chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fear, Hypoaesthesia, Intervertebral disc protrusion, Magnetic resonance imaging head normal, Magnetic resonance imaging spinal abnormal
Clinical narrative: I woke up in the middle of the night 23 days after my second dose of the Pfizer covid vaccine with intense chest pain like I have never felt before. Nothing I did would lessen it (moving, ice, drinking water, etc). Eventually, I went back to sleep until I went to urgent care the next day where they said costochondritis and prescribed rest and ibuprofen. This did not help at all and the pain was consistently there for the next week. Then the tingles started. I first felt it in the back of my arms, then my legs, soon my face, and then all over my chest. My thumbs went numb intermittently. These symptoms appeared seemingly at random throughout my day for weeks at varying levels of intensity. They could come suddenly and then persist from anywhere from 20 minutes to hours. Then they would fade and a different part of my body begin to tingle. All while having a now dull chest pain constantly. Several times I would wake up in the middle of the night tingling all over and would not be able to go back to sleep - it was terrifying to feel like your body is attacking itself. Over the course of several months, I had extensive blood work done, an EKG heart stress test, and an MRI of my brain and spine along with numerous phone and in-person appointments with multiple general practitioners, specialists, physical therapists, and a psychologist.  ALL of them said everything looked fine and on paper, I am perfectly healthy with no explanation for my symptoms. Eventually, after months, the symptoms began to fade. The tingling left first and then the chest pain - although I do occasionally still feel it but much less intense. It is like waves come and go with each wave lasting less time and being less intense. I can only hope that eventually it will go away and I will not feel like this anymore. I have no underlying health conditions and am a healthy 34-year-old woman at a healthy weight.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Paraesthesia, Sleep disorder, Spinal X-ray normal
Clinical narrative: I woke up in the middle of the night 23 days after my second dose of the Pfizer covid vaccine with intense chest pain like I have never felt before. Nothing I did would lessen it (moving, ice, drinking water, etc). Eventually, I went back to sleep until I went to urgent care the next day where they said costochondritis and prescribed rest and ibuprofen. This did not help at all and the pain was consistently there for the next week. Then the tingles started. I first felt it in the back of my arms, then my legs, soon my face, and then all over my chest. My thumbs went numb intermittently. These symptoms appeared seemingly at random throughout my day for weeks at varying levels of intensity. They could come suddenly and then persist from anywhere from 20 minutes to hours. Then they would fade and a different part of my body begin to tingle. All while having a now dull chest pain constantly. Several times I would wake up in the middle of the night tingling all over and would not be able to go back to sleep - it was terrifying to feel like your body is attacking itself. Over the course of several months, I had extensive blood work done, an EKG heart stress test, and an MRI of my brain and spine along with numerous phone and in-person appointments with multiple general practitioners, specialists, physical therapists, and a psychologist.  ALL of them said everything looked fine and on paper, I am perfectly healthy with no explanation for my symptoms. Eventually, after months, the symptoms began to fade. The tingling left first and then the chest pain - although I do occasionally still feel it but much less intense. It is like waves come and go with each wave lasting less time and being less intense. I can only hope that eventually it will go away and I will not feel like this anymore. I have no underlying health conditions and am a healthy 34-year-old woman at a healthy weight.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Immediate post-injection reaction
Clinical narrative: Felt light headed for 3 days immediately after vaccine.  Felt off balance.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Joint swelling
Clinical narrative: left wrist was swollen but got better; left wrist was swollen but got better/Right wrist is also swollen; Right knee is still swollen/Right knee was so messed up; Could not walk/Can barely walk; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Right knee is still swollen/Right knee was so messed up), GAIT DISTURBANCE (Could not walk/Can barely walk), JOINT SWELLING (left wrist was swollen but got better) and JOINT SWELLING (left wrist was swollen but got better/Right wrist is also swollen) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN for Diabetes.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2021, the patient experienced GAIT DISTURBANCE (Could not walk/Can barely walk). On an unknown date, the patient experienced JOINT SWELLING (Right knee is still swollen/Right knee was so messed up), JOINT SWELLING (left wrist was swollen but got better) and JOINT SWELLING (left wrist was swollen but got better/Right wrist is also swollen). The patient was treated with MELOXICAM for Inflammation, at an unspecified dose and frequency and HYDROCODONE for Pain, at an unspecified dose and frequency. At the time of the report, JOINT SWELLING (Right knee is still swollen/Right knee was so messed up) had not resolved, GAIT DISTURBANCE (Could not walk/Can barely walk) and JOINT SWELLING (left wrist was swollen but got better/Right wrist is also swollen) outcome was unknown and JOINT SWELLING (left wrist was swollen but got better) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was very active people. Patient consulted with several doctors and were prescribed medication for the inflammation and pain, that helped a little.   This case was linked to MOD-2021-367126 (Patient Link).
