chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Rash pruritic
Clinical narrative: She broke out in rash on her torso; lethargic/ tiredness; lethargic/ tiredness; she had an allergic reaction to the first dose of the vaccine; This is a spontaneous report from a contactable consumer.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation.  Medical history included She had covid back in Nov2020.     The patient's concomitant medications were not reported.  The patient experienced she had an allergic reaction to the first dose of the vaccine she took a couple of weeks ago. She broke out in rash on her torso, it was a red covering, had lethargic/ tiredness. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy to vaccine, Fatigue, Lethargy, Rash
Clinical narrative: She broke out in rash on her torso; lethargic/ tiredness; lethargic/ tiredness; she had an allergic reaction to the first dose of the vaccine; This is a spontaneous report from a contactable consumer.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation.  Medical history included She had covid back in Nov2020.     The patient's concomitant medications were not reported.  The patient experienced she had an allergic reaction to the first dose of the vaccine she took a couple of weeks ago. She broke out in rash on her torso, it was a red covering, had lethargic/ tiredness. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Pruritus, Rash
Clinical narrative: My body (from scalp to feet) were red and very itchy and had rashes here and there; My body (from scalp to feet) were red and very itchy and had rashes here and there; My body (from scalp to feet) were red and very itchy and had rashes here and there; I also experienced multiple headaches; This is a spontaneous from a contactable consumer (patient) reported herself. A 46-years-old non-pregnant female patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, Lot number: EW0191), via an unknown route of administration in left arm on 05Jun2021 at 08:15 (at the age of 46-years-old) as dose 2 (booster), single for COVID-19 immunization at hospital. The patient's medical history included allergic to alcohol, and she had dermatographia especially when she was little (teens). Concomitant medication was not reported. No other vaccine in four weeks. No other medications in two weeks. The patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, Lot number: EW0175), via an unknown route of administration in left arm on 04May2021 at 08:15 (at the age of 46-years-old) as historical vaccine as dose 1, single for COVID-19 immunization. The patient took her booster shot on 05Jun2021, an after 2 days, on 07Jun2021 at 09:00 Monday, she noticed her body (from scalp to feet) were red and very itchy and had rashes here and there. They come and go away in one to a few hours, and come back and go away, again and again. It has been more than 3 months now. She also experienced multiple headaches. They have affected her normal life significantly. All symptoms distracted her a lot. Event resulted in emergency room/department or urgent care. No COVID prior vaccination. No COVID tested post vaccination. It was unknown if treatment received for events. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Pruritus, Rash, Rash erythematous
Clinical narrative: My body (from scalp to feet) were red and very itchy and had rashes here and there; My body (from scalp to feet) were red and very itchy and had rashes here and there; My body (from scalp to feet) were red and very itchy and had rashes here and there; I also experienced multiple headaches; This is a spontaneous from a contactable consumer (patient) reported herself. A 46-years-old non-pregnant female patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, Lot number: EW0191), via an unknown route of administration in left arm on 05Jun2021 at 08:15 (at the age of 46-years-old) as dose 2 (booster), single for COVID-19 immunization at hospital. The patient's medical history included allergic to alcohol, and she had dermatographia especially when she was little (teens). Concomitant medication was not reported. No other vaccine in four weeks. No other medications in two weeks. The patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, Lot number: EW0175), via an unknown route of administration in left arm on 04May2021 at 08:15 (at the age of 46-years-old) as historical vaccine as dose 1, single for COVID-19 immunization. The patient took her booster shot on 05Jun2021, an after 2 days, on 07Jun2021 at 09:00 Monday, she noticed her body (from scalp to feet) were red and very itchy and had rashes here and there. They come and go away in one to a few hours, and come back and go away, again and again. It has been more than 3 months now. She also experienced multiple headaches. They have affected her normal life significantly. All symptoms distracted her a lot. Event resulted in emergency room/department or urgent care. No COVID prior vaccination. No COVID tested post vaccination. It was unknown if treatment received for events. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Muscle spasms, Nausea, SARS-CoV-2 test negative
