chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Insomnia, Pain in extremity, Papule, Pruritus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (uncomfortable), INSOMNIA (cant sleep), PAPULE (a little bump on her arm, not red nor inflamed), PAIN IN EXTREMITY (Pain on left arm) and PRURITUS (but 3 days ago terrible itchy) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 038A21A and 014M20A) for COVID-19 vaccination. Concurrent medical conditions included Blood disorder and Heart disorder (Heart problem).On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021, the patient experienced DISCOMFORT (uncomfortable), INSOMNIA (cant sleep), PAPULE (a little bump on her arm, not red nor inflamed), PAIN IN EXTREMITY (Pain on left arm) and PRURITUS (but 3 days ago terrible itchy). At the time of the report, DISCOMFORT (uncomfortable), INSOMNIA (cant sleep), PAPULE (a little bump on her arm, not red nor inflamed), PAIN IN EXTREMITY (Pain on left arm) and PRURITUS (but 3 days ago terrible itchy) outcome was unknown. Patient did  not taken any medications yet.Patient is on NSAID Reported as Concomitant medication. 3 days ago patient had all the events.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vial that was at room temperature since the 23Nov2021.; vial that was at room temperature since  the 23Nov2021.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vial that was at room temperature since the 23Nov2021.) and PRODUCT STORAGE ERROR (vial that was at room temperature since  the 23Nov2021.) 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 26-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vial that was at room temperature since the 23Nov2021.) and PRODUCT STORAGE ERROR (vial that was at room temperature since  the 23Nov2021.). On 26-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vial that was at room temperature since the 23Nov2021.) and PRODUCT STORAGE ERROR (vial that was at room temperature since  the 23Nov2021.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that on visual inspection noting any vaccine state change looks normal , a bit cloudy , no particles, nothing look abnormal.  Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Tinnitus
Clinical narrative: Tinnitus; Sudden and strange headaches; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus) and HEADACHE (Sudden and strange headaches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced TINNITUS (Tinnitus) and HEADACHE (Sudden and strange headaches). At the time of the report, TINNITUS (Tinnitus) and HEADACHE (Sudden and strange headaches) outcome was unknown.            No concomitant medication was reported by the reporter.  No treatment medication was reported by the reporter.   This case was linked to MOD-2021-398835 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Joint swelling
Clinical narrative: swollen knee; This spontaneous case was reported by an other health care professional and describes the occurrence of JOINT SWELLING (swollen knee) 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 JOINT SWELLING (swollen knee). At the time of the report, JOINT SWELLING (swollen knee) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Urticaria, Vomiting
Clinical narrative: Hives; Extreme Body aches; Fever; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), MYALGIA (Extreme Body aches), PYREXIA (Fever), NAUSEA (Nausea) and VOMITING (Vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination.     Concurrent medical conditions included Immune disorder (NOS) (Unidentified Immune condition). Concomitant products included HYDROXYCHLOROQUINE for Immune disorder (NOS).    On 26-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced URTICARIA (Hives), MYALGIA (Extreme Body aches), PYREXIA (Fever), NAUSEA (Nausea) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives), MYALGIA (Extreme Body aches), PYREXIA (Fever), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.            The patient reported that unidentified immune condition that was treated with steroid medication (unspecified). The patient treated the events by taking anti spasmodic (unspecified) and over the counter medications (unspecified).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Tenderness
Clinical narrative: Aches and pain in the left arm; Felt achy and tender; Felt achy and tender; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Aches and pain in the left arm), PAIN (Felt achy and tender) and TENDERNESS (Felt achy and tender) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A, 013M20A and 071F21A) for COVID-19 vaccination.     Concomitant products included LOSARTAN, ATORVASTATIN, HYDROCHLOROTHIAZIDE, AMLODIPINE, GABAPENTIN, METFORMIN and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Aches and pain in the left arm), PAIN (Felt achy and tender) and TENDERNESS (Felt achy and tender). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Aches and pain in the left arm) had resolved and PAIN (Felt achy and tender) and TENDERNESS (Felt achy and tender) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient experienced aches and pain in the left arm which resolved within two days. The pain in the arm returned 2 weeks later, felt achy and tender. The side effect was ongoing.