chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Rhinorrhoea, Sinusitis
Clinical narrative: bad sinus infection; excess secretion coming out of their nose; excess secretion in their lung,have been coughing; This spontaneous case was reported by an other health care professional and describes the occurrence of SINUSITIS (bad sinus infection), RHINORRHOEA (excess secretion coming out of their nose) and COUGH (excess secretion in their lung,have been coughing) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Foramen ovale patent, Atrial septal defect repair and Thyroidectomy. Concurrent medical conditions included Lymphedema since 2011, Lipedema since 2011 and Asthma. Concomitant products included BECLOMETASONE DIPROPIONATE (QVAR) for Asthma, APIXABAN (ELIQUIS) for Clot blood, CORTISONE for Foramen ovale patent, OMEPRAZOLE for Reflux gastritis, LEVOTHYROXINE for an unknown indication.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Sep-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SINUSITIS (bad sinus infection), RHINORRHOEA (excess secretion coming out of their nose) and COUGH (excess secretion in their lung,have been coughing). The patient was treated with LEVALBUTEROL [LEVOSALBUTAMOL] ongoing since an unknown date at a dose of UNK UNK, q6h. At the time of the report, SINUSITIS (bad sinus infection), RHINORRHOEA (excess secretion coming out of their nose) and COUGH (excess secretion in their lung,have been coughing) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   they need 2 knee replacement. Patient had Lymphedema and Lipedema for which they use a leg compression chamber due to a condition called degenerated osteoarthritis that is at their final stage. They had this for 10 years now but it got worse about 20 months back and they can hardly walk and had to stop working and retired.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Having flu like symptoms; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (Having flu like symptoms) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Having flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Having flu like symptoms) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Paraesthesia, Pruritus, Rash
Clinical narrative: itching burning rash in whole face; itching burning rash in whole face; is only tingling/today is the first day can say it is only tingling; A week after booster patient developed itching in face; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (A week after booster patient developed itching in face), PARAESTHESIA (is only tingling/today is the first day can say it is only tingling), BURNING SENSATION (itching burning rash in whole face) and RASH (itching burning rash in whole face) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 935904, 001B21A and 024M20A) 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) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Oct-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 PRURITUS (A week after booster patient developed itching in face). On 27-Dec-2021, the patient experienced PARAESTHESIA (is only tingling/today is the first day can say it is only tingling). On an unknown date, the patient experienced BURNING SENSATION (itching burning rash in whole face) and RASH (itching burning rash in whole face). At the time of the report, PRURITUS (A week after booster patient developed itching in face), BURNING SENSATION (itching burning rash in whole face) and RASH (itching burning rash in whole face) had resolved and PARAESTHESIA (is only tingling/today is the first day can say it is only tingling) had not resolved.            No concomitant medication was given.  Patient treatment included cold in the face and anithisitamines. Reportedly, booster hurt 3-times as bad as the other too.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site induration, Vaccination site mass, Vaccination site rash, Vaccination site swelling
Clinical narrative: the swelling moved down and was a puffy bubble on the top of her elbow that was hot; the swelling moved down and was a puffy bubble on the top of her elbow that was hot; the injection site was hard; had a rash from the injection site to her elbow; body ached; the injection site swelled up really big; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (the swelling moved down and was a puffy bubble on the top of her elbow that was hot), VACCINATION SITE INDURATION (the injection site was hard), VACCINATION SITE MASS (the swelling moved down and was a puffy bubble on the top of her elbow that was hot), VACCINATION SITE RASH (had a rash from the injection site to her elbow) and MYALGIA (body ached) in an 80-year-old female 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.     The patient's past medical history included COVID-19 in August 2021.    On 23-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Dec-2021, the patient experienced VACCINATION SITE INDURATION (the injection site was hard), VACCINATION SITE RASH (had a rash from the injection site to her elbow), MYALGIA (body ached) and VACCINATION SITE SWELLING (the injection site swelled up really big). On 25-Dec-2021, the patient experienced VACCINATION SITE WARMTH (the swelling moved down and was a puffy bubble on the top of her elbow that was hot) and VACCINATION SITE MASS (the swelling moved down and was a puffy bubble on the top of her elbow that was hot). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (the swelling moved down and was a puffy bubble on the top of her elbow that was hot), VACCINATION SITE INDURATION (the injection site was hard), VACCINATION SITE MASS (the swelling moved down and was a puffy bubble on the top of her elbow that was hot), VACCINATION SITE RASH (had a rash from the injection site to her elbow) and MYALGIA (body ached) outcome was unknown and VACCINATION SITE SWELLING (the injection site swelled up really big) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment includes: An allergy tab & iced. No concomitant medications were reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: the swelling moved down and was a puffy bubble on the top of her elbow that was hot; the swelling moved down and was a puffy bubble on the top of her elbow that was hot; the injection site was hard; had a rash from the injection site to her elbow; body ached; the injection site swelled up really big; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (the swelling moved down and was a puffy bubble on the top of her elbow that was hot), VACCINATION SITE INDURATION (the injection site was hard), VACCINATION SITE MASS (the swelling moved down and was a puffy bubble on the top of her elbow that was hot), VACCINATION SITE RASH (had a rash from the injection site to her elbow) and MYALGIA (body ached) in an 80-year-old female 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.     The patient's past medical history included COVID-19 in August 2021.    On 23-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Dec-2021, the patient experienced VACCINATION SITE INDURATION (the injection site was hard), VACCINATION SITE RASH (had a rash from the injection site to her elbow), MYALGIA (body ached) and VACCINATION SITE SWELLING (the injection site swelled up really big). On 25-Dec-2021, the patient experienced VACCINATION SITE WARMTH (the swelling moved down and was a puffy bubble on the top of her elbow that was hot) and VACCINATION SITE MASS (the swelling moved down and was a puffy bubble on the top of her elbow that was hot). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (the swelling moved down and was a puffy bubble on the top of her elbow that was hot), VACCINATION SITE INDURATION (the injection site was hard), VACCINATION SITE MASS (the swelling moved down and was a puffy bubble on the top of her elbow that was hot), VACCINATION SITE RASH (had a rash from the injection site to her elbow) and MYALGIA (body ached) outcome was unknown and VACCINATION SITE SWELLING (the injection site swelled up really big) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment includes: An allergy tab & iced. No concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Surgery
Clinical narrative: Got a surgery; This spontaneous case was reported by a consumer and describes the occurrence of SURGERY (Got a surgery) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced SURGERY (Got a surgery). At the time of the report, SURGERY (Got a surgery) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain in extremity, Product dose omission issue
Clinical narrative: She never received a second dose of the vaccine; She has a sore arm, and could not sleep on it for 2 nights after the injection; She has a sore arm, and could not sleep on it for 2 nights after the injection; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (She has a sore arm, and could not sleep on it for 2 nights after the injection), PAIN IN EXTREMITY (She has a sore arm, and could not sleep on it for 2 nights after the injection) and PRODUCT DOSE OMISSION ISSUE (She never received a second dose of the vaccine) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Aug-2021, the patient experienced INSOMNIA (She has a sore arm, and could not sleep on it for 2 nights after the injection) and PAIN IN EXTREMITY (She has a sore arm, and could not sleep on it for 2 nights after the injection). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (She never received a second dose of the vaccine). On 30-Aug-2021, INSOMNIA (She has a sore arm, and could not sleep on it for 2 nights after the injection) and PAIN IN EXTREMITY (She has a sore arm, and could not sleep on it for 2 nights after the injection) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (She never received a second dose of the vaccine) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Concomitant medications were not reported.  It was reported that the patient received a single dose of the Moderna covid-19 vaccine by intramuscular injection on 28-AUG-2021. She had a sore arm, and could not sleep on it for 2 nights after the injection. She never received a second dose of the vaccine.  Treatment was reported as none.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Influenza like illness, Malaise, Myalgia
