chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Eructation, Non-cardiac chest pain, On and off phenomenon, Sleep disorder
Clinical narrative: disrupted her sleep; On and off; Chest pain subsided; Bubble popping; Extreme chest pain; shortness of breath; chest would "squeeze tight for a few minutes"; feeling like burping; possible bad heartburn; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (possible bad heartburn), CHEST PAIN (Extreme chest pain), DYSPNOEA (shortness of breath), CHEST DISCOMFORT (chest would "squeeze tight for a few minutes") and ERUCTATION (feeling like burping) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Systemic lupus erythematosis in 2005, Shellfish allergy, Drug allergy (Erythromycin), Cholesterol and Hypertension. Concomitant products included HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and BELIMUMAB (BENLYSTA) for an unknown indication.    On 25-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, the patient experienced DYSPEPSIA (possible bad heartburn). On 02-Aug-2021, the patient experienced CHEST PAIN (Extreme chest pain), DYSPNOEA (shortness of breath), CHEST DISCOMFORT (chest would "squeeze tight for a few minutes"), ERUCTATION (feeling like burping) and EAR DISCOMFORT (Bubble popping). On an unknown date, the patient experienced SLEEP DISORDER (disrupted her sleep), ON AND OFF PHENOMENON (On and off) and NON-CARDIAC CHEST PAIN (Chest pain subsided). At the time of the report, DYSPEPSIA (possible bad heartburn), DYSPNOEA (shortness of breath), CHEST DISCOMFORT (chest would "squeeze tight for a few minutes"), ERUCTATION (feeling like burping), SLEEP DISORDER (disrupted her sleep), EAR DISCOMFORT (Bubble popping) and ON AND OFF PHENOMENON (On and off) outcome was unknown, CHEST PAIN (Extreme chest pain) had resolved and NON-CARDIAC CHEST PAIN (Chest pain subsided) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication provided by reporter.  Lab data included The caller stated that she had a echocardiogram procedure yesterday (10Aug2021) but the results have not come back yet.  On follow-up patient repprted that she is doing much better.   Most recent FOLLOW-UP information incorporated above includes: On 18-Oct-2021: Follow-up received, Chest pain event outcome updated from unknown to recovering and added information in inarrative.From initial  Source Document- Captured reporter contact number and mail id and medical history( which was missed out to capture in initial submitted version). On 21-Oct-2021: Follow-up information received on 21-Oct-2021 included about outcome of event chest pain updated.
Age: 83.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Extra dose administered
Clinical narrative: In  vaccination clinic, patient presented for two vaccination, Fluzone-HD and Covid-19 booster, shots. While in preparation to give the vaccinations, I had patient to repeat what vaccines he was going to received that day. He said that he wanted the Flu and Covid-19 booster. Then, I processed to vaccinate. When processing, I saw that he had previously received this shots.
Age: 83.0
Sex: F
Vaccine: FLU4
Symptoms: Abnormal behaviour, Extra dose administered
Clinical narrative: In a local clinic, patient presented for Fluzone-HD vaccination.  While in preparation to give her the vaccination, I had patient to repeat what vaccines she was going to received that day. She said that she wanted the Flu vaccine. Then, I processed to vaccinate her. When processing her content form, that when I realize that she had a previous Fluzone-HD several days ago... When trying to contact the patient, I finally reach their daughter (name unknown).  She said that her parents can appear to be very lucid. But, their are not.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Tinnitus
Clinical narrative: Within 24 hours I got tinnitus. It is gradually getting worse. Some nights I get <3 hours of sleep because it's so loud. Some days it's difficult to think clearly or concentrate because it's so loud. Some days/nights are better/worse than others. Contacted my PCP who said she never heard of that as being related to the vaccine. Told to contact my employer's employee health. Contacted them and they also said they never heard of that as being related to the vaccine and to contact my PCP. Contacted my PCP again and she wrote for an ENT referral, which I still haven't heard from.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Lymph node pain, Lymphadenopathy, Myalgia
Clinical narrative: Sore swollen lymph nodes on injection side, fever (101), lethargy, sore muscles, headache
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Sore swollen lymph nodes on injection side, fever (101), lethargy, sore muscles, headache
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Maternal exposure during pregnancy
