chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 68-year-old male 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 11:29 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 11:33 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 POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 68.79 years for dose administered on 28-Feb-2021 and 68.87 years for dose administered on 28-Mar-2021.  No concomitant medications were reported.  Batch number 014M20A underwent temperature excursion on 28-Feb-2021 with temperature 27 and 26 degrees Fahrenheit at 09:00 AM and 01:00 PM respectively. This vial was moved to fridge on 24-Feb-2021 and BUD date for the vial was reported as 26-Mar-2021. Product moved to clinic on 27-Feb-2021.  Batch number 019B21A underwent temperature excursion on 28-Mar-2021 with temperature 35 degrees Fahrenheit at 10:00 AM. This vial was moved to fridge on 23-Mar-2021 and BUD date for the vial was reported as 22-Apr-2021. Product moved to clinic on 27-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a  traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Someone told her that a magnet would stick to the injection site after taking the first injection, and it did; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Someone told her that a magnet would stick to the injection site after taking the first injection, and it did) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Someone told her that a magnet would stick to the injection site after taking the first injection, and it did). At the time of the report, VACCINATION COMPLICATION (Someone told her that a magnet would stick to the injection site after taking the first injection, and it did) outcome was unknown.            Concomitant medications were not reported. Treatment medications were not reported.
painful lump / cyst on collar bone lymph nodes  3 days after shot. Pain subsided after 2 weeks  today still slightly enlarged.
Patient had a swollen warm to touch arm which started 6 hours after the vaccine on 11/12/2017. Arm was improving when he came to the pharmacy on 11/15/2019 but arm was still warm to touch. Both shots were given in left arm. He was referred to the ER where he received prednisone and antibiotic as a precaution.
Fluvarix injection Prefilled syringe Lot Aflua470ca, one syringe was defective, syringe was broken.
Fever early morning, seizure following with some cyanosis and was taken to the ER to be evaluated treated and released. Follow-up appt given. Seen in office on 5/10/2000.
Administered vaccine after 33 days in the refrigerator; Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) and PRODUCT STORAGE ERROR (Administered vaccine after 33 days in the refrigerator) in a 49-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) and PRODUCT STORAGE ERROR (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) and PRODUCT STORAGE ERROR (Administered vaccine after 33 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was reported.    This case was linked to MOD-2021-356818, MOD-2021-357274.
had it despite being vaxed/suspected vaccination failure; had it, constant activation; pain that lingers; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient stated that the patient had shingles and suffering from the pain that lingers and constant activation, despite being vaccinated. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset for event and laboratory confirmation of shingles were not provided.
Patient, Available medical record and patient's sister.    History of Present Illness:  This is a 67y.o. male with a history of muscular dystrophy, DM II, CAD, atrial fibrillation and HTN who presents to this hospital via EMS with concern for generalized weakness. Patient reports that he is having a cough and congestion approximately 2 days ago. His sister took him to an urgent care today to get tested for COVID. Upon returning home, patient took two 12 hr Sudafed tablets, one at 9 AM and the other at 11 AM. After that, she started feeling increasingly weak, had difficulty ambulating and getting off of the toilet. Denies any falls, head trauma, difficulties with speech or sensory deficits. He admits to mild shortness of breath. He is not on oxygen at home. Patient denies chest pain, abdominal pain, nausea, vomiting, diarrhea, constipation, headache, dizziness, lightheadedness. Patient received his COVID vaccines in March 2021.
A report has been received from a Health Professional concerning a 28 year old, male subject, who had been receiving nasal FLUMIST. FLUMIST started on 17-SEP-2013. It ws reported that the patient was administered two full doses of FLUMIST, one in each nostril on 17-SEP-2013. The outcome of the event of two full doses of FLUMIST, one in each nostril is unknown. The report was considered to be non-serious.
A little uncomfortable feeling after the first 2 doses; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (A little uncomfortable feeling after the first 2 doses) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included INFLIXIMAB (REMICADE) for Rheumatoid arthritis.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (A little uncomfortable feeling after the first 2 doses). At the time of the report, FEELING ABNORMAL (A little uncomfortable feeling after the first 2 doses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment drug details was reported. Had rheumatoid arthritis and has been on Remicade even before receiving the first dose of the moderna vaccine.  Consumer stated that on 9-Nov-2021 the patient had an infusion for rheumatoid arthritis of Remicade for 2 hours.   This case was linked to MOD-2021-378050 (Patient Link).
