chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Secondary syphilis, Urticaria
Clinical narrative: Secondary syphilis; Spontaneous urticaria exacerbation; This literature-non-study case was reported in a literature article and describes the occurrence of SECONDARY SYPHILIS (Secondary syphilis) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE.    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, the patient experienced SECONDARY SYPHILIS (Secondary syphilis) (seriousness criterion medically significant) and URTICARIA (Spontaneous urticaria exacerbation). At the time of the report, SECONDARY SYPHILIS (Secondary syphilis) and URTICARIA (Spontaneous urticaria exacerbation) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered SECONDARY SYPHILIS (Secondary syphilis) and URTICARIA (Spontaneous urticaria exacerbation) to be related.    No Concomitant medication were reported  No Treatment information was reported  Company Comment:  This is a literature non-study case concerning young adult male patient of an unknown specific age with no medical history reported, who experienced the unexpected serious (medically significant) event of Secondary syphilis, which occurred after receiving the first dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. It was reported that the patient also noted appearance of a heterogeneous rash the day after mRNA-1273 vaccination and spontaneous urticaria exacerbation post mRNA-1273 vaccination. No further details about the diagnostic procedures and treatments were provided. Outcome of the events were unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a literature non-study case concerning young adult male patient of an unknown specific age with no medical history reported, who experienced the unexpected serious (medically significant) event of Secondary syphilis, which occurred after receiving the first dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. It was reported that the patient also noted appearance of a heterogeneous rash the day after mRNA-1273 vaccination and spontaneous urticaria exacerbation post mRNA-1273 vaccination. No further details about the diagnostic procedures and treatments were provided. Outcome of the events were unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient got COVID-19 three weeks ago; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Patient got COVID-19 three weeks ago) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (Patient got COVID-19 on 2020 and was hospitalized) in 2020. Concurrent medical conditions included Thyroid disorder (Thyroid issues).   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received 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 20-Jun-2022, the patient experienced COVID-19 (Patient got COVID-19 three weeks ago). At the time of the report, COVID-19 (Patient got COVID-19 three weeks ago) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jun-2022, SARS-CoV-2 test: Positive.         No concomitant medications were reported. The caller stated that she was calling on behalf of her son. who presumably received 1st, 2nd and 1st booster shot of Moderna COVID-19 Vaccine (caller did not know dates). also caller did not know for sure, but caller thought her son did not experienced any Adverse Events after any of the vaccines, but the patient got COVID-19 3 weeks ago. It was unknown if symptoms from COVID-19 were still ongoing by the time of reporting. No treatment information was provided.  Company comment: This spontaneous case concerns a 63 years old male patient with no relevant medical history, who experienced the unexpected non serious AESI event of Covid -19, which occurred unspecified days after a third dose (reported as booster)of mRNA-1273 vaccine. SARS-CoV-2 test is Positive. It is reported that patient got Covid-19 3 weeks ago. Current ongoing pandemia remains as confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 63 years old male patient with no relevant medical history, who experienced the unexpected non serious AESI event of Covid -19, which occurred unspecified days after a third dose (reported as booster)of mRNA-1273 vaccine. SARS-CoV-2 test is Positive. It is reported that patient got Covid-19 3 weeks ago. Current ongoing pandemia remains as confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Got tired with the first dose; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Got tired with the first dose) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cough (when she gets sick(non COVID)) and Bronchitis (when working in an office). Concomitant products included OXYMETAZOLINE HYDROCHLORIDE (ZICAM [OXYMETAZOLINE HYDROCHLORIDE]) and VITAMIN C [ASCORBIC ACID] for an unknown indication.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced FATIGUE (Got tired with the first dose). In 2021, FATIGUE (Got tired with the first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment  medications were reported.   This case was linked to MOD-2022-606222 (Patient Link).
