chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired ACTHIB was administered to a patient with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Medical Information (MI) (Reference number- 00818652) and transmitted to Sanofi on 19-Oct-2021.  This case involves a six-month-old female patient who vaccinated with third 0.5 mL (once) dose of expired HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ404AAB and expiry date 04-Oct-2021) via intramuscular route in the left thigh on 18-Oct-2021 for prophylactic vaccination (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) and PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL 13 VALENT VACCINE) for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: No symptoms, passed away 31 hours after vaccine
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams, Screaming
Clinical narrative: Intense vivid dream resulting in thrashing around, yelling, screaming. Intensity of dream not typical. Woke up entire household
Age: 44.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chills, Muscle spasms, Muscle twitching
Clinical narrative: Had uncontrollable muscle spasms and shivering (not fever related). After 2 hours, I took 2 benedryl tabs to force sleep. When I woke up. Muscle spasms were gone, but periodic twitching of various body parts remained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenitis, Pain, Pyrexia, Skin warm
Clinical narrative: Extremely large lymphadenitis in left axillary region and left supraclavicular area following fever, chills and body aches. Left accolade swelling the size of grapefruit with pain and tenderness. Left supraclavicular area tender to touch and warm also.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Tenderness
Clinical narrative: Extremely large lymphadenitis in left axillary region and left supraclavicular area following fever, chills and body aches. Left accolade swelling the size of grapefruit with pain and tenderness. Left supraclavicular area tender to touch and warm also.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes around armpit and breast on left side where shot was administered. Began 48 hours after vaccine
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Caesarean section, Exposure during pregnancy, Foetal heart rate abnormal, Stillbirth
Clinical narrative: Baby born stillborn to vaccinated mother. Was pregnant at start of 2nd trimester when vaccine was received. Pregnancy seemed to progress uncomplicated. Due date was 10/8/21. Baby was moving around a s had a heartbeat on 10/8/21. A scheduled C-section was set for 10/15/21. Upon arrival to hospital for scheduled C-section baby was found to have no heartbeat and was born stillborn. Nothing visibly wrong with baby girl (e.g. no cord wrapped around neck, no obvious trauma or deformities not viable to life, etc.).
Age: 9.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Flushing, Headache, Pallor, Somnolence
Clinical narrative: Dizzy, headache, pale, flush within 10-15 mins post-injection. Resolved, then felt sleepy.  Transferred to the hospital for eval. D/C'd home the following day in stable condition.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Erythema, Joint range of motion decreased, Peripheral swelling, Skin warm
Clinical narrative: SWOLLEN ARM, RED, HOT TO TOUCH, LIMITED RANGE OF MOTION
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Swelling face
Clinical narrative: Face swelled up (lips and cheeks), lasted 48 hours. Treated with OTC antihistamines
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Antinuclear antibody negative, Arthralgia, Back pain, Blood cortisol
Clinical narrative: Apr ?21: Joint pain May ?21: Chronic fatigue, brain fog/cognitive impairment, light sensitivity Jul ?21: Abdominal bloating Aug ?21: Tachycardia upon standing, dizziness, back pain, swollen glands, decreased appetite, lightheadedness, disorientation, headaches, sweating, excess thirst/dry mouth, leg & glute pain Sep ?21: Hand tremors, finger/hand/arm pain, itchy/flaky ears & skin
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blood folate normal, Blood immunoglobulin G, Blood immunoglobulin M, Blood iron normal, Blood lactate dehydrogenase increased
Clinical narrative: Apr ?21: Joint pain May ?21: Chronic fatigue, brain fog/cognitive impairment, light sensitivity Jul ?21: Abdominal bloating Aug ?21: Tachycardia upon standing, dizziness, back pain, swollen glands, decreased appetite, lightheadedness, disorientation, headaches, sweating, excess thirst/dry mouth, leg & glute pain Sep ?21: Hand tremors, finger/hand/arm pain, itchy/flaky ears & skin
