chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED DOSE ADMINISTERED; This spontaneous report received from a health care professional concerned a 36 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient have no known drug allergies and no significant past medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 21-SEP-2021) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-SEP-2021, the patient experienced expired dose administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired dose administered was not reported. This report was non-serious.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 56 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: No known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 21-SEP-2021) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 23-SEP-2021, the patient experienced expired vaccine administered.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Patient's brother came to health unit on 09/27/2021 and reported that his brother passed away of undetermined causes on 09/21/2021.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect product formulation administered, Interchange of vaccine products
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Product administered to patient of inappropriate age
Clinical narrative: Child was given the incorrect vaccination.  He was previously given Pfizer for his first vaccine.  Confusion, weak, vomiting, unable to sleep.  He has to go back for observation on Monday 10/04/2021.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Confusional state, Insomnia, Interchange of vaccine products, Product administered to patient of inappropriate age
Clinical narrative: Child was given the incorrect vaccination.  He was previously given Pfizer for his first vaccine.  Confusion, weak, vomiting, unable to sleep.  He has to go back for observation on Monday 10/04/2021.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Disturbance in attention, Fatigue, Immediate post-injection reaction, Interchange of vaccine products
Clinical narrative: Child was given the incorrect vaccination.  He was previously given Pfizer for his first vaccine.  Confusion, weak, vomiting, unable to sleep.  He has to go back for observation on Monday 10/04/2021.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Memory impairment, Pallor, Vomiting
Clinical narrative: Child was given the incorrect vaccination.  He was previously given Pfizer for his first vaccine.  Confusion, weak, vomiting, unable to sleep.  He has to go back for observation on Monday 10/04/2021.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: 1 DOSE OF VACCINE ADMINISTERED 6  DAYS PAST EXPIRATION; This spontaneous report received from a health care professional concerned a 54 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 21-SEP-2021) dose was not reported, administered on 27-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-SEP-2021, the patient experienced 1 dose of vaccine administered 6 days past expiration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 1 dose of vaccine administered 6 days past expiration was not reported. This report was non-serious.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall, Feeling cold, Tremor
Clinical narrative: Patient received the pfizer vaccine first dose. I asked patient stay after for 15 minutes so he did, but he wander around the vitamin aisle, and he stated he suddenly felt dizzy and he fell over on the floor. I helped patient up and he sat on a chair and he stated he felt cold and was shaking. This all happens within 10 minutes after giving him the vaccine. After about 15  minutes, patient began to return back to normal and he stated he was fine without needing to go to hospital.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Craniocerebral injury, Electroencephalogram, Magnetic resonance imaging, Muscular weakness
Clinical narrative: Lower extremity weakness,  collapsed and had TBI, hospitalized for possible spinal stroke
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Lower extremity weakness,  collapsed and had TBI, hospitalized for possible spinal stroke
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypertension, Interchange of vaccine products, Muscle spasms, Palpitations
Clinical narrative: Heart palpitations, Head ache, Muscle spasms, tachycardia (170), high blood pressure
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Heart palpitations, Head ache, Muscle spasms, tachycardia (170), high blood pressure
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain, Paraesthesia oral, Rash
Clinical narrative: I received the Modena vaccination 09/14/2021.  I expected side effects within 48 to 72 hours or 2 more days.  I started having extreme joint pains on Wednesday, 09/22/2021.  I have osteoarthritis, 3 hip replacements, and this pain  worsened over several days, (still going on), than I have experienced, ever.; (aside of having the flu back in 1993).  After having the joint pain x 2 days, then came to my muscles.  I ached all over, as if, I had received the injection in every muscle of my body. ( post vaccine muscle soreness).   Still having joint aches, muscle aches, and now a rash to my upper arms, across my chest, and on my abdomen.  Makes my skin feel like it is on fire.  (Try to sleep with that mess- ah, no) I am now having tingling on my tongue, which will not go away.  I still have my taste and smell.  Halaleuja
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Skin burning sensation
Clinical narrative: I received the Modena vaccination 09/14/2021.  I expected side effects within 48 to 72 hours or 2 more days.  I started having extreme joint pains on Wednesday, 09/22/2021.  I have osteoarthritis, 3 hip replacements, and this pain  worsened over several days, (still going on), than I have experienced, ever.; (aside of having the flu back in 1993).  After having the joint pain x 2 days, then came to my muscles.  I ached all over, as if, I had received the injection in every muscle of my body. ( post vaccine muscle soreness).   Still having joint aches, muscle aches, and now a rash to my upper arms, across my chest, and on my abdomen.  Makes my skin feel like it is on fire.  (Try to sleep with that mess- ah, no) I am now having tingling on my tongue, which will not go away.  I still have my taste and smell.  Halaleuja
