chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vitamin B12 normal, Vitamin D
Clinical narrative: followed by 10 days of arm and hand tremors in both arms; muscle weakness; possible vaccine induced neuro inflammation; Piercing headache on Day 1; sensation of entire torso vibrating; joint pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Aug2021 11:00 (Lot number: FC3180) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy to pollen" (unspecified if ongoing), notes: Tree pollen; "Allergy to cat dander" (unspecified if ongoing), notes: Cat dander. Concomitant medication(s) included: VITAMINE D; MULTIVIT [VITAMINS NOS]; PROBIOTICS; TURMERIC CURCUMIN. The following information was reported: TREMOR (non-serious) with onset 08Aug2021 15:00, outcome "not recovered", described as "followed by 10 days of arm and hand tremors in both arms"; MUSCULAR WEAKNESS (non-serious) with onset 08Aug2021 15:00, outcome "not recovered", described as "muscle weakness"; INFLAMMATION (non-serious) with onset 08Aug2021 15:00, outcome "not recovered", described as "possible vaccine induced neuro inflammation"; HEADACHE (non-serious) with onset 08Aug2021 15:00, outcome "not recovered", described as "Piercing headache on Day 1"; FEELING ABNORMAL (non-serious) with onset 08Aug2021 15:00, outcome "not recovered", described as "sensation of entire torso vibrating"; ARTHRALGIA (non-serious) with onset 08Aug2021 15:00, outcome "not recovered", described as "joint pain". The events "followed by 10 days of arm and hand tremors in both arms", "muscle weakness", "possible vaccine induced neuro inflammation", "piercing headache on day 1", "sensation of entire torso vibrating" and "joint pain" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of tremor, muscular weakness, inflammation, headache, feeling abnormal, arthralgia.  Additional information: The most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Treatment received for the adverse event include ibuprofen to try to reduce inflammation. Device Date was 18Aug2021. Clinical course: Piercing headache on Day 1, followed by 10 days of arm and hand tremors in both arms, sensation of entire torso vibrating, joint pain, muscle weakness. Day 10 (today) diagnosed as possible vaccine induced neuro inflammation  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Feeling abnormal, Headache, Inflammation, Muscular weakness
Clinical narrative: followed by 10 days of arm and hand tremors in both arms; muscle weakness; possible vaccine induced neuro inflammation; Piercing headache on Day 1; sensation of entire torso vibrating; joint pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Aug2021 11:00 (Lot number: FC3180) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy to pollen" (unspecified if ongoing), notes: Tree pollen; "Allergy to cat dander" (unspecified if ongoing), notes: Cat dander. Concomitant medication(s) included: VITAMINE D; MULTIVIT [VITAMINS NOS]; PROBIOTICS; TURMERIC CURCUMIN. The following information was reported: TREMOR (non-serious) with onset 08Aug2021 15:00, outcome "not recovered", described as "followed by 10 days of arm and hand tremors in both arms"; MUSCULAR WEAKNESS (non-serious) with onset 08Aug2021 15:00, outcome "not recovered", described as "muscle weakness"; INFLAMMATION (non-serious) with onset 08Aug2021 15:00, outcome "not recovered", described as "possible vaccine induced neuro inflammation"; HEADACHE (non-serious) with onset 08Aug2021 15:00, outcome "not recovered", described as "Piercing headache on Day 1"; FEELING ABNORMAL (non-serious) with onset 08Aug2021 15:00, outcome "not recovered", described as "sensation of entire torso vibrating"; ARTHRALGIA (non-serious) with onset 08Aug2021 15:00, outcome "not recovered", described as "joint pain". The events "followed by 10 days of arm and hand tremors in both arms", "muscle weakness", "possible vaccine induced neuro inflammation", "piercing headache on day 1", "sensation of entire torso vibrating" and "joint pain" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of tremor, muscular weakness, inflammation, headache, feeling abnormal, arthralgia.  