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blood magnesium decreased, Blood test, Blood thyroid stimulating hormone, Cardiac monitoring, Catecholamines urine normal
Clinical narrative: Apr ?21: Joint pain May ?21: Chronic fatigue, brain fog/cognitive impairment, light sensitivity Jul ?21: Abdominal bloating Aug ?21: Tachycardia upon standing, dizziness, back pain, swollen glands, decreased appetite, lightheadedness, disorientation, headaches, sweating, excess thirst/dry mouth, leg & glute pain Sep ?21: Hand tremors, finger/hand/arm pain, itchy/flaky ears & skin
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Cognitive disorder, Computerised tomogram normal, Decreased appetite, Differential white blood cell count, Disorientation
Clinical narrative: Apr ?21: Joint pain May ?21: Chronic fatigue, brain fog/cognitive impairment, light sensitivity Jul ?21: Abdominal bloating Aug ?21: Tachycardia upon standing, dizziness, back pain, swollen glands, decreased appetite, lightheadedness, disorientation, headaches, sweating, excess thirst/dry mouth, leg & glute pain Sep ?21: Hand tremors, finger/hand/arm pain, itchy/flaky ears & skin
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dry mouth, Ear pruritus, Fatigue, Feeling abnormal
Clinical narrative: Apr ?21: Joint pain May ?21: Chronic fatigue, brain fog/cognitive impairment, light sensitivity Jul ?21: Abdominal bloating Aug ?21: Tachycardia upon standing, dizziness, back pain, swollen glands, decreased appetite, lightheadedness, disorientation, headaches, sweating, excess thirst/dry mouth, leg & glute pain Sep ?21: Hand tremors, finger/hand/arm pain, itchy/flaky ears & skin
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Headache, Helicobacter test, Iron binding capacity total normal, Laboratory test
Clinical narrative: Apr ?21: Joint pain May ?21: Chronic fatigue, brain fog/cognitive impairment, light sensitivity Jul ?21: Abdominal bloating Aug ?21: Tachycardia upon standing, dizziness, back pain, swollen glands, decreased appetite, lightheadedness, disorientation, headaches, sweating, excess thirst/dry mouth, leg & glute pain Sep ?21: Hand tremors, finger/hand/arm pain, itchy/flaky ears & skin
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lipids, Lymphadenopathy, Magnetic resonance imaging head, Magnetic resonance imaging neck, Metabolic function test
Clinical narrative: Apr ?21: Joint pain May ?21: Chronic fatigue, brain fog/cognitive impairment, light sensitivity Jul ?21: Abdominal bloating Aug ?21: Tachycardia upon standing, dizziness, back pain, swollen glands, decreased appetite, lightheadedness, disorientation, headaches, sweating, excess thirst/dry mouth, leg & glute pain Sep ?21: Hand tremors, finger/hand/arm pain, itchy/flaky ears & skin
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Metanephrine urine normal, Musculoskeletal pain, Pain in extremity, Photophobia, Platelet count decreased
Clinical narrative: Apr ?21: Joint pain May ?21: Chronic fatigue, brain fog/cognitive impairment, light sensitivity Jul ?21: Abdominal bloating Aug ?21: Tachycardia upon standing, dizziness, back pain, swollen glands, decreased appetite, lightheadedness, disorientation, headaches, sweating, excess thirst/dry mouth, leg & glute pain Sep ?21: Hand tremors, finger/hand/arm pain, itchy/flaky ears & skin
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rheumatoid factor, Serum ferritin normal, Skin exfoliation, Swelling
Clinical narrative: Apr ?21: Joint pain May ?21: Chronic fatigue, brain fog/cognitive impairment, light sensitivity Jul ?21: Abdominal bloating Aug ?21: Tachycardia upon standing, dizziness, back pain, swollen glands, decreased appetite, lightheadedness, disorientation, headaches, sweating, excess thirst/dry mouth, leg & glute pain Sep ?21: Hand tremors, finger/hand/arm pain, itchy/flaky ears & skin
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Thirst, Thyroxine normal, Tremor, Ultrasound abdomen normal
Clinical narrative: Apr ?21: Joint pain May ?21: Chronic fatigue, brain fog/cognitive impairment, light sensitivity Jul ?21: Abdominal bloating Aug ?21: Tachycardia upon standing, dizziness, back pain, swollen glands, decreased appetite, lightheadedness, disorientation, headaches, sweating, excess thirst/dry mouth, leg & glute pain Sep ?21: Hand tremors, finger/hand/arm pain, itchy/flaky ears & skin
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan vagina, Urine analysis, Vitamin B12 normal, Vitamin D