Clinical narrative: Not feeling well after booster dose; flu like symptoms,Minor flu like symptoms,Mild case of the flu; will feel crappy when she goes to work; Muscles are sore,Minor muscle aches; Minor headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well after booster dose), INFLUENZA LIKE ILLNESS (flu like symptoms,Minor flu like symptoms,Mild case of the flu), FEELING ABNORMAL (will feel crappy when she goes to work), MYALGIA (Muscles are sore,Minor muscle aches) and HEADACHE (Minor headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068H21A, 011A21A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, the patient experienced MALAISE (Not feeling well after booster dose), INFLUENZA LIKE ILLNESS (flu like symptoms,Minor flu like symptoms,Mild case of the flu), FEELING ABNORMAL (will feel crappy when she goes to work), MYALGIA (Muscles are sore,Minor muscle aches) and HEADACHE (Minor headache). At the time of the report, MALAISE (Not feeling well after booster dose), INFLUENZA LIKE ILLNESS (flu like symptoms,Minor flu like symptoms,Mild case of the flu), FEELING ABNORMAL (will feel crappy when she goes to work), MYALGIA (Muscles are sore,Minor muscle aches) and HEADACHE (Minor headache) outcome was unknown.            No concomitant medication details was provided. No treatment medication details was provided. The patient stated that the first 2 doses worked beautifully where patient was exposed to someone with covid and was hospitalized but the caller stated that patient was protected after being exposed to that person as patient had received her moderna vaccinations
Sex: U
Vaccine: COVID19
Symptoms: Cerebral haemorrhage
Clinical narrative: bleeding in the brain after vaccination; This spontaneous case was reported by a nurse and describes the occurrence of CEREBRAL HAEMORRHAGE (bleeding in the brain after vaccination) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     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 CEREBRAL HAEMORRHAGE (bleeding in the brain after vaccination) (seriousness criteria death and medically significant). The reported cause of death was bleeding in the brain after vaccination. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter.  Retired nurse read something online where there was a case of bleeding in the brain after vaccination and consumer ended up passing away.  No treatment medication was reported.  Company Comment: This spontaneous case concerns a patient, of unknown age and gender, with no medical history reported, who experienced the unexpected, serious AESI of cerebral haemorrhage after administration of an unspecified dose of the Moderna mRNA-1273 vaccine. The patient experienced bleeding in the brain after vaccination and eventually passed away on an unspecified date. No further information was provided. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient, of unknown age and gender, with no medical history reported, who experienced the unexpected, serious AESI of cerebral haemorrhage after administration of an unspecified dose of the Moderna mRNA-1273 vaccine. The patient experienced bleeding in the brain after vaccination and eventually passed away on an unspecified date. No further information was provided. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: bleeding in the brain after vaccination
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash after receiving Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash after receiving Moderna vaccine) 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 RASH (rash after receiving Moderna vaccine). At the time of the report, RASH (rash after receiving Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment drugs were reported.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dyspnoea, Fatigue, Nausea, Pyrexia
Clinical narrative: Had a tightness in her throat.; Feeling anxious; Shortness of breath; Fever; Nausea; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Had a tightness in her throat.), ANXIETY (Feeling anxious), DYSPNOEA (Shortness of breath), PYREXIA (Fever) and NAUSEA (Nausea) in a female patient of an unknown age 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 COVID-19 vaccination: Johnson and Johnson COVID-19 Vaccine (Covid-19 vaccine by intramuscular injection (lot number 1805022)) on 12-Mar-2021.  Past adverse reactions to the above products included No adverse event with Johnson and Johnson COVID-19 Vaccine.   On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROAT TIGHTNESS (Had a tightness in her throat.), ANXIETY (Feeling anxious), DYSPNOEA (Shortness of breath), PYREXIA (Fever), NAUSEA (Nausea) and FATIGUE (Felt tired). The patient was treated with IBUPROFEN on 24-Dec-2021 for Adverse event, at a dose of 2 extra strength. At the time of the report, THROAT TIGHTNESS (Had a tightness in her throat.), ANXIETY (Feeling anxious), DYSPNOEA (Shortness of breath), PYREXIA (Fever), NAUSEA (Nausea) and FATIGUE (Felt tired) outcome was unknown.     No Concomitant medication reported. Patient did not experience any side effects after receiving the J and J vaccine. She felt she had been anxious which had made the throat tightness worse. This tightness felt like someone's hands were around her throat. She took  ibuprofen for her symptoms, which made her feel better. She noted that symptom felt worse when she was stressed.
