chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Blister, Cytomegalovirus test, Full blood count, Herpes virus test, Mouth ulceration
Clinical narrative: Blister; Mouth ulcer; This is a spontaneous report from a contactable consumer (parent), from a Pfizer Sponsored Program Pfizer Rx Pathway. An 18-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history included type one diabetes. Concomitant medications were not reported. It was reported that, reporter son, age 18 who has type one diabetes probably had a blister, mouth ulcer, severe reaction to his first dose of Your Pfizer covid 19 vaccine. He was seen by his pediatrician, and his DM physician . an immunologist and infectious disease doctor were consulted via photos. All appropriate test were done- herpes, cytomegalovirus, mono. a CBC were all negative . The time frame suggests an adverse reaction. All experts advice was mixed on whether patient should receive his second. The patient underwent lab tests and procedures which included Cytomegalovirus (cytomegalovirus test): negative on an unspecified date, Mono. a CBC (full blood count): negative on an unspecified date, Herpes Test (herpes virus test): negative on an unspecified date. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Rash, Rash papular
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 28-years-old female patient received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EP7534) (age at the time of vaccination was 28 years and non-pregnant at the time of vaccination) via an unspecified route of administration on 16Mar2021 16:30 in right arm as dose 1, single for COVID-19 immunisation. The patient medical history included allergy to metals and had reactions to magnesium and was not sure if there was any in the vaccine. Concomitant medication was not reported. No other vaccine in four weeks. On 16Mar2021, the patient experienced she had gone to the emergency room for a migraine and she got rash on her. On 17Mar2021, the patient noticed today a big red rash that formed on her stomach. Therapeutic measures were taken as a result of she had gone to the emergency room for a migraine. The outcome of the event for big red raised rash on stomach was not recovered. The outcome of the event for migraine and she got rash on her were unknown. No follow up attempts are possible. No further information was expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Heart rate increased, Vaccination site pain
Clinical narrative: Extreme fatigue; Severe chills; Heart rate up to 130 while laying down; Severe headache; Injection site sore and swollen; Injection site sore and swollen; This is a spontaneous report from a contactable consumer (patient herself). A 55-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6204), via an unspecified route of administration, administered in left arm on 16Mar2021 15:45 (age at vaccination: 55 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included ongoing High blood pressure , ongoing known allergies to bananas, ancef. Concomitant medication(s) included calcitriol; hctz; levothyroxine; lisinopril; estradiol; metformin; rosuvastatin; desvenlafaxine; colecalciferol (VIT D3); ascorbic acid (+) zinc; biotin and cyanocobalamin (B12-VITAMIIN). The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9266) in the left arm on 24Feb2021 16:15 as DOSE 1, SINGLE for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Mar2021 17:00, the patient experienced extreme fatigue with in 30 minutes of injection, severe chills in excess of 8 hours, heart rate up to 130 while laying down, severe headache, injection site sore and swollen. The patient did not receive any treatment for the adverse events. The patient was not diagnosed with covid-19 prior to vaccination nor was tested since vaccination. The outcome of the events was recovered on an unknown date in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Extreme fatigue; Severe chills; Heart rate up to 130 while laying down; Severe headache; Injection site sore and swollen; Injection site sore and swollen; This is a spontaneous report from a contactable consumer (patient herself). A 55-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6204), via an unspecified route of administration, administered in left arm on 16Mar2021 15:45 (age at vaccination: 55 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included ongoing High blood pressure , ongoing known allergies to bananas, ancef. Concomitant medication(s) included calcitriol; hctz; levothyroxine; lisinopril; estradiol; metformin; rosuvastatin; desvenlafaxine; colecalciferol (VIT D3); ascorbic acid (+) zinc; biotin and cyanocobalamin (B12-VITAMIIN). The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9266) in the left arm on 24Feb2021 16:15 as DOSE 1, SINGLE for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Mar2021 17:00, the patient experienced extreme fatigue with in 30 minutes of injection, severe chills in excess of 8 hours, heart rate up to 130 while laying down, severe headache, injection site sore and swollen. The patient did not receive any treatment for the adverse events. The patient was not diagnosed with covid-19 prior to vaccination nor was tested since vaccination. The outcome of the events was recovered on an unknown date in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Erythema, Fatigue, Feeling hot, Oral herpes
