chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Felt achy; He had the chills; Tired overnight; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Felt achy), CHILLS (He had the chills) and FATIGUE (Tired overnight) in a 35-year-old male patient 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) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Felt achy), CHILLS (He had the chills) and FATIGUE (Tired overnight). At the time of the report, PAIN (Felt achy), CHILLS (He had the chills) and FATIGUE (Tired overnight) had resolved.            No concomitant medications were reported.  Treatment information was not provided. Patient received Moderna vaccine and after the second shot, he had chills, felt achy and tired overnight. Patient was fine the next day.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effect for booster shot; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Side effect for booster shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effect for booster shot). At the time of the report, VACCINATION COMPLICATION (Side effect for booster shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication were provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: caller also mentioned not feeling very well/Possible AE; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (caller also mentioned not feeling very well/Possible AE) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In September 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 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 VACCINATION COMPLICATION (caller also mentioned not feeling very well/Possible AE). At the time of the report, VACCINATION COMPLICATION (caller also mentioned not feeling very well/Possible AE) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.  It was reported that the patient was not feeling very well and was thinking to get a flu vaccine and also a COVID test. The patient stated that there were no side effects experienced after the first two doses. It was reported that the patient may had a cold or the flu.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: acute urticaria; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (acute urticaria) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (acute urticaria). At the time of the report, URTICARIA (acute urticaria) outcome was unknown.            No concomitant medication was reported. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Influenza, Oropharyngeal pain
Clinical narrative: throat pain; flu; headaches; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (throat pain), INFLUENZA (flu) and HEADACHE (headaches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (throat pain), INFLUENZA (flu) and HEADACHE (headaches). At the time of the report, OROPHARYNGEAL PAIN (throat pain), INFLUENZA (flu) and HEADACHE (headaches) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.  Patient wanted to get tested for COVID19 as was experiencing throat pain, flu and headaches.Patient believed it was because of the changing weather and didn't want to provide more information.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Vaccination site pain
Clinical narrative: the pain went into his right shoulder& now is in his legs & toe; the shot area was painful; the pain went into his right shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (the pain went into his right shoulder& now is in his legs & toe), VACCINATION SITE PAIN (the shot area was painful) and ARTHRALGIA (the pain went into his right shoulder) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 024C21A and 016C21A) for COVID-19 vaccination.     The patient's past medical history included Arthritis (Svere arthritis in spine & all joints.).   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (the pain went into his right shoulder& now is in his legs & toe), VACCINATION SITE PAIN (the shot area was painful) and ARTHRALGIA (the pain went into his right shoulder). At the time of the report, PAIN IN EXTREMITY (the pain went into his right shoulder& now is in his legs & toe), VACCINATION SITE PAIN (the shot area was painful) and ARTHRALGIA (the pain went into his right shoulder) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported. No Concomitant medication was reported. After his booster dose the patient  shot area was painful.  As that declined the pain went into his right shoulder & now is in his legs & toe.  He also mentioned being stuffed up sometimes due to his lifestyle.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Erythema, Heart rate, Oxygen saturation, Pain in extremity
Clinical narrative: Breathing rate is 79 bpm; Does not have pain in the area, but it is red; Slightly sore arm that started around 8PM, which is about 5 hours after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATION ABNORMAL (Breathing rate is 79 bpm), PAIN IN EXTREMITY (Slightly sore arm that started around 8PM, which is about 5 hours after vaccination) and ERYTHEMA (Does not have pain in the area, but it is red) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (Patient is currently receiving cancer treatment.) and Cellulitis (She is also receiving IV treatment for cellulitis and the area that has cellulitis is red.).    On 04-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022, the patient experienced PAIN IN EXTREMITY (Slightly sore arm that started around 8PM, which is about 5 hours after vaccination). On an unknown date, the patient experienced RESPIRATION ABNORMAL (Breathing rate is 79 bpm) and ERYTHEMA (Does not have pain in the area, but it is red). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, RESPIRATION ABNORMAL (Breathing rate is 79 bpm), PAIN IN EXTREMITY (Slightly sore arm that started around 8PM, which is about 5 hours after vaccination) and ERYTHEMA (Does not have pain in the area, but it is red) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98.4 (normal) temperature 98.4F. On an unknown date, Heart rate: 70-71 bpm (normal) heart rate is at 70-71 bpm. On an unknown date, Oxygen saturation: 96% (normal) pulse oxygen level 96%. On an unknown date, Respiratory rate increased: 79 bpm (High) breathing rate is 79 bpm.         Patient was receiving IV infusion treatment for cellulitis and treatment for cancer. Her dermatologist had recommended to take Allegra during the day and Zyrtec in the evening. But she would prefer to just take Benadryl. No concomitant drug details were reported. Patient received 1st dose of Moderna Covid-19 vaccine on 04-Feb-2021 or 08-Feb-2021 and 2nd dose of Moderna Covid-19 vaccine on 04-Mar-2021 or 08-Mar-2021.   This case was linked to MOD-2022-440018, MOD-2022-439924 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Respiration abnormal, Respiratory rate increased
Clinical narrative: Breathing rate is 79 bpm; Does not have pain in the area, but it is red; Slightly sore arm that started around 8PM, which is about 5 hours after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATION ABNORMAL (Breathing rate is 79 bpm), PAIN IN EXTREMITY (Slightly sore arm that started around 8PM, which is about 5 hours after vaccination) and ERYTHEMA (Does not have pain in the area, but it is red) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (Patient is currently receiving cancer treatment.) and Cellulitis (She is also receiving IV treatment for cellulitis and the area that has cellulitis is red.).    On 04-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022, the patient experienced PAIN IN EXTREMITY (Slightly sore arm that started around 8PM, which is about 5 hours after vaccination). On an unknown date, the patient experienced RESPIRATION ABNORMAL (Breathing rate is 79 bpm) and ERYTHEMA (Does not have pain in the area, but it is red). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, RESPIRATION ABNORMAL (Breathing rate is 79 bpm), PAIN IN EXTREMITY (Slightly sore arm that started around 8PM, which is about 5 hours after vaccination) and ERYTHEMA (Does not have pain in the area, but it is red) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98.4 (normal) temperature 98.4F. On an unknown date, Heart rate: 70-71 bpm (normal) heart rate is at 70-71 bpm. On an unknown date, Oxygen saturation: 96% (normal) pulse oxygen level 96%. On an unknown date, Respiratory rate increased: 79 bpm (High) breathing rate is 79 bpm.         Patient was receiving IV infusion treatment for cellulitis and treatment for cancer. Her dermatologist had recommended to take Allegra during the day and Zyrtec in the evening. But she would prefer to just take Benadryl. No concomitant drug details were reported. Patient received 1st dose of Moderna Covid-19 vaccine on 04-Feb-2021 or 08-Feb-2021 and 2nd dose of Moderna Covid-19 vaccine on 04-Mar-2021 or 08-Mar-2021.   This case was linked to MOD-2022-440018, MOD-2022-439924 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Dizziness, Nausea, Pain in extremity
Clinical narrative: This spontaneous case reported by a non-healthcare professional, describes the occurrence of pain in extremity (arm), asthenia (felt very weak), dizziness (lightheaded) and nausea in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Previous vaccinations included Pfizer dose 1 and 2. No adverse event occurred with either vaccine. On Jan 4, 2022, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jan 5, 2022, patient experienced  pain in extremity (arm), asthenia (felt very weak), dizziness (lightheaded) and nausea. At the time of the report, pain in extremity (arm), asthenia (felt very weak), dizziness (lightheaded) and nausea outcome: unknown. Diagnostic results: On Jan 5, 2021 blood pressure measurement/blood pressure changes: result not reported (inconclusive). No concomitant medication or treatment information provided. Reporter did not allow further contact.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Disorientation, Dizziness
Clinical narrative: soreness in the shoulder; being disoriented and dizzy, not to the point of spinning but disorientated; being disoriented and dizzy, not to the point of spinning but disorientated; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (being disoriented and dizzy, not to the point of spinning but disorientated), DIZZINESS (being disoriented and dizzy, not to the point of spinning but disorientated) and ARTHRALGIA (soreness in the shoulder) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2021 at 10:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Dec-2021, the patient experienced DISORIENTATION (being disoriented and dizzy, not to the point of spinning but disorientated) and DIZZINESS (being disoriented and dizzy, not to the point of spinning but disorientated). On an unknown date, the patient experienced ARTHRALGIA (soreness in the shoulder). At the time of the report, DISORIENTATION (being disoriented and dizzy, not to the point of spinning but disorientated) and DIZZINESS (being disoriented and dizzy, not to the point of spinning but disorientated) had not resolved and ARTHRALGIA (soreness in the shoulder) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.   The patient experienced dizziness and disorientation at the afternoon of 31-Dec-2021.  The patient would make an appointment with the local general practitioner and asked whether the event was a side effect of Moderna vaccine or not. The patient was physically fine, could walk, but would not drive now because of this reason.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Skin reaction, Swelling