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Had a tightness in her throat.; Feeling anxious; Shortness of breath; Fever; Nausea; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Had a tightness in her throat.), ANXIETY (Feeling anxious), DYSPNOEA (Shortness of breath), PYREXIA (Fever) and NAUSEA (Nausea) in a female patient of an unknown age 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 COVID-19 vaccination: Johnson and Johnson COVID-19 Vaccine (Covid-19 vaccine by intramuscular injection (lot number 1805022)) on 12-Mar-2021.  Past adverse reactions to the above products included No adverse event with Johnson and Johnson COVID-19 Vaccine.   On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROAT TIGHTNESS (Had a tightness in her throat.), ANXIETY (Feeling anxious), DYSPNOEA (Shortness of breath), PYREXIA (Fever), NAUSEA (Nausea) and FATIGUE (Felt tired). The patient was treated with IBUPROFEN on 24-Dec-2021 for Adverse event, at a dose of 2 extra strength. At the time of the report, THROAT TIGHTNESS (Had a tightness in her throat.), ANXIETY (Feeling anxious), DYSPNOEA (Shortness of breath), PYREXIA (Fever), NAUSEA (Nausea) and FATIGUE (Felt tired) outcome was unknown.     No Concomitant medication reported. Patient did not experience any side effects after receiving the J and J vaccine. She felt she had been anxious which had made the throat tightness worse. This tightness felt like someone's hands were around her throat. She took  ibuprofen for her symptoms, which made her feel better. She noted that symptom felt worse when she was stressed.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Feeding disorder, Headache, Malaise
Clinical narrative: feels really sick; couldn't get out of bed and eat; couldn't get out of bed and eat; dizzy; headache; because of her nausea; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feels really sick), ASTHENIA (couldn't get out of bed and eat), FEEDING DISORDER (couldn't get out of bed and eat), DIZZINESS (dizzy) and HEADACHE (headache) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced MALAISE (feels really sick), ASTHENIA (couldn't get out of bed and eat), FEEDING DISORDER (couldn't get out of bed and eat), DIZZINESS (dizzy), HEADACHE (headache) and NAUSEA (because of her nausea). The patient was treated with CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) for Nausea, at an unspecified dose and frequency. At the time of the report, MALAISE (feels really sick), ASTHENIA (couldn't get out of bed and eat), FEEDING DISORDER (couldn't get out of bed and eat), DIZZINESS (dizzy), HEADACHE (headache) and NAUSEA (because of her nausea) outcome was unknown.      Concomitant medication included thyroid medication.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: feels really sick; couldn't get out of bed and eat; couldn't get out of bed and eat; dizzy; headache; because of her nausea; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feels really sick), ASTHENIA (couldn't get out of bed and eat), FEEDING DISORDER (couldn't get out of bed and eat), DIZZINESS (dizzy) and HEADACHE (headache) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced MALAISE (feels really sick), ASTHENIA (couldn't get out of bed and eat), FEEDING DISORDER (couldn't get out of bed and eat), DIZZINESS (dizzy), HEADACHE (headache) and NAUSEA (because of her nausea). The patient was treated with CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) for Nausea, at an unspecified dose and frequency. At the time of the report, MALAISE (feels really sick), ASTHENIA (couldn't get out of bed and eat), FEEDING DISORDER (couldn't get out of bed and eat), DIZZINESS (dizzy), HEADACHE (headache) and NAUSEA (because of her nausea) outcome was unknown.      Concomitant medication included thyroid medication.
