chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Temperature excursion/Vaccines administered to patients after temperature excursion; Expired vaccines/Vaccines administered to patients after being expired; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion/Vaccines administered to patients after temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Expired vaccines/Vaccines administered to patients after being expired) 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.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion/Vaccines administered to patients after temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Expired vaccines/Vaccines administered to patients after being expired). In 2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion/Vaccines administered to patients after temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Expired vaccines/Vaccines administered to patients after being expired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant and treatment medications are provided by the reporter. Some time ago the super cold freezer where the vaccines were stored in frozen condition, failed. The freezer went up to (+)21 degrees Fahrenheit so the vaccines were moved to a kitchen refrigerator freezer that kept the vaccines around (+) 18 degrees Fahrenheit. The vaccines were in that environment for 2-3 days because they were thawing out the original freezer per manufacturer's instructions. The vaccines in meantime were then placed in refrigerator because they were past the (+) 5 degrees Fahrenheit mark. The vaccines were maintained in the refrigerator between 36-46 degrees Fahrenheit. maximum 21 degrees Fahrenheit in frozen storage condition,Excursion duration is of  2-3 days,Number of vials impacted 150 vials.
Itchy rash on arms, abdomen and neck then left eye swelling and itch.
Headache, Fever, NauseaVomiting, chills Narrative:  Other Relevant History:
Shaky arm twitching, anxious feeling, she was picked up from school Tuesday Feb the 9th for shaking and thoughts of hurting herself was taken to ER and then admitted to psychiatric ward.
Severe flu-like symptoms starting 11 hrs after and lasting 36 hours (expected) After 2 days: Severe fatigue/loss of strength (unable to care for myself), pain in back of legs (not sciatica), hot/sweats, insomnia, migraines and vomiting through first week after Through 4 weeks after: Headaches, severe fatigue, tingling left leg, itchy, rash on face, random itching, don?t feel like eating Through 6 weeks after: FATIGUE/No strength, wear out easy and breathing feels like I went for a run ***Overall improvement after prescribed Ketotifen  After 8 weeks: Random fatigue but getting better  I saw two doctors who said this is common in some people after the vaccine. My specialist suspects Mast Cell Activation Syndrome.
Flare ups w/ Rhumatoid Athritis, major headaches , episodes of passing out for long periods of time, redness and swelling at injection site (lasted for seven days), memory fog and confussion, no appetite, weight loss (10 lbs since receiving shot), loss of taste and smell.  Pt had Covid in March.  Side effects from shot are the same as having Covid.
Muscle aches, joint aches, fatigue, low grade fever, severe pain and swelling in Left shoulder and arm.  Multiple sites of blistering aside from the inoculation site in left shoulder. 3/18/09-records received-seen for C/O sick with fevers and chills, myalgias and sleepiness times 1 week. Symptoms resolved now with constellation of sores in deltoid region. Painful lymphadenopathy in axillary area. Arm is numb. PE: warmth and cellulitis emanating around periphery of constellation of sores. Neurovascularly intact about left hand and arm. Assessment:cellulitis of left arm likely due to small pox vaccination.  3/23/09-records received for DOS 11/12/08-Since vaccines on 10/31/08 C/O left arm muscle aches, joint aches, fatigue, low grade fevers and severe pain and swelling in left shoulder and arm. Treated day before in ED for infection of left arm. Multiple blisters aside the site. Left shoulder redness, swelling tenderness and 5-6 blisters primary inoculation site forming eschar. Assessment: cellulitis due to vaccine. Likely adverse reaction to smallpox vaccination
Patient observed from 1:22 pm to 1:52 pm. Patient states she feels fine at 1:50 pm. Patient reports tongue feels thick and lips itch at 1:52 pm. RN assessed patient and noted no swelling of tongue or lips. Patient vitals at 1:53 pm= 128/79, 81 heart rate, 14 respirations, 100% on room air. Patient given 25 mg Benadryl tablet at 1:59 pm per MD order. EMS called at 2 pm. CBG= 80 at 2:05 pm. EMS arrives at 2:11 pm. EMT assess patient; pt states her symptoms have not gotten worse and she does not want to go to the hospital. Patient eats cookie at 2:22 pm per NP request. EMS leave at 2:25 pm. Patient observed until 2:45 pm and states she would like to go home. Vital signs at 2:45 pm= 132/77, 76 heart rate, 14 respirations, 100% on room air. Patient discharged home with her husband.
6SEP91 according to mom pt had temp of above 103 since 5SEP91 evening not controlled w/APAP, vomited x 2; c/o h/a, temp rose to 104 @ 1030AM 6SEP91;
received the first vaccine on 20Jan2021 and on 23Jan2021, covid virus tested positive; This is a spontaneous report from a contactable consumer (patient's spouse) via a Pfizer-sponsored program, . A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 20Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received the first vaccine on 20Jan2021 and on 23Jan2021, covid virus tested positive. He was scheduled for #2 covax on 08Feb2021 and was asking if he should get the vaccine. Outcome of the event was unknown.  Information about lot/batch number has been requested.
