chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021 at 2:49 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 2:22 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 46.63  Concomitant medication was not provided.  On 13-Feb-2021, Excursion time was 09 AM, with temperature as 32. Total doses given for the day was 152 vials. Condition of vaccine prior to administration was not frozen. Vaccine was moved to fridge on 09-feb-2021 and. Vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  On 20-Mar-2021, Excursion time was 09 AM and 10 AM, with temperature as 34, and 37 respectively. Total doses given for the day was 184 for 9AM vials. Condition of vaccine prior to administration was not frozen. Vaccine was moved to fridge on 09-Mar-2021 and. Vial was moved to clinic on 20-Mar-2021. 19 vials were sent to clinic. Vaccine BUD date was 08-Apr-2021 for 9AM. On 20-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: Not provided, 9 AM: 34, 10 AM: 30, 11 AM: 41, 12 AM: 45, 1PM: 44, 2 PM: 44, 3 PM: 44, and 4 PM: 44. and 5 PM: 43. .  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Information has been received from a physician concerning a 15 year old who, on an unknown date between July 2006 to 05-MAR-2007 was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (lot # 654813/1088F). Subsequently, within two to three days post vaccination, the patient developed a large, two to three inch injection site reaction on the upper arms. The reaction lasted approximately one week. Unspecified medical attention was sought; no treatment was required. No additional information to report. There was no product quality complaint involved. This is one of several reports received from the same source. Additional information is not expected.
first dose of Twinrix in July 2020 and the second dose in July 2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 60-year-old male patient who received HAB (Twinrix adult) (batch number GG3S5, expiry date 28th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix adult (1st dose received in July 2020, batch number 3Y7NL, expiry date 24th May 2022).   In July 2021, the patient received the 2nd dose of Twinrix adult and Twinrix Pre-Filled Syringe Device. In July 2021, unknown after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long 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 details were provided as follows: The reporter stated that, the patient received 2nd dose late than the recommended time interval, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Ever since I got Flu vaccine on 9/23/2018 my right arm has been frozen with sever pain. I received a cortisone shot but not much relief.
Moderate to severe sudden hearing loss and tinnitus starting on March 27th - 10 days post-vaccination.
This spontaneous report was received from a consumer, referring on herself, an 81 year old female patient. The patient's medical history included hip replacement, knee surgery (left knee) and heart surgery. Current conditions included hypertension and hypothyroidism. The patient did not have any drug allergy or drug reactions. On 21-MAR-2016, the patient was vaccinated a first dose of ZOSTAVAX, subcutaneously (dose, frequency, anatomical location, lot # and expiry date were not reported). Concomitant therapies included atenolol, SYNTHROID, simvastatin (manufacturer unknown), warfarin and amlodipine. After vaccination, the patient experienced an injection site reaction of pain, swelling and redness in her arm. It was reported that the effects had slowly resolved over time and symptoms had subsequently resolved. On approximately 30-MAR-2016, reported as within the past 5 or 6 days, the patient began to experience pain in her thigh; the patient attributed that pain to the bad weather as she has had a knee and hip surgery. The pain has increased and exacerbated across her right thigh up to her hip (arthralgia). It was reported that she was on severe pain and took TYLENOL as a treatment; however, the pain was not relieved. the patient was unable to use other painkillers due to her heart surgery. Laboratory test were not performed. It was reported that the patient was seen by the doctor on 05-APR-2016, to discuss the matter. There was no product quality complaint involved. The patient recovered from the injection site reaction, pain, swelling and redness in her arm. Nevertheless, at the reporting time pain in thigh and hip was reported as not recovered. Additional information has been requested.
Confusion, lethargy, inability to walk (severe weakness bilaterally), low grade fever 98.8 (normal is 97.0), slurred speech. All symptoms resolved within 24 hours without treatment.
BREAKTHROUGH COVID: FULLY VACCINATED WITH BOOSTER. The patient presents with Failure to thrive.COVID PNA/URI w/ acute moderate protein calorie malnx, atrophied pancreas w/ chronic daily EtOH use w/o known SUD. VSS on RA with intermittent tachycardia and elevated BP.  No BMs recorded since admission.  Gross leukocytosis, elevated platelets.  Renal indices WNL with GFR in 60s, troponin elevated-peak 76 COVID positive.  UA negative.  CT abdomen pelvis:  Diverticulosis without diverticulitis, no acute inflammatory processes, chronic moderate T12-L3 compression fractures, severe diffuse pancreatic atrophy- on personal review mod stool in pelvis/sigmoid.
