. Presented to the emergency department with worsening shortness of breath associated with dry cough and difficulty breathing over the last week, symptoms got much worse over the last 4 days.  Reported fever at home, no body aches, no runny nose or sore throat.  No chest pain or palpitations.  No changes in bowel movements or urinary habits.  Denied any lower extremity swelling rash or open wounds.  Denies smoking, no alcohol use, received COVID-19 vaccine/Moderna roughly 1 year ago, patient with sick because of COVID-19 more than 1 year ago.  He is full code.   In ED, he was hypoxic, was placed on oxygen by nasal cannula 2 L, D-dimer was mildly elevated and CT angiogram ruled out pulmonary embolism but showed ground-glass opacity suggestive of possible viral pneumonia.  Was given levofloxacin, was given steroids, hour long breathing treatment.  12/10/21: Patient was admitted on 12/05/2021 of a presenting to the emergency department with a chief complaint of shortness of breath.  Patient was diagnosed acute hypoxic respiratory failure secondary to COVID-19 pneumonia with possible superimposed bacterial pneumonia and COPD exacerbation.  Patient was treated with remdesivir, Decadron, five-day course of azithromycin and Rocephin, breathing treatments.  Patient was weaned off oxygen.  Home O2 walk was performed on day of discharge and patient passed, did not have need for home O2.  Patient will discharge home with COVID safe at home kit including pulse oximeter so he can monitor his oxygen saturation. Patient will restart his VNA services.  Patient will continue his home inhalers for COPD including p.r.n. albuterol.  Discharge instructions and return precautions reviewed with patient.
Patient received vaccine on 5/5/17 and went to urgent care that evening and was started on KEFLEX x10 days. By time of appointment on 5/9 the swelling and redness was greatly reduced per MD. Symptoms: Erythema, cellulitis. Treatment: Cephalexin 500 mg QID.
large (6-8cm) erythematous swelling @ inject site; pt questioned whether had an insect bit the day a/ 21JUN94;
red circle around injection site about 2 inches in diameter and about 3inches down back of arm, sore to the touch at the injection site
Information has been received from a female patient who was vaccinated with ZOSTAVAX. She reported that she experienced injection site reaction after receiving the ZOSTAVAX. This report is one of the two reports received from the same source. Additional information is not expected.
Large life-like rash developed behind both knees, and Psoriasis like rash with white bumps on my for arms.
Chills, fever 101.4 F, Excessive nausea, vomiting, headache, malaise. Given Tylenol.
62 y.o. female with a history of stroke in 2018.  <30 minutes status post-Pfizer vaccination #1, she complains of numbness on the left side of the face, inability to move the left side of lips.  Vital signs checked & normal by the EMS crew. Unable to smile left side of the face.  Speech slightly slurred. Romberg negative.  Possible cerebral ischemic event.  Offered ambulance transport to ED; preferred to go by personal vehicle.  Discharge to ED
Pt recvd 2nd dose of vax on 18AUG92 w/in an hr following vax pt exp sore arm w/pain @ inject site; sx resolved w/in 24 hrs; No further details were provided;
Could not move arm for 15 mins. Stabbing pain underarm pit of left arm. Nausea. She was monitored and symptoms subsided. All symptoms were gone after 20mins. Informed she could take tylenol or advil 6 hrs after vaccination. Told to contact our office of symptoms return.
2 wks after #1 MMR vaccine had prolonged high fever and rash. Self-resolved. 2 wks after Varivax #2 vaccine, had 5 days of high fever, dizziness, congestion, nightmares, fatigue, poor appetite. Self-resolved.
Site of shot fine through 1st week. Then itching, redness, swelling, pain evening of day 8. Now day 10 and about the same. I took an aspirin on day 8 and an aleve on day 9.
Pt recvd vax & w/in minutes following vax pt devel feeling of faintness, nausea, diaphoresis, tachycardia;
BREAKTHROUGH COVID-19 VACCINE HOSPITALIZATION She was vaccinated with Janssen vaccine in March 2021. Rapid testing for covid-19 was positive on 12/7/21 after having symptoms of fever, chills, muscle aches, headache, cough and shortness of breath.  She was then hospitalized.
Rec'd 1 shot of Engerix-B 26JUN90; Had pain on inject & experienced listlessness & fatigued for 3-4 wks; c/o varying deg pain & soreness in inject arm.  Vax d/c'd.
Hives/urticaria; treatment with dexamethasone IM injection, prednisone taper, loratadine 10mg daily, famotidine 20mg twice daily; showing improvement but still resolving.
Bilateral peripheral neuropathy, feet; also aggecting hands and arms to a lesser extent.  Permanent loss of sensation in toes and sole of foot/loss of balance.
I was forced by the company that I work for to get the Covid 19 vaccine or I would loose my job.  I got the covid vaccine to keep my job and a few hours after the Covid vaccine I started having chills and sweats, headache, dizziness, Short of Breath, heartburn, pain in my whole right arm to right shoulder to right side of my back and face, low grade fever, and spontaneous cough.  I am still having these issues.
