chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Eye pruritus, Eye swelling
Clinical narrative: swelling and itching of my eyes; swelling and itching of my eyes; full body rash abs patches of itching; This is a spontaneous report from a contactable consumer (patient). A 23-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date (Age at Vaccination was 23 years), as dose 2, single for COVID-19 immunization. The patient medical history included syncope, low blood pressure, menstrual issues, Environmental allergies, and allergic to mushrooms. Concomitant medications included Fluoxetine hydrochloride (PROZAC), Trazodone, and birth control. Patient did not receive any other vaccine in four weeks prior COVID vaccination. Patient was not diagnosed with COVID prior vaccination and not tested with COVID post vaccination. The patient previously received first does of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0150) via an unspecified route of administration, administered in Arm Left on 07Apr2021 14:30 (Age at Vaccination was 23 years), as dose 1, single for COVID-19 immunization and on 07Apr2021 19:00, patient experienced swelling around her eyes and they were very itchy and received Oral steroids for swelling and itching. On an unspecified date, the patient experienced swelling and itching of my eyes, and full body rash abs patches of itching. The patient visited Emergency room as a result of events. Therapeutic measures were taken as a result of events which included Oral steroids for swelling and itching. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Eye pruritus, Eye swelling, Rash
Clinical narrative: swelling and itching of my eyes; swelling and itching of my eyes; full body rash abs patches of itching; This is a spontaneous report from a contactable consumer (patient). A 23-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date (Age at Vaccination was 23 years), as dose 2, single for COVID-19 immunization. The patient medical history included syncope, low blood pressure, menstrual issues, Environmental allergies, and allergic to mushrooms. Concomitant medications included Fluoxetine hydrochloride (PROZAC), Trazodone, and birth control. Patient did not receive any other vaccine in four weeks prior COVID vaccination. Patient was not diagnosed with COVID prior vaccination and not tested with COVID post vaccination. The patient previously received first does of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0150) via an unspecified route of administration, administered in Arm Left on 07Apr2021 14:30 (Age at Vaccination was 23 years), as dose 1, single for COVID-19 immunization and on 07Apr2021 19:00, patient experienced swelling around her eyes and they were very itchy and received Oral steroids for swelling and itching. On an unspecified date, the patient experienced swelling and itching of my eyes, and full body rash abs patches of itching. The patient visited Emergency room as a result of events. Therapeutic measures were taken as a result of events which included Oral steroids for swelling and itching. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Lymphadenopathy, Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: fever (tmax 102.3)/I am continuing to have fevers at night. Around 100-101°.; dry cough; chills; nausea; This is a spontaneous report from a non- contactable nurse (patient). A 29-year-old Non-Pregnant female patient received BNT162B2 (Pfizer- BioNTech COVID 19, solution for injection, Batch/ Lot number: ER8734) via an unspecified route of administration in left arm on 30Mar2021 (At the age of 29-year-old) as Dose 2, Single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patients medical history and concomitant medications were not reported. Historical vaccine included the patient previously received BNT162B2 (Pfizer- BioNTech COVID 19, solution for injection, Batch/ Lot number: EN6198) via an unspecified route of administration on 09Mar2021 (At the age of 29-year-old) as Dose 1, Single for COVID-19 immunization. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. the patient was not received other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. On 31Mar2021 the patient experienced as expected, about 16 hours later, she developed chills, fever (tmax 102.3) and nausea. The fever resolved with Tylenol. Over the next few days, Thursday, Friday, the weekend and now Monday, she continuing to have fevers at night. Around 100-101°. she did also develop a dry cough, which is non-productive. About a week after her first injection, she did notice that the muscle on the right side of my neck was sore to the point where it hurt to swallow. she originally thought she was sleeping on her pillow wrong. However, the soreness is worse, feels like a burning sensation on the right side of her neck. The dry cough does make this worse and her neck is tender to the touch and movement. Advil and heat does help the pain through out the day. The patient visited to clinic. The patient underwent laboratory test on 07Apr2021 nasal swab which resulted as negative, temperature 102.3, on unspecified date  Apr 2021 temperature as 100-101°. The oucome of event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Cough, Nausea, Pyrexia
Clinical narrative: fever (tmax 102.3)/I am continuing to have fevers at night. Around 100-101°.; dry cough; chills; nausea; This is a spontaneous report from a non- contactable nurse (patient). A 29-year-old Non-Pregnant female patient received BNT162B2 (Pfizer- BioNTech COVID 19, solution for injection, Batch/ Lot number: ER8734) via an unspecified route of administration in left arm on 30Mar2021 (At the age of 29-year-old) as Dose 2, Single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patients medical history and concomitant medications were not reported. Historical vaccine included the patient previously received BNT162B2 (Pfizer- BioNTech COVID 19, solution for injection, Batch/ Lot number: EN6198) via an unspecified route of administration on 09Mar2021 (At the age of 29-year-old) as Dose 1, Single for COVID-19 immunization. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. the patient was not received other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. On 31Mar2021 the patient experienced as expected, about 16 hours later, she developed chills, fever (tmax 102.3) and nausea. The fever resolved with Tylenol. Over the next few days, Thursday, Friday, the weekend and now Monday, she continuing to have fevers at night. Around 100-101°. she did also develop a dry cough, which is non-productive. About a week after her first injection, she did notice that the muscle on the right side of my neck was sore to the point where it hurt to swallow. she originally thought she was sleeping on her pillow wrong. However, the soreness is worse, feels like a burning sensation on the right side of her neck. The dry cough does make this worse and her neck is tender to the touch and movement. Advil and heat does help the pain through out the day. The patient visited to clinic. The patient underwent laboratory test on 07Apr2021 nasal swab which resulted as negative, temperature 102.3, on unspecified date  Apr 2021 temperature as 100-101°. The oucome of event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: fever (tmax 102.3)/I am continuing to have fevers at night. Around 100-101°.; dry cough; chills; nausea; This is a spontaneous report from a non- contactable nurse (patient). A 29-year-old Non-Pregnant female patient received BNT162B2 (Pfizer- BioNTech COVID 19, solution for injection, Batch/ Lot number: ER8734) via an unspecified route of administration in left arm on 30Mar2021 (At the age of 29-year-old) as Dose 2, Single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patients medical history and concomitant medications were not reported. Historical vaccine included the patient previously received BNT162B2 (Pfizer- BioNTech COVID 19, solution for injection, Batch/ Lot number: EN6198) via an unspecified route of administration on 09Mar2021 (At the age of 29-year-old) as Dose 1, Single for COVID-19 immunization. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. the patient was not received other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. On 31Mar2021 the patient experienced as expected, about 16 hours later, she developed chills, fever (tmax 102.3) and nausea. The fever resolved with Tylenol. Over the next few days, Thursday, Friday, the weekend and now Monday, she continuing to have fevers at night. Around 100-101°. she did also develop a dry cough, which is non-productive. About a week after her first injection, she did notice that the muscle on the right side of my neck was sore to the point where it hurt to swallow. she originally thought she was sleeping on her pillow wrong. However, the soreness is worse, feels like a burning sensation on the right side of her neck. The dry cough does make this worse and her neck is tender to the touch and movement. Advil and heat does help the pain through out the day. The patient visited to clinic. The patient underwent laboratory test on 07Apr2021 nasal swab which resulted as negative, temperature 102.3, on unspecified date  Apr 2021 temperature as 100-101°. The oucome of event was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Thrombosis
Clinical narrative: Blood clot near liver; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose on an unspecified date (lot/batch number not reported) at dose 1, single, then second dose on an unspecified date (lot/batch number not reported) at dose 2, single in the left arm; both via an unspecified route of administration at an unspecified age for COVID-19 immunization. Medical history included in remission 9 years from Stage IV cancer colon and liver. Concomitant medication included nadolol, iron, and multivitamin. The patient has no other vaccines received in four weeks. The patient has no history of COVID-19 infection. After vaccination, the patient was tested for COVID-19. The patient has no known allergies. On Apr2021, the patient experienced blood clot near the liver. Due to the event, the patient was placed on Xantac blood thinner. On Aug2021, the patient underwent COVID-19 rapid test (nasal swab) with negative result. Outcome of the event was not recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test, Thrombosis
