chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Diarrhoea
Clinical narrative: as a single dose for covid-19 immunisation. Patient had no medical history and no past drug. At pharmacy or drug store the most recent COVID-19 vaccine was administered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 20Apr2021 at 09:00 the second day of the first dose, she started with diarrhea, a little chest pressure. Patient did not receive any treatment for events. The events assessed as nonserious with outcome of not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: She had an allergic reaction, a rash all over her body and itching after the dose.; She had an allergic reaction, a rash all over her body and itching after the dose.; This is a spontaneous report from a contactable consumer . A 54-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 09Apr2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Consumer reported regarding her housekeeper who got her first dose on 09Apr2021. She had an allergic reaction a rash all over her body and itching after the dose on an unspecified date in Apr2021. Her doctor gave her allergy medication. She took it and she was ok after 1 week. The outcome of the events was recovered on an unspecified date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19; This is a spontaneous report from a consumer (Patient) via Pfizer- sponsored program. A male patient of an unspecified age received first dose of BNT162B2(Pfizer Covid-19 Vaccine, solution for injection, Lot# unknown), via an unspecified route of administration on 11Apr2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 22Apr2021, the patient was tested positive for Covid-19. The patient underwent lab which included SARS-CoV-2 test: Positive on 22Apr2021. The patient was wondering if this would affect his second dose that was scheduled on 02May2021 and if he needs to reschedule. The outcome of the event was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Food aversion, Headache, Malaise
Clinical narrative: Tenderness in his arm; Did not feel well at first 2-3 days; Swelling on his body; Headache; Chills; Aversion to food; His stomach did not feel well; This is a spontaneous report received from a contactable consumer (patient) from Pfizer sponsored program.  A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: Unknown) via an unspecified route of administration on 18Apr2021 as a single dose for COVID-19 immunization. On Apr2021, after first dose of vaccine, the patient experienced tenderness in his arm, but he wanted to ask if it is okay that it continues for a week. He said he did not feel well at first 2-3 days, somewhat swelling on his body, his stomach did not feel well, headache, chills and aversion to food; when he saw food commercials, he does not have any interest to look at them. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Swelling
Clinical narrative: Tenderness in his arm; Did not feel well at first 2-3 days; Swelling on his body; Headache; Chills; Aversion to food; His stomach did not feel well; This is a spontaneous report received from a contactable consumer (patient) from Pfizer sponsored program.  A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: Unknown) via an unspecified route of administration on 18Apr2021 as a single dose for COVID-19 immunization. On Apr2021, after first dose of vaccine, the patient experienced tenderness in his arm, but he wanted to ask if it is okay that it continues for a week. He said he did not feel well at first 2-3 days, somewhat swelling on his body, his stomach did not feel well, headache, chills and aversion to food; when he saw food commercials, he does not have any interest to look at them. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Erythema, Peripheral swelling, Pruritus, Upper limb fracture
Clinical narrative: A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and Expiration date was not reported), via an unspecified route of administration on 19Apr2021 as a single dose for COVID-19 immunization. The patients medical history and concomitant medications were not reported. On an unspecified date the patient states that on Sunday, her under armpit was painful. When she went to take a shower, it's hurting, and she examined it and it was swelling up a little. On Monday, the swelling got a little bigger. Last night, the swelling got hot. It's bigger this morning and hard and swollen and red and it's cracking and itchy. The patient did not receive any treatment for the event. 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
Symptoms: Red blood cell count, Red blood cell count increased
Clinical narrative: I have high levels of absolute nucleated RBC and nucleated RBC; This is a spontaneous report from a contactable consumer reporting for herself.    A 60-years-old female patient received bnt162b2 (BNT162B2), dose 2 and 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.  Medical history included autoimmune disorder. The patient's concomitant medications were not reported. The patient experienced high levels of absolute nucleated RBC and nucleated RBC  on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included red blood cell count: high. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Amnesia
Clinical narrative: hair loss; memory loss, to the degree where she is forgetting to take her medications; This is a spontaneous report from a contactable consumer. A 81-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient has been experiencing hair loss and memory loss, to the degree where she is forgetting to take her medications. 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: Body temperature, Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: The patient's concomitant medications were not reported. The reporter stated that she received the first dose of the Pfizer Covid-19 vaccine on Sunday (25APR2021) and she did not feel much on that day, on the second day she had a sore arm and the next day she had a headache and felt exhausted, also had a feverish feeling on an unspecified date. The Patient took some ibuprofen and by the time she took her temperature she did not present fever. Therapeutic measures were taken as a result of sore arm, headache, exhausted and feverish feeling and treatment included ibuprofen. The outcome of the event feverish feeling was recovered on an unspecified date, and other events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Heart rate increased, Hypersensitivity, Hypoaesthesia, Nervous system disorder
