chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope
Clinical narrative: diarrhea; chills; nausea; weakness; sweating; thought she was going to pass out; A spontaneous report was received from a Consumer concerning 92 years of  age female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced diarrhea, chills, nausea, weakness,sweating and thought she was going to pass out.  The patient's medical history was not provided. No Concomitant medications were  provided.   On 07,feb,2021 on the same day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (batch 012M20A) intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection. On 7,feb,2021, the patient experienced the events diarrhea, chills, nausea, weakness, sweating and thought she was going to pass out.  No Laboratory details  provided. Action taken with mRNA-1273 in response to the events was not provided.  At the time of this report, the events outcomes  diarrhea, chills, nausea, weakness, sweating and thought she was going to pass out were unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: warm to touch; arm itchy; blotchy diffuse red rash size of orange; arm red; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (arm itchy), VACCINATION SITE RASH (blotchy diffuse red rash size of orange) and VACCINATION SITE ERYTHEMA (arm red) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 102M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (arm red). On 05-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (arm itchy) and VACCINATION SITE RASH (blotchy diffuse red rash size of orange). The patient was treated with HYDROCORTISONE (CORTIZONE 10) at a dose of 1% and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Itch, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (arm itchy), VACCINATION SITE RASH (blotchy diffuse red rash size of orange) and VACCINATION SITE ERYTHEMA (arm red) had resolved.        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.   Concomitant medications were not provided. Patient's arm was red, but 3-4 days ago became blotchy diffuse red rash size of orange, warm to touch and itchy. Patient was using Cortizone cream 1% and took Benadryl and had less itching.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Additional information received via TCR, patient informed everything was fine and reporter information updated.
Sex: F
Vaccine: COVID19
Symptoms: Injection site discolouration, Injection site inflammation
Clinical narrative: Inflammation at injection site; Injection site turned red and then white; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INFLAMMATION (Inflammation at injection site) and INJECTION SITE DISCOLOURATION (Injection site turned red and then white) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Inflammation.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced INJECTION SITE INFLAMMATION (Inflammation at injection site) and INJECTION SITE DISCOLOURATION (Injection site turned red and then white). At the time of the report, INJECTION SITE INFLAMMATION (Inflammation at injection site) and INJECTION SITE DISCOLOURATION (Injection site turned red and then white) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: The patient confirmed that the events were resolved and had no concerns.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash papular
Clinical narrative: rash and itching started again, but 2000 times worse than before; itching started again, but 2000 times worse than before; itching; prickly rash all over the body; rash was beet red and raised all over body; A regulatory authority report was received from a consumer concerning a 87-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed itching, bad rash, prickly rash.   The patient's medical history included Diabetes mellitus. Products known to have been used by the patient, within two weeks prior to the event, included Diabetic medication.  On 26 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot 041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 01 Feb 2021, the patient developed bad rash and itching.  Patient reported rash spread all over the body and later got fused. Patient described rash was beet red and raised all over body. On 02 Feb 2021, patient went to emergency department.  Treatment received for the event include,prednisone and Benadryl  On 08 Feb 2021, patient again visited emergency department as she developed rash and itching again, but 2000 times worse than before. Treatment received for the event ,included Pepcid, Benadryl and  Prednisone   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event,developed itching, bad rash, prickly rash, was considered not resolved.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-014649:
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia
Clinical narrative: difficulty of swallowing; A spontaneous report  was received from a non heath care professional  concerning a 97 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events list.      The patient's medical history was not provided. No relevant concomitant medications were reported.      On Date 15/02/2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 with lot/batch: 006M20A/006W20A  administered intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection.    On same date after receiving the vaccine, after a few hours she is having difficulty of swallowing which is non serious.   Laboratory details are not provided.    Treatment details are not provided    Action taken with mRNA-1273 in response to the events was not reported.     The outcome of the event was unknown.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Pruritus
Clinical narrative: burning sensation; itching sensation; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning sensation) and PRURITUS (itching sensation) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced BURNING SENSATION (burning sensation) and PRURITUS (itching sensation). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (burning sensation) and PRURITUS (itching sensation) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication reported. Patient started feeling burning and itching sensation all over 3 weeks after the 1st Shot. Patient has only taken Benadryl the last two days. Benadryl helps but the reaction comes back.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Influenza like illness, Pain, Pruritus
Clinical narrative: Itchy hands; Private area red; Flu like symptoms; Achy; Tired; red (hands); (Private area) Itchy; A spontaneous report was received from a (Consumer) concerning a 85 years - old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Itchy hands, Private area red, Flu like symptoms, Achy, Tired, Red (hands), (Private area) Itchy.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 13 Feb 2021,  prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown)in the left Arm for prophylaxis of COVID-19 infection.  On  an unknown date, The patient  experienced Itchy hands, Private area red, Flu like symptoms, Achy, Tired, Red (hands), (Private area) Itchy.     No treatment received was provided.  Action taken with mRNA-1273 in response to the events was not reported.    At this time of the report, the outcome of the event(s) Itchy hands, Private area red, Flu like symptoms, Achy, Tired, Red (hands), (Private area) Itchy were not reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Lymph node pain, Lymphadenopathy
Clinical narrative: lymph node clavicle swollen; lymph node clavicle tender to touch; rash on left arm; chills; fever; tiredness; headache; body ache; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lymph node clavicle swollen), LYMPH NODE PAIN (lymph node clavicle tender to touch), VACCINATION SITE RASH (rash on left arm), CHILLS (chills) and PYREXIA (fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Family history included Lymphoma (Previous history of mother with lymphoma). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) from 03-Jul-2014 to an unknown date for an unknown indication.   On 12-Jan-2021 at 1:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021 at 1:45 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE RASH (rash on left arm), CHILLS (chills), PYREXIA (fever), FATIGUE (tiredness), HEADACHE (headache) and MYALGIA (body ache). On 13-Feb-2021 at 5:00 PM, the patient experienced LYMPHADENOPATHY (lymph node clavicle swollen) and LYMPH NODE PAIN (lymph node clavicle tender to touch). On 10-Feb-2021, HEADACHE (headache) and MYALGIA (body ache) had resolved. On 11-Feb-2021, VACCINATION SITE RASH (rash on left arm), CHILLS (chills), PYREXIA (fever) and FATIGUE (tiredness) had resolved. On 03-Mar-2021, LYMPHADENOPATHY (lymph node clavicle swollen) and LYMPH NODE PAIN (lymph node clavicle tender to touch) had resolved.            It was reported that the patient took 2 Moultrie in Feb 2021, two days before the initial report.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Adverse drug reaction safety information received and patient sent pictures via email.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site rash
Clinical narrative: lymph node clavicle swollen; lymph node clavicle tender to touch; rash on left arm; chills; fever; tiredness; headache; body ache; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lymph node clavicle swollen), LYMPH NODE PAIN (lymph node clavicle tender to touch), VACCINATION SITE RASH (rash on left arm), CHILLS (chills) and PYREXIA (fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Family history included Lymphoma (Previous history of mother with lymphoma). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) from 03-Jul-2014 to an unknown date for an unknown indication.   