chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lethargy, Pain in extremity, SARS-CoV-2 test
Clinical narrative: sore arm; lethargic; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 13 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 09Oct2021 15:00 (Batch/Lot number: unknown) at the age of 13 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cold-induced asthma" (unspecified if ongoing); "COVID" (unspecified if ongoing), notes: if Covid prior vaccination: Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose:, lot number: 301308A, Dose administrator route: Intramuscular, vaccine location: Left arm), administration date: 18Sep2021, when the patient was 13 years old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10Oct2021 12:00, outcome "recovered" (2021), described as "sore arm"; LETHARGY (non-serious) with onset 10Oct2021 12:00, outcome "recovered" (2021), described as "lethargic". The event "sore arm" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. The patient underwent lab test which included the rapid PCR (45min) with Nasal Swab was negative on 12Oct2021. Therapeutic measures were taken as a result of pain in extremity, lethargy.   where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store  The patient receive didn't any other vaccines within 4 weeks prior to the COVID vaccine. The patient received within 2 weeks of vaccination was No. Reported Event: Day after vaccine, patient had sore arm and was lethargic. Two days after vaccine, at 08:30am, patient received Flu shot and HPV shot and then experienced fever, coughing, respiratory distress, sore throat, lethargy. Symptoms continued for several days. Dr prescribed one dose of decadrone (oral steroid) and daily albuterol. Day 8 patient was back to normal, no symptoms. The patient received treatment Decadrone (oral steroid), Albuterol.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, Eye pruritus, SARS-CoV-2 test
Clinical narrative: I had a really bad blood shot eye on a Friday and I said if it's bad by Monday; I had a really bad blood shot eye on a Friday and I said if it's bad by Monday; 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 female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization, reaction(s): "COVID-19", "My eyes were itching". The following information was reported: CONDITION AGGRAVATED (non-serious), OCULAR HYPERAEMIA (non-serious), outcome "unknown" and all described as "I had a really bad blood shot eye on a Friday and I said if it's bad by Monday". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information  "My eyes were itching  I do have allergies  so I put drop in and it goes away. So I went up and got a rapid test for the heck of it and I tested positive. but I felt fine, I had no symptoms other than my itchy eyes you know that went away with my allergies. I was great but I had to quarantine for 10 days then I went and got my second vaccine. Well, 22Oct with be 6 months. Well I went in on Monday, again for the heck of it and got an antibody test, well I tested positive and the 1GM I tested negative. So I do have antibodies in me which could be that I had COVID at some time, correct? That was one question and here is the other question Here is another thing about 3 weeks ago I had a really bad blood shot eye on a Friday and I said if it's bad by Monday  I will call the Withheld then I put drops in and it went away. Well I was reading online last night that blood shot eyes is a symptom of Covid. Caller states I know you have to wait 6 months to get the booster but what is the longest length of time I could wait to get the booster.  What's the longest time you could wait to get it with it you know being effective? I know it says at least 6 months but can you go 10 months 12 months before you get it? 1st attempt call to obtain mailing address for reporter in slider #1 not completed due to it was already obtained in cross-reference case #. Please add the following address for reporter in slider #1 in this case as follows: (Address withheld).  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antibody test, Blood immunoglobulin M, Condition aggravated, Ocular hyperaemia
Clinical narrative: I had a really bad blood shot eye on a Friday and I said if it's bad by Monday; I had a really bad blood shot eye on a Friday and I said if it's bad by Monday; 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 female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization, reaction(s): "COVID-19", "My eyes were itching". The following information was reported: CONDITION AGGRAVATED (non-serious), OCULAR HYPERAEMIA (non-serious), outcome "unknown" and all described as "I had a really bad blood shot eye on a Friday and I said if it's bad by Monday". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information  "My eyes were itching  I do have allergies  so I put drop in and it goes away. So I went up and got a rapid test for the heck of it and I tested positive. but I felt fine, I had no symptoms other than my itchy eyes you know that went away with my allergies. I was great but I had to quarantine for 10 days then I went and got my second vaccine. Well, 22Oct with be 6 months. Well I went in on Monday, again for the heck of it and got an antibody test, well I tested positive and the 1GM I tested negative. So I do have antibodies in me which could be that I had COVID at some time, correct? That was one question and here is the other question Here is another thing about 3 weeks ago I had a really bad blood shot eye on a Friday and I said if it's bad by Monday  I will call the Withheld then I put drops in and it went away. Well I was reading online last night that blood shot eyes is a symptom of Covid. Caller states I know you have to wait 6 months to get the booster but what is the longest length of time I could wait to get the booster.  What's the longest time you could wait to get it with it you know being effective? I know it says at least 6 months but can you go 10 months 12 months before you get it? 1st attempt call to obtain mailing address for reporter in slider #1 not completed due to it was already obtained in cross-reference case #. Please add the following address for reporter in slider #1 in this case as follows: (Address withheld).  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Abdominal pain, Chills, Headache, Nausea, Vomiting
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (nurse) from medical information team via Company Representative. A 16 year-old female patient received Meningococcal group B rlp2086 (TRUMENBA,NDC number of Trumenba: 005-0100-10), intramuscular, administered in deltoid left, administration date 18Nov2021 16:26 (Lot number: ER2622, Expiration Date: Jan2024) at the age of 16 years as dose number unknown, 0.5 ml, single for immunisation; Meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA,manufacturer: Sanofi,NDC number of Menactra: 49281-589-05), administered in arm left, administration date 18Nov2021 (Lot number: U7208AA, Expiration Date: 10Feb2023) as dose number unknown,0.5 ml, single for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HEADACHE (medically significant) with onset 18Nov2021, outcome "recovered" (Nov2021), described as "10/10 headache"; NAUSEA (non-serious) with onset 18Nov2021, outcome "recovered" (Nov2021), described as "nausea"; VOMITING (non-serious) with onset 18Nov2021, outcome "recovered" (Nov2021), described as "vomiting"; CHILLS (non-serious) with onset 18Nov2021, outcome "recovered" (Nov2021), described as "shivering". The events "10/10 headache", "nausea", "vomiting" and "shivering" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of headache, nausea, vomiting, chills.Administered Zofran and Ibuprofen.Vaccination Facility Type was Physician Office. Relevant Tests: None. Event was occurred in 1 hour. Sender's Comments: Based on a drug event temporal association and on the compatibility with the known adverse event profile of the suspect product, the company cannot completely exclude a reasonable possibility that the suspect vaccine Meningococcal group B rlp2086 may have contributed to the onset of reported serious event headache. The impact of this report on the benefit/risk profile of the Pfizer product 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: 16.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Chills, Headache, Nausea, Vomiting
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (nurse) from medical information team via Company Representative. A 16 year-old female patient received Meningococcal group B rlp2086 (TRUMENBA,NDC number of Trumenba: 005-0100-10), intramuscular, administered in deltoid left, administration date 18Nov2021 16:26 (Lot number: ER2622, Expiration Date: Jan2024) at the age of 16 years as dose number unknown, 0.5 ml, single for immunisation; Meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA,manufacturer: Sanofi,NDC number of Menactra: 49281-589-05), administered in arm left, administration date 18Nov2021 (Lot number: U7208AA, Expiration Date: 10Feb2023) as dose number unknown,0.5 ml, single for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HEADACHE (medically significant) with onset 18Nov2021, outcome "recovered" (Nov2021), described as "10/10 headache"; NAUSEA (non-serious) with onset 18Nov2021, outcome "recovered" (Nov2021), described as "nausea"; VOMITING (non-serious) with onset 18Nov2021, outcome "recovered" (Nov2021), described as "vomiting"; CHILLS (non-serious) with onset 18Nov2021, outcome "recovered" (Nov2021), described as "shivering". The events "10/10 headache", "nausea", "vomiting" and "shivering" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of headache, nausea, vomiting, chills.Administered Zofran and Ibuprofen.Vaccination Facility Type was Physician Office. Relevant Tests: None. Event was occurred in 1 hour. Sender's Comments: Based on a drug event temporal association and on the compatibility with the known adverse event profile of the suspect product, the company cannot completely exclude a reasonable possibility that the suspect vaccine Meningococcal group B rlp2086 may have contributed to the onset of reported serious event headache. The impact of this report on the benefit/risk profile of the Pfizer product 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: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, Computerised tomogram, Deafness, Ear discomfort, Tinnitus
