chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: We have some Moderna Covid-19 vaccine that expired on 20Mar2022 that we gave a few doses of.; Moderna Covid-19 vaccine that expired on 20-Mar-2022 was initially stored in the refrigerator on 31-Mar-2022 and administered on 31-Mar-2022.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-19 vaccine that expired on 20Mar2022 that we gave a few doses of.) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that expired on 20-Mar-2022 was initially stored in the refrigerator on 31-Mar-2022 and administered on 31-Mar-2022.) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 31-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-19 vaccine that expired on 20Mar2022 that we gave a few doses of.) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that expired on 20-Mar-2022 was initially stored in the refrigerator on 31-Mar-2022 and administered on 31-Mar-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-19 vaccine that expired on 20Mar2022 that we gave a few doses of.) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that expired on 20-Mar-2022 was initially stored in the refrigerator on 31-Mar-2022 and administered on 31-Mar-2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   The vial was initially stored in the refrigerator on 31-Mar-2022. The vial did not undergo temperature excursion.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2022: Follow-up received included no new information.
Age: 78.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Moderna Covid-19 vaccine that expired on 20-Mar-2022/ refrigerated on 31-Mar-2022; Patient received Moderna Covid-19 vaccine that expired on 20-Mar-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that expired on 20-Mar-2022) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that expired on 20-Mar-2022/ refrigerated on 31-Mar-2022) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 31-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that expired on 20-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that expired on 20-Mar-2022/ refrigerated on 31-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that expired on 20-Mar-2022) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that expired on 20-Mar-2022/ refrigerated on 31-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially stored in refrigerator on 31-Mar-2022 and the vial did not undergo any temperature excursions.  The expiry date was mentioned as 27-Mar-2022.  The reporter wanted to know whether the patient should revaccinate or not.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2022: Follow-up document received contains no new information.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Received a full Moderna Covid-19 vaccine Third dose as a Booster Moderna Covid-19 vaccine dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Received a full Moderna Covid-19 vaccine Third dose as a Booster Moderna Covid-19 vaccine dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced ACCIDENTAL OVERDOSE (Received a full Moderna Covid-19 vaccine Third dose as a Booster Moderna Covid-19 vaccine dose). At the time of the report, ACCIDENTAL OVERDOSE (Received a full Moderna Covid-19 vaccine Third dose as a Booster Moderna Covid-19 vaccine dose) outcome was unknown.            No concomitant medications was provided.  No treatment medications was provided.  The Patient wanted to know if she can receive a second Moderna covid-19 vaccine Booster dose after receiving a First, Second and Third Moderna Covid-19 vaccine full doses. Patient was not immunocompromised, but stated that patient received a full third dose as a Booster dose because at the time, Moderna's Booster dose was not available and patient needed to get back to work. Patient experienced no symptoms after getting vaccinated.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Extra dose administered
Clinical narrative: booster dose given at 1/3 the full dose; immunocompromised patient given a booster dose for her 3rd dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromised patient given a booster dose for her 3rd dose) and EXTRA DOSE ADMINISTERED (booster dose given at 1/3 the full dose) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A, 022M20A and 042J21A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation (she takes unspecified medications) and Immunodeficiency.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL UNDERDOSE (immunocompromised patient given a booster dose for her 3rd dose). On 04-Feb-2022, the patient experienced EXTRA DOSE ADMINISTERED (booster dose given at 1/3 the full dose). At the time of the report, ACCIDENTAL UNDERDOSE (immunocompromised patient given a booster dose for her 3rd dose) and EXTRA DOSE ADMINISTERED (booster dose given at 1/3 the full dose) outcome was unknown.            It was reported that the patient was immunodeficient and had MS (unspecified condition).  The patient did not have COVID-19 diagnosis prior to or after getting the vaccine.   The patient had no history of allergies.  Concomitant medications included unspecified medications.  Lot number for 1st booster dose was 088_21A (could not decipher the 4th character in the lot number).  The had her last flu vaccine in Sep-2021.  The reporter mentioned he would clarify with the pharmacy the dose that was administered to her on 08-Aug-2021 and 04-Feb-2022.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-529184 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired booster 1 day beyond the MFG Exp. Date) and PRODUCT TEMPERATURE EXCURSION ISSUE (vial exposed to several temperature excursion) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination. No Medical History information was reported. On 28-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired booster 1 day beyond the MFG Exp. Date) and PRODUCT TEMPERATURE EXCURSION ISSUE (vial exposed to several temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired booster 1 day beyond the MFG Exp. Date) and PRODUCT TEMPERATURE EXCURSION ISSUE (vial exposed to several temperature excursion) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported. It was reported that the unpunctured vial was moved from Freezer to the refrigerator on 10-Mar-2022 and kept in the refrigerator under recommended temperature. Storage condition at the time of the excursion was Refrigerated storage. Maximum or minimum temperature reached was 36° to 46°F. Excursion duration was 15.5 hours past expiration, approximately dose was administered at 3:24 PM on 28-Mar-2022. Vial was moved from freezer to refrigerator on 10-Mar-2022, They had discarded the vial post that date. Vaccine was normal and in liquid phase during visual inspection. 1 vial of 10 dose each was impacted. There was no previous excursion happened and vial was unpunctured.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vial had been opened for 24 hours but kept in the fridge; Moderna Covid booster dose was administered to patient after its expiration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid booster dose was administered to patient after its expiration time) and PRODUCT STORAGE ERROR (vial had been opened for 24 hours but kept in the fridge) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2022 at 8:24 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2022 at 8:24 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid booster dose was administered to patient after its expiration time). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial had been opened for 24 hours but kept in the fridge). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid booster dose was administered to patient after its expiration time) and PRODUCT STORAGE ERROR (vial had been opened for 24 hours but kept in the fridge) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The vial was moved from freezer to refrigerator on 17-Mar-2022.  The vial of the vaccine was opened on 28-Mar-2022 at 08:06 A.M. The reporter would like to know about what action needs to be taken as the next step and whether the patient needs to repeat that dose or not.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2022: Follow-up document received contains significant information: batch number of suspect vaccine and narrative were updated.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Dose administered after temperature excursion; Dose administered after temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Dose administered after temperature excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose administered after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Dose administered after temperature excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  Nurse reported that on the morning of 30 Mar 2022, the temperature went to 39.38 Fahrenheit for the same vaccines.  The minimum temperature was reported as 38.08 F, and the maximum temperature was reported as 46.77 F. She is unsure of the duration of the excursion.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Two patients received Moderna vaccines 15 days after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Two patients received Moderna vaccines 15 days after expiration date) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2022 at 11:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Jan-2022 at 11:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Two patients received Moderna vaccines 15 days after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Two patients received Moderna vaccines 15 days after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter called to report that two patients received Moderna vaccines 15 days after expiration date. The expiration date was 04-Jan-2022. The date the vial initially stored in the refrigerator was unknown. It was reported that the vial didn't undergo any temperature excursions.  Reportedly, the patient did not experience any physical adverse reaction and was notified regarding the expired vaccine and would come to clinic to get a repeat booster. The patient received the booster as 0.25 of unknown unit. It was also reported that the patient had no known allergies.  No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Ocular hyperaemia, Vaccination site pain
Clinical narrative: The next day the eye was red; had really bad pain in the left arm; pain in the left eye; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (pain in the left eye), OCULAR HYPERAEMIA (The next day the eye was red) and VACCINATION SITE PAIN (had really bad pain in the left arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis since 1986.    On 10-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jul-2021, the patient experienced EYE PAIN (pain in the left eye) and VACCINATION SITE PAIN (had really bad pain in the left arm). On 11-Jul-2021, the patient experienced OCULAR HYPERAEMIA (The next day the eye was red). At the time of the report, EYE PAIN (pain in the left eye), OCULAR HYPERAEMIA (The next day the eye was red) and VACCINATION SITE PAIN (had really bad pain in the left arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment information were provided.   This case was linked to MOD-2022-530641 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Disturbance in attention, Insomnia, Tinnitus
Clinical narrative: constant ring in ears; cannot sleep; cannot sleep or concentrate on the job , feel like you are loosing my mind; This spontaneous case was reported by a nurse and describes the occurrence of TINNITUS (constant ring in ears), INSOMNIA (cannot sleep) and DISTURBANCE IN ATTENTION (cannot sleep or concentrate on the job , feel like you are loosing my mind) in a  patient of an unknown age and gender 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 TINNITUS (constant ring in ears), INSOMNIA (cannot sleep) and DISTURBANCE IN ATTENTION (cannot sleep or concentrate on the job , feel like you are loosing my mind). At the time of the report, TINNITUS (constant ring in ears), INSOMNIA (cannot sleep) and DISTURBANCE IN ATTENTION (cannot sleep or concentrate on the job , feel like you are loosing my mind) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Expired product administered, Pyrexia, Vaccination site pain
Clinical narrative: mild low grade fever; injection site arm hurt; received expired Moderna Covid-19 vaccine for a booster dose; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (mild low grade fever), VACCINATION SITE PAIN (injection site arm hurt) and EXPIRED PRODUCT ADMINISTERED (received expired Moderna Covid-19 vaccine for a booster dose) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer Vaccine (Primary Series of the vaccine.). Past adverse reactions to the above products included No adverse event with Pfizer Vaccine.    On 28-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2022, the patient experienced PYREXIA (mild low grade fever), VACCINATION SITE PAIN (injection site arm hurt) and EXPIRED PRODUCT ADMINISTERED (received expired Moderna Covid-19 vaccine for a booster dose). At the time of the report, PYREXIA (mild low grade fever), VACCINATION SITE PAIN (injection site arm hurt) and EXPIRED PRODUCT ADMINISTERED (received expired Moderna Covid-19 vaccine for a booster dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2022, Body temperature: high (High) mild low grade fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Oral pain, Swollen tongue
Clinical narrative: tongue swelling; mouth pain the night after booster dose; This spontaneous case was reported by a patient family member or friend and describes the occurrence of SWOLLEN TONGUE (tongue swelling) and ORAL PAIN (mouth pain the night after booster dose) in a 9-decade-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 fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWOLLEN TONGUE (tongue swelling) and ORAL PAIN (mouth pain the night after booster dose). At the time of the report, SWOLLEN TONGUE (tongue swelling) and ORAL PAIN (mouth pain the night after booster dose) outcome was unknown.            Concomitant medication information was not provided by the reporter.  It was reported that, the patient was administered fourth booster dose as he was in his 80s. Later, the patient had tongue swelling and mouth pain the night after the booster.  Treatment information was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: immunocompromised patient received half booster dose as 3rd dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (immunocompromised patient received half booster dose as 3rd dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (immunocompromised patient received half booster dose as 3rd dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (immunocompromised patient received half booster dose as 3rd dose) outcome was unknown.            No concomitant medications were reported.  An immunocompromised patient who did not receive a third primary series dose as indicated but already received a booster half dose. Reporter enquired if an immunocompromised patient who failed to receive a third primary dose but received a booster dose still be eligible for Evusheld.   No treatment information was provided.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, Disorientation, Fear, Hallucination, Pyrexia
Clinical narrative: Hallucinations/didn't know where she was; Fear; didn't know where she was; very high fever over 104 degree, extremely high fever; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (Hallucinations/didn't know where she was), FEAR (Fear), DISORIENTATION (didn't know where she was) and PYREXIA (very high fever over 104 degree, extremely high fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051f21a, 031l20a and 013l20a) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), SERTRALINE, VIT D [VITAMIN D NOS] and MIRABEGRON (MYRBETRIQ) for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced HALLUCINATION (Hallucinations/didn't know where she was), FEAR (Fear), DISORIENTATION (didn't know where she was) and PYREXIA (very high fever over 104 degree, extremely high fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HALLUCINATION (Hallucinations/didn't know where she was), FEAR (Fear), DISORIENTATION (didn't know where she was) and PYREXIA (very high fever over 104 degree, extremely high fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Nov-2021, Body temperature: 104 (High) 104 degree.         No medical history information reported.  Following vaccination with the booster patient started to experience the next morning: worst side effects, very high fever over 104 degree, did not know where she was, extremely high fever, hallucinations and fear which lasted for several days. Patient started to experience a condition following vaccination which make her to take Myrbetriq.   This case was linked to MOD-2022-530858 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immunisation reaction
Clinical narrative: Hallucinations/didn't know where she was; Fear; didn't know where she was; very high fever over 104 degree, extremely high fever; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (Hallucinations/didn't know where she was), FEAR (Fear), DISORIENTATION (didn't know where she was) and PYREXIA (very high fever over 104 degree, extremely high fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051f21a, 031l20a and 013l20a) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), SERTRALINE, VIT D [VITAMIN D NOS] and MIRABEGRON (MYRBETRIQ) for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced HALLUCINATION (Hallucinations/didn't know where she was), FEAR (Fear), DISORIENTATION (didn't know where she was) and PYREXIA (very high fever over 104 degree, extremely high fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HALLUCINATION (Hallucinations/didn't know where she was), FEAR (Fear), DISORIENTATION (didn't know where she was) and PYREXIA (very high fever over 104 degree, extremely high fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Nov-2021, Body temperature: 104 (High) 104 degree.         No medical history information reported.  Following vaccination with the booster patient started to experience the next morning: worst side effects, very high fever over 104 degree, did not know where she was, extremely high fever, hallucinations and fear which lasted for several days. Patient started to experience a condition following vaccination which make her to take Myrbetriq.   This case was linked to MOD-2022-530858 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immunisation reaction, Pyrexia
Clinical narrative: Hallucinations/didn't know where she was; Fear; didn't know where she was; very high fever over 104 degree, extremely high fever; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (Hallucinations/didn't know where she was), FEAR (Fear), DISORIENTATION (didn't know where she was) and PYREXIA (very high fever over 104 degree, extremely high fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051f21a, 031l20a and 013l20a) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), SERTRALINE, VIT D [VITAMIN D NOS] and MIRABEGRON (MYRBETRIQ) for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced HALLUCINATION (Hallucinations/didn't know where she was), FEAR (Fear), DISORIENTATION (didn't know where she was) and PYREXIA (very high fever over 104 degree, extremely high fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HALLUCINATION (Hallucinations/didn't know where she was), FEAR (Fear), DISORIENTATION (didn't know where she was) and PYREXIA (very high fever over 104 degree, extremely high fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Nov-2021, Body temperature: 104 (High) 104 degree.         No medical history information reported.  Following vaccination with the booster patient started to experience the next morning: worst side effects, very high fever over 104 degree, did not know where she was, extremely high fever, hallucinations and fear which lasted for several days. Patient started to experience a condition following vaccination which make her to take Myrbetriq.   This case was linked to MOD-2022-530858 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: report after his booster dose of the Moderna COVID-19 vaccine he started to experience tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (report after his booster dose of the Moderna COVID-19 vaccine he started to experience tinnitus) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-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 TINNITUS (report after his booster dose of the Moderna COVID-19 vaccine he started to experience tinnitus). At the time of the report, TINNITUS (report after his booster dose of the Moderna COVID-19 vaccine he started to experience tinnitus) outcome was unknown.            No concomitant medications reported. No treatment reported.   This case was linked to MOD-2022-531762, MOD-2022-531761 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Insomnia, Peripheral swelling
Clinical narrative: Couldn't sleep all night; arm is swollen; back hurts; Just feels weak; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Couldn't sleep all night), PERIPHERAL SWELLING (arm is swollen), BACK PAIN (back hurts) and ASTHENIA (Just feels weak) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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. On an unknown date, the patient experienced INSOMNIA (Couldn't sleep all night), PERIPHERAL SWELLING (arm is swollen), BACK PAIN (back hurts) and ASTHENIA (Just feels weak). At the time of the report, INSOMNIA (Couldn't sleep all night), PERIPHERAL SWELLING (arm is swollen), BACK PAIN (back hurts) and ASTHENIA (Just feels weak) outcome was unknown.            No concomitant medications were reported.  The dates and lot number were unknown for dose 1 and 2.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2022: Follow-up document received includes no new information was added.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 6 patients were administered from expired doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 patients were administered from expired doses) in a 56-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 31-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 patients were administered from expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (6 patients were administered from expired doses) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator on 17-Mar-2022 The vial did not undergo any temperature excursions  No concomitant medication were provided No treatment details were provided   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2022: No New information On 01-Apr-2022: Patient demographics added
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Feeling fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Feeling fatigue) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A and 042B21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced FATIGUE (Feeling fatigue). At the time of the report, FATIGUE (Feeling fatigue) outcome was unknown.            No concomitant medications were provided. The patient had no adverse reactions after first and second dose of Moderna Covid-19 vaccine. The patient is immunocompromised and has received 3 full Moderna Covid-19 vaccines. No treatment medications were reported.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered after published expiration date; The vaccine was stored in refrigerated on 30-Mar-2022, it got expired on 24-Mar-2022 but was administered on 31-Mar-2022.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after published expiration date) and PRODUCT STORAGE ERROR (The vaccine was stored in refrigerated on 30-Mar-2022, it got expired on 24-Mar-2022 but was administered on 31-Mar-2022.) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2022, the patient experienced PRODUCT STORAGE ERROR (The vaccine was stored in refrigerated on 30-Mar-2022, it got expired on 24-Mar-2022 but was administered on 31-Mar-2022.). On 31-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after published expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after published expiration date) and PRODUCT STORAGE ERROR (The vaccine was stored in refrigerated on 30-Mar-2022, it got expired on 24-Mar-2022 but was administered on 31-Mar-2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. Reporter states, it was unaware if the patient was immunocompromised. Vial was initially stored in the refrigerator on 30-March-2022 and Vial did not undergo any temperature excursions. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2022: Live Follow-up document received .
