chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic bacteriuria
Clinical narrative: 2.5 hours after vaccination she had a follow up appointment with her doctor and when she went to the restroom the she had no symptoms, she did not feel anything when she urinated; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Mar-2021 and was forwarded to Moderna on 24-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ASYMPTOMATIC BACTERIURIA (2.5 hours after vaccination she had a follow up appointment with her doctor and when she went to the restroom the she had no symptoms, she did not feel anything when she urinated) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040a21a) for COVID-19 vaccination.     Concurrent medical conditions included UTI.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced ASYMPTOMATIC BACTERIURIA (2.5 hours after vaccination she had a follow up appointment with her doctor and when she went to the restroom the she had no symptoms, she did not feel anything when she urinated). At the time of the report, ASYMPTOMATIC BACTERIURIA (2.5 hours after vaccination she had a follow up appointment with her doctor and when she went to the restroom the she had no symptoms, she did not feel anything when she urinated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: TCR form- Non significant info- Contact info updated
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Dyspnoea, Fatigue, Headache
Clinical narrative: productive cough but no fever; difficult breathing; Chest pain; Fatigue/tired all day; balance problem; left foot plantar fascia pain; headache on top of head; puffy face; explosive bowel movement; abdomen feels like it's burning; burning of anus; Sore shoulder after second dose; temperature increase; General malaise; clearing throat; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Sore shoulder after second dose), PYREXIA (temperature increase), MALAISE (General malaise), THROAT IRRITATION (clearing throat) and ABDOMINAL DISCOMFORT (abdomen feels like it's burning) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history is provided by reporter.  Concomitant products included LEVOTHYROXINE, THYROID (ARMOUR THYROID) and KETOCONAZOLE for an unknown indication.    On 07-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced ARTHRALGIA (Sore shoulder after second dose), PYREXIA (temperature increase), MALAISE (General malaise) and THROAT IRRITATION (clearing throat). On 10-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (abdomen feels like it's burning), ANORECTAL DISCOMFORT (burning of anus) and DIARRHOEA (explosive bowel movement). On 12-Mar-2021, the patient experienced HEADACHE (headache on top of head) and SKIN SWELLING (puffy face). On 04-Apr-2021, the patient experienced CHEST PAIN (Chest pain), FATIGUE (Fatigue/tired all day), BALANCE DISORDER (balance problem), PLANTAR FASCIITIS (left foot plantar fascia pain) and DYSPNOEA (difficult breathing). On 08-Apr-2021, the patient experienced COUGH (productive cough but no fever). On 08-Mar-2021, PYREXIA (temperature increase) and MALAISE (General malaise) had resolved. On 04-Apr-2021, CHEST PAIN (Chest pain) and FATIGUE (Fatigue/tired all day) was resolving. At the time of the report, ARTHRALGIA (Sore shoulder after second dose) had resolved, THROAT IRRITATION (clearing throat), ABDOMINAL DISCOMFORT (abdomen feels like it's burning), ANORECTAL DISCOMFORT (burning of anus), HEADACHE (headache on top of head), SKIN SWELLING (puffy face), DIARRHOEA (explosive bowel movement) and DYSPNOEA (difficult breathing) outcome was unknown and PLANTAR FASCIITIS (left foot plantar fascia pain) and COUGH (productive cough but no fever) was resolving. Not Provided          On 07-MAR-2021 Patient had received second dose of Moderna COVID-19 Vaccine. On 07-MAR-2021 Patient felt spacey, sluggish, really off, made mistakes on things that she normally avoid or would not do and not function well   This case was linked to US-MODERNATX, INC.-MOD-2021-057948 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Event list is updated. On 14-May-2021: Event information is updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-057948:1st dose case
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Chills, Feeling cold, Headache, Nervousness
