chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Myalgia, Pyrexia
Clinical narrative: Feeling Cold; General body pain, sore body; high fever 103.8F; Bad Head Ache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Feeling Cold), MYALGIA (General body pain, sore body), PYREXIA (high fever 103.8F) and HEADACHE (Bad Head Ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis. Concomitant products included TERIFLUNOMIDE (AUBAGIO) for an unknown indication.    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 FEELING COLD (Feeling Cold), MYALGIA (General body pain, sore body), PYREXIA (high fever 103.8F) and HEADACHE (Bad Head Ache). At the time of the report, FEELING COLD (Feeling Cold), MYALGIA (General body pain, sore body), PYREXIA (high fever 103.8F) and HEADACHE (Bad Head Ache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 103.8f (High) 103.8F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported .  Patient had sore body that she described feeling as "hit by a Mack truck" and a horrendous pain (pain) (onset and latency: unknown). Patient expressed anxiety about getting the second shot of the COVID-19 vaccine.It was not reported if the patient received a corrective treatment   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Initial Additional-1
Sex: U
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: Weight loss; 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 WEIGHT DECREASED (Weight loss) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 WEIGHT DECREASED (Weight loss). At the time of the report, WEIGHT DECREASED (Weight loss) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported. No treatment medication were reported.
Sex: U
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: shivering; 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 CHILLS (shivering) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) .5 milliliter. On an unknown date, the patient experienced CHILLS (shivering). At the time of the report, CHILLS (shivering) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was provided by the reporter. No treatment was provided by the reporter.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Headache, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Arm hurt tremendously (sore); Bad vertigo; Excruciating pain / Hurtful; Needle felt different; Trouble moving the arm; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt tremendously (sore)), VERTIGO (Bad vertigo), PAIN (Excruciating pain / Hurtful), DEVICE CONNECTION ISSUE (Needle felt different) and MOBILITY DECREASED (Trouble moving the arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Muscle damage (Muscle damage on shoulder 10 years ago). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurt tremendously (sore)), VERTIGO (Bad vertigo), PAIN (Excruciating pain / Hurtful), DEVICE CONNECTION ISSUE (Needle felt different), MOBILITY DECREASED (Trouble moving the arm) and HEADACHE (Headaches). At the time of the report, PAIN IN EXTREMITY (Arm hurt tremendously (sore)), VERTIGO (Bad vertigo), PAIN (Excruciating pain / Hurtful), DEVICE CONNECTION ISSUE (Needle felt different), MOBILITY DECREASED (Trouble moving the arm) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that she received 1st shot on beginning of April,2021. Concomitant medication also included Blood pressure medications but was unable to provide the name of the blood pressure medication. Treatment included 1 pill for vertigo which was a common generic medication.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Arm hurt tremendously (sore); Bad vertigo; Excruciating pain / Hurtful; Needle felt different; Trouble moving the arm; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt tremendously (sore)), VERTIGO (Bad vertigo), PAIN (Excruciating pain / Hurtful), DEVICE CONNECTION ISSUE (Needle felt different) and MOBILITY DECREASED (Trouble moving the arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Muscle damage (Muscle damage on shoulder 10 years ago). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurt tremendously (sore)), VERTIGO (Bad vertigo), PAIN (Excruciating pain / Hurtful), DEVICE CONNECTION ISSUE (Needle felt different), MOBILITY DECREASED (Trouble moving the arm) and HEADACHE (Headaches). At the time of the report, PAIN IN EXTREMITY (Arm hurt tremendously (sore)), VERTIGO (Bad vertigo), PAIN (Excruciating pain / Hurtful), DEVICE CONNECTION ISSUE (Needle felt different), MOBILITY DECREASED (Trouble moving the arm) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that she received 1st shot on beginning of April,2021. Concomitant medication also included Blood pressure medications but was unable to provide the name of the blood pressure medication. Treatment included 1 pill for vertigo which was a common generic medication.