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Confusional state, Diarrhoea, Fatigue, Headache
Clinical narrative: Fever, chills,  nausea, vomiting, diarrhea, headache, extreme pain at injection site, blurred vision, confusion, exhaustion, night sweats, hard lump at injection site/muscle knot two weeks later. Took anti-nausea medication, ibuprofen, acetaminophen, used ice packs. 48 hours later fever broke.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site mass, Injection site nodule, Injection site pain, Nausea
Clinical narrative: Fever, chills,  nausea, vomiting, diarrhea, headache, extreme pain at injection site, blurred vision, confusion, exhaustion, night sweats, hard lump at injection site/muscle knot two weeks later. Took anti-nausea medication, ibuprofen, acetaminophen, used ice packs. 48 hours later fever broke.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Pyrexia, Vision blurred, Vomiting
Clinical narrative: Fever, chills,  nausea, vomiting, diarrhea, headache, extreme pain at injection site, blurred vision, confusion, exhaustion, night sweats, hard lump at injection site/muscle knot two weeks later. Took anti-nausea medication, ibuprofen, acetaminophen, used ice packs. 48 hours later fever broke.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Flushing, Headache, Inappropriate schedule of product administration
Clinical narrative: fever like feeling with only a 1 degree rise in temperature, severe chills, headache, upset stomach, flush feeling in face, stiffness in knee and ankle joints, very drowsy.  Drowsiness started 20-24 hours after the shot and lasted for 36-48 hours.  More severe side effects lasted 6-8 hours.  Ibuprofen and tylenol together were very effective.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Joint stiffness, Pyrexia, Somnolence
Clinical narrative: fever like feeling with only a 1 degree rise in temperature, severe chills, headache, upset stomach, flush feeling in face, stiffness in knee and ankle joints, very drowsy.  Drowsiness started 20-24 hours after the shot and lasted for 36-48 hours.  More severe side effects lasted 6-8 hours.  Ibuprofen and tylenol together were very effective.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Colitis, Computerised tomogram thorax normal, Culture negative, Hepatosplenomegaly
Clinical narrative: Child w MIS-C admitted to PICU: hypotension, hyperbili, hepatosplenomegaly, 4d fever, neg cultures, neck pain, abd pain, tachycardia.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hyperbilirubinaemia, Hypotension, Inflammatory marker increased, Intensive care, Multisystem inflammatory syndrome in children
Clinical narrative: Child w MIS-C admitted to PICU: hypotension, hyperbili, hepatosplenomegaly, 4d fever, neg cultures, neck pain, abd pain, tachycardia.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Neck pain, Pyrexia, Tachycardia, Ultrasound abdomen abnormal
Clinical narrative: Child w MIS-C admitted to PICU: hypotension, hyperbili, hepatosplenomegaly, 4d fever, neg cultures, neck pain, abd pain, tachycardia.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Vaccine administration was uneventful. Patient and son confirmed that patient was cleared for vaccine and that she was well during and after the observation period. No signs of distress and no abnormality of breathing.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Autopsy, Blood caffeine, Cardiomegaly, Condition aggravated, Deep vein thrombosis
Clinical narrative: Vaccine administration was uneventful. Patient and son confirmed that patient was cleared for vaccine and that she was well during and after the observation period. No signs of distress and no abnormality of breathing.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hepatic steatosis, Oedema peripheral, Pelvic venous thrombosis, Pulmonary embolism, Pulmonary infarction
Clinical narrative: Vaccine administration was uneventful. Patient and son confirmed that patient was cleared for vaccine and that she was well during and after the observation period. No signs of distress and no abnormality of breathing.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Sudden death, Toxicologic test
Clinical narrative: Vaccine administration was uneventful. Patient and son confirmed that patient was cleared for vaccine and that she was well during and after the observation period. No signs of distress and no abnormality of breathing.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: Began having high blood pressure within a month of vaccine. Blood pressure has never been anything but low/normal before now.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Arthritis, Cardiac discomfort, Chest discomfort, Hypoaesthesia
Clinical narrative: Joint Inflammation - Numbness and tightness in joints fingers, wrists, shoulders, neck, knees, feet.  Pain at 8/10 of threshold-decision point to seek hospital visitation.  Tightness back left and front right of heart /left chest cavity mostly from abnormal arythmia.  Onset ~6-12hrs post vaccination administration; episodic 6x / day with both decreasing severity and frequency.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Joint stiffness, Muscle tightness, Pain
Clinical narrative: Joint Inflammation - Numbness and tightness in joints fingers, wrists, shoulders, neck, knees, feet.  Pain at 8/10 of threshold-decision point to seek hospital visitation.  Tightness back left and front right of heart /left chest cavity mostly from abnormal arythmia.  Onset ~6-12hrs post vaccination administration; episodic 6x / day with both decreasing severity and frequency.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Feeling hot, Lymphadenopathy, Rash, Rash erythematous
Clinical narrative: Arm extremely hot to the touch 12 hours after vaccination. Red rash up arm to shoulder after 24 hours of vaccination. Lymph node swelling/extreme pain in armpit after 5 days of vaccination.
Age: 84.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site mass
Clinical narrative: Went to give pt flu vaccine in same arm he rec'd flu vaccine in last year (right arm). Noticed a large lump at the site I would give him injection. Pt stated the lump had been there since his flu vaccine last year.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: PATIENT HAD RECEIVED 1ST DOSE MODERNA AT OUR FACILITY, THEN WAS HOSPITALIZED DUE TO MALIGNANCIES AND OTHER MEDICAL CONDITIONS. SHE WAS CONFUSED AND MISPLACED HER VACCINE CARD. SHE CAME BACK TO OUR FACILITY TO GET HER 2ND DOSE, BELIEVING SHE HAD RECEIVED PFIZER AS HER 1ST DOSE. PHARMACIST ON DUTY WAS A TEMPORARY FLOAT PHARMACIST FILLING IN FOR THE DAY. SHE DID NOT CHECK IMMUNIZATION RECORD. PT DID NOT HAVE HER VACCINE CARD WITH HER. PHARMACIST GAVE HER PFIZER AS REQUESTED FOR 2ND DOSE.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Oropharyngeal pain, Pain
Clinical narrative: 09/25 morning: Fever, headache, body ache, chills, sore throat, sore arm, arm rash, fatigue
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Rash
Clinical narrative: 09/25 morning: Fever, headache, body ache, chills, sore throat, sore arm, arm rash, fatigue
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Itching (assumed it was a mosquito bite) was not a mosquito bite. Next morning itching persisted. Area had begun to swell, looks like a bump. By noon, area was still itchy and had turn a pinkish red color, bump is still visible into the evening.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy, Pulmonary embolism
Clinical narrative: Patient received vaccine on May 4th. She was 9 weeks pregnant. In June she had a miscarriage. September 27 pt is admitted to hospital with PE.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Myalgia, Nausea, Pyrexia
Clinical narrative: For about 1 week after receiving this vaccination, I was running a fever of about 101F, had diarrhea really bad, whole body muscle aches, and nausea. Since some other people I know had the same problems as I did, I just let it run it's course and did not go see a doctor about these side effects.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time, Brain natriuretic peptide, Chest X-ray, Differential white blood cell count, Dizziness
Clinical narrative: Near Syncope. Began late in the evening, laying in bed, nothing unusual, started feeling extremely lightheaded and the room starting to black out. Blood pressure at home was extremely low. Went to local ER, fluids given, treated and released to follow up with both primary care physician and cardiologist.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Fibrin D dimer, Full blood count, Hypotension, International normalised ratio
Clinical narrative: Near Syncope. Began late in the evening, laying in bed, nothing unusual, started feeling extremely lightheaded and the room starting to black out. Blood pressure at home was extremely low. Went to local ER, fluids given, treated and released to follow up with both primary care physician and cardiologist.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lipase, Loss of consciousness, Metabolic function test, Presyncope, Prothrombin time
Clinical narrative: Near Syncope. Began late in the evening, laying in bed, nothing unusual, started feeling extremely lightheaded and the room starting to black out. Blood pressure at home was extremely low. Went to local ER, fluids given, treated and released to follow up with both primary care physician and cardiologist.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin
Clinical narrative: Near Syncope. Began late in the evening, laying in bed, nothing unusual, started feeling extremely lightheaded and the room starting to black out. Blood pressure at home was extremely low. Went to local ER, fluids given, treated and released to follow up with both primary care physician and cardiologist.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort, Chest pain, Condition aggravated, Discomfort
Clinical narrative: On the second evening post injection I experienced tightening, fullness and heaviness in my throat, air hunger, chest tightness/heaviness,  chest pain and palpitations/irregular heart beats, anxiety, increase thirst and urination from 8pm to 3:30 am. The symptoms resolved enough by 3:30 so that I could fall asleep. I have an epi pen with me left from when I used to have severe allergies regularly (a condition I have healed form over the last 1.5 years following removing myself from the mold exposure). I considered going to the ER but waited. On day 3 I began taking antihistamines for 7 days - Claratin which helped take the edge off the 3rd and 4th night. I am now taking half a claratin but still experiencing slight symptoms at night, airway, chest tightness, insomnia. Mast cells have a circadian rhythm which I think is why it's worse at night. I truly hope it fades because I have made tremendous progress on my health and this feels like a set back.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate irregular, Insomnia, Mast cell activation syndrome, Palpitations