Clinical narrative: allergic reaction; fast heartbeat; numbness from the injection site to face and in the mouth, upper lip, tip of the nose and tips of the toes; numbness from the injection site to face and in the mouth, upper lip, tip of the nose and tips of the toes; terrible chills; blurred vision; neurological damage; injection site in still sore and its goes down to thumb; injection site in still sore and its goes down to thumb; This is a spontaneous report received from a contactable consumer. A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation Solution for injection, Lot number and expiration date was not reported) via unspecified route of administration on an unspecified date in Feb2021 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced allergic reaction, fast heartbeat, numbness from the injection site to face and in the mouth, upper lip, tip of the nose and tips of the toes, terrible chills and blurred vision, on an unspecified date in Feb2021 neurological damage and injection site in still sore and its goes down to thumb on an unspecified date in 2021. The reporter stated that the patient received her first dose of the Pfizer covid vaccine in Feb2021. The patient experienced an allergic reaction 30 mins after the shot, fast heartbeat, numbness from the injection site to face and in the mouth, upper lip, tip of the nose and tips of the toes. She took and treatment included BENADRYL, which helped some, but she still have it. She also had terrible chills, blurred vision. She has seen doctors and was advised to not take the second dose and stated she still has the numbness in tips of her fingers, toes and on the tip of the nose. Her neurologist was going to see her today and do a scan of the head. She thought she might be allergic to PEG in the vaccine, but her doctor thought she might have neurological damage. She said her injection site in still sore and it goes down to thumb. Re-porter wanted to know should she take the second dose or not. Therapeutic measures were taken as a result of allergic reaction and numbness from the injection site to face and in the mouth, up-per lip, tip of the nose and tips of the toes and treatment included BENADRYL. The outcome of the events allergic reaction and numbness from the injection site to face and in the mouth, upper lip, tip of the nose and tips of the toes with outcome of not recovered, fast heartbeat, terrible chills, blurred vision, neurological damage and injection site in still sore with outcome of unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site hypoaesthesia, Vaccination site pain, Vision blurred
Clinical narrative: allergic reaction; fast heartbeat; numbness from the injection site to face and in the mouth, upper lip, tip of the nose and tips of the toes; numbness from the injection site to face and in the mouth, upper lip, tip of the nose and tips of the toes; terrible chills; blurred vision; neurological damage; injection site in still sore and its goes down to thumb; injection site in still sore and its goes down to thumb; This is a spontaneous report received from a contactable consumer. A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation Solution for injection, Lot number and expiration date was not reported) via unspecified route of administration on an unspecified date in Feb2021 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced allergic reaction, fast heartbeat, numbness from the injection site to face and in the mouth, upper lip, tip of the nose and tips of the toes, terrible chills and blurred vision, on an unspecified date in Feb2021 neurological damage and injection site in still sore and its goes down to thumb on an unspecified date in 2021. The reporter stated that the patient received her first dose of the Pfizer covid vaccine in Feb2021. The patient experienced an allergic reaction 30 mins after the shot, fast heartbeat, numbness from the injection site to face and in the mouth, upper lip, tip of the nose and tips of the toes. She took and treatment included BENADRYL, which helped some, but she still have it. She also had terrible chills, blurred vision. She has seen doctors and was advised to not take the second dose and stated she still has the numbness in tips of her fingers, toes and on the tip of the nose. Her neurologist was going to see her today and do a scan of the head. She thought she might be allergic to PEG in the vaccine, but her doctor thought she might have neurological damage. She said her injection site in still sore and it goes down to thumb. Re-porter wanted to know should she take the second dose or not. Therapeutic measures were taken as a result of allergic reaction and numbness from the injection site to face and in the mouth, up-per lip, tip of the nose and tips of the toes and treatment included BENADRYL. The outcome of the events allergic reaction and numbness from the injection site to face and in the mouth, upper lip, tip of the nose and tips of the toes with outcome of not recovered, fast heartbeat, terrible chills, blurred vision, neurological damage and injection site in still sore with outcome of unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching uncontrollably on her torso; This is a spontaneous report from a contactable consumer. A 46-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 15Apr2021 as single dose for covid-19 immunisation. The patient reported, she had her first dose of the Pfizer covid-19 vaccine on 15Apr2021. The patient reported, she received first Pfizer Covid 19 Vaccine on 15Apr2021. On 23Apr2021 caller experienced itching uncontrollably on her torso. She was seen by her allergist & prescribed prednisone, Benadryl and Pepcid with little relief. She was asking if she should take the second Pfizer Covid 19 Vaccine? The outcome of event was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: had a mild cold last night but it is gone now; This is the spontaneous report received from a contactable consumer (the patient). A 23-year-old-female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The caller stated she was supposed to have the second dose of the vaccine "today" but had a mild cold last night (onset date not specified) but it was gone currently. The outcome of the event was recovered on an unspecified date.  Information about lot/batch number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dysgeusia, Inappropriate schedule of product administration, Malaise
Clinical narrative: First dose was on 9Apr2021 and the second was on 26Apr2021; First dose was on 9Apr2021 and the second was on 26Apr2021; Feeling "a little sick and stuff"; Dizziness; Nasty taste in my mouth; Weakness; This is a spontaneous report from a contactable consumer. This male consumer (patient) of an unspecified age reported for himself that he received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration on 26Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine includes 1st dose of BNT162B2 for COVID-19 immunization on 9Apr2021. Caller reports that he received both dose of the Pfizer covid vaccine. First dose was on 9Apr2021 and the second was on 26Apr2021. Caller reports that the night he received his second dose around 19:00 he began having symptoms. Reports feeling "a little sick and stuff" with dizziness, a "nasty taste in my mouth" and weakness. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events was reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: First dose was on 9Apr2021 and the second was on 26Apr2021; First dose was on 9Apr2021 and the second was on 26Apr2021; Feeling "a little sick and stuff"; Dizziness; Nasty taste in my mouth; Weakness; This is a spontaneous report from a contactable consumer. This male consumer (patient) of an unspecified age reported for himself that he received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration on 26Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine includes 1st dose of BNT162B2 for COVID-19 immunization on 9Apr2021. Caller reports that he received both dose of the Pfizer covid vaccine. First dose was on 9Apr2021 and the second was on 26Apr2021. Caller reports that the night he received his second dose around 19:00 he began having symptoms. Reports feeling "a little sick and stuff" with dizziness, a "nasty taste in my mouth" and weakness. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events was reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Nausea, Vomiting
Clinical narrative: Nausea; Vomiting; Chills; Diarrhea; This is a spontaneous report from a contactable consumer. A 46-year-old female patient (patient herself) received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 24Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The pa-tient's medical history and concomitant medications were not reported.  The patