chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: chills; bad headache for 12 hours; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and HEADACHE (bad headache for 12 hours) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and HEADACHE (bad headache for 12 hours). At the time of the report, CHILLS (chills) outcome was unknown and HEADACHE (bad headache for 12 hours) had resolved.            No concomitant medication was reported.  No treatment medication was reported.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Incomplete course of vaccination, Oesophageal pain, Pain, Paraesthesia
Clinical narrative: I instantly felt my esophagus burning and 12 hours later I woke up itching and covered in a full body rash that did not heal for four days. Headaches all of those four days. I didn?t want to report this because I want to believe in the vaccine, but after my reaction I just don?t. I had a tingling pain for about a month that moved around my body afterward that I believe to be a blood clot. And four months later, I just recently started breathing normal again and got my full vision back after it being blurred. I have never had these symptoms until I took that stupid vaccine. Now I refuse to get the second shot and I want to know how to get an exemption from a doctor since this was obviously not for lack of willing to get the vaccine..it just triggered something and left a several day rash and several months long effects. I believe I CANT take the second shot or it will kill me. So I expect information on an exemption since it?s not for lack of willing
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Respiration abnormal, Vision blurred
Clinical narrative: I instantly felt my esophagus burning and 12 hours later I woke up itching and covered in a full body rash that did not heal for four days. Headaches all of those four days. I didn?t want to report this because I want to believe in the vaccine, but after my reaction I just don?t. I had a tingling pain for about a month that moved around my body afterward that I believe to be a blood clot. And four months later, I just recently started breathing normal again and got my full vision back after it being blurred. I have never had these symptoms until I took that stupid vaccine. Now I refuse to get the second shot and I want to know how to get an exemption from a doctor since this was obviously not for lack of willing to get the vaccine..it just triggered something and left a several day rash and several months long effects. I believe I CANT take the second shot or it will kill me. So I expect information on an exemption since it?s not for lack of willing
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Fatigue, Feeling abnormal, Headache, Nausea
Clinical narrative: I had extreme fatigue and a headache with nausea about 5-6 hours after receiving the vaccine. These symptoms were pretty severe for a week. I thought they would subside but still continue to have headaches, fatigue and nausea and have just started noticing a lot of memory loss that became more noticeable and bothersome within the last week (started 09/01/2021) I overall just don't feel my normal self.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Pyrexia
Clinical narrative: Shingles vaccine caused a very bad headache, 99.2 fever,  aches and pain at the sight.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness on the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness on the injection arm) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, PANTOPRAZOLE, BUPROPION HYDROCHLORIDE (WELLBUTRIN), FLUOXETINE HYDROCHLORIDE (PROZAC), ROSUVASTATIN, ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) and VITAMINS NOS (MVI [VITAMINS NOS]) for an unknown indication.    On 27-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 PAIN IN EXTREMITY (Soreness on the injection arm). At the time of the report, PAIN IN EXTREMITY (Soreness on the injection arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-292274 (Patient Link).
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia, Rash
Clinical narrative: a rash on her neck,rash on her chest ,rash on her stomach; a fever; a headache; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of RASH (a rash on her neck,rash on her chest ,rash on her stomach), PYREXIA (a fever), HEADACHE (a headache) and MYALGIA (Body aches) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced PYREXIA (a fever), HEADACHE (a headache) and MYALGIA (Body aches). On 18-Aug-2021, the patient experienced RASH (a rash on her neck,rash on her chest ,rash on her stomach). On 18-Aug-2021, PYREXIA (a fever), HEADACHE (a headache) and MYALGIA (Body aches) had resolved. At the time of the report, RASH (a rash on her neck,rash on her chest ,rash on her stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported. Treatment medication were not reported.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site nodule, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: A little bump at the injection site/ golf ball size; A little itchy at the injection site; Swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE NODULE (A little bump at the injection site/ golf ball size), VACCINATION SITE PRURITUS (A little itchy at the injection site) and VACCINATION SITE SWELLING (Swelling at the injection site) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced VACCINATION SITE NODULE (A little bump at the injection site/ golf ball size), VACCINATION SITE PRURITUS (A little itchy at the injection site) and VACCINATION SITE SWELLING (Swelling at the injection site). At the time of the report, VACCINATION SITE NODULE (A little bump at the injection site/ golf ball size), VACCINATION SITE PRURITUS (A little itchy at the injection site) and VACCINATION SITE SWELLING (Swelling at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported.  Treatment information was not provided.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Hypoaesthesia, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: 2nd dose administered outside of the recommended dosing window; feeling crummy overnight; numbness in his feet which started about a month ago.; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered outside of the recommended dosing window), FEELING ABNORMAL (feeling crummy overnight), HYPOAESTHESIA (numbness in his feet which started about a month ago.), CHILLS (chills) and PYREXIA (fever) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, PANTOPRAZOLE, BUPROPION HYDROCHLORIDE (WELLBUTRIN), FLUOXETINE HYDROCHLORIDE (PROZAC), ROSUVASTATIN, ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) and VITAMINS NOS (MVI [VITAMINS NOS]) for an unknown indication.    On 04-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered outside of the recommended dosing window), FEELING ABNORMAL (feeling crummy overnight), HYPOAESTHESIA (numbness in his feet which started about a month ago.), CHILLS (chills) and PYREXIA (fever). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered outside of the recommended dosing window), FEELING ABNORMAL (feeling crummy overnight), HYPOAESTHESIA (numbness in his feet which started about a month ago.), CHILLS (chills) and PYREXIA (fever) had resolved.            Treatment medications were not reported.   This case was linked to MOD-2021-292238 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: Fever of a 104 degrees Fahrenheit / Intense fever for 24 hours, side effects lasted 48 hours; Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (Fever of a 104 degrees Fahrenheit / Intense fever for 24 hours, side effects lasted 48 hours) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills) and PYREXIA (Fever of a 104 degrees Fahrenheit / Intense fever for 24 hours, side effects lasted 48 hours). At the time of the report, CHILLS (Chills) and PYREXIA (Fever of a 104 degrees Fahrenheit / Intense fever for 24 hours, side effects lasted 48 hours) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 (High) 104 degrees Fahrenheit.         Concomitant medications was not provided by the reporter.  Treatment information was not provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered greater than 12 hours on pre-draw syringe; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours on pre-draw syringe) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours on pre-draw syringe). On 19-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours on pre-draw syringe) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   The pre-drawn syringe was given 1hour and 45minutes beyond the recommended 12hour period to a patient, only one dose was given. Patient was given today dose at around 11:17am and the dose in syringe expired at 09:30am.  Treatment information was not provided.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Sore shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Sore shoulder) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Sore shoulder). At the time of the report, ARTHRALGIA (Sore shoulder) outcome was unknown.            Concomitant product was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-292324.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Quarter will stick to injection area/a magnetic pull at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Quarter will stick to injection area/a magnetic pull at injection site) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) 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 VACCINATION COMPLICATION (Quarter will stick to injection area/a magnetic pull at injection site). At the time of the report, VACCINATION COMPLICATION (Quarter will stick to injection area/a magnetic pull at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter  Treatment information was not provided
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick after first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick after first vaccine) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced ILLNESS (Sick after first vaccine). On 16-Jan-2021, ILLNESS (Sick after first vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment history was not reported. The concomitant medication was not reported.   This case was linked to MOD-2021-292111 (Patient Link).
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: My husbands left arm was sore after the second shot; My husbands left arm was red after the second shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (My husbands left arm was sore after the second shot) and VACCINATION SITE ERYTHEMA (My husbands left arm was red after the second shot) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A, 031L20A and 063E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE PAIN (My husbands left arm was sore after the second shot) and VACCINATION SITE ERYTHEMA (My husbands left arm was red after the second shot). At the time of the report, VACCINATION SITE PAIN (My husbands left arm was sore after the second shot) and VACCINATION SITE ERYTHEMA (My husbands left arm was red after the second shot) outcome was unknown.            Concomitant  mediations were not reported.  Treatment history was not provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: achy; fever, temperature; Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (achy), PYREXIA (fever, temperature) and HEADACHE (Headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 026L20A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for Hypertension, IBANDRONATE SODIUM (BONIVA) for Osteoporosis, VITAMINS for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (achy), PYREXIA (fever, temperature) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, PAIN (achy), PYREXIA (fever, temperature) and HEADACHE (Headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided. No treatment medications were provided. The side effects weren't real bad but enough to keep the patient  home from work.   Most recent FOLLOW-UP information incorporated above includes: On 24-Aug-2021: Follow Up information was received on 24-Aug-2021 and first and second dose details were added, concomitant medications added,narrative updated, reporter occupation added.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: Anxiety increased through taking the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Anxiety increased through taking the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety.    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 ANXIETY (Anxiety increased through taking the vaccine). At the time of the report, ANXIETY (Anxiety increased through taking the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Lymphoedema, Peripheral swelling, Skin discolouration
Clinical narrative: Lymphedema after vaccine; Arm blew up; Her arm blue up really big; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOEDEMA (Lymphedema after vaccine), SKIN DISCOLOURATION (Arm blew up) and PERIPHERAL SWELLING (Her arm blue up really big) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included ALPRAZOLAM (XANAX) and ZOLPIDEM TARTRATE (AMBIEN) 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 an unknown date, the patient experienced LYMPHOEDEMA (Lymphedema after vaccine), SKIN DISCOLOURATION (Arm blew up) and PERIPHERAL SWELLING (Her arm blue up really big). At the time of the report, LYMPHOEDEMA (Lymphedema after vaccine), SKIN DISCOLOURATION (Arm blew up) and PERIPHERAL SWELLING (Her arm blue up really big) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medication included blood pressure medication.  Patient experienced lymphedema after her first dose and she started the lymphedema therapy.   This case was linked to MOD-2021-292652 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Chills, Illness
Clinical narrative: Had extreme chills ,chills went all the way to the bone; After the second dose I was sick as a dog for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (After the second dose I was sick as a dog for 2 days) and CHILLS (Had extreme chills ,chills went all the way to the bone) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (After the second dose I was sick as a dog for 2 days) and CHILLS (Had extreme chills ,chills went all the way to the bone). At the time of the report, ILLNESS (After the second dose I was sick as a dog for 2 days) had resolved and CHILLS (Had extreme chills ,chills went all the way to the bone) outcome was unknown.            Relevant concomitant medications were not provided.  Patient was sick for 2 days. Patient was informed to take the 3rd dose.  Treatment medication was not provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   Reporter did not allow further contact
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Gait disturbance, Headache, Joint stiffness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (Left knee started to feel tight), CONDITION AGGRAVATED (Worsening the next day until I could barely walk), JOINT SWELLING (Left knee started to feel swallon), GAIT DISTURBANCE (He could barely walk) and ARTHRALGIA (Pain started to switch from my left to my right) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced JOINT STIFFNESS (Left knee started to feel tight) and JOINT SWELLING (Left knee started to feel swallon). On 26-Apr-2021, the patient experienced CONDITION AGGRAVATED (Worsening the next day until I could barely walk) and GAIT DISTURBANCE (He could barely walk). On 29-Apr-2021, the patient experienced ARTHRALGIA (Pain started to switch from my left to my right). On an unknown date, the patient experienced HEADACHE (Headaches) and PRODUCT DOSE OMISSION ISSUE (Second dose or a booster dose as he has not received those yet). The patient was treated with PREDNISONE at an unspecified dose and frequency. On 02-May-2021, JOINT STIFFNESS (Left knee started to feel tight), CONDITION AGGRAVATED (Worsening the next day until I could barely walk), JOINT SWELLING (Left knee started to feel swallon), GAIT DISTURBANCE (He could barely walk) and ARTHRALGIA (Pain started to switch from my left to my right) had resolved. At the time of the report, HEADACHE (Headaches) and PRODUCT DOSE OMISSION ISSUE (Second dose or a booster dose as he has not received those yet) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. It was reported that recent lab data included antibody  test showed a count of 313. He had not received  the second dose. Relevant concomitant medications were not provided by the reporter.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Product dose omission issue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (Left knee started to feel tight), CONDITION AGGRAVATED (Worsening the next day until I could barely walk), JOINT SWELLING (Left knee started to feel swallon), GAIT DISTURBANCE (He could barely walk) and ARTHRALGIA (Pain started to switch from my left to my right) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced JOINT STIFFNESS (Left knee started to feel tight) and JOINT SWELLING (Left knee started to feel swallon). On 26-Apr-2021, the patient experienced CONDITION AGGRAVATED (Worsening the next day until I could barely walk) and GAIT DISTURBANCE (He could barely walk). On 29-Apr-2021, the patient experienced ARTHRALGIA (Pain started to switch from my left to my right). On an unknown date, the patient experienced HEADACHE (Headaches) and PRODUCT DOSE OMISSION ISSUE (Second dose or a booster dose as he has not received those yet). The patient was treated with PREDNISONE at an unspecified dose and frequency. On 02-May-2021, JOINT STIFFNESS (Left knee started to feel tight), CONDITION AGGRAVATED (Worsening the next day until I could barely walk), JOINT SWELLING (Left knee started to feel swallon), GAIT DISTURBANCE (He could barely walk) and ARTHRALGIA (Pain started to switch from my left to my right) had resolved. At the time of the report, HEADACHE (Headaches) and PRODUCT DOSE OMISSION ISSUE (Second dose or a booster dose as he has not received those yet) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. It was reported that recent lab data included antibody  test showed a count of 313. He had not received  the second dose. Relevant concomitant medications were not provided by the reporter.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Slow speech
Clinical narrative: Drawling; Pain in the arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SLOW SPEECH (Drawling), MYALGIA (Pain in the arm) and FATIGUE (Fatigue) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included SULPHASALAZINE for an unknown indication.   On 15-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Aug-2021, the patient experienced SLOW SPEECH (Drawling), MYALGIA (Pain in the arm) and FATIGUE (Fatigue). On 15-Aug-2021, MYALGIA (Pain in the arm) had resolved. On 17-Aug-2021, SLOW SPEECH (Drawling) and FATIGUE (Fatigue) had resolved.            Relevant concomitant medications were also included immunosuppressants.  The treatment information was  not provided.  It was reported that patient was immunosuppressed.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Peripheral swelling, Rash, Skin discolouration, Swelling
Clinical narrative: Dark area where the blisters healed; Had blisters /blisters also kept getting "really big"; More swelling; Had a rash; Arm started swelling /arm kept getting "really big"; This spontaneous case was reported by a pharmacist and describes the occurrence of PERIPHERAL SWELLING (Arm started swelling /arm kept getting "really big"), BLISTER (Had blisters /blisters also kept getting "really big"), SWELLING (More swelling), SKIN DISCOLOURATION (Dark area where the blisters healed) and RASH (Had a rash) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 013L20A) for COVID-19 vaccination.     The patient's past medical history included Lymphadenectomy (removed several lymph nodes in left side of the neck (the same side of the injection)). Concurrent medical conditions included Lymphocytic lymphoma (Small lymphocytic lymphoma (In Jan2021, not too long before the vaccine).) in January 2021, Hypertension and High cholesterol. Concomitant products included HYDROCHLOROTHIAZIDE, AMLODIPINE, ATORVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN 81), ZOLPIDEM and GABAPENTIN for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced PERIPHERAL SWELLING (Arm started swelling /arm kept getting "really big") and RASH (Had a rash). On 21-Feb-2021, the patient experienced BLISTER (Had blisters /blisters also kept getting "really big") and SWELLING (More swelling). On an unknown date, the patient experienced SKIN DISCOLOURATION (Dark area where the blisters healed). The patient was treated with DEXAMETHASONE (DEXPAK JR) for Adverse event, at a dose of 1 dosage form and TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE [TRIAMCINOLONE ACETONIDE]) for Adverse event, at a dose of 1 dosage form. At the time of the report, PERIPHERAL SWELLING (Arm started swelling /arm kept getting "really big"), BLISTER (Had blisters /blisters also kept getting "really big"), SWELLING (More swelling) and RASH (Had a rash) had resolved and SKIN DISCOLOURATION (Dark area where the blisters healed) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported that she removed several lymph nodes in left side of the neck from the same side of the injection.  Patient reported that events eventually went away but now she had a dark area where the blisters healed.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 7 patients vaccinated with a vial that was Greater than 12 hours after initial vial puncture; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 patients vaccinated with a vial that was Greater than 12 hours after initial vial puncture) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (7 patients vaccinated with a vial that was Greater than 12 hours after initial vial puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (7 patients vaccinated with a vial that was Greater than 12 hours after initial vial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided Treatment information was not reported  It was reported that the vial was removed from the fridge on 17Aug2021 in the morning, punctured at 3:00 PM and put back in the fridge around 5:00PM.  On 18Aug2021, the punctured vial was taken out of the fridge at 8:00 AM, administered to 7 patients between 8:00AM - 12:00 PM. 2  patients received their first dose, and 5 received their second dose. Duration of excursion - 15 hrs between 3:00 AM and 12:00 PM
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort
Clinical narrative: Stomach bothered her; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach bothered her) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Stomach bothered her). At the time of the report, ABDOMINAL DISCOMFORT (Stomach bothered her) had resolved.            Concomitant product use was not provided.   Treatment information was not  provided.  Patient drank water and the issue was resolved.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Feeling abnormal, Pyrexia
Clinical narrative: Feeling bad; feeling rocky; Feeling really weak; Woke up with 102 fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling bad), FEELING ABNORMAL (feeling rocky), ASTHENIA (Feeling really weak) and PYREXIA (Woke up with 102 fever) 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 Coronavirus infection in January 2021.    On 18-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Feeling bad), FEELING ABNORMAL (feeling rocky), ASTHENIA (Feeling really weak) and PYREXIA (Woke up with 102 fever). At the time of the report, FEELING ABNORMAL (Feeling bad), FEELING ABNORMAL (feeling rocky), ASTHENIA (Feeling really weak) and PYREXIA (Woke up with 102 fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102 fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication of the patient was not reported.  The patient told those adverse events were similar to what when he had coronavirus in January, 2021. The patient also told that he will do to see a doctor.   No treatment information was provided by the reporter.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Unable to get the 2nd dose due to snowstorm and due to visa issues; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Unable to get the 2nd dose due to snowstorm and due to visa issues) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 21-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 PRODUCT DOSE OMISSION ISSUE (Unable to get the 2nd dose due to snowstorm and due to visa issues). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Unable to get the 2nd dose due to snowstorm and due to visa issues) had resolved.            No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: pain in lower back; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (pain in lower back) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (pain in lower back). At the time of the report, BACK PAIN (pain in lower back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: lose her hair; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (lose her hair) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (lose her hair). At the time of the report, ALOPECIA (lose her hair) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: pain in lower back; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (pain in lower back) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (pain in lower back). At the time of the report, BACK PAIN (pain in lower back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   Reporter did not allow further contact