Additional information: The most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Treatment received for the adverse event include ibuprofen to try to reduce inflammation. Device Date was 18Aug2021. Clinical course: Piercing headache on Day 1, followed by 10 days of arm and hand tremors in both arms, sensation of entire torso vibrating, joint pain, muscle weakness. Day 10 (today) diagnosed as possible vaccine induced neuro inflammation  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: followed by 10 days of arm and hand tremors in both arms; muscle weakness; possible vaccine induced neuro inflammation; Piercing headache on Day 1; sensation of entire torso vibrating; joint pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Aug2021 11:00 (Lot number: FC3180) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy to pollen" (unspecified if ongoing), notes: Tree pollen; "Allergy to cat dander" (unspecified if ongoing), notes: Cat dander. Concomitant medication(s) included: VITAMINE D; MULTIVIT [VITAMINS NOS]; PROBIOTICS; TURMERIC CURCUMIN. The following information was reported: TREMOR (non-serious) with onset 08Aug2021 15:00, outcome "not recovered", described as "followed by 10 days of arm and hand tremors in both arms"; MUSCULAR WEAKNESS (non-serious) with onset 08Aug2021 15:00, outcome "not recovered", described as "muscle weakness"; INFLAMMATION (non-serious) with onset 08Aug2021 15:00, outcome "not recovered", described as "possible vaccine induced neuro inflammation"; HEADACHE (non-serious) with onset 08Aug2021 15:00, outcome "not recovered", described as "Piercing headache on Day 1"; FEELING ABNORMAL (non-serious) with onset 08Aug2021 15:00, outcome "not recovered", described as "sensation of entire torso vibrating"; ARTHRALGIA (non-serious) with onset 08Aug2021 15:00, outcome "not recovered", described as "joint pain". The events "followed by 10 days of arm and hand tremors in both arms", "muscle weakness", "possible vaccine induced neuro inflammation", "piercing headache on day 1", "sensation of entire torso vibrating" and "joint pain" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of tremor, muscular weakness, inflammation, headache, feeling abnormal, arthralgia.  Additional information: The most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Treatment received for the adverse event include ibuprofen to try to reduce inflammation. Device Date was 18Aug2021. Clinical course: Piercing headache on Day 1, followed by 10 days of arm and hand tremors in both arms, sensation of entire torso vibrating, joint pain, muscle weakness. Day 10 (today) diagnosed as possible vaccine induced neuro inflammation  Follow-up attempts are completed. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient was given Moderna under the age of 18
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Cardiac stress test abnormal, Chest pain, Dyspnoea, Electrocardiogram abnormal
Clinical narrative: right arm, shoulder and chest pain difficulty breathing problems still continues today
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: right arm, shoulder and chest pain difficulty breathing problems still continues today
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Product administered at inappropriate site, Product administered to patient of inappropriate age
Clinical narrative: Fatigue; Daughter received the adult dose of the Pfizer COVID vaccine instead of the pediatric dose; Patient received BNT162B2 in the right thigh; This is a spontaneous report received from a contactable reporter (Pharmacist) from medical information team. The reporter is the parent.  An 8-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in thigh right, administration date 04Nov2021 11:00 (Batch/Lot number: unknown) at the age of 8 years as dose 1, 30 ug single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 04Nov2021, outcome "unknown", described as "Daughter received the adult dose of the Pfizer COVID vaccine instead of the pediatric dose"; PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 04Nov2021, outcome "unknown", described as "Patient received BNT162B2 in the right thigh"; FATIGUE (non-serious) with onset 05Nov2021, outcome "recovered", described as "Fatigue". Therapeutic measures were not taken as a result of product administered to patient of inappropriate age, product administered at inappropriate site, fatigue. Additional information: The patient's mother stated her 8-year-old daughter received the adult dose of the Pfizer COVID vaccine instead of the pediatric dose. A pharmacy student administered a 30-mcg adult COVID-19 vaccine dose to the patient instead of the 10-mcg dose by accident. The patient's mother asked what side effects she should look out for and if her daughter should receive a second dose. Regarding the seriousness, it was reported as unknown, the patient's mother monitored her for the first hour and there was nothing unusual with her, but the patient's mother did not know what to expect. When querying dose, the patient's mother stated she thought her daughter received 0.3ml since that dose was intended for the patient's mother's booster dose, but instead it was given to her daughter. There were no additional vaccines administered on the same date of the Pfizer suspect.  The adverse events did not require a visit to the emergency room or a physician office. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. There were no adverse events following prior vaccinations. There was no family medical history relevant. There were no relevant tests taken (specific relevant test for thromboembolic events with thrombocytopenia: none). The patient's mother consider that the Pfizer product had a casual effect to the adverse event.  The patient received the second dose (Lot number: FK5127) on 26Nov2021 at 11:00 in the right deltoid intramuscularly. There were no side effects after the second dose. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Hypersensitivity, Mouth swelling, Paraesthesia
