chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Headache; Chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Mar-2021 and was forwarded to Moderna on 01-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and CHILLS (Chills) 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 (No medical History is 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, the patient experienced HEADACHE (Headache) and CHILLS (Chills). At the time of the report, HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: skin is itching like crazy; Red; Rash started on her arm/ rash on her back/ rash on her legs/rash on bottom of feet; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Apr-2021 and was forwarded to Moderna on 06-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (skin is itching like crazy), ERYTHEMA (Red) and RASH (Rash started on her arm/ rash on her back/ rash on her legs/rash on bottom of feet) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced PRURITUS (skin is itching like crazy) and RASH (Rash started on her arm/ rash on her back/ rash on her legs/rash on bottom of feet). 04-Apr-2021, the patient experienced ERYTHEMA (Red). At the time of the report, PRURITUS (skin is itching like crazy), ERYTHEMA (Red) and RASH (Rash started on her arm/ rash on her back/ rash on her legs/rash on bottom of feet) outcome was unknown.             No relevant concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: not sure if she has shingles right now; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (not sure if she has shingles right now) 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 Shingles. Concurrent medical conditions included Allergy NOS.    On 08-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 HERPES ZOSTER (not sure if she has shingles right now). At the time of the report, HERPES ZOSTER (not sure if she has shingles right now) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pediatric patient had vaccine (under 18 years of age); This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Pediatric patient had vaccine (under 18 years of age)) in a 17-year-old patient of an unknown 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Pediatric patient had vaccine (under 18 years of age)). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Pediatric patient had vaccine (under 18 years of age)) 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.   No concomitant medications reported.  No treatment information was provided.  This report refers to a case of product administered to patient of inappropriate age, for mRNA-1273, lot #: unknown,  with no associated AEs.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Follow-up received does not contain any significant information.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age, for mRNA-1273, lot #: unknown,  with no associated AEs.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Altered state of consciousness, Asthenia, Bradyphrenia, Confusional state, Dehydration
Clinical narrative: On 3/13 my mother reported just feeling right.  Only lasted a short time.  On 3/14 she had  mild stroke like symptoms.  Went to ER.  Symptoms improved. Diagnosis- dehydration. Discharged home fully alert and oriented. 3/15 Back to ER for altered level of consciousness in Early afternoon.  Her level of consciousness continued to deteriorate until she became totally confused and eventually unresponsive for 3 days. (I have video if needed, I will also provide and tested results you request).  They r/o a stroke, UTI, pneumonia and dehydration.  Diagnosis on admission was encephalopathy.   Six months later she is still have issues with slow thought processing, extreme fatigue, weakness and episodes of  confusion.   She was totally independent prior to this reaction.  Now she is not.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Depressed level of consciousness, Encephalopathy, Fatigue, Feeling abnormal, Loss of personal independence in daily activities
Clinical narrative: On 3/13 my mother reported just feeling right.  Only lasted a short time.  On 3/14 she had  mild stroke like symptoms.  Went to ER.  Symptoms improved. Diagnosis- dehydration. Discharged home fully alert and oriented. 3/15 Back to ER for altered level of consciousness in Early afternoon.  Her level of consciousness continued to deteriorate until she became totally confused and eventually unresponsive for 3 days. (I have video if needed, I will also provide and tested results you request).  They r/o a stroke, UTI, pneumonia and dehydration.  Diagnosis on admission was encephalopathy.   Six months later she is still have issues with slow thought processing, extreme fatigue, weakness and episodes of  confusion.   She was totally independent prior to this reaction.  Now she is not.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neurological symptom, Unresponsive to stimuli
Clinical narrative: On 3/13 my mother reported just feeling right.  Only lasted a short time.  On 3/14 she had  mild stroke like symptoms.  Went to ER.  Symptoms improved. Diagnosis- dehydration. Discharged home fully alert and oriented. 3/15 Back to ER for altered level of consciousness in Early afternoon.  Her level of consciousness continued to deteriorate until she became totally confused and eventually unresponsive for 3 days. (I have video if needed, I will also provide and tested results you request).  They r/o a stroke, UTI, pneumonia and dehydration.  Diagnosis on admission was encephalopathy.   Six months later she is still have issues with slow thought processing, extreme fatigue, weakness and episodes of  confusion.   She was totally independent prior to this reaction.  Now she is not.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nodule, Pain in extremity, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Left arm is hot, very swollen, sore.  Good sized knot.  Some itching.  Started day after vaccination and has gotten much worse.  Taking Benedryl and OTC pain relievers.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation, Joint range of motion decreased, Limb discomfort, Muscle spasticity, Off label use
