chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Pain in extremity, Paraesthesia, Rash, Vaccination site erythema
Clinical narrative: On day 6, developed large, urticarial hives at injection site associated with significant burning, aching, and tingling of entire right extremity; On day 6, developed large, urticarial hives at injection site associated with significant burning, aching, and tingling of entire right extremity; On day 6, developed large, urticarial hives at injection site associated with significant burning, aching, and tingling of entire right extremity; Developed diffuse, pinpoint, non-pruritic, flat rash to trunk.; redness, and itching at injection site; redness, and itching at injection site; Developed mild hives at injection site/large, urticarial hives at injection site; This is a spontaneous report from a contactable nurse (patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK9231), intramuscular from 28Dec2020 08:00 at single dose in the right arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took cephalosporin and experienced allergies. The patient developed mild hives, redness, and itching at injection site on days 2 and 3. Symptoms resolved entirely on days 4 and 5. On day 6, developed large, urticarial hives at injection site associated with significant burning, aching, and tingling of entire right extremity. On 30Dec2020, she developed diffuse, pinpoint, non-pruritic, flat rash to trunk. Rash resolved with Benadryl. Extremity pain and burning persists despite Benadryl. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive any other medications within 2 weeks.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did receive treatment for the events which included Benadryl and Pepcid. The events resulted in emergency room/department or urgent care. The outcome of the events "Developed mild hives at injection site/large, urticarial hives at injection site", "On day 6, developed large, urticarial hives at injection site associated with significant burning, aching, and tingling of entire right extremity" was unknown; for events "Paraesthesia" and "pain in extremity" was not recovered; and for the other events was recovered on an unspecified date.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pruritus, Vaccination site urticaria
Clinical narrative: On day 6, developed large, urticarial hives at injection site associated with significant burning, aching, and tingling of entire right extremity; On day 6, developed large, urticarial hives at injection site associated with significant burning, aching, and tingling of entire right extremity; On day 6, developed large, urticarial hives at injection site associated with significant burning, aching, and tingling of entire right extremity; Developed diffuse, pinpoint, non-pruritic, flat rash to trunk.; redness, and itching at injection site; redness, and itching at injection site; Developed mild hives at injection site/large, urticarial hives at injection site; This is a spontaneous report from a contactable nurse (patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK9231), intramuscular from 28Dec2020 08:00 at single dose in the right arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took cephalosporin and experienced allergies. The patient developed mild hives, redness, and itching at injection site on days 2 and 3. Symptoms resolved entirely on days 4 and 5. On day 6, developed large, urticarial hives at injection site associated with significant burning, aching, and tingling of entire right extremity. On 30Dec2020, she developed diffuse, pinpoint, non-pruritic, flat rash to trunk. Rash resolved with Benadryl. Extremity pain and burning persists despite Benadryl. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive any other medications within 2 weeks.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did receive treatment for the events which included Benadryl and Pepcid. The events resulted in emergency room/department or urgent care. The outcome of the events "Developed mild hives at injection site/large, urticarial hives at injection site", "On day 6, developed large, urticarial hives at injection site associated with significant burning, aching, and tingling of entire right extremity" was unknown; for events "Paraesthesia" and "pain in extremity" was not recovered; and for the other events was recovered on an unspecified date.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Constant tinnitus; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received the first dose of bnt162b2 (Covid 19 vaccine, brand: Pfizer) lot no: EJ1685, via an unspecified route of administration in right arm on 29Dec2020 11:00 at a single dose for COVID-19 immunization. The patient had no other medical history. No known allergies. Concomitant medication included fish oil, allium sativum (GARLIC), ascorbic acid (VITAMINS C), vitamin D, vitamin K, and multivitamin. The patient did not receive other vaccines within 4 weeks prior to the covid vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient experienced constant tinnitus on 30Dec2020 12:00. The event was reported as non-serious. The patient did not receive treatment for the event. The patient had not recovered from the event.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pruritus, Rash, Urticaria