Clinical narrative: Patient called the clinic around 10 minutes after receiving her vaccine to report that she was driving back because she was experiencing symptoms of an allergic reaction. Clinic staff readied an emergency bag and evaluated whether patient should head to the emergency room. When patient arrived back at clinic, she described tingling and heaviness in her face and some swelling in her mouth. She was given Benadryl and water and seated in the observation area for 30 minutes. Patient then reported feeling better and drove herself home.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Pfizer vaccine given
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: expired vaccine given to patient
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine given
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Expired dose given
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 pneumonia, SARS-CoV-2 test positive
Clinical narrative: Received Pfizer vaccines on 2/17, 3/10/21 COVID-19 positive by PCR on  1/7/22 admitted to hospital on 1/7/22 d/t COVID pneumonia
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Interchange of vaccine products, Pain
Clinical narrative: Patient went to pharmacy for a flu vaccine, but given a COVID-19 booster in error. At the time of administration, the COVID-19 booster was not even approved for her age group. As a result of the error, she experienced high fevers, bodyaches, chills, loss of appetite and fatigue.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: Patient went to pharmacy for a flu vaccine, but given a COVID-19 booster in error. At the time of administration, the COVID-19 booster was not even approved for her age group. As a result of the error, she experienced high fevers, bodyaches, chills, loss of appetite and fatigue.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Culture stool, Diarrhoea, Feeling abnormal, Stress
Clinical narrative: chronic serious diarrhea; extra stressed and miserable; extra stressed and miserable/freaked out and upset; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 54-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Nov2021 10:40 (Lot number: FJ1620) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing), notes: Patient History: No; Family Medical History Relevant to AE(s): No, nothing. She is really healthy. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the vaccine.  The following information was reported: DIARRHOEA (medically significant) with onset 26Nov2021, outcome "not recovered", described as "chronic serious diarrhea"; STRESS (non-serious) with onset 2021, outcome "unknown", described as "extra stressed and miserable"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "extra stressed and miserable/freaked out and upset". The patient developed chronic serious diarrhea on 26Nov2021 and had it pretty consistently since then (as of 28Dec2021). She reported getting up several times at night with it, 12 or more times per night with it. She had chronic serious diarrhea since about 2 days after the vaccine and it had not stopped, so it had been going on for 5 weeks. She was extra stressed and miserable. It had stayed about the same and she went to a doctor to see if there was any other reason for it and it was still there (as of 28Dec2021). It was just really bad chronic diarrhea and it was happening all night. It woke her up at night and it was in the morning. She wasn't on any medications and she was not on any prescriptions. There was nothing else that she thought could be relevant to it because it was sudden watery major diarrhea. She went to the doctor and they ran stool samples and they all came back fine and this was related to the vaccine, nothing else had changed.  The events "chronic serious diarrhea", "extra stressed and miserable" and "extra stressed and miserable/freaked out and upset" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: culture stool: (2021) negative, notes: all came back fine. Her stool tests were negative. It was also reported the patient had her second dose of bnt162b2 on 15De2021 at 10:00 (lot number 33130BA) because she didn't know that it (diarrhea) was related to the vaccine and now she pretty much knew that they were related.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Immunodeficiency, SARS-CoV-2 test, Urticaria
Clinical narrative: episodes of angioedema; immuno issue; hives; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Aug2021 14:00 (Lot number: EW0179) at the age of 49 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Hormone replacement tx due to hysterectomy" (unspecified if ongoing); "Hormone replacement tx due to hysterectomy" (unspecified if ongoing); "degenerative disc disease" (unspecified if ongoing). Concomitant medication(s) included: ARMOUR THYROID; PROGEST; PRILOSEC [OMEPRAZOLE]; TIZANIDINE; BI EST. Vaccination history included: Bnt162b2 (First dose, COVID 19 vaccine Pfizer, lot number: EW0186, administration date: 31Jul2021, administration time: 02:00 PM, vaccine location: Left arm), administration date: 31Jul2021, when the patient was 49 years old, for Covid-19 Immunization. No other vaccine in four weeks. The following information was reported: ANGIOEDEMA (medically significant) with onset 01Dec2021 15:00, outcome "not recovered", described as "episodes of angioedema"; IMMUNODEFICIENCY (medically significant) with onset 01Dec2021 15:00, outcome "not recovered", described as "immuno issue"; URTICARIA (non-serious) with onset 01Dec2021 15:00, outcome "not recovered", described as "hives".  The patient reported that starting 01Dec2021 began having episodes of angioedema and hives. No environmental or dietary changes of note. Prednisone was the only thing that alleviated the symptoms but only as long as she was taking it. According to her physician this indicates and immuno issue, not contact dermatitis or other. The patient underwent the following laboratory tests and procedures: Abbott Binax sars-cov-2 test: (06Sep2021) negative, notes: Nasal Swab; (13Sep2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of angioedema, immunodeficiency, urticaria: Prednisone 40 mg for 5 days.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Ischaemic stroke
Clinical narrative: Ischemic brain stroke in mid brain region; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 66 year-old male patient received bnt162b2 (BNT162B2), administration date 14Mar2021 09:00 (Lot number: EN6208) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Open heart by pass surgery" (unspecified if ongoing); "knee replacement surgery" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ISCHAEMIC STROKE (caused and prolonged hospitalization, disability, medically significant) with onset 02Apr2021 14:00, outcome "recovered with sequelae", described as "Ischemic brain stroke in mid brain region". The patient was hospitalized and prolonged hospitalization for ischaemic stroke (hospitalization duration: 47 day(s)). The event "ischemic brain stroke in mid brain region" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of ischaemic stroke.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Sore arm; Fever; Dermatographia (chronic hive condition); This spontaneous case was reported by a consumer and describes the occurrence of MECHANICAL URTICARIA (Dermatographia (chronic hive condition)), PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 029L20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MECHANICAL URTICARIA (Dermatographia (chronic hive condition)). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever). The patient was treated with LORATADINE at an unspecified dose and frequency and MOMETASONE FUROATE at an unspecified dose and frequency. At the time of the report, MECHANICAL URTICARIA (Dermatographia (chronic hive condition)) had not resolved and PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever) had resolved.            No concomitant medications were reported by the reporter.   This case was linked to MOD-2022-445046, MOD-2022-445048 (Patient Link).
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mechanical urticaria, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; Fever; Dermatographia (chronic hive condition); This spontaneous case was reported by a consumer and describes the occurrence of MECHANICAL URTICARIA (Dermatographia (chronic hive condition)), PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 029L20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MECHANICAL URTICARIA (Dermatographia (chronic hive condition)). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever). The patient was treated with LORATADINE at an unspecified dose and frequency and MOMETASONE FUROATE at an unspecified dose and frequency. At the time of the report, MECHANICAL URTICARIA (Dermatographia (chronic hive condition)) had not resolved and PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever) had resolved.            No concomitant medications were reported by the reporter.   This case was linked to MOD-2022-445046, MOD-2022-445048 (Patient Link).