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Blood test, Cough, Dyspnoea
Clinical narrative: Soreness at injection site, fatigue, headache day for about a week long. Friday 10/22 I went to the ER because I was having difficulty breathing and felt some stomach tightness/ pain close to my left chest area. I recovered the next day. Saturday 10/30 I experienced covid like symptoms such as coughing, sneezing, runny and stuffy nose along with headache and body aches. Majority of those symptoms lasted until Thursday 11/4. On 11/ 4 I went to the doctor and took a covid-19 test and flu test. Both came out negative, however my WBC count was still high so the doctor took some blood work to further investigate. Today , I feel better but still experiencing sore throat cough and nasal drainage which cause me to have to blow my nose sometimes. I?d like to add that because of my allergies blowing my nose often isn?t uncommon. However, the sore throat and coughing is.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza virus test negative, Injection site pain, Malaise
Clinical narrative: Soreness at injection site, fatigue, headache day for about a week long. Friday 10/22 I went to the ER because I was having difficulty breathing and felt some stomach tightness/ pain close to my left chest area. I recovered the next day. Saturday 10/30 I experienced covid like symptoms such as coughing, sneezing, runny and stuffy nose along with headache and body aches. Majority of those symptoms lasted until Thursday 11/4. On 11/ 4 I went to the doctor and took a covid-19 test and flu test. Both came out negative, however my WBC count was still high so the doctor took some blood work to further investigate. Today , I feel better but still experiencing sore throat cough and nasal drainage which cause me to have to blow my nose sometimes. I?d like to add that because of my allergies blowing my nose often isn?t uncommon. However, the sore throat and coughing is.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal pain, Pain, Rhinorrhoea, SARS-CoV-2 test negative
Clinical narrative: Soreness at injection site, fatigue, headache day for about a week long. Friday 10/22 I went to the ER because I was having difficulty breathing and felt some stomach tightness/ pain close to my left chest area. I recovered the next day. Saturday 10/30 I experienced covid like symptoms such as coughing, sneezing, runny and stuffy nose along with headache and body aches. Majority of those symptoms lasted until Thursday 11/4. On 11/ 4 I went to the doctor and took a covid-19 test and flu test. Both came out negative, however my WBC count was still high so the doctor took some blood work to further investigate. Today , I feel better but still experiencing sore throat cough and nasal drainage which cause me to have to blow my nose sometimes. I?d like to add that because of my allergies blowing my nose often isn?t uncommon. However, the sore throat and coughing is.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing, White blood cell count increased
Clinical narrative: Soreness at injection site, fatigue, headache day for about a week long. Friday 10/22 I went to the ER because I was having difficulty breathing and felt some stomach tightness/ pain close to my left chest area. I recovered the next day. Saturday 10/30 I experienced covid like symptoms such as coughing, sneezing, runny and stuffy nose along with headache and body aches. Majority of those symptoms lasted until Thursday 11/4. On 11/ 4 I went to the doctor and took a covid-19 test and flu test. Both came out negative, however my WBC count was still high so the doctor took some blood work to further investigate. Today , I feel better but still experiencing sore throat cough and nasal drainage which cause me to have to blow my nose sometimes. I?d like to add that because of my allergies blowing my nose often isn?t uncommon. However, the sore throat and coughing is.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Aphasia, Cerebral venous thrombosis, Facial paralysis, Headache
Clinical narrative: Cerebral venous thrombosis presenting with persistent, severe, localised headache, aphasia and right peripheral facial paralysis. Symptoms resolved after treatment with LMWH at 100U/kg twice daily for 14 days, followed by oral anticoagulants for 30 days.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pain in extremity
Clinical narrative: Sore arm, muscle aches, chills
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: 13 year old male received 10 microgram dose appropriate for 5-11 year old. Patient and father was made aware. Patient was observed in the observation area. No adverse reaction note.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Watery poops
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Foetal death, Foetal disorder, Foetal heart rate abnormal, Muscle spasms
Clinical narrative: Adverse side affects started 4 days after vaccination. I started light bleeding that intensified each day. Cramping also accompanied the bleeding. I presented for an early pregnancy ultrasound on 11/5/21 to find a fetus that was at the appropriate gestational age, with no detectable heartbeat. This tells me baby was growing at least until the time of  Covid vaccine injection. Estimated delivery day was June 24,  2022. However, that is no longer as the vaccine most likely killed my growing baby.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound foetal abnormal, Vaginal haemorrhage
Clinical narrative: Adverse side affects started 4 days after vaccination. I started light bleeding that intensified each day. Cramping also accompanied the bleeding. I presented for an early pregnancy ultrasound on 11/5/21 to find a fetus that was at the appropriate gestational age, with no detectable heartbeat. This tells me baby was growing at least until the time of  Covid vaccine injection. Estimated delivery day was June 24,  2022. However, that is no longer as the vaccine most likely killed my growing baby.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Lichen planus, Rash
Clinical narrative: Lichen planus/ autoimmune skin disease; she started having 1 or 2 rashes/then started having this rash all over her body/Then it kept getting worse and worse; This spontaneous case was reported by a patient and describes the occurrence of LICHEN PLANUS (Lichen planus/ autoimmune skin disease) and RASH (she started having 1 or 2 rashes/then started having this rash all over her body/Then it kept getting worse and worse) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013B21A and 002B21A) for COVID-19 vaccination.     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 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (she started having 1 or 2 rashes/then started having this rash all over her body/Then it kept getting worse and worse). On an unknown date, the patient experienced LICHEN PLANUS (Lichen planus/ autoimmune skin disease). At the time of the report, LICHEN PLANUS (Lichen planus/ autoimmune skin disease) and RASH (she started having 1 or 2 rashes/then started having this rash all over her body/Then it kept getting worse and worse) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: abnormal (abnormal) She went to the dermatologist, did a biopsy, and the diagnose was lichen planus, like autoimmune skin disease.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. As treatment, patient received cream with steroids to apply. Patient reported that there is no treatment for the disease and she received something only to treat symptoms.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Fatigued; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigued) and HEADACHE (Headache) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A and 039D21A) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced FATIGUE (Fatigued) and HEADACHE (Headache). On 27-Oct-2021, FATIGUE (Fatigued) and HEADACHE (Headache) 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 medication use was reported.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: administered with the vaccine which has been stored in the refrigerator for 34 days; administered with the vaccine which has been stored in the refrigerator for 34 days; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (administered with the vaccine which has been stored in the refrigerator for 34 days) and EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for 34 days) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 27-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (administered with the vaccine which has been stored in the refrigerator for 34 days) and EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for 34 days). At the time of the report, PRODUCT STORAGE ERROR (administered with the vaccine which has been stored in the refrigerator for 34 days) and EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for 34 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  No concomitant medications reported. No treatment reported.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache in the back of his head; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache in the back of his head) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included LISINOPRIL for Blood pressure high.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced HEADACHE (Headache in the back of his head). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache in the back of his head) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-367111, MOD-2021-367114, MOD-2021-367396 (Patient Link).
