chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Gait disturbance, Tinnitus
Clinical narrative: unbalance movement; couldn't walk straight which leads to pitching in to the wall; Buzzing in ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Buzzing in ears), BALANCE DISORDER (unbalance movement) and GAIT DISTURBANCE (couldn't walk straight which leads to pitching in to the wall) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 immunisation.     The patient's past medical history included No adverse event and Head injury (Patient had head injury when she was 23 years old and also had one in 2010).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced TINNITUS (Buzzing in ears). On 18-Mar-2021, the patient experienced BALANCE DISORDER (unbalance movement) and GAIT DISTURBANCE (couldn't walk straight which leads to pitching in to the wall). At the time of the report, TINNITUS (Buzzing in ears), BALANCE DISORDER (unbalance movement) and GAIT DISTURBANCE (couldn't walk straight which leads to pitching in to the wall) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: My heart rate got up to 132 beats per minute; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (My heart rate got up to 132 beats per minute) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included Anxiety since an unknown date and Hypertension since an unknown date. Previously administered products included for an unreported indication: TETANUS TOXOID.    On 24-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 24-Mar-2021, the patient experienced HEART RATE INCREASED (My heart rate got up to 132 beats per minute). The patient was treated with ALPRAZOLAM (XANAX) for Anxiety, at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (My heart rate got up to 132 beats per minute) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.  High blood pressure medication for hypertension. Xanax for chronic anxiety disorder     Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2021: No specific follow-up information recorded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: pain in the muscle; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (pain in the muscle) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included Blood disorder.  relevant concomitant products usage were not reported by the reporter.  No treatment information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced MYALGIA (pain in the muscle). On 05-Mar-2021, MYALGIA (pain in the muscle) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Pain, Pyrexia
Clinical narrative: Slight pain; Has no appetite; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Slight pain), DECREASED APPETITE (Has no appetite) and PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN (Slight pain), DECREASED APPETITE (Has no appetite) and PYREXIA (Fever). On 25-Mar-2021, PYREXIA (Fever) had resolved. At the time of the report, PAIN (Slight pain) and DECREASED APPETITE (Has no appetite) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: F/U received on 11-may-2021,Significant: Event Fever was added, Event outcome provided
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 27-May-2021. On 08-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On 08-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included allergy medication. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Headache, Pyrexia, Vaccination site pain
Clinical narrative: back pain; vomiting; site of injection is sore; headache; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), VOMITING (vomiting), VACCINATION SITE PAIN (site of injection is sore), HEADACHE (headache) and PYREXIA (fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O26A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history not included .  relevant concomitant products usage were not reported by the reporter.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 25-Mar-2021, the patient experienced BACK PAIN (back pain), VOMITING (vomiting), VACCINATION SITE PAIN (site of injection is sore), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills).  At the time of the report, BACK PAIN (back pain), VOMITING (vomiting), VACCINATION SITE PAIN (site of injection is sore), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills) outcome was unknown.       No treatment information was reported.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: back pain; vomiting; site of injection is sore; headache; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), VOMITING (vomiting), VACCINATION SITE PAIN (site of injection is sore), HEADACHE (headache) and PYREXIA (fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O26A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history not included .  relevant concomitant products usage were not reported by the reporter.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 25-Mar-2021, the patient experienced BACK PAIN (back pain), VOMITING (vomiting), VACCINATION SITE PAIN (site of injection is sore), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills).  At the time of the report, BACK PAIN (back pain), VOMITING (vomiting), VACCINATION SITE PAIN (site of injection is sore), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills) outcome was unknown.       No treatment information was reported.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Constipation
