chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chest discomfort, Chills, Cough, Headache
Clinical narrative: contracted the Covid 19 virus; body aches; chills; sinus pressure; headaches; cough; chest congestion and tightness; chest congestion and tightness; This is a spontaneous report from a contactable consumer (patient) through a Pfizer-sponsored program. This 46-year-old male patient, weight: 90.72 kg & height: 180 cm, received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733), via an unspecified route of administration in the left arm on 02Apr2021 11:30 (at the age of 46-year-old) as single dose for COVID-19 immunization. Medical history included sinus infection with his seasonal allergies. Concomitant medications included cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC-D) taken to manage his sinus flare ups and drainage during the allergy season. The patient did not receive any other vaccines within four weeks prior to the vaccination. There were no predisposing factors. The patient was not enrolled in the clinical trial. The patient received his first COVID 19 vaccine on 02Apr2021 and subsequently contracted the COVID 19 virus and tested positive for the COVID 19 virus on 12Apr2021 with a rapid test at a physician's office. During the first full week of Apr2021, he started having symptoms: body aches, chills, sinus pressure, headaches, cough, chest congestion and tightness but he did not have a fever. It went on for about 2 weeks, with some varying between his symptoms during that time. He reported that he normally has seasonal allergies and all of his symptoms were coinciding with his typical allergy symptoms. The chills dissipated during the first 3 days following the COVID 19 vaccine and the chills subsided. Then the sinus drainage and all the other symptoms kicked in. He thought maybe his symptoms were from the COVID 19 vaccine but he also thought it could be the sinus symptoms he has in the spring time. Obviously, his symptoms continued, and he knew it was not related to his seasonal allergies. He usually would get a sinus infection with his seasonal allergies, bacteria would jump in his sinus issues, and he didn't have that. His sinus infections can be. That's when he knew what he had was not related to his seasonal allergies. The patient stated that he is due to receive his second COVID 19 Vaccine on 23Apr2021 or if he needs to reschedule the vaccine considering his second vaccine is such close proximity to his COVID 19 diagnosis. The event, chills, was resolved in Apr2021 while the clinical outcome of the events, contracted the COVID 19 virus, body aches, sinus pressure, headaches, cough, chest congestion and tightness were unknown.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Lower respiratory tract congestion, Pain, Paranasal sinus discomfort, SARS-CoV-2 test
Clinical narrative: contracted the Covid 19 virus; body aches; chills; sinus pressure; headaches; cough; chest congestion and tightness; chest congestion and tightness; This is a spontaneous report from a contactable consumer (patient) through a Pfizer-sponsored program. This 46-year-old male patient, weight: 90.72 kg & height: 180 cm, received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733), via an unspecified route of administration in the left arm on 02Apr2021 11:30 (at the age of 46-year-old) as single dose for COVID-19 immunization. Medical history included sinus infection with his seasonal allergies. Concomitant medications included cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC-D) taken to manage his sinus flare ups and drainage during the allergy season. The patient did not receive any other vaccines within four weeks prior to the vaccination. There were no predisposing factors. The patient was not enrolled in the clinical trial. The patient received his first COVID 19 vaccine on 02Apr2021 and subsequently contracted the COVID 19 virus and tested positive for the COVID 19 virus on 12Apr2021 with a rapid test at a physician's office. During the first full week of Apr2021, he started having symptoms: body aches, chills, sinus pressure, headaches, cough, chest congestion and tightness but he did not have a fever. It went on for about 2 weeks, with some varying between his symptoms during that time. He reported that he normally has seasonal allergies and all of his symptoms were coinciding with his typical allergy symptoms. The chills dissipated during the first 3 days following the COVID 19 vaccine and the chills subsided. Then the sinus drainage and all the other symptoms kicked in. He thought maybe his symptoms were from the COVID 19 vaccine but he also thought it could be the sinus symptoms he has in the spring time. Obviously, his symptoms continued, and he knew it was not related to his seasonal allergies. He usually would get a sinus infection with his seasonal allergies, bacteria would jump in his sinus issues, and he didn't have that. His sinus infections can be. That's when he knew what he had was not related to his seasonal allergies. The patient stated that he is due to receive his second COVID 19 Vaccine on 23Apr2021 or if he needs to reschedule the vaccine considering his second vaccine is such close proximity to his COVID 19 diagnosis. The event, chills, was resolved in Apr2021 while the clinical outcome of the events, contracted the COVID 19 virus, body aches, sinus pressure, headaches, cough, chest congestion and tightness were unknown.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rash, Urticaria
Clinical narrative: pain; hives are everywhere, from her shoulders to her feet, from the size of a dime to the size of an egg, belly, back, breasts, bottom, legs; face rash, like rosacea; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8734) via an unspecified route of administration at left arm on 03Apr2021 (44-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included ongoing Hashimoto's disease (diagnosed at least 5 years ago); chronic idiopathic urticaria (history of hives, she has not had them in about 5 years). Concomitant medications included ongoing levothyroxine sodium (SYNTHROID) for Hashimoto's disease (been taking for at least 3 years). Patient state she has had her first dose of Pfizer COVID vaccine, states her next dose is scheduled on Saturday 24Apr 2021. Patient states about 2 weeks after the first dose, on 12 Apr2021, she started getting face rash, like rosacea, states that went away about 2 days later. States on 16Apr2021 she started getting hives. Patient states she does have a history of hives, clarifies she has chronic idiopathic urticaria, however, she states she has not had them in about 5 years. Patient is concerned these may be related to the first dose of the COVID vaccine, states she is trying to see if she should go for second dose or not, states she is not swelling or having trouble breathing, just trying to hear from someone that it is okay to get the second dose. Patient states the hives are everywhere, from her shoulders to her feet, from the size of a dime to the size of an egg, belly, back, breasts, bottom, legs. Patient states she is treating the hives with antihistamines, states they do not go completely away but the pain goes away. Taking Allegra, Zyrtec, and Benadryl/ all daily. The outcome of the event face rash was recovered on 15Apr2021; outcome of pain was recovered; outcome of hives was not recovered (worsened).  No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Tired; Soreness of the arm; This is a spontaneous report received from a contactable consumer reporting on husband. A 66-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Apr2021 at single dose for COVID-19 immunization. Medical history included severe allergies. concomitant medications were not reported. Caller's husband received his first dose of Pfizer Covid Vaccine on 15Apr2021. He is scheduled for second dose of Pfizer Covid Vaccine on 06May2021. Caller asked, they are scheduled for the 6th and are leaving on the 7th back on the 11th. Asked if there was anyway to get the second dose that week of the 13th when they return home. Her husband has severe allergies and has an Epi pen and god forbid problem should occur, he would have an anaphylactic reaction. After he received his first dose of Pfizer Covid Vaccine, they kept him after longer to monitor him. The only side effect her husband experienced was that he was tired and had soreness of the arm. Caller clarified she did not call to report about her husband, she called to ask the question about the second dose, with them traveling and it being Mother's Day. Caller mentioned that everyone she has spoken to that has had the Pfizer vaccine or Moderna has had problems with the second dose, not the first. Caller and Spouse received the 1st vaccine on 15Apr2021 and are scheduled to receive the 2nd dose on 05May2021, stated that they will be out of town and would the 2nd dose be able to be given on another day after they return. Outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasal congestion, Nasopharyngitis, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID; congestion and a cold; congestion and a cold; Cough; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 15Apr2021 around 15:50 (at age of 41 years old, Lot Number: EW0158; Expiration Date: Jul2021) as single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient stated she was calling about the Pfizer COVID 19 vaccine that she received on Thursday (15Apr2021), on Thursday and Friday she was fine and then Saturday (17Apr2021) she started experiencing congestion and a cold, cough. The treatment received included Tylenol. Patient stated her kids also got sick and on 19Apr2021 she was tested for COVID and result was positive for COVID. The outcome of event "Congestion nasal" was recovering. The outcome of event "Cough" was not recovered. The outcome of other events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Flushing, Heart rate, Heart rate increased, Hypersensitivity
Clinical narrative: severe allergic reactions; Skin is starting to blister, like a poison ivy breakout, where the rash is located.; Elevated heart beat, feels flushed; Elevated heart beat, feels flushed; Itching; Broke out in a rash; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration in left arm on 20Apr2021 10:00 (Lot Number: EW0171) as single dose for covid-19 immunisation. Medical history included ongoing diabetic reported as 10 years ago. No other products. No investigation assessment. No prior vaccinations within 4 weeks. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. On 20Apr2021 after 10 am, patient experienced broke out in a rash, it improved when he took his medication, that he was given in the hospital, but then the rash came back as the medications wears off. About a half hour after the vaccine on 20Apr2021 10:30, patient had itching, when he took the medicine it helped the itching, but as the medicine wears off, the itching came back, with a vengeance. He went to the emergency room, yesterday for treatment. He was released and made contact with his family physician. He was taking Famotidine 20 mg by mouth once a day, and Benadryl every 25 mg, 2 pills, by mouth every 4 hours. He had some relief with these medications, but then started to feel the events as he got closer to taking his next dose. An hour or so after the initial shot on 20Apr2021 11:00 and then at the hospital, patient had elevated heartbeat, felt flushed. He seemed ok, but he wasn't sure, what his heart rate was, as he felt flushed once in a while. This morning on 21Apr2021, skin was starting to blister, like a poison ivy breakout, where the rash was located, it was about the same as when he took the medicine it helped, but as the medicine wears off, it came back. He had severe allergic reactions. Events required a visit to emergency room and physician office. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: severe allergic reactions; Skin is starting to blister, like a poison ivy breakout, where the rash is located.; Elevated heart beat, feels flushed; Elevated heart beat, feels flushed; Itching; Broke out in a rash; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration in left arm on 20Apr2021 10:00 (Lot Number: EW0171) as single dose for covid-19 immunisation. Medical history included ongoing diabetic reported as 10 years ago. No other products. No investigation assessment. No prior vaccinations within 4 weeks. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. On 20Apr2021 after 10 am, patient experienced broke out in a rash, it improved when he took his medication, that he was given in the hospital, but then the rash came back as the medications wears off. About a half hour after the vaccine on 20Apr2021 10:30, patient had itching, when he took the medicine it helped the itching, but as the medicine wears off, the itching came back, with a vengeance. He went to the emergency room, yesterday for treatment. He was released and made contact with his family physician. He was taking Famotidine 20 mg by mouth once a day, and Benadryl every 25 mg, 2 pills, by mouth every 4 hours. He had some relief with these medications, but then started to feel the events as he got closer to taking his next dose. An hour or so after the initial shot on 20Apr2021 11:00 and then at the hospital, patient had elevated heartbeat, felt flushed. He seemed ok, but he wasn't sure, what his heart rate was, as he felt flushed once in a while. This morning on 21Apr2021, skin was starting to blister, like a poison ivy breakout, where the rash was located, it was about the same as when he took the medicine it helped, but as the medicine wears off, it came back. He had severe allergic reactions. Events required a visit to emergency room and physician office. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Cough, Influenza, Pain, Pyrexia
Clinical narrative: achy/breathe in I felt a sharp pain under my breast; fever real achy; bad flu like coughing; coughing; weak; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history included covid-19 from Jun2020 (for about 6 days last June). The patient's concomitant medications were not reported. it is unusual that still have anti bodies from last June but its almost May now. Patient had covid for about 6 days last June. Ever since then have been donating plasma every 6 weeks. I have been giving whole blood and plasma. Doctor told the patient could help sick people. The PA told that the patient would have natural anti bodies and the anti bodies from the inject fever real achy. When the patient would breathe in patient felt a sharp pain under breast. It was a bad flu like coughing. Patient was very weak for about 6 days just felt like laying there. haven't been sick since Then. Patient have been getting tested regularly for anti bodies in blood and it has been about a year. Patient want to know if patient should wait to take the vaccine because still have those anti bodies, do pfizer want to run test on my blood? Events outcome was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test
Clinical narrative: achy/breathe in I felt a sharp pain under my breast; fever real achy; bad flu like coughing; coughing; weak; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history included covid-19 from Jun2020 (for about 6 days last June). The patient's concomitant medications were not reported. it is unusual that still have anti bodies from last June but its almost May now. Patient had covid for about 6 days last June. Ever since then have been donating plasma every 6 weeks. I have been giving whole blood and plasma. Doctor told the patient could help sick people. The PA told that the patient would have natural anti bodies and the anti bodies from the inject fever real achy. When the patient would breathe in patient felt a sharp pain under breast. It was a bad flu like coughing. Patient was very weak for about 6 days just felt like laying there. haven't been sick since Then. Patient have been getting tested regularly for anti bodies in blood and it has been about a year. Patient want to know if patient should wait to take the vaccine because still have those anti bodies, do pfizer want to run test on my blood? Events outcome was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine, Rash, Rash erythematous, Rash pruritic
Clinical narrative: I started getting like a rash on my body like on my chest and stomach; it's not painful and it's just itchy, small, red like bumps; I started getting like a rash on my body like on my chest and stomach; it's not painful and it's just itchy, small, red like bumps; i started getting like a rash on my body like on my chest and stomach; it's not painful and it's just itchy, small, red like bumps; it looks like my body is a little bit allergic to the vaccine; This is a spontaneous report from a contactable consumer (patient). A patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Lot Number: ER8729) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 20Mar2021 (Lot Number: EP6955) as SINGLE DOSE for covid-19 immunization and experienced "after the first vaccine it was a little bit around my neck/I started getting like a rash on my body". It was reported "i started getting like a rash on my body like on my chest and stomach; it's not painful and it's just itchy, small, red like bumps. after the first vaccine, It was a little bit around my neck; after I took the vaccine its spread to my chest and my stomach" on an unspecified date. Consumer stated, "I am just calling cause, my mom suggested that I call because after I received the vaccine I started getting like a rash on my body like on my chest and stomach, it's not painful and it's just itchy, small, red like bumps that I don't normally have look I don't normally have allergies so after shot I wasn't changed and my life nothing has changed except the fact that I have actually get the vaccine about 8 days ago the second dose 8 days ago, I have been taking Benadryl and it's been getting little better but my mon wanted me to call because in case I have to go get a booster shot because it looks like my body is a little bit allergic to the vaccine." The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Headache; Nausea; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: unknown), via an unspecified route of administration in left arm on 18Mar2021 16:00 (at 39-year-old) at single dose for COVID-19 immunisation. Patient's medical history was reported as none. Family medical history was none. Concomitant medications included other products from an unspecified date (reported as 2 years ago) and ongoing. No additional vaccines administered on same date of the BNT162B2. No prior vaccinations within 4 weeks. On 19Mar2021, the patient experienced headache at 6:30 am, nausea in the afternoon. No investigation assessment. Therapeutic measures were taken as a result of the event headache, included paracetamol (TYLENOL), with good effect. The outcome of event nausea was recovered on 20Mar2021, event headache was recovered on 21Mar2021.  No follow-up attempts are possible, information about batch/lot number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: after the first vaccine it was a little bit around my neck/I started getting like a rash on my body; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 20Mar2021 (Lot Number: EP6955) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient stated, "Just wondering after the first vaccine it was a little bit rash around my neck/I started getting like a rash on my body and after I took the second vaccine, its spread to my chest and my stomach." The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: felt discomfort in the arm, a little sore; felt discomfort in the arm, a little sore; This is a spontaneous report received from a contactable consumer (patient). A 75-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0150), via an unspecified route of administration at Left Arm on 30Mar2021 (at age of 75 years old) as single dose for COVID-19 immunization. The patient medical history included: Cholesterol abnormal, Blood pressure abnormal. Concomitant medication(s) included atorvastatin for Cholesterol; lisinopril for Blood pressure. Caller clarifies he received the first dose of the vaccine on 30Mar2021 between 1415PM and 1430PM in the left arm. The first shot patient felt discomfort in the arm, a little sore, but it went away. No Emergency Room visit, no Physician Office visit. The outcome of the events was recovered in 2021.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Headache, Hypoaesthesia, Investigation, Myositis
Clinical narrative: numbness on left side described as stroke like symptoms/ ruled out for a stroke; paresthesia; Chest discomfort; could be inflammation of her muscles; Headache, after the second vaccine; Nausea; This is a spontaneous report from a contactable consumer (patient).  A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in arm left on 15Apr2021 16:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and investigation assessment was reported as none. Concomitant medications included ongoing products for birth control from 2 years ago. No prior vaccinations within 4 weeks. No patient medical history and family medical history relevant to events. No relevant tests. No additional vaccines administered on same date of the Pfizer suspect. The patient previously received first dose of BNT162B2 in left arm on 18Ma2021 16:00 and experienced headache and nausea. The patient experienced headache on 16Apr2021 6:30 am and nausea on 16Apr2021 in the afternoon. She had to go to the emergency room yesterday. Patient had numbness on left side described as stroke like symptoms and paresthesia on 20Apr2021 9:30 am, went to the urgent care first, and they wanted her to go to the emergency room. She was ruled out for a stroke, after they did some testing. They could not diagnose her, so they referred her to a neurologist. She has heard the name Bell's Palsy, when she was on the internet. On 20Apr2021 9:30 am she also felt chest discomfort when she went to the emergency room and in the morning today, but they thought it could be inflammation of her muscles. They gave her methyl prednisone and she still had chest discomfort, but it was not as bad. She was noting improvement. She was released from the emergency room. Events numbness and chest discomfort required a visit to emergency room. Outcome of the events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Paraesthesia
Clinical narrative: numbness on left side described as stroke like symptoms/ ruled out for a stroke; paresthesia; Chest discomfort; could be inflammation of her muscles; Headache, after the second vaccine; Nausea; This is a spontaneous report from a contactable consumer (patient).  A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in arm left on 15Apr2021 16:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and investigation assessment was reported as none. Concomitant medications included ongoing products for birth control from 2 years ago. No prior vaccinations within 4 weeks. No patient medical history and family medical history relevant to events. No relevant tests. No additional vaccines administered on same date of the Pfizer suspect. The patient previously received first dose of BNT162B2 in left arm on 18Ma2021 16:00 and experienced headache and nausea. The patient experienced headache on 16Apr2021 6:30 am and nausea on 16Apr2021 in the afternoon. She had to go to the emergency room yesterday. Patient had numbness on left side described as stroke like symptoms and paresthesia on 20Apr2021 9:30 am, went to the urgent care first, and they wanted her to go to the emergency room. She was ruled out for a stroke, after they did some testing. They could not diagnose her, so they referred her to a neurologist. She has heard the name Bell's Palsy, when she was on the internet. On 20Apr2021 9:30 am she also felt chest discomfort when she went to the emergency room and in the morning today, but they thought it could be inflammation of her muscles. They gave her methyl prednisone and she still had chest discomfort, but it was not as bad. She was noting improvement. She was released from the emergency room. Events numbness and chest discomfort required a visit to emergency room. Outcome of the events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Headache
Clinical narrative: Headache; Eyes hurting; This is a spontaneous report from a contactable consumer (patient's friend). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 07Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache and eyes hurting in Apr2021. The patient still has a headache on the third day of this and her eyes are still hurting. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Headache; tired; arm was sore; This is a spontaneous report from a contactable consumer (patient) reporting for different event under the same suspect product for herself. This is one of two reports.  A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 04Mar2021 at 09:05 (at age of 67 years old, Lot Number: EN6206) as single dose for covid-19 immunization. Medical history included ongoing allergy and hypothyroid; Inflammatory arthritis, diagnosed at least 5 years before; stated that was when they really found out she had the spondylosis and she got the CRPS, Complex regional pain syndrome, with nerve damage in her right foot from surgery. Adds she doesn't take anything for it. Concomitant medications included fexofenadine hydrochloride (ALLEGRA) taken for allergy from an unspecified start date and ongoing; levothyroxine sodium (LEVOTHYROXINE) taken for hypothyroid from an unspecified start date and ongoing. The patient experienced headache, tired and arm was sore on 04Mar2021. she had the first dose of Pfizer on 4Mar2021 and initially she had a headache within about 15 minutes; she felt tired and her arm was sore. The outcome of the event headache was recovered on 25Mar2021, event tiredness was recovered on 31Mar2021 and outcome for event pain in arm was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Colitis, Investigation, Malaise
Clinical narrative: She is too sick; she has symptoms of her colitis reappearing; This is a spontaneous report from a non-contactable consumer (patient) from a Pfizer sponsored program. A female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced she is too sick, she has symptoms of her colitis reappearing on an unspecified date. Reported as: Caller wanted to know how to make a new appointment as she indicated that she is in the middle of a medical problem and has to have some tests done. She is too sick, but doesn't think it is related to the vaccine as it happened like 5 days after the vaccine and she has symptoms of her colitis reappearing. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: The reported event of feeling sick is likely related to the patient's intercurrent condition and is not related with BNT162B2 use.
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer, Body temperature, Pain of skin, Pyrexia, Vaccination site pain
Clinical narrative: fever; Skin hurt; injection site burned; 5 canker sores in her mouth; This is a spontaneous report received from a contactable consumer (Patient). This 43-year-old female consumer(patient) reported for herself that she received bnt162b2 (bnt162b2,  solution for injection, Lot number: unknown) dose 2, via an unspecified route as a single dose on an unspecified date for covid-19 immunization. The patient's medical and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (bnt162b2, solution for injection, Lot number: unknown) through an unspecified route as a single dose on unspecified date for covid-19 immunization. On an unspecified date, approximately 24hrs after the vaccine she developed a fever of 102 and reported her skin hurt. She also noted that the injection site burned on an unspecified date. The fever lasted approximately 24 hours and 36 hours after the vaccine she noted around 5 canker sores in her mouth on an unspecified date. Not aware of other underlying conditions. Event took place after use of product. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Sex: U
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: has experienced hypertension; This is a spontaneous report from a contactable pharmacist via medical information team. An elderly patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Since receiving the Pfizer COVID vaccine on an unspecified date, the patient experienced hypertension. The cardiologist ruled out other possible causes and wanted to know if the vaccine was the cause. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: brought about a terrible case shingles for me; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported as taking our 2 vaccine shots has brought about a terrible case shingles for the patient. Not enough testing and warnings.Outcome of the event was unknown.   No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Eye swelling
Clinical narrative: eyes are swollen and itching; eyes are swollen and itching; This is a spontaneous report received from a contactable consumer(patient) via medical information team. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was unknown), via an unspecified route of administration on 21Apr2021 as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was unknown) via an unspecified route of administration, on an unknown date in 2021, at single dose for COVID-19 immunization. Patient stated that upon awaking this morning her eyes are swollen and itching. Patient asked that if symptom has been reported. The treatment was not received for the events. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fungal infection
Clinical narrative: Severe yeast infection; This is a spontaneous report received from a contactable consumer (mother of the patient).  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received COVID-19 vaccine on 17Feb2021 and shortly after was diagnosed with a severe yeast infection and received treatment for this (unspecified). Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain
Clinical narrative: Abdominal pain; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of an unspecified age received first and second doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified routes of administration on unspecified dates at single doses for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had abdominal pains after the first dose and had bad abdominal pain again after getting the second shot, on unspecified dates. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper
Clinical narrative: Abdominal pain; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of an unspecified age received first and second doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified routes of administration on unspecified dates at single doses for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had abdominal pains after the first dose and had bad abdominal pain again after getting the second shot, on unspecified dates. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous, Swelling, Urticaria
Clinical narrative: high swelling in her entire body; whole body has swells, like hives on it; really itchy; My whole body is covered in rash, like red; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in left arm on 16Apr2021 (Batch/Lot Number: ER8737) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medication were not reported. Caller reported that she took the first dose of Pfizer COVID shot on last Friday, 16Apr2021. Caller stated that on Monday, 19Apr2021. she started getting really itchy and then all day Tuesday, 20Apr2021 through today, she experiencing high swelling in her entire body, her whole body has swells, like hives on it. In Apr2021, her whole body is covered in rash, like red was reported as worsened. Consumer stated right now she was taking Benadryl. Because it was an allergy medicine and her body covered in rash. It was a tablet she took last night from Walgreens, taking it for the rash. She just took it last night, orally. Caller would like to know are these side effects from the Pfizer COVID shot or should she go to the doctor. Patient was scheduled the second dose on Friday 07May2021. The outcome of whole body is covered in rash, like red was not recovered, of other events was unknown.   No follow up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rash, Rash pruritic