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired booster dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired booster dose administered) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A, 029L20A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired booster dose administered). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired booster dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: An expired booster dose was given to a patient; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (An expired booster dose was given to a patient) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (An expired booster dose was given to a patient). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (An expired booster dose was given to a patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: full dose of Moderna booster [not immunocompromised]; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (full dose of Moderna booster [not immunocompromised]) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 627L20A and 031120A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (full dose of Moderna booster [not immunocompromised]). On 22-Oct-2021, ACCIDENTAL OVERDOSE (full dose of Moderna booster [not immunocompromised]) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was mentioned. No treatment medication was mentioned.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: An expired booster dose was given to a patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (An expired booster dose was given to a patient) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (An expired booster dose was given to a patient). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (An expired booster dose was given to a patient) 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.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: mild headache in back of my head; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (mild headache in back of my head) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02AL20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LISINOPRIL for Hypertension.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced HEADACHE (mild headache in back of my head). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, HEADACHE (mild headache in back of my head) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-367092, MOD-2021-367114 (Patient Link).
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091F21A, 013L20A and 02AL20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Blood pressure. Concomitant products included LISINOPRIL for Blood pressure.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. On 27-Oct-2021, HEADACHE (Headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Expiration dates for all 3 doses are unknown.   This case was linked to MOD-2021-367092, MOD-2021-367111, MOD-2021-367396 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: An expired booster dose was given to a patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (An expired booster dose was given to a patient) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (An expired booster dose was given to a patient). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (An expired booster dose was given to a patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications was reported.  No treatment information was reported.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A, 025L20A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: She had a itchy rash around the injection site; She had a itchy rash around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (She had a itchy rash around the injection site) and VACCINATION SITE PRURITUS (She had a itchy rash around the injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Contrast media allergy (Injectable MRI dye).    On 26-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 VACCINATION SITE RASH (She had a itchy rash around the injection site) and VACCINATION SITE PRURITUS (She had a itchy rash around the injection site). At the time of the report, VACCINATION SITE RASH (She had a itchy rash around the injection site) and VACCINATION SITE PRURITUS (She had a itchy rash around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-367456 (Patient Link).   Reporter did not allow further contact
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Mouth haemorrhage
Clinical narrative: have bleeding in her mouth.; didn't feel good at all that day , and they fought with the pharmacist.; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH HAEMORRHAGE (have bleeding in her mouth.) and FEELING ABNORMAL (didn't feel good at all that day , and they fought with the pharmacist.) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046c21a and 004f21a) for COVID-19 vaccination.   No medical history was provided by the reporter.   On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Sep-2021, the patient experienced FEELING ABNORMAL (didn't feel good at all that day , and they fought with the pharmacist.). On 18-Oct-2021, the patient experienced MOUTH HAEMORRHAGE (have bleeding in her mouth.). At the time of the report, MOUTH HAEMORRHAGE (have bleeding in her mouth.) and FEELING ABNORMAL (didn't feel good at all that day , and they fought with the pharmacist.) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Zyrtec were reported as concomitant no treatment medications was provided patient need a specialist to draw blood for them. patient felt sick. patient received 2nd dose on 21st sep 2021   This case was linked to MOD-2021-367181 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: An expired 2nd dose was given to a patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (An expired 2nd dose was given to a patient) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (An expired 2nd dose was given to a patient). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (An expired 2nd dose was given to a patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was mentioned. No treatment medication was mentioned.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Illness, Nausea, Pyrexia