Clinical narrative: Left arm is hot, very swollen, sore.  Good sized knot.  Some itching.  Started day after vaccination and has gotten much worse.  Taking Benedryl and OTC pain relievers.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Unresponsive to stimuli
Clinical narrative: Patient received Johnson & Johnson (#207A21A, exp 09/21) to the left deltoid. While reviewing instructions for post-vax the patient asked if he should be feeling nauseous and then immediately felt lightheaded. Told him it was possible, sit where he was (did not drive to post-vax), turn up AC & honk if felt any worse. Returned to check on the patient & found him unresponsive. Unable to arouse him to verbal command, touch, or sternal rub for 2-3 minutes. 911 was immediately called when the patient was found unable to arouse. Vitals of BP 105-82, pulse 60. Once he awoke he was unable to answer questions or remain awake. After nearly 5 minutes of re-awakening & questioning the patient, he gave his name.. Fire & EMT showed up with pressure 60, pulse 40, 02 90. Patient was moved to an ambulance, where he was evaluated and determined to be stable. Family was called and came to pick up the patient.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain
Clinical narrative: Headache, nausea, body aches, extreme fatigue starting approximately 18 hours after receiving vaccine
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood thyroid stimulating hormone, Fatigue, Feeling abnormal, Full blood count
Clinical narrative: fatigue, diffuse arthralgias, "brain fog" and frontal headache all started shortly after vaccination and persisting to present 3/21-8/21
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Glycosylated haemoglobin, Headache, Metabolic function test, Prostatic specific antigen, Red blood cell sedimentation rate
Clinical narrative: fatigue, diffuse arthralgias, "brain fog" and frontal headache all started shortly after vaccination and persisting to present 3/21-8/21
Age: 45.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Feeling abnormal, Head discomfort, Headache, Nausea
Clinical narrative: Fog headache nausea throwing up head pain  sore joints tired  head pressure
Age: 45.0
Sex: F
Vaccine: UNK
Symptoms: Vomiting
Clinical narrative: Fog headache nausea throwing up head pain  sore joints tired  head pressure
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure, Death, Fluid retention
Clinical narrative: Brought on water retention and heart failure symptoms 3 weeks after second dose. Death on August 5 2021
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Polymenorrhoea
Clinical narrative: Period started 13 days early. Severe cramping- do not usually have cramping with periods.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Vaginal haemorrhage
Clinical narrative: Spotting, possible early menstrual period. Began on cycle day 11, so far has continued through cycle day 12.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Cardiac stress test, Chest X-ray normal, Chest pain, Computerised tomogram coronary artery normal
Clinical narrative: I had my vaccine at 08:15 in the morning and felt fine throughout the day.  I got home around 05;00 PM and started to feel lightheaded. I sat down and drank some water. I then got up and went to the restroom. As i was walking back from the bathroom I developed severe chest pain felt like I couldn?t breathe. According to my wife I collapsed and she immediately called 911. When they arrived I was completely out of it.  I started coming to in the ambulance. I can remember bits and pieces. My wife wasn?t allowed to come with me or be with me in the hospital due to COVID restrictions. I followed up the cardiologist and was diagnosed with costochondritis and was told to take ibuprofen 3x a day. I had been strongly advised to get the second shot and with the mandates quickly approaching even with my own and my wife?s apprehension I scheduled my second shot  There was no diagnosis stating that I had a reaction to the shot.  I held off as long as I could. My second shot was scheduled 08/19/21 at 08:15AM.  I felt fine through out the day but later in the evening I began to feel dizzy. I just went to sleep. In the morning I felt ok so I went to work and started my morning run. I then began to feel lightheaded had severe chest pain and felt like I couldn?t  breathe. I collapsed and again 911 was called.  I am still being advised to get the booster when necessary because ?the benefits out way the risks? states the cardiologist that seen me. I had no life threatening issues and all my tests came back normal. There was no damage noted from the tests.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Costochondritis, Dizziness, Dyspnoea, Echocardiogram, Electrocardiogram normal
Clinical narrative: I had my vaccine at 08:15 in the morning and felt fine throughout the day.  I got home around 05;00 PM and started to feel lightheaded. I sat down and drank some water. I then got up and went to the restroom. As i was walking back from the bathroom I developed severe chest pain felt like I couldn?t breathe. According to my wife I collapsed and she immediately called 911. When they arrived I was completely out of it.  I started coming to in the ambulance. I can remember bits and pieces. My wife wasn?t allowed to come with me or be with me in the hospital due to COVID restrictions. I followed up the cardiologist and was diagnosed with costochondritis and was told to take ibuprofen 3x a day. I had been strongly advised to get the second shot and with the mandates quickly approaching even with my own and my wife?s apprehension I scheduled my second shot  There was no diagnosis stating that I had a reaction to the shot.  I held off as long as I could. My second shot was scheduled 08/19/21 at 08:15AM.  I felt fine through out the day but later in the evening I began to feel dizzy. I just went to sleep. In the morning I felt ok so I went to work and started my morning run. I then began to feel lightheaded had severe chest pain and felt like I couldn?t  breathe. I collapsed and again 911 was called.  I am still being advised to get the booster when necessary because ?the benefits out way the risks? states the cardiologist that seen me. I had no life threatening issues and all my tests came back normal. There was no damage noted from the tests.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Memory impairment, Syncope
Clinical narrative: I had my vaccine at 08:15 in the morning and felt fine throughout the day.  I got home around 05;00 PM and started to feel lightheaded. I sat down and drank some water. I then got up and went to the restroom. As i was walking back from the bathroom I developed severe chest pain felt like I couldn?t breathe. According to my wife I collapsed and she immediately called 911. When they arrived I was completely out of it.  I started coming to in the ambulance. I can remember bits and pieces. My wife wasn?t allowed to come with me or be with me in the hospital due to COVID restrictions. I followed up the cardiologist and was diagnosed with costochondritis and was told to take ibuprofen 3x a day. I had been strongly advised to get the second shot and with the mandates quickly approaching even with my own and my wife?s apprehension I scheduled my second shot  There was no diagnosis stating that I had a reaction to the shot.  I held off as long as I could. My second shot was scheduled 08/19/21 at 08:15AM.  I felt fine through out the day but later in the evening I began to feel dizzy. I just went to sleep. In the morning I felt ok so I went to work and started my morning run. I then began to feel lightheaded had severe chest pain and felt like I couldn?t  breathe. I collapsed and again 911 was called.  I am still being advised to get the booster when necessary because ?the benefits out way the risks? states the cardiologist that seen me. I had no life threatening issues and all my tests came back normal. There was no damage noted from the tests.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Drug screen, Full blood count normal, Metabolic function test, Muscle twitching, Tic
Clinical narrative: Patient received second dose of Gardasil 9 on 8/18/2021, approx three hours after at home was noted to have involuntary twitching. Was seen in ED at Medical Center on 8/18/2021, Given Ativan, discharged home, improved, slept well, but upon awakening 8/19/2021 was noted to have the involuntary twitching again and was taken back to ED at Medical Center on 8/19/2021. Had lab work done and drug screen which was unremarkable and neuro was consulted, likely to be motor tic, advised could use Ativan and Benadryl as needed.  Discharged home, to follow up with neurology outpatient.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Deafness, Hypertension, Tinnitus
Clinical narrative: Non-control of previously controlled hypertension, worsened tinnitus, loss of high range hearing
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Headache, Mass, Myalgia
Clinical narrative: extreme headache; chills; body ache; fever; swelling at the armpit; lumps; itchy; redness; tenderness on the right arm (site where the vaccine was injected); Injection site was swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling at the armpit), MASS (lumps), PRURITUS (itchy), ERYTHEMA (redness) and VACCINATION SITE PAIN (tenderness on the right arm (site where the vaccine was injected)) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 009CZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: SHINGRIX since an unknown date. Concurrent medical conditions included Drug allergy (allergic to biaxin). Concomitant products included IBUPROFEN from 29-Mar-2021 to 29-Mar-2021 for Back pain, DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL PM) from 01-Jan-2021 to 27-Apr-2021 for Headache and Myalgia, PROBIOTICS NOS from 01-Jan-2021 to an unknown date and VITAMIN E NOS for an unknown indication.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced PERIPHERAL SWELLING (swelling at the armpit), MASS (lumps), PRURITUS (itchy), ERYTHEMA (redness), VACCINATION SITE PAIN (tenderness on the right arm (site where the vaccine was injected)) and VACCINATION SITE SWELLING (Injection site was swollen). On 26-Apr-2021, the patient experienced HEADACHE (extreme headache), CHILLS (chills), MYALGIA (body ache) and PYREXIA (fever). On 10-Apr-2021, PERIPHERAL SWELLING (swelling at the armpit), PRURITUS (itchy), ERYTHEMA (redness), VACCINATION SITE PAIN (tenderness on the right arm (site where the vaccine was injected)) and VACCINATION SITE SWELLING (Injection site was swollen) had resolved. At the time of the report, MASS (lumps) outcome was unknown and HEADACHE (extreme headache), CHILLS (chills), MYALGIA (body ache) and PYREXIA (fever) had resolved.            other meds: concomitant medications include vitamin d 4000 iu , osteo bi-flex   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: information was provided, added events, concomitant medications and vaccine details.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: extreme headache; chills; body ache; fever; swelling at the armpit; lumps; itchy; redness; tenderness on the right arm (site where the vaccine was injected); Injection site was swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling at the armpit), MASS (lumps), PRURITUS (itchy), ERYTHEMA (redness) and VACCINATION SITE PAIN (tenderness on the right arm (site where the vaccine was injected)) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 009CZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: SHINGRIX since an unknown date. Concurrent medical conditions included Drug allergy (allergic to biaxin). Concomitant products included IBUPROFEN from 29-Mar-2021 to 29-Mar-2021 for Back pain, DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL PM) from 01-Jan-2021 to 27-Apr-2021 for Headache and Myalgia, PROBIOTICS NOS from 01-Jan-2021 to an unknown date and VITAMIN E NOS for an unknown indication.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced PERIPHERAL SWELLING (swelling at the armpit), MASS (lumps), PRURITUS (itchy), ERYTHEMA (redness), VACCINATION SITE PAIN (tenderness on the right arm (site where the vaccine was injected)) and VACCINATION SITE SWELLING (Injection site was swollen). On 26-Apr-2021, the patient experienced HEADACHE (extreme headache), CHILLS (chills), MYALGIA (body ache) and PYREXIA (fever). On 10-Apr-2021, PERIPHERAL SWELLING (swelling at the armpit), PRURITUS (itchy), ERYTHEMA (redness), VACCINATION SITE PAIN (tenderness on the right arm (site where the vaccine was injected)) and VACCINATION SITE SWELLING (Injection site was swollen) had resolved. At the time of the report, MASS (lumps) outcome was unknown and HEADACHE (extreme headache), CHILLS (chills), MYALGIA (body ache) and PYREXIA (fever) had resolved.            other meds: concomitant medications include vitamin d 4000 iu , osteo bi-flex   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: information was provided, added events, concomitant medications and vaccine details.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Presyncope
Clinical narrative: really severe cold symptoms; fell like I might pass out; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (really severe cold symptoms) and PRESYNCOPE (fell like I might pass out) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003BNA) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced NASOPHARYNGITIS (really severe cold symptoms) and PRESYNCOPE (fell like I might pass out). At the time of the report, NASOPHARYNGITIS (really severe cold symptoms) and PRESYNCOPE (fell like I might pass out) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On the morning of 07-Apr-2021 the patient took Advil and a typical severe cold and cough medication. He's drinking a lot of water.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (very sore arm - left arm), myalgia (muscle pain), fatigue (exhaustion) and headache in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 023M20A) for COVID-19 immunization. No medical history reported. On Mar 24, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On Mar 24, 2021, patient experienced pain in extremity (very sore arm - left arm), myalgia (muscle pain), fatigue (exhaustion) and headache. At the time of the report, pain in extremity (very sore arm - left arm), myalgia (muscle pain), fatigue (exhaustion) and headache outcome: unknown. No concomitant medication or treatment information reported. Reporter did not allow further contact.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Insomnia, Joint adhesion, Joint stiffness
Clinical narrative: 9.5 out of 10 on the pain scale; Not even able to sleep; Can barely move around; Knee hurting; Stiff knee; Difficulty in bending knee; This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (Stiff knee), JOINT ADHESION (Difficulty in bending knee), PAIN ASSESSMENT (9.5 out of 10 on the pain scale), INSOMNIA (Not even able to sleep) and GAIT DISTURBANCE (Can barely move around) in a 49-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 No adverse event.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced JOINT STIFFNESS (Stiff knee), JOINT ADHESION (Difficulty in bending knee) and ARTHRALGIA (Knee hurting). On an unknown date, the patient experienced PAIN ASSESSMENT (9.5 out of 10 on the pain scale), INSOMNIA (Not even able to sleep) and GAIT DISTURBANCE (Can barely move around). At the time of the report, JOINT STIFFNESS (Stiff knee), JOINT ADHESION (Difficulty in bending knee), PAIN ASSESSMENT (9.5 out of 10 on the pain scale), INSOMNIA (Not even able to sleep), GAIT DISTURBANCE (Can barely move around) and ARTHRALGIA (Knee hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment information were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: Follow-up received on 08 April 2021. Additional events added
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Pain assessment
Clinical narrative: 9.5 out of 10 on the pain scale; Not even able to sleep; Can barely move around; Knee hurting; Stiff knee; Difficulty in bending knee; This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (Stiff knee), JOINT ADHESION (Difficulty in bending knee), PAIN ASSESSMENT (9.5 out of 10 on the pain scale), INSOMNIA (Not even able to sleep) and GAIT DISTURBANCE (Can barely move around) in a 49-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 No adverse event.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced JOINT STIFFNESS (Stiff knee), JOINT ADHESION (Difficulty in bending knee) and ARTHRALGIA (Knee hurting). On an unknown date, the patient experienced PAIN ASSESSMENT (9.5 out of 10 on the pain scale), INSOMNIA (Not even able to sleep) and GAIT DISTURBANCE (Can barely move around). At the time of the report, JOINT STIFFNESS (Stiff knee), JOINT ADHESION (Difficulty in bending knee), PAIN ASSESSMENT (9.5 out of 10 on the pain scale), INSOMNIA (Not even able to sleep), GAIT DISTURBANCE (Can barely move around) and ARTHRALGIA (Knee hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment information were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: Follow-up received on 08 April 2021. Additional events added