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: felt sick when he got the first 2 dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (felt sick when he got the first 2 dose) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21) 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (felt sick when he got the first 2 dose). At the time of the report, ILLNESS (felt sick when he got the first 2 dose) outcome was unknown.        No Concomitant medication details were provided. No Treatment medication details were provided.   This case was linked to MOD-2021-398877, MOD-2021-398918 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: reddish; rash about a size of an orange; very itchy; hot to touch; swelling of the left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE SWELLING (swelling of the left arm), VACCINATION SITE ERYTHEMA (reddish), VACCINATION SITE RASH (rash about a size of an orange) and VACCINATION SITE PRURITUS (very itchy) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU) for an unknown indication.    No Medical History information was reported.   On 26-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU) (unknown route) 1 dosage form. In November 2021, the patient experienced VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE SWELLING (swelling of the left arm), VACCINATION SITE RASH (rash about a size of an orange) and VACCINATION SITE PRURITUS (very itchy). On 28-Nov-2021, the patient experienced VACCINATION SITE ERYTHEMA (reddish). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE SWELLING (swelling of the left arm), VACCINATION SITE ERYTHEMA (reddish), VACCINATION SITE RASH (rash about a size of an orange) and VACCINATION SITE PRURITUS (very itchy) outcome was unknown.            No relevant concomitant medications were reported. Treatment information included Cold compress.   The patient was administered Moderna booster shot on same day together with her flu shot same arm, left side.  So it was reported that the patient was not sure whether the reaction for the Moderna booster or the flu shot.   This case was linked to MOD-2021-398893, MOD-2021-398894 (Patient Link).
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: I started feeling dizzy; This spontaneous case was reported by a pharmacist and describes the occurrence of DIZZINESS (I started feeling dizzy) 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.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced DIZZINESS (I started feeling dizzy). At the time of the report, DIZZINESS (I started feeling dizzy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had booster at 5pm yesterday and about an hour ago patient started feeling dizzy. No concomitant medications were mentioned. No treatment details were reported.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Heart rate increased, Pain in extremity
Clinical narrative: I started feeling dizzy; This spontaneous case was reported by a pharmacist and describes the occurrence of DIZZINESS (I started feeling dizzy) 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.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced DIZZINESS (I started feeling dizzy). At the time of the report, DIZZINESS (I started feeling dizzy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had booster at 5pm yesterday and about an hour ago patient started feeling dizzy. No concomitant medications were mentioned. No treatment details were reported.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: Short of breath; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Short of breath) and PAIN IN EXTREMITY (Sore arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included POTASSIUM and WATER for an unknown indication.    On 27-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Nov-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 29-Nov-2021, the patient experienced DYSPNOEA (Short of breath). At the time of the report, DYSPNOEA (Short of breath) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Nov-2021, Heart rate increased: 101 beats per minute (High) Had a heart beat 101 beats per minute while resting.         Concomitant medications included blood pressure medication and blood thinner along with above mentioned medications. Treatment details stated that patient took no medication after the symptoms appeared.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Heart rate increased, Pain in extremity
Clinical narrative: Short of breath; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Short of breath) and PAIN IN EXTREMITY (Sore arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included POTASSIUM and WATER for an unknown indication.    On 27-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Nov-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 29-Nov-2021, the patient experienced DYSPNOEA (Short of breath). At the time of the report, DYSPNOEA (Short of breath) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Nov-2021, Heart rate increased: 101 beats per minute (High) Had a heart beat 101 beats per minute while resting.         Concomitant medications included blood pressure medication and blood thinner along with above mentioned medications. Treatment details stated that patient took no medication after the symptoms appeared.
