chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Myalgia, Pain in extremity, Taste disorder
Clinical narrative: ACHY BONES/BONES HURT; TASTE SCREWED UP; CANNOT CROSS LEGS THEY TOO HURT BAD; ACHY MUSCLES/MUSCLES HURTING; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetic.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: 21-SEP-2021) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-JUN-2021, the patient experienced achy bones/bones hurt. On 16-JUN-2021, the patient experienced taste screwed up. On 16-JUN-2021, the patient experienced cannot cross legs they too hurt bad. On 16-JUN-2021, the patient experienced achy muscles/muscles hurting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from achy bones/bones hurt, achy muscles/muscles hurting, taste screwed up, and cannot cross legs they too hurt bad. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Feel nauseated; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Feel nauseated) 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 NAUSEA (Feel nauseated). At the time of the report, NAUSEA (Feel nauseated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Arthralgia, Chest pain, Groin pain, Pain
Clinical narrative: really bad pain from her groin that went to her hip/pain stuff; right thumb swelled up painfully; memory lost/ can't remember well; really bad pain from her groin that went to her hip; joint pain; pain on the left side of her chest that just came 2-3 weeks ago; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (really bad pain from her groin that went to her hip/pain stuff), PERIPHERAL SWELLING (right thumb swelled up painfully), CHEST PAIN (pain on the left side of her chest that just came 2-3 weeks ago), AMNESIA (memory lost/ can't remember well) and GROIN PAIN (really bad pain from her groin that went to her hip) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004m20a and 021l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure. Concomitant products included METFORMIN, MULTIVITAMIN [VITAMINS NOS] and COLECALCIFEROL (VIT D3) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced CHEST PAIN (pain on the left side of her chest that just came 2-3 weeks ago). On 19-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (really bad pain from her groin that went to her hip/pain stuff), PERIPHERAL SWELLING (right thumb swelled up painfully), AMNESIA (memory lost/ can't remember well), GROIN PAIN (really bad pain from her groin that went to her hip) and ARTHRALGIA (joint pain). The patient was treated with IBUPROFEN in April 2021 at an unspecified dose and frequency. At the time of the report, PAIN (really bad pain from her groin that went to her hip/pain stuff), PERIPHERAL SWELLING (right thumb swelled up painfully), CHEST PAIN (pain on the left side of her chest that just came 2-3 weeks ago), AMNESIA (memory lost/ can't remember well), GROIN PAIN (really bad pain from her groin that went to her hip) and ARTHRALGIA (joint pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was about to get booster ,but before which encountered with the events.  Patient also uses blood pressure pills
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: really bad pain from her groin that went to her hip/pain stuff; right thumb swelled up painfully; memory lost/ can't remember well; really bad pain from her groin that went to her hip; joint pain; pain on the left side of her chest that just came 2-3 weeks ago; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (really bad pain from her groin that went to her hip/pain stuff), PERIPHERAL SWELLING (right thumb swelled up painfully), CHEST PAIN (pain on the left side of her chest that just came 2-3 weeks ago), AMNESIA (memory lost/ can't remember well) and GROIN PAIN (really bad pain from her groin that went to her hip) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004m20a and 021l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure. Concomitant products included METFORMIN, MULTIVITAMIN [VITAMINS NOS] and COLECALCIFEROL (VIT D3) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced CHEST PAIN (pain on the left side of her chest that just came 2-3 weeks ago). On 19-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (really bad pain from her groin that went to her hip/pain stuff), PERIPHERAL SWELLING (right thumb swelled up painfully), AMNESIA (memory lost/ can't remember well), GROIN PAIN (really bad pain from her groin that went to her hip) and ARTHRALGIA (joint pain). The patient was treated with IBUPROFEN in April 2021 at an unspecified dose and frequency. At the time of the report, PAIN (really bad pain from her groin that went to her hip/pain stuff), PERIPHERAL SWELLING (right thumb swelled up painfully), CHEST PAIN (pain on the left side of her chest that just came 2-3 weeks ago), AMNESIA (memory lost/ can't remember well), GROIN PAIN (really bad pain from her groin that went to her hip) and ARTHRALGIA (joint pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was about to get booster ,but before which encountered with the events.  Patient also uses blood pressure pills