Clinical narrative: hearing loss; right ear was so stuffy I could not hear out of it; issues hearing; fluid in the ear; Tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 07Apr2021 10:00 (Lot number: ER8737) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: Name of Drug as Reported: No. There were no concomitant medications. The following information was reported: DEAFNESS (medically significant) with onset 10Apr2021, outcome "not recovered", described as "hearing loss"; HYPOACUSIS (non-serious) with onset 10Apr2021, outcome "not recovered", described as "right ear was so stuffy I could not hear out of it"; HEARING DISABILITY (non-serious) with onset 10Apr2021, outcome "not recovered", described as "issues hearing"; EAR DISORDER (non-serious) with onset 10Apr2021, outcome "not recovered", described as "fluid in the ear"; TINNITUS (non-serious) with onset 10Apr2021, outcome "not recovered", described as "Tinnitus". The events "hearing loss", "right ear was so stuffy i could not hear out of it", "issues hearing", "fluid in the ear" and "tinnitus" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: computerised tomogram: (2021) unknown results; sars-cov-2 test: (Aug2021) negative. Therapeutic measures were taken as a result of deafness, hypoacusis, hearing disability, ear disorder, tinnitus. The patient received bnt162b2 (BNT162B2), administration date 14May2021 10:00 AM (Lot number: EP6955) as dose 2, single for covid-19 immunisation. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient received no other medications within 2 weeks of vaccination. No known allergies reported. 3 days after first dose, right ear was so stuffy I could not hear out of it. Went to Dr. with diagnosis of fluid in the ear and got a shot of anti-biotics. Weeks after ear still felt stuffy, issues hearing. Went to specialist for testing. Now suffer from hearing loss and Tinnitus to this day. The patient received the Antibiotics therapy for claimed events. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  No follow up attempts needed. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Deafness, Ear disorder, Hearing disability, Hypoacusis
Clinical narrative: hearing loss; right ear was so stuffy I could not hear out of it; issues hearing; fluid in the ear; Tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 07Apr2021 10:00 (Lot number: ER8737) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: Name of Drug as Reported: No. There were no concomitant medications. The following information was reported: DEAFNESS (medically significant) with onset 10Apr2021, outcome "not recovered", described as "hearing loss"; HYPOACUSIS (non-serious) with onset 10Apr2021, outcome "not recovered", described as "right ear was so stuffy I could not hear out of it"; HEARING DISABILITY (non-serious) with onset 10Apr2021, outcome "not recovered", described as "issues hearing"; EAR DISORDER (non-serious) with onset 10Apr2021, outcome "not recovered", described as "fluid in the ear"; TINNITUS (non-serious) with onset 10Apr2021, outcome "not recovered", described as "Tinnitus". The events "hearing loss", "right ear was so stuffy i could not hear out of it", "issues hearing", "fluid in the ear" and "tinnitus" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: computerised tomogram: (2021) unknown results; sars-cov-2 test: (Aug2021) negative. Therapeutic measures were taken as a result of deafness, hypoacusis, hearing disability, ear disorder, tinnitus. The patient received bnt162b2 (BNT162B2), administration date 14May2021 10:00 AM (Lot number: EP6955) as dose 2, single for covid-19 immunisation. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient received no other medications within 2 weeks of vaccination. No known allergies reported. 3 days after first dose, right ear was so stuffy I could not hear out of it. Went to Dr. with diagnosis of fluid in the ear and got a shot of anti-biotics. Weeks after ear still felt stuffy, issues hearing. Went to specialist for testing. Now suffer from hearing loss and Tinnitus to this day. The patient received the Antibiotics therapy for claimed events. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  No follow up attempts needed. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test, Tinnitus