Clinical narrative: Rash; Itching at different spot at different time; Hives; This is a spontaneous report from a contactable consumer.  A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration on 02Jan2021 at single dose as reported for "Indication: Consumer stated, "Because I work in Covid testing, in healthcare."  Medical history included hypertension and allergy.  Concomitant medication included amlodipine, lisinopril, metoprolol, hydrochlorothiazide (HYDROCHLORZIDE), desloratadine and montelukast.  The patient stated, "had the first dose of the Pfizer vaccine yesterday for the Covid 19, 2 hours after I started itching and it has been different places all over my body. I do not know has it anything to do with the way that it goes through the body, I do not know. I have had to take a lots of Benadryl. I have had to take some steroids that I had here at the house I never had started and I thought it was okay. Last night my husband put hydrocortisone cream (later clarified as treatment) on areas I was itching and had hives. I slept all night I did not have any problem since I got up this morning I started itching in other place. So, I have done the whole thing again. I am going to has to go. I did not want to go ER because I am not having trouble on breathing or anything like that but I have got various places it is like different places every time it starts. So, I need to I am going to go and have a probably a strong steroid shot and have strong steroid given to me, not for oral but I just want to let you know if that is a side effect and I do not know whether I am going to take the second one or not?" I have taken Benadryl and I have taken Methylprednisolone and I have used on the Cortisone Cream, the topical cream". The outcome of the events was unknown.; Sender's Comments: A causal association between BNT162B2 and the events rash, pruritus and urticaria cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Rash; Itching at different spot at different time; Hives; This is a spontaneous report from a contactable consumer.  A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration on 02Jan2021 at single dose as reported for "Indication: Consumer stated, "Because I work in Covid testing, in healthcare."  Medical history included hypertension and allergy.  Concomitant medication included amlodipine, lisinopril, metoprolol, hydrochlorothiazide (HYDROCHLORZIDE), desloratadine and montelukast.  The patient stated, "had the first dose of the Pfizer vaccine yesterday for the Covid 19, 2 hours after I started itching and it has been different places all over my body. I do not know has it anything to do with the way that it goes through the body, I do not know. I have had to take a lots of Benadryl. I have had to take some steroids that I had here at the house I never had started and I thought it was okay. Last night my husband put hydrocortisone cream (later clarified as treatment) on areas I was itching and had hives. I slept all night I did not have any problem since I got up this morning I started itching in other place. So, I have done the whole thing again. I am going to has to go. I did not want to go ER because I am not having trouble on breathing or anything like that but I have got various places it is like different places every time it starts. So, I need to I am going to go and have a probably a strong steroid shot and have strong steroid given to me, not for oral but I just want to let you know if that is a side effect and I do not know whether I am going to take the second one or not?" I have taken Benadryl and I have taken Methylprednisolone and I have used on the Cortisone Cream, the topical cream". The outcome of the events was unknown.; Sender's Comments: A causal association between BNT162B2 and the events rash, pruritus and urticaria cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Dysgeusia, Flushing, Headache, Hyperhidrosis
Clinical narrative: low back ache; sore throat; low grade fever; body aches; severe headache; hot flashes; sweating heavily; felt flushed; This is a spontaneous report from a contactable Nurse. This 22-year-old female patient received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported) on 31Dec2020 16:30 (at the age of 22-years) as single dose, intramuscular in left arm for COVID-19 immunization. Medical history included the patient had no known allergies. The patient was not pregnant. Prior to vaccination, the patient was diagnosed with COVID virus in Oct2020.  Concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient was given first dose of the COVID vaccine on 31Dec2020. The patient was monitored 15 minutes after receiving the vaccine. When she went back to work on 31Dec2020 she felt flushed, having hot flashes and she started sweating heavily. The patient was taken to the nearest Emergency room (ER) for evaluation and states that the (ER) doctor told her it could have been a reaction to the vaccine. On 01Jan2021, the patient started having low grade fever, body aches and severe headache. On 02Jan2021, the patient was having a sore throat and low grade fever still, but no body aches or headache. On 03Jan2021, the patient was still having the sore throat and a low back ache, the patient was told to go to an Urgent Care to be evaluated. The patient states that she was given antibiotics and was negative for Strep. The patient was also swabbed for COVID again. The patient was given treatment for sore throat but it was unknown if patient received treatment for other events.  