chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Moderna vaccine was given beyond its use by date; Moderna Covid-19 vaccine that was beyond its use-by date was given; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond its use-by date was given) and PRODUCT STORAGE ERROR (Moderna vaccine was given beyond its use by date) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond its use-by date was given). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna vaccine was given beyond its use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond its use-by date was given) and PRODUCT STORAGE ERROR (Moderna vaccine was given beyond its use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  Patient was administered with the booster dose (1/2 dose). No treatment medications were provided.   This case was linked to MOD-2022-516081 (Patient Link).
Sex: F
Vaccine: VARZOS
Symptoms: Genital herpes
Clinical narrative: Vaginal herpes; This case was reported by a physician via call center representative and described the occurrence of genital herpes in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced genital herpes. On an unknown date, the outcome of the genital herpes was unknown.   It was unknown if the reporter considered the genital herpes to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The physician reported that a patient who was approximately 55 years old at the time of reporting, experienced an outbreak of vaginal herpes 3 to 4 days after the administration of the first dose of Shingrix.  The physician reported the patient had not had any vaginal herpes outbreaks in the last 30 years. The reporter consented to follow up.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: PSORIASIS / LOOKED LIKE SOMEONE SCRATCHED / WREATH AROUND THE BACK OF THE HEAD; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no previous medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821288, expiry: UNKNOWN) dose was not reported, administered on 18-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, the patient experienced psoriasis / looked like someone scratched / wreath around the back of the head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from psoriasis / looked like someone scratched / wreath around the back of the head. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator was 24-Jan-2022 and administered on 10-Mar-2022; Pharmacy gave Moderna COVID-19 vaccine past its beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna COVID-19 vaccine past its beyond use date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator was 24-Jan-2022 and administered on 10-Mar-2022) in a 47-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna COVID-19 vaccine past its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator was 24-Jan-2022 and administered on 10-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna COVID-19 vaccine past its beyond use date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator was 24-Jan-2022 and administered on 10-Mar-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The pharmacist wrote an expiration date of 24-Mar-2022 on the Moderna COVID-19 vaccine instead of 24-Feb-2022. The Moderna COVID-19 vaccine was transferred from the freezer to the refrigerator on 24-Jan-2022. The vial did not undergo any temperature excursions. The reporter did not know which dose the patient was received. The reporter did not have any other adverse events or side effects to report for the patient.  No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Omicron diagnosis; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Omicron diagnosis) 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.   In September 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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. In December 2021, the patient experienced COVID-19 (Omicron diagnosis). At the time of the report, COVID-19 (Omicron diagnosis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, SARS-CoV-2 test: positive (Positive) Positive(Omicron Variant).         Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter. Patient reported she received the Moderna COVID-19 two-dose primary series.  Company comment: This spontaneous case concerns a female patient with an unspecified age, with no reported medical history, who experienced the unexpected non serious adverse event of special interest COVID-19, that occurred on an unspecified date (sometime in December 2021) approximately 3-4 months after receiving the third dose (booster) of mRNA-1273. The dates and interval between the first and second doses of mRNA-1273 vaccine were not specified. No clinical, laboratory or treatment details were provided. It was reported that the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a female patient with an unspecified age, with no reported medical history, who experienced the unexpected non serious adverse event of special interest COVID-19, that occurred on an unspecified date (sometime in December 2021) approximately 3-4 months after receiving the third dose (booster) of mRNA-1273. The dates and interval between the first and second doses of mRNA-1273 vaccine were not specified. No clinical, laboratory or treatment details were provided. It was reported that the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Acute myocarditis; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Mar-2022 and was forwarded to Moderna on 16-Mar-2022.    This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Acute myocarditis) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Acute myocarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (Acute myocarditis) outcome was unknown. Related      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDITIS (Acute myocarditis) to be related.    Concomitant and treatment medication information was not provided.  Company Comment: This literature non-study case concerns  a 19 year old male patient with no medical history reported , who experienced Serious ( hospitalization , medically significant ) , expected event of myocarditis. This event occurred on an unknown date after receiving  the 2nd dose of mRNA-1273 vaccine This patient was admitted because of acute chest pain. . The details surrounding this event were not reported since the full text of this literature for review is not available .The event outcome was unknown.. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report. The reviewer has limited information regarding this case as mentioned since the full text was not available at the time of the medical review.   This case was linked to MOD-2022-513579, MOD-2022-513580, MOD-2022-513581.; Sender's Comments: This literature non-study case concerns  a 19 year old male patient with no medical history reported , who experienced Serious ( hospitalization , medically significant ) , expected event of myocarditis. This event occurred on an unknown date after receiving  the 2nd dose of mRNA-1273 vaccine This patient was admitted because of acute chest pain. . The details surrounding this event were not reported since the full text of this literature for review is not available.The event outcome was unknown.. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report. The reviewer has limited information regarding this case as mentioned since the full text was not available at the time of the medical review.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose received > 35 days from 1st dose/2nd dose received beyond 35 days from 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received > 35 days from 1st dose/2nd dose received beyond 35 days from 1st dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 19-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 19-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received > 35 days from 1st dose/2nd dose received beyond 35 days from 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received > 35 days from 1st dose/2nd dose received beyond 35 days from 1st dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was provided. No treatment medication was provided.   This case was linked to MOD-2022-515212 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (one ended up almost paralyzed) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARALYSIS (one ended up almost paralyzed). At the time of the report, PARALYSIS (one ended up almost paralyzed) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. Reporter was not absolutely sure if patient received the Moderna vaccine or another one. The patient read information that some of the dosages were more than they should had been. She wanted to know if there were any issues with the batch. Her lot numbers were 038A21A and 023M20A. She also stated that different communities were given different types (different batches) of the vaccine. They were targeting specific communities with different batches. She was not sure, might be the government or companies. No concomitant product was provided. No treatment information was provided. Reporter did not allow further contact. Most recent FOLLOW-UP information incorporated above includes: On 18-Mar-2022: Follow up received and contained no significant new information. (Quality complaints team updated that, This report was received on 18Mar2022 and would be processed for cancellation under QE-016290 and QE-016291).
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Activated partial thromboplastin time, Activated partial thromboplastin time prolonged, Antiphospholipid antibodies
Clinical narrative: States in Oct2021 PTT was too high to operate; Was diagnosed with Lupus anticoagulant; This spontaneous case was reported by a consumer and describes the occurrence of ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED (States in Oct2021 PTT was too high to operate) and ANTIPHOSPHOLIPID ANTIBODIES (Was diagnosed with Lupus anticoagulant) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A 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) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED (States in Oct2021 PTT was too high to operate) and ANTIPHOSPHOLIPID ANTIBODIES (Was diagnosed with Lupus anticoagulant). At the time of the report, ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED (States in Oct2021 PTT was too high to operate) and ANTIPHOSPHOLIPID ANTIBODIES (Was diagnosed with Lupus anticoagulant) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Activated partial thromboplastin time: high (High) PTT was too high. In October 2021, Antiphospholipid antibodies: diagnosed with lupus anticoagulant (Positive) diagnosed with Lupus anticoagulant.         No concomitant medication was reported. No treatment medication was reported.  States in Oct-2021 patient was supposed to get knees replaced Patient declines to provide further personal medical history was reported.   This case was linked to MOD-2022-515380 (Patient Link).
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Activated partial thromboplastin time, Antiphospholipid antibodies, Blood test
Clinical narrative: States in Oct2021 PTT was too high to operate; Was diagnosed with Lupus anticoagulant; This spontaneous case was reported by a consumer and describes the occurrence of ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED (States in Oct2021 PTT was too high to operate) and ANTIPHOSPHOLIPID ANTIBODIES (Was diagnosed with Lupus anticoagulant) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A 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) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED (States in Oct2021 PTT was too high to operate) and ANTIPHOSPHOLIPID ANTIBODIES (Was diagnosed with Lupus anticoagulant). At the time of the report, ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED (States in Oct2021 PTT was too high to operate) and ANTIPHOSPHOLIPID ANTIBODIES (Was diagnosed with Lupus anticoagulant) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Activated partial thromboplastin time: high (High) PTT was too high. In October 2021, Antiphospholipid antibodies: diagnosed with lupus anticoagulant (Positive) diagnosed with Lupus anticoagulant.         No concomitant medication was reported. No treatment medication was reported.  States in Oct-2021 patient was supposed to get knees replaced Patient declines to provide further personal medical history was reported.   This case was linked to MOD-2022-515380 (Patient Link).
