chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Eye swelling, Lip swelling, Pain
Clinical narrative: FEELING ACHY; EYES SWELLED SHUT; LIPS SWELLED; FACE HAD TURNED BRIGHT RED; FACE SWELLED TWICE ITS NORMAL SIZE; CHILLS; FEVER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A expiry: UNKNOWN) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-SEP-2021, the patient experienced feeling achy. On 25-SEP-2021, the patient experienced eyes swelled shut. On 25-SEP-2021, the patient experienced lips swelled. On 25-SEP-2021, the patient experienced face had turned bright red. On 25-SEP-2021, the patient experienced face swelled twice its normal size. On 25-SEP-2021, the patient experienced chills. On 25-SEP-2021, the patient experienced fever. Treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling achy, chills, fever, eyes swelled shut, lips swelled, face had turned bright red and face swelled twice its normal size was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling face
Clinical narrative: FEELING ACHY; EYES SWELLED SHUT; LIPS SWELLED; FACE HAD TURNED BRIGHT RED; FACE SWELLED TWICE ITS NORMAL SIZE; CHILLS; FEVER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A expiry: UNKNOWN) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-SEP-2021, the patient experienced feeling achy. On 25-SEP-2021, the patient experienced eyes swelled shut. On 25-SEP-2021, the patient experienced lips swelled. On 25-SEP-2021, the patient experienced face had turned bright red. On 25-SEP-2021, the patient experienced face swelled twice its normal size. On 25-SEP-2021, the patient experienced chills. On 25-SEP-2021, the patient experienced fever. Treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling achy, chills, fever, eyes swelled shut, lips swelled, face had turned bright red and face swelled twice its normal size was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: ALL OVER PAIN FOR A COUPLE OF WEEKS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced all over pain for a couple of weeks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from all over pain for a couple of weeks. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE 6 DAYS AFTER EXPIRATION DAY; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 27-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-SEP-2021, the patient experienced administration of expired vaccine 6 days after expiration day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine 6 days after expiration day was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 27-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned an adult of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 026A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of expired vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Off label use
Clinical narrative: INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; OFF LABEL USE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced inappropriate schedule of vaccine administered, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the inappropriate schedule of vaccine administered and off label use was not reported. This report was non-serious. This report was associated with product quality complaint: 90000195046.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: lost sense of taste; lost sense of smell; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (lost sense of taste) and ANOSMIA (lost sense of smell) 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 AGEUSIA (lost sense of taste) and ANOSMIA (lost sense of smell). At the time of the report, AGEUSIA (lost sense of taste) and ANOSMIA (lost sense of smell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was provided by the reporter. No concomitant medication was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Follow up received and contains non significant information.; Sender's Comments: This case concerns a female patient of an unknown age with no relevant medical history, who experienced the unexpected non-serious events of anosmia and ageusia. The events occurred at an unknown date after the first dose of Spikevax. The rechallenge was unknown as the events happened after the first dose and no information about the second dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Glycosylated haemoglobin, Glycosylated haemoglobin increased
Clinical narrative: Elevated A1C level; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Jul-2021. The most recent information was received on 21-Sep-2021 and was forwarded to Moderna on 22-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of GLYCOSYLATED HAEMOGLOBIN INCREASED (Elevated A1C level) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GLYCOSYLATED HAEMOGLOBIN INCREASED (Elevated A1C level). At the time of the report, GLYCOSYLATED HAEMOGLOBIN INCREASED (Elevated A1C level) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Glycosylated haemoglobin: 8.2 (High) 8.2 and 9.4 (High) 9.4.         Concomitant medications were not provided. Treatment information was not reported. It was reported that for the last 7 years, the patient had maintained an A1C average from 6.5 to 6.9. The patient asked if there was a problem with high A1C reported after having the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Follow-up information received on 22SEP2021and updated narrative.