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 POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 4:25 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (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 57.23.  Concomitant products were not provided.  On 11-JAN-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 96, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-JAN-2021, vial was moved to clinic on 08-JAN-2021. 2 vials were sent to clinic. Vaccine BUD date was 04-FEB-2021. On 11-JAN-2021, Excursion time was 02 AM, temperature was 35, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 08-JAN-2021, vial was moved to clinic on 11-JAN-2021. 9 vials were sent to clinic. Vaccine BUD date was 07-FEB-2021.   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 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.
Sore throat, body aches, fever lasted almost 2 days. Treated with rest, liquids, Tylenol, Motrin.
Patient had a lump at the injection site for about 4 days, then developed a rash about 2 weeks later w/intermittent elevated temperature, pain radiating into shoulder/arm, and myalgias.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 34-year-old female patient who received RABAVERT NVS. On 12th April 2017, the patient received the 3rd dose of RABAVERT 1 ml. On 12th April 2017, unknown after receiving RABAVERT, the patient experienced vaccine administered at inappropriate site and wrong injection technique. In April 2017, the patient experienced pain in arm. The patient was treated with ADVIL. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the vaccine administered at inappropriate site and wrong injection technique were unknown. It was unknown if the reporter considered the pain in arm to be related to RABAVERT. Additional details were reported as follows: This case was reported by the patient's husband. The age at vaccination was not reported. The patient received the a dose of the RABAVERT vaccine as a prophylaxis treatment for a bat that was found in their home and the nurse that administered the vaccine was shaking violently and the injection was administered in her bursa or joint muscle rather than her deltoid muscle, which led to vaccine administered at inappropriate site and wrong injection technique. The patient experienced arm pain for three days and she could not move her arm which was improving at the time of reporting. The patient was screaming all night due to the pain and her father who was a physician, prescribed prescription ADVIL to take around the clock and advised to stay home from work. The hospital staff confirmed that the nurse that administered the vaccine had a problem but they would not confirm what the issue was with her hand shaking. The patient's healthcare provider recommended a four dose series as a prophylaxis treatment for RABAVERT.
Little reaction; Felt weak all day; Vomited 11 times; Arm got itchy at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Little reaction), ASTHENIA (Felt weak all day), VACCINATION SITE PRURITUS (Arm got itchy at the injection site) and VOMITING (Vomited 11 times) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 006B21A and 031M20A) for COVID-19 vaccination.   No Medical History information was reported.  On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In October 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PRURITUS (Arm got itchy at the injection site). On 31-Oct-2021, the patient experienced ASTHENIA (Felt weak all day) and VOMITING (Vomited 11 times). On an unknown date, the patient experienced VACCINATION COMPLICATION (Little reaction). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 1 dosage form. At the time of the report, VACCINATION COMPLICATION (Little reaction), ASTHENIA (Felt weak all day), VACCINATION SITE PRURITUS (Arm got itchy at the injection site) and VOMITING (Vomited 11 times) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Little reaction to the Covid booster they got 28-Oct-2021 afternoon.  Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Follow up received on 02-Nov-2021 contains significant information, first and second dosage regimen added, event details added and treatment medication added.
2nd shot- Arm bled quite a bit after injection; Headache lasting a few days; Sore Arm; This is a spontaneous report from a contactable consumer (patient) reporting for herself. A 34-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: FF2588), via an unspecified route of administration, administered in Left arm on 27Aug2021 at the age of 34-years-old as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concurrent conditions were none. The patient was not pregnant at the time of vaccination. There was no relevant past drug history. The patient's concomitant medications were not reported. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: FA7484), via an unspecified route of administration, administered in Left arm on 03Aug2021 (at the age of 34-years-old) as single dose for covid-19 immunisation and experienced Horrible headache lasting 6 days, Chills, Nausea and Sore arm. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Device Date: 19Sep2021. On an unspecified date in 2021, the patient experienced Arm bled quite a bit after injection, Headache lasting a few days and Sore Arm. Adverse events resulted in none of the above. No treatment was received for adverse events. The reporter assessed events as non-serious with no seriousness criteria of resulting in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. The outcome of Headache lasting a few days was recovered on an unspecified date in 2021 and other events was unknown.  No follow-up attempts are needed. No further information is expected.