Clinical narrative: Apr ?21: Joint pain May ?21: Chronic fatigue, brain fog/cognitive impairment, light sensitivity Jul ?21: Abdominal bloating Aug ?21: Tachycardia upon standing, dizziness, back pain, swollen glands, decreased appetite, lightheadedness, disorientation, headaches, sweating, excess thirst/dry mouth, leg & glute pain Sep ?21: Hand tremors, finger/hand/arm pain, itchy/flaky ears & skin
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Cholecystitis, Chromaturia, Nausea
Clinical narrative: nausea, RUQ pain, orange urine. Resolved spontaneously after two days. No hx of RUQ pain, cholecystitis previously or since.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Electroencephalogram, No adverse event
Clinical narrative: None stated.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Diarrhoea, Fluid retention, Nausea
Clinical narrative: severe fever, chills, body aches, nausea, vomiting, diarrhea, lack of appetite - lasted for 10 days  Lack of appetite, nausea, body aches for over 1 month  congestion and fluid in chest - from 6/11/21 - to present
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Respiratory tract congestion, Vomiting
Clinical narrative: severe fever, chills, body aches, nausea, vomiting, diarrhea, lack of appetite - lasted for 10 days  Lack of appetite, nausea, body aches for over 1 month  congestion and fluid in chest - from 6/11/21 - to present
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Fatigue, Headache, Heart rate increased
Clinical narrative: Chills and fever, fast heartbeat, headache, body aches, syncope, projectile vomiting, nausea, intense stomach ache, tiredness.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Syncope, Vomiting projectile
Clinical narrative: Chills and fever, fast heartbeat, headache, body aches, syncope, projectile vomiting, nausea, intense stomach ache, tiredness.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, Fatigue, Headache, Myalgia, Rhinorrhoea
Clinical narrative: 1st dose no side effects 2nd dose side effects consist of  muscle pain, temperature, fatigue and fever over 2 days 3rd dose side effects consist of extreme muscle pain, temperature, fatigue, headache, sleep apena, runny nose still existing over 4 days now.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Sleep apnoea syndrome
Clinical narrative: 1st dose no side effects 2nd dose side effects consist of  muscle pain, temperature, fatigue and fever over 2 days 3rd dose side effects consist of extreme muscle pain, temperature, fatigue, headache, sleep apena, runny nose still existing over 4 days now.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: I have a headache, severe pain in my left arm, nausea (starting about 1:30 pm), extreme tiredness and fatigue (starting at 12:30 pm) that has continued the whole day.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: Randomly smell cigarette smoke since vaccination.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Inflammation, Pain in extremity, Peripheral swelling, Sciatica
Clinical narrative: Vaccine 1: warts/welts developed immediately following and continuing outer upper joint left  middle finger, after than same location on right middle finger, next left index finger outer upper joint , then mirrored on right joint. Now I have a little on on outer pinkie finger-right hand-not sore like the others. Left middle finger is still sore. hand ortho. X-rays  it and said it was spontaneous arthritis that happened dot occur after shot. 48 hours after second shot- middle of night- I felt back of legs feel inflamed and swollen. Difficulty walking for 2 days- then left leg cleared dup and rights leg ongoing for a while. It recurred  with the exact pattern two Sundays ago. u knee orthopedist says it is not his area. he is referring me to a rheumatologist. I wish there was a COVID clinic for complications. I would also like to consult with an immunologist. My sciatic nerve on right has been inflamed.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray abnormal
Clinical narrative: Vaccine 1: warts/welts developed immediately following and continuing outer upper joint left  middle finger, after than same location on right middle finger, next left index finger outer upper joint , then mirrored on right joint. Now I have a little on on outer pinkie finger-right hand-not sore like the others. Left middle finger is still sore. hand ortho. X-rays  it and said it was spontaneous arthritis that happened dot occur after shot. 48 hours after second shot- middle of night- I felt back of legs feel inflamed and swollen. Difficulty walking for 2 days- then left leg cleared dup and rights leg ongoing for a while. It recurred  with the exact pattern two Sundays ago. u knee orthopedist says it is not his area. he is referring me to a rheumatologist. I wish there was a COVID clinic for complications. I would also like to consult with an immunologist. My sciatic nerve on right has been inflamed.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: The Thumb and index finger and middle finger became numb within 60 seconds of getting first Vaccine injection, still persistent, constant numbness for almost 2 full months now.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Feeling abnormal, Incomplete course of vaccination, Inflammation, Influenza like illness