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Activated partial thromboplastin time, Activated partial thromboplastin time prolonged, Antiphospholipid antibodies
Clinical narrative: States he had blood work and diagnosis made Jan2022, Was diagnosed with Lupus anticoagulant.; This spontaneous case was reported by a consumer and describes the occurrence of ANTIPHOSPHOLIPID ANTIBODIES (States he had blood work and diagnosis made Jan2022, Was diagnosed with Lupus anticoagulant.) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939909, 027B21A 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 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced ANTIPHOSPHOLIPID ANTIBODIES (States he had blood work and diagnosis made Jan2022, Was diagnosed with Lupus anticoagulant.). At the time of the report, ANTIPHOSPHOLIPID ANTIBODIES (States he had blood work and diagnosis made Jan2022, Was diagnosed with Lupus anticoagulant.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Activated partial thromboplastin time: high (High) PTT was too high. In January 2022, Blood test: abnormal (abnormal) Patient had blood work and diagnosis made Jan2022.         No concomitant medications was provided. Patient called 18-Mar-2022 stating he never had this problem until received Moderna doses. On Oct-2021 patient was supposed to get knees replaced.On Oct-2021 patient's PTT was too high to operate on for knee replacements. Patient states he had blood work and diagnosis made on Jan-2022. No treatment medications was provided.   This case was linked to MOD-2022-515349 (Patient Link).
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Activated partial thromboplastin time, Antiphospholipid antibodies, Blood test
Clinical narrative: States he had blood work and diagnosis made Jan2022, Was diagnosed with Lupus anticoagulant.; This spontaneous case was reported by a consumer and describes the occurrence of ANTIPHOSPHOLIPID ANTIBODIES (States he had blood work and diagnosis made Jan2022, Was diagnosed with Lupus anticoagulant.) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939909, 027B21A 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 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced ANTIPHOSPHOLIPID ANTIBODIES (States he had blood work and diagnosis made Jan2022, Was diagnosed with Lupus anticoagulant.). At the time of the report, ANTIPHOSPHOLIPID ANTIBODIES (States he had blood work and diagnosis made Jan2022, Was diagnosed with Lupus anticoagulant.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Activated partial thromboplastin time: high (High) PTT was too high. In January 2022, Blood test: abnormal (abnormal) Patient had blood work and diagnosis made Jan2022.         No concomitant medications was provided. Patient called 18-Mar-2022 stating he never had this problem until received Moderna doses. On Oct-2021 patient was supposed to get knees replaced.On Oct-2021 patient's PTT was too high to operate on for knee replacements. Patient states he had blood work and diagnosis made on Jan-2022. No treatment medications was provided.   This case was linked to MOD-2022-515349 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Polymenorrhoea
Clinical narrative: Instead of having one cycle per month, she has two; This spontaneous case was reported by a consumer and describes the occurrence of POLYMENORRHOEA (Instead of having one cycle per month, she has two) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced POLYMENORRHOEA (Instead of having one cycle per month, she has two). At the time of the report, POLYMENORRHOEA (Instead of having one cycle per month, she has two) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. Reporter was not sure if patient received the Moderna vaccine or another one.  Concomitant medication was not provided.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-Mar-2022: Follow up received and contained no significant new information. (Quality complaints team updated that, this report was received on 18Mar2022 & will be processed for cancellation under QE-016290 and QE-016291).