27 months old was scheduled to receive a dose of Bexsero; This case was reported by a consumer via call center representative and described the occurrence of intercepted product administration error in a 27-month-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced intercepted product administration error. On an unknown date, the outcome of the intercepted product administration error 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: This case was reported by the patient's mother. The age at vaccination was not applicable for this report. The patient's demographics were not provided.  The family was moving to Europe and the mother wanted to get her daughter vaccinated based on the European vaccine recommendations. The patient was scheduled to receive a dose of Bexsero tomorrow from the date of reporting. The mother read in the online PI that Bexsero was only indicated for patients aged 10 to 25 years old. At the time of reporting, the mother stated that she would not give the Bexsero to her daughter at this time, which led to intercepted drug administration error. Mother was given medical disclaimer and was referred to her health care professional. Consent to contact the doctor was not obtained.
Pt recvd 1st dose of vax on 2APR92 & 8APR92 exp a sore throat, fever, musculoskeletal pain, fatigue & migratory arthralgias; hospitalized to r/o rheumatic fever; pt exp paresthesias; MD felt exp serum sickness-type reaction;
PATIENT PRESENTED WITH REDNESS AND SWELLING AND WARM TO TOUCH LEFT UPPER ARM AT VACCINE SITE.
Bowel stopped producing stools; Bowel stopped producing stools; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 11Apr2021 11:00 (Lot number: EW0153) as dose 1, single for COVID-19 immunisation. Medical history included gastritis, and back pain. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications received within 2 weeks of vaccination included zolpidem tartrate (AMBIEN); alprazolam (XANAX); and phentermine. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took levofloxacin (LEVAQUIN), naproxen and pethidine hydrochloride (DEMEROL), and experienced drug allergies. The patient experienced bowel stopped producing stools on 11May2021 when patient noticed it. The AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization (days of hospitalization: 5), Life threatening illness (immediate risk of death from the event), and Disability or permanent damage. No treatment was received for the reported event. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab test which included COVID test: negative nasal swab on 03Jun2021. The outcome of the event was not recovered.
Itching, tenderness, induration, swelling of injection site that has spread down to the bicep muscle (about one inch from the antecubital fossa)
Redness, heat, swelling, and itching. TX: Benadryl and Triamcinalone.
diagnosed with Shingles; back pain; rash; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) (batch number 7XY2P, expiry date 24th January 2022) for prophylaxis.   On 15th July 2020, the patient received the 1st dose of Shingrix (intramuscular). In July 2020, less than 3 weeks after receiving Shingrix, the patient experienced back pain and rash. On 27th July 2020, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the back pain and rash were unknown.   It was unknown if the reporter considered the shingles, back pain and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and visited his HCP and was diagnosed with Shingles.  The patient noticed some back pain several days before but thought it was due to playing golf until he noticed the rash.  The reporter made an appointment with his HCP and was diagnosed with Shingles. The HCP information was not provided.
Allergic reaction to Moderna dose one; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction to Moderna dose one) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic reaction to Moderna dose one). At the time of the report, HYPERSENSITIVITY (Allergic reaction to Moderna dose one) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported.  No treatment information was provided.
DTaP administered to LUA on 4/2/02. On 4/3/02 developed redness and swelling at site. Better today. Area 5 x 5cm today, red, slightly warm to touch. Slightly swollen. Able to use arm. T-97.8 ear, BP 80/40, P 104, R 28.
Fatigue after1st dose; Arm pain after1st dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Arm pain after1st dose) and FATIGUE (Fatigue after1st dose) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L208a) for COVID-19 vaccination.     Concurrent medical conditions included Hepatitis C antibody positive.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Dec-2020, the patient experienced PAIN IN EXTREMITY (Arm pain after1st dose). On 29-Dec-2020, the patient experienced FATIGUE (Fatigue after1st dose). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 30-Dec-2020, FATIGUE (Fatigue after1st dose) had resolved. On 01-Jan-2021, PAIN IN EXTREMITY (Arm pain after1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and 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.   No Concomitant medications were reported.  Patient has reported race information as Black.   This case was linked.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Patient denied having any reaction to vaccine. Contact information was updated. Patient's race, height, weight was updated.
left upper arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hypertension.   On 13th August 2020, the patient received Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received the first dose of the Shingrix vaccine in her left arm and she had left upper arm pain for 3 days and it resolved. The reporter consented to follow up. For tolerance of 2nd dose of Shingrix, refer case US2020220481; Sender's Comments:  US-GLAXOSMITHKLINE-US2020220481:same reporter
Information has been received from a licensed practical nurse concerning a 47 year old female with no medical history and/or drug/allergic reactions who on 18-APR-2007 was vaccinated subcutaneously with a dose of Zostavax (Oka/Merck).  There was no concomitant medication.  No symptoms were noted.  No diagnostic laboratory tests were performed.  There was no product quality complaint.  Additional information has been received which stated that there was no adverse reaction and the vaccine was administered in error instead of a dose of Varivax (MSD).  Additional information has been received from the licensed practical nurse who stated that the patient's zoster IgG test showed no immunity.  A new nurse in the office showed the negative results to the physician and asked if she could vaccinate the patient.  The physician said yes in reference to vaccinating the patient with a dose of Varivax (MSD).  The new nurse was unfamiliar with both vaccines assumed the vaccine to be given was Zostavax (MSD).  So the patient was vaccinated with a dose of Zostavax (MSD).  It was reported that the patient was doing "fine".  No further information is expected.
