chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: This spontaneous retrospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (conceived within days after receiving the second dose, probably 2 or 3 days after the second/had a healthy baby on 27October2021/conceived right away on her first try and had no complications) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A, 013L20A and 061E21A) for COVID-19 vaccination. The patient's past medical history included Miscarriage from December 2019 to December 2020.On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 01-Nov-2021. On 13-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (conceived within days after receiving the second dose, probably 2 or 3 days after the second/had a healthy baby on 27October2021/conceived right away on her first try and had no complications). The delivery occurred  on 27-Oct-2021, which was reported as Full-term.For neonate 1, The outcome was reported as Delivered NOS. She gave birth on 27-Oct-2021, 5 days early, full term. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (conceived within days after receiving the second dose, probably 2 or 3 days after the second/had a healthy baby on 27October2021/conceived right away on her first try and had no complications) had resolved.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant and treatment medication were provided. Patient's last menstrual period was on 25January2021.Company comment: This is a case of Maternal Exposure during Pregnancy concerns a 38-year-old female patient with no relevant medical history, who experienced no other associated adverse events. The patient was exposed to the second dose of mRNA-1273 Vaccine during her pregnancy at an unknown age of gestation. The benefit-risk relationship of mRNA-1273 Vaccine in not affected by this report. Sender's Comments: This is a case of Maternal Exposure during Pregnancy concerns a 38-year-old female patient with no relevant medical history, who experienced no other associated adverse events. The patient was exposed to the second dose of mRNA-1273 Vaccine during her pregnancy at an unknown age of gestation. The benefit-risk relationship of mRNA-1273 Vaccine in not affected by this report.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Dose given to a 13 year old) in a 13-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination. No Medical History information was reported.On 15-Nov-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Nov-2021 at 3:00 PM, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Dose given to a 13 year old). On 15-Nov-2021 at 3:00 PM, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Dose given to a 13 year old) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.No concomitant product use was provided by the reporter. No treatment medication was provided.Patient did not had any events till the time of reporting. This case was linked to MOD21-164677 (Patient Link).Most recent FOLLOW-UP information incorporated above includes:On 17-Nov-2021: Follow-up received include reporter, patient and product details.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Drug interaction, Feeling abnormal, Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DRUG INTERACTION (she was advised to use antibiotics for some reason. Interaction between the vaccine and antibiotics), FEELING ABNORMAL (did not feel good), CHILLS (Shivering) and MYALGIA (pain in her muscles) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039DZIA) for COVID-19 vaccination. No Medical History information was reported.On 26-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced FEELING ABNORMAL (did not feel good), CHILLS (Shivering) and MYALGIA (pain in her muscles). In November 2021, the patient experienced DRUG INTERACTION (she was advised to use antibiotics for some reason. Interaction between the vaccine and antibiotics). At the time of the report, DRUG INTERACTION (she was advised to use antibiotics for some reason. Interaction between the vaccine and antibiotics), FEELING ABNORMAL (did not feel good), CHILLS (Shivering) and MYALGIA (pain in her muscles) outcome was unknown. Treatment medications include Antibiotics.No concomitant medications were provided.Most recent FOLLOW-UP information incorporated above includes:On 16-Nov-2021: Non-Significant Follow up appended on 16-11-2021 contains.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Feeling weak a day or so) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension (blood pressure), Hyperlipidemia (cholesterol) and Pain.Concomitant products included AMLODIPINE BESILATE (AMLODIPINE [AMLODIPINE BESILATE]) for Blood pressure, PRAVASTATIN SODIUM (PRAVASTATIN [PRAVASTATIN SODIUM]) for Cholesterol, MELOXICAM for Pain.On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced ASTHENIA (Feeling weak a day or so). At the time of the report, ASTHENIA (Feeling weak a day or so) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.No treatment drug details was reported.  This case was linked to MOD-2021-388271 (Patient Link).