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness/numbing on his hand/finger tips like getting numb; Tickles in the finger tips/tickles/tickles in his hand/tickles in his fingers and also his mouth/tickling in my chin/feet as well (referring to the tickles); This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness/numbing on his hand/finger tips like getting numb) and PARAESTHESIA (Tickles in the finger tips/tickles/tickles in his hand/tickles in his fingers and also his mouth/tickling in my chin/feet as well (referring to the tickles)) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053G21A, 0R0M20A and 014M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VALSARTAN (DIOVAN) for Blood pressure, LEVOTHYROXINE SODIUM (SYNTHROID) and HYDROXYCHLOROQUINE for an unknown indication.   On 26-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 29-Aug-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 HYPOAESTHESIA (Numbness/numbing on his hand/finger tips like getting numb) and PARAESTHESIA (Tickles in the finger tips/tickles/tickles in his hand/tickles in his fingers and also his mouth/tickling in my chin/feet as well (referring to the tickles)). At the time of the report, HYPOAESTHESIA (Numbness/numbing on his hand/finger tips like getting numb) and PARAESTHESIA (Tickles in the finger tips/tickles/tickles in his hand/tickles in his fingers and also his mouth/tickling in my chin/feet as well (referring to the tickles)) outcome was unknown.            No treatment medication were reported   This case was linked to MOD-2021-377936 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site bruising, Vaccination site haemorrhage, Vaccination site swelling
Clinical narrative: left arm is sore; slight bruise at the injection site; injection site bleed, It looked like a hematoma; ballooned up a bit, made a raised knot, was a small ball; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm is sore), VACCINATION SITE BRUISING (slight bruise at the injection site), VACCINATION SITE HAEMORRHAGE (injection site bleed, It looked like a hematoma) and VACCINATION SITE SWELLING (ballooned up a bit, made a raised knot, was a small ball) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058F21A, 041L20A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (injection site bleed, It looked like a hematoma) and VACCINATION SITE SWELLING (ballooned up a bit, made a raised knot, was a small ball). On 02-Nov-2021, the patient experienced PAIN IN EXTREMITY (left arm is sore) and VACCINATION SITE BRUISING (slight bruise at the injection site). On 01-Nov-2021, VACCINATION SITE HAEMORRHAGE (injection site bleed, It looked like a hematoma) and VACCINATION SITE SWELLING (ballooned up a bit, made a raised knot, was a small ball) had resolved. At the time of the report, PAIN IN EXTREMITY (left arm is sore) and VACCINATION SITE BRUISING (slight bruise at the injection site) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Rash
Clinical narrative: Headache after booster; Fatigue after booster; Rash on  face, arm and chest after booster; Sore left arm after booster; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on  face, arm and chest after booster), MYALGIA (Sore left arm after booster), HEADACHE (Headache after booster) and FATIGUE (Fatigue after booster) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced MYALGIA (Sore left arm after booster). On 30-Oct-2021, the patient experienced RASH (Rash on  face, arm and chest after booster). On 02-Nov-2021, the patient experienced HEADACHE (Headache after booster) and FATIGUE (Fatigue after booster). On 30-Oct-2021, MYALGIA (Sore left arm after booster) had resolved. At the time of the report, RASH (Rash on  face, arm and chest after booster), HEADACHE (Headache after booster) and FATIGUE (Fatigue after booster) outcome was unknown.            No concomitant medications was provided by the reporter. No treatment was provided by the reporter.   This case was linked to MOD-2021-372412, MOD-2021-372307 (Patient Link).