Clinical narrative: hearing loss; right ear was so stuffy I could not hear out of it; issues hearing; fluid in the ear; Tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 07Apr2021 10:00 (Lot number: ER8737) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: Name of Drug as Reported: No. There were no concomitant medications. The following information was reported: DEAFNESS (medically significant) with onset 10Apr2021, outcome "not recovered", described as "hearing loss"; HYPOACUSIS (non-serious) with onset 10Apr2021, outcome "not recovered", described as "right ear was so stuffy I could not hear out of it"; HEARING DISABILITY (non-serious) with onset 10Apr2021, outcome "not recovered", described as "issues hearing"; EAR DISORDER (non-serious) with onset 10Apr2021, outcome "not recovered", described as "fluid in the ear"; TINNITUS (non-serious) with onset 10Apr2021, outcome "not recovered", described as "Tinnitus". The events "hearing loss", "right ear was so stuffy i could not hear out of it", "issues hearing", "fluid in the ear" and "tinnitus" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: computerised tomogram: (2021) unknown results; sars-cov-2 test: (Aug2021) negative. Therapeutic measures were taken as a result of deafness, hypoacusis, hearing disability, ear disorder, tinnitus. The patient received bnt162b2 (BNT162B2), administration date 14May2021 10:00 AM (Lot number: EP6955) as dose 2, single for covid-19 immunisation. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient received no other medications within 2 weeks of vaccination. No known allergies reported. 3 days after first dose, right ear was so stuffy I could not hear out of it. Went to Dr. with diagnosis of fluid in the ear and got a shot of anti-biotics. Weeks after ear still felt stuffy, issues hearing. Went to specialist for testing. Now suffer from hearing loss and Tinnitus to this day. The patient received the Antibiotics therapy for claimed events. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  No follow up attempts needed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electroencephalogram, Generalised tonic-clonic seizure, Magnetic resonance imaging head
Clinical narrative: seizure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 11 year-old male patient received bnt162b2 (BNT162B2), administration date 20Nov2021 (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SEIZURE (medically significant) with onset 21Nov2021, outcome "unknown", described as "seizure". The event "seizure" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of seizure. Clinical course: On 21Nov2021, the patient experienced his first seizure that lasted about 1 minute. On 28Nov2021, the patient had two other seizures, one seizure in the morning that lasted about 30 seconds and another seizure in the evening that lasted about 2 and a half minutes to 3 minutes. The caller took the patient to the ER after the last seizure in the evening of 28Nov2021 where he was prescribed anti-seizure medication. The caller wanted to know if anyone else had experienced this side effect and wanted to know if there were any treatment recommendations. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Diarrhoea, Generalised tonic-clonic seizure, Nightmare, Pain in extremity, Seizure
Clinical narrative: seizure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 11 year-old male patient received bnt162b2 (BNT162B2), administration date 20Nov2021 (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SEIZURE (medically significant) with onset 21Nov2021, outcome "unknown", described as "seizure". The event "seizure" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of seizure. Clinical course: On 21Nov2021, the patient experienced his first seizure that lasted about 1 minute. On 28Nov2021, the patient had two other seizures, one seizure in the morning that lasted about 30 seconds and another seizure in the evening that lasted about 2 and a half minutes to 3 minutes. The caller took the patient to the ER after the last seizure in the evening of 28Nov2021 where he was prescribed anti-seizure medication. The caller wanted to know if anyone else had experienced this side effect and wanted to know if there were any treatment recommendations. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Somnolence
Clinical narrative: seizure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 11 year-old male patient received bnt162b2 (BNT162B2), administration date 20Nov2021 (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SEIZURE (medically significant) with onset 21Nov2021, outcome "unknown", described as "seizure". The event "seizure" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of seizure. Clinical course: On 21Nov2021, the patient experienced his first seizure that lasted about 1 minute. On 28Nov2021, the patient had two other seizures, one seizure in the morning that lasted about 30 seconds and another seizure in the evening that lasted about 2 and a half minutes to 3 minutes. The caller took the patient to the ER after the last seizure in the evening of 28Nov2021 where he was prescribed anti-seizure medication. The caller wanted to know if anyone else had experienced this side effect and wanted to know if there were any treatment recommendations. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Seizure
Clinical narrative: seizure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 11 year-old male patient received bnt162b2 (BNT162B2), administration date 20Nov2021 (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SEIZURE (medically significant) with onset 21Nov2021, outcome "unknown", described as "seizure". The event "seizure" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of seizure. Clinical course: On 21Nov2021, the patient experienced his first seizure that lasted about 1 minute. On 28Nov2021, the patient had two other seizures, one seizure in the morning that lasted about 30 seconds and another seizure in the evening that lasted about 2 and a half minutes to 3 minutes. The caller took the patient to the ER after the last seizure in the evening of 28Nov2021 where he was prescribed anti-seizure medication. The caller wanted to know if anyone else had experienced this side effect and wanted to know if there were any treatment recommendations. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Muscle tightness, Neck pain, Pain in extremity, Paraesthesia
Clinical narrative: Severe right shoulder, neck and arm pain; Severe right shoulder, neck and arm pain; Severe right shoulder, neck and arm pain; Muscle tightness; Aches; Finger tingling; Dose 1: 07Apr2021, Dose 2: 30Sep2021; This is a spontaneous report from a contactable reporter (consumer). The reporter is the patient.   A 30 year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in right arm, administration date 30Sep2021 at 12:00 (Batch/Lot number: 506780) at the age of 30 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "COVID-19". Concomitant medications were not reported. Vaccination history included: BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 1, SINGLE, Lot Number: EW0153, Anatomical site: Left Arm, Route of administration: Unspecified, Administration time: 12:00), administration date: 07Apr2021, when the patient was 30 years old, for COVID-19 immunisation.  The following information was reported: ARTHRALGIA (non-serious), NECK PAIN (non-serious), PAIN IN EXTREMITY (non-serious), MUSCLE TIGHTNESS (non-serious), PAIN (non-serious), PARAESTHESIA (non-serious) all with onset 01Oct2021 at 06:00, outcome "not recovered", and all described as "severe right shoulder, neck and arm pain, muscle tightness, aches and finger tingling.'' The events severe right shoulder, neck and arm pain, muscle tightness, aches and finger tingling were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia, neck pain, pain in extremity, muscle tightness, pain and paraesthesia.   Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Therapeutic measures were taken as a result of arthralgia, neck pain, pain in extremity, muscle tightness, pain and paraesthesia and included treatment with chiropractor, cupping and acupuncture.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Inappropriate schedule of product administration, Muscle tightness, Neck pain, Pain
Clinical narrative: Severe right shoulder, neck and arm pain; Severe right shoulder, neck and arm pain; Severe right shoulder, neck and arm pain; Muscle tightness; Aches; Finger tingling; Dose 1: 07Apr2021, Dose 2: 30Sep2021; This is a spontaneous report from a contactable reporter (consumer). The reporter is the patient.   A 30 year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in right arm, administration date 30Sep2021 at 12:00 (Batch/Lot number: 506780) at the age of 30 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "COVID-19". Concomitant medications were not reported. Vaccination history included: BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 1, SINGLE, Lot Number: EW0153, Anatomical site: Left Arm, Route of administration: Unspecified, Administration time: 12:00), administration date: 07Apr2021, when the patient was 30 years old, for COVID-19 immunisation.  The following information was reported: ARTHRALGIA (non-serious), NECK PAIN (non-serious), PAIN IN EXTREMITY (non-serious), MUSCLE TIGHTNESS (non-serious), PAIN (non-serious), PARAESTHESIA (non-serious) all with onset 01Oct2021 at 06:00, outcome "not recovered", and all described as "severe right shoulder, neck and arm pain, muscle tightness, aches and finger tingling.'' The events severe right shoulder, neck and arm pain, muscle tightness, aches and finger tingling were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia, neck pain, pain in extremity, muscle tightness, pain and paraesthesia.   Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Therapeutic measures were taken as a result of arthralgia, neck pain, pain in extremity, muscle tightness, pain and paraesthesia and included treatment with chiropractor, cupping and acupuncture.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia, SARS-CoV-2 test