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: had a resting racing heart over 130 most nights since my vaccinations; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (had a resting racing heart over 130 most nights since my vaccinations) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 043B214) for COVID-19 vaccination.     Concurrent medical conditions included Grass allergy, Hypothyroidism since 2006, Allergy to plants, Allergic to cats, Allergy to molds and Dust allergy.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (had a resting racing heart over 130 most nights since my vaccinations). The patient was treated with THYROID (ARMOUR THYROID) at a dose of 1 mg. At the time of the report, HEART RATE INCREASED (had a resting racing heart over 130 most nights since my vaccinations) outcome was unknown.            No Concomitant medications was reported  Nightly around 9 pm patient experienced a resting rapid heart rate of 110-130 for about 10 min. This happened probably 5 of 7 nights.   Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: added: reporters information, patient details updated, medical history, lot/batch number, start date  of suspected dose
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported by reporter.  Concomitant products included VALSARTAN (DIOVAN) and OXITRIPTAN (5 HTP [OXITRIPTAN]) for an unknown indication.    On 10-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced VERTIGO (Vertigo). At the time of the report, VERTIGO (Vertigo) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication were not reported.  The Vertigo that patient had was gone within 2 and half weeks. It could be a condition due to DM. The vaccine is working perfectly.   Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Follow-up received on 21-Sep-2021 contains significant info. event outcome for vertigo reported as resolved.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Insomnia, Nausea
Clinical narrative: Says she tried to get up and her "legs either got weak or legs stopped working"; Felt like she fainted/around 4AM she woke up and was "sitting on toilet and out of clear blue, got a wave of dizziness and; could not sleep; after the 2nd dose she felt tired by bedtime; nausea that hit me like ton of bricks"; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Says she tried to get up and her "legs either got weak or legs stopped working"), DIZZINESS (Felt like she fainted/around 4AM she woke up and was "sitting on toilet and out of clear blue, got a wave of dizziness and), INSOMNIA (could not sleep), FATIGUE (after the 2nd dose she felt tired by bedtime) and NAUSEA (nausea that hit me like ton of bricks") in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 038A21A) for COVID-19 vaccination.     No medical history provided by the reporter.  Concomitant products included METOPROLOL for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Says she tried to get up and her "legs either got weak or legs stopped working"), DIZZINESS (Felt like she fainted/around 4AM she woke up and was "sitting on toilet and out of clear blue, got a wave of dizziness and), INSOMNIA (could not sleep), FATIGUE (after the 2nd dose she felt tired by bedtime) and NAUSEA (nausea that hit me like ton of bricks"). At the time of the report, ASTHENIA (Says she tried to get up and her "legs either got weak or legs stopped working"), DIZZINESS (Felt like she fainted/around 4AM she woke up and was "sitting on toilet and out of clear blue, got a wave of dizziness and), INSOMNIA (could not sleep), FATIGUE (after the 2nd dose she felt tired by bedtime) and NAUSEA (nausea that hit me like ton of bricks") had resolved.            The concomitant medicines also include turmeric, proton pump inhibitor, Statins at night, supplements(not specified)   This case was linked to MOD-2021-273346, MOD-2021-125560 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: AE outcome updates as Resolved. On 22-Sep-2021: Follow up
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 08-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine). On 08-Sep-2021, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD-2021-314567, MOD-2021-314793, MOD-2021-314468, MOD-2021-314545, MOD-2021-314540, MOD-2021-314570, MOD-2021-314517, MOD21-141641, MOD21-141642, MOD-2021-314555, MOD-2021-314573, MOD-2021-314805, MOD-2021-314810, MOD-2021-314573 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Follow-up information included no new information On 15-Sep-2021: Follow up information contains no new information.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 15 year old received 1st dose of Moderna COVID-19 vaccination; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old received 1st dose of Moderna COVID-19 vaccination) in a 15-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003F21A) for COVID-19 vaccination.     Concomitant products included FLUTICASONE for an unknown indication.    