chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse practitioner concerning a 5 year old female who was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Subsequently, the patient experienced arm pain. No further information was provided. There was no product quality complaint. It was also reported that the patient's uncle developed an adverse event after vaccination. (WAES#: 0711USA00017) Additional information has been requested.
Diagnosed with shingles on 3/26/22 following the development of nerve-related pain (burning, tingling) on the right side of the body (upper thighs, groin, and lower torso). Prescribed antiviral (Valtrex) for 7 days which has led to some mild improvement after 5 days.
More than 35 days after the first dose without receiving the second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days after the first dose without receiving the second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days after the first dose without receiving the second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days after the first dose without receiving the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Patient had swelling at injection site. First informed patient to use cold compresses at injection site. Patient was also informed to go to ER/Urgent care of swelling increased in area or temperature developed. Patient returned next day area of swelling increased and patient was instructed to go to urgent care.
Redness, swelling, heat approx 5x7 cm extending under rt arm into ax lymph nodes, throbbing fever undetermined height; S&S's began 24JUL swelling dec by 26JUL; redness & heat still present;
Pt had her 2nd Moderna vaccine on 3/18/21. She was brought to the ER on 5/25/21 c/o nausea and vomiting and abdominal pain and not feeling well. work up at the time was negative. she was thought to possibly have a UTI and sent home on antibiotics. urine culture from that visit was ultimately negative for infection/growth. She retuned to the ER on 6/1/21 c/o weakness, confusion and new shortness of breath. Her temp was 99.5, chest x ray showed extensive bilateral patchy opacities. head CT was neg. Her wbc was 14.4 with left neutrophilic shift, lactic acidosis of 2.1 and dehydration. She was admitted with sepsis and possible pneumonia. She was started on ivf and antibiotics and admitted. She was also started on oxygen for new hypoxia of 81%. CT chest showed interstitial pulmonary edema, interstitial pneumonia. echo showed normal LVEF and grade 2 diastolic dysfunction with severely dilated left atrium. Her wbc returned to normal and her shortness of breath improved. She was started on lasix 10mg qod. Previous chest x rays showed no interstitial disease. Covid 19 testing negative.
Fever for 48 hours, swollen lymph node in left arm pit, fatigue. Treated fever with Tylenol and Motrin around the clock.
not sure how much of the medication the patient got, with no ae; There is a crack in the syringe, with no ae; More of the vaccine got on her arm and her face than she received intramuscularly, with no ae; Initial information received on 21-Nov-2019 regarding an unsolicited valid non-serious case received from an office Staff.   This case involves a 64 years old female patient who received 0.5 ml dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot: UJ273AB, expiry date: 30-Jun-2020), via intramuscular route in the Left Deltoid, on 21-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to vaccine underdose and exposure via skin contact. It was also a case of syringe issue as there was a crack in the syringe. When injected the needle in the patient and it felt like it popped and a lot of liquid went out of the syringe. More of the vaccine got on her arm and her face than she received intramuscularly. The crack is not on the area where anyone screw the needle on but it is on that end of the syringe.  At the time of reporting, the patient had no adverse event.  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.
22nd- left eye twitch, 23rd- eye twitch plus cheek numbness, 24th- same with numbness into forehead, 25th- same with numbness into neck, 26th- same with numbness of left arm (elbow to fingers). ER visit on 26th. Diagnosed as mini stroke.
pt at home, Also noted initially felt tired. Symptoms lasted 5-6 days, used APAP to treat and Aleve to tx. This is second day after the second shot. The second shot has been better tolerated than the first. Adv to call back if issues, ?s, concerns.
Paralyzed for about 12 hours. Fell out of bed to go to the bathroom. Could not even crawl to the toilet.
sudden weakness/ collapse no loss of consciousness  recurrent event approximately every six months.3/3/21, 10/1/21, 5/2022, 11/25/2022 Each event resulted in treatment and admission to hospital
pt recv vax & pt exp hives;reporter was concerned about 6 multi-dose vials of particular lot of vax;MD also reported an inc in number of adverse events p/pneumococcal vax;
Covid Arm - swollen hot painful spot at the injection site, radiating pain down arm bullseye formation, still evident but less painful today 03/16/21
Information has been received from a registered nurse concerning a 6-year-old male who in December 1999, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 20-AUG-2005 the patient developed shingles. On an unspecified date the patient recovered from shingles. A product quality complaint was not involved. Additional information has been requested.