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, SARS-CoV-2 test
Clinical narrative: patient received a Moderna vaccine that was open since the 8Jul2022; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received a Moderna vaccine that was open since the 8Jul2022) in a 45-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 059A22A and 059A22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 08-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 11-Jul-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 11-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received a Moderna vaccine that was open since the 8Jul2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received a Moderna vaccine that was open since the 8Jul2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-May-2022, SARS-CoV-2 test: Positive.     For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. The patient received a Moderna vaccine that was open since 08-Jul-2022, on the 11-Jul-2022. Treatment information was not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 10-Jun-2022 at 10:38 pm and the vaccine was administered on 11-Jul-2022; patient received Moderna COVID-19 vaccine 31 days after the vaccine was placed in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-Jun-2022 at 10:38 pm and the vaccine was administered on 11-Jul-2022) and EXPIRED PRODUCT ADMINISTERED (patient received Moderna COVID-19 vaccine 31 days after the vaccine was placed in the refrigerator) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014B22A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (primary series (first dose)), Pfizer (primary series (first booster dose)) and Pfizer (primary series (second dose)). Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer.    On 11-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received Moderna COVID-19 vaccine 31 days after the vaccine was placed in the refrigerator). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-Jun-2022 at 10:38 pm and the vaccine was administered on 11-Jul-2022). At the time of the report, PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-Jun-2022 at 10:38 pm and the vaccine was administered on 11-Jul-2022) and EXPIRED PRODUCT ADMINISTERED (patient received Moderna COVID-19 vaccine 31 days after the vaccine was placed in the refrigerator) 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 vial did not undergo any temperature excursions.  The patient did not report any other adverse reactions or side effects.  No treatment information was provided by the reporter.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: the vial was initially stored in the refrigerator on 10-JUN-2022 at 10:38PM, administration of vaccine on 11-JUL-2022; 4 patients  received Moderna Covid-19 vaccine 31 days after the vaccine was placed in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 patients  received Moderna Covid-19 vaccine 31 days after the vaccine was placed in the refrigerator) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 10-JUN-2022 at 10:38PM, administration of vaccine on 11-JUL-2022) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 patients  received Moderna Covid-19 vaccine 31 days after the vaccine was placed in the refrigerator). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 10-JUN-2022 at 10:38PM, administration of vaccine on 11-JUL-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 patients  received Moderna Covid-19 vaccine 31 days after the vaccine was placed in the refrigerator) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 10-JUN-2022 at 10:38PM, administration of vaccine on 11-JUL-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. The patient received vaccine past the 30 day use by date as her second booster dose. It was reported that the vial did not undergo any temperature excursions. The patient received the vaccine in left arm shoulder deltoid muscle and reports no other adverse reactions or side effects. No treatment drug was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-606358, US-MODERNATX, INC.-MOD-2022-606361 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-606358:Same reporter US-MODERNATX, INC.-MOD-2022-606361:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: Had blood pressure spikes; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HYPERTENSION (Had blood pressure spikes) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     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 HYPERTENSION (Had blood pressure spikes). At the time of the report, HYPERTENSION (Had blood pressure spikes) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication were reported. No treatment information were provided.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 10-Jun-2022 at 10:38 pm and the vaccine was administered on 11-Jul-2022; patient received Moderna Covid-19 vaccine  31 days after the vaccine was placed in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received Moderna Covid-19 vaccine  31 days after the vaccine was placed in the refrigerator) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-Jun-2022 at 10:38 pm and the vaccine was administered on 11-Jul-2022) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received Moderna Covid-19 vaccine  31 days after the vaccine was placed in the refrigerator). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-Jun-2022 at 10:38 pm and the vaccine was administered on 11-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received Moderna Covid-19 vaccine  31 days after the vaccine was placed in the refrigerator) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-Jun-2022 at 10:38 pm and the vaccine was administered on 11-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  On 11-Jul-2022, the patient received second booster dose.  Date the vial was initially stored in the refrigerator on 10-JUN-2022 at 10:38PM.The vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-606336, US-MODERNATX, INC.-MOD-2022-606349, US-MODERNATX, INC.-MOD-2022-606361 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-606336:Same reporter US-MODERNATX, INC.-MOD-2022-606349:Same reporter US-MODERNATX, INC.-MOD-2022-606361:Same reporter
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysgeusia, Immunisation reaction, Swollen tongue