Clinical narrative: Severe right shoulder, neck and arm pain; Severe right shoulder, neck and arm pain; Severe right shoulder, neck and arm pain; Muscle tightness; Aches; Finger tingling; Dose 1: 07Apr2021, Dose 2: 30Sep2021; This is a spontaneous report from a contactable reporter (consumer). The reporter is the patient.   A 30 year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in right arm, administration date 30Sep2021 at 12:00 (Batch/Lot number: 506780) at the age of 30 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "COVID-19". Concomitant medications were not reported. Vaccination history included: BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 1, SINGLE, Lot Number: EW0153, Anatomical site: Left Arm, Route of administration: Unspecified, Administration time: 12:00), administration date: 07Apr2021, when the patient was 30 years old, for COVID-19 immunisation.  The following information was reported: ARTHRALGIA (non-serious), NECK PAIN (non-serious), PAIN IN EXTREMITY (non-serious), MUSCLE TIGHTNESS (non-serious), PAIN (non-serious), PARAESTHESIA (non-serious) all with onset 01Oct2021 at 06:00, outcome "not recovered", and all described as "severe right shoulder, neck and arm pain, muscle tightness, aches and finger tingling.'' The events severe right shoulder, neck and arm pain, muscle tightness, aches and finger tingling were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia, neck pain, pain in extremity, muscle tightness, pain and paraesthesia.   Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Therapeutic measures were taken as a result of arthralgia, neck pain, pain in extremity, muscle tightness, pain and paraesthesia and included treatment with chiropractor, cupping and acupuncture.
Age: 9.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Electrocardiogram normal, Fatigue, Headache, Myocarditis
Clinical narrative: Pt received 2nd COVID vaccine in Rt arm.  Several hours later he complained of chest pain and palpitations.  Per message from mother left on  VM he was diagnosed with myocarditis. She wanted to let urgent care be aware in case "we needed to report it"
Age: 9.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Troponin increased
Clinical narrative: Pt received 2nd COVID vaccine in Rt arm.  Several hours later he complained of chest pain and palpitations.  Per message from mother left on  VM he was diagnosed with myocarditis. She wanted to let urgent care be aware in case "we needed to report it"
Age: 9.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Myocarditis, Palpitations
Clinical narrative: Pt received 2nd COVID vaccine in Rt arm.  Several hours later he complained of chest pain and palpitations.  Per message from mother left on  VM he was diagnosed with myocarditis. She wanted to let urgent care be aware in case "we needed to report it"
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Fall, Pain, Pain in extremity
Clinical narrative: BITTER TASTE IN MOUTH; STARTED HURTING ON LEGS, FEET, HEELS AND MUSCLES; STINGING ON LEFT ARM; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: sulfonamide allergy, and other pre-existing medical conditions included: No medication. The patient experienced drug allergy when treated with thiamine hydrochloride, and tramadol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 17-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 17-NOV-2021, the patient experienced stinging on left arm. On 18-NOV-2021, the patient experienced bitter taste in mouth. On 18-NOV-2021, the patient experienced started hurting on legs, feet, heels and muscles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from bitter taste in mouth, and had not recovered from stinging on left arm, and started hurting on legs, feet, heels and muscles. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia, Pain, Pain in extremity
Clinical narrative: BITTER TASTE IN MOUTH; STARTED HURTING ON LEGS, FEET, HEELS AND MUSCLES; STINGING ON LEFT ARM; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: sulfonamide allergy, and other pre-existing medical conditions included: No medication. The patient experienced drug allergy when treated with thiamine hydrochloride, and tramadol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 17-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 17-NOV-2021, the patient experienced stinging on left arm. On 18-NOV-2021, the patient experienced bitter taste in mouth. On 18-NOV-2021, the patient experienced started hurting on legs, feet, heels and muscles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from bitter taste in mouth, and had not recovered from stinging on left arm, and started hurting on legs, feet, heels and muscles. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Condition aggravated, Dizziness, Electric shock sensation, Injection site mass