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Stuffy nose couple days ago) in a sixty-four-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (Batch no. 051C21A) for COVID-19 vaccination.  No Medical History information was reported. On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Aug-2021, the patient experienced NASAL CONGESTION (Stuffy nose couple days ago). At the time of the report, NASAL CONGESTION (Stuffy nose couple days ago) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  The patient was scheduled to take his second shot vaccine.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 infection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19 infection). At the time of the report, COVID-19 (COVID-19 infection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication information was reported. No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever (102.5-103); This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever (102.5-103)) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever (102.5-103)). At the time of the report, PYREXIA (Fever (102.5-103)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: increased (High) 102.5-103.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.    Reporter did not allow further contact
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose early; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose early) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006D21A and 052E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose early). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose early) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided by the reporter  No treatment medication were provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: TCR Follow up received on 23 AUG 2021 contains Non significant information(reporter's contact number and Fax number)
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash pruritic, Skin reaction, Vaccination site rash
Clinical narrative: rash kind of itches,; Delayed reaction; The injection site has a rash about the size of a couple of quarters; soreness in the arm for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm for 2 days), RASH PRURITIC (rash kind of itches,), SKIN REACTION (Delayed reaction) and VACCINATION SITE RASH (The injection site has a rash about the size of a couple of quarters) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Lanolin), Allergy to antibiotic (Neomycin), Drug allergy (Pabrinex), Allergy to chemicals (MDGN), Drug allergy (balsam of peru), Allergy to chemicals (Propylene Glycol), Allergy to chemicals (Fragrance mixes), Allergy to chemicals (Compistane mix), Drug allergy (lidocaine), Allergy to chemicals (oak moss), Alcohol allergy (alcohol), Allergy to chemicals (Eugenol), Allergy to chemicals (Tea tree oil), Allergy to chemicals (sandalwood oil), Allergy to chemicals (lang lang oil) and Allergy to chemicals (hydroperoxide).    On 11-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced PAIN IN EXTREMITY (soreness in the arm for 2 days). On 19-Aug-2021, the patient experienced RASH PRURITIC (rash kind of itches,), SKIN REACTION (Delayed reaction) and VACCINATION SITE RASH (The injection site has a rash about the size of a couple of quarters). On 13-Aug-2021, PAIN IN EXTREMITY (soreness in the arm for 2 days) had resolved. At the time of the report, RASH PRURITIC (rash kind of itches,), SKIN REACTION (Delayed reaction) and VACCINATION SITE RASH (The injection site has a rash about the size of a couple of quarters) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include Primarin Cream Twice a week. No treatment information was mentioned.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Drug ineffective, Fatigue
Clinical narrative: Numbness in toes,uderside toes,both feet; chills; really tired,very fatigued; developed fever; COVID-19; COVID-19 positive after second dose; slight cough; nasal congestion; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), HYPOAESTHESIA (Numbness in toes,uderside toes,both feet), COUGH (slight cough), NASAL CONGESTION (nasal congestion) and DRUG INEFFECTIVE (COVID-19 positive after second dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included METHYLPHENIDATE HYDROCHLORIDE (RITALIN) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2021, the patient experienced COUGH (slight cough) and NASAL CONGESTION (nasal congestion). On 13-Aug-2021, the patient experienced COVID-19 (COVID-19) and DRUG INEFFECTIVE (COVID-19 positive after second dose). On an unknown date, the patient experienced HYPOAESTHESIA (Numbness in toes,uderside toes,both feet), CHILLS (chills), FATIGUE (really tired,very fatigued) and PYREXIA (developed fever). At the time of the report, COVID-19 (COVID-19), HYPOAESTHESIA (Numbness in toes,uderside toes,both feet), COUGH (slight cough), NASAL CONGESTION (nasal congestion), DRUG INEFFECTIVE (COVID-19 positive after second dose), CHILLS (chills), FATIGUE (really tired,very fatigued) and PYREXIA (developed fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Aug-2021, SARS-CoV-2 test: positive (Positive) Caught delta variant and tested positive for covid.         Treatment medications were not reported.   This case was linked to MOD-2021-292464 (Patient Link).