Clinical narrative: constipation; This spontaneous case was reported by a patient and describes the occurrence of CONSTIPATION (constipation) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Surgery (A year ago the patient was diagnosed with a geo blastoma with a mass the size of an avocado that was removed from his brain) and Radiation therapy in December 2020.   On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONSTIPATION (constipation). At the time of the report, CONSTIPATION (constipation) outcome was unknown. Not Provided          No concomitant medications were reported.  No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not Applicable   This case was linked to MOD21-062435 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-057927:MOD-2021-057927 - 2nd dose of vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Received the Polio vaccine less than 24 after the first Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received the Polio vaccine less than 24 after the first Moderna vaccine) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced WRONG PRODUCT ADMINISTERED (Received the Polio vaccine less than 24 after the first Moderna vaccine). On 24-Feb-2021, WRONG PRODUCT ADMINISTERED (Received the Polio vaccine less than 24 after the first Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Covid Arm, Itched for 3 weeks, arm broked out, red and swolllen/ itchy; Covid Arm, Itched for 3 weeks, arm broked out, red and swolllen/ itchy; Covid Arm, Itched for 3 weeks, arm broked out, red and swolllen/ itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Covid Arm, Itched for 3 weeks, arm broked out, red and swolllen/ itchy), VACCINATION SITE RASH (Covid Arm, Itched for 3 weeks, arm broked out, red and swolllen/ itchy) and VACCINATION SITE SWELLING (Covid Arm, Itched for 3 weeks, arm broked out, red and swolllen/ itchy) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Covid Arm, Itched for 3 weeks, arm broked out, red and swolllen/ itchy), VACCINATION SITE RASH (Covid Arm, Itched for 3 weeks, arm broked out, red and swolllen/ itchy) and VACCINATION SITE SWELLING (Covid Arm, Itched for 3 weeks, arm broked out, red and swolllen/ itchy). At the time of the report, VACCINATION SITE PRURITUS (Covid Arm, Itched for 3 weeks, arm broked out, red and swolllen/ itchy), VACCINATION SITE RASH (Covid Arm, Itched for 3 weeks, arm broked out, red and swolllen/ itchy) and VACCINATION SITE SWELLING (Covid Arm, Itched for 3 weeks, arm broked out, red and swolllen/ itchy) outcome was unknown. Not Provided      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.   This case was linked: INC.-MOD-2021-057910 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-057910:Case for events occured after dose 2
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Neuralgia, Pain, Vaccination site pain
Clinical narrative: nerves are crunching in my arm; spasm are little closer; not in pain; spasm of nerves from wrist to all the way up to her arm to site of injection; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (nerves are crunching in my arm), MUSCLE SPASMS (spasm are little closer), PAIN (not in pain) and VACCINATION SITE PAIN (spasm of nerves from wrist to all the way up to her arm to site of injection) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history not  included . relevant concomitant products usage were product related to blood pressure.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On an unknown date, the patient experienced NEURALGIA (nerves are crunching in my arm), MUSCLE SPASMS (spasm are little closer), PAIN (not in pain) and VACCINATION SITE PAIN (spasm of nerves from wrist to all the way up to her arm to site of injection).  At the time of the report, NEURALGIA (nerves are crunching in my arm), MUSCLE SPASMS (spasm are little closer), PAIN (not in pain) and VACCINATION SITE PAIN (spasm of nerves from wrist to all the way up to her arm to site of injection) outcome was unknown.        The patient received both scheduled doses of mRNA 1273 before the events, therefore Action taken with mRNA-1273 in response to the events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dosing error (2nd dose administered earlier than the recommended interval; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dosing error (2nd dose administered earlier than the recommended interval) 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 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dosing error (2nd dose administered earlier than the recommended interval). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dosing error (2nd dose administered earlier than the recommended interval) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medication information was reported.   Reporter stated that the 2 doses received by the patient were given at the health department who told the patient that she must get a 3rd dose, who was mad at them for the error and so she showed up at their vaccine clinic for her 3rd dose so the reporter called to clarify that they did not give the patient a 3rd dose. Reporter declined for further follow-up.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Updated patient demographics.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Oropharyngeal pain
