chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Scan with contrast normal, Ultrasound Doppler normal
Clinical narrative: Vaccine booster given on 11/1/2021. Muscle aching noted the next day.  The days following I began to become winded doing things as simple as normal walking.  The feeling of being winded continued and worsened by the day until I went to the Emergency Room during the early morning hours of 11/9/2021.  I was transferred by ambulance from there to the  Medical Center in Emergency Room to see cardiology.  I had flown from 11/4 to 11/8.   I was diagnosed by cardiology as having pericarditis.  I was sent to the cardiac cath lab to remove the fluid.  1075 cc's of fluid was removed from my heart.  My cardiologist said that my heart had gone into cardiac tamponade during the procedure.  I was moved to the ICU after the procedure and then discharged home the next day.  I was placed on preventative meds on discharge.  In follow-up chest imaging, it was determined that I also had a small pulmonary embolus that showed in my right lung.  The cardiologist said it appeared to be older and likely from when the pericarditis was.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea
Clinical narrative: Client presented at a HCF vaccination site on 01/18/22. The client reported he received his Janssen COIVD vaccine on 06/23/21. Client reported after seven to eight hours after vaccination, he had shortness of breath (SOB) with lightheadedness for 5 minutes. Client reported he did deep breath, and the SOB went away. Client reported he did not follow-up with his PCP. Client told he has no chronic illnesses, not taking any medications, nor has any known allergy. Client is requesting booster dose of Pfizer COVID vaccine today. PHN submitted a medical consult via text message to clinical project coordinator requesting to proceed with the booster dose of Pfizer COVID vaccine. Per the doctor, approval to proceed with the booster dose of Pfizer COVID vaccine was obtained via text message from clinical project coordinator. Client received the booster dose of Pfizer COVID vaccine, LOT#: FL3209 on 01/18/22 at 1737 by LVN. The client did not report any symptoms during the 30-minute observation period. PHN educated client on possible adverse reactions and when to seek EMS. Client verbalized understanding. Client left vaccination site at 1807 unassisted and with a steady gait.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Arrhythmia, Cardiac monitoring abnormal, Chest X-ray abnormal, Costochondritis
Clinical narrative: Costochondritis, angina, arrythmia, and tachycardia.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Sinus tachycardia
Clinical narrative: Costochondritis, angina, arrythmia, and tachycardia.
Age: 1.25
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse reactions; wrong imm given to child
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Injection site rash, Rash, Rash erythematous, Rash papular
Clinical narrative: Rash started about 12 days after vaccine - papulovesicular rash with slight erythema 8cm x 4cm at injection site R thigh. Spread to trunk after onset
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Blood pressure measurement, Cardiac function test, Chest discomfort, Chest pain
Clinical narrative: Caller tested positive for Covid on 20Apr2022; Caller tested positive for Covid on 20Apr2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: ER2613) and on 12Apr2021 as dose 2, single (Lot number: ER8731) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "blockage" (unspecified if ongoing), notes: He had four heart attacks that was triggered by a blockage that no one knew about. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Apr2022, outcome "unknown" and all described as "Caller tested positive for Covid on 20Apr2022". The patient underwent the following laboratory tests and procedures: Angiogram: (Apr2021) three blockages, 2 at 90% and 1 at 99%.; Blood pressure measurement: (Apr2021) 200's; Cardiac function test: (08Apr2021) He didn't do great or terrible either, notes: On 08Apr2021 he had full cardiac workup and a nuclear study and stress EKG; Electrocardiogram: (08Apr2021) He didn't do great or terrible either, notes: On 08Apr2021 he had full cardiac workup and a nuclear study and stress EKG; Pericardial drainage test: (Sep2021) Positive for pericarditis in Sep2021; SARS-CoV-2 test: (20Apr2022) Positive, notes: A rapid test at home gave positive result; Heart rate: (unspecified date) High. Therapeutic measures were taken as a result of vaccination failure, covid-19. With the first vaccine the patient had no problems at all. With the second one he had big problems. The patient tested positive for COVID on Wednesday and when he called to get something for the symptoms he was prescribed Paxlovid. He started Paxlovid on 20Apr2022. Last night when going to bed he thought to double check the active mechanism of Paxlovid and to make sure it was not the same as the MRNA to make sure he didn't have the same thing happen. He stated he had already taken it for a day and it did not feel like he was getting pericarditis but wanted to know the mechanism of action in the Paxlovid. He had taken two doses of Paxlovid and didn't sleep last night. He had a hard time sleeping anyway. He felt anxious. He started thinking about and wanted to know if there was connection with how the two drugs in Paxlovid and mRNA work. The caller stated that it sounds like they were different, and he would be ok. He wanted to know if there were similarities in how they get absorbed and how they function in the body. There was a Product complaint. This case was reported as non-serious.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200615411 similar report from same reporter
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Electrocardiogram, Heart rate increased, Hypertension, Myocardial infarction
Clinical narrative: Caller tested positive for Covid on 20Apr2022; Caller tested positive for Covid on 20Apr2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: ER2613) and on 12Apr2021 as dose 2, single (Lot number: ER8731) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "blockage" (unspecified if ongoing), notes: He had four heart attacks that was triggered by a blockage that no one knew about. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Apr2022, outcome "unknown" and all described as "Caller tested positive for Covid on 20Apr2022". The patient underwent the following laboratory tests and procedures: Angiogram: (Apr2021) three blockages, 2 at 90% and 1 at 99%.; Blood pressure measurement: (Apr2021) 200's; Cardiac function test: (08Apr2021) He didn't do great or terrible either, notes: On 08Apr2021 he had full cardiac workup and a nuclear study and stress EKG; Electrocardiogram: (08Apr2021) He didn't do great or terrible either, notes: On 08Apr2021 he had full cardiac workup and a nuclear study and stress EKG; Pericardial drainage test: (Sep2021) Positive for pericarditis in Sep2021; SARS-CoV-2 test: (20Apr2022) Positive, notes: A rapid test at home gave positive result; Heart rate: (unspecified date) High. Therapeutic measures were taken as a result of vaccination failure, covid-19. With the first vaccine the patient had no problems at all. With the second one he had big problems. The patient tested positive for COVID on Wednesday and when he called to get something for the symptoms he was prescribed Paxlovid. He started Paxlovid on 20Apr2022. Last night when going to bed he thought to double check the active mechanism of Paxlovid and to make sure it was not the same as the MRNA to make sure he didn't have the same thing happen. He stated he had already taken it for a day and it did not feel like he was getting pericarditis but wanted to know the mechanism of action in the Paxlovid. He had taken two doses of Paxlovid and didn't sleep last night. He had a hard time sleeping anyway. He felt anxious. He started thinking about and wanted to know if there was connection with how the two drugs in Paxlovid and mRNA work. The caller stated that it sounds like they were different, and he would be ok. He wanted to know if there were similarities in how they get absorbed and how they function in the body. There was a Product complaint. This case was reported as non-serious.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200615411 similar report from same reporter
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pericardial drainage test, Pericarditis, SARS-CoV-2 test, Sleep disorder
Clinical narrative: Caller tested positive for Covid on 20Apr2022; Caller tested positive for Covid on 20Apr2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: ER2613) and on 12Apr2021 as dose 2, single (Lot number: ER8731) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "blockage" (unspecified if ongoing), notes: He had four heart attacks that was triggered by a blockage that no one knew about. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Apr2022, outcome "unknown" and all described as "Caller tested positive for Covid on 20Apr2022". The patient underwent the following laboratory tests and procedures: Angiogram: (Apr2021) three blockages, 2 at 90% and 1 at 99%.; Blood pressure measurement: (Apr2021) 200's; Cardiac function test: (08Apr2021) He didn't do great or terrible either, notes: On 08Apr2021 he had full cardiac workup and a nuclear study and stress EKG; Electrocardiogram: (08Apr2021) He didn't do great or terrible either, notes: On 08Apr2021 he had full cardiac workup and a nuclear study and stress EKG; Pericardial drainage test: (Sep2021) Positive for pericarditis in Sep2021; SARS-CoV-2 test: (20Apr2022) Positive, notes: A rapid test at home gave positive result; Heart rate: (unspecified date) High. Therapeutic measures were taken as a result of vaccination failure, covid-19. With the first vaccine the patient had no problems at all. With the second one he had big problems. The patient tested positive for COVID on Wednesday and when he called to get something for the symptoms he was prescribed Paxlovid. He started Paxlovid on 20Apr2022. Last night when going to bed he thought to double check the active mechanism of Paxlovid and to make sure it was not the same as the MRNA to make sure he didn't have the same thing happen. He stated he had already taken it for a day and it did not feel like he was getting pericarditis but wanted to know the mechanism of action in the Paxlovid. He had taken two doses of Paxlovid and didn't sleep last night. He had a hard time sleeping anyway. He felt anxious. He started thinking about and wanted to know if there was connection with how the two drugs in Paxlovid and mRNA work. The caller stated that it sounds like they were different, and he would be ok. He wanted to know if there were similarities in how they get absorbed and how they function in the body. There was a Product complaint. This case was reported as non-serious.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200615411 similar report from same reporter
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Blood pressure measurement, COVID-19, Cardiac function test, Electrocardiogram
Clinical narrative: Caller tested positive for Covid on 20Apr2022; Caller tested positive for Covid on 20Apr2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: ER2613) and on 12Apr2021 as dose 2, single (Lot number: ER8731) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "blockage" (unspecified if ongoing), notes: He had four heart attacks that was triggered by a blockage that no one knew about. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Apr2022, outcome "unknown" and all described as "Caller tested positive for Covid on 20Apr2022". The patient underwent the following laboratory tests and procedures: Angiogram: (Apr2021) three blockages, 2 at 90% and 1 at 99%.; Blood pressure measurement: (Apr2021) 200's; Cardiac function test: (08Apr2021) He didn't do great or terrible either, notes: On 08Apr2021 he had full cardiac workup and a nuclear study and stress EKG; Electrocardiogram: (08Apr2021) He didn't do great or terrible either, notes: On 08Apr2021 he had full cardiac workup and a nuclear study and stress EKG; Pericardial drainage test: (Sep2021) Positive for pericarditis in Sep2021; SARS-CoV-2 test: (20Apr2022) Positive, notes: A rapid test at home gave positive result; Heart rate: (unspecified date) High. Therapeutic measures were taken as a result of vaccination failure, covid-19. With the first vaccine the patient had no problems at all. With the second one he had big problems. The patient tested positive for COVID on Wednesday and when he called to get something for the symptoms he was prescribed Paxlovid. He started Paxlovid on 20Apr2022. Last night when going to bed he thought to double check the active mechanism of Paxlovid and to make sure it was not the same as the MRNA to make sure he didn't have the same thing happen. He stated he had already taken it for a day and it did not feel like he was getting pericarditis but wanted to know the mechanism of action in the Paxlovid. He had taken two doses of Paxlovid and didn't sleep last night. He had a hard time sleeping anyway. He felt anxious. He started thinking about and wanted to know if there was connection with how the two drugs in Paxlovid and mRNA work. The caller stated that it sounds like they were different, and he would be ok. He wanted to know if there were similarities in how they get absorbed and how they function in the body. There was a Product complaint. This case was reported as non-serious.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200615411 similar report from same reporter
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Heart rate, Pericardial drainage test, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Caller tested positive for Covid on 20Apr2022; Caller tested positive for Covid on 20Apr2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: ER2613) and on 12Apr2021 as dose 2, single (Lot number: ER8731) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "blockage" (unspecified if ongoing), notes: He had four heart attacks that was triggered by a blockage that no one knew about. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Apr2022, outcome "unknown" and all described as "Caller tested positive for Covid on 20Apr2022". The patient underwent the following laboratory tests and procedures: Angiogram: (Apr2021) three blockages, 2 at 90% and 1 at 99%.; Blood pressure measurement: (Apr2021) 200's; Cardiac function test: (08Apr2021) He didn't do great or terrible either, notes: On 08Apr2021 he had full cardiac workup and a nuclear study and stress EKG; Electrocardiogram: (08Apr2021) He didn't do great or terrible either, notes: On 08Apr2021 he had full cardiac workup and a nuclear study and stress EKG; Pericardial drainage test: (Sep2021) Positive for pericarditis in Sep2021; SARS-CoV-2 test: (20Apr2022) Positive, notes: A rapid test at home gave positive result; Heart rate: (unspecified date) High. Therapeutic measures were taken as a result of vaccination failure, covid-19. With the first vaccine the patient had no problems at all. With the second one he had big problems. The patient tested positive for COVID on Wednesday and when he called to get something for the symptoms he was prescribed Paxlovid. He started Paxlovid