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site
Clinical narrative: she felt that he injected the vaccine more towards her shoulder bone then her muscle; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (she felt that he injected the vaccine more towards her shoulder bone then her muscle) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 023M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 30-Mar-2021, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (she felt that he injected the vaccine more towards her shoulder bone then her muscle). On 30-Mar-2021, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (she felt that he injected the vaccine more towards her shoulder bone then her muscle) had resolved.            Patient called pharmacy same day and pharmacist confirmed that the dose was properly administered.  Concomitant medications were not reported.  This report refers to a case of Product administered at Inappropriate site, for mRNA-1273, lot # 002B21A, with no associated AEs.; Sender's Comments: This report refers to a case of Product administered at Inappropriate site, for mRNA-1273, lot # 002B21A, with no associated AEs.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine administered after temperature excursion; Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion). On 02-Apr-2021, PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was unkown.
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinus infection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse event.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced SINUSITIS (sinus infection). On 19-Mar-2021, SINUSITIS (sinus infection) had resolved.            No concomitant medications were reported.  No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not Applicable
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Neck pain
Clinical narrative: neck aches; Headache; This spontaneous case was reported by an other caregiver and describes the occurrence of NECK PAIN (neck aches) and HEADACHE (Headache) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported). Concomitant products included ADALIMUMAB (HUMIRA AC), COLECALCIFEROL (VITAMIN D 3), POTASSIUM, RABEPRAZOLE SODIUM (ACIPHEX) and CYANOCOBALAMIN (VIT B12).   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 31-Mar-2021, the patient experienced NECK PAIN (neck aches) and HEADACHE (Headache). At the time of the report, NECK PAIN (neck aches) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment details not included.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Taste disorder
Clinical narrative: peculiar taste; heavy arms; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (peculiar taste) and PAIN IN EXTREMITY (heavy arms) 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) (Intramuscular) 1. On an unknown date, the patient experienced TASTE DISORDER (peculiar taste) and PAIN IN EXTREMITY (heavy arms). At the time of the report, TASTE DISORDER (peculiar taste) and PAIN IN EXTREMITY (heavy arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Pyrexia
Clinical narrative: Not feeling well; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Not feeling well), PYREXIA (Fever) and CHILLS (Chills) 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 06-Apr-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. On 06-Apr-2021, the patient experienced FEELING ABNORMAL (Not feeling well), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, FEELING ABNORMAL (Not feeling well), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            The patient's medical history was not provided.  No relevant concomitant medications were reported. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, the action taken with the drug in response to the events was not applicable.   Reporter did not allow further contact.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: hot in the injection arm; sore in the injection arm; achy in the injection arm; swollen in the injection arm; Red in the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot in the injection arm), VACCINATION SITE PAIN (sore in the injection arm), MYALGIA (achy in the injection arm), VACCINATION SITE SWELLING (swollen in the injection arm) and VACCINATION SITE ERYTHEMA (Red in the injection arm) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE WARMTH (hot in the injection arm), VACCINATION SITE PAIN (sore in the injection arm), MYALGIA (achy in the injection arm), VACCINATION SITE SWELLING (swollen in the injection arm) and VACCINATION SITE ERYTHEMA (Red in the injection arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. On 06-Apr-2021, VACCINATION SITE WARMTH (hot in the injection arm), VACCINATION SITE PAIN (sore in the injection arm) and VACCINATION SITE SWELLING (swollen in the injection arm) had resolved. At the time of the report, MYALGIA (achy in the injection arm) and VACCINATION SITE ERYTHEMA (Red in the injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not reported.   This case was linked to MOD-2021-142573 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow up received on 08-jul-2021 contains significant information. Added reporters Mail id, City, Postal code and report media updated.