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Extra dose administered, Vaccination site swelling
Clinical narrative: got another dose of the Moderna Covid-19 on 15Mar2022 - this time given at 0.25 ml; right arm was swollen; had pain on his right axilla but this was not as intense and bad as the last one; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE SWELLING (right arm was swollen), AXILLARY PAIN (had pain on his right axilla but this was not as intense and bad as the last one) and EXTRA DOSE ADMINISTERED (got another dose of the Moderna Covid-19 on 15Mar2022 - this time given at 0.25 ml) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Mar-2022, the patient experienced VACCINATION SITE SWELLING (right arm was swollen) and AXILLARY PAIN (had pain on his right axilla but this was not as intense and bad as the last one). On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (got another dose of the Moderna Covid-19 on 15Mar2022 - this time given at 0.25 ml). At the time of the report, VACCINATION SITE SWELLING (right arm was swollen) and AXILLARY PAIN (had pain on his right axilla but this was not as intense and bad as the last one) had not resolved and EXTRA DOSE ADMINISTERED (got another dose of the Moderna Covid-19 on 15Mar2022 - this time given at 0.25 ml) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. Patient had the same symptoms like the one he had after he got the 3rd dose - his right arm was swollen and he had pain on his right axilla but this was not as intense and bad as the last one. He still was experiencing the symptoms at the time of the call. No treatment reported   This case was linked to MOD-2022-515692 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding
Clinical narrative: Breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding). At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding) had resolved. Patient had the first 2 shots of COVID-19 vaccine of Moderna. She was supposed to have the 3rd shots of Moderna vaccine tomorrow. She had been breastfeeding her baby since day one. The child was almost 3 and she wanted to see if it would be safe to get that shot.  No concomitant and treatment medication were provided
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort
Clinical narrative: tummy trouble after wards; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (tummy trouble after wards) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (tummy trouble after wards). At the time of the report, ABDOMINAL DISCOMFORT (tummy trouble after wards) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: she had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (she had a sore arm) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (she had a sore arm). At the time of the report, PAIN IN EXTREMITY (she had a sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Experienced a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Experienced a sore arm) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Experienced a sore arm). At the time of the report, PAIN IN EXTREMITY (Experienced a sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was provided by the reporter.  No treatment medications was provided by the reporter.   This case was linked to MOD-2022-516393 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: feel fatigued for one full day; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (feel fatigued for one full day) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 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. On an unknown date, the patient experienced FATIGUE (feel fatigued for one full day). At the time of the report, FATIGUE (feel fatigued for one full day) had resolved. No concomitant medications were reported. No treatment medications were reported. This case was linked to MOD-2022-516385 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: 5 doses were given from a vial exposed to several tempereature excursions; 5 doses were given from a vial exposed to several tempereature excursions; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (5 doses were given from a vial exposed to several tempereature excursions) and POOR QUALITY PRODUCT ADMINISTERED (5 doses were given from a vial exposed to several tempereature excursions) in a 72-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (5 doses were given from a vial exposed to several tempereature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (5 doses were given from a vial exposed to several tempereature excursions). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (5 doses were given from a vial exposed to several tempereature excursions) and POOR QUALITY PRODUCT ADMINISTERED (5 doses were given from a vial exposed to several tempereature excursions) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. It was reported that vaccines exposed to temperature out of range. Too warm Too cold  On 28-Jan-22  at 1.8 Degrees Celsius for 1 hour On 27-Jan-22  at 8.7 Degrees Celsius for 30 mins On 03-Feb-22  at 12.3 Degrees Celsius for 1 hour On 09-Feb-22  at 11.4 Degrees Celsius for 30 mins On 10-Feb-22  at 8.2 Degrees Celsius for 30 mins On 09-Feb-22  at 11.4 Degrees Celsius for 30 mins On 28-Feb-22  at 8.7 Degrees Celsius for 30 mins On 03-Mar-22  at 11.7 Degrees Celsius for 30 mins On 08-Mar-22  at -199.9 Degrees Celsius for 30 mins which was the minimum temperature On 13-Mar-22  at 1.9 Degrees Celsius for 1 hour  Hours accumulated 3.5 2.5  It was reported that the storage condition at the time of the excursion was refrigerated storage and total 5 vials were involved.