chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Nausea, Vaccination site pain, Vaccination site swelling
Clinical narrative: day after the injection the patient was tired/down for the count that day; nausea; pain in her injection site arm; swelling in her injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), VACCINATION SITE PAIN (pain in her injection site arm), VACCINATION SITE SWELLING (swelling in her injection site arm) and FATIGUE (day after the injection the patient was tired/down for the count that day) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 031L20A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL [PARACETAMOL]) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced NAUSEA (nausea), VACCINATION SITE PAIN (pain in her injection site arm) and VACCINATION SITE SWELLING (swelling in her injection site arm). On 27-Feb-2021, the patient experienced FATIGUE (day after the injection the patient was tired/down for the count that day). At the time of the report, NAUSEA (nausea), VACCINATION SITE PAIN (pain in her injection site arm), VACCINATION SITE SWELLING (swelling in her injection site arm) and FATIGUE (day after the injection the patient was tired/down for the count that day) outcome was unknown.            The patient received her first vaccine in her left arm shoulder deltoid muscle and no adverse reactions reported.   The patient down for the count that day and the day after the injection on 26 Feb 2021.  No treatment information was reported.   This case was linked to MOD-2022-544226 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2022: Follow up contains no new information.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: day after the injection the patient was tired/down for the count that day; nausea; pain in her injection site arm; swelling in her injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), VACCINATION SITE PAIN (pain in her injection site arm), VACCINATION SITE SWELLING (swelling in her injection site arm) and FATIGUE (day after the injection the patient was tired/down for the count that day) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 031L20A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL [PARACETAMOL]) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced NAUSEA (nausea), VACCINATION SITE PAIN (pain in her injection site arm) and VACCINATION SITE SWELLING (swelling in her injection site arm). On 27-Feb-2021, the patient experienced FATIGUE (day after the injection the patient was tired/down for the count that day). At the time of the report, NAUSEA (nausea), VACCINATION SITE PAIN (pain in her injection site arm), VACCINATION SITE SWELLING (swelling in her injection site arm) and FATIGUE (day after the injection the patient was tired/down for the count that day) outcome was unknown.            The patient received her first vaccine in her left arm shoulder deltoid muscle and no adverse reactions reported.   The patient down for the count that day and the day after the injection on 26 Feb 2021.  No treatment information was reported.   This case was linked to MOD-2022-544226 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2022: Follow up contains no new information.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Nausea, Vaccination site pain, Vaccination site swelling
Clinical narrative: injection site arm was warm to the touch in the area from her shoulder to the elbow; left arm was very painful; left arm was  swollen from her shoulder on down to her elbow; headache; very tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site arm was warm to the touch in the area from her shoulder to the elbow), VACCINATION SITE PAIN (left arm was very painful), VACCINATION SITE SWELLING (left arm was  swollen from her shoulder on down to her elbow), HEADACHE (headache) and FATIGUE (very tired) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 030M20A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-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 25-Oct-2021, the patient experienced VACCINATION SITE WARMTH (injection site arm was warm to the touch in the area from her shoulder to the elbow), VACCINATION SITE PAIN (left arm was very painful), VACCINATION SITE SWELLING (left arm was  swollen from her shoulder on down to her elbow), HEADACHE (headache) and FATIGUE (very tired). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (injection site arm was warm to the touch in the area from her shoulder to the elbow), VACCINATION SITE PAIN (left arm was very painful), VACCINATION SITE SWELLING (left arm was  swollen from her shoulder on down to her elbow), HEADACHE (headache) and FATIGUE (very tired) was resolving.            No treatment medication information was provided.  It was reported that patient had no adverse event from the first vaccine.  The patient took tylenol and then slept. After that the patient felt better.   This case was linked to MOD-2022-544136 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2022: Follow-up appended: Reporter details updated
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: injection site arm was warm to the touch in the area from her shoulder to the elbow; left arm was very painful; left arm was  swollen from her shoulder on down to her elbow; headache; very tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site arm was warm to the touch in the area from her shoulder to the elbow), VACCINATION SITE PAIN (left arm was very painful), VACCINATION SITE SWELLING (left arm was  swollen from her shoulder on down to her elbow), HEADACHE (headache) and FATIGUE (very tired) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 030M20A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-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 25-Oct-2021, the patient experienced VACCINATION SITE WARMTH (injection site arm was warm to the touch in the area from her shoulder to the elbow), VACCINATION SITE PAIN (left arm was very painful), VACCINATION SITE SWELLING (left arm was  swollen from her shoulder on down to her elbow), HEADACHE (headache) and FATIGUE (very tired). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (injection site arm was warm to the touch in the area from her shoulder to the elbow), VACCINATION SITE PAIN (left arm was very painful), VACCINATION SITE SWELLING (left arm was  swollen from her shoulder on down to her elbow), HEADACHE (headache) and FATIGUE (very tired) was resolving.            No treatment medication information was provided.  It was reported that patient had no adverse event from the first vaccine.  The patient took tylenol and then slept. After that the patient felt better.   This case was linked to MOD-2022-544136 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2022: Follow-up appended: Reporter details updated