limp & unresponsive excessive sleeping for 4 1/2 hrs Friday eve, urinating on chair, no tx;
This spontaneous report as received from an Emergency Medical Technician (EMT) refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patients received improperly stored doses of VARIVAX (dose, route of administration, lot number and expiration date were not reported). It was stated that the vaccine underwent a temperature excursion of 17.6 degrees Fahrenheit for 84 hours. No previous excursion was reported. No data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Myocarditis in the setting of recent second Moderna vaccine. Troponin peaked at 9.67 and trended downward. He was taken for cardiac catheterization on 5/17/2021 and was found to have normal coronaries. He had a cardiac MRI on 5/17/2021 which was found to be positive for myocarditis. Echo completed displaying preserved EF without wall motion abnormality or Due to the episode of NSVT will start low dose metoprolol tartrate until follow up with cardiology in the outpatient setting then hopefully able to discontinue. Post procedure restrictions discussed, patient verbalized understanding. No cardiac rehab indicated.
It has been 4 months since I got the j and j shot and I still have pain at injection site, that radiates outward on my upper arm and shoots down to my elbow. It is always there, however certain motions and positions irritate it more.
delirious; arm pain; developed a temperature of 103; vomiting; Chills; A spontaneous report was received from a health care professional concerning a  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm pain ,vomiting, chills,fever 103'F and was delirious.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Jan 2021 , prior to the onset of the events the patient received his first of two planned doses of mRNA-1273 (lot/batch:unknown ) via unknown route of administration and unknown anatomical location for prophylaxis of COVID-19 infection.  On 23 Jan 2021. the patient experienced significant arm pain and as the night went on began vomiting, chills and developed a temperature of 103 and was delirious at the point where he was taken to emergency room. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events significant arm pain, vomiting, chills, fever and delirium was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No Medical History information was reported.  On 14-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 14-Sep-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of refrigeration: 06-Aug-2021.  No concomitant medications were reported.  No treatment information was provided.
1/30 vaccination, 1st day of menstrual cycle. By 4:30 I felt feverish. By 7:30PM, went to bed and slept on and off for 12 hours. 1/31 When I woke up, not feeling well. Increased cramping, dehydrated. I had been in the bathroom, then went into the kitchen to turn off stove and fainted. During syncopal episode, I hit my head. I did black out. I woke up on the floor, the cramping increased again 10/10 for pain, I yelled for my husband. I asked him to call 911. Transported to the ER. They gave me 2 bags of fluids and discharged me home. Mild concussion. 2/1/2021 PCM. Physical and mental rest, no screens, cognitive rest. I was out of work for 2 weeks. I did have a mild concussion. 3/12/2021 Neurology. Post concussive HA/syndrome and fatigue. Stayed out of work for 7 weeks. I have been seeing a doctor every 2-3 weeks. I will see her in a few weeks. Cranio-therapy for PT and acupuncture.
Patient got the second dose shingles vaccine around 9:15am on 3/1/19. Per patients husband around 7pm that night patient got out of bed and could not stand. Patient also had a fever. They called her doctor who then started her on prednisone.
Feeling tired and weak Fever Redness where shot was given Headache Muscle pain No treatment Back to normal within 2 days except for redness (still pink 1 week later)
4-12-08 48 hours after injection developed macular/papular/vesicular rash inner right thigh and right buttocks.
Patient came to pharmacy today (2/13/19) to report of pain and redness that has been present for a week. Patient reported that it is getting better but she was concerned.
woke up at 3am with diarrhea and nausea . Woke at 6 am with fever of 101.7, joint pain, Headache and fatigue any myalgia
Few weeks after shots, pain became unbearable so I needed to rest often. I visited a clinic nearby but they told me to wait as vaccines can cause temporary pain. However, three plus years later, I am in pain often and when such pain occurs, it is acute.
5 days p/vax pt broke out in hugh hives from head to toe;@ time of this report has now had these intermittently x 6wk;rash/hives 5 days later;
Patient got the shot that was expired; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient got the shot that was expired) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 048F21A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder NOS (have two autoimmune conditions.).   On 11-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 11-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient got the shot that was expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient got the shot that was expired) outcome was unknown.      Concomitant medications were not reported.  It was reported that, they would like to know if there had been extension shelf life for lot 048F21A. Patient received a vaccine from lot number 048F21A about an hour ago. They would like to know what the ramifications were of receiving a vaccine that had been expired. Patient got the shot that was expired. Reporter told the vaccination provider lied about the self-life of the vaccine. Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2022: Follow-up received contains no new information
Clostridioides difficile infection. Hospital admission within 6 weeks of receiving the COVID vaccine.
Patient received a vaccine after the Moderna vial had been punctured 20 times. Patient was the 24th patient to get vaccinated from the vial. Moderna was contacted and informed of the incident.