Information has been received from a pharmacist concerning a 29 year old female who on 09-Sep-2008 was vaccinated IM with VARIVAX (Oka/Merck) (lot number and site not reported). Concomitant therapy included Poliovirus vaccine (manufacture unknown). On the morning of 11-Sep-2008 the patient experienced redness and swelling at the injection site. The reaction was about the size of quarter to fifty cents coin. The patient sought medical attention. No further information is available.
Large local reaction reaction at site at injection (Larm) approx. 1-2 d post vaccination. swelling and erythema extended beyond elbow toward wrist Ended in proximal forearm
Couldn't urinate for  about 12 hours, fever 102.2, couldn't move out bed for 36 hours, chills, sweating, stomach ache, vomited.
Patient complains of swelling at injection site and inward pressure radiating from shoulder and down into fingers plus she was experiencing pain in these areas.
No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring to a 15-month-old female patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 19-NOV-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S007770, expiration date: 24-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (10.7 Celsius) for 33 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S007770; expirationdate: 24-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1910USA012749:
Headache, chills, body aches, muscle aches, fatigue. Next day, symptoms worsened. Worsened on third day. No fever. Fourth day nausea. into fifth day. Sixth day vomiting. Seventh day severe diarrhea, pain in shoulder blades.  Eighth day severe cramping in intestines, fatigue, back pain and dizziness. Ninth day symptoms continued. Tenth day chills and traveling pain left leg to hip. No medication administered. Went to Emergency Room.
Sterile abscess and cellulitis on upper L thigh 4x4cm 11x15cm.
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 70-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (received 1st dose 6 months ago). On 6th August 2018, the patient received the 2nd dose of SHINGRIX (subcutaneous). On 6th August 2018, unknown after receiving SHINGRIX the patient experienced intramuscular formulation administered by other route. On 7th August 2018, the patient experienced injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site erythema and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The caller reported that he got his 2nd dose of SHINGRIX yesterday on 6th August 2018, and was told by the pharmacist that she was administering it into the fatty part of his arm. She did administer it in the back of his arm and not into the muscle, which led to intramuscular formulation administered by other route. Today on 7th August 2018 it was very red and swollen around the injection site, the area was about the size of a baseball and raised up a good 1/2 inch from his arm. The patient got his 1st dose of SHINGRIX about 6 months ago. The patient did not know if that was also administered subcutaneously or not, but thought the reaction was the same then.
Right lung nodule s/p video-assisted thoracic surgery for a wedge resection of a right lower lobe nodule; pathology revealed metastatic papillary thyroid carcinoma. Hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 53-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported.  Reporter stated that no adverse reactions were reported by any patients.
Patient was administered dose from vial that was expired due to being punctured and un-refrigerated for 21 hours.
This spontaneous report was received from a 46 year old female patient, who was reporting on herself. The patient's pertinent medical history, was not provided but reported that she had a flu shot in past years. Concurrently, the patient had diabetes, a thyroid disorder and had a drug reaction/allergy to codeine products. Concomitant therapies included metformin, glipizide, lisinopril (manufacturer unknown) and levothyroxine sodium (manufacturer unknown). On 03-JAN-2018, the patient was seen at a local clinic where she was vaccinated with a first dose of PNEUMOVAX23 0.5 ml, intramuscularly in the left upper arm, as immunization for the prevention of pneumococal disease (strength, lot # and expiration date were not reported) and with an influenza virus vaccine (unspecified). The patient stated that later at evening, on this same date, her left arm swelled at the injection site and pain travelled/radiated into my chest and back. The patient also stated that it felt like fireballs were inside her arm. After to contact a clinic provider, the patient was advised to ice the injection site and to take unspecified over the counter anti-inflammatory medications, for the pain and swelling; no laboratory studies were performed. The patient stated that, on 07-FEB-2018, her arm looked that there was no anything unusual on the outside of it, but she still had pain in her arm when she move it in certain way. She said that was so painful and she could fall to the floor because of the intense pain. At the reporting time, the outcome of burning sensation, injection site swelling and pain was unknown. The causality assessment between the events and vaccination with PNEUMOVAX23 and influenza virus vaccine (unspecified) was not provided.