Clinical narrative: Inappropriate schedule of product administration; I'm 6 weeks pregnant; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration) and MATERNAL EXPOSURE DURING PREGNANCY (I'm 6 weeks pregnant) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 11-Aug-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (I'm 6 weeks pregnant). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration). On 11-Aug-2021, MATERNAL EXPOSURE DURING PREGNANCY (I'm 6 weeks pregnant) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medication were provided HCP did not remember whether the patient got first dose of Moderna vaccine on February or March.  CC: This is a case of Inappropriate schedule of vaccine administration of this 39-year-old, female patient with no disclosed medical history, who experienced the non-serious, unexpected event of Maternal exposure during pregnancy. The patient received the second dose of vaccine at 6 weeks of gestation. The benefit-risk relationship of Moderna vaccine is not affected by this report.; Sender's Comments: This is a case of Inappropriate schedule of vaccine administration of this 39-year-old, female patient with no disclosed medical history, who experienced the non-serious, unexpected event of Maternal exposure during pregnancy. The patient received the second dose of vaccine at 6 weeks of gestation. The benefit-risk relationship of Moderna vaccine is not affected by this report.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Product administered to patient of inappropriate age
Clinical narrative: administered to a patient 17 years of age; Pregnant; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered to a patient 17 years of age) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 31-Mar-2022. On 14-Oct-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered to a patient 17 years of age) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On 14-Oct-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered to a patient 17 years of age) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   ? No treatment information was provided.  No underlying medical conditions identified.  CC:This case concerns a 17 year old pregnant female with unknown LMP, EDC and weeks gestation and no reported history who experienced the non-serious unlisted events of Maternal exposure during pregnancy and Product administered to patient of inappropriate age the day of dose 1 of mRNA-1273. Re-challenge is not applicable as dose 2 not scheduled yet. Benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 17 year old pregnant female with unknown LMP, EDC and weeks gestation and no reported history who experienced the non-serious unlisted events of Maternal exposure during pregnancy and Product administered to patient of inappropriate age the day of dose 1 of mRNA-1273. Re-challenge is not applicable as dose 2 not scheduled yet. Benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose administered past the 30-day use by date was the first or second shot; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered past the 30-day use by date was the first or second shot) in an elderly 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered past the 30-day use by date was the first or second shot). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered past the 30-day use by date was the first or second shot) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Palpitations, Somnolence
Clinical narrative: Palpations of the Heart; Sleepy; Headache until to date; Nausea, no vomiting; Chills; Soreness of Upper Left Arm where the Shot was given; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpations of the Heart), SOMNOLENCE (Sleepy), HEADACHE (Headache until to date), NAUSEA (Nausea, no vomiting) and CHILLS (Chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Heart disorder.   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 PALPITATIONS (Palpations of the Heart), SOMNOLENCE (Sleepy), HEADACHE (Headache until to date), NAUSEA (Nausea, no vomiting), CHILLS (Chills) and VACCINATION SITE PAIN (Soreness of Upper Left Arm where the Shot was given). At the time of the report, PALPITATIONS (Palpations of the Heart), SOMNOLENCE (Sleepy), NAUSEA (Nausea, no vomiting), CHILLS (Chills) and VACCINATION SITE PAIN (Soreness of Upper Left Arm where the Shot was given) outcome was unknown and HEADACHE (Headache until to date) had not resolved.            No concomitant medication was reported   No treatment medication was reported.  The patient had two shots of the Moderna Vaccine of which during the same night and awoke to reaction.   This case was linked to MOD-2021-354427 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Oct-2021: FU Received on 19 Oct 2021, its contain no new information