Clinical narrative: really really itchy, and anytime after you scratch or touch anywhere on the skin, it becomes red and bumpy and welty; really really itchy, and anytime after you scratch or touch anywhere on the skin, it becomes red and bumpy and welty; really really itchy, and anytime after you scratch or touch anywhere on the skin, it becomes red and bumpy and welty; Bumpy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (really really itchy, and anytime after you scratch or touch anywhere on the skin, it becomes red and bumpy and welty), ERYTHEMA (really really itchy, and anytime after you scratch or touch anywhere on the skin, it becomes red and bumpy and welty), SKIN REACTION (really really itchy, and anytime after you scratch or touch anywhere on the skin, it becomes red and bumpy and welty) and SWELLING (Bumpy) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 017C21A and 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced PRURITUS (really really itchy, and anytime after you scratch or touch anywhere on the skin, it becomes red and bumpy and welty), ERYTHEMA (really really itchy, and anytime after you scratch or touch anywhere on the skin, it becomes red and bumpy and welty), SKIN REACTION (really really itchy, and anytime after you scratch or touch anywhere on the skin, it becomes red and bumpy and welty) and SWELLING (Bumpy). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (really really itchy, and anytime after you scratch or touch anywhere on the skin, it becomes red and bumpy and welty), ERYTHEMA (really really itchy, and anytime after you scratch or touch anywhere on the skin, it becomes red and bumpy and welty), SKIN REACTION (really really itchy, and anytime after you scratch or touch anywhere on the skin, it becomes red and bumpy and welty) and SWELLING (Bumpy) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided Patient reported that  they are using allergy medication to help with events.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Receiving a 0.25ml dose as a first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Receiving a 0.25ml dose as a first dose) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013f21a) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 21-Nov-2021, the patient experienced UNDERDOSE (Receiving a 0.25ml dose as a first dose). On 21-Nov-2021, UNDERDOSE (Receiving a 0.25ml dose as a first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicines were reported. No treatment medicines were reported.   This case was linked to MOD-2022-440136 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Jan-2022: Followup document received contains no new information.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Palpitations
Clinical narrative: chest palpitations; blood pressure went "way up"; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (chest palpitations) and BLOOD PRESSURE INCREASED (blood pressure went "way up") in a 72-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (chest palpitations) and BLOOD PRESSURE INCREASED (blood pressure went "way up"). At the time of the report, PALPITATIONS (chest palpitations) and BLOOD PRESSURE INCREASED (blood pressure went "way up") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information provided by the reporter. No treatment information provided.   This case was linked to MOD-2022-440090 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Jan-2022: Follow up document contains non significant information reporters details updated.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: She experienced small, sharp pains in the chest; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (She experienced small, sharp pains in the chest) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (She experienced small, sharp pains in the chest). At the time of the report, CHEST PAIN (She experienced small, sharp pains in the chest) had resolved.            No Concomitant product use was reported.  The patient reported after receiving the Moderna booster dose the patient experienced small, sharp pains in the chest that went away. It was unknown if the IM injection was given into the left or right deltoid.  No treatment information was provided.   This case was linked to MOD-2022-440060 (Patient Link).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: not receiving 2nd dose on time; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (not receiving 2nd dose on time) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031h21a and 013f21a) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 03-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 ml. On 03-Jan-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (not receiving 2nd dose on time). On 03-Jan-2022, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (not receiving 2nd dose on time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.    This case was linked to MOD-2022-440055 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Jan-2022: No new information received