Headache, malaise that progressed to flu-like symptoms and left shoulder blade and back ache. Breasts were achy. Noticed rash on top and below left breast. Diagnosed with Shingles on 6/12/14. Prescribed Acyclovir.
NO Known Adverse Effects have to this time been reported.  Patient is 17 years old and a Refugee. She was part of the diaspora in August, 2021. Initially, she was settled and she was given Janssen vaccine at 16 years of age on 09.26.2021. I gave the Moderna booster dose of 0.25 ml given to adults to her, recommended at age 18 and older. I was notified by the Covid vaccine administration department today of the error and told to submit a VAERS report 11 weeks later from the date of administration. She has been seen by her primary care staff where Dr. is on staff, on 06.16.2022 and 06.22.2022 without any adverse effects.
11/17 Received influenza and pneumococcal vaccine at clinic. 11/18 to ER. Diagnosed with vaccine site cellulitis to the left arm T - 100 degrees, left arm parasthesia elbow to fingers. Arm was warm and swollen. Started on doxycycline q 12 hours x 7 days.
Narrative:  Patient with tingling and pain in his bilateral palms and base of his feet for 5-6 days. Developed gradual onset of burning sensation in bilateral feet and palms of hands along with decreased sensation and feeling of discoordination. He and his daughter also noted slowed mentation with worse recall than normal. He had tried gabapentin for these symptoms but did not find the medication helpful. On day of presentation to ED, he was unable to close left eye and noted left-sided facial droop. He denied any recent viral illness or vaccinations. Neurology was consulted and patient diagnosed with acute sensorimotor polyneuropathy - Guillain-Barre syndrome and treated with IVIG. Patient was hospitalized 10/18 through 11/2/21. Hospital course complicated by delirium with hallucinations and hyponatremia (suspected secondary to IVIG). Transferred to extended care 11/2 through 11/30/21 for continued care and rehabilitation. Discharged to home after that time. Vaccine ADR entered by primary care nurse practitioner following this patient's hospitalization and extended care stay. Neurologist is doubtful of association of GBS with vaccination 10 weeks prior.
DVT; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEEP VEIN THROMBOSIS (DVT) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced DEEP VEIN THROMBOSIS (DVT) (seriousness criteria death and medically significant). The reported cause of death was dvt. It is unknown if an autopsy was performed.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not reported. Company comment: This fatal spontaneous case concerns adult female patient in her twenties, with no medical history, who experienced the fatal and unexpected AESI of DEEP VEIN THROMBOSIS (death and medically significant) after an unspecified dose of mRNA-1273.222 vaccine. No details of previous doses were provided. The reported cause of death was deep vein thrombosis. It is unknown if an autopsy was performed. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273.222 is not affected by this report.; Reported Cause(s) of Death: DVT
Flush face; This is a spontaneous report from a contactable consumer. This 73-years-old male consumer (patient) reported that he received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration on 01Mar2021 15:30 (Batch/Lot Number: EN6205) as SINGLE DOSE for covid-19 immunisation. Medical history included hypothyroidism and drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (LEVOTHYROXINE SODIUM) taken for an unspecified indication, start and stop date were not reported. The patient previously took sulfur and experienced drug hypersensitivity. The patient experienced flush face on 01Mar2021 15:45. Flush face about 20 mins after injection lasting less than an hour. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was reported as recovered.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 22-Jul-2022; No adverse event; Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 22-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 39-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 22-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 22-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 22-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 22-Jul-2022).    No concomitant medication information was provided.  The reporter administered the vaccine to the patient after the 30 day by used.  Patient received half dose.  The vial was initially stored in refrigerator on 04-Jun-2022.  The vial did not undergo any temperature excursions.  No treatment drug details was reported.
chest pressure/ tachycardia/ POTS/ sleep issues; This spontaneous report has been received from a physician via medical records from a case in litigation for Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (MARRS # 2112USA008168), concerning a female patient of an unknown age.  On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, units, route of administration, lot#, and expiration date were not reported ) for prophylaxis.  On an unknown date, the patient experienced sleep issues, episodes of chest pressure and tachycardia, postural orthostatic tachycardia syndrome (POTS). The outcome of the event was not reported.  The causality between the event of POTS and the suspect vaccine was not reported.
4 days after receiving the vaccine, pt reported soreness of arm and a patch of red skin surrounding the injection site. they reported this to the pharmacy 1 day after the adverse event took place. While being counseled, pt concluded she did not feel the need to seek medical attention.