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: 5 doses were given from a vial exposed to several tempereature excursions; 5 doses were given from a vial exposed to several tempereature excursions; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (5 doses were given from a vial exposed to several tempereature excursions) and POOR QUALITY PRODUCT ADMINISTERED (5 doses were given from a vial exposed to several tempereature excursions) in an 81-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (5 doses were given from a vial exposed to several tempereature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (5 doses were given from a vial exposed to several tempereature excursions). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (5 doses were given from a vial exposed to several tempereature excursions) and POOR QUALITY PRODUCT ADMINISTERED (5 doses were given from a vial exposed to several tempereature excursions) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The vial was exposed at minimum temperature of 199.9 degree Celsius for 30 minutes. Storage condition at the time of the excursion was refrigerated storage. No concomitant and treatment medications were reported by the reporter
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: allergy; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergy) in a 51-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (allergy). At the time of the report, HYPERSENSITIVITY (allergy) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant and treatment medication were reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: After the first Moderna Covid-19 injection the Injection site arm was very sore; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (After the first Moderna Covid-19 injection the Injection site arm was very sore) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Overweight and Diabetes. Concomitant products included PARACETAMOL (TYLENOL [PARACETAMOL]) for an unknown indication.    In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (After the first Moderna Covid-19 injection the Injection site arm was very sore). At the time of the report, VACCINATION SITE PAIN (After the first Moderna Covid-19 injection the Injection site arm was very sore) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. No treatment details were reported. This case was linked to MOD-2022-516534 (Patient Link).   Reporter did not allow further contact
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Very sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Very sore left arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Asthma (started since 3 years ago and recently no change in condition).    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (Very sore left arm). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Pain in arm, at an unspecified dose and frequency. On 19-Mar-2021, PAIN IN EXTREMITY (Very sore left arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       It was reported that patient had no other vaccine given within 1 month prior to Moderna COVID-19 vaccine.  No concomitant medication was reported by reporter.   This case was linked to MOD-2022-516796 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test
Clinical narrative: 1-2 weeks after 1st shot she noticed a headache on her temple/These headaches now are different; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (1-2 weeks after 1st shot she noticed a headache on her temple/These headaches now are different) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Contrast media allergy (allergic to contrast dye) and Migraine (She dealt with migraines all her life, but it got much better as she got older). Concomitant products included ALIROCUMAB (PRALUENT) for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, 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 experienced HEADACHE (1-2 weeks after 1st shot she noticed a headache on her temple/These headaches now are different). The patient was treated with BUTALBITAL at an unspecified dose and frequency; TRAMADOL at an unspecified dose and frequency; CAFFEINE, PARACETAMOL (EXCEDRIN ASPIRIN FREE) at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, HEADACHE (1-2 weeks after 1st shot she noticed a headache on her temple/These headaches now are different) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication also include bone density injection every 6 months.   Patient didn't had any vaccine within 1 month prior to Moderna.  Reporter stated that patient seek the medical care went to neurologist to see for her migraines around August 2021. She also had unspecified tests, bloodwork and scans for which results not provided.  It was  also reported that she also had the similar event in past but with a different type of migraine. It was reported that the pressure was behind the eye and then the temple, it does switch. Sometimes it goes from left to right. Right now it is in the right. It was very sensitive to touch and they're strange for her.   This case was linked to MOD-2022-516644 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: 2 Patients were administered from vials that experienced a T excursion.  Min T:38.40°F, Max T: 46.20°F Occurred: 23Feb2022; 2 Patients were administered from vials that experienced a T excursion.  Min T:38.40degree F, Max T: 46.20 degree F Occurred: 23Feb2022; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (2 Patients were administered from vials that experienced a T excursion.  Min T:38.40°F, Max T: 46.20°F Occurred: 23Feb2022) and POOR QUALITY PRODUCT ADMINISTERED (2 Patients were administered from vials that experienced a T excursion.  