chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: possibly experienced was a severe allergic reaction; This is a spontaneous report from a contactable consumer. The consumer (patient's mother) reported for patient (reporter's daughter). A 55-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection: Lot number: unknown), via an unspecified route of administration on 03Jun2021 as a single dose for COVID-19 immunization. The patient also given Benadryl and other premeds (other premeds not specified), 2 hours before taking the 2nd dose. The patient's medical history was not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection: Lot number: unknown), on 02Apr2021 for COVID-19 immunization. The caller stated that, 5 hours after the first dose, her daughter's throat started to close. The caller Immediately called 911 and 911 mentioned that the patient did not require an EpiPen and was not advised to go to the ER. Immediately after receiving the 2nd dose on 03Jun2021, the patient had the same reaction (throat started to close) and her heart seemed to be beating out of her body. The caller stated that her daughter went to urgent care and was currently on oxygen. The caller stated that her daughter has been in the urgent care unit for over 1 hour and 1/2 now. The caller stated that, prior to receiving the second dose, her daughter consulted an allergist, but her allergist urged her to get the 2nd dose. The patient was even prescribed Benadryl and other premeds (other premeds not specified), 2 hours before taking the 2nd dose. The patient also did called CDC to report this event, but CDC did not advise them otherwise. Caller was complaining why should her daughter's doctors (an allergist and immunologist) advised her to get the second dose given the reaction her daughter experienced. The caller was informed as per general pharmacy/medical knowledge, what her daughter could have possibly experienced was a severe allergic reaction post vaccination. The caller enquired about what are the risks of the vaccine and it was reported that, there was a remote chance that the Pfizer-BioNTech COVID-19 Vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the Pfizer-BioNTech COVID-19 Vaccine. Signs of a severe allergic reaction can include: Difficulty breathing and A fast heartbeat (similar to what her daughter could possibly experience). The caller was also asking if the vaccinators on the site were employed by Pfizer and why do they not have this information and advised her daughter not to take the 2nd dose given the above-mentioned reactions post vaccination of 1st dose. Caller wanted to know whether her daughter was going to be okay, and she can give her an assurance that this was not going happen when her daughter comes back to home because her daughter was living alone in her apartment. The outcome of the event was unknown.  Follow up attempts are needed, information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product use issue, Urticaria
Clinical narrative: Hives all over his body; Her son who is 13 years old received his first dose of the COVID-19 vaccine on Sunday; Her son who is 13 years old received his first dose of the COVID-19 vaccine on Sunday; This is a spontaneous report from a contactable consumer (patient mother) via medical information team. A 13-years-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EU0185), via intramuscular route, administered in Arm Left on 16May2021 15:00 as a SINGLE DOSE for COVID-19 immunisation. Medical history included food allergy, allergy to tree nuts, allergy to sesame seeds and egg allergy (onset date: at 18months of age). The patient's concomitant medications were not reported. Patient had not received any other vaccines within 4 weeks prior to the first administration date of the suspect vaccine. The patient experienced hives all over his body on 19May2021 22:00 (3 days after vaccination), her son who is 13 years old received his first dose of the COVID-19 vaccine on Sunday on 16May2021. Patient mother called to inquire about side effects for children ages 12-18 (or whatever the ages are that was just released). She had called specifically in regards to children who have food allergies and wanted to know have any side effects been reported. Reporter stated that her son who was 13 years old received his first dose of the COVID-19 vaccine on Sunday, 16May2021. On Wednesday (19May2021) 22:00, after receiving the vaccine he developed hives all over his body including his chest, back, torso, thighs, neck and had been in contact with her son's allergist and pediatrician inquiring about getting his second dose, but the caller wanted to know what has been reported. She tried to determine the safety of her son which continued with his second vaccination dose and gather much information as she could. She confirmed within 24-48 hours, he recovered completely from the hives. No vaccine administered at military facility. The outcome of hives all over his body was recovered on an unknown date in May2021 and for other events was unknown.  Information about lot/batch number is available. Follow-up attempts are needed.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lethargy, Paraesthesia, Vaccination site mass, Vaccination site pain