Clinical narrative: very sick after second dose; headache after second dose; fever 100°F after second dose; nausea after second dose; threw up after second dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very sick after second dose), HEADACHE (headache after second dose), PYREXIA (fever 100°F after second dose), NAUSEA (nausea after second dose) and VOMITING (threw up after second dose) 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 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-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 ILLNESS (very sick after second dose), HEADACHE (headache after second dose), PYREXIA (fever 100°F after second dose), NAUSEA (nausea after second dose) and VOMITING (threw up after second dose). At the time of the report, ILLNESS (very sick after second dose), HEADACHE (headache after second dose), PYREXIA (fever 100°F after second dose), NAUSEA (nausea after second dose) and VOMITING (threw up after second dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 degree f (High) 100 degree F.         No concomitant medications were reported No treatment medications were reported.   This case was linked to MOD-2021-367283 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: very sick after second dose; headache after second dose; fever 100°F after second dose; nausea after second dose; threw up after second dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very sick after second dose), HEADACHE (headache after second dose), PYREXIA (fever 100°F after second dose), NAUSEA (nausea after second dose) and VOMITING (threw up after second dose) 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 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-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 ILLNESS (very sick after second dose), HEADACHE (headache after second dose), PYREXIA (fever 100°F after second dose), NAUSEA (nausea after second dose) and VOMITING (threw up after second dose). At the time of the report, ILLNESS (very sick after second dose), HEADACHE (headache after second dose), PYREXIA (fever 100°F after second dose), NAUSEA (nausea after second dose) and VOMITING (threw up after second dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 degree f (High) 100 degree F.         No concomitant medications were reported No treatment medications were reported.   This case was linked to MOD-2021-367283 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site discolouration
Clinical narrative: Area was a little bit pink in the subcutaneous zone; Shot had been subcutaneous, at an inch or 2 below the axillary line; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE DISCOLOURATION (Area was a little bit pink in the subcutaneous zone) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Shot had been subcutaneous, at an inch or 2 below the axillary line) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 23-Oct-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Area was a little bit pink in the subcutaneous zone) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Shot had been subcutaneous, at an inch or 2 below the axillary line). On 23-Oct-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Shot had been subcutaneous, at an inch or 2 below the axillary line) had resolved. At the time of the report, VACCINATION SITE DISCOLOURATION (Area was a little bit pink in the subcutaneous zone) outcome was unknown.            Concomitant information was not provided. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: COVID arm after getting booster vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Oct-2021 and was forwarded to Moderna on 28-Oct-2021.    This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (COVID arm after getting booster vaccine) 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 VACCINATION COMPLICATION (COVID arm after getting booster vaccine). At the time of the report, VACCINATION COMPLICATION (COVID arm after getting booster vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. It was reported that she did not have antibody when tested after that she was going to get another anti-body test. No treatment medications were provided.   This case was linked to MOD-2021-341126 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Headache, Vaccination complication
Clinical narrative: She says this vaccine has knocked her down; She is weak; has no appetite; headache; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (She says this vaccine has knocked her down), ASTHENIA (She is weak), DECREASED APPETITE (has no appetite) and HEADACHE (headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F) for COVID-19 vaccination.     The patient's past medical history included Kidney absent.    On 23-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced VACCINATION COMPLICATION (She says this vaccine has knocked her down), ASTHENIA (She is weak), DECREASED APPETITE (has no appetite) and HEADACHE (headache). At the time of the report, VACCINATION COMPLICATION (She says this vaccine has knocked her down), ASTHENIA (She is weak), DECREASED APPETITE (has no appetite) and HEADACHE (headache) outcome was unknown.        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.   Her health history includes having only one kidney  Concomitant medication use was unknown  Treatment information was unknown
