chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: some left arm soreness since receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (some left arm soreness since receiving the vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart attack (Patient had heart attack 5 weeks prior to dose vaccination) in December 2020.  On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 13-Jan-2021, the patient experienced VACCINATION SITE PAIN (some left arm soreness since receiving the vaccine).   At the time of the report, VACCINATION SITE PAIN (some left arm soreness since receiving the vaccine) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  It is reported that patient was taking blood thinner post-heart attack condition. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Flushing, Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Rash is at 10 centimeter round, red and hot touch; Rash is at 10 centimeter round, red and hot touch; Whole arm was sore down all the day down to finger; Flushed; Fever; Tired; Rash of 3 centimeter; A spontaneous report was received from a nurse, concerning herself, a 63-year-old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed flushed; rash is at 10 centimeter round, red and hot touch; rash of 3 centimeter; fever; tired and whole arm was sore down all the day down to finger.  The patient's medical history was not provided. Concomitant medications reported included apixaban, bupropion, venlafaxine, simvastatin, levothyroxine and montelukast.  On 04-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number 025L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 04-Jan-2021, after the shot of vaccine, the patient developed a rash of 3cm at the site of injection and additionally developed low fever and became flush and felt tired. The next day, on 05-Jan-2021, patient's whole arm was sore down all day down to her finger. However, after 4 days, on 07-Jan-2021 the patient was out of tiredness, but on 12-Jan-2021, her rash had increased to 10cm, red and hot to the touch. Treatment medication included acetaminophen.     Action taken with mRNA-1273 in response to the events were not provided.   The outcome of events flushed; rash is at 10-centimeter round, red and hot touch; rash of 3 centimeter; fever and whole arm was sore down all the day down to finger were considered unknown. The event, tired was considered to be resolved on 07-Jan-2021.; Reporter's Comments: This spontaneous report concerns a 63-year-old female patient who experienced flushed; rash is at 10-centimeter round, red and hot touch; rash of 3 centimeter; fever; tired and whole arm was sore down all day down to finger.  The events occurred the same day after the administration of the first dose of the mRNA-1273 vaccine (Lot #: 025L20A, expiration date-unknown).  Treatment reported was acetaminophen and the outcome is resolved. Based on the information provided, which includes a temporal association between the reported events and the administration of mRNA-1273 vaccine, a causal association cannot be excluded. The events of fever, injection site rash, redness, muscle soreness and tiredness are consistent with the known safety profile of mRNA-1273 vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Rash is at 10 centimeter round, red and hot touch; Rash is at 10 centimeter round, red and hot touch; Whole arm was sore down all the day down to finger; Flushed; Fever; Tired; Rash of 3 centimeter; A spontaneous report was received from a nurse, concerning herself, a 63-year-old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed flushed; rash is at 10 centimeter round, red and hot touch; rash of 3 centimeter; fever; tired and whole arm was sore down all the day down to finger.  The patient's medical history was not provided. Concomitant medications reported included apixaban, bupropion, venlafaxine, simvastatin, levothyroxine and montelukast.  On 04-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number 025L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 04-Jan-2021, after the shot of vaccine, the patient developed a rash of 3cm at the site of injection and additionally developed low fever and became flush and felt tired. The next day, on 05-Jan-2021, patient's whole arm was sore down all day down to her finger. However, after 4 days, on 07-Jan-2021 the patient was out of tiredness, but on 12-Jan-2021, her rash had increased to 10cm, red and hot to the touch. Treatment medication included acetaminophen.     Action taken with mRNA-1273 in response to the events were not provided.   The outcome of events flushed; rash is at 10-centimeter round, red and hot touch; rash of 3 centimeter; fever and whole arm was sore down all the day down to finger were considered unknown. The event, tired was considered to be resolved on 07-Jan-2021.; Reporter's Comments: This spontaneous report concerns a 63-year-old female patient who experienced flushed; rash is at 10-centimeter round, red and hot touch; rash of 3 centimeter; fever; tired and whole arm was sore down all day down to finger.  The events occurred the same day after the administration of the first dose of the mRNA-1273 vaccine (Lot #: 025L20A, expiration date-unknown).  Treatment reported was acetaminophen and the outcome is resolved. Based on the information provided, which includes a temporal association between the reported events and the administration of mRNA-1273 vaccine, a causal association cannot be excluded. The events of fever, injection site rash, redness, muscle soreness and tiredness are consistent with the known safety profile of mRNA-1273 vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 08-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). On 08-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information was not provided.  This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Body temperature, Grip strength decreased, Hypoaesthesia, Lymphadenopathy
Clinical narrative: extreme pain in her arm pit; her lymph nodes on the left side of her body were swollen from her neck to her groin; tingling in her left arms; numbness in her left arm; unable to grip her left hand or able to hold anything; low grade fever of 99.4F; inflammation; soreness at injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE INFLAMMATION (inflammation), VACCINATION SITE PAIN (soreness at injection), AXILLARY PAIN (extreme pain in her arm pit), PARAESTHESIA (tingling in her left arms) and HYPOAESTHESIA (numbness in her left arm) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 08-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE INFLAMMATION (inflammation) and VACCINATION SITE PAIN (soreness at injection). On 13-Jan-2021, the patient experienced AXILLARY PAIN (extreme pain in her arm pit), PARAESTHESIA (tingling in her left arms), HYPOAESTHESIA (numbness in her left arm), GRIP STRENGTH DECREASED (unable to grip her left hand or able to hold anything) and PYREXIA (low grade fever of 99.4F). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE INFLAMMATION (inflammation), VACCINATION SITE PAIN (soreness at injection), AXILLARY PAIN (extreme pain in her arm pit), PARAESTHESIA (tingling in her left arms), HYPOAESTHESIA (numbness in her left arm), GRIP STRENGTH DECREASED (unable to grip her left hand or able to hold anything) and PYREXIA (low grade fever of 99.4F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, Body temperature: 99.4f (Low) low grade fever of 99.4F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medications were not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia, Vaccination site inflammation, Vaccination site pain
Clinical narrative: extreme pain in her arm pit; her lymph nodes on the left side of her body were swollen from her neck to her groin; tingling in her left arms; numbness in her left arm; unable to grip her left hand or able to hold anything; low grade fever of 99.4F; inflammation; soreness at injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE INFLAMMATION (inflammation), VACCINATION SITE PAIN (soreness at injection), AXILLARY PAIN (extreme pain in her arm pit), PARAESTHESIA (tingling in her left arms) and HYPOAESTHESIA (numbness in her left arm) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 08-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE INFLAMMATION (inflammation) and VACCINATION SITE PAIN (soreness at injection). On 13-Jan-2021, the patient experienced AXILLARY PAIN (extreme pain in her arm pit), PARAESTHESIA (tingling in her left arms), HYPOAESTHESIA (numbness in her left arm), GRIP STRENGTH DECREASED (unable to grip her left hand or able to hold anything) and PYREXIA (low grade fever of 99.4F). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE INFLAMMATION (inflammation), VACCINATION SITE PAIN (soreness at injection), AXILLARY PAIN (extreme pain in her arm pit), PARAESTHESIA (tingling in her left arms), HYPOAESTHESIA (numbness in her left arm), GRIP STRENGTH DECREASED (unable to grip her left hand or able to hold anything) and PYREXIA (low grade fever of 99.4F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, Body temperature: 99.4f (Low) low grade fever of 99.4F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medications were not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site warmth, Pain in extremity, Pruritus, Swelling
Clinical narrative: itchiness; little heat; soreness (pain); redness; swelling; A spontaneous report (United States) was received from a consumer who is a 73-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness, redness, swelling, itching and a little heat.   The patient's medical history includes high blood pressure and diabetes. Products known to have been used by the patient, within two weeks prior to the event, metformin, losartan and atenolol.  On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) for prophylaxis of COVID-19 infection.   On 30 Dec 2020, after receiving the Moderna COVID-19 vaccine, the patient reported she had some soreness (pain), redness and swelling (location not provided) that lasted for 3 days.  On 08 Jan 2020, the patient reported the same symptoms, soreness, redness and swelling returned with itching and a little heat (location not provided). The patient reported that she was not feeling bad but just experiencing the symptoms described.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, soreness, redness, swelling, itching and a little heat, were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Cold symptoms; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold symptoms) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included Immunodeficiency NOS.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced NASOPHARYNGITIS (Cold symptoms). The patient was treated with PREDNISONE for Immunodeficiency, at an unspecified dose and frequency and AMOXICILLIN, CLAVULANATE POTASSIUM (AUGMENTINE SR) at an unspecified dose and frequency. On 11-Jan-2021, NASOPHARYNGITIS (Cold symptoms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided; Sender's Comments: Based on the start date of the event (prior administration of mRNA-1273) the event is assessed as unlikely related to mRNA-1273.