Clinical narrative: the tingling that she is feeling to her side of the face; lethargy; chills; pain to injection site; and a lump under injection armpit; This is a spontaneous report from a contactable consumer (Patient). A 36-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: not provided), via an unspecified route of administration on 02Jun2021 as a single dose for Covid-19 immunisation. Patient had previously received first dose of BNT162B2 for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient experienced side effects which included lethargy, chills, pain to injection site, a lump under injection armpit. Patient stated her concern is the tingling that she is feeling to her side of the face. Is this something that I need to worry about? It was reported that a review of the Prescribing Information for Pfizer-Biontech Vaccine did not find information regarding tingling to the side of your face. As the Prescribing Information does not include all adverse reactions that have been reported or that may occur, please consult with your doctor/healthcare provider about what you have experienced/are experiencing. Because your doctor/healthcare provider is most familiar with your medical condition, clinical history, how your treatment has been conducted and any relevant information to your specific case, your doctor/healthcare provider is in the best position to advise you about the appropriate action to take. The outcome events was reported as unknown.  Information about lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Musculoskeletal pain, Pain in extremity, Pyrexia
Clinical narrative: it was a pain in the butt; fever; arm just hurts.; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 42-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection Lot number: EW0170) via an unspecified route of administration on an unspecified date as 2nd dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient asked how long my fever was going to last and I got the shot yesterday. It was only 99.5 and took Tylenol, she felt ok, except her arm just hurts and it was a pain in the butt. the patient wanted to know how long a fever last after your second shot. The patient underwent lab tests which included body temperature resulted as 99.5 Fahrenheit on an unspecified date. The clinical outcome of the events was unknown.  Information about batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Chills, Cough, Dyspnoea, Nasal congestion
Clinical narrative: chills; cough; shortness of breath; body aching; loss of taste; lots of nasal congestion and mucus; lots of nasal congestion and mucus; This is a spontaneous report from a contactable consumer or other non hcp (parent). A 16-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 14May2021 as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 15May2021, one of her children experienced chills, cough, shortness of breath, body aching, loss of taste, lots of nasal congestion and mucus, did not have a fever, then she presented the symptoms 4 days after receiving the vaccine and her other son presented it a week later. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 24May2021. Treatment medication included antibiotics for the events. Outcome of the reported events are unknown at this point of time.   Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021651028 Same reporter/drug/event, different patient.;US-PFIZER INC-2021650327 Same reporter/drug/event, different patient.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: chills; cough; shortness of breath; body aching; loss of taste; lots of nasal congestion and mucus; lots of nasal congestion and mucus; This is a spontaneous report from a contactable consumer or other non hcp (parent). A 16-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 14May2021 as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 15May2021, one of her children experienced chills, cough, shortness of breath, body aching, loss of taste, lots of nasal congestion and mucus, did not have a fever, then she presented the symptoms 4 days after receiving the vaccine and her other son presented it a week later. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 24May2021. Treatment medication included antibiotics for the events. Outcome of the reported events are unknown at this point of time.   Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021651028 Same reporter/drug/event, different patient.;US-PFIZER INC-2021650327 Same reporter/drug/event, different patient.
Sex: M
Vaccine: COVID19
Symptoms: Movement disorder, Pain in extremity, Scab, Vaccination site pain, Vaccination site swelling
Clinical narrative: sharp pain in his arm where they gave him the shot.; have a little scab on it; It seemed a little puffy where they gave him the shot; Arm was sore where he got the shot; Difficulty lifting arm after the shot; This is a spontaneous report from a contactable consumer (patients brother). A 75-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration Date not reported) via an unspecified route of administration on Apr2021, as 2nd dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Previously patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration Date not reported) via an unspecified route of administration on an unspecified date, as 1st dose, single dose for COVID-19 immunization. It was reported that patients brother called today because he knows that the caller works for Pfizer. Patient received a second shot and he was wondering if what he was experiencing was normal for him to have this reaction and he wanted to see if caller knew anything. Caller states he does not have a lot number or any information on the product. Patient received the second shot, he believes that he said back in April. Patient reported to caller that every now and then he gets a sharp pain in his arm where they gave him the shot. It also seemed to have a little scab on it every now and then. Then it would scab off. Caller doesn't know if it was a little swollen at the tip of the skin. Patient said every now and then he gets a sharp pain in his arm where they gave him the shot. His arm hurt more than a couple of days. It seemed a little puffy where they gave him the shot. Sharp pain in arm when got the shot, his arm was sore when he got the shot. It lasted a couple days. Caller assumes it is ongoing because he wouldn't call him if it wasn't ongoing. exact dates are unknown for this event but he got the shot in Apr2021 so he was assuming that was when it started. Caller reports this comes and goes, it is not consistent. Caller thinks the scab may be intermittent.  When Patient received the shot, he started experiencing these symptoms. Patient said he received it in April and it's been a month and a half. This has persisted over the last month and a half off and on. He would be sitting there and all if the sudden he would have a sharp pain in his arm where he got the shot. The outcome of the event Arm was sore where he got the shot was unknown and rest all events was not recovered.  Information about batch/Lot number has been requested.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Decreased appetite, Fatigue, Feeling abnormal
Clinical narrative: lost a few pounds; Stomach pain; Vomited; Loss of appetite; Feels like he is in a fog; Twitching in left ankle; Injection site pain left arm; feeling very unwell; Headache; very tired; Feverish; Chills; This is a spontaneous report from a contactable consumer (patient). A 65-years-old male patient received first dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Formulation: Solution for injection, Lot number: EW0177), via intramuscular route, in left arm on 27May2021 at 16:25 (at age of 65 years) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included cancer (family medical history), cholesterol, blood pressure and heart attack from an unknown date and his father had heart attack in his 50's but he chain smokes. AE(s) following prior vaccinations: When he was 16, he got the flu shot and got severely sick. The patient concomitant medications were not reported. Patient received the first shot on 27May2021. The next day on 28May2021, he had all the symptoms such as injection site pain, very tired, headache, chills, Feverish, feeling very unwell. The next day on 29May2021, it seemed like he was fine. Now, ever since then, all he wanted to do was lay down. He doesn't feel well. He had stomach pain. He was kind of in a fog. He just wanted to lay in bed. He did vomit one time. He had loss of appetite. He wanted to know if someone could provide advice, that he should get second dose or not. He lost a few pounds in the last week. He was still in a fog. Injection site pain went away the following day. Other than having stomach pain, he doesn't feel that bad. The headache lasted 3 days. Therapeutic measures were taken as a result of headache. He has been on Tylenol. Stomach pain was not as bad as it was for 4 days. He was feeling feverish though. Regarding loss of appetite, he did eat something for breakfast, but that was it. The foggy feeling lasted until 02 Jun 2021 (yesterday as reported) and improved on 03Jun2021 (today as reported). All of symptoms kicked in on 29 May 2021. He added that in his left ankle, he does not know how to describe it. It was not like an electric shock but a twitching. It only lasted one day and went away. The injection did not hurt and did not hit bone. He feels sure it was given in the muscle. He took blood pressure medication and never had any reaction. He did not think it was relevant. His cholesterol and blood pressure were good now. He had a test for his heart a couple of years ago. The doctor said one of his arteries for his age looks like it was pretty normal, but one had a build-up in it. The case was assessed as non-serious. Outcome of events Muscle twitching, Feeling abnormal, Decreased appetite, Vomiting, Pyrexia, Fatigue and Malaise was recovering while outcome of Abdominal pain upper was not recovered and unknown for weight decreased. Patient was recovered from Vaccination site pain and Headache on an unknown date and Chills on 29May2021.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise, Muscle twitching, Pyrexia, Vaccination site pain
Clinical narrative: lost a few pounds; Stomach pain; Vomited; Loss of appetite; Feels like he is in a fog; Twitching in left ankle; Injection site pain left arm; feeling very unwell; Headache; very tired; Feverish; Chills; This is a spontaneous report from a contactable consumer (patient). A 65-years-old male patient received first dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Formulation: Solution for injection, Lot number: EW0177), via intramuscular route, in left arm on 27May2021 at 16:25 (at age of 65 years) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included cancer (family medical history), cholesterol, blood pressure and heart attack from an unknown date and his father had heart attack in his 50's but he chain smokes. AE(s) following prior vaccinations: When he was 16, he got the flu shot and got severely sick. The patient concomitant medications were not reported. Patient received the first shot on 27May2021. The next day on 28May2021, he had all the symptoms such as injection site pain, very tired, headache, chills, Feverish, feeling very unwell. The next day on 29May2021, it seemed like he was fine. Now, ever since then, all he wanted to do was lay down. He doesn't feel well. He had stomach pain. He was kind of in a fog. He just wanted to lay in bed. He did vomit one time. He had loss of appetite. He wanted to know if someone could provide advice, that he should get second dose or not. He lost a few pounds in the last week. He was still in a fog. Injection site pain went away the following day. Other than having stomach pain, he doesn't feel that bad. The headache lasted 3 days. Therapeutic measures were taken as a result of headache. He has been on Tylenol. Stomach pain was not as bad as it was for 4 days. He was feeling feverish though. Regarding loss of appetite, he did eat something for breakfast, but that was it. The foggy feeling lasted until 02 Jun 2021 (yesterday as reported) and improved on 03Jun2021 (today as reported). All of symptoms kicked in on 29 May 2021. He added that in his left ankle, he does not know how to describe it. It was not like an electric shock but a twitching. It only lasted one day and went away. The injection did not hurt and did not hit bone. He feels sure it was given in the muscle. He took blood pressure medication and never had any reaction. He did not think it was relevant. His cholesterol and blood pressure were good now. He had a test for his heart a couple of years ago. The doctor said one of his arteries for his age looks like it was pretty normal, but one had a build-up in it. The case was assessed as non-serious. Outcome of events Muscle twitching, Feeling abnormal, Decreased appetite, Vomiting, Pyrexia, Fatigue and Malaise was recovering while outcome of Abdominal pain upper was not recovered and unknown for weight decreased. Patient was recovered from Vaccination site pain and Headache on an unknown date and Chills on 29May2021.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting, Weight decreased
Clinical narrative: lost a few pounds; Stomach pain; Vomited; Loss of appetite; Feels like he is in a fog; Twitching in left ankle; Injection site pain left arm; feeling very unwell; Headache; very tired; Feverish; Chills; This is a spontaneous report from a contactable consumer (patient). A 65-years-old male patient received first dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Formulation: Solution for injection, Lot number: EW0177), via intramuscular route, in left arm on 27May2021 at 16:25 (at age of 65 years) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included cancer (family medical history), cholesterol, blood pressure and heart attack from an unknown date and his father had heart attack in his 50's but he chain smokes. AE(s) following prior vaccinations: When he was 16, he got the flu shot and got severely sick. The patient concomitant medications were not reported. Patient received the first shot on 27May2021. The next day on 28May2021, he had all the symptoms such as injection site pain, very tired, headache, chills, Feverish, feeling very unwell. The next day on 29May2021, it seemed like he was fine. Now, ever since then, all he wanted to do was lay down. He doesn't feel well. He had stomach pain. He was kind of in a fog. He just wanted to lay in bed. He did vomit one time. He had loss of appetite. He wanted to know if someone could provide advice, that he should get second dose or not. He lost a few pounds in the last week. He was still in a fog. Injection site pain went away the following day. Other than having stomach pain, he doesn't feel that bad. The headache lasted 3 days. Therapeutic measures were taken as a result of headache. He has been on Tylenol. Stomach pain was not as bad as it was for 4 days. He was feeling feverish though. Regarding loss of appetite, he