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Received a refreeze vaccine once thawed; Received a refreeze vaccine once thawed; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Received a refreeze vaccine once thawed) and PRODUCT STORAGE ERROR (Received a refreeze vaccine once thawed) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Apr-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Received a refreeze vaccine once thawed). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received a refreeze vaccine once thawed). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Received a refreeze vaccine once thawed) and PRODUCT STORAGE ERROR (Received a refreeze vaccine once thawed) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. Reportedly, a thawed shipment of vials of the Moderna COVID-19 vaccine were received. Once received, they placed the shipment on the refrigerator except for 1 vial, that was stored on the freezer. The vial was again thawed and then administered to 4 patients in the facility. The doses applied were 2 second boosters and 2 first boosters on the 16Apr2022. No temperature excursions was observed.  No treatment medication was provided.   This case was linked to MOD-2022-545266, MOD-2022-545272, MOD-2022-545269 (Patient Link).
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site irritation
Clinical narrative: Minor irritation in his injection site arm after each dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE IRRITATION (Minor irritation in his injection site arm after each dose) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 an unknown date, the patient experienced VACCINATION SITE IRRITATION (Minor irritation in his injection site arm after each dose). At the time of the report, VACCINATION SITE IRRITATION (Minor irritation in his injection site arm after each dose) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-546133, MOD-2022-546141 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2022: Non significant follow up received.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient may have received an expired vaccine for the 2nd booster; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient may have received an expired vaccine for the 2nd booster) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017S21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient may have received an expired vaccine for the 2nd booster). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient may have received an expired vaccine for the 2nd booster) outcome was unknown.            Patient was mentioned that there was another Lot number written in ink - 056A22A Expiration date 07Sep2022.  No Concomitant Medications were provided by the Reporter No Treatment Medications were provided by the Reporter   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2022: Live Followup received contains No new information
Sex: U
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: had anxiety reactions after receiving their Moderna Covid- 19 vaccinations; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (had anxiety reactions after receiving their Moderna Covid- 19 vaccinations) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANXIETY (had anxiety reactions after receiving their Moderna Covid- 19 vaccinations). At the time of the report, ANXIETY (had anxiety reactions after receiving their Moderna Covid- 19 vaccinations) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication were reported.  Reportedly no other adverse events were reported.  No treatment medication were reported.   This case was linked to MOD-2022-546513, MOD-2022-546517 (Patient Link).
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Daughter had minimal common side effects after the first dose.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Daughter had minimal common side effects after the first dose.) in a 22-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Daughter had minimal common side effects after the first dose.). At the time of the report, VACCINATION COMPLICATION (Daughter had minimal common side effects after the first dose.) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant product was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2022-546539, MOD-2022-546543 (Patient Link).   Reporter did not allow further contact
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Infection, Lymphadenopathy, Musculoskeletal stiffness, Oropharyngeal pain
Clinical narrative: Low grade infection for a month now; Sore throat; Really stiff neck; Gland swelling; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (Low grade infection for a month now), OROPHARYNGEAL PAIN (Sore throat), MUSCULOSKELETAL STIFFNESS (Really stiff neck) and LYMPHADENOPATHY (Gland swelling) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 040A21A and 003A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Allergic sinusitis, Heart disease, unspecified, Chronic lung disease, Renal failure chronic, Heart failure and Pain. Concomitant products included TADALAFIL (CIALIS) for Heart failure, OXYCODONE for Pain, LISINOPRIL, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), FUROSEMIDE (LASIX [FUROSEMIDE]) and POTASSIUM for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFECTION (Low grade infection for a month now), OROPHARYNGEAL PAIN (Sore throat), MUSCULOSKELETAL STIFFNESS (Really stiff neck) and LYMPHADENOPATHY (Gland swelling). At the time of the report, INFECTION (Low grade infection for a month now), OROPHARYNGEAL PAIN (Sore throat), MUSCULOSKELETAL STIFFNESS (Really stiff neck) and LYMPHADENOPATHY (Gland swelling) had not resolved.            Other concomitant medications included steroid nasal spray for sinus allergy.  Patient started having the reported events for a month now.  No treatment medication was provided.   This case was linked to MOD-2021-041085 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: My friend received the primary series of the Moderna Covid-19 vaccine.  My friend has a rash all over her body after receiving the vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of RASH (My friend received the primary series of the Moderna Covid-19 vaccine.  My friend has a rash all over her body after receiving the vaccine.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (My friend received the primary series of the Moderna Covid-19 vaccine.  My friend has a rash all over her body after receiving the vaccine.). At the time of the report, RASH (My friend received the primary series of the Moderna Covid-19 vaccine.  My friend has a rash all over her body after receiving the vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Drug details were reported.  No Treatment information was provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st and 2nd dose given 7 months apart; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st and 2nd dose given 7 months apart) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Breast implant user.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st and 2nd dose given 7 months apart). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st and 2nd dose given 7 months apart) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication was not reported. Treatment information was not provided.   This case was linked to MOD-2022-546553 (Patient Link).