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Palpations of the Heart; Sleepy; Headache until to date; Nausea, no vomiting; Chills; Soreness of Upper Left Arm where the Shot was given; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpations of the Heart), SOMNOLENCE (Sleepy), HEADACHE (Headache until to date), NAUSEA (Nausea, no vomiting) and CHILLS (Chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Heart disorder.   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 PALPITATIONS (Palpations of the Heart), SOMNOLENCE (Sleepy), HEADACHE (Headache until to date), NAUSEA (Nausea, no vomiting), CHILLS (Chills) and VACCINATION SITE PAIN (Soreness of Upper Left Arm where the Shot was given). At the time of the report, PALPITATIONS (Palpations of the Heart), SOMNOLENCE (Sleepy), NAUSEA (Nausea, no vomiting), CHILLS (Chills) and VACCINATION SITE PAIN (Soreness of Upper Left Arm where the Shot was given) outcome was unknown and HEADACHE (Headache until to date) had not resolved.            No concomitant medication was reported   No treatment medication was reported.  The patient had two shots of the Moderna Vaccine of which during the same night and awoke to reaction.   This case was linked to MOD-2021-354427 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Oct-2021: FU Received on 19 Oct 2021, its contain no new information
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered with an expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Reporter reported that  expired (expiration date 13 Oct 2021) Moderna Covid-19 vaccine was given  to 4 patients on 15 Oct 2021 between 8:00-10:00am.  Reporter had no adverse drug reaction to report on four patients that received Moderna vaccine 36 hours post vial expiration.   Most recent FOLLOW-UP information incorporated above includes: On 18-Oct-2021: Non Significant Follow Up received and updated contact information of reporter. On 19-Oct-2021: Non-Significant follow up  received. Email failure notification received. On 20-Oct-2021: Source Document contains no new information.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Product selection error
Clinical narrative: 12 yo given moderna vaccine and not Pfizer vaccine/1st dose of Moderna vaccine on accident today; 12 yo given moderna vaccine and not Pfizer vaccine; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 yo given moderna vaccine and not Pfizer vaccine/1st dose of Moderna vaccine on accident today) and PRODUCT SELECTION ERROR (12 yo given moderna vaccine and not Pfizer vaccine) in a 12-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Oct-2021, the patient experienced PRODUCT SELECTION ERROR (12 yo given moderna vaccine and not Pfizer vaccine). On 15-Oct-2021 at 5:00 PM, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 yo given moderna vaccine and not Pfizer vaccine/1st dose of Moderna vaccine on accident today). On 15-Oct-2021, PRODUCT SELECTION ERROR (12 yo given moderna vaccine and not Pfizer vaccine) had resolved. On 15-Oct-2021 at 5:00 PM, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 yo given moderna vaccine and not Pfizer vaccine/1st dose of Moderna vaccine on accident today) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment information was not reported.  12 yo given 1st dose of Moderna vaccine on accident on 15-Oct-2021 instead of Pfizer and stayed for 15 minutes after vaccination and did not have any side effects or reaction as per doctor. Also patient was asymptomatic. Medical test or laboratory test result related to the event was reported as none. The patient did not received any other vaccines within one month or prior to moderna vaccine.  It was unknown if prescription, over the counter medications, dietary supplements, or herbal remedies being taken at the time of vaccination and other illnesses at the time of vaccination and up to one month prior. It was unknown if the patient had allergies to medications, food or other products and chronic or long standing health conditions. Other illnesses at the time of vaccination and up to one month prior.   Most recent FOLLOW-UP information incorporated above includes: On 19-Oct-2021: Follow-up received on 19-Oct-2021. Added patient information and Vaccination information.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: body ache; mild fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body ache) and FATIGUE (mild fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 014C21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: PFIZER (LOT- EN6201) on 24-Jan-2021 and PFIZER (LOT-EN5318) on 13-Feb-2021. Concurrent medical conditions included Immunocompromised. Concomitant products included METFORMIN, GABAPENTIN, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), LISINOPRIL, TRAZODONE, ACETYLSALICYLIC ACID (BABY ASPIRIN), ESCITALOPRAM OXALATE (LEXAPRO), ATORVASTATIN and CERTOLIZUMAB PEGOL (CIMZIA) for an unknown indication.   On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-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 MYALGIA (body ache) and FATIGUE (mild fatigue). At the time of the report, MYALGIA (body ache) and FATIGUE (mild fatigue) had resolved.            No treatment reported. It was reported that patient also received 2 doses of COVID-19 vaccines from Pfizer and experienced localized tenderness around the area of the shot.   