did eat something for breakfast, but that was it. The foggy feeling lasted until 02 Jun 2021 (yesterday as reported) and improved on 03Jun2021 (today as reported). All of symptoms kicked in on 29 May 2021. He added that in his left ankle, he does not know how to describe it. It was not like an electric shock but a twitching. It only lasted one day and went away. The injection did not hurt and did not hit bone. He feels sure it was given in the muscle. He took blood pressure medication and never had any reaction. He did not think it was relevant. His cholesterol and blood pressure were good now. He had a test for his heart a couple of years ago. The doctor said one of his arteries for his age looks like it was pretty normal, but one had a build-up in it. The case was assessed as non-serious. Outcome of events Muscle twitching, Feeling abnormal, Decreased appetite, Vomiting, Pyrexia, Fatigue and Malaise was recovering while outcome of Abdominal pain upper was not recovered and unknown for weight decreased. Patient was recovered from Vaccination site pain and Headache on an unknown date and Chills on 29May2021.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Fatigue, Haematoma, Headache, Nausea
Clinical narrative: had swelling all the way up her arm and to her shoulder and to the shoulder blade and almost down to the elbow; hematoma; hot and its feels like a line a fire into her palm where it was on the nerve; The second dose, the caller was down for about three days.; Second dose:  extreme nausea ; Second dose: extreme headache ; Swelling at the injection site; This is a spontaneous report from a contactable female consumer (patient) reported for herself. A 57-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0178, Expiration date: unknown), via unspecified route, administered in left arm on 27May2021 (at the age of 57-year-old) as 2nd dose, single dose for COVID-19 immunisation. patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW976, Expiration date: unknown), via unspecified route, administered in right arm on 06May2021 (at the age of 57-year-old) as 1st dose, single dose for COVID-19 immunisation. The patient medical history includes ulcer. Concomitant medications were not reported. The patient historical vaccines include allergy shots and she experienced swelling as a reaction. The swelling happened after every allergy shot, she ever had, this was 20 years ago. The swelling would start about a day later. The caller would get one allergy shot on a Monday and then one shot on a Friday. The caller also explained he was diagnosed in the fall of 2020 and the caller cannot take Ibuprofen because of this. On 27May2021, after the vaccination, the patient experienced vaccination site swelling, had swelling all the way up her arm and to her shoulder and to the shoulder blade and almost down to the elbow. The swelling is very raised and hot and it felt like a line of fire into her palm where it was on the nerve. The caller thinks it's a hematoma now. The swelling is now the size of an egg in both shape and depth on 29May2021, patient experienced headache and nausea for 2 days.  On an unspecified date patient also experienced feeling down for 3 days. The reporter assessed all events as non-serious. The caller explained he will not get the booster vaccine if Pfizer offers it. also explained that Swelling at the injection site has improved and now it is down to the hematoma the size of an egg. The hematoma is sitting on a nerve and the only thing the caller can do is ice it until it goes away. The outcome of the events mentioned as vaccination site swelling recovering. Nausea, headache and fatigue recovered on 31May2021 and the outcome of peripheral swelling and burning sensation was unknown.  No follow-up attempts possible. No further information expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site swelling
Clinical narrative: had swelling all the way up her arm and to her shoulder and to the shoulder blade and almost down to the elbow; hematoma; hot and its feels like a line a fire into her palm where it was on the nerve; The second dose, the caller was down for about three days.; Second dose:  extreme nausea ; Second dose: extreme headache ; Swelling at the injection site; This is a spontaneous report from a contactable female consumer (patient) reported for herself. A 57-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0178, Expiration date: unknown), via unspecified route, administered in left arm on 27May2021 (at the age of 57-year-old) as 2nd dose, single dose for COVID-19 immunisation. patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW976, Expiration date: unknown), via unspecified route, administered in right arm on 06May2021 (at the age of 57-year-old) as 1st dose, single dose for COVID-19 immunisation. The patient medical history includes ulcer. Concomitant medications were not reported. The patient historical vaccines include allergy shots and she experienced swelling as a reaction. The swelling happened after every allergy shot, she ever had, this was 20 years ago. The swelling would start about a day later. The caller would get one allergy shot on a Monday and then one shot on a Friday. The caller also explained he was diagnosed in the fall of 2020 and the caller cannot take Ibuprofen because of this. On 27May2021, after the vaccination, the patient experienced vaccination site swelling, had swelling all the way up her arm and to her shoulder and to the shoulder blade and almost down to the elbow. The swelling is very raised and hot and it felt like a line of fire into her palm where it was on the nerve. The caller thinks it's a hematoma now. The swelling is now the size of an egg in both shape and depth on 29May2021, patient experienced headache and nausea for 2 days.  On an unspecified date patient also experienced feeling down for 3 days. The reporter assessed all events as non-serious. The caller explained he will not get the booster vaccine if Pfizer offers it. also explained that Swelling at the injection site has improved and now it is down to the hematoma the size of an egg. The hematoma is sitting on a nerve and the only thing the caller can do is ice it until it goes away. The outcome of the events mentioned as vaccination site swelling recovering. Nausea, headache and fatigue recovered on 31May2021 and the outcome of peripheral swelling and burning sensation was unknown.  No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: she got sick; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection,  Batch/Lot Number: Not Provided), via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient got sick, will not be taking her second dose.  Patient stated reports that her husband has been sick for months after getting the first Covid vaccine shot, she had her first dose as well and would not be taking her second dose since her husband has developed symptoms after getting the first dose and wanted to speak to someone to help her husband to heal. She had to get it, the company that she worked for said if she do not got it she would not get paid. She got sick but do not got as bad as him, symptoms lasted 3 days, then she was out of bed. The outcome of events she got sick was recovered on an unspecified date.   Information about batch/Lot number has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Under her arm hurt terribly under the muscle; Under her arm hurt terribly under the muscle; This is a spontaneous report from a contactable consumer or other non-health professional (patient) via Pfizer sponsored program.  A 75-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 17Jan2021 12:00 (Age at vaccination 75 Years) as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications was none. There was no family history relevant to AE. Reportedly, no additional vaccines were administered on same date of the Pfizer suspect. There were no prior vaccinations within 4 weeks. AE(s) following prior vaccinations was reported as none, patient did not took vaccines, never took shingles, flu, or pneumonia vaccine. She only got what she needed as a child and the last shot she had was about 10 years ago, it was a tetanus shot. The patient reported she took the first vaccine and under her arm hurt terribly under the muscle and it lasted 2 or 3 days and then it went away. The report was related to a study or program. The investigation assessment was done. Reported she finally got her hcp to order blood tests for her. Patient finally took the necessary blood tests. Reportedly, patient took second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported) on 07Feb2021 around 10:30 in left arm. Event did not require visit to emergency room/physician office. No relevant tests were done. The patient wanted to know who to write or talk to about having an adverse reaction after the covid vaccine. Patient was asking what to do about the reaction. The outcome of events was recovered on an unspecified date in 2021.  Follow-up attempts needed. Further information has been expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Headache, Malaise
Clinical narrative: I have been feeling very dizzy; Having shortness of breathe; Head hurts; I am really tired; Feeling ill; This is a spontaneous report from a contactable consumer or other non HCP (patient). A 26-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8736), intramuscular in left arm on 02Jun2021 at 13:30 (at the age of 26-years-old) as 2nd dose, single for COVID-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8735), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient did not receive any vaccination 4 weeks prior. On 03Jun2021, patient experienced feeling very dizzy, shortness of breathe, head hurt, really tired, and feeling ill. The patient did not take any treatment for the events. The outcome of the events was not recovered.   Information on Lot/Batch number was available. Additional information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Chapped lips, Lip haemorrhage
Clinical narrative: My lips had been chipped and now they are kind of bloody; My lips had been chipped and now they are kind of bloody; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. Medical history included blindness. The patient's concomitant medications were not reported. The patient was trying to find out some side effects for the Covid19 Shot. It has been couple of months since the patient had last one. It has been a few weeks patient's lips had been chipped and now they are kind of bloody. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Pain in extremity
