chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine used beyond the used date of 09 oct 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine used beyond the used date of 09 oct 2021) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine used beyond the used date of 09 oct 2021). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (vaccine used beyond the used date of 09 oct 2021) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment information was not provided by the reporter.  This case concerns a 75-year-old patient, unknown gender, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after third dose of mRNA 1273 vaccine. The rechallenge is not applicable due to the nature of the events. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 75-year-old patient, unknown gender, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after third dose of mRNA 1273 vaccine. The rechallenge is not applicable due to the nature of the events. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 80.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        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.  Company comment- This case concerns an 80 year old patient, unknown gender, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after third dose of mRNA 1273 vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns an 80 year old patient, unknown gender, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after third dose of mRNA 1273 vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 51-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication was not provided.  The vaccine was manufactured on 09 Mar 2021. Delivered at vaccination center on 30 Sep 2021. Patient did not experienced adverse event.
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Product administration error
Clinical narrative: full syringe was not properly injected, so worries she didn't' get the full dose of the vaccine; so worries she didn't' get the full dose of the vaccine; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTRATION ERROR (full syringe was not properly injected, so worries she didn't' get the full dose of the vaccine) and ACCIDENTAL UNDERDOSE (so worries she didn't' get the full dose of the vaccine) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (full syringe was not properly injected, so worries she didn't' get the full dose of the vaccine) and ACCIDENTAL UNDERDOSE (so worries she didn't' get the full dose of the vaccine). At the time of the report, PRODUCT ADMINISTRATION ERROR (full syringe was not properly injected, so worries she didn't' get the full dose of the vaccine) and ACCIDENTAL UNDERDOSE (so worries she didn't' get the full dose of the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was a health care provider, therefore having high risk due to potential exposures. Patient was not immunocompromised. No concomitant medications were reported.  Treatment information was not provided.  This case concerns a female patient, unknown age, with no known medical history, who experienced the non-serious events of product administration error and accidental underdose. The events occurred  on the same day after booster dose of mRNA 1273 vaccine. The rechallenge is not applicable due to the nature of the events. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a female patient, unknown age, with no known medical history, who experienced the non-serious events of product administration error and accidental underdose. The events occurred  on the same day after booster dose of mRNA 1273 vaccine. The rechallenge is not applicable due to the nature of the events. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 80.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that on 15-Oct-2021, the patient received vaccine with expiration date 09-Oct-2021.  No concomitant medications was reported. No treatment drug details was reported.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Had stroke after the 1st and 2nd dose of the Moderna COVID 19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Had stroke after the 1st and 2nd dose of the Moderna COVID 19 vaccine) in a male 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Had stroke after the 1st and 2nd dose of the Moderna COVID 19 vaccine) (seriousness criterion medically significant). The patient was treated with ROSUVASTATIN for Adverse event, at an unspecified dose and frequency; LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) for Adverse event, at an unspecified dose and frequency; EVOLOCUMAB (REPATHA) for Adverse event, at an unspecified dose and frequency and APIXABAN (ELIQUIS) for Adverse event, at an unspecified dose and frequency. At the time of the report, CEREBROVASCULAR ACCIDENT (Had stroke after the 1st and 2nd dose of the Moderna COVID 19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Company comment: This case concerns a male patient with unknown age with no reported medical history, who experienced Serious ( Medically Significant )  , unlexpected , ADR event of Cerebrovascualr accident which occurred on July 23 , 2021 t with the 1st dose of mRNA -1273 vaccine ( Moderna Covid 19 vaccine ).  Time to onset  is unknown since the vaccination date was not reported. The re-challenge for this case is not applicable since the outcome of the event was  unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.   This case was linked to MOD-2021-391796 (Patient Link).; Sender's Comments: This case concerns a male patient with unknown age with no reported medical history, who experienced Serious ( Medically Significant )  , unlexpected , ADR event of Cerebrovascualr accident which occurred on July 23 , 2021 t with the 1st dose of mRNA -1273 vaccine ( Moderna Covid 19 vaccine ).  Time to onset  is unknown since the vaccination date was not reported. The re-challenge for this case is not applicable since the outcome of the event was  unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Moderna booster made me feel so bad; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (Moderna booster made me feel so bad) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Moderna booster made me feel so bad). At the time of the report, FEELING ABNORMAL (Moderna booster made me feel so bad) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided.; Sender's Comments: This is a spontaneous case concerning a female patient of unknown age with no relevant medical history, who experienced the non serious event of feeling abnormal. The event feeling abnormal exact occurrence unknown with respect to the booster dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event following immunisation
Clinical narrative: Report a side effect; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT FOLLOWING IMMUNISATION (Report a side effect) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     Concomitant products included LEVOCETIRIZINE for Allergy, LEVOTHYROXINE SODIUM for Thyroid disorder NOS, MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 04-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 ADVERSE EVENT FOLLOWING IMMUNISATION (Report a side effect). At the time of the report, ADVERSE EVENT FOLLOWING IMMUNISATION (Report a side effect) outcome was unknown.        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 treatment details were reported.   This case was linked to MOD-2021-391837, MOD-2021-391838 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Pain
Clinical narrative: She feels pain; swelling at the occipital lymph nodes; feel pain at the base of my skull, occipital lymph nodes are there which is exactly where the pain is. It is also sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (She feels pain), LYMPHADENOPATHY (swelling at the occipital lymph nodes) and LYMPH NODE PAIN (feel pain at the base of my skull, occipital lymph nodes are there which is exactly where the pain is. It is also sore) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0652F4) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder and Allergy NOS. Concomitant products included LEVOCETIRIZINE for Allergy, LEVOTHYROXINE SODIUM for Thyroid disorder, COMPLETE MULTI VIT for an unknown indication.    On 14-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (She feels pain), LYMPHADENOPATHY (swelling at the occipital lymph nodes) and LYMPH NODE PAIN (feel pain at the base of my skull, occipital lymph nodes are there which is exactly where the pain is. It is also sore). At the time of the report, PAIN (She feels pain), LYMPHADENOPATHY (swelling at the occipital lymph nodes) and LYMPH NODE PAIN (feel pain at the base of my skull, occipital lymph nodes are there which is exactly where the pain is. It is also sore) outcome was unknown.            For complete multivitamin medication, Indication was reported as for ages >50 years.  No treatment medications were reported   This case was linked to MOD-2021-391830, MOD-2021-391837 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) in a male 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore Arm). At the time of the report, PAIN IN EXTREMITY (Sore Arm) outcome was unknown.            No concomitant medications were reported. No treatment medication were reported. This case concerns a male patient of an unknown age with no relevant medical history, who experienced the unexpected event of Pain in Extremity. The event occurred on an unknown date after receiving an unknown dose number of mRNA-1273 Vaccine. The rechallenge was not applicable since no information about the dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a male patient of an unknown age with no relevant medical history, who experienced the unexpected event of Pain in Extremity. The event occurred on an unknown date after receiving an unknown dose number of mRNA-1273 Vaccine. The rechallenge was not applicable since no information about the dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after 30-day Use By Date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). In 2021, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that 108 patient received vaccine after stored in Refrigerator on 16-SEP-2021  Date(s) of administration of vaccine: 18Oct2021-2Nov2021.  No concomitant information provided by the reporter.  No treatment information provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after 30-day Use By Date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) 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) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) had resolved. Not Provided    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.  The vial was initially stored in the refrigerator on 16-SEP-2021.  On 18-OCT-2021 and 21-OCT-2021 two vaccines were administered.  On 19-OCT-2021 and 22-OCT-2021 one vaccine was administered.  On 20-OCT-2021 and 26-OCT-2021 three vaccines were administered.  On 27-OCT-2021 eleven vaccines were administered.  On 28-OCT-2021 twenty-nine vaccines were administered.  On 29-OCT-2021 fourteen vaccines were administered.  On 01-NOV-2021 and 02-NOV-2021 twenty-one vaccines were administered.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vials were used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vials were used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vials were used). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vials were used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Non-Significant follow up appended secondary reporter information added.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Blood test, Cardiac stress test, Chest pain
Clinical narrative: Started to experience symptoms 3 days after my second dose.  Went to Urgent Care with what felt like a viral infection, it was treated as such.  Soon after, started having increased heart rate with chest pain, increased blood pressure, sensitivity to heat and lack of energy.  I have had EKG's, ultrasounds, X-Ray's, blood work and stress tests with no findings.  Symptoms have not gone away but have steadily increased.  Was seen in ER for tachycardia
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Electrocardiogram ambulatory, Heart rate increased, Tachycardia, Temperature intolerance
Clinical narrative: Started to experience symptoms 3 days after my second dose.  Went to Urgent Care with what felt like a viral infection, it was treated as such.  Soon after, started having increased heart rate with chest pain, increased blood pressure, sensitivity to heat and lack of energy.  I have had EKG's, ultrasounds, X-Ray's, blood work and stress tests with no findings.  Symptoms have not gone away but have steadily increased.  Was seen in ER for tachycardia
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound scan, Viral infection
Clinical narrative: Started to experience symptoms 3 days after my second dose.  Went to Urgent Care with what felt like a viral infection, it was treated as such.  Soon after, started having increased heart rate with chest pain, increased blood pressure, sensitivity to heat and lack of energy.  I have had EKG's, ultrasounds, X-Ray's, blood work and stress tests with no findings.  Symptoms have not gone away but have steadily increased.  Was seen in ER for tachycardia
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Dysgeusia, SARS-CoV-2 test negative
Clinical narrative: Metallic taste on 11/24 07:30, then Loss of taste (front part of tongue) after 8:00. Went to got a pcr test got negative result
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Haematoma, Sudden death
Clinical narrative: Patient had hematoma form on arm then 3 days later died suddenly
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Myocarditis
Clinical narrative: I thought I was having a heart attack. I went to the hospital. And was experiencing adverse symptoms, as defined by the hospital record. Myoconditus
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: have the Shingrix vaccines and still continue to get it/Suspected vaccination failure; still continue to get it; 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 (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (get shingles when he/she was stressed).   On an unknown date, the patient received Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received Shingrix vaccines and still continues to get shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming for shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pruritus
Clinical narrative: just itched; arm was really sore for 3-4 days; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (had the old shot).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm and pruritus. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the pruritus was unknown.   It was unknown if the reporter considered the pain in arm and pruritus 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 reporter informed that if you had the old shingles shot, the shingles would worry you but not be too painful and her husband was just getting over them and that was his experience. The reporter had the old shot as well, but no shingles so she got the new shot right away, it was a two-dose shot, so she would have to get the second one within the six-month period.  The reporter informed that her arm was really sore for 3 to 4 days and after that it just itched. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Pyrexia
Clinical narrative: right arm is red; right arm is swollen; had fever all day; This case was reported by a consumer via  interactive digital media and described the occurrence of erythema of extremities in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On 19th November 2021, the patient received Shingles vaccine. In November 2021, less than a week after receiving Shingles vaccine, the patient experienced erythema of extremities, swelling arm and fever. On an unknown date, the outcome of the erythema of extremities, swelling arm and fever were not recovered/not resolved.   It was unknown if the reporter considered the erythema of extremities, swelling arm and fever to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had shingles over left eye.  The patient took Shingles shot yesterday from the day of reporting.  The patient's right arm was red and swollen and had fever all day, also said that hope tomorrow would better. No contact details were available. Note according to patient sequence of talking shingles over left eye was captured as historical condition.
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Eyelid sensory disorder, Herpes zoster oticus, Hypoaesthesia oral
Clinical narrative: I got one shingle, on the outside of my ear.; upper lip went numb.; eyelid went numb. Thought I was having a stroke; Made me dizzy; This case was reported by a consumer via interactive digital media and described the occurrence of herpes zoster otitis externa in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced herpes zoster otitis externa (serious criteria GSK medically significant), dizziness, numb lips and numbness of eyelid. On an unknown date, the outcome of the herpes zoster otitis externa, numb lips and numbness of eyelid were unknown and the outcome of the dizziness was recovered/resolved.   It was unknown if the reporter considered the herpes zoster otitis externa, dizziness, numb lips and numbness of eyelid to be related to Shingles vaccine.  Additional details provided were as follows: The case was processed by patient himself/herself. The age at vaccination was not reported. The patient had one shot and did not realize that he/she needed second shot. The patient got one shingles, but it was on outside of his/her ear. The patient further stated that it made him/her dizzy for a month. The patient's upper lip went numb and also the eyelid. The patient thought he/she was having a stroke and went to the emergency room (ER). Later, got the second shot. The patient did not want to go through that again. Follow-up would not be possible as no contact details available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shingles after vaccine/ Suspected vaccination failure; Shingles, still suffering through process; 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) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated anyone could get shingles after the vaccine and the patient was still suffering through this process. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: I couldn't move my arm for days; so painful!; This case was reported by a consumer via interactive digital media and described the occurrence of mobility decreased in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced mobility decreased and pain in arm. Shingles vaccine was discontinued. On an unknown date, the outcome of the mobility decreased was recovered/resolved and the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the mobility decreased and pain in arm to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had 1st shot, they said it was time for the 2nd one but the patient said no thanks. The patient could not move his/her arm for several days, so painful. No contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had 2 shot vaccines. GAVE me shingles/suspected vaccination failure; Shingles; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (on an unknown date, had 1 shot vaccine).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had both the one shot and 2 shot vaccines, and they both gave him/her shingles. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis, Pericarditis
Clinical narrative: MYOCARDITIS; PERICARDITIS; This spontaneous report received from a consumer concerned multiple patients (123 of 3,030) of unspecified age, sex, race and ethnic origin. The height and weight of the patients 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, and batch number and expiry were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  Reporter states that "of the 3,030 events of myocarditis and pericarditis, 123 were attributed to Janssen COVID vaccine". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the myocarditis and pericarditis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211149169-COVID-19 VACCINE AD26.COV2.S-myocarditis, pericarditis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Dizziness, Ear pain, Tinnitus, Vertigo
Clinical narrative: Vertigo; Dizziness; Tinnitus/ loud buzzing in right ear/ Ringing would not stop sounded like morse code; sharp pain in right ear; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus/ loud buzzing in right ear/ Ringing would not stop sounded like morse code), EAR PAIN (sharp pain in right ear), VERTIGO (Vertigo) and DIZZINESS (Dizziness) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to plants (Poison IVY). Concomitant products included PREDNISONE from 22-Apr-2021 to 02-May-2021 for Allergy to plants.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced EAR PAIN (sharp pain in right ear). On 23-Apr-2021, the patient experienced TINNITUS (Tinnitus/ loud buzzing in right ear/ Ringing would not stop sounded like morse code). On an unknown date, the patient experienced VERTIGO (Vertigo) and DIZZINESS (Dizziness). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) on 15-Jul-2021 for Tinnitus, at an unspecified dose and frequency; FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) on 03-Aug-2021 at an unspecified dose and frequency and IVERMECTIN on 26-Sep-2021 at an unspecified dose and frequency. On 12-Apr-2021, EAR PAIN (sharp pain in right ear) had resolved. At the time of the report, TINNITUS (Tinnitus/ loud buzzing in right ear/ Ringing would not stop sounded like morse code) had not resolved and VERTIGO (Vertigo) and DIZZINESS (Dizziness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Nov-2021, Acoustic stimulation tests: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that  on 08-Nov-2021 she had diagnosis of middle ear muscle myoclonus and results were unknown and ENT advised her to take calcium and potassium. Also stated that she had auditory nerve inflammation which was improving after 7 months.   Most recent FOLLOW-UP information incorporated above includes: On 20-Nov-2021: Patient demographics, Events start date, concomitant and Treatment medications, Reporters causality were updated.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: Expired doses administered; Inappropriate age at vaccine administration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired doses administered) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient did not experienced any adverse effect.  No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Product start date, Expiry date and Event start date were updated. On 18-Nov-2021: Non significant follow up On 18-Nov-2021: follow up received contains event onset date and date of administration updated On 19-Nov-2021: Follow-up received on 19-Nov-21contains no new information.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered). On 04-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported No treatment medication were reported There were no adverse effect on patient and was under supervision for 20 min after vaccine was administered.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Additional information received and reporter details, Start and stop date of vaccine administration was updated. On 18-Nov-2021: Follow up received and contains no new information On 18-Nov-2021: Patient demographics were updated. Suspect product details (start date updated from 02-Nov-2021 to 04-Nov-2021)
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Chills, Feeling hot, Heart rate
Clinical narrative: shakes/ got the shakes; fast heartbeat; hot; blood pressure a little low; chills; my son ended up with 100.4 temp for a day and half but recovered afterwards; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shakes/ got the shakes), HEART RATE INCREASED (fast heartbeat), FEELING HOT (hot), HYPOTENSION (blood pressure a little low) and CHILLS (chills) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 929929) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced TREMOR (shakes/ got the shakes), HEART RATE INCREASED (fast heartbeat), FEELING HOT (hot), HYPOTENSION (blood pressure a little low), CHILLS (chills) and PYREXIA (my son ended up with 100.4 temp for a day and half but recovered afterwards). At the time of the report, TREMOR (shakes/ got the shakes), HEART RATE INCREASED (fast heartbeat), FEELING HOT (hot), HYPOTENSION (blood pressure a little low) and CHILLS (chills) outcome was unknown and PYREXIA (my son ended up with 100.4 temp for a day and half but recovered afterwards) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: low (Low) Low. On an unknown date, Body temperature: 100.4 (High) 100.4. On an unknown date, Heart rate: fast (High) Fast.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had experienced very bad reaction after Moderna second dose No concomitant and treatment information were reported by the reporter Reporter stated that her son ended up with 100.4 temp for a day and half but recovered afterwards. Heard appt of people having this with second dose.   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: FollowUp received on 22-Nov-2021.New Event Fever occur and resolved updated and in lab data also updated.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Hypotension, Pyrexia, Tremor
Clinical narrative: shakes/ got the shakes; fast heartbeat; hot; blood pressure a little low; chills; my son ended up with 100.4 temp for a day and half but recovered afterwards; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shakes/ got the shakes), HEART RATE INCREASED (fast heartbeat), FEELING HOT (hot), HYPOTENSION (blood pressure a little low) and CHILLS (chills) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 929929) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced TREMOR (shakes/ got the shakes), HEART RATE INCREASED (fast heartbeat), FEELING HOT (hot), HYPOTENSION (blood pressure a little low), CHILLS (chills) and PYREXIA (my son ended up with 100.4 temp for a day and half but recovered afterwards). At the time of the report, TREMOR (shakes/ got the shakes), HEART RATE INCREASED (fast heartbeat), FEELING HOT (hot), HYPOTENSION (blood pressure a little low) and CHILLS (chills) outcome was unknown and PYREXIA (my son ended up with 100.4 temp for a day and half but recovered afterwards) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: low (Low) Low. On an unknown date, Body temperature: 100.4 (High) 100.4. On an unknown date, Heart rate: fast (High) Fast.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had experienced very bad reaction after Moderna second dose No concomitant and treatment information were reported by the reporter Reporter stated that her son ended up with 100.4 temp for a day and half but recovered afterwards. Heard appt of people having this with second dose.   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: FollowUp received on 22-Nov-2021.New Event Fever occur and resolved updated and in lab data also updated.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Gait disturbance, Lethargy, Muscle spasms
Clinical narrative: most people getting lethargic; pain going across their back; Patient also states they had Charly horse that were visible all over their body; They could not even walk; They felt electricity going through their body to their fingers; car accident; whiplash on their neck; tired after the first dose,They get very tired, it hurts so they cannot move; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (most people getting lethargic), BACK PAIN (pain going across their back), MUSCLE SPASMS (Patient also states they had Charly horse that were visible all over their body), GAIT DISTURBANCE (They could not even walk) and PARAESTHESIA (They felt electricity going through their body to their fingers) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Knee replacement (at the age of 10) and Nervous system neoplasm surgery (had 2 months ago and put a titanium plaque on their back. patient had their vocal cord snip during surgery). Concurrent medical conditions included Osteoarthritis, Arthritis and Disability (since 33 year ago).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LETHARGY (most people getting lethargic), BACK PAIN (pain going across their back), MUSCLE SPASMS (Patient also states they had Charly horse that were visible all over their body), GAIT DISTURBANCE (They could not even walk), PARAESTHESIA (They felt electricity going through their body to their fingers), ROAD TRAFFIC ACCIDENT (car accident), POST-TRAUMATIC NECK SYNDROME (whiplash on their neck) and FATIGUE (tired after the first dose,They get very tired, it hurts so they cannot move). At the time of the report, LETHARGY (most people getting lethargic), BACK PAIN (pain going across their back), MUSCLE SPASMS (Patient also states they had Charly horse that were visible all over their body), GAIT DISTURBANCE (They could not even walk), PARAESTHESIA (They felt electricity going through their body to their fingers), ROAD TRAFFIC ACCIDENT (car accident), POST-TRAUMATIC NECK SYNDROME (whiplash on their neck) and FATIGUE (tired after the first dose,They get very tired, it hurts so they cannot move) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient also reported that they felt electricity going through their body to their fingers. They had a lot of nerve problems since affecting their legs and arms. Patient also mentioned getting zap when touching a socket. Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-389035 (Patient Link).