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Hands feel swollen; Itching at the injection site; Red patch at the injection site; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (Hands feel swollen), VACCINATION SITE PRURITUS (Itching at the injection site) and VACCINATION SITE ERYTHEMA (Red patch at the injection site) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) 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) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site) and VACCINATION SITE ERYTHEMA (Red patch at the injection site). On 13-Jan-2021, the patient experienced PERIPHERAL SWELLING (Hands feel swollen). At the time of the report, PERIPHERAL SWELLING (Hands feel swollen) had not resolved and VACCINATION SITE PRURITUS (Itching at the injection site) and VACCINATION SITE ERYTHEMA (Red patch at the injection site) 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.   Concomitant medication was not reported.  Treatment medication was not reported.    Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Heart rate, Heart rate increased, Hyperhidrosis
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of HEART RATE INCREASED (Increased pulse), THIRST (thirsty as heck when I wake up in the morning), HYPERHIDROSIS (wake up with sweat and have to change tshirt), CHILLS (Chills) and PYREXIA (Fever) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had COVID -19 the day after Thanksgiving 2020) on 27-Nov-2020, Pneumonia (Mild pneumonia in his right lung) and X-ray (Results came back showing the pneumonia had cleared.) on 26-Dec-2020. Previously administered products included for Pneumonia: Zpak, Cefdinir and Prednisone. Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for an unknown indication.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced HEART RATE INCREASED (Increased pulse), THIRST (thirsty as heck when I wake up in the morning), HYPERHIDROSIS (wake up with sweat and have to change tshirt), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (Increased pulse), THIRST (thirsty as heck when I wake up in the morning), HYPERHIDROSIS (wake up with sweat and have to change tshirt), CHILLS (Chills) and PYREXIA (Fever) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Nov-2020, SARS-CoV-2 test: Positive. On 26-Dec-2020, X-ray (positive-negative): no pneumonia (Negative) pneumonia had cleared. On 29-Dec-2020, Body temperature: 102.7 f Rechecked after some time-103 F. On 29-Dec-2020, Heart rate: 163 rechecked again after resting - dropped to 129.     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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Thirst, X-ray
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of HEART RATE INCREASED (Increased pulse), THIRST (thirsty as heck when I wake up in the morning), HYPERHIDROSIS (wake up with sweat and have to change tshirt), CHILLS (Chills) and PYREXIA (Fever) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had COVID -19 the day after Thanksgiving 2020) on 27-Nov-2020, Pneumonia (Mild pneumonia in his right lung) and X-ray (Results came back showing the pneumonia had cleared.) on 26-Dec-2020. Previously administered products included for Pneumonia: Zpak, Cefdinir and Prednisone. Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for an unknown indication.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced HEART RATE INCREASED (Increased pulse), THIRST (thirsty as heck when I wake up in the morning), HYPERHIDROSIS (wake up with sweat and have to change tshirt), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (Increased pulse), THIRST (thirsty as heck when I wake up in the morning), HYPERHIDROSIS (wake up with sweat and have to change tshirt), CHILLS (Chills) and PYREXIA (Fever) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Nov-2020, SARS-CoV-2 test: Positive. On 26-Dec-2020, X-ray (positive-negative): no pneumonia (Negative) pneumonia had cleared. On 29-Dec-2020, Body temperature: 102.7 f Rechecked after some time-103 F. On 29-Dec-2020, Heart rate: 163 rechecked again after resting - dropped to 129.     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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose abnormal, Blood glucose increased, Immunisation
Clinical narrative: Blood sugar higher than normal at 144; Received vaccine in thigh; blood sugar was elevated at 170; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (blood sugar was elevated at 170), BLOOD GLUCOSE ABNORMAL (Blood sugar higher than normal at 144) and IMMUNISATION (Received vaccine in thigh) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced BLOOD GLUCOSE INCREASED (blood sugar was elevated at 170) and IMMUNISATION (Received vaccine in thigh). On 21-Jan-2021, the patient experienced BLOOD GLUCOSE ABNORMAL (Blood sugar higher than normal at 144). On 21-Feb-2021, BLOOD GLUCOSE INCREASED (blood sugar was elevated at 170) was resolving. At the time of the report, BLOOD GLUCOSE ABNORMAL (Blood sugar higher than normal at 144) was resolving and IMMUNISATION (Received vaccine in thigh) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Blood glucose increased: 170 High. On 21-Jan-2021, Blood glucose increased: 144 abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information provided.    Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: No new information was added
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Flushing, Heart rate, Limb discomfort, Palpitations
Clinical narrative: Had hives on her left side; Felt itchy; Had rash on her left side; weird flush; Felt tingly; her heart was racing; sleepy; Heavy feeling; Could not talk; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of FLUSHING (weird flush), PARAESTHESIA (Felt tingly), PALPITATIONS (her heart was racing), SOMNOLENCE (sleepy) and LIMB DISCOMFORT (Heavy feeling) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SULFAMETHOXAZOLE, TRIMETHOPRIM (MORTIN).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced FLUSHING (weird flush), PARAESTHESIA (Felt tingly), PALPITATIONS (her heart was racing), SOMNOLENCE (sleepy), LIMB DISCOMFORT (Heavy feeling) and APHASIA (Could not talk). On 15-Jan-2021, the patient experienced URTICARIA (Had hives on her left side), PRURITUS (Felt itchy) and RASH (Had rash on her left side). The patient was treated with HYDROXYZINE HCL on 14-Jan-2021 at a dose of 25 mg three times a day. At the time of the report, FLUSHING (weird flush), PARAESTHESIA (Felt tingly), PALPITATIONS (her heart was racing), SOMNOLENCE (sleepy), LIMB DISCOMFORT (Heavy feeling), APHASIA (Could not talk), URTICARIA (Had hives on her left side), PRURITUS (Felt itchy) and RASH (Had rash on her left side) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Heart rate: 160 bpm 160 beats per minute.     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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus, Rash, Somnolence, Urticaria
Clinical narrative: Had hives on her left side; Felt itchy; Had rash on her left side; weird flush; Felt tingly; her heart was racing; sleepy; Heavy feeling; Could not talk; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of FLUSHING (weird flush), PARAESTHESIA (Felt tingly), PALPITATIONS (her heart was racing), SOMNOLENCE (sleepy) and LIMB DISCOMFORT (Heavy feeling) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SULFAMETHOXAZOLE, TRIMETHOPRIM (MORTIN).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced FLUSHING (weird flush), PARAESTHESIA (Felt tingly), PALPITATIONS (her heart was racing), SOMNOLENCE (sleepy), LIMB DISCOMFORT (Heavy feeling) and APHASIA (Could not talk). On 15-Jan-2021, the patient experienced URTICARIA (Had hives on her left side), PRURITUS (Felt itchy) and RASH (Had rash on her left side). The patient was treated with HYDROXYZINE HCL on 14-Jan-2021 at a dose of 25 mg three times a day. At the time of the report, FLUSHING (weird flush), PARAESTHESIA (Felt tingly), PALPITATIONS (her heart was racing), SOMNOLENCE (sleepy), LIMB DISCOMFORT (Heavy feeling), APHASIA (Could not talk), URTICARIA (Had hives on her left side), PRURITUS (Felt itchy) and RASH (Had rash on her left side) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Heart rate: 160 bpm 160 beats per minute.     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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site urticaria
Clinical narrative: Hives at injection site; Redness below the injection site; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE URTICARIA (Hives at injection site) and VACCINATION SITE ERYTHEMA (Redness below the injection site) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (Hives at injection site) and VACCINATION SITE ERYTHEMA (Redness below the injection site). At the time of the report, VACCINATION SITE URTICARIA (Hives at injection site) and VACCINATION SITE ERYTHEMA (Redness below the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment for the event included diphenhydramine HCL.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort
Clinical narrative: soreness that turned to discomfort on the lower part of her back, on her spine; A spontaneous report  was received from a consumer concerning a 31-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness that turned to discomfort on the lower part of her back, on her spine.   The patient's medical history was not provided by the reporter. Concomitant medications reported included protonix and synthroid; products used for unknown indication.  On 06 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 07 Jan 2021, the patient experienced soreness that turned to discomfort on the lower part of her back, on her spine.    Lab details was not provided by the reporter.  Treatment for the event was unknown.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, soreness that turned to discomfort on the lower part of her back, on her spine was recovered / resolved on 08 Jan 2021.; Reporter's Comments: Based on the information provided which includes a temporal association, a causal association between the reported event and the product use cannot be excluded.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Cough, Fatigue, Headache
Clinical narrative: COVID-19; cough; fatigue; headache; muscle and body aches; fever of 102.7° F; His arm where he gave shot was a little sore; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Jan-2021. The most recent information was received on 07-Jun-2021 and was forwarded to Moderna on 07-Jun-2021.    This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID-19), COUGH (cough), FATIGUE (fatigue), HEADACHE (headache) and MYALGIA (muscle and body aches) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, the patient experienced COUGH (cough), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle and body aches), PYREXIA (fever of 102.7° F) and VACCINATION SITE PAIN (His arm where he gave shot was a little sore). On 02-Jan-2021, the patient experienced COVID-19 (COVID-19). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of 400 mg and PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 500 mg. At the time of the report, COVID-19 (COVID-19), COUGH (cough), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle and body aches), PYREXIA (fever of 102.7° F) and VACCINATION SITE PAIN (His arm where he gave shot was a little sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jan-2021, Body temperature: 102.7 (High) 102.7F temperature. On 02-Jan-2021, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.   This case was linked to MOD-2021-209796 .   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: No specific follow-up information recorded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded with the events other than COVID-19 infection.  COVID-19 infection is unlikely related to the product.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: COVID-19; cough; fatigue; headache; muscle and body aches; fever of 102.7° F; His arm where he gave shot was a little sore; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Jan-2021. The most recent information was received on 07-Jun-2021 and was forwarded to Moderna on 07-Jun-2021.    This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID-19), COUGH (cough), FATIGUE (fatigue), HEADACHE (headache) and MYALGIA (muscle and body aches) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, the patient experienced COUGH (cough), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle and body aches), PYREXIA (fever of 102.7° F) and VACCINATION SITE PAIN (His arm where he gave shot was a little sore). On 02-Jan-2021, the patient experienced COVID-19 (COVID-19). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of 400 mg and PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 500 mg. At the time of the report, COVID-19 (COVID-19), COUGH (cough), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle and body aches), PYREXIA (fever of 102.7° F) and VACCINATION SITE PAIN (His arm where he gave shot was a little sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jan-2021, Body temperature: 102.7 (High) 102.7F temperature. On 02-Jan-2021, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.   This case was linked to MOD-2021-209796 .   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: No specific follow-up information recorded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded with the events other than COVID-19 infection.  COVID-19 infection is unlikely related to the product.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: redness around the injection site 3x4 spot around the injection site; hurts at night; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (redness around the injection site 3x4 spot around the injection site) and INJECTION SITE PAIN (hurts at night) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced INJECTION SITE PAIN (hurts at night). On 13-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (redness around the injection site 3x4 spot around the injection site). At the time of the report, INJECTION SITE ERYTHEMA (redness around the injection site 3x4 spot around the injection site) and INJECTION SITE PAIN (hurts at night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Based on current available information and the temporal association between product use and start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and start date of the events a causal relationship cannot be excluded.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Possible "COVID arm"-Mild
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Head injury, Seizure, Syncope, Tremor
Clinical narrative: Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe, Systemic: Shakiness-Severe, Additional Details: Received vaccine at 2:14 pm, moved to chair at 2:14:30, leaning forward in chair. Squatted next to companion at 2:15:20 for ~1 min. Seated again at 2:16:30, leaning forward. Rubs head at 2:18, held head at 2:18:30. At 2:19:30 pulled arms up bent at elbow, shook for 5 sec, fell out of chair, hit head, shook for 5 more sec, regained consciousness.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe, Systemic: Shakiness-Severe, Additional Details: Received vaccine at 2:14 pm, moved to chair at 2:14:30, leaning forward in chair. Squatted next to companion at 2:15:20 for ~1 min. Seated again at 2:16:30, leaning forward. Rubs head at 2:18, held head at 2:18:30. At 2:19:30 pulled arms up bent at elbow, shook for 5 sec, fell out of chair, hit head, shook for 5 more sec, regained consciousness.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chest discomfort, Chest pain, Flushing, Hyperhidrosis
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: STATED BURNING SENSATION IN ARM AND CHEST AND  PATIENT REQUESTED RPH TO CALL 911. 911 ARRIVED IN STORE-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: 911 TOOK PATIENT TO LOCAL HOSPITAL
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: STATED BURNING SENSATION IN ARM AND CHEST AND  PATIENT REQUESTED RPH TO CALL 911. 911 ARRIVED IN STORE-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: 911 TOOK PATIENT TO LOCAL HOSPITAL
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Diarrhoea, Flushing, Hyperhidrosis, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Diarrhea-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Syncope, Unresponsive to stimuli
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Diarrhea-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Loss of consciousness, Unresponsive to stimuli
Clinical narrative: PATIENT RECEIVED 1ST COVID VACCINE ON 8/7/21. AFTER RECEIVING THE VACCINE HE PASSED OUT AND LOST CONCIOUSNESS IN THE WAITING ROOM. THE FAMILY SAID THE PATIENT "ALWAYS DOES THIS" AFTER A VACCINE AND SAID IT USUALLY LASTS FOR 30 MINUTES. THE PATIENT WAS OBSERVED AND PULSE MONITORED. EMS WERE CALLED AS THE PATIENT REMAINED UNCONSCIOUS AND WAS STILL NOT AWARE AND RESPONSIVE WHEN EMS ARRIVED. THE FAMILY CAME BACK LATER THAT DAY AND SAID HE IS FINE NOW. THEY DID NOT SCHEDULE A 2ND VACCINE AND I MADE AWARE THEY COULD RESCHEDULE OR WALK IN IF DESIRED.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed, Nausea
Clinical narrative: Was supposed to start my menstrual cycle 7/26 and still hav not.  In addition I?ve been experiencing nausea off and on
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early-
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Error: Patient Too Young for Vaccine Administered-
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Injection site erythema, Lethargy, Nausea
Clinical narrative: Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Medium, Systemic: Diarrhea-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Nausea-Medium, Additional Details: Patient received shot on thursday and had fever, nausea, and diarrhea. On sunday he noticed a rash coming up all over his body. no problems breathing. went to dr today and told him it was hives. he received steroid pack to help and dr recommened 2nd shot while taking steroid
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Medium, Systemic: Diarrhea-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Nausea-Medium, Additional Details: Patient received shot on thursday and had fever, nausea, and diarrhea. On sunday he noticed a rash coming up all over his body. no problems breathing. went to dr today and told him it was hives. he received steroid pack to help and dr recommened 2nd shot while taking steroid
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Nodule, Skin warm, Sleep disorder
Clinical narrative: I may have what they call COVID arm?  I still have a sore spot (small red circle) on my left arm where I received the injection and today is day 11 afterwards.  It is still warm and there is lump under my skin about the size of a nickel and very painful - still waking me up at night.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: I may have what they call COVID arm?  I still have a sore spot (small red circle) on my left arm where I received the injection and today is day 11 afterwards.  It is still warm and there is lump under my skin about the size of a nickel and very painful - still waking me up at night.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives all over my body that I have had since July 20th- prescription drugs have not helped
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis
Clinical narrative: Systemic: Flushed / Sweating-Medium
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Injection site bruising
Clinical narrative: Site: Bruising at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite
Clinical narrative: Error: Patient Too Young for Vaccine Administered-
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dysphonia, Dyspnoea, Pharyngeal swelling, Pruritus
Clinical narrative: Pt c/o of shortness of breath and feeling like throat swelling.  Lungs clear bilat, w/o wheezing on auscultation but diminished.. no stridor noted over upper airway on auscultation, air movement heard however. No swelling noted to throat or tongue.  Pt voice is real hoarse and difficulty to understand.  Dry cough noted. No hives noted but pt did complain of feeling like her legs were itching.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Pruritus
Clinical narrative: Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Additional Details: Patient experienced a mild itch in the left arm, which was the arm the vaccine was injected into. Benadry given and after 20 minutes itching resolved
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Pyrexia
Clinical narrative: Shot at 10am -2pm Headache starts, located in the forehead/eye area. -3-4pm Tiredness/Fatigue sets in. -7-8pm Chills and slight fever start. Next day Still tired and fatigued, again chills/fever start during the day but tylenol helps.   -Dizziness starts along with tinnitus around 2pm. Lasts 4-5 hours.  -Tired and fatigued the rest of the day.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Shot at 10am -2pm Headache starts, located in the forehead/eye area. -3-4pm Tiredness/Fatigue sets in. -7-8pm Chills and slight fever start. Next day Still tired and fatigued, again chills/fever start during the day but tylenol helps.   -Dizziness starts along with tinnitus around 2pm. Lasts 4-5 hours.  -Tired and fatigued the rest of the day.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Pain in extremity, Pruritus, Rash
Clinical narrative: Day 1 evening of, pain in the arm. Day 2 Next morning Pain in every joint from the waist up, Severe tiredness, and internal itching. Day 3 Severe pain in joints from waist up, Moderate tiredness, Severe itching only benadryl could stop, and Mild Rash. Day 4 Moderate joint pain from waist up. Severe internal itching only benadryl could stop and Increasing Rash. Day 5 Mild Joint pain, Severe itching only benadryl could stop and increasing rash. Day 6 Continued Severe itching and mild rash sought medical attention. Dr prescribed Medrol dose and mile joint pain went away, rash stopped and itching slowed down.