Clinical narrative: On the second evening post injection I experienced tightening, fullness and heaviness in my throat, air hunger, chest tightness/heaviness,  chest pain and palpitations/irregular heart beats, anxiety, increase thirst and urination from 8pm to 3:30 am. The symptoms resolved enough by 3:30 so that I could fall asleep. I have an epi pen with me left from when I used to have severe allergies regularly (a condition I have healed form over the last 1.5 years following removing myself from the mold exposure). I considered going to the ER but waited. On day 3 I began taking antihistamines for 7 days - Claratin which helped take the edge off the 3rd and 4th night. I am now taking half a claratin but still experiencing slight symptoms at night, airway, chest tightness, insomnia. Mast cells have a circadian rhythm which I think is why it's worse at night. I truly hope it fades because I have made tremendous progress on my health and this feels like a set back.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pollakiuria, Thirst, Throat tightness
Clinical narrative: On the second evening post injection I experienced tightening, fullness and heaviness in my throat, air hunger, chest tightness/heaviness,  chest pain and palpitations/irregular heart beats, anxiety, increase thirst and urination from 8pm to 3:30 am. The symptoms resolved enough by 3:30 so that I could fall asleep. I have an epi pen with me left from when I used to have severe allergies regularly (a condition I have healed form over the last 1.5 years following removing myself from the mold exposure). I considered going to the ER but waited. On day 3 I began taking antihistamines for 7 days - Claratin which helped take the edge off the 3rd and 4th night. I am now taking half a claratin but still experiencing slight symptoms at night, airway, chest tightness, insomnia. Mast cells have a circadian rhythm which I think is why it's worse at night. I truly hope it fades because I have made tremendous progress on my health and this feels like a set back.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Cough, Dyspnoea, Epistaxis
Clinical narrative: Extreme aches in all joints Swelling at injection site that continues to swell more even three days after injection  High fever lasting three or more days Cough starting at day three after injection  Repeated nosebleeds for first two days after injection Tightness in chest with difficulty breathing
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Extreme aches in all joints Swelling at injection site that continues to swell more even three days after injection  High fever lasting three or more days Cough starting at day three after injection  Repeated nosebleeds for first two days after injection Tightness in chest with difficulty breathing
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Paraesthesia, Shock, Sneezing, Swelling
Clinical narrative: swelling, shock, tingling, sneezing
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram retina, Magnetic resonance imaging, Optic neuritis, Optic neuropathy, Optical coherence tomography
Clinical narrative: Less than 3 weeks after my vaccination, I started getting a blurry spot in the middle of my left eye. It eventually turned into a grey floating blob, and I went to see my ophthalmologist, who said it would go away. I gave it a couple days and it got worse. It resulted in my blindness in my left eye.  I went to see a retinal specialist, who diagnosed me with optic neuropathy -- and I sought a second opinion from a neuro-ophthalmologist, who diagnosed me with optic neuritis affecting my myelin sheath.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred, Visual field tests, Vitreous floaters
Clinical narrative: Less than 3 weeks after my vaccination, I started getting a blurry spot in the middle of my left eye. It eventually turned into a grey floating blob, and I went to see my ophthalmologist, who said it would go away. I gave it a couple days and it got worse. It resulted in my blindness in my left eye.  I went to see a retinal specialist, who diagnosed me with optic neuropathy -- and I sought a second opinion from a neuro-ophthalmologist, who diagnosed me with optic neuritis affecting my myelin sheath.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: Paralisis facial/Facial paralysis; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: EP6955), via an unspecified route of administration, administered in the left arm on 08Apr2021 (at the age of 60-years-old) as dose 2, single for COVID-19 immunization. Medical history included prostate cancer. The patient has no known allergies. Prior to vaccination, the patient had no history of COVID-19. Concomitant medications included ascorbic acid (VITAMIN C), colecalciferol (VITAMIN D 3), and cyanocobalamin (VITAMIN B12). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EP7534) via an unspecified route of administration, administered in the left arm on 17Mar2021 (at the age of 60-years-old) as dose 1, single for COVID-19 immunization. Since the vaccination, the patient has not been tested for COVID-19. On 15Apr2021 13:00, the patient experienced paralisis facial/facial paralysis which resulted in emergency room visit and physician's office visit. Therapeutic measures were taken as result of the event which included physical therapy and prednisone. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Swelling face