Clinical narrative: cellulits of arm; arm inflammed all the way up on scapula; received her first dose a year ago; sore arm; couldn't lift arm; felt horrible, awful; felt like the flu; fever; This case was reported by a nurse via call center representative and described the occurrence of cellulitis in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Moderna COVID (received dose on an unknown date).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced cellulitis (serious criteria GSK medically significant), pain in arm, injected limb mobility decreased, feels awful, influenza like illness, fever, inflammation localized and incomplete course of vaccination. On an unknown date, the outcome of the cellulitis, inflammation localized and incomplete course of vaccination were unknown and the outcome of the pain in arm, injected limb mobility decreased, feels awful, influenza like illness and fever were recovered/resolved.   It was unknown if the reporter considered the cellulitis, pain in arm, injected limb mobility decreased, feels awful, influenza like illness, fever and inflammation localized to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself, who was also the nurse. The age at vaccination was not reported. The patient received the first dose of Shingrix exactly about a year ago (unsure of date) on a Thursday and she had a terrifically sore arm, worse than the Moderna COVID shot. Her arm was sore that night (Thursday) after receiving the shot and lasted until that Monday. She couldn't lift her arm for 2 days. She thought she had cellulitis of arm.  The next morning after receiving the Shingrix shot (Friday), she felt horrible.  She felt like she had the flu and had a fever.  These symptoms lasted until that Sunday afternoon. Till the of reporting, the patient did not receive her second dose, which led to incomplete course of vaccination. The reporter consented to follow up. This case was liked with US2021215443 and US2021215524, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021215443:same reporter US-GLAXOSMITHKLINE-US2021215524:same reporter
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: cellulits of arm; arm inflammed all the way up on scapula; received her first dose a year ago; sore arm; couldn't lift arm; felt horrible, awful; felt like the flu; fever; This case was reported by a nurse via call center representative and described the occurrence of cellulitis in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Moderna COVID (received dose on an unknown date).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced cellulitis (serious criteria GSK medically significant), pain in arm, injected limb mobility decreased, feels awful, influenza like illness, fever, inflammation localized and incomplete course of vaccination. On an unknown date, the outcome of the cellulitis, inflammation localized and incomplete course of vaccination were unknown and the outcome of the pain in arm, injected limb mobility decreased, feels awful, influenza like illness and fever were recovered/resolved.   It was unknown if the reporter considered the cellulitis, pain in arm, injected limb mobility decreased, feels awful, influenza like illness, fever and inflammation localized to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself, who was also the nurse. The age at vaccination was not reported. The patient received the first dose of Shingrix exactly about a year ago (unsure of date) on a Thursday and she had a terrifically sore arm, worse than the Moderna COVID shot. Her arm was sore that night (Thursday) after receiving the shot and lasted until that Monday. She couldn't lift her arm for 2 days. She thought she had cellulitis of arm.  The next morning after receiving the Shingrix shot (Friday), she felt horrible.  She felt like she had the flu and had a fever.  These symptoms lasted until that Sunday afternoon. Till the of reporting, the patient did not receive her second dose, which led to incomplete course of vaccination. The reporter consented to follow up. This case was liked with US2021215443 and US2021215524, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021215443:same reporter US-GLAXOSMITHKLINE-US2021215524:same reporter