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: Sweats/greasy oil sweats start halfway up head and drip down/getting worse and worse/starts 2 PM and lasts until morning; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweats/greasy oil sweats start halfway up head and drip down/getting worse and worse/starts 2 PM and lasts until morning) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Stent placement (Stent in heart). Concurrent medical conditions included Blood pressure abnormal. Concomitant products included CANDESARTAN for Blood pressure, ACETYLSALICYLIC ACID (BABY ASPIRIN) for Stent placement, ATORVASTATIN, METFORMIN, VITAMIN B12 [VITAMIN B12 NOS], VITAMIN D3, MULTIVITAMINS [VITAMINS NOS], FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced HYPERHIDROSIS (Sweats/greasy oil sweats start halfway up head and drip down/getting worse and worse/starts 2 PM and lasts until morning). The patient was treated with HYDROCORTISONE for Adverse event, at a dose of 25 milligram. At the time of the report, HYPERHIDROSIS (Sweats/greasy oil sweats start halfway up head and drip down/getting worse and worse/starts 2 PM and lasts until morning) had not resolved.            Patient started having a lot of trouble with sweats, greasy oily sweats that start halfway up the head and drips down. Its been getting worse and worse. It starts around 2 PM in the afternoon and lasts until the morning. The patient reports his regular physician has given up, his dermatologist has given up. He reports his HCP prescribed him Hydrocortisone HCL 25 mg, but it did not work much, so he stopped it.
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Expired product administered
Clinical narrative: Patient may have been administered an expired dose for the 2nd booster; Patient may have been administered an expired dose for the 2nd booster; This spontaneous case was reported by a consumer and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Patient may have been administered an expired dose for the 2nd booster) and EXPIRED PRODUCT ADMINISTERED (Patient may have been administered an expired dose for the 2nd booster) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2022, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Patient may have been administered an expired dose for the 2nd booster) and EXPIRED PRODUCT ADMINISTERED (Patient may have been administered an expired dose for the 2nd booster). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Patient may have been administered an expired dose for the 2nd booster) and EXPIRED PRODUCT ADMINISTERED (Patient may have been administered an expired dose for the 2nd booster) outcome was unknown.            No concomitant medication was provided.  It was reported that on 21-Apr-2022, the patient received the 2nd booster, and when patient's wife entered the Lot number in the online tool, the message was that the vaccine was expired, Lot number was read from the vaccination card: 017S21A, Expiration date: 27-Mar-2022, patient stated that this lot number was typed in computer like a medicine prescription. Then she mentioned that there was another Lot number written in ink: 056A22A Expiration date 07-Sep-2022.  No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2022: Follow-up includes no new information.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial initially stored in refrigerator on 23 Mar 2022, Vaccine beyond use date 17APR2022, Administration date was 20 Apr 2022; Past beyond use date Moderna Covid-19 vaccine given to 6 patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Past beyond use date Moderna Covid-19 vaccine given to 6 patients.) and PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 23 Mar 2022, Vaccine beyond use date 17APR2022, Administration date was 20 Apr 2022) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Past beyond use date Moderna Covid-19 vaccine given to 6 patients.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 23 Mar 2022, Vaccine beyond use date 17APR2022, Administration date was 20 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Past beyond use date Moderna Covid-19 vaccine given to 6 patients.) and PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 23 Mar 2022, Vaccine beyond use date 17APR2022, Administration date was 20 Apr 2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Vial was initially stored in the refrigerator on 23 Mar 2022. The beyond use date was 17 Apr 2022. Vial did not undergo any temperature excursion. No treatment information was provided.   