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Today, 12/03/2021, patient is stating her symptoms started to improve at approximately 12pm. Patient still has throbbing pain on the upper Left arm, but the swelling has reduced by 50% on deltoid muscle. Her armpit swelling is still present, but the swelling has improved since 12/02/2021. Patient is still having tingling and radiating pain to her extremities/fingertips, in addition to ringing (tinnitus) in the left ear.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Injection site warmth, Musculoskeletal chest pain, Tinnitus
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Today, 12/03/2021, patient is stating her symptoms started to improve at approximately 12pm. Patient still has throbbing pain on the upper Left arm, but the swelling has reduced by 50% on deltoid muscle. Her armpit swelling is still present, but the swelling has improved since 12/02/2021. Patient is still having tingling and radiating pain to her extremities/fingertips, in addition to ringing (tinnitus) in the left ear.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain, Paraesthesia
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Today, 12/03/2021, patient is stating her symptoms started to improve at approximately 12pm. Patient still has throbbing pain on the upper Left arm, but the swelling has reduced by 50% on deltoid muscle. Her armpit swelling is still present, but the swelling has improved since 12/02/2021. Patient is still having tingling and radiating pain to her extremities/fingertips, in addition to ringing (tinnitus) in the left ear.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Today, 12/03/2021, patient is stating her symptoms started to improve at approximately 12pm. Patient still has throbbing pain on the upper Left arm, but the swelling has reduced by 50% on deltoid muscle. Her armpit swelling is still present, but the swelling has improved since 12/02/2021. Patient is still having tingling and radiating pain to her extremities/fingertips, in addition to ringing (tinnitus) in the left ear.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood glucose normal, Chest X-ray normal, Chest discomfort, Chest pain, Chills
Clinical narrative: Patient presented with chest pain and elevated troponins 48 hours following his second covid vaccine dose. Elevated troponin and ST segment changes on EKG. Normal LVEF on ECHO and normal coronary anatomy. Troponin, EKG changes and chest pain resolved at the time of discharge.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Echocardiogram normal, Electrocardiogram ST segment depression, Headache, Metabolic function test normal, Pyrexia
Clinical narrative: Patient presented with chest pain and elevated troponins 48 hours following his second covid vaccine dose. Elevated troponin and ST segment changes on EKG. Normal LVEF on ECHO and normal coronary anatomy. Troponin, EKG changes and chest pain resolved at the time of discharge.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Troponin increased
Clinical narrative: Patient presented with chest pain and elevated troponins 48 hours following his second covid vaccine dose. Elevated troponin and ST segment changes on EKG. Normal LVEF on ECHO and normal coronary anatomy. Troponin, EKG changes and chest pain resolved at the time of discharge.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chest pain, Echocardiogram normal, Ejection fraction, Electrocardiogram ST segment abnormal, Troponin increased
Clinical narrative: Patient presented with chest pain and elevated troponins 48 hours following his second covid vaccine dose. Elevated troponin and ST segment changes on EKG. Normal LVEF on ECHO and normal coronary anatomy. Troponin, EKG changes and chest pain resolved at the time of discharge.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAP, DTAP, IPV, MMRV
Symptoms: Breath holding, Excessive eye blinking, Full blood count normal, Metabolic function test normal, Rhinorrhoea
Clinical narrative: Patient had his 4 year checkup on 3/12/21. Everything was perfect and no concerns. He had his recommended 4 year vaccines. When he woke up the next am on 3/13/21, he was rolling his head and his eyes. Patient was very agitated and emotionally not himself. He also appeared hyper active for short periods of time. The head rolling and eye rolling stopped and progressed into a sniff. This happened for a month and ended up going away. In September 2021, patient got sick and developed a fever. The sniffing reappeared. After the sniff stopped, he started doing the eye rolling. This has since disappeared again. Our son was a perfectly normal 4 year old and the next day after his checkup had neurological side effects.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAP, DTAP, IPV, MMRV
Symptoms: Seasonal allergy, Streptococcus test negative, Urine analysis normal
Clinical narrative: Patient had his 4 year checkup on 3/12/21. Everything was perfect and no concerns. He had his recommended 4 year vaccines. When he woke up the next am on 3/13/21, he was rolling his head and his eyes. Patient was very agitated and emotionally not himself. He also appeared hyper active for short periods of time. The head rolling and eye rolling stopped and progressed into a sniff. This happened for a month and ended up going away. In September 2021, patient got sick and developed a fever. The sniffing reappeared. After the sniff stopped, he started doing the eye rolling. This has since disappeared again. Our son was a perfectly normal 4 year old and the next day after his checkup had neurological side effects.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAP, DTAP, IPV, MMRV
Symptoms: Agitation, Emotional distress, Eye movement disorder, Malaise, Psychomotor hyperactivity
Clinical narrative: Patient had his 4 year checkup on 3/12/21. Everything was perfect and no concerns. He had his recommended 4 year vaccines. When he woke up the next am on 3/13/21, he was rolling his head and his eyes. Patient was very agitated and emotionally not himself. He also appeared hyper active for short periods of time. The head rolling and eye rolling stopped and progressed into a sniff. This happened for a month and ended up going away. In September 2021, patient got sick and developed a fever. The sniffing reappeared. After the sniff stopped, he started doing the eye rolling. This has since disappeared again. Our son was a perfectly normal 4 year old and the next day after his checkup had neurological side effects.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAP, DTAP, IPV, MMRV
Symptoms: Pyrexia, Rhinorrhoea, Tic
Clinical narrative: Patient had his 4 year checkup on 3/12/21. Everything was perfect and no concerns. He had his recommended 4 year vaccines. When he woke up the next am on 3/13/21, he was rolling his head and his eyes. Patient was very agitated and emotionally not himself. He also appeared hyper active for short periods of time. The head rolling and eye rolling stopped and progressed into a sniff. This happened for a month and ended up going away. In September 2021, patient got sick and developed a fever. The sniffing reappeared. After the sniff stopped, he started doing the eye rolling. This has since disappeared again. Our son was a perfectly normal 4 year old and the next day after his checkup had neurological side effects.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Red rash directly under shot
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Axillary pain, Breast pain, Chest discomfort, Chills
Clinical narrative: After receiving the shot, while waiting 15 mins, my chest felt heavy briefly maybe 1-2 minutes then went away. I brushed off the symptom, carried on with my day. Around 1800 on 11/30, I felt severely fatigued and I went to sleep and woke up the following morning feeling groggy but ok. Within 2 hours I had chills, severe fatigue, left sided armpit pain, left breast pain, left arm weakness (by 12 pm I could barely twist open a baby food pouch) body aches and pains, then the headache came later in the day but my ears, sinuses were hurting too. Also left side abdominal cramps., loss of appetite, nausea, i noticed around 8pm my heart rate seems elevated, so I checked on portable pulse ox, HR ranging from 99-126. I went to bed and woke up around midnight 12/2 sweating all over but I felt like- like myself. By the morning i felt much better, I could tell my Hr was back to normal and when I checked it was 87.  I also noticed swelling in my left armpit, I?m guessing it?s a lymph node about the size of a Persian lime.  It?s still very painful. I did not go to a doctor.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Ear pain, Fatigue, Headache, Heart rate increased
Clinical narrative: After receiving the shot, while waiting 15 mins, my chest felt heavy briefly maybe 1-2 minutes then went away. I brushed off the symptom, carried on with my day. Around 1800 on 11/30, I felt severely fatigued and I went to sleep and woke up the following morning feeling groggy but ok. Within 2 hours I had chills, severe fatigue, left sided armpit pain, left breast pain, left arm weakness (by 12 pm I could barely twist open a baby food pouch) body aches and pains, then the headache came later in the day but my ears, sinuses were hurting too. Also left side abdominal cramps., loss of appetite, nausea, i noticed around 8pm my heart rate seems elevated, so I checked on portable pulse ox, HR ranging from 99-126. I went to bed and woke up around midnight 12/2 sweating all over but I felt like- like myself. By the morning i felt much better, I could tell my Hr was back to normal and when I checked it was 87.  I also noticed swelling in my left armpit, I?m guessing it?s a lymph node about the size of a Persian lime.  It?s still very painful. I did not go to a doctor.