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic reactions; This literature-non-study case was reported in a literature article and describes the occurrence of ANAPHYLACTIC REACTION (anaphylactic reactions) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.      Concurrent medical conditions included Asthma, Allergic rhinitis, Chronic urticaria and Food allergy.   On an unknown date, the patient received first 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. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (anaphylactic reactions) (seriousness criterion medically significant). The patient was treated with SALBUTAMOL (ALBUTEROL HFA) ongoing since an unknown date for Asthma, at an unspecified dose and frequency. At the time of the report, ANAPHYLACTIC REACTION (anaphylactic reactions) outcome was unknown. Possible      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ANAPHYLACTIC REACTION (anaphylactic reactions) to be possibly related.    Concomitant product use was not provided by the reporter.   Treatment information was not provided.  Patient had symptoms of Generalized itching, hives, Shortness of breath (SOB). Patient declined skin test and received and tolerated 2nd dose in high-risk clinic  Company Comment: This case concerns a 32-year-old female patient, with history of asthma, food allergy, chronic rhinitis and chronic urticaria, who experienced the serious expected event of ANAPHYLACTIC REACTION. The event occurred on an unknown date after receiving the first dose of Moderna COVID 19 vaccine. The rechallenge is not applicable, since it is stated that patient tolerated the second dose with prior administration of albuterol. Patient's history of asthma, food allergy, chronic rhinitis and chronic urticaria remains as a confounder. The benefit-risk relation of Moderna COVID 19 vaccine is not affected by this report.   This case was linked to MOD-2021-372371, MOD-2021-372465, MOD-2021-372466 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: Follow up received by safety on 04-Nov-2021 included an Email with FTA received from team. Reporter information, Treatment drug are added.; Sender's Comments: This case concerns a 32-year-old female patient, with history of asthma, food allergy, chronic rhinitis and chronic urticaria, who experienced the serious expected event of ANAPHYLACTIC REACTION. The event occurred on an unknown date after receiving the first dose of Moderna COVID 19 vaccine. The rechallenge is not applicable, since it is stated that patient tolerated the second dose with prior administration of albuterol. Patient's history of asthma, food allergy, chronic rhinitis and chronic urticaria remains as a confounder. The benefit-risk relation of Moderna COVID 19 vaccine is not affected by this report.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Pyrexia
Clinical narrative: chills; fever; joint paint; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Nov-2021 and was forwarded to Moderna on 02-Nov-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever) and ARTHRALGIA (joint paint) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills), PYREXIA (fever) and ARTHRALGIA (joint paint). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, CHILLS (chills), PYREXIA (fever) and ARTHRALGIA (joint paint) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported .   This case was linked to MOD-2021-372805, MOD-2021-372818 (Patient Link).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dysphagia, Eye pruritus, Oropharyngeal discomfort, Pruritus
Clinical narrative: says she had anaphylaxis; itching eyeballs,itching beneath the lids,itching near the lashes; throat did not close; it felt weird when swallowing; itching internally all her body for 7 hours; swelling; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (says she had anaphylaxis) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS and CETIRIZINE for an unknown indication.    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 ANAPHYLACTIC REACTION (says she had anaphylaxis) (seriousness criterion medically significant), EYE PRURITUS (itching eyeballs,itching beneath the lids,itching near the lashes), OROPHARYNGEAL DISCOMFORT (throat did not close), DYSPHAGIA (it felt weird when swallowing), PRURITUS (itching internally all her body for 7 hours) and SWELLING (swelling). At the time of the report, ANAPHYLACTIC REACTION (says she had anaphylaxis), EYE PRURITUS (itching eyeballs,itching beneath the lids,itching near the lashes), OROPHARYNGEAL DISCOMFORT (throat did not close) and DYSPHAGIA (it felt weird when swallowing) outcome was unknown and PRURITUS (itching internally all her body for 7 hours) and SWELLING (swelling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Cetirizine 10mg took it earlier than usual, but it did not help to relieve the symptoms.  Company comment : This case concerns a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) with no relevant medical history who experienced serious expected event (AESI) of anaphylactic reaction on unknown date after the a dose of the vaccine received on unknown date. Rechallenge is not applicable, since no further dosing is expected. The benefit-risk relationship is not affected by this report; Sender's Comments: This case concerns a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) with no relevant medical history who experienced serious expected event (AESI) of anaphylactic reaction on unknown date after the a dose of the vaccine received on unknown date. Rechallenge is not applicable, since no further dosing is expected. The benefit-risk relationship is not affected by this report