on 20Apr2022. Last night when going to bed he thought to double check the active mechanism of Paxlovid and to make sure it was not the same as the MRNA to make sure he didn't have the same thing happen. He stated he had already taken it for a day and it did not feel like he was getting pericarditis but wanted to know the mechanism of action in the Paxlovid. He had taken two doses of Paxlovid and didn't sleep last night. He had a hard time sleeping anyway. He felt anxious. He started thinking about and wanted to know if there was connection with how the two drugs in Paxlovid and mRNA work. The caller stated that it sounds like they were different, and he would be ok. He wanted to know if there were similarities in how they get absorbed and how they function in the body. There was a Product complaint. This case was reported as non-serious.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200615411 similar report from same reporter
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine recipient was 17 when they received a dose of Moderna vaccine ( approved for 18 and up)
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Oxygen saturation decreased, Pyrexia, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID -19 Breakthrough: I was admitted to the hospital for 17 days, I had a high fever and low oxygen. I tested positive for COVID-19.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray abnormal, Computerised tomogram thorax abnormal, Cough, Dyspnoea, Fatigue
Clinical narrative: Acquired persistent cough and fever one day after vaccine (assumed it was side effect).  Cough persisted.  I went to Urgent Care on August 25, 2021 --received negative Covid results (false negative).  Health did not improve.  I felt as though I acquired pneumonia (constant fatigue and shortness of breath).  I returned to Urgent Care on Sept 2, 2021.  I received 2nd false negative on Covid test.  I insisted on chest x-ray.  Results showed massive clotting in right lung.....was immediately transported to hospital.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoxia, Pneumonia, Pulmonary embolism, Pulmonary thrombosis, Pyrexia
Clinical narrative: Acquired persistent cough and fever one day after vaccine (assumed it was side effect).  Cough persisted.  I went to Urgent Care on August 25, 2021 --received negative Covid results (false negative).  Health did not improve.  I felt as though I acquired pneumonia (constant fatigue and shortness of breath).  I returned to Urgent Care on Sept 2, 2021.  I received 2nd false negative on Covid test.  I insisted on chest x-ray.  Results showed massive clotting in right lung.....was immediately transported to hospital.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Sepsis
Clinical narrative: Acquired persistent cough and fever one day after vaccine (assumed it was side effect).  Cough persisted.  I went to Urgent Care on August 25, 2021 --received negative Covid results (false negative).  Health did not improve.  I felt as though I acquired pneumonia (constant fatigue and shortness of breath).  I returned to Urgent Care on Sept 2, 2021.  I received 2nd false negative on Covid test.  I insisted on chest x-ray.  Results showed massive clotting in right lung.....was immediately transported to hospital.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Fatigue, Head discomfort, Headache, Pyrexia
Clinical narrative: she started with fever; Vertigo/still has vertigo; Tinnitus/ still has tinnitus; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received about 3 months ago from the date of reporting, refer case US2022068156).   On 5th April 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 5th April 2022, 12 hrs after receiving Shingrix, the patient experienced fever, vertigo and tinnitus. The patient was treated with meclozine (Meclizine). On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the vertigo and tinnitus were not recovered/not resolved.   It was unknown if the reporter considered the fever, vertigo and tinnitus to be related to Shingrix.     Linked case(s) involving the same patient:  US2022068156   Additional Information: GSK Receipt Date: 21-APR-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix vaccine and experienced fever, vertigo and tinnitus about 12 hours after the vaccination. The fever had resolved, but still had vertigo and tinnitus. The patient went to an urgent care and they gave her Meclizine to treat the tinnitus and vertigo.  The patient didn't have any further information about the vaccines (lot number, expiry date) and disconnected prior to getting her date of birth. The reporter did not consent to follow-up. The reporter disconnected prior to asking to Follow up with HCP.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022068156:Same Reporter
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Tinnitus