Sex: F
Vaccine: COVID19
Symptoms: Breast feeding, Maternal exposure before pregnancy, Postpartum disorder, Premature delivery
Clinical narrative: Postpartum; Breastfeeding; Maternal Exposure before pregnancy; Had a c-section at 34 weeks; This spontaneous retrospective pregnancy case was reported by a nurse and describes the occurrence of POSTPARTUM DISORDER (Postpartum), PREMATURE DELIVERY (Had a c-section at 34 weeks), BREAST FEEDING (Breastfeeding) and MATERNAL EXPOSURE BEFORE PREGNANCY (Maternal Exposure before pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 18-Dec-2021, the patient experienced PREMATURE DELIVERY (Had a c-section at 34 weeks). On an unknown date, the patient experienced POSTPARTUM DISORDER (Postpartum), BREAST FEEDING (Breastfeeding) and MATERNAL EXPOSURE BEFORE PREGNANCY (Maternal Exposure before pregnancy). The cesarean delivery occurred on 18-Dec-2021, which was reported as Premature. For neonate 1, The outcome was reported as Delivered NOS. Patient was pumping and breastfeeding. At the time of the report, POSTPARTUM DISORDER (Postpartum) and PREMATURE DELIVERY (Had a c-section at 34 weeks) outcome was unknown and BREAST FEEDING (Breastfeeding) and MATERNAL EXPOSURE BEFORE PREGNANCY (Maternal Exposure before pregnancy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications list was not provided. Treatment information was not provided.   Patient needed to get her booster, and second dose was back in January. Patient was postpartum and wanted to make sure there were no contraindications to get the booster.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Cystitis noninfective, Cystoscopy, Fatigue, Palpitations, Urinary tract infection
Clinical narrative: Heart palpitation was worst after the second dose; Vascular swelling; Tired; Urinary tract infection; Bladder inflammation; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpitation was worst after the second dose), CYSTITIS NONINFECTIVE (Bladder inflammation), VASCULITIS (Vascular swelling), URINARY TRACT INFECTION (Urinary tract infection) and FATIGUE (Tired) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M2A) for COVID-19 vaccination.     The patient's past medical history included Partial lung resection (Lung surgery- Part of her lung was removed) in July 2020. Concomitant products included LEVOTHYROXINE and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced CYSTITIS NONINFECTIVE (Bladder inflammation) and URINARY TRACT INFECTION (Urinary tract infection). On an unknown date, the patient experienced PALPITATIONS (Heart palpitation was worst after the second dose), VASCULITIS (Vascular swelling) and FATIGUE (Tired). In December 2021, URINARY TRACT INFECTION (Urinary tract infection) had resolved. At the time of the report, PALPITATIONS (Heart palpitation was worst after the second dose), CYSTITIS NONINFECTIVE (Bladder inflammation), VASCULITIS (Vascular swelling) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cystoscopy: positive (Positive) Showed bladder infection. On an unknown date, Urine analysis: normal (normal) No infection.         No Treatment details were reported.  Patient stated that she was supposed to take the booster at 12:15 pm on 27-Dec-2021. She had a urinary tract infection about 2 weeks ago. She took antibiotic for 10 days now her urine shows no infection. She stated her doctor noticed that she had inflammation in her bladder. She had mild heart palpitation after the first dose, and it was worst after the second dose. She was taking Lipitor for a months before the first dose. She stop taking it because the doctor believe the bladder inflammation could be due to the medication. She stopped taking Lipitor before the second shot for a couple weeks.   This case was linked to MOD-2021-428396 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis, Vasculitis
Clinical narrative: Heart palpitation was worst after the second dose; Vascular swelling; Tired; Urinary tract infection; Bladder inflammation; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpitation was worst after the second dose), CYSTITIS NONINFECTIVE (Bladder inflammation), VASCULITIS (Vascular swelling), URINARY TRACT INFECTION (Urinary tract infection) and FATIGUE (Tired) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M2A) for COVID-19 vaccination.     The patient's past medical history included Partial lung resection (Lung surgery- Part of her lung was removed) in July 2020. Concomitant products included LEVOTHYROXINE and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced CYSTITIS NONINFECTIVE (Bladder inflammation) and URINARY TRACT INFECTION (Urinary tract infection). On an unknown date, the patient experienced PALPITATIONS (Heart palpitation was worst after the second dose), VASCULITIS (Vascular swelling) and FATIGUE (Tired). In December 2021, URINARY TRACT INFECTION (Urinary tract infection) had resolved. At the time of the report, PALPITATIONS (Heart palpitation was worst after the second dose), CYSTITIS NONINFECTIVE (Bladder inflammation), VASCULITIS (Vascular swelling) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cystoscopy: positive (Positive) Showed bladder infection. On an unknown date, Urine analysis: normal (normal) No infection.         