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: says she had anaphylaxis; itching eyeballs,itching beneath the lids,itching near the lashes; throat did not close; it felt weird when swallowing; itching internally all her body for 7 hours; swelling; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (says she had anaphylaxis) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS and CETIRIZINE for an unknown indication.    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 ANAPHYLACTIC REACTION (says she had anaphylaxis) (seriousness criterion medically significant), EYE PRURITUS (itching eyeballs,itching beneath the lids,itching near the lashes), OROPHARYNGEAL DISCOMFORT (throat did not close), DYSPHAGIA (it felt weird when swallowing), PRURITUS (itching internally all her body for 7 hours) and SWELLING (swelling). At the time of the report, ANAPHYLACTIC REACTION (says she had anaphylaxis), EYE PRURITUS (itching eyeballs,itching beneath the lids,itching near the lashes), OROPHARYNGEAL DISCOMFORT (throat did not close) and DYSPHAGIA (it felt weird when swallowing) outcome was unknown and PRURITUS (itching internally all her body for 7 hours) and SWELLING (swelling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Cetirizine 10mg took it earlier than usual, but it did not help to relieve the symptoms.  Company comment : This case concerns a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) with no relevant medical history who experienced serious expected event (AESI) of anaphylactic reaction on unknown date after the a dose of the vaccine received on unknown date. Rechallenge is not applicable, since no further dosing is expected. The benefit-risk relationship is not affected by this report; Sender's Comments: This case concerns a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) with no relevant medical history who experienced serious expected event (AESI) of anaphylactic reaction on unknown date after the a dose of the vaccine received on unknown date. Rechallenge is not applicable, since no further dosing is expected. The benefit-risk relationship is not affected by this report
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain, Vaccination site swelling
Clinical narrative: swollen arm; sore arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swollen arm), VACCINATION SITE PAIN (sore arm) and HEADACHE (Headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism since 1995, High cholesterol since 1999 and Drug allergy. Concomitant products included SIMVASTATIN (ZOCOR) for Cholesterol, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, TRAZODONE for Insomnia, CALCIUM for Osteopenia, MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Oct-2021, the patient experienced VACCINATION SITE SWELLING (swollen arm), VACCINATION SITE PAIN (sore arm) and HEADACHE (Headache). On 29-Oct-2021, HEADACHE (Headache) had resolved. At the time of the report, VACCINATION SITE SWELLING (swollen arm) and VACCINATION SITE PAIN (sore arm) had not 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 did not provide any causality assessments.   No treatment medication was reported.   This case was linked to MOD-2021-372786, MOD-2021-365112 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired moderna vaccine mistakenly administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Paraesthesia, Pyrexia, Vaccination site pain
Clinical narrative: Chills; Fever; Joint pain; Pain near injection site; Pins and needle pains down her left arm to fingers; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Pins and needle pains down her left arm to fingers), CHILLS (Chills), PYREXIA (Fever), ARTHRALGIA (Joint pain) and VACCINATION SITE PAIN (Pain near injection site) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 037K20A and 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced PARAESTHESIA (Pins and needle pains down her left arm to fingers) and VACCINATION SITE PAIN (Pain near injection site). On an unknown date, the patient experienced CHILLS (Chills), PYREXIA (Fever) and ARTHRALGIA (Joint pain). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Pins and needle pains down her left arm to fingers), CHILLS (Chills), PYREXIA (Fever), ARTHRALGIA (Joint pain) and VACCINATION SITE PAIN (Pain near injection site) outcome was unknown.      No concomitant medications were reported.  Patient took two Advil for the first night and then one Advil the next morning.   This case was linked to MOD-2021-372579, MOD-2021-372805 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered dose past the manufacture expiry date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered dose past the manufacture expiry date) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered dose past the manufacture expiry date). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered dose past the manufacture expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  No treatment information was provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired moderna vaccine mistakenly administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided No treatment medication provided  (removed from freezer 10-14-21 into refrigerator and never opened before today and temperature never compromised).