Clinical narrative: she started with fever; Vertigo/still has vertigo; Tinnitus/ still has tinnitus; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received about 3 months ago from the date of reporting, refer case US2022068156).   On 5th April 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 5th April 2022, 12 hrs after receiving Shingrix, the patient experienced fever, vertigo and tinnitus. The patient was treated with meclozine (Meclizine). On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the vertigo and tinnitus were not recovered/not resolved.   It was unknown if the reporter considered the fever, vertigo and tinnitus to be related to Shingrix.     Linked case(s) involving the same patient:  US2022068156   Additional Information: GSK Receipt Date: 21-APR-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix vaccine and experienced fever, vertigo and tinnitus about 12 hours after the vaccination. The fever had resolved, but still had vertigo and tinnitus. The patient went to an urgent care and they gave her Meclizine to treat the tinnitus and vertigo.  The patient didn't have any further information about the vaccines (lot number, expiry date) and disconnected prior to getting her date of birth. The reporter did not consent to follow-up. The reporter disconnected prior to asking to Follow up with HCP.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022068156:Same Reporter
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Tinnitus, Vertigo
Clinical narrative: she started with fever; Vertigo/still has vertigo; Tinnitus/ still has tinnitus; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received about 3 months ago from the date of reporting, refer case US2022068156).   On 5th April 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 5th April 2022, 12 hrs after receiving Shingrix, the patient experienced fever, vertigo and tinnitus. The patient was treated with meclozine (Meclizine). On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the vertigo and tinnitus were not recovered/not resolved.   It was unknown if the reporter considered the fever, vertigo and tinnitus to be related to Shingrix.     Linked case(s) involving the same patient:  US2022068156   Additional Information: GSK Receipt Date: 21-APR-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix vaccine and experienced fever, vertigo and tinnitus about 12 hours after the vaccination. The fever had resolved, but still had vertigo and tinnitus. The patient went to an urgent care and they gave her Meclizine to treat the tinnitus and vertigo.  The patient didn't have any further information about the vaccines (lot number, expiry date) and disconnected prior to getting her date of birth. The reporter did not consent to follow-up. The reporter disconnected prior to asking to Follow up with HCP.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022068156:Same Reporter
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging neck, Pain in extremity, Palpitations, Paraesthesia, Sleep disorder
Clinical narrative: She got her vaccine at 11:30 AM, she went to bed, woke up on Monday morning between 2-3:00 AM, and the symptoms were the same as with the 2nd vaccine but more intense.  She woke up feeling her heart beating.  She was having a prickly like feeling all through her chest and through both arms, from the shoulder down to the fingers of both arms.  It was more intense than the 2nd vaccine.  She had this with the 2nd vaccine, and were more intense when lying down to go to bed, but when she got up if she was walking they would be less intense but still present.  Sitting down they were more intense.  Because of the experience with the 2nd she was not overly concerned, and felt comfortable it was not cardiac related as she had a full cardiac work up after the 2nd vaccine.  She mentioned to her PCP who felt it was symptoms from her neck, but never suggested any further treatment.  She is still having these symptoms now and sees a spinal doctor, talked to him who did not feel it was her neck.  He ordered an MRI of the neck did not show anything that would suggest it was related to her neck.  Then had nerve conduction study that showed that the ulnar nerve had  a little something, but nothing that would contribute to her symptoms.  She is going to see a neurologist.  The doctor for the nerve conduction study told her to go to a neurologist, and that it may be something more central nervous system (brain), and she plans to do that.    With the booster the symptoms stayed significant for a while but got less, but she still can feel the tingling/prickly feeling in her arms and also in her chest.    Cardiologist: After her work by Dr. he sent it to her PCP and to FU with her.  She waited for them to give her a call and did not get one.  She called and got a message from her PCP that she does not need to follow her until her next APT date.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging neck, Musculoskeletal discomfort, Nerve conduction studies abnormal, Palpitations, Paraesthesia