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Pain in extremity, Vaccination complication
Clinical narrative: Reaction unspecified to the 3 shots; Got 3rd dose and is not immunocompromised; They had arm pain pretty immediate, the same day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (They had arm pain pretty immediate, the same day), VACCINATION COMPLICATION (Reaction unspecified to the 3 shots) and EXTRA DOSE ADMINISTERED (Got 3rd dose and is not immunocompromised) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, the patient experienced PAIN IN EXTREMITY (They had arm pain pretty immediate, the same day) and EXTRA DOSE ADMINISTERED (Got 3rd dose and is not immunocompromised). On an unknown date, the patient experienced VACCINATION COMPLICATION (Reaction unspecified to the 3 shots). On 12-Oct-2021, EXTRA DOSE ADMINISTERED (Got 3rd dose and is not immunocompromised) had resolved. At the time of the report, PAIN IN EXTREMITY (They had arm pain pretty immediate, the same day) and VACCINATION COMPLICATION (Reaction unspecified to the 3 shots) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.   This case was linked to MOD-2021-354077, MOD-2021-354097, MOD-2021-353213 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Oct-2021: Significant follow up contains added Batch number.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Facial discomfort, Feeding disorder, Feeling abnormal, Headache
Clinical narrative: felt electricity going through her body in her nerve endings; excruciating pain in her head; nauseous; inflammation; migraine; could not eat; felt like her body tingled; light headed; left side of her face was caving; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (inflammation), MIGRAINE (migraine), FEEDING DISORDER (could not eat), PARAESTHESIA (felt like her body tingled) and DIZZINESS (light headed) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced FEELING ABNORMAL (felt electricity going through her body in her nerve endings). In September 2021, the patient experienced INFLAMMATION (inflammation), MIGRAINE (migraine), FEEDING DISORDER (could not eat), PARAESTHESIA (felt like her body tingled), DIZZINESS (light headed), FACIAL DISCOMFORT (left side of her face was caving), HEADACHE (excruciating pain in her head) and NAUSEA (nauseous). On 10-Sep-2021, FEELING ABNORMAL (felt electricity going through her body in her nerve endings) had resolved. In September 2021, INFLAMMATION (inflammation), MIGRAINE (migraine), FEEDING DISORDER (could not eat), PARAESTHESIA (felt like her body tingled), DIZZINESS (light headed), FACIAL DISCOMFORT (left side of her face was caving), HEADACHE (excruciating pain in her head) and NAUSEA (nauseous) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications are provided. treatment to the events not reported.  Reportedly, Peroxide on the side of patients mouth and pain pills that are not working   This case was linked to MOD-2021-354507 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Migraine, Nausea, Paraesthesia
Clinical narrative: felt electricity going through her body in her nerve endings; excruciating pain in her head; nauseous; inflammation; migraine; could not eat; felt like her body tingled; light headed; left side of her face was caving; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (inflammation), MIGRAINE (migraine), FEEDING DISORDER (could not eat), PARAESTHESIA (felt like her body tingled) and DIZZINESS (light headed) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced FEELING ABNORMAL (felt electricity going through her body in her nerve endings). In September 2021, the patient experienced INFLAMMATION (inflammation), MIGRAINE (migraine), FEEDING DISORDER (could not eat), PARAESTHESIA (felt like her body tingled), DIZZINESS (light headed), FACIAL DISCOMFORT (left side of her face was caving), HEADACHE (excruciating pain in her head) and NAUSEA (nauseous). On 10-Sep-2021, FEELING ABNORMAL (felt electricity going through her body in her nerve endings) had resolved. In September 2021, INFLAMMATION (inflammation), MIGRAINE (migraine), FEEDING DISORDER (could not eat), PARAESTHESIA (felt like her body tingled), DIZZINESS (light headed), FACIAL DISCOMFORT (left side of her face was caving), HEADACHE (excruciating pain in her head) and NAUSEA (nauseous) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications are provided. treatment to the events not reported.  Reportedly, Peroxide on the side of patients mouth and pain pills that are not working   This case was linked to MOD-2021-354507 (Patient Link).