Sex: M
Vaccine: COVID19
Symptoms: Conjunctivitis
Clinical narrative: Pink eye; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Apr-2021 and was forwarded to Moderna on 07-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CONJUNCTIVITIS (Pink eye) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONJUNCTIVITIS (Pink eye). At the time of the report, CONJUNCTIVITIS (Pink eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. The patient received unspecified antibiotics for the event as a treatment.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Vaccination site warmth; Vaccination site erythema; Vaccination site pain; Vaccination site tenderness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE PAIN (Vaccination site tenderness) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE PAIN (Vaccination site tenderness). At the time of the report, VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE PAIN (Vaccination site tenderness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided. Patient took a steroid shot as treatment medication.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Myalgia, Pyrexia
Clinical narrative: dry cough; fever; Tested positive for COVID; chills; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID), COUGH (dry cough), PYREXIA (fever), CHILLS (chills) and MYALGIA (muscle aches) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced COVID-19 (Tested positive for COVID). On an unknown date, the patient experienced COUGH (dry cough), PYREXIA (fever), CHILLS (chills) and MYALGIA (muscle aches). At the time of the report, COVID-19 (Tested positive for COVID) outcome was unknown, COUGH (dry cough) and PYREXIA (fever) had not resolved and CHILLS (chills) and MYALGIA (muscle aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Events added. Lab data added.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: dry cough; fever; Tested positive for COVID; chills; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID), COUGH (dry cough), PYREXIA (fever), CHILLS (chills) and MYALGIA (muscle aches) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced COVID-19 (Tested positive for COVID). On an unknown date, the patient experienced COUGH (dry cough), PYREXIA (fever), CHILLS (chills) and MYALGIA (muscle aches). At the time of the report, COVID-19 (Tested positive for COVID) outcome was unknown, COUGH (dry cough) and PYREXIA (fever) had not resolved and CHILLS (chills) and MYALGIA (muscle aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Events added. Lab data added.
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient under 16 years old received the vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Apr-2021 and was forwarded to Moderna on 07-Apr-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 16 years old received the vaccine) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 16 years old received the vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 16 years old received the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter did not provide any causality assessments.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Blood testosterone, Feeling hot, Hypoaesthesia, Loss of libido
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of loss of libido (loss of sexual desire and ability to keep an erection), hypoesthesia (numbness in genital area) and feeling hot (warm-to-touch in genital area) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concomitant products included Prilosec (omeprazole) for an unknown indication. On Mar 31, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 31, 2021, patient experienced loss of libido (loss of sexual desire and ability to keep an erection), hypoesthesia (numbness in genital area) and feeling hot (warm-to-touch in genital area). The patient treated with Cialis (tadalafil) for decreased sexual feeling, at an unspecified dose and frequency. At the time of the report, loss of libido (loss of sexual desire and ability to keep an erection), hypoesthesia (numbness in genital area) and feeling hot (warm-to-touch in genital area) outcome: unknown/not provided. Diagnostic results: On an unknown date, testosterone: Normal.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nasal congestion, Pain in extremity, Pyrexia
Clinical narrative: Sore Arm; Stuffy Nose; Fever; Body Ache; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), NASAL CONGESTION (Stuffy Nose), HEADACHE (headache), PYREXIA (Fever) and MYALGIA (Body Ache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced HEADACHE (headache). On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm), NASAL CONGESTION (Stuffy Nose), PYREXIA (Fever) and MYALGIA (Body Ache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (Sore Arm), NASAL CONGESTION (Stuffy Nose), HEADACHE (headache), PYREXIA (Fever) and MYALGIA (Body Ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.