chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Chills, Dyspnoea, Illness, Oropharyngeal discomfort
Clinical narrative: was sick; achy; broke out in blisters; broke out in rash on arms; high temperatures; teeth chattering; something in my throat; swelling in throat; I couldn't breathe; shaking; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OROPHARYNGEAL DISCOMFORT (something in my throat), PHARYNGEAL SWELLING (swelling in throat), DYSPNOEA (I couldn't breathe), TREMOR (shaking) and ILLNESS (was sick) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038821A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and ALPRAZOLAM (XANAX) for an unknown indication.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (something in my throat), PHARYNGEAL SWELLING (swelling in throat), DYSPNOEA (I couldn't breathe), TREMOR (shaking) and CHILLS (teeth chattering). On 16-May-2021, the patient experienced ILLNESS (was sick), PAIN (achy), BLISTER (broke out in blisters), RASH (broke out in rash on arms) and PYREXIA (high temperatures). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and EPINEPHRINE (EPIPEN) at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL DISCOMFORT (something in my throat), PHARYNGEAL SWELLING (swelling in throat), DYSPNOEA (I couldn't breathe), TREMOR (shaking), ILLNESS (was sick), PAIN (achy), BLISTER (broke out in blisters), RASH (broke out in rash on arms), CHILLS (teeth chattering) and PYREXIA (high temperatures) had resolved.            Additional concomitant product used included Lortab (generic), 1 a day.  This patient was treated by EMS (Emergency Medical Services) and transferred to the hospital. While at the ER (Emergency Room), she was treated with steroid shots NOS, epi pen, adrenaline, diphenhydramine (Benadryl) and IVs and sent home. The next day on 16-May-2021, she broke out in blisters that were the size of the end of a pen that you push.  Treatment provided included Tylenol (paracetamol), Benadryl, steroid shots NOS, Epi Pen, adrenaline and IV NOS.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pharyngeal swelling, Pyrexia, Rash, Tremor
Clinical narrative: was sick; achy; broke out in blisters; broke out in rash on arms; high temperatures; teeth chattering; something in my throat; swelling in throat; I couldn't breathe; shaking; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OROPHARYNGEAL DISCOMFORT (something in my throat), PHARYNGEAL SWELLING (swelling in throat), DYSPNOEA (I couldn't breathe), TREMOR (shaking) and ILLNESS (was sick) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038821A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and ALPRAZOLAM (XANAX) for an unknown indication.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (something in my throat), PHARYNGEAL SWELLING (swelling in throat), DYSPNOEA (I couldn't breathe), TREMOR (shaking) and CHILLS (teeth chattering). On 16-May-2021, the patient experienced ILLNESS (was sick), PAIN (achy), BLISTER (broke out in blisters), RASH (broke out in rash on arms) and PYREXIA (high temperatures). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and EPINEPHRINE (EPIPEN) at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL DISCOMFORT (something in my throat), PHARYNGEAL SWELLING (swelling in throat), DYSPNOEA (I couldn't breathe), TREMOR (shaking), ILLNESS (was sick), PAIN (achy), BLISTER (broke out in blisters), RASH (broke out in rash on arms), CHILLS (teeth chattering) and PYREXIA (high temperatures) had resolved.            Additional concomitant product used included Lortab (generic), 1 a day.  This patient was treated by EMS (Emergency Medical Services) and transferred to the hospital. While at the ER (Emergency Room), she was treated with steroid shots NOS, epi pen, adrenaline, diphenhydramine (Benadryl) and IVs and sent home. The next day on 16-May-2021, she broke out in blisters that were the size of the end of a pen that you push.  Treatment provided included Tylenol (paracetamol), Benadryl, steroid shots NOS, Epi Pen, adrenaline and IV NOS.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Patient experienced swelling to injection sites following second dose of Moderna COVID vaccine on 1-Jun-2021; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE SWELLING (Patient experienced swelling to injection sites following second dose of Moderna COVID vaccine on 1-Jun-2021) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jun-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Patient experienced swelling to injection sites following second dose of Moderna COVID vaccine on 1-Jun-2021). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (Patient experienced swelling to injection sites following second dose of Moderna COVID vaccine on 1-Jun-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received Restylane Kysse and Restylane Silk in the lips in Mar 2021.    