Clinical narrative: fever blister on top lip; Swollen arm; throwing up; Diarrhea; tired; swelling and redness, it is really itchy.; swelling and redness, it is really itchy.; She has been putting ice on the arm and as soon as she takes it off it gets warm and hot again.; This is a spontaneous report from a contactable consumer (Patient). A 81-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEHC COVID-19 VACCINE, Batch/Lot Number: EN6208), Solution for injection, via an unspecified route of administration, administered in Arm Left on 13Mar2021 14:00 (at the age of 81-year-old) as single dose for covid-19 immunisation. Medical history included diabetes, high cholesterol, blood pressure high, breast cancer and lymph nodes removed. he patient's concomitant medications were not reported. Family medical history was reported as none. No additional vaccines were administered on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historic vaccine included first dose of BNT162B2 (PFIZER-BIONTEHC COVID-19 VACCINE, Batch/Lot Number: EL9266), Solution for injection, via an unspecified route of administration, administered in Arm Left on 20Feb2021 (at the age of 81-year-old) as single dose for covid-19 immunisation. On 14Mar2021, the patient experienced swollen arm, throwing up, diarrhea, on 16Mar2021, fever blister on top lip, on an unspecified date in Mar2021, tired, swelling and redness, it is really itchy, she has been putting ice on the arm and as soon as she takes it off it gets warm and hot again. The patient did not have any reactions from the first dose, but she got the second dose on Saturday 13Mar2021. Sunday afternoon, her arm was swollen, she was tired, throwing up, and had diarrhea. On Tuesday the patient had a fever blister on her top lip. Patent had been putting ice on her arm to help with the swelling and redness, it was really itchy. She was unable to put her dentures in because she was throwing up. Her stomach still feels like it was not good. She was fine as far as she can tell with the diarrhea. She had been putting Abreva on her fever blister on her top lip. She got both doses in her left arm because she had lymph nodes removed from her right arm because of breast cancer. Therapeutic measures were taken as a result of swollen arm, fever blister on top lip, swelling and redness, it is really itchy, swelling and redness, it is really itchy. Patient did not visit emergency room or physician office due to adverse events. No relevant test was performed. The outcome of event swollen arm, fever blister on top lip was not recovered and outcome of all other events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Vomiting
Clinical narrative: fever blister on top lip; Swollen arm; throwing up; Diarrhea; tired; swelling and redness, it is really itchy.; swelling and redness, it is really itchy.; She has been putting ice on the arm and as soon as she takes it off it gets warm and hot again.; This is a spontaneous report from a contactable consumer (Patient). A 81-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEHC COVID-19 VACCINE, Batch/Lot Number: EN6208), Solution for injection, via an unspecified route of administration, administered in Arm Left on 13Mar2021 14:00 (at the age of 81-year-old) as single dose for covid-19 immunisation. Medical history included diabetes, high cholesterol, blood pressure high, breast cancer and lymph nodes removed. he patient's concomitant medications were not reported. Family medical history was reported as none. No additional vaccines were administered on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historic vaccine included first dose of BNT162B2 (PFIZER-BIONTEHC COVID-19 VACCINE, Batch/Lot Number: EL9266), Solution for injection, via an unspecified route of administration, administered in Arm Left on 20Feb2021 (at the age of 81-year-old) as single dose for covid-19 immunisation. On 14Mar2021, the patient experienced swollen arm, throwing up, diarrhea, on 16Mar2021, fever blister on top lip, on an unspecified date in Mar2021, tired, swelling and redness, it is really itchy, she has been putting ice on the arm and as soon as she takes it off it gets warm and hot again. The patient did not have any reactions from the first dose, but she got the second dose on Saturday 13Mar2021. Sunday afternoon, her arm was swollen, she was tired, throwing up, and had diarrhea. On Tuesday the patient had a fever blister on her top lip. Patent had been putting ice on her arm to help with the swelling and redness, it was really itchy. She was unable to put her dentures in because she was throwing up. Her stomach still feels like it was not good. She was fine as far as she can tell with the diarrhea. She had been putting Abreva on her fever blister on her top lip. She got both doses in her left arm because she had lymph nodes removed from her right arm because of breast cancer. Therapeutic measures were taken as a result of swollen arm, fever blister on top lip, swelling and redness, it is really itchy, swelling and redness, it is really itchy. Patient did not visit emergency room or physician office due to adverse events. No relevant test was performed. The outcome of event swollen arm, fever blister on top lip was not recovered and outcome of all other events was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Lung disorder, Malaise, Pyrexia