No Treatment details were reported.  Patient stated that she was supposed to take the booster at 12:15 pm on 27-Dec-2021. She had a urinary tract infection about 2 weeks ago. She took antibiotic for 10 days now her urine shows no infection. She stated her doctor noticed that she had inflammation in her bladder. She had mild heart palpitation after the first dose, and it was worst after the second dose. She was taking Lipitor for a months before the first dose. She stop taking it because the doctor believe the bladder inflammation could be due to the medication. She stopped taking Lipitor before the second shot for a couple weeks.   This case was linked to MOD-2021-428396 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Mild heart palpitation; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Mild heart palpitation) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M2A) for COVID-19 vaccination.     The patient's past medical history included Lung lobectomy (She had lung surgery, part of her lung was removed.) in July 2020. Concomitant products included LEVOTHYROXINE and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Mild heart palpitation). At the time of the report, PALPITATIONS (Mild heart palpitation) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       It was reported that the patient was taking Lipitor for a months before the first dose and stopped taking Lipitor before the second shot for a couple weeks.   Treatment information was not reported.    This case was linked to MOD-2021-428375 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: had the 2nd jab of moderna, About 10 days later the hospital called and said the vaccine wasn't expired but had been in the fridge 7 days too long; had the 2nd jab of moderna, About 10 days later the hospital called and said the vaccine wasn't expired but had been in the fridge 7 days too long.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (had the 2nd jab of moderna, About 10 days later the hospital called and said the vaccine wasn't expired but had been in the fridge 7 days too long) and PRODUCT STORAGE ERROR (had the 2nd jab of moderna, About 10 days later the hospital called and said the vaccine wasn't expired but had been in the fridge 7 days too long.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (had the 2nd jab of moderna, About 10 days later the hospital called and said the vaccine wasn't expired but had been in the fridge 7 days too long) and PRODUCT STORAGE ERROR (had the 2nd jab of moderna, About 10 days later the hospital called and said the vaccine wasn't expired but had been in the fridge 7 days too long.). In October 2021, EXPIRED PRODUCT ADMINISTERED (had the 2nd jab of moderna, About 10 days later the hospital called and said the vaccine wasn't expired but had been in the fridge 7 days too long) and PRODUCT STORAGE ERROR (had the 2nd jab of moderna, About 10 days later the hospital called and said the vaccine wasn't expired but had been in the fridge 7 days too long.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-427852 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: rash under her right arm were the booster was administered; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash under her right arm were the booster was administered) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027h21b, 009c21a and 002c21a) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included BENAZEPRIL for an unknown indication.   On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced VACCINATION SITE RASH (rash under her right arm were the booster was administered). The patient was treated with HYDROCORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE RASH (rash under her right arm were the booster was administered) had not resolved.            Concomitant products included hypertension medication.   This case was linked to MOD-2021-428466 (Patient Link).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Dizziness, Heart rate, Nausea, Paraesthesia
Clinical narrative: tingling in lips; tingling in hands; felt faint; felt nauseas; This spontaneous case was reported by an other health care professional and describes the occurrence of PARAESTHESIA ORAL (tingling in lips), PARAESTHESIA (tingling in hands), DIZZINESS (felt faint) and NAUSEA (felt nauseas) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (Pfizer 1st dose) on 05-Feb-2021 and Pfizer (Pfizer 2nd dose) on 26-Feb-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 27-Dec-2021, the patient experienced PARAESTHESIA ORAL (tingling in lips), PARAESTHESIA (tingling in hands), DIZZINESS (felt faint) and NAUSEA (felt nauseas). On 27-Dec-2021, PARAESTHESIA ORAL (tingling in lips), PARAESTHESIA (tingling in hands), DIZZINESS (felt faint) and NAUSEA (felt nauseas) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Dec-2021, Blood glucose: low (Low) low. On 27-Dec-2021, Heart rate: normal (normal) normal. On 27-Dec-2021, Respiratory rate: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Products were reported. Treatment medication include Coke- For sugar level increase.  Patient has no pre-existing conditions.  Patient had the events within  15 minutes of getting the booster. It was reported that the symptoms resolved soon after and the  total time of this event was 11:30 AM  to 12:20 PM.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Respiratory rate