Around 6PM patient stated she started with severe body and bone aches, weakness, chills and slight headache..she felt better in the morning when she woke up...nearly 100% better the following day.
Information has been received from a physician and healthcare worker concerning a 4 year old male with no allergy who on an unspecified date was vaccinated with the first dose of VARIVAX (Merck) (LOT# not reported). Second suspect vaccine included MMR II (Lot # not reported). Other concomitant therapy included ZYRTEC. The physician and healthcare worker reported that the patient experienced Guillain Barre Syndrome. The patient was hospitalized and received a treatment of IV IG (immune globulin) for five days for Guillain Barre on 02-JUN-2009. The physician felt that Guillain Barre Syndrome was not related to vaccinations but was caused by a virus. At the time of this report the patient had not recovered. The patient was hospitalized. The physician felt the Guillain Barre Syndrome was an other important medical event. Follow-up information has been received from the physician who indicated that the patient (was new to their practice 14-JUL-2009, birth weight 7 lb 4 oz., 2 siblings) who on 02-JUN-2009 was diagnosed with Guillain Barre Syndrome in the hospital. The patient received a treatment of IV IG (immune globulin) for six days (also reported as five days). Subsequently, the patient was undergoing physical therapy. Subsequent vaccine update the MMR II, VARICELLA (Merck), IPV (unspecified) and Tdap were to delayed three months after immune globulin (IVIG) as per the Center for Disease Control (CDC). The patient was hospitalized for 6 days. The physician considered the Guillain Barre Syndrome to be disabling. Additional information has been requested.
You got the vaccine, had no reaction initially.  Arm never got sore, nothing at all.  Approximately 8 days later he was watching TV, woke up,  got up to use the restroom and walked about 40' to get to the bathroom and was breathing so hard that he had to sit down.  He went to go back to the couch and was exhausted, got light headed and fell on the floor.  He got his wife up, got her dressed and he went to the ER .  They said he had a pulmonary embolism and kept him in ICU for 5 days.   He has since been okay, been on Eliquis since he has been discharged.   Admitted on 2/18/21 and discharged on 2/22/21.
Presented to hospital 14Apr2021 with dyspnea and found to have bilateral pulmonary Embolism.; Presented to hospital 14Apr2021 with dyspnea and found to have bilateral pulmonary Embolism.; This is a spontaneous report from a contactable physician.  A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), intramuscular first dose on 08Apr2021 at single dose for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient was not pregnant at time of vaccination. The patient was presented to hospital on 14Apr2021 (also reported on 04Jan2021) with dyspnea and found to have bilateral pulmonary Embolism. The event caused hospitalization on 14Apr2021. The patient was treated with Anticoagulation. The patient underwent lab tests and procedures which included Nasal Swab: negative on 14Apr2021. The outcome of the events was recovered.  Information on the lot/batch number has been requested.
Patient given 0.2ml dose of undiluted vaccine. no symptoms or side effects noted.