Clinical narrative: She got her vaccine at 11:30 AM, she went to bed, woke up on Monday morning between 2-3:00 AM, and the symptoms were the same as with the 2nd vaccine but more intense.  She woke up feeling her heart beating.  She was having a prickly like feeling all through her chest and through both arms, from the shoulder down to the fingers of both arms.  It was more intense than the 2nd vaccine.  She had this with the 2nd vaccine, and were more intense when lying down to go to bed, but when she got up if she was walking they would be less intense but still present.  Sitting down they were more intense.  Because of the experience with the 2nd she was not overly concerned, and felt comfortable it was not cardiac related as she had a full cardiac work up after the 2nd vaccine.  She mentioned to her PCP who felt it was symptoms from her neck, but never suggested any further treatment.  She is still having these symptoms now and sees a spinal doctor, talked to him who did not feel it was her neck.  He ordered an MRI of the neck did not show anything that would suggest it was related to her neck.  Then had nerve conduction study that showed that the ulnar nerve had  a little something, but nothing that would contribute to her symptoms.  She is going to see a neurologist.  The doctor for the nerve conduction study told her to go to a neurologist, and that it may be something more central nervous system (brain), and she plans to do that.    With the booster the symptoms stayed significant for a while but got less, but she still can feel the tingling/prickly feeling in her arms and also in her chest.    Cardiologist: After her work by Dr. he sent it to her PCP and to FU with her.  She waited for them to give her a call and did not get one.  She called and got a message from her PCP that she does not need to follow her until her next APT date.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ulnar nerve injury, Vaccine positive rechallenge
Clinical narrative: She got her vaccine at 11:30 AM, she went to bed, woke up on Monday morning between 2-3:00 AM, and the symptoms were the same as with the 2nd vaccine but more intense.  She woke up feeling her heart beating.  She was having a prickly like feeling all through her chest and through both arms, from the shoulder down to the fingers of both arms.  It was more intense than the 2nd vaccine.  She had this with the 2nd vaccine, and were more intense when lying down to go to bed, but when she got up if she was walking they would be less intense but still present.  Sitting down they were more intense.  Because of the experience with the 2nd she was not overly concerned, and felt comfortable it was not cardiac related as she had a full cardiac work up after the 2nd vaccine.  She mentioned to her PCP who felt it was symptoms from her neck, but never suggested any further treatment.  She is still having these symptoms now and sees a spinal doctor, talked to him who did not feel it was her neck.  He ordered an MRI of the neck did not show anything that would suggest it was related to her neck.  Then had nerve conduction study that showed that the ulnar nerve had  a little something, but nothing that would contribute to her symptoms.  She is going to see a neurologist.  The doctor for the nerve conduction study told her to go to a neurologist, and that it may be something more central nervous system (brain), and she plans to do that.    With the booster the symptoms stayed significant for a while but got less, but she still can feel the tingling/prickly feeling in her arms and also in her chest.    Cardiologist: After her work by Dr. he sent it to her PCP and to FU with her.  She waited for them to give her a call and did not get one.  She called and got a message from her PCP that she does not need to follow her until her next APT date.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Vibratory sense increased
Clinical narrative: severe muscle spasm; entire body violently shaking; This case was reported by a consumer via call center representative and described the occurrence of muscle spasm in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number N3755, expiry date 26th June 2023) for prophylaxis.   On 12th April 2022, the patient received the 1st dose of Shingrix. On 12th April 2022 15:00, less than a day after receiving Shingrix, the patient experienced muscle spasm and shaking. On an unknown date, the outcome of the muscle spasm and shaking were recovered/resolved.   It was unknown if the reporter considered the muscle spasm and shaking to be related to Shingrix.     Additional Information: GSK receipt date: 21-Apr-2022 Reporter's comment: The patient called and stated that he had his first dose of Shingrix in the morning and he laid down for a nap and woke up at 3 pm experiencing his entire body violently shaking and had sever muscle spasms. Gave medical disclaimer.  Referred to health care professional.  Spoken as per package insert and content.  Consented to follow-up.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Muscle spasms, Tremor
