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 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021 at 10:03 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 10:06 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, 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 reported as 42.93 on 28-Feb-2021 and 43.01 on 28-Mar-2021.  Concomitant products were not reported.  On 28-Mar-2021, Excursion time was 10 AM, temperature was 35, total doses given for the day was 150, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 27-Mar-2021. 15 vials were sent to clinic. Vaccine date was 22-Apr-2021.  On 28-Feb-2021, Excursion time was 09 AM, and 1 PM, temperature was 27 and 26, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 27-Feb-2021. 20 vials were sent to clinic. Vaccine date was 26-Mar-2021.   On 28-Feb-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 27, 10 AM: 40, 11 AM: 44, 12 AM: 46, 1PM: 26, 2 PM: 37, 3 PM: 43 and 4 PM: 45.  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 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.
Tested positive for Covid; Flu like symptoms; Cough; Viral rash; Chills; Fever; Sore throat; Vomiting; Vaccine was administered in the side of her arm and not in her deltoid muscle; Abdominal cramps; Diarrhea; Pain/body ache; A spontaneous report was received from a Healthcare Professional concerning a 64-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events abdominal cramps, pain, diarrhea, flu like symptoms, viral rash, fever, chills, cough, sore throat, body aches, vomiting, tested positive for covid.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Dec 2020, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 037K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 27 Jan 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot batch: 011M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 27JAN2021 the patient received the 2nd dose of the Moderna vaccine in her left arm and reported that the vaccine was administered in the side of her arm and not in her deltoid muscle. On the same day the patient reported nausea, headache, injection site swelling, redness 2 inches below the injection site and pain. Nausea ended on 28JAN2021 and the other symptoms are ongoing  On 11 Jan 2021, the patient experienced the events abdominal cramps. pain, diarrhea.   On 12 Jan 2021, the patient experienced the events flu like symptoms. viral rash, fever, chills, cough, sore throat, body aches, vomiting.   On 13 Jan 2021, the patient experienced the events tested positive for covid.   Treatment details included Claritin and Ibuprofen  Action taken with mRNA-1273 in response to the events was not reported.   On 22 Jan 2021, the patient was completely recovered from abdominal cramps. pain, diarrhea, flu like symptoms. viral rash, fever, chills, cough, sore throat, body aches, vomiting and coronavirus test positive.   The outcome of all events was recovered/resolved.; Reporter's Comments: This case concerns a 64 Y/O M with NS unexpected COVID-19, influenza-like symptoms, abdominal cramps, diarrhea, viral rash, sore throat, cough, and NS expected fever, chills, vomiting, pain. Onset 13 days after first dose mRNA-1273. Events resolved. Second dose mRNA-1273 with nausea, headache, injection site swelling, redness, pain. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Redness, inch and a half red area; Tenderness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness, inch and a half red area) and TENDERNESS (Tenderness) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event .     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Redness, inch and a half red area) and TENDERNESS (Tenderness). The patient was treated with IBUPROFEN at an unspecified dose and frequency; Wound care (He was told to apply ice on the affected area by the doctor) for Erythema and Wound care (He was told to apply ice on the affected area by the doctor) for Tenderness. At the time of the report, ERYTHEMA (Redness, inch and a half red area) and TENDERNESS (Tenderness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Pt stated that she had a runny nose and mild cough for about a week.  She was being tested for COVID prior to having spine surgery
I am currently not able to elevate my left arm above the level of my shoulder without excruciating pain.
Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding six patient who were administered improperly stored vaccine (1 degree C). The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant medications were nor reported. Six patients were administered the Prevnar vaccine that was stored at 1 degree c (poor quality drug administered). No additional information was available at the time of this report. The reporter indicated that six patients were administered improperly stored vaccine, however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.
This spontaneous report as received from a pharmacy technician refers to a 1-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 27-FEB-2018 the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA001558.
expired vaccine is stored and then administered/ Vial refrigerated on 03-Nov-2021 after expiry; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (expired vaccine is stored and then administered/ Vial refrigerated on 03-Nov-2021 after expiry) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (expired vaccine is stored and then administered/ Vial refrigerated on 03-Nov-2021 after expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (expired vaccine is stored and then administered/ Vial refrigerated on 03-Nov-2021 after expiry) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  Treatment medication was not provided by the reporter  It was mentioned that the vial was initially refrigerated  on 03 Nov 2021, the vial did not undergo any temperature excursion and the patient did not experienced any adverse events.
was tired and slept more than usual; was tired and slept more than usual; Soreness in left arm; This is a spontaneous report from a contactable consumer reported for himself.  A 71-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 22Dec2020 13:50 at single dose for covid-19 immunisation. There were no medical history or concomitant medications.  The patient got it at 1:50 pm, and got home and was really tired, so he said he was going to bed at 6pm and woke up at 7:30 feeling pretty refreshed.  He then told himself, if he didn't get up, he wouldn't sleep at night, so he got up until 11:00 and slept until 8am.  The patient was tired and slept more than usual on 22Dec2020 at 16:00. The only side effect was that he got a little bit more rest than normal.  The other side effect is he got soreness in left arm and it was pretty sore unspecified date in Dec2020.  He did not have any headaches or anything else.  He was pretty satisfied. The outcome of the events was tired and slept more than usual was recovering while for other event was unknown. Information on lot/batch number has been requested.