Clinical narrative: heart beat fast; feel agitated; nervousness; chills; headache; cold all the time; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (heart beat fast), AGITATION (feel agitated), NERVOUSNESS (nervousness), FEELING COLD (cold all the time) and CHILLS (chills) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for Anxiety, ATORVASTATIN for Cholesterol, AMLODIPINE for Hypertension, TACROLIMUS for Kidney transplant.    On 21-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced FEELING COLD (cold all the time). On an unknown date, the patient experienced TACHYCARDIA (heart beat fast), AGITATION (feel agitated), NERVOUSNESS (nervousness), CHILLS (chills) and HEADACHE (headache). At the time of the report, TACHYCARDIA (heart beat fast), AGITATION (feel agitated), NERVOUSNESS (nervousness), FEELING COLD (cold all the time), CHILLS (chills) and HEADACHE (headache) outcome was unknown.            Concomitant medications reported were second medication for anti rejection for kidney transplant and med for allergies. Treatment details include Tylenol.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was Not applicable.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: heart beat fast; feel agitated; nervousness; chills; headache; cold all the time; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (heart beat fast), AGITATION (feel agitated), NERVOUSNESS (nervousness), FEELING COLD (cold all the time) and CHILLS (chills) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for Anxiety, ATORVASTATIN for Cholesterol, AMLODIPINE for Hypertension, TACROLIMUS for Kidney transplant.    On 21-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced FEELING COLD (cold all the time). On an unknown date, the patient experienced TACHYCARDIA (heart beat fast), AGITATION (feel agitated), NERVOUSNESS (nervousness), CHILLS (chills) and HEADACHE (headache). At the time of the report, TACHYCARDIA (heart beat fast), AGITATION (feel agitated), NERVOUSNESS (nervousness), FEELING COLD (cold all the time), CHILLS (chills) and HEADACHE (headache) outcome was unknown.            Concomitant medications reported were second medication for anti rejection for kidney transplant and med for allergies. Treatment details include Tylenol.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was Not applicable.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Hot flush, Rash, Vaccination site erythema, Vaccination site haemorrhage
Clinical narrative: Flashes; Large bruises; Bleeding right after injection; Broke up rash, rash was on her chest, back arm, and upper leg side but not on her hand and feet; Redness; Itching; A spontaneous report was received from a consumer concerning a 63-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA -1273) and was bleeding right after the injection/hemorrhage and experienced events, having flashes/hot flush, redness/erythema, itching/pruritus, large bruises/contusion and broke up rash/rash.  The patient's medical history provided included allergy to prednisone. Concomitant medications reported included sumatriptan and vitamin.  On 04 Mar 2021, approximately few minutes prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 013A21A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 04 Mar 2021, the patient was bleeding right after the injection, had flashes few minutes after the injection, had redness, itching, large bruises and rash broke up. The rash was on her chest, back arm, and upper leg side but not on her hand and feet. Her doctor is not comfortable to recommend that she take the second dose since she is allergic to prednisone and would not know what to treat her with if something happens. Treatment for the event included diphenhydramine HCl.  Action taken with mRNA-1273 in response to the events were not provided.  The outcome of the event rash broke up resolved on 10 Mar 2021 and the events, was bleeding right after the injection and having flashes were resolved on 04 Mar 2021. At the time of this report, the outcome of the events, redness, itching and large bruise were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Flashes; Large bruises; Bleeding right after injection; Broke up rash, rash was on her chest, back arm, and upper leg side but not on her hand and feet; Redness; Itching; A spontaneous report was received from a consumer concerning a 63-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA -1273) and was bleeding right after the injection/hemorrhage and experienced events, having flashes/hot flush, redness/erythema, itching/pruritus, large bruises/contusion and broke up rash/rash.  The patient's medical history provided included allergy to prednisone. Concomitant medications reported included sumatriptan and vitamin.  On 04 Mar 2021, approximately few minutes prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 013A21A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 04 Mar 2021, the patient was bleeding right after the injection, had flashes few minutes after the injection, had redness, itching, large bruises and rash broke up. The rash was on her chest, back arm, and upper leg side but not on her hand and feet. Her doctor is not comfortable to recommend that she take the second dose since she is allergic to prednisone and would not know what to treat her with if something happens. Treatment for the event included diphenhydramine HCl.  