On 12-Jan-2021 at 1:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021 at 1:45 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE RASH (rash on left arm), CHILLS (chills), PYREXIA (fever), FATIGUE (tiredness), HEADACHE (headache) and MYALGIA (body ache). On 13-Feb-2021 at 5:00 PM, the patient experienced LYMPHADENOPATHY (lymph node clavicle swollen) and LYMPH NODE PAIN (lymph node clavicle tender to touch). On 10-Feb-2021, HEADACHE (headache) and MYALGIA (body ache) had resolved. On 11-Feb-2021, VACCINATION SITE RASH (rash on left arm), CHILLS (chills), PYREXIA (fever) and FATIGUE (tiredness) had resolved. On 03-Mar-2021, LYMPHADENOPATHY (lymph node clavicle swollen) and LYMPH NODE PAIN (lymph node clavicle tender to touch) had resolved.            It was reported that the patient took 2 Moultrie in Feb 2021, two days before the initial report.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Adverse drug reaction safety information received and patient sent pictures via email.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Pyrexia, SARS-CoV-2 test
Clinical narrative: COVID-19; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), CHILLS (Chills) and PYREXIA (Fever) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Unknown.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever). On 14-Jan-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow-up received included no new information.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Vaccination site pruritus
Clinical narrative: Diarrhea; Nausea; Itching around vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), VACCINATION SITE PRURITUS (Itching around vaccination site) and NAUSEA (Nausea) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching around vaccination site). On 11-Feb-2021, the patient experienced DIARRHOEA (Diarrhea) and NAUSEA (Nausea). At the time of the report, DIARRHOEA (Diarrhea), VACCINATION SITE PRURITUS (Itching around vaccination site) and NAUSEA (Nausea) was resolving.            Relevant concomitant medications were not reported. Treatment information was not provided. Patient reported that he was doing well at the time of report.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow-up information received and patient reported doing well now hence, events outcome were updated from unknown to recovering/resolving.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Injection site pain, Swelling
Clinical narrative: Redness; Fatigue; SWELLING; Tenderness at injection site; A spontaneous report was received on 15-FEB-2021, concerning a female patient of 80 years old, stated she experienced adverse event with the use of mRNA-1273 as prophylaxis for COVID-19 infection.   The patient's history was not reported.    The patient took second dose of Moderna COVID-19 Vaccine on 13-FEB-2021 in the patient's left arm intramuscularly for COVID-19 infection. Lot no:031L20A was provided.    After the vaccine administered, patient experienced sudden redness spot at the Injection site. The patient noticed redness, fatigue, swelling and felt resolved at present. Also, had diarrhea on and off after the vaccine administered, but not so sure of it.   Concomitant medications were not provided.  The outcome of the event was Unknown.  Consent given for Safety follow-up with patient.  The action taken for the adverse events were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Nerve compression, Swelling
Clinical narrative: Back pain; swelling; pinched nerve; This spontaneous case was reported by a consumer and describes the occurrence of   in a female patient of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the parent received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Unknown.     No Medical History information was reported.    On an unknown date, the parent received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment drugs were not reported concomitant drugs were not reported   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Followup received on 13-06-2021 is non significant; Sender'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: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Having delayed reactions of itching at the injection site; Having delayed reactions of swelling at the injection site; Having delayed reactions of redness at the injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Having delayed reactions of itching at the injection site), VACCINATION SITE SWELLING (Having delayed reactions of swelling at the injection site) and VACCINATION SITE ERYTHEMA (Having delayed reactions of redness at the injection site) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Having delayed reactions of itching at the injection site), VACCINATION SITE SWELLING (Having delayed reactions of swelling at the injection site) and VACCINATION SITE ERYTHEMA (Having delayed reactions of redness at the injection site). At the time of the report, VACCINATION SITE PRURITUS (Having delayed reactions of itching at the injection site), VACCINATION SITE SWELLING (Having delayed reactions of swelling at the injection site) and VACCINATION SITE ERYTHEMA (Having delayed reactions of redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Additional information received included no new information and the reporter refused to provide further information.
