chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Inadvertently had the Moderna in the freezer and the freezer was not approved for over 30 days of storage; They used two vials from the freezer after 30 days to administer them to 4 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They used two vials from the freezer after 30 days to administer them to 4 patients) and PRODUCT STORAGE ERROR (Inadvertently had the Moderna in the freezer and the freezer was not approved for over 30 days of storage) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They used two vials from the freezer after 30 days to administer them to 4 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Inadvertently had the Moderna in the freezer and the freezer was not approved for over 30 days of storage). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They used two vials from the freezer after 30 days to administer them to 4 patients) and PRODUCT STORAGE ERROR (Inadvertently had the Moderna in the freezer and the freezer was not approved for over 30 days of storage) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. No treatment drug was reported.  Reporter stated that it was notified to them that their upright freezer (two separate doors for freezer and fridge) was not good to use after 30 days. They normally pull the vials out before the 30 days to thaw. Reporter further stated that they wanted to have a stand alone freezer because of an automatic defrost cycle on some two door freezer/fridge combinations. The vial was initially stored in the refrigerator on 17-May-2022 (1 vial) and 19-May-2022 (1 vial). The temperature had not gone out of range at all, no temperature excursion happened. The patient received booster dose. Reporter further stated that the patients had not contacted them about any problems.
Information has been received from a physician concerning a 16 year old female who was vaccinated with a second dose of Gardasil (no lot # provided).  Subsequently the patient fainted after receiving the injection.  Subsequently, the patient recovered from fainting.  The patient sought unspecified medical attention.  No product quality complaint was involved.  This is one of the multiple reports from the same source (WAES# 0803USA04759).  Additional information has been requested.
Initial information received on 14-Aug-2018 regarding an unsolicited valid non-serious case received from a non-healthcare professional. This case involves a patient (age and gender not reported), who was vaccinated with an expired dose of MENACTRA (Batch number: U5567CA and expiry date: 28-Jun-2018) (dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to expired vaccine used. It was unknown if any adverse event was occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: None.
Mother states redness, tenderness, and irritation started on left outer thigh where vaccines were given. Mother states increased in last 3 days. Seen today and put on antibiotics, instructed to do warm compresses, go to ER if worsening symptoms and return to clinic in 1 week for re-evaluation.
Pt had mild COVID in January and did not require hospitalization. Endorses anosmia with infection and lasted 7 weeks before fully recovering. Approx 2mo after recovering from COVID received both doses of Moderna vaccine in March. He endorsed developing recurrence of anosmia within few days after first dose, which was significantly worsened shortly after the 2nd dose. Has since established care w/ ENT, was found to have enlarged turbinates, chronic sinusitis started on zyrtec and flonase. Pt also endorses childhood h/o allergies but denies seasonal allergies. His smell/taste has gradually been improving on current regimen and nasal rinse. Has never experienced anosmia w/ allergies in the past.
This patient had the PNEUMOVAX injection 2 hours after having a HUMIRA injection. Later that night she reported severe aching in her arm and could not move her arm until the next morning. She was told to consult with her physician.
Received expired vaccine greater than 12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine greater than 12 hours post puncture) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine greater than 12 hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine greater than 12 hours post puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  Patient in their 30's received vaccine which is initially stored in refrigerator on 03-Mar-2022, on 07-Mar-2022 at 05:00 PM vial was initially punctured and stored in room temperature range (8 degree to 25 degree C, 46 degree to 77 degree F) for about 20 hours, on 08-Mar-2022 two patients got vaccinated at 12:45PM and 01:17PM. It mentioned that the vial did not undergo any temperature excursions.
This case was reported by a physician via call center representative and described the occurrence of myalgia in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 3rd January 2019, the patient received the 1st dose of SHINGRIX. On 3rd January 2019, less than a day after receiving SHINGRIX, the patient experienced myalgia, arthralgia, nausea, vomiting, fever, headache, weakness generalized and walking difficulty. The patient was treated with TYLENOL. On an unknown date, the outcome of the myalgia, arthralgia, nausea, vomiting, fever, headache, weakness generalized and walking difficulty were not recovered/not resolved. It was unknown if the reporter considered the myalgia, arthralgia, nausea, vomiting, fever, headache, weakness generalized and walking difficulty to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient's friend. The health care professional (HCP) was unsure of site or route of administration of SHINGRIX. The HCP was unaware of lot and expiration date for SHINGRIX. The physician reported that, the patient experienced grade 3 myalgia and arthralgia (had difficulty getting out of bed and walking around), general weakness, nausea, vomiting, fever and headache following the 1st dose of SHINGRIX on the day before reporting. The patient received multiple doses of TYLENOL but had not touched the fever. The symptoms developed last night, within 6 hours of receiving SHINGRIX, and have not gotten better. The reporter gave consent to follow up.
Information has been received from a LPN concerning a female who in 1997 was vaccinated with 2 doses of varicella virus vaccine live. Subsequently, the patient tested negative for varicella. Additional information has been requested.
Pt reported that at about 7pm the day of her vaccine she developed a rash on her left arm/leg. It was itchy and so she took a Benadryl. She said her "throat felt thicker" but the Benadryl helped. She went to sleep and was fine. When she woke up the next morning on 1-6-2021 she reported the rash had spread. When she got to work and found me about 9:30 am to ask if that was normal I encouraged her to call her PCP and take a Benadryl. At that time she was having no difficulty breathing. She chose to call her PCP and not take a Benadryl as it makes her sleepy.  After she called her PCP she ended up leaving work. I found out later that her breathing had become labored and her neck/throat was starting to swell. Per her report, her PCP gave her epi and steroids, and R/X her an epi pen. She took her medicine and Benadryl around the clock and returned to work on 1-8-2021. When I spoke to her on that day she stated all of her symptoms had resolved, but her lymph nodes in her neck were still a little swollen.
pt recvd vax & inject site became more red & swollen & tender; fever of 102.7; joint aches; tx ibuprophen;
sore arm; started developing early osteopenia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 78 year-old male patient received bnt162b2 (BNT162B2) (Lot number: FN5318) as dose 1, single and (Lot number: EL9266) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; OSTEOPENIA (non-serious), outcome "unknown", described as "started developing early osteopenia". Therapeutic measures were taken as a result of osteopenia.  Additional Information: Transferring agent stated, He is 78 years old (Further not clarified hence not captured) and he was calling to ask a medical information question and while saying he reported that during his first two doses of the Pfizer COVID-19 Vaccine he only experience the sore arm. He also said that his son he also received the vaccine series and do not feel well for a day and then other than that he didn't have any other symptoms. (Further clarifications unknown hence split was not made) So, he is here to share that information. So I just had a little bit of issue with the sore arm. Caller did state he started developing early osteopenia, and this was after his pfizer covid-19 vaccine shots.  No follow-up attempts are possible. No further information is expected.
Immediate reaction at sight of erythema, swelling, Benadryl given. Relief.
Patient recived a dose of improperly stored PROQUAD; No adverse event; This spontaneous case was received from and healthcare professional regarding to a patient of unknown age, gender and ethnicity. The patient's concurrent conditions, medical history, drug allergies and concomitant therapies were not reported.   On 24-FEB-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T027114 with expiration date reported as 07-FEB-2022) 0.5 (units not reported) (route of administration and anatomical location of vaccine were not reported) for prophylaxis. The vaccine was exposed to a temperature between 5.0 °F and 8.0 °F for 8 hours and 40 minutes. A previous temperature excursion was reported. No adverse effect was reported.  Albumin status has been verified for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T027114) to be recombinant human albumin (rHa).  This is one of several reports received from the same source.
Information has been received from a registered nurse concerning a female patient who on 15-DEC-2009 was vaccinated with a dose of GARDASIL (lot#, route and site of administration not reported). On 16-DEC-2009, in the morning, the patient called the office and reported that she was having abdominal pain. At the time of this report, the patient had not recovered. Additional information has been requested.
started spotting this morning; low back pain mild; breast tenderness; abdominal pain mild; The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 30Dec2020 this case now contains all required information to be considered valid.  A contactable nurse (patient) reported a 56-year-old female patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EH9899), intramuscular on the left deltoid on 17Dec2020 at SINGLE DOSE for COVID-19 vaccination at the hospital, estradiol (ESTRADIOL gel), oral from May2020 and ongoing at 1 mg, 1x/day for menopause and progesterone (PROGESTERONE tablet), oral from May2020 and ongoing at 100 mg, 1x/day for menopausal symptoms. Medical history included blood pressure issues since 2000 and ongoing. The patient was also menopausal (ongoing).  Concomitant medication included losartan (LOSARTAN) for blood pressure issues. On 28Dec2020, the patient experienced abdominal pain mild. She also had low back pain mild and breast tenderness noted on 29Dec2020. The patient also stated that she felt like she was going to have a period even she has not had a period in 3 years as she was on progesterone and estradiol. The patient will see doctor to make sure that it was not anything. On 30Dec2020, the patient reported that she started spotting this morning.  The patient did not receive any treatments for the events. The action taken in response for progesterone and estradiol as dose not change.  The patient recovered from abdominal pain mild on 28Dec2020; low back pain mild and breast tenderness on 29Dec2020. Stated that the spotting resolved at noon on 30Dec2020. The reporter considered the events as non-serious. The reporter also considered that the events were related to Pfizer BioNTech Vaccine while unrelated to estradiol and progesterone.