This case was linked to MOD-2022-546559, MOD-2022-546563, MOD-2022-546567, MOD-2022-546561, MOD-2022-546566, MOD-2022-546561 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in refrigerator on 23 Mar 2022, beyong use date was 17 Apr 2022 and administered on 20 Apr 2022.; past beyond use date Moderna Covid-19 vaccine given to 6 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (past beyond use date Moderna Covid-19 vaccine given to 6 patients) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 23 Mar 2022, beyong use date was 17 Apr 2022 and administered on 20 Apr 2022.) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (past beyond use date Moderna Covid-19 vaccine given to 6 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 23 Mar 2022, beyong use date was 17 Apr 2022 and administered on 20 Apr 2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (past beyond use date Moderna Covid-19 vaccine given to 6 patients) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 23 Mar 2022, beyong use date was 17 Apr 2022 and administered on 20 Apr 2022.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. The vial was initially stored in the refrigerator on 23-Mar-2022. The vial did not undergo any temperature excursions. The vaccine's beyond use date was reported as 17-Apr-2022. No treatment medications were provided.   This case was linked to MOD-2022-546559, MOD-2022-546567, MOD-2022-546561, MOD-2022-546566, MOD-2022-546544 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine beyond use date 17APR2022; Past beyond use date Moderna Covid-19 vaccine given to 6 patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Past beyond use date Moderna Covid-19 vaccine given to 6 patients.) and PRODUCT STORAGE ERROR (Vaccine beyond use date 17APR2022) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Past beyond use date Moderna Covid-19 vaccine given to 6 patients.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine beyond use date 17APR2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Past beyond use date Moderna Covid-19 vaccine given to 6 patients.) and PRODUCT STORAGE ERROR (Vaccine beyond use date 17APR2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Vial was initially stored in the refrigerator on 23-MAR-2022. Vial did not undergo any temperature excursion.  No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2022-546559, MOD-2022-546563, MOD-2022-546567, MOD-2022-546561 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06 Apr 2022; Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06 Apr 2022) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included FLUTICASONE, FAMOTIDINE, ASA, LOSARTAN, ESCITALOPRAM, LORAZEPAM, MIRTAZAPINE, OMEPRAZOLE, MECLIZINE [MECLOZINE], CETIRIZINE, BENZONATATE, KETOTIFEN FUMARATE (ZADITOR), ATORVASTATIN, ESOMEPRAZOLE, SITAGLIPTIN PHOSPHATE (JANUVIA), GLIMEPIRIDE and METFORMIN for an unknown indication.    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 (Dose administered after 30-day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06 Apr 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had not tested positive within last month. The expiration date was 25 Mar 2022. The vaccine adminstration time was 09:35. Date and time the vial was initially stored in the refrigerator on 25 Feb 2022. No treatment medication information provided
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 18Jan2021 Dose 1 Lot # 026L20A Right arm,02Feb2021 Dose 2 Lot # 032L20A Right arm; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (18Jan2021 Dose 1 Lot # 026L20A Right arm,02Feb2021 Dose 2 Lot # 032L20A Right arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included CLL (Leukemia diagnosis goes back at least a year or two (but could not give specifics).), Hypercholesterolaemia and Blood pressure high (medicine). Concomitant products included ACALABRUTINIB (CALQUENCE) for CLL, ZINC and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (18Jan2021 Dose 1 Lot # 026L20A Right arm,02Feb2021 Dose 2 Lot # 032L20A Right arm). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (18Jan2021 Dose 1 Lot # 026L20A Right arm,02Feb2021 Dose 2 Lot # 032L20A Right arm) outcome was unknown.            Patient had no history of COVID. Concomitant medications included blood pressure medicine, high cholesterol medicine and Glameron. No treatment drug was reported.   This case was linked to MOD-2022-546508, MOD-2022-546680 (Patient Link).