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received dose from vial more than 12 hours punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from vial more than 12 hours punctured) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) 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) (Intramuscular) 1 dosage form. On 17-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from vial more than 12 hours punctured). On 17-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from vial more than 12 hours punctured) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 17-Oct-2021: Significant follow up received on 17-OCT-2021 and  Patient information updated, dose number and dose details updated.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Loss of personal independence in daily activities, Mouth ulceration, Pain, Stomatitis
Clinical narrative: Feels miserable; Cannot function; Much pain; Ulcers in her mouth; Sores in her mouth on the left side; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH ULCERATION (Ulcers in her mouth), STOMATITIS (Sores in her mouth on the left side), FEELING ABNORMAL (Feels miserable), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Cannot function) and PAIN (Much pain) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A and 050E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2021, the patient experienced MOUTH ULCERATION (Ulcers in her mouth) and STOMATITIS (Sores in her mouth on the left side). On an unknown date, the patient experienced FEELING ABNORMAL (Feels miserable), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Cannot function) and PAIN (Much pain). The patient was treated with HYDROGEN PEROXIDE (PEROXIDE) for Adverse event, at an unspecified dose and frequency. At the time of the report, MOUTH ULCERATION (Ulcers in her mouth), STOMATITIS (Sores in her mouth on the left side), FEELING ABNORMAL (Feels miserable), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Cannot function) and PAIN (Much pain) outcome was unknown.            No Concomitant medications were reported. Treatment medication include pain pills that are not working.  Additional information reported include that the only thing patient did different than before was getting the vaccine.   This case was linked to MOD-2021-354275 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered to 30 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 30 patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 30 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 30 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.  Reporter stated that the Vials were refrigerated until the day of administration and unused portions discarded within 12 hours.   Most recent FOLLOW-UP information incorporated above includes: On 18-Oct-2021: Contains Non significant information.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of administered expired product (expired vaccine administered to patient/dose administered after 30-day use by date/expired lot) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 045B21A) for COVID-19 immunization. Concurrent medical conditions included Type 2 diabetes mellitus and non-alcoholic fatty liver (non-alcoholic cirrhosis). On Oct 15, 2021 at 8:15, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; .5 milliliter. On Oct 15, 2021, patient administered expired product (expired vaccine administered to patient/dose administered after 30-day use by date/expired lot). On Oct 15, 2021, administered expired product (expired vaccine administered to patient/dose administered after 30-day use by date/expired lot) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Reporter stated patient tolerated vaccine well and no acute distress noted. This case linked to MOD-2021-354279 (patient link). Most recent follow-up information incorporated: On Oct 19, 2021: Follow-up received on  Oct 19, 2021: Patient's demographics and medical history updated.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: Sore arm; Tiredness; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FATIGUE (Tiredness) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002F21A and 033C21A) for COVID-19 vaccination.     no medical history was reported.  Concurrent medical conditions included Angina pectoris, Blood pressure and Cholesterol. Concomitant products included ISOSORBIDE for Angina pectoris, LOSARTAN and HYDROCHLOROTHIAZIDE for Blood pressure, SIMVASTATIN for Cholesterol, CALCIUM CARBONATE, VITAMIN D NOS (CALCIUM + VIT D) and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 17-May-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Aug-2021 at 3:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 15-Aug-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tiredness). On 14-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. On 17-Aug-2021, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tiredness) had resolved.            No treatment medications were reported.   This case was linked to MOD-2021-286661 (Patient Link).