Action taken with drug is not applicable.  No concomitant medication was reported.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 45 Days post First Vaccine, No Second Dose yet; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (45 Days post First Vaccine, No Second Dose yet) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (45 Days post First Vaccine, No Second Dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (45 Days post First Vaccine, No Second Dose yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment information not provided.   This case was linked to MOD-2021-108572 (E2B Linked Report).; Sender's Comments:  MOD-2021-108572:crosslinked to Wife case
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Feeling abnormal
Clinical narrative: Feeling Miserable; Covid-19; Shoulder Soreness; This spontaneous case was reported by a health care professional and describes the occurrence of FEELING ABNORMAL (Feeling Miserable), COVID-19 (Covid-19) and ARTHRALGIA (Shoulder Soreness) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unk and unk) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Feeling Miserable), COVID-19 (Covid-19) and ARTHRALGIA (Shoulder Soreness). At the time of the report, FEELING ABNORMAL (Feeling Miserable) outcome was unknown and COVID-19 (Covid-19) and ARTHRALGIA (Shoulder Soreness) was resolving.        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 medication and treatment  medication was provided by the reporter.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Vaccination site pain
Clinical narrative: off label benefit; soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (off label benefit) and VACCINATION SITE PAIN (soreness at injection site) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to plants (severe allergic reaction to poison ivy). Concomitant products included FISH OIL (OMEGA 3 [FISH OIL]), ESOMEPRAZOLE, MAGNESIUM, MULTIVITAMINS [VITAMINS NOS], COLECALCIFEROL (VITAMIN D3), UBIDECARENONE (COQ10 [UBIDECARENONE]) and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness at injection site). On an unknown date, the patient experienced OFF LABEL USE (off label benefit). At the time of the report, OFF LABEL USE (off label benefit) and VACCINATION SITE PAIN (soreness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not reported for mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessment.   This case was linked to MOD-2021-213422 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Fatigue, Paraesthesia, Peripheral swelling
Clinical narrative: Fatigue; Swelling and burning in her feet; Burning in her feet; Tingling in my fingers; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling and burning in her feet), BURNING SENSATION (Burning in her feet), PARAESTHESIA (Tingling in my fingers) and FATIGUE (Fatigue) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 027C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jun-2021, the patient experienced PERIPHERAL SWELLING (Swelling and burning in her feet), BURNING SENSATION (Burning in her feet) and PARAESTHESIA (Tingling in my fingers). On an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, PERIPHERAL SWELLING (Swelling and burning in her feet), BURNING SENSATION (Burning in her feet), PARAESTHESIA (Tingling in my fingers) and FATIGUE (Fatigue) 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 medications were not reported . Treatment The patient went to the health club and began to exercise on 07Jun2021, and the tingling went away
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Erythematous with pruritis.; Erythematous with pruritis.; Golf ball size swelling at injection site after first jab; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (Erythematous with pruritis.), VACCINATION SITE PRURITUS (Erythematous with pruritis.) and VACCINATION SITE SWELLING (Golf ball size swelling at injection site after first jab) 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Erythematous with pruritis.), VACCINATION SITE PRURITUS (Erythematous with pruritis.) and VACCINATION SITE SWELLING (Golf ball size swelling at injection site after first jab). At the time of the report, VACCINATION SITE ERYTHEMA (Erythematous with pruritis.), VACCINATION SITE PRURITUS (Erythematous with pruritis.) and VACCINATION SITE SWELLING (Golf ball size swelling at injection site after first jab) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information of patient was provided. Patient's treatment information was not provided. Patient had no Adverse Reaction to second shot of Moderna Vaccine.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Injection site erythema, Myalgia, Peripheral swelling