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Bone pain, Headache, Pain in extremity, Pyrexia
Clinical narrative: every bone in her body was aching after booster dose; arm aches after booster dose; ongoing headache after booster dose; temperature of 99.6°F after booster dose; leg aches after booster dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (leg aches after booster dose), BONE PAIN (every bone in her body was aching after booster dose), VACCINATION SITE PAIN (arm aches after booster dose), HEADACHE (ongoing headache after booster dose) and PYREXIA (temperature of 99.6°F after booster dose) 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 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced PAIN IN EXTREMITY (leg aches after booster dose), BONE PAIN (every bone in her body was aching after booster dose), VACCINATION SITE PAIN (arm aches after booster dose), HEADACHE (ongoing headache after booster dose) and PYREXIA (temperature of 99.6°F after booster dose). At the time of the report, PAIN IN EXTREMITY (leg aches after booster dose), BONE PAIN (every bone in her body was aching after booster dose) and VACCINATION SITE PAIN (arm aches after booster dose) outcome was unknown and HEADACHE (ongoing headache after booster dose) and PYREXIA (temperature of 99.6°F after booster dose) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.6 (High) 99.6 Degree F.         Concomitant product use was not provided by the reporter.  No treatment information was provided. Patient took  the booster dose; at 2-3am, the symptoms are started.   This case was linked to MOD-2021-367247 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: every bone in her body was aching after booster dose; arm aches after booster dose; ongoing headache after booster dose; temperature of 99.6°F after booster dose; leg aches after booster dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (leg aches after booster dose), BONE PAIN (every bone in her body was aching after booster dose), VACCINATION SITE PAIN (arm aches after booster dose), HEADACHE (ongoing headache after booster dose) and PYREXIA (temperature of 99.6°F after booster dose) 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 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced PAIN IN EXTREMITY (leg aches after booster dose), BONE PAIN (every bone in her body was aching after booster dose), VACCINATION SITE PAIN (arm aches after booster dose), HEADACHE (ongoing headache after booster dose) and PYREXIA (temperature of 99.6°F after booster dose). At the time of the report, PAIN IN EXTREMITY (leg aches after booster dose), BONE PAIN (every bone in her body was aching after booster dose) and VACCINATION SITE PAIN (arm aches after booster dose) outcome was unknown and HEADACHE (ongoing headache after booster dose) and PYREXIA (temperature of 99.6°F after booster dose) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.6 (High) 99.6 Degree F.         Concomitant product use was not provided by the reporter.  No treatment information was provided. Patient took  the booster dose; at 2-3am, the symptoms are started.   This case was linked to MOD-2021-367247 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Hyperhidrosis, Nervousness, Pyrexia
Clinical narrative: He was getting antsy and nervous, got worse and worse; Antsy; Fever went to 104 and some temps last night 27Oct2021; He started sweating and feels better today 28Oct2021; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (He was getting antsy and nervous, got worse and worse), FEELING ABNORMAL (Antsy), HYPERHIDROSIS (He started sweating and feels better today 28Oct2021) and PYREXIA (Fever went to 104 and some temps last night 27Oct2021) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 037A21B and 045A21A) for COVID-19 vaccination.     Concomitant products included IPRATROPIUM BROMIDE (ATROVENT), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and MELOXICAM for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced HYPERHIDROSIS (He started sweating and feels better today 28Oct2021). On 27-Oct-2021, the patient experienced PYREXIA (Fever went to 104 and some temps last night 27Oct2021). On an unknown date, the patient experienced NERVOUSNESS (He was getting antsy and nervous, got worse and worse) and FEELING ABNORMAL (Antsy). At the time of the report, NERVOUSNESS (He was getting antsy and nervous, got worse and worse), FEELING ABNORMAL (Antsy) and PYREXIA (Fever went to 104 and some temps last night 27Oct2021) outcome was unknown and HYPERHIDROSIS (He started sweating and feels better today 28Oct2021) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Pyrexia: 104 (High) fever went to 104.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details was not reported by the reporter.  Patient Reported that he took  inhalers and a nebulizer four times a day.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with an expired vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A.) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine) 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 provided.  Consent for follow up obtained. Preferred method of contact: email.   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow-up received on 28-oct-2021 contains no new information.