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site warmth
Clinical narrative: her left arm and is hot to the touch; Sore arm; Red circle in the size of coin at her left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (her left arm and is hot to the touch), PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE ERYTHEMA (Red circle in the size of coin at her left arm) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-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 WARMTH (her left arm and is hot to the touch), PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE ERYTHEMA (Red circle in the size of coin at her left arm). At the time of the report, VACCINATION SITE WARMTH (her left arm and is hot to the touch) and VACCINATION SITE ERYTHEMA (Red circle in the size of coin at her left arm) outcome was unknown and PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information was provided.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Reaction affected his breathing, could not breathe,get short of breath even if he was sitting down,when he took a couple steps it was hard to breathe; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Reaction affected his breathing, could not breathe,get short of breath even if he was sitting down,when he took a couple steps it was hard to breathe) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-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 DYSPNOEA (Reaction affected his breathing, could not breathe,get short of breath even if he was sitting down,when he took a couple steps it was hard to breathe). At the time of the report, DYSPNOEA (Reaction affected his breathing, could not breathe,get short of breath even if he was sitting down,when he took a couple steps it was hard to breathe) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications was reported. Treatment information was not provided.  The reaction he had happened shortly after the second shot. The reaction affected his breathing, he could not breathe and as a result of that he had a pacemaker put in July2021. He would get short of breath even if he was sitting down, when he took a couple steps it was hard to breathe. He stated he did not have COVID, he does not know, if he had it, it was after the second shot.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Diarrhoea, Headache, Weight decreased
Clinical narrative: lost 15 pounds; real bad headache; severe diarrhea/even when he drinks water, it goes straight out/Everything he's taken in has come straight out; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (severe diarrhea/even when he drinks water, it goes straight out/Everything he's taken in has come straight out), WEIGHT DECREASED (lost 15 pounds) and HEADACHE (real bad headache) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A and 048F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Oct-2021, the patient experienced DIARRHOEA (severe diarrhea/even when he drinks water, it goes straight out/Everything he's taken in has come straight out) and HEADACHE (real bad headache). On an unknown date, the patient experienced WEIGHT DECREASED (lost 15 pounds). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at a dose of UNK UNK, qid. At the time of the report, DIARRHOEA (severe diarrhea/even when he drinks water, it goes straight out/Everything he's taken in has come straight out) had not resolved and WEIGHT DECREASED (lost 15 pounds) and HEADACHE (real bad headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Oct-2021, Blood test: negative (Negative) blood test negative..         no concomitant medications are provided, The diarrhea is so severe even when he drinks water, it goes straight out. patient went ER on 14-Oct-2021 and had  urine tests the results were negative. Everything he's taken in has come straight out.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination site pain
Clinical narrative: There was maybe a little pain around the injection site for the second shot; I was scheduled to get my second shot a few days after my surgery and just didn't think I could do it, so I re-scheduled for 06/21/21; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (There was maybe a little pain around the injection site for the second shot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I was scheduled to get my second shot a few days after my surgery and just didn't think I could do it, so I re-scheduled for 06/21/21) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 025C21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy (Typical symptoms: running nose, watery eyes, stuffy nose, itching, sneezing, etc.), Food allergy (Peppers causes Diarrhea, abdominal discomfort, gas, pain during digestion), Milk allergy (Symptoms of lactose intolerance.), Food allergy (Ice cream: Symptoms of lactose intolerance.), Obesity and Pain. Concomitant products included PARACETAMOL (TYLENOL) for Pain.   