Age: 9.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: My 9 year old daughter was diagnosed with bell's palsy after she received the second vaccine shot . she received her 1st vaccine shot on November 29, 2021 and her second on December 22,2021 we noticed her left side of her face was swollen and the left side of her mouth was twisted. she lost all feeling on her left side of face, she couldn't smile , eat properly, wink her eyes,  chew her food, drink without the fluid pouring back out her mouth, drooling or laugh like a normal child. My daughter became depressed worried if she would return to normal. we as parents try to do whats best for our children thinking its safe and depending on the CDC to make sure the vaccines they developed would help us not hurt us and in this case if hurt us. The fact that we didnt hear anything from the location where she received the vaccine from nor did we hear from the CDC as the medical team told us we would. I just think this is ridiculous on how we are being treated  as a human being but worst being treated this way as a child.   The fact that no one has even called to apologized is ridiculous. I need answers
Age: 9.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Bell's palsy, Depression, Eating disorder, Facial paralysis
Clinical narrative: My 9 year old daughter was diagnosed with bell's palsy after she received the second vaccine shot . she received her 1st vaccine shot on November 29, 2021 and her second on December 22,2021 we noticed her left side of her face was swollen and the left side of her mouth was twisted. she lost all feeling on her left side of face, she couldn't smile , eat properly, wink her eyes,  chew her food, drink without the fluid pouring back out her mouth, drooling or laugh like a normal child. My daughter became depressed worried if she would return to normal. we as parents try to do whats best for our children thinking its safe and depending on the CDC to make sure the vaccines they developed would help us not hurt us and in this case if hurt us. The fact that we didnt hear anything from the location where she received the vaccine from nor did we hear from the CDC as the medical team told us we would. I just think this is ridiculous on how we are being treated  as a human being but worst being treated this way as a child.   The fact that no one has even called to apologized is ridiculous. I need answers
Age: 9.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial paresis, Hypoaesthesia, Mastication disorder, Swelling face
Clinical narrative: My 9 year old daughter was diagnosed with bell's palsy after she received the second vaccine shot . she received her 1st vaccine shot on November 29, 2021 and her second on December 22,2021 we noticed her left side of her face was swollen and the left side of her mouth was twisted. she lost all feeling on her left side of face, she couldn't smile , eat properly, wink her eyes,  chew her food, drink without the fluid pouring back out her mouth, drooling or laugh like a normal child. My daughter became depressed worried if she would return to normal. we as parents try to do whats best for our children thinking its safe and depending on the CDC to make sure the vaccines they developed would help us not hurt us and in this case if hurt us. The fact that we didnt hear anything from the location where she received the vaccine from nor did we hear from the CDC as the medical team told us we would. I just think this is ridiculous on how we are being treated  as a human being but worst being treated this way as a child.   The fact that no one has even called to apologized is ridiculous. I need answers
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Laboratory test abnormal, Pulmonary embolism
Clinical narrative: diagnosed with pulmonary embolus; feeling dyspneic; booster; This is a spontaneous report received from a non-contactable Other HCP.  A 75 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 11Oct2021 (Lot number: 301458A) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "DM" (unspecified if ongoing); "HLD" (unspecified if ongoing); "OSA" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose brand Pfizer, lot number unknown, number 2), administration date: 05Mar2021, when the patient was 75 years old, for COVID-19 immunization; Bnt162b2 (dose brand Pfizer, lot number unknown, number 1), administration date: 12Feb2021, when the patient was 75 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (hospitalization, life threatening) with onset 11Oct2021, outcome "not recovered", described as "booster"; PULMONARY EMBOLISM (hospitalization, life threatening) with onset 31Dec2021, outcome "not recovered", described as "diagnosed with pulmonary embolus"; DYSPNOEA (hospitalization, life threatening) with onset 15Dec2021, outcome "not recovered", described as "feeling dyspneic". The events "booster", "diagnosed with pulmonary embolus" and "feeling dyspneic" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: unknown results, notes: tested post vaccination. Therapeutic measures were taken as a result of pulmonary embolism, dyspnoea: transferred to higher level of care for thrombectomy; anticoagulants. Extensive work up provided. The patient had no Covid prior vaccination.