Clinical narrative: tingling in lips; tingling in hands; felt faint; felt nauseas; This spontaneous case was reported by an other health care professional and describes the occurrence of PARAESTHESIA ORAL (tingling in lips), PARAESTHESIA (tingling in hands), DIZZINESS (felt faint) and NAUSEA (felt nauseas) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (Pfizer 1st dose) on 05-Feb-2021 and Pfizer (Pfizer 2nd dose) on 26-Feb-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 27-Dec-2021, the patient experienced PARAESTHESIA ORAL (tingling in lips), PARAESTHESIA (tingling in hands), DIZZINESS (felt faint) and NAUSEA (felt nauseas). On 27-Dec-2021, PARAESTHESIA ORAL (tingling in lips), PARAESTHESIA (tingling in hands), DIZZINESS (felt faint) and NAUSEA (felt nauseas) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Dec-2021, Blood glucose: low (Low) low. On 27-Dec-2021, Heart rate: normal (normal) normal. On 27-Dec-2021, Respiratory rate: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Products were reported. Treatment medication include Coke- For sugar level increase.  Patient has no pre-existing conditions.  Patient had the events within  15 minutes of getting the booster. It was reported that the symptoms resolved soon after and the  total time of this event was 11:30 AM  to 12:20 PM.
Sex: U
Vaccine: COVID19
Symptoms: Burning mouth syndrome
Clinical narrative: Burning mouth syndrome; This spontaneous case was reported by a consumer and describes the occurrence of BURNING MOUTH SYNDROME (Burning mouth syndrome) 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 February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 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 BURNING MOUTH SYNDROME (Burning mouth syndrome). At the time of the report, BURNING MOUTH SYNDROME (Burning mouth syndrome) had not resolved. Not Provided          The  concomitant medications on use were not provided. No treatment information was provided.  Patient is yet to receive third booster shot.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass
Clinical narrative: hard lump at the injection site; redness at the injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE MASS (hard lump at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Dec-2021, the patient experienced VACCINATION SITE MASS (hard lump at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site). At the time of the report, VACCINATION SITE MASS (hard lump at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. The patient reported no pain injection. Treatment medications were not reported.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Vaccine given to a 16 year old age/Given to less han 18 years; 2nd dose administered beyond 35 days; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to a 16 year old age/Given to less han 18 years) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered beyond 35 days) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A and 041b21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jul-2021 at 11:41 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Oct-2021 at 10:51 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Oct-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to a 16 year old age/Given to less han 18 years) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered beyond 35 days). On 13-Oct-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to a 16 year old age/Given to less han 18 years) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered beyond 35 days) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided. No treatment information was provided.    This case was linked to MOD-2021-288047 (Patient Link).
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Lymphadenopathy, Malaise
Clinical narrative: swelling of throat; bad headache; swelling of lymph nodes; general fatigue; feeling of chills; being under the weather; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (being under the weather), PHARYNGEAL SWELLING (swelling of throat), FATIGUE (general fatigue), CHILLS (feeling of chills) and HEADACHE (bad headache) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041J21A, 003A21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced MALAISE (being under the weather), FATIGUE (general fatigue) and CHILLS (feeling of chills). On 23-Dec-2021, the patient experienced PHARYNGEAL SWELLING (swelling of throat), HEADACHE (bad headache) and LYMPHADENOPATHY (swelling of lymph nodes). At the time of the report, MALAISE (being under the weather), PHARYNGEAL SWELLING (swelling of throat), FATIGUE (general fatigue), CHILLS (feeling of chills), HEADACHE (bad headache) and LYMPHADENOPATHY (swelling of lymph nodes) was resolving.            Concomitant product use was not provided by the reporter. Treatment information was not provided. Patient was on day 5 and patient still recovering.