chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest discomfort, Dyspnoea, Feeling abnormal, Heart rate
Clinical narrative: shortness of breath; ringing in ears; felt naive due to ringing in the ears / felt like falling; chest tightness; numbness of legs and arms / numbness in the head; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), TINNITUS (ringing in ears), FEELING ABNORMAL (felt naive due to ringing in the ears / felt like falling), CHEST DISCOMFORT (chest tightness) and HYPOAESTHESIA (numbness of legs and arms / numbness in the head) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 047A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (she had severe abdominal pain and shortness of breath started. No treatment provided.) on 27-Nov-2020. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced DYSPNOEA (shortness of breath), TINNITUS (ringing in ears), FEELING ABNORMAL (felt naive due to ringing in the ears / felt like falling), CHEST DISCOMFORT (chest tightness) and HYPOAESTHESIA (numbness of legs and arms / numbness in the head). The patient was treated with ALBUTEROL [SALBUTAMOL] for Adverse event, at an unspecified dose and frequency and XYLOMETAZOLINE HYDROCHLORIDE (NASAL SPRAY II) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (shortness of breath), TINNITUS (ringing in ears), FEELING ABNORMAL (felt naive due to ringing in the ears / felt like falling), CHEST DISCOMFORT (chest tightness) and HYPOAESTHESIA (numbness of legs and arms / numbness in the head) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Nov-2020, SARS-CoV-2 test: positive (Positive) infected with Covid-19 with a positive RT PCR. On 22-Feb-2021, Heart rate: increased (High) increased. On an unknown date, Blood test: normal (normal) normal.         Patient has no allergies and Patient has no prior medical history nor was diagnose of pericarditis/myocarditis.  Patient had seen pulmo and cardio.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, SARS-CoV-2 test, Tinnitus
Clinical narrative: shortness of breath; ringing in ears; felt naive due to ringing in the ears / felt like falling; chest tightness; numbness of legs and arms / numbness in the head; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), TINNITUS (ringing in ears), FEELING ABNORMAL (felt naive due to ringing in the ears / felt like falling), CHEST DISCOMFORT (chest tightness) and HYPOAESTHESIA (numbness of legs and arms / numbness in the head) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 047A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (she had severe abdominal pain and shortness of breath started. No treatment provided.) on 27-Nov-2020. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced DYSPNOEA (shortness of breath), TINNITUS (ringing in ears), FEELING ABNORMAL (felt naive due to ringing in the ears / felt like falling), CHEST DISCOMFORT (chest tightness) and HYPOAESTHESIA (numbness of legs and arms / numbness in the head). The patient was treated with ALBUTEROL [SALBUTAMOL] for Adverse event, at an unspecified dose and frequency and XYLOMETAZOLINE HYDROCHLORIDE (NASAL SPRAY II) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (shortness of breath), TINNITUS (ringing in ears), FEELING ABNORMAL (felt naive due to ringing in the ears / felt like falling), CHEST DISCOMFORT (chest tightness) and HYPOAESTHESIA (numbness of legs and arms / numbness in the head) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Nov-2020, SARS-CoV-2 test: positive (Positive) infected with Covid-19 with a positive RT PCR. On 22-Feb-2021, Heart rate: increased (High) increased. On an unknown date, Blood test: normal (normal) normal.         Patient has no allergies and Patient has no prior medical history nor was diagnose of pericarditis/myocarditis.  Patient had seen pulmo and cardio.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Administration of a dose after 12 hours the vial was first puncture; administration of a dose after 12 hours the vial was first puncture and was exposed at RT for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of a dose after 12 hours the vial was first puncture) and PRODUCT TEMPERATURE EXCURSION ISSUE (administration of a dose after 12 hours the vial was first puncture and was exposed at RT for more than 12 hours) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of a dose after 12 hours the vial was first puncture) and PRODUCT TEMPERATURE EXCURSION ISSUE (administration of a dose after 12 hours the vial was first puncture and was exposed at RT for more than 12 hours). On 23-Feb-2022, EXPIRED PRODUCT ADMINISTERED (Administration of a dose after 12 hours the vial was first puncture) and PRODUCT TEMPERATURE EXCURSION ISSUE (administration of a dose after 12 hours the vial was first puncture and was exposed at RT for more than 12 hours) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medication details were reported.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered vaccine to a 17 year old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered vaccine to a 17 year old) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered vaccine to a 17 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered vaccine to a 17 year old) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported. Nurse reported that they inadvertently administered 1st dose of the Moderna Covid-19 vaccine to a 17 year old.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered after 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered after 30-day use by date) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.  No Medical History information was reported.  On 21-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered after 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered after 30-day use by date) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Concomitant medication of the patient was not reported.   Beyond use date of the vaccine was 16-Jan-2022. Date the vial was initially stored in the refrigerator was 17-Dec-2021 and the vial did not undergo any temperature excursions.  No treatment information was provided by the reporter.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Booster Doses Administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Booster Doses Administered) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007J21-2A, 036C21A and 036C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 EXPIRED PRODUCT ADMINISTERED (Expired Booster Doses Administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Booster Doses Administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Limb mass
Clinical narrative: little bumps under her arm and it looks like bee sting; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date 29Jul2021 (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: LIMB MASS (non-serious) with onset 29Jul2021, outcome "unknown", described as "little bumps under her arm and it looks like bee sting".  Additional Information: "My daughter (consumer) ended up getting shot today the Pfizer Covid-19 Vaccine and she have like little Bumps under her arm and it looks like bee sting." In response to file safety report, reporter stated, "I am just trying to figure out, do I need to take her Emergency room or not because I can't understand what you are saying."  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pruritus, Urticaria
Clinical narrative: Patient reported feeling hot and began to break out in hives that spread over her chest. Her chest was visibly red and patient was observed scratching the area. Symptoms began around 2:35 pm post injection. Patient was given 50 mg of Benadryl and stayed in the clinic for the remaining 30 minute observation period. Patient reported before leaving the clinic that she that symptoms were improving, she felt better and would take additional Benadryl as needed at home.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chest X-ray, Dyspnoea, Facial paralysis, Pruritus
Clinical narrative: Itchy burning sensation, hives all over body and face, droopy face, and wheezy hard to breath at times.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Wheezing
Clinical narrative: Itchy burning sensation, hives all over body and face, droopy face, and wheezy hard to breath at times.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Flank pain, Hyperhidrosis, Nausea, Vomiting
Clinical narrative: 2 hours after vaccination. Patient became sweaty, chills, nausea with vomiting and flank pain. 3 hours after reporting, nausea and chills had subsided, but flank pain was still present.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash, Rash pruritic, Skin warm
Clinical narrative: Patient had soreness, warmth, and an itchy rash on right upper arm after receiving the vaccine.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Blood glucose, Blood grouping, Blood lactic acid, Chest X-ray
Clinical narrative: Shortness of breathe, fever, dehydration, diarrhea, abdominal pain, chest pain, chills,
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dehydration, Diarrhoea, Differential white blood cell count
Clinical narrative: Shortness of breathe, fever, dehydration, diarrhea, abdominal pain, chest pain, chills,
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Full blood count, International normalised ratio, Investigation, Lactic acidosis
Clinical narrative: Shortness of breathe, fever, dehydration, diarrhea, abdominal pain, chest pain, chills,
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Metabolic function test, Procalcitonin, Prothrombin level, Prothrombin time, Pyrexia
Clinical narrative: Shortness of breathe, fever, dehydration, diarrhea, abdominal pain, chest pain, chills,
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Reticulocyte count, Staphylococcus test, Ultrasound abdomen
Clinical narrative: Shortness of breathe, fever, dehydration, diarrhea, abdominal pain, chest pain, chills,
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Muscle spasms, Nausea, Vomiting
Clinical narrative: Nausea cramping vomiting diarrhea
Age: 62.0
Sex: M
Vaccine: FLUX
Symptoms: Cardiac arrest, Death, General physical health deterioration, Injection site erythema, Injection site pain
Clinical narrative: Patient developed increasing pain, redness, and swelling around injection site. Transported to emergency room the following day, 10/23/21. Continued to worsen, went into cardiac arrest and pronounced deceased in the emergency room.
Age: 62.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site swelling
Clinical narrative: Patient developed increasing pain, redness, and swelling around injection site. Transported to emergency room the following day, 10/23/21. Continued to worsen, went into cardiac arrest and pronounced deceased in the emergency room.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Incorrect product formulation administered
Clinical narrative: patient was given the Pfizer 5-11yo vaccine that was not diluted. the dosage of the vaccine given was equivalent to an adult Pfizer dose.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count, Lymph node pain, Lymphadenopathy, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Swelling of lymphnode under armpit of right arm. Was told it was a normal side effect and to add ice to the area to reduce swelling and ease the discomfort. The lymphnode swelling has not subsided and feels as if it has grown larger. The tenderness around the left arm has spread and now I have developed a fever that one doctor has described as life threatening.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound scan, Urine analysis
Clinical narrative: Swelling of lymphnode under armpit of right arm. Was told it was a normal side effect and to add ice to the area to reduce swelling and ease the discomfort. The lymphnode swelling has not subsided and feels as if it has grown larger. The tenderness around the left arm has spread and now I have developed a fever that one doctor has described as life threatening.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Incorrect product formulation administered
Clinical narrative: Gave patient the wrong dosage of the peds Pfizer vaccine due not diluting the vaccine. Gave a dose equivalent to an adult dose.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Antinuclear antibody negative, Aortic valve incompetence, Atrioventricular block complete, Borrelia test negative, C-reactive protein increased
Clinical narrative: Patient developed third degree heart block . Symptoms started on 2/23/2022 and EKG at an urgent care center confirmed heart block on 2/24/2022.  Patient was hemodynamically stable and admitted for 2 days for telemetry, labs , echocardiogram and cardiac MRI.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac imaging procedure abnormal, Cardiac telemetry, Echocardiogram normal, Ejection fraction, Ejection fraction normal
Clinical narrative: Patient developed third degree heart block . Symptoms started on 2/23/2022 and EKG at an urgent care center confirmed heart block on 2/24/2022.  Patient was hemodynamically stable and admitted for 2 days for telemetry, labs , echocardiogram and cardiac MRI.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram QRS complex, Electrocardiogram QT interval, Electrocardiogram abnormal, Haematocrit normal, Haemoglobin normal
Clinical narrative: Patient developed third degree heart block . Symptoms started on 2/23/2022 and EKG at an urgent care center confirmed heart block on 2/24/2022.  Patient was hemodynamically stable and admitted for 2 days for telemetry, labs , echocardiogram and cardiac MRI.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging heart, Metabolic function test normal, Nodal rhythm, Platelet count normal, Prohormone brain natriuretic peptide increased
Clinical narrative: Patient developed third degree heart block . Symptoms started on 2/23/2022 and EKG at an urgent care center confirmed heart block on 2/24/2022.  Patient was hemodynamically stable and admitted for 2 days for telemetry, labs , echocardiogram and cardiac MRI.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate increased, Troponin increased, White blood cell count increased
Clinical narrative: Patient developed third degree heart block . Symptoms started on 2/23/2022 and EKG at an urgent care center confirmed heart block on 2/24/2022.  Patient was hemodynamically stable and admitted for 2 days for telemetry, labs , echocardiogram and cardiac MRI.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Neck pain
Clinical narrative: neck pain; stiffness; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the parent.  A 14 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Jul2021 (Lot number: FA7485) at the age of 14 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: NECK PAIN (non-serious) with onset 01Aug2021, outcome "not recovered", described as "neck pain"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 01Aug2021, outcome "not recovered", described as "stiffness". Therapeutic measures were taken as a result of neck pain, musculoskeletal stiffness. Additional Information: The caller stated that the patient started experiencing neck pain and stiffness, worsening today. He says he would like to know have any other children reported this type of symptom. Caller says that their son has been taking Motrin and he says his pain and stiffness are worse tonight than this morning, it is on the left side of his neck, the same side as he got his shot.  No follow-up attempts are possible. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular
Clinical narrative: Has developed bumps on her arm from her wrist to her elbow that look like mosquito or ant bites/ Bump under her right eye; 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 14 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 30Jul2021 (Lot number: ER8736) at the age of 14 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Seizures" (ongoing), notes: Since she was 9 years old. There were no concomitant medications. The following information was reported: RASH PAPULAR (non-serious) with onset 2021, outcome "recovering", described as "Has developed bumps on her arm from her wrist to her elbow that look like mosquito or ant bites/ Bump under her right eye". Therapeutic measures were not taken as a result of rash papular.  Additional Information:   The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. The caller stated his 14 year old daughter received the first dose of the vaccine on Friday 30Jul after 6pm. The patient experienced bumps from her wrist to elbow on her arm. They looked like ant or mosquito bites. The patient mentioned previous night she had a bump under her right eye. That morning she texted the caller with pictures of the bumps on her right arm, wrist and hand and on the left elbow and above the elbow. They were small bumps puffed out a little like an ant or mosquito bite. They were on both the top and bottom sides of the right arm and there were 12 bumps. It looked like they were going down then. Caller confirmed the information regarding the bumps and the location of one on the right eye and on the right and left arm. No treatment at that point as they seemed to be going down but it the got worse he could do something more. Caller asked if she should get the second dose if it was related to the Covid vaccine.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Pain in extremity, Rhinorrhoea
Clinical narrative: My arm is still sore from the injection site; My nose is been running; 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), intramuscular, administered in arm left, administration date 04Feb2021 (Lot number: EL3249) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ENBREL; TOPROL XL. Vaccination history included: Bnt162b2 (First Dose, Lot no: EL1283, Intramuscularly, Left side.), administration date: 14Jan2021, for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Feb2021, outcome "not recovered", described as "My arm is still sore from the injection site"; RHINORRHOEA (non-serious) with onset Feb2021, outcome "not recovered", described as "My nose is been running". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Jul2021 (Lot number: EW0180) at the age of 41 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: MYALGIA (non-serious) with onset 2021, outcome "not recovered", described as "Muscle pain". Therapeutic measures were taken as a result of myalgia.  Additional information: Prior vaccination before four week : No. Muscle pain started before I took the second dose. The first dose I took on July 9(Confirmed as 09Jul2021) and the second dose I took on 30Jul2021  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Inappropriate schedule of product administration
Clinical narrative: Caller then mentions her voice is hoarse; Date of start of drug:12May2021/Date of last administration:25May2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), administration date 25May2021 (Batch/Lot number: unknown) at the age of 45 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Smoking" (unspecified if ongoing), notes: Smoking. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose number: 1, Anatomical location: Left arm, Lot number: 675, Time the Vaccination Was Given: in the evening), administration date: 12May2021, when the patient was 45 years old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 25May2021, outcome "unknown", described as "Date of start of drug:12May2021/Date of last administration:25May2021"; DYSPHONIA (non-serious), outcome "unknown", described as "Caller then mentions her voice is hoarse". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: bright red spot where the injection was; I can still the heat and it is still a little swollen, at injection site; I can still the heat and it is still a little swollen, at injection site; 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), administration date 28Jul2021 (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, she had no problems with he 1st dose), for COVID-19 immunization, reaction(s): "no problems".  The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset Aug2021, outcome "not recovered", described as "bright red spot where the injection was"; VACCINATION SITE WARMTH (non-serious) with onset Aug2021, outcome "not recovered", VACCINATION SITE SWELLING (non-serious) with onset Aug2021, outcome "recovering" and all described as "I can still the heat and it is still a little swollen, at injection site". Therapeutic measures were taken as a result of vaccination site erythema, vaccination site warmth, vaccination site swelling.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Hypoacusis
Clinical narrative: hearing impaired; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  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: HYPOACUSIS (non-serious), outcome "unknown", described as "hearing impaired".  Additional information: It was reported that Sign language interpreter number was made. Calling was done to ask some questions about covid vaccine. Not happy had to be transferred. Not clarified if caller (patient) had either dose of covid vaccine and if had vaccine was hearing impaired before or after.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP. A 50-year-old patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EP6955), at the age of 50, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient experienced tinnitus (like a consistent buzzing in the ear), with outcome of unknown. Additional information: The reporter stated someone in the household got the Pfizer COVID-19 vaccination, and experienced specific side-effects. Tinnitus. It was like a consistent buzzing in the ear. No follow-up attempts possible. No further information expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Agitation, Blood pressure increased, Blood pressure measurement, Migraine, Movement disorder
Clinical narrative: very amped up and could not lie down or sit down; feels like his blood pressure was raised like racing inside; very amped up and could not lie down or sit down; massive migraine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Jul2021 10:00 (Lot number: EW0217) at the age of 55 years 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: MIGRAINE (non-serious) with onset 16Jul2021, outcome "recovered" (17Jul2021), described as "massive migraine"; AGITATION (non-serious) with onset 16Jul2021 10:30, outcome "recovered" (16Jul2021), BLOOD PRESSURE INCREASED (non-serious) with onset 16Jul2021, outcome "recovered" (17Jul2021) and all described as "feels like his blood pressure was raised like racing inside"; MOVEMENT DISORDER (non-serious) with onset 16Jul2021, outcome "recovered" (16Jul2021), described as "very amped up and could not lie down or sit down". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of migraine. No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Chills, Fatigue, Feeling abnormal, Hypoaesthesia
Clinical narrative: The next day she felt like very sluggish, fuzzy, and very tired; The next day she felt like very sluggish, fuzzy, and very tired; The next day she felt like very sluggish, fuzzy, and very tired; When I received that vaccine at the same day, I felt nothing/Since I got the vaccine it's not like steady, very tired; I felt like something in my body, kind of like tired like, chill kind of like, middle of numb; I felt like something in my body, kind of like tired like, chill kind of like, middle of numb; I always react to medication differently; 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 45 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid right, administration date 29Jul2021 (Lot number: SA7484) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type 1 diabetes" (unspecified if ongoing). Concomitant medication(s) included: NOVOLOG MIX taken for type 1 diabetes mellitus; LEVEMIR taken for type 1 diabetes mellitus. The following information was reported: SLUGGISHNESS (non-serious), FEELING ABNORMAL (non-serious), FATIGUE (non-serious) all with onset 30Jul2021, outcome "unknown" and all described as "The next day she felt like very sluggish, fuzzy, and very tired"; FEELING ABNORMAL (non-serious) with onset 30Jul2021, outcome "unknown", described as "When I received that vaccine at the same day, I felt nothing/Since I got the vaccine it's not like steady, very tired"; CHILLS (non-serious), HYPOAESTHESIA (non-serious) all with onset 30Jul2021, outcome "unknown" and all described as "I felt like something in my body, kind of like tired like, chill kind of like, middle of numb"; ADVERSE REACTION (non-serious) with onset 30Jul2021, outcome "unknown", described as "I always react to medication differently". Therapeutic measures were not taken as a result of sluggishness, feeling abnormal, fatigue, feeling abnormal, chills, hypoaesthesia, adverse reaction.  Additional information: The consumer further asked whether she should receive the second dose or not because of this feeling  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Sluggishness
Clinical narrative: The next day she felt like very sluggish, fuzzy, and very tired; The next day she felt like very sluggish, fuzzy, and very tired; The next day she felt like very sluggish, fuzzy, and very tired; When I received that vaccine at the same day, I felt nothing/Since I got the vaccine it's not like steady, very tired; I felt like something in my body, kind of like tired like, chill kind of like, middle of numb; I felt like something in my body, kind of like tired like, chill kind of like, middle of numb; I always react to medication differently; 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 45 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid right, administration date 29Jul2021 (Lot number: SA7484) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type 1 diabetes" (unspecified if ongoing). Concomitant medication(s) included: NOVOLOG MIX taken for type 1 diabetes mellitus; LEVEMIR taken for type 1 diabetes mellitus. The following information was reported: SLUGGISHNESS (non-serious), FEELING ABNORMAL (non-serious), FATIGUE (non-serious) all with onset 30Jul2021, outcome "unknown" and all described as "The next day she felt like very sluggish, fuzzy, and very tired"; FEELING ABNORMAL (non-serious) with onset 30Jul2021, outcome "unknown", described as "When I received that vaccine at the same day, I felt nothing/Since I got the vaccine it's not like steady, very tired"; CHILLS (non-serious), HYPOAESTHESIA (non-serious) all with onset 30Jul2021, outcome "unknown" and all described as "I felt like something in my body, kind of like tired like, chill kind of like, middle of numb"; ADVERSE REACTION (non-serious) with onset 30Jul2021, outcome "unknown", described as "I always react to medication differently". Therapeutic measures were not taken as a result of sluggishness, feeling abnormal, fatigue, feeling abnormal, chills, hypoaesthesia, adverse reaction.  Additional information: The consumer further asked whether she should receive the second dose or not because of this feeling  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: first dose: arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Jul2021 11:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Jul2021, outcome "recovered" (Jul2021), described as "first dose: arm pain".  Additional information: First dose, thinks it was 11Jul2021, left arm, around 11 am. He is unsure of the date of his first dose but states it was 21 days prior to his second dose. No additional vaccines administered on same date of the Pfizer suspect. Patient had no prior Vaccinations (within 4 weeks). There are no AE(s) following prior vaccinations. Patient had no relevant tests. There was no family medical history relevant to AE(s). Patient does not required to visit to emergency room or physician office because of event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: got a little pain in my arm; 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 58 year-old female patient received bnt162b2 (BNT162B2) (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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "got a little pain in my arm".  Additional information: The patient stated that after first shot was fine just got a little pain in arm and then it went away. She stated that after her second shot in Jun pains all over body and in joints and muscles. She stated that was not like this before the second shot. The second one its really bad. The side effects had been really bad there's times got up from bed and cold not even move because of how joints were hurting and muscles like had the flu, that's how the patient felt. The patient stated that it had been really hard for body and was not like this before the shot. She stated that she was going back to the doctor.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Diarrhoea, Fatigue, Somnolence, Vaccination site pain
Clinical narrative: tiredness; extreme sleepiness could not keep eyes open lasted 1 day; diarreah; followed by sensation of fullness subsiding 4th day; Area a shot mild pain 2 days.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Apr2021 09:00 (Lot number: ER8737) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies : penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 05Apr2021, outcome "recovered" (06Apr2021), described as "tiredness"; SOMNOLENCE (non-serious) with onset 05Apr2021, outcome "recovered" (06Apr2021), described as "extreme sleepiness could not keep eyes open lasted 1 day"; DIARRHOEA (non-serious) with onset 05Apr2021, outcome "recovered" (07Apr2021), described as "diarrhea"; ABDOMINAL DISTENSION (non-serious) with onset 05Apr2021, outcome "recovered" (09Apr2021), described as "followed by sensation of fullness subsiding 4th day"; VACCINATION SITE PAIN (non-serious) with onset 05Apr2021, outcome "recovered" (07Apr2021), described as "Area a shot mild pain 2 days.". The events "tiredness", "extreme sleepiness could not keep eyes open lasted 1 day", "diarrhea", "followed by sensation of fullness subsiding 4th day" and "area a shot mild pain 2 days." were evaluated at the physician office visit. Additional information: After first dose patient experienced tiredness, extreme sleepiness could not keep eyes open lasted 1 day. Within 12 hours got diarrhea it lasted 2 days, followed by sensation of fullness subsiding on fourth day. Mild pain in the area of shot for two days. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and not received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Insomnia, Lethargy
Clinical narrative: Her attention span has going to nothing; Bad insomnia; I was getting lethargic, I couldn't get all of that like for two weeks; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 02Jul2021 (Lot number: EN6207) 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: DISTURBANCE IN ATTENTION (non-serious) with onset Jul2021, outcome "unknown", described as "Her attention span has going to nothing"; INSOMNIA (non-serious) with onset Jul2021, outcome "unknown", described as "Bad insomnia"; LETHARGY (non-serious) with onset Jul2021, outcome "unknown", described as "I was getting lethargic, I couldn't get all of that like for two weeks".  Additional information: Reporter seriousness for events: Unspecified. NDC number/UPC number/Expiry Date of COVID-19 Vaccine: Unknown. She just took the shot, two weeks ago and she had bad tremors for like two weeks now. She took this shot, she was getting lethargic, she couldn't get all of that like for two weeks. She took the shot like, around several weeks ago, for the first one. Now she had started getting lethargic and her attention span had going to nothing, when she talked to the reporter she was in bad insomnia. It's gone up for like several weeks and took second shot and they got worse, didn't sleep like sixteen hours a day and a left arm started bad tremors possibly and she got after shot. She believed she got a Pfizer. She got the card, believed one is administered yesterday, received the card from the hospital. She threw her card outside, she believed. It's a Pfizer so, First says the Pfizer and another one at work. She took the Pfizer EN6207 (LOT confirmed) and the second one was EW0173 Pfizer and the first one was administered 02Jul2021 and second one was administered 23Jul2021, confirmed. She probably needed to see a doctor. She started calling the doctor already. She didn't know, she called you guys. She needed to speak to somebody about this, continue like and get worse. Everything has taken five times longer and supposed to, had tremors in her arm from last three five days. He can call doctor an hear in. As reporter hung up the call abruptly. Hence further probing could not be done. Limited information available over the call.  No follow-up attempts are possible. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Menstruation irregular
Clinical narrative: headache; menstrual changes/she still has her period and that is very unusual; . This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 15 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 23Jul2021 19:00 (Formulation: solution for injection, Lot number: FA7485) at the age of 15 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache"; MENSTRUATION IRREGULAR (non-serious), outcome "not recovered", described as "menstrual changes/she still has her period and that is very unusual". Therapeutic measures were not taken as a result of menstruation irregular.  Additional information: The reporter is the grandmother of a 15-year-old female patient and just got her granddaughter aged 15 vaccinated and the 1st dose of the vaccine was on 23Jul2021 and states the patient's period started on 19Jul2021 and she still has her period and that is very unusual, and she is always regular and wanted to know if this is related to the vaccine. And the patient also stated that she will not be getting the second dose as scheduled on 13Aug2021 if they don't figure out what's going on or her period doesn't stop. And reporter also wants to know where to go and what to do and if this has something to do with the vaccine. And the reporter declined to provide HCP information and states the patient has a pediatrician that will not see the patient for this, and it is (HCP name withheld) and the HCP said she does not know anything about this and there is nobody to call for the HCP, and reporter also states can Pfizer not direct them to where to go. The patient was not administered any additional Vaccines on Same Date of the Pfizer Suspect. Patient was not going any emergency room visit or not went to any Physician office. The patient had not received any other vaccine within 4 weeks prior to the vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, SARS-CoV-2 test
Clinical narrative: My period has been irregular. My cycle after the first dose was slightly shorter (23 days).  The next cycle was slightly longer (34 days).  The cycle after that was excessively long (107 days); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18Feb2021 (Lot number: EL3247) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sarcoidosis" (unspecified if ongoing). Concomitant medication(s) included: KYLEENA. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 07Mar2021, outcome "unknown", described as "My period has been irregular. My cycle after the first dose was slightly shorter (23 days).  The next cycle was slightly longer (34 days).  The cycle after that was excessively long (107 days)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstruation irregular.  Additional information: Facility type vaccine was Workplace clinic. The patient did not have other vaccine in four weeks. Kyleena IUD in two weeks. The patient has been Covid tested post vaccination and result was negative. The patient did not have known allergies. The patient had bnt162b2 (BNT162B2) (Lot number: EN6203) on 12Mar2021 at right arm.  Response: It only recently dawned on me that there may be a connection. I don't know that there is for sure but when I looked at my period tracker to try to figure out what coincided with the gaps, I realized the only thing different was the vaccine. I did some quick searching online and saw that a number of women were having similar experiences. So I submitted a report right away.  No follow-up attempts are possible. No further information is expected.  Follow-up (05Aug2021): New information received in response to the mail trail sent regarding the confirmation of below mentioned query. Added the response in narrative.  No follow-up attempts are possible. No further information is expected.