chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 21 patients administered with expired vaccines; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines). At the time of the report, EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in refrigerator on 17-FEB-2022 10:00 am The vial did not undergo any temperature excursion. No concomitant medication were provided No treatment details were provided  Upon follow up reporter stated analysis of the vials associated with storage excursion is completed.   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Follow up information was received on 11/Apr/2022: reporters comment added.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Urticaria
Clinical narrative: Woke up with hives at night; Had a slight case of bell's palsy; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Had a slight case of bell's palsy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048L21A, 076C2A, 011M20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BELL'S PALSY (Had a slight case of bell's palsy) (seriousness criterion medically significant). On 08-Apr-2022, the patient experienced URTICARIA (Woke up with hives at night). At the time of the report, BELL'S PALSY (Had a slight case of bell's palsy) and URTICARIA (Woke up with hives at night) outcome was unknown.            No treatment information was provided.  On 27-Oct-2021, patient received first booster shot.  On 07-Apr-2022, next day of second booster shot, patient had a slight case of bell's palsy. Patient woke up with hives at night on 08-Apr-2022.  Company Comment: This spontaneous case concerns a 71 year old female patient, with no reported medical history, who experienced expected, serious (medically significant) AESI Bell's Palsy one day after receiving a fourth dose (second booster) of mRNA-1273.  She also had non-serious urticaria one day later.  Subsequent clinical course, labs and treatment details were not reported.  The outcome of the events is unknown.  The benefit risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-538089 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 71 year old female patient, with no reported medical history, who experienced expected, serious (medically significant) AESI Bell's Palsy one day after receiving a fourth dose (second booster) of mRNA-1273.  She also had non-serious urticaria one day later.  Subsequent clinical course, labs and treatment details were not reported.  The outcome of the events is unknown.  The benefit risk relationship of mRNA-1273 is not affected by this report.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received Moderna COVID vaccine on 4/7/22 but its expiration date was 4/6/22; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna COVID vaccine on 4/7/22 but its expiration date was 4/6/22) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     The data was unknown whether the patient ever been diagnosed or tested positive for COVID-19. Acute illness at the time of vaccination and up to one month before was none.  Concurrent medical conditions included Penicillin allergy.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022 at 10:00 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna COVID vaccine on 4/7/22 but its expiration date was 4/6/22). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna COVID vaccine on 4/7/22 but its expiration date was 4/6/22) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Weight was reported as 218 with no units. Patient had no chronic illness. No concomitant medications were reported. No treatment medications were reported. No adverse reaction to the vaccine was reported.   This case was linked to MOD-2022-538543 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (COVID vaccine was administered on 07-Apr-2022 and expiration date was 06-Apr-2022) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination. Concomitant products included AMLODIPINE, ATORVASTATIN, LEVOTHYROXINE SODIUM (EUTHYROX), HYDROCHLOROTHIAZIDE and LISINOPRIL for an unknown indication. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022 at 8:40 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 07-Apr-2022 at 8:40 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (COVID vaccine was administered on 07-Apr-2022 and expiration date was 06-Apr-2022). On 07-Apr-2022 at 8:40 AM, EXPIRED PRODUCT ADMINISTERED (COVID vaccine was administered on 07-Apr-2022 and expiration date was 06-Apr-2022) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient's weight was reported as 196. Reporter stated that patient had no known allergies and it was unknown that the patient had been tested positive or diagnosed with COVID-19, had no acute illness at the time of vaccination and up to one month before and chronic or long standing health conditions information was unknown. It was unknown that the patient experienced similar event in the past and unknown for other potential causes for the event and Patient did not seek medical care for the event. Reporter also stated that no adverse reaction to the vaccine took place after administration. Treatment information was not provided by the reporter. This case was linked to MOD-2022-538544, MOD-2022-538516, MOD-2022-535445 (Patient Link).
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received Moderna COVID vaccine on 4/7/22. vaccine expiration date for lot 069H21A was 4/6/22.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna COVID vaccine on 4/7/22. vaccine expiration date for lot 069H21A was 4/6/22.) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     Concurrent medical conditions included Environmental allergy.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022 at 10:00 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 07-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna COVID vaccine on 4/7/22. vaccine expiration date for lot 069H21A was 4/6/22.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna COVID vaccine on 4/7/22. vaccine expiration date for lot 069H21A was 4/6/22.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient's weight was reported as 185. It was unknown if patient had been tested positive for or diagnosed with COVID-19. Patient had no chronic illness. No adverse reaction to the vaccine was reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vomiting
Clinical narrative: Itchy rash at vaccine site; Itchy rash at vaccine site; vomiting last night; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE RASH (Itchy rash at vaccine site), VOMITING (vomiting last night) and VACCINATION SITE PRURITUS (Itchy rash at vaccine site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2022, the patient experienced VOMITING (vomiting last night). On an unknown date, the patient experienced VACCINATION SITE RASH (Itchy rash at vaccine site) and VACCINATION SITE PRURITUS (Itchy rash at vaccine site). At the time of the report, VACCINATION SITE RASH (Itchy rash at vaccine site), VOMITING (vomiting last night) and VACCINATION SITE PRURITUS (Itchy rash at vaccine site) outcome was unknown.            No concomitant medication was reported. Patient reported she was going to leave to get cortisone cream.   This case was linked to MOD-2021-047879 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Nurse said she felt this way after the vaccine then got over it; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Nurse said she felt this way after the vaccine then got over it) 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 VACCINATION COMPLICATION (Nurse said she felt this way after the vaccine then got over it). At the time of the report, VACCINATION COMPLICATION (Nurse said she felt this way after the vaccine then got over it) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were mentioned. It was reported that patient felt this way after the vaccine and then got over it. No treatment details were reported.   This case was linked to MOD-2022-539079 (Patient Link).
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Dysstasia, Gait disturbance, Loss of consciousness
Clinical narrative: collapsed/From  toilet to his bed where he essentially collapsed; could not stand; couldn't walk; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (collapsed/From  toilet to his bed where he essentially collapsed), DYSSTASIA (could not stand) and GAIT DISTURBANCE (couldn't walk) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065K21A, 032F21A, 001A21A and 0011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Dementia and Walker user.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2022, the patient experienced LOSS OF CONSCIOUSNESS (collapsed/From  toilet to his bed where he essentially collapsed), DYSSTASIA (could not stand) and GAIT DISTURBANCE (couldn't walk). At the time of the report, LOSS OF CONSCIOUSNESS (collapsed/From  toilet to his bed where he essentially collapsed), DYSSTASIA (could not stand) and GAIT DISTURBANCE (couldn't walk) outcome was unknown.            The concomitant medication was not reported. The treatment medication was not reported. The patients wife reported that her husband received 4 doses of the Moderna covid19 vaccine by intramuscular injection. He had no problems after receiving the first three doses. He had a history of dementia and normally ambulates with a walker. Today as reported he was using the toilet, but could not stand from the toilet on his own. He normally was able to do this quickly, but it took him about 20 minutes to stand from the toilet today. He was eventually able to make it from the toilet to his bed where he essentially collapsed. This occurred about an hour ago as reported. He had not taken any medications or treatments for his symptoms. The contact had called his neurologist and PCP leaving messages. The patients wife was not concerned for stroke or heart attack at this time.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The dose administered today had expired on 6APR2022, 6 days ago.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The dose administered today had expired on 6APR2022, 6 days ago.) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The dose administered today had expired on 6APR2022, 6 days ago.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The dose administered today had expired on 6APR2022, 6 days ago.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the patient was immunocompromised. No reported symptoms. No additional doses, medications or treatments have been administered in response to this administration error. Concomitant medications were not reported. Treatment medications were not reported.   This case was linked to MOD-2022-538601 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Initial sore arm; Fever; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Initial sore arm), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Initial sore arm), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, PAIN IN EXTREMITY (Initial sore arm), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.            No concomitant medication information was reported. It was reported that patient was received second booster dose. No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2022: Follow-up received and contains no new information.