I experienced "COVID arm" exactly 1 week after the jab, on Wednesday, March 17.  I also experienced a bout of brain fog and confusion that same day, which is something I had never experienced before.  Since then, I have experienced general malaise and ongoing fatigue consistently throughout the day.  I have felt the need to go to sleep earlier than my normal bedtime and have difficulty waking up from sleep in the morning as well.  Again, all of these symptoms are new to me.
Not unexpected - reported possible side effect, but parent would like VAERS form done. Patient developed a mild case of chicken pox after vaccine. No treatment necessary or indicated.
Cellulitis developed at the injection site. Treatment Drugs Used: 1 - CEPHALEXIN Dose: 500 Units: MG Freq: BID Route: PO
full bodyaches; body temperature dropped; chills; horrible muscle cramps; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 08Apr2021 14:15 (Lot number: ER8734) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Soy allergy" (unspecified if ongoing), notes: anything with eggs or soy; "Egg allergy" (unspecified if ongoing), notes: anything with eggs; "Nerve damage" (unspecified if ongoing), notes: nerve damage left arm; "EBV" (unspecified if ongoing). Concomitant medication(s) included: SPIRULINA [SPIRULINA SPP.]; VITAMIN D NOS; VITAMIN C [ASCORBIC ACID]. The following information was reported: PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "full bodyaches"; BODY TEMPERATURE DECREASED (non-serious) with onset Apr2021, outcome "unknown", described as "body temperature dropped"; CHILLS (non-serious) with onset Apr2021, outcome "unknown", described as "chills"; MUSCLE SPASMS (non-serious) with onset Apr2021, outcome "unknown", described as "horrible muscle cramps". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain, body temperature decreased, chills, muscle spasms.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent lab tests and procedures which included body temperature: body temp dropped to 96.1 in Apr2021. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care.   No follow-up attempts are possible. No further information is expected.
irritability x 2 days ( 24 hrs p/vax); temp to 101.1 R sent to hosp for workup;
weeping blisters and rash (painless) lasting more than 7 days. No treatment received.
Background: pharmacy received 49 vials of Pfizer COVID vaccine (Lot number EN6199) on 5 March 2021 and stored them in the pharmacy refrigerator. The doses were labeled with an expiration date of 10 March 2021 at 0701.   Since starting the COVID-19 vaccine program, the MOB has always used the doses before they approached the expiration date.  This time, there were 16 vials of the Pfizer vaccine that had not been used and set to expire. The labeled expiration date and time were clearly present on the outside of the bag containing the doses.  On the morning of 10 March 2021, a pharmacist retrieved 1 vial at 0754 and 7 vials at 1138 from that allocation and provided them to nursing for the day?s administrations.  The pharmacy placed those doses in a new amber bag and did not label the bag with an expiration date and time.   The nursing team received the vials, diluted and drew up 20 doses that were administered to patients before 1230.    The charge nurse did not question the expiration date until after 20 patients had been vaccinated.  At that time she messaged the pharmacist to verify the expiration date.  The pharmacist indicated that the label did not state am or pm and misinterpreted the expiration time for the doses as 7:01 PM rather than 7:01 AM.  There was not a defined double check at the time of distribution from the pharmacy to nursing  The remaining 11 vials were quarantined.  The pharmacy manager contacted the manufacturer.  According to Pfizer it?s recommended to use the thawed vaccine within 120 hours, but can be used up to 144 hours.  The doses in question were administered before 125 hours after they were thawed.  The remaining expired vials will be wasted and appropriate notifications sent.  Assessment: Twenty patients received Pfizer COVID vaccine 5 hours passed the labeled expiration date and time.  While exceeding the manufacturer?s recommended beyond use dating, the doses were within the acceptable 144 hours post thaw period and still safe for patient administration.  There was misinterpretation of the labeled expiration time by the dispensing pharmacist, the container of COVID vaccine vials provided to nursing was not labeled with an expiration date or time, there was not a double check on hand off, the nursing team did not double check the expiration date/time before dilution or administration.  Recommendation:  When repackaging COVID Vaccine vials for distribution to vaccination centers, a label including the expiration date and time should be placed on the new container.    When COVID vaccine is transferred from one location or department to the next, a double check of the product, quantity, integrity and expiration date and time may prevent a recurrence of this situation.