I TESTED AT HOME COVID POSITIVE ON 25-May-2022; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I TESTED AT HOME COVID POSITIVE ON 25-May-2022) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Patient had allergy to unknown drug.).    On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2022, the patient experienced COVID-19 (I TESTED AT HOME COVID POSITIVE ON 25-May-2022). On 31-May-2022, COVID-19 (I TESTED AT HOME COVID POSITIVE ON 25-May-2022) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 31-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 06-Jun-2022, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. COVID-19 treatment included Pfzer product from 26-May-2022 to 30-May-2022. On 04June2022, the patient had nasal congestion, running nose, sneezing, slight chills, and then a positive Covid test again. Device date was reported as 04-Jun-2022  Company Comment: This is a spontaneous case concerning a 71-year-old male patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately 5 months after receiving a dose of mRNA-1273 vaccine. The patient was given COVID-19 treatment for 5 days and tested negative. The patient reported nasal congestion, running nose, sneezing, chills with positive test for COVID 5 days after completing the treatment. The event had not resolved at the time of report. It should be noted that the dose was reported as third dose however, there were no information regarding the previous 2 doses of COVID-19 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 71-year-old male patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately 5 months after receiving a dose of mRNA-1273 vaccine. The patient was given COVID-19 treatment for 5 days and tested negative. The patient reported nasal congestion, running nose, sneezing, chills with positive test for COVID 5 days after completing the treatment. The event had not resolved at the time of report. It should be noted that the dose was reported as third dose however, there were no information regarding the previous 2 doses of COVID-19 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.
2/10/21 - 915AM - tachycardia for 10 minutes - 30 minutes after receiving vaccine. 2/11/21 - 8AM - injection site stiffness, swelling, redness, hot to touch                                       body aches with severe headache and nausea                                        inability to focus at work (RN duties) 2/11/21 - 12PM - Sent home from work - tylenol for pain/headache, slept for 18 hours. 2/12/21 - 8AM - Returned to work - body aches resolved - headache controlled with tylenol,                                        Feeling of fatigue                                       Continued injection site tenderness, swelling and redness 2/13/21 - Symptoms resolved
Severe bruising and red swollen splotches on right upper arm. Extremely sore on same arm.
Clients reports on 2-12-08 he developed nausea, cramps and bloating 3 days after receiving vaccinations on 1/9/08. Patient saw PCP on 2-02-08 and had x-rays, blood work, antibiotics for possible bacterial infection. States was also presented pills for bloating. States is scheduled for endoscopy 2-19-08
Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning a 16 year old female with no pertinent medical history or drug reactions who was vaccinated with at lease one dose of GARDASIL (lot#, route and site of administration not reported) in the last 4 weeks. Concomitant therapy included prenatal vitamins. The patient was pregnant and developed immune thrombocytopenia purpura. On approximately 14-AUG-2009 ("4 weeks ago"), the patient's platelet level, 8000/L, was extremely low. On 04-SEP-2009 she started with treatment with prednisone 20 mg, twice daily. Her platelet level was already 116000/L. Other than the low platelet the patient was asymptomatic. At the time of this report, the patient had not recovered. The patient's "due date" was 20-APR-2010. Follow up information has been received from a registered nurse who stated that on 23-AUG-2009 the 16 year old female patient was in a fight and received an injury to her eyes and head. The patient was 7.5 weeks pregnant at the time. She underwent a CT of the head (hospital location and results not available). No blood work was done at that time. On 04-SEP-2009 her blood work was drawn and the platelet result was 8000. The patient was diagnosed with immune thrombocytopenia purpura. Additional follow up information has been received from a licensed practical nurse concerning the 16 year old female patient who on 15-JUN-2009 was vaccinated with the first dose of GARDASIL (lot# 659441/1446U, route and site of administration not reported). On 17-AUG-2009 she was vaccinated with the second dose of GARDASIL (lot#661953/1130X, route and site of administration not reported). No other vaccines were administered on these two dates. Upon internal review, the immune thrombocytopenia purpura was determined to be an other important medical event. Additional information has been requested.  10/01/09 Received PCP medical records. FINAL DX: Idiopathic Thtombocytopenic Purpura Records reveal patient in usual state of good health on 6/15/09.  Records indicate patient also received Menactra & Adacel on 6/15/09 but no lot numbers recorded.  Records of 9/09 reveal patient pregnant & prenatal labs revealed plts of 8K.  Patient was asymtomatic & tx w/oral steroids.  Plts increased to 116K.  Heme & OB/GYN consults done.