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the Life threatening events and the suspect BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Immunisation, Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: diagnosed with pulmonary embolus; feeling dyspneic; booster; This is a spontaneous report received from a non-contactable Other HCP.  A 75 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 11Oct2021 (Lot number: 301458A) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "DM" (unspecified if ongoing); "HLD" (unspecified if ongoing); "OSA" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose brand Pfizer, lot number unknown, number 2), administration date: 05Mar2021, when the patient was 75 years old, for COVID-19 immunization; Bnt162b2 (dose brand Pfizer, lot number unknown, number 1), administration date: 12Feb2021, when the patient was 75 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (hospitalization, life threatening) with onset 11Oct2021, outcome "not recovered", described as "booster"; PULMONARY EMBOLISM (hospitalization, life threatening) with onset 31Dec2021, outcome "not recovered", described as "diagnosed with pulmonary embolus"; DYSPNOEA (hospitalization, life threatening) with onset 15Dec2021, outcome "not recovered", described as "feeling dyspneic". The events "booster", "diagnosed with pulmonary embolus" and "feeling dyspneic" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: unknown results, notes: tested post vaccination. Therapeutic measures were taken as a result of pulmonary embolism, dyspnoea: transferred to higher level of care for thrombectomy; anticoagulants. Extensive work up provided. The patient had no Covid prior vaccination.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the Life threatening events and the suspect BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 9.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain upper, Asthenia, Chest discomfort, Chest pain, Lethargy
Clinical narrative: Mom reports COVID vaccine reaction Got vaccine 1/5 at 5:05pm - was without any complaints/abnormalities 3 minutes after the vaccine c/o chest pain 15 minute check from nurse was stable 20 minute check from nurse - pale, lethargic, nausea, stomach pain In the ER waiting room, patient developed hives The ER gave benadryl and epi pen - started feeling better immediately Mom reports two coughs after the ordeal, feels it was from the vaccine reaction Didn't develop fever, rhinorrhea, cough, n/v/c, HA They did a COVID swab, was negative The hospital d/c paperwork indicates suspected viral illness Mom reports that the discharging physician who gave this diagnosis is not the same as the original physician that gave the epipen and recommended going home with epipen Has intermittently had hives until 1/10 and treated intermittently with benadryl
Age: 9.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Mom reports COVID vaccine reaction Got vaccine 1/5 at 5:05pm - was without any complaints/abnormalities 3 minutes after the vaccine c/o chest pain 15 minute check from nurse was stable 20 minute check from nurse - pale, lethargic, nausea, stomach pain In the ER waiting room, patient developed hives The ER gave benadryl and epi pen - started feeling better immediately Mom reports two coughs after the ordeal, feels it was from the vaccine reaction Didn't develop fever, rhinorrhea, cough, n/v/c, HA They did a COVID swab, was negative The hospital d/c paperwork indicates suspected viral illness Mom reports that the discharging physician who gave this diagnosis is not the same as the original physician that gave the epipen and recommended going home with epipen Has intermittently had hives until 1/10 and treated intermittently with benadryl
Age: 9.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Acute kidney injury, Asthenia, COVID-19, COVID-19 pneumonia, Dehydration
Clinical narrative: Mom reports COVID vaccine reaction Got vaccine 1/5 at 5:05pm - was without any complaints/abnormalities 3 minutes after the vaccine c/o chest pain 15 minute check from nurse was stable 20 minute check from nurse - pale, lethargic, nausea, stomach pain In the ER waiting room, patient developed hives The ER gave benadryl and epi pen - started feeling better immediately Mom reports two coughs after the ordeal, feels it was from the vaccine reaction Didn't develop fever, rhinorrhea, cough, n/v/c, HA They did a COVID swab, was negative The hospital d/c paperwork indicates suspected viral illness Mom reports that the discharging physician who gave this diagnosis is not the same as the original physician that gave the epipen and recommended going home with epipen Has intermittently had hives until 1/10 and treated intermittently with benadryl
Age: 9.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Diarrhoea haemorrhagic, Hypophagia, Malaise, Pain, Retching
Clinical narrative: Mom reports COVID vaccine reaction Got vaccine 1/5 at 5:05pm - was without any complaints/abnormalities 3 minutes after the vaccine c/o chest pain 15 minute check from nurse was stable 20 minute check from nurse - pale, lethargic, nausea, stomach pain In the ER waiting room, patient developed hives The ER gave benadryl and epi pen - started feeling better immediately Mom reports two coughs after the ordeal, feels it was from the vaccine reaction Didn't develop fever, rhinorrhea, cough, n/v/c, HA They did a COVID swab, was negative The hospital d/c paperwork indicates suspected viral illness Mom reports that the discharging physician who gave this diagnosis is not the same as the original physician that gave the epipen and recommended going home with epipen Has intermittently had hives until 1/10 and treated intermittently with benadryl