Action taken with mRNA-1273 in response to the events were not provided.  The outcome of the event rash broke up resolved on 10 Mar 2021 and the events, was bleeding right after the injection and having flashes were resolved on 04 Mar 2021. At the time of this report, the outcome of the events, redness, itching and large bruise were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received 2nd dose on 22nd day from 1st shot; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose on 22nd day from 1st shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.).   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose on 22nd day from 1st shot). On 25-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose on 22nd day from 1st shot) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment related information has been reported.; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: Not Provided) with no associated AEs.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Head discomfort, Pain in extremity
Clinical narrative: Fatigued; Patient experienced sore arm; Hotness; Pressure in the head at night; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Patient experienced sore arm), FEELING HOT (Hotness), HEAD DISCOMFORT (Pressure in the head at night) and FATIGUE (Fatigued) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (Patient experienced sore arm), FEELING HOT (Hotness) and HEAD DISCOMFORT (Pressure in the head at night). On 19-Mar-2021, the patient experienced FATIGUE (Fatigued). On 19-Mar-2021, PAIN IN EXTREMITY (Patient experienced sore arm), FEELING HOT (Hotness) and HEAD DISCOMFORT (Pressure in the head at night) had resolved. On 20-Mar-2021, FATIGUE (Fatigued) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information included paracetamol.    This case was linked to US-MODERNATX, INC.-MOD-2021-058032, US-MODERNATX, INC.-MOD-2021-057976, US-MODERNATX, INC.-MOD-2021-059170 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-058032: US-MODERNATX, INC.-MOD-2021-057976: US-MODERNATX, INC.-MOD-2021-059170:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Blister, Bone pain, Breast pain, Dizziness
Clinical narrative: lingering side effects of pain in her arm; pain in her breast; pain in armpit of the opposite arm; bone aching but it's not terrible, but still hurts; developed a scab/blister that appeared on her elbow a day later; not feeling so great; swelling of the lymph nodes which started after week 1; dizzy /lightheaded; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (lingering side effects of pain in her arm), BREAST PAIN (pain in her breast), AXILLARY PAIN (pain in armpit of the opposite arm), BONE PAIN (bone aching but it's not terrible, but still hurts) and BLISTER (developed a scab/blister that appeared on her elbow a day later) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced DIZZINESS (dizzy /lightheaded). On an unknown date, the patient experienced PAIN IN EXTREMITY (lingering side effects of pain in her arm), BREAST PAIN (pain in her breast), AXILLARY PAIN (pain in armpit of the opposite arm), BONE PAIN (bone aching but it's not terrible, but still hurts), BLISTER (developed a scab/blister that appeared on her elbow a day later), MALAISE (not feeling so great) and LYMPHADENOPATHY (swelling of the lymph nodes which started after week 1). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (lingering side effects of pain in her arm), BREAST PAIN (pain in her breast), AXILLARY PAIN (pain in armpit of the opposite arm), BONE PAIN (bone aching but it's not terrible, but still hurts), BLISTER (developed a scab/blister that appeared on her elbow a day later), MALAISE (not feeling so great), DIZZINESS (dizzy /lightheaded) and LYMPHADENOPATHY (swelling of the lymph nodes which started after week 1) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported. Treatment details included, acetaminophen.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Malaise, Pain in extremity
Clinical narrative: lingering side effects of pain in her arm; pain in her breast; pain in armpit of the opposite arm; bone aching but it's not terrible, but still hurts; developed a scab/blister that appeared on her elbow a day later; not feeling so great; swelling of the lymph nodes which started after week 1; dizzy /lightheaded; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (lingering side effects of pain in her arm), BREAST PAIN (pain in her breast), AXILLARY PAIN (pain in armpit of the opposite arm), BONE PAIN (bone aching but it's not terrible, but still hurts) and BLISTER (developed a scab/blister that appeared on her elbow a day later) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced DIZZINESS (dizzy /lightheaded). On an unknown date, the patient experienced PAIN IN EXTREMITY (lingering side effects of pain in her arm), BREAST PAIN (pain in her breast), AXILLARY PAIN (pain in armpit of the opposite arm), BONE PAIN (bone aching but it's not terrible, but still hurts), BLISTER (developed a scab/blister that appeared on her elbow a day later), MALAISE (not feeling so great) and LYMPHADENOPATHY (swelling of the lymph nodes which started after week 1). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (lingering side effects of pain in her arm), BREAST PAIN (pain in her breast), AXILLARY PAIN (pain in armpit of the opposite arm), BONE PAIN (bone aching but it's not terrible, but still hurts), BLISTER (developed a scab/blister that appeared on her elbow a day later), MALAISE (not feeling so great), DIZZINESS (dizzy /lightheaded) and LYMPHADENOPATHY (swelling of the lymph nodes which started after week 1) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported. Treatment details included, acetaminophen.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Nausea
Clinical narrative: felt weak; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt weak), NAUSEA (nausea) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D2M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included THYROID.    On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced ASTHENIA (felt weak), NAUSEA (nausea) and HEADACHE (headache). At the time of the report, ASTHENIA (felt weak), NAUSEA (nausea) and HEADACHE (headache) had not resolved.            No Treatment information  provided
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria, Vaccination site mass, Vaccination site pruritus
Clinical narrative: welts on arm; round bumps on arm; itching over entire body; itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching over entire body), URTICARIA (welts on arm), VACCINATION SITE MASS (round bumps on arm) and VACCINATION SITE PRURITUS (itching at the injection site) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced VACCINATION SITE PRURITUS (itching at the injection site). On 22-Mar-2021, the patient experienced PRURITUS (itching over entire body). On 25-Mar-2021, the patient experienced URTICARIA (welts on arm) and VACCINATION SITE MASS (round bumps on arm). At the time of the report, PRURITUS (itching over entire body), URTICARIA (welts on arm), VACCINATION SITE MASS (round bumps on arm) and VACCINATION SITE PRURITUS (itching at the injection site) had resolved.            The action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medication was reported.  Treatment details included, acetaminophen and some cream.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: AE outcome was updated.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed second dose; A spontaneous report was received from a pharmacist, concerning a 57-year-old female patient, who received Moderna's COVID-19 vaccine and missed second dose(product dose omission issue).  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 24 Jan 2021, prior to the onset of events, the patient received her first of the two planned vaccine doses of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis.  On an unspecified date, patient had to go out of state due to medical emergency due to which she missed the second dose. It was reported that it has been past 42 days since the first dose.  No treatment medication was reported.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, missed second dose, was considered to be resolved on an unspecified date.; Reporter's Comments: This report refers to a case of Product dose omission issue, for mRNA-1273, lot # unknown, with no associated AEs.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inflammation
Clinical narrative: Over all body inflammation; headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Over all body inflammation) and HEADACHE (headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Polymyalgia rheumatica (Recurrence after 7 years of having disease under control) since 02-Jan-2012, Sulfonamide allergy, Glaucoma, Hypothyroidism and Seasonal allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (CETRIZINE) from 15-Feb-2010 to an unknown date for Allergy, LATANOPROST (LATANOPROST OPTIC) from 15-May-1990 to an unknown date for Glaucoma, LEVOTHYROXINE from 01-Jun-1965 to an unknown date for Hypothyroidism, VITAMIN D NOS from 01-May-2002 to an unknown date and FISH OIL for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced INFLAMMATION (Over all body inflammation) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency; IBUPROFEN for Pain, at an unspecified dose and frequency and PREDNISONE (oral) on 04-May-2021 at a dose of 5 mg twice a day. On 25-May-2021, INFLAMMATION (Over all body inflammation) and HEADACHE (headache) had resolved.            This case was linked to MOD-2021-057674.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Significant FU-ADR: event outcomes updated.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymph node pain, Lymphadenopathy, Rhinorrhoea
Clinical narrative: sniffling; lymph node under my arm is painful; lymph node under my arm is swollen; fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of RHINORRHOEA (sniffling), LYMPH NODE PAIN (lymph node under my arm is painful), LYMPHADENOPATHY (lymph node under my arm is swollen) and FATIGUE (fatigue) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 ml. On 20-Mar-2021, the patient experienced RHINORRHOEA (sniffling), LYMPH NODE PAIN (lymph node under my arm is painful), LYMPHADENOPATHY (lymph node under my arm is swollen) and FATIGUE (fatigue). At the time of the report, RHINORRHOEA (sniffling), LYMPH NODE PAIN (lymph node under my arm is painful), LYMPHADENOPATHY (lymph node under my arm is swollen) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant was provided. Patient treatment information was not provided.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Diarrhoea, Dry throat, Nausea, Oropharyngeal pain
Clinical narrative: off-balance when walking; mildly dry throat; now mild sore throat; scratchy throat; diarrhea; Nausea; This spontaneous case was reported by a patient and describes the occurrence of BALANCE DISORDER (off-balance when walking), DRY THROAT (mildly dry throat), OROPHARYNGEAL PAIN (now mild sore throat), THROAT IRRITATION (scratchy throat) and DIARRHOEA (diarrhea) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BALANCE DISORDER (off-balance when walking), DRY THROAT (mildly dry throat), OROPHARYNGEAL PAIN (now mild sore throat), THROAT IRRITATION (scratchy throat), DIARRHOEA (diarrhea) and NAUSEA (Nausea). At the time of the report, BALANCE DISORDER (off-balance when walking), DRY THROAT (mildly dry throat), OROPHARYNGEAL PAIN (now mild sore throat), THROAT IRRITATION (scratchy throat), DIARRHOEA (diarrhea) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. No Treatment information  provided
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: off-balance when walking; mildly dry throat; now mild sore throat; scratchy throat; diarrhea; Nausea; This spontaneous case was reported by a patient and describes the occurrence of BALANCE DISORDER (off-balance when walking), DRY THROAT (mildly dry throat), OROPHARYNGEAL PAIN (now mild sore throat), THROAT IRRITATION (scratchy throat) and DIARRHOEA (diarrhea) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BALANCE DISORDER (off-balance when walking), DRY THROAT (mildly dry throat), OROPHARYNGEAL PAIN (now mild sore throat), THROAT IRRITATION (scratchy throat), DIARRHOEA (diarrhea) and NAUSEA (Nausea). At the time of the report, BALANCE DISORDER (off-balance when walking), DRY THROAT (mildly dry throat), OROPHARYNGEAL PAIN (now mild sore throat), THROAT IRRITATION (scratchy throat), DIARRHOEA (diarrhea) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. No Treatment information  provided
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site urticaria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (Red welt at the injection site), VACCINATION SITE ERYTHEMA (A red spot at the injection site) and VACCINATION SITE SWELLING (Bump at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history).    On 16-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced VACCINATION SITE URTICARIA (Red welt at the injection site). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (A red spot at the injection site) and VACCINATION SITE SWELLING (Bump at the injection site). At the time of the report, VACCINATION SITE URTICARIA (Red welt at the injection site), VACCINATION SITE ERYTHEMA (A red spot at the injection site) and VACCINATION SITE SWELLING (Bump at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. No Treatment information  provided
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Sore arm; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and ARTHRALGIA (Joint pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included LEVOTHYROXINE for an unknown indication.    On 27-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 PAIN IN EXTREMITY (Sore arm) and ARTHRALGIA (Joint pain). At the time of the report, PAIN IN EXTREMITY (Sore arm) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included Motrin, used Heating pad and applied Bengay.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Trigeminal neuralgia
