chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: dose received from vial opend> 12h; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dose received from vial opend> 12h) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included COVID-19, Pulmonary embolism and Renal disease (Acute). Previously administered products included for Product used for unknown indication: Pfizer (Dose 1) on 23-Feb-2021 and Pfizer (Dose 2) on 18-Mar-2021; for Influenza: Fluzone (Route of administration of vaccine was IM ) on 01-Dec-2021; for Pneumonia: pneumonia (Route of administration of vaccine was IM ) on 01-Dec-2021. Past adverse reactions to the above products included No adverse event with Fluzone, Pfizer, Pfizer and pneumonia. Concurrent medical conditions included Hypertension and COPD. Concomitant products included ALBUTEROL [SALBUTAMOL], ALLOPURINOL, BACLOFEN and APIXABAN (ELIQUIS) for an unknown indication.    On 06-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dose received from vial opend> 12h). On 06-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dose received from vial opend> 12h) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drug Abnol Treatment information was not provided.   This case was linked to MOD-2021-416295 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Booster given greater than 12 hours post puncture of vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster given greater than 12 hours post puncture of vial) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster given greater than 12 hours post puncture of vial). On 14-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Booster given greater than 12 hours post puncture of vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-416295 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: muscle aches; muscles that move joint behind knees aches/both knees and shoulders aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle aches) and ARTHRALGIA (muscles that move joint behind knees aches/both knees and shoulders aches) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A and 025C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In June 2021, the patient experienced MYALGIA (muscle aches) and ARTHRALGIA (muscles that move joint behind knees aches/both knees and shoulders aches). The patient was treated with ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, MYALGIA (muscle aches) and ARTHRALGIA (muscles that move joint behind knees aches/both knees and shoulders aches) was resolving.            No concomitant medications were reported.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: body aches; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches) and PYREXIA (Low grade fever) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (body aches) and PYREXIA (Low grade fever). At the time of the report, MYALGIA (body aches) and PYREXIA (Low grade fever) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication details were not reported by the reporter.  Partent took Antihistamines daily as treatment medications.   This case was linked to MOD-2021-435530, MOD-2021-435537 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: administered 2 doses from vials that were stored for more than 30 days at the fridge; administered 2 doses from vials that were stored for more than 30 days at the fridge; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 2 doses from vials that were stored for more than 30 days at the fridge) and PRODUCT STORAGE ERROR (administered 2 doses from vials that were stored for more than 30 days at the fridge) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Drug allergy (Norvasc).    On 06-Dec-2021 at 2:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 06-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 2 doses from vials that were stored for more than 30 days at the fridge) and PRODUCT STORAGE ERROR (administered 2 doses from vials that were stored for more than 30 days at the fridge). On 06-Dec-2021, EXPIRED PRODUCT ADMINISTERED (administered 2 doses from vials that were stored for more than 30 days at the fridge) and PRODUCT STORAGE ERROR (administered 2 doses from vials that were stored for more than 30 days at the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were provided.  Dose was stored in the fridge on 3 Nov 2021. Patient had no adverse event.   This case was linked to MOD-2021-406580 (Patient Link).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Hypersensitivity, Oropharyngeal discomfort, Periorbital swelling
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (hives/welts all over his body), PHARYNGEAL SWELLING (throat was swelling up), PERIORBITAL SWELLING (eyes all puffy), PRURITUS (itchiness) and OROPHARYNGEAL DISCOMFORT (throat closing sensation) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for Product used for unknown indication: Johnson and Johnson vaccine (Primary series.) on 20-Apr-2021.Past adverse reactions to the above products included No adverse event with Johnson and Johnson vaccine. On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced RASH (rash are mostly on his upper thigh, upper body, and hands). On 17-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (hives/welts all over his body), PRURITUS (itchiness), HYPERSENSITIVITY (Allergic reaction), PYREXIA (Fever) and CHILLS (Chills). On 18-Nov-2021, the patient experienced PERIORBITAL SWELLING (eyes all puffy). On 20-Nov-2021, the patient experienced PHARYNGEAL SWELLING (throat was swelling up) and DYSPNOEA (he was having trouble breathing/difficulty breathing). On 23-Nov-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (throat closing sensation). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) in November 2021 for Adverse event, at an unspecified dose and frequency and EPINEPHRINE (EPIPEN) in November 2021 for Adverse event, at an unspecified dose and frequency. In December 2021, DYSPNOEA (he was having trouble breathing/difficulty breathing) had resolved. At the time of the report, URTICARIA (hives/welts all over his body), PHARYNGEAL SWELLING (throat was swelling up), PERIORBITAL SWELLING (eyes all puffy), PRURITUS (itchiness), RASH (rash are mostly on his upper thigh, upper body, and hands), HYPERSENSITIVITY (Allergic reaction), PYREXIA (Fever) and CHILLS (Chills) had not resolved and OROPHARYNGEAL DISCOMFORT (throat closing sensation) outcome was unknown. Concomitant product use was not provided by the reporter.For patient other treatment medication included Steroids. Steroids has been prescribed on 18-Nov-2021 when patient visited to an urgent care.Further on 18-NOV-2021 patient visited urgent care twice. On 20-Nov-2021 patient visited emergency room once again and he was administrated steroids. On 23-Nov-2021 patient was in emergency room once again where he was observed for three to four hours then discharged. Patient took epinephrine before his next appointment and which was fixed on 09-Dec-2021. On 09-Dec-2021 patient's primary care doctor referred him to an allergist.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Pruritus, Pyrexia, Rash, Urticaria
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (hives/welts all over his body), PHARYNGEAL SWELLING (throat was swelling up), PERIORBITAL SWELLING (eyes all puffy), PRURITUS (itchiness) and OROPHARYNGEAL DISCOMFORT (throat closing sensation) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for Product used for unknown indication: Johnson and Johnson vaccine (Primary series.) on 20-Apr-2021.Past adverse reactions to the above products included No adverse event with Johnson and Johnson vaccine. On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced RASH (rash are mostly on his upper thigh, upper body, and hands). On 17-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (hives/welts all over his body), PRURITUS (itchiness), HYPERSENSITIVITY (Allergic reaction), PYREXIA (Fever) and CHILLS (Chills). On 18-Nov-2021, the patient experienced PERIORBITAL SWELLING (eyes all puffy). On 20-Nov-2021, the patient experienced PHARYNGEAL SWELLING (throat was swelling up) and DYSPNOEA (he was having trouble breathing/difficulty breathing). On 23-Nov-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (throat closing sensation). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) in November 2021 for Adverse event, at an unspecified dose and frequency and EPINEPHRINE (EPIPEN) in November 2021 for Adverse event, at an unspecified dose and frequency. In December 2021, DYSPNOEA (he was having trouble breathing/difficulty breathing) had resolved. At the time of the report, URTICARIA (hives/welts all over his body), PHARYNGEAL SWELLING (throat was swelling up), PERIORBITAL SWELLING (eyes all puffy), PRURITUS (itchiness), RASH (rash are mostly on his upper thigh, upper body, and hands), HYPERSENSITIVITY (Allergic reaction), PYREXIA (Fever) and CHILLS (Chills) had not resolved and OROPHARYNGEAL DISCOMFORT (throat closing sensation) outcome was unknown. Concomitant product use was not provided by the reporter.For patient other treatment medication included Steroids. Steroids has been prescribed on 18-Nov-2021 when patient visited to an urgent care.Further on 18-NOV-2021 patient visited urgent care twice. On 20-Nov-2021 patient visited emergency room once again and he was administrated steroids. On 23-Nov-2021 patient was in emergency room once again where he was observed for three to four hours then discharged. Patient took epinephrine before his next appointment and which was fixed on 09-Dec-2021. On 09-Dec-2021 patient's primary care doctor referred him to an allergist.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Myalgia, Pyrexia
Clinical narrative: First dose was on 15-Apr-2021 and second on 31-May-2021; body aches; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), PYREXIA (low grade fever) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was on 15-Apr-2021 and second on 31-May-2021) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A and 044B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was on 15-Apr-2021 and second on 31-May-2021). On an unknown date, the patient experienced MYALGIA (body aches) and PYREXIA (low grade fever). On 31-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was on 15-Apr-2021 and second on 31-May-2021) had resolved. At the time of the report, MYALGIA (body aches) and PYREXIA (low grade fever) had resolved.            Concomitant medication details were not reported by the reporter.  Patient took treatment drug as Antihistamines daily.   This case was linked to MOD-2021-435507, MOD-2021-435537 (Patient Link).
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis, Urticaria
Clinical narrative: breaking in hives; felt like psoriasis; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (breaking in hives) and PSORIASIS (felt like psoriasis) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068h21a, 022c21a and 009c21a) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Dec-2021, the patient experienced URTICARIA (breaking in hives) and PSORIASIS (felt like psoriasis). At the time of the report, URTICARIA (breaking in hives) and PSORIASIS (felt like psoriasis) had not resolved.            Concomitant information was not provided. Treatment information was not provided.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: inappropriate schedule of vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to Bactrim), Coronary artery disease (CAD), Low back pain, AFib, Hypertension (HTN) and Hyperlipidaemia (HLD). Concomitant products included ATORVASTATIN, APIXABAN (ELIQUIS), TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), FLUOXETINE HYDROCHLORIDE (PROZAC) and POTASSIUM for an unknown indication.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). On 18-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received booster dose on 13-Dec-2021.  Treatment information was not reported.   This case was linked to MOD-2021-435309 (Patient Link).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Feeling tight in the throat; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Feeling tight in the throat) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H214) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer (First two shots were Pfizer.). Past adverse reactions to the above products included No adverse event with Pfizer. Concurrent medical conditions included Shellfish allergy (Patient mentioned whenever she had contact with shellfish, her hand would blow up.). Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced THROAT TIGHTNESS (Feeling tight in the throat). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Throat tightness, at an unspecified dose and frequency. At the time of the report, THROAT TIGHTNESS (Feeling tight in the throat) was resolving.            Patient was not pregnant. Patient asked whether shellfish or shellfish-derivatives ingredients in the Moderna booster were there shot. She said she read the ingredients but was not sure. Patient was not sure if throat was feeling tight was related to the vaccine. Apart from that patient had no other symptoms. Symptoms started around 2 hours after the shot, it was subtle at first, but started feeling tight in the throat so patient looked up the ingredient list. She's feeling better after taking one Benadryl. Patient has not seen a doctor about it.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Discomfort, Dyspnoea, Fatigue
Clinical narrative: first 48-52 hours were like torture; call it brain fog, have no cognitive ability; couldn't go out of bed; couldn't get comfortable; couldn't eat; it was hard to sleep; was tremendously weak; winded, it was hard to catch breath; feel achy literally all over; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (first 48-52 hours were like torture), FEELING ABNORMAL (call it brain fog, have no cognitive ability), BEDRIDDEN (couldn't go out of bed), DISCOMFORT (couldn't get comfortable) and FEEDING DISORDER (couldn't eat) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COVID-19 (kept him sick until he got the second dose of the vaccine) since September 2020 and COVID-19 (beginning of April 2021, COVID-sick for 8 months up until he received the second dose of the vaccine.) since April 2021.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced VACCINATION COMPLICATION (first 48-52 hours were like torture), FEELING ABNORMAL (call it brain fog, have no cognitive ability), BEDRIDDEN (couldn't go out of bed), DISCOMFORT (couldn't get comfortable), FEEDING DISORDER (couldn't eat), INSOMNIA (it was hard to sleep), ASTHENIA (was tremendously weak), DYSPNOEA (winded, it was hard to catch breath), MYALGIA (feel achy literally all over) and FATIGUE (Fatigue). In April 2021, VACCINATION COMPLICATION (first 48-52 hours were like torture), FEELING ABNORMAL (call it brain fog, have no cognitive ability), BEDRIDDEN (couldn't go out of bed), DISCOMFORT (couldn't get comfortable), FEEDING DISORDER (couldn't eat), INSOMNIA (it was hard to sleep), ASTHENIA (was tremendously weak), DYSPNOEA (winded, it was hard to catch breath), MYALGIA (feel achy literally all over) and FATIGUE (Fatigue) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient received his vaccine on his left side. Patient takes concomitant medication for many years  but it was not reported.  COVID test was not done. No treatment information was reported.    This case was linked to MOD-2021-435744, MOD-2021-435745 (Patient Link).
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Feeding disorder, Feeling abnormal, Insomnia, Myalgia, Vaccination complication
Clinical narrative: first 48-52 hours were like torture; call it brain fog, have no cognitive ability; couldn't go out of bed; couldn't get comfortable; couldn't eat; it was hard to sleep; was tremendously weak; winded, it was hard to catch breath; feel achy literally all over; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (first 48-52 hours were like torture), FEELING ABNORMAL (call it brain fog, have no cognitive ability), BEDRIDDEN (couldn't go out of bed), DISCOMFORT (couldn't get comfortable) and FEEDING DISORDER (couldn't eat) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COVID-19 (kept him sick until he got the second dose of the vaccine) since September 2020 and COVID-19 (beginning of April 2021, COVID-sick for 8 months up until he received the second dose of the vaccine.) since April 2021.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced VACCINATION COMPLICATION (first 48-52 hours were like torture), FEELING ABNORMAL (call it brain fog, have no cognitive ability), BEDRIDDEN (couldn't go out of bed), DISCOMFORT (couldn't get comfortable), FEEDING DISORDER (couldn't eat), INSOMNIA (it was hard to sleep), ASTHENIA (was tremendously weak), DYSPNOEA (winded, it was hard to catch breath), MYALGIA (feel achy literally all over) and FATIGUE (Fatigue). In April 2021, VACCINATION COMPLICATION (first 48-52 hours were like torture), FEELING ABNORMAL (call it brain fog, have no cognitive ability), BEDRIDDEN (couldn't go out of bed), DISCOMFORT (couldn't get comfortable), FEEDING DISORDER (couldn't eat), INSOMNIA (it was hard to sleep), ASTHENIA (was tremendously weak), DYSPNOEA (winded, it was hard to catch breath), MYALGIA (feel achy literally all over) and FATIGUE (Fatigue) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient received his vaccine on his left side. Patient takes concomitant medication for many years  but it was not reported.  COVID test was not done. No treatment information was reported.    This case was linked to MOD-2021-435744, MOD-2021-435745 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Pain, Paraesthesia, Peripheral swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (achiness), PARAESTHESIA (Left ring finger started to feel tingly), SKIN DISCOLOURATION (Her left ring finger, it started swelling and was purplish) and PERIPHERAL SWELLING (Her left ring finger, it started swelling and was purplish) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A, 028L20A and 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Aug-2021, the patient experienced PARAESTHESIA (Left ring finger started to feel tingly), SKIN DISCOLOURATION (Her left ring finger, it started swelling and was purplish) and PERIPHERAL SWELLING (Her left ring finger, it started swelling and was purplish). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (achiness) and FATIGUE (Extreme fatigue, exhausted). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) 23-Aug-2021 for Adverse event, at an unspecified dose and frequency. On 23-Aug-2021, PARAESTHESIA (Left ring finger started to feel tingly), SKIN DISCOLOURATION (Her left ring finger, it started swelling and was purplish) and PERIPHERAL SWELLING (Her left ring finger, it started swelling and was purplish) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (achiness) and FATIGUE (Extreme fatigue, exhausted) outcome was unknown. No Concomitant medications were reported. She experienced flu like symptoms with all of the doses of the Moderna vaccine with achiness, extreme fatigue, and feeling totally exhausted the next day.5-10 minutes following the booster dose of the vaccine, her left ring finger started to feel tingly. It started swelling and was purplish. Her symptoms resolved for a total of 1.5 hours.The patient spoke to her oncologist who said that she should receive an additional dose of the vaccine as it was nearing 6 months after her first booster dose. The patient has been taking a long term hormonal treatment under the direction of her oncologist.This case was linked to MOD-2021-435755, MOD-2021-435757 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (achiness), PARAESTHESIA (Left ring finger started to feel tingly), SKIN DISCOLOURATION (Her left ring finger, it started swelling and was purplish) and PERIPHERAL SWELLING (Her left ring finger, it started swelling and was purplish) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A, 028L20A and 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Aug-2021, the patient experienced PARAESTHESIA (Left ring finger started to feel tingly), SKIN DISCOLOURATION (Her left ring finger, it started swelling and was purplish) and PERIPHERAL SWELLING (Her left ring finger, it started swelling and was purplish). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (achiness) and FATIGUE (Extreme fatigue, exhausted). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) 23-Aug-2021 for Adverse event, at an unspecified dose and frequency. On 23-Aug-2021, PARAESTHESIA (Left ring finger started to feel tingly), SKIN DISCOLOURATION (Her left ring finger, it started swelling and was purplish) and PERIPHERAL SWELLING (Her left ring finger, it started swelling and was purplish) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (achiness) and FATIGUE (Extreme fatigue, exhausted) outcome was unknown. No Concomitant medications were reported. She experienced flu like symptoms with all of the doses of the Moderna vaccine with achiness, extreme fatigue, and feeling totally exhausted the next day.5-10 minutes following the booster dose of the vaccine, her left ring finger started to feel tingly. It started swelling and was purplish. Her symptoms resolved for a total of 1.5 hours.The patient spoke to her oncologist who said that she should receive an additional dose of the vaccine as it was nearing 6 months after her first booster dose. The patient has been taking a long term hormonal treatment under the direction of her oncologist.This case was linked to MOD-2021-435755, MOD-2021-435757 (Patient Link).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic spontaneous urticaria, Histamine level, Mechanical urticaria, Rhinorrhoea, Urticaria
Clinical narrative: Hives all over the body; dermatagraphism; chronic spontaneous urticaria; runny nose in the beginning; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives all over the body), MECHANICAL URTICARIA (dermatagraphism), CHRONIC SPONTANEOUS URTICARIA (chronic spontaneous urticaria) and RHINORRHOEA (runny nose in the beginning) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 013M20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient experienced URTICARIA (Hives all over the body). November 2021, the patient experienced MECHANICAL URTICARIA (dermatagraphism), CHRONIC SPONTANEOUS URTICARIA (chronic spontaneous urticaria) and RHINORRHOEA (runny nose in the beginning). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing from November 2021 for Hives and Dermatographism, at a dose of 2 dosage form once a day and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing from November 2021 for Hives and Dermatographism, at a dose of UNK, qd. At the time of the report, URTICARIA (Hives all over the body), MECHANICAL URTICARIA (dermatagraphism), CHRONIC SPONTANEOUS URTICARIA (chronic spontaneous urticaria) and RHINORRHOEA (runny nose in the beginning) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Histamine level: high (High) high histamine levels..         Concomitant product use was not provided by the reporter.  Patient stated that  8 days later after the booster shot, patient had hives all over the body and visited a dermatologist who said she was having dermatagraphism for which she took oral antihistamines and stated that it was a month long thing now. Patient was taking two  Zyrtec per day and one  Benadryl in the evening.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Dyspepsia, Flatulence, Muscle spasms, Vaccination site pain
Clinical narrative: feels like i had a bruise; Stated" probably i got a reaction; and tender on the injection site , Caller also stated that it is sore on the injection site , on her left side it is tender; within half an hour she got really bad cramps on her chest; almost like gas; like indigestion; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (within half an hour she got really bad cramps on her chest), FLATULENCE (almost like gas), DYSPEPSIA (like indigestion), CONTUSION (feels like i had a bruise) and VACCINATION SITE REACTION (Stated" probably i got a reaction) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041J21A, 044A21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Dec-2021, the patient experienced MUSCLE SPASMS (within half an hour she got really bad cramps on her chest), FLATULENCE (almost like gas) and DYSPEPSIA (like indigestion). On an unknown date, the patient experienced CONTUSION (feels like i had a bruise) and VACCINATION SITE REACTION (Stated" probably i got a reaction). an unknown date, the patient experienced VACCINATION SITE PAIN (and tender on the injection site , Caller also stated that it is sore on the injection site , on her left side it is tender). On 27-Dec-2021, MUSCLE SPASMS (within half an hour she got really bad cramps on her chest), FLATULENCE (almost like gas) and DYSPEPSIA (like indigestion) had resolved. At the time of the report, CONTUSION (feels like i had a bruise), VACCINATION SITE REACTION (Stated" probably i got a reaction) and VACCINATION SITE PAIN (and tender on the injection site , Caller also stated that it is sore on the injection site , on her left side it is tender) outcome was unknown.            patient concomitant medication 3 high blood pressure pills   This case was linked to MOD-2021-435768 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: feels like i had a bruise; Stated" probably i got a reaction; and tender on the injection site , Caller also stated that it is sore on the injection site , on her left side it is tender; within half an hour she got really bad cramps on her chest; almost like gas; like indigestion; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (within half an hour she got really bad cramps on her chest), FLATULENCE (almost like gas), DYSPEPSIA (like indigestion), CONTUSION (feels like i had a bruise) and VACCINATION SITE REACTION (Stated" probably i got a reaction) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041J21A, 044A21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Dec-2021, the patient experienced MUSCLE SPASMS (within half an hour she got really bad cramps on her chest), FLATULENCE (almost like gas) and DYSPEPSIA (like indigestion). On an unknown date, the patient experienced CONTUSION (feels like i had a bruise) and VACCINATION SITE REACTION (Stated" probably i got a reaction). an unknown date, the patient experienced VACCINATION SITE PAIN (and tender on the injection site , Caller also stated that it is sore on the injection site , on her left side it is tender). On 27-Dec-2021, MUSCLE SPASMS (within half an hour she got really bad cramps on her chest), FLATULENCE (almost like gas) and DYSPEPSIA (like indigestion) had resolved. At the time of the report, CONTUSION (feels like i had a bruise), VACCINATION SITE REACTION (Stated" probably i got a reaction) and VACCINATION SITE PAIN (and tender on the injection site , Caller also stated that it is sore on the injection site , on her left side it is tender) outcome was unknown.            patient concomitant medication 3 high blood pressure pills   This case was linked to MOD-2021-435768 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Pain
Clinical narrative: flu like symptoms; achiness; extreme fatigue, exhausted; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (achiness) and FATIGUE (extreme fatigue, exhausted) in a 60-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 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (achiness) and FATIGUE (extreme fatigue, exhausted). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (achiness) and FATIGUE (extreme fatigue, exhausted) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-435712, MOD-2021-435757 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Pain
Clinical narrative: flu like symptoms; achiness; extreme fatigue, exhausted; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (achiness) and FATIGUE (extreme fatigue, exhausted) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (achiness) and FATIGUE (extreme fatigue, exhausted). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (achiness) and FATIGUE (extreme fatigue, exhausted) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment medications were reported.  Patient experienced flu like symptoms with all of the doses of the Moderna vaccine with achiness, extreme fatigue, and feeling totally exhausted the next day.  She has been taking a long term hormonal treatment under the direction of her oncologist.   This case was linked to MOD-2021-435712, MOD-2021-435755 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Vaccination site induration
Clinical narrative: Patient felt a pressure on arm; Patient felt a ball of hardness like an abscess in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Patient felt a pressure on arm) and VACCINATION SITE INDURATION (Patient felt a ball of hardness like an abscess in the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051H21A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 29-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced LIMB DISCOMFORT (Patient felt a pressure on arm) and VACCINATION SITE INDURATION (Patient felt a ball of hardness like an abscess in the injection site). At the time of the report, LIMB DISCOMFORT (Patient felt a pressure on arm) and VACCINATION SITE INDURATION (Patient felt a ball of hardness like an abscess in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient treated with mega garlic for the pain
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Illness, Mobility decreased
Clinical narrative: had awful reactions; Took everything that I had to get up to get something to eat and go to the bathroom.; sick for 2 weeks; diarrhea; high fever; vomiting; chills; bad headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had awful reactions), MOBILITY DECREASED (Took everything that I had to get up to get something to eat and go to the bathroom.), ILLNESS (sick for 2 weeks), DIARRHOEA (diarrhea) and PYREXIA (high fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. 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 01-Mar-2021, the patient experienced VACCINATION COMPLICATION (had awful reactions), MOBILITY DECREASED (Took everything that I had to get up to get something to eat and go to the bathroom.), ILLNESS (sick for 2 weeks), DIARRHOEA (diarrhea), PYREXIA (high fever), VOMITING (vomiting), CHILLS (chills) and HEADACHE (bad headache). In March 2021, ILLNESS (sick for 2 weeks) had resolved. At the time of the report, VACCINATION COMPLICATION (had awful reactions), MOBILITY DECREASED (Took everything that I had to get up to get something to eat and go to the bathroom.), DIARRHOEA (diarrhea), PYREXIA (high fever), VOMITING (vomiting), CHILLS (chills) and HEADACHE (bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. No treatment information was reported. Patient stated that she received her vaccine in her left arm shoulder deltoid muscle.   This case was linked to MOD-2021-435845 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination complication, Vomiting
Clinical narrative: had awful reactions; Took everything that I had to get up to get something to eat and go to the bathroom.; sick for 2 weeks; diarrhea; high fever; vomiting; chills; bad headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had awful reactions), MOBILITY DECREASED (Took everything that I had to get up to get something to eat and go to the bathroom.), ILLNESS (sick for 2 weeks), DIARRHOEA (diarrhea) and PYREXIA (high fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. 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 01-Mar-2021, the patient experienced VACCINATION COMPLICATION (had awful reactions), MOBILITY DECREASED (Took everything that I had to get up to get something to eat and go to the bathroom.), ILLNESS (sick for 2 weeks), DIARRHOEA (diarrhea), PYREXIA (high fever), VOMITING (vomiting), CHILLS (chills) and HEADACHE (bad headache). In March 2021, ILLNESS (sick for 2 weeks) had resolved. At the time of the report, VACCINATION COMPLICATION (had awful reactions), MOBILITY DECREASED (Took everything that I had to get up to get something to eat and go to the bathroom.), DIARRHOEA (diarrhea), PYREXIA (high fever), VOMITING (vomiting), CHILLS (chills) and HEADACHE (bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. No treatment information was reported. Patient stated that she received her vaccine in her left arm shoulder deltoid muscle.   This case was linked to MOD-2021-435845 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Pain in extremity
Clinical narrative: didn't feel right; soreness on his arm; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (didn't feel right), PAIN IN EXTREMITY (soreness on his arm) and FATIGUE (tiredness) 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 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 MALAISE (didn't feel right), PAIN IN EXTREMITY (soreness on his arm) and FATIGUE (tiredness). At the time of the report, MALAISE (didn't feel right), PAIN IN EXTREMITY (soreness on his arm) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient mentioned that her husband for 4-5 days after vaccination didn't feel right and experienced soreness on his arm and tiredness No concomitant treatment was provided. No treatment medication was provided.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given to patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patients) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patients). On 29-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medication were not reported.  The vial was punctured on 28 DEC 2021, and used for up to 17 hours post puncture. No patients have reported any side effects from this dose.