chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Ear discomfort, Ear pruritus, Mixed deafness, Myringotomy
Clinical narrative: Patient developed sudden right sided hearing loss/pressure, vertigo, nausea, and phonophobia starting five hours after Moderna #2 on 29 March 2021. She was seen on 22 April by Audiology and ENT specialists, found to have a mixed conductive/sensorineural (mostly conductive) hearing loss (Type B tympanogram), unilateral right ear. Treated with Methylprednisolone taper pak without improvement in hearing. Seen again on 29 April 2021, again with Type B tympanogram; attempted myringotomy without return of fluid. Patient continues to have right sided conductive hearing loss and pressure sensation, dizziness, and periodic nausea. No improvement in ear pressure at this time. Starting approximately 10 April 2021, patient reports difficulty swallowing water and managing her oral secretions; she says the fluid will start to go towards the windpipe and she will have to cough and more deliberately swallow to ensure it goes down the esophagus.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Phonophobia, Saliva altered, Vertigo
Clinical narrative: Patient developed sudden right sided hearing loss/pressure, vertigo, nausea, and phonophobia starting five hours after Moderna #2 on 29 March 2021. She was seen on 22 April by Audiology and ENT specialists, found to have a mixed conductive/sensorineural (mostly conductive) hearing loss (Type B tympanogram), unilateral right ear. Treated with Methylprednisolone taper pak without improvement in hearing. Seen again on 29 April 2021, again with Type B tympanogram; attempted myringotomy without return of fluid. Patient continues to have right sided conductive hearing loss and pressure sensation, dizziness, and periodic nausea. No improvement in ear pressure at this time. Starting approximately 10 April 2021, patient reports difficulty swallowing water and managing her oral secretions; she says the fluid will start to go towards the windpipe and she will have to cough and more deliberately swallow to ensure it goes down the esophagus.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram abnormal, Dyspnoea, Pulmonary thrombosis, Thrombosis, Ultrasound Doppler
Clinical narrative: resulted into blood clots in his throat and left side of his body; This is a spontaneous report from a contactable consumer via a Pfizer sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose on 22Jan2021 (Batch/Lot Number: EL1283) as 1st dose, single, second dose on 16Feb2021 (Batch/Lot Number: EL9264) as 2nd dose, single; both via an unspecified route of administration for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient reported that he ended up in the hospital after receiving both covid vaccines which resulted into blood clots in his throat and left side of his body from the waist down on an unspecified date. The patient was hospitalized due to the event from 25Apr2021 to 27Apr2021. The outcome of the event was unknown.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ultrasound Doppler abnormal
Clinical narrative: resulted into blood clots in his throat and left side of his body; This is a spontaneous report from a contactable consumer via a Pfizer sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose on 22Jan2021 (Batch/Lot Number: EL1283) as 1st dose, single, second dose on 16Feb2021 (Batch/Lot Number: EL9264) as 2nd dose, single; both via an unspecified route of administration for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient reported that he ended up in the hospital after receiving both covid vaccines which resulted into blood clots in his throat and left side of his body from the waist down on an unspecified date. The patient was hospitalized due to the event from 25Apr2021 to 27Apr2021. The outcome of the event was unknown.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: resulted into blood clots in his throat and left side of his body; This is a spontaneous report from a contactable consumer via a Pfizer sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose on 22Jan2021 (Batch/Lot Number: EL1283) as 1st dose, single, second dose on 16Feb2021 (Batch/Lot Number: EL9264) as 2nd dose, single; both via an unspecified route of administration for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient reported that he ended up in the hospital after receiving both covid vaccines which resulted into blood clots in his throat and left side of his body from the waist down on an unspecified date. The patient was hospitalized due to the event from 25Apr2021 to 27Apr2021. The outcome of the event was unknown.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Angiogram cerebral abnormal, Cerebral haemorrhage, Cerebral venous sinus thrombosis, Endotracheal intubation
Clinical narrative: Patient presented with seizures, found to have an Intracranial hemorrhage.  On further investigation patient noted to have cerebral venous thrombosis of his superior sagittal sinus.  No other obvious etiologies for venous thrombosis noted patient.  Which included an extensive hypercoagulable workup..
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Extubation, Laboratory test, Magnetic resonance imaging head abnormal, Mental status changes, Seizure
Clinical narrative: Patient presented with seizures, found to have an Intracranial hemorrhage.  On further investigation patient noted to have cerebral venous thrombosis of his superior sagittal sinus.  No other obvious etiologies for venous thrombosis noted patient.  Which included an extensive hypercoagulable workup..
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Subarachnoid haemorrhage, Superior sagittal sinus thrombosis
Clinical narrative: Patient presented with seizures, found to have an Intracranial hemorrhage.  On further investigation patient noted to have cerebral venous thrombosis of his superior sagittal sinus.  No other obvious etiologies for venous thrombosis noted patient.  Which included an extensive hypercoagulable workup..
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Haemorrhage intracranial, Laboratory test, Seizure, Superior sagittal sinus thrombosis
Clinical narrative: Patient presented with seizures, found to have an Intracranial hemorrhage.  On further investigation patient noted to have cerebral venous thrombosis of his superior sagittal sinus.  No other obvious etiologies for venous thrombosis noted patient.  Which included an extensive hypercoagulable workup..
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Dyspnoea, Fatigue, Pulmonary function test
Clinical narrative: CHILLS; FATIGUE/TIRED; HEADACHE; SHORTNESS OF BREATH; FALLS ASLEEP FOR SEVERAL HOURS AT A TIME; TROUBLE WALKING; This spontaneous report received from a parent concerned a 24 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, allergic to peanuts and tree nuts, non alcohol user, and non smoker.T he patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced falls asleep for several hours at a time. On APR-2021, the subject experienced trouble walking. On 05-APR-2021, the subject experienced shortness of breath. On 05-APR-2021, the subject experienced fatigue/tired. On 05-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced chills. On 07-MAY-2021, Laboratory data included: Blood test (NR: not provided) Not provided. On 12-MAY-2021, Laboratory data included: Pulmonary function test (NR: not provided) Not provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 07-APR-2021, had not recovered from fatigue/tired, and shortness of breath, and the outcome of headache, trouble walking and falls asleep for several hours at a time was not reported. This report was non-serious.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chills, Dyspnoea, Fatigue, Gait disturbance
Clinical narrative: CHILLS; FATIGUE/TIRED; HEADACHE; SHORTNESS OF BREATH; FALLS ASLEEP FOR SEVERAL HOURS AT A TIME; TROUBLE WALKING; This spontaneous report received from a parent concerned a 24 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, allergic to peanuts and tree nuts, non alcohol user, and non smoker.T he patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced falls asleep for several hours at a time. On APR-2021, the subject experienced trouble walking. On 05-APR-2021, the subject experienced shortness of breath. On 05-APR-2021, the subject experienced fatigue/tired. On 05-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced chills. On 07-MAY-2021, Laboratory data included: Blood test (NR: not provided) Not provided. On 12-MAY-2021, Laboratory data included: Pulmonary function test (NR: not provided) Not provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 07-APR-2021, had not recovered from fatigue/tired, and shortness of breath, and the outcome of headache, trouble walking and falls asleep for several hours at a time was not reported. This report was non-serious.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypersomnia, Pulmonary function test
Clinical narrative: CHILLS; FATIGUE/TIRED; HEADACHE; SHORTNESS OF BREATH; FALLS ASLEEP FOR SEVERAL HOURS AT A TIME; TROUBLE WALKING; This spontaneous report received from a parent concerned a 24 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, allergic to peanuts and tree nuts, non alcohol user, and non smoker.T he patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced falls asleep for several hours at a time. On APR-2021, the subject experienced trouble walking. On 05-APR-2021, the subject experienced shortness of breath. On 05-APR-2021, the subject experienced fatigue/tired. On 05-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced chills. On 07-MAY-2021, Laboratory data included: Blood test (NR: not provided) Not provided. On 12-MAY-2021, Laboratory data included: Pulmonary function test (NR: not provided) Not provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 07-APR-2021, had not recovered from fatigue/tired, and shortness of breath, and the outcome of headache, trouble walking and falls asleep for several hours at a time was not reported. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a patient who is 47 years old who brought in a prescription to receive GARDASIL 9; No additional AE reported; he has a patient who is 47 years old who brought in a prescription to receive GARDASIL 9; This spontaneous report was received from a pharmacist via a company representative referring to a 47 years old female patient. No information was provided regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies.  On an unknown date, the patient was prescribed with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (product prescribing issue). On approximately 29-APR-2021 (reported as about 1 week ago), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot# and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age). It was unknown if the patient completed the series or is just starting. No additional adverse event was reported.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Slight left arm pain in muscle near injection site.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 29-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: El3247), dose 1 via an unspecified route of administration in left arm on 26Jan2021 at 13:15 (at the age of 29-years-old) 1ST DOSE SINGLE for Covid-19 immunisation. Patient's medical and concomitant medication history were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. No other vaccine in four weeks. The patient didn't receive other medication in two weeks. The patient experienced slight left arm pain in muscle near injection site on 26Jan2021 at 21:00. The adverse events did not require any treatment. The outcome of the event was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity
Clinical narrative: Sore arm; Tiredness; Body Aches; This is a spontaneous report from a Contactable Consumer(other Non HCP). A 20-year old non pregnant female patient started to receive first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EK9231),via intramuscular route of administration in left arm on 15Jan2021 02:15 PM as 1st dose single dose for COVID-19 immunization. The patient medical history was reported as none, No known allergies reported. Patient received medications within 2 weeks of vaccination which was Penicillin. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 15Jan2021 at 8:00pm the patient experienced Sore arm, Tiredness, Body Aches. The patient did not receive any treatment for the adverse events. The outcome for the events were recovered/resolved on an unspecified date.  Follow-up attempts are completed. No further information is expected.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Insomnia
Clinical narrative: Headache; insomnia; This is a spontaneous report from a contactable Other HCP (patient). A 24-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration in right arm on 25Jan2021 at 05:00 PM as 2nd dose, single for COVID-19 immunization. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. Medical history and concomitant medication were not reported. Facility where the most recent COVID-19 vaccine administered was 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 the vaccination, the patient had not been tested for COVID-19. On 26Jan2021 at 07:00 PM, patient experienced headache, insomnia. No treatment was received for the adverse events. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.  Follow-up (15Apr2021): This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Myalgia, Nausea, Taste disorder
Clinical narrative: Severe nausea and strange taste in mouth, localized muscle pain in left arm, dizziness, headache; Severe nausea and strange taste in mouth, localized muscle pain in left arm, dizziness, headache; Severe nausea and strange taste in mouth, localized muscle pain in left arm, dizziness, headache; Severe nausea and strange taste in mouth, localized muscle pain in left arm, dizziness, headache; Severe nausea and strange taste in mouth, localized muscle pain in left arm, dizziness, headache; This is a spontaneous report from a contactable pharmacist (patient). A 34-years -old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot Number: EL9262) (non-pregnant at the time of vaccination) via unspecified route of administered in arm left on 26Jan2021 at 11:00 AM as SINGLE DOSE for COVID-19 immunisation. The patient's medical history included known allergies: sulfa antibiotics. Concomitant medications (list of any other medications the patient received within 2 weeks of vaccination) included sertraline, baclofen, tylenol, pantoprazole. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot Number: EL1284) via unspecified route of administered in arm left on 05Jan2021 at 10:30 AM as SINGLE DOSE for COVID-19 immunisation. 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 the vaccination the patient was not tested for COVID-19. On 26Jan2021, at 12:30 PM the patient had severe nausea and strange taste in mouth, localized muscle pain in left arm, dizziness, headache. It was unknown whether the patient received treatment for the events. The outcome of the events was not recovered/ not resolved.  Follow-up attempts are completed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Severe heart palpitations for two days; This is a spontaneous report received from a contactable physician (Patient) reported for herself. A 73-year-old non pregnant female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: 123) via an unspecified route of administration in right arm on 19Jan2021 14.30 single dose for covid-19 immunisation. The patient medical history included irregular heart beat. Concomitant medication included diltiazem. Allergies to medications, food, or other products were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since vaccination. On 21Jan2021, the patient experienced severe heart palpitations for two days. No treatment was received for the adverse events. The reporter considered the event as non-serious. The outcome of events was recovered.   Follow-up attempts are completed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Lymph node pain, Lymphadenopathy, Smear test
Clinical narrative: Swollen and painful lymph node at base of the neck (over the clavicle) on left side (side of injection) and tender lymph nodes on the right side of the neck; Swollen and painful lymph node at base of the neck (over the clavicle) on left side (side of injection) and tender lymph nodes on the right side of the neck; This is a spontaneous report from a contactable other HCP (patient reported herself). A 22-year-old non-pregnant female patient received second dose of BNT162B2 (COVID 19, Pfizer, Solution for injection) via an unspecified route of administration to her left arm on 25Jan2021 02.00 PM as single dose for Covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient's medical history included anxiety and depression. No known allergies. Concomitant medications included iron supplements and desogestrel/ethinylestradiol (DESOGESTREL AND ETHINYL ESTRADIOL) (both received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took BNT162B2 (COVID 19, Pfizer) via an unspecified route of administration to her left arm on 06Jan2021 03.00 PM as single dose for Covid-19 immunization. On 26Jan2021 07:00 PM, the patient experienced swollen and painful lymph node at base of the neck (over the clavicle) on left side (side of injection) and tender lymph nodes on the right side of the neck. The events were assessed as non-serious. The patient had been tested for COVID-19. Covid test type post vaccination, nasal swab in Oct2020 showed negative and saliva test in Nov2020 showed negative. She did not receive any treatment in response to the events. Outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Headache, Ocular discomfort, Pain
Clinical narrative: headache; eye dryness; having trouble with my eyes; soreness; This is a spontaneous report from a contactable consumer (patient) via Medical information Team. A female patient of an unspecified age received BNT162B2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/lot number: Not Provided, NDC number of Pfizer COVID 19 vaccine: Not Provided, Reason for no lot number: of Pfizer COVID 19 vaccine: Caller unwilling to complete the report, Expiry Date of Pfizer COVID 19 vaccine: Not Provided) as 1st Dose, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced headache (non-serious) on an unspecified date, eye dryness (non-serious) on an unspecified date, having trouble with my eyes (non-serious) on an unspecified date, soreness (non-serious) on an unspecified date. Consumer was calling reporting AE after receiving her first dose of Pfizer-Biontech Covid19 vaccine.  She stated that she got the headache and the soreness but those "didn't bother her" she was worried about "having trouble with my eyes" specifically eye dryness, was this normal.  She was due for the second shot on 09Feb2021, should she still get it. Patient stated that HA soreness but that didn't bother me- " i've been having trouble with my eyes" due for 2nd shot 09Feb2021. Trouble with her eyes being dry- SE. Should I go ahead and get the second one. Headache lasting 2-3 days. Additional Context: Received call from consumer regrading the Pfizer Covid 19 vaccine which she received a few days ago. She had a slight headache for 2-3 days, which she thought was normal. She was also having trouble with her eyes being dry and she would like to know if that is normal. She did not wish to provide an address or email. She did not wish to complete report and requested to be transferred to have her question answered. No further details provided. For events, headache, outcome was recovered on an unspecified date, eye dryness, outcome was unknown, having trouble with my eyes, outcome was unknown, soreness, outcome was unknown.    Information on lot and Batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: after receiving her first vaccine dose she experienced body aches and fever; after receiving her first vaccine dose she experienced body aches and fever; sore throat; This is a spontaneous report from a Pfizer-sponsored Program. A Contactable female Pharmacist reported that: A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection;), dose 1 via an unspecified route of administration on an unspecified date  as SINGLE DOSE for an unspecified indication.The patient medical history was not reported.The patient's concomitant medications were not reported. The patient experienced after receiving her first vaccine dose she experienced body aches and fever , after receiving her first vaccine dose she experienced body aches and fever , sore throat on an unspecified date Question: Warm transfer from (name) with Pfizer first connect, CEP 2191. Caller is a pharmacist, asking if it is ok to get the second dose of the covid vaccine with a recent sore throat that may or may not be strep Caller reports that she has a sore throat, she has not been tested for strep but is due to get her second vaccine dose and is asking for additional guidance During this call the caller also reported that after receiving her first vaccine dose she experienced body aches and fever but did not report it because it was consistent with the common side effects. E-transmitting for AE data capture. Caller did not report symptoms because they were consistent with the listed common side effects. Remembered AE after call end. The events were assessed as Non serious by health authority outcome of the events was sore throat was unknown. Outcome of remaining events was recovered.  Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Movement disorder, Pain in extremity
Clinical narrative: left arm was inflamed and in pain and she was unable to lift it; woke up with pain in my left arm from my shoulder to my wrist; her left arm was inflamed; This is a spontaneous report from a contactable consumer.  A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: unknown), on unspecified route of administration on unspecified date at single dose for COVID-19 immunisation. Medical history was not reported. concomitant medication included Apixban (ELIQUIS) from an unknown date. The patient had taken vaccine in right arm, but she did not have any discomfort in that arm, whereas At 3:00am her left arm was inflamed and in pain and she was unable to lift it, she had to use her right arm to move her left arm. she had taken a blood thinner right before she got her vaccination. The outcome of events was unknown.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  Information on the Batch/Lot number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vaccination site pain
Clinical narrative: Headache; nausea; injection site pain; This is a spontaneous report from a contactable 43-year-old female Other HCP reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EU9231), via an unspecified route of administration on 18Jan2021 at 09:00 am in left arm as single dose for covid-19 immunization. The patient's medical history and concomitant medications not reported. Historical vaccine included bnt162b2 on 28Dec2020 (lot number=EJ1685, vaccine location-left arm, dose number-1, administration time-09:00 AM) for covid-19 immunisation. On 18Jan2021, the patient experienced headache, nausea, and injection site pain. The patient did not take treatment for the events. The outcome of the events was recovered on an unknown date.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Had first dose yesterday experienced normal side effects also had diarrhea asking how long it will go; This is a spontaneous report from a contactable consumer (reported for herself). A female patient of an unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot number: Not Provided) via an unknown route of administration on 26Jan2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The reporter (type of HCP the reporter was, not clarified) stated that she had the first dose on 26Jan2021 and was experiencing normal side effects and also experienced diarrhea. Reporter did not provide what the normal side effects were. Outcome of the event was not reported (unknown)   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Erythema, Facial pain, Pruritus, Skin burning sensation
Clinical narrative: Hands it started drying up; My skin when I washed my hand it started too turn red and felt like they were on fire; My skin when I washed my hand it started too turn red and felt like they were on fire; Body is irritated/ my hands is turning irritated; Feel itchy almost anywhere my face, neck. Arms, and legs upper back/ my legs get itchy/ itchy skin feeling; My face is irritated by the itchy skin feeling; This is a spontaneous report from a contactable Other HCP (reported for herself). A 37-years-old non pregnant female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection, Batch/Lot number: not reported) administered in left arm via an unknown route of administration on 20Jan2021 at 03:00 as SINGLE DOSE for covid-19 immunization. Medical history included allergies to medications, food, and other products included catfish, fish oil pills. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and medications within 2 weeks of vaccination. It was reported that On 22Jan2021 at 10:00, patient had all the side effects plus a few more as hands it started drying up patient skin when she washed hand it started to turn red and felt like they were on fire and still today a week down the road patient still having trouble with hands and body is irritated by it. Patient feel itchy almost anywhere on face, neck. Arms, and legs upper back, still is bothersome with irritation to itch cause skin is drying up or something and hands are turning irritated the most when patient get them wet and legs get itchy after wash them. patient face was irritated by the itchy skin feeling. No treatment was received for the adverse events. On an unknown date, the events were recovered with sequelae. The vaccine was administered in nursing home/senior living facility. Prior to vaccination, was the patient has not diagnosed with COVID-19. Since the vaccination, the patient has been not tested for COVID-19.  No follow-up attempts were possible; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Skin irritation
Clinical narrative: Hands it started drying up; My skin when I washed my hand it started too turn red and felt like they were on fire; My skin when I washed my hand it started too turn red and felt like they were on fire; Body is irritated/ my hands is turning irritated; Feel itchy almost anywhere my face, neck. Arms, and legs upper back/ my legs get itchy/ itchy skin feeling; My face is irritated by the itchy skin feeling; This is a spontaneous report from a contactable Other HCP (reported for herself). A 37-years-old non pregnant female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection, Batch/Lot number: not reported) administered in left arm via an unknown route of administration on 20Jan2021 at 03:00 as SINGLE DOSE for covid-19 immunization. Medical history included allergies to medications, food, and other products included catfish, fish oil pills. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and medications within 2 weeks of vaccination. It was reported that On 22Jan2021 at 10:00, patient had all the side effects plus a few more as hands it started drying up patient skin when she washed hand it started to turn red and felt like they were on fire and still today a week down the road patient still having trouble with hands and body is irritated by it. Patient feel itchy almost anywhere on face, neck. Arms, and legs upper back, still is bothersome with irritation to itch cause skin is drying up or something and hands are turning irritated the most when patient get them wet and legs get itchy after wash them. patient face was irritated by the itchy skin feeling. No treatment was received for the adverse events. On an unknown date, the events were recovered with sequelae. The vaccine was administered in nursing home/senior living facility. Prior to vaccination, was the patient has not diagnosed with COVID-19. Since the vaccination, the patient has been not tested for COVID-19.  No follow-up attempts were possible; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Headache, Pain, Pain assessment, Pyrexia
Clinical narrative: Intense Headache 7-10 of 10; Low grade fever 100.4; Significant bodyaches; cold sweats; This is a spontaneous report from a contactable other health care professional (Patient, self-reported). A 51-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3247) via an unspecified route of administration, administered in arm left on 27Jan2021 07:30AM, as second dose, single, dose 1, (Batch/Lot Number: EJ1686), via an unspecified route of administration, administered in Arm Left on 06Jan2021 07:30AM, as first dose, single for covid-19 immunization. Reportedly other medical history was none. Patient did not have allergies to medications, food, or other products/known allergies. Concomitant medication included paracetamol (TYLENOL) and ibuprofen (MOTRIN [IBUPROFEN]) received in two weeks of vaccinations. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID-19 prior vaccination. Patient has not been tested for COVID-19, post vaccination. On 28Jan2021 02:45AM, the patient experienced intense headache 7-10 of 10, low grade fever 100.4, significant body aches and cold sweats. The patient underwent lab tests and procedures which included pain assessment: 7-10 of 10 and pyrexia: 100.4 on 28Jan2021. Treatment was not received for adverse events. Outcome of the events was recovering.  Follow-Up (15-Apr-2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: tenderness of arm/arm hurts; Headache; This is a spontaneous report from a contactable Consumer. An unspecified age female Consumer (patient) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number/Expiry date: not provided) via unspecified route of administration as a 2ND DOSE, SINGLE for COVID-19 immunization on 27Jan2021. The patients past medical history and concomitant medications were not reported. On an unknown date, the patient experienced tenderness of arm/arm hurts and Headache. The patient took Ibuprofen since she could not bear the pain. She had asked if it was ok to take Ibuprofen. Consumer had called about the Pfizer COVID-19 vaccine and says she got the second dose yesterday. She said she thought was stupid to report this side effect of a headache and her arm hurts. She says that she read somewhere or heard that taking Ibuprofen with COVID issues or the vaccine is not recommended so she wanted to verify this before she did that and takes Ibuprofen or Tylenol. She said that she is having a common side effect that everyone had. Caller declines to complete a report and requests to be transferred to Pfizer Medical Information for her question. No further details captured, reported, or documented at this time. The reporters contact information was available. It was unknown if the reporter was the prescribing HCP. Outcome of events was unknown.  Follow-up (28Jan2021): This is a follow-up spontaneous report from a contactable Consumer. This Consumer(patient) reported new clinical information.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Eye swelling, Headache, Lacrimation increased, Ocular hyperaemia
Clinical narrative: headaches; runny nose; red, teary and painful eyes; red, teary and painful eyes; red, teary and painful eyes; She woke up with pain and swollen red watery eyes; This is a spontaneous report from a contactable consumer (patient, self-reported). A 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL3248 and expiry date was not provided), via an unspecified route of administration, in Arm Left, on 27Jan2021 at 12:00 o'clock noon, as a single dose for COVID-19 immunization at local hospital. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. The patient reported that she was administered with the first dose of the vaccine yesterday. On 27Jan2021, at night, around 7 pm and after that her eyes started getting red and the headache started, and also had a runny nose, red, teary and painful eyes. After midnight, either being 27Jan2021 or 28Jan2021, she had very huge pain in both eyes and swelling as well as the wateriness in the eyes. It wasn't tolerable and so she started having Tylenol. She woke up with pain and swollen red watery eyes. She started having eye drops and that helped but she was still having pain. Her headache went away last night when she slept. She did not have positive COVID test or Antibody test before the vaccine. She did not have any issues with vaccines in the past. Outcome of the event headache was recovered on an unknown date. Outcome of the event runny nose was unknown and for all other events, it was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: headaches; runny nose; red, teary and painful eyes; red, teary and painful eyes; red, teary and painful eyes; She woke up with pain and swollen red watery eyes; This is a spontaneous report from a contactable consumer (patient, self-reported). A 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL3248 and expiry date was not provided), via an unspecified route of administration, in Arm Left, on 27Jan2021 at 12:00 o'clock noon, as a single dose for COVID-19 immunization at local hospital. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. The patient reported that she was administered with the first dose of the vaccine yesterday. On 27Jan2021, at night, around 7 pm and after that her eyes started getting red and the headache started, and also had a runny nose, red, teary and painful eyes. After midnight, either being 27Jan2021 or 28Jan2021, she had very huge pain in both eyes and swelling as well as the wateriness in the eyes. It wasn't tolerable and so she started having Tylenol. She woke up with pain and swollen red watery eyes. She started having eye drops and that helped but she was still having pain. Her headache went away last night when she slept. She did not have positive COVID test or Antibody test before the vaccine. She did not have any issues with vaccines in the past. Outcome of the event headache was recovered on an unknown date. Outcome of the event runny nose was unknown and for all other events, it was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Flushing, Pain in extremity, Peripheral swelling
Clinical narrative: flushed; elbow hip pain covid; elbow hip pain covid; appearing toes red swollen painful; appearing toes red swollen painful; appearing toes red swollen painful; elbow hip pain covid; This is a spontaneous report from a contactable other hcp (patient). A 77-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: el3247), via an unspecified route of administration in arm left on 19Jan2021 at 08:30 AM as single dose for COVID-19 immunisation. Medical history included htn (hypertension). Patient had allergy from Indocin. Concomitant medication included (other medications the patient received within 2 weeks of vaccination) lisinopril (LISINOPRIL). The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Jan2021 at 08:30, the patient experienced flushed, elbow hip pain covid appearing toes red swollen painful still on day 8. The events were considered as non-serious. Patient reported no for seriousness criteria-results in death, seriousness criteria-life threatening, seriousness criteria-caused/prolonged hospitalization, seriousness criteria-disabling/incapacitating and seriousness criteria-congenital anomaly/birth defect. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Treatment was received for the adverse event (home care). The outcome of the events was reported as not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: flushed; elbow hip pain covid; elbow hip pain covid; appearing toes red swollen painful; appearing toes red swollen painful; appearing toes red swollen painful; elbow hip pain covid; This is a spontaneous report from a contactable other hcp (patient). A 77-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: el3247), via an unspecified route of administration in arm left on 19Jan2021 at 08:30 AM as single dose for COVID-19 immunisation. Medical history included htn (hypertension). Patient had allergy from Indocin. Concomitant medication included (other medications the patient received within 2 weeks of vaccination) lisinopril (LISINOPRIL). The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Jan2021 at 08:30, the patient experienced flushed, elbow hip pain covid appearing toes red swollen painful still on day 8. The events were considered as non-serious. Patient reported no for seriousness criteria-results in death, seriousness criteria-life threatening, seriousness criteria-caused/prolonged hospitalization, seriousness criteria-disabling/incapacitating and seriousness criteria-congenital anomaly/birth defect. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Treatment was received for the adverse event (home care). The outcome of the events was reported as not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: really bad headache; This is a spontaneous report from a contactable consumer (patient herself).  A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, lot number: EL8982 , expiry date: May2021), via an unknown route in the right arm on 21Jan2021 at 11:45 hrs as a single dose for COVID-19 vaccination. Patient's 4 weeks prior vaccination was none. The patient's medical history included allergy and headaches. The patient's concomitant medications included Benadryl for allergy and Excedrin for headache. On 28Jan2021, the patient woke up with a really bad headache. The patient was wondering whether the vaccine triggered the headache as she does get headaches before. She wanted to know if it is vaccine-related so that she could know how to take care of it. The patient didnot visit any emergency room or physician office due to the event. The outcome of the event was unknown.  Follow-up (28Jan2021): This is a follow-up spontaneous report from a contactable Consumer included: Patient demographics (weight and height added, Therapy start date, time, lot number and expiry date, medical history, concomitant medications added, event onset date added.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Vertigo
Clinical narrative: Headache; vertigo; nausea; body aches; chills; This is a spontaneous report from a contactable consumer (patient). A 52-years-old non-pregnant female patient who received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot: EK9261, Expiration date unknown), via an unspecified route of administration in right arm on 27Jan2021 at 12:30, 2ND DOSE, SINGLE for covid-19 immunization (at the age of 52 years). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot: EK9231, Expiration date unknown), via an unspecified route of administration in left arm on 06Jan2021 at 11:30, at a single dose for covid-19 immunization on (at the age of 52 years) in hospital. Patient's medical history included rheumatoid arthritis and fibromyalgia. Patient's concomitant medications included doxepin, pregabalin, sulfasalazine, and celecoxib (CELEBREX). The patient had penicillin allergy to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient was not tested for COVID-19. On 27Jan2021 at 14:30, the patient experienced headache, vertigo, nausea, body aches, and chills. The patient did not receive any treatment. The outcome of events was recovering.  Follow-up attempts are completed. No further information is expected.