pt developed hives, tongue swelling within 4 hours after receiving first dose. developed rash on arm 7 days after receiving vaccination. hives resolved with benadryl
non stop diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (non stop diarrhea) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included Diarrhea (the patient said that he had same diarrhea a few months ago and asked about loperamide 2mg.).    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced DIARRHOEA (non stop diarrhea). On 03-Mar-2021, DIARRHOEA (non stop diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details was not reported by the reporter.
pt recvd vax; fever & aches for 3 days p/ 2nd dose; p/ 3rd vax on 23jun93, fever & aching all over; no problem w/ 1st dose;
Redness and swelling in right arm and site of vaccine. Add Amoxicillin 500 mg bid x 7 days.
Large reactive axillary lymphadenopathy; First dose: 17Nov2020, second dose: 07Jan2021; This is a spontaneous report from a contactable healthcare professional. A 51-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular on left arm on 07Jan2021 16:15 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (lot number: EJ165) for COVID-19 immunization on 17Nov2020 18:45 at left arm and tested positive for COVID test/Nasal Swab on 27Dec2020. The patient experienced large reactive axillary lymphadenopathy on 08Jan2021 that resulted in emergency room/department or urgent care. The patient took a CT scan as treatment with unknown results. The outcome of the event was unknown.
postherpetic neuralgia; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  In January 2018, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), patient suffered postherpetic neuralgia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using the vaccine. Patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries and suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  Postherpetic neuralgia was considered to be disabling.
Body aches on day 2 - relieved by ibuprofen. Headache also relieved by ibuprofen. Beginning about 24 hours after the vaccine I have developed pain in the joints of my fingers that do not seem to be responsive to pain medications. Certain movements are more painful than others and seems to be worse on my right hand. Vaccine administered at 1730 on 1/20. Within 4 hours body aches and HA developed. 24 hours after joint pain started.
heart beating fast; chest pain; difficulty of breathing; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (heart beating fast), CHEST PAIN (chest pain) and DYSPNOEA (difficulty of breathing) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation.    On 06-Apr-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021 at 5:00 PM, the patient experienced HEART RATE INCREASED (heart beating fast) (seriousness criterion medically significant), CHEST PAIN (chest pain) (seriousness criterion medically significant) and DYSPNOEA (difficulty of breathing) (seriousness criterion medically significant). On 06-Apr-2021, HEART RATE INCREASED (heart beating fast) and DYSPNOEA (difficulty of breathing) had resolved. On 07-Apr-2021, CHEST PAIN (chest pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Electrocardiogram: abnormal (abnormal) She took an electrocardiogram (ECG) with her home cardio machine and reported that her heart was beating extremely bad.     The action taken with 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 provided. Treatment included for the events were metoprolol 75mg that night, 25mg in the morning of the next day (07 Apr2021) and 50mg that night. The patient reported that she was now feeling fine.  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. Further information has been requested. However, the patient's history of Atrial fibrillation is a risk factor and confounds causality assessment.; Sender'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. Further information has been requested. However, the patient's history of Atrial fibrillation is a risk factor and confounds causality assessment.
Hives all over body, started in hands and feet, then succeeding days progressed to other parts of the body. Prednisone (3days) and antihistamines (5days) were taken but hives are still coming and going
Pulmonary embolism; This spontaneous case was reported by a pharmacist and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 27-Jun-2022 due to PULMONARY EMBOLISM. At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient never had a diagnosis of COVID and she had no other brand of COVID-19 vaccine. No concomitant medication was reported. Reporter does not know the cause of the pulmonary embolism. No treatment medications was reported.  Company comment: This spontaneous case concerns a 60 year old female patient with no reported medical history, who experienced the unexpected serious (hospitalization, medically significant) AESI of Pulmonary embolism, about 14 months and 11 days after receiving the second dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the first dose with the same vaccine 35 days ago, with no reported adverse events. No further information on risk factors, co morbidities, clinical course and management of the event was available in the report. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 60 year old female patient with no reported medical history, who experienced the unexpected serious (hospitalization, medically significant) AESI of Pulmonary embolism, about 14 months and 11 days after receiving the second dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the first dose with the same vaccine 35 days ago, with no reported adverse events. No further information on risk factors, co morbidities, clinical course and management of the event was available in the report. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Stopped all cooing and mimicking. Complete loss of vocalization. Decreased eye contact. Lump on left leg. Mild fever.