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Pain, Pain in extremity
Clinical narrative: Sore arm; Aching; Extreme high blood pressure 200/100; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PAIN (Aching) and HYPERTENSION (Extreme high blood pressure 200/100) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Diabetic (Patient  had  been diabetic for 20 years.). Concomitant products included ENALAPRIL MALEATE for Blood pressure high, METFORMIN, METOPROLOL and SITAGLIPTIN PHOSPHATE (JANUVIA) for an unknown indication.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PAIN (Aching) and HYPERTENSION (Extreme high blood pressure 200/100). The patient was treated with AMLODIPINE BESYLATE for Blood pressure high, at a dose of 5 milligram and ENALAPRIL MALEATE for Blood pressure high, at a dose of 20 milligram. At the time of the report, PAIN IN EXTREMITY (Sore arm) and PAIN (Aching) outcome was unknown and HYPERTENSION (Extreme high blood pressure 200/100) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Blood pressure measurement: 195/76 (abnormal) 195/76. In February 2021, Blood pressure measurement: 200/100 (High) 200/100. On 20-Feb-2021, Blood pressure measurement: 150/63 (abnormal) 150/63. On 22-Feb-2021, Blood pressure measurement: 171/74 (abnormal) 171/74.     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.   Patient went to the pharmacy the next day and her blood pressure was still high. She later contacted her doctor who increased one of her blood pressure medication Enalapril Maleate from 10 mg to 20mg.   This case was linked to MOD-2021-435439 (Patient Link).
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site reaction, Vaccination site urticaria
Clinical narrative: COVID ARM after 2nd shot; Hives on right arm injection site (size of a grapefruit) after 2nd shot; Big rash on right arm injection site (size of a grapefruit) after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID ARM after 2nd shot), VACCINATION SITE URTICARIA (Hives on right arm injection site (size of a grapefruit) after 2nd shot) and VACCINATION SITE RASH (Big rash on right arm injection site (size of a grapefruit) after 2nd shot) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE REACTION (COVID ARM after 2nd shot), VACCINATION SITE URTICARIA (Hives on right arm injection site (size of a grapefruit) after 2nd shot) and VACCINATION SITE RASH (Big rash on right arm injection site (size of a grapefruit) after 2nd shot). On 13-Apr-2021, VACCINATION SITE REACTION (COVID ARM after 2nd shot), VACCINATION SITE URTICARIA (Hives on right arm injection site (size of a grapefruit) after 2nd shot) and VACCINATION SITE RASH (Big rash on right arm injection site (size of a grapefruit) after 2nd shot) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.    No treatment medications were reported.   This case was linked to MOD-2022-440306 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Miliaria
Clinical narrative: bottom of my feet to my legs all my body got heat like a type of neuropathy heat; It's like inside the body is wounded and it gets hot (when you press on it/got hot/It's getting hot and a little dots/got hot and last night got hot all over my whole body.; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (bottom of my feet to my legs all my body got heat like a type of neuropathy heat) and MILIARIA (It's like inside the body is wounded and it gets hot (when you press on it/got hot/It's getting hot and a little dots/got hot and last night got hot all over my whole body.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A, 024M20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-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 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced FEELING HOT (bottom of my feet to my legs all my body got heat like a type of neuropathy heat) and MILIARIA (It's like inside the body is wounded and it gets hot (when you press on it/got hot/It's getting hot and a little dots/got hot and last night got hot all over my whole body.). At the time of the report, FEELING HOT (bottom of my feet to my legs all my body got heat like a type of neuropathy heat) and MILIARIA (It's like inside the body is wounded and it gets hot (when you press on it/got hot/It's getting hot and a little dots/got hot and last night got hot all over my whole body.) had not resolved.     No concomitant medications were provided. Patient had been sitting with ice under feet and under butt. Then I waited another week. It was getting hot and a little dot. On 03-Jan-2022 caller states he went to doctor again and he gave patient injection to calm it down and then doctor prescribed him steroids pills. First day patient took 6, second day patient took 5. Today was the second day patient was taking the pills. Once patient got the got injection on Monday, two- or three-hours patient body cooled down. Monday night for the first-time patient slept well. He got hot and had to put ice. The patient was healthy, was eating good and was physical. After physical (in November before vaccine) doctor said patient's (antibodies) was low so he should get the booster.