Sex: U
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: Post one vaccination with Moderna if exposed to COVID; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    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 EXPOSURE TO SARS-COV-2 (Post one vaccination with Moderna if exposed to COVID) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) at an unspecified dose. On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (Post one vaccination with Moderna if exposed to COVID). At the time of the report, EXPOSURE TO SARS-COV-2 (Post one vaccination with Moderna if exposed to COVID) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information not provided. List of concomitant medication were not given.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Headache, Nausea, Pyrexia
Clinical narrative: fever & chills that same night/fever (today it's 102.7°F); headache; shakes; loss appetite; nausea; Rapid test for Covid-19; fever & chills that same night/fever (today it's 102.7°F); This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    Med Info Agent: 24May2021: Received 2nd dose of the Moderna Covid-19 vaccine. She had fever & chills that same night. 25May2021-28May2021: Reports she was fine. 29May2021-01Jun2021:  She experienced fever (today it's 102.7°F), headache, shakes, chills, loss appetite & nausea. 31May2021: She did the rapid test for Covid-19, which yielded negative result.  Reports she's been taking Tylenol & Ibuprofen, but it hasn't been helpful with breaking the fever. Admits she's going to the Emergency Room, because her symptoms are just not improving.   inj site: left arm Verbal consent given
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Tremor
Clinical narrative: fever & chills that same night/fever (today it's 102.7°F); headache; shakes; loss appetite; nausea; Rapid test for Covid-19; fever & chills that same night/fever (today it's 102.7°F); This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    Med Info Agent: 24May2021: Received 2nd dose of the Moderna Covid-19 vaccine. She had fever & chills that same night. 25May2021-28May2021: Reports she was fine. 29May2021-01Jun2021:  She experienced fever (today it's 102.7°F), headache, shakes, chills, loss appetite & nausea. 31May2021: She did the rapid test for Covid-19, which yielded negative result.  Reports she's been taking Tylenol & Ibuprofen, but it hasn't been helpful with breaking the fever. Admits she's going to the Emergency Room, because her symptoms are just not improving.   inj site: left arm Verbal consent given
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: I received the 1st dose of modern and now I am missing my menstrual cycle; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of MENSTRUATION IRREGULAR (I received the 1st dose of modern and now I am missing my menstrual cycle) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 MENSTRUATION IRREGULAR (I received the 1st dose of modern and now I am missing my menstrual cycle). At the time of the report, MENSTRUATION IRREGULAR (I received the 1st dose of modern and now I am missing my menstrual cycle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: have a reaction to second vaccination two weeks later; 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 COMPLICATION (have a reaction to second vaccination two weeks later) 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) (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 VACCINATION COMPLICATION (have a reaction to second vaccination two weeks later). At the time of the report, VACCINATION COMPLICATION (have a reaction to second vaccination two weeks later) outcome was unknown.            Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    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 INFLUENZA LIKE ILLNESS (Flu like symptoms) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported by the reporter No treatment medications was  provided by the reporter.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Myalgia, Pyrexia
Clinical narrative: Arm pain; fever; chills; was very weak; This spontaneous case was reported by a nurse and describes the occurrence of MYALGIA (Arm pain), PYREXIA (fever), CHILLS (chills) and ASTHENIA (was very weak) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 04-Jan-2021, the patient experienced MYALGIA (Arm pain), PYREXIA (fever), CHILLS (chills) and ASTHENIA (was very weak). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at a dose of Unknown. On 05-Jan-2021, MYALGIA (Arm pain), PYREXIA (fever), CHILLS (chills) and ASTHENIA (was very weak) had resolved.        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.   Patient was medical info agent,Call  was transferred from Moderna Customer Care. Case number: 00170866,Caller reported that her husband saw a video about people being magnetic in vaccine area.her Husband put a magnet on the callers arm and it stuck to her. She wants to know why it is sticking and is concerned what is going on. She was  taking birth control pills (name of medication unknown).   This case was linked to MOD-2021-194540 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Pain following vaccination; 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 MYALGIA (Pain following vaccination) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Pain following vaccination). At the time of the report, MYALGIA (Pain following vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported by reporter No treatment details was reported by reporter.