chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia, Tremor
Clinical narrative: heavy headache; high fever; shaking; nausea; This is spontaneous report from a contactable consumer (patient) from Regulatory Authority. A female patient of an unspecified age received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 31Mar2021 as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced heavy headache, high fever, shaking, and nausea. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease, Disease recurrence, Dyspnoea, Hot flush, Pharyngeal swelling
Clinical narrative: COPD; Really difficult even for the difficulty breathing that I already have; COPD, difficulty breathing; Throat swelled up; Rash on the arm that got the injection; Hot flushes; This is a spontaneous report from a non-contactable consumer. A 58-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6207 and expiration date was not reported), via an unspecified route of administration on 19Mar2021 (at the age of 58-years-old) at dose 1, single for covid-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD) and difficulty breathing. The patient's concomitant medications were not reported. Patient stated that people who had COPD could not take the shot as it almost put patient in the hospital and it made difficult even for the difficulty breathing that patient already have, throat swelled up, rash on the arm that got the injection, hot flushes, COPD on an unspecified date. Patient told that people who have COPD should not be getting this shot. Patient took breathing medication and breathing machine with the medication as a treatment for the events (COPD, difficulty breathing) at home that actually helped. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: COPD; Really difficult even for the difficulty breathing that I already have; COPD, difficulty breathing; Throat swelled up; Rash on the arm that got the injection; Hot flushes; This is a spontaneous report from a non-contactable consumer. A 58-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6207 and expiration date was not reported), via an unspecified route of administration on 19Mar2021 (at the age of 58-years-old) at dose 1, single for covid-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD) and difficulty breathing. The patient's concomitant medications were not reported. Patient stated that people who had COPD could not take the shot as it almost put patient in the hospital and it made difficult even for the difficulty breathing that patient already have, throat swelled up, rash on the arm that got the injection, hot flushes, COPD on an unspecified date. Patient told that people who have COPD should not be getting this shot. Patient took breathing medication and breathing machine with the medication as a treatment for the events (COPD, difficulty breathing) at home that actually helped. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Skin irritation
Clinical narrative: Since receiving both doses of the shot I have developed a skin irritation under both devices. Red, itchy bumps.; Since receiving both doses of the shot I have developed a skin irritation under both devices. Red, itchy bumps.; Since receiving both doses of the shot I have developed a skin irritation under both devices. Red, itchy bumps.; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date as dose 1, single and dose 2, single for COVID-19 immunization. Medical history included type 1 diabetes using a continuous glucose monitors (CGM) and insulin pump. The patient's concomitant medications were not reported. Prior to vaccination, the patient had zero skin irritation from either device. After vaccination with both the doses, the patient developed a skin irritation under both devices which were red, itchy bumps on an unspecified date. The outcome of the events was unknown at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Feeling abnormal, Headache, Nausea
Clinical narrative: head hurts; fluctuating fever; Nauseous; extremely tired ; Fatigue; her whole body hurt; Feeling bad; Groggy; This is a spontaneous report from a contactable consumer or other non-health care professional (patient) via medical information team. A 23-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number was reported as ER8733; Expiration Date was reported as 31Jul2021) via an unspecified route of administration on 03Apr2021 09:15 (at the age of 23 years old) as dose 1, single for covid-19 immunisation. Medical history included haematoma from Feb2021 to an unknown date she had donated plasma and got a hematoma in her right arm at location where her blood was taken. There were no concomitant medications. The patient had not received any other vaccine within 4 weeks. The reporter reported that, she got her first COVID-19 Vaccine dose on Saturday, 03Apr2021, at 9:15AM. She said she had bad symptoms the day of the COVID-19 Vaccine. She said she was nauseous, felt extremely tired: Fatigue, her whole body hurt, she felt bad, and was really groggy. She said