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose given to Paitent) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination. No Medical History information was reported.On 15-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose given to Paitent). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose given to Paitent) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported.It was reported that the patient was not comfortable to get re-vaccinated.No treatment medication was reported.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Arm was very painful) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 039K20A) for COVID-19 vaccination. No Medical History information was reported.On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm was very painful). At the time of the report, PAIN IN EXTREMITY (Arm was very painful) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant mediation were reported. No treatment drug were reported.This case was linked to MOD-2021-388352, MOD-2021-388405 (Patient Link).
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pain, Vaccination site pain
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Pain), VACCINATION SITE PAIN (his left arm was painful), ARTHRALGIA (wrist was so painful) and HEADACHE (headache that felt like he was hit on the head) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 039K20A and 026L20A) for COVID-19 vaccination. No Medical History information was reported. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, the patient experienced PAIN (Pain), VACCINATION SITE PAIN (his left arm was painful), ARTHRALGIA (wrist was so painful) and HEADACHE (headache that felt like he was hit on the head). At the time of the report, PAIN (Pain), VACCINATION SITE PAIN (his left arm was painful), ARTHRALGIA (wrist was so painful) and HEADACHE (headache that felt like he was hit on the head) outcome was unknown.For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medication was reported.No treatment medication was reported.This case was linked to MOD-2021-388396, MOD-2021-388352 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1st dose administered to patient out of a vial which was punctured for ~21 hours) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination. No Medical History information was reported. On 08-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (1st dose administered to patient out of a vial which was punctured for ~21 hours). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (1st dose administered to patient out of a vial which was punctured for ~21 hours) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.Concomitant medication details were not provided.Treatment details were not provided. Consumer did not report any adverse events or reactions to the vaccine.Most recent FOLLOW-UP information incorporated above includes:On 16-Nov-2021: Follow up received included non significant information.
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Given the  booster at a double dose (0.5); This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Given the  booster at a double dose (0.5)) 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 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 04-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (Given the  booster at a double dose (0.5)). On 04-Nov-2021, ACCIDENTAL OVERDOSE (Given the  booster at a double dose (0.5)) had resolved.      No concomitant medications were reported.  No treatment information was provided.
Age: 56.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Chills, Fatigue, Feeling cold, Nausea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (feeling cold/she is really cold), FATIGUE (feeling really tired), CHILLS (she is shivering) and NAUSEA (feeling nausea, requested for a bucket because was felling like throw up) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 027B21A and 031A21A) for COVID-19 vaccination.Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.No Medical History information was reported.On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 15-Nov-2021, the patient started INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) at an unspecified dose. In November 2021, the patient experienced FEELING COLD (feeling cold/she is really cold), FATIGUE (feeling really tired), CHILLS (she is shivering) and NAUSEA (feeling nausea, requested for a bucket because was felling like throw up). At the time of the report, FEELING COLD (feeling cold/she is really cold), FATIGUE (feeling really tired), CHILLS (she is shivering) and NAUSEA (feeling nausea, requested for a bucket because was felling like throw up) had not resolved.Concomitant drugs were not reported. Treatment medications were not provided.It was reported that patient received Flu shot with booster dose at same time.This case was linked to MOD-2021-388600 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Headache, Influenza like illness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms Hot and Cold), FEELING OF BODY TEMPERATURE CHANGE (Hot and Cold) and HEADACHE (Headache) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms Hot and Cold), FEELING OF BODY TEMPERATURE CHANGE (Hot and Cold) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) in November 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms Hot and Cold) and FEELING OF BODY TEMPERATURE CHANGE (Hot and Cold) had resolved and HEADACHE (Headache) had not resolved.No concomitant medications were reported.The patient was doing better. She still have headache other then she was doing ok. Patient did not had any problems with the first two shots.Most recent FOLLOW-UP information incorporated above includes:On 17-Nov-2021: Follow-up was received on 17-NOV-2021 and Added new event  headache. Added event details in narrative.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose date 01Mar2021 2nd dose date 08Apr2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose date 01Mar2021 2nd dose date 08Apr2021) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 031A21A) for COVID-19 vaccination. No Medical History information was reported.On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose date 01Mar2021 2nd dose date 08Apr2021). On 08-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose date 01Mar2021 2nd dose date 08Apr2021) had resolved. No concomitant medications were reported.No treatment medications were reported.This case was linked to MOD-2021-388541 (Patient Link).