Clinical narrative: Chills; Had a sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Had a sore throat) and CHILLS (Chills) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No prior medical history was reported).    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Had a sore throat). On 24-Mar-2021, the patient experienced CHILLS (Chills). At the time of the report, OROPHARYNGEAL PAIN (Had a sore throat) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment details included gargling with benzydamine and salt water for sore throat and had taken acetaminophen. Patient stated that she did not have any side effects or problems with the vaccine.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: follow up updated on 21-JUN-2021 :Event out come updated for the event chills and soar throat from unknown to resolved
Sex: F
Vaccine: COVID19
Symptoms: Blister, Body temperature increased, Chills, Oral mucosal blistering, Pyrexia
Clinical narrative: Blisters in mouth; Blisters all over lips; chills; Fever to 102F; Injection arm sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection arm sore), CHILLS (chills), PYREXIA (Fever to 102F), ORAL MUCOSAL BLISTERING (Blisters in mouth) and BLISTER (Blisters all over lips) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included Blood pressure high. Concurrent medical conditions included Drug allergy (Erythromycin, Amoxicillin, Darvocet).    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE PAIN (Injection arm sore). On 21-Mar-2021, the patient experienced CHILLS (chills) and PYREXIA (Fever to 102F). On 23-Mar-2021, the patient experienced ORAL MUCOSAL BLISTERING (Blisters in mouth) and BLISTER (Blisters all over lips). On 22-Mar-2021, PYREXIA (Fever to 102F) was resolving. At the time of the report, VACCINATION SITE PAIN (Injection arm sore), CHILLS (chills), ORAL MUCOSAL BLISTERING (Blisters in mouth) and BLISTER (Blisters all over lips) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, Body temperature increased: 102f High. On 22-Mar-2021, Body temperature increased: 101f High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications  provided by the reporter included high blood pressure medications. Treatment for the event Blisters in mouth and all over lips included Abreva.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Blisters in mouth; Blisters all over lips; chills; Fever to 102F; Injection arm sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection arm sore), CHILLS (chills), PYREXIA (Fever to 102F), ORAL MUCOSAL BLISTERING (Blisters in mouth) and BLISTER (Blisters all over lips) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included Blood pressure high. Concurrent medical conditions included Drug allergy (Erythromycin, Amoxicillin, Darvocet).    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE PAIN (Injection arm sore). On 21-Mar-2021, the patient experienced CHILLS (chills) and PYREXIA (Fever to 102F). On 23-Mar-2021, the patient experienced ORAL MUCOSAL BLISTERING (Blisters in mouth) and BLISTER (Blisters all over lips). On 22-Mar-2021, PYREXIA (Fever to 102F) was resolving. At the time of the report, VACCINATION SITE PAIN (Injection arm sore), CHILLS (chills), ORAL MUCOSAL BLISTERING (Blisters in mouth) and BLISTER (Blisters all over lips) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, Body temperature increased: 102f High. On 22-Mar-2021, Body temperature increased: 101f High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications  provided by the reporter included high blood pressure medications. Treatment for the event Blisters in mouth and all over lips included Abreva.
Age: 73.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Rash macular
Clinical narrative: red blotch on her shoulder; tired; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red blotch on her shoulder) and FATIGUE (tired) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 006B21A) for COVID-19 vaccination.     The patient's past medical history not included . Concomitant products included OMEPRAZOLE and HYDROCHLOROTHIAZIDE, Cartia XL  for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) . On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .  On 10-Mar-2021, the patient experienced RASH MACULAR (red blotch on her shoulder) and FATIGUE (tired). On 10-Mar-2021, RASH MACULAR (red blotch on her shoulder) and FATIGUE (tired) had resolved.    The patient received both scheduled doses of mRNA 1273 before the events, therefore Action taken with mRNA-1273 in response to the events was not applicable.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Skin burning sensation, Vaccination site pain
Clinical narrative: Vaccination site to elbow burning/stinging sensation; burns like a bee sting; Vaccination site to elbow burning/stinging sensation; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Vaccination site to elbow burning/stinging sensation), SKIN BURNING SENSATION (burns like a bee sting) and VACCINATION SITE PAIN (Vaccination site to elbow burning/stinging sensation) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN (Vaccination site to elbow burning/stinging sensation), SKIN BURNING SENSATION (burns like a bee sting) and VACCINATION SITE PAIN (Vaccination site to elbow burning/stinging sensation). At the time of the report, PAIN (Vaccination site to elbow burning/stinging sensation), SKIN BURNING SENSATION (burns like a bee sting) and VACCINATION SITE PAIN (Vaccination site to elbow burning/stinging sensation) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment included  Ibuprofen  Action taken with mRNA-1273 in response to the events was not Applicable   This case was linked.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Myalgia