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: A patient had been administered doses of the Moderna covid-19 vaccine on 8 APR 2021,9 DEC 2021; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A patient had been administered doses of the Moderna covid-19 vaccine on 8 APR 2021,9 DEC 2021) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A and 007B21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A patient had been administered doses of the Moderna covid-19 vaccine on 8 APR 2021,9 DEC 2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A patient had been administered doses of the Moderna covid-19 vaccine on 8 APR 2021,9 DEC 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were mentioned.  No treatment details were reported.  Patient did not reported any symptoms.   This case was linked to MOD-2022-538598 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 05-APR-2022 and Administered after 30-day Use By Date or after manufacturer date of expiry) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 05-APR-2022 and Administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 05-APR-2022 and Administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications was reported. Reporter reported that the administration of vaccine occurred from 6-Apr-2022 to 9-Apr-2022. Patient did not experience any adverse reactions after receiving the expired vaccine. The manufacturing date of the vial was 1-Dec-2021. Vial was initially placed in refrigerator on 5-Apr-2022. The product didn't undergo any temperature excursion issue. No treatment drug details was reported. This case was linked to MOD-2022-537580, MOD-2022-538672, MOD-2022-538673, MOD-2022-538675, MOD-2022-538676, MOD-2022-538677, MOD-2022-538678, MOD-2022-538681, MOD-2022-538682, MOD-2022-538689, MOD-2022-538691, MOD-2022-538692, MOD-2022-538693, MOD-2022-538697, MOD-2022-538698, MOD-2022-538701, MOD-2022-538702, MOD-2022-538689, MOD-2022-538672, MOD-2022-538676 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Follow up contains patient demographics.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Give first booster instead of a third dose to an immunocompromised patient; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Give first booster instead of a third dose to an immunocompromised patient) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (Give first booster instead of a third dose to an immunocompromised patient). At the time of the report, ACCIDENTAL UNDERDOSE (Give first booster instead of a third dose to an immunocompromised patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided. Patient did not had COVID positive test or diagnosis.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an expired dose) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016s21-29) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer, Pfizer and Pfizer. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer.    On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received an expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received an expired dose) outcome was unknown.            No concomitant medication information was provided.  It was reported that the patient had previously received 3 Pfizer vaccines and then received the second Moderna booster dose on 06-Apr-2022.  Further it was reported that the patient wanted to know how this would affect future vaccination and what was the efficacy of an expired vaccine.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2022: Follow up contains significant information: patient details (date of birth) updated, historical vaccine added.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Rash/ it' was horrible and hurt so bad; Itches so bad; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash/ "it's horrible and hurts so bad") and RASH PRURITIC (Itches so bad) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017821A, 0321A and 0321A) for COVID-19 vaccination.     The patient's past medical history included Brain operation (2 brain surgeries). Previously administered products included for Product used for unknown indication: Flu vaccine. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Stroke (strokes), Aneurysm, Blood pressure high, Seizures, Diabetes and Hip fracture (Broke her hip). Concomitant products included LINAGLIPTIN, METFORMIN HYDROCHLORIDE (JENTADUETO) for Diabetes, LACOSAMIDE (VIMPAT) for Seizures, MENADIONE (KAPPA), CLOPIDOGREL BISULFATE (PLAVIX), MONTELUKAST, AMLODIPINE, ROSUVASTATIN CALCIUM (CRESTOR) and ALENDRONATE SODIUM (ALENDRONATE) for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-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 RASH (Rash/ "it's horrible and hurts so bad") and RASH PRURITIC (Itches so bad). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH (Rash/ "it's horrible and hurts so bad") and RASH PRURITIC (Itches so bad) had not resolved.            The patient received her vaccines in both left and right deltoid muscle. The patient has no allergies, never tested positive for Covid-19. Treatment medications also included an unspecified lotion.   This case was linked to MOD-2022-538662, MOD-2022-538663 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Felt tired after getting the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt tired after getting the vaccine) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A22A) for COVID-19 vaccination.     The patient's past medical history included Stomach upset, Faint (Patient fainted in the past, due to vertigo.) and Vertigo. Concurrent medical conditions included Blood pressure high (15 years ago it started and patient did not know how her blood pressure was.). Concomitant products included AMLODIPINE, LISINOPRIL and ASPIRIN [ACETYLSALICYLIC ACID] for Blood pressure high, CYCLOBENZAPRINE for Muscle relaxation.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced FATIGUE (Felt tired after getting the vaccine). On 07-Mar-2021, FATIGUE (Felt tired after getting the vaccine) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had no allergy. Patient had not taken any other vaccine within 1 month. Patient had never tested positive for COVID-19.   This case was linked to MOD-2022-538656 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt tired) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 030A22A) for COVID-19 vaccination.     It was reported patient had no allergies to medications, food and other products and did not have COVID positive test or diagnosis. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  The patient's past medical history included Stomach discomfort (before getting the vaccine), Faint (patient fainted in the past, due to vertigo) and Vertigo (patient fainted in the past, due to vertigo). Concurrent medical conditions included Blood pressure high (15 years ago and patient did not knowhow was her blood pressure.). Concomitant products included AMLODIPINE, LISINOPRIL and ASPIRIN [ACETYLSALICYLIC ACID] for Blood pressure management, CYCLOBENZAPRINE for Muscle relaxation.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Felt tired). On 04-Apr-2021, FATIGUE (Felt tired) had resolved.            No treatment information was provided.   This case was linked to MOD-2022-538649, MOD-2022-538657 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Blood pressure measurement, Dizziness, Headache
Clinical narrative: nausea; patient felt like she was about to faint; headache; stomachache; patient felt very weak; patient felt like her blood pressure was low; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomachache), ASTHENIA (patient felt very weak), HYPOTENSION (patient felt like her blood pressure was low), NAUSEA (nausea) and DIZZINESS (patient felt like she was about to faint) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045L21A, 032B21A and 030A22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vertigo. Concurrent medical conditions included Blood pressure high (15 years ago) and Abdominal symptom NOS. Concomitant products included AMLODIPINE, LISINOPRIL and ASPIRIN [ACETYLSALICYLIC ACID] for Blood pressure high, CYCLOBENZAPRINE for Muscle relaxation.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022, the patient experienced ABDOMINAL PAIN UPPER (stomachache), ASTHENIA (patient felt very weak), HYPOTENSION (patient felt like her blood pressure was low), DIZZINESS (patient felt like she was about to faint) and HEADACHE (headache). On 08-Apr-2022, the patient experienced NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. On 08-Apr-2022, NAUSEA (nausea) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (stomachache), ASTHENIA (patient felt very weak), HYPOTENSION (patient felt like her blood pressure was low), DIZZINESS (patient felt like she was about to faint) and HEADACHE (headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2022, Blood pressure measurement: low (Low) blood pressure was low.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported no allergies, patient never had COVID  test or diagnosis and no Other vaccines given within 1 month prior to Moderna COVID-19 vaccine. The recent status of blood pressure was reported as not known  how her blood pressure. patient fainted in the past, due to vertigo. Patient reported that the symptoms worsened.   This case was linked to MOD-2022-538656, MOD-2022-538649 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Nausea
Clinical narrative: nausea; patient felt like she was about to faint; headache; stomachache; patient felt very weak; patient felt like her blood pressure was low; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomachache), ASTHENIA (patient felt very weak), HYPOTENSION (patient felt like her blood pressure was low), NAUSEA (nausea) and DIZZINESS (patient felt like she was about to faint) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045L21A, 032B21A and 030A22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vertigo. Concurrent medical conditions included Blood pressure high (15 years ago) and Abdominal symptom NOS. Concomitant products included AMLODIPINE, LISINOPRIL and ASPIRIN [ACETYLSALICYLIC ACID] for Blood pressure high, CYCLOBENZAPRINE for Muscle relaxation.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022, the patient experienced ABDOMINAL PAIN UPPER (stomachache), ASTHENIA (patient felt very weak), HYPOTENSION (patient felt like her blood pressure was low), DIZZINESS (patient felt like she was about to faint) and HEADACHE (headache). On 08-Apr-2022, the patient experienced NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. On 08-Apr-2022, NAUSEA (nausea) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (stomachache), ASTHENIA (patient felt very weak), HYPOTENSION (patient felt like her blood pressure was low), DIZZINESS (patient felt like she was about to faint) and HEADACHE (headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2022, Blood pressure measurement: low (Low) blood pressure was low.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported no allergies, patient never had COVID  test or diagnosis and no Other vaccines given within 1 month prior to Moderna COVID-19 vaccine. The recent status of blood pressure was reported as not known  how her blood pressure. patient fainted in the past, due to vertigo. Patient reported that the symptoms worsened.   This case was linked to MOD-2022-538656, MOD-2022-538649 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose given beyond use date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose given beyond use date) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 066k21a) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2022 at 10:30 AM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022 at 10:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose given beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose given beyond use date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.  No temperature excursions were reported. On 11-April-2022  at 10.30 AM was date and time vial was first punctured. It was reported that dose administered >12/24 hours post puncture. Vial was exposed to room temperature for 5 minutes.