This case was linked to MOD-2021-355779 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Oct-2021: The follow up includes no new information.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received a dose past 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a dose past 30-day use by date) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-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 third 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 EXPIRED PRODUCT ADMINISTERED (Received a dose past 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received a dose past 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter No treatment medications were provided by the reporter.   This case was linked to MOD-2021-355943, MOD-2021-356165, MOD-2021-355963, MOD-2021-355936, MOD-2021-355901, MOD-2021-355936, MOD-2021-355911, MOD-2021-355963, MOD-2021-356222, MOD-2021-356295 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Follow-up information included no new information
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Bedridden, Chills, Contusion, Feeling of body temperature change
Clinical narrative: lump where shot was given; lump is discolored/initially was reddishpurple but now is reddish-brown like a bruise.; now is reddish-brown like a bruise; stayed in bed all day; became sick for 3 days; back of her neck was hurting; got hot and cold; had chills; top of her head was hurting/headache; injection site pain under left arm; Accidental overdose; Off label use; got nervous; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (got nervous), ILLNESS (became sick for 3 days), NECK PAIN (back of her neck was hurting), FEELING OF BODY TEMPERATURE CHANGE (got hot and cold) and BEDRIDDEN (stayed in bed all day) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Latex allergy (medication sensitivities including latex).    On 14-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Oct-2021, the patient experienced NERVOUSNESS (got nervous), ACCIDENTAL OVERDOSE (Accidental overdose) and OFF LABEL USE (Off label use). On 15-Oct-2021, the patient experienced ILLNESS (became sick for 3 days), NECK PAIN (back of her neck was hurting), FEELING OF BODY TEMPERATURE CHANGE (got hot and cold), CHILLS (had chills), HEADACHE (top of her head was hurting/headache) and VACCINATION SITE PAIN (injection site pain under left arm). On 16-Oct-2021, the patient experienced BEDRIDDEN (stayed in bed all day). On 18-Oct-2021, the patient experienced VACCINATION SITE MASS (lump where shot was given), VACCINATION SITE DISCOLOURATION (lump is discolored/initially was reddishpurple but now is reddish-brown like a bruise.) and CONTUSION (now is reddish-brown like a bruise). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of UNK, qid. On 14-Oct-2021, ACCIDENTAL OVERDOSE (Accidental overdose) and OFF LABEL USE (Off label use) had resolved. In October 2021, ILLNESS (became sick for 3 days) had resolved. On 18-Oct-2021, BEDRIDDEN (stayed in bed all day) was resolving. At the time of the report, NERVOUSNESS (got nervous), NECK PAIN (back of her neck was hurting), FEELING OF BODY TEMPERATURE CHANGE (got hot and cold), VACCINATION SITE MASS (lump where shot was given), VACCINATION SITE DISCOLOURATION (lump is discolored/initially was reddishpurple but now is reddish-brown like a bruise.), CONTUSION (now is reddish-brown like a bruise), CHILLS (had chills), HEADACHE (top of her head was hurting/headache) and VACCINATION SITE PAIN (injection site pain under left arm) outcome was unknown.            Concomitant medications were not reported.  Patient lump was about the size of a dime. The patient has gained 25 lbs.   This case was linked to MOD-2021-355953 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Neck pain, Nervousness, Off label use
Clinical narrative: lump where shot was given; lump is discolored/initially was reddishpurple but now is reddish-brown like a bruise.; now is reddish-brown like a bruise; stayed in bed all day; became sick for 3 days; back of her neck was hurting; got hot and cold; had chills; top of her head was hurting/headache; injection site pain under left arm; Accidental overdose; Off label use; got nervous; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (got nervous), ILLNESS (became sick for 3 days), NECK PAIN (back of her neck was hurting), FEELING OF BODY TEMPERATURE CHANGE (got hot and cold) and BEDRIDDEN (stayed in bed all day) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Latex allergy (medication sensitivities including latex).    