Lab data included SARS-CoV-2 test (PCR nasal swab) on 03Jan2021 which is pending.  The patient did not received treatment as a result of the event.  The outcome of event felt flushed was recovering, hot flashes was recovering,  sweating heavily was recovering, low grade fever was not recovered, body aches was recovered Jan2021, severe headache was recovered on Jan2021, sore throat was not recovered and low back ache was not recovered.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: low back ache; sore throat; low grade fever; body aches; severe headache; hot flashes; sweating heavily; felt flushed; This is a spontaneous report from a contactable Nurse. This 22-year-old female patient received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported) on 31Dec2020 16:30 (at the age of 22-years) as single dose, intramuscular in left arm for COVID-19 immunization. Medical history included the patient had no known allergies. The patient was not pregnant. Prior to vaccination, the patient was diagnosed with COVID virus in Oct2020.  Concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient was given first dose of the COVID vaccine on 31Dec2020. The patient was monitored 15 minutes after receiving the vaccine. When she went back to work on 31Dec2020 she felt flushed, having hot flashes and she started sweating heavily. The patient was taken to the nearest Emergency room (ER) for evaluation and states that the (ER) doctor told her it could have been a reaction to the vaccine. On 01Jan2021, the patient started having low grade fever, body aches and severe headache. On 02Jan2021, the patient was having a sore throat and low grade fever still, but no body aches or headache. On 03Jan2021, the patient was still having the sore throat and a low back ache, the patient was told to go to an Urgent Care to be evaluated. The patient states that she was given antibiotics and was negative for Strep. The patient was also swabbed for COVID again. The patient was given treatment for sore throat but it was unknown if patient received treatment for other events.  Lab data included SARS-CoV-2 test (PCR nasal swab) on 03Jan2021 which is pending.  The patient did not received treatment as a result of the event.  The outcome of event felt flushed was recovering, hot flashes was recovering,  sweating heavily was recovering, low grade fever was not recovered, body aches was recovered Jan2021, severe headache was recovered on Jan2021, sore throat was not recovered and low back ache was not recovered.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Flushing, Headache, Hot flush, Hyperhidrosis
Clinical narrative: low back ache; sore throat; low grade fever; body aches; severe headache; hot flashes; sweating heavily; felt flushed; This is a spontaneous report from a contactable Nurse. This 22-year-old female patient received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported) on 31Dec2020 16:30 (at the age of 22-years) as single dose, intramuscular in left arm for COVID-19 immunization. Medical history included the patient had no known allergies. The patient was not pregnant. Prior to vaccination, the patient was diagnosed with COVID virus in Oct2020.  Concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient was given first dose of the COVID vaccine on 31Dec2020. The patient was monitored 15 minutes after receiving the vaccine. When she went back to work on 31Dec2020 she felt flushed, having hot flashes and she started sweating heavily. The patient was taken to the nearest Emergency room (ER) for evaluation and states that the (ER) doctor told her it could have been a reaction to the vaccine. On 01Jan2021, the patient started having low grade fever, body aches and severe headache. On 02Jan2021, the patient was having a sore throat and low grade fever still, but no body aches or headache. On 03Jan2021, the patient was still having the sore throat and a low back ache, the patient was told to go to an Urgent Care to be evaluated. The patient states that she was given antibiotics and was negative for Strep. The patient was also swabbed for COVID again. The patient was given treatment for sore throat but it was unknown if patient received treatment for other events.  Lab data included SARS-CoV-2 test (PCR nasal swab) on 03Jan2021 which is pending.  The patient did not received treatment as a result of the event.  The outcome of event felt flushed was recovering, hot flashes was recovering,  sweating heavily was recovering, low grade fever was not recovered, body aches was recovered Jan2021, severe headache was recovered on Jan2021, sore throat was not recovered and low back ache was not recovered.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, Pain, Pyrexia, SARS-CoV-2 test, Streptococcus test
Clinical narrative: low back ache; sore throat; low grade fever; body aches; severe headache; hot flashes; sweating heavily; felt flushed; This is a spontaneous report from a contactable Nurse. This 22-year-old female patient received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported) on 31Dec2020 16:30 (at the age of 22-years) as single dose, intramuscular in left arm for COVID-19 immunization. Medical history included the patient had no known allergies. The patient was not pregnant. Prior to vaccination, the patient was diagnosed with COVID virus in Oct2020.  Concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient was given first dose of the COVID vaccine on 31Dec2020. The patient was monitored 15 minutes after receiving the vaccine. When she went back to work on 31Dec2020 she felt flushed, having hot flashes and she started sweating heavily. The patient was taken to the nearest Emergency room (ER) for evaluation and states that the (ER) doctor told her it could have been a reaction to the vaccine. On 01Jan2021, the patient started having low grade fever, body aches and severe headache. On 02Jan2021, the patient was having a sore throat and low grade fever still, but no body aches or headache. On 03Jan2021, the patient was still having the sore throat and a low back ache, the patient was told to go to an Urgent Care to be evaluated. The patient states that she was given antibiotics and was negative for Strep. The patient was also swabbed for COVID again. The patient was given treatment for sore throat but it was unknown if patient received treatment for other events.  Lab data included SARS-CoV-2 test (PCR nasal swab) on 03Jan2021 which is pending.  The patient did not received treatment as a result of the event.  The outcome of event felt flushed was recovering, hot flashes was recovering,  sweating heavily was recovering, low grade fever was not recovered, body aches was recovered Jan2021, severe headache was recovered on Jan2021, sore throat was not recovered and low back ache was not recovered.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Pain, Pyrexia, Sensitive skin
Clinical narrative: Fever up to 100.8 (unknown unit); chills; shaking; general muscle aches; generalized sensitive skin; mild headache lasting 1 day; This is a spontaneous report from a contactable nurse (patient).  A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: EK5730, intramuscular on Right arm from 22Dec2020 09:45 to 22Dec2020 09:45 as single dose for COVID-19 immunization.  Medical history included hypertension, and glaucoma.  Concomitant medication included losartan (LOSARTAN), hctz (HCTZ), fluticasone propionate (FLONASE), and latanoprost (XALATAN). On 24Dec2020 08:30 am, the patient experienced fever up to 100.8 (unknown unit), chills, shaking, general muscle aches, generalized sensitive skin, mild headache lasting 1 day. The patient was not tested for Covid post vaccination. The patient is not pregnant. The outcome of the events was recovered on 25Dec2020. No treatment was received for the events.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: Fever up to 100.8 (unknown unit); chills; shaking; general muscle aches; generalized sensitive skin; mild headache lasting 1 day; This is a spontaneous report from a contactable nurse (patient).  A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: EK5730, intramuscular on Right arm from 22Dec2020 09:45 to 22Dec2020 09:45 as single dose for COVID-19 immunization.  Medical history included hypertension, and glaucoma.  Concomitant medication included losartan (LOSARTAN), hctz (HCTZ), fluticasone propionate (FLONASE), and latanoprost (XALATAN). On 24Dec2020 08:30 am, the patient experienced fever up to 100.8 (unknown unit), chills, shaking, general muscle aches, generalized sensitive skin, mild headache lasting 1 day. The patient was not tested for Covid post vaccination. The patient is not pregnant. The outcome of the events was recovered on 25Dec2020. No treatment was received for the events.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia, Sensitive skin
Clinical narrative: Fever up to 100.8 (unknown unit); chills; shaking; general muscle aches; generalized sensitive skin; mild headache lasting 1 day; This is a spontaneous report from a contactable nurse (patient).  A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: EK5730, intramuscular on Right arm from 22Dec2020 09:45 to 22Dec2020 09:45 as single dose for COVID-19 immunization.  Medical history included hypertension, and glaucoma.  Concomitant medication included losartan (LOSARTAN), hctz (HCTZ), fluticasone propionate (FLONASE), and latanoprost (XALATAN). On 24Dec2020 08:30 am, the patient experienced fever up to 100.8 (unknown unit), chills, shaking, general muscle aches, generalized sensitive skin, mild headache lasting 1 day. The patient was not tested for Covid post vaccination. The patient is not pregnant. The outcome of the events was recovered on 25Dec2020. No treatment was received for the events.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: After injection, was feeling flushed, dizzy, and off balance.  When I got home, I was ok until about 4am on Sunday January 3rd, 2020, I woke up with chills, fever of 102.00, nausea, sore throat, body was achy and left arm was severely bruised and sore.   I was like this for Sunday & Monday, finally Monday night around 7pm, my fever broke.  I was finally able to return to work on Tuesday, I was still quite tired and worn out from the weekend.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Contusion, Dizziness, Fatigue, Flushing
Clinical narrative: After injection, was feeling flushed, dizzy, and off balance.  When I got home, I was ok until about 4am on Sunday January 3rd, 2020, I woke up with chills, fever of 102.00, nausea, sore throat, body was achy and left arm was severely bruised and sore.   I was like this for Sunday & Monday, finally Monday night around 7pm, my fever broke.  I was finally able to return to work on Tuesday, I was still quite tired and worn out from the weekend.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Impaired work ability, Nausea, Oropharyngeal pain, Pain
Clinical narrative: After injection, was feeling flushed, dizzy, and off balance.  When I got home, I was ok until about 4am on Sunday January 3rd, 2020, I woke up with chills, fever of 102.00, nausea, sore throat, body was achy and left arm was severely bruised and sore.   I was like this for Sunday & Monday, finally Monday night around 7pm, my fever broke.  I was finally able to return to work on Tuesday, I was still quite tired and worn out from the weekend.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: After injection, was feeling flushed, dizzy, and off balance.  When I got home, I was ok until about 4am on Sunday January 3rd, 2020, I woke up with chills, fever of 102.00, nausea, sore throat, body was achy and left arm was severely bruised and sore.   I was like this for Sunday & Monday, finally Monday night around 7pm, my fever broke.  I was finally able to return to work on Tuesday, I was still quite tired and worn out from the weekend.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Injection site pain, Lymph node pain, Lymphadenopathy, Musculoskeletal chest pain
Clinical narrative: Swollen lymph node with no relief.; experiencing left shoulder, left muscle, cannot lift, push, pull and pain has not decreased; experiencing left shoulder, left muscle, cannot lift, push, pull and pain has not decreased; experiencing left shoulder, left muscle, cannot lift, push, pull and pain has not decreased; This is a spontaneous report from a contactable other hcp.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Dec2020 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The reporter stated states she previously reported adverse event. Received first dose of vaccine 24Dec2020 experiencing left shoulder, left muscle, cannot lift, push, pull and pain has not decreased.  Swollen lymph node with no relief.  Chest x-ray was negative.  Muscle relaxer made her feel like a "pile of goo". Therapeutic measures were taken as a result of experiencing left shoulder, left muscle, cannot lift, push, pull and pain has not decreased (arthralgia), experiencing left shoulder, left muscle, cannot lift, push, pull and pain has not decreased (myalgia). The outcome of the events was not resolved.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myalgia, Pain, Painful respiration
Clinical narrative: Swollen lymph node with no relief.; experiencing left shoulder, left muscle, cannot lift, push, pull and pain has not decreased; experiencing left shoulder, left muscle, cannot lift, push, pull and pain has not decreased; experiencing left shoulder, left muscle, cannot lift, push, pull and pain has not decreased; This is a spontaneous report from a contactable other hcp.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Dec2020 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The reporter stated states she previously reported adverse event. Received first dose of vaccine 24Dec2020 experiencing left shoulder, left muscle, cannot lift, push, pull and pain has not decreased.  Swollen lymph node with no relief.  Chest x-ray was negative.  Muscle relaxer made her feel like a "pile of goo". Therapeutic measures were taken as a result of experiencing left shoulder, left muscle, cannot lift, push, pull and pain has not decreased (arthralgia), experiencing left shoulder, left muscle, cannot lift, push, pull and pain has not decreased (myalgia). The outcome of the events was not resolved.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Chest X-ray, Lymph node pain, Movement disorder, Myalgia
Clinical narrative: Swollen lymph node with no relief.; experiencing left shoulder, left muscle, cannot lift, push, pull and pain has not decreased; experiencing left shoulder, left muscle, cannot lift, push, pull and pain has not decreased; experiencing left shoulder, left muscle, cannot lift, push, pull and pain has not decreased; This is a spontaneous report from a contactable other hcp.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Dec2020 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The reporter stated states she previously reported adverse event. Received first dose of vaccine 24Dec2020 experiencing left shoulder, left muscle, cannot lift, push, pull and pain has not decreased.  Swollen lymph node with no relief.  Chest x-ray was negative.  Muscle relaxer made her feel like a "pile of goo". Therapeutic measures were taken as a result of experiencing left shoulder, left muscle, cannot lift, push, pull and pain has not decreased (arthralgia), experiencing left shoulder, left muscle, cannot lift, push, pull and pain has not decreased (myalgia). The outcome of the events was not resolved.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Bone pain, Chest pain, Discomfort, Lymph node pain
Clinical narrative: Swollen lymph node with no relief.; experiencing left shoulder, left muscle, cannot lift, push, pull and pain has not decreased; experiencing left shoulder, left muscle, cannot lift, push, pull and pain has not decreased; experiencing left shoulder, left muscle, cannot lift, push, pull and pain has not decreased; This is a spontaneous report from a contactable other hcp.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Dec2020 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The reporter stated states she previously reported adverse event. Received first dose of vaccine 24Dec2020 experiencing left shoulder, left muscle, cannot lift, push, pull and pain has not decreased.  Swollen lymph node with no relief.  Chest x-ray was negative.  Muscle relaxer made her feel like a "pile of goo". Therapeutic measures were taken as a result of experiencing left shoulder, left muscle, cannot lift, push, pull and pain has not decreased (arthralgia), experiencing left shoulder, left muscle, cannot lift, push, pull and pain has not decreased (myalgia). The outcome of the events was not resolved.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lymphadenopathy, Myalgia, Pain in extremity, Vaccination site pain
Clinical narrative: Swollen lymph node with no relief.; experiencing left shoulder, left muscle, cannot lift, push, pull and pain has not decreased; experiencing left shoulder, left muscle, cannot lift, push, pull and pain has not decreased; experiencing left shoulder, left muscle, cannot lift, push, pull and pain has not decreased; This is a spontaneous report from a contactable other hcp.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Dec2020 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The reporter stated states she previously reported adverse event. Received first dose of vaccine 24Dec2020 experiencing left shoulder, left muscle, cannot lift, push, pull and pain has not decreased.  Swollen lymph node with no relief.  Chest x-ray was negative.  Muscle relaxer made her feel like a "pile of goo". Therapeutic measures were taken as a result of experiencing left shoulder, left muscle, cannot lift, push, pull and pain has not decreased (arthralgia), experiencing left shoulder, left muscle, cannot lift, push, pull and pain has not decreased (myalgia). The outcome of the events was not resolved.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Injection site pain, Lymph node pain, Lymphadenopathy, Musculoskeletal chest pain
Clinical narrative: shoulder pain; shoulder pain, from the injection site; shoulder pain, from the injection site, began to spread through the pectoral muscle; shoulder pain, from the injection site, began to spread through the pectoral muscle and through the chest/soreness of my left arm and chest; soreness of my left arm; swollen lymph node in my collar bone, like a goose egg; pain from my left collar bone to my sternum; swollen lymph node in my collar bone, like a goose egg, and is tender to touch; discomfort; This is a spontaneous report from a non-contactable consumer via Medical information team. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Dec2020 at single dose for COVID-19 immunization. Medical history included Crohn's disease from an unknown date and unknown if ongoing. The patient stated, "started experiencing effects that night;  (L) shoulder pain, from the injection site, began to spread through the pectoral muscle and through the chest, and my left side. No other issues, no other reactions, just soreness of my left arm and chest and a swollen lymph node in my collar bone, like a goose egg, and is tender to touch. I chatted with my  gastroenterologist, I have Crohn's disease and am on a biologic medication. My doctor stated that this could just be an immune response. I am having pain from my left collar bone to my sternum that is always persistent all the time and flares at times, when doing some movement. The area is tender to touch but I feel discomfort all the time through that left side. I also feel this when I take a deep breath. I even experience this with a flu shot, but doesn't last this long. I will be going to see my doctor so that he can evaluate me." The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myalgia, Pain, Painful respiration
Clinical narrative: shoulder pain; shoulder pain, from the injection site; shoulder pain, from the injection site, began to spread through the pectoral muscle; shoulder pain, from the injection site, began to spread through the pectoral muscle and through the chest/soreness of my left arm and chest; soreness of my left arm; swollen lymph node in my collar bone, like a goose egg; pain from my left collar bone to my sternum; swollen lymph node in my collar bone, like a goose egg, and is tender to touch; discomfort; This is a spontaneous report from a non-contactable consumer via Medical information team. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Dec2020 at single dose for COVID-19 immunization. Medical history included Crohn's disease from an unknown date and unknown if ongoing. The patient stated, "started experiencing effects that night;  (L) shoulder pain, from the injection site, began to spread through the pectoral muscle and through the chest, and my left side. No other issues, no other reactions, just soreness of my left arm and chest and a swollen lymph node in my collar bone, like a goose egg, and is tender to touch. I chatted with my  gastroenterologist, I have Crohn's disease and am on a biologic medication. My doctor stated that this could just be an immune response. I am having pain from my left collar bone to my sternum that is always persistent all the time and flares at times, when doing some movement. The area is tender to touch but I feel discomfort all the time through that left side. I also feel this when I take a deep breath. I even experience this with a flu shot, but doesn't last this long. I will be going to see my doctor so that he can evaluate me." The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Chest X-ray, Lymph node pain, Movement disorder, Myalgia
Clinical narrative: shoulder pain; shoulder pain, from the injection site; shoulder pain, from the injection site, began to spread through the pectoral muscle; shoulder pain, from the injection site, began to spread through the pectoral muscle and through the chest/soreness of my left arm and chest; soreness of my left arm; swollen lymph node in my collar bone, like a goose egg; pain from my left collar bone to my sternum; swollen lymph node in my collar bone, like a goose egg, and is tender to touch; discomfort; This is a spontaneous report from a non-contactable consumer via Medical information team. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Dec2020 at single dose for COVID-19 immunization. Medical history included Crohn's disease from an unknown date and unknown if ongoing. The patient stated, "started experiencing effects that night;  (L) shoulder pain, from the injection site, began to spread through the pectoral muscle and through the chest, and my left side. No other issues, no other reactions, just soreness of my left arm and chest and a swollen lymph node in my collar bone, like a goose egg, and is tender to touch. I chatted with my  gastroenterologist, I have Crohn's disease and am on a biologic medication. My doctor stated that this could just be an immune response. I am having pain from my left collar bone to my sternum that is always persistent all the time and flares at times, when doing some movement. The area is tender to touch but I feel discomfort all the time through that left side. I also feel this when I take a deep breath. I even experience this with a flu shot, but doesn't last this long. I will be going to see my doctor so that he can evaluate me." The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Bone pain, Chest pain, Discomfort, Lymph node pain
Clinical narrative: shoulder pain; shoulder pain, from the injection site; shoulder pain, from the injection site, began to spread through the pectoral muscle; shoulder pain, from the injection site, began to spread through the pectoral muscle and through the chest/soreness of my left arm and chest; soreness of my left arm; swollen lymph node in my collar bone, like a goose egg; pain from my left collar bone to my sternum; swollen lymph node in my collar bone, like a goose egg, and is tender to touch; discomfort; This is a spontaneous report from a non-contactable consumer via Medical information team. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Dec2020 at single dose for COVID-19 immunization. Medical history included Crohn's disease from an unknown date and unknown if ongoing. The patient stated, "started experiencing effects that night;  (L) shoulder pain, from the injection site, began to spread through the pectoral muscle and through the chest, and my left side. No other issues, no other reactions, just soreness of my left arm and chest and a swollen lymph node in my collar bone, like a goose egg, and is tender to touch. I chatted with my  gastroenterologist, I have Crohn's disease and am on a biologic medication. My doctor stated that this could just be an immune response. I am having pain from my left collar bone to my sternum that is always persistent all the time and flares at times, when doing some movement. The area is tender to touch but I feel discomfort all the time through that left side. I also feel this when I take a deep breath. I even experience this with a flu shot, but doesn't last this long. I will be going to see my doctor so that he can evaluate me." The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lymphadenopathy, Myalgia, Pain in extremity, Vaccination site pain