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: feeling achy; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (feeling achy) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, the patient experienced MYALGIA (feeling achy). At the time of the report, MYALGIA (feeling achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.   No treatment was reported for the events.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: feel bad after second shot; 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 FEELING ABNORMAL (feel bad after second 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (feel bad after second shot). At the time of the report, FEELING ABNORMAL (feel bad after second shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Difficulty breathing; 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 DYSPNOEA (Difficulty breathing) 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Difficulty breathing). At the time of the report, DYSPNOEA (Difficulty breathing) outcome was unknown.            concomitant medicines was not reported by reporter  treatment information was not provided
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pollakiuria, Pruritus, Weight decreased
Clinical narrative: "tight muscles in my neck"; "terrible diarrhea"; "was sick as a dog"; "really bad leg cramps"; "zero appetite like when I had COVID-19"; lost 2 pounds; "I feel like I have to urinate all the time"; "my bladder is very uncomfortable since getting the vaccine"; I can't eat; "a little itchy"; abdomen hurting; backside hurting; "violent chills"; "super bad headache"; "it hurt really bad"; "I am scared"; "real hot"; "started feeling really bad"; This spontaneous case was reported by an other health care professional and describes the occurrence of FEAR ("I am scared"), FEELING HOT ("real hot"), FEELING ABNORMAL ("started feeling really bad"), MUSCLE TIGHTNESS ("tight muscles in my neck") and DIARRHOEA ("terrible diarrhea") in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), MONTELUKAST SODIUM (SINGULAIR), Flomax, Breo Inhaler, ESTROGENS CONJUGATED (PREMARIN), Celexa, CLONAZEPAM (KLONOPIN) and Flexeril for an unknown indication.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, the patient experienced FEAR ("I am scared"), FEELING HOT ("real hot"), FEELING ABNORMAL ("started feeling really bad"), CHILLS ("violent chills"), HEADACHE ("super bad headache") and MYALGIA ("it hurt really bad"). On 01-Jun-2021, the patient experienced MUSCLE TIGHTNESS ("tight muscles in my neck"), DIARRHOEA ("terrible diarrhea"), ILLNESS ("was sick as a dog"), MUSCLE SPASMS ("really bad leg cramps"), DECREASED APPETITE ("zero appetite like when I had COVID-19"), WEIGHT DECREASED (lost 2 pounds), POLLAKIURIA ("I feel like I have to urinate all the time"), BLADDER DISCOMFORT ("my bladder is very uncomfortable since getting the vaccine"), FEEDING DISORDER (I can't eat), PRURITUS ("a little itchy"), ABDOMINAL PAIN UPPER (abdomen hurting) and BACK PAIN (backside hurting). At the time of the report, FEAR ("I am scared"), FEELING HOT ("real hot"), FEELING ABNORMAL ("started feeling really bad"), MUSCLE TIGHTNESS ("tight muscles in my neck"), DIARRHOEA ("terrible diarrhea"), ILLNESS ("was sick as a dog"), MUSCLE SPASMS ("really bad leg cramps"), DECREASED APPETITE ("zero appetite like when I had COVID-19"), WEIGHT DECREASED (lost 2 pounds), POLLAKIURIA ("I feel like I have to urinate all the time"), BLADDER DISCOMFORT ("my bladder is very uncomfortable since getting the vaccine"), FEEDING DISORDER (I can't eat), PRURITUS ("a little itchy"), ABDOMINAL PAIN UPPER (abdomen hurting), BACK PAIN (backside hurting), CHILLS ("violent chills"), HEADACHE ("super bad headache") and MYALGIA ("it hurt really bad") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vaccination site mass
Clinical narrative: soreness; Bump at injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Mar-2021 and was forwarded to Moderna on 03-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness) and VACCINATION SITE MASS (Bump at injection site) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 011A21A) for COVID-19 vaccination.     Concomitant products included WARFARIN SODIUM (COUMADIN) for an unknown indication.   On 02-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE MASS (Bump at injection site). On an unknown date, the patient experienced PAIN (soreness). The patient was treated with WARFARIN SODIUM (COUMADIN) at a dose of 1 dosage form. At the time of the report, PAIN (soreness) and VACCINATION SITE MASS (Bump at injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable      This case was linked to MOD-2021-033458 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Dyspnoea, Headache
Clinical narrative: shortness of breath; Dizzy; Tachycardia; fever 102-103F; Headache; Nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), DIZZINESS (Dizzy), TACHYCARDIA (Tachycardia), PYREXIA (fever 102-103F) and HEADACHE (Headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vitrectomy in 2018. Concurrent medical conditions included Stroke (Stroke through eye and loss her vision).    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced DYSPNOEA (shortness of breath), DIZZINESS (Dizzy), TACHYCARDIA (Tachycardia), PYREXIA (fever 102-103F), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (Chills). On 16-Apr-2021, TACHYCARDIA (Tachycardia), PYREXIA (fever 102-103F), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (Chills) had resolved. At the time of the report, DYSPNOEA (shortness of breath) outcome was unknown and DIZZINESS (Dizzy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Body temperature: 102-103f (High) fever 102-103F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Treatment information was not reported.   This case was linked to MOD-2021-209164 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow up information received on 2/7/2021 contains significant information. The previously reported adverse event related to second dose i.e., vision had not resolved. On 13-Aug-2021: Follow up received on 13/8/2021 contains No new information
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Tachycardia
Clinical narrative: shortness of breath; Dizzy; Tachycardia; fever 102-103F; Headache; Nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), DIZZINESS (Dizzy), TACHYCARDIA (Tachycardia), PYREXIA (fever 102-103F) and HEADACHE (Headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vitrectomy in 2018. Concurrent medical conditions included Stroke (Stroke through eye and loss her vision).    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced DYSPNOEA (shortness of breath), DIZZINESS (Dizzy), TACHYCARDIA (Tachycardia), PYREXIA (fever 102-103F), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (Chills). On 16-Apr-2021, TACHYCARDIA (Tachycardia), PYREXIA (fever 102-103F), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (Chills) had resolved. At the time of the report, DYSPNOEA (shortness of breath) outcome was unknown and DIZZINESS (Dizzy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Body temperature: 102-103f (High) fever 102-103F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Treatment information was not reported.   This case was linked to MOD-2021-209164 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow up information received on 2/7/2021 contains significant information. The previously reported adverse event related to second dose i.e., vision had not resolved. On 13-Aug-2021: Follow up received on 13/8/2021 contains No new information
Sex: U
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: urinary tract infection; 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 URINARY TRACT INFECTION (urinary tract infection) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (urinary tract infection). At the time of the report, URINARY TRACT INFECTION (urinary tract infection) outcome was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching all over her body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching all over her body) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching all over her body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; METOPROLOL at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZIRTEC) at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching all over her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Mechanical urticaria, Pruritus, Scratch
Clinical narrative: I developed a really bad Dermatographia; Just a slight scratch like someone wrote in my arms all the time; Sometimes its really itchy; Even my face its really red from head to toes/when I wash my hand with hot or cold water it turns red; This spontaneous case was reported by a consumer and describes the occurrence of MECHANICAL URTICARIA (I developed a really bad Dermatographia), SCRATCH (Just a slight scratch like someone wrote in my arms all the time), PRURITUS (Sometimes its really itchy) and ERYTHEMA (Even my face its really red from head to toes/when I wash my hand with hot or cold water it turns red) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 025O20A) for COVID-19 vaccination.     Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Jan-2021, the patient experienced MECHANICAL URTICARIA (I developed a really bad Dermatographia), SCRATCH (Just a slight scratch like someone wrote in my arms all the time), PRURITUS (Sometimes its really itchy) and ERYTHEMA (Even my face its really red from head to toes/when I wash my hand with hot or cold water it turns red). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy, at a dose of UNK, bid and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Allergy, at a dose of UNK, bid. At the time of the report, MECHANICAL URTICARIA (I developed a really bad Dermatographia), SCRATCH (Just a slight scratch like someone wrote in my arms all the time), PRURITUS (Sometimes its really itchy) and ERYTHEMA (Even my face its really red from head to toes/when I wash my hand with hot or cold water it turns red) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No medical history was provided by reporter. Concomitant medicine include Vitamin D Treatment Took Zyrtec, Benadryl or Claritin  but still doesn't help
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm Sore two weeks after shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Sore two weeks after 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm Sore two weeks after shot). At the time of the report, PAIN IN EXTREMITY (Arm Sore two weeks after shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment details were provided.
Age: 47.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Psoriasis
Clinical narrative: psoriasis aggravated; This spontaneous case was reported by an other health care professional and describes the occurrence of PSORIASIS (psoriasis aggravated) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for an unknown indication.    No Medical History information was reported.   On 22-Mar-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced PSORIASIS (psoriasis aggravated). At the time of the report, PSORIASIS (psoriasis aggravated) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drugs were reported. No treatment drugs were reported.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Fatigue, Headache
Clinical narrative: temp 100.2 oral; body aches; chills; fatigue; headache; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (temp 100.2 oral), MYALGIA (body aches), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (temp 100.2 oral), MYALGIA (body aches), CHILLS (chills), FATIGUE (fatigue), HEADACHE (headache) and NAUSEA (Nausea). At the time of the report, PYREXIA (temp 100.2 oral), MYALGIA (body aches), CHILLS (chills), FATIGUE (fatigue), HEADACHE (headache) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jan-2021, Body temperature:. On 01-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Body temperature: 100.2 (High) 100.2.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 Moderna COVID-19 Vaccination was Not applicable.  No Concomitant medication was provided.  No Treatment medication was provided.   This case was linked to MOD-2021-006050 (Patient Link).
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, SARS-CoV-2 test
Clinical narrative: temp 100.2 oral; body aches; chills; fatigue; headache; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (temp 100.2 oral), MYALGIA (body aches), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (temp 100.2 oral), MYALGIA (body aches), CHILLS (chills), FATIGUE (fatigue), HEADACHE (headache) and NAUSEA (Nausea). At the time of the report, PYREXIA (temp 100.2 oral), MYALGIA (body aches), CHILLS (chills), FATIGUE (fatigue), HEADACHE (headache) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jan-2021, Body temperature:. On 01-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Body temperature: 100.2 (High) 100.2.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 Moderna COVID-19 Vaccination was Not applicable.  No Concomitant medication was provided.  No Treatment medication was provided.   This case was linked to MOD-2021-006050 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Asthma, Dyspnoea
Clinical narrative: Shortness of Breath; Asthma; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of Breath) and ASTHMA (Asthma) 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 28-Apr-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 DYSPNOEA (Shortness of Breath) and ASTHMA (Asthma). At the time of the report, DYSPNOEA (Shortness of Breath) and ASTHMA (Asthma) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.   Reporter did not allow further contact
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Injection site pain, Insomnia, Limb discomfort, Muscle spasms
Clinical narrative: lot of pain in the arm of the injection site; Warm; Can't lift arm; Muscle spasms; Doesn't let her sleep; Pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Warm), LIMB DISCOMFORT (Can't lift arm), MUSCLE SPASMS (Muscle spasms), INSOMNIA (Doesn't let her sleep) and PAIN IN EXTREMITY (Pain in the arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included LEVOTHYROXINE SODIUM (EUTHYROX) for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced FEELING HOT (Warm), LIMB DISCOMFORT (Can't lift arm) and INSOMNIA (Doesn't let her sleep). 04-May-2021, the patient experienced MUSCLE SPASMS (Muscle spasms) and PAIN IN EXTREMITY (Pain in the arm). On an unknown date, the patient experienced INJECTION SITE PAIN (lot of pain in the arm of the injection site). The patient was treated with NAPROXEN at a dose of 500 mg. At the time of the report, FEELING HOT (Warm), LIMB DISCOMFORT (Can't lift arm), MUSCLE SPASMS (Muscle spasms), INSOMNIA (Doesn't let her sleep), PAIN IN EXTREMITY (Pain in the arm) and INJECTION SITE PAIN (lot of pain in the arm of the injection site) outcome was unknown.            Treatment included Warm compresses   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow-up received on 30-JUN-2021 contains NNI
