chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after temperature excursion; Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication information was reported. No Treatment medications were provided Excursion duration: From 09Nov2021 to current date.There are total of 10 15-dose vials were impacted. The HCP mentioned that they always had the freezer between this temperature range. Two vials were used to administer to healthcare provider's office employees. Anatomical location was reported as Deltoid muscle Vaccine administration dates were reported as 23-Nov-2021 and 27-Nov-2021.  The reporter informed that, the vaccine was administered after being frozen at 23 degrees Fahrenheit since receipt.   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2022: Follow up document contains updated the event verbatim and I narrative supplement.
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 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021 at 10:58 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 11:40 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 76.94 for dose administered on 27-Mar-2021 and 76.86 for dose administered on 27-Feb-2021.  No concomitant medications were reported.  Batch number 019B21A underwent temperature excursion on 27-Mar-2021 with temperature 35 degrees Fahrenheit from 9 AM to10 AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 27-Mar-2021.  Batch number 014M20A underwent temperature excursion on 27-Feb-2021 with temperature 33 and 35 degrees Fahrenheit from 09 AM to 05 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 27-Feb-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 Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
Information has been received from a RN concerning a 6 year old male who was vaccinated on 05/07/1998 with a dose of varicella virus vaccine, live. On 06/27/03, the pt was seen with skin lesions "all over" The child was noted to have  breakthrough chicken pox. Unspecfied medical attention was sought. There was no product quality complaint. The reporter indicated that 19 other pt's were vaccinated with a dose of varicella virus vaccien live, and developed chickenpox breakthrough/ shingles(WAES # 0404USA00205, WAES # 0404USA00418, WAES # 0404USA00420, WAES# 0404USA00421, WAES # 0404USA00422, WAES # 0404USA00423, WAES # 0404USA00424, WAES # 0404USA00425, WAES # 0404USA00426, WAES # 0404USA00427, WAES # 0404USA00428, WAES # 0404USA00429,  WAES # 0404USA00430, WAES # 0404USA00431, WAES # 0404USA00432, WAES # 0404USA00433, WAES # 0404USA00434, WAES # 0404USA00435, AND WAES # 0404USA00436. No further information is expected.
Pain in left hip thigh and calf shin, Swelling and blue raised warm area on shin aches. My whole leg aches.  My head is inflamed my brain I can feel pressure. I have brain fog.  I am exhausted.   Nothing helps the pain
Treatment of COVID-19; Treatment of COVID-19; Moderna Dose Number: 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 66 years and on 21Apr2023 as dose 6 (booster), single (Lot number: GL2042) at the age of 66 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Lot number: EW0151) at the age of 64 years, on 07May2021 as dose 2, single (Lot number: EW0162) at the age of 64 years and on 15Apr2022 as dose 4 (booster), single (Lot number: FK9896) at the age of 65 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 05Nov2021 as dose 3 (booster), single (Lot number: 051C21A) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 05Nov2021, outcome "unknown", described as "Moderna Dose Number: 3"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 08Sep2023 to 12Sep2023. Patient had no known allergies.
Left sided facial weakness, diagnosed with Bell's Palsy. He was treated with prednisone and recovered.
Varivax vaccine given on 10/11/2001, chickenpox on 07/15/2005.
Abdominal pain, anorexia, renal failure, Sepsis.  Continues to have abd pain and now with continued renal failure associated with hypokalemia and hyponatremia and protein/casts in the urine.
anaphylactic reaction; This case was reported by a nurse via call center representative and described the occurrence of anaphylactic reaction in a 60-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On 26th October 2020, the patient received Influenza vaccine Quadrivalent 2020-2021 season. In October 2020, less than a week after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced anaphylactic reaction (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylactic reaction was unknown.   It was unknown if the reporter considered the anaphylactic reaction to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported, but could be 59 or 60 years. The patient received Flu vaccine approximately on 26th October 2020. The patient presented an anaphylactic reaction after administration of Flu vaccine approximately two weeks ago from the time of reporting. The reporter did not consent to follow up.
Patient stated fever started 11/23/20 with chills for 5 days.  Very painful at injection site.  She feels it was injected low in the deltoid muscle.  Resulted in cellulitis.
