chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dementia, Disturbance in attention, Fatigue, Feeling abnormal
Clinical narrative: thought it was early dementia/ this was much worse; Headache; chills; sweats; redness at injection site quite large and swollen; redness at injection site quite large and swollen; Mind wouldn't relax to sleep; couldn't concentrate or remember; couldn't concentrate or remember; extreme tiredness; foggy headedness; This is a spontaneous report from a contactable consumer (patient). A 68-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 301358A), via an unspecified route of administration in right arm on 26Sep2021 at 12:30 (at the age of 68-years-old) at dose 3 (booster), single for COVID-19 immunization. The patient's medical history was not reported. She has no COVID prior to vaccination. Concomitant medications included influenza vaccine (FLU), via an unspecified route of administration in right arm 16Sep2021 at dose number unknown, single for immunization and vitamin D NOS (VITAMIN D). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 08Feb2021 at 10:00 (at the age of 67-years-old) at dose 1, single (lot number: EM9809) and via an unspecified route of administration in right arm on 01Mar2021 at 11:00 (at the age of 67-years-old) at dose 2, single (lot number: EW6201) for COVID-19 immunization and experienced foggy headedness and early dementia. She also previously took BIAXIN and experienced allergies. Vaccination facility type was reported as pharmacy or drug store. She was not tested for COVID post to vaccination. On 26Sep2021 at 15:00, the patient experienced headache; chills; sweats; redness at injection site which was quite large and swollen; her mind wouldn't relax to sleep for 3 days (as reported); she couldn't concentrate or remember what was just told to her for 3 days (as reported), she couldn't remember what she just read or watched on TV; extreme tiredness for a week; and foggy headedness. She had a shot on Sunday morning, 26Sep2021, and symptoms, except tiredness which lasted for a week, were gone by Thursday, 30Sep2021. The foggy headedness had her concerned and was scary. Her husband was concerned as well. She thought it was early dementia, she had a little of that with the second shot, but this was much worse after the third shot. She did not receive any treatment in response to the events. The outcome of the event "extreme tiredness" was recovered on 03Oct2021 and recovered on 30Sep2021 for all other events.   Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Insomnia, Memory impairment, Vaccination site erythema
Clinical narrative: thought it was early dementia/ this was much worse; Headache; chills; sweats; redness at injection site quite large and swollen; redness at injection site quite large and swollen; Mind wouldn't relax to sleep; couldn't concentrate or remember; couldn't concentrate or remember; extreme tiredness; foggy headedness; This is a spontaneous report from a contactable consumer (patient). A 68-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 301358A), via an unspecified route of administration in right arm on 26Sep2021 at 12:30 (at the age of 68-years-old) at dose 3 (booster), single for COVID-19 immunization. The patient's medical history was not reported. She has no COVID prior to vaccination. Concomitant medications included influenza vaccine (FLU), via an unspecified route of administration in right arm 16Sep2021 at dose number unknown, single for immunization and vitamin D NOS (VITAMIN D). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 08Feb2021 at 10:00 (at the age of 67-years-old) at dose 1, single (lot number: EM9809) and via an unspecified route of administration in right arm on 01Mar2021 at 11:00 (at the age of 67-years-old) at dose 2, single (lot number: EW6201) for COVID-19 immunization and experienced foggy headedness and early dementia. She also previously took BIAXIN and experienced allergies. Vaccination facility type was reported as pharmacy or drug store. She was not tested for COVID post to vaccination. On 26Sep2021 at 15:00, the patient experienced headache; chills; sweats; redness at injection site which was quite large and swollen; her mind wouldn't relax to sleep for 3 days (as reported); she couldn't concentrate or remember what was just told to her for 3 days (as reported), she couldn't remember what she just read or watched on TV; extreme tiredness for a week; and foggy headedness. She had a shot on Sunday morning, 26Sep2021, and symptoms, except tiredness which lasted for a week, were gone by Thursday, 30Sep2021. The foggy headedness had her concerned and was scary. Her husband was concerned as well. She thought it was early dementia, she had a little of that with the second shot, but this was much worse after the third shot. She did not receive any treatment in response to the events. The outcome of the event "extreme tiredness" was recovered on 03Oct2021 and recovered on 30Sep2021 for all other events.   Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: thought it was early dementia/ this was much worse; Headache; chills; sweats; redness at injection site quite large and swollen; redness at injection site quite large and swollen; Mind wouldn't relax to sleep; couldn't concentrate or remember; couldn't concentrate or remember; extreme tiredness; foggy headedness; This is a spontaneous report from a contactable consumer (patient). A 68-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 301358A), via an unspecified route of administration in right arm on 26Sep2021 at 12:30 (at the age of 68-years-old) at dose 3 (booster), single for COVID-19 immunization. The patient's medical history was not reported. She has no COVID prior to vaccination. Concomitant medications included influenza vaccine (FLU), via an unspecified route of administration in right arm 16Sep2021 at dose number unknown, single for immunization and vitamin D NOS (VITAMIN D). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 08Feb2021 at 10:00 (at the age of 67-years-old) at dose 1, single (lot number: EM9809) and via an unspecified route of administration in right arm on 01Mar2021 at 11:00 (at the age of 67-years-old) at dose 2, single (lot number: EW6201) for COVID-19 immunization and experienced foggy headedness and early dementia. She also previously took BIAXIN and experienced allergies. Vaccination facility type was reported as pharmacy or drug store. She was not tested for COVID post to vaccination. On 26Sep2021 at 15:00, the patient experienced headache; chills; sweats; redness at injection site which was quite large and swollen; her mind wouldn't relax to sleep for 3 days (as reported); she couldn't concentrate or remember what was just told to her for 3 days (as reported), she couldn't remember what she just read or watched on TV; extreme tiredness for a week; and foggy headedness. She had a shot on Sunday morning, 26Sep2021, and symptoms, except tiredness which lasted for a week, were gone by Thursday, 30Sep2021. The foggy headedness had her concerned and was scary. Her husband was concerned as well. She thought it was early dementia, she had a little of that with the second shot, but this was much worse after the third shot. She did not receive any treatment in response to the events. The outcome of the event "extreme tiredness" was recovered on 03Oct2021 and recovered on 30Sep2021 for all other events.   Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Coccydynia, Fatigue, Headache, Illness
Clinical narrative: she "passed out for 9 hours"; My legs felt paralyzed and it was very hard to move; had a headache; felt sick; My legs felt paralyzed and it was very hard to move; was weak; tired; Body aches, after booster; felt like I had Covid-19/not sure if she had Covid; sore arm/Arm a little sore; my coccyx is very sore; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration, administered in arm left on 29Sep2021 (lot number: (reported as '1308A'); expiry date: unknown) at the age of 75-years-old, as dose 3 (booster), single, for Covid-19 immunisation. Medical history included ongoing polymyalgia. There were no concomitant medications. The patient previously received bnt162b2 (COMIRNATY), on 15Jan2021 (lot number: EL1284) at the age of 74-years-old as dose 1, single, and on 05Feb2021 (lot number: EL9262) at the age of 74-years-old as dose 2, single, for Covid-19 immunisation. Patient reported side effects after receiving her Pfizer BT Covid vaccine booster on 29Sep2021. She felt fine right after the shot. On the same day of vaccination her arm was a little sore. On 30Sep2021, patient got up from lying down, and then passed out in her bathroom, she thinks she was unconscious for 9 hours and was evaluated by primary care physician (PCP). She also had headache, sore arm and body aches after booster. She got the vaccine in her arm and then the next day, she was getting ready to go out, she had a terrible headache, felt sick/ ill, weak, felt like she had Covid-19 but she was not sure if she had Covid. Patient got in to bed at 12:00pm and must have gotten up to bedroom while it was still daylight, because there were no lights on and she woke up on the bathroom floor and it was dark outside and it was 5am. Her legs felt paralyzed, and it was very hard to move. She dragged herself to bed and went to sleep. Her daughter took her to the doctor the next day. She was better but her coccyx was very sore on unspecified date in 2021. She called CVS to ask if these could be side effects. The healthcare provider recommended that she does not take another shot. She will call her healthcare provider before she gets her Flu shot. Patient stated that she believes in Science, and she has a history of taking vaccines and they have worked. Outcome of the events passed out and paralyzed was recovered on 01Oct2021, for events headache, pain in arm, sickness and weakness was recovered in Oct2021, for event tired was not recovered, for event body aches after booster was recovering, while for the other events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Movement disorder, Pain, Pain in extremity, Paralysis
Clinical narrative: she "passed out for 9 hours"; My legs felt paralyzed and it was very hard to move; had a headache; felt sick; My legs felt paralyzed and it was very hard to move; was weak; tired; Body aches, after booster; felt like I had Covid-19/not sure if she had Covid; sore arm/Arm a little sore; my coccyx is very sore; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration, administered in arm left on 29Sep2021 (lot number: (reported as '1308A'); expiry date: unknown) at the age of 75-years-old, as dose 3 (booster), single, for Covid-19 immunisation. Medical history included ongoing polymyalgia. There were no concomitant medications. The patient previously received bnt162b2 (COMIRNATY), on 15Jan2021 (lot number: EL1284) at the age of 74-years-old as dose 1, single, and on 05Feb2021 (lot number: EL9262) at the age of 74-years-old as dose 2, single, for Covid-19 immunisation. Patient reported side effects after receiving her Pfizer BT Covid vaccine booster on 29Sep2021. She felt fine right after the shot. On the same day of vaccination her arm was a little sore. On 30Sep2021, patient got up from lying down, and then passed out in her bathroom, she thinks she was unconscious for 9 hours and was evaluated by primary care physician (PCP). She also had headache, sore arm and body aches after booster. She got the vaccine in her arm and then the next day, she was getting ready to go out, she had a terrible headache, felt sick/ ill, weak, felt like she had Covid-19 but she was not sure if she had Covid. Patient got in to bed at 12:00pm and must have gotten up to bedroom while it was still daylight, because there were no lights on and she woke up on the bathroom floor and it was dark outside and it was 5am. Her legs felt paralyzed, and it was very hard to move. She dragged herself to bed and went to sleep. Her daughter took her to the doctor the next day. She was better but her coccyx was very sore on unspecified date in 2021. She called CVS to ask if these could be side effects. The healthcare provider recommended that she does not take another shot. She will call her healthcare provider before she gets her Flu shot. Patient stated that she believes in Science, and she has a history of taking vaccines and they have worked. Outcome of the events passed out and paralyzed was recovered on 01Oct2021, for events headache, pain in arm, sickness and weakness was recovered in Oct2021, for event tired was not recovered, for event body aches after booster was recovering, while for the other events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: she "passed out for 9 hours"; My legs felt paralyzed and it was very hard to move; had a headache; felt sick; My legs felt paralyzed and it was very hard to move; was weak; tired; Body aches, after booster; felt like I had Covid-19/not sure if she had Covid; sore arm/Arm a little sore; my coccyx is very sore; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration, administered in arm left on 29Sep2021 (lot number: (reported as '1308A'); expiry date: unknown) at the age of 75-years-old, as dose 3 (booster), single, for Covid-19 immunisation. Medical history included ongoing polymyalgia. There were no concomitant medications. The patient previously received bnt162b2 (COMIRNATY), on 15Jan2021 (lot number: EL1284) at the age of 74-years-old as dose 1, single, and on 05Feb2021 (lot number: EL9262) at the age of 74-years-old as dose 2, single, for Covid-19 immunisation. Patient reported side effects after receiving her Pfizer BT Covid vaccine booster on 29Sep2021. She felt fine right after the shot. On the same day of vaccination her arm was a little sore. On 30Sep2021, patient got up from lying down, and then passed out in her bathroom, she thinks she was unconscious for 9 hours and was evaluated by primary care physician (PCP). She also had headache, sore arm and body aches after booster. She got the vaccine in her arm and then the next day, she was getting ready to go out, she had a terrible headache, felt sick/ ill, weak, felt like she had Covid-19 but she was not sure if she had Covid. Patient got in to bed at 12:00pm and must have gotten up to bedroom while it was still daylight, because there were no lights on and she woke up on the bathroom floor and it was dark outside and it was 5am. Her legs felt paralyzed, and it was very hard to move. She dragged herself to bed and went to sleep. Her daughter took her to the doctor the next day. She was better but her coccyx was very sore on unspecified date in 2021. She called CVS to ask if these could be side effects. The healthcare provider recommended that she does not take another shot. She will call her healthcare provider before she gets her Flu shot. Patient stated that she believes in Science, and she has a history of taking vaccines and they have worked. Outcome of the events passed out and paralyzed was recovered on 01Oct2021, for events headache, pain in arm, sickness and weakness was recovered in Oct2021, for event tired was not recovered, for event body aches after booster was recovering, while for the other events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Feeling abnormal, Heart rate, Heart rate increased
Clinical narrative: heart rate was going up to 125-130; feels like there is no oxygen in her body; feels like she is going down; weak; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the third (booster) dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: FF2590), via an unspecified route of administration on 11Oct2021 (at the age of 59-years-old) at dose 3 (booster), single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine includes the first dose of BNT162B2 (lot number: EL0140) received on 05Jan2021 (at the age of 58-years-old) for COVID-19 immunization, and second dose of BNT162B2 (lot number: EL1283) received on 27Jan2021 (at the age of 58-years-old) for COVID-19 immunization and experienced arrythmia diagnosed on Feb2021 and has not yet recovered. On 11Oct2021, at nighttime, the patient felt so weak, so she took some medication and went to bed. The patient thought that she already felt better, but upon waking up on 12Oct2021, the patient still felt so weak. The patient did not go to work but still felt weak and stated that on 12Oct2021, her heart was so fast, monitored her blood pressure and oxygen. On the same day, 12Oct2021, the patient felt like sometimes there was no oxygen in her body, and her heart rate was going up to 125-130 and felt like it was going to her head and was going down. This happened every now and then. The patient stated that the symptoms were not getting worse but were staying the same. The patient wanted to know if she was dying and wanted to know if other people also experienced these symptoms. On 12Oct2021, the patient underwent lab tests and procedures which included: heart rate: 125-130 (heart rate was going up), blood pressure: unknown result, and oxygen: unknown result. Outcome of the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Oxygen saturation decreased
Clinical narrative: heart rate was going up to 125-130; feels like there is no oxygen in her body; feels like she is going down; weak; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the third (booster) dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: FF2590), via an unspecified route of administration on 11Oct2021 (at the age of 59-years-old) at dose 3 (booster), single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine includes the first dose of BNT162B2 (lot number: EL0140) received on 05Jan2021 (at the age of 58-years-old) for COVID-19 immunization, and second dose of BNT162B2 (lot number: EL1283) received on 27Jan2021 (at the age of 58-years-old) for COVID-19 immunization and experienced arrythmia diagnosed on Feb2021 and has not yet recovered. On 11Oct2021, at nighttime, the patient felt so weak, so she took some medication and went to bed. The patient thought that she already felt better, but upon waking up on 12Oct2021, the patient still felt so weak. The patient did not go to work but still felt weak and stated that on 12Oct2021, her heart was so fast, monitored her blood pressure and oxygen. On the same day, 12Oct2021, the patient felt like sometimes there was no oxygen in her body, and her heart rate was going up to 125-130 and felt like it was going to her head and was going down. This happened every now and then. The patient stated that the symptoms were not getting worse but were staying the same. The patient wanted to know if she was dying and wanted to know if other people also experienced these symptoms. On 12Oct2021, the patient underwent lab tests and procedures which included: heart rate: 125-130 (heart rate was going up), blood pressure: unknown result, and oxygen: unknown result. Outcome of the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Cough, Influenza like illness, Lethargy, Lip swelling
Clinical narrative: substantial and extensive swelling of male genital organs; left visible evidence of surface bruising and discoloration; left visible evidence of surface bruising and discoloration; swelling moved to upper right lip and adjacent area of face; swelling in lower right lip; lethargy; mild flu-like symptoms; chronic severe cough/ occasional light cough; This is a spontaneous report from a contactable consumer (patient himself) via COVID-19 Vaccine Adverse Event Self-Reporting Solution portal. A 69-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 10Oct2021 at 12:30 (Batch/Lot Number: FH8020, Expiration date: unknown) as dose 3 (booster), single for COVID-19 immunization. The vaccination facility type was a pharmacy or drug store. Relevant medical history included back issues, peripheral neuropathy, and hypothyroid, all from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications in two weeks included levothyroxine taken for an unspecified indication, start and stop date were not reported and unspecified supplements and homeopathic therapy. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), administered in the left arm on 05Mar2021 at 02:00 PM at the age of 69 years old (Batch/Lot number: EN6198, Expiration date: unknown) as dose 1, single and administered in the left arm on 26Mar2021 at 02:00 PM at the age of 69 years old (Batch/Lot number: ER8727, Expiration date: unknown) as dose 2, single for COVID-19 immunization. The patient had no other vaccine in four weeks. The patient had no COVID-19 prior vaccination and was not tested for COVID-19 post vaccination. On day 2, on 11Oct2021 at 10:00, the patient experienced adverse events (AEs), which included mild flu-like symptoms and beginning of chronic severe cough. On day 3, on 12Oct2021, the patient continued with severe cough and also experienced lethargy. In the morning (a.m.) of day 4, on 13Oct2021, the patient had swelling in lower right lip with occasional light cough. In the a.m. of day 5, on 14Oct2021, the patient's swelling moved to upper right lip and adjacent area of face; then in the afternoon, there was reduced swelling in the upper right and increased swelling in the lower right lip and adjacent area of face. Beginning on the evening of day 6, on 15Oct2021 at 21:00, the patient began to have substantial and extensive swelling of male genital organs, which persisted for approximately 36 hours before normalizing and left visible evidence of surface bruising and discoloration. The patient did not receive any treatment for the adverse events. At the time of the report, the patient was recovering from the substantial and extensive swelling of male genital organs, which left visible evidence of surface bruising and discoloration, while he was not recovered from the rest of the events.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Oedema genital, Skin discolouration, Swelling face
Clinical narrative: substantial and extensive swelling of male genital organs; left visible evidence of surface bruising and discoloration; left visible evidence of surface bruising and discoloration; swelling moved to upper right lip and adjacent area of face; swelling in lower right lip; lethargy; mild flu-like symptoms; chronic severe cough/ occasional light cough; This is a spontaneous report from a contactable consumer (patient himself) via COVID-19 Vaccine Adverse Event Self-Reporting Solution portal. A 69-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 10Oct2021 at 12:30 (Batch/Lot Number: FH8020, Expiration date: unknown) as dose 3 (booster), single for COVID-19 immunization. The vaccination facility type was a pharmacy or drug store. Relevant medical history included back issues, peripheral neuropathy, and hypothyroid, all from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications in two weeks included levothyroxine taken for an unspecified indication, start and stop date were not reported and unspecified supplements and homeopathic therapy. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), administered in the left arm on 05Mar2021 at 02:00 PM at the age of 69 years old (Batch/Lot number: EN6198, Expiration date: unknown) as dose 1, single and administered in the left arm on 26Mar2021 at 02:00 PM at the age of 69 years old (Batch/Lot number: ER8727, Expiration date: unknown) as dose 2, single for COVID-19 immunization. The patient had no other vaccine in four weeks. The patient had no COVID-19 prior vaccination and was not tested for COVID-19 post vaccination. On day 2, on 11Oct2021 at 10:00, the patient experienced adverse events (AEs), which included mild flu-like symptoms and beginning of chronic severe cough. On day 3, on 12Oct2021, the patient continued with severe cough and also experienced lethargy. In the morning (a.m.) of day 4, on 13Oct2021, the patient had swelling in lower right lip with occasional light cough. In the a.m. of day 5, on 14Oct2021, the patient's swelling moved to upper right lip and adjacent area of face; then in the afternoon, there was reduced swelling in the upper right and increased swelling in the lower right lip and adjacent area of face. Beginning on the evening of day 6, on 15Oct2021 at 21:00, the patient began to have substantial and extensive swelling of male genital organs, which persisted for approximately 36 hours before normalizing and left visible evidence of surface bruising and discoloration. The patient did not receive any treatment for the adverse events. At the time of the report, the patient was recovering from the substantial and extensive swelling of male genital organs, which left visible evidence of surface bruising and discoloration, while he was not recovered from the rest of the events.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Immunisation, Off label use, Pain in extremity
Clinical narrative: fainted for approximately one minute; weakness; dizzy; Dose number=3; Dose number=3; Day of injection sore arm.; This is a spontaneous report from a contactable consumer (patient).   A 69-year-old non-pregnant female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 01Oct2021 14:00, at the age of 69-years-old, (Lot Number: Fc3184) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation.  Medical history included Recovering cancer patient, and post heart surgery patient.  The patient did not have COVID-19 prior the vaccination. There were no concomitant medications. Historical vaccine includes dose 1 of BNT162B2 received on 25Jan2021 on left arm (lot number: EL 9261), and dose 2 received on 15Feb2021 on left arm (lot number: Pfizer en6201).  On 01Oct2021, the patient experienced injection sore arm for 1 day. On 02Oct2021, the patient experienced dizzy then fainted for approximately one minute then weakness throughout that day. The outcome of the events was recovered. The patient was not tested for COVID-19 post vaccination. No treatment was received for the events.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: fainted for approximately one minute; weakness; dizzy; Dose number=3; Dose number=3; Day of injection sore arm.; This is a spontaneous report from a contactable consumer (patient).   A 69-year-old non-pregnant female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 01Oct2021 14:00, at the age of 69-years-old, (Lot Number: Fc3184) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation.  Medical history included Recovering cancer patient, and post heart surgery patient.  The patient did not have COVID-19 prior the vaccination. There were no concomitant medications. Historical vaccine includes dose 1 of BNT162B2 received on 25Jan2021 on left arm (lot number: EL 9261), and dose 2 received on 15Feb2021 on left arm (lot number: Pfizer en6201).  On 01Oct2021, the patient experienced injection sore arm for 1 day. On 02Oct2021, the patient experienced dizzy then fainted for approximately one minute then weakness throughout that day. The outcome of the events was recovered. The patient was not tested for COVID-19 post vaccination. No treatment was received for the events.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Chest pain, Diarrhoea, Full blood count
Clinical narrative: felt bad of pain above left knee for few hours; right hip was painful; diarrhoea; right sided jawpain; gums inflamed for a bottom; Chest pressure; chest pain; This is a follow-up spontaneous report from a contactable Physician reporting in re-sponse to HCP follow-up letter sent in a cross-reference case for DOSE 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).A 65-Years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: not reported) on 06Mar2021 intramuscularly in right arm as DOSE 2, single for covid-19 immunisation (age at vaccination: 64-Years-old).The patient previous medical history included: Allergic to Biaxin, Vicodin, Penicillin. Patient was not taking any medications, did not receive any recent vaccines for any other conditions, did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech Covid-19 vaccine prior to the event being reported. The patient did not receive any other vaccines around the time of Pfizer-BioNTech Covid-19 vaccine vaccination. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: not reported) on 06Feb2021 intramuscularly in right arm as DOSE 1, single for covid-19 immunisation. On 06Mar2021, after second shot the patient experienced chest pressure within 5 min and 1 hour later she had chest pain which lasted for 8 hours. She keeps on experiencing the Chest pressure for couple of days. She also felt bad of pain above left knee for few hours, and the next day right hip was painful. She had diarrhoea. 1 week later she had right sided jaw pain and gums inflamed for a bottom. The patient Laboratory test included: CBC performed on 20Mar2021, and the result was normal. CMP performed on 20Mar2021, and the result showed Blood upper 109, NA+ 135.The patient was started on antibiotic by dentist. The outcome of the event felt bad of pain above left knee for few hours was resolved on an unspecified date. The outcome of the events right hip was painful, diarrhoea, right sided jaw pain, gums inflamed for a bottom, Chest pres-sure and chest pain was unknown.  It was reported that the patient required medical intervention: cardiac evaluation. The patient was not seen in the emergency department, nor hospitalized and was not sent to Intensive Care Unit. It was unknown if the patient Capillary refill time was greater than 3 sec or her central pulse volume was reduced.  No follow up attempts are possible. Information about lot/batch number cannot be re-quested. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Noninfective gingivitis, Pain, Pain in jaw
Clinical narrative: felt bad of pain above left knee for few hours; right hip was painful; diarrhoea; right sided jawpain; gums inflamed for a bottom; Chest pressure; chest pain; This is a follow-up spontaneous report from a contactable Physician reporting in re-sponse to HCP follow-up letter sent in a cross-reference case for DOSE 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).A 65-Years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: not reported) on 06Mar2021 intramuscularly in right arm as DOSE 2, single for covid-19 immunisation (age at vaccination: 64-Years-old).The patient previous medical history included: Allergic to Biaxin, Vicodin, Penicillin. Patient was not taking any medications, did not receive any recent vaccines for any other conditions, did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech Covid-19 vaccine prior to the event being reported. The patient did not receive any other vaccines around the time of Pfizer-BioNTech Covid-19 vaccine vaccination. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: not reported) on 06Feb2021 intramuscularly in right arm as DOSE 1, single for covid-19 immunisation. On 06Mar2021, after second shot the patient experienced chest pressure within 5 min and 1 hour later she had chest pain which lasted for 8 hours. She keeps on experiencing the Chest pressure for couple of days. She also felt bad of pain above left knee for few hours, and the next day right hip was painful. She had diarrhoea. 1 week later she had right sided jaw pain and gums inflamed for a bottom. The patient Laboratory test included: CBC performed on 20Mar2021, and the result was normal. CMP performed on 20Mar2021, and the result showed Blood upper 109, NA+ 135.The patient was started on antibiotic by dentist. The outcome of the event felt bad of pain above left knee for few hours was resolved on an unspecified date. The outcome of the events right hip was painful, diarrhoea, right sided jaw pain, gums inflamed for a bottom, Chest pres-sure and chest pain was unknown.  It was reported that the patient required medical intervention: cardiac evaluation. The patient was not seen in the emergency department, nor hospitalized and was not sent to Intensive Care Unit. It was unknown if the patient Capillary refill time was greater than 3 sec or her central pulse volume was reduced.  No follow up attempts are possible. Information about lot/batch number cannot be re-quested. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Limb mass, Product administered at inappropriate site, Urticaria
Clinical narrative: hives all over left leg; lump on left leg; vaccine location: Left leg; This is a spontaneous report from a contactable consumer or other non HCP (patient reported for self). A 16-years-old (non-Pregnant) female patient received first dose of bnt162b2 (COVID-19 mRNA VACCINE BIONTECH, Formulation; Solution for Injection, Batch/Lot Number: EW0162), dose 1 via an unspecified route of administration, vaccine location: left leg on 18Apr2021 at 13:30 (age at vaccination is 16 years) as dose 1, single for COVID-19 Immunisation. Medical history included Asthma from an unknown date and unknown if ongoing. Had Asthma triggered by allergies prior to 2016; underwent allergy shots for 4.5 years. Asthma free. Known allergies included allergy to Amoxicillin/Augmentin. Patient previously took AUGMENTINE and AMOXICILLIN for unspecified indication(s) and experienced allergy (drug hypersensitivity), start and stop date were not reported for allergy. There were no concomitant medications. Patient did not receive any other vaccines in four weeks nor any other medications two weeks. No covid prior vaccination. and was not even tested for covid post vaccination. The patient experienced lump on left leg on 28Apr2021 at 07:00, started the size of eraser with 2 hours was the size of an eraser, then hives all over left leg on 28Apr2021 at 09:00. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Patient was not tested for covid post vaccination. Therapeutic measures were taken as a result for the events, includes Keppra on 15Sep2021. The events were non serious. The outcome of events, lump on left leg, hives all over left leg was reported as not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Drug ineffective, Nasopharyngitis, Suspected COVID-19
Clinical narrative: I still have a cough and a cold but it's nothing like it's related to the covid; I have a little bit of cough; I did have a doubt of Covid approximately 19 days ago; I did have a doubt of Covid approximately 19 days ago; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm on 24Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on 24Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE (at the age of 65 years) for covid-19 immunisation. Medical history included diabetic, high blood pressure and a heart condition that's nothing changed from an unknown date and unknown if ongoing (I am a Diabetic, I have high blood pressure and I have heart condition that's nothing changed). Concomitant medications included immunoglobulin human normal (GLOBULIN); clopidogrel (CLOPIDOGREL); simvastatin (SIMVASTATIN); hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ); furosemide (FUROSEMIDE); amlodipine (AMLODIPINE); metoprolol tartrate (METOPROLOL TARTRATE); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); paracetamol (TYLENOL); potassium chloride (POTASSIUM CHLORIDE); vitamin b [vitamin b nos] (VITAMIN B [VITAMIN B NOS]), all taken for an unspecified indication, start and stop date were not reported. The patient experienced  "I did have a doubt of covid approximately 19 days ago" in Sep2021. On an unknown date, patient still have a cough and a cold but it's nothing like it's related to the covid and have a little bit of cough. It was further reported that the patient received first and second dose of Pfizer vaccine and the second dose was in end of Mar2021 and this caller is 65 years old and over the 6 months, he wants to get the booster shot and apparently 19 days ago he had Covid or just it possibly Covid and a little bit cough. The patient paraphrased his concern and it is that he did have a doubt of Covid approximately 19 days ago and although, He didn't have Covid symptoms. He still have a bit of cough and a cold but it's nothing like, it's related to the Covid. His only concern, if he can get his third shot the booster shot with the fact that he had the Covid symptoms 19 days ago and I have a little bit of cough. The outcome of the events cold and cough was not recovered and unknown outcome for the other events.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Depression, Fatigue, Nausea, Pain
Clinical narrative: lingering fatigue issues; spent two days in bed with fever; chills; body aches; nausea; depression; This is a spontaneous report from a contactable other HCP (patient) reported for herself that:  A 38-years-old female patient (Non pregnant) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EJI686), via an unspecified route of administration, administered in Arm Right on 20Jan2021 (At the age of 38 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ELI284), via an unspecified route of administration, administered in Arm Right on 30Dec2020, 07:00 (At the age of 38 years) as DOSE 1, SINGLE for covid-19 immunisation. and experienced after first dose I believe the vaccine may have impacted my hormones as well as my menstrual cycle. My FSH levels were taken on 07Jan2021 (one week after dose one) and were 9.1 (high end of normal prompting retest in three cycles). Upon retest on 22Feb2021 (one month after dose two) it was 17.4 (very high prompting referral to fertility). On 22Mar2021 my AMH was down to .54 (low) but on that same day my follicle count was 11 (pretty good). My period which previously was 27 days consistently and light flow. Since December my period has been very heavy and also my cycle has been 23-25 days in length. Medical history included chronic fatigue syndrome from an unknown date and unknown if ongoing. Patient was allergies to penicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included Advil taken for an unspecified indication, start and stop date were not reported. On an unspecified date, the patient had stated that I also had significant fatigue following second dose and spent two days in bed with fever, chills, body aches, and nausea. I also had some depression in the weeks following the second dose and lingering fatigue issues until two months later. The patient had nasal Swab test on sars-cov-2 and resulted as negative on 17Dec2020. Treatment was received for adverse event. At the time of reporting the outcome of the events were unknown.  No follow-up attempts are required. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: lingering fatigue issues; spent two days in bed with fever; chills; body aches; nausea; depression; This is a spontaneous report from a contactable other HCP (patient) reported for herself that:  A 38-years-old female patient (Non pregnant) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EJI686), via an unspecified route of administration, administered in Arm Right on 20Jan2021 (At the age of 38 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ELI284), via an unspecified route of administration, administered in Arm Right on 30Dec2020, 07:00 (At the age of 38 years) as DOSE 1, SINGLE for covid-19 immunisation. and experienced after first dose I believe the vaccine may have impacted my hormones as well as my menstrual cycle. My FSH levels were taken on 07Jan2021 (one week after dose one) and were 9.1 (high end of normal prompting retest in three cycles). Upon retest on 22Feb2021 (one month after dose two) it was 17.4 (very high prompting referral to fertility). On 22Mar2021 my AMH was down to .54 (low) but on that same day my follicle count was 11 (pretty good). My period which previously was 27 days consistently and light flow. Since December my period has been very heavy and also my cycle has been 23-25 days in length. Medical history included chronic fatigue syndrome from an unknown date and unknown if ongoing. Patient was allergies to penicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included Advil taken for an unspecified indication, start and stop date were not reported. On an unspecified date, the patient had stated that I also had significant fatigue following second dose and spent two days in bed with fever, chills, body aches, and nausea. I also had some depression in the weeks following the second dose and lingering fatigue issues until two months later. The patient had nasal Swab test on sars-cov-2 and resulted as negative on 17Dec2020. Treatment was received for adverse event. At the time of reporting the outcome of the events were unknown.  No follow-up attempts are required. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Neck pain, Oropharyngeal discomfort
Clinical narrative: Neck sore; Headache; extremely tired; feverish; achy all over; pelvis/hip joints ached all day; pelvis/hip joints ached all day; Aching in lungs late in day and sharpness in throat when I took a deep breath; Aching in lungs late in day and sharpness in throat when I took a deep breath; This is a spontaneous report from a contactable consumer or other non hcp. A 39-year-old female patient received third dose of BNT162B2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 13Oct2021 at 12:00 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. Medical history included High blood pressure from an unknown date. The patient previously received first dose of BNT162B2 on Jan2021 (Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion) and second dose of BNT162B2 on 05Feb2021 (Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion) for Covid-19 immunization. Concomitant medication included influenza vaccine (INFLUENZA) taken for an unspecified indication from Feb2021 and lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported. The patient experienced neck sore, headache, extremely tired, feverish, achy all over, pelvis/hip joints ached all day and aching in lungs late in day and sharpness in throat when I took a deep breath on 14Oct2021. Outcome of the events was recovered on unspecified date.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pelvic pain, Pulmonary pain, Pyrexia
Clinical narrative: Neck sore; Headache; extremely tired; feverish; achy all over; pelvis/hip joints ached all day; pelvis/hip joints ached all day; Aching in lungs late in day and sharpness in throat when I took a deep breath; Aching in lungs late in day and sharpness in throat when I took a deep breath; This is a spontaneous report from a contactable consumer or other non hcp. A 39-year-old female patient received third dose of BNT162B2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 13Oct2021 at 12:00 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. Medical history included High blood pressure from an unknown date. The patient previously received first dose of BNT162B2 on Jan2021 (Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion) and second dose of BNT162B2 on 05Feb2021 (Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion) for Covid-19 immunization. Concomitant medication included influenza vaccine (INFLUENZA) taken for an unspecified indication from Feb2021 and lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported. The patient experienced neck sore, headache, extremely tired, feverish, achy all over, pelvis/hip joints ached all day and aching in lungs late in day and sharpness in throat when I took a deep breath on 14Oct2021. Outcome of the events was recovered on unspecified date.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.