Clinical narrative: Experienced symptoms of trigeminal neuralgia in face; This spontaneous case was reported by a consumer and describes the occurrence of TRIGEMINAL NEURALGIA (Experienced symptoms of trigeminal neuralgia in face) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included Trigeminal neuralgia.    On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced TRIGEMINAL NEURALGIA (Experienced symptoms of trigeminal neuralgia in face). At the time of the report, TRIGEMINAL NEURALGIA (Experienced symptoms of trigeminal neuralgia in face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. No Treatment information  provided
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Pain
Clinical narrative: she has a shooting pain; blood glucose went high; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (she has a shooting pain) and BLOOD GLUCOSE INCREASED (blood glucose went high) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included Diabetes (diabetes with neurological complications) and Osteoporosis (bone pain due to osteoporosis). Concomitant products included TAPENTADOL HYDROCHLORIDE (NUCYNTA) for an unknown indication.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 28-Feb-2021, the patient experienced BLOOD GLUCOSE INCREASED (blood glucose went high). On an unknown date, the patient experienced PAIN (she has a shooting pain). On 28-Feb-2021, BLOOD GLUCOSE INCREASED (blood glucose went high) had resolved. At the time of the report, PAIN (she has a shooting pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The treatment information was The patient has used her pain medications which she was using prior to having the first dose for her bone pain symptoms since having the first dose. She uses under the prescribed level of pain medication because she is afraid of the pain medications. Her insulin pump gave a basal dose to correct for the high blood sugar. She kept trying to get her blood glucose under control using the pump until midnight when the blood glucose went down and was able to be controlled.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Rash, Rash erythematous, Rash papular
Clinical narrative: chills; I felt crappy; red and itchy; bumpy on my chest; red and itchy; allergic reaction to the shot; Rash  on my groin area/ it spread to my neck, and a couple spots on my chest; This spontaneous case was reported by a non-health professional and describes the occurrence of FEELING ABNORMAL (I felt crappy), RASH ERYTHEMATOUS (red and itchy), RASH PAPULAR (bumpy on my chest), RASH PRURITIC (red and itchy) and VACCINATION SITE REACTION (allergic reaction to the shot) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced RASH (Rash  on my groin area/ it spread to my neck, and a couple spots on my chest). On 24-Mar-2021, the patient experienced FEELING ABNORMAL (I felt crappy), RASH ERYTHEMATOUS (red and itchy), RASH PAPULAR (bumpy on my chest), RASH PRURITIC (red and itchy) and VACCINATION SITE REACTION (allergic reaction to the shot). On 25-Mar-2021, the patient experienced CHILLS (chills). At the time of the report, FEELING ABNORMAL (I felt crappy), RASH ERYTHEMATOUS (red and itchy), RASH PAPULAR (bumpy on my chest), RASH PRURITIC (red and itchy), VACCINATION SITE REACTION (allergic reaction to the shot), RASH (Rash  on my groin area/ it spread to my neck, and a couple spots on my chest) and CHILLS (chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided.  Treatment included Benadryl and Prednisone   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: F/U 1 : AE details and outcome
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic, Vaccination site reaction
Clinical narrative: chills; I felt crappy; red and itchy; bumpy on my chest; red and itchy; allergic reaction to the shot; Rash  on my groin area/ it spread to my neck, and a couple spots on my chest; This spontaneous case was reported by a non-health professional and describes the occurrence of FEELING ABNORMAL (I felt crappy), RASH ERYTHEMATOUS (red and itchy), RASH PAPULAR (bumpy on my chest), RASH PRURITIC (red and itchy) and VACCINATION SITE REACTION (allergic reaction to the shot) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced RASH (Rash  on my groin area/ it spread to my neck, and a couple spots on my chest). On 24-Mar-2021, the patient experienced FEELING ABNORMAL (I felt crappy), RASH ERYTHEMATOUS (red and itchy), RASH PAPULAR (bumpy on my chest), RASH PRURITIC (red and itchy) and VACCINATION SITE REACTION (allergic reaction to the shot). On 25-Mar-2021, the patient experienced CHILLS (chills). At the time of the report, FEELING ABNORMAL (I felt crappy), RASH ERYTHEMATOUS (red and itchy), RASH PAPULAR (bumpy on my chest), RASH PRURITIC (red and itchy), VACCINATION SITE REACTION (allergic reaction to the shot), RASH (Rash  on my groin area/ it spread to my neck, and a couple spots on my chest) and CHILLS (chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided.  Treatment included Benadryl and Prednisone   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: F/U 1 : AE details and outcome
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information  provided. No Treatment information  provided   This case was linked to -MODERNATX, INC.-MOD-2021-057960 (E2B Linked Report).; Sender's Comments:  -MODERNATX, INC.-MOD-2021-057960:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: felt throbbing  at site of injection; pain at site of shot,felt throbbing yesterday at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at site of shot,felt throbbing yesterday at site of injection) and PAIN (felt throbbing  at site of injection) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain at site of shot,felt throbbing yesterday at site of injection). On 24-Mar-2021, the patient experienced PAIN (felt throbbing  at site of injection). At the time of the report, VACCINATION SITE PAIN (pain at site of shot,felt throbbing yesterday at site of injection) and PAIN (felt throbbing  at site of injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Steroid cream was taken as a concomitant medication for hair. No treatment medication was taken.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hot flush, Nausea
Clinical narrative: Hot flashes both occasionally; Fourth week of having nausea; Headaches; This spontaneous case was reported by a health care professional and describes the occurrence of HOT FLUSH (Hot flashes both occasionally), NAUSEA (Fourth week of having nausea) and HEADACHE (Headaches) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 010A21A) for COVID-19 immunisation.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced HOT FLUSH (Hot flashes both occasionally), NAUSEA (Fourth week of having nausea) and HEADACHE (Headaches). The patient was treated with OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) at a dose of 1 dosage form and LANSOPRAZOLE (PREVACID) at a dose of 1 dosage form. At the time of the report, HOT FLUSH (Hot flashes both occasionally), NAUSEA (Fourth week of having nausea) and HEADACHE (Headaches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant information  provided. Action taken was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow-up information received on 22-jun-2021 , Contains no new information
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pain in extremity
Clinical narrative: Pain in the arm, soreness; Pregnant; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) and PAIN IN EXTREMITY (Pain in the arm, soreness) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3001176) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included FOLIC ACID (FOLATE), COLECALCIFEROL (VITAMIN D 3) and OMEPRAZOLE (LOSECA) for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 05-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in the arm, soreness). On 05-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in the arm, soreness) outcome was unknown. Unknown      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.   No Treatment information  provided   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2021: Internal review on 19-Jul-2021 resulted in updates to the pregnancy details.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Diarrhoea, Feeling abnormal, Pain, Sinusitis
Clinical narrative: sinus is completely stuffed and; Doesn't feel good; Body Aches; Aches; feels like he has covid; Diarrhea; (sinus) flutters; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinus is completely stuffed and), FEELING ABNORMAL (Doesn't feel good), PAIN (Body Aches), PAIN (Aches) and COVID-19 (feels like he has covid) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 026A2114) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included OMEPRAZOLE, SUCRALFATE and LOPERAMIDE HYDROCHLORIDE (IMODIUM) for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-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 SINUSITIS (sinus is completely stuffed and), FEELING ABNORMAL (Doesn't feel good), PAIN (Body Aches), PAIN (Aches), COVID-19 (feels like he has covid), DIARRHOEA (Diarrhea) and SINUSITIS ((sinus) flutters). At the time of the report, SINUSITIS (sinus is completely stuffed and), FEELING ABNORMAL (Doesn't feel good), PAIN (Body Aches), PAIN (Aches), COVID-19 (feels like he has covid), DIARRHOEA (Diarrhea) and SINUSITIS ((sinus) flutters) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information  provided
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Pinkish spot at injection site /Pinkish spot 3 inches long 2 inches wide; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011a21) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included SYNTHROID, BABY ASPIRIN, LIPITOR, METOPROLOL, and VITAMINS for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA. At the time of the report, VACCINATION SITE ERYTHEMA outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.