Clinical narrative: Left arm pain; Left cheek swollen and numb; Left cheek swollen and numb/Left side of the brain numb; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported for herself that: An adult non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EN6204), via an unspecified route of administration, administered in Arm Left on 14Mar2021 as single dose for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included apnoea, hypertension, albuminuria, naevus flammeus, salmon, milk protein, mushrooms, allergic rhinitis, allergy to animal and grama from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included paracetamol (TYLENOL) and paracetamol (PANADOL) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine within 4 weeks prior to COVID vaccination. On 14Mar2021 the patient experienced left arm pain, left cheek swollen and numb, left side of the brain numb. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of left arm pain with Tylenol/Panadol. The patient did not receive treatment for left cheek swollen and numb and left side of the brain numb. The outcome of the event Left arm pain was recovering and Left cheek swollen and numb, left cheek swollen and numb/Left side of the brain numb was recovered on an unspecified date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Parosmia, Pericarditis
Clinical narrative: Pericarditis and changes in sense of smell; Pericarditis and changes in sense of smell; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (Pericarditis and changes in sense of smell) and PERICARDITIS (Pericarditis and changes in sense of smell) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAROSMIA (Pericarditis and changes in sense of smell) (seriousness criterion hospitalization), PERICARDITIS (Pericarditis and changes in sense of smell) (seriousness criteria hospitalization and medically significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, PAROSMIA (Pericarditis and changes in sense of smell) and PERICARDITIS (Pericarditis and changes in sense of smell) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.            Concomitant medications were not provided. Treatment information was not provided.  Patient  height was 185.42 cm  Action taken was not applicable.  company comment  This case concerns a 68-year-old patient, of an unknown gender with no relevant medical history reported, who experienced the unexpected event of parosmia and expected event of pericarditis. The event occurred on an unknown date and it is not clear if it was before or after the vaccination  with the Moderna Covid-19 vaccine. Additional  unexpected event of Inappropriate Schedule of Product Administration was added. The rechallenge was not applicable, as the event occurred on an unknown date. The reporter's assessment is not provided in this case. The benefit-risk relationship of the vaccine is not affected by this report.; Sender's Comments: This case concerns a 68-year-old patient, of an unknown gender with no relevant medical history reported, who experienced the unexpected event of parosmia and expected event of pericarditis. The event occurred on an unknown date and it is not clear if it was before or after the vaccination  with the Moderna Covid-19 vaccine. Additional  unexpected event of Inappropriate Schedule of Product Administration was added. The rechallenge was not applicable, as the event occurred on an unknown date. The reporter's assessment is not provided in this case. The benefit-risk relationship of the vaccine is not affected by this report.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus, Swelling, Urticaria
Clinical narrative: Severe allergic reaction developed 8 days after vaccination- severe hives all over body, face with swelling and itching
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Hypotension, Injection site reaction, Lip swelling
Clinical narrative: Swollen lips, tongue and throat. Very large red rash where injected. Itching and hives. Trouble breathing. Low blood pressure.Dizzy. Nauseaus.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pharyngeal swelling, Pruritus, Rash erythematous, Swollen tongue
Clinical narrative: Swollen lips, tongue and throat. Very large red rash where injected. Itching and hives. Trouble breathing. Low blood pressure.Dizzy. Nauseaus.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Swollen lips, tongue and throat. Very large red rash where injected. Itching and hives. Trouble breathing. Low blood pressure.Dizzy. Nauseaus.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time normal, Angiogram cerebral normal, Aphasia, Arteriogram carotid abnormal, Computerised tomogram head normal
Clinical narrative: Patient received second COVID-19 Vaccine on 9/26. He reported being  diagnosed with pericarditis after his initial COVID-19 vaccination.   He came to the Emergency Department on 9/27 with left sided weakness, numbness, expressive aphasia, and nystagmus. NIH stroke scale 6. Symptoms started around 5:30 p.m. on day of presentation, 1 hr prior to coming to ED.  His vitals were WNL. TPA was offered however patient refused and started having slight improvement in his weakness while in the emergency department.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Emphysema, Full blood count normal, Hemiparesis, Hypoaesthesia, International normalised ratio normal
Clinical narrative: Patient received second COVID-19 Vaccine on 9/26. He reported being  diagnosed with pericarditis after his initial COVID-19 vaccination.   He came to the Emergency Department on 9/27 with left sided weakness, numbness, expressive aphasia, and nystagmus. NIH stroke scale 6. Symptoms started around 5:30 p.m. on day of presentation, 1 hr prior to coming to ED.  His vitals were WNL. TPA was offered however patient refused and started having slight improvement in his weakness while in the emergency department.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head normal, Metabolic function test normal, Nystagmus, Perfusion brain scan normal, Prothrombin time normal
Clinical narrative: Patient received second COVID-19 Vaccine on 9/26. He reported being  diagnosed with pericarditis after his initial COVID-19 vaccination.   He came to the Emergency Department on 9/27 with left sided weakness, numbness, expressive aphasia, and nystagmus. NIH stroke scale 6. Symptoms started around 5:30 p.m. on day of presentation, 1 hr prior to coming to ED.  His vitals were WNL. TPA was offered however patient refused and started having slight improvement in his weakness while in the emergency department.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Carditis, Chest pain
Clinical narrative: After 30 minutes of the vaccine my heart started to hurt, i?ve never had heart pain in my life and I was a bit afraid but I figure the symptoms will go away quickly.I got this burning sensation like if my heart had a splinter, The pain was about three out of 10 after the fourth day that the symptoms did not go away I visit my local clinic doctor. He told me I had heart inflammation and he prescribed me some Advil now is day 9/28 and the symptoms have not gone.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: No signs or symptoms reported. No other AE reported; temperature excursion that occurred on 3/AUG/2021 and 5/AUG/2021; temperature excursion that occurred on 3/AUG/2021 and 5/AUG/2021; This spontaneous report was received from a medical assistant referring to an unreported age and gender patient. The patient's pertinent medical history, drug reactions or allergies, and concomitant medications were not reported.    The medical assistant reported that a temperature excursion occurred on 03-AUG-2021 and 05-AUG-2021 involving hepatitis A vaccine, inactivated (VAQTA) lot number T037788, verified to be valid for prefilled syringe formulation, with expiration date 30-APR-2022. The vaccine underwent a temperature excursion of 35.4 and 35.8 degrees Fahrenheit (F) for a cumulative timeframe of 15 minutes (product storage error). There was not a previous temperature excursion.   The 1-time dose vaccine was administered to the patient on an unspecified subsequent date in 2021 for prophylaxis (route and anatomical location of vaccination were not reported).  No signs or symptoms nor other adverse events (AE) were reported (no adverse event).  This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T037788; expirationdate: 30-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2109USA003634:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: I GOT shingles AFTER being vaccinated; This spontaneous report was received via GlaxoSmithKline from a consumer of unknown age and gender reporting on themselves. Their pertinent medical history, concomitant medications  or previous drug allergies or reactions were not reported.  On an unspecified date, the subject was vaccinated with zoster vaccine live (ZOSTAVAX) for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number and expiration date were not reported).  On an unknown date after being vaccinated, the patient experienced shingles (herpes zoster). They also reported that the vaccine was much stronger than the old. It was not reported if the patient sought medical attention, received any treatment or if they had laboratory tests or studies performed for the event.  The outcome of the event and the causal relationship between herpes zoster and therapy with zoster vaccine live (ZOSTAVAX) were not reported.