PATIENT WAS ADMINISTERED BIVALENT VACCINE INSTEAD OF FIRST DOSE OF PRIMARY SERIES
Feeling of irregular heart beats & chest tightness started about 45min of COVID 19 Pfizer initial vaccinations INtermittent episodes since occurring at random times NOT particularly related to exertioN. Pt is currently on day #3 of 14 day cardiac monitor
This ADR was self-reported via the hospital ADR reporting system. In the patient's own words, "Received the 2nd shot on 2/3/21 @ around 08:00. Left feeling fine. At around 15:00 started experiencing sore throat. Then switched to chills, with body pain and aches along with low fever and massive headache. Experienced such symptoms during Thursday, February 4th with requesting a day off to recover. On Friday, still had a headache, tiredness, aches and pain, but returned to work".
pt vax w/ hepta B on 08Aug89 + 05Sep89; exp localized allergic reactions.
Pain and swelling of the gums began approximately 36 hours after the injection. This worsened to include the roof of the mouth at 72 hours post injection. At 5 days post injection, small sores appeared on the end of the tongue and the skin of the lips completely peeled.    Treatment: stringent swishing with antiseptic to prevent gingivitis, use of salt water rinses to inhibit growth of bacteria and promote healing. Use of lip ointment. -- comfort measures.
Patient verbalized dizziness and tunnel hearing. RN noted patient diaphoretic w/face pallor.  Safely placed patient on the floor and elevated legs on a chair. O2 97-99%RA and HR 70-80.  Patient A/Ox4.   RN provided and encouraged small sips of juice and snack (cracker); continued to observe the patient for additional 15minutes.  Patient back to baseline/normal.  The patient left the observation site accompanied by his mother in stable condition.
Redness, hives, shortness of breath indicated a change in state of feeling. "Strange" bounding pulse. Rapid respirations. Transported to Emergency Room. 11/16/2009 ED record for 11/11/2009, Dx allergic reaction   patient with c/o's rash. Tx : benadryl, pepcid and prednisone as discharge meds.
Nurse administered too much vaccine.  Checked on patient today.  Headache and fatigue.  Advised to monitor for worsening symptoms.
This spontaneous report received from a registered nurse, via company representative, refers to a 17 year old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 22-SEP-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # M009378 (dose, frequency, expiry date were not reported), for prophylaxis, under Vaccine for children program (VFC). On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA014830.
Vaccination site rash; Vaccination site pruritus; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain), VACCINATION SITE RASH (Vaccination site rash) and VACCINATION SITE PRURITUS (Vaccination site pruritus) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On an unknown date, the patient experienced VACCINATION SITE RASH (Vaccination site rash) and VACCINATION SITE PRURITUS (Vaccination site pruritus). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain), VACCINATION SITE RASH (Vaccination site rash) and VACCINATION SITE PRURITUS (Vaccination site pruritus) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No Treatment History was provided. No Concomitant medications were provided.
Chest pain (felt like heart attack) Hospitalized 9/5/2021-9/7/2021.  Did thorough heart work up and labs; Chest XR, NM myocardial perfusion w Adenosine, US venous duplex venous extremity, EKG, unexplained Lipase levels elevated for possible pancreatitis (do not drink, eat plant-based).  Except for Lipase all heart tests normal.  Continue to have chronic chest pains.  No explanation for it.  Pain keeps me up at night. Take 1200 mg Advil a day for pain. On 9/14 also had a heart calcification score and several visits to the cardiologist and EKG done.  Since vaccine other health issues: May 26-30 hospitalized for diverticulitis, contracted CDiff.  On Vancomycin for 16 days in June and again August 15-current. Tapered to 1 every other day will complete the Vancomycin on 10/15/2021.  Have been to ER 5x for colon pain usually had CTs done.  On 9/24 ER for kidney stone.  Before the vaccine was healthy and active.  I would go to yearly check-ups. Since the middle of May started having health issues (diverticulitis), June-September (CDiff), September (chest pain & kidney stone) and feeling like I'm in survival mode each day/night with health issues.  My main concern is the chest pain won't go away and doctors aren't able to find out the cause.    The first dose of Moderna was 2/26/2021 and second dose of Moderna was 3/26/2021.  Both times sore arm at injection site.  (Have had my flu vaccine on 9/11/2021.)  Doctors I have been to since May 2021