chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Paraesthesia
Clinical narrative: Aches in bones all over body but worse on the bones in the left arm including shoulder, elbow, Wrist; Burning and tingling on left side of of face, jaw; tingling on left side of of face, jaw; burning in breast; burning in arm and leg of left side of body; Chills; "flu" like feeling; Burning in chest and down left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Aug2021 12:00 (Lot number: Ew1075) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "covid" (unspecified if ongoing), notes: 9 months ago. The patient's concomitant medications were not reported. The following information was reported: BONE PAIN (non-serious) with onset 11Aug2021 17:00, outcome "recovering", described as "Aches in bones all over body but worse on the bones in the left arm including shoulder, elbow, Wrist"; BURNING SENSATION (non-serious) with onset 11Aug2021 17:00, outcome "recovering", described as "Burning and tingling on left side of of face, jaw"; PARAESTHESIA (non-serious) with onset 11Aug2021 17:00, outcome "recovering", described as "tingling on left side of of face, jaw"; BREAST PAIN (non-serious) with onset 11Aug2021 17:00, outcome "recovering", described as "burning in breast"; BURNING SENSATION (non-serious) with onset 11Aug2021 17:00, outcome "recovering", described as "burning in arm and leg of left side of body"; CHILLS (non-serious) with onset 11Aug2021 17:00, outcome "recovering", described as "Chills"; INFLUENZA LIKE ILLNESS (non-serious) with onset 11Aug2021 17:00, outcome "recovering", described as ""flu" like feeling"; CHEST PAIN (non-serious) with onset 11Aug2021 17:00, outcome "recovering", described as "Burning in chest and down left arm". Therapeutic measures were not taken as a result of bone pain, burning sensation, paraesthesia, breast pain, burning sensation, chills, influenza like illness, chest pain.  Additional information: Aches in bones all over body but worse on the bones in the left arm including shoulder, elbow, Wrist. Burning and tingling on left side of face, jaw and burning in breast, arm and leg of left side of the body. Chills and "flu" like feeling. Burning in chest and down left arm two days after the same as when I had Covid 9 months ago. No other vaccine in four weeks. Other medications were received in two weeks. Had covid prior vaccination. No covid test post vaccination.No known allergies and none other medical history.  Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Unknown if consumer was experiencing chest pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 40 year-old male patient received bnt162b2 (BNT162B2), administration date 30Jul2021 (Lot number: EW0181) at the age of 40 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: CHEST PAIN (non-serious), outcome "unknown", described as "Unknown if consumer was experiencing chest pain". Additional information: Can I ask you a question? Can you give me an information on individuals that, I mean not the people who called but are people calling in for symptoms of chest pain?" (further clarification unknown if consumer was experiencing chest pain, hence event captured as-Unknown if consumer was experiencing chest pain).  No follow-up attempts are possible. No further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: After the 2nd dose, he had a gushing bloody nose for over 20 min 3 hrs and 10 min after.; After the first dose, he had a bloody nose for about 10 min 6 hours after.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 13 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Jul2021 20:30 (Lot number: FA8484) at the age of 13 years as dose 1, single and administered in arm left, administration date 13Aug2021 09:00 (Lot number: FC3180) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: EPISTAXIS (non-serious) with onset 13Aug2021 12:15, outcome "recovering", described as "After the 2nd dose, he had a gushing bloody nose for over 20 min 3 hrs and 10 min after."; EPISTAXIS (non-serious) with onset 24Jul2021 12:30, outcome "recovering", described as "After the first dose, he had a bloody nose for about 10 min 6 hours after.". Therapeutic measures were not taken as a result of epistaxis, epistaxis.  Additional information: No treatment was given. No Covid prior vaccination. No Covid tested post vaccination. No known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Contusion, Peripheral swelling, Platelet count
Clinical narrative: Has a squeezing and turning sensation like a tight burn from her ankles to her knees; Bruising on her feet that went up her legs and on her wrists up her arms; Swelling to her feet up to her legs, arms and hands; 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 29 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Jul2021 17:30 (Lot number: FA6780) at the age of 29 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: PERIPHERAL SWELLING (non-serious) with onset 09Aug2021, outcome "recovering", described as "Swelling to her feet up to her legs, arms and hands"; CONTUSION (non-serious) with onset 10Aug2021, outcome "not recovered", described as "Bruising on her feet that went up her legs and on her wrists up her arms"; BURNING SENSATION (non-serious) with onset 11Aug2021, outcome "not recovered", described as "Has a squeezing and turning sensation like a tight burn from her ankles to her knees". The events "swelling to her feet up to her legs, arms and hands", "bruising on her feet that went up her legs and on her wrists up her arms" and "has a squeezing and turning sensation like a tight burn from her ankles to her knees" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient had no AE(s) following prior vaccinations. It was reported that bruising started on feet, going up legs, on wrists to arms looks like petechiae, spreading and turning brown in the evening. The patient reported that it was worsened. Squeezing and turning sensation, Indian burn, tight burn, specific to ankles and knees started early evening. Caller stated that she went to the emergency room.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams, Arthralgia, Back pain, Bone pain, Chills
Clinical narrative: 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 47 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Aug2021 09:00 (Lot number: EW0186) at the age of 47 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "lymphoma", start date: 1985 (unspecified if ongoing), notes: cancer survivor, he was 13 years old, diagnosed 1985-1986. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Pfizer Covid 19 Vaccine, LOT: EN0180, NDC: Unknown, Expiry Date: Unknown, Injection, unknown dosage, left shoulder), administration date: 22Jul2021, when the patient was 47 years old, for COVID-19 Immunisation, reaction(s): "shoulder hurts twice as much as the first shot". The following information was reported: CHILLS (non-serious) with onset 12Aug2021 22:30, outcome "not recovered", described as "chills"; DIZZINESS (non-serious) with onset 12Aug2021 22:30, outcome "not recovered", described as "light headed/real lightheadedness"; PYREXIA (non-serious) with onset 12Aug2021 22:30, outcome "not recovered", described as "fever"; TENDERNESS (non-serious) with onset 12Aug2021 22:30, outcome "not recovered", described as "lower back was tender"; BONE PAIN (non-serious) with onset 12Aug2021, outcome "not recovered", described as "his bones, it's not as bad as his back"; BACK PAIN (non-serious), outcome "unknown", described as "his back hurt so damn bad, he couldn't touch it"; ARTHRALGIA (non-serious) with onset 12Aug2021, outcome "not recovered", described as "His shoulder hurts twice as much as the first shot, he had it in the same arm."; ABNORMAL DREAMS (non-serious) with onset 12Aug2021, outcome "not recovered", described as "dreaming kind of funny"; TREMOR (non-serious), outcome "unknown", described as "got the shakes"; INSOMNIA (non-serious), outcome "unknown", described as "couldn't go back to sleep"; PAIN IN EXTREMITY (non-serious) with onset 12Aug2021, outcome "unknown", described as "had the second dose in the same arm, it hurt about an hour after, the muscle ache because of the needle"; MYALGIA (non-serious) with onset 12Aug2021, outcome "unknown", described as "it hurt about an hour after, the muscle ache because of the needle"; PAIN (non-serious) with onset 12Aug2021 10:30, outcome "unknown", described as "pain".  Additional information: Patient confirms all symptoms are dragging on, persisting. Patient's events did not require any emergency Room and physician office visit. Patient hasn't been to a doctor. Patient did not have any other vaccinations within four weeks prior to the first administration date of the suspect vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Insomnia, Myalgia, Pain, Pain in extremity
Clinical narrative: 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 47 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Aug2021 09:00 (Lot number: EW0186) at the age of 47 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "lymphoma", start date: 1985 (unspecified if ongoing), notes: cancer survivor, he was 13 years old, diagnosed 1985-1986. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Pfizer Covid 19 Vaccine, LOT: EN0180, NDC: Unknown, Expiry Date: Unknown, Injection, unknown dosage, left shoulder), administration date: 22Jul2021, when the patient was 47 years old, for COVID-19 Immunisation, reaction(s): "shoulder hurts twice as much as the first shot". The following information was reported: CHILLS (non-serious) with onset 12Aug2021 22:30, outcome "not recovered", described as "chills"; DIZZINESS (non-serious) with onset 12Aug2021 22:30, outcome "not recovered", described as "light headed/real lightheadedness"; PYREXIA (non-serious) with onset 12Aug2021 22:30, outcome "not recovered", described as "fever"; TENDERNESS (non-serious) with onset 12Aug2021 22:30, outcome "not recovered", described as "lower back was tender"; BONE PAIN (non-serious) with onset 12Aug2021, outcome "not recovered", described as "his bones, it's not as bad as his back"; BACK PAIN (non-serious), outcome "unknown", described as "his back hurt so damn bad, he couldn't touch it"; ARTHRALGIA (non-serious) with onset 12Aug2021, outcome "not recovered", described as "His shoulder hurts twice as much as the first shot, he had it in the same arm."; ABNORMAL DREAMS (non-serious) with onset 12Aug2021, outcome "not recovered", described as "dreaming kind of funny"; TREMOR (non-serious), outcome "unknown", described as "got the shakes"; INSOMNIA (non-serious), outcome "unknown", described as "couldn't go back to sleep"; PAIN IN EXTREMITY (non-serious) with onset 12Aug2021, outcome "unknown", described as "had the second dose in the same arm, it hurt about an hour after, the muscle ache because of the needle"; MYALGIA (non-serious) with onset 12Aug2021, outcome "unknown", described as "it hurt about an hour after, the muscle ache because of the needle"; PAIN (non-serious) with onset 12Aug2021 10:30, outcome "unknown", described as "pain".  Additional information: Patient confirms all symptoms are dragging on, persisting. Patient's events did not require any emergency Room and physician office visit. Patient hasn't been to a doctor. Patient did not have any other vaccinations within four weeks prior to the first administration date of the suspect vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tenderness, Tremor
Clinical narrative: 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 47 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Aug2021 09:00 (Lot number: EW0186) at the age of 47 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "lymphoma", start date: 1985 (unspecified if ongoing), notes: cancer survivor, he was 13 years old, diagnosed 1985-1986. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Pfizer Covid 19 Vaccine, LOT: EN0180, NDC: Unknown, Expiry Date: Unknown, Injection, unknown dosage, left shoulder), administration date: 22Jul2021, when the patient was 47 years old, for COVID-19 Immunisation, reaction(s): "shoulder hurts twice as much as the first shot". The following information was reported: CHILLS (non-serious) with onset 12Aug2021 22:30, outcome "not recovered", described as "chills"; DIZZINESS (non-serious) with onset 12Aug2021 22:30, outcome "not recovered", described as "light headed/real lightheadedness"; PYREXIA (non-serious) with onset 12Aug2021 22:30, outcome "not recovered", described as "fever"; TENDERNESS (non-serious) with onset 12Aug2021 22:30, outcome "not recovered", described as "lower back was tender"; BONE PAIN (non-serious) with onset 12Aug2021, outcome "not recovered", described as "his bones, it's not as bad as his back"; BACK PAIN (non-serious), outcome "unknown", described as "his back hurt so damn bad, he couldn't touch it"; ARTHRALGIA (non-serious) with onset 12Aug2021, outcome "not recovered", described as "His shoulder hurts twice as much as the first shot, he had it in the same arm."; ABNORMAL DREAMS (non-serious) with onset 12Aug2021, outcome "not recovered", described as "dreaming kind of funny"; TREMOR (non-serious), outcome "unknown", described as "got the shakes"; INSOMNIA (non-serious), outcome "unknown", described as "couldn't go back to sleep"; PAIN IN EXTREMITY (non-serious) with onset 12Aug2021, outcome "unknown", described as "had the second dose in the same arm, it hurt about an hour after, the muscle ache because of the needle"; MYALGIA (non-serious) with onset 12Aug2021, outcome "unknown", described as "it hurt about an hour after, the muscle ache because of the needle"; PAIN (non-serious) with onset 12Aug2021 10:30, outcome "unknown", described as "pain".  Additional information: Patient confirms all symptoms are dragging on, persisting. Patient's events did not require any emergency Room and physician office visit. Patient hasn't been to a doctor. Patient did not have any other vaccinations within four weeks prior to the first administration date of the suspect vaccine.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Clot retraction, Joint injury, Joint swelling, Myalgia
Clinical narrative: lesion on ankle; muscle and joint cap pain; muscle and joint cap pain; feeling ringing in her ears; ankle swelling; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), administration date 21Jul2021 (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: JOINT INJURY (non-serious), outcome "unknown", described as "lesion on ankle"; TINNITUS (non-serious) with onset Aug2021, outcome "unknown", described as "feeling ringing in her ears"; JOINT SWELLING (non-serious) with onset Aug2021, outcome "unknown", described as "ankle swelling"; MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 02Aug2021, outcome "unknown" and all described as "muscle and joint cap pain". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient reported that the lesion on ankle is on her bone looked like it was from years ago or from when she was born but about a week ago it started bothering her.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: lesion on ankle; muscle and joint cap pain; muscle and joint cap pain; feeling ringing in her ears; ankle swelling; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), administration date 21Jul2021 (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: JOINT INJURY (non-serious), outcome "unknown", described as "lesion on ankle"; TINNITUS (non-serious) with onset Aug2021, outcome "unknown", described as "feeling ringing in her ears"; JOINT SWELLING (non-serious) with onset Aug2021, outcome "unknown", described as "ankle swelling"; MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 02Aug2021, outcome "unknown" and all described as "muscle and joint cap pain". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient reported that the lesion on ankle is on her bone looked like it was from years ago or from when she was born but about a week ago it started bothering her.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate irregular
Clinical narrative: Shortness of breath, irrational heartbeat; Shortness of breath, irrational heartbeat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Aug2021 13:00 (Lot number: EW0179) at the age of 31 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: HEART RATE IRREGULAR (non-serious), DYSPNOEA (non-serious) all with onset 03Aug2021, outcome "not recovered" and all described as "Shortness of breath, irrational heartbeat". Therapeutic measures were not taken as a result of heart rate irregular, dyspnoea.  Addition Information: No other vaccine in four weeks. No other medications in two weeks. She did not have Covid prior vaccination, She did not have Covid tested post vaccination. Patient had not any known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate irregular, Illness, Rash, Swelling, Vaccination site pain
Clinical narrative: Started to get sick; rashes; pain in the injection site; swelling; irregular heartbeat; 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 female patient received bnt162b2 (BNT162B2), administration date 09Aug2021 (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: ILLNESS (non-serious) with onset Aug2021, outcome "unknown", described as "Started to get sick"; RASH (non-serious) with onset Aug2021, outcome "unknown", described as "rashes"; VACCINATION SITE PAIN (non-serious) with onset Aug2021, outcome "unknown", described as "pain in the injection site"; SWELLING (non-serious) with onset Aug2021, outcome "unknown", described as "swelling"; HEART RATE IRREGULAR (non-serious) with onset Aug2021, outcome "unknown", described as "irregular heartbeat".  Additional information: No medical questions were addressed by this program forwarded/ referred to medical information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Myoclonus, Neuralgia, Pain in extremity
Clinical narrative: Excruciating left foot/ankle & shin electrical nerve shooting pain; Entire body muscle twitching & spasms.; Entire body muscle twitching & spasms.; Feeling of cramping in legs, calves & shins (primarily left leg); Feeling of needle stabbing in left calf; Severe left hip and lower back pain; Severe left hip and lower back pain; Left leg and ankle joint weakness; Myoclonic limb jerks; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 12Apr2021 13:15 (Lot number: EIN 0158) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). Concomitant medication(s) included: KRILL OIL; TURMERIC CURCUMIN; AREDS; VIT D3; VITAMIN K 2; PROBIOTICS.  The following information was reported: NEURALGIA (non-serious) with onset 19Apr2021 13:00, outcome "not recovered", described as "Excruciating left foot/ankle & shin electrical nerve shooting pain"; MUSCLE SPASMS (non-serious) with onset 19Apr2021 13:00, outcome "not recovered", described as "Entire body muscle twitching & spasms."; MUSCLE SPASMS (non-serious) with onset 19Apr2021 13:00, outcome "not recovered", described as "Feeling of cramping in legs, calves & shins (primarily left leg)"; PAIN IN EXTREMITY (non-serious) with onset 19Apr2021 13:00, outcome "not recovered", described as "Feeling of needle stabbing in left calf"; ARTHRALGIA (non-serious), BACK PAIN (non-serious) all with onset 19Apr2021 13:00, outcome "not recovered" and all described as "Severe left hip and lower back pain"; MUSCULAR WEAKNESS (non-serious) with onset 19Apr2021 13:00, outcome "not recovered", described as "Left leg and ankle joint weakness"; MYOCLONUS (non-serious) with onset 19Apr2021 13:00, outcome "not recovered", described as "Myoclonic limb jerks". The events "excruciating left foot/ankle & shin electrical nerve shooting pain", "entire body muscle twitching & spasms.", "feeling of cramping in legs, calves & shins (primarily left leg)", "feeling of needle stabbing in left calf", "severe left hip and lower back pain", "severe left hip and lower back pain", "left leg and ankle joint weakness" and "myoclonic limb jerks" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of neuralgia, muscle spasms, muscle spasms, pain in extremity, arthralgia, back pain, muscular weakness, myoclonus.  Additional information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received treatment included with Oral steroids & Gabapentin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.  Follow-Up (25Aug2021): Follow-up attempts are completed. No further information is expected
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement
Clinical narrative: Precipitous pressure drop. Outcome good; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from a sales representative.  A patient (no qualifiers provided) 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: BLOOD PRESSURE DECREASED (non-serious), outcome "unknown", described as "Precipitous pressure drop. Outcome good". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Extremely erratic menstruation patterns since vaccination; I have had gotten my period multiple times in a month, heavy each time with fresh red blood; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07May2021 11:15 (Lot number: EW0173) at the age of 24 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: KYLEENA. Vaccination history included: Bnt162b2 (Product=COVID 19,, lot number=EW0153,, Administration time=11:15 AM,, dose number=1,, vaccine location=Left arm), administration date: 09Apr2021, when the patient was 24 years old, for COVID-19 immunization. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 14May2021, outcome "not recovered", described as "Extremely erratic menstruation patterns since vaccination"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 14May2021, outcome "not recovered", described as "I have had gotten my period multiple times in a month, heavy each time with fresh red blood". Therapeutic measures were not taken as a result of menstruation irregular, heavy menstrual bleeding.  Additional information: Extremely erratic menstruation patterns since vaccination. My typical cycle is very regular occurring once a month, lasting about 3 days, with little dried blood. Since my vaccine, I have had gotten my period multiple times in a month, heavy each time with fresh red blood. I can bleed through a maxi pad within a few hours. During the month of Jul2021, I had my period 3 times. First starting on 28Jun2021-05Jul2021, then from 11Jul2021-16Jul2021, and again from 28Jul2021-04Aug2021. Now I have it again from 8/10 to today. Serious : No, Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store, Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Swelling face
Clinical narrative: My face is swelling a little bit; My face was little fussy; 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 12Aug2021 (Lot number: EW0165) 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: SWELLING FACE (non-serious) with onset Aug2021, outcome "unknown", described as "My face is swelling a little bit"; FEELING ABNORMAL (non-serious) with onset Aug2021, outcome "unknown", described as "My face was little fussy".  Follow-up (31Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Malaise, Pain in extremity, Pyrexia
Clinical narrative: soreness at the arm where the injection was; Chills; running a fever; do not feel well; leg hurts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 14 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 12Aug2021 (Lot number: EW0165) 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: VACCINATION SITE PAIN (non-serious) with onset Aug2021, outcome "unknown", described as "soreness at the arm where the injection was"; CHILLS (non-serious) with onset Aug2021, outcome "unknown", described as "Chills"; PYREXIA (non-serious) with onset Aug2021, outcome "not recovered", described as "running a fever"; MALAISE (non-serious) with onset Aug2021, outcome "unknown", described as "do not feel well"; PAIN IN EXTREMITY (non-serious) with onset Aug2021, outcome "unknown", described as "leg hurts". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Reporter stated no other prior vaccination was administered.   No follow-up attempts are possible. No further information is expected
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness at the arm where the injection was; Chills; running a fever; do not feel well; leg hurts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 14 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 12Aug2021 (Lot number: EW0165) 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: VACCINATION SITE PAIN (non-serious) with onset Aug2021, outcome "unknown", described as "soreness at the arm where the injection was"; CHILLS (non-serious) with onset Aug2021, outcome "unknown", described as "Chills"; PYREXIA (non-serious) with onset Aug2021, outcome "not recovered", described as "running a fever"; MALAISE (non-serious) with onset Aug2021, outcome "unknown", described as "do not feel well"; PAIN IN EXTREMITY (non-serious) with onset Aug2021, outcome "unknown", described as "leg hurts". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Reporter stated no other prior vaccination was administered.   No follow-up attempts are possible. No further information is expected
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: Little chills; A little fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 12Aug2021 11:00 (Lot number: FA7484) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sinus issues" (ongoing), notes: Sinus issues began about 6 years ago. when he gets a cold he gets bronchitis.; "Cold" (unspecified if ongoing); "bronchitis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Flu vaccine, for Flu immunization, reaction(s): "No adverse event". The following information was reported: CHILLS (non-serious) with onset 13Aug2021, outcome "unknown", described as "Little chills"; PYREXIA (non-serious) with onset 13Aug2021, outcome "unknown", described as "A little fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The caller was a consumer reporting he received the first dose Pfizer Covid 19 Vaccine yesterday, 12Aug2021. The caller works at the county jail. The caller woke up this morning with a little chills and got a little fever, just the fever and chills every now and then. The caller knows to drink a lot of fluids. The chills happen once in a blue moon, a little if not a lot. A little fever: The caller states he took his temperature with a thermometer and it was 101. The caller took his temperature again at the jail he works at and the temperature was 97.5. The caller states the thermometer initial temperature was taken with was where you place the thermometer under the tongue. The thermometer used at the caller's workplace was a forehead thermometer. Any AE(s) did not require a visit to Emergency Room and Physician Office. Prior Vaccinations (within 4 weeks) was no AE(s) following prior vaccinations was No, because the caller has received a flu vaccine and had no symptoms at all. The caller states having symptoms after receiving the first dose Pfizer Covid Vaccine is a first for the caller. The caller will call his doctor because the doctor is out at the hospital. The caller states the sinus issues began about 6 years ago. The caller states when he gets a cold he gets bronchitis.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Headache, Heavy menstrual bleeding, Lymph node pain, Lymphadenopathy
Clinical narrative: menstrual cycle change; menstrual cycle day 5 continued and additional 8 days; axillary lump; Axillary lymph node began swelling with mild pain; Axillary lymph node began swelling with mild pain; Headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 11Aug2021 13:30 (Lot number: EW0172) at the age of 31 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism", start date: 2006 (ongoing). Concomitant medication(s) included: LEVOTHYROXINE SODIUM; VYVANSE; ACETAMINOPHEN. Past drug history included: Cephalexin, reaction(s): "allergies". The following information was reported: HEADACHE (non-serious) with onset 12Aug2021, outcome "recovered" (03Sep2021), described as "Headache"; MENSTRUAL DISORDER (non-serious) with onset 13Aug2021, outcome "recovered" (20Aug2021), described as "menstrual cycle change"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 13Aug2021, outcome "recovered" (20Aug2021), described as "menstrual cycle day 5 continued and additional 8 days"; AXILLARY MASS (non-serious) with onset 13Aug2021, outcome "not recovered", described as "axillary lump"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 13Aug2021, outcome "not recovered" and all described as "Axillary lymph node began swelling with mild pain". The events "menstrual cycle change", "menstrual cycle day 5 continued and additional 8 days" and "axillary lump" were evaluated at the physician office visit. Therapeutic measures were taken as a result of headache. Therapeutic measures were not taken as a result of menstrual disorder, heavy menstrual bleeding. It was unknown if therapeutic measures were taken as a result of axillary mass.  Additional Information: The vaccine was administered in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since vaccination, the patient has not been tested for COVID-19. Treatment for headache included acetaminophen. The axillary lump was continuously monitored. The patient received the second dose on 01Sep2021 at 11:30, intramuscularly administered in the left deltoid  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: menstrual cycle change; menstrual cycle day 5 continued and additional 8 days; axillary lump; Axillary lymph node began swelling with mild pain; Axillary lymph node began swelling with mild pain; Headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 11Aug2021 13:30 (Lot number: EW0172) at the age of 31 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism", start date: 2006 (ongoing). Concomitant medication(s) included: LEVOTHYROXINE SODIUM; VYVANSE; ACETAMINOPHEN. Past drug history included: Cephalexin, reaction(s): "allergies". The following information was reported: HEADACHE (non-serious) with onset 12Aug2021, outcome "recovered" (03Sep2021), described as "Headache"; MENSTRUAL DISORDER (non-serious) with onset 13Aug2021, outcome "recovered" (20Aug2021), described as "menstrual cycle change"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 13Aug2021, outcome "recovered" (20Aug2021), described as "menstrual cycle day 5 continued and additional 8 days"; AXILLARY MASS (non-serious) with onset 13Aug2021, outcome "not recovered", described as "axillary lump"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 13Aug2021, outcome "not recovered" and all described as "Axillary lymph node began swelling with mild pain". The events "menstrual cycle change", "menstrual cycle day 5 continued and additional 8 days" and "axillary lump" were evaluated at the physician office visit. Therapeutic measures were taken as a result of headache. Therapeutic measures were not taken as a result of menstrual disorder, heavy menstrual bleeding. It was unknown if therapeutic measures were taken as a result of axillary mass.  Additional Information: The vaccine was administered in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since vaccination, the patient has not been tested for COVID-19. Treatment for headache included acetaminophen. The axillary lump was continuously monitored. The patient received the second dose on 01Sep2021 at 11:30, intramuscularly administered in the left deltoid  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Vaccination site hypoaesthesia
Clinical narrative: Numbness/Lost feeling in my left arm from the shot site to the tip of my thumb; Numbness/Lost feeling in my left arm from the shot site to the tip of my thumb; The initial safety information received was reporting only non-serious adverse drug reaction(s). Upon receipt of follow-up information on 05Jan2022, this case now contains serious adverse reaction. Information processed together.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Aug2021 13:00 (Lot number: FA7485) at the age of 38 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: HYPOAESTHESIA (disability, medically significant), VACCINATION SITE HYPOAESTHESIA (disability, medically significant) all with onset 13Aug2021 07:00, outcome "not recovered" and all described as "Numbness/Lost feeling in my left arm from the shot site to the tip of my thumb". It was unknown if therapeutic measures were taken as a result of hypoaesthesia, vaccination site hypoaesthesia. Additional information: The day after the first shot, patient lost feeling in the left arm from the shot site to the tip of the thumb. Prior vaccine in four weeks was None. Relevant test was none.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: I have some disturbing stuffs, so right after vaccination I got bad, vaccine is not safe and effective; 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) (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: FEELING ABNORMAL (non-serious), outcome "unknown", described as "I have some disturbing stuffs, so right after vaccination I got bad, vaccine is not safe and effective".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (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: ILLNESS (non-serious), outcome "unknown", described as "sick". Additional information: The reporter was the patient's mother. The patient received the dose 1 at home but cannot go to the office where the vaccine was to receive the second dose because he was sick.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: running nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CHANTIX. The following information was reported: RHINORRHOEA (non-serious), outcome "not recovered", described as "running nose". Additional information: It was reported that the patient has been experiencing running nose, when she keeps her head down she has to keep wiping it; she does not feel bad but her nose keeps running. Patient was querying if that was okay. The patient also wanted to know if the running nose she was experiencing was due to Pfizer COVID vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Herpes zoster, Pain
Clinical narrative: Shingles; Blisters; Pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administration date 02Apr2021 (Batch/Lot number: unknown) at the age of 74 years as dose 2, single and administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Shingle vaccine (In 2019 she had shingle vaccine), administration date: 2019, for Immunization. The following information was reported: HERPES ZOSTER (non-serious) with onset 2021, outcome "unknown", described as "Shingles"; BLISTER (non-serious) with onset 2021, outcome "recovered" (2021), described as "Blisters"; PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Pain".  Additional Information: 5 to 6 weeks ago patient developed shingles. She was able to get the two doses of the covid vaccine. Patient was planning to get the covid booster dose. She wanted to know the timing on when she could have the booster shot. Agent referred her to her hcp. Stated she can be followed up with and she was waiting for a call.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation, Product use issue, Rash
Clinical narrative: Severe whole body rash, not itchy; Left armpit pain; Booster; Other vaccine same date vaccine date 22Nov2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Nov2021 08:30 (Batch/Lot number: unknown) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU, administration date 22Nov2021; CLARITIN ALLERGIC; BENADRYL. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0172, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 03May2021, when the patient was 46 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8729, Location of injection: Leg Left, Vaccine Administration Time: 12:00 PM), administration date: 12Apr2021, when the patient was 46 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Nov2021 08:30, outcome "unknown", described as "Booster"; PRODUCT USE ISSUE (non-serious) with onset 22Nov2021, outcome "unknown", described as "Other vaccine same date vaccine date 22Nov2021"; RASH (non-serious) with onset 23Nov2021 06:00, outcome "not recovered", described as "Severe whole body rash, not itchy"; AXILLARY PAIN (non-serious) with onset 23Nov2021 06:00, outcome "not recovered", described as "Left armpit pain". Therapeutic measures were taken as a result of rash, axillary pain.  Additional Information: The patient received prior vaccination within 4 weeks. Patient had no known allergies. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Treatment received for adverse events was reported as Claritin and Benadryl.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.