I had a sinus infection sort of like I did with the last vaccine , which consist of runny nose and congestion
Pain,swelling in left arm day 2 pain continued left side; continued day 3 increasing pain and stiffness with tired feeling limiting daily activities; day 4 muscle pain and stiffness which spread to back, Hips, thighs, knees,  continued with added joint pain that made it difficult to stand, sit, or lie down by late that evening discomfort too severe to sleep. Used aspirin for pain, rested until symptoms gradually decreased through day 5.
Approx 6 hours after vaccination, lasted approx 11 hrs chillls, body aches involuntary muscle contraction Fever (not documented)
Fever; This is a spontaneous report from a contactable Physician via Pfizer sales representative.  A female patient of an unspecified age received meningococcal group b rlp2086 (TRUMENBA) , via an unspecified route of administration on an unspecified date at single dose for immunisation .  The patient medical history and concomitant medications were not reported.  The patient experienced fever, leading to patient's hospitalization,  on an unspecified date with outcome of recovered.  The information on the batch number has been requested.; Sender's Comments: Based on the information available, the Company cannot exclude that the suspect vaccine meningococcal group b rlp2086 (TRUMENBA) contributed to the development of the reported event fever.
Muscle and joint aches, chills, exhaustion, head aches.  Note  - the lots numbers on the 1st and 2nd dose given 4 weeks apart at separate facilities are the same.
pt recvd vax 24AUG93 & a few hrs following vax pt exp weakness, faintness, t102, rash, adenopathy, sore throat, pharyngitis, arthralgia of the knees; w/in 2 days fever had inc to 104; pt was adm to hosp;
96hrs following vaccine (12/25/2020)developed acute submandibular gland swelling Visited physician (12/28/2020) performed ultrasound; dx acute Sialadenitis; rx Augmentin
Felt like she took a lot of Benadryl; made her sleepy; This is a spontaneous report from a contactable consumer or other non-health care professional (mother). This is report 3 of 4. A female patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient experienced felt like she took a lot of benadryl; made her sleepy. Outcome of the event was unknown.   No follow-up attempts are possible. Information on Batch number, Lot number cannot be obtained. No further information is expected.
VOMITING; FEELING HOT; RED ARMS; FEVER 102.6F; HEADACHE; SHAKING VIOLENTLY; This spontaneous report received from a patient concerned a 24 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to latex. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 16:30 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021;03:00 a.m, the subject experienced shaking violently. Laboratory data included: Body temperature (NR: not provided) 102.6 F. On 17-MAR-2021, the subject experienced feeling hot. On 17-MAR-2021, the subject experienced red arms. On 17-MAR-2021, the subject experienced fever 102.6f. On 17-MAR-2021, the subject experienced headache. On 17-MAR-2021 03:00 a.m, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from red arms on MAR-2021, and had not recovered from vomiting, shaking violently, fever 102.6f, headache, and feeling hot. This report was non-serious.
a patient was administered the liquid only portion of the Pentacel vaccine which was the Dtap and polio and it was never reconstituted with Hib powder/No AE; Initial information received on 17-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA262075.  This case involves a 8 weeks old female (also reported as two months) patient who was administered the liquid only portion of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] vaccine which was the dtap and polio and it was never reconstituted with hib powder lot number and expiry date not reported via intramuscular route in the left thigh on 13-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE), PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  It was an actual medication error due to inappropriate reconstitution technique.  At the time of report no adverse event was reported.  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 2001/83/EC 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.  Information on the batch number was requested.  List of documents held by sender: none.
I had losing sensation in the fingertips, they feel numb a lot, I have also lost sensation in my toes. I had test run to find that I had peripheral neuropathy in my hands, arms, legs, feet. I am not taking medication for this at this time. I am not experiencing pain, burning sensation.
Patient seen at urgent care on 10/6/2017 for swelling to left cheek and swelling to lips. Urgent care diagnosed patient with Bell's palsy, negative for lyme's disease. Patient followed up with PCP 10/11/17 with continued symptoms - unable to close right eyelid, raise eyebrow or smile on right side. No treatment. When seen on 10/11/17 patient continued with symptoms.