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: product storage error; Doses administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (product storage error) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism and Drug allergy (Sulfur). Concomitant products included AMIODARONE, COLECALCIFEROL (VITAMIN D 3), FEXOFENADINE, ESOMEPRAZOLE, APIXABAN (ELIQUIS), PRAVASTATIN SODIUM (PRAVACHOL), MACROGOL 3350 (MIRALAX), FLUTICASONE, FAMOTIDINE and VITAMIN B12 [VITAMIN B12 NOS] for an unknown indication.    On 06-Apr-2022 at 3:02 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022 at 3:02 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (product storage error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not had COVID-19 preceding month of vaccination. On 25-FEB-2022 the vial was initially stored in the refrigerator. Vial didn't undergo any temperature excursions. It was reported that the patient did not experienced any side effects yet. No Treatment information was reported.   This case was linked to MOD-2022-545267 (Patient Link).
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient received a vaccine past the 30 day storage on the refrigerator; Dose administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 immunisation.     Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC), ASPIRIN [ACETYLSALICYLIC ACID], FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), LORATADINE, AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), ACYCLOVIR [ACICLOVIR] and SALBUTAMOL SULFATE (PROAIR HFA) for an unknown indication.    On 01-Apr-2022 at 9:18 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2022 at 9:18 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   COVID 19 test:: Negative within last month.  No Concomitant Products were reported. Date the vial was initially stored in the refrigerator: 25 Feb 2022. Expiration date of vaccine: 25 Mar 2022. Vial didn't undergo any temperature excursions. Patient not experienced any side effects yet. No Treatment information was reported.
Age: 73.0
Sex: F
Vaccine: TYP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: if a dose of expired TYPHIM Vi was administered would it still count as a valid dose(with no reported adverse event); Initial information received on 06-Apr-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves a 73 years old female patient to whom a dose of expired typhim vi was administered would it still count as a valid dose(with no reported adverse event) while receiving typhoid vi polysaccharide vaccine .  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included meningococcal vaccine a/c/y/w conj (tet tox) (Menquadfi) for Prophylactic vaccination.  On 22-Feb-2022, the patient received a 0.5 ml dose of suspect typhoid vi polysaccharide vaccine (unknown formulation and strength) (batch lot T1A671M,Expiry date : 17-feb-2022)via intramuscular route in the right deltoid for immunization.  On 22-FEB-2022 (latency :same day)the patient developed a non-serious event of expired typhim vi was administered would it still count as a valid dose(with no reported adverse event) (expired product administered) following the administration of typhoid vi polysaccharide vaccine.  Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the event .  At time of reporting, the outcome was Unknown for the event.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  related case- 01051939:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood test, Depressed level of consciousness, Dizziness, Electronystagmogram
Clinical narrative: Since receiving the vaccine, I have experienced continued dizziness and episodes of vertigo. Initially vertigo episodes were easily triggered and dizziness was not constant. Episodes triggered severe anxiety and panic attacks due to extreme dizziness and the sensation of losing consciousness. After 2 months dizziness was present at all times and I continued to have episodes of vertigo regularly. Commonly experiencing motion sickness. Symptoms have no subsided in the past 5 months. I have been prescribed meclazine and Flonase. I?ve had a MRI, it was ?immaculate?. I?ve had vestibular testing, negative. I am now referred to a neurologist and vestibular therapy. Was told there is a possibility of diagnosis of vestibular migraine.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging normal, Motion sickness, Panic attack, Vertigo, Vestibular function test normal
Clinical narrative: Since receiving the vaccine, I have experienced continued dizziness and episodes of vertigo. Initially vertigo episodes were easily triggered and dizziness was not constant. Episodes triggered severe anxiety and panic attacks due to extreme dizziness and the sensation of losing consciousness. After 2 months dizziness was present at all times and I continued to have episodes of vertigo regularly. Commonly experiencing motion sickness. Symptoms have no subsided in the past 5 months. I have been prescribed meclazine and Flonase. I?ve had a MRI, it was ?immaculate?. I?ve had vestibular testing, negative. I am now referred to a neurologist and vestibular therapy. Was told there is a possibility of diagnosis of vestibular migraine.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vitamin D decreased