Clinical narrative: chronic fatigue; I have no energy don't wanna getup and and do anything; almost feels like my skull hurt and I don't really have, its not like that inside headache its like my skull hurt; leg pains radiating down to the legs from hips down to the ankles; leg pains radiating down to the legs from hips down to the ankles; general low grade headache; Nausea; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EM9809, expiration date was not reported) via an unspecified route of administration, on 16Feb2021 (at the age of 68-years-old), at dose 2, single for covid-19 immunization. The patient had no medical history and was healthy. There were no concomitant medications. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, on 19Jan2021, at dose 1, single for covid-19 immunization. On Feb2021, a couple days after the vaccination, the patient experienced general low-grade headache, nausea; nausea again and dry heat on morning on the day of report; feeling nauseated for last 3 or 4 days, a month later (Mar2021), chronic fatigue/ or something like no energy, don't want to get up and do anything, almost feels like the skull hurt (as reported), leg pains radiating down to the legs from hips down to the ankles on both legs, not constantly so on and off, hurting again on walking. It was reported that the event nausea was constant, and the other events were reoccurring. Therapeutic measures were taken included: aspirin and Tylenol. There were no relevant test results. The outcome of the events was not recovered.    No Follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Feeling abnormal, Headache
Clinical narrative: chronic fatigue; I have no energy don't wanna getup and and do anything; almost feels like my skull hurt and I don't really have, its not like that inside headache its like my skull hurt; leg pains radiating down to the legs from hips down to the ankles; leg pains radiating down to the legs from hips down to the ankles; general low grade headache; Nausea; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EM9809, expiration date was not reported) via an unspecified route of administration, on 16Feb2021 (at the age of 68-years-old), at dose 2, single for covid-19 immunization. The patient had no medical history and was healthy. There were no concomitant medications. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, on 19Jan2021, at dose 1, single for covid-19 immunization. On Feb2021, a couple days after the vaccination, the patient experienced general low-grade headache, nausea; nausea again and dry heat on morning on the day of report; feeling nauseated for last 3 or 4 days, a month later (Mar2021), chronic fatigue/ or something like no energy, don't want to get up and do anything, almost feels like the skull hurt (as reported), leg pains radiating down to the legs from hips down to the ankles on both legs, not constantly so on and off, hurting again on walking. It was reported that the event nausea was constant, and the other events were reoccurring. Therapeutic measures were taken included: aspirin and Tylenol. There were no relevant test results. The outcome of the events was not recovered.    No Follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: chronic fatigue; I have no energy don't wanna getup and and do anything; almost feels like my skull hurt and I don't really have, its not like that inside headache its like my skull hurt; leg pains radiating down to the legs from hips down to the ankles; leg pains radiating down to the legs from hips down to the ankles; general low grade headache; Nausea; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EM9809, expiration date was not reported) via an unspecified route of administration, on 16Feb2021 (at the age of 68-years-old), at dose 2, single for covid-19 immunization. The patient had no medical history and was healthy. There were no concomitant medications. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, on 19Jan2021, at dose 1, single for covid-19 immunization. On Feb2021, a couple days after the vaccination, the patient experienced general low-grade headache, nausea; nausea again and dry heat on morning on the day of report; feeling nauseated for last 3 or 4 days, a month later (Mar2021), chronic fatigue/ or something like no energy, don't want to get up and do anything, almost feels like the skull hurt (as reported), leg pains radiating down to the legs from hips down to the ankles on both legs, not constantly so on and off, hurting again on walking. It was reported that the event nausea was constant, and the other events were reoccurring. Therapeutic measures were taken included: aspirin and Tylenol. There were no relevant test results. The outcome of the events was not recovered.    No Follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: high fever 104 F; This is a spontaneous report from a contactable consumer or other non hcp.   An adult male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection), dose 2 via an unspecified route of administration on 25Mar2021 (Batch/Lot Number: Unknown) as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, (Batch/Lot Number was unknown) as single dose 1 for covid-19 immunisation.Prior to vaccination, was the patient diagnosed with COVID was unknown, Since the vaccination, patient been tested for COVID was unknown. It was Reported that, the patient experienced high fever 104 f on 26Mar2021 with outcome of unknown. Patient took extra prednisone and a cool bath. The patient underwent lab tests and procedures which included body temperature: 104 Fahrenheit on.  The Pfizer Drug safety unit recently received the attached report submitted by you via regulatory authority. Please help to confirm the date that you became aware of the adverse events in this report as these effects regulatory reporting timelines. This awareness date is the date you became aware of the occurrence of the reported events. If you are the patient in the case, your awareness date would be the date that you became aware you were experiencing the reported events. If you are not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events. This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If you learned of these events from another Pfizer colleague, please provide the date that the first Pfizer colleague became aware of the event reported, as regulatory reporting due dates are calculated based on the first day that a Pfizer colleague became aware of the adverse events.  Follow-up (30Mar2021): This is a follow-up spontaneous report received from a contactable consumer. This consumer reported in response to the Query letter sent which included the information.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: high fever 104 F; This is a spontaneous report from a contactable consumer or other non hcp.   An adult male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection), dose 2 via an unspecified route of administration on 25Mar2021 (Batch/Lot Number: Unknown) as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, (Batch/Lot Number was unknown) as single dose 1 for covid-19 immunisation.Prior to vaccination, was the patient diagnosed with COVID was unknown, Since the vaccination, patient been tested for COVID was unknown. It was Reported that, the patient experienced high fever 104 f on 26Mar2021 with outcome of unknown. Patient took extra prednisone and a cool bath. The patient underwent lab tests and procedures which included body temperature: 104 Fahrenheit on.  The Pfizer Drug safety unit recently received the attached report submitted by you via regulatory authority. Please help to confirm the date that you became aware of the adverse events in this report as these effects regulatory reporting timelines. This awareness date is the date you became aware of the occurrence of the reported events. If you are the patient in the case, your awareness date would be the date that you became aware you were experiencing the reported events. If you are not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events. This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If you learned of these events from another Pfizer colleague, please provide the date that the first Pfizer colleague became aware of the event reported, as regulatory reporting due dates are calculated based on the first day that a Pfizer colleague became aware of the adverse events.  Follow-up (30Mar2021): This is a follow-up spontaneous report received from a contactable consumer. This consumer reported in response to the Query letter sent which included the information.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Computerised tomogram, Disturbance in attention, Fatigue, Feeling abnormal
Clinical narrative: right ear ache; overactive smelling; rash was on her love handles the top of her legs top of her arms but not on her chest or face and it was really bright red; redness in eyes; loss of appetite; stomach was gurgling; Tightness in chest; slimy tongue; Fatigue; fever of 105; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: 6207; Expiration Date: Jul2021), via an unspecified route of administration, administered in Arm Right on 15Mar2021 14:15 (at the age of 61-year-old), as dose number unknown, single, for COVID-19 immunisation. Medical history included hypertension diagnosed about 10 year ago, overactive immune system from 2006, severe vertigo from Sep2009, MS (multiple sclerosis) from 2006, skin lesion and increased white blood cell counts. It was reported that the patient's sister also had MS. Concomitant medications included vitamin D NOS and cyanocobalamin (B12-VITAMIIN). No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. On 15Mar2021, the patient had some difficulty after COVID shot. The patient's right ear felt like it was getting an earache. The patient had overactive smelling problem. The patient had a rash, but her rash was on her love handles the top of her legs top of her arms but not on her chest or face and it was bright red, it was like it was coming from the inside out. The patient's eyes were red, she had tightness of the chest, loss of appetite, her stomach was gurgling. The patient had a slimy tongue, she doesn't know if it was from swelling. The patient was scared of getting the second dose. The patient had a fever of 105. The events happened about 4 hours after the shot. The patient had small redness from the rash and was fatigued. The gurgling in the patient stomach only happens when she lay in bed. The patient took Benadryl. The patient had been taking Visine for her red eyes. No relevant test was done. The outcome of right earache, rash, redness in eyes, loss of appetite was recovering; the outcome of overactive smelling, slimy tongue, and fever was unknown; the outcome of stomach was gurgling was not recovered; the outcome of tightness in chest and fatigue was recovered.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza, Magnetic resonance imaging, Movement disorder, Ocular hyperaemia, Pain of skin
Clinical narrative: right ear ache; overactive smelling; rash was on her love handles the top of her legs top of her arms but not on her chest or face and it was really bright red; redness in eyes; loss of appetite; stomach was gurgling; Tightness in chest; slimy tongue; Fatigue; fever of 105; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: 6207; Expiration Date: Jul2021), via an unspecified route of administration, administered in Arm Right on 15Mar2021 14:15 (at the age of 61-year-old), as dose number unknown, single, for COVID-19 immunisation. Medical history included hypertension diagnosed about 10 year ago, overactive immune system from 2006, severe vertigo from Sep2009, MS (multiple sclerosis) from 2006, skin lesion and increased white blood cell counts. It was reported that the patient's sister also had MS. Concomitant medications included vitamin D NOS and cyanocobalamin (B12-VITAMIIN). No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. On 15Mar2021, the patient had some difficulty after COVID shot. The patient's right ear felt like it was getting an earache. The patient had overactive smelling problem. The patient had a rash, but her rash was on her love handles the top of her legs top of her arms but not on her chest or face and it was bright red, it was like it was coming from the inside out. The patient's eyes were red, she had tightness of the chest, loss of appetite, her stomach was gurgling. The patient had a slimy tongue, she doesn't know if it was from swelling. The patient was scared of getting the second dose. The patient had a fever of 105. The events happened about 4 hours after the shot. The patient had small redness from the rash and was fatigued. The gurgling in the patient stomach only happens when she lay in bed. The patient took Benadryl. The patient had been taking Visine for her red eyes. No relevant test was done. The outcome of right earache, rash, redness in eyes, loss of appetite was recovering; the outcome of overactive smelling, slimy tongue, and fever was unknown; the outcome of stomach was gurgling was not recovered; the outcome of tightness in chest and fatigue was recovered.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Rash, Secretion discharge, Swollen tongue, Vertigo
Clinical narrative: right ear ache; overactive smelling; rash was on her love handles the top of her legs top of her arms but not on her chest or face and it was really bright red; redness in eyes; loss of appetite; stomach was gurgling; Tightness in chest; slimy tongue; Fatigue; fever of 105; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: 6207; Expiration Date: Jul2021), via an unspecified route of administration, administered in Arm Right on 15Mar2021 14:15 (at the age of 61-year-old), as dose number unknown, single, for COVID-19 immunisation. Medical history included hypertension diagnosed about 10 year ago, overactive immune system from 2006, severe vertigo from Sep2009, MS (multiple sclerosis) from 2006, skin lesion and increased white blood cell counts. It was reported that the patient's sister also had MS. Concomitant medications included vitamin D NOS and cyanocobalamin (B12-VITAMIIN). No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. On 15Mar2021, the patient had some difficulty after COVID shot. The patient's right ear felt like it was getting an earache. The patient had overactive smelling problem. The patient had a rash, but her rash was on her love handles the top of her legs top of her arms but not on her chest or face and it was bright red, it was like it was coming from the inside out. The patient's eyes were red, she had tightness of the chest, loss of appetite, her stomach was gurgling. The patient had a slimy tongue, she doesn't know if it was from swelling. The patient was scared of getting the second dose. The patient had a fever of 105. The events happened about 4 hours after the shot. The patient had small redness from the rash and was fatigued. The gurgling in the patient stomach only happens when she lay in bed. The patient took Benadryl. The patient had been taking Visine for her red eyes. No relevant test was done. The outcome of right earache, rash, redness in eyes, loss of appetite was recovering; the outcome of overactive smelling, slimy tongue, and fever was unknown; the outcome of stomach was gurgling was not recovered; the outcome of tightness in chest and fatigue was recovered.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chest discomfort, Decreased appetite, Ear pain, Fatigue
Clinical narrative: right ear ache; overactive smelling; rash was on her love handles the top of her legs top of her arms but not on her chest or face and it was really bright red; redness in eyes; loss of appetite; stomach was gurgling; Tightness in chest; slimy tongue; Fatigue; fever of 105; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: 6207; Expiration Date: Jul2021), via an unspecified route of administration, administered in Arm Right on 15Mar2021 14:15 (at the age of 61-year-old), as dose number unknown, single, for COVID-19 immunisation. Medical history included hypertension diagnosed about 10 year ago, overactive immune system from 2006, severe vertigo from Sep2009, MS (multiple sclerosis) from 2006, skin lesion and increased white blood cell counts. It was reported that the patient's sister also had MS. Concomitant medications included vitamin D NOS and cyanocobalamin (B12-VITAMIIN). No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. On 15Mar2021, the patient had some difficulty after COVID shot. The patient's right ear felt like it was getting an earache. The patient had overactive smelling problem. The patient had a rash, but her rash was on her love handles the top of her legs top of her arms but not on her chest or face and it was bright red, it was like it was coming from the inside out. The patient's eyes were red, she had tightness of the chest, loss of appetite, her stomach was gurgling. The patient had a slimy tongue, she doesn't know if it was from swelling. The patient was scared of getting the second dose. The patient had a fever of 105. The events happened about 4 hours after the shot. The patient had small redness from the rash and was fatigued. The gurgling in the patient stomach only happens when she lay in bed. The patient took Benadryl. The patient had been taking Visine for her red eyes. No relevant test was done. The outcome of right earache, rash, redness in eyes, loss of appetite was recovering; the outcome of overactive smelling, slimy tongue, and fever was unknown; the outcome of stomach was gurgling was not recovered; the outcome of tightness in chest and fatigue was recovered.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gastrointestinal sounds abnormal, Ocular hyperaemia, Parosmia, Pyrexia, Rash erythematous
Clinical narrative: right ear ache; overactive smelling; rash was on her love handles the top of her legs top of her arms but not on her chest or face and it was really bright red; redness in eyes; loss of appetite; stomach was gurgling; Tightness in chest; slimy tongue; Fatigue; fever of 105; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: 6207; Expiration Date: Jul2021), via an unspecified route of administration, administered in Arm Right on 15Mar2021 14:15 (at the age of 61-year-old), as dose number unknown, single, for COVID-19 immunisation. Medical history included hypertension diagnosed about 10 year ago, overactive immune system from 2006, severe vertigo from Sep2009, MS (multiple sclerosis) from 2006, skin lesion and increased white blood cell counts. It was reported that the patient's sister also had MS. Concomitant medications included vitamin D NOS and cyanocobalamin (B12-VITAMIIN). No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. On 15Mar2021, the patient had some difficulty after COVID shot. The patient's right ear felt like it was getting an earache. The patient had overactive smelling problem. The patient had a rash, but her rash was on her love handles the top of her legs top of her arms but not on her chest or face and it was bright red, it was like it was coming from the inside out. The patient's eyes were red, she had tightness of the chest, loss of appetite, her stomach was gurgling. The patient had a slimy tongue, she doesn't know if it was from swelling. The patient was scared of getting the second dose. The patient had a fever of 105. The events happened about 4 hours after the shot. The patient had small redness from the rash and was fatigued. The gurgling in the patient stomach only happens when she lay in bed. The patient took Benadryl. The patient had been taking Visine for her red eyes. No relevant test was done. The outcome of right earache, rash, redness in eyes, loss of appetite was recovering; the outcome of overactive smelling, slimy tongue, and fever was unknown; the outcome of stomach was gurgling was not recovered; the outcome of tightness in chest and fatigue was recovered.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tongue disorder
Clinical narrative: right ear ache; overactive smelling; rash was on her love handles the top of her legs top of her arms but not on her chest or face and it was really bright red; redness in eyes; loss of appetite; stomach was gurgling; Tightness in chest; slimy tongue; Fatigue; fever of 105; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: 6207; Expiration Date: Jul2021), via an unspecified route of administration, administered in Arm Right on 15Mar2021 14:15 (at the age of 61-year-old), as dose number unknown, single, for COVID-19 immunisation. Medical history included hypertension diagnosed about 10 year ago, overactive immune system from 2006, severe vertigo from Sep2009, MS (multiple sclerosis) from 2006, skin lesion and increased white blood cell counts. It was reported that the patient's sister also had MS. Concomitant medications included vitamin D NOS and cyanocobalamin (B12-VITAMIIN). No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. On 15Mar2021, the patient had some difficulty after COVID shot. The patient's right ear felt like it was getting an earache. The patient had overactive smelling problem. The patient had a rash, but her rash was on her love handles the top of her legs top of her arms but not on her chest or face and it was bright red, it was like it was coming from the inside out. The patient's eyes were red, she had tightness of the chest, loss of appetite, her stomach was gurgling. The patient had a slimy tongue, she doesn't know if it was from swelling. The patient was scared of getting the second dose. The patient had a fever of 105. The events happened about 4 hours after the shot. The patient had small redness from the rash and was fatigued. The gurgling in the patient stomach only happens when she lay in bed. The patient took Benadryl. The patient had been taking Visine for her red eyes. No relevant test was done. The outcome of right earache, rash, redness in eyes, loss of appetite was recovering; the outcome of overactive smelling, slimy tongue, and fever was unknown; the outcome of stomach was gurgling was not recovered; the outcome of tightness in chest and fatigue was recovered.  No follow-up attempts are needed. No further information is expected.
Age: 94.0
Sex: F
Vaccine: FLUA3, UNK
Symptoms: Arthralgia, Emotional distress, Pain in extremity
Clinical narrative: Pain radiating from shoulder all the way down to wrist / pain has been constant for the last 48 hours; Pain radiating from shoulder all the way down to wrist / pain has been constant for the last 48 hours; Patient is distressed at how her arm is feeling; This spontaneous case from the  was retrieved on 27-Sep-2021 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1651534-1), reported by other health professional and concerned a 94-year-old, female patient.   The patient's relevant medical history and concomitant medications were not reported.    On 26-Aug-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: reported as one, route of administration: intramuscular, anatomical location: right upper arm and indication: not reported). The batch number reported was 312826. The patient had no pain in upper arm during vaccination.  On the same day, 30 minutes after receiving Fluad Quadrivalent, the patient developed severe pain, radiating from shoulder all the way down to wrist.   On an unspecified date in Aug-2021, the patient went to hospital for treatment, since pain was constant for 48 hours, was very severe and unrelenting. The patient was distressed at how her arm was feeling. She also visited physician's office, but no further details were provided  At the time of initial reporting, the patient had not recovered from the events.   The reporter did not provide causality assessment.  The case was assessed as non-serious.  Company comment: A 94-year-old, female patient developed arthralgia with pain radiating from shoulder all the way down to wrist 30 minutes after vaccination with the suspect product Fluad Quadrivalent. The patient was distressed at how her arm was feeling. Information regarding the underlying medical history, related diagnostic findings and concomitant medications have not been provided. Based on biological implausibility causality for the event emotional distress is assessed as not related. Causality for the other two events is assessed as possibly related based on plausible time relationship.; Sender's Comments: A 94-year-old, female patient developed arthralgia with pain radiating from shoulder all the way down to wrist 30 minutes after vaccination with the suspect product Fluad Quadrivalent. The patient was distressed at how her arm was feeling. Information regarding the underlying medical history, related diagnostic findings and concomitant medications have not been provided. Based on biological implausibility causality for the event emotional distress is assessed as not related. Causality for the other two events is assessed as possibly related based on plausible time relationship.
Age: 94.0
Sex: F
Vaccine: FLUA3, UNK
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: Pain radiating from shoulder all the way down to wrist / pain has been constant for the last 48 hours; Pain radiating from shoulder all the way down to wrist / pain has been constant for the last 48 hours; Patient is distressed at how her arm is feeling; This spontaneous case from the  was retrieved on 27-Sep-2021 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1651534-1), reported by other health professional and concerned a 94-year-old, female patient.   The patient's relevant medical history and concomitant medications were not reported.    On 26-Aug-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: reported as one, route of administration: intramuscular, anatomical location: right upper arm and indication: not reported). The batch number reported was 312826. The patient had no pain in upper arm during vaccination.  On the same day, 30 minutes after receiving Fluad Quadrivalent, the patient developed severe pain, radiating from shoulder all the way down to wrist.   On an unspecified date in Aug-2021, the patient went to hospital for treatment, since pain was constant for 48 hours, was very severe and unrelenting. The patient was distressed at how her arm was feeling. She also visited physician's office, but no further details were provided  At the time of initial reporting, the patient had not recovered from the events.   The reporter did not provide causality assessment.  The case was assessed as non-serious.  Company comment: A 94-year-old, female patient developed arthralgia with pain radiating from shoulder all the way down to wrist 30 minutes after vaccination with the suspect product Fluad Quadrivalent. The patient was distressed at how her arm was feeling. Information regarding the underlying medical history, related diagnostic findings and concomitant medications have not been provided. Based on biological implausibility causality for the event emotional distress is assessed as not related. Causality for the other two events is assessed as possibly related based on plausible time relationship.; Sender's Comments: A 94-year-old, female patient developed arthralgia with pain radiating from shoulder all the way down to wrist 30 minutes after vaccination with the suspect product Fluad Quadrivalent. The patient was distressed at how her arm was feeling. Information regarding the underlying medical history, related diagnostic findings and concomitant medications have not been provided. Based on biological implausibility causality for the event emotional distress is assessed as not related. Causality for the other two events is assessed as possibly related based on plausible time relationship.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Insomnia, Weight decreased
Clinical narrative: A lot of joint pain, especially in the neck area, neck pain; A lot of joint pain, especially in the neck area, neck pain; his mouth and throat so dry that his tongue sticks to parts of his mouth; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EN6205, Expiration Date: not reported) via an unspecified route of administration, administered in Left Arm on 09Mar2021 14:30 and dose 2 via an unspecified route of administration, administered in Right Arm on 31Mar2021 14:30 (Batch/Lot Number: EN6198) as single for COVID-19 immunization (at the age of 70-year-old). Medical history included sinus disorder from 2008 and ongoing, Sinus issues described as real bad. Onset about 13 years ago. Family Medical History Relevant to AE(s) was none. Concomitant medication(s) included potassium; nifedipine; hydrochlorothiazide (HYDROCHLORZIDE); pantoprazole for the stomach; acetylsalicylic acid (ASPIRINE); pancrelipase (ZENPEP) for Pancreas; olmesartan medoxomil (OLMESARTAN MEDOXOMIL) all from an unspecified start date at least a couple of years ago and ongoing. Additional Vaccines Administered on same date of the Pfizer suspect was none. The only other recent vaccines were flu shot and pneumonia shot that he got 6 months to a year apart from the Pfizer-BioNTech Covid-19 Vaccine. Mild reaction to one of the flu shots, where he felt woozy and kind of felt bad later on for a while. This event didn't last long but that was the only time that happened. He's been getting flu shots and hasn't had any other reactions or adverse events with the others. The patient experienced a lot of joint pain, especially in the neck area, neck pain, his mouth and throat so dry that his tongue sticks to parts of his mouth on an unspecified date in Apr2021. It was reported that, he was administered his second dose of Pfizer-BioNTech Covid-19 Vaccine on 31Mar2021. Started last week, specific date unknown other than last week in Apr2021, he started having a lot of joint pain, especially in the neck area, neck pain; and along with that, every night since the neck pain started he woke up 2-3 times per night with his mouth and throat so dry that his tongue sticks to parts of his mouth. AE(s) did not require a visit to Emergency Room/Physician Office. Patient was not hospitalized. He had lab work on 12Mar2021 but there were no notable results from that, nothing to provide for this report that caller was aware of. These events are not getting any better, verified outcome as persistent, very persistent. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Dry mouth, Neck pain