Clinical narrative: fever; thought his lungs were inflamed; headache; felt unwell; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (Solution for injection), dose 1 via an unspecified route of administration on 03Mar2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included covid-19 from Jul2020. He had Covid-19 on July last year, allergic to NSAIDs. The patient's concomitant medications was not reported. The patient previously took montelukast for allergies and experienced pneumonia. He has already been taking Montelukast to treat his allergies. The patient after receiving the 1st dose of the vaccine, he had fever, felt unsettled, and thought his lungs were inflamed so he took Montelukast. He said he only took it one time and wants to know if this has affected the vaccine. Low grade fevers ranging from 99.7 to 99.8. He said his fever ranged from a low temperature of 96.2, and the highest it reached was 99.8. He said the fever comes and goes for a week now. He also said he had headache and felt unwell. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Heart rate, Heart rate increased, Pharyngeal swelling
Clinical narrative: Slight swelling of throat; Heart rate went up to 103 bpm then 159 bpm. For the next 8 hours bpm rates ranged from 103 to 179; Had small increase in temperature by 1 degree; No events other than slight soreness of injection site until 24 hours after injection; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 62-years-old male patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6208), via an unspecified route of administration, administered in Arm Right on 18Mar2021 12:00 (age at vaccination: 62-years-old) as single dose for covid-19 immunization. (Vaccination facility: Other). Medical history included covid-19, heart rate increased from Jul2020 to an unknown date (I did have COVID the last two weeks of July2020 and increased heart rates were very common during that time). had a 50% collapsed left lung from 2020 to an unknown date (I had a 50% collapsed left lung shortly after contributed to the COVID infection and also contributed to COPD-like lung conditions). chronic obstructive pulmonary disease from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Patient did not receive any other vaccine four weeks. It was reported that on 19Mar2021 12:00 patient experienced no events other than slight soreness of injection site until 24 hours after injection. Had small increase in temperature by 1 degree and slight swelling of throat. Main issue was heart rate went up to 103 bpm, then 159 bpm. For the next 8 hours bpm rates ranged from 103 to 179. After taking Tylenol and a nights sleep, bpm back down to 79 bpm and temperature/throat are now normal. Therapeutic measures were taken as a result of events. Patient did not tested for covid post vaccination. The patient underwent lab tests and procedures which included body temperature: increase in temperature by 1 degree on 19Mar2021, body temperature: normal on 20Mar2021, heart rate: 103 on 19Mar2021, heart rate: 159 on 19Mar2021, heart rate: 103-179 on 19Mar2021, heart rate: 79 on 20Mar2021. The outcome for the events was reported as resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Slight swelling of throat; Heart rate went up to 103 bpm then 159 bpm. For the next 8 hours bpm rates ranged from 103 to 179; Had small increase in temperature by 1 degree; No events other than slight soreness of injection site until 24 hours after injection; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 62-years-old male patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6208), via an unspecified route of administration, administered in Arm Right on 18Mar2021 12:00 (age at vaccination: 62-years-old) as single dose for covid-19 immunization. (Vaccination facility: Other). Medical history included covid-19, heart rate increased from Jul2020 to an unknown date (I did have COVID the last two weeks of July2020 and increased heart rates were very common during that time). had a 50% collapsed left lung from 2020 to an unknown date (I had a 50% collapsed left lung shortly after contributed to the COVID infection and also contributed to COPD-like lung conditions). chronic obstructive pulmonary disease from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Patient