Sex: F
Vaccine: COVID19
Symptoms: Chronic gastritis, Colitis, Eye disorder, Oesophageal achalasia, Pernicious anaemia
Clinical narrative: multiple autoimmune disease including AMAG with pernicious anemia; AMAG with pernicious anemia; aclasia; methocylic colitis; some eye disease; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC GASTRITIS (multiple autoimmune disease including AMAG with pernicious anemia), PERNICIOUS ANAEMIA (AMAG with pernicious anemia), OESOPHAGEAL ACHALASIA (aclasia), COLITIS (methocylic colitis) and EYE DISORDER (some eye disease) 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 first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHRONIC GASTRITIS (multiple autoimmune disease including AMAG with pernicious anemia), PERNICIOUS ANAEMIA (AMAG with pernicious anemia), OESOPHAGEAL ACHALASIA (aclasia), COLITIS (methocylic colitis) and EYE DISORDER (some eye disease). At the time of the report, CHRONIC GASTRITIS (multiple autoimmune disease including AMAG with pernicious anemia), PERNICIOUS ANAEMIA (AMAG with pernicious anemia), OESOPHAGEAL ACHALASIA (aclasia), COLITIS (methocylic colitis) and EYE DISORDER (some eye disease) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired Moderna vaccine administered to patient; Vaccine expired on 01 Apr 2022 and was stored in refrigerator on 05 Apr 2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine administered to patient) and PRODUCT STORAGE ERROR (Vaccine expired on 01 Apr 2022 and was stored in refrigerator on 05 Apr 2022) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine administered to patient) and PRODUCT STORAGE ERROR (Vaccine expired on 01 Apr 2022 and was stored in refrigerator on 05 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine administered to patient) and PRODUCT STORAGE ERROR (Vaccine expired on 01 Apr 2022 and was stored in refrigerator on 05 Apr 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter reported that the administration of vaccine occurred from 6 Apr 2022 to 9 Apr 2022. Patients have not reported any adverse reaction after the vaccination. The manufacturing date of the vial was 01 Dec 2021 Vial was initially placed in refrigerator on 5 Apr 2022. The product did not undergo any temperature excursion issue. No treatment drug information was reported.   This case was linked to MOD-2022-538614, MOD-2022-538673, MOD-2022-538675, MOD-2022-538676, MOD-2022-538677, MOD-2022-538678, MOD-2022-538681, MOD-2022-538682, MOD-2022-538688, MOD-2022-538688, MOD-2022-538691, MOD-2022-538692, MOD-2022-538693, MOD-2022-538696, MOD-2022-538697, MOD-2022-538698, MOD-2022-538701, MOD-2022-538702, MOD-2022-537580, MOD-2022-538688, MOD-2022-538614, MOD-2022-538698, MOD-2022-538689, MOD-2022-538701 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: expired Moderna vaccine administered to patients; Date the vial was expired on 01-APR-2022 and initially stored in the refrigerator: 05-APR-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (Date the vial was expired on 01-APR-2022 and initially stored in the refrigerator: 05-APR-2022) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (Date the vial was expired on 01-APR-2022 and initially stored in the refrigerator: 05-APR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (Date the vial was expired on 01-APR-2022 and initially stored in the refrigerator: 05-APR-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided.  Reporter reported that the administration of vaccine occurred from 6-Apr-2022 to 9-Apr-2022. Patients have not reported any adverse reaction after the vaccination. The manufacturing date of the vial was 1-Dec-2021. Vial was initially placed in refrigerator on 5-Apr-2022. The product didn't undergo any temperature excursion issue.  