Sex: U
Vaccine: COVID19
Symptoms: Oral mucosal blistering, Oral mucosal eruption
Clinical narrative: mouth rash/blisters; mouth rash/blisters; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of ORAL MUCOSAL ERUPTION (mouth rash/blisters) and ORAL MUCOSAL BLISTERING (mouth rash/blisters) 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 ORAL MUCOSAL ERUPTION (mouth rash/blisters) and ORAL MUCOSAL BLISTERING (mouth rash/blisters). At the time of the report, ORAL MUCOSAL ERUPTION (mouth rash/blisters) and ORAL MUCOSAL BLISTERING (mouth rash/blisters) outcome was unknown.        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 concomitant medications were reported  No treatment medications were reported
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Mammogram, Myalgia, Nausea
Clinical narrative: back ache (bones); headache; body ache; nausea; lymph node inflammation both armpits (ongoing); This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back ache (bones)), VACCINATION SITE LYMPHADENOPATHY (lymph node inflammation both armpits (ongoing)), HEADACHE (headache), MYALGIA (body ache) and NAUSEA (nausea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 041L20A) for COVID-19 vaccination.     Concomitant products included OXCARBAZEPINE (TRILEPTAL), GABAPENTIN (NEURONTIN), SERTRALINE HYDROCHLORIDE (ZOLOFT), ATORVASTATIN, METFORMIN and VITAMINS NOS for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced BACK PAIN (back ache (bones)), HEADACHE (headache), MYALGIA (body ache) and NAUSEA (nausea). In 2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (lymph node inflammation both armpits (ongoing)). The patient was treated with Immunotherapy for Myalgia. On 18-Feb-2021, BACK PAIN (back ache (bones)), HEADACHE (headache), MYALGIA (body ache) and NAUSEA (nausea) had resolved. At the time of the report, VACCINATION SITE LYMPHADENOPATHY (lymph node inflammation both armpits (ongoing)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Mammogram: lymph node inflammation (abnormal) lymph node inflammation. In October 2021, Mammogram: nodules were still inflamed (abnormal) nodules were still inflamed.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 19-Jan-2021, the patient received the first dose of vaccine and states no adverse event after first dose. On 16-Feb-2021, she receive the second dose of vaccine and experienced headache, body ache, back ache (bones), nausea. All side effects started the next day after the second dose and lasted during all day. By midday of the third day everything was back to normal. She did not notice any lymph node inflammation at the time, these appeared in the mammogram in August/September. She did perform another mammogram in October, and the nodules were still inflamed.  It was stated that, she might have taken something for the pain, but does not recall.  No concomitant medications were reported.  No treatment information was reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy
Clinical narrative: back ache (bones); headache; body ache; nausea; lymph node inflammation both armpits (ongoing); This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back ache (bones)), VACCINATION SITE LYMPHADENOPATHY (lymph node inflammation both armpits (ongoing)), HEADACHE (headache), MYALGIA (body ache) and NAUSEA (nausea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 041L20A) for COVID-19 vaccination.     Concomitant products included OXCARBAZEPINE (TRILEPTAL), GABAPENTIN (NEURONTIN), SERTRALINE HYDROCHLORIDE (ZOLOFT), ATORVASTATIN, METFORMIN and VITAMINS NOS for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced BACK PAIN (back ache (bones)), HEADACHE (headache), MYALGIA (body ache) and NAUSEA (nausea). In 2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (lymph node inflammation both armpits (ongoing)). The patient was treated with Immunotherapy for Myalgia. On 18-Feb-2021, BACK PAIN (back ache (bones)), HEADACHE (headache), MYALGIA (body ache) and NAUSEA (nausea) had resolved. At the time of the report, VACCINATION SITE LYMPHADENOPATHY (lymph node inflammation both armpits (ongoing)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Mammogram: lymph node inflammation (abnormal) lymph node inflammation. In October 2021, Mammogram: nodules were still inflamed (abnormal) nodules were still inflamed.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 19-Jan-2021, the patient received the first dose of vaccine and states no adverse event after first dose. On 16-Feb-2021, she receive the second dose of vaccine and experienced headache, body ache, back ache (bones), nausea. All side effects started the next day after the second dose and lasted during all day. By midday of the third day everything was back to normal. She did not notice any lymph node inflammation at the time, these appeared in the mammogram in August/September. She did perform another mammogram in October, and the nodules were still inflamed.  It was stated that, she might have taken something for the pain, but does not recall.  No concomitant medications were reported.  No treatment information was reported.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Pain in extremity
Clinical narrative: chest pains; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pains) and PAIN IN EXTREMITY (sore arm) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A, 027821A and 027H21B) for COVID-19 vaccination.     The patient's past medical history included Open heart surgery. Concomitant products included TERAZOSIN, METOPROLOL, HYDRALAZINE, ATORVASTATIN, ISOSORBIDE and IBUPROFEN for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced CHEST PAIN (chest pains) and PAIN IN EXTREMITY (sore arm). The patient was treated with GLYCERYL TRINITRATE (NITROGLYCERINE) for Chest pain, at an unspecified dose and frequency. At the time of the report, CHEST PAIN (chest pains) had not resolved and PAIN IN EXTREMITY (sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported taking nitroglycerin after the chest pains and still experiencing the chest pains.  Patient passed his stress test.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity, Vision blurred, Visual impairment