Clinical narrative: had a rash and it hurts when she touches it and it also itches; had a rash and it hurts when she touches it and it also itches; maybe it is shingles; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program . A female patient of an unspecified age received the first dose bnt162b2, via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included ongoing Advanced Lung Cancer. The patient's concomitant medications were not reported. For the past week (Apr2021), she had a rash and it hurts when she touches it and it also itches. She talked to her physician and said that maybe it is shingles. Asked if she can go ahead and take the second shot if she has shingles. The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: Bruise; This is a spontaneous report received from a Pfizer sponsored program. This consumer reported for her husband (patient) that a male patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on unknown date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter (patient's wife) stated that, after my husband had his 1st vaccine he started to bruise (Contusion) it finally got better. 2 weeks ago, it began to bruise again for no reason. He had been to 2 different doctors. She thought if anyone else has had this issue. The outcome of the event bruise was not recovered.  No follow-up attempts are needed. No further information was expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: he started having pain in his right arm, from elbow to shoulder. He still has it on and off; This is a spontaneous report from a contactable consumer reporting for himself. A 77-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration, administered in left arm on 15Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 16Apr2021, he started having pain in his arm, from elbow to shoulder. He still has it on and off. When it goes away it's only for a little bit. He received the shot in his left arm and the pain is in his right arm. The event had not resolved yet at the time of the report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Throwing up every 10-15 minutes; This is a spontaneous report received from a contactable consumer (patients mother). An 18-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Caller reported that a couple of days ago both she and her daughter received the first covid vaccine dose. She reported that as of last night all through the night her daughter has been constantly throwing up every 10-15 minutes. Outcome of event was unknown.  No follow-up attempts are possible; Information related to batch/Lot number could not be requested.
Sex: F
Vaccine: COVID19
Symptoms: Ecchymosis
Clinical narrative: she developed 2 black and blue marks on her hands and one on her forehead; This is a spontaneous report from a contactable pharmacist via Medical information team. A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on 01Apr2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After the first dose, the patient developed two black and blue marks on her hands and one on her forehead on an unspecified date. The side effect went away after a day. The pharmacist wants to know if the patient will be able to receive the second dose of the vaccine safely.The outcome of the event was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash
Clinical narrative: he had a poison ivy rash/Arm rash; Swollen arm; This is a spontaneous report received from a contactable consumer (reporting on himself). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Formulation: Solution for injection, lot number and Expiry date was not reported), via an unspecified route of administration on 30Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient, called to say that tomorrow on 21APR2021, his 2nd dose schedule together with his wife. wanted to know if he can get his 2nd dose tomorrow, he has a poison ivy rash because he gardened last week or if they need to reschedule their 2nd dose. Patient experienced swollen arm and arm rashes and he's taking Prednisone 6 days medication for his rashes on his skin. Caller mentioned that his rash was not mild, it's severe. And His wife received their 1st dose on 30MAR2021. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Tinnitus
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration in right arm on 21Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 22Apr2021, the patient was woken up by a buzzing on her right ear. The patient described it as a not too high buzz that appears every two minutes. The patient stated that she did not present tinnitus before having the vaccine and that it impacts her sleeping, she thought that her ear drum was pressed by something and that she read online that other people have also presented tinnitus. The patient would like to know if there was any correlation with vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Pain
Clinical narrative: lot of pain; feel so woozy; This is a spontaneous report from Pfizer sponsored program, received  from a contactable consumer (patient). An 83-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration second dose on 14Apr2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient historical vaccine includesnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on an unspecified date for covid-19 immunisation and experienced Adverse event.  It was reported that patient got the second dose on 14Apr2021. The patient mentioned that he got sick very bad that leads him to a hospital, he mentioned that no one came to assist him even the doctors and right now he wants to know if we can help him to file a complaint, he stated that he experienced a lot of pain and feel so woozy. The outcome of the events was unknown.  Information about lot/batch number has been requested.