Clinical narrative: new onset of redness at the injection site.; swelling of the injection arm(right arm); soreness of the injection arm; headache; bad body ache / quoted," body pain felt like ran over by a car",/; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling of the injection arm(right arm)), ARTHRALGIA (soreness of the injection arm), HEADACHE (headache), MYALGIA (bad body ache / quoted," body pain felt like ran over by a car",/) and INJECTION SITE ERYTHEMA (new onset of redness at the injection site.) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 049C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jun-2021, the patient experienced PERIPHERAL SWELLING (swelling of the injection arm(right arm)), ARTHRALGIA (soreness of the injection arm), HEADACHE (headache) and MYALGIA (bad body ache / quoted," body pain felt like ran over by a car",/). On 08-Jun-2021, the patient experienced INJECTION SITE ERYTHEMA (new onset of redness at the injection site.). At the time of the report, PERIPHERAL SWELLING (swelling of the injection arm(right arm)), ARTHRALGIA (soreness of the injection arm), HEADACHE (headache), MYALGIA (bad body ache / quoted," body pain felt like ran over by a car",/) and INJECTION SITE ERYTHEMA (new onset of redness at the injection site.) outcome was unknown.            Concomitant product was not provided by the reporter.  Treatment information was not provided  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Vaccination site pain
Clinical narrative: pain in both arms; headaches at the front and back of my head, more headaches than usual; pain on the injection site; still feels fatigued; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in both arms), HEADACHE (headaches at the front and back of my head, more headaches than usual), VACCINATION SITE PAIN (pain on the injection site) and FATIGUE (still feels fatigued) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 037Ac13) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Neuropathy.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced PAIN IN EXTREMITY (pain in both arms), HEADACHE (headaches at the front and back of my head, more headaches than usual), VACCINATION SITE PAIN (pain on the injection site) and FATIGUE (still feels fatigued). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form and IBUPROFEN for Adverse event, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (pain in both arms), HEADACHE (headaches at the front and back of my head, more headaches than usual), VACCINATION SITE PAIN (pain on the injection site) and FATIGUE (still feels fatigued) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: normal (normal) both arms.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up information was received on 29-jun-2021 contains Significant information. Added new events Pain in both arms and Fatigue. Anatomical location of vaccine updated.
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction, Chills, Fatigue, Feeling hot, Headache
Clinical narrative: Sweating; Shaking; Sensation of heat; Sleeplessness; Adverse drug reaction; Irritable; Shivering; Exhaustion; Queasy; Headache; This spontaneous case was reported by a physician and describes the occurrence of HYPERHIDROSIS (Sweating), TREMOR (Shaking), FEELING HOT (Sensation of heat), INSOMNIA (Sleeplessness) and ADVERSE DRUG REACTION (Adverse drug reaction) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Psoriasis and METHOTREXATE for an unknown indication.    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) (unknown route) dosage was changed to 1 dosage form., ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose and METHOTREXATE (unknown route) at an unspecified dose. On an unknown date, the patient experienced HYPERHIDROSIS (Sweating), TREMOR (Shaking), FEELING HOT (Sensation of heat), INSOMNIA (Sleeplessness), ADVERSE DRUG REACTION (Adverse drug reaction), IRRITABILITY (Irritable), CHILLS (Shivering), FATIGUE (Exhaustion), NAUSEA (Queasy) and HEADACHE (Headache). At the time of the report, HYPERHIDROSIS (Sweating), TREMOR (Shaking), FEELING HOT (Sensation of heat), INSOMNIA (Sleeplessness), ADVERSE DRUG REACTION (Adverse drug reaction), IRRITABILITY (Irritable), CHILLS (Shivering), FATIGUE (Exhaustion), NAUSEA (Queasy) and HEADACHE (Headache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reference number: 21K-163-3927397-00 No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Events Adverse drug reaction, Queasy, Chills, Sensation of heat, Sleeplessness, Irritable and Headache all  having outcome Not recovered/not resolved were added. Suspect drug METHOTREXATE was added.