Sex: M
Vaccine: COVID19
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Rash; Swelling; A spontaneous report was received from a Consumer concerning an unknown age male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Swelling, and Rash.     The patient's medical history was not provided. No relevant concomitant medications were reported.    On 07-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch: 011J20A) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, approximately 10 days after vaccination, the patient experienced Swelling, Rash on the injection arm. The side effects continued to worsen until the patient went to an Emergency Room for detail. The patients doctor informed the patient that he should not receive the second dose of the vaccine.  Treatment for the events included Antibiotics and Prednisone.   The second dose of mRNA-1273 was discontinued in response to the events.   At the time of this report, the outcome of the events, Swelling and Rash were not resolved.; 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. Further information has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: itching; welts; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching) and URTICARIA (welts) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included  (No reported medical history). Concomitant products included BUPROPION HYDROCHLORIDE (BUPROPION HCL XL) for an unknown indication.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 08-Feb-2021, the patient experienced PRURITUS (itching) and URTICARIA (welts).  At the time of the report, PRURITUS (itching) and URTICARIA (welts) outcome was unknown.  Action taken with mRNA-1273 I response to the event was unknown.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the reported events, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: very hard lump in area of injection; hot in area of injection; itchy in area of injection; red in area of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (very hard lump in area of injection), VACCINATION SITE WARMTH (hot in area of injection), VACCINATION SITE PRURITUS (itchy in area of injection) and VACCINATION SITE ERYTHEMA (red in area of injection) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L201A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE MASS (very hard lump in area of injection), VACCINATION SITE WARMTH (hot in area of injection), VACCINATION SITE PRURITUS (itchy in area of injection) and VACCINATION SITE ERYTHEMA (red in area of injection). On 15-Feb-2021, VACCINATION SITE MASS (very hard lump in area of injection), VACCINATION SITE WARMTH (hot in area of injection), VACCINATION SITE PRURITUS (itchy in area of injection) and VACCINATION SITE ERYTHEMA (red in area of injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included cold water. No relevant concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. The reported events are consistent with the product safety profile
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: excrutiating pain from the right arm to the back; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (excrutiating pain from the right arm to the back) 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 reported.).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (excrutiating pain from the right arm to the back). At the time of the report, PAIN IN EXTREMITY (excrutiating pain from the right arm to the back) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable. No treatment information and concomitant medications were not provided.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypotension
Clinical narrative: Blood pressure was low (74/33); This spontaneous case was reported by a consumer and describes the occurrence of HYPOTENSION (Blood pressure was low (74/33)) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041LZ0A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced HYPOTENSION (Blood pressure was low (74/33)). On 14-Jan-2021, HYPOTENSION (Blood pressure was low (74/33)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Blood pressure measurement: 74/33 (Low) Low blood pressure.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product include Something for the thyroid and something for bone density.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: Follow-up received on 08-Apr-2021 included no new information; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Nasal pruritus, Sinus disorder
Clinical narrative: nasal itching; sinus really bothering her; This spontaneous case was reported by a consumer and describes the occurrence of NASAL PRURITUS (nasal itching) and SINUS DISORDER (sinus really bothering her) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASAL PRURITUS (nasal itching) and SINUS DISORDER (sinus really bothering her). At the time of the report, NASAL PRURITUS (nasal itching) and SINUS DISORDER (sinus really bothering her) outcome was unknown.            No Concomitant medications included were provided.   No Treatment information was not reported. Action taken with mRNA-1273 in response to the events was not applicable.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Therapy date and onset date of the event is lacking as well as the patient's medical history and list of concomitant medication. information has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site rash, Lymphadenopathy, Myalgia