Age: 33.0
Sex: F
Vaccine: FLUX, HPV9, TDAP
Symptoms: Exposure during pregnancy, Fatigue, Nasal congestion, Wrong product administered
Clinical narrative: Vaccine exposure during pregnancy; accidently received GARDASIL 9 instead of TDAP vaccine; severe fatigue; nasal congestion; This spontaneous prospective pregnancy report was received from a medical assistant via company representative and a consumer (the patient) concerning a 33-year-old female patient. No concurrent condition, medical history, or concomitant therapy was reported. The patient became pregnant with last menstrual period (LMP) of 26-FEB-2021 and estimated date of delivery (EDD) of 03-DEC-2021.   On 10-SEP-2021, the patient was accidently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength and dose were unknown; lot # T025369 has been verified to be a valid lot number, expiration date reported and confirm upon internal validation as 01-DEC-2022), intramuscularly for Human Papilloma virus prevention instead of diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) at 28 weeks pregnant (wrong vaccine administered and vaccine exposure during pregnancy). On an unknown date in September 2021(reported as on the same week), she also received diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (TDAP) (strength, dose, frequency, route, indication, lot # and expiration date were unknown) and influenza vaccine (strength, dose, frequency, route, indication, lot # and expiration date were unknown).  In September 2021, after receiving vaccines, the patient experienced severe fatigue and nasal congestion. The patient did not know which vaccines caused the symptoms. The outcome of fatigue and nasal congestion was unknown. The outcome of wrong product administered was reported as not recovered (this is an inconsistence information). The pregnancy outcome was not provided. The causality assessment was not provided. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); devicelotnumber: T025369; expirationdate: 01-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: no additional adverse events reported; the patient was not up to date with his MMR II; the patient received a dose of MMR II in 24Apr2015 and their office administered a dose today (15Sep2021), the patient potentially received a dose in August 2019; This spontaneous report was received from a registered nurse and refers to a 7-year-old child patient of unknown gender. No information regarding patient's pertinent medical hisotry, drug reactions, allergies and concomitant medications.   On 24-APR-2021, the patient was vaccinated with his first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 1 dose for prophylaxis (lot #, expiration date, exact dose, route and anatomical location were not reported). The patient's father stated that the patient was not up to date with his measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and received a next dose on 15-SEP-2021 lot # T018893, expiration date was not reported but upon internal validation it was established as 06-FEB-2022 ((albumin status: recombinant Human albumin (rHA)). The patient's mother called back and stated that the patient potentially received a second dose on an unknown date in August 2019 (extra dose administered) (lot #, expiration date, exact dose, route and anatomical location were not reported). No additional adverse events reported.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Incomplete course of vaccination
Clinical narrative: non-immunity on a recent titer test and had a negative titer; This spontaneous report was received from a registered nurse concerning a 40 years old female patient. Her current conditions included bipolar disorder, polycystic ovaries, major depression, attention deficit hyperactivity disorder, dyslipidaemia, headache, vitamin D deficiency and naproxen caused nausea. Historical drug included naproxen. Concomitant therapies included buspirone, clonazepam (KLONOPIN), bupropion hydrochloride (WELLBUTRIN XL), atorvastatin, ethinylestradiol (+) levonorgestrel (SRONYX), colecalciferol (VITDERA D), hydroxyzine, risperidone (RISPERDAL) and topiramate (TROKENDI XR).     On 09-NOV-2005, the patient was vaccinated with first dose of varicella virus vaccine live (oka/merck)(VARIVAX) (dose, route and lot# were not reported) for prophylaxis. The patient never returned for her second dose.   On 10-DEC-2020, the patient showed non-immunity on a recent titer test and had a negative titer (antibody test negative). The outcome of the event was not resolved. Action taken with varicella virus vaccine live (oka/merck)(VARIVAX) was not applicable.   The causality between the event and suspect vaccine was not reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: lmproperly stored PROQUAD administered to a patient.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 25-JUL-2021, a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot # T016990, expiration date 11-NOV-2021 experienced the temperature excursion of 6 to 14 degrees Fahrenheit (7.3F) for 37 minutes. On 31-AUG-2021, the patient was vaccinated with the improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T016990, 0.5 mL x 1 dose, subcutaneously (SQ) (formulation and anatomical location were not reported) for prophylaxis (product storage error). No product quality complain reported. On 14-SEP-2021, the vaccine experienced temperature excursion of 6 to 14 (9.9F) or 2 hours and 11 minutes. On 15-SEP-2021, the vaccine experienced temperature excursion of 6 to 14 (6.6F) for 59 minutes.