Age: 9.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Vomiting
Clinical narrative: Mom reports COVID vaccine reaction Got vaccine 1/5 at 5:05pm - was without any complaints/abnormalities 3 minutes after the vaccine c/o chest pain 15 minute check from nurse was stable 20 minute check from nurse - pale, lethargic, nausea, stomach pain In the ER waiting room, patient developed hives The ER gave benadryl and epi pen - started feeling better immediately Mom reports two coughs after the ordeal, feels it was from the vaccine reaction Didn't develop fever, rhinorrhea, cough, n/v/c, HA They did a COVID swab, was negative The hospital d/c paperwork indicates suspected viral illness Mom reports that the discharging physician who gave this diagnosis is not the same as the original physician that gave the epipen and recommended going home with epipen Has intermittently had hives until 1/10 and treated intermittently with benadryl
Age: 9.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Chest discomfort, Fatigue, SARS-CoV-2 test negative, Throat irritation
Clinical narrative: Mom reports COVID vaccine reaction Got vaccine 1/5 at 5:05pm - was without any complaints/abnormalities 3 minutes after the vaccine c/o chest pain 15 minute check from nurse was stable 20 minute check from nurse - pale, lethargic, nausea, stomach pain In the ER waiting room, patient developed hives The ER gave benadryl and epi pen - started feeling better immediately Mom reports two coughs after the ordeal, feels it was from the vaccine reaction Didn't develop fever, rhinorrhea, cough, n/v/c, HA They did a COVID swab, was negative The hospital d/c paperwork indicates suspected viral illness Mom reports that the discharging physician who gave this diagnosis is not the same as the original physician that gave the epipen and recommended going home with epipen Has intermittently had hives until 1/10 and treated intermittently with benadryl
Age: 9.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain upper, Chest pain, Cough, Illness, Lethargy
Clinical narrative: Mom reports COVID vaccine reaction Got vaccine 1/5 at 5:05pm - was without any complaints/abnormalities 3 minutes after the vaccine c/o chest pain 15 minute check from nurse was stable 20 minute check from nurse - pale, lethargic, nausea, stomach pain In the ER waiting room, patient developed hives The ER gave benadryl and epi pen - started feeling better immediately Mom reports two coughs after the ordeal, feels it was from the vaccine reaction Didn't develop fever, rhinorrhea, cough, n/v/c, HA They did a COVID swab, was negative The hospital d/c paperwork indicates suspected viral illness Mom reports that the discharging physician who gave this diagnosis is not the same as the original physician that gave the epipen and recommended going home with epipen Has intermittently had hives until 1/10 and treated intermittently with benadryl
Age: 9.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Nausea, Pallor, SARS-CoV-2 test negative, Urticaria
Clinical narrative: Mom reports COVID vaccine reaction Got vaccine 1/5 at 5:05pm - was without any complaints/abnormalities 3 minutes after the vaccine c/o chest pain 15 minute check from nurse was stable 20 minute check from nurse - pale, lethargic, nausea, stomach pain In the ER waiting room, patient developed hives The ER gave benadryl and epi pen - started feeling better immediately Mom reports two coughs after the ordeal, feels it was from the vaccine reaction Didn't develop fever, rhinorrhea, cough, n/v/c, HA They did a COVID swab, was negative The hospital d/c paperwork indicates suspected viral illness Mom reports that the discharging physician who gave this diagnosis is not the same as the original physician that gave the epipen and recommended going home with epipen Has intermittently had hives until 1/10 and treated intermittently with benadryl
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Bladder catheterisation, Body temperature increased, COVID-19, Chlamydia test positive, Complication of pregnancy
Clinical narrative: ADMISSION 01042022: 25yo G2P1001 with IUP @ 37+5 wga who presented to triage secondary to decreased FM and COVID sx. Pt's temp was 100.4 and COVID test was positive. While obtaining NST pt had recurrent late decels. Despite IV hydration and position changes decels persisted. As a result, pt counseled regarding need for c/s. Discussed risks of c/s including but not limited to anesthesia, infection, bleeding with need for blood transfusion, damage to bowel, bladder - requiring an indwelling foley for a few weeks as the bladder heals, muscles, nerves, etc. Informed consent obtained. Pt has had prenatal care with Dr since 18+6 wga. Pregnancy complicated by + chlam. Pt had neg TOC for chlam 8/16/21. Please see prenatals for further details. PT AND BABY ARE INPATIENT AT THIS TIME.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Exposure during pregnancy, Foetal heart rate deceleration abnormality, Foetal hypokinesia, Foetal non-stress test abnormal, Malaise