did not receive any other vaccine four weeks. It was reported that on 19Mar2021 12:00 patient experienced no events other than slight soreness of injection site until 24 hours after injection. Had small increase in temperature by 1 degree and slight swelling of throat. Main issue was heart rate went up to 103 bpm, then 159 bpm. For the next 8 hours bpm rates ranged from 103 to 179. After taking Tylenol and a nights sleep, bpm back down to 79 bpm and temperature/throat are now normal. Therapeutic measures were taken as a result of events. Patient did not tested for covid post vaccination. The patient underwent lab tests and procedures which included body temperature: increase in temperature by 1 degree on 19Mar2021, body temperature: normal on 20Mar2021, heart rate: 103 on 19Mar2021, heart rate: 159 on 19Mar2021, heart rate: 103-179 on 19Mar2021, heart rate: 79 on 20Mar2021. The outcome for the events was reported as resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Herpes zoster, Pain, Pruritus
Clinical narrative: This is a spontaneous report from a contactable consumer (patient herself). A 70-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EN6206, Expiry date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 18Mar2021 09:15 as dose 2, single for COVID-19 immunisation. Medical history included hypertension (High Blood Pressure managed by medication) and known allergies to Penicillin and Sulphur Drugs. Concomitant medications included Losartan at 100mg and Hydrochlorothiazide 25mg tablets taken for hypertension. It was reported that she was not a pregnant at the time of vaccination. She did not take any other vaccine in four weeks prior COVID -19 vaccine. She was not diagnosed with COVID prior vaccination and not tested with COVID post vaccination. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EN6198), via an unspecified route of administration, administered in Arm Left on 25Feb2021 09:45 as dose 1, single for COVID-19 immunisation. On 18Mar2021 22:30, patient experienced, on the night of the second shot she woke up with fever. On 18Mar2021, patient experienced headache, ache and chills which they say can happen. On 20Mar2021, the patient experienced, on sunday patient woke up with like a rash on her neck and part of her face and she did not like the way it looked. On 21Mar2021, the patient experienced several quarter size hives on her neck. On an unspecified date patient experienced shingles. Patient did not received treatment till she went to doctor. The outcome of the events fever, chills, headache was recovering, for the events several quarter size hives on her neck and itchy was not recovered and rash on my neck and part of my face, ache, shingles was unknown. No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer (patient herself). A 70-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EN6206, Expiry date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 18Mar2021 09:15 as dose 2, single for COVID-19 immunisation. Medical history included hypertension (High Blood Pressure managed by medication) and known allergies to Penicillin and Sulphur Drugs. Concomitant medications included Losartan at 100mg and Hydrochlorothiazide 25mg tablets taken for hypertension. It was reported that she was not a pregnant at the time of vaccination. She did not take any other vaccine in four weeks prior COVID -19 vaccine. She was not diagnosed with COVID prior vaccination and not tested with COVID post vaccination. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EN6198), via an unspecified route of administration, administered in Arm Left on 25Feb2021 09:45 as dose 1, single for COVID-19 immunisation. On 18Mar2021 22:30, patient experienced, on the night of the second shot she woke up with fever. On 18Mar2021, patient experienced headache, ache and chills which they say can happen. On 20Mar2021, the patient experienced, on sunday patient woke up with like a rash on her neck and part of her face and she did not like the way it looked. On 21Mar2021, the patient experienced several quarter size hives on her neck. On an unspecified date patient experienced shingles. Patient did not received treatment till she went to doctor. The outcome of the events fever, chills, headache was recovering, for the events several quarter size hives on her neck and itchy was not recovered and rash on my neck and part of my face, ache, shingles was unknown. No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenopia, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: shingles; sores in mouth; mouth felt weird; eyelids felt heavy; felt tired; Headache; chills; fever and chills; This is a spontaneous report from a contactable consumer. A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EN6199) via an unspecified route of administration, administered in Arm Left on 08Mar2021 as DOSE 2, SINGLE (at the age of 72-year-old) for covid-19 immunisation. Medical history included hypertension, blood pressure abnormal, blood potassium decreased. Concomitant medications included triamterene taken for blood pressure abnormal; potassium chloride taken for blood potassium decreased. Patient received the first dose of the Covid-19 vaccine on 15Feb2021. Lot: EM9809, NDC and Expiry not provided.On 09Mar2021, patient had the normal fever and chills, headache and all that stuff for a day or two. On 11Mar2021, patient developed sores in her mouth. The patient thought she had a canker sore. The patient went to the dentist. The dentist was able to see the sores and thought it was shingles. On an unspecified date patient had the shingles vaccine. On 10Mar2021, her mouth felt weird two days after she received the Covid-19 vaccine. Patient didn't relate this to the sores. Patient rinsed her mouth with Listerine 3-4 times day. It was sore when patient rinsed her mouth. Patient dentist appointment was previously scheduled. Patient kept rinsing with Listerine and it improved. The dentist took a picture of the sores and send it off to get another opinion. Patient added that her eyelids felt heavy and felt tired. After she got home remembered she had the vaccine and the dentist probably didn't know that she had it. The outcome of sores in mouth and mouth felt weird was resolving and other events was resolved on 10Mar2021.   No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Oral pain, Pyrexia
Clinical narrative: shingles; sores in mouth; mouth felt weird; eyelids felt heavy; felt tired; Headache; chills; fever and chills; This is a spontaneous report from a contactable consumer. A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EN6199) via an unspecified route of administration, administered in Arm Left on 08Mar2021 as DOSE 2, SINGLE (at the age of 72-year-old) for covid-19 immunisation. Medical history included hypertension, blood pressure abnormal, blood potassium decreased. Concomitant medications included triamterene taken for blood pressure abnormal; potassium chloride taken for blood potassium decreased. Patient received the first dose of the Covid-19 vaccine on 15Feb2021. Lot: EM9809, NDC and Expiry not provided.On 09Mar2021, patient had the normal fever and chills, headache and all that stuff for a day or two. On 11Mar2021, patient developed sores in her mouth. The patient thought she had a canker sore. The patient went to the dentist. The dentist was able to see the sores and thought it was shingles. On an unspecified date patient had the shingles vaccine. On 10Mar2021, her mouth felt weird two days after she received the Covid-19 vaccine. Patient didn't relate this to the sores. Patient rinsed her mouth with Listerine 3-4 times day. It was sore when patient rinsed her mouth. Patient dentist appointment was previously scheduled. Patient kept rinsing with Listerine and it improved. The dentist took a picture of the sores and send it off to get another opinion. Patient added that her eyelids felt heavy and felt tired. After she got home remembered she had the vaccine and the dentist probably didn't know that she had it. The outcome of sores in mouth and mouth felt weird was resolving and other events was resolved on 10Mar2021.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: severe diarrhea; low-grade fever; abdominal pain; headache; chills; fatigue; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on 15Mar2021 as DOSE 2, SINGLE for covid-19 immunisation. Patient received first dose of the Pfizer covid vaccine. The patient's medical history and concomitant medications were not reported. Patient received second dose of the Pfizer covid vaccine on March 15 and experienced chills and fatigue within five hours of receiving the dose. Within 24 hours experienced severe diarrhea low-grade fever abdominal pain and chills and headache. The patient continued to feel the side effects for days after the second dose administration. The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be requested.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: severe diarrhea; low-grade fever; abdominal pain; headache; chills; fatigue; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on 15Mar2021 as DOSE 2, SINGLE for covid-19 immunisation. Patient received first dose of the Pfizer covid vaccine. The patient's medical history and concomitant medications were not reported. Patient received second dose of the Pfizer covid vaccine on March 15 and experienced chills and fatigue within five hours of receiving the dose. Within 24 hours experienced severe diarrhea low-grade fever abdominal pain and chills and headache. The patient continued to feel the side effects for days after the second dose administration. The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Dysphonia, Fatigue, Hyperhidrosis