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Insomnia, Irritability, Nausea, Tremor
Clinical narrative: Sweating; Shaking; Sensation of heat; Sleeplessness; Adverse drug reaction; Irritable; Shivering; Exhaustion; Queasy; Headache; This spontaneous case was reported by a physician and describes the occurrence of HYPERHIDROSIS (Sweating), TREMOR (Shaking), FEELING HOT (Sensation of heat), INSOMNIA (Sleeplessness) and ADVERSE DRUG REACTION (Adverse drug reaction) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Psoriasis and METHOTREXATE for an unknown indication.    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) (unknown route) dosage was changed to 1 dosage form., ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose and METHOTREXATE (unknown route) at an unspecified dose. On an unknown date, the patient experienced HYPERHIDROSIS (Sweating), TREMOR (Shaking), FEELING HOT (Sensation of heat), INSOMNIA (Sleeplessness), ADVERSE DRUG REACTION (Adverse drug reaction), IRRITABILITY (Irritable), CHILLS (Shivering), FATIGUE (Exhaustion), NAUSEA (Queasy) and HEADACHE (Headache). At the time of the report, HYPERHIDROSIS (Sweating), TREMOR (Shaking), FEELING HOT (Sensation of heat), INSOMNIA (Sleeplessness), ADVERSE DRUG REACTION (Adverse drug reaction), IRRITABILITY (Irritable), CHILLS (Shivering), FATIGUE (Exhaustion), NAUSEA (Queasy) and HEADACHE (Headache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reference number: 21K-163-3927397-00 No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Events Adverse drug reaction, Queasy, Chills, Sensation of heat, Sleeplessness, Irritable and Headache all  having outcome Not recovered/not resolved were added. Suspect drug METHOTREXATE was added.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Breast pain, Chest pain, Computerised tomogram
Clinical narrative: crap for a month / had weird symptoms for a month straight; felt better after the second vaccine; weird flush feeling; sore arm; breast pain; tachycardia; lymph node under arm pain; tired; shortness of breath; chest pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (crap for a month / had weird symptoms for a month straight), THERAPEUTIC RESPONSE UNEXPECTED (felt better after the second vaccine), FLUSHING (weird flush feeling), LIMB DISCOMFORT (sore arm) and DYSPNOEA (shortness of breath) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Postpartum disorder.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, the patient experienced DYSPNOEA (shortness of breath) and CHEST PAIN (chest pain). On an unknown date, the patient experienced FEELING ABNORMAL (crap for a month / had weird symptoms for a month straight), THERAPEUTIC RESPONSE UNEXPECTED (felt better after the second vaccine), FLUSHING (weird flush feeling), LIMB DISCOMFORT (sore arm), BREAST PAIN (breast pain), TACHYCARDIA (tachycardia), LYMPH NODE PAIN (lymph node under arm pain) and FATIGUE (tired). The patient was treated with NAPROXEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (crap for a month / had weird symptoms for a month straight), THERAPEUTIC RESPONSE UNEXPECTED (felt better after the second vaccine), FLUSHING (weird flush feeling), LIMB DISCOMFORT (sore arm), DYSPNOEA (shortness of breath), CHEST PAIN (chest pain), BREAST PAIN (breast pain), TACHYCARDIA (tachycardia), LYMPH NODE PAIN (lymph node under arm pain) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2021, Blood test: normal normal. On 18-May-2021, Body temperature: 100.5 (High) High. On 18-May-2021, Computerised tomogram: normal (normal) with oral contrast. On 18-May-2021, Echocardiogram: normal (normal) soft echo to look for blood clots. On 18-May-2021, Heart rate increased: 120-130 (abnormal) Abnormal. On 18-May-2021, SARS-CoV-2 test negative: negative (Negative) COVID test-negative. On 18-May-2021, White blood cell count: double to normal (abnormal) Double to normal. On an unknown date, Heart rate increased: 138 (abnormal) 130-Abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Due for second dose of vaccine on 26 may 2021and rescheduled. Lab data-blood test and chest x-ray were performed Event reported-mother in law also had the same experience No concomitant medications were reported Antibiotics  are used as treatment medications   This case was linked to MOD-2021-213408 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Echocardiogram, Fatigue, Feeling abnormal, Flushing