The 1st odd vision event around December 07. I called the doctor, they did not seem concerned. A couple of months later  it happened again in my left eye and I thought that was weird. The next day it happened in my right eye and it was at that time that I went to see the doctor. I have had 3 events lasting 3-5 minutes each. The diagnosis was that these were ocular migraines. He advised that there was no treatment and did not seem concerned. He did advise me to watch out for common foods or triggers.
Very swollen, very red (rash), very itchy and painful upper left arm near area of injection. Swelling and redness have gotten worse on day three. Also have started to lose hair on scalp since time of first vaccination on 1/15/2021 at 6:00 p.m. at the same vaccination site. The make and lot number of that vaccination is Moderna lot # 012L20A.
FELT ITCHING TO RIGHT SHOULDER AND NOTICED SWELLING OF 3 INCHES. SYMPTOMS LASTED UNTIL 3/23/2014. NO TREATMENT ADMINISTERED.
I had horrible shaking/trembling in my arms, chest, and legs about six hours after the vaccine, and they continued for about four hours more, uncontrollably. I passed out briefly around 12 hours after the vaccine, and I'm not sure how long I remained unconscious. Through all of this, my left arm was difficult to move or use, I felt hot suddenly and then cold, and I was tired. The next day, the most serious side effects were gone, but I remained feverish, tired, and largely unable to move my left arm. Those side effects were gone on the third day and now I'm better.
Onset of heart palpitations with tachycardia, SOB, and left sided chest pain approximately 12 hours after vaccination. Additional symptoms: body aches, fatigue, dizziness, headache, chills, severe pain at injection site.  I assessed my own vital signs using my fitness watch and resting heart rate remained between 105-110bpm, blood pressure < 120/80mmHg and my SpaO2 remained at or above 97%. After 12 hours of symptoms that were not subsiding  I self treated with 400mg OTC ibuprofen and approximately 3 hours later all side effects resolved resting heart rate returned to my baseline of 55-60bpm.
pt recv vax & devel loss of appetite, nausea, dizzy, h/a;hosp;cellulitis;
Fever, high pitched non stop screaming for 24 hours, seizure. Was given Tylenol for the fever.
pain, mild swelling & rash developed approx.  7 hours after injection. It is now 9 days later and rash is still present.
A clinical diagnosis of myocarditis with elevated troponin and chest pain requiring hospitalization for 5 days.
Left deltoid area 5.5 cm x 3.5 cm area of redness, erythema, warmth & tenderness central area at inject site indurated 2 x 2 cm.
worse shingles; pain; Neck pain; increase blood pressure; increase cholesterol; elevated liver function tests; Weight loss; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included biopsy (had punch biopsy of his left wrist by a dermatologist), knee operation, blister (had the blisters on the left side of his face  forehead and chin, around his waist and between his legs) and crushing injury of back (crushed lumber and cervical vertebrae). Concurrent medical conditions included shingles (began with the shingles episode in early March and April 2019), urticaria and pain.   On 23rd April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced shingles, chest pain, neck pain, increased blood pressure, blood cholesterol increased, raised liver function tests and weight loss. On an unknown date, the outcome of the shingles, chest pain, neck pain, increased blood pressure, blood cholesterol increased, raised liver function tests and weight loss were unknown.   It was unknown if the reporter considered the shingles, chest pain, neck pain, increased blood pressure, blood cholesterol increased, raised liver function tests and weight loss to be related to Shingrix.  Additional details were provided as follows: The patient had active case of shingles, urticaria, and pain all over his body before he received both his first and 2nd dose. The patient had the blisters on the left side of his face forehead and chin, around his waist and between his legs. The patient noted that the vaccine probably super charged the issues, but does not blame GSK because he stated the doctors were aware he had the issues before he received the vaccine and everything he has read about the vaccine says that he should not receive the vaccine with active case. The patient noted that had an episode of pain in his chest and neck that he thought he was having a heart attack and thought he was going to die. The patient had increased blood pressure off and on, and his cholesterol went up to 236 from 215. The patient lost 20 pounds by changing his eating habits. The patient did not consent to follow up.      Lab Comments: On an unknown date nuclear medicine test was done. On an unknown date Blood pressure was noted. elevated liver function tests was around July, August or September 2019.
COVID-19 Moderna EUA: Pain at injection site; fever; headache; body ache; joint ache.
No adverse event. Gave shot Intramuscular instead of giving the vaccine subcutaneous.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. An adolescent male patient of unspecified ethnicity received the first dose of TRUMENBA via an unspecified route of administration, on unknown date, at single dose. Relevant medical history and concomitant medications were not reported. The patient experienced high fever and neck pain on unknown date, the day after the vaccination. The patient was hospitalized due to the events. He had a spinal tap and other tests to make sure he did not have meningitis. The outcome of the events was unknown.