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: AFIB; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Mar2022 09:30 (Lot number: FM0698) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "HBP controlled" (unspecified if ongoing); "AFIB", start date: 2009 (unspecified if ongoing), notes: 2017. Concomitant medication(s) included: TOPROL XL; POTASSIUM; TEKTURNA. Past drug history included: Septa, reaction(s): "known allergies: Septa"; Eliquis, reaction(s): "known allergies: Eloquis"; Xarelto, reaction(s): "known allergies: Xaralto". The following information was reported: ATRIAL FIBRILLATION (hospitalization), outcome "recovering", described as "AFIB". The event "afib" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of atrial fibrillation: IV Cardizem, magnesium, digoxin, potassium.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This is a spontaneous report received from a contactable reporter (consumer) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection), administration date 02Sep2021 (lot number unknown) as dose number unknown, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset 21Sep2021, outcome "unknown", described as "stroke".  The lot number for bnt162b2 was not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "all caught Covid-19". Clinical Course: Recently, despite receiving the three shots, reporter's daughter, son-in-law, and himself all caught Covid-19 from his unvaccinated 2 year old granddaughter. Fortunately it was very mild for all of us and we recovered quickly. The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: Linked Report(s): US-PFIZER INC-202200460138 same reporter/drug/event, different patient.
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Colitis ulcerative, Fatigue, SARS-CoV-2 test
Clinical narrative: I have a confirmed case ulcerative colitis, with associated problems of arthritis and fatigue; I have a confirmed case ulcerative colitis, with associated problems of arthritis and fatigue; I have a confirmed case ulcerative colitis, with associated problems of arthritis and fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Colitis ulcerative" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Mesalamine, reaction(s): "Known allergies: Mesalamine". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: Feb2021, when the patient was 57 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: Jan2021, when the patient was 57 years old, for Covid-19 immunization. The following information was reported: COLITIS ULCERATIVE (medically significant), ARTHRITIS (non-serious), FATIGUE (non-serious) all with onset Oct2021, outcome "unknown" and all described as "I have a confirmed case ulcerative colitis, with associated problems of arthritis and fatigue". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Feb2022) negative. Therapeutic measures were not taken as a result of colitis ulcerative, arthritis, fatigue.  Additional Information: There were no other vaccine administered within 4weeks. There was no COVID prior vaccination. The patient had not been diagnosed COVID tested post vaccination. The Nasal Swab test had been performed.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Cardiomyopathy, Investigation
Clinical narrative: 10 y/o test positive MYBPC3 familial hypertrophic cardiomayopathy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 10 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIOMYOPATHY (medically significant), outcome "unknown", described as "10 y/o test positive MYBPC3 familial hypertrophic cardiomayopathy". The patient underwent the following laboratory tests and procedures: investigation: positive, notes: patient genetic test positive for MYBPC 3.  Clinical Course: 10 yo patient genetic test positive for MYBPC 3 familial hypertrophic cardiomyopathy, as is mom and mom's side. Mom is being evaluated for palpitations and inappropriate sinus tachycardia after your 2nd Covid 19 vax and again after the booster. No history of true myopericarditis. I imagine not population information, but is this myosin genetic abnormality "prone" to myocardial "irritation", and is there predictable problems for the child with the same genetic substrate abnormality?.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202200463173
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis, Pericarditis
Clinical narrative: A 14 year old and An 18 year old were hospitalized for myocarditis/pericarditis; A 14 year old and An 18 year old were hospitalized for myocarditis/pericarditis; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A 14 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERICARDITIS (hospitalization, medically significant), MYOCARDITIS (hospitalization, medically significant), outcome "recovered" and all described as "A 14 year old and An 18 year old were hospitalized for myocarditis/pericarditis".  Clinical course: Description of Event: A 14 year old and An 18 year old were hospitalized at (withheld) in (withheld) for myocarditis/pericarditis. After hospitalization, symptoms resolved. Event took place after use of product.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 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: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Swelling face, Urticaria
Clinical narrative: Severe allergic reaction; Full body hives; Face swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization, reaction(s): "no reaction to the 1st or 2nd dose of this vaccine"; Bnt162b2 (Dose: 2), for COVID-19 immunization, reaction(s): "no reaction to the 1st or 2nd dose of this vaccine". The following information was reported: HYPERSENSITIVITY (medically significant), outcome "unknown", described as "Severe allergic reaction"; URTICARIA (medically significant), outcome "unknown", described as "Full body hives"; SWELLING FACE (medically significant), outcome "unknown", described as "Face swelling". The events "severe allergic reaction", "full body hives" and "face swelling" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of hypersensitivity, urticaria, swelling face treated with multiple Epinephrine shots.  Clinical course: The patient have no known allergies and have no reaction to the 1st or 2nd dose of this vaccine. This random excessive allergic reaction has happened again requiring ER visits and EPI shots.  The lot number for bnt162b2 was not provided and will be requested during follow up.