Clinical narrative: crap for a month / had weird symptoms for a month straight; felt better after the second vaccine; weird flush feeling; sore arm; breast pain; tachycardia; lymph node under arm pain; tired; shortness of breath; chest pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (crap for a month / had weird symptoms for a month straight), THERAPEUTIC RESPONSE UNEXPECTED (felt better after the second vaccine), FLUSHING (weird flush feeling), LIMB DISCOMFORT (sore arm) and DYSPNOEA (shortness of breath) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Postpartum disorder.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, the patient experienced DYSPNOEA (shortness of breath) and CHEST PAIN (chest pain). On an unknown date, the patient experienced FEELING ABNORMAL (crap for a month / had weird symptoms for a month straight), THERAPEUTIC RESPONSE UNEXPECTED (felt better after the second vaccine), FLUSHING (weird flush feeling), LIMB DISCOMFORT (sore arm), BREAST PAIN (breast pain), TACHYCARDIA (tachycardia), LYMPH NODE PAIN (lymph node under arm pain) and FATIGUE (tired). The patient was treated with NAPROXEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (crap for a month / had weird symptoms for a month straight), THERAPEUTIC RESPONSE UNEXPECTED (felt better after the second vaccine), FLUSHING (weird flush feeling), LIMB DISCOMFORT (sore arm), DYSPNOEA (shortness of breath), CHEST PAIN (chest pain), BREAST PAIN (breast pain), TACHYCARDIA (tachycardia), LYMPH NODE PAIN (lymph node under arm pain) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2021, Blood test: normal normal. On 18-May-2021, Body temperature: 100.5 (High) High. On 18-May-2021, Computerised tomogram: normal (normal) with oral contrast. On 18-May-2021, Echocardiogram: normal (normal) soft echo to look for blood clots. On 18-May-2021, Heart rate increased: 120-130 (abnormal) Abnormal. On 18-May-2021, SARS-CoV-2 test negative: negative (Negative) COVID test-negative. On 18-May-2021, White blood cell count: double to normal (abnormal) Double to normal. On an unknown date, Heart rate increased: 138 (abnormal) 130-Abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Due for second dose of vaccine on 26 may 2021and rescheduled. Lab data-blood test and chest x-ray were performed Event reported-mother in law also had the same experience No concomitant medications were reported Antibiotics  are used as treatment medications   This case was linked to MOD-2021-213408 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Limb discomfort, Lymph node pain, SARS-CoV-2 test negative, Tachycardia
Clinical narrative: crap for a month / had weird symptoms for a month straight; felt better after the second vaccine; weird flush feeling; sore arm; breast pain; tachycardia; lymph node under arm pain; tired; shortness of breath; chest pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (crap for a month / had weird symptoms for a month straight), THERAPEUTIC RESPONSE UNEXPECTED (felt better after the second vaccine), FLUSHING (weird flush feeling), LIMB DISCOMFORT (sore arm) and DYSPNOEA (shortness of breath) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Postpartum disorder.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, the patient experienced DYSPNOEA (shortness of breath) and CHEST PAIN (chest pain). On an unknown date, the patient experienced FEELING ABNORMAL (crap for a month / had weird symptoms for a month straight), THERAPEUTIC RESPONSE UNEXPECTED (felt better after the second vaccine), FLUSHING (weird flush feeling), LIMB DISCOMFORT (sore arm), BREAST PAIN (breast pain), TACHYCARDIA (tachycardia), LYMPH NODE PAIN (lymph node under arm pain) and FATIGUE (tired). The patient was treated with NAPROXEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (crap for a month / had weird symptoms for a month straight), THERAPEUTIC RESPONSE UNEXPECTED (felt better after the second vaccine), FLUSHING (weird flush feeling), LIMB DISCOMFORT (sore arm), DYSPNOEA (shortness of breath), CHEST PAIN (chest pain), BREAST PAIN (breast pain), TACHYCARDIA (tachycardia), LYMPH NODE PAIN (lymph node under arm pain) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2021, Blood test: normal normal. On 18-May-2021, Body temperature: 100.5 (High) High. On 18-May-2021, Computerised tomogram: normal (normal) with oral contrast. On 18-May-2021, Echocardiogram: normal (normal) soft echo to look for blood clots. On 18-May-2021, Heart rate increased: 120-130 (abnormal) Abnormal. On 18-May-2021, SARS-CoV-2 test negative: negative (Negative) COVID test-negative. On 18-May-2021, White blood cell count: double to normal (abnormal) Double to normal. On an unknown date, Heart rate increased: 138 (abnormal) 130-Abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Due for second dose of vaccine on 26 may 2021and rescheduled. Lab data-blood test and chest x-ray were performed Event reported-mother in law also had the same experience No concomitant medications were reported Antibiotics  are used as treatment medications   This case was linked to MOD-2021-213408 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected, White blood cell count