Clinical narrative: Increase in muscle pain in the pelvic that is getting worse after getting the vaccine; Increase in muscle pain in the pelvic that is getting worse after getting the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Increase in muscle pain in the pelvic that is getting worse after getting the vaccine) and MYALGIA (Increase in muscle pain in the pelvic that is getting worse after getting the vaccine) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Muscle pain.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CONDITION AGGRAVATED (Increase in muscle pain in the pelvic that is getting worse after getting the vaccine) and MYALGIA (Increase in muscle pain in the pelvic that is getting worse after getting the vaccine). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, CONDITION AGGRAVATED (Increase in muscle pain in the pelvic that is getting worse after getting the vaccine) and MYALGIA (Increase in muscle pain in the pelvic that is getting worse after getting the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: NNI case, TCR attached, It was reported that the event muscle pain was pre existing and her PCP is taking care of it and that it had nothing to do with vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Pruritus
Clinical narrative: arms felt burning like a sunburn; leg redness; legs are itchy; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (arms felt burning like a sunburn), ERYTHEMA (leg redness) and PRURITUS (legs are itchy) 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 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced BURNING SENSATION (arms felt burning like a sunburn), ERYTHEMA (leg redness) and PRURITUS (legs are itchy). At the time of the report, BURNING SENSATION (arms felt burning like a sunburn), ERYTHEMA (leg redness) and PRURITUS (legs are itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications are not provided by the reporter. No treatment drugs are not provided by reporter.   She characterizes these symptoms as not severe.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Nausea, Vomiting
Clinical narrative: nausea; vomiting; cold sweat; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (cold sweat), NAUSEA (nausea) and VOMITING (vomiting) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0071321A) for COVID-19 vaccination.     The patient's past medical history not  included .  relevant concomitant products usage were not reported by the reporter.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced COLD SWEAT (cold sweat). On 24-Mar-2021, the patient experienced NAUSEA (nausea) and VOMITING (vomiting).  At the time of the report, COLD SWEAT (cold sweat), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced HEADACHE (Headaches). At the time of the report, HEADACHE (Headaches) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications were not provided. The treatment information was not provided.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling hot, Paraesthesia
Clinical narrative: Tingling in legs and feet; Hotness in feet; Weird nuisances; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in legs and feet), FEELING HOT (Hotness in feet) and FEELING ABNORMAL (Weird nuisances) 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 No adverse event (No reported medical history).    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Tingling in legs and feet), FEELING HOT (Hotness in feet) and FEELING ABNORMAL (Weird nuisances). At the time of the report, PARAESTHESIA (Tingling in legs and feet), FEELING HOT (Hotness in feet) and FEELING ABNORMAL (Weird nuisances) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-057873 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Mother developed red looking rash around the area with a little bump a week after receiving 1st dose; Injection site area was little hot; She also started with soreness on injection site on same day which progressed and getting worse; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site area was little hot), VACCINATION SITE ERYTHEMA (Mother developed red looking rash around the area with a little bump a week after receiving 1st dose) and VACCINATION SITE PAIN (She also started with soreness on injection site on same day which progressed and getting worse) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history not included .    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 03-Mar-2021, the patient experienced VACCINATION SITE PAIN (She also started with soreness on injection site on same day which progressed and getting worse). On 10-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Injection site area was little hot). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Mother developed red looking rash around the area with a little bump a week after receiving 1st dose).  At the time of the report, VACCINATION SITE WARMTH (Injection site area was little hot), VACCINATION SITE ERYTHEMA (Mother developed red looking rash around the area with a little bump a week after receiving 1st dose) and VACCINATION SITE PAIN (She also started with soreness on injection site on same day which progressed and getting worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort
Clinical narrative: some shoulder discomfort; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (some shoulder discomfort) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history not  included . Concomitant products included OMEPRAZOLE, HYDROCHLOROTHIAZIDE and DILTIAZEM HYDROCHLORIDE (CARTIA XT) for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (some shoulder discomfort). At the time of the report, MUSCULOSKELETAL DISCOMFORT (some shoulder discomfort) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Food allergy
Clinical narrative: She reports having diarrhea 4 times a day for 2 days after both doses; Patient states she is allergic to the sugar in the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (She reports having diarrhea 4 times a day for 2 days after both doses) and FOOD ALLERGY (Patient states she is allergic to the sugar in the vaccine) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (allergy to sugar in vaccine). Relevant concomitant products usage were not reported by the reporter.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (She reports having diarrhea 4 times a day for 2 days after both doses) and FOOD ALLERGY (Patient states she is allergic to the sugar in the vaccine).  At the time of the report, DIARRHOEA (She reports having diarrhea 4 times a day for 2 days after both doses) and FOOD ALLERGY (Patient states she is allergic to the sugar in the vaccine) outcome was unknown.     No treatment information  was reported.   The patient received both scheduled doses of mRNA 1273 before the events, therefore Action taken with mRNA-1273 in response to the events was not applicable.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Chills, Myalgia
Clinical narrative: Spent 2 days not getting out of bed; Chills; Muscular Pain; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (Spent 2 days not getting out of bed), CHILLS (Chills) and MYALGIA (Muscular Pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced BEDRIDDEN (Spent 2 days not getting out of bed), CHILLS (Chills) and MYALGIA (Muscular Pain). At the time of the report, BEDRIDDEN (Spent 2 days not getting out of bed), CHILLS (Chills) and MYALGIA (Muscular Pain) outcome was unknown. Not Provided          Treatment medications of the patient were not provided. Concomitant medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-057893 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-057893:Case for events occured after dose 1
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Burning sensation, Feeling abnormal, Heart rate, Heart rate increased
Clinical narrative: He still doesn't feel great like 100%; He feels like nervous anxiety in his body; His feet were burning; He felt nauseated; His body was warm; something came out of blue on a flash, and he had a weird reaction; His heart rate became elevated; Patient had very bad reaction for 24 to 48 hours after receiving 1st dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (Patient had very bad reaction for 24 to 48 hours after receiving 1st dose), FEELING ABNORMAL (something came out of blue on a flash, and he had a weird reaction), HEART RATE INCREASED (His heart rate became elevated), FEELING ABNORMAL (He still doesn't feel great like 100%) and SKIN WARM (His body was warm) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included IBUPROFEN for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION COMPLICATION (Patient had very bad reaction for 24 to 48 hours after receiving 1st dose). On 24-Mar-2021, the patient experienced FEELING ABNORMAL (something came out of blue on a flash, and he had a weird reaction), HEART RATE INCREASED (His heart rate became elevated), SKIN WARM (His body was warm), BURNING SENSATION (His feet were burning) and NAUSEA (He felt nauseated). On 25-Mar-2021, the patient experienced FEELING ABNORMAL (He still doesn't feel great like 100%) and ANXIETY (He feels like nervous anxiety in his body). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Patient had very bad reaction for 24 to 48 hours after receiving 1st dose), FEELING ABNORMAL (something came out of blue on a flash, and he had a weird reaction), HEART RATE INCREASED (His heart rate became elevated), FEELING ABNORMAL (He still doesn't feel great like 100%), SKIN WARM (His body was warm), ANXIETY (He feels like nervous anxiety in his body), BURNING SENSATION (His feet were burning) and NAUSEA (He felt nauseated) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Heart rate: increase (High) elevated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Skin warm, Vaccination complication
Clinical narrative: He still doesn't feel great like 100%; He feels like nervous anxiety in his body; His feet were burning; He felt nauseated; His body was warm; something came out of blue on a flash, and he had a weird reaction; His heart rate became elevated; Patient had very bad reaction for 24 to 48 hours after receiving 1st dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (Patient had very bad reaction for 24 to 48 hours after receiving 1st dose), FEELING ABNORMAL (something came out of blue on a flash, and he had a weird reaction), HEART RATE INCREASED (His heart rate became elevated), FEELING ABNORMAL (He still doesn't feel great like 100%) and SKIN WARM (His body was warm) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included IBUPROFEN for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION COMPLICATION (Patient had very bad reaction for 24 to 48 hours after receiving 1st dose). On 24-Mar-2021, the patient experienced FEELING ABNORMAL (something came out of blue on a flash, and he had a weird reaction), HEART RATE INCREASED (His heart rate became elevated), SKIN WARM (His body was warm), BURNING SENSATION (His feet were burning) and NAUSEA (He felt nauseated). On 25-Mar-2021, the patient experienced FEELING ABNORMAL (He still doesn't feel great like 100%) and ANXIETY (He feels like nervous anxiety in his body). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Patient had very bad reaction for 24 to 48 hours after receiving 1st dose), FEELING ABNORMAL (something came out of blue on a flash, and he had a weird reaction), HEART RATE INCREASED (His heart rate became elevated), FEELING ABNORMAL (He still doesn't feel great like 100%), SKIN WARM (His body was warm), ANXIETY (He feels like nervous anxiety in his body), BURNING SENSATION (His feet were burning) and NAUSEA (He felt nauseated) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Heart rate: increase (High) elevated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site induration
Clinical narrative: A little itchy; Hard to the touch; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (A little itchy) and VACCINATION SITE INDURATION (Hard to the touch) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026c70a) 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. On 08-Jan-2021, the patient experienced PRURITUS (A little itchy) and VACCINATION SITE INDURATION (Hard to the touch). At the time of the report, PRURITUS (A little itchy) and VACCINATION SITE INDURATION (Hard to the touch) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (A little itchy) and VACCINATION SITE INDURATION (Hard to the touch) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026c70a) for an unknown indication.     No Medical History information was reported.   Concomitent medications includes antidepressants.  On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PRURITUS (A little itchy) and VACCINATION SITE INDURATION (Hard to the touch). At the time of the report, PRURITUS (A little itchy) and VACCINATION SITE INDURATION (Hard to the touch) outcome was unknown. Not Provided          Reporter did not allow further contact
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Vaccination site erythema; Swoleness in the vaccination area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE SWELLING (Swoleness in the vaccination area) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003D21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 24-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE SWELLING (Swoleness in the vaccination area). At the time of the report, VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE SWELLING (Swoleness in the vaccination area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was given. No laboratory details was given. No treatment information was given
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment medication was not provided.   Reporter did not allow further contact
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Discomfort, Pain, Vaccination site induration
Clinical narrative: Uncomfortable; very bad pain, hurt really bad; Very weak; Huge hard lump; Lymph node reaction; Pain at the injection site; Started getting swelling; chills; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Uncomfortable), PAIN (very bad pain, hurt really bad), ASTHENIA (Very weak), VACCINATION SITE INDURATION (Huge hard lump) and VACCINATION SITE LYMPHADENOPATHY (Lymph node reaction) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 22-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced DISCOMFORT (Uncomfortable), PAIN (very bad pain, hurt really bad), ASTHENIA (Very weak), VACCINATION SITE INDURATION (Huge hard lump), VACCINATION SITE LYMPHADENOPATHY (Lymph node reaction), VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE SWELLING (Started getting swelling) and CHILLS (chills). At the time of the report, DISCOMFORT (Uncomfortable), PAIN (very bad pain, hurt really bad), ASTHENIA (Very weak), VACCINATION SITE INDURATION (Huge hard lump), VACCINATION SITE LYMPHADENOPATHY (Lymph node reaction), VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE SWELLING (Started getting swelling) and CHILLS (chills) outcome was unknown.            No treatment information was provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy, Vaccination site pain, Vaccination site swelling
Clinical narrative: Uncomfortable; very bad pain, hurt really bad; Very weak; Huge hard lump; Lymph node reaction; Pain at the injection site; Started getting swelling; chills; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Uncomfortable), PAIN (very bad pain, hurt really bad), ASTHENIA (Very weak), VACCINATION SITE INDURATION (Huge hard lump) and VACCINATION SITE LYMPHADENOPATHY (Lymph node reaction) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 22-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced DISCOMFORT (Uncomfortable), PAIN (very bad pain, hurt really bad), ASTHENIA (Very weak), VACCINATION SITE INDURATION (Huge hard lump), VACCINATION SITE LYMPHADENOPATHY (Lymph node reaction), VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE SWELLING (Started getting swelling) and CHILLS (chills). At the time of the report, DISCOMFORT (Uncomfortable), PAIN (very bad pain, hurt really bad), ASTHENIA (Very weak), VACCINATION SITE INDURATION (Huge hard lump), VACCINATION SITE LYMPHADENOPATHY (Lymph node reaction), VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE SWELLING (Started getting swelling) and CHILLS (chills) outcome was unknown.            No treatment information was provided.