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Skin wrinkling
Clinical narrative: Skin all wrinkled up in his injection arm/wrinkled up skin then went to the other arm/all wrinkly; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WRINKLING (Skin all wrinkled up in his injection arm/wrinkled up skin then went to the other arm/all wrinkly) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A, 030A21A and 031L20A) for COVID-19 vaccination. Concurrent medical conditions included Cancer. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SKIN WRINKLING (Skin all wrinkled up in his injection arm/wrinkled up skin then went to the other arm/all wrinkly). At the time of the report, SKIN WRINKLING (Skin all wrinkled up in his injection arm/wrinkled up skin then went to the other arm/all wrinkly) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. The treatment information was unknown. The patient experienced skin wrinkly was started in the injection arm and about a week later went into the other arm. It was started the day after the shot and is still ongoing. This case was linked to MOD-2021-017366 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Fatigue, Feeling abnormal, Feeling hot
Clinical narrative: feeling awfully funny; got very warm to the point that he thought it might be the heating system; broke out in a cold sweat; felt light headed to the point where he thought it might be heart related; felt washed out; had a sore left arm/sore left shoulder/was sore underneath the left arm into the ribcage of left side; had a sore left arm/sore left shoulder/was sore underneath the left arm into the ribcage of left side; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling awfully funny), FEELING HOT (got very warm to the point that he thought it might be the heating system), COLD SWEAT (broke out in a cold sweat), DIZZINESS (felt light headed to the point where he thought it might be heart related) and FATIGUE (felt washed out) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A, 006B21A and 031A20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced FEELING ABNORMAL (feeling awfully funny), FEELING HOT (got very warm to the point that he thought it might be the heating system), COLD SWEAT (broke out in a cold sweat) and DIZZINESS (felt light headed to the point where he thought it might be heart related). October 2021, the patient experienced FATIGUE (felt washed out), VACCINATION SITE PAIN (had a sore left arm/sore left shoulder/was sore underneath the left arm into the ribcage of left side) and VACCINATION SITE JOINT PAIN (had a sore left arm/sore left shoulder/was sore underneath the left arm into the ribcage of left side). At the time of the report, FEELING ABNORMAL (feeling awfully funny), FEELING HOT (got very warm to the point that he thought it might be the heating system), COLD SWEAT (broke out in a cold sweat) and DIZZINESS (felt light headed to the point where he thought it might be heart related) was resolving and FATIGUE (felt washed out), VACCINATION SITE PAIN (had a sore left arm/sore left shoulder/was sore underneath the left arm into the ribcage of left side) and VACCINATION SITE JOINT PAIN (had a sore left arm/sore left shoulder/was sore underneath the left arm into the ribcage of left side) outcome was unknown.            No Concomitant medications were reported. No Treatment information was reported.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site joint pain, Vaccination site pain
Clinical narrative: feeling awfully funny; got very warm to the point that he thought it might be the heating system; broke out in a cold sweat; felt light headed to the point where he thought it might be heart related; felt washed out; had a sore left arm/sore left shoulder/was sore underneath the left arm into the ribcage of left side; had a sore left arm/sore left shoulder/was sore underneath the left arm into the ribcage of left side; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling awfully funny), FEELING HOT (got very warm to the point that he thought it might be the heating system), COLD SWEAT (broke out in a cold sweat), DIZZINESS (felt light headed to the point where he thought it might be heart related) and FATIGUE (felt washed out) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A, 006B21A and 031A20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced FEELING ABNORMAL (feeling awfully funny), FEELING HOT (got very warm to the point that he thought it might be the heating system), COLD SWEAT (broke out in a cold sweat) and DIZZINESS (felt light headed to the point where he thought it might be heart related). October 2021, the patient experienced FATIGUE (felt washed out), VACCINATION SITE PAIN (had a sore left arm/sore left shoulder/was sore underneath the left arm into the ribcage of left side) and VACCINATION SITE JOINT PAIN (had a sore left arm/sore left shoulder/was sore underneath the left arm into the ribcage of left side). At the time of the report, FEELING ABNORMAL (feeling awfully funny), FEELING HOT (got very warm to the point that he thought it might be the heating system), COLD SWEAT (broke out in a cold sweat) and DIZZINESS (felt light headed to the point where he thought it might be heart related) was resolving and FATIGUE (felt washed out), VACCINATION SITE PAIN (had a sore left arm/sore left shoulder/was sore underneath the left arm into the ribcage of left side) and VACCINATION SITE JOINT PAIN (had a sore left arm/sore left shoulder/was sore underneath the left arm into the ribcage of left side) outcome was unknown.            No Concomitant medications were reported. No Treatment information was reported.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles) in a 90-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 HERPES ZOSTER (shingles). At the time of the report, HERPES ZOSTER (shingles) had resolved.            No concomitant medications were provided.  Treatment medications include antivirals for adverse event.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site reaction, Vaccination site swelling