Third shot/booster given on 12/31/21 to 12 year old.  Not approved yet
(Received Menactra at age 11 w/o problem)  Headache, dizziness, myalgias, fatigue, on menses seen at ED on 3/8/2022 at 7:50pm with HR 125 BP 87/55.  3/18/2022 22.4>11.7<261 - 35.5   82/9 9/0
won't wake up, vomited, shook when moved, t101, breathing problems;MD ordered blood test & told mom on 12-15 that WBC was sl elevated most likely from a viral infect that was caused by MMR;
After patient completed 15 minute observation post vaccination started to put her coat on and stood up. Started to feel SOB and felt like was running on a treadmill and felt heart racing. Told observer and taken back to exam room. On the way down the hall stopped in hallway and needed assistance in exam room. B/P elevated 172/74, O2 sats 97% and pulse 130. Patient was instructed to use albuterol that she had in her purse 2 puffs with good effort demonstrated. Patient able to sit alone in chair and stated started t feel better but was feeling anxious. Denies SOB, dizziness, chest tightness and stated has been feeling well. Injection given around lunchtime and patient had not eaten since this am ( coffee and toast). Patient observed for 10 minutes and B/P  dropped to 14/76 and pulse 105 and 02 Sats at 98%
Patient received the 3 listed vaccines as part of routine well child visit, but receive them using incorrect technique (inadequate depth of IM administration). The  provider who examined the patient apparently relayed that they felt the administration was likely subcutaneous.  The administrations occurred on April 7th. The patient was following up for unrelated reason (what sounds like mild URI) and "dad noted firmness in BL thighs and tender".  Notes from provider physical exam : "Nodules on thighs from immunizations-parents to monitor, no sign of infection".  No known interventions; no known worsening of patient.
01/02/21 discomfort, flushing  sweat, waves of gastro pain, bloating, explosive bowel movements; 01/03/21 loose, mucous bowel movement, not feeling well; 01/04/21 feeling better, urges for loose bowel movements continue and slight stomach pains.
patients were administered the vaccine after the 30-day beyond use date; No adverse event; administered after the 30 day beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered after the 30 day beyond use date), PRODUCT STORAGE ERROR (patients were administered the vaccine after the 30-day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 63-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered after the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (patients were administered the vaccine after the 30-day beyond use date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered after the 30 day beyond use date), PRODUCT STORAGE ERROR (patients were administered the vaccine after the 30-day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (administered after the 30 day beyond use date) and PRODUCT STORAGE ERROR (patients were administered the vaccine after the 30-day beyond use date).    No concomitant medications were reported. The vial size was 2.5mL. The vial was initially stored in the refrigerator on 20-Sep-2022. The vial did not undergo any temperature excursions. No treatment medications were reported.
Cant sleep at night; Dizziness; headache; weak and tired; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Cant sleep at night), DIZZINESS (Dizziness), HEADACHE (headache) and FATIGUE (weak and tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history 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 INSOMNIA (Cant sleep at night), DIZZINESS (Dizziness), HEADACHE (headache) and FATIGUE (weak and tired). At the time of the report, INSOMNIA (Cant sleep at night), DIZZINESS (Dizziness) and FATIGUE (weak and tired) outcome was unknown and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       relevant concomitant products usage were not reported by the reporter. Treatment details not included.
PATIENT COMPLAINED THAT TECHNICIAN WHO ADMINISTERED THE VACCINE JABBED HER BADLY AND DUE TO WHICH SHE HAD SWELLING. BLOOD AND PAIN ON THE LEFT ARM THAT BECAME SEVERE  WITHING 24 HOURS. WE CREATED AN INCIDENT REPORT TO GET PATIENT CALLED AND BE CHECKED BY  A HEALTH CARE PROVIDER.
10/21/2010 Patient passed out at the front desk after receiving the TDAP and Varicella vaccines. Patient states.