On 09-May-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jun-2021 at 11:00 AM, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I was scheduled to get my second shot a few days after my surgery and just didn't think I could do it, so I re-scheduled for 06/21/21). On an unknown date, the patient experienced VACCINATION SITE PAIN (There was maybe a little pain around the injection site for the second shot). On 21-Jun-2021 at 11:00 AM, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I was scheduled to get my second shot a few days after my surgery and just didn't think I could do it, so I re-scheduled for 06/21/21) had resolved. At the time of the report, VACCINATION SITE PAIN (There was maybe a little pain around the injection site for the second shot) outcome was unknown.            Treatment details were not reported.   This case was linked to MOD-2021-221086 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: After  24 hours my right are and right side was extremely itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (After  24 hours my right are and right side was extremely itching) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Reaction to preservatives (patient have rare allergy and Allergic to common preservative that is found in food an sometimes list as non-medical ingredient in some prescription medication.) and Drug allergy (allergic to sorbates in sorbic acid).    In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PRURITUS (After  24 hours my right are and right side was extremely itching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency. In 2021, PRURITUS (After  24 hours my right are and right side was extremely itching) had resolved.            no concomitant medications are provided by the reporter. patient want to know allergic response interfere with the effectiveness of the vaccination.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Back pain, Decreased appetite, Fatigue
Clinical narrative: Lower back; Put me down for 10 days; Muscle problem  sides and surface of lower rib cage; Loss of appetite(similar reaction like dose2)); Sore arm; Fatigue(similar reaction Like dose2); Right knee problem; This spontaneous case was reported by a patient and describes the occurrence of BACK PAIN (Lower back), ASTHENIA (Put me down for 10 days), MUSCULOSKELETAL CHEST PAIN (Muscle problem  sides and surface of lower rib cage), DECREASED APPETITE (Loss of appetite(similar reaction like dose2))) and VACCINATION SITE PAIN (Sore arm) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced BACK PAIN (Lower back), ASTHENIA (Put me down for 10 days), MUSCULOSKELETAL CHEST PAIN (Muscle problem  sides and surface of lower rib cage), DECREASED APPETITE (Loss of appetite(similar reaction like dose2))), VACCINATION SITE PAIN (Sore arm), FATIGUE (Fatigue(similar reaction Like dose2)) and ARTHRALGIA (Right knee problem). At the time of the report, BACK PAIN (Lower back), ASTHENIA (Put me down for 10 days), MUSCULOSKELETAL CHEST PAIN (Muscle problem  sides and surface of lower rib cage), DECREASED APPETITE (Loss of appetite(similar reaction like dose2))), VACCINATION SITE PAIN (Sore arm), FATIGUE (Fatigue(similar reaction Like dose2)) and ARTHRALGIA (Right knee problem) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications, Lab data details and Treatment information were not provided.  No Fever, Respiratory, head or stomach aches.   This case was linked to MOD-2021-293649 (Patient Link).
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain, Vaccination site pain
Clinical narrative: Lower back; Put me down for 10 days; Muscle problem  sides and surface of lower rib cage; Loss of appetite(similar reaction like dose2)); Sore arm; Fatigue(similar reaction Like dose2); Right knee problem; This spontaneous case was reported by a patient and describes the occurrence of BACK PAIN (Lower back), ASTHENIA (Put me down for 10 days), MUSCULOSKELETAL CHEST PAIN (Muscle problem  sides and surface of lower rib cage), DECREASED APPETITE (Loss of appetite(similar reaction like dose2))) and VACCINATION SITE PAIN (Sore arm) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced BACK PAIN (Lower back), ASTHENIA (Put me down for 10 days), MUSCULOSKELETAL CHEST PAIN (Muscle problem  sides and surface of lower rib cage), DECREASED APPETITE (Loss of appetite(similar reaction like dose2))), VACCINATION SITE PAIN (Sore arm), FATIGUE (Fatigue(similar reaction Like dose2)) and ARTHRALGIA (Right knee problem). At the time of the report, BACK PAIN (Lower back), ASTHENIA (Put me down for 10 days), MUSCULOSKELETAL CHEST PAIN (Muscle problem  sides and surface of lower rib cage), DECREASED APPETITE (Loss of appetite(similar reaction like dose2))), VACCINATION SITE PAIN (Sore arm), FATIGUE (Fatigue(similar reaction Like dose2)) and ARTHRALGIA (Right knee problem) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications, Lab data details and Treatment information were not provided.  No Fever, Respiratory, head or stomach aches.   This case was linked to MOD-2021-293649 (Patient Link).