On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old received 1st dose of Moderna COVID-19 vaccination). On 23-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old received 1st dose of Moderna COVID-19 vaccination) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: Fever; Pain at injection site; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), VACCINATION SITE PAIN (Pain at injection site) and PAIN IN EXTREMITY (Pain in arm) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced PYREXIA (Fever). In April 2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site) and PAIN IN EXTREMITY (Pain in arm). In April 2021, VACCINATION SITE PAIN (Pain at injection site) and PAIN IN EXTREMITY (Pain in arm) had resolved. On 23-Apr-2021, PYREXIA (Fever) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PYREXIA (Fever) to be possibly related. No further causality assessments were provided for VACCINATION SITE PAIN (Pain at injection site) and PAIN IN EXTREMITY (Pain in arm).    Concomitant product use was unknown by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-246782.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Pfizer-Moderna Interacction; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Pfizer-Moderna Interacction) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) 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, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Pfizer-Moderna Interacction). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Pfizer-Moderna Interacction) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: Sore arm; He did have a temperature; first vaccine to underage patient on 16/Aug/2021; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PYREXIA (He did have a temperature) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first vaccine to underage patient on 16/Aug/2021) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C219) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PYREXIA (He did have a temperature) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first vaccine to underage patient on 16/Aug/2021). On 16-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first vaccine to underage patient on 16/Aug/2021) had resolved. On 18-Aug-2021, PAIN IN EXTREMITY (Sore arm) and PYREXIA (He did have a temperature) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Aug-2021, Body temperature: increased (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment  medications were provided.  It was reported that patient went to get the second dose on 17-SEP-2021 but did not get the second dose because  as he was under age. The clinic did not have any vaccines made by other manufacturers. His mother was concerned because he could not get another vaccine until he would be 16. He had a letter from the vaccine provider for his school as the vaccine was required.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination complication, Vomiting
Clinical narrative: feels like she is going to die/ does not feel well today; Fever; vomited; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (feels like she is going to die/ does not feel well today), PYREXIA (Fever) and VOMITING (vomited) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart rate high, Lung operation and Oophorectomy. Concurrent medical conditions included Breast cancer (Breast Cancer that traveled to her lungs) and Immunocompromised. Concomitant products included METOPROLOL, CLONAZEPAM (KLONOPIN), SERTRALINE, LETROZOLE and ABEMACICLIB (VERZENIO) for an unknown indication.    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, the patient experienced VACCINATION COMPLICATION (feels like she is going to die/ does not feel well today), PYREXIA (Fever) and VOMITING (vomited). At the time of the report, VACCINATION COMPLICATION (feels like she is going to die/ does not feel well today), PYREXIA (Fever) and VOMITING (vomited) outcome was unknown.            Treatment medication was not provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (adverse reaction) in a  patient of an unknown age and 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (adverse reaction). At the time of the report, VACCINATION COMPLICATION (adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were reported. No treatment medication details were reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingle in tips in both finger and toes in both; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingle in tips in both finger and toes in both) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder. Concomitant products included FLECAINIDE for Heart disorder, COLECALCIFEROL (VIT D3) for an unknown indication.    On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced PARAESTHESIA (Tingle in tips in both finger and toes in both). On 20-Aug-2021, PARAESTHESIA (Tingle in tips in both finger and toes in both) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment information was provided.   This case was linked to MOD-2021-324280 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Hypoaesthesia