low grade fever and body aches with fatigue three days after second dose in series. see ADR narrative area for detailed more serious AE's Narrative:  When I received the second vaccine, I had body aches (3 days) and fever. Jan. 2021 - Covid - Quarantined through Jan. 14th. Loss of taste, smell for two-three weeks; body aches 1st four days (prior to being tested) Mar. 24, 2021 - Moderna Vaccine Sore Arm, nothing else Apr. 21, 2021 - Moderna Vaccine Low grade temp/body aches. Fatigued for around 3 days. Jun. 2021 - Physical Jun. 14, 2021 - Seen for hand numbness - Index and middle finger on Left Hand, felt a little tired, but thought this was my new normal. June 26, 2021 - Back for follow-up Numbness moved in left hand. Prescribed Diclofenac (pills) - stopped taking because my BP was steadily going up Recommended nerve testing and hand therapy Aug. 6 & 10th - Hand therapy On 10th, a massage was performed. That night my left arm burned. Started to have ups and downs (energy then no energy). Noticed my right ankle was swelling up so discontinued eating out (sodium/MSG?) and would elevate. Also, started having issues with my left knee. Aug. 23rd - Requested to be tested for Lyme's. PA stated that the symptoms did not sound like lymes, but did the lymes (negative) and the ANA. Tested at 320 titer. Referral to rheumatology with care instructions, which did not work Weakness in arms Knuckles in both hands looked bruised Hands both swelled up Left knee pain increased Both Right and Left ankle swelled up, but right was worse than the left. Difficulty getting up from a sitting positive (must find legs as I feel unsteady, but once walking, I'm okay) Neck pain on right side, noticed lump on base of neck By morning swelling would be down. Difficulty turning around in bed at night Morning walks ceased as it was painful in hips at first. (Used to walk at least 3 miles each morning, cut it down to 1 1/2 miles)
Site: Swelling at Injection Site-Mild, Additional Details: Swelling at site of injection, round, approximately 5 cm in diameter, raised approximately 1.5 cm in the center.  Swelling was realized in less than 3 seconds.  Applied cool compress with chilled water bottle. Patient denied any itching, pain or other symptoms. Patient remained in pharmacy under observation for 30 minutes. After 30 minutes swelling had subsided and some faint, blue hue could be seen in the area where swelling had subsided. Patient requested to leave under her own supervision.
Received Boostrix in right arm on 03/05/09. Noted swelling, discomfort and pain at injection site on 03/11/09, 6 days after vaccination.  Contacted facility on 03/13/2009 to report.  Contact made with patient this date to followup. Patient states that she no longer is having pain, edema or heat at injection site.  Did not receive any evaluation or treatment.
Soreness of right arm; Partial administration, got some of the dose; Medicine ran down the arm; Medicine ran down the arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th January 2023, the patient received the 2nd dose of Shingrix. On 5th January 2023, less than a day after receiving Shingrix, the patient experienced pain in arm, accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the accidental underdose, exposure via skin contact and inadvertent exposure to vaccine were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-JAN-2023 Reporter's Comments: The patient reported that when the Shingrix dose was being administered in her right arm, the patient pulled away and caused partial administration of the shingles vaccine (adverse event filed). The patient reported some Shingrix medicine ran down her arm after she pulled away (adverse event filed). The patient reported soreness of her right arm since she received the Shingrix dose and reported that the administrating pharmacist said she got some of the Shingrix dose. The patient declined to give full address. The patient unable to provide lot number or expiration date of the Shingrix she received. The patient declined to provide consent for health care professional. Additional Supportive Information: The patient reported some Shingrix medicine ran down her arm after she pulled away and caused partial administration of vaccine, which led to accidental underdose, exposure via skin contact and inadvertent exposure to vaccine.
fluid like blister on roof of mouth, red dots on skin, extreme fatigue and worsening of arthritis symptoms and GERD
Female patient reports feeling palpitations in the heart area after the first dose of her vaccine. She had symptoms after a week of administration. On 07/24/2021 she visited the hospital where the Dr. performed laboratory testing, EKG, chest radiological images, then indicated that her symptoms are due to an adverse reaction to the Pfizer vaccine and referred her to a specialist (cardiologist).
This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection, lot # L037554, expiration date 25-DEC-2017 (dose, route and site of administration were not reported). No adverse effects were reported. Product quality complaint was not involved. The administered doses of GARDASIL 9 were stored in a temperature of 13.98 degrees Celsius for 10 minutes and in the temperature of 10.58 degrees Celsius for 10 minutes. Data logger was involved. There were no previous temperature excursions reported. At the time of reporting, there was no further information to provide. This is one of four reports received from the same reporter. Additional information has been requested.