Clinical narrative: Chills; Fatigue; Fever; Injection site rash; General body aches; Swollen lymph nodes; Redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph nodes), INJECTION SITE RASH (Injection site rash), MYALGIA (General body aches), PYREXIA (Fever) and CHILLS (Chills) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20a and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  No Medical History information was reported.  On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) Dose #1. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to Dose #2. On an unknown date, the patient experienced LYMPHADENOPATHY (swollen lymph nodes), INJECTION SITE RASH (Injection site rash), MYALGIA (General body aches), PYREXIA (Fever), CHILLS (Chills), FATIGUE (Fatigue) and VACCINATION SITE ERYTHEMA (Redness at the injection site). At the time of the report, LYMPHADENOPATHY (swollen lymph nodes), INJECTION SITE RASH (Injection site rash), MYALGIA (General body aches), PYREXIA (Fever), CHILLS (Chills), FATIGUE (Fatigue) and VACCINATION SITE ERYTHEMA (Redness at the injection site) outcome was unknown.     Treatment information was not provided. Concomitant product use was not provided by the reporter.    Action taken with mRNA-1273 in response to the events is not applicable.  This case was linked to MOD-2021-014361 (Patient Link).  Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. The reported events are consistent with the product safety profile
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema
Clinical narrative: Chills; Fatigue; Fever; Injection site rash; General body aches; Swollen lymph nodes; Redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph nodes), INJECTION SITE RASH (Injection site rash), MYALGIA (General body aches), PYREXIA (Fever) and CHILLS (Chills) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20a and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  No Medical History information was reported.  On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) Dose #1. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to Dose #2. On an unknown date, the patient experienced LYMPHADENOPATHY (swollen lymph nodes), INJECTION SITE RASH (Injection site rash), MYALGIA (General body aches), PYREXIA (Fever), CHILLS (Chills), FATIGUE (Fatigue) and VACCINATION SITE ERYTHEMA (Redness at the injection site). At the time of the report, LYMPHADENOPATHY (swollen lymph nodes), INJECTION SITE RASH (Injection site rash), MYALGIA (General body aches), PYREXIA (Fever), CHILLS (Chills), FATIGUE (Fatigue) and VACCINATION SITE ERYTHEMA (Redness at the injection site) outcome was unknown.     Treatment information was not provided. Concomitant product use was not provided by the reporter.    Action taken with mRNA-1273 in response to the events is not applicable.  This case was linked to MOD-2021-014361 (Patient Link).  Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. The reported events are consistent with the product safety profile
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Malaise, Myalgia
Clinical narrative: Fever of 99.7; Myalgias; arm was sore; felt like I was hit by a Mac Truck; general malaise; Aching in the body; headache; Chills; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (arm was sore), FEELING ABNORMAL (felt like I was hit by a Mac Truck), MALAISE (general malaise), PAIN (Aching in the body) and HEADACHE (headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse reaction. Concomitant products included METFORMIN, GLYBURIDE, SIMVASTATIN, DULAGLUTIDE (TRULICITY), AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3) and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication, LISINOPRIL.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was sore), FEELING ABNORMAL (felt like I was hit by a Mac Truck), MALAISE (general malaise), PAIN (Aching in the body), HEADACHE (headache), CHILLS (Chills) and MYALGIA (Myalgias). On 16-Feb-2021, the patient experienced PYREXIA (Fever of 99.7). On an unknown date, the patient experienced NAUSEA (Nausea). At the time of the report, PAIN IN EXTREMITY (arm was sore), FEELING ABNORMAL (felt like I was hit by a Mac Truck), MALAISE (general malaise), PAIN (Aching in the body), HEADACHE (headache), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (Myalgias) and PYREXIA (Fever of 99.7) outcome was unknown. Possible    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 99.7f 99.7F.     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 for the events included Tylenol, Ibuprofen, Zofran.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Chills, headache, nausea, myalgia and fever are consistent with the product safety profile
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever of 99.7; Myalgias; arm was sore; felt like I was hit by a Mac Truck; general malaise; Aching in the body; headache; Chills; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (arm was sore), FEELING ABNORMAL (felt like I was hit by a Mac Truck), MALAISE (general malaise), PAIN (Aching in the body) and HEADACHE (headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse reaction. Concomitant products included METFORMIN, GLYBURIDE, SIMVASTATIN, DULAGLUTIDE (TRULICITY), AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3) and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication, LISINOPRIL.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was sore), FEELING ABNORMAL (felt like I was hit by a Mac Truck), MALAISE (general malaise), PAIN (Aching in the body), HEADACHE (headache), CHILLS (Chills) and MYALGIA (Myalgias). On 16-Feb-2021, the patient experienced PYREXIA (Fever of 99.7). On an unknown date, the patient experienced NAUSEA (Nausea). At the time of the report, PAIN IN EXTREMITY (arm was sore), FEELING ABNORMAL (felt like I was hit by a Mac Truck), MALAISE (general malaise), PAIN (Aching in the body), HEADACHE (headache), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (Myalgias) and PYREXIA (Fever of 99.7) outcome was unknown. Possible    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 99.7f 99.7F.     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 for the events included Tylenol, Ibuprofen, Zofran.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Chills, headache, nausea, myalgia and fever are consistent with the product safety profile
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discharge
Clinical narrative: Felt some dripping/discharge/leaking from injection site/backtracking; A spontaneous report, concerning a 26 year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and felt some dripping after the administrator removed the needle (Vaccination site leakage).  The patient's medical history was not provided. No concomitant medications were reported.  On 14 Feb2021, prior to the onset of the events, the patient received a dose of mRNA-1273 (Lot number: 011M20A), intramuscularly for prophylaxis of COVID-19 infection. The patient reported feeling some dripping after the removal of the vaccination needle. No treatment information was provided. The dose number the patient received was unknown.    On 14 Feb 2021, the patient reported that she felt some dripping after the administrator removed the needle.  No treatment information was provided.  Action taken with second dose of mRNA-1273 in response to the events was unknown/not reported.  The event, felt some dripping, was considered as resolved on 14 Feb 2021.; Reporter's Comments: This report refers to a case of discharge/leaking from vaccination injection site for mRNA-1273, lot # 001M20A with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Condition aggravated, Confusional state, Decreased appetite, Headache
Clinical narrative: made her reflux and hernia worse; Couldn't get out of her bed; No appetite; my brain just isn't working right; Periods of confusion; I feel lethargic; I am constantly wanted to sleep; Crushing headache; Throwing up vile; fever; Red; Left arm swelled up (Raised up); arm hot; A spontaneous report was received from a consumer concerning a 74 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events like left arm which got swelled up (raised up), hot, red and had fever, crushing headache, periods of confusion, no appetite, made her reflux, hernia worse, I feel unattached from things, I feel lethargic, I am constantly wanting to sleep and my brain just isn't working right.  The patient's medical history was provided. Patient medical history shows that patient had brain tumor extracted years ago (1881) and now as current condition patients suffers from spinal stenosis and Sjogren disease.  Concomitant medications were reported. The patient is taking a list of concomitant medications like Divalproex, Mig Release, Pilocarpine (for Sjogren disease) and Montelukast .  On 14-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 ( Batch Number 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 11-FEB-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (038L20A) intramuscularly in right arm for prophylaxis of COVID-19 infection.  On 14-JAN-2021, the patient experienced the events left arm which got swelled up (raised up), hot, red and had fever.  On 11-FEB-2021,the patient experienced the events like  a crushing headache, periods of confusion, no appetite, made her reflux, hernia worse, I feel unattached from things, I feel lethargic, I am constantly wanting to sleep and my brain just isn't working right. event my brain just isn't working right was considered medically significant.  Laboratory details was not provided.  Treatment information was reported. For the event occurred after first dose of vaccination patient took treatment. Cold compresses and Benadryl and Tylenol took but for which event is not mentioned.  On 14-JAN-2021, the outcomes of the events left arm which got swelled up (raised up), hot, red and had fever remains unknown.  On 11-FEB-2021,the outcomes of the events crushing headache, periods of confusion, no appetite, made her reflux, hernia worse, I feel unattached from things, I feel lethargic, I am constantly wanting to sleep and my brain just isn't working right was considered 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 event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Injection site warmth, Lethargy, Nonspecific reaction, Peripheral swelling