experienced acid reflux; aching; chills; hurting head; hurting in her chest; funny and dry feeling in her mouth; a little numbness on her lips; congestion; This is a spontaneous report from a contactable consumer or other non-health care professional via Medical Information Team. A female patient of an Age: 79; Unit: unknown received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown) both via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient experienced acid reflux, aching, chills, hurting head, hurting in her chest, funny and dry feeling in her mouth, a little numbness on her lips, which patient attributed to the acid reflux and congestion. Patient had already seen a doctor for the acid reflux and got some medicine for it. Patient was also taking Mucinex for her congestion. Patient wanted to know if these were common side effects of the vaccine. Outcome of the events was unknown.  Information on batch/lot number was requested.
First dose of vaccine administered after excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (First dose of vaccine administered after excursion) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) 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) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 11-Mar-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (First dose of vaccine administered after excursion). On 11-Mar-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (First dose of vaccine administered after excursion) had resolved.        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.   Reporter reported that  the vaccines were kept in hot weather during transport and  the vaccine could have been exposed to temperatures around 90 degrees Fahrenheit in the car.   This case was linked to MOD-2021-250540 (Patient Link).
A spontaneous report has been received from a Health Professional concerning a female patient, who had been receiving nasal FLUMIST Quadrivalent started on an unknown date. It was reported that the patient describe who received expired FLUMIST Quadrivalent administered. The outcome of the event expired FLUMIST Quadrivalent administered is unknown. The report was considered to be non-serious.
No physical adverse event.  Gave Pfizer Bivalent Pediatric dose diluted to 0.2 ml  instead of Pfizer Primary Pediatric dose diluted  to 0.2 ml for second vaccine in series.
UrticariaPruritus As reported by employee: "tingling of face lips and throat, itching and feeling apprehensiveness, sever cramping of entire body, daily restless leg movement and twitching of hand." Narrative:  As reported by employee:****************************** "Any medications used for treatment? If so, what meds and doses: antihistamine Did you seek any medical treatment from a physician? (YES or NO): yes, Hospital "Did you recover completely from event? (YES or NO): not completely, much improved leg twitching now only random episodes. "OVERALL I'M DOING WELL, I STILL HAVE SOME PAIN MY FEET, THAT RESTLESS LEG."
pt became ill immed p/inject; felt hot, vomited, unconsolable, irritable, t104 R, tepid baths 7 APAP x 3 days w/o relief temp; late on 3rd day, temp dec;
numbness in extremities;legs froze, dizzy, could not get up, flu like sx, gained 10lbs w/in 2wk of vax w/no change in diet, immune problems;sx of chronic fatigue synd;body temp dropped;brain feels inflamed;MS sx;hypothyroid;adrenal glands
12/9/02 Flu shot. 12/11/02 Developed scratchy throat. 12/12/02 Developed hoarseness, runny nose, sneezing and slight cough. 12/14/02 Developed hives on left side of face. No vital signs taken. Client did not see MD nor report to RN.
Chills, fever, body aches, headache  for over 2 days so far.