Clinical narrative: I began to feel numbness on the lower left side of my face/I also had some numbness in general on the left side of my body; Hypersensitivity; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (I began to feel numbness on the lower left side of my face/I also had some numbness in general on the left side of my body) and HYPERSENSITIVITY (Hypersensitivity) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 032B21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Hay fever, Allergy (itchy mouth) since 01-Jan-1970, Asthma since 06-Nov-1988, Hyperthyroidism since 01-Jan-1992, Allergy (itchy eyes, runny nose, scratchy throat) since 01-Jan-1982, Drug allergy (Seldane medication) since 05-Nov-1998, Allergy (stomach ache) since 01-Jan-1970 and Pre-diabetes since 01-Jan-2015. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) from 15-Nov-2020 to an unknown date for Asthma, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) from 01-Jan-2017 to an unknown date for Hyperthyroidism.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced HYPOAESTHESIA (I began to feel numbness on the lower left side of my face/I also had some numbness in general on the left side of my body) and HYPERSENSITIVITY (Hypersensitivity). The patient was treated with CETIRIZINE (oral) from 03-May-2021 to 08-May-2021 for Allergy, at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) (oral) from 04-May-2021 to 07-May-2021 for Allergy, at an unspecified dose and frequency. On 12-May-2021, HYPERSENSITIVITY (Hypersensitivity) had resolved. At the time of the report, HYPOAESTHESIA (I began to feel numbness on the lower left side of my face/I also had some numbness in general on the left side of my body) had resolved. Not Provided          No treatment drugs were provided.   This case was linked to MOD-2021-103533 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 2nd shot was administered with a vial that was past 12 hours after puncture/The patient received 2nd shot with an expired vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd shot was administered with a vial that was past 12 hours after puncture/The patient received 2nd shot with an expired vial) in a  patient of an unknown age and 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) (unknown route) 1 dosage form. In 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd shot was administered with a vial that was past 12 hours after puncture/The patient received 2nd shot with an expired vial). In 2021, EXPIRED PRODUCT ADMINISTERED (2nd shot was administered with a vial that was past 12 hours after puncture/The patient received 2nd shot with an expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: My cousin got the booster and she is not immunocompromised or anything; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (My cousin got the booster and she is not immunocompromised or anything) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (My cousin got the booster and she is not immunocompromised or anything). At the time of the report, OFF LABEL USE (My cousin got the booster and she is not immunocompromised or anything) had resolved.            Concomitant medication use was unknown Treatment information was unknown
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Implant site inflammation
Clinical narrative: Patient experienced a little bit of INFLAMMATORY RESPONSE(Implant site inflammation) on right cheek only; This spontaneous case was reported by a nurse and describes the occurrence of IMPLANT SITE INFLAMMATION (Patient experienced a little bit of INFLAMMATORY RESPONSE(Implant site inflammation) on right cheek only) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products HYALURONIC ACID, LIDOCAINE HYDROCHLORIDE (RESTYLANE LIDOCAINE) injection for an unknown indication and HYALURONIC ACID, LIDOCAINE HYDROCHLORIDE (RESTYLANE DEFYNE) injection for an unknown indication.    No Medical History information was reported.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jul-2021, the patient started HYALURONIC ACID, LIDOCAINE HYDROCHLORIDE (RESTYLANE LIDOCAINE) (unknown route) 2 syringe and HYALURONIC ACID, LIDOCAINE HYDROCHLORIDE (RESTYLANE DEFYNE) (unknown route) 1 syringe. On 16-Jul-2021, the patient experienced IMPLANT SITE INFLAMMATION (Patient experienced a little bit of INFLAMMATORY RESPONSE(Implant site inflammation) on right cheek only). The patient was treated with CEFADROXIL from 17-Jul-2021 to 22-Jul-2021 for Adverse event, at a dose of 500 milligram. On 20-Jul-2021, IMPLANT SITE INFLAMMATION (Patient experienced a little bit of INFLAMMATORY RESPONSE(Implant site inflammation) on right cheek only) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. Patient stated that she had used Voluma filler to her cheeks in 2018 and had no other vaccine in the last 6-12 months or dental procedures. On 16-Jul-2021, the patient received treatment with 2 syringe Restylane Lyft with Lidocaine (lot 18723 (unknown injection technique and needle type) to cheeks (CK1, CK3, CK4 and bilateral angle of jaw),1 syringe Restylane Kysse (lot 18078,expiry Mar-2021) (unknown injection technique and needle type) to the upper and lower lips.The EXPIRED RESTYLANE KYSSE was used (Expired device used) and 1 syringe Restylane Defyne (lot 18671) (unknown injection technique and needle type) to chin divided between C2, C1 JW4 and JW5 bilaterally.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Feeling abnormal, Joint swelling, Swelling
Clinical narrative: Some lumps under his armpit;  the lumps moved to his neck and spine. It's like a flowing lava (the lump); Attacking every joint in his body; Lump is ripping everything; His whole body is swollen all the way up to his brain; Underwear is too small for him now; Things are getting tighter, including his cloths because everything is swollen; He feels like scrap; he feels like marshmallow; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (Some lumps under his armpit;  the lumps moved to his neck and spine. It's like a flowing lava (the lump)), JOINT SWELLING (Attacking every joint in his body; Lump is ripping everything), SWELLING (His whole body is swollen all the way up to his brain; Underwear is too small for him now; Things are getting tighter, including his cloths because everything is swollen) and FEELING ABNORMAL (He feels like scrap; he feels like marshmallow) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AXILLARY MASS (Some lumps under his armpit;  the lumps moved to his neck and spine. It's like a flowing lava (the lump)), JOINT SWELLING (Attacking every joint in his body; Lump is ripping everything), SWELLING (His whole body is swollen all the way up to his brain; Underwear is too small for him now; Things are getting tighter, including his cloths because everything is swollen) and FEELING ABNORMAL (He feels like scrap; he feels like marshmallow). At the time of the report, AXILLARY MASS (Some lumps under his armpit;  the lumps moved to his neck and spine. It's like a flowing lava (the lump)), JOINT SWELLING (Attacking every joint in his body; Lump is ripping everything), SWELLING (His whole body is swollen all the way up to his brain; Underwear is too small for him now; Things are getting tighter, including his cloths because everything is swollen) and FEELING ABNORMAL (He feels like scrap; he feels like marshmallow) had not resolved.            No Concomitant medications reported  No Treatment medications reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Inflammation, Injection site pain, Pain in extremity
Clinical narrative: her arm stays really painful; inflammation; the first dose her injection spot was little sore; shoulders' joint and right hip joint continued to hurt; constant headache; upper respiratory problem; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (the first dose her injection spot was little sore), UPPER RESPIRATORY TRACT INFECTION (upper respiratory problem), ARTHRALGIA (shoulders' joint and right hip joint continued to hurt), INFLAMMATION (inflammation) and PAIN IN EXTREMITY (her arm stays really painful) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, the patient experienced UPPER RESPIRATORY TRACT INFECTION (upper respiratory problem). On an unknown date, the patient experienced INJECTION SITE PAIN (the first dose her injection spot was little sore), ARTHRALGIA (shoulders' joint and right hip joint continued to hurt), INFLAMMATION (inflammation), PAIN IN EXTREMITY (her arm stays really painful) and HEADACHE (constant headache). The patient was treated with ACETAMINOPHEN for Adverse event, at a dose of 500mg; MELOXICAM for Adverse event, at an unspecified dose and frequency and COLISTIMETHATE SODIUM, ERYTHROMYCIN GLUCOHEPTONATE (ANTIBIOTIC SIMPLEX) for Adverse event, at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (the first dose her injection spot was little sore), UPPER RESPIRATORY TRACT INFECTION (upper respiratory problem), ARTHRALGIA (shoulders' joint and right hip joint continued to hurt), INFLAMMATION (inflammation), PAIN IN EXTREMITY (her arm stays really painful) and HEADACHE (constant headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative Negative. On an unknown date, X-ray: abnormal (abnormal) abnormal.         No concomitant medication was provided.Her injection spot was little sore
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Upper respiratory tract infection, X-ray
Clinical narrative: her arm stays really painful; inflammation; the first dose her injection spot was little sore; shoulders' joint and right hip joint continued to hurt; constant headache; upper respiratory problem; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (the first dose her injection spot was little sore), UPPER RESPIRATORY TRACT INFECTION (upper respiratory problem), ARTHRALGIA (shoulders' joint and right hip joint continued to hurt), INFLAMMATION (inflammation) and PAIN IN EXTREMITY (her arm stays really painful) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, the patient experienced UPPER RESPIRATORY TRACT INFECTION (upper respiratory problem). On an unknown date, the patient experienced INJECTION SITE PAIN (the first dose her injection spot was little sore), ARTHRALGIA (shoulders' joint and right hip joint continued to hurt), INFLAMMATION (inflammation), PAIN IN EXTREMITY (her arm stays really painful) and HEADACHE (constant headache). The patient was treated with ACETAMINOPHEN for Adverse event, at a dose of 500mg; MELOXICAM for Adverse event, at an unspecified dose and frequency and COLISTIMETHATE SODIUM, ERYTHROMYCIN GLUCOHEPTONATE (ANTIBIOTIC SIMPLEX) for Adverse event, at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (the first dose her injection spot was little sore), UPPER RESPIRATORY TRACT INFECTION (upper respiratory problem), ARTHRALGIA (shoulders' joint and right hip joint continued to hurt), INFLAMMATION (inflammation), PAIN IN EXTREMITY (her arm stays really painful) and HEADACHE (constant headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative Negative. On an unknown date, X-ray: abnormal (abnormal) abnormal.         No concomitant medication was provided.Her injection spot was little sore
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site rash