Clinical narrative: severe muscle spasm; entire body violently shaking; This case was reported by a consumer via call center representative and described the occurrence of muscle spasm in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number N3755, expiry date 26th June 2023) for prophylaxis.   On 12th April 2022, the patient received the 1st dose of Shingrix. On 12th April 2022 15:00, less than a day after receiving Shingrix, the patient experienced muscle spasm and shaking. On an unknown date, the outcome of the muscle spasm and shaking were recovered/resolved.   It was unknown if the reporter considered the muscle spasm and shaking to be related to Shingrix.     Additional Information: GSK receipt date: 21-Apr-2022 Reporter's comment: The patient called and stated that he had his first dose of Shingrix in the morning and he laid down for a nap and woke up at 3 pm experiencing his entire body violently shaking and had sever muscle spasms. Gave medical disclaimer.  Referred to health care professional.  Spoken as per package insert and content.  Consented to follow-up.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Cyst, Immune system disorder, Pain in extremity, Skin mass
Clinical narrative: she caught Covid; she caught Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EN6208), in left arm and on 31Mar2021 as dose 2, single (Lot number: EW0150) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "she caught Covid".  Additional information: Caller states she got the Pfizer Vaccines back in 10Mar2021, then she got a back up dose, her second dose on 31Mar2021, states within 6 months she came down with subcutaneous soft cystic nodules, went to a dermatologist and that is what they diagnosed her with. States she went to her doctor in Sep2021, sent her to a dermatologist in Nov2021, that is when she was diagnosed, states she just had one cyst to begin with and now has 4 on right leg and 3 on left leg, 4 on her back and some on each side of her chest, started with one on her hip. States in Jan2022, she caught Covid and the cysts all went away, states now in Mar2022 they all came back. Caller states she figures it is from the Covid vaccines because she never had any of this before she got the shots. States they hurt like hell. Caller states she will be seeing a surgeon to get them removed, states they have to do an MRI first. Patient wants to know if this is a side effect of the vaccines or not.   No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: she caught Covid; she caught Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EN6208), in left arm and on 31Mar2021 as dose 2, single (Lot number: EW0150) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "she caught Covid".  Additional information: Caller states she got the Pfizer Vaccines back in 10Mar2021, then she got a back up dose, her second dose on 31Mar2021, states within 6 months she came down with subcutaneous soft cystic nodules, went to a dermatologist and that is what they diagnosed her with. States she went to her doctor in Sep2021, sent her to a dermatologist in Nov2021, that is when she was diagnosed, states she just had one cyst to begin with and now has 4 on right leg and 3 on left leg, 4 on her back and some on each side of her chest, started with one on her hip. States in Jan2022, she caught Covid and the cysts all went away, states now in Mar2022 they all came back. Caller states she figures it is from the Covid vaccines because she never had any of this before she got the shots. States they hurt like hell. Caller states she will be seeing a surgeon to get them removed, states they have to do an MRI first. Patient wants to know if this is a side effect of the vaccines or not.   No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Cough, Fatigue, Gastrointestinal pain, Headache
Clinical narrative: Since the vaccination, has the patient been tested for COVID-19?:Yes; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 at 08:00 as dose 1, single (Lot number: EN6199), in right arm, on 24Mar2021 at 20:00 as dose 2, single (Lot number: ER8727), in right arm and on 26Sep2021 at 12:00 as dose 3 (booster), single (Lot number: FC3182) at the age of 47 years, in right arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto thyroiditis" (unspecified if ongoing); "anxiety/depression" (unspecified if ongoing); "environmental allergies" (unspecified if ongoing); "anxiety/depression" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; EFFEXOR; FLONASE [MOMETASONE FUROATE]; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: COVID-19 (medically significant) with onset 23Apr2022, outcome "recovering"; VACCINATION FAILURE (medically significant) with onset 23Apr2022, outcome "unknown", described as "Since the vaccination, has the patient been tested for COVID-19?:Yes". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Apr2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Ocular discomfort, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Since the vaccination, has the patient been tested for COVID-19?:Yes; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 at 08:00 as dose 1, single (Lot number: EN6199), in right arm, on 24Mar2021 at 20:00 as dose 2, single (Lot number: ER8727), in right arm and on 26Sep2021 at 12:00 as dose 3 (booster), single (Lot number: FC3182) at the age of 47 years, in right arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto thyroiditis" (unspecified if ongoing); "anxiety/depression" (unspecified if ongoing); "environmental allergies" (unspecified if ongoing); "anxiety/depression" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; EFFEXOR; FLONASE [MOMETASONE FUROATE]; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: COVID-19 (medically significant) with onset 23Apr2022, outcome "recovering"; VACCINATION FAILURE (medically significant) with onset 23Apr2022, outcome "unknown", described as "Since the vaccination, has the patient been tested for COVID-19?:Yes". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Apr2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Sinus congestion, Sneezing