Clinical narrative: ADMISSION 01042022: 25yo G2P1001 with IUP @ 37+5 wga who presented to triage secondary to decreased FM and COVID sx. Pt's temp was 100.4 and COVID test was positive. While obtaining NST pt had recurrent late decels. Despite IV hydration and position changes decels persisted. As a result, pt counseled regarding need for c/s. Discussed risks of c/s including but not limited to anesthesia, infection, bleeding with need for blood transfusion, damage to bowel, bladder - requiring an indwelling foley for a few weeks as the bladder heals, muscles, nerves, etc. Informed consent obtained. Pt has had prenatal care with Dr since 18+6 wga. Pregnancy complicated by + chlam. Pt had neg TOC for chlam 8/16/21. Please see prenatals for further details. PT AND BABY ARE INPATIENT AT THIS TIME.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: ADMISSION 01042022: 25yo G2P1001 with IUP @ 37+5 wga who presented to triage secondary to decreased FM and COVID sx. Pt's temp was 100.4 and COVID test was positive. While obtaining NST pt had recurrent late decels. Despite IV hydration and position changes decels persisted. As a result, pt counseled regarding need for c/s. Discussed risks of c/s including but not limited to anesthesia, infection, bleeding with need for blood transfusion, damage to bowel, bladder - requiring an indwelling foley for a few weeks as the bladder heals, muscles, nerves, etc. Informed consent obtained. Pt has had prenatal care with Dr since 18+6 wga. Pregnancy complicated by + chlam. Pt had neg TOC for chlam 8/16/21. Please see prenatals for further details. PT AND BABY ARE INPATIENT AT THIS TIME.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Body temperature increased, COVID-19, Chlamydia test positive, Complication of pregnancy, Exposure during pregnancy
Clinical narrative: ADMISSION 01042022: 25yo G2P1001 with IUP @ 37+5 wga who presented to triage secondary to decreased FM and COVID sx. Pt's temp was 100.4 and COVID test was positive. While obtaining NST pt had recurrent late decels. Despite IV hydration and position changes decels persisted. As a result, pt counseled regarding need for c/s. Discussed risks of c/s including but not limited to anesthesia, infection, bleeding with need for blood transfusion, damage to bowel, bladder - requiring an indwelling foley for a few weeks as the bladder heals, muscles, nerves, etc. Informed consent obtained. Pt has had prenatal care with Dr since 18+6 wga. Pregnancy complicated by + chlam. Pt had neg TOC for chlam 8/16/21. Please see prenatals for further details. PT AND BABY ARE INPATIENT AT THIS TIME.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Foetal heart rate deceleration abnormality, Foetal hypokinesia, Foetal non-stress test abnormal, Malaise, SARS-CoV-2 test positive
Clinical narrative: ADMISSION 01042022: 25yo G2P1001 with IUP @ 37+5 wga who presented to triage secondary to decreased FM and COVID sx. Pt's temp was 100.4 and COVID test was positive. While obtaining NST pt had recurrent late decels. Despite IV hydration and position changes decels persisted. As a result, pt counseled regarding need for c/s. Discussed risks of c/s including but not limited to anesthesia, infection, bleeding with need for blood transfusion, damage to bowel, bladder - requiring an indwelling foley for a few weeks as the bladder heals, muscles, nerves, etc. Informed consent obtained. Pt has had prenatal care with Dr since 18+6 wga. Pregnancy complicated by + chlam. Pt had neg TOC for chlam 8/16/21. Please see prenatals for further details. PT AND BABY ARE INPATIENT AT THIS TIME.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: No adverse event
Clinical narrative: Was given the vaccine which was slightly outside the 12 hour recommended period/administered Moderna booster doses to 2 patients from a vial which has been punctured for more than 12 hours; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Was given the vaccine which was slightly outside the 12 hour recommended period/administered Moderna booster doses to 2 patients from a vial which has been punctured for more than 12 hours) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (1st dose, Lot number - EN6206) on 08-Mar-2021, Pfizer (2nd dose and Lot number - ER8730) on 29-Mar-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Was given the vaccine which was slightly outside the 12 hour recommended period/administered Moderna booster doses to 2 patients from a vial which has been punctured for more than 12 hours). On 07-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Was given the vaccine which was slightly outside the 12 hour recommended period/administered Moderna booster doses to 2 patients from a vial which has been punctured for more than 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment medication were reported.  The vial was initially stored in the refrigerator on 06 Jan 2022 at 8 am and the vial was first punctured on the same day at 10 am.  The vaccine was administered on 07 Jan 2022 at 10 am and 10:15 am. The vial was stored in refrigerator after puncture. The vial did not undergone any temperature excursion.   This case was linked to MOD-2022-445137 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jan-2022: Added reporter. Updated suspect product details.