she had a fluctuating fever on Saturday (03Apr2021), and that was to be expected. She said she still had the fever today (06Apr2021) and was unable to break the fever. She clarified she had a fever Saturday night (03Apr2021) that was 102-degrees. She said she did not check her temperature on Sunday (04Apr2021), but on Monday (05Apr2021) she had a 100-degree temperature that increased to 102 degrees. She said today (06Apr2021) she had a 100-degree temperature. She said her symptoms had improved. She said she still felt a bit like she was fatigued, had the fever, and her head hurts. She said her head started to hurt on Sunday morning (04Apr2021) when she woke up. She said she was not sure if her head hurting was caused by the fever, or if she had a headache. The patient reported that, she started taking the Tylenol on Saturday night (03Apr2021) and was taking 2 Tylenol tablets every 6 hours. She said she did not take any Tylenol on Sunday (04Apr2021). She said she took the Tylenol on Monday and was planning to take a dose of Tylenol when she got home today (06Apr2021). The events do not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests and procedures which included body temperature: 102 degrees on 03Apr2021, body temperature: 100 degrees temperature that increased to 102 degrees on 05Apr2021, body temperature: 100 degrees on 06Apr2021. The outcome for the events nauseous, extremely tired; fatigue, her whole body hurt, feeling bad, groggy was recovering and for the events fluctuating fever and head hurts was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Somnolence
Clinical narrative: head hurts; fluctuating fever; Nauseous; extremely tired ; Fatigue; her whole body hurt; Feeling bad; Groggy; This is a spontaneous report from a contactable consumer or other non-health care professional (patient) via medical information team. A 23-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number was reported as ER8733; Expiration Date was reported as 31Jul2021) via an unspecified route of administration on 03Apr2021 09:15 (at the age of 23 years old) as dose 1, single for covid-19 immunisation. Medical history included haematoma from Feb2021 to an unknown date she had donated plasma and got a hematoma in her right arm at location where her blood was taken. There were no concomitant medications. The patient had not received any other vaccine within 4 weeks. The reporter reported that, she got her first COVID-19 Vaccine dose on Saturday, 03Apr2021, at 9:15AM. She said she had bad symptoms the day of the COVID-19 Vaccine. She said she was nauseous, felt extremely tired: Fatigue, her whole body hurt, she felt bad, and was really groggy. She said she had a fluctuating fever on Saturday (03Apr2021), and that was to be expected. She said she still had the fever today (06Apr2021) and was unable to break the fever. She clarified she had a fever Saturday night (03Apr2021) that was 102-degrees. She said she did not check her temperature on Sunday (04Apr2021), but on Monday (05Apr2021) she had a 100-degree temperature that increased to 102 degrees. She said today (06Apr2021) she had a 100-degree temperature. She said her symptoms had improved. She said she still felt a bit like she was fatigued, had the fever, and her head hurts. She said her head started to hurt on Sunday morning (04Apr2021) when she woke up. She said she was not sure if her head hurting was caused by the fever, or if she had a headache. The patient reported that, she started taking the Tylenol on Saturday night (03Apr2021) and was taking 2 Tylenol tablets every 6 hours. She said she did not take any Tylenol on Sunday (04Apr2021). She said she took the Tylenol on Monday and was planning to take a dose of Tylenol when she got home today (06Apr2021). The events do not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests and procedures which included body temperature: 102 degrees on 03Apr2021, body temperature: 100 degrees temperature that increased to 102 degrees on 05Apr2021, body temperature: 100 degrees on 06Apr2021. The outcome for the events nauseous, extremely tired; fatigue, her whole body hurt, feeling bad, groggy was recovering and for the events fluctuating fever and head hurts was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Pruritus, Urticaria
Clinical narrative: I did not eat dinner; woke up with hives; I had itching in my hand/ Itching all over/itching was worsened; This is a spontaneous report from a contactable consumer (Patient).   A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 03Apr2021 between 13:10 to 13:15 (at the age of 33-year-old) as single dose for COVID-19 immunisation. The patient's medical history was reported as none. Family medical history relevant to adverse events was none. There were no concomitant medications. The patient did not receive any products. There was no history of previous immunization with the Pfizer vaccine that was considered as suspect. Additional Vaccines administered on Same Date of the Pfizer Suspect was reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no adverse events following prior vaccinations, The patient reported that she was experiencing a side effect. On 05Apr2021, the patient did not eat dinner and had itching in hand in the night at 20:00, but that was mostly all. The patient got the vaccine Saturday evening (03Apr2021) and got hives 06 Apr2021 morning. On 06 Apr2021, patient woke up in the morning and went into bathroom and looked in the mirror and she had hives all up and down her arms around 9:00am and had itching all over. The patient had hives on her arms, back, thighs, lower stomach, and around her panty line area. Hives was reported as worsened on an unspecified date in 2021 and she can see them on her side now and she did not see them there before. The patient knows that hives are a side effect but she did not think it would be this late. The patient did not know if she needs to go to the doctor for care or if she should take Benadryl or what she should do. The patient wanted to know if this was a side effect from the vaccine and she should get second dose of Pfizer-BioNTech COVID-19 Vaccine or not. The patient did not receive any treatment for the events. Adverse events did not require a visit to emergency Room or physician Office. This report was not related to a study or program. Investigation assessment was not done. The patient did not recover from events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: rash that she had in the upper body/had an upper body rash on her front and back; The rash is itchy; The red color of the rash faded a little bit but it came back and then there are little dots and some of them have become big lumps; This a spontaneous report from a contactable consumer(patient) via medical information team. A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: ER8733, Expiry Date: Unknown) via an unspecified route of administration, administered in left upper arm on 01Apr2021(at the age of 59-year-old) as dose 1, single for COVID-19 immunization. Medical history included Vitamin D low and Immune enhancement therapy (she heard it increases the immune system) both are from an unknown date and unknown if ongoing. Concomitant medications included Colecalciferol (VITAMIN D) 50,000 grams weekly via an unspecified route of administration Indicated for Vitamin D low from an unknown date (Started it several years ago) unknown if ongoing, Ascorbic acid(VITAMIN-C) 500 mg once a day and Tocopherol(VITAMIN E)180 mg once a day both are via an unspecified route of administration from an unknown date (Started taking it at the beginning of the year) indicated for increasing immune system( she heard it increases the immune system) unknown if ongoing. It was reported that on 05Apr2021 about 22:00 or 23:00 patient had an upper body rash on her front and back and she did not know if it was related to the vaccine because it had been a few days. The rash was itchy, but she did not touch it because she did not want to make it worse. The red color of the rash faded a little bit but it came back and then there were little dots and some of them have become big lumps. The reporter also had itching on her upper arms. Reporter queried that was this related to the vaccine, and how long would this last. Reporter stated scheduled to receive the second dose of the Pfizer-BioNTech COVID-19 Vaccine on 22Apr2021. And queried can still take the second dose. Patient stated she was taking COVID vaccine for Prevention of COVID and everyone had a turn, and it was her turn. Reporter seriousness for upper body rash was Unspecified. There was no Investigation Assessment. Outcome of the events was not recovered.  No follow up attempts are possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Discomfort, Dyspnoea, Feeling abnormal, Headache
Clinical narrative: small headache; low-grade fever; increased heart rate; little bit of mental fogginess; shallow, short breaths; my body was in a lot of pain; Pretty bad reaction; the arm the shot was in I almost couldn't move at all entire body couldn't move due to pain/some tenderness at the injection site if he presses on it; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 40-years-old male patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 02Apr2021 (at the age of 40-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history included Covid 19 infection (last year (2020). Concomitant medications were not reported. On an unspecified date of Apr2021, patient experienced arm the shot was in he almost couldn't move at all entire body couldn't move due to pain, some tenderness at the injection site if he presses on it. On 03Apr2021 patient experienced small headache, low-grade fever, increased heart rate, little bit of mental fogginess, shallow, short breaths, his body was in a lot of pain and pretty bad reaction. Patient reported adverse events that started on Saturday (03Apr2021) which include being in a lot of pain throughout his whole body with difficulty moving, but mostly in his