Clinical narrative: had a little bit of a reaction to it; had a weird metal taste in her mouth which the metal taste continued for 2 weeks; some mild, minimal swelling under the tongue; dizziness; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (had a little bit of a reaction to it), DYSGEUSIA (had a weird metal taste in her mouth which the metal taste continued for 2 weeks), SWOLLEN TONGUE (some mild, minimal swelling under the tongue) and DIZZINESS (dizziness) in a 30-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 059A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Jun-2022, the patient experienced IMMUNISATION REACTION (had a little bit of a reaction to it), DYSGEUSIA (had a weird metal taste in her mouth which the metal taste continued for 2 weeks), SWOLLEN TONGUE (some mild, minimal swelling under the tongue) and DIZZINESS (dizziness). At the time of the report, IMMUNISATION REACTION (had a little bit of a reaction to it), SWOLLEN TONGUE (some mild, minimal swelling under the tongue) and DIZZINESS (dizziness) outcome was unknown and DYSGEUSIA (had a weird metal taste in her mouth which the metal taste continued for 2 weeks) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication reported. Patient reported that she was told to wait around longer at the vaccination facility for monitoring purpose and later gave her an antihistamine & something for dizziness.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient received Moderna Covid-19 vaccine 31 days after the vaccine was placed in the refrigerator on 10JUN2022; The patient received vaccine past the 30 day use by date as his second booster dose of the Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received vaccine past the 30 day use by date as his second booster dose of the Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (Patient received Moderna Covid-19 vaccine 31 days after the vaccine was placed in the refrigerator on 10JUN2022) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014B22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 11-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received vaccine past the 30 day use by date as his second booster dose of the Moderna Covid-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received Moderna Covid-19 vaccine 31 days after the vaccine was placed in the refrigerator on 10JUN2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received vaccine past the 30 day use by date as his second booster dose of the Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (Patient received Moderna Covid-19 vaccine 31 days after the vaccine was placed in the refrigerator on 10JUN2022) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Dosage text was reported as second booster dose.  Number of doses or vials were 4 doses. Date the vial was initially stored in the refrigerator was on 10-Jun-2022 at 10:38 PM. The vial did not underwent any temperature excursions.  The patient received the vaccine in his left arm shoulder deltoid muscle and reported no other adverse reactions or side effects.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-606358, US-MODERNATX, INC.-MOD-2022-606349, US-MODERNATX, INC.-MOD-2022-606336 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-606358:Same reporter US-MODERNATX, INC.-MOD-2022-606349:Same reporter US-MODERNATX, INC.-MOD-2022-606336:Same reporter
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Product use issue
Clinical narrative: From the 18 and up vials; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT USE ISSUE (From the 18 and up vials) in a 2-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 037A22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jul-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .25 milligram. On 11-Jul-2022, the patient experienced PRODUCT USE ISSUE (From the 18 and up vials). At the time of the report, PRODUCT USE ISSUE (From the 18 and up vials) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. The vaccine was given from the vial with a red cap and light blue label border No treatment information was provided by the reporter.
Age: 5.0
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, Incorrect dose administered, Product preparation error
Clinical narrative: Vaccine with 0.2 mL dose was administered to 1 child that was 5 years and 2 months; Vaccine with 0.2 mL dose was administered to 1 child that was 5 years and 2 months; The vaccine was administered after being diluted by the Pfizer COVID-19 vaccine diluent, 2.2 mL of 0.9% sodium chloride (normal saline, preservative free) of the diluent used for Pfizer COVID-19 vaccine into the bottle of magenta border Moderna; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (Vaccine with 0.2 mL dose was administered to 1 child that was 5 years and 2 months), ACCIDENTAL UNDERDOSE (Vaccine with 0.2 mL dose was administered to 1 child that was 5 years and 2 months) and PRODUCT PREPARATION ERROR (The vaccine was administered after being diluted by the Pfizer COVID-19 vaccine diluent, 2.2 mL of 0.9% sodium chloride (normal saline, preservative free) of the diluent used for Pfizer COVID-19 vaccine into the bottle of magenta border Moderna) in a 5-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .2 milliliter. 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 INCORRECT DOSE ADMINISTERED (Vaccine with 0.2 mL dose was administered to 1 child that was 5 years and 2 months), ACCIDENTAL UNDERDOSE (Vaccine with 0.2 mL dose was administered to 1 child that was 5 years and 2 months) and PRODUCT PREPARATION ERROR (The vaccine was administered after being diluted by the Pfizer COVID-19 vaccine diluent, 2.2 mL of 0.9% sodium chloride (normal saline, preservative free) of the diluent used for Pfizer COVID-19 vaccine into the bottle of magenta border Moderna). At the time of the report, INCORRECT DOSE ADMINISTERED (Vaccine with 0.2 mL dose was administered to 1 child that was 5 years and 2 months), ACCIDENTAL UNDERDOSE (Vaccine with 0.2 mL dose was administered to 1 child that was 5 years and 2 months) and PRODUCT PREPARATION ERROR (The vaccine was administered after being diluted by the Pfizer COVID-19 vaccine diluent, 2.2 mL of 0.9% sodium chloride (normal saline, preservative free) of the diluent used for Pfizer COVID-19 vaccine into the bottle of magenta border Moderna) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was 5 years and 2 months old. No concomitant medications were provided by the reporter. The parents stated no side effects or adverse reactions post vaccination. No treatment medications were provided by the reporter.   This case was linked to MOD-2022-604280 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine had expired on 02-Jul-2022 and it was refrigerated on 07-Jul-2022; Vaccine had expired on 02-Jul-2022 and it was administered on 07-Jul-2022.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine had expired on 02-Jul-2022 and it was administered on 07-Jul-2022.) and PRODUCT STORAGE ERROR (Vaccine had expired on 02-Jul-2022 and it was refrigerated on 07-Jul-2022) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027l21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine had expired on 02-Jul-2022 and it was administered on 07-Jul-2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine had expired on 02-Jul-2022 and it was refrigerated on 07-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine had expired on 02-Jul-2022 and it was administered on 07-Jul-2022.) and PRODUCT STORAGE ERROR (Vaccine had expired on 02-Jul-2022 and it was refrigerated on 07-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  On 07-Jul-2022, the vial was initially stored in the refrigerator. Patient received second booster shot.  The vial did not undergo any temperature excursions.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-606413 (Patient Link).
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, SARS-CoV-2 test
Clinical narrative: They gave a third dose of 0.5ml, instead of a booster dose to a patient; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (They gave a third dose of 0.5ml, instead of a booster dose to a patient) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B22A, 039B21A and 022c21a) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 on 26-May-2022. Concomitant products included LISINOPRIL for an unknown indication.   On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 11-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (They gave a third dose of 0.5ml, instead of a booster dose to a patient). At the time of the report, ACCIDENTAL OVERDOSE (They gave a third dose of 0.5ml, instead of a booster dose to a patient) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2022, SARS-CoV-2 test: (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient's height was reported as 5 feet 10 inches. No treatment details were reported. AE did not caused the patient to seek medical care. Patient had never experienced the similar event in the past.   This case was linked to MOD-2022-606454 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Influenza like illness, Myalgia
Clinical narrative: First dose on 20-March-2021 and Second dose on 17-Sep-2021; Flu like symptoms; Headache; Body ache; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Headache), MYALGIA (Body ache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 20-March-2021 and Second dose on 17-Sep-2021) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 04382H and 237192B) for COVID-19 prophylaxis.     Concurrent medical conditions included Multiple sclerosis. Concomitant products included OCRELIZUMAB (OCREVUS) for Multiple sclerosis.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 20-March-2021 and Second dose on 17-Sep-2021). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Headache) and MYALGIA (Body ache). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Headache) and MYALGIA (Body ache) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 20-March-2021 and Second dose on 17-Sep-2021) outcome was unknown.            Patient reported that after a day of receiving vaccines she experienced flu like symptoms including headache and body ache and it was resolved after a day.   No treatment information was provided by the reporter.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine had expired on 02-Jul-2022 and it was refrigerated on 07-Jul-2022; Vaccine had expired on 02-Jul-2022 and it was administered on 07-Jul-2022.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine had expired on 02-Jul-2022 and it was administered on 07-Jul-2022.) and PRODUCT STORAGE ERROR (Vaccine had expired on 02-Jul-2022 and it was refrigerated on 07-Jul-2022) in a 45-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 027l21a) for COVID-19 prophylaxis. No Medical History information was reported.    On 07-Jul-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine had expired on 02-Jul-2022 and it was administered on 07-Jul-2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine had expired on 02-Jul-2022 and it was refrigerated on 07-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine had expired on 02-Jul-2022 and it was administered on 07-Jul-2022.) and PRODUCT STORAGE ERROR (Vaccine had expired on 02-Jul-2022 and it was refrigerated on 07-Jul-2022) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. On 07-Jul-2022, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. The patient received 2nd dose, which had expired on 02-Jul-2022. Treatment information was not provided.   This case was linked to MOD-2022-606376 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin discolouration
Clinical narrative: Both arms from her elbows down to the hands like a golden color/different spots in both arms/As the days went by (spots) appeared on her chest and legs/little brown spots that sometimes are darker and shaped like a state/scattered all over; Sometimes a little bit of itching, but they are not painful; This spontaneous case was reported by a patient and describes the occurrence of SKIN DISCOLOURATION (Both arms from her elbows down to the hands like a golden color/different spots in both arms/As the days went by (spots) appeared on her chest and legs/little brown spots that sometimes are darker and shaped like a state/scattered all over) and PRURITUS (Sometimes a little bit of itching, but they are not painful) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A and 011F21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022, the patient experienced SKIN DISCOLOURATION (Both arms from her elbows down to the hands like a golden color/different spots in both arms/As the days went by (spots) appeared on her chest and legs/little brown spots that sometimes are darker and shaped like a state/scattered all over). In May 2022, the patient experienced PRURITUS (Sometimes a little bit of itching, but they are not painful). At the time of the report, SKIN DISCOLOURATION (Both arms from her elbows down to the hands like a golden color/different spots in both arms/As the days went by (spots) appeared on her chest and legs/little brown spots that sometimes are darker and shaped like a state/scattered all over) and PRURITUS (Sometimes a little bit of itching, but they are not painful) had not resolved.            Patient had chronic medication but declined to provide the list. No treatment information were provided.
Age: 1.25
Sex: M
Vaccine: COVID19
Symptoms: Product use issue
Clinical narrative: Patient was given injection from the presentation of the vaccine with a red cap and light blue label border; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT USE ISSUE (Patient was given injection from the presentation of the vaccine with a red cap and light blue label border) in a 15-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 11-Jul-2022, the patient experienced PRODUCT USE ISSUE (Patient was given injection from the presentation of the vaccine with a red cap and light blue label border). At the time of the report, PRODUCT USE ISSUE (Patient was given injection from the presentation of the vaccine with a red cap and light blue label border) 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 did not experience any symptoms.   No additional doses, concomitant medications, or treatment medications had been administered.
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Patient stated she is considered legally blinded; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (Patient stated she is considered legally blinded) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In August 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced VISUAL IMPAIRMENT (Patient stated she is considered legally blinded). At the time of the report, VISUAL IMPAIRMENT (Patient stated she is considered legally blinded) outcome was unknown.            No concomitant medication was provided. No treatment medication were provided. It was reported that patient had no allergic history. Patient had never test or diagnosis of COVID. No other vaccines was received by the patient within 1 month prior to Moderna COVID-19 vaccine.  It was reported that patient visited different doctors after this symptom began and patient made a lot of medical tests but patient did not had any autoimmune diseases. Some doctors told patient that it may be caused by meningitis, or due to COVID-19. Patient was afraid that her health will get worse.   Reporter did not allow further contact
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dysphagia, Lip swelling, Papule, Swelling
Clinical narrative: lip swelling/lip swelling is bad on the left side of his lip; tongue swelling/. Patient has difficulty swallowing due to his tongue swelling/swelling is constant but varies in severity which is intermitent.; neck swelling; scattered red papules that itch severely on his back and arms; Patient has difficulty swallowing due to his tongue swelling.; facial swelling; cough due to the swelling of his tongue.; This spontaneous case was reported by a nurse and describes the occurrence of LIP SWELLING (lip swelling/lip swelling is bad on the left side of his lip), SWOLLEN TONGUE (tongue swelling/. Patient has difficulty swallowing due to his tongue swelling/swelling is constant but varies in severity which is intermitent.), SWELLING (neck swelling), PAPULE (scattered red papules that itch severely on his back and arms) and DYSPHAGIA (Patient has difficulty swallowing due to his tongue swelling.) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005M21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 vaccination: Johnson and Johnson vaccine (primary series). Past adverse reactions to the above products included No adverse event with Johnson and Johnson vaccine.    On 17-May-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022, the patient experienced LIP SWELLING (lip swelling/lip swelling is bad on the left side of his lip), SWOLLEN TONGUE (tongue swelling/. Patient has difficulty swallowing due to his tongue swelling/swelling is constant but varies in severity which is intermitent.), SWELLING (neck swelling), PAPULE (scattered red papules that itch severely on his back and arms), DYSPHAGIA (Patient has difficulty swallowing due to his tongue swelling.), SWELLING FACE (facial swelling) and COUGH (cough due to the swelling of his tongue.). At the time of the report, LIP SWELLING (lip swelling/lip swelling is bad on the left side of his lip), SWOLLEN TONGUE (tongue swelling/. Patient has difficulty swallowing due to his tongue swelling/swelling is constant but varies in severity which is intermitent.), SWELLING (neck swelling), PAPULE (scattered red papules that itch severely on his back and arms), DYSPHAGIA (Patient has difficulty swallowing due to his tongue swelling.), SWELLING FACE (facial swelling) and COUGH (cough due to the swelling of his tongue.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The patient received the Moderna Covid-19 vaccine on 17-May-2022 for his booster dose of Covid-19 vaccine. Patient had experienced several side effects shortly after receiving his Moderna Covid-19 vaccine booster dose. It was reported that patient swelling was constant but varies in severity which was intermittent. No treatment medication was reported.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling face, Swollen tongue
Clinical narrative: lip swelling/lip swelling is bad on the left side of his lip; tongue swelling/. Patient has difficulty swallowing due to his tongue swelling/swelling is constant but varies in severity which is intermitent.; neck swelling; scattered red papules that itch severely on his back and arms; Patient has difficulty swallowing due to his tongue swelling.; facial swelling; cough due to the swelling of his tongue.; This spontaneous case was reported by a nurse and describes the occurrence of LIP SWELLING (lip swelling/lip swelling is bad on the left side of his lip), SWOLLEN TONGUE (tongue swelling/. Patient has difficulty swallowing due to his tongue swelling/swelling is constant but varies in severity which is intermitent.), SWELLING (neck swelling), PAPULE (scattered red papules that itch severely on his back and arms) and DYSPHAGIA (Patient has difficulty swallowing due to his tongue swelling.) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005M21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 vaccination: Johnson and Johnson vaccine (primary series). Past adverse reactions to the above products included No adverse event with Johnson and Johnson vaccine.    On 17-May-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022, the patient experienced LIP SWELLING (lip swelling/lip swelling is bad on the left side of his lip), SWOLLEN TONGUE (tongue swelling/. Patient has difficulty swallowing due to his tongue swelling/swelling is constant but varies in severity which is intermitent.), SWELLING (neck swelling), PAPULE (scattered red papules that itch severely on his back and arms), DYSPHAGIA (Patient has difficulty swallowing due to his tongue swelling.), SWELLING FACE (facial swelling) and COUGH (cough due to the swelling of his tongue.). At the time of the report, LIP SWELLING (lip swelling/lip swelling is bad on the left side of his lip), SWOLLEN TONGUE (tongue swelling/. Patient has difficulty swallowing due to his tongue swelling/swelling is constant but varies in severity which is intermitent.), SWELLING (neck swelling), PAPULE (scattered red papules that itch severely on his back and arms), DYSPHAGIA (Patient has difficulty swallowing due to his tongue swelling.), SWELLING FACE (facial swelling) and COUGH (cough due to the swelling of his tongue.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The patient received the Moderna Covid-19 vaccine on 17-May-2022 for his booster dose of Covid-19 vaccine. Patient had experienced several side effects shortly after receiving his Moderna Covid-19 vaccine booster dose. It was reported that patient swelling was constant but varies in severity which was intermittent. No treatment medication was reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Got COVID Disease 8 months  after first booster; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Got COVID Disease 8 months  after first booster) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-Feb-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 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jun-2022, the patient experienced COVID-19 (Got COVID Disease 8 months  after first booster). At the time of the report, COVID-19 (Got COVID Disease 8 months  after first booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jun-2022, SARS-CoV-2 test: (Positive) Positive home COVID test.         No concomitant medications reported.  On 21JUN2022, Patient visited the urgent care and received Monoclonal antibody treatment.  Company comment: This is a regulatory authority case concerning a 69-year-old female  patient with no reported medical history, who experienced the serious unexpected event of COVID-19 (AESI), approximately8  months after receiving the third dose of mRNA-1273 vaccine.  SARS-CoV-2 test was performed with positive result and patient received Monoclonal antibody treatment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-606307 (Patient Link).; Sender's Comments: Company comment: This is a regulatory authority case concerning a 69-year-old female  patient with no reported medical history, who experienced the serious unexpected event of COVID-19 (AESI), approximately8  months after receiving the third dose of mRNA-1273 vaccine.  SARS-CoV-2 test was performed with positive result and patient received Monoclonal antibody treatment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: circular rash on leg at the administration site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE RASH (circular rash on leg at the administration site) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jul-2022, the patient experienced VACCINATION SITE RASH (circular rash on leg at the administration site). At the time of the report, VACCINATION SITE RASH (circular rash on leg at the administration site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was soft and non-painful. On 11 July 2022, the rash was almost resolved. Treatment medications were not reported.