Clinical narrative: A lot of joint pain, especially in the neck area, neck pain; A lot of joint pain, especially in the neck area, neck pain; his mouth and throat so dry that his tongue sticks to parts of his mouth; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EN6205, Expiration Date: not reported) via an unspecified route of administration, administered in Left Arm on 09Mar2021 14:30 and dose 2 via an unspecified route of administration, administered in Right Arm on 31Mar2021 14:30 (Batch/Lot Number: EN6198) as single for COVID-19 immunization (at the age of 70-year-old). Medical history included sinus disorder from 2008 and ongoing, Sinus issues described as real bad. Onset about 13 years ago. Family Medical History Relevant to AE(s) was none. Concomitant medication(s) included potassium; nifedipine; hydrochlorothiazide (HYDROCHLORZIDE); pantoprazole for the stomach; acetylsalicylic acid (ASPIRINE); pancrelipase (ZENPEP) for Pancreas; olmesartan medoxomil (OLMESARTAN MEDOXOMIL) all from an unspecified start date at least a couple of years ago and ongoing. Additional Vaccines Administered on same date of the Pfizer suspect was none. The only other recent vaccines were flu shot and pneumonia shot that he got 6 months to a year apart from the Pfizer-BioNTech Covid-19 Vaccine. Mild reaction to one of the flu shots, where he felt woozy and kind of felt bad later on for a while. This event didn't last long but that was the only time that happened. He's been getting flu shots and hasn't had any other reactions or adverse events with the others. The patient experienced a lot of joint pain, especially in the neck area, neck pain, his mouth and throat so dry that his tongue sticks to parts of his mouth on an unspecified date in Apr2021. It was reported that, he was administered his second dose of Pfizer-BioNTech Covid-19 Vaccine on 31Mar2021. Started last week, specific date unknown other than last week in Apr2021, he started having a lot of joint pain, especially in the neck area, neck pain; and along with that, every night since the neck pain started he woke up 2-3 times per night with his mouth and throat so dry that his tongue sticks to parts of his mouth. AE(s) did not require a visit to Emergency Room/Physician Office. Patient was not hospitalized. He had lab work on 12Mar2021 but there were no notable results from that, nothing to provide for this report that caller was aware of. These events are not getting any better, verified outcome as persistent, very persistent. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Skin mass
Clinical narrative: ALLERGIC REACTION TO SHOT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced allergic reaction to shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of allergic reaction to shot was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity
Clinical narrative: ALLERGIC REACTION TO SHOT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced allergic reaction to shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of allergic reaction to shot was not reported. This report was non-serious.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Electromyogram, Guillain-Barre syndrome, Lumbar puncture, Magnetic resonance imaging
Clinical narrative: Guillain-Barre syndrome; Numbness; heaviness; nearly paralyzing/paralysis; sensation of swelling with no circulation; sensation of swelling with no circulation; difficulty moving; Whole body aches like being in a car wreck; Random pain throughout body, toe, finger, jaw, heel, knee, etc.; Random pain throughout body, toe, finger, jaw, heel, knee, etc.; Random pain throughout body, toe, finger, jaw, heel, knee, etc.; feelings of being bloated; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient (currently 55-year-old) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 16Apr2021 12:00 (at the age of 54-years-old) (Batch/Lot Number: ER8731) as dose 1, single for COVID-19 immunization. Medical history included digestive disorders, gastroparesis, hiatal hernia, GERD, allergic to onions. The patient did not have COVID prior to vaccination. Concomitant medication included quetiapine; buspirone; and sertraline; all taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine in four weeks. The patient previously took flu vaccines for immunization (unspecified date) and 100% of the time resulting in upper middle back pain lasting approximately 2-weeks. Because of this have not had a vaccine in at least 25-years. Wanted to help end the pandemic and decided to get the Covid-19 vaccine even though he expected to have an adverse event similar to his prior experiences. On 17Apr2021 15:00 (reported as 3:00 pm), the patient described the adverse event as far more serious than expected, nearly paralyzing him. Symptoms were consistent with Guillain-Barre syndrome. Numbness, heaviness, paralysis, sensation of swelling with no circulation, difficulty moving. Worsens if stagnate or over stimulated physically. Whole body aches like being in a car wreck. Random pain throughout body, toe, finger, jaw, heel, knee etc. Feeling of bloated and weighing 10-times normal weight. The events resulted in doctor or other healthcare professional office/clinic visit. The patient considered the events to be life-threatening illness (immediate risk of death from the event) and disability or permanent damage. The patient received gabapentin as treatment for the events. The patient has not recovered from the events.. The patient was not COVID tested post vaccination.