Clinical narrative: shoulder pain; shoulder pain, from the injection site; shoulder pain, from the injection site, began to spread through the pectoral muscle; shoulder pain, from the injection site, began to spread through the pectoral muscle and through the chest/soreness of my left arm and chest; soreness of my left arm; swollen lymph node in my collar bone, like a goose egg; pain from my left collar bone to my sternum; swollen lymph node in my collar bone, like a goose egg, and is tender to touch; discomfort; This is a spontaneous report from a non-contactable consumer via Medical information team. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Dec2020 at single dose for COVID-19 immunization. Medical history included Crohn's disease from an unknown date and unknown if ongoing. The patient stated, "started experiencing effects that night;  (L) shoulder pain, from the injection site, began to spread through the pectoral muscle and through the chest, and my left side. No other issues, no other reactions, just soreness of my left arm and chest and a swollen lymph node in my collar bone, like a goose egg, and is tender to touch. I chatted with my  gastroenterologist, I have Crohn's disease and am on a biologic medication. My doctor stated that this could just be an immune response. I am having pain from my left collar bone to my sternum that is always persistent all the time and flares at times, when doing some movement. The area is tender to touch but I feel discomfort all the time through that left side. I also feel this when I take a deep breath. I even experience this with a flu shot, but doesn't last this long. I will be going to see my doctor so that he can evaluate me." The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute disseminated encephalomyelitis, CSF test, Magnetic resonance imaging, Paraesthesia, Sensory loss
Clinical narrative: a left sided nystagmus; urgent MRI showing multiple brain lesions consistent with Acute disseminated encephalomyelitis; Patient developed paresthesias on entire right side of body / The paresthesias continued, not progressing; a brief headache; episode of dizziness / developed severe dizziness; This is a spontaneous report from a contactable physician (patient). A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) intramuscularly at right arm on 21Dec2020 07:00 at single dose for COVID-19 immunization. Medical history included known allergies to sulfa meds. The patient's concomitant medications included multivitamins [vitamins nos] within 2 weeks of vaccination. Patient developed paresthesias on entire right side of body after a brief headache and episode of dizziness, all since 29Dec2020 15: 00. The paresthesias continued, not progressing, but patient was advised to obtain an MRI Brain and C spine as an outpatient. On 02Jan2021, the patient developed severe dizziness and a left sided nystagmus. She went to the ER and underwent urgent MRI showing multiple brain lesions consistent with acute disseminated encephalomyelitis. Lumbar puncture (LP) was performed, awaiting final results. Patient was admitted and was receiving IV steroids (solumedrol). Duration of hospitalization was 5 days since Dec2020. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures, which included Nasal Swab and Rapid covid swab, both on 02Jan2020 with result of negative. The outcome of the events was recovering.; Sender's Comments: Based on temporal association and lack of other provided etiology, a possible contributory role of suspect BNT162B2 vaccine cannot be excluded for reported acute disseminated encephalomyelitis, paraesthesia, headache, dizziness and nystagmus. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: a left sided nystagmus; urgent MRI showing multiple brain lesions consistent with Acute disseminated encephalomyelitis; Patient developed paresthesias on entire right side of body / The paresthesias continued, not progressing; a brief headache; episode of dizziness / developed severe dizziness; This is a spontaneous report from a contactable physician (patient). A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) intramuscularly at right arm on 21Dec2020 07:00 at single dose for COVID-19 immunization. Medical history included known allergies to sulfa meds. The patient's concomitant medications included multivitamins [vitamins nos] within 2 weeks of vaccination. Patient developed paresthesias on entire right side of body after a brief headache and episode of dizziness, all since 29Dec2020 15: 00. The paresthesias continued, not progressing, but patient was advised to obtain an MRI Brain and C spine as an outpatient. On 02Jan2021, the patient developed severe dizziness and a left sided nystagmus. She went to the ER and underwent urgent MRI showing multiple brain lesions consistent with acute disseminated encephalomyelitis. Lumbar puncture (LP) was performed, awaiting final results. Patient was admitted and was receiving IV steroids (solumedrol). Duration of hospitalization was 5 days since Dec2020. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures, which included Nasal Swab and Rapid covid swab, both on 02Jan2020 with result of negative. The outcome of the events was recovering.; Sender's Comments: Based on temporal association and lack of other provided etiology, a possible contributory role of suspect BNT162B2 vaccine cannot be excluded for reported acute disseminated encephalomyelitis, paraesthesia, headache, dizziness and nystagmus. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.