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Ear inflammation, Vertigo
Clinical narrative: Vertigo requiring prednisone  then  ear drops. Had to not work / do anything for 2 weeks then work remotely did 2 more weeks
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Dyspnoea, Fatigue, Malaise
Clinical narrative: (I received both Pfizer vaccines, but there was only room to report one. I received the first vaccine on 5/12/21 and felt sick for a few days. The details here will be about what happened after the second dose which I received on 6/2/21). The evening after getting the second dose of the Pfizer Covid 19 vaccine, I began to feel body aches and had a low fever. That persisted on and off for four days. The fatigue from that didn't seem to get better. As time went over over the next few weeks. I was sleeping a lot, with extreme muscle weakness. I normally exercise frequently and am a healthy adult, but it was extremely difficult to catch my breath when running, and I had trouble breathing when I was singing ( I could only sing a couple words before having to gasp for breath again). I made an appointment with my doc and she ordered blood tests. Before I could get those results, my health had declined to the point where I was taking several naps throughout the day, my muscles felt extremely weak, and joint pain (which I had never had before) was getting extreme. It was so bad I could barely walk in the morning, and my normal tennis days were impossible. I also had a bizarre stabbing pain in the top of my right foot. I began to wonder if I would be able to go back to work in the Fall (I'm a teacher). This was crazy! I'm a healthy adult woman with no health problems! I thought my life was over as I knew it. The results from my blood tests showed that I had possible lupus. I had full blood work done as part of a physical just before my vaccines and everything was normal. Out of desperation, I began a severe elimination diet to try to cut down on inflammation. (I've been a distance runner most of my adult life and was super scared my joints were getting damaged). Within a day of starting that diet (basically eating just meat), my joint pain went away. Later that month, one of the three lupus markers my doctor had tested for came back normal (the other two were still positive for possible lupus). The fatigue continued and is still present. I must take a nap daily, and leave work feeling like I can barely stay awake. I am still eating my super strict diet and as soon as I stray from it a little bit, the joint pain returns with a vengeance. I don't know how I'm going to return to a normal life. I have a rheumatolist appointment scheduled for January.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pain, Pain in extremity, Pyrexia
Clinical narrative: (I received both Pfizer vaccines, but there was only room to report one. I received the first vaccine on 5/12/21 and felt sick for a few days. The details here will be about what happened after the second dose which I received on 6/2/21). The evening after getting the second dose of the Pfizer Covid 19 vaccine, I began to feel body aches and had a low fever. That persisted on and off for four days. The fatigue from that didn't seem to get better. As time went over over the next few weeks. I was sleeping a lot, with extreme muscle weakness. I normally exercise frequently and am a healthy adult, but it was extremely difficult to catch my breath when running, and I had trouble breathing when I was singing ( I could only sing a couple words before having to gasp for breath again). I made an appointment with my doc and she ordered blood tests. Before I could get those results, my health had declined to the point where I was taking several naps throughout the day, my muscles felt extremely weak, and joint pain (which I had never had before) was getting extreme. It was so bad I could barely walk in the morning, and my normal tennis days were impossible. I also had a bizarre stabbing pain in the top of my right foot. I began to wonder if I would be able to go back to work in the Fall (I'm a teacher). This was crazy! I'm a healthy adult woman with no health problems! I thought my life was over as I knew it. The results from my blood tests showed that I had possible lupus. I had full blood work done as part of a physical just before my vaccines and everything was normal. Out of desperation, I began a severe elimination diet to try to cut down on inflammation. (I've been a distance runner most of my adult life and was super scared my joints were getting damaged). Within a day of starting that diet (basically eating just meat), my joint pain went away. Later that month, one of the three lupus markers my doctor had tested for came back normal (the other two were still positive for possible lupus). The fatigue continued and is still present. I must take a nap daily, and leave work feeling like I can barely stay awake. I am still eating my super strict diet and as soon as I stray from it a little bit, the joint pain returns with a vengeance. I don't know how I'm going to return to a normal life. I have a rheumatolist appointment scheduled for January.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis
Clinical narrative: Systemic: Flushed / Sweating-Mild, Additional Details: Patient experienced mild facial flushing within 10 minutes of vaccination of booster dose.  Temperature, HR and Pulse Ox unremarkable.  Denies all other symptoms other than flushed, warm cheeks and neck.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heavy menstrual bleeding, Skin lesion
Clinical narrative: Skin lesions to legs, heavy menstrual bleeding, fatigue
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Herpes zoster, Injection site erythema, Lymphadenopathy, Pain
Clinical narrative: Site: Redness at Injection Site-Mild, Additional Details: Patient recieved pfizer covid vaccine on thursday 11/18/2021, pt stated experiencing painful rash around armpit area and swelling of armpit lymphnodes. Pt was in an excruciating pain by sunday 11/21, and seeked medical care, saw dermatolist and got diagnosed with shingles on tuesday 11/23, pt is indicating that this is relating to the vaccine.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Site: Redness at Injection Site-Mild, Additional Details: Patient recieved pfizer covid vaccine on thursday 11/18/2021, pt stated experiencing painful rash around armpit area and swelling of armpit lymphnodes. Pt was in an excruciating pain by sunday 11/21, and seeked medical care, saw dermatolist and got diagnosed with shingles on tuesday 11/23, pt is indicating that this is relating to the vaccine.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Bursitis, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: bursitis-Severe, Additional Details: Diagnosed with bursitis on 11/16/2021, 6 days after vaccination
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, Chest discomfort, Fatigue, Headache
Clinical narrative: 2 hours after shot, joint pain increased 10 fold. I became exhausted, headache temp of 101. Started to get tight in chest. Felt the same as when I started with COVID in Oct of 2020
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Hyperventilation, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting/Unresponsive-Medium, Systemic: Flushed/Sweating-Medium, Systemic: Hyperventilation-Medium.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) 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 EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine) had resolved.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medications were reported. Treatment information was not provided.Expiry date of the vaccine is on 11-Oct-2021. As of 15-Nov-2021, at least 30 patients were administered by this expired vaccine. It was reported that the no Adverse events occurred after administration of any of the vaccines that were reported as being expired.Most recent FOLLOW-UP information incorporated above includes:On 17-Nov-2021: Follow up received. Updated Batch/lot number and expiration date of Suspect and updated Action taken, De challenge as Not Applicable, Updated event outcome as Recovered/ Resolved. Updated company causality as Not Applicable from Initial version.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Feeling hot, Malaise, Mobility decreased
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FEELING HOT (Arm became hot), ERYTHEMA (red, like a big red blob), PERIPHERAL SWELLING (swollen like a big blob) and MALAISE (did not feel 100%) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 028A21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.No Medical History information was reported. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Nov-2021, the patient experienced PAIN IN EXTREMITY (sore arm), FEELING HOT (Arm became hot), PERIPHERAL SWELLING (swollen like a big blob) and MALAISE (did not feel 100%). 13-Nov-2021, the patient experienced ERYTHEMA (red, like a big red blob). On 14-Nov-2021, the patient experienced MOBILITY DECREASED (tough time playing music, hurt moving my left arm). 14-Nov-2021, the patient experienced FATIGUE (so wiped out). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency and IBUPROFEN ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), FEELING HOT (Arm became hot), ERYTHEMA (red, like a big red blob), PERIPHERAL SWELLING (swollen like a big blob), MALAISE (did not feel 100%), MOBILITY DECREASED (tough time playing music, hurt moving my left arm) and FATIGUE (so wiped out) was resolving. No concomitant medications were reported.This case was linked to MOD-2021-388704, MOD-2021-388689 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FEELING HOT (Arm became hot), ERYTHEMA (red, like a big red blob), PERIPHERAL SWELLING (swollen like a big blob) and MALAISE (did not feel 100%) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 028A21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.No Medical History information was reported. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Nov-2021, the patient experienced PAIN IN EXTREMITY (sore arm), FEELING HOT (Arm became hot), PERIPHERAL SWELLING (swollen like a big blob) and MALAISE (did not feel 100%). 13-Nov-2021, the patient experienced ERYTHEMA (red, like a big red blob). On 14-Nov-2021, the patient experienced MOBILITY DECREASED (tough time playing music, hurt moving my left arm). 14-Nov-2021, the patient experienced FATIGUE (so wiped out). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency and IBUPROFEN ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), FEELING HOT (Arm became hot), ERYTHEMA (red, like a big red blob), PERIPHERAL SWELLING (swollen like a big blob), MALAISE (did not feel 100%), MOBILITY DECREASED (tough time playing music, hurt moving my left arm) and FATIGUE (so wiped out) was resolving. No concomitant medications were reported.This case was linked to MOD-2021-388704, MOD-2021-388689 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL OVERDOSE (Patient received her booster dose as 0.5ml instead of 0.25ml) in a 48-year-old female patient 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Patient received her booster dose as 0.5ml instead of 0.25ml). At the time of the report, ACCIDENTAL OVERDOSE (Patient received her booster dose as 0.5ml instead of 0.25ml) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.Concomitant product information was not provided.Treatment information was not provided.Most recent FOLLOW-UP information incorporated above includes:On 18-Nov-2021: Follow up received and contains No New Information.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Influenza like illness