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: I've had hives every day since; Itchy skin every day/I've had itchy hives every day since; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (I've had hives every day since) and PRURITUS (Itchy skin every day/I've had itchy hives every day since) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 003A21A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included LISINOPRIL for Blood pressure.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Dec-2021, the patient experienced URTICARIA (I've had hives every day since) and PRURITUS (Itchy skin every day/I've had itchy hives every day since). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) for Hives and Itching, at an unspecified dose and frequency. At the time of the report, URTICARIA (I've had hives every day since) and PRURITUS (Itchy skin every day/I've had itchy hives every day since) outcome was unknown.            The patient has been treating the symptoms with over the counter medication. The patient had hives and itchy skin every day since, and had been treating the symptoms with over the counter medication.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia
Clinical narrative: Fatigue; Low grade temperature 100 degree; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and PYREXIA (Low grade temperature 100 degree) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included Hives, Urticaria, Fever from 13-Nov-2020 to 19-Mar-2021, Ache from 13-Nov-2020 to 19-Mar-2021, Pain from 13-Nov-2020 to 19-Mar-2021, Swelling from 13-Nov-2020 to 19-Mar-2021, Chills from 13-Nov-2020 to 19-Mar-2021, Nausea from 13-Nov-2020 to 19-Mar-2021, Vomiting from 13-Nov-2020 to 19-Mar-2021, Difficulty breathing from 13-Nov-2020 to 19-Mar-2021, Consciousness decreased from 13-Nov-2020 to 19-Mar-2021, Numbness from 13-Nov-2020 to 19-Mar-2021, Feeling hot from 13-Nov-2020 to 19-Mar-2021 and Hip replacement (Within one week was walking one mile and felt quite well). Previously administered products included for Product used for unknown indication: Levaquin. Past adverse reactions to the above products included Muscle ache with Levaquin. Concurrent medical conditions included Hypersensitivity reaction and High cholesterol (Improved with rosuvastatin). Concomitant products included ESCITALOPRAM for Anxiety, ROSUVASTATIN for Cholesterol.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue) and PYREXIA (Low grade temperature 100 degree). At the time of the report, FATIGUE (Fatigue) and PYREXIA (Low grade temperature 100 degree) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (Low) Low grade temperature 100 degrees.     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 treatment medications were reported. Patient was not pregnant. Patient took suspect drug on site of left arm in full dose at AM. It was reported that patient got cold temps in 2015 and had a reaction of rash/hives on exposed skin.   This case was linked to MOD-2021-419387, MOD-2021-419309 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vaccination site pain
Clinical narrative: Pain at the injection site; Fever/high the fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site) and PYREXIA (Fever/high the fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain at the injection site) and PYREXIA (Fever/high the fever). At the time of the report, VACCINATION SITE PAIN (Pain at the injection site) and PYREXIA (Fever/high the fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2022, Body temperature: 98.5f (normal) normal temperature of around 98.5F.         Patient reported that more the severe pain at the injection site the high the fever patient had. On 05-Jan-2022, in the morning patient woke up with almost no pain and a normal body temperature of around 98.5 F.  No concomitant use were reported.  No treatment were reported.  Vaccine Information statement version date given is 19-Nov-2021.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: patient had arm soreness, sore arm from COVID 19 booster shot.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (patient had arm soreness, sore arm from COVID 19 booster shot.) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Secondary pulmonary arterial hypertension since 09-Sep-2020. Concomitant products included TREPROSTINIL SODIUM (TYVASO) from 09-Sep-2020 to an unknown date for Secondary pulmonary arterial hypertension, RIOCIGUAT (ADEMPAS), APIXABAN (ELIQUIS) and DILTIAZEM HYDROCHLORIDE (DILTIAZEM [DILTIAZEM HYDROCHLORIDE]) for an unknown indication.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (patient had arm soreness, sore arm from COVID 19 booster shot.). At the time of the report, PAIN IN EXTREMITY (patient had arm soreness, sore arm from COVID 19 booster shot.) outcome was unknown. Not Provided          No treatment information was provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: had a little bit of fever for two days; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (had a little bit of fever for two days) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced PYREXIA (had a little bit of fever for two days). On 30-Apr-2021, PYREXIA (had a little bit of fever for two days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported. No treatment medications were reported.  Patient had lots of medical conditions (pre-existing) that affect her health and was used to this.   This case was linked to MOD-2022-440473 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dysuria, Feeling abnormal
Clinical narrative: was bad ("bien mala"); pain while trying to pee; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (was bad ("bien mala")) and DYSURIA (pain while trying to pee) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 044B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-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 FEELING ABNORMAL (was bad ("bien mala")) and DYSURIA (pain while trying to pee). At the time of the report, FEELING ABNORMAL (was bad ("bien mala")) and DYSURIA (pain while trying to pee) outcome was unknown.            Patient has lots of medical conditions which are pre-existing that affect her health, so she is used to this. No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   This case was linked to MOD-2022-440451 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: it was heard "an IV"; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (it was heard "an IV") in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (it was heard "an IV"). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (it was heard "an IV") had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jan-2022: Non Significant FollowUp Appended, contained No New Information.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired vaccine on 05Jan2022; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine on 05Jan2022) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 05-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine on 05Jan2022). On 05-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine on 05Jan2022) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure before pregnancy, Product dose omission issue
Clinical narrative: more than 11 months after first shot & not received 2nd shot; Pregnant after first vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (more than 11 months after first shot & not received 2nd shot) and MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnant after first vaccine) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In 2021, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnant after first vaccine). On 05-Jan-2022, the patient experienced PRODUCT DOSE OMISSION ISSUE (more than 11 months after first shot & not received 2nd shot). In 2021, MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnant after first vaccine) had resolved. On 05-Jan-2022, PRODUCT DOSE OMISSION ISSUE (more than 11 months after first shot & not received 2nd shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant and Treatment Medication Were Reported.   Reporter did not allow further contact
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired vaccine on 05Jan2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine on 05Jan2022) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 05-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine on 05Jan2022). On 05-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine on 05Jan2022) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided. The vaccine was open at 8:17 AM on 04Jan2022 and needed to be discarded at 8:17 PM on 04Jan2022. No adverse event reported to the facility.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error
Clinical narrative: Received expired vaccine on 05Jan2022; 3 patients who received the vaccine from same vial/ vaccine was opened on 04JAN2022 and administered on 05JAN2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine on 05Jan2022) and PRODUCT ADMINISTRATION ERROR (3 patients who received the vaccine from same vial/ vaccine was opened on 04JAN2022 and administered on 05JAN2022) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 05-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine on 05Jan2022) and PRODUCT ADMINISTRATION ERROR (3 patients who received the vaccine from same vial/ vaccine was opened on 04JAN2022 and administered on 05JAN2022). On 05-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine on 05Jan2022) and PRODUCT ADMINISTRATION ERROR (3 patients who received the vaccine from same vial/ vaccine was opened on 04JAN2022 and administered on 05JAN2022) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vaccine was opened at 8:17 AM on 04Jan2022 and needed to be discarded at 8:17 PM 04Jan2022. However, the same vial was used to administer the vaccine to 3 patients on 05Jan2022.  No adverse event reported to the facility. Treatment medications were not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Rash, Tenderness, Urticaria
Clinical narrative: tender to touch on left head/scalp, left ear and neck; Hives; skin rash; Throbbing headache; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tender to touch on left head/scalp, left ear and neck), URTICARIA (Hives), RASH (skin rash) and HEADACHE (Throbbing headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (tender to touch on left head/scalp, left ear and neck), URTICARIA (Hives), RASH (skin rash) and HEADACHE (Throbbing headache). At the time of the report, TENDERNESS (tender to touch on left head/scalp, left ear and neck), URTICARIA (Hives), RASH (skin rash) and HEADACHE (Throbbing headache) had not resolved.            No concomitant medications reported by reporter No treatment medications provided by the reporter.   Patient stated that two weeks post booster, patient had throbbing headache, skin rash/ hive and tender to touch on left head/scalp, left ear and neck. Its day 4 of these symptoms.