Clinical narrative: Blood clot near liver; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose on an unspecified date (lot/batch number not reported) at dose 1, single, then second dose on an unspecified date (lot/batch number not reported) at dose 2, single in the left arm; both via an unspecified route of administration at an unspecified age for COVID-19 immunization. Medical history included in remission 9 years from Stage IV cancer colon and liver. Concomitant medication included nadolol, iron, and multivitamin. The patient has no other vaccines received in four weeks. The patient has no history of COVID-19 infection. After vaccination, the patient was tested for COVID-19. The patient has no known allergies. On Apr2021, the patient experienced blood clot near the liver. Due to the event, the patient was placed on Xantac blood thinner. On Aug2021, the patient underwent COVID-19 rapid test (nasal swab) with negative result. Outcome of the event was not recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pruritus, Skin warm, Swelling, Tenderness
Clinical narrative: second one it got really itchy; sore; giant welt, that was hard, and seems to have bumps on it too; This is a spontaneous report from a contactable consumer. This 36-years-old female consumer reported for herself.  A 36-years-old non-pregnant female patient (no pregnant at the time of vaccination) received second dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: EW0158, Expiry date: not reported) via an unspecified route of administration, administered in left arm on 12Apr2021 at 10:15 (36-year-old at the time of vaccination) as dose 2, single for COVID-19 immunization. Medical history included asthma, allergies to shellfish, fish and year-round allergies. Concomitant medication(s) included levonorgestrel (MIRENA), neomycin (NEOMYCIN), polymyxin b (POLYMYXIN B) and Allergy shots. The patient previously took amoxicillin and experienced hypersensitivity. The patient previously took first dose of bnt162b2(PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: EP7534, Expiry date: not reported) via an unspecified route of administration, administered in left arm on 22Mar2021 10:30 (36-year-old at the time of vaccination) as dose 1, single for COVID-19 immunization and experienced itchy. Patient did not have covid prior vaccination and not tested covid post vaccination. On 13Apr2021 at 12:00, the patient experienced second one it got really itchy, sore and giant welt, that was hard, and seems to have bumps on it too. Patient stated that my first vaccine my arm was just itchy after. But with this second one it got really itchy and was sore. Noticed a giant welt, that was hard, and seems to have bumps on it too. The patient did not receive any treatment for the events. The outcome of the vents was reported as not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: second one it got really itchy; sore; giant welt, that was hard, and seems to have bumps on it too; This is a spontaneous report from a contactable consumer. This 36-years-old female consumer reported for herself.  A 36-years-old non-pregnant female patient (no pregnant at the time of vaccination) received second dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: EW0158, Expiry date: not reported) via an unspecified route of administration, administered in left arm on 12Apr2021 at 10:15 (36-year-old at the time of vaccination) as dose 2, single for COVID-19 immunization. Medical history included asthma, allergies to shellfish, fish and year-round allergies. Concomitant medication(s) included levonorgestrel (MIRENA), neomycin (NEOMYCIN), polymyxin b (POLYMYXIN B) and Allergy shots. The patient previously took amoxicillin and experienced hypersensitivity. The patient previously took first dose of bnt162b2(PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: EP7534, Expiry date: not reported) via an unspecified route of administration, administered in left arm on 22Mar2021 10:30 (36-year-old at the time of vaccination) as dose 1, single for COVID-19 immunization and experienced itchy. Patient did not have covid prior vaccination and not tested covid post vaccination. On 13Apr2021 at 12:00, the patient experienced second one it got really itchy, sore and giant welt, that was hard, and seems to have bumps on it too. Patient stated that my first vaccine my arm was just itchy after. But with this second one it got really itchy and was sore. Noticed a giant welt, that was hard, and seems to have bumps on it too. The patient did not receive any treatment for the events. The outcome of the vents was reported as not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pruritus, Urticaria
Clinical narrative: second one it got really itchy; sore; giant welt, that was hard, and seems to have bumps on it too; This is a spontaneous report from a contactable consumer. This 36-years-old female consumer reported for herself.  A 36-years-old non-pregnant female patient (no pregnant at the time of vaccination) received second dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: EW0158, Expiry date: not reported) via an unspecified route of administration, administered in left arm on 12Apr2021 at 10:15 (36-year-old at the time of vaccination) as dose 2, single for COVID-19 immunization. Medical history included asthma, allergies to shellfish, fish and year-round allergies. Concomitant medication(s) included levonorgestrel (MIRENA), neomycin (NEOMYCIN), polymyxin b (POLYMYXIN B) and Allergy shots. The patient previously took amoxicillin and experienced hypersensitivity. The patient previously took first dose of bnt162b2(PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: EP7534, Expiry date: not reported) via an unspecified route of administration, administered in left arm on 22Mar2021 10:30 (36-year-old at the time of vaccination) as dose 1, single for COVID-19 immunization and experienced itchy. Patient did not have covid prior vaccination and not tested covid post vaccination. On 13Apr2021 at 12:00, the patient experienced second one it got really itchy, sore and giant welt, that was hard, and seems to have bumps on it too. Patient stated that my first vaccine my arm was just itchy after. But with this second one it got really itchy and was sore. Noticed a giant welt, that was hard, and seems to have bumps on it too. The patient did not receive any treatment for the events. The outcome of the vents was reported as not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Nausea, Pain, Pyrexia
Clinical narrative: sore arm; swollen at injection site; lumps under left arm; nausea; fever; body ache; This is a spontaneous report from a contactable consumer. This female consumer reported for herself:  A 52-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: Unknown), via unspecified route of administration, in left arm on 12Apr2021 10:30 (at the age of 52-year-old) as single dose for COVID-19 immunization. The patient medical history was not reported. The concomitant medication of the patient included escitalopram and cetirizine hydrochloride (ZYTREC) in two weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: Unknown), via unspecified route of administration, in right arm on 22Mar2021 10:30 as single dose for COVID-19 immunization just a sore arm with swelling in the hand and arm. Patient had no known allergy. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not having covid prior vaccination and has not been covid tested post vaccination. On 12Apr2021 18:00 the patient experienced sore arm, swollen at injection site, lumps under left arm, nausea, fever and body ache. It was unknown if the patient received the treatment for all the reported events. The outcome for all the reported events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mass, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: sore arm; swollen at injection site; lumps under left arm; nausea; fever; body ache; This is a spontaneous report from a contactable consumer. This female consumer reported for herself:  A 52-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: Unknown), via unspecified route of administration, in left arm on 12Apr2021 10:30 (at the age of 52-year-old) as single dose for COVID-19 immunization. The patient medical history was not reported. The concomitant medication of the patient included escitalopram and cetirizine hydrochloride (ZYTREC) in two weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: Unknown), via unspecified route of administration, in right arm on 22Mar2021 10:30 as single dose for COVID-19 immunization just a sore arm with swelling in the hand and arm. Patient had no known allergy. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not having covid prior vaccination and has not been covid tested post vaccination. On 12Apr2021 18:00 the patient experienced sore arm, swollen at injection site, lumps under left arm, nausea, fever and body ache. It was unknown if the patient received the treatment for all the reported events. The outcome for all the reported events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site swelling
Clinical narrative: sore arm; swollen at injection site; lumps under left arm; nausea; fever; body ache; This is a spontaneous report from a contactable consumer. This female consumer reported for herself:  A 52-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: Unknown), via unspecified route of administration, in left arm on 12Apr2021 10:30 (at the age of 52-year-old) as single dose for COVID-19 immunization. The patient medical history was not reported. The concomitant medication of the patient included escitalopram and cetirizine hydrochloride (ZYTREC) in two weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: Unknown), via unspecified route of administration, in right arm on 22Mar2021 10:30 as single dose for COVID-19 immunization just a sore arm with swelling in the hand and arm. Patient had no known allergy. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not having covid prior vaccination and has not been covid tested post vaccination. On 12Apr2021 18:00 the patient experienced sore arm, swollen at injection site, lumps under left arm, nausea, fever and body ache. It was unknown if the patient received the treatment for all the reported events. The outcome for all the reported events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Fibrin D dimer, Full blood count, Muscle spasms, Paraesthesia
Clinical narrative: Very tired, high blood pressure, lost of feeling on right side of the body
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Hypertension, Hypoaesthesia
Clinical narrative: Very tired, high blood pressure, lost of feeling on right side of the body
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Discomfort, Head discomfort, Nodule
Clinical narrative: "I" woke up with a sizable lump on "my" right collarbone; "my" lump could be cupped with "my" hand due to the large size and "I" felt pressure in the right side of "my"chest.; The pressure is so uncomfortable at times though that "I" can feel it in the back of "my" head; This is a spontaneous report from a contactable consumer, the patient. A 39 -year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the right arm on 22Apr2021 at 13:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history included borderline hypothyroidism and allergic to kiwi. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included acetylsalicylic acid/ caffeine/ paracetamol (EXCEDRIN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the right arm on 19Mar2021 at 14:15 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. On 23Apr2021 at 9:30, the patient woke up with a sizable lump on her right collarbone. On the same day night her lump could be "cupped" with her hand due to the large size and she felt pressure in the right side of her chest. The pressure was so uncomfortable at times though that she could feel it in her chest and the back of her head. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sizable lump on right collarbone, lump could be cupped with hand due to the large size and felt pressure in the right side of chest and pressure on the back of head were not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: 1. Vaccination Facility Name and Vaccination Facility Country added.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Head discomfort, Mass
Clinical narrative: "I" woke up with a sizable lump on "my" right collarbone; "my" lump could be cupped with "my" hand due to the large size and "I" felt pressure in the right side of "my"chest.; The pressure is so uncomfortable at times though that "I" can feel it in the back of "my" head; This is a spontaneous report from a contactable consumer, the patient. A 39 -year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the right arm on 22Apr2021 at 13:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history included borderline hypothyroidism and allergic to kiwi. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included acetylsalicylic acid/ caffeine/ paracetamol (EXCEDRIN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the right arm on 19Mar2021 at 14:15 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. On 23Apr2021 at 9:30, the patient woke up with a sizable lump on her right collarbone. On the same day night her lump could be "cupped" with her hand due to the large size and she felt pressure in the right side of her chest. The pressure was so uncomfortable at times though that she could feel it in her chest and the back of her head. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sizable lump on right collarbone, lump could be cupped with hand due to the large size and felt pressure in the right side of chest and pressure on the back of head were not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: 1. Vaccination Facility Name and Vaccination Facility Country added.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Hypoaesthesia, Myalgia, Pain, Pain in extremity
Clinical narrative: Felt squeezing pressure up and down left arm for several days; Felt pain/pressure on back left side of shoulder; Felt pain/pressure on back left side of shoulder and on arm; Tingling/numbness in left hand; Tingling/numbness in left hand; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Mar2021 at 12:15 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included West Nile virus with encephalitis, endometriosis, Epstein-Barr. The patient was allergic to onions and milk products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the vaccination. Concomitant medications included acyclovir (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04Mar2021 at 11:15 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. On 09Apr2021, after the 2nd shot, the patient felt squeezing pressure up and down left arm for several days. A week or so after that stopped, on an unknown date in Apr2021, the patient felt pain/pressure on the back left side of the shoulder and on the arm and tingling/numbness in the left hand which was still going and was 24 by 7. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events felt squeezing pressure up and down left arm was resolved with sequelae on an unknown date in Apr2021. The clinical outcome of the events felt pain/pressure on back left side of shoulder and on arm, tingling/numbness in left hand were not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: Felt squeezing pressure up and down left arm for several days; Felt pain/pressure on back left side of shoulder; Felt pain/pressure on back left side of shoulder and on arm; Tingling/numbness in left hand; Tingling/numbness in left hand; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Mar2021 at 12:15 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included West Nile virus with encephalitis, endometriosis, Epstein-Barr. The patient was allergic to onions and milk products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the vaccination. Concomitant medications included acyclovir (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04Mar2021 at 11:15 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. On 09Apr2021, after the 2nd shot, the patient felt squeezing pressure up and down left arm for several days. A week or so after that stopped, on an unknown date in Apr2021, the patient felt pain/pressure on the back left side of the shoulder and on the arm and tingling/numbness in the left hand which was still going and was 24 by 7. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events felt squeezing pressure up and down left arm was resolved with sequelae on an unknown date in Apr2021. The clinical outcome of the events felt pain/pressure on back left side of shoulder and on arm, tingling/numbness in left hand were not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Hypoaesthesia, Limb discomfort, Pain in extremity, Paraesthesia
Clinical narrative: Felt squeezing pressure up and down left arm for several days; Felt pain/pressure on back left side of shoulder; Felt pain/pressure on back left side of shoulder and on arm; Tingling/numbness in left hand; Tingling/numbness in left hand; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Mar2021 at 12:15 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included West Nile virus with encephalitis, endometriosis, Epstein-Barr. The patient was allergic to onions and milk products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the vaccination. Concomitant medications included acyclovir (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04Mar2021 at 11:15 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. On 09Apr2021, after the 2nd shot, the patient felt squeezing pressure up and down left arm for several days. A week or so after that stopped, on an unknown date in Apr2021, the patient felt pain/pressure on the back left side of the shoulder and on the arm and tingling/numbness in the left hand which was still going and was 24 by 7. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events felt squeezing pressure up and down left arm was resolved with sequelae on an unknown date in Apr2021. The clinical outcome of the events felt pain/pressure on back left side of shoulder and on arm, tingling/numbness in left hand were not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dyspnoea, Injection site pain, Pain, Pyrexia
Clinical narrative: fever chills extreme body aches for 24 to 48 hours; fever chills extreme body aches for 24 to 48 hours; also developed a small red patchy itchy rash on my left fore arm after shot 2 approx. 3 hours after injection; also developed a small red patchy itchy rash on my left fore arm after shot 2 approx. 3 hours after injection; This is a spontaneous report from a contactable HCP (patient). A 62-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch Number: ER8734), dose 2 via an unspecified route of administration, administered in Arm Left on 08Apr2021 16:00 (age at vaccination 62-year-old) as dose 2, single for COVID-19 immunization. Medical history included diabetes mellitus, asthma, hypothyroidism, drug hypersensitivity being monitored by an immunologist from an unknown date. The patient having known allergies to vancomycin, penicillin, augmentin, bactrim, keflex, macrodantin. Concomitant medications included levothyroxine sodium (UNITHROID), insulin degludec (TRESIBA), metformin (METFORMIN), repaglinide (PRANDIN) taken for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch Number: ER8727), dose 1 via an unspecified route of administration, administered in Arm Left on 18Mar2021, 14:30 (age at vaccination 62-year-old) as dose 1, single for COVID-19 immunization. On 08Apr2021 19:00, 3 hours after vaccination fever chills extreme body aches for 24 to 48 hours, also developed a small red patchy itchy rash on my left forearm after shot 2 approx. 3 hours after injection. The patient received treatment for the events with Benadryl. The patient underwent lab tests and procedures which included sars-cov-2 test was negative on 12Apr2021. The outcome of the events was recovered on an unspecified date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash erythematous, Tachycardia
Clinical narrative: fever chills extreme body aches for 24 to 48 hours; fever chills extreme body aches for 24 to 48 hours; also developed a small red patchy itchy rash on my left fore arm after shot 2 approx. 3 hours after injection; also developed a small red patchy itchy rash on my left fore arm after shot 2 approx. 3 hours after injection; This is a spontaneous report from a contactable HCP (patient). A 62-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch Number: ER8734), dose 2 via an unspecified route of administration, administered in Arm Left on 08Apr2021 16:00 (age at vaccination 62-year-old) as dose 2, single for COVID-19 immunization. Medical history included diabetes mellitus, asthma, hypothyroidism, drug hypersensitivity being monitored by an immunologist from an unknown date. The patient having known allergies to vancomycin, penicillin, augmentin, bactrim, keflex, macrodantin. Concomitant medications included levothyroxine sodium (UNITHROID), insulin degludec (TRESIBA), metformin (METFORMIN), repaglinide (PRANDIN) taken for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch Number: ER8727), dose 1 via an unspecified route of administration, administered in Arm Left on 18Mar2021, 14:30 (age at vaccination 62-year-old) as dose 1, single for COVID-19 immunization. On 08Apr2021 19:00, 3 hours after vaccination fever chills extreme body aches for 24 to 48 hours, also developed a small red patchy itchy rash on my left forearm after shot 2 approx. 3 hours after injection. The patient received treatment for the events with Benadryl. The patient underwent lab tests and procedures which included sars-cov-2 test was negative on 12Apr2021. The outcome of the events was recovered on an unspecified date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pruritus, Pyrexia, Rash, SARS-CoV-2 test negative
Clinical narrative: fever chills extreme body aches for 24 to 48 hours; fever chills extreme body aches for 24 to 48 hours; also developed a small red patchy itchy rash on my left fore arm after shot 2 approx. 3 hours after injection; also developed a small red patchy itchy rash on my left fore arm after shot 2 approx. 3 hours after injection; This is a spontaneous report from a contactable HCP (patient). A 62-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch Number: ER8734), dose 2 via an unspecified route of administration, administered in Arm Left on 08Apr2021 16:00 (age at vaccination 62-year-old) as dose 2, single for COVID-19 immunization. Medical history included diabetes mellitus, asthma, hypothyroidism, drug hypersensitivity being monitored by an immunologist from an unknown date. The patient having known allergies to vancomycin, penicillin, augmentin, bactrim, keflex, macrodantin. Concomitant medications included levothyroxine sodium (UNITHROID), insulin degludec (TRESIBA), metformin (METFORMIN), repaglinide (PRANDIN) taken for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch Number: ER8727), dose 1 via an unspecified route of administration, administered in Arm Left on 18Mar2021, 14:30 (age at vaccination 62-year-old) as dose 1, single for COVID-19 immunization. On 08Apr2021 19:00, 3 hours after vaccination fever chills extreme body aches for 24 to 48 hours, also developed a small red patchy itchy rash on my left forearm after shot 2 approx. 3 hours after injection. The patient received treatment for the events with Benadryl. The patient underwent lab tests and procedures which included sars-cov-2 test was negative on 12Apr2021. The outcome of the events was recovered on an unspecified date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthma, Chest discomfort, Chest pain, Cough, Fatigue
Clinical narrative: On 02Apr2021, she flared up with asthma (10 days after the second dose); She had flu-like symptoms for 2-3 days and these symptoms and the headache were gone on 28Mar2021; She had flu-like symptoms for 2-3 days and these symptoms and the headache were gone on 28Mar2021; This is a spontaneous report from a contactable pharmacist (patient). A 68-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 24Mar2021 (at the age of 68-year-old) as dose 2, single for COVID-19 immunization. The patient medical history included Flu in Jan2021 (she had a bad episode of flu (maybe Covid)) and ongoing asthma (in Jan2021, flared up her asthma). Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR) and salbutamol sulfate (PROAIR [SALBUTAMOL SULFATE]). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. It was reported that, the patient received the second dose of the Pfizer-BioNtech Covid-19 vaccine on 24Mar2021. On an unspecified date in Mar2021, "she had flu-like symptoms for 2-3 days and these symptoms and the headache were gone on 28Mar2021". On 02Apr2021, she flared up with asthma (10 days after the second dose). The patient wanted to know if this had been seen during the clinical trials or reported (anything that affects the immune system). The patient stated she usually takes a low dose of Advair and Proair. Around 03Apr2021 she received Duoneb nebulizer solution as a treatment for flared up asthma. The case was reported as non-serious. The outcome of the events flu like symptoms and headache was reported as resolved on 28Mar2021. The outcome of event "On 02Apr2021, she flared up with asthma (10 days after the second dose)" was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Influenza like illness, Laryngitis, Nausea, Pain
Clinical narrative: On 02Apr2021, she flared up with asthma (10 days after the second dose); She had flu-like symptoms for 2-3 days and these symptoms and the headache were gone on 28Mar2021; She had flu-like symptoms for 2-3 days and these symptoms and the headache were gone on 28Mar2021; This is a spontaneous report from a contactable pharmacist (patient). A 68-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 24Mar2021 (at the age of 68-year-old) as dose 2, single for COVID-19 immunization. The patient medical history included Flu in Jan2021 (she had a bad episode of flu (maybe Covid)) and ongoing asthma (in Jan2021, flared up her asthma). Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR) and salbutamol sulfate (PROAIR [SALBUTAMOL SULFATE]). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. It was reported that, the patient received the second dose of the Pfizer-BioNtech Covid-19 vaccine on 24Mar2021. On an unspecified date in Mar2021, "she had flu-like symptoms for 2-3 days and these symptoms and the headache were gone on 28Mar2021". On 02Apr2021, she flared up with asthma (10 days after the second dose). The patient wanted to know if this had been seen during the clinical trials or reported (anything that affects the immune system). The patient stated she usually takes a low dose of Advair and Proair. Around 03Apr2021 she received Duoneb nebulizer solution as a treatment for flared up asthma. The case was reported as non-serious. The outcome of the events flu like symptoms and headache was reported as resolved on 28Mar2021. The outcome of event "On 02Apr2021, she flared up with asthma (10 days after the second dose)" was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.