No treatment drug information was reported.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: expired dose of the Moderna COVID-19 vaccine was administered; expired vaccine was stored in refrigerator (vaccine expired on 01-Apr-2022 and stored in refrigerator on 05-Apr-2022); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose of the Moderna COVID-19 vaccine was administered) and PRODUCT STORAGE ERROR (expired vaccine was stored in refrigerator (vaccine expired on 01-Apr-2022 and stored in refrigerator on 05-Apr-2022)) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose of the Moderna COVID-19 vaccine was administered) and PRODUCT STORAGE ERROR (expired vaccine was stored in refrigerator (vaccine expired on 01-Apr-2022 and stored in refrigerator on 05-Apr-2022)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose of the Moderna COVID-19 vaccine was administered) and PRODUCT STORAGE ERROR (expired vaccine was stored in refrigerator (vaccine expired on 01-Apr-2022 and stored in refrigerator on 05-Apr-2022)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The reporter reported that they received Moderna COVID-19 vaccine vials with a manufacturing date of 01-Dec-2021 and an expiration date of 01-Apr-2022 (Lot: 026L21B). The reporter used Moderna's online expiration tool to confirm the expiration date.  The reporter reported that unknowingly, expired doses of the Moderna COVID-19 vaccine were administered to 20 patients from lot 026L21B. The administration occurred from 06-Apr-2022 to 09-Apr-2022. The vials were initially stored in the refrigerator was on 05-Apr-2022 and the vials did not undergo any temperature excursions.  The patient did not report any adverse reactions.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-537580, MOD-2022-538614, MOD-2022-538672, MOD-2022-538673, MOD-2022-538676, MOD-2022-538677, MOD-2022-538678, MOD-2022-538681, MOD-2022-538682, MOD-2022-538688, MOD-2022-538689, MOD-2022-538691, MOD-2022-538692, MOD-2022-538693, MOD-2022-538696, MOD-2022-538698, MOD-2022-538701, MOD-2022-538702, MOD-2022-538688, MOD-2022-538614, MOD-2022-538698, MOD-2022-538689, MOD-2022-538672, MOD-2022-538676, MOD-2022-538692 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired Moderna vaccine administered to patients; Vials were initially stored in the refrigerator on 05 Apr 2022 and Expiration date was on 01 Apr 2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (Vials were initially stored in the refrigerator on 05 Apr 2022 and Expiration date was on 01 Apr 2022) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (Vials were initially stored in the refrigerator on 05 Apr 2022 and Expiration date was on 01 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (Vials were initially stored in the refrigerator on 05 Apr 2022 and Expiration date was on 01 Apr 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 reported that the administration of vaccine occurred from 6 Apr 2022 to 9 Apr 2022. Patient had no adverse reaction after the vaccination. The manufacturing date of the vial was 01 Dec 2021. Vial was initially placed in refrigerator on 05 Apr 2022. The product did not undergo any temperature excursion issue.  No treatment medication was reported.   This case was linked to MOD-2022-537580, MOD-2022-538614, MOD-2022-538672, MOD-2022-538673, MOD-2022-538675, MOD-2022-538677, MOD-2022-538678, MOD-2022-538681, MOD-2022-538682, MOD-2022-538688, MOD-2022-538689, MOD-2022-538691, MOD-2022-538692, MOD-2022-538693, MOD-2022-538696, MOD-2022-538697, MOD-2022-538698, MOD-2022-538701, MOD-2022-538702, MOD-2022-538688, MOD-2022-538614, MOD-2022-538689, MOD-2022-538701, MOD-2022-538672 (Patient Link).