No adverse event; Patient administered with the Moderna vaccine, which were beyond the 30day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered with the Moderna vaccine, which were beyond the 30day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053c21a and 042J21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered with the Moderna vaccine, which were beyond the 30day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered with the Moderna vaccine, which were beyond the 30day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient administered with the Moderna vaccine, which were beyond the 30day beyond use date).    Concomitant product use was not provided by the reporter. Patients administered Moderna vaccine monovalent beyond the 30 day beyond use date. Batch number 053C21A (BUD- 01 Jul 2021). No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (inked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Non significant Follow up Appended; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
dead skin on my face. But I think it was caused by the sun; dead skin on my face. But I think it was caused by the sun; got Covid; got Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. Other Case identifier(s): MOD22-029530 (Moderna).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 27Dec2021 as dose 3 (booster), single (Lot number: FE3594) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Jan2021 as dose 1, single (Lot number: 029L20A) and on 23Feb2021 as dose 2, single (Lot number: 01M20A) for covid-19 immunisation. The patient's relevant medical history included: "psoriasis" (ongoing). The patient's concomitant medications were not reported. Past drug history included: Vitamin d3; Vitamin c; Zinc. Before the covid shots, the patient has been taking Vitamin pills (Vitamin D3, C, Zinc) and his/her psoriasis has completely disappeared. After Moderna covid-19 vaccine, it just started with patches of bumps on elbows. There was no itching. On 24Feb2021, psoriasis came all the way back. The patient had bumps on buttocks, groin, back of legs and thighs. Never had it there before. The patient also had it on elbows. It's spotty. It was usually on there for a bit, then after a while the dead skin peeled off. After booster dose, the patient had dead skin on face. But patient thought it was caused by the sun. It did not look like psoriasis. The patient had this procedure done by dermatologist regularly. He used liquid nitrogen that he sprayed on face. The patient was going to see dermatologist again next month. The patient got Covid in Aug2022. It was a mild case. Therapeutic measures were taken as a result of skin exfoliation, photodermatosis.The event "dead skin on my face. but i think it was caused by the sun" required physician office visit. Therapeutic measures were taken as a result of skin exfoliation, photodermatosis.
runny nose; injection site pain; intermittent fever; malaise; aches and pains; inappropriate schedule of vaccine; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number ABX794AZ, expiry date 31st August 2020) for prophylaxis.   Concomitant products included Men B NVS (Bexsero).   On 29th July 2019, the patient received the 2nd dose of Bexsero (intramuscular) .5 ml. On 29th July 2019, unknown after receiving Bexsero and 28 days after receiving Bexsero, the patient experienced drug dose administration interval too short. On 30th July 2019, the patient experienced injection site pain (serious criteria clinically significant/intervention required), intermittent fever (serious criteria clinically significant/intervention required), malaise (serious criteria clinically significant/intervention required) and pain (serious criteria clinically significant/intervention required). On 31st July 2019, the patient experienced runny nose (serious criteria clinically significant/intervention required). The patient was treated with ibuprofen and paracetamol (Tylenol). On an unknown date, the outcome of the injection site pain, intermittent fever, pain and runny nose were not recovered/not resolved and the outcome of the malaise was recovered/resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the injection site pain, intermittent fever, malaise, pain and runny nose to be related to Bexsero.  Additional details were reported as follows: The patient received Boostrix on right deltoid. The patient received Bexsero, and experienced fever of 101, malaise, aches, pains, and injection site pain. The nurse advised the patient to treat this with alternating Tylenol and Ibuprofen. Next day, the patient's fever was as high as 103 and he developed a runny noise. The nurse reported that the fever was responding to the interventions and had resolved at this time, all other symptoms continued. The batch number was reported as SKBABX794AZ, however it was corrected to ABX794AZ upon sales data sheet. The reporter consented for follow up.
I woke up around 5:30 with a high fever. I went to the restroom and on the way back I passed out and was unresponsive for a few seconds (10-20 seconds). I have since being running a fever, breaking out in a sweat, had a severe migraine, and body aches and joint aches. It has been over 24 hours since the vaccine and am still having side affects.