Shot given on 5/9/17. From 5/10/17 - 5/17/17 had diarrhea with a low grade fever. 5/19/17 injection site was very red and she started to break out in a rash on her back. By the next day 5/20/17 she was broke out head to toe with a rash and fever. (Injection site was Rt thigh).
long term covin, includes: short of breath, cough, very tired and catch breath; long term covin, includes: short of breath, cough, very tired and catch breath; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "long term covin, includes: short of breath, cough, very tired and catch breath".  Clinical course: I took you Covid vaccine x3 I now have long term covin. These are just some of my problems.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Patient states that within 30 minutes of being vaccinated, while she was driving home from the pharmacy, she started experiencing HEART PALPITATIONS, HEADACHE and DIZZINESS. When she got home  (she lives less than 15 minutes from the pharmacy), she had a FEVER and felt  FATIGUED. Patient states symptoms lasted approximately 1 week and she did consult with her Primary Care Physician.
29MAR96 the day p/vax approx 1-2PM H20 blisters ? described @ shot site that passed to large, swollen welt? rt thigh;mom took pt to ER & told to use DPH x 3 days;
I had body aches, headache, diarrhea, and fatigue. I tested positive for Covid-19 with a home test on 12/25/2021 and with a PCR test on 12/28/2021. It lasted a lot longer than I expected it to. I experienced symptoms for over 2 weeks. The symptoms were mild but I still could not go to work or do anything around the house. I did not receive any treatment. I only took Tylenol.
STUDENT WITH FINE RASH NOTED TO FOREARMS, NECK AND CHEEK. NO DIFFICULTY BREATHING OR SHORTNESS OF BREATH.  STUDENT GIVEN ORAL BENADRYL 12.5 MG.  RASH IMPROVED.  STUDENT WAS WELL THE NEXT DAY PER SCHOOL NURSE.
Pt recvd Engerix-B according to a 0, 1 & 6 mo schedule & it was determined that pts titer was neg;
Pt's (R) deltoid area (site of varicella vaccine adm.) became reddened, tender to touch, approx 50mm. Pt was taken to urgent care after the 3rd day of inflammation. No previous adverse rx to vaccine. Antibiotics prescribed. Pt. doing well within 24 hrs. of antibiotics. No fever. Pt. received Tdap/MVC4 in opposite arm at the same time.
The first 2 days she had mild nausea and headaches.   The 3rd day she developed chest pain, worse on the left than right, radiates to the back. She states chest pain has continued and has been constant since then. Worse with movement, deep breaths, and lifting a heavy case at work. Rates pain 3-6/10 and describes as sharp and "twinge" with movement. She has taken OTC medication for the pain without relief. There is no where that is tender to touch. She is able to do her usual activities and states she is very active at work. Feels the pain limits her breathing at times and causes some SOB. She is able to speak in full sentences over the phone without difficulty. No audible wheeze.   Had asthma as a child but much improved as an adult. Denies left arm, neck or jaw pain, lightheadedness, dizziness, nausea, vomiting, cough, fever, or sore throat. She is eating and drinking normally. She notes she has a family hx of cardiac disease and stroke. No MI before the age of 50 or sudden cardiac death that she knows of. She has a nexplanon implant and is on norethindrone and estradiol.
Headache/Migraine that is continuous and will not go away with any medication .  all started 10 hours after second covid 19 shot.....
Patient stated he developed a fever three days after receiving the vaccine and then three days after that he developed shingles and has nerve pain down left side of his face. He is scheduled to have an MRI.
lost hair; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD22-023857 (Moderna).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "diabetes (controlled with diet)" (unspecified if ongoing); "Allergies: Sulfa" (unspecified if ongoing); "tetracycline allergy" (unspecified if ongoing); "Allergies: NSAIDs" (unspecified if ongoing); "GERD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "lost hair". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
patient arm swollen, red and hot. two hours later she returns with some signs of bleeding under the skin on the same arm.  First advised the patient to take some Benadryl, the when she returns I advise to check with urgent care
c/o dizziness, was seated, upper portion of body became stiff; pt slid to floor, head turned to lt, eyes open, body stiff, sweaty, no verbal, pulse rapid breath; administered spirits of ammonia; verbal p/1 minute, c/o h/a & lip bleeding;
Vagal response while being in observation area, occurred about 10 mins after vaccination.  EMS responded while on site, checked vitals and attended to patient until vitals normalized.
A 57 year old female received Pnu-Imune 23 and Flu-Shield (2000- 2001 Formula) on 12/12/00. The next day, she developed an injection site reaction characterized by redness, swelling, and tenderness below the Pnu-Imune 23 injection site.