Min T:38.40degree F, Max T: 46.20 degree F Occurred: 23Feb2022) in a 73-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 025L21B) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus and Chronic kidney disease.    On 01-Mar-2022 at 2:45 PM, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 01-Mar-2022 at 2:45 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (2 Patients were administered from vials that experienced a T excursion.  Min T:38.40degree F, Max T: 46.20 degree F Occurred: 23Feb2022). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (2 Patients were administered from vials that experienced a T excursion.  Min T:38.40°F, Max T: 46.20°F Occurred: 23Feb2022). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (2 Patients were administered from vials that experienced a T excursion.  Min T:38.40°F, Max T: 46.20°F Occurred: 23Feb2022) and POOR QUALITY PRODUCT ADMINISTERED (2 Patients were administered from vials that experienced a T excursion.  Min T:38.40degree F, Max T: 46.20 degree F Occurred: 23Feb2022) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Patient did not have any known drug allergies. It was unknown if the patient ever been diagnosed with/ tested positive for COVID-19.  No concomitant medication was reported.  Storage condition at the time of the excursion was Refrigerated. Excursion duration was at 9.56 for 10 min. Vials were discarded when they reported the excursion then continued using the vials out of range. Number of vials/doses impacted were 3 vials. 2 patients were administered from these vials. The first dose on 25-Feb-2022, 1 vial was discarded.  Patient did not report any adverse event. No treatment information was provided.   This case was linked to MOD-2022-512132 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Knee arthroplasty, Therapeutic response shortened
Clinical narrative: Wearing off effect; Total knee replacement; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4183195-00.  A 58 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 31Mar2021 (Batch/Lot number: unknown) at the age of 58 years as dose 2, single and intramuscular, administration date 03Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1152115) at cf for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: KNEE ARTHROPLASTY (medically significant) with onset 07Oct2021, outcome "unknown", described as "Total knee replacement"; THERAPEUTIC RESPONSE SHORTENED (medically significant), outcome "unknown", described as "Wearing off effect". The action taken for adalimumab was unknown.  Causality for Humira(Adalimumab)The reporter's causality for the event(s) of left knee replacement and not lasting entire injection cycle/Humira effects seemed to mildly wear off a little before next Humira injection was not provided. Companyc's opinion is that there is no reasonable possibility that the events of left knee replacement and not lasting entire injection cycle/Humira effects seemed to mildly wear off a little before next Humira injection are related to Humira(Adalimumab).  The reporter considered "total knee replacement" and "wearing off effect" related to bnt162b2.  Additional information: The patient had Right and left knee replacement on 07Oct2021.The patient stated that before next injection that the effect seemed to mildly was wear off. The patient did not stopped Humira for either operation. Doctor said that to patient should stopped Humira but her gastro physician was not okay with stopped Humira.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events "total knee replacement" and "wearing off effect" Cannot be excluded  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count, White blood cell count increased
Clinical narrative: getting very high wbc 15,000; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A 57 year-old male patient received bnt162b2 (BNT162B2), administration date Aug2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Xeljanz, start date: 2021, stop date: 2021, notes: TAB 5MG. Vaccination history included: Bnt162b2 (Dose 1), administration date: 2021, when the patient was 57 years old, for COVID-19 Immunization. The following information was reported: WHITE BLOOD CELL COUNT INCREASED (non-serious) with onset 2021, outcome "unknown", described as "getting very high wbc 15,000". The event "getting very high wbc 15,000" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of white blood cell count increased. Additional Information: Completed xeljanz d/c call with pt. Patient reports taking medication as prescribed. Stated he does not know what was going on, if the medication was losing it was effectiveness or if he was having SE from the covid vaccine. Stated he had his second dose in Aug and 2 weeks after that he started getting very high wbc 15,000. Stated he was seeing a hematologist now and they are trying to figure out what was going on. Stated they put him back on the Leflunomide. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: they both did not have vertigo or did not have the vertigo this severe with at least the first two doses of their Pfizer Covid vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 17 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 17 years as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VERTIGO (non-serious), outcome "unknown", described as "they both did not have vertigo or did not have the vertigo this severe with at least the first two doses of their Pfizer Covid vaccines".  Additional information: Prior Vaccinations (within 4 weeks) was none. Patients Medical History (including any illness at time of vaccination) was  none. Family Medical History Relevant to AE(s) was none. The patient no visited Emergency Room or Physician Office.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.