Clinical narrative: made her reflux and hernia worse; Couldn't get out of her bed; No appetite; my brain just isn't working right; Periods of confusion; I feel lethargic; I am constantly wanted to sleep; Crushing headache; Throwing up vile; fever; Red; Left arm swelled up (Raised up); arm hot; A spontaneous report was received from a consumer concerning a 74 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events like left arm which got swelled up (raised up), hot, red and had fever, crushing headache, periods of confusion, no appetite, made her reflux, hernia worse, I feel unattached from things, I feel lethargic, I am constantly wanting to sleep and my brain just isn't working right.  The patient's medical history was provided. Patient medical history shows that patient had brain tumor extracted years ago (1881) and now as current condition patients suffers from spinal stenosis and Sjogren disease.  Concomitant medications were reported. The patient is taking a list of concomitant medications like Divalproex, Mig Release, Pilocarpine (for Sjogren disease) and Montelukast .  On 14-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 ( Batch Number 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 11-FEB-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (038L20A) intramuscularly in right arm for prophylaxis of COVID-19 infection.  On 14-JAN-2021, the patient experienced the events left arm which got swelled up (raised up), hot, red and had fever.  On 11-FEB-2021,the patient experienced the events like  a crushing headache, periods of confusion, no appetite, made her reflux, hernia worse, I feel unattached from things, I feel lethargic, I am constantly wanting to sleep and my brain just isn't working right. event my brain just isn't working right was considered medically significant.  Laboratory details was not provided.  Treatment information was reported. For the event occurred after first dose of vaccination patient took treatment. Cold compresses and Benadryl and Tylenol took but for which event is not mentioned.  On 14-JAN-2021, the outcomes of the events left arm which got swelled up (raised up), hot, red and had fever remains unknown.  On 11-FEB-2021,the outcomes of the events crushing headache, periods of confusion, no appetite, made her reflux, hernia worse, I feel unattached from things, I feel lethargic, I am constantly wanting to sleep and my brain just isn't working right was considered 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 event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vomiting
Clinical narrative: made her reflux and hernia worse; Couldn't get out of her bed; No appetite; my brain just isn't working right; Periods of confusion; I feel lethargic; I am constantly wanted to sleep; Crushing headache; Throwing up vile; fever; Red; Left arm swelled up (Raised up); arm hot; A spontaneous report was received from a consumer concerning a 74 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events like left arm which got swelled up (raised up), hot, red and had fever, crushing headache, periods of confusion, no appetite, made her reflux, hernia worse, I feel unattached from things, I feel lethargic, I am constantly wanting to sleep and my brain just isn't working right.  The patient's medical history was provided. Patient medical history shows that patient had brain tumor extracted years ago (1881) and now as current condition patients suffers from spinal stenosis and Sjogren disease.  Concomitant medications were reported. The patient is taking a list of concomitant medications like Divalproex, Mig Release, Pilocarpine (for Sjogren disease) and Montelukast .  On 14-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 ( Batch Number 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 11-FEB-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (038L20A) intramuscularly in right arm for prophylaxis of COVID-19 infection.  On 14-JAN-2021, the patient experienced the events left arm which got swelled up (raised up), hot, red and had fever.  On 11-FEB-2021,the patient experienced the events like  a crushing headache, periods of confusion, no appetite, made her reflux, hernia worse, I feel unattached from things, I feel lethargic, I am constantly wanting to sleep and my brain just isn't working right. event my brain just isn't working right was considered medically significant.  Laboratory details was not provided.  Treatment information was reported. For the event occurred after first dose of vaccination patient took treatment. Cold compresses and Benadryl and Tylenol took but for which event is not mentioned.  On 14-JAN-2021, the outcomes of the events left arm which got swelled up (raised up), hot, red and had fever remains unknown.  On 11-FEB-2021,the outcomes of the events crushing headache, periods of confusion, no appetite, made her reflux, hernia worse, I feel unattached from things, I feel lethargic, I am constantly wanting to sleep and my brain just isn't working right was considered 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 event, a causal relationship cannot be excluded.