Clinical narrative: a rash underneath the arm pit where she got the shot; is burning; bright red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (a rash underneath the arm pit where she got the shot), VACCINATION SITE PAIN (is burning) and VACCINATION SITE ERYTHEMA (bright red) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A and 002F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Aug-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 2 dosage form. In September 2021, the patient experienced VACCINATION SITE RASH (a rash underneath the arm pit where she got the shot), VACCINATION SITE PAIN (is burning) and VACCINATION SITE ERYTHEMA (bright red). The patient was treated with ZINC OXIDE (BALMEX [ZINC OXIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE RASH (a rash underneath the arm pit where she got the shot), VACCINATION SITE PAIN (is burning) and VACCINATION SITE ERYTHEMA (bright red) outcome was unknown.            Patient was not allergic to any component of the vaccine. Patient had used cold compresses and lotion. Patient stopped using the remedies because it was burring. Concomitant medication use was unknown
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injury, Limb injury, Paraesthesia, Product administration error
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Lethargy, Nausea, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: nausea-Medium, Systemic: Nausea-Medium, Additional Details: patient fainted 30 sec or minutes after.patient was left with caretaker and caretaker left after pharmacist left after making sur pt is okay. patient fainted twice. after finding on floor rph rush and made sure pt is concious and vital are okay. made sure pt was not hurt after translating as language barrior. after 20 minute emergency services was called. paramedic came and check vital. after checking everything pt was sent home. rph consulted to paramedic and ask if everything is okay, paramedic reply wasm ok
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: nausea-Medium, Systemic: Nausea-Medium, Additional Details: patient fainted 30 sec or minutes after.patient was left with caretaker and caretaker left after pharmacist left after making sur pt is okay. patient fainted twice. after finding on floor rph rush and made sure pt is concious and vital are okay. made sure pt was not hurt after translating as language barrior. after 20 minute emergency services was called. paramedic came and check vital. after checking everything pt was sent home. rph consulted to paramedic and ask if everything is okay, paramedic reply wasm ok
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Back pain, Fatigue, Lethargy
Clinical narrative: Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: sewlling and join pain-Medium, Systemic: Weakness-Medium, Additional Details: Pt called today 09/29/2021 about AE to vaccine. She has been expereincing swelling in her hands and feet. gernalized pain on back and all over body. joint pain as well. Has been lasting since saturday. Does not have a PCP but advised her to find one or f/u with Phjysciian that knows her best. Pt will keep us updated and will f/u with provider.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling
Clinical narrative: Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: sewlling and join pain-Medium, Systemic: Weakness-Medium, Additional Details: Pt called today 09/29/2021 about AE to vaccine. She has been expereincing swelling in her hands and feet. gernalized pain on back and all over body. joint pain as well. Has been lasting since saturday. Does not have a PCP but advised her to find one or f/u with Phjysciian that knows her best. Pt will keep us updated and will f/u with provider.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Injection site swelling
Clinical narrative: Site: Swelling at Injection Site-Mild, Additional Details: it was fluzone HD shot. patient did experience the swelling at the site of injection.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood test normal, Electrocardiogram normal, Heart rate increased, Malaise
Clinical narrative: Heart palpitations, increased heart rate, increased blood pressure, shaking legs, overall feeling of unwell/uneasiness; since initial date of incidents, increased heart rate comes and goes
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Tremor
Clinical narrative: Heart palpitations, increased heart rate, increased blood pressure, shaking legs, overall feeling of unwell/uneasiness; since initial date of incidents, increased heart rate comes and goes
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Injection site pruritus, Peripheral swelling
Clinical narrative: Left shoulder swollen, red with hardness. itching around injection site Taking Aleve and applying ice twice a day since 9/28/21........................as of 9/30/21  still no improvement in condition
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Incorrect product formulation administered, Interchange of vaccine products
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Chills, Dysphagia, Dyspnoea, Hyperhidrosis
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Chills-Mild, Additional Details: Patients mother called to report her daughter had to go to ED on the night of the 24th to receive care for anaphylactic shock after having difficulty breathing and swollen tongue at home. She reports common side effects earlier on (chills,sweats,etc). cost of care on ed were ~$1000+ and she wants the company to be responsible for administering the vaccine. reports RPH didnt scan the doctor's orders, which were specific to what had to be administered.