Clinical narrative: My arm  was sore; I had dizziness late that evening; I had vision changes; My right eye was blurry; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My arm  was sore), DIZZINESS (I had dizziness late that evening), VISUAL IMPAIRMENT (I had vision changes) and VISION BLURRED (My right eye was blurry) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 011A21A and 037A21B) for COVID-19 vaccination.     The patient's past medical history included Eye laser surgery (Laser surgery on her right eye a few hours before she got the booster dose.) in November 2021. Concurrent medical conditions included Heartbeats premature, Anxiety (She had it all her life.) and Stress (She had it all her life.). Concomitant products included BISOPROLOL FUMARATE and CLONAZEPAM for an unknown indication.   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 24-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021, the patient experienced PAIN IN EXTREMITY (My arm  was sore), DIZZINESS (I had dizziness late that evening), VISUAL IMPAIRMENT (I had vision changes) and VISION BLURRED (My right eye was blurry). The patient was treated with MECLIZINE [MECLOZINE] on 27-Nov-2021 for Dizziness, at a dose of 12.5 milligram. At the time of the report, PAIN IN EXTREMITY (My arm  was sore), DIZZINESS (I had dizziness late that evening) and VISUAL IMPAIRMENT (I had vision changes) outcome was unknown and VISION BLURRED (My right eye was blurry) was resolving.            On 24 Nov 2021 patient drove her self after vaccine administration. On 25 Nov 2021 patient had blurred vision and on 29 Nov 2021 she had the same blurred vision but it was better than the previous nights. Patient got lightheaded all the time with bisoprolol and had been taking this medicine for past 3 years.   This case was linked to MOD-2021-400034, MOD-2021-400041 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vomiting
Clinical narrative: Fever; Achyness; Vomiting; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Fever), MYALGIA (Achyness) and VOMITING (Vomiting) 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 PYREXIA (Fever), MYALGIA (Achyness) and VOMITING (Vomiting). At the time of the report, PYREXIA (Fever), MYALGIA (Achyness) and VOMITING (Vomiting) outcome was unknown.        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 concomitant medication was provided.  No treatment information was provided.   Reporter did not allow further contact
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: chills for 4 days; headache for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills for 4 days) and HEADACHE (headache for 4 days) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 006M20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu vaccine. Past adverse reactions to the above products included No adverse event with Flu vaccine.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced CHILLS (chills for 4 days) and HEADACHE (headache for 4 days). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency; IBUPROFEN for Adverse event, at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PARACETAMOL (NYQUIL COLD & FLU) for Adverse event, at an unspecified dose and frequency. On 19-Mar-2021, CHILLS (chills for 4 days) and HEADACHE (headache for 4 days) had resolved.            No concomitant medications were reported.  Treatment medication also included decongestant.   This case was linked to MOD-2021-400107 (Patient Link).; Sender's Comments: No CC is required as all reported events are non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Received Moderna booster dose in error; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Received Moderna booster dose in error) 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.   In October 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Received Moderna booster dose in error). On 29-Nov-2021, PRODUCT ADMINISTRATION ERROR (Received Moderna booster dose in error) had resolved.            No concomitant medications were reported.  No treatment information was reported.  It was reported that, the patient received the Moderna booster half dose today 29Nov2021 in error. It was unknown if the intramuscular injection was given into the left or right deltoid. The patient was supposed to have received the second full Moderna COVID-19 dose in the series.  Further, he was instructed by the facility to come back tomorrow to receive the Moderna full second dose.      Reporter did not allow further contact
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: still dealing with the dizziness/dizzy spells; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (still dealing with the dizziness/dizzy spells) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 001B21A and 008B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-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 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (still dealing with the dizziness/dizzy spells). At the time of the report, DIZZINESS (still dealing with the dizziness/dizzy spells) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2021-400114 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache [after second dose] for a couple hours; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache [after second dose] for a couple hours) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020821A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced HEADACHE (headache [after second dose] for a couple hours). In March 2021, HEADACHE (headache [after second dose] for a couple hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medication were reported no treatment medication were reported   This case was linked to MOD-2021-400113 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M2DA and 042L20A) 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) 1 dosage form. On 24-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 experienced TINNITUS (tinnitus). At the time of the report, TINNITUS (tinnitus) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided. Patient developed tinnitus, it started about July or August.   This case was linked to MOD-2021-067759 (Patient Link).