This spontaneous report as received from a physician assistant referred to a currently 29 year old patient. The patient was vaccinated with dose 1 GARDASIL, about 3 years ago, in 2009, when she was 26 years old. No other co-suspects were reported. No concomitant medications were reported. On 10-JUL-2012 the patient went in to the physician's office to possibly complete the GARDASIL series. The patient is now 29 years old. No adverse effects were reported. No treatment information was reported. Additional information has been requested.
Initial unsolicited report received from a non-healthcare professional on 29 OCTOBER 2014. A 13-year-old female patient, whose medical history and concomitant medication were not reported, had received a dose of INFLUENZA, (batch number, expiry date of vaccine, cycle in series, route and site of vaccination was not reported, on 25 OCT 2014. On 26 OCT 2014, patient experienced skin irritation. On 27 OCT 2014, she had hives on her body. On 28 OCT 2014, patient's condition got worse. Corrective treatment was reported as BENADRYL cream and liquid BENADRYL . Laboratory investigations were not reported. At the time of this report, the outcome of the event was reported as unknown. Documents held by sender: none. Follow-up information received from a Consumer on 13 JANUARY 2015: The responsible physician address was updated. The patient born on 23 MAY 2001 visited the physician who advised to continue on liquid BENADRYL and follow with visit if symptoms do not disappear. The patient was administered fifth dose of influenza vaccine (manufacturer Sanofi Pasteur) and presented with adverse events on 27 OCTOBER 2014 at 07:30 hours. The patient had no illness at the time of vaccination and did not receive any concomitant medications. The patient did not have any adverse event following prior vaccination. On 31 OCTOBER 2014, all skin irritation had disappeared and the patient outcome was recovered. Follow-up information received from a Consumer on 11 FEBRUARY 2015. It was reported that patient received intramuscularly a dose of INFLUENZA QUADRIVALENT, batch no. UI207AA in left deltoid. List of documents held by sender: none.
This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 02-MAY-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB "10Pk 10mcg/1mL SD LLok Cap AD", lot # L001441 with expiration date 17-AUG-2016 (route of administration and anatomical location were not reported). There were no concomitant therapies and adverse effects reported. No product quality complain was involved. On an unspecified date, the RECOMBIVAX HB had six temperature excursion of 30 F (-1.1 Celsius Degrees) for 288 hours, 34 F (1.1 Celsius Degrees) for 184 hours, 33 F (0.5 Celsius Degrees) for 168 hours, 31 F (-0.5 Celsius Degrees) for 552 hours, 29 F (-1.6 Celsius Degrees) for 256 hours and 32 F (0 Celsius Degrees) for 496 hours, respectively. The vaccine status was reported as "in excursion". The vaccine storage criteria and type of excursion were reported as "Refrigerator (R)". This is one of several cases from the same reporter. Additional information has been requested.
5ml syringes were used to draw up diluent for mixing the 5-11 year old Pfizer COVID-19 vaccine vial on 12/21/21.  Diluent drawn up and injected into the vaccine vial was 1.6ml rather than 1.3ml.  Diluent was measured on the 5ml syringes incorrectly:  Counting each mark as 0.1 rather than 0.2ml.  This resulted in the vial being mixed with 0.3ml extra diluent.  Vial had a bonus dose (so 11 doses total).  Patient was given a vaccine dose at 90% of the correct concentration.  Error has been reported to Pfizer.  Families are currently being contacted by letter and by phone to be alerted of the error and offered a re-dose if they would like this.  No adverse effects to patients have been reported.
Rash started a few hours after the patient recieved the vaccinations.  The rash was all over the patients body. The continued to get worse over the next few days and is still on the child.
pt recvd vax & exp a small round rxn w/halo @ inj site w/in 24hrs;
HAND EXTREMELY COLD; SEVERE CHILLS/TEETH CHATTERED; FREEZING; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's past medical history included leukopenia, hypothyroid, and epstein barr, and concurrent conditions included unspecified allergies, chronic medical condition, non alcohol, non smoker,  arthirits, high cholesterol, gastroesophageal reflux disease, fibromyalgia, food allergy, animal allergy, nickel allergy, and degenerative disc disease, and other pre-existing medical conditions included the patient is on thyroid medication, no history of drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 15:30 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for blood thinner, calcium for general health, fish oil for general health, vitamins nos for general health, levothyroxine sodium for hypothyroid, and fluticasone for unspecified allergies. On 21-MAR-2021, the subject experienced hand extremely cold. On 21-MAR-2021, the subject experienced severe chills/teeth chattered. On 21-MAR-2021, the subject experienced freezing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hand extremely cold, severe chills/teeth chattered, and freezing on 22-MAR-2021 04:00. This report was non-serious.  This case, from the same reporter is linked to 20210342283.  Additional information was received from (patient) on 13-apr-2021 .The following information was updated and incorporated into the case narrative;  Events details ,disease, concomitant product