Clinical narrative: arm being sore; numbness with that shot/numbness in the lips or in the nose; numbness in the lips or in the nose; This is a spontaneous report from a contactable consumer or other non health care professional (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number EW0187, Expiration Date 31Aug2021) via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient experienced side effects. Patient enquired if this side effect beside the arm being sore was this side effect of though have you heard of numbness with that shot or no. Have you heard of numbness in the lips or in the nose. Patient had side effects when had first shot and was wondering if you have heard of this before with other people or not. Patient enquired whether second dose can be taken or not. The clinical outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Pain, Pain in extremity
Clinical narrative: Patient complained of having full body aches and joint paint (multiple joints affected: knees, ankles, toes, hands, wrist and elbows) and continued arthritis type symptoms.; Patient complained of having full body aches and joint paint (multiple joints affected: knees, ankles, toes, hands, wrist and elbows) and continued arthritis type symptoms.; Patient complained of having full body aches and joint paint (multiple joints affected: knees, ankles, toes, hands, wrist and elbows) and continued arthritis type symptoms.; Patient complained of having full body aches and joint paint (multiple joints affected: knees, ankles, toes, hands, wrist and elbows) and continued arthritis type symptoms.; This is a spontaneous report from a contactable consumer or other non-healthcare professional. This consumer reported for a 58-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, patient complained of having full body aches and joint paint (multiple joints affected: knees, ankles, toes, hands, wrist and elbows) weeks after taking 2nd dose of COVID vaccine and continued arthritis type symptoms. It was reported that onset linked to after 2nd dose of vaccine and no other changes in diet, medications or physical exercise attributed to joint pain. Event took place after use of product. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Rectal haemorrhage
Clinical narrative: rectal bleeding; lower abdominal cramps; This is a spontaneous report from a contactable consumer or other non hcp (reported herself).    A 27-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 03Jun2021 at single dose for COVID-19 immunisation. The patient took 1st dose of BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE solution for injection) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 03Jun2021, the patient experienced rectal bleeding (medically significant and lower abdominal cramps (abdominal pain) (non-serious). At the time of reporting, the outcome of the events were unknown.  Information about the Lot/batch number has been requested
Age: 59.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Abdominal discomfort, Condition aggravated, Headache, Illness, Swelling
Clinical narrative: She already took Tylenol yesterday because of headache and high hernia and high hernia is swelling; I got headache; I have a higher hernia and after the Tylenol it made my high hernia to swell, it made my stomach open up and I got sick; stomach open up; I got sick; high hernia is swelling; This is a spontaneous report from a Pfizer sponsored program via contactable consumer (patient, self-reported). A 59-year-old female patient (age at vaccination: 59 year) received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 02Jun2021 at 13:05 PM, as a single dose for COVID-19 immunization; paracetamol (TYLENOL), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication; ibuprofen (IBUPROFEN), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she already took Tylenol (Captured as suspect) yesterday because of headache and high hernia and high hernia was swelling; she got headache. She had a higher hernia and after the Tylenol it made her high hernia to swell, it made her stomach open up and she got sick on 02Jun2021. The patient stated, she wanted to find out if it was okay for her to take the Ibuprofen (captured as suspect) because she was told that we are taking the shot, she already had her second shot, this was her second, she had it was second, but they told her to take Tylenol and she had a higher hernia and after the Tylenol it made her high hernia to swell, it made her stomach open up and she got sick. She got headache like so and all and she mean she just, she was for bed off. So, she wanted to find out if it was okay to take as Ibuprofen and two doses of the Tylenol. The action taken in response to the events for Tylenol and Ibuprofen was unknown. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: my arm is little sore yesterday; This is a spontaneous report from a Pfizer sponsored program. Female consumer (patient) reported for herself that: A 71-year-old female patient received of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA vaccine, Formulation: Solution injection; Lot number: unknown; expiration date unknown), via unspecified route of administration on 03Jun2021 (at the age of 71-year-old) as first dose, single dose for COVID-19 immunization. The patient medical history included hypertension.Concomitant medications were not reported. The patient wanted to see the dates if she can take that medication. The patient received Amitriptyline on regular basis on unspecified date. The patient wanted to see if she can take that medication Amitriptyline on regular basis. The patient received her first dose earlier today 03Jun2021 and her second dose was scheduled on 24Jun2021 which is exactly 21 days apart, the correct dose was scheduled however she forgot to ask her vaccination provider if she can take her evening medication which is Amitriptyline medication, she said pain reliever for her. The patient had arm is little sore yesterday but right now she seems to be okay, and she wanted to see if she can take that medication. She takes Amitriptyline on regular basis, indication of Amitriptyline is to helps with sleep and pain with the muscle, it is a muscle relaxer and helps her to sleep. On unspecified date, the patient experienced my arm is little sore yesterday. The patient seriousness reported as unspecified. The patient did not receive lab tests. The outcome of the event is recovering on unspecified date.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Hyperhidrosis, Inflammation, Nausea
Clinical narrative: He says he experiences nausea; Sweating; Dizziness; He can't walk straight.; He's experiencing inflammation; This is a spontaneous report received from a contactable consumer (Patient). A male patient of an unspecified age received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unknown date in May2021 as single dose for covid-19 immunisation. Medical history included autoimmune disorder. The patient's concomitant medications were not reported. The patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unknown date in Apr2021 as single dose for covid-19 immunisation. On an unknown date, the patient experienced nausea, sweating, dizziness, he cannot walk straight and experienced inflammation. Clinical course of the events was reported as Every morning, he says he experiences nausea, sweating, dizziness, and he can't walk straight. He's experiencing inflammation and it's not settling down. Outcome of the events nausea, sweating, dizziness and he cannot walk straight was reported as unknown and event he's experiencing inflammation was reported as not recovered at the time of this report.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Inflammation, Myalgia, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer. A 47-years-old male patient (reporter's husband) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. A Consumer calls for information on behalf of her husband about severe muscle pain and inflammation and required hospitalization studies and observation due to severe inflammation and pain in the legs as a consequence of after the administration of the second dose of the Pfizer's COVID-19 vaccine. Outcome of the event was unknown. Information about the Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Brain neoplasm, Feeling abnormal, Headache, Vision blurred
Clinical narrative: I was having a brain tumor; vision goes blurry; head hurts; brain fog; very scary symptom; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 02Apr2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Patient reported that, she was experiencing side effects after receiving the Pfizer Covid 19 vaccine. She received the second dose on 02Apr2021 and had no side effects immediately after the vaccine. She reported that, the effects began two weeks later on an unspecified date in Apr2021, she thought at first, she was having a brain tumor. her vision goes blurry, her head hurts, the brain fog its horrible. She had to make herself think about what she needed to do, like getting a glass of water. It was very scary symptom. She was concerned about "How can she be helped before she goes crazy". The reporter assessed the events as non serious. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on the top of both arms like a sunburn and came on and off for days after the vaccine, also noticed a little rash on the inside of her arm, a little pink circle.; This is a spontaneous report from a contactable consumer (patient) or other non HCP.   A female patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE Solution for injection, Lot Number and expiry date were not reported) via an unspecified route of administration, on May2021 as first dose single dose for covid-19 immunisation. Patient medical history and concomitant medications were not reported. On an unspecified date (8 hours after vaccination), patient developed rash on the top of both arms like a sunburn and came on and off for days after the vaccine, also noticed a little rash on the inside of her arm, a little pink circle. Patient want to know that she had a side effect after the first dose of the vaccine. should get the second dose. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Reporter wants to know she should get the second dose after experiencing this rash with the first dose, wants to know if it is okay to get the second vaccine 5 hours earlier in the day than she received the first dose. Response was provided information from the attached document. The outcome of event was unknown.