Clinical narrative: Since receiving the vaccine, I have experienced continued dizziness and episodes of vertigo. Initially vertigo episodes were easily triggered and dizziness was not constant. Episodes triggered severe anxiety and panic attacks due to extreme dizziness and the sensation of losing consciousness. After 2 months dizziness was present at all times and I continued to have episodes of vertigo regularly. Commonly experiencing motion sickness. Symptoms have no subsided in the past 5 months. I have been prescribed meclazine and Flonase. I?ve had a MRI, it was ?immaculate?. I?ve had vestibular testing, negative. I am now referred to a neurologist and vestibular therapy. Was told there is a possibility of diagnosis of vestibular migraine.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Appetite disorder, Paraesthesia, Urinary incontinence
Clinical narrative: Pin and needles right side of scalp over ear and down neck in spine,3 days loss of bladder control 24 hrs. Uncontrolled appetite I?ve a month
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: Client presented at vaccination site on 12.09.21. Client reported she received first dose Pfizer COVID vaccine on 04/23/21 (lot #: EW0161) & received second dose Pfizer COVID vaccine on 05/14/21 (lot #: EW0177) both at Pharmacy. Client reported with first dose Pfizer COVID vaccine (4/23/21), she had headache, chill, fever, muscle ache, tiredness, fatigue, weakness, nausea but no vomiting within 30 minutes while driving home from vaccination site. She reported with second dose Pfizer COVID vaccine (5/14/21), she had headache, chill, fever, muscle ache, tiredness, fatigue, weakness, nausea but no vomiting within one hour. She reported with both dose the symptoms lasted for two days without taking any medications. She reported she didn?t follow-up with her PCP. Client denied SOB or dizziness with both doses. Client told she had Leukemia at the end of 2017 & beginning of 2018. Client stated she is in remission with leukemia and taking daily 420 Mg ?Imbruvica.? She told she has history of anxiety and controlled with homeopathic medications. She stated she ate breakfast at 0730 today and eating crackers, juice, and water provided by PHN at EMT station while waiting for medical consult. At 1250, PHN took her vitals: BP 114/70, HR 73, O2 Sat. 98%. Client is requesting for booster dose of Pfizer COVID vaccine today. PHN submitted a medical consult via text message to clinical project coordinator, requesting to proceed with the booster dose of Pfizer COVID vaccine. Per the doctor, approval to proceed with the booster dose of Pfizer COVID vaccine was obtained from medical consult team via text message from clinical project coordinator. Client received the booster dose of Pfizer COVID vaccine, LOT#:  FF8841 on 12/09/21 at 1309 by a nurse. The client did not report any symptoms during the 30-minute observation period. PHN educated client on possible adverse reactions and when to seek EMS. Client verbalized understanding. Client left vaccination site at 1339 unassisted and with a steady gait.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Client presented to the vaccination site on 12/02/2021 accompanied by his parent for his second dose Pfizer COVID vaccine. Today, the client received the second dose Pfizer COVID vaccine for 5 through 11 years of age (Lot #: FK5127 exp: 01/24/22) at 1040. LVN noted the client was 12 years old after administration of the second dose Pfizer COVID vaccine for 5 through 11 years of age. PHN provided education to client?s parent stating the client received the incorrect formulation of the Pfizer COVID vaccine after LVN notified PHN. PHN educated client?s parent and client on possible adverse reactions and when to seek medical care. The client denied any chronic conditions, current medications, or known allergies. PHN submitted a medical consult via text message to Clinical Project Coordinator requesting for guidance on how to proceed. PHN received recommendation from the doctor was received via text message from Clinical Project Coordinator. The doctor recommended against repeat vaccination today but stated in 21 days the client may receive a dose of Pfizer COVID vaccine for 12 years of age and older at the parent's request. PHN talked to the client's parent at the EMT station. PHN provided education regarding administration of the incorrect formulation of the Pfizer COVID vaccine and the recommendation from the doctor stating the client may receive a third dose of Pfizer COVID vaccine for 12 years of age and older in 21 days, and that client?s appointment is scheduled for 12/27/21. PHN provided education to the client's parent again regarding possible adverse reactions, and when to seek medical care. The client did not report any symptoms during the 30-minute observation period. The client left the vaccination site with his parent at 1110 ambulating unassisted with a steady gait.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AE; Nurse calling to report MMRII had been administered that expired on 3/36/2022 and asked about it's viability past expiration. No prior temperature excursions. Permission obtained to follow up with HCP. No additional AE. No PQC.; This spontaneous report has been received from a nurse, concerning a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies was unknown.  On 28-MAR-2022, the patient was vaccinated with one (1) dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live human recombinant albumin (rHA) (M-M-R II) as prophylaxis (lot number T010650 has been verified to be a valid lot, expiration date reported and stablished as 26-MAR-2022) (formulation, strength, exact dose, vaccination scheme, route of administration and anatomical location, lot number and expiration date were not provided) (expired product administered). No adverse events (AE) reported (no adverse event).