On 14-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Oct-2021, the patient experienced NERVOUSNESS (got nervous), ACCIDENTAL OVERDOSE (Accidental overdose) and OFF LABEL USE (Off label use). On 15-Oct-2021, the patient experienced ILLNESS (became sick for 3 days), NECK PAIN (back of her neck was hurting), FEELING OF BODY TEMPERATURE CHANGE (got hot and cold), CHILLS (had chills), HEADACHE (top of her head was hurting/headache) and VACCINATION SITE PAIN (injection site pain under left arm). On 16-Oct-2021, the patient experienced BEDRIDDEN (stayed in bed all day). On 18-Oct-2021, the patient experienced VACCINATION SITE MASS (lump where shot was given), VACCINATION SITE DISCOLOURATION (lump is discolored/initially was reddishpurple but now is reddish-brown like a bruise.) and CONTUSION (now is reddish-brown like a bruise). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of UNK, qid. On 14-Oct-2021, ACCIDENTAL OVERDOSE (Accidental overdose) and OFF LABEL USE (Off label use) had resolved. In October 2021, ILLNESS (became sick for 3 days) had resolved. On 18-Oct-2021, BEDRIDDEN (stayed in bed all day) was resolving. At the time of the report, NERVOUSNESS (got nervous), NECK PAIN (back of her neck was hurting), FEELING OF BODY TEMPERATURE CHANGE (got hot and cold), VACCINATION SITE MASS (lump where shot was given), VACCINATION SITE DISCOLOURATION (lump is discolored/initially was reddishpurple but now is reddish-brown like a bruise.), CONTUSION (now is reddish-brown like a bruise), CHILLS (had chills), HEADACHE (top of her head was hurting/headache) and VACCINATION SITE PAIN (injection site pain under left arm) outcome was unknown.            Concomitant medications were not reported.  Patient lump was about the size of a dime. The patient has gained 25 lbs.   This case was linked to MOD-2021-355953 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site mass, Vaccination site pain
Clinical narrative: lump where shot was given; lump is discolored/initially was reddishpurple but now is reddish-brown like a bruise.; now is reddish-brown like a bruise; stayed in bed all day; became sick for 3 days; back of her neck was hurting; got hot and cold; had chills; top of her head was hurting/headache; injection site pain under left arm; Accidental overdose; Off label use; got nervous; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (got nervous), ILLNESS (became sick for 3 days), NECK PAIN (back of her neck was hurting), FEELING OF BODY TEMPERATURE CHANGE (got hot and cold) and BEDRIDDEN (stayed in bed all day) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Latex allergy (medication sensitivities including latex).    On 14-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Oct-2021, the patient experienced NERVOUSNESS (got nervous), ACCIDENTAL OVERDOSE (Accidental overdose) and OFF LABEL USE (Off label use). On 15-Oct-2021, the patient experienced ILLNESS (became sick for 3 days), NECK PAIN (back of her neck was hurting), FEELING OF BODY TEMPERATURE CHANGE (got hot and cold), CHILLS (had chills), HEADACHE (top of her head was hurting/headache) and VACCINATION SITE PAIN (injection site pain under left arm). On 16-Oct-2021, the patient experienced BEDRIDDEN (stayed in bed all day). On 18-Oct-2021, the patient experienced VACCINATION SITE MASS (lump where shot was given), VACCINATION SITE DISCOLOURATION (lump is discolored/initially was reddishpurple but now is reddish-brown like a bruise.) and CONTUSION (now is reddish-brown like a bruise). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of UNK, qid. On 14-Oct-2021, ACCIDENTAL OVERDOSE (Accidental overdose) and OFF LABEL USE (Off label use) had resolved. In October 2021, ILLNESS (became sick for 3 days) had resolved. On 18-Oct-2021, BEDRIDDEN (stayed in bed all day) was resolving. At the time of the report, NERVOUSNESS (got nervous), NECK PAIN (back of her neck was hurting), FEELING OF BODY TEMPERATURE CHANGE (got hot and cold), VACCINATION SITE MASS (lump where shot was given), VACCINATION SITE DISCOLOURATION (lump is discolored/initially was reddishpurple but now is reddish-brown like a bruise.), CONTUSION (now is reddish-brown like a bruise), CHILLS (had chills), HEADACHE (top of her head was hurting/headache) and VACCINATION SITE PAIN (injection site pain under left arm) outcome was unknown.            Concomitant medications were not reported.  Patient lump was about the size of a dime. The patient has gained 25 lbs.   This case was linked to MOD-2021-355953 (Patient Link).
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore left arm) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore left arm). At the time of the report, PAIN IN EXTREMITY (Sore left arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.   This case was linked to MOD-2021-356211 (Patient Link).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash in his armpit; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash in his armpit) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013a21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE (DECONGESTANT II) for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash in his armpit). The patient was treated with PREDNISONE for Allergy, at an unspecified dose and frequency. At the time of the report, RASH (rash in his armpit) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-356213 (Patient Link).
