chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Rash, Rash pruritic, Sensory loss, Urticaria
Clinical narrative: bleeding at injection site; It is itching today; does not feel anything; flat rash, not elevated/rash advancing, going down forearm; flat pink advancing/ pink area was replaced by a mustard yellow; hives 3-4 inches down injection site 3-4 inches down the arm; not feeling good; site of injection was kind of itchy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (not feeling good), VACCINATION SITE DISCOLOURATION (flat pink advancing/ pink area was replaced by a mustard yellow), URTICARIA (hives 3-4 inches down injection site 3-4 inches down the arm), VACCINATION SITE HAEMORRHAGE (bleeding at injection site) and RASH PRURITIC (It is itching today) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Nov-2021, the patient experienced FEELING ABNORMAL (not feeling good) and VACCINATION SITE PRURITUS (site of injection was kind of itchy). On 29-Nov-2021, the patient experienced VACCINATION SITE DISCOLOURATION (flat pink advancing/ pink area was replaced by a mustard yellow) and URTICARIA (hives 3-4 inches down injection site 3-4 inches down the arm). On 02-Dec-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (bleeding at injection site), RASH PRURITIC (It is itching today), SENSORY LOSS (does not feel anything) and RASH (flat rash, not elevated/rash advancing, going down forearm). At the time of the report, FEELING ABNORMAL (not feeling good), VACCINATION SITE DISCOLOURATION (flat pink advancing/ pink area was replaced by a mustard yellow), URTICARIA (hives 3-4 inches down injection site 3-4 inches down the arm), VACCINATION SITE HAEMORRHAGE (bleeding at injection site), RASH PRURITIC (It is itching today), SENSORY LOSS (does not feel anything) and VACCINATION SITE PRURITUS (site of injection was kind of itchy) outcome was unknown and RASH (flat rash, not elevated/rash advancing, going down forearm) had not resolved.            Patient is on concomitant medication, but does not provide the names.  Treatment information was not provided.  On 02-DEC-2021, the pink area was replaced by a mustard yellow.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site haemorrhage, Vaccination site pruritus
Clinical narrative: bleeding at injection site; It is itching today; does not feel anything; flat rash, not elevated/rash advancing, going down forearm; flat pink advancing/ pink area was replaced by a mustard yellow; hives 3-4 inches down injection site 3-4 inches down the arm; not feeling good; site of injection was kind of itchy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (not feeling good), VACCINATION SITE DISCOLOURATION (flat pink advancing/ pink area was replaced by a mustard yellow), URTICARIA (hives 3-4 inches down injection site 3-4 inches down the arm), VACCINATION SITE HAEMORRHAGE (bleeding at injection site) and RASH PRURITIC (It is itching today) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Nov-2021, the patient experienced FEELING ABNORMAL (not feeling good) and VACCINATION SITE PRURITUS (site of injection was kind of itchy). On 29-Nov-2021, the patient experienced VACCINATION SITE DISCOLOURATION (flat pink advancing/ pink area was replaced by a mustard yellow) and URTICARIA (hives 3-4 inches down injection site 3-4 inches down the arm). On 02-Dec-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (bleeding at injection site), RASH PRURITIC (It is itching today), SENSORY LOSS (does not feel anything) and RASH (flat rash, not elevated/rash advancing, going down forearm). At the time of the report, FEELING ABNORMAL (not feeling good), VACCINATION SITE DISCOLOURATION (flat pink advancing/ pink area was replaced by a mustard yellow), URTICARIA (hives 3-4 inches down injection site 3-4 inches down the arm), VACCINATION SITE HAEMORRHAGE (bleeding at injection site), RASH PRURITIC (It is itching today), SENSORY LOSS (does not feel anything) and VACCINATION SITE PRURITUS (site of injection was kind of itchy) outcome was unknown and RASH (flat rash, not elevated/rash advancing, going down forearm) had not resolved.            Patient is on concomitant medication, but does not provide the names.  Treatment information was not provided.  On 02-DEC-2021, the pink area was replaced by a mustard yellow.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Moderna vaccine was given to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine was given to patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine was given to patients). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine was given to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicines were reported. No treatment medicines were reported.  Vial moved from freezer to refrigerator on 1DEC 2021.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Product quality issue
Clinical narrative: received dose from vial that had black particulates in previous syringe; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT QUALITY ISSUE (received dose from vial that had black particulates in previous syringe) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced PRODUCT QUALITY ISSUE (received dose from vial that had black particulates in previous syringe). On 01-Dec-2021, PRODUCT QUALITY ISSUE (received dose from vial that had black particulates in previous syringe) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Flushing, Headache, Inappropriate schedule of product administration, Malaise
Clinical narrative: He is not right; Flushed, red in face; Red in face; Horrible headaches; Given the booster dose of the Moderna vaccine under 3 months from 2nd dose; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Given the booster dose of the Moderna vaccine under 3 months from 2nd dose), MALAISE (He is not right), FLUSHING (Flushed, red in face), ERYTHEMA (Red in face) and HEADACHE (Horrible headaches) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   In September 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Given the booster dose of the Moderna vaccine under 3 months from 2nd dose). On an unknown date, the patient experienced MALAISE (He is not right), FLUSHING (Flushed, red in face), ERYTHEMA (Red in face) and HEADACHE (Horrible headaches). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. On 29-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Given the booster dose of the Moderna vaccine under 3 months from 2nd dose) had resolved. At the time of the report, MALAISE (He is not right), FLUSHING (Flushed, red in face), ERYTHEMA (Red in face) and HEADACHE (Horrible headaches) outcome was unknown.            No concomitant medications were reported
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product quality issue
Clinical narrative: 9 patients received Moderna booster (vial had black particle floating in it); 9 patients received Moderna booster (vial had black particle floating in it); This spontaneous case was reported by a health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (9 patients received Moderna booster (vial had black particle floating in it)) and PRODUCT QUALITY ISSUE (9 patients received Moderna booster (vial had black particle floating in it)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (9 patients received Moderna booster (vial had black particle floating in it)) and PRODUCT QUALITY ISSUE (9 patients received Moderna booster (vial had black particle floating in it)). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (9 patients received Moderna booster (vial had black particle floating in it)) and PRODUCT QUALITY ISSUE (9 patients received Moderna booster (vial had black particle floating in it)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: arm pain for 2 days 2nd dose; mild joint pain 2nd dose/joint achiness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain for 2 days 2nd dose) and ARTHRALGIA (mild joint pain 2nd dose/joint achiness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoarthritis and Arthritis (History of arthritis in left thumb, basil joint issues in  left hand).   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm pain for 2 days 2nd dose) and ARTHRALGIA (mild joint pain 2nd dose/joint achiness). On 24-Mar-2021, PAIN IN EXTREMITY (arm pain for 2 days 2nd dose) had resolved. At the time of the report, ARTHRALGIA (mild joint pain 2nd dose/joint achiness) outcome was unknown.            No concomitant medications reported by reporter No treatment medications provided by the reporter.   This case was linked to MOD-2021-403805, MOD-2021-403852 (Patient Link).
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Product administration error, Product physical issue
Clinical narrative: received dose from vial that had black particulates in previous syringe; received dose from vial that had black particulates in previous syringe; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT PHYSICAL ISSUE (received dose from vial that had black particulates in previous syringe) and PRODUCT ADMINISTRATION ERROR (received dose from vial that had black particulates in previous syringe) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced PRODUCT PHYSICAL ISSUE (received dose from vial that had black particulates in previous syringe) and PRODUCT ADMINISTRATION ERROR (received dose from vial that had black particulates in previous syringe). On 01-Dec-2021, PRODUCT PHYSICAL ISSUE (received dose from vial that had black particulates in previous syringe) and PRODUCT ADMINISTRATION ERROR (received dose from vial that had black particulates in previous syringe) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2021: Follow up received contains patient demographics and dose information.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Illness, Influenza like illness, Loss of personal independence in daily activities
Clinical narrative: I have flu like symptoms; Severe headache; Have not been able to get out of bed; Body ache; Chills; I never get sick and I can't afford to get sick; Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 10Sep2021 (Lot number: FC3183) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 11Sep2021, outcome "unknown", described as "I have flu like symptoms"; HEADACHE (non-serious) with onset 11Sep2021, outcome "unknown", described as "Severe headache"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 11Sep2021, outcome "unknown", described as "Have not been able to get out of bed"; PAIN (non-serious) with onset 11Sep2021, outcome "unknown", described as "Body ache"; CHILLS (non-serious) with onset 11Sep2021, outcome "unknown", described as "Chills"; ILLNESS (non-serious) with onset 11Sep2021, outcome "unknown", described as "I never get sick and I can't afford to get sick"; PYREXIA (non-serious) with onset 11Sep2021, outcome "unknown", described as "Fever". The Consumer stated that I just had a quick question. I have a question in regard to how long the symptoms after the 1st dose last consumer stated the first one, I got the 1st one yesterday and it has been 24 hours and I have flu like symptoms, severe headache, have not been able to get out of bed and chills and body aches. Now, I want to know how long it is going to take because I need to be functioning you know for the rest of the week. And when it was informed about the Medical Information Department for the concern, the consumer hung up the call abruptly. Thus, contact details for MI could not be shared and further probing could not be done over the call. Hence, limited information available. The Consumer stated that, I had called earlier but my phone dropped (Further not clarified hence, captured as Initial for report), I was calling because I got the 1st dose yesterday and it's been 24 hours and I have a fever and have a headache and body ache and chills and I wanted to know how long this symptoms is going to last because, I never get sick and I can't afford to get sick and so I do want to know how long this symptoms is going to last, specially because of this 1st dose and if this how the 1st dose feels, I don't know how to get the 2nd dose. The consumer stated that, So what I have to do in the meantime, do I just stay here and get sick and feel sick And again informed about Pfizer Medical Information and also informed the role of Pfizer Drug Safety.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: I have flu like symptoms; Severe headache; Have not been able to get out of bed; Body ache; Chills; I never get sick and I can't afford to get sick; Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 10Sep2021 (Lot number: FC3183) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 11Sep2021, outcome "unknown", described as "I have flu like symptoms"; HEADACHE (non-serious) with onset 11Sep2021, outcome "unknown", described as "Severe headache"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 11Sep2021, outcome "unknown", described as "Have not been able to get out of bed"; PAIN (non-serious) with onset 11Sep2021, outcome "unknown", described as "Body ache"; CHILLS (non-serious) with onset 11Sep2021, outcome "unknown", described as "Chills"; ILLNESS (non-serious) with onset 11Sep2021, outcome "unknown", described as "I never get sick and I can't afford to get sick"; PYREXIA (non-serious) with onset 11Sep2021, outcome "unknown", described as "Fever". The Consumer stated that I just had a quick question. I have a question in regard to how long the symptoms after the 1st dose last consumer stated the first one, I got the 1st one yesterday and it has been 24 hours and I have flu like symptoms, severe headache, have not been able to get out of bed and chills and body aches. Now, I want to know how long it is going to take because I need to be functioning you know for the rest of the week. And when it was informed about the Medical Information Department for the concern, the consumer hung up the call abruptly. Thus, contact details for MI could not be shared and further probing could not be done over the call. Hence, limited information available. The Consumer stated that, I had called earlier but my phone dropped (Further not clarified hence, captured as Initial for report), I was calling because I got the 1st dose yesterday and it's been 24 hours and I have a fever and have a headache and body ache and chills and I wanted to know how long this symptoms is going to last because, I never get sick and I can't afford to get sick and so I do want to know how long this symptoms is going to last, specially because of this 1st dose and if this how the 1st dose feels, I don't know how to get the 2nd dose. The consumer stated that, So what I have to do in the meantime, do I just stay here and get sick and feel sick And again informed about Pfizer Medical Information and also informed the role of Pfizer Drug Safety.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Illness, Pyrexia
Clinical narrative: Sick; being sick ever since he got the shot; Got a slight temperature; he is warm; Severe headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) (Patient's boyfriend).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Sick; being sick ever since he got the shot"; PYREXIA (non-serious), outcome "unknown", described as "Got a slight temperature; he is warm"; HEADACHE (non-serious), outcome "unknown", described as "Severe headache". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information: He received COVID-19 Vaccine (manufacturer unspecified, NDC number and UPC number: Unknown) and a day later (at the time of report), he was in bed. He was being sick, like 2 hours after he got the shot, he started having severe headache and then he was being sick ever since he got the shot. So the reporter was wondering what could they do, he had got a slight temperature at the time of report, the reporter did not know what it was. The reporter could tell him that he was warm. The reporter was just trying to figure out what need to be done.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia, SARS-CoV-1 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 49 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Sep2021 13:00 (Lot number: FF2587) at the age of 49 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "migraine headaches" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: if covid prior vaccination :Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number:01, Lot number: FC3184, Administration time: 01:00 PM, Vaccine Location: Left arm), administration date: 02Sep2021, when the patient was 49 years old, for Covid-19 Immunization. The following information was reported: PAIN (non-serious) with onset 26Sep2021, outcome "recovering", described as "aches"; CHILLS (non-serious) with onset 26Sep2021, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 26Sep2021, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 26Sep2021, outcome "recovered" (27Sep2021), described as "severe headache"; URTICARIA (non-serious) with onset 26Sep2021, outcome "recovering", described as "hives in the pelvic region". Relevant laboratory tests and procedures are available in the appropriate section. These events were not serious. (medically significant, Life threatening , hospitalisation, disabling, resulting in death or congenital anomaly). Therapeutic measures were not taken as a result of pain, chills, pyrexia, headache, urticaria. Additional information: Facility type vaccine: Pharmacy or Drug Store. The patient did not had other vaccine in four weeks nor other medications in two weeks. The day following the second dose, the patient had had aches, chills followed by fever, and a severe headache for 24 hours along with hives in the pelvic region. The patient had no known allergies. Device Date : 27Sep2021. Follow-up attempts completed. No further information expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 49 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Sep2021 13:00 (Lot number: FF2587) at the age of 49 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "migraine headaches" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: if covid prior vaccination :Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number:01, Lot number: FC3184, Administration time: 01:00 PM, Vaccine Location: Left arm), administration date: 02Sep2021, when the patient was 49 years old, for Covid-19 Immunization. The following information was reported: PAIN (non-serious) with onset 26Sep2021, outcome "recovering", described as "aches"; CHILLS (non-serious) with onset 26Sep2021, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 26Sep2021, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 26Sep2021, outcome "recovered" (27Sep2021), described as "severe headache"; URTICARIA (non-serious) with onset 26Sep2021, outcome "recovering", described as "hives in the pelvic region". Relevant laboratory tests and procedures are available in the appropriate section. These events were not serious. (medically significant, Life threatening , hospitalisation, disabling, resulting in death or congenital anomaly). Therapeutic measures were not taken as a result of pain, chills, pyrexia, headache, urticaria. Additional information: Facility type vaccine: Pharmacy or Drug Store. The patient did not had other vaccine in four weeks nor other medications in two weeks. The day following the second dose, the patient had had aches, chills followed by fever, and a severe headache for 24 hours along with hives in the pelvic region. The patient had no known allergies. Device Date : 27Sep2021. Follow-up attempts completed. No further information expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis contact, Headache, Pruritus
Clinical narrative: Started with the inside of the left wrist as itching then became what looked like poison ivy; Started with the inside of the left wrist as itching then became what looked like poison ivy; Also had a severe headache a few days later.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Sep2021 11:00 (Lot number: 301358A) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Compounded PTSD" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "High funtioning autistic" (unspecified if ongoing); "fatty liver" (unspecified if ongoing); "kidney stones" (unspecified if ongoing); "IBS" (unspecified if ongoing); "Leaky gut" (unspecified if ongoing); "concussion" (unspecified if ongoing); "Cerebral vascular disease" (unspecified if ongoing); "degenerative disc" (unspecified if ongoing); "restless limb" (unspecified if ongoing); "tremors" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: If COVID prior vaccination: Yes; "known allergies: Yes- topical iodine" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Dicyclomine, reaction(s): "known allergies: Yes-Dicyclomine". The following information was reported: PRURITUS (non-serious), DERMATITIS CONTACT (non-serious) all with onset 15Sep2021, outcome "recovered" (2021) and all described as "Started with the inside of the left wrist as itching then became what looked like poison ivy"; HEADACHE (non-serious) with onset 15Sep2021, outcome "recovered" (2021), described as "Also had a severe headache a few days later.". Therapeutic measures were not taken as a result of pruritus, dermatitis contact, headache.  Additional information: The patient not tested COVID post vaccination and not had other vaccine in four weeks.  Follow-up attempts are completed. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Blood immunoglobulin A, Feeling abnormal, Nucleic acid test, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 17 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24May2021 10:00 (Lot number: EW0177) at the age of 17 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Wasp stings" (unspecified if ongoing), notes: known allergies of Wasp stings. There were no concomitant medications. The following information was reported: FEELING ABNORMAL (non-serious) with onset 27May2021 16:00, outcome "recovering", described as "I experienced severe brain fog". The event "i experienced severe brain fog" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of feeling abnormal. Additional information: Patient had other vaccine in four weeks. Patient did not have any other medications in two weeks. Patient experienced severe brain fog & disconnectedness within one week of the first dose. It was persistent daily for at least one month. Patient still had frequent sensations of brain fog now 4 months after the last dose, but it was decreasing slowly. Patient did not have covid prior vaccination. Patient was covid tested post vaccination. Patient received Dose 2 of bnt162b2 (BNT162B2) administration date 14Jul2021 10:00 (Lot number: EW0217) as dose 2, single, administration in left arm.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, International normalised ratio increased, Lactic acidosis, Liver function test abnormal, Prothrombin time prolonged
Clinical narrative: AKI, abnormal LFTS, lactic acidosis, elevated PT/INR 1 week post covid booster
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase normal, Anion gap normal, Aspartate aminotransferase normal, Blood alkaline phosphatase normal, Blood bilirubin increased
Clinical narrative: Pt developed palpitations and left arm pain several hours after receiving vaccination.  Developed subjective fever as well.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Blood chloride normal, Blood creatine increased, Blood glucose normal, Blood potassium decreased, Blood sodium normal
Clinical narrative: Pt developed palpitations and left arm pain several hours after receiving vaccination.  Developed subjective fever as well.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Carbon dioxide normal, Electrocardiogram T wave inversion, Haemoglobin decreased, Pain in extremity, Palpitations
Clinical narrative: Pt developed palpitations and left arm pain several hours after receiving vaccination.  Developed subjective fever as well.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Platelet count normal, Pyrexia, Sinus tachycardia, Troponin increased, White blood cell count increased
Clinical narrative: Pt developed palpitations and left arm pain several hours after receiving vaccination.  Developed subjective fever as well.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Gait disturbance, Hypersensitivity, Malaise, Nausea
Clinical narrative: Pfizer booster shot received Wednesday AM Dec 1st.  At 3 AM Dec 2nd, awakened with vertigo. Sat up and the world turned upside down. From 3 AM through to December 6th had severe, severe vertigo side effect reaction to booster shot. At this time, i still have vertigo but it's debilitating effect has lessened enough so that I can stand and walk without a "death" grip on some sort of support.  Needed to sit quietly with head straight and not move during the day and to sleep (in a chair) with minimal moving around the home to avoid falling and to keep the vertigo from making me ill. On Friday AM vertigo caused nausea which passed.  Vertigo is getting better, BUT it is unknown IF the vertigo will remain to some degree or come back at some point. very unsettling.  IN research Vertigo and definitely not severe vertigo (not dizziness but vertigo) is NOT listed even as a rare side effect. It should be listed because I have talked to a few people and found out that I am not the only one who got this same reaction to the booster shot.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Pfizer booster shot received Wednesday AM Dec 1st.  At 3 AM Dec 2nd, awakened with vertigo. Sat up and the world turned upside down. From 3 AM through to December 6th had severe, severe vertigo side effect reaction to booster shot. At this time, i still have vertigo but it's debilitating effect has lessened enough so that I can stand and walk without a "death" grip on some sort of support.  Needed to sit quietly with head straight and not move during the day and to sleep (in a chair) with minimal moving around the home to avoid falling and to keep the vertigo from making me ill. On Friday AM vertigo caused nausea which passed.  Vertigo is getting better, BUT it is unknown IF the vertigo will remain to some degree or come back at some point. very unsettling.  IN research Vertigo and definitely not severe vertigo (not dizziness but vertigo) is NOT listed even as a rare side effect. It should be listed because I have talked to a few people and found out that I am not the only one who got this same reaction to the booster shot.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Musculoskeletal stiffness
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOAESTHESIA (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious) all with onset 2021, outcome "unknown" and all described as "Arm has been going numb and stiff". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Additional information: "When probed for the concern, reporter (patient's husband) stated, "I am actually calling about my wife (consumer). I actually just had a question, my wife got her first (dose) vaccine and her arm has been going numb". 1st attempt by phone to consumer to obtain mailing information. Phone answered by the consumer who provided the mailing address as withheld. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Polymerase chain reaction
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Oct2021 (Lot number: FF8839) at the age of 65 years as dose 3 (booster), single for covid-19 immunization. Relevant medical history included: "Dermatomyositis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: No, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (DOSE 2,SINGLE, Dose Number: 2, Batch/Lot No: EN5318, Location of injection: Arm Left), administration date: 27Jan2021, for COVID-19 immunization; Bnt162b2 (DOSE 1,SINGLE, Dose Number: 1, Batch/Lot No: FJ1686, Location of injection: Arm Left), administration date: 06Jan2021, for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 11Oct2021 22:45, outcome "recovered" (Oct2021), described as "Severe rigors 12 hours after vaccination". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills. Additional information: The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient didn't received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. Patient did Not had any Hospitalization Prolonged. Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Immunisation, Malaise, Pyrexia
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A male patient received bnt162b2 (BNT162B2), administration date 22Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID" (unspecified if ongoing); "rotator cuff surgery" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization; Bnt162b2 (2nd dose), for COVID-19 immunization.The following information was reported: IMMUNISATION (non-serious) with onset 22Oct2021, outcome "unknown", described as "Vaccine Booster Dose this evening"; ARTHRALGIA (non-serious) with onset 22Oct2021, outcome "recovering", described as "severe shoulder pain"; PYREXIA (non-serious) with onset 22Oct2021, outcome "recovering", described as "fever"; MALAISE (non-serious) with onset 22Oct2021, outcome "recovering", described as "malaise".Additional information: Complaints of severe shoulder pain (worse than rotator cuff surgery), fever, malaise lasting 24 hours post dose. The symptoms were significantly worse than the first or second doses of the vaccine received previously. The patient might had COVID before receiving the first vaccination series. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Blood test, Echocardiogram, Electrocardiogram
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 71 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 (Lot number: ER8730) at the age of 71 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Sulfa" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6205, Location of injection: Arm Left), administration date: 09Mar2021, when the patient was 71 years old, for COVID-19 Immunization. The following information was reported: ARTHRALGIA (non-serious), BACK PAIN (non-serious), NECK PAIN (non-serious), MUSCLE TIGHTNESS (non-serious) all with onset 28Apr2021, outcome "recovering" and all described as "I began having pain and tightness in my shoulder, back and neck"; PYREXIA (non-serious) with onset 28Apr2021, outcome "recovering", described as "running a low grad temperature"; PAIN (non-serious) with onset 23Apr2021, outcome "recovering", described as "had significant pain when inhaling"; PLEURAL EFFUSION (non-serious) with onset 28Apr2021, outcome "recovering", described as "I had an echo cardiogram which indicated a left plural effusion". The events "i began having pain and tightness in my shoulder, back and neck", "i began having pain and tightness in my shoulder, back and neck", "i began having pain and tightness in my shoulder, back and neck", "i began having pain and tightness in my shoulder, back and neck", "running a low grad temperature" and "had significant pain when inhaling" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia, back pain, neck pain, muscle tightness, pyrexia, pain, pleural effusion. Additional information: The patient did not receive any other vaccine in 4 weeks. The patient was not diagnosed with COVID-19 prior to vaccination and the patient was tested negative for COVID-19 post vaccination. The patient received recent COVID-19 vaccine at pharmacy or drug store. The patient began to having pain and tightness in her shoulder, back and neck and running a low grad temperature and had significant pain when inhaling around 23Apr2021. She went to the doctor's office on 28Apr2021 because she was concerned. The physician did an EKG which was negative but sent her to the ER as a precaution. She continued with the symptoms saw several doctors had numerous blood tests and scans. She had an echo cardiogram which indicated a left plural effusion. She was not certain if the problems were due to the vaccine, but everything else has been ruled out. Anti-inflammatory treatment medications were prescribed to patient due to events. Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Neck pain, Pain, Pleural effusion, Pyrexia
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 71 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 (Lot number: ER8730) at the age of 71 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Sulfa" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6205, Location of injection: Arm Left), administration date: 09Mar2021, when the patient was 71 years old, for COVID-19 Immunization. The following information was reported: ARTHRALGIA (non-serious), BACK PAIN (non-serious), NECK PAIN (non-serious), MUSCLE TIGHTNESS (non-serious) all with onset 28Apr2021, outcome "recovering" and all described as "I began having pain and tightness in my shoulder, back and neck"; PYREXIA (non-serious) with onset 28Apr2021, outcome "recovering", described as "running a low grad temperature"; PAIN (non-serious) with onset 23Apr2021, outcome "recovering", described as "had significant pain when inhaling"; PLEURAL EFFUSION (non-serious) with onset 28Apr2021, outcome "recovering", described as "I had an echo cardiogram which indicated a left plural effusion". The events "i began having pain and tightness in my shoulder, back and neck", "i began having pain and tightness in my shoulder, back and neck", "i began having pain and tightness in my shoulder, back and neck", "i began having pain and tightness in my shoulder, back and neck", "running a low grad temperature" and "had significant pain when inhaling" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia, back pain, neck pain, muscle tightness, pyrexia, pain, pleural effusion. Additional information: The patient did not receive any other vaccine in 4 weeks. The patient was not diagnosed with COVID-19 prior to vaccination and the patient was tested negative for COVID-19 post vaccination. The patient received recent COVID-19 vaccine at pharmacy or drug store. The patient began to having pain and tightness in her shoulder, back and neck and running a low grad temperature and had significant pain when inhaling around 23Apr2021. She went to the doctor's office on 28Apr2021 because she was concerned. The physician did an EKG which was negative but sent her to the ER as a precaution. She continued with the symptoms saw several doctors had numerous blood tests and scans. She had an echo cardiogram which indicated a left plural effusion. She was not certain if the problems were due to the vaccine, but everything else has been ruled out. Anti-inflammatory treatment medications were prescribed to patient due to events. Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Scan
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 71 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 (Lot number: ER8730) at the age of 71 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Sulfa" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6205, Location of injection: Arm Left), administration date: 09Mar2021, when the patient was 71 years old, for COVID-19 Immunization. The following information was reported: ARTHRALGIA (non-serious), BACK PAIN (non-serious), NECK PAIN (non-serious), MUSCLE TIGHTNESS (non-serious) all with onset 28Apr2021, outcome "recovering" and all described as "I began having pain and tightness in my shoulder, back and neck"; PYREXIA (non-serious) with onset 28Apr2021, outcome "recovering", described as "running a low grad temperature"; PAIN (non-serious) with onset 23Apr2021, outcome "recovering", described as "had significant pain when inhaling"; PLEURAL EFFUSION (non-serious) with onset 28Apr2021, outcome "recovering", described as "I had an echo cardiogram which indicated a left plural effusion". The events "i began having pain and tightness in my shoulder, back and neck", "i began having pain and tightness in my shoulder, back and neck", "i began having pain and tightness in my shoulder, back and neck", "i began having pain and tightness in my shoulder, back and neck", "running a low grad temperature" and "had significant pain when inhaling" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia, back pain, neck pain, muscle tightness, pyrexia, pain, pleural effusion. Additional information: The patient did not receive any other vaccine in 4 weeks. The patient was not diagnosed with COVID-19 prior to vaccination and the patient was tested negative for COVID-19 post vaccination. The patient received recent COVID-19 vaccine at pharmacy or drug store. The patient began to having pain and tightness in her shoulder, back and neck and running a low grad temperature and had significant pain when inhaling around 23Apr2021. She went to the doctor's office on 28Apr2021 because she was concerned. The physician did an EKG which was negative but sent her to the ER as a precaution. She continued with the symptoms saw several doctors had numerous blood tests and scans. She had an echo cardiogram which indicated a left plural effusion. She was not certain if the problems were due to the vaccine, but everything else has been ruled out. Anti-inflammatory treatment medications were prescribed to patient due to events. Follow-up attempts are completed. No further information is expected.