chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial and follow-up information has been received from a physician concerning a 70 year old female with no known allergies or drug reactions and no illness at the time of vaccination who on 04-NOV-2008 was vaccinated with a dose of PNEUMOVAX 23 (lot no. 660685/0519X) 0.5 ml into the left arm. It was also reported that on 10-OCT-2008 the patient was vaccinated with FLUVIRIN (lot no. 89684) into the left arm. Concomitant medications included, alendronate sodium (MSD), CADUET, aspirin and AMBIEN. The physician reported that on 06-NOV-2008 the patient was seen at the physician's office because had redness, swelling and pain in her left upper arm for two days. The patient had no fever or itching, her temperature was 98. The patient's left arm had erythema. Swelling warmthness, tenderness from mid deltoid to the elbow and there were tender left axillary nodes. The physician's impression was cellulitis and the patient was given ROCEPHIN IM into the office and was prescribed oral antibiotics (unspecified). The physician reported that the patient did not take the oral antibiotics, but instead she went to see another physician who admitted her to the hospital on 07-NOV-2008 for left arm cellulitis. A chest X-ray and X ray of the left arm was performed. The radiology report stated that the views of the left humerus were negative for osseous abnormality, adjacent joint spaces appeared to be intact and no subcutaneous air was identified. No acute lung findings. The physician suggested correlation. Laboratory test performed on 07-NOV-2008 included: anion gap 16 (normal range 5-14), serum glucose test 91 mg/dl (normal range 70 to 110), serum blood urea nitrogen test 16 mg/dl (normal range 7 to 18), serum creatinine test 1.0 mg/dl (normal range 0.7 to 1.2), serum calcium test 10.2 mg/dl (normal range 8.4 to 10.2) total serum protein test 8.2 g/dl normal range (6.3 to 8.2), serum albumin test 4.5 g/dl (normal range 3.9 to 5.0), serum alkaline phosphatase test 92 units/L (normal range 38 to 126), serum aspartate aminotransferase test 65 units/L (normal range 5 to 40), serum alanine aminotransferase test 91units/L (normal range 7 to 56), total serum bilirubin test 0.3 mg/dl (normal range 0.2 to 1.3, serum sodium test 147 mmol/L (normal range 137 to 145), serum chloride test 104 mmol/L (normal range 98 to 107), serum potassium test 3.8 mmol/L (normal range 3.6 to 5.0) total serum carbon dioxide test 27 mmol/L (normal range 22 to 31), blood hemoglobin test 14.3 mmol/L (normal range 11.5 to 15.3) whole blood hematocrit 43.2% (normal range 34 to 45), blood platelet count 263x10e3 (normal range 140 to 400), blood neutrophil count 63.3% (normal range 37-80), blood eosinophilic leukocyte count 2.6% (normal range 0 to 6.0) blood monocyte count 9.8% (normal range 1 to 13), blood basophilic leukocyte count 0.4% (normal range 0-2), blood lymphocyte count 23.8% (normal range 20 to 45), urinalysis test between the normal range, Urine culture which showed no growth and multiple blood culture from different venipuncture sites that showed no growth at 97 hours. The discharge date is 09-NOV-2008. Additional information is not available.
IN TODAY WITH GRANDMOTHER FOR C/O RASH ON BOTH ARMS, LEGS, AND HIS BACK. RAISED CIRCULAR BUMPS 9APPROX LESS THAN ONE MILLIMETER LOCATED ON BILATERAL ARMS AND LEGS. RIASED BUMPS ALSO NOTED ON BUTTOCKS. NO FACIAL RASH OR BUMPS @ INJECTION SITES. AFEBRILE @ PRESENT. NO ERYTHEMA NOTED @ INJECTION SITES. MILD ITCHING NOTED BY GRANDMOTHER. PLANS TO TAKE CHILD TO PMD NEXT WEEK FOR EVALUATION. DISCUSSED OATMEAL BATH FOR ITCHING.
Patient experienced extreme shoulder pain.  Went ER November 16, 2015 diagnosed as rotator cuff tendonitis need to have physical therapy.
May 2003, patient presented in hospital with bilateral lymph edema.  Rt arm was significant more edematous than the left.  Mild swollen glands in neck with Lt breast tenderness. Doctor was notified and pt instructed to take tylenol and use ice packs for comfort.  This should subside in 5-7 days.
Thursday afternoon received vaccine booster. Thursday evening my heart started racing and was sweating with no activity. Friday I woke to body aches and muscle soreness. I also experienced fevers on and off all day (ranging from normal of 97.6 to 1001.0). Sweating continued the rest of the day. Saturday I woke up to more sweating spells with no activity to explain them. My fever reached 101.0 again. Heart rate was still a higher than normal. Sunday morning still woke up to more aches but focused to my neck and a headache.
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions were reported from the patients. On unspecified dates between 14-OCT-2015 and 16-OCT-2015, the unspecified number of patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L013429, expiration date 21-JUL-2017 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Severe headache, like fire, 7 days after vaccine. Swollen lymph nodes in neck, breast, under chin and behind ears, 9 days after vaccine. Trouble talking due to enlarged glands.
S: Pt states blurred vision after administration of Rabies Vaccine lot#340011 on 10/Mar/05 approximately; 10 minutes afterwards.  Pt also states she had symptoms of dry mouth.  Prior to this event on (16 Feb 05), patient displayed symptoms of possible Vasovagal reaction and was treated with B/P monitoring with evidence of slight elevated B/P, lower extremities were elevated, and released without any complications after drinking water and eating some sweet snacks.  On 16 Feb 05 & 24 Feb 05, similar symptoms of blurred vision/dry mouth w/onset of sxs in 10 minutes, increasing with severity of blurred vision then decreasing in severity later in the evening.  Pt denies loss of total eyesight or vision.  Pt staes she has a "foggy eyesight" when focusing and feels light-headed.  Pt is able to read.  I informed the patient today that it is important to inform medical staff of adverse/abnormal reactions as soon as they occur and that we will be discontinuing the Rabies vaccine.
Acute neck lymphadenitis x 1 week after the shot of HPV and FLUVIRIN. Given Augmentin after ENT consult and diagnosis of ? Cat scratch vs ? HPV shot allergy.
Around 4:00pm-4:15pm, began pin and needles discomfort in joints between fingers on right hand. Between 4:15pm-4:30pm, the palms of both hands, and my left wrist began to itch uncontrollably. Reported to EMT on duty to exam. Experienced elevated blood pressure of 163/93. No itching of throat nor any other body parts. Was advised to take Benadryl.
Received vaccine on Sept 30 ,2023  Several days later came down with a cold which eventually got worse and had temp and upper respiratory issues. Had to go to hospital on 10-08-2023 to be treated for Upper respiratory infection given antibiotics. Still recovering and in addition have Nasal issues now.
pt recvd vax 4APR93 & 5NOV93 did not feel well & felt the sides of face hurt; seen by MD 6NOV93 who said was sinus & ear infect; 7NOV93 had stroke w/no use lt arm & leg & speech slurred;
She developed psychosis and major depression with hallucinations after she delivered her baby.  She received the injection and delivered the baby next day. She quickly went into psychosis after deliver. now nonverbal to nonfamily members in catatonic state.
Immediately after injection, patient had a short(3-5 second) seizure. I held her head up and N/A started talking to her and she came back around quickly and complained of nausea. A few minutes later she vomited a small amount and then said she felt better. I had 911 called when seizure first started and they arrived a few minutes later and took patient to ER. I had asked her prior to shot if she ever had a reaction to a shot. She said a few years ago she had gotten nauseated. Patient is employee in deli.
fever,  muscle aches,  headache,  shortness of breath,  loss of appetite,  fatigue sleep,  Tylenol,  cpap with oxygen, aspirin (Bufferin) 2.5 days I am up and dressed on 2/3 (third day),  but very tired and sleepy.
Developed widespread pruritic rash over chest, abdomen, back, scalp, forehead, and then arms and legs sparing the palms and soles.  He was seen 4 days later, treated with Prednisone with improvement.
Wife called stating  husband had a "small seizure" in the car on the way home from receiving the first shingles vaccine. Vaccine given at 12:40pm 09/20/2021 and she contacted pharmacy at 1:22pm 9/20/2021.  Wife said he seems ok and is in bed resting. I suggested to call his doctor as well as er/urgent care to see if they feel he should be evaluated.
Information has been received from a healthcare worker (medical assistant) concerning multiple unspecified patients of unknown age and gender. No concurrent condition, medical history and concomitant therapies were reported. On multiple unspecified dates, unspecified doses of VAQTA which were improperly stored under 70 F for 38 hours were administered to multiple unspecified patients. The lot # of the VAQTA included: L043029, non-valid lot# for VAQTA with expiration date reported as 17-SEP-2017; L015460 with expiration date: 20-JUL-2017 and L045713 with expiration date: 14-JAN-2017. There was no previous temperature excursion. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Redness/swelling of injected arm. Treatment - OTC Benadryl. Will contact MD Monday if no relief.
LOCAL PAIN, REDNESS, AND SWELLING AT THE SITE OF THE INJECTION (RIGHT ARM).  SWELLING AND REDNESS TRAVELING DOWN THE ARM.
pain in the shoulder for 2 days now; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (pain in the shoulder for 2 days now) and MYALGIA (muscle aches) in an elderly male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 27-Sep-2023, the patient experienced ARTHRALGIA (pain in the shoulder for 2 days now) and MYALGIA (muscle aches). At the time of the report, ARTHRALGIA (pain in the shoulder for 2 days now) had resolved and MYALGIA (muscle aches) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported that patient and his brother had 6 Moderna shots. On 27SEP2023, patient only had pain in the shoulder for 2 days and muscle aches.  Treatment information was not reported.   This case was linked to MOD-2022-647145, MOD-2021-015968, MOD-2022-647146 (Patient Link).
04/07/2021 cold hands, alternating hot and cold sweats, arm stiffness, shaking, aphasic and blank stare.  Date of death 04/07/2021.
Pain in the left hand (side where the vaccine was injected); This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Pain in the left hand (side where the vaccine was injected)".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient presented to the ED on 6/2/2021 for covid-19 infection. On 6/9/2021 patient presented to the ED and was subsequently hospitalized for pneumonia due to covid-19 virus. On 6/16/2021 patient presented to the ED with STEMI and was subsequently hospitalized. These visits are within 6 weeks of receiving first dose of covid vaccination.
Unknown adverse event. Pfizer pediatric vaccine was mixed using incorrect diluent--Bacteriostatic rather than NON-bacteriostatic as recommended by manufacturer.
This case was reported by a consumer via call center representative and described the occurrence of tendon rupture in a 75-year-old female patient who received SHINGRIX for prophylaxis. On 6th September 2018, the patient received the 1st dose of SHINGRIX. On 6th September 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain and erythema. On 26th October 2018, the patient experienced tendon rupture. On an unknown date, the patient experienced pain. On an unknown date, the outcome of the tendon rupture and injection site pain were not recovered/not resolved and the outcome of the erythema was recovered/resolved and the outcome of the pain was unknown. It was unknown if the reporter considered the tendon rupture, injection site pain, erythema and pain to be related to SHINGRIX. Additional details were provided as follows: The patient immediately had soreness at the injection site and she also developed redness. The redness did go away, but the soreness lingered. She had an magnetic resonance and was diagnosed with a ruptured tendon. She was still experiencing pain from the ruptured tendon. The reporter consented to follow up. Emergency room (ER) visit was required. For tolerance to 2nd dose, refer case US2019GSK040396.
Received telephone call from parent. Per report by parent on 8/2/18, patient had injection site swelling to right deltoid. Area was hard, red, and warm to touch. Swelling was about the size of the mother's hand (maybe 4"x4" or so). Parent said that the area on 7/31/18 was the size of a walnut after the injections by the time they arrived home. Patient notified parent of increased swelling on Wednesday night. Patient able to move arm. Patient was not complaining of pain, feels like a bruise. Patient complains of itching to site. Mother denies patient having any difficulty breathing, fever, hives, upset stomach. Mother states that patient has bad allergies (seasonal, pollen, dust). Mother applied ice to arm Wednesday night. Mother has not tried ibuprofen. Mother to try ibuprofen and call HD or doctor if area worsens.
dark spot at injection site 6 weeks later; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (dark spot at injection site 6 weeks later) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (dark spot at injection site 6 weeks later). At the time of the report, INJECTION SITE ERYTHEMA (dark spot at injection site 6 weeks later) outcome was unknown.            Concomitant medications were not reported. Treatment information in response to events was not provided.
Donor recieved injection on 8/3/10 donor stated when he woke up on 8/4/10 his arm was hurting, swollen, hot to the touch and red at injection site.
Headache, feeling exhausted for 24 hours, painful, hot to the touch and red circle at injection site.
"I couldn't lift my arm above my elbow or move it away from my body".  Patient describes immobility secondary to pain of 8-9/10 that lasted 1 week.  Pain 4/10 with improving mobility in 2nd week following vaccination. Did not use any treatment.
This spontaneous report was received from a medical assistant regarding a multiple unspecified patients of unknown demographics. There was no information about the patients' concurrent conditions and medical history. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) lot # L012034, expiration date- 07-APR-2017, (dose, route of administration and anatomical location were not provided). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a registered nurse concerning a 19 female who, on an unspecified date was vaccinated in the right arm with a first dose of Gardasil and experienced redness that went away fairly quickly but the arm hurt for 2 weeks after. On 07-AUG-2007 the patient was vaccinated intramuscularly in the left arm with a 0.5mL second dose of Gardasil (Lot# 658222/0927U). Subsequently, the patient developed redness and pain in the left arm from the elbow to shoulder, was nauseous and pale. No shortness of breath. The patient was treated with BENADRYL and was observed. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients (demographics unknown). Pertinent medical history, drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with VAQTA (dose, lot and route were not reported) which was improperly stored outside the temperature stated in the prescribing information. No adverse reactions reported. This is one of multiple cases from the same reporter. Additional information is not expected.
5cc of erythema/induration right u pper arm. Claritin, cool compresses.
Information has been received from a physician and a practice manager via two company representatives referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On 21-JAN-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml (lot # L010598, expiration date 06-AUG-2016, route unknown). This specified lot number vaccine was exposed to temperature excursion sixteen times. The total cumulative excursion time (hour) and lowest recorded temperature (Fahrenheit degree) for each time were as below: (216, 29.3); (144, 34.2); (24, 34.7); (52, 33.1); (72, 32.9); (144, 32.4); (100, 34.5); (28, 30); (24, 34.3); (104, 29.1); (48, 34.9); (36, 31.1); (100, 33.6); (24, 34.8); (56, 33.4); (64, 34). The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to 4-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-FEB-2017, the patient was vaccinated with improperly stored dose of PROQUAD recombinant human albumin (rHA) lot # L046506, expiration date of 17-MAY-2017 (dose and route of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent (MRK). Administered dose of vaccine experienced the temperature excursion between 6 degrees Fahrenheit (°F) and 14 °F for 30 minutes. The reported also stated that the temperature excursion took place on 03-FEB-2017 and that the vaccine was deemed to still be viable. No previous temperature excursions occurred. No product quality complaint was involved. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same source. Additional information is not expected as all relevant information has already been received. Follow up information has been received from the nurse by a phone call on 18-MAY-2017. A request was made for patient identifiers and dates of administration for the improperly stored vaccines. The registered nurse asked if there was a form to complete. Additional information has been requested. Sender's Comments: US-009507513-1704USA009837: US-009507513-1704USA010916: US-009507513-1706USA003482: US-009507513-1706USA003483: US-009507513-1706USA003484: US-009507513-1706USA003485: US-009507513-1706USA003486: US-009507513-1706USA003487: US-009507513-1706USA003488: US-009507513-1706USA003474: US-009507513-1706USA003475: US-009507513-1706USA003476: US-009507513-1706USA003477: US-009507513-1706USA003478: US-009507513-1706USA003479: US-009507513-1706USA003480: US-009507513-1706USA003481.
Information has been received from a physician concerning a 77 year old male with a penicillin and codeine allergy who on 30-MAR-2007 was vaccinated with a 0.65 ml dose of Zostavax (Merck-lot# 656859/0357U). Concomitant therapy included LIPITOR, ACIPHEX, LEVOXYL, ANDRODERM and vitamins (unspecified). On 06-APR-2007, the patient reported an irritated feeling on the posterior chest wall. On 07-APR-2007, the patient developed a patch of shingles on the posterior chest wall below the arm pit. The shingles were sensitive to touch. On 09-APR-2007, the patient was seen in the office and zoster was diagnosed. At the time, treatment with VALTREX 1 gram every 8 hours for 7 days and Darvocet N-100 one tablet every 4-6 hours PRN pain was prescribed. No lab testing was performed. The patient had not recovered. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/14/2007. Follow-up information received by the physician indicating that the patient developed a case of shingles 8 days post vaccine administration. No illness at the time of vaccination. No relevant diagnostic tests or laboratory data. Non-serious report.
This spontaneous case reported by a consumer, describes the occurrence of candida infection (candida overgrowth) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Aug 26, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced candida infection (candida overgrowth). At the time of the report, candida infection (candida overgrowth) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
received Fluzone SD instead of Fluzone HD with no reported adverse event; Initial information received on 31-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves Elderly male patient who received INFLUENZA QUADRIVAL A-B INTRADERMAL VACCINE (FLUZONE SD) instead of Fluzone HD with no reported adverse event while receiving 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 QUADRIVAL A-B INTRADERMAL VACCINE, Solution for injection in pre-filled syringe, ( lot number and expiry date: not reported)  via intramuscular route in unknown administration site for immunization.  On an unknown date the patient received Fluzone SD instead of fluzone HD with no reported adverse event (wrong product administered) (latency: same day).  Action taken : not applicable.  Outcome: unknown  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 the 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.