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Vaccination site pruritus
Clinical narrative: Starting having a cough; Itching at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Starting having a cough) and VACCINATION SITE PRURITUS (Itching at the site of the injection) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PRURITUS (Itching at the site of the injection). On 22-Nov-2021, the patient experienced COUGH (Starting having a cough). On 23-Nov-2021, VACCINATION SITE PRURITUS (Itching at the site of the injection) had resolved. At the time of the report, COUGH (Starting having a cough) outcome was unknown.            Patient had no record of allergies. Patient had taken Moderna booster shot 6 months after second dose. No Concomitant medications were reported. No treatment medications were reported. Patient's itching went away for a few hours then came back. It was coming and going for the past two days. Patient started having a cough after the first day.
Age: 0.92
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: the patient has had no known side effects; inadvertently gave PROQUAD and VARlVAX instead of MMR-11 and VARlVAX resulting in the 1 year old patient getting an extra dose of varicella; This spontaneous report was received from a medical assistant and refers to a 11-month-old (also reported as 1 year old) patient of an unknown gender. Information regarding the patient's drug reactions or allergies, concomitant therapies and pertinent medical history was not provided. On 04-NOV-2021, the reporter inadvertently gave the patient measles (+) mumps (+) rubella (+) varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (lot # T032150, expiry date 20-MAR-2022) and varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U010399, expiry date 01-APR-2023), both: 0.5mL (1 dose), subcutaneously, for prophylaxis (formulation, concentration, dose number, frequency for both vaccines were not reported) instead of measles (+) mumps (+) rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX), resulting in the patient getting an extra dose of varicella. The patient has had no known side effects at this time.
Age: 0.17
Sex: U
Vaccine: HIBV, UNK
Symptoms: Accidental overdose, No adverse event, Wrong product administered
Clinical narrative: no additional adverse events reported; patient received V AXELIS plus PEDV AXHIB today in error; received VAXELIS plus PEDVAXHIB today in error / PREVNAR was intended to be given instead of PEDVAXHIB / this was a general human error; This spontaneous report was received from a certified medical assistant and refers to a 2-month-old patient of an unknow gender. No information regarding the patient's medical history or concurrent condition was provided. Her concomitant medications included Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ).  On 22-NOV-2021, the patient received diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (VAXELIS) lot # U7124AA was confirmed to be valid, expiration date 13-JUL-2024, 1 dose (exact dose, route and site of administration were not reported) and Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot # T042015 was confirmed to be valid, expiration date 23-JUL-2023, 1 dose (exact dose, route and site of administration were not reported) both for prophylaxis, reported as in error. Pneumococcal vaccine conj 7v (crm197) (PREVNAR) was intended to be given instead of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) and there was nothing regarding packaging that caused this error. It was reported as a general human error (wrong product administered, accidental overdose). No further information was provided. No additional adverse events were reported.
Sex: M
Vaccine: HEPAB, HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a male patient of unknown age. The patient's medical history, concurrent conditions, and drug reactions/allergies were not reported. His concomitant therapies included Hepatitis A vaccine inact, Hepatitis B vaccine rhbsag (yeast) (TWINRIX) (administered on the same dates as hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)). On 22-OCT-2021, he was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (dose, frequency, route of administration, lot number and expiration date were not provided). Then, on 29-NOV-2021 (also reported as today), he was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) dose 2 (inappropriate schedule of product administration). No other events were reported by the pharmacist. The outcome of the event was unknown.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: Expired product administered, No adverse event, Product preparation issue
Clinical narrative: no additional AE reproted; Varivax was mixed with an expired diluent and administered to a patient; Varivax was mixed with an expired diluent and administered to a patient; This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies, and concomitant therapies were not reported.  On 26-NOV-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (dose, frequency, and route of administration were not reported, lot number U002398, expiration date 22-JAN-2023) for prophylaxis. The vaccine was mixed with an expired sterile diluent (lot number R009955, expiration date 24-JAN-2021) (expired product administered and product preparation issue). Both products were properly stored. No additional adverse event occurred.  The outcome of the events was unknown.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; MMR-II that underwent temperature excursions was administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided.      On 03-SEP-2021 the patient was vaccinated with a Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant human albumin (rHA) (M-M-RVAXPRO) however reporter was unsure about which lot number administered to patient (Lot T000890 with expiration date reported 08-JAN-2022 and Lot T010650 with expiration date reported 26-MAR-2022 (dose, strength, frequency, route of administration and anatomical location were not provided) for prophylaxis, which was improperly stored (product storage error).  The temperature of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-RVAXPRO) was stored had been above was 46F (49.6F) for 2 hours 21 minutes for lot T000890 and was 46F (56.1F) for 3 hours 33 minutes for Lot T010650. No additional adverse effect was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA000049: US-009507513-2112USA000050: US-009507513-2112USA000051:
Sex: U
Vaccine: VARZOS
Symptoms: Oral herpes, Therapeutic response unexpected
Clinical narrative: This case was reported by a consumer and described the occurrence of unexpected therapeutic effect in a patient who received Herpes Zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of no adverse event (Shingrix vaccine was administered over 2 years ago.). On an unknown date, the patient received Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced unexpected therapeutic effect and fever blister. On an unknown date, the outcome of the unexpected therapeutic effect and fever blister were unknown. It was unknown if the reporter considered the unexpected therapeutic effect and fever blister to be related to Shingrix. Additional details were reported as follows: The patient had suffered with fever blisters through his/her entire life. The patient reported that he/she had administered with dose of Shingrix over 2 years ago and experienced a positive side effect of reduction in fever blisters. Age at vaccination were not reported. Consent to follow up was requested.
Sex: U
Vaccine: COVID19, MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: received Menveo reconstituted with Pfizer Covid diluent; received Menveo reconstituted with Pfizer Covid diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA569A, expiry date unknown) for prophylaxis.   Co-suspect products included TOZINAMERAN (COVID 19 VACCINE PFIZER) for prophylaxis.   On an unknown date, the patient received Menveo and COVID 19 VACCINE PFIZER. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination were not reported. The health care professional  reported that patient who were due for MENVEO and were going to receive Covid Pfizer vaccine. On the same day received the Menveo lyophilized powder portion after being reconstituted with Pfizer Covid diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. No reactions reported. The reporter consented to follow up. This case was linked with 12 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR243478:Same reporter US-GLAXOSMITHKLINE-US2021AMR243472:Same reporter US-GLAXOSMITHKLINE-US2021AMR243477:Same reporter US-GLAXOSMITHKLINE-US2021AMR243469:Same reporter US-GLAXOSMITHKLINE-US2021AMR243475:Same reporter US-GLAXOSMITHKLINE-US2021AMR243473:Same reporter US-GLAXOSMITHKLINE-US2021AMR243470:Same reporter US-GLAXOSMITHKLINE-US2021AMR243476:Same reporter US-GLAXOSMITHKLINE-US2021AMR243474:Same reporter US-GLAXOSMITHKLINE-US2021AMR243479:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient received 1st dose of Shingrix and he had a fever but it only lasted 2 days. The reporter consented to follow up. For tolerance of 2nd dose refer case US2021245483, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021245483:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st shot 11 months ago; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose, 11 months ago of reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not applicable for this report. The patient missed second shingrix shot, which led to incomplete course of vaccination. The patient waned to know what was the plan, if he/she needed to start over or he/she should get the second shot would that be ok. The follow-up would not possible as no contact details were available.