Sex: M
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: Pneumovax 23 use for Rupture spleen; Severe allergic reaction; This spontaneous report has been received from the patient's wife and refers to a 38-years-old male patient.  The patient's concurrent conditions included high blood sugar, high iron and ruptured spleen.   In September 1983, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot #, expiration date, dose, frequency, route of administration and anatomical location of vaccine were not reported) for splenic rupture.   In September 1983, the patient had a severe allergic reaction. At the reporting time, the outcome of the event was not reported.   The reporter considered allergy to vaccine to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: lmpropely stored vaccine administered; administered IM instead of SC; This spontaneous report was received from a nurse referring to a 6 years old (also reported as 5 years old) female patient. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.    On 17-AUG-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # T002847 has been verified to be valid, expiration date reported as 23-JAN-2023, but upon internal validation established as 23-JAN-2022, intramuscular (IM) in the left thigh for prophylaxis in a clinic (dose and strength were not reported) (product storage error and incorrect route of product administration). There was 1 previous dose. Temperature exposure detected. Data logger was involved. Vaccine was removed immediately. No further vaccine was administered. Parents were being noticed and this dose of vaccine would  be repeated with new vaccine stock.     This is one of several reports received from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE's/PQC's reported; Temperature excursion for VARIVAX; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, and concomitant medications were not reported.   On 09-SEP-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX)  (strength, dose, anatomical location, and route of administration were not reported) (lot# U015682 with an expiration date on 18-MAY-2023 and lot# U002394 with an expiration date on 22-JAN-2023) for prophylaxis wich experienced a temperature excursión of 4°C Celsius degrees for 20 minutes on 07-SEP-2021 during transport and 4°C for 20minutes on 09-SEP-2021 during transport as well as -10°C to 8°C (4°C) for 20 minutes (product storage error).  It was reported previous temperature excursions of -10°C to 8°C (4°C) for 7 hours and 30 minutes.   No additional adverse events were reported.; Sender's Comments:  US-009507513-2109USA005628:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration
Clinical narrative: Caller reports no additional AE or PQC; patient was inadvertently administered VARlVAX via intramuscular route as opposed to the recommended subcutaneous route.; This spontaneous report was received from a registered nurse and refers to a patient of unspecified age and gender. Information about the patient's pertinent medical history, concomitant medications, past drug reactions or allergies was not provided.  On 21-SEP-2021, it was reported that the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliters (mL) (dose number and vaccination scheme frequency were not reported; lot number U010401 that was verified to be a valid lot number with an expiration date reported and established as 01-APR-2023) for prophylaxis intramuscularly instead of the recommended subcutaneous route (incorrect route of product administration).  No additional adverse event (AE) was reported.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE's; products experienced an excursion of ( 4C) for 20 minutes on 9/7 during transport and ( 4C) for 20 minutes on 9/9 during transport.; This spontaneous report as received from a registered nurse refers to a 4-year-old patient of unknown gender. The patient's concurrent conditions, medical history, and concomitant therapies were not reported.      The varicella virus vaccine live (oka/merck)(VARIVAX) vaccine experienced an excursion of ( 4°C) for 20 minutes on 07-SEP-2021 during transport and ( 4°C) for 20 minutes on 09-SEP-2021 during transport.  On 13-SEP-2021, the patient was vaccinated with an inappropriate storage dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # U002394 and expiration date 22-JAN-2023, dose reported as 1 (units not provided) (strength and route were not reported) for prophylaxis. The temperature and Time frame was reported as  -10°C to 8°C ( 4°C) for 20 minutes. There was a previous temperature excursion, which was -10°C to 8°C ( 4°C) for 7 hours and 30 minutes. No additional events were reported.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2109USA005618: US-009507513-2109USA005628: US-009507513-2109USA005632: US-009507513-2109USA005639: US-009507513-2109USA005641: US-009507513-2109USA005648: US-009507513-2109USA005651: US-009507513-2109USA005662: US-009507513-2109USA005730: US-009507513-2109USA005795: US-009507513-2109USA005891: US-009507513-2109USA005964: US-009507513-2109USA005628: