chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: 3" diameter rash at the injection site 10 days after the injection that was hot to the touch and itchy; 3" diameter rash at the injection site 10 days after the injection that was hot to the touch and itchy; 3" diameter rash at the injection site 10 days after the injection that was hot to the touch and itchy; This is a spontaneous report from a contactable consumer. An elderly male patient received BNT162B2 (BNT162B2, solution for injection), dose unknown via an unspecified route of administration on 01Feb2021, as dose number unknown single (Batch/Lot number was not reported Expiry date was not reported), for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. Patient (friend's father) experienced a 3" diameter rash at the injection site 10 days after the injection that was hot to the touch and itchy. It was unknown whether patient had covid prior vaccination or post vaccination. It was unknown whether patient had received treatment for the events. The outcome of events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm from the first shot; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 17Jan2021 (Lot Number: EL3246) as dose 1, single for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced sore arm from the first shot. The outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Malaise, Pyrexia, Vomiting
Clinical narrative: feeling sick; Threw up; Fever; Chills; This is a spontaneous report from a non-contactable consumer (Patient's wife). A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 30Jan2021 (Batch/Lot Number: Unknown) as dose 1, single for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD) from an unknown date. The patient's concomitant medications were not reported. No allergies to medications, food, or other products. It was reported that he received the vaccine on Saturday 30Jan2021 but was feeling sick on Monday (01Feb2021) following, better Tuesday but still sick, Wednesday was better. On 01Feb2021, the patient also threw up, experienced fever and chills. 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 has not been tested for COVID-19. There were no treatment received for the adverse event. The outcome of the event feeling sick was recovered on 03Feb2021, while the other events was recovered on unspecified date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Erythema, Pain, Pain in extremity
Clinical narrative: Sensitivity; Taste of soap for about a day; Redness in area; sore arm; This is a spontaneous report from contactable consumers. A 66-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Feb2021 (Batch/Lot number was not reported) (at the age of 66-years-old) as dose 2, single  for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient has no allergies to medication, food or other products. The patient previously took the first dose of bnt162b2 on 30Jan2021 (at the age of 66-years-old) for COVID-19 immunisation. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. On 20Feb2021, the patient experienced sensitivity, taste of soap for about a day, redness in area and sore arm. The patient did not receive treatment for the events. The events were considered non-serious by the consumer. The patient recovered from taste of soap for about a day in Feb2021, while the remaining events recovered in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Chills, Hyperhidrosis
Clinical narrative: Exactly 24 hours later injection site was sore; body began to ache at joints; fever kicked in 100.4; chills so bad my body was shaking; sweating so much I needed to change clothes; my entire body was tingling; Lasted about 12 hours then I was just weak; This is a spontaneous report from a contactable consumer (patient). A 43-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6201) via an unspecified route of administration, administered in left arm on 22Feb2021 13:45 as dose 1, single for COVID-19 immunisation. Medical history included COVID-19 (I did have COVID in June). No known allergies were reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medication within 2 weeks of vaccination. COVID prior vaccination. Post vaccination, the patient has not been tested for COVID-19. Concomitant medication was not reported. On 23Feb2021 14:00 the patient experienced exactly 24 hours later injection site was sore, body began to ache at joints, fever kicked in 100.4, chills so bad my body was shaking, sweating so much the patient needed to change clothes and the entire body was tingling and on an unspecified date in Feb2021, lasted about 12 hours then patient was just weak. The patient underwent lab tests and procedures which included body temperature: 100.4 on an unspecified date, sars-cov-2 antibody test: still had the antibodies an unspecified date. No treatment was received for events. The outcome of the events was recovering.  Follow-up attempts completed. No further information expected.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia, SARS-CoV-2 antibody test, Vaccination site pain
Clinical narrative: Exactly 24 hours later injection site was sore; body began to ache at joints; fever kicked in 100.4; chills so bad my body was shaking; sweating so much I needed to change clothes; my entire body was tingling; Lasted about 12 hours then I was just weak; This is a spontaneous report from a contactable consumer (patient). A 43-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6201) via an unspecified route of administration, administered in left arm on 22Feb2021 13:45 as dose 1, single for COVID-19 immunisation. Medical history included COVID-19 (I did have COVID in June). No known allergies were reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medication within 2 weeks of vaccination. COVID prior vaccination. Post vaccination, the patient has not been tested for COVID-19. Concomitant medication was not reported. On 23Feb2021 14:00 the patient experienced exactly 24 hours later injection site was sore, body began to ache at joints, fever kicked in 100.4, chills so bad my body was shaking, sweating so much the patient needed to change clothes and the entire body was tingling and on an unspecified date in Feb2021, lasted about 12 hours then patient was just weak. The patient underwent lab tests and procedures which included body temperature: 100.4 on an unspecified date, sars-cov-2 antibody test: still had the antibodies an unspecified date. No treatment was received for events. The outcome of the events was recovering.  Follow-up attempts completed. No further information expected.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Diarrhoea, Fatigue, Headache
Clinical narrative: threw up; fever; achy; headache; has no energy; hasn't eaten anything either/ not eating very well; she had cramps; Diarrhea; just tired/very tired; This is a spontaneous report from a contactable consumer (patient's mother). A female patient (consumer's daughter) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 12Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient threw up, had fever, was achy, and had a headache. Reporter stated that, they (reporter and her daughter) hadn't been anywhere to even pick anything up. She stated her daughter (patient) was better but had no energy but hasn't eaten anything either. Her daughter (patient) was worse off than her (reporter) she had cramps diarrhea, fever and nausea. Patient was achy too. Later, reporter clarified that, her daughter (patient) was not nauseous, she was just saying, she feels no energy and was very tired. Her daughter (patient) told her (reporter) that, she was feeling better but she was not eating very well and she was just tired and had no energy. The clinical outcome for the events was recovering except for events, has no energy, hasn't eaten anything either/ not eating very well and just tired/very tired was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain, Pyrexia, Vomiting
Clinical narrative: threw up; fever; achy; headache; has no energy; hasn't eaten anything either/ not eating very well; she had cramps; Diarrhea; just tired/very tired; This is a spontaneous report from a contactable consumer (patient's mother). A female patient (consumer's daughter) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 12Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient threw up, had fever, was achy, and had a headache. Reporter stated that, they (reporter and her daughter) hadn't been anywhere to even pick anything up. She stated her daughter (patient) was better but had no energy but hasn't eaten anything either. Her daughter (patient) was worse off than her (reporter) she had cramps diarrhea, fever and nausea. Patient was achy too. Later, reporter clarified that, her daughter (patient) was not nauseous, she was just saying, she feels no energy and was very tired. Her daughter (patient) told her (reporter) that, she was feeling better but she was not eating very well and she was just tired and had no energy. The clinical outcome for the events was recovering except for events, has no energy, hasn't eaten anything either/ not eating very well and just tired/very tired was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Pruritus, Rash
Clinical narrative: rash on face,neck,back,arms,shoulders; chills; Itchy and hot; Itchy and hot; This is a spontaneous report from a contactable consumer (patient). A 68-year-old non-pregnant female patient received unknown number dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration in left arm on 18Feb2021 [Thursday] at 16:45 (at the age of 68-year-old) as single dose for COVID-19 immunization at Doctor's office/urgent care. Medical history of the patient included none. Patient has allergy to eggs, garlic. Concomitant/other medications in two weeks included levothyroxine sodium [SYNTHROID], venlafaxine hydrochloride [EFFEXOR], cetirizine hydrochloride [ZYRTEC], hydrochlorothiazide taken for unspecified indications. Patient previously received Penicillin, statins on an unspecified date and experienced allergy. Patient did not receive any other vaccine in four weeks of COVID-19 vaccine. Patient did not have COVID prior vaccination and was not tested post vaccination. On 23Feb2021 [Tuesday] at 16:45, 5 days later, patient woke up from very restless night with rash on face, neck, back, arms, shoulder. Itchy and hot, had chills but no fever. Patient was taking Benadryl. It has taken all day to. Outcome of the events were resolving.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthma
Clinical narrative: asthmatic; This is a spontaneous report from a contactable consumer (parent). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 26Jan2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient was very asthmatic. Her second dose has been canceled twice. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Illness, Nausea
Clinical narrative: Feeling nauseous; Fever; Chills; Headache; Slight joint aching; Sick; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 5 patients. This is 2nd report of 5 reports. A patient of unspecified age and gender received bnt162b2 (COMIRNATY COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 18Feb2021, woke up at 3am post-vaccination feeling nauseous, then went back to sleep. Woke up at 7am with fever, chills, headache, slight joint aching. Slept all day and still felt very sick. Patient and was a total of at least six employees in department out sick with similar symptoms out 18Feb2021 or/ and 19Feb2021. Four of patients all woke up between 2-3am with noticeable symptoms, including high fever and chills. Please note that 5/6 mentioned employees are in our mid-20s to early 30s in age (in case there's a trend). The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. Information about Lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021178458 Same reporter, same event, different patient.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Feeling nauseous; Fever; Chills; Headache; Slight joint aching; Sick; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 5 patients. This is 2nd report of 5 reports. A patient of unspecified age and gender received bnt162b2 (COMIRNATY COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 18Feb2021, woke up at 3am post-vaccination feeling nauseous, then went back to sleep. Woke up at 7am with fever, chills, headache, slight joint aching. Slept all day and still felt very sick. Patient and was a total of at least six employees in department out sick with similar symptoms out 18Feb2021 or/ and 19Feb2021. Four of patients all woke up between 2-3am with noticeable symptoms, including high fever and chills. Please note that 5/6 mentioned employees are in our mid-20s to early 30s in age (in case there's a trend). The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. Information about Lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021178458 Same reporter, same event, different patient.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Illness, Nausea
Clinical narrative: feeling nauseous; fever/high fever; chills; slight joint aching; headache; sick; This is a spontaneous report from a contactable consumer. This consumer reported for a patient (Reporter's colleague) that: A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on 17Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history was none and concomitant medications were not reported. Patient had no known allergies. Patient did not receive vaccine in four weeks. Patient did not have COVID prior vaccination. Patient was not tested COVID-19 post vaccination. The patient previously received dose 1 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration, as dose 1, single for COVID-19 immunization. It was reported that on 18Feb2021 03:00, the patient experienced feeling nauseous, high fever, chills, headache, slight joint aching and sick. Three other colleagues and my department out sick after second vaccine with same symptoms. Four of us all woke up between 2-3am with noticeable symptoms, including high fever and chills. We have all since recovered. The patient did not received any treatment for the events. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. Information on lot number, batch number could not be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: feeling nauseous; fever/high fever; chills; slight joint aching; headache; sick; This is a spontaneous report from a contactable consumer. This consumer reported for a patient (Reporter's colleague) that: A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on 17Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history was none and concomitant medications were not reported. Patient had no known allergies. Patient did not receive vaccine in four weeks. Patient did not have COVID prior vaccination. Patient was not tested COVID-19 post vaccination. The patient previously received dose 1 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration, as dose 1, single for COVID-19 immunization. It was reported that on 18Feb2021 03:00, the patient experienced feeling nauseous, high fever, chills, headache, slight joint aching and sick. Three other colleagues and my department out sick after second vaccine with same symptoms. Four of us all woke up between 2-3am with noticeable symptoms, including high fever and chills. We have all since recovered. The patient did not received any treatment for the events. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. Information on lot number, batch number could not be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Illness, Nausea
Clinical narrative: feeling nauseous; high fever; chills; headache; slight joint aching; sick; This is a spontaneous report from a contactable consumer. This consumer reported for a patient (Reporter's colleague) that: A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 17Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history was none and concomitant medications were not reported. Patient had no known allergies. Patient did not receive vaccine in four weeks. Patient did not have COVID prior vaccination. Patient was not tested COVID-19 post vaccination. It was reported that on 18Feb2021 03:00, the patient experienced feeling nauseous, high fever, chills, headache, slight joint aching, sick. Three other colleagues and my department out sick after second vaccine with same symptoms. Four of us all woke up between 2-3am with noticeable symptoms, including high fever and chills. We have all since recovered. The patient did not received any treatment for the events. The outcome of the events was recovered in 2021.  No follow-up attempts are possible. Information on lot number, batch number could not be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: feeling nauseous; high fever; chills; headache; slight joint aching; sick; This is a spontaneous report from a contactable consumer. This consumer reported for a patient (Reporter's colleague) that: A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 17Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history was none and concomitant medications were not reported. Patient had no known allergies. Patient did not receive vaccine in four weeks. Patient did not have COVID prior vaccination. Patient was not tested COVID-19 post vaccination. It was reported that on 18Feb2021 03:00, the patient experienced feeling nauseous, high fever, chills, headache, slight joint aching, sick. Three other colleagues and my department out sick after second vaccine with same symptoms. Four of us all woke up between 2-3am with noticeable symptoms, including high fever and chills. We have all since recovered. The patient did not received any treatment for the events. The outcome of the events was recovered in 2021.  No follow-up attempts are possible. Information on lot number, batch number could not be obtained.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall
Clinical narrative: Severe dizziness to the point of falling in home twice; Severe dizziness to the point of falling in home twice; This is a Spontaneous report from a Non-Contactable Consumer (patient). A 43-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: En6198), dose 1 via an unspecified route of administration on 23Feb2021 at 11:30 (at the age of 43-years-old) as a DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included covid-19 on an unknown date. The patient's concomitant medications were not reported. Other vaccine received in four weeks was none. Patient had covid prior vaccination and was not tested for covid post vaccination. The patient experienced severe dizziness to the point of falling in home twice on an unspecified date. Patient did not receive any treatment for the event. Event resulted in the Doctor or other healthcare professional office/clinic visit. Outcome of the event was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain
Clinical narrative: pain in the back when moving; pain in the chest when breathing or talking a little; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team. An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number and Expiration date: not reported) via an unspecified route of administration on 24Feb2021 (at the age of 83 years old) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Feb2021, the patient experienced pain in the back when moving and pain in the chest when breathing or talking a little. The outcome of the reported events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fall, Vaccination site pain
Clinical narrative: she" flipped and fell"; hurt her shoulder, rotator cuff  and site of injection; hurt her shoulder, rotator cuff  and site of injection; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (Age: 65; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration on 25Feb2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 25Feb2021, the patient received the vaccine on morning and was walking the dogs after the vaccine when she" flipped and fell" and hurt her shoulder, rotator cuff and site of injection. It was reported that she had ice on the injection site and wanted to know if that will affect the efficacy of the vaccine. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain
Clinical narrative: hip and back pain; hip and back pain; This is a spontaneous report from a contactable consumer. A 40-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 24Feb2021 (Batch/Lot number was not reported) as dose 2, single for Covid-19 immunisation. Medical history was not reported. The patient had unspecified concomitant medication. The patient previously took first dose of BNT162B2 on an unspecified date for covid-19 immunisation. On 25Feb2021, the patient woke up with excruciating hip and back pain. He stated he has hip and back pain at baseline and takes narcotic pain relievers regularly. The outcome of the events was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Inflammation
Clinical narrative: Taking anti-inflammatory daily; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient was taking anti-inflammatory daily on an unspecified date. The patient did received the treatment. The outcome of event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot been obtained
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Flushing, Headache
Clinical narrative: headache for the four days following; Flushed face from almost a moment of receiving the vaccine; fatigue; This is a spontaneous report from a contactable consumer (patient).   A non-pregnant 17-years-old female patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: En6201) via an unspecified route of administration, administered in arm right on 22Feb2021 16:30 (at the age of 17 years old) as dose 1, single for COVID-19 immunisation. Medical history included POTS, congenital heart defect mitral, tricuspal valve defect bradycardia and tea tree oil allergy. Concomitant medications were not reported. On 22Feb2021 16:45, the patient experienced flushed face from almost a moment of receiving the vaccine, fatigue, and headache for the four days following the vaccine. The facility type vaccine was reported as other. There was no other vaccine in four weeks and no other medications in two weeks. The patient had no COVID prior vaccination and not COVID tested post vaccination. There was no treatment for the events. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Feeling abnormal, Headache, Laboratory test
Clinical narrative: Fatigue; fogginess; headache; her arm hurt a little; rash intensified it was a dark red; itchy arms; tiredness; had rash on her back; hives; it was a dark red color; This is a spontaneous report received from a contactable consumer or other non hcp. A 70-years-old female patient received 2nd dose of bnt162b2 (Batch/Lot Number: EL9263), via an unspecified route of administration on 06Feb2021 as Dose 2,single for covid-19 immunization.Medical history included anaemia from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.The patient experienced fatigue, fogginess, headache, her arm hurt a little, rash intensified it was a dark red, itchy arms, tiredness, had rash on her back, hives, it was a dark red color on an unspecified date.The patient underwent lab tests and procedures which included laboratory test: unknown result on 2020.The outcome of the event fatigue was recovered and other events was unknown.Caller says she had the vaccination COVID 19 vaccine on the 16Jan and then 06Feb. The one on the 16Jan did nothing and then the next day she had pain in her arm for like 5 minutes and that was it, the second one was a different story. That day she had a rash on her back and she forgot to tell the person she had rash on her back and she took the thing and she went about her day, the next day she had headache it was severe, she took some Advil later on in the afternoon. No further information provided.The next day her arm hurt a little and it hurt on the other arm, in the same place. She does not know if it was sympathetic pain or what but both arms hurt in the muscle towards the back.The  rash on her back was due to patient eating eggs and she wonder whether allergic reaction is happening due to egg.She had gastric problems and she had difficulty getting out of bed.  No follow-up attempts are possible. No further information is expected. Follow-up (25Feb2021): This is a follow-up spontaneous report received from a contactable consumer. This consumer reported that she had a rash on her back before the second dose, after the vaccine the rash intensified it was a dark red color.The patient mentioned about the adverse events she faced after getting 2nd dose of vaccine such as fatigue,rash and arm hurting.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Limb injury, Pruritus, Rash, Urticaria
Clinical narrative: Fatigue; fogginess; headache; her arm hurt a little; rash intensified it was a dark red; itchy arms; tiredness; had rash on her back; hives; it was a dark red color; This is a spontaneous report received from a contactable consumer or other non hcp. A 70-years-old female patient received 2nd dose of bnt162b2 (Batch/Lot Number: EL9263), via an unspecified route of administration on 06Feb2021 as Dose 2,single for covid-19 immunization.Medical history included anaemia from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.The patient experienced fatigue, fogginess, headache, her arm hurt a little, rash intensified it was a dark red, itchy arms, tiredness, had rash on her back, hives, it was a dark red color on an unspecified date.The patient underwent lab tests and procedures which included laboratory test: unknown result on 2020.The outcome of the event fatigue was recovered and other events was unknown.Caller says she had the vaccination COVID 19 vaccine on the 16Jan and then 06Feb. The one on the 16Jan did nothing and then the next day she had pain in her arm for like 5 minutes and that was it, the second one was a different story. That day she had a rash on her back and she forgot to tell the person she had rash on her back and she took the thing and she went about her day, the next day she had headache it was severe, she took some Advil later on in the afternoon. No further information provided.The next day her arm hurt a little and it hurt on the other arm, in the same place. She does not know if it was sympathetic pain or what but both arms hurt in the muscle towards the back.The  rash on her back was due to patient eating eggs and she wonder whether allergic reaction is happening due to egg.She had gastric problems and she had difficulty getting out of bed.  No follow-up attempts are possible. No further information is expected. Follow-up (25Feb2021): This is a follow-up spontaneous report received from a contactable consumer. This consumer reported that she had a rash on her back before the second dose, after the vaccine the rash intensified it was a dark red color.The patient mentioned about the adverse events she faced after getting 2nd dose of vaccine such as fatigue,rash and arm hurting.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Insomnia, Myalgia, Pain in extremity
Clinical narrative: Severe Headache; Muscle Aches; unable to sleep due to severity; Sore Arm; Fever; injection site still hot to touch and sore; injection site still hot to touch and sore; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3247), via an unspecified route of administration, administered in arm left on 19Feb2021 12:45 (at the age of 50-years-old) as dose 2, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3247), via unspecified route of administration, administered in arm left on 29Jan2021 14:00 as dose 1, single for covid-19 immunisation. On 20Feb2021 19:00, the patient fever spiked to 101 degrees. Severe/moderate headache, muscle aches continued in which patient was unable to sleep due severity, and sore arm. It was also reported that the injection site was still hot to touch and sore, but temperature normal and all other symptoms improving. The outcome of the events was recovering without treatment.   No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain, Vaccination site warmth
Clinical narrative: Severe Headache; Muscle Aches; unable to sleep due to severity; Sore Arm; Fever; injection site still hot to touch and sore; injection site still hot to touch and sore; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3247), via an unspecified route of administration, administered in arm left on 19Feb2021 12:45 (at the age of 50-years-old) as dose 2, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3247), via unspecified route of administration, administered in arm left on 29Jan2021 14:00 as dose 1, single for covid-19 immunisation. On 20Feb2021 19:00, the patient fever spiked to 101 degrees. Severe/moderate headache, muscle aches continued in which patient was unable to sleep due severity, and sore arm. It was also reported that the injection site was still hot to touch and sore, but temperature normal and all other symptoms improving. The outcome of the events was recovering without treatment.   No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis atopic
Clinical narrative: Atopic dermatitis; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose on 11Feb2021 16:30 (lot number: EL9264) on the left arm, and second dose on 04Mar2021 16:30 (lot number: EN6199) on the right arm, both via unspecified route of administration as single dose for covid-19 immunisation. Medical history included fatty liver. The patient's concomitant medications were not reported. The patient was not diagnosed with covid-19 prior to vaccination. The patient did not receive other medications within two weeks of vaccination. The patient previously received second dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) on 20Jan2021 for immunization. The patient also previously took ibuprofen and experienced allergy. On 17Feb2021 (also reported as on day 7-8), the patient was diagnosed with atopic dermatitis described as red blotchy rash over most of body, with moderate itching on back, hips, and one leg. The rash started after the first dose, took prednisone. Rash flared back after 2nd dose. The patient was seeing a doctor due to the event. Since the vaccination, the patient had not been tested for covid-19. The patient had not recovered from atopic dermatitis at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: large rash on face, back and chest; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, administered in the left arm, on 24Feb2021 13:30 (Batch/lot number: EN6202), at age 35 years old, as dose 2, single, for COVID-19 immunisation. Relevant medical history included asthma, obesity, and bipolar disorder, all from unknown dates, not reported if ongoing or not. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); levocetirizine dihydrochloride (XYZAL); and cariprazine hydrochloride (VRAYLAR), all taken for unknown indications, start and stop dates not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), administered in the left arm, on 03Feb2021 14:00 (Batch/lot number unknown), at age 35 years old, as dose 1, single, for COVID-19 immunisation. On 25Feb2021 18:00, after the second dose, the patient developed a large rash on face, back and chest. The patient did not receive treatment for the event. The patient recovered from the event on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Erythema nodosum
Clinical narrative: she had an auto immune condition - loefgren syndrome (erythema nodosum) and had no flare up in a few years. Within 1 week of receiving her 1st dose she had flare up, a bump under her skin; she had an auto immune condition - loefgren syndrome (erythema nodosum) and had no flare up in a few years. Within 1 week of receiving her 1st dose she had flare up, a bump under her skin; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot number and Expiry date: was not reported) via an unspecified route of administration on an unspecified date (at the age of 72-year-old) as dose 1, single for covid-19 immunization. Medical history included Lofgren syndrome (erythema nodosum) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient stated that she had an auto immune condition - loefgren syndrome (erythema nodosum) and had no flare up in a few years. Within 1 week of receiving her 1st dose she had flare up, a bump under her skin before 10-15 days before the 2nd injection that's when she saw it came. She spoke with her physician who prescribed prednisone. However, she only took one dose stating that she stopped because she was scheduled to receive her 2nd dose of the vaccine at though she should not take prednisone in between the doses. As a result, her physician instead prescribed a Medrol dose pack, which she completed taking on 15Feb. She received her 2nd dose of the Covid vaccine on 16Feb. She is concerned that if she does not resume taking prednisone that she will have further flare ups and wants to know when it might be ok to resume taking medication for the treatment of her auto-immune condition. She is also concerned that the medicine might have affected the vaccine and would like to speak with someone concerning this. The clinical outcome of events was unknown. No follow-up attempts are possible, information about lot/batch number cannot been obtained.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Muscle strain
Clinical narrative: has now started experiencing pain in the hip; he might have just strained it; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via an unspecified route of administration on 24Feb2021 as single dose for covid-19 immunisation. The patient's medical history included patient had new parts in his hip a year ago in 2020. Concomitant medications were not reported. On an unspecified date, the patient started to experience pain in the hip. He's not sure if it was from the vaccine or not. He still does PT for the hip whenever he think about it. He thinks he might have just strained it. Outcome of pain in hip and "just strained it" was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: joint pain; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Batch/Lot Number, and Expiration Date not reported) via an unspecified route of administration on 17Feb2021, as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced joint pain on an unspecified date. Patient wanted to check how many days usually the symptoms appear after getting the dose of the vaccine. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Discharge, Ear swelling, Hypertension
Clinical narrative: Severe swelling and fluid behind ear drums along with high blood pressure; Severe swelling and fluid behind ear drums along with high blood pressure; Severe swelling and fluid behind ear drums along with high blood pressure; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 52-years-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: UH-WON), via an unspecified route of administration, administered in Arm Left on 20Feb2021 09:30 (Age at vaccination: 52-years-old) as single dose for covid-19 immunization. (Vaccination facility: Other). Medical history included Sjogrens, Hypothyroidism, allergies to Shellfish all from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (TIROSINT) taken for an unspecified indication, start and stop date were not reported. patient did not receive any other vaccine in four weeks. On 21Feb2021 20:00 patient experienced Severe swelling and fluid behind ear drums along with high blood pressure. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events with Antihistamines and decongestants. patient underwent lab tests and procedures which included blood pressure measurement: high. The outcome for the events was reported as not resolved a the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: She broke out in a rash; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: Unknown), via an unspecified route of administration, on an unknown date, as dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date, the patient experienced a broke out rash. Caller does not know if the rash is due to covid vaccine. The patient enquired if she could take an antibody test. And also enquired if she should take a second dose after her reaction. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: severe body ache; headache; fever; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on 25Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced severe body ache, headache and fever. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Rash
Clinical narrative: Rashes on neck; High blood pressure; This is a spontaneous report from a contactable consumer (patient) via the Medical Information Team. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration on 16Feb2021 (lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she got her first BNT162B2 dose in in (institution name) in (state name) last 16Feb2021 and was scheduled on 09Mar2021 for her second dose. On an unspecified date, the patient experienced rashes on her neck and high blood pressure. The patient was given Benadryl and Aveeno lotion for the rashes. The patient added that already spoke to her doctor regarding this and was continuing to update him. Her doctor told her to call her vaccination provider. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.