arms, especially in the arm where he received the vaccine. He also reported a small headache, a low-grade fever of 99.2 degree F, increased heart rate, and a little bit of mental fogginess. He was most concerned about a change in his breathing which wasn't difficulty breathing but he describes it as shallow, short breaths. He refrained from a lot of activity over the weekend. His symptoms were less noticeable on Sunday, also improved on Monday, and are almost non-existent today beside some tenderness at the injection site if he presses on it. Of note, caller also reports that he had a Covid19 infection last year (2020). Patient would like to know if he should get the second shot, given his experience with the first? He had a side effect after the first dose of the vaccine. Should he get the second dose? The patient underwent lab tests and procedures which included heart rate: increased and pyrexia: 99.2 fahrenheit. The events outcome was reported as unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Pain, Pyrexia, Vaccination site pain
Clinical narrative: small headache; low-grade fever; increased heart rate; little bit of mental fogginess; shallow, short breaths; my body was in a lot of pain; Pretty bad reaction; the arm the shot was in I almost couldn't move at all entire body couldn't move due to pain/some tenderness at the injection site if he presses on it; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 40-years-old male patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 02Apr2021 (at the age of 40-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history included Covid 19 infection (last year (2020). Concomitant medications were not reported. On an unspecified date of Apr2021, patient experienced arm the shot was in he almost couldn't move at all entire body couldn't move due to pain, some tenderness at the injection site if he presses on it. On 03Apr2021 patient experienced small headache, low-grade fever, increased heart rate, little bit of mental fogginess, shallow, short breaths, his body was in a lot of pain and pretty bad reaction. Patient reported adverse events that started on Saturday (03Apr2021) which include being in a lot of pain throughout his whole body with difficulty moving, but mostly in his arms, especially in the arm where he received the vaccine. He also reported a small headache, a low-grade fever of 99.2 degree F, increased heart rate, and a little bit of mental fogginess. He was most concerned about a change in his breathing which wasn't difficulty breathing but he describes it as shallow, short breaths. He refrained from a lot of activity over the weekend. His symptoms were less noticeable on Sunday, also improved on Monday, and are almost non-existent today beside some tenderness at the injection site if he presses on it. Of note, caller also reports that he had a Covid19 infection last year (2020). Patient would like to know if he should get the second shot, given his experience with the first? He had a side effect after the first dose of the vaccine. Should he get the second dose? The patient underwent lab tests and procedures which included heart rate: increased and pyrexia: 99.2 fahrenheit. The events outcome was reported as unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Gout, Pain in extremity
Clinical narrative: Major pain in right big toe joint; Gout; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male 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 02Apr2021 at 11:15 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient's medical history reported as not applicable. The patient had no known allergies to medications, food, or other products. 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 were not reported. 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 11Mar2021 at 10:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. On 03Apr2021 at 01:00, also reported as approximately 12 hours after the second shot, the patient experienced major pain in right big toe joint that was later diagnosed to be gout. The patient had never had gout before that. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of major pain in right big toe joint and gout and included treatment with colchicine (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events major pain in right big toe joint and gout was resolving at the time of report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Feeling hot, Lymphadenopathy, Swelling face
Clinical narrative: my face swelled up; my neck to my chest area then my neck broke out; like a burn; My body has been heating up in the inside; swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 53 (unit not reported) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 19Feb2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. Medical history included latex allergy. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Jan2021 for COVID-19 immunization and experienced soreness. The patient experienced face swelled up, her neck to her chest area then her neck broke out; like a burn, her body has been heating up in the inside, swollen lymph nodes on 22Feb2021. The course of the events was as follows: The 2nd vaccine, 3 days later her face swelled up, her neck to her chest area then her neck broke out; like a burn. The patient been using a steroid cream. Her body had been heating up in the inside (like she had a fever but she does not have a fever) throughout the day (like menopause though she have not had menopause). It calms down and comes up again. This had been going on since the 3rd day of the 2nd dose. She felt it (the injection) move from her arm into her breast area. Her doctor thought it was swollen lymph nodes. Her doctor said they will be watching it. It's a little swollen. She did not feel that anymore. The heating up sensation worried her. The outcome of event swollen lymph nodes was recovered on an unspecified date in 2021; outcome of events her neck to her chest area then her neck broke out; like a burn, her body has been heating up in the inside was not recovered; outcome of event face swelled up was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Herpes zoster, Neuralgia, Rash, Rash erythematous
Clinical narrative: very mild neuralgia around the rash on her temple, sensitivity around her scalp; very mild neuralgia around the rash on her temple, sensitivity around her scalp; Red and itchy rash; red and itchy rash; it could be shingles; bruise that seems to be a rash; Peeling; This is a spontaneous report from a contactable consumer or other non hcp. A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: 6/2015; Expiration Date: Jun2021), dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 11:55 (at the age of 67-years old) as dose 1, single for COVID-19 immunisation. Patient medical history was reported as none. The patient concomitant medications was reported as none. No adverse events prior vaccination. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient was calling about the COVID 19 vaccine she received her dose on 19Mar2021 and about a week later or so she thinks she kind of bumped her head on a low ceiling and then she got this a bump and still has not healed which is kind of odd. Since having the vaccine, caller was wondering if getting a small bruise could develop or cause a reaction to a bruise because it is like a rash and it is peeling and healing up. Caller stated she is concerned about if this is any way a reaction to the vaccination. Patient stated she thinks she bumped her head but she does not keep track of something like that. Then, she gets this rash she clarifies its a rash more so than a bump. Bruise that seems to be a rash is like a normal bump on the head the way it's preceded. Patient stated it started about a week after injection which the vaccine was on 19Mar2021 so around 26Mar2021 or so but she did not pay attention since she thought she bumped her head. Caller stated it is going away and it seems to be healing, but it's not all gone. It seems like it is taking an inordinate amount of time to go away. Also, there is a very mild neuralgia around that spot, like sensitivity. She clarifies it's on her temple, so the sensitivity is around her scalp thinks this started a week ago since she noticed peeling and it is getting better but naturally she looked more closely and felt this kind of sensitivity around that area and still has it, but it is diminishing and improving. Also reported the red and itchy rash. The peeling started about a week ago. There's still a little bit of peeling and thinks it is getting better since it seems to be healing. Patient asked nurse if she should be concerned about a worse reaction when she went for 2nd dose. Nurse said it could be shingles, which patient believed it is (mild case). It travelled (under hair) towards the back of scalp. The adverse event does not resulted in Emergency Room or Physician Office. The outcome of the events contusion and skin exfoliation was recovering and for all other events unknown.  No follow-up attempts are possible. No further information is expected
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Skin exfoliation
Clinical narrative: very mild neuralgia around the rash on her temple, sensitivity around her scalp; very mild neuralgia around the rash on her temple, sensitivity around her scalp; Red and itchy rash; red and itchy rash; it could be shingles; bruise that seems to be a rash; Peeling; This is a spontaneous report from a contactable consumer or other non hcp. A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: 6/2015; Expiration Date: Jun2021), dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 11:55 (at the age of 67-years old) as dose 1, single for COVID-19 immunisation. Patient medical history was reported as none. The patient concomitant medications was reported as none. No adverse events prior vaccination. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient was calling about the COVID 19 vaccine she received her dose on 19Mar2021 and about a week later or so she thinks she kind of bumped her head on a low ceiling and then she got this a bump and still has not healed which is kind of odd. Since having the vaccine, caller was wondering if getting a small bruise could develop or cause a reaction to a bruise because it is like a rash and it is peeling and healing up. Caller stated she is concerned about if this is any way a reaction to the vaccination. Patient stated she thinks she bumped her head but she does not keep track of something like that. Then, she gets this rash she clarifies its a rash more so than a bump. Bruise that seems to be a rash is like a normal bump on the head the way it's preceded. Patient stated it started about a week after injection which the vaccine was on 19Mar2021 so around 26Mar2021 or so but she did not pay attention since she thought she bumped her head. Caller stated it is going away and it seems to be healing, but it's not all gone. It seems like it is taking an inordinate amount of time to go away. Also, there is a very mild neuralgia around that spot, like sensitivity. She clarifies it's on her temple, so the sensitivity is around her scalp thinks this started a week ago since she noticed peeling and it is getting better but naturally she looked more closely and felt this kind of sensitivity around that area and still has it, but it is diminishing and improving. Also reported the red and itchy rash. The peeling started about a week ago. There's still a little bit of peeling and thinks it is getting better since it seems to be healing. Patient asked nurse if she should be concerned about a worse reaction when she went for 2nd dose. Nurse said it could be shingles, which patient believed it is (mild case). It travelled (under hair) towards the back of scalp. The adverse event does not resulted in Emergency Room or Physician Office. The outcome of the events contusion and skin exfoliation was recovering and for all other events unknown.  No follow-up attempts are possible. No further information is expected
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Body temperature, Chills, Fatigue
Clinical narrative: migraine; Severe lower back pain; severe wrist and thumb joint pain; low-grade fever; Chills; body ache; headache; tiredness; This is a spontaneous report from a non-contactable consumer (Patient reported for self). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Lot Number: ER8733), via unspecified route of administration, in left arm on 31Mar2021 at 14:34 as a dose 2, single for COVID-19 immunization. The patient medical history included migraines. The concomitant medication of the patient was not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown), via unspecified route of administration, on an unspecified date as a dose 1 single for COVID-19 immunization. On 01Apr2021 at 05:00 the patient experienced chills, body ache, headache, low grade fever. Patient also experienced tiredness on 01Apr2021. On 03Mar2021 the patient experienced severe lower back pain and severe wrist and thumb joint pain (especially when trying to lift or hold anything). On an unspecified date the patient also experienced migraine. On 03Apr2021 and 04Apr2021 took oral sumatriptan (50 mg) to treat the migraine. On an unspecified date the patient underwent lab tests and procedures which included body temperature 99-98 Fahrenheit normal body temperature. At 8 AM of an unspecified date the temperature was 99-10 Fahrenheit. On 01Apr2021 the patient had multiple body temperature measurements which included 101 at 10 AM, 102 at 12 PM to 2 PM, 100 at 4 PM and 98 at 8 PM all in Fahrenheit. The patient received the query regarding the awareness of the occurrence of the reported events. The patient responded it with on 01Apr2021. Outcome of the reported event was recovered for low grade fever on 01Apr2021 20:00. Outcome was unknown for all other reported events.  Follow-up (08Apr2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the PRD. The response included: awareness date reported by patient.  Follow-up (08Apr2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation below mentioned query. The response included: clinical course details of the patient.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Migraine, Pain, Pyrexia
Clinical narrative: migraine; Severe lower back pain; severe wrist and thumb joint pain; low-grade fever; Chills; body ache; headache; tiredness; This is a spontaneous report from a non-contactable consumer (Patient reported for self). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Lot Number: ER8733), via unspecified route of administration, in left arm on 31Mar2021 at 14:34 as a dose 2, single for COVID-19 immunization. The patient medical history included migraines. The concomitant medication of the patient was not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown), via unspecified route of administration, on an unspecified date as a dose 1 single for COVID-19 immunization. On 01Apr2021 at 05:00 the patient experienced chills, body ache, headache, low grade fever. Patient also experienced tiredness on 01Apr2021. On 03Mar2021 the patient experienced severe lower back pain and severe wrist and thumb joint pain (especially when trying to lift or hold anything). On an unspecified date the patient also experienced migraine. On 03Apr2021 and 04Apr2021 took oral sumatriptan (50 mg) to treat the migraine. On an unspecified date the patient underwent lab tests and procedures which included body temperature 99-98 Fahrenheit normal body temperature. At 8 AM of an unspecified date the temperature was 99-10 Fahrenheit. On 01Apr2021 the patient had multiple body temperature measurements which included 101 at 10 AM, 102 at 12 PM to 2 PM, 100 at 4 PM and 98 at 8 PM all in Fahrenheit. The patient received the query regarding the awareness of the occurrence of the reported events. The patient responded it with on 01Apr2021. Outcome of the reported event was recovered for low grade fever on 01Apr2021 20:00. Outcome was unknown for all other reported events.  Follow-up (08Apr2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the PRD. The response included: awareness date reported by patient.  Follow-up (08Apr2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation below mentioned query. The response included: clinical course details of the patient.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, Suspected COVID-19
Clinical narrative: covid like symptoms/ fever/ chills; unusual smell; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Medical history included COVID-19 in the previous year (2020). The patient's concomitant medications were not reported. On an unspecified date, the patient got the first dose and became pretty sick. She was in bed for a few days - had COVID like symptoms - fever, chills - unusual smell. The patient wanted to know is she has to get the second dose. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: muscle pain; Chills; severe headache; low grade fever; tired; swelling and redness on injection site; swelling and redness on injection site; This is a spontaneous report from a contactable consumer or other non-HCP.  A 61-year-old non pregnant female received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, at on 05Apr2021 at 10:00 (Lot number was Ew0151, age at the time of vaccination was 61-year-old), administered in arm left as single dose for COVID-19 immunization. The patient's relevant medical history included fibromyalgia, migraine, nerve damage, Cipro and quinone allergies from an unspecified date. Past drug included ciprofloxacin (CIPRO) and quinone and had allergies from both on an unspecified date. The patient's concomitant medications included Synthroid (LEVOTHYROXINE SODIUM), Propranolol and Fluticasone taken for an unspecified indication. The patient had no other vaccines within 4 weeks. The patient did not have COVID-19 prior to vaccination and had not been tested for COVID-19 post vaccination. Previously, the patient also received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration administered in arm left on 15Mar2021 at 12:00 (Lot number was EN6208, age at the time of vaccination was 61-year-old), as single dose for COVID-19 immunization. On 05Apr2021 at 19:00, the patient experienced muscle pain, chills, severe headache, low grade fever, tired, swelling and redness on injection site. No treatment was received for the adverse events. The clinical outcome of muscle pain, chills, severe headache, low grade fever and swelling and redness on injection site was recovering, while the clinical outcome of tired was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: muscle pain; Chills; severe headache; low grade fever; tired; swelling and redness on injection site; swelling and redness on injection site; This is a spontaneous report from a contactable consumer or other non-HCP.  A 61-year-old non pregnant female received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, at on 05Apr2021 at 10:00 (Lot number was Ew0151, age at the time of vaccination was 61-year-old), administered in arm left as single dose for COVID-19 immunization. The patient's relevant medical history included fibromyalgia, migraine, nerve damage, Cipro and quinone allergies from an unspecified date. Past drug included ciprofloxacin (CIPRO) and quinone and had allergies from both on an unspecified date. The patient's concomitant medications included Synthroid (LEVOTHYROXINE SODIUM), Propranolol and Fluticasone taken for an unspecified indication. The patient had no other vaccines within 4 weeks. The patient did not have COVID-19 prior to vaccination and had not been tested for COVID-19 post vaccination. Previously, the patient also received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration administered in arm left on 15Mar2021 at 12:00 (Lot number was EN6208, age at the time of vaccination was 61-year-old), as single dose for COVID-19 immunization. On 05Apr2021 at 19:00, the patient experienced muscle pain, chills, severe headache, low grade fever, tired, swelling and redness on injection site. No treatment was received for the adverse events. The clinical outcome of muscle pain, chills, severe headache, low grade fever and swelling and redness on injection site was recovering, while the clinical outcome of tired was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site nodule, Vaccination site swelling, Vaccination site warmth, Weight
Clinical narrative: Ever since I got it (medication), it is red and swollen. It is like hard in that spot and warm; Ever since I got it (medication), it is red and swollen. It is like hard in that spot and warm; Ever since I got it (medication), it is red and swollen. It is like hard in that spot and warm; The site where vaccine is given is hard; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER2613), dose 2 via an unspecified route of administration, administered in Arm Right on 27Mar2021 (at the age of 74-years-old) as dose 2, single for covid-19 immunization. Patient medical history included cancer in right breast (cancer in right breast, this year) from 2021 to an unknown date. Patient also had high blood pressure from an unknown date and unknown if ongoing. Patient took other products as well. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported), dose 1 via an unspecified route of administration on 05Mar2021 as dose 1, single for covid-19 immunization. On 27Mar2021, the patient reported that ever since the (medication), it was red and swollen. it was like hard in that spot and warm, the site where vaccine was given was hard. It was reported that patient was putting ice on it as a treatment but can't sit all day putting ice on it. Patient stated that with the first medication there was no problem at all, this second one was problem. Patient wanted to know what she can do about the swelling, the hardness, the heat and the hard where it was and was asking can she put some ice on it, she did not know what to do. On an unspecified date, the patient underwent lab tests and procedures which included weight as 170. The outcome of all events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: there was red mark at the injection site that was 2 inches by 2 inches and by 2Apr2021 the redness around the injection site was 2 inches by 4 inches/Redness at the injection site; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on 18Mar2021, as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported, by 30Mar2021 there was red mark at the injection site that was 2 inches by 2 inches and by 2Apr2021 the redness around the injection site was 2 inches by 4 inches. Currently its still visible but not as bad as it was. The clinical outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Erythema, Pruritus
Clinical narrative: she had redness across her chest; it was itchy and really red and about an hour later it subsided; It was like a dry skin type itch; This is a spontaneous report from a contactable consumer. This female consumer (Patient) reported for herself that: A 44-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot Number: EW0150) via an unspecified route of administration on 06Apr2021 10:45 (44-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The concomitant medications were reported as none. On 06Apr2021, the patient experienced redness across her chest, it was itchy and red, and it was like a dry skin type itch. The patient stated that she got the first dose of the vaccine yesterday and waited there about 20 minutes. Around 4:00, about 5 hours later, the patient had redness across her chest and it was itchy, but it was not hives and really red and about an hour later it subsided. The patient does not have discomfort in breathing or anything. Around 9:30 last night the patient's arm was itchy, both arms and her chest but there was no rash, so she knew in her little it was symptomatic reactions but she was trying to find out if she would take the second dose, but it wasn't on 'CDC'. It was like a dry skin type itch. The patient took a Benadryl, which helped. The patient asked if this was normal and if it was okay to take the second vaccine after these symptoms. Therapeutic measures were taken because of the events. The outcome of the events were unknown.   No follow up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: mild fever; general tiredness; This is a spontaneous report from a non-contactable consumer (reported for himself).   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: Unknown), via unspecified route of administration, on 01Apr2021 as a dose 2, single for COVID-19 immunization. The patient medical history and concomitant medication were not reported. The patient previously received first dose of BNT162B2 (solution for injection, Lot number: Unknown) via unspecified route of administration, on an unspecified date as a dose 1, single for COVID-19 immunization. On 02Apr2021 the patient experienced mild fever and tiredness. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.