Clinical narrative: crap for a month / had weird symptoms for a month straight; felt better after the second vaccine; weird flush feeling; sore arm; breast pain; tachycardia; lymph node under arm pain; tired; shortness of breath; chest pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (crap for a month / had weird symptoms for a month straight), THERAPEUTIC RESPONSE UNEXPECTED (felt better after the second vaccine), FLUSHING (weird flush feeling), LIMB DISCOMFORT (sore arm) and DYSPNOEA (shortness of breath) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Postpartum disorder.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, the patient experienced DYSPNOEA (shortness of breath) and CHEST PAIN (chest pain). On an unknown date, the patient experienced FEELING ABNORMAL (crap for a month / had weird symptoms for a month straight), THERAPEUTIC RESPONSE UNEXPECTED (felt better after the second vaccine), FLUSHING (weird flush feeling), LIMB DISCOMFORT (sore arm), BREAST PAIN (breast pain), TACHYCARDIA (tachycardia), LYMPH NODE PAIN (lymph node under arm pain) and FATIGUE (tired). The patient was treated with NAPROXEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (crap for a month / had weird symptoms for a month straight), THERAPEUTIC RESPONSE UNEXPECTED (felt better after the second vaccine), FLUSHING (weird flush feeling), LIMB DISCOMFORT (sore arm), DYSPNOEA (shortness of breath), CHEST PAIN (chest pain), BREAST PAIN (breast pain), TACHYCARDIA (tachycardia), LYMPH NODE PAIN (lymph node under arm pain) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2021, Blood test: normal normal. On 18-May-2021, Body temperature: 100.5 (High) High. On 18-May-2021, Computerised tomogram: normal (normal) with oral contrast. On 18-May-2021, Echocardiogram: normal (normal) soft echo to look for blood clots. On 18-May-2021, Heart rate increased: 120-130 (abnormal) Abnormal. On 18-May-2021, SARS-CoV-2 test negative: negative (Negative) COVID test-negative. On 18-May-2021, White blood cell count: double to normal (abnormal) Double to normal. On an unknown date, Heart rate increased: 138 (abnormal) 130-Abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Due for second dose of vaccine on 26 may 2021and rescheduled. Lab data-blood test and chest x-ray were performed Event reported-mother in law also had the same experience No concomitant medications were reported Antibiotics  are used as treatment medications   This case was linked to MOD-2021-213408 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: sore arm/mild body aches; headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm/mild body aches), HEADACHE (headache) and FATIGUE (Tired) 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 (sore arm/mild body aches), HEADACHE (headache) and FATIGUE (Tired). At the time of the report, MYALGIA (sore arm/mild body aches), HEADACHE (headache) and FATIGUE (Tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant or treatment medications were provided by reporter.   This case was linked to MOD-2021-213485 (Patient Link).
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site pain, Vaccination site reaction
Clinical narrative: Covid arm; Pain at the injection site; Full body rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm), RASH (Full body rash) and VACCINATION SITE PAIN (Pain at the injection site) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced VACCINATION SITE REACTION (Covid arm) and VACCINATION SITE PAIN (Pain at the injection site). In May 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Full body rash). At the time of the report, VACCINATION SITE REACTION (Covid arm), RASH (Full body rash) and VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  Additional information was that the patient consulted her physician and got advised that she should not have the second dose.  Treatment information was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: sore arm/ Mild body aches; mild headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm/ Mild body aches), HEADACHE (mild headache) and FATIGUE (Tired) 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (sore arm/ Mild body aches), HEADACHE (mild headache) and FATIGUE (Tired). At the time of the report, MYALGIA (sore arm/ Mild body aches), HEADACHE (mild headache) and FATIGUE (Tired) outcome was unknown. Not Provided          No relevant concomitant medications were reported.   Treatment information was not provided.  The patient was tired and experienced sore arm, mild headache and mild body aches after both the Moderna shots.    This case was linked to MOD-2021-213478 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: What preservative is used in Moderna vaccine? The only potential allergy listed is Polyethylene; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (What preservative is used in Moderna vaccine? The only potential allergy listed is Polyethylene) 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 ALLERGY TO VACCINE (What preservative is used in Moderna vaccine? The only potential allergy listed is Polyethylene). At the time of the report, ALLERGY TO VACCINE (What preservative is used in Moderna vaccine? The only potential allergy listed is Polyethylene) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Cluster headache
Clinical narrative: Clusters of headaches; This spontaneous case was reported by a consumer and describes the occurrence of CLUSTER HEADACHE (Clusters of headaches) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Chronic headaches since 2013. Concomitant products included VERAPAMIL, VALPROATE SEMISODIUM (DIVALPROEX) and FROVATRIPTAN for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced CLUSTER HEADACHE (Clusters of headaches). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Adverse event, at an unspecified dose and frequency. At the time of the report, CLUSTER HEADACHE (Clusters of headaches) had not resolved.            As per report, patient had been suffering from headaches for about eight years, which had worsened after receiving the second dose of the Moderna covid-19 vaccine. He stated that his preventive medications were no longer effective in controlling the headaches. The patient had made a neurology consultation appointment for 13-Jul-2021.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Significant follow up (Concomitant medication added)
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Rash, Rash vesicular, Skin warm, Urticaria
Clinical narrative: little red bumps, itches; rash is warm to the touch; big hump would go away but the redness stayed; rash more sensitive to heat; rash like little bubbles; rash all over body; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Jun-2021 and was forwarded to Moderna on 08-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (little red bumps, itches), SKIN WARM (rash is warm to the touch), ERYTHEMA (big hump would go away but the redness stayed), URTICARIA THERMAL (rash more sensitive to heat) and RASH VESICULAR (rash like little bubbles) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Leukemia (In remission). Concurrent medical conditions included Diabetes and Single functional kidney.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced URTICARIA (little red bumps, itches), SKIN WARM (rash is warm to the touch), ERYTHEMA (big hump would go away but the redness stayed), URTICARIA THERMAL (rash more sensitive to heat), RASH VESICULAR (rash like little bubbles) and RASH (rash all over body). The patient was treated with PREDNISONE ongoing since an unknown date for Itch, at an unspecified dose and frequency and HYDROXYZINE ongoing since an unknown date for Itch, at an unspecified dose and frequency. At the time of the report, URTICARIA (little red bumps, itches), SKIN WARM (rash is warm to the touch), ERYTHEMA (big hump would go away but the redness stayed), URTICARIA THERMAL (rash more sensitive to heat), RASH VESICULAR (rash like little bubbles) and RASH (rash all over body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  This patient first thought the rash was bug bites. They had them on their arm, down back and down legs. They were intense and the whelps got really big. This patient received her second vaccination on 11-May-2021 (lot #036C21A).  Treatment included 2 doses of steroids, prednisone and hydroxyzine. Initial doctor told her to use bug spray. The patient thought rash was chiggers and put nail polish on rash.  It was reported that it appeared to be clearing up, but was not completely gone.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow up report received.  Event details and treatment updated.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria thermal
Clinical narrative: little red bumps, itches; rash is warm to the touch; big hump would go away but the redness stayed; rash more sensitive to heat; rash like little bubbles; rash all over body; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Jun-2021 and was forwarded to Moderna on 08-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (little red bumps, itches), SKIN WARM (rash is warm to the touch), ERYTHEMA (big hump would go away but the redness stayed), URTICARIA THERMAL (rash more sensitive to heat) and RASH VESICULAR (rash like little bubbles) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Leukemia (In remission). Concurrent medical conditions included Diabetes and Single functional kidney.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced URTICARIA (little red bumps, itches), SKIN WARM (rash is warm to the touch), ERYTHEMA (big hump would go away but the redness stayed), URTICARIA THERMAL (rash more sensitive to heat), RASH VESICULAR (rash like little bubbles) and RASH (rash all over body). The patient was treated with PREDNISONE ongoing since an unknown date for Itch, at an unspecified dose and frequency and HYDROXYZINE ongoing since an unknown date for Itch, at an unspecified dose and frequency. At the time of the report, URTICARIA (little red bumps, itches), SKIN WARM (rash is warm to the touch), ERYTHEMA (big hump would go away but the redness stayed), URTICARIA THERMAL (rash more sensitive to heat), RASH VESICULAR (rash like little bubbles) and RASH (rash all over body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  This patient first thought the rash was bug bites. They had them on their arm, down back and down legs. They were intense and the whelps got really big. This patient received her second vaccination on 11-May-2021 (lot #036C21A).  Treatment included 2 doses of steroids, prednisone and hydroxyzine. Initial doctor told her to use bug spray. The patient thought rash was chiggers and put nail polish on rash.  It was reported that it appeared to be clearing up, but was not completely gone.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow up report received.  Event details and treatment updated.