Clinical narrative: arm hurt; back of shoulder hurt; chest tightness/Chest was like a little tight; Voice was Rusty/had a hoarse voice; lethargic; Wheezing; sweats; body aches; fatigued; allergies; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number: EN6207), dose 1 via an unspecified route of administration, administered in Left arm on 19Mar2021 at 01:00 (58-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. Medical history included hbp (high blood pressure) from an unknown date and ongoing and thyroid disorder from an unknown date and unknown if ongoing. The patient had allergies. Concomitant medications included Levothyroxine sodium (LEVOXYL), Pregabalin (LYRICA), Salbutamol Sulfate (INHALERIN); all for unknown indications from unknown dates and unknown if ongoing. On 19MAR2021, the patient was very lethargic. On 20MAR2021, the patient experienced her arm and back of shoulder hurt, chest tightness/Chest was like a little tight and Voice was Rusty/had a hoarse voice. On an unspecified date in 2021, the patient experienced sweats, body aches, fatigued, allergies and wheezing. The patient got the vaccine on Friday, and did not have any symptoms in the morning but then the next day her arm and back of shoulder hurt, also with her chest she had tightness, the patient also had a hoarse voice and was fatigued. The patient was concerned with chest tightness and the hoarseness, wanting to know if that was a normal side effect and if she is okay to get the second dose. Because of the patient's allergies, is the second dose going to be worse. Last night the patient had sweats and body aches, she does not know if that was normal. The patient stated that all her symptoms at the moment are getting better, but she is still just tired. The patient wanted to know if her main concern if she will be okay to get the second shot, since she had the chest tightness, wheezing, and hoarse voice. The outcome of the events were un-known.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Lethargy, Pain, Pain in extremity, Wheezing
Clinical narrative: arm hurt; back of shoulder hurt; chest tightness/Chest was like a little tight; Voice was Rusty/had a hoarse voice; lethargic; Wheezing; sweats; body aches; fatigued; allergies; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number: EN6207), dose 1 via an unspecified route of administration, administered in Left arm on 19Mar2021 at 01:00 (58-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. Medical history included hbp (high blood pressure) from an unknown date and ongoing and thyroid disorder from an unknown date and unknown if ongoing. The patient had allergies. Concomitant medications included Levothyroxine sodium (LEVOXYL), Pregabalin (LYRICA), Salbutamol Sulfate (INHALERIN); all for unknown indications from unknown dates and unknown if ongoing. On 19MAR2021, the patient was very lethargic. On 20MAR2021, the patient experienced her arm and back of shoulder hurt, chest tightness/Chest was like a little tight and Voice was Rusty/had a hoarse voice. On an unspecified date in 2021, the patient experienced sweats, body aches, fatigued, allergies and wheezing. The patient got the vaccine on Friday, and did not have any symptoms in the morning but then the next day her arm and back of shoulder hurt, also with her chest she had tightness, the patient also had a hoarse voice and was fatigued. The patient was concerned with chest tightness and the hoarseness, wanting to know if that was a normal side effect and if she is okay to get the second dose. Because of the patient's allergies, is the second dose going to be worse. Last night the patient had sweats and body aches, she does not know if that was normal. The patient stated that all her symptoms at the moment are getting better, but she is still just tired. The patient wanted to know if her main concern if she will be okay to get the second shot, since she had the chest tightness, wheezing, and hoarse voice. The outcome of the events were un-known.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Dizziness, Electric shock sensation, Paraesthesia, Urticaria
Clinical narrative: dizziness; diarrhea; tingling sensation; knee joints electric shock feeling; hives; This is a spontaneous report from a contactable female consumer (patient) via Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on 16Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced dizziness, diarrhea, tingling sensation, knee joints electric shock feeling and hives. Patient took anti-allergy medication and tylenol the second night after her first dose. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Headache, Hypersensitivity, Illness, Paraesthesia oral
Clinical narrative: dizziness; diarrhea; tingling sensation; knee joints electric shock feeling; hives; This is a spontaneous report from a contactable female consumer (patient) via Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on 16Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced dizziness, diarrhea, tingling sensation, knee joints electric shock feeling and hives. Patient took anti-allergy medication and tylenol the second night after her first dose. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash, Vaccination site urticaria
Clinical narrative: dizziness; diarrhea; tingling sensation; knee joints electric shock feeling; hives; This is a spontaneous report from a contactable female consumer (patient) via Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on 16Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced dizziness, diarrhea, tingling sensation, knee joints electric shock feeling and hives. Patient took anti-allergy medication and tylenol the second night after her first dose. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Hypersomnia, Vaccination site erythema, Vaccination site mass, Vaccination site warmth
Clinical narrative: I slept all day; allergic reaction; I have huge red circle on the injection site, it's warm, red and lumpy; I have huge red circle on the injection site, it's warm, red and lumpy; I have huge red circle on the injection site, it's warm, red and lumpy; This is a spontaneous report from a contactable consumer. This 53-year-old female consumer reported. A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN5318), dose 2 via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had second vaccine on Friday, and on 19Mar2021, had huge red circle on the injection site, it's warm, red and lumpy. She slept all day yesterday, had a fever, just like pure exhaustion, and still not feeling great today, headache, nauseas on Friday a little bit. The Pharmacist was that she was having an allergic reaction. The patient recevie treatment with Tylenol. Outcome of the event hypersomnia was unknown and rest all event was not recovered, at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pharyngitis streptococcal, SARS-CoV-2 test, Tonsillar hypertrophy
Clinical narrative: Strep throat; Swollen tonsils; Extreme pain; This is a spontaneous report from a contactable other healthcare professional, the patient. A 32-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown, Expiry date: unknown, at the age of 32-year-old), via an unspecified route of administration, administered in left arm on 20Mar2021 15:30 as dose 1, single for covid-19 immunisation. Medical history included fibroids. The patient was allergic to latex. It was unknown if the patient was pregnant. Concomitant medications included montelukast sodium (SINGULAIR), amlodipine, sertraline, aripiprazole (ABILIFY). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. On 22Mar2021 08:00, the patient experienced strep throat, swollen tonsils, extreme pain. The patient received amoxicillin as a therapeutic measure for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient underwent nasal swab test twice on 23Mar2021 and the results were negative and pending. The outcome of events was not recovered.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: rash; shingles; This is a spontaneous report from a contactable consumer. A 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEHC COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on 18Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced rash and shingles. It was reported that, slight rash turned into shingles. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bursitis, Headache, Insomnia, Magnetic resonance imaging
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional. A 69 year old non pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 30Dec2020 09:45 (Batch/Lot Number: EL3246) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included levothyroxine sodium (LEVOTHYROXINE SODIUM) taken for an unspecified indication, start and stop date were not reported. The patient previously took levoquin. She is known allergic to levoquin. The patient experienced arm, neck, shoulder pain causing pain in extremity on 30Dec2020 09:45 with outcome of not recovered, she was given the covid vaccine in her upper bursa, nausea, muscle spasms, on 30Dec2020 09:45 with outcome of not recovered, can't sleep causing insomnia on 30Dec2020 09:45 with outcome of not recovered , headaches and bursitis on 30Dec2020 09:45 with outcome of not recovered. The patient underwent lab tests and procedures which included magnetic resonance imaging which showed communicated bursitis, sars-cov-2 test: negative on 31Dec2020, x-ray n/a on 31Dec2020..Therapeutic measures were taken as a result of this. No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Nausea, Neck pain, Pain in extremity, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional. A 69 year old non pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 30Dec2020 09:45 (Batch/Lot Number: EL3246) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included levothyroxine sodium (LEVOTHYROXINE SODIUM) taken for an unspecified indication, start and stop date were not reported. The patient previously took levoquin. She is known allergic to levoquin. The patient experienced arm, neck, shoulder pain causing pain in extremity on 30Dec2020 09:45 with outcome of not recovered, she was given the covid vaccine in her upper bursa, nausea, muscle spasms, on 30Dec2020 09:45 with outcome of not recovered, can't sleep causing insomnia on 30Dec2020 09:45 with outcome of not recovered , headaches and bursitis on 30Dec2020 09:45 with outcome of not recovered. The patient underwent lab tests and procedures which included magnetic resonance imaging which showed communicated bursitis, sars-cov-2 test: negative on 31Dec2020, x-ray n/a on 31Dec2020..Therapeutic measures were taken as a result of this. No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional. A 69 year old non pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 30Dec2020 09:45 (Batch/Lot Number: EL3246) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included levothyroxine sodium (LEVOTHYROXINE SODIUM) taken for an unspecified indication, start and stop date were not reported. The patient previously took levoquin. She is known allergic to levoquin. The patient experienced arm, neck, shoulder pain causing pain in extremity on 30Dec2020 09:45 with outcome of not recovered, she was given the covid vaccine in her upper bursa, nausea, muscle spasms, on 30Dec2020 09:45 with outcome of not recovered, can't sleep causing insomnia on 30Dec2020 09:45 with outcome of not recovered , headaches and bursitis on 30Dec2020 09:45 with outcome of not recovered. The patient underwent lab tests and procedures which included magnetic resonance imaging which showed communicated bursitis, sars-cov-2 test: negative on 31Dec2020, x-ray n/a on 31Dec2020..Therapeutic measures were taken as a result of this. No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chills, Diarrhoea, Hyperhidrosis, Nausea
Clinical narrative: nasau; diarrhea; Soreness then pain in the left arm; Later during the night, severe chills; Later sweats; This is a spontaneous report from a contactable consumer (patient) reported himself. A 61-year-old male patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot Number: ER8727), via an unknown route of administration in left arm on 23Mar2021 at 16:00 (at the age of 61-years-old) as single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was reported as other. The patient's medical history included allergies, high cholesterol, acid reflux, prostate cancer and COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication was not reported. Yes, other medications in two weeks. Other vaccine same date was none. On 23Mar2021 at 22:00, the patient experienced soreness then pain in the left arm. Later during the night, severe chills and Later sweats. Next day, same thing with nausea and diarrhoea. Event resulted to visit emergency room/department or urgent care. No COVID tested post vaccination. Received fluids, medicine for nausea and pain as treatment and blood work was unknown. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: nasau; diarrhea; Soreness then pain in the left arm; Later during the night, severe chills; Later sweats; This is a spontaneous report from a contactable consumer (patient) reported himself. A 61-year-old male patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot Number: ER8727), via an unknown route of administration in left arm on 23Mar2021 at 16:00 (at the age of 61-years-old) as single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was reported as other. The patient's medical history included allergies, high cholesterol, acid reflux, prostate cancer and COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication was not reported. Yes, other medications in two weeks. Other vaccine same date was none. On 23Mar2021 at 22:00, the patient experienced soreness then pain in the left arm. Later during the night, severe chills and Later sweats. Next day, same thing with nausea and diarrhoea. Event resulted to visit emergency room/department or urgent care. No COVID tested post vaccination. Received fluids, medicine for nausea and pain as treatment and blood work was unknown. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site pruritus
Clinical narrative: Mild itching near the injection sight and all over body.; Mild itching  near the injection sight and all over body.; This is a spontaneous report from a contactable other HCP. This 23-year-old other HCP (Patient) reported for herself that: A 23-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: ER3782), via an unspecified route of administration, administered in Arm Left on 26Mar2021 (at the age of 23-year-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included hypothyroidism from an unknown date and unknown if ongoing. Patient not diagnosed with covid-19 prior to vaccination. The patient's concomitant medications were not reported. Patient was not received any other vaccine four weeks prior vaccination. The patient experienced mild itching near the injection sight and all over body on 26Mar2021. Since vaccination patient not tested for covid-19. The case assessed as non-serious by the reporter. No therapeutic measures were taken as a result of the events. The outcome of the events was reported as unknown.  No follow up attempts are possible. Information related to batch/lot number could not be requested.