Clinical narrative: Since the vaccination, has the patient been tested for COVID-19?:Yes; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 at 08:00 as dose 1, single (Lot number: EN6199), in right arm, on 24Mar2021 at 20:00 as dose 2, single (Lot number: ER8727), in right arm and on 26Sep2021 at 12:00 as dose 3 (booster), single (Lot number: FC3182) at the age of 47 years, in right arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto thyroiditis" (unspecified if ongoing); "anxiety/depression" (unspecified if ongoing); "environmental allergies" (unspecified if ongoing); "anxiety/depression" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; EFFEXOR; FLONASE [MOMETASONE FUROATE]; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: COVID-19 (medically significant) with onset 23Apr2022, outcome "recovering"; VACCINATION FAILURE (medically significant) with onset 23Apr2022, outcome "unknown", described as "Since the vaccination, has the patient been tested for COVID-19?:Yes". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Apr2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Since the vaccination, has the patient been tested for COVID-19?:Yes; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 at 08:00 as dose 1, single (Lot number: EN6199), in right arm, on 24Mar2021 at 20:00 as dose 2, single (Lot number: ER8727), in right arm and on 26Sep2021 at 12:00 as dose 3 (booster), single (Lot number: FC3182) at the age of 47 years, in right arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto thyroiditis" (unspecified if ongoing); "anxiety/depression" (unspecified if ongoing); "environmental allergies" (unspecified if ongoing); "anxiety/depression" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; EFFEXOR; FLONASE [MOMETASONE FUROATE]; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: COVID-19 (medically significant) with onset 23Apr2022, outcome "recovering"; VACCINATION FAILURE (medically significant) with onset 23Apr2022, outcome "unknown", described as "Since the vaccination, has the patient been tested for COVID-19?:Yes". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Apr2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: I received two Pfizer vaccinations, one Pfizer booster, and this last one was a Moderna booster. On April 18 I had a headache, diarrhea, and a fever of 101.5 F. I took extra strength Tylenol and took a home test for Covid, which gave a negative result. The next day I called my doctor?s office because I didn?t know what to do. The nurse gave me advice for diarrhea and told me if I still had a fever to call back the following day. My temperature on April 19 was 100.9 F and the next day my temperature was normal. The headache and diarrhea dissipated and I did not contact my doctor?s office.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: 5 year old patient received the adult (30 mcg) dose of the Pfizer COVID-19 vaccine rather than the pediatric (10 mcg) dose. Patient did not experience any immediate side effects.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Peripheral swelling, Trigger finger
Clinical narrative: The evening of the booster, I could not make a fist/could not close my hand. Now, 6 months later, I have "trigger finger" in my middle finger; severe swelling on the top knuckle of the forth finger and pinkie finger on the same hand.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: The day after receiving the Shingrix vaccine, symptoms of shingles in my right eye began to appear.    Within less than a week Dr diagnosed it as shingles.   She prescribed Valacyclovir,  Prednisolone Ac 1% Eye Drop, Gabapentin, Ibuprofen, Acetaminophen. The incredibly intense pain lasted 6 weeks.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram abnormal, Headache, Injection site pain, Injection site pruritus
Clinical narrative: Low-grade fever (99.9), severe headache, chest pain, swelling of armpit (of the injected arm), swelling of injected arm, severe pain of injected arm, itching of injected arm and severe body ache. I saw my doctor on 4/27/2022 and he did an EKG that concerned him. Now I have to go get a  stress test with ECHO.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, Pyrexia, Swelling
Clinical narrative: Low-grade fever (99.9), severe headache, chest pain, swelling of armpit (of the injected arm), swelling of injected arm, severe pain of injected arm, itching of injected arm and severe body ache. I saw my doctor on 4/27/2022 and he did an EKG that concerned him. Now I have to go get a  stress test with ECHO.