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Neck mass
Clinical narrative: face a little warm; a little red; after a week, I noticed a lump on my neck; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (face a little warm), ERYTHEMA (a little red) and NECK MASS (after a week, I noticed a lump on my neck) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On 04-Feb-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 FEELING HOT (face a little warm), ERYTHEMA (a little red) and NECK MASS (after a week, I noticed a lump on my neck). At the time of the report, FEELING HOT (face a little warm) and ERYTHEMA (a little red) outcome was unknown and NECK MASS (after a week, I noticed a lump on my neck) was resolving.        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.  No treatment information was provided. Patient went to his doctor to do an ultrasound, but it wasn't anything.   This case was linked to MOD-2021-356657, MOD-2021-356658 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient administered vaccine that has possibly expired; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine that has possibly expired) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine that has possibly expired). On 04-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine that has possibly expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator- 02-OCT-2021 The vial  doesn't  undergo any temperature excursions  Concomitant medication were not reported.  Treatment information were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: Follow-up received and had no significant information. A query has been raised about expiration date extension of vaccine LOT#033B21A
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore left arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore left arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (sore left arm). At the time of the report, PAIN IN EXTREMITY (sore left arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and Treatment was not specified. Case is crosslinked to MOD21-153943   This case was linked to MOD-2021-356211 (Patient Link).
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Gave 14 years old 1st dose; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Gave 14 years old 1st dose) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 005C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVETIRACETAM DIHYDROCHLORIDE (KEPPRA [LEVETIRACETAM DIHYDROCHLORIDE]) from 16-Sep-2021 to an unknown date, MAGNESIUM OXIDE from 16-Sep-2021 to an unknown date and TRETINOIN (RETIN-A) for an unknown indication.   On 16-Sep-2021 at 5:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021 at 4:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Gave 14 years old 1st dose). On 16-Sep-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Gave 14 years old 1st dose) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment drug details was received.   Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2021: Follow-up document received on 21-Oct-21 : patient height, weight ,race, ethinicity, second dose information, concomitant medications were updated.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Neoplasm, Pyrexia, Vaccination site pain
Clinical narrative: he had pain in his arm at the injection site; lymph nodes on the groin area were huge/ tumor/lumps in my groin area are still there; he didn't feel anything right away/everything came down right away; tired; very low-grade fever; a little weak; really sick; joints and legs below the knees/  he couldn't walk for 7 hours; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (a little weak), ILLNESS (really sick), GAIT DISTURBANCE (joints and legs below the knees/  he couldn't walk for 7 hours), NEOPLASM (lymph nodes on the groin area were huge/ tumor/lumps in my groin area are still there) and FEELING ABNORMAL (he didn't feel anything right away/everything came down right away  ) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 88D21A, 015M20H and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-2021, the patient experienced ASTHENIA (a little weak), ILLNESS (really sick), GAIT DISTURBANCE (joints and legs below the knees/  he couldn't walk for 7 hours), FEELING ABNORMAL (he didn't feel anything right away/everything came down right away  ), FATIGUE (tired) and PYREXIA (very low-grade fever ). On 15-Oct-2021, the patient experienced NEOPLASM (lymph nodes on the groin area were huge/ tumor/lumps in my groin area are still there). On an unknown date, the patient experienced VACCINATION SITE PAIN (he had pain in his arm at the injection site). The patient was treated with PARACETAMOL (TYLENOL A) on 08-Sep-2021 at a dose of 1 dosage form. At the time of the report, ASTHENIA (a little weak), ILLNESS (really sick), GAIT DISTURBANCE (joints and legs below the knees/  he couldn't walk for 7 hours), NEOPLASM (lymph nodes on the groin area were huge/ tumor/lumps in my groin area are still there), FEELING ABNORMAL (he didn't feel anything right away/everything came down right away  ), FATIGUE (tired), PYREXIA (very low-grade fever ) and VACCINATION SITE PAIN (he had pain in his arm at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  Patient felt really sick. He had a very low-grade fever. His joints and legs below the knees he couldn't walk for 7 hours. He was just laying down and had a bottle of Tylenol and water.  The patient adds that after the second and third dose, he had pain in his arm at the injection site. It was worse after the third dose   This case was linked to MOD-2021-356190, MOD-2021-356657 (Patient Link).
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-356818 (Patient Link).
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment drugs were reported.
Age: 52.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 52-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) 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.  No treatment information was provided.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment medications provided.