DIZZINESS; VERTIGO; SPINNING AND FALLING SENSATION; FELT OFF; This spontaneous report received from a patient concerned a 64 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had not known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced dizziness. On 19-MAR-2021, the subject experienced vertigo. On 19-MAR-2021, the subject experienced spinning and falling sensation. On 19-MAR-2021, the subject experienced felt off. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from dizziness, vertigo, spinning and falling sensation, and felt off. This report was non-serious.
OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855835, and expiry: 27-APR-2022) dose was not reported, administered on 29-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-DEC-2021, the patient experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of out of specification product use was not reported. This report was non-serious.
Shot given 10/16. 10/17 Rash developed. 10/20 Rash was worse - upper back, bilateral and upper arms and right thigh. Pt went to Dr office and was prescribed some medicine. Went back to Dr office on 10/27 Rash, felt hot to pt. Biopsy was done at site of reaction.
Dry cough that continues; Fatigue for a week; Has a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Has a sore arm), FATIGUE (Fatigue for a week) and COUGH (Dry cough that continues) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced VACCINATION SITE PAIN (Has a sore arm). On 03-Apr-2021, the patient experienced FATIGUE (Fatigue for a week). On 08-Apr-2021, the patient experienced COUGH (Dry cough that continues). At the time of the report, VACCINATION SITE PAIN (Has a sore arm), FATIGUE (Fatigue for a week) and COUGH (Dry cough that continues) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medications provided. No Treatment History was provided.
did not feel well; dry heaves; bedridden; fever; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (did not feel well), RETCHING (dry heaves), BEDRIDDEN (bedridden), PYREXIA (fever) and HEADACHE (headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 04-Mar-2021, the patient experienced MALAISE (did not feel well), RETCHING (dry heaves), BEDRIDDEN (bedridden), PYREXIA (fever), HEADACHE (headache) and CHILLS (chills).   At the time of the report, MALAISE (did not feel well), RETCHING (dry heaves), BEDRIDDEN (bedridden), PYREXIA (fever), HEADACHE (headache) and CHILLS (chills) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-034401 (Patient Link).
a 2 months patient was used an expired diluent on a patient/No AE; Initial information was received on 23-Jun-2020 regarding an unsolicited valid non-serious case from a other health professional in the.  This case involves a two month old male patient who received expired diluent of HIB (PRP/T) VACCINE [ACT-HIB].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR), ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination and PARACETAMOL (PEDIATRIX).  On 22-Jun-2020, the patient received a 0.5ml first dose of suspect HIB (PRP/T) VACCINE (Lot number: UJ033AAC ,expiry date: 07-OCT-2020, Diluent: U6205AC expiry date: 22-APR-2020) via intramuscular route in the left thigh for prophylactic vaccination.  It was a case of an actual medication error due to expired medical agent used. Caller stated that the Acthib vials and diluent have different expiration dates. they used an expired diluent on a patient.  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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.
After receiving patients first Pfizer Covid shot patient passed out twice. EMS was contacted at this time. Patient regained consciousness each time. He then passed out  a third time after EMS arrived at the seen.  Due to this he was transported to nearest hospital ER for further testing
This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age. Concurrent or medical conditions were not reported. On 10-OCT-2014, the patient was vaccinated with the first dose of GARDASIL, on 20-DEC-2014, the patient was vaccinated with the second dose of GARDASIL and on 11-MAR-2015, less than 3 months after the second dose, the patient received the third dose of GARDASIL (dose, strength, route and lot number were not reported). No adverse effects were reported. No product quality complain (PQC) reported. Additional information has been requested.
Lactating mother; This spontaneous case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Lactating mother) in a female patient of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): The mother's past medical history included No adverse event (No medical history provided).    MEDICAL HISTORY (Patient): The patient's past medical history included Pregnancy (Delivered in Dec 2020).   In January 2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient was diagnosed with MATERNAL EXPOSURE DURING BREAST FEEDING (Lactating mother). At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (Lactating mother) outcome was unknown.            No concomitant medication reported   No treatment medication reported