Clinical narrative: Flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Hypertension since 02-Nov-2021 and Endometrial cancer (Patient using Lenvima for endometrial cancer and also reported having diarrhea symptoms since starting lenvima.).Concomitant products included LISINOPRIL from 02-Nov-2021 to an unknown date for Blood pressure management, PEMBROLIZUMAB (KEYTRUDA) and LENVATINIB MESILATE (LENVIMA) from 26-Oct-2021 to an unknown date for Endometrial cancer.On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms) had not resolved. Not Provided .DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On 02-Nov-2021, Blood pressure measurement: 177/94 (High) to a high of 177/94.On 06-Nov-2021, Blood pressure measurement: diasolic 80 and apposed to 90 (High) but diastolic has been in the 80's as apposed to the 90's lately.No treatment medication was provided. Patient also reported that diarrhea symptoms have been less severe lately.This case was linked to MOD-2021-388720 (Patient Link).
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Localised infection
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of LOCALISED INFECTION (Infection in a finger) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOCALISED INFECTION (Infection in a finger). At the time of the report, LOCALISED INFECTION (Infection in a finger) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient wanted to know if the patient could get Moderna booster dose or not, if the patient was taking antibiotics. The patient had an infection in a finger. Treatment medication included antibiotics.No Concomitant drug details was reported.This case concerns a 74-year-old patient of an unknown gender with no relevant medical history, who experienced the unexpected event of Localized Infection. The event occurred on an unknown date after receiving an unknown dose of mRNA-1273 Vaccine. The rechallenge was not applicable since no information about the dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Sender's Comments: This case concerns a 74-year-old patient of an unknown gender with no relevant medical history, who experienced the unexpected event of Localized Infection. The event occurred on an unknown date after receiving an unknown dose of mRNA-1273 Vaccine. The rechallenge was not applicable since no information about the dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given more than 12 hours after first pulled) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination. No Medical History information was reported.On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given more than 12 hours after first pulled). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Given more than 12 hours after first pulled) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.No Concomitant medication was reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: felt like she was going to die; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like she was going to die) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt like she was going to die). At the time of the report, FEELING ABNORMAL (felt like she was going to die) outcome was unknown.            No concomitant medications were reported  No treatment medications were reported
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Pain in extremity
Clinical narrative: Sore Arm; Moderna covid-19 vaccine were administered on 15NOV2021 after bein initially punctured on 12NOV2021 at 8:53 AM; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) and EXPIRED PRODUCT ADMINISTERED (Moderna covid-19 vaccine were administered on 15NOV2021 after bein initially punctured on 12NOV2021 at 8:53 AM) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 011M20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna covid-19 vaccine were administered on 15NOV2021 after bein initially punctured on 12NOV2021 at 8:53 AM). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore Arm). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Moderna covid-19 vaccine were administered on 15NOV2021 after bein initially punctured on 12NOV2021 at 8:53 AM) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore Arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported. No treatment medication were reported.  This case concerns a 80 year old male with no reported medical history , who experienced non-serious event of  Expired product Administered after vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) . The patient also reported  Non-serious , unexpected  event of pain in extremity which occurred on an unknown date with an unknown dose number of the vaccine. The re-challenge for this case is not applicable. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 80 year old male with no reported medical history , who experienced non-serious event of  Expired product Administered after vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) . The patient also reported  Non-serious , unexpected  event of pain in extremity which occurred on an unknown date with an unknown dose number of the vaccine. The re-challenge for this case is not applicable. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna covid-19 vaccine were administered on 15NOV2021 after bein initially punctured on 12NOV2021 at 8:53 AM) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 029L20A and 011M20A) for COVID-19 vaccination. No Medical History information was reported.On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna covid-19 vaccine were administered on 15NOV2021 after bein initially punctured on 12NOV2021 at 8:53 AM). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Moderna covid-19 vaccine were administered on 15NOV2021 after bein initially punctured on 12NOV2021 at 8:53 AM) 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 reported.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Got vaccinated with Moderna booster at age of 5 years) in a 5-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication. On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Got vaccinated with Moderna booster at age of 5 years). On 15-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Got vaccinated with Moderna booster at age of 5 years) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.Patient was supposed to get Pfizer booster but the pharmacist gave Moderna booster on 15-Nov-2021 by accident. Reporter already informed their HCP and no reported side effects as of the call. No treatment medications were provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (soreness) and FATIGUE (feeling tired) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination. No Medical History information was reported.On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (soreness) and FATIGUE (feeling tired). At the time of the report, MYALGIA (soreness) and FATIGUE (feeling tired) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.Company Comment-This case concerns a 61-year-old female patient with no relevant medical history, who experienced the unexpected event of Pain and expected event of Fatigue. The events occurred on an unknown date after receiving the first dose of mRNA-1273 Vaccine. The rechallenge was unknown since the mentioned events also happened on the second dose but the outcome was unknown. The event Fatigue is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.The patient was not using any concomitant medication.The patient did not use any treatment medications of the events.This case was linked to MOD-2021-389098, MOD-2021-389050 (Patient Link). Sender's Comments: This case concerns a 61-year-old female patient with no relevant medical history, who experienced the unexpected event of Pain and expected event of Fatigue. The events occurred on an unknown date after receiving the first dose of mRNA-1273 Vaccine. The rechallenge was unknown since the mentioned events also happened on the second dose but the outcome was unknown. The event Fatigue is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Having lots of problems since getting these shot) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (Codeine) and Drug allergy (Demerol).On 27-Aug-2021 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION COMPLICATION (Having lots of problems since getting these shot). At the time of the report, VACCINATION COMPLICATION (Having lots of problems since getting these shot) had not resolved. Not Provided. 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. No concomitant medications were reported. Treatment information was not provided.This case was linked to MOD-2021-369133 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Hypokinesia, Pain, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in his arm like with the previous shots or with any shots that you get in the arm), PAIN (This pain became progressively worse) and HYPOKINESIA (I can barely move my arm 1/4 the way I normally can) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A, EN6198 and EL9266) for COVID-19 vaccination. No Medical History information was reported.On 22-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) (Intramuscular) dosage was changed to 1 dosage form.On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, the patient experienced PAIN IN EXTREMITY (Pain in his arm like with the previous shots or with any shots that you get in the arm) and PAIN (This pain became progressively worse). In November 2021, the patient experienced HYPOKINESIA (I can barely move my arm 1/4 the way I normally can). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at an unspecified dose and frequency and IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in his arm like with the previous shots or with any shots that you get in the arm), PAIN (This pain became progressively worse) and HYPOKINESIA (I can barely move my arm 1/4 the way I normally can) had not resolved. No Concomitant medication were reported.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness) 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 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 FATIGUE (Tiredness). At the time of the report, FATIGUE (Tiredness) outcome was unknown. No concomitant medications were reported.No treatment medications were reported.