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: lot of pain in the arm of the injection site; Warm; Can't lift arm; Muscle spasms; Doesn't let her sleep; Pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Warm), LIMB DISCOMFORT (Can't lift arm), MUSCLE SPASMS (Muscle spasms), INSOMNIA (Doesn't let her sleep) and PAIN IN EXTREMITY (Pain in the arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included LEVOTHYROXINE SODIUM (EUTHYROX) for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced FEELING HOT (Warm), LIMB DISCOMFORT (Can't lift arm) and INSOMNIA (Doesn't let her sleep). 04-May-2021, the patient experienced MUSCLE SPASMS (Muscle spasms) and PAIN IN EXTREMITY (Pain in the arm). On an unknown date, the patient experienced INJECTION SITE PAIN (lot of pain in the arm of the injection site). The patient was treated with NAPROXEN at a dose of 500 mg. At the time of the report, FEELING HOT (Warm), LIMB DISCOMFORT (Can't lift arm), MUSCLE SPASMS (Muscle spasms), INSOMNIA (Doesn't let her sleep), PAIN IN EXTREMITY (Pain in the arm) and INJECTION SITE PAIN (lot of pain in the arm of the injection site) outcome was unknown.            Treatment included Warm compresses   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow-up received on 30-JUN-2021 contains NNI
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, SARS-CoV-2 test
Clinical narrative: no taste or smell; no taste or smell; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (no taste or smell) and ANOSMIA (no taste or smell) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 20-Apr-2021 at 11:45 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021 at 6:00 PM, the patient experienced AGEUSIA (no taste or smell) and ANOSMIA (no taste or smell). At the time of the report, AGEUSIA (no taste or smell) and ANOSMIA (no taste or smell) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         No concomitant medications were provided by the reporter.  Treatment information was not provided.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Pulmonary pain, Renal pain, SARS-CoV-2 test
Clinical narrative: Pain in the lungs or kidney; Pain in the lungs or kidney; without strength; tired; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY PAIN (Pain in the lungs or kidney), RENAL PAIN (Pain in the lungs or kidney), ASTHENIA (without strength) and FATIGUE (tired) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 038A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Had COVID in 2020).   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PULMONARY PAIN (Pain in the lungs or kidney), RENAL PAIN (Pain in the lungs or kidney), ASTHENIA (without strength) and FATIGUE (tired). At the time of the report, PULMONARY PAIN (Pain in the lungs or kidney), RENAL PAIN (Pain in the lungs or kidney), ASTHENIA (without strength) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Had COVID in 2020.         No concomitant medications were mentioned.  The patient's symptoms started a week after the second dose and. The patient mentioned that after the first dose felt something on the arm, but that was all.  No treatment details were reported.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments    This case was linked to MOD-2021-213314 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash macular, Urticaria
Clinical narrative: Hives/The hives mostly stayed on my chest, my breast had terrible rash too; I still have blotchiness on my legs; I had that rash all over my stomach, back, arms, groin, all over the place; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives/The hives mostly stayed on my chest, my breast had terrible rash too), RASH MACULAR (I still have blotchiness on my legs) and RASH (I had that rash all over my stomach, back, arms, groin, all over the place) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included ENALAPRIL, METFORMIN, GABAPENTIN (NEURONTIN), LEVOTHYROXINE SODIUM (LEVOXYL), GEMFIBROZIL, IBUPROFEN, ASCORBIC ACID (VITAMIN C ACID), ZINC, FISH OIL, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and CALCIUM for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives/The hives mostly stayed on my chest, my breast had terrible rash too), RASH MACULAR (I still have blotchiness on my legs) and RASH (I had that rash all over my stomach, back, arms, groin, all over the place). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK dosage form and HYDROCORTISONE ACETATE (HYDROCORTISONE [HYDROCORTISONE ACETATE]) at a dose of UNK dosage form. At the time of the report, URTICARIA (Hives/The hives mostly stayed on my chest, my breast had terrible rash too) and RASH (I had that rash all over my stomach, back, arms, groin, all over the place) had resolved and RASH MACULAR (I still have blotchiness on my legs) had not resolved.            Treatment information was not provided by reported.    This case was linked to MOD-2021-213312 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Jul-2021: Follow up received and contained No New Information.