G40.802 APHASIA W EPILEPSY 8/19/2021 HX OF FALL G40.802 APHASIA W EPILEPSY 8/19/2021 GOUT G40.802 APHASIA W EPILEPSY 8/19/2021 EPILEPSY, INTRACTABLE
Dizziness, tinnitus, ear fullness, nausea, heart palpitations, fatigue, neck pain and heart arrhythmia.
C/O dizziness, diaphoresis, pale and lightheaded. Numbness to fingers. O2 Sat 96% HR 55, BP 100/60. Pt offered a water and ice pack. He said he felt better after 10 minutes
Patient was very nervous about vaccines when being called to the exam room. After vitals were taken and she was in the room she was nervous and getting herself upset. Spoke with Dr. about her nervousness and Dr. reviewed their charts and said to go ahead and give the vaccines to get them over with so she could then calm down. Patient was given her Tdap, MENACTRA, and HPV vaccines. Afterward she asked to sit with her grandmother, which she did in the exam room. She at that point said she felt fine. The MA left the room for 5-10 minutes, and patient's mother came out of the room saying that patient is vomiting and she can't walk. The MA and doctor went into the room and had patient lie down on the exam table. Dr. was able to finish her exam and patient returned to baseline by the end of the visit.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 as dose 4 (booster), single (Lot number: GH9693), in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: The patient recovered from coronavirus test positive; Positive, notes: tested positive again 10 days later. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 22Sep2023 to 26Sep2023. Clinical course: The patient recovered from coronavirus test positive but began to feel ill again around 8 days later and tested positive again 10 days later.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300317215 same patient, different drug, different event;
Pfizer Dose 1 4/6/21 (EM9810) Pfizer Dose 2 5/11/21 (EM9810) Pfizer Dose 3 1/5/22 (FL3197) COVID Positive 1/8/22 COVID Positive 1/13/22  1/13/22: Patient has vascular dementia, altered mental status and is not a reliable historian.  Most of the history is obtained by personal review of records.  He is 68-year-old resident at nursing home. Past history of stroke, hemiplegia, dysphagia, aphasia, diabetes mellitus, status post craniotomy,  status post PEG tube placement, neurogenic bladder and other medical problems.  He also has atrial fibrillation and is on chronic Xarelto therapy.    Is not known when he was last seen normal.  He reportedly was more somnolent.  Diagnosed with COVID on 1/8/2022.  CT scan of chest shows bilateral pneumonia.  He was on 2 L oxygen at the time of my examination.  No witnessed seizures as per records.  He has atrial fibrillation and is on Xarelto.  CT scan of abdomen showed distended gallbladder with surrounding inflammatory changes.  1/22/22: Patient is a 68-year-old male with history of unspecified neurological injury, status post craniectomy, IDDM, neurogenic bladder with chronic Foley catheter, and chronic dysphagia who was admitted on 1/13/2022 with complicated UTI, bilateral COVID pneumonia, acute metabolic encephalopathy, and acute cholecystitis.  He was admitted to the medical floor and was started on IV antibiotics, remdesivir, and dexamethasone.  His Foley catheter was changed at that time.  The general surgeon was consulted. On 1/17/2022 the patient had a CT-guided percutaneous cholecystostomy drain placed.  His abdominal pain has essentially resolved since that time.  The patient was noted to have some leukocytosis.  He had a follow-up abdominal CT which did not show any acute processes.  His urine culture grew E coli.  He has completed an antibiotic regimen.  The patient today is resting in bed and reports that he is feeling much better.  He denies shortness of breath at rest, chest pain, palpitations.  Still has mild tenderness to the right upper quadrant, but this has been associated to the site of the cystostomy tube.  His tube feedings were resumed and he has been tolerating those well.  His Xarelto was resumed and his hemoglobin has been stable.  He was cleared by surgery for discharge this morning.  The patient will be discharged back to long-term care center.
Pain and decreased ROM in left arm.  Pain began approximately 3 weeks after receiving vaccine and has progressively worsened.
#1 ...extreme fatigue, sleepiness, drowsiness. (several days) #2 mild low grain headache (3 hrs) #3 mild nausea (short period) #4 sniffles... runny nose. #5 soreness on right arm  I have a general negative disposition to the Pfizer vaccine, overall I felt much better before taking the vaccine then after.  There are well defined 'side effects' that are notable. Overall feeling after the vaccine is unwell. (Nothing like the side effects for say the flu virus)  The side effects are much more pronounced. The side effect that is/was most notable is fatigue and drowsiness. I've felt unusually fatigued and sleepy over the past few days with the severest fatigue occurring the day after taking the vaccine. (I've felt fatigue like symptoms over the past few days since taking the vaccine on 4/22.)
chest pain elevated troponin, trended down within 24 hours of inpatient hospitalization and discharged 1 day after being admitted. normal biventricular function on echocardiogram