Clinical narrative: covid arm; I had  feeling swelling at the injection site; swelling at the injection site, covid arm, redness and itching; swelling at the injection site, covid arm, redness and itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (covid arm), VACCINATION SITE SWELLING (I had  feeling swelling at the injection site), VACCINATION SITE ERYTHEMA (swelling at the injection site, covid arm, redness and itching) and VACCINATION SITE PRURITUS (swelling at the injection site, covid arm, redness and itching) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 019B21A and 013A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and CLONIDINE HYDROCHLORIDE (CATAPRES TTS) for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-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 VACCINATION SITE REACTION (covid arm), VACCINATION SITE SWELLING (I had  feeling swelling at the injection site), VACCINATION SITE ERYTHEMA (swelling at the injection site, covid arm, redness and itching) and VACCINATION SITE PRURITUS (swelling at the injection site, covid arm, redness and itching). At the time of the report, VACCINATION SITE REACTION (covid arm), VACCINATION SITE SWELLING (I had  feeling swelling at the injection site), VACCINATION SITE ERYTHEMA (swelling at the injection site, covid arm, redness and itching) and VACCINATION SITE PRURITUS (swelling at the injection site, covid arm, redness and itching) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment medications were not provided.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus, Urticaria
Clinical narrative: Hives; Was itchy around neck, arm, chest and underneath the arms; Bad allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), PRURITUS (Was itchy around neck, arm, chest and underneath the arms) and HYPERSENSITIVITY (Bad allergic reaction) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 029K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-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 received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives), PRURITUS (Was itchy around neck, arm, chest and underneath the arms) and HYPERSENSITIVITY (Bad allergic reaction). At the time of the report, URTICARIA (Hives), PRURITUS (Was itchy around neck, arm, chest and underneath the arms) and HYPERSENSITIVITY (Bad allergic reaction) had resolved.      No concomitant medications were reported.  Treatment details included antihistamines after booster.  Reporter informed that it took 5 days to resolve the events.   This case was linked to MOD-2021-373466, MOD-2021-373467 (Patient Link).
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: injection on the knee, and for 3 days they had pains and it was bothering them too; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (injection on the knee, and for 3 days they had pains and it was bothering them too) in a 76-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (injection on the knee, and for 3 days they had pains and it was bothering them too). At the time of the report, PAIN (injection on the knee, and for 3 days they had pains and it was bothering them too) outcome was unknown.            No Concomitant medications were reported.  No Treatment information was reported.  Patient recalls that after the second Moderna vaccine they were going through therapy for an injection on the knee, and for 3 days they had pains and it was bothering them too, so much they had to skip therapy for a few days.   This case was linked to MOD-2021-372716 (Patient Link).
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Chills; Fever; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), FATIGUE (Fatigue) and HEADACHE (Headache) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever), FATIGUE (Fatigue) and HEADACHE (Headache). On 16-Apr-2021, CHILLS (Chills), PYREXIA (Fever), FATIGUE (Fatigue) and HEADACHE (Headache) had resolved.            Patient received the first dose on 19MAR2021 into her left arm having lot no 036A21A No concomitant and treatment information were reported by the reporter   This case was linked to MOD-2021-370400 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administration of expire dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expire dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21) 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 EXPIRED PRODUCT ADMINISTERED (administration of expire dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administration of expire dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue after the first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue after the first vaccine) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (fatigue after the first vaccine). At the time of the report, FATIGUE (fatigue after the first vaccine) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-373774, MOD-2021-373777 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Fatigue
Clinical narrative: redness all down his arm; tired; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (redness all down his arm) and FATIGUE (tired) 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 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced ERYTHEMA (redness all down his arm) and FATIGUE (tired). At the time of the report, ERYTHEMA (redness all down his arm) and FATIGUE (tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment drugs were provided. It was reported that, patient didn't feel a thing when he got the shot in his right arm. There were no other problems with the other 2 shots. She stated he was tired but not sleepy.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: She has 38C temperature and it peaked at 39.4C; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PYREXIA (She has 38C temperature and it peaked at 39.4C) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (She has 38C temperature and it peaked at 39.4C). At the time of the report, PYREXIA (She has 38C temperature and it peaked at 39.4C) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 38 (High) 38 degree Celsius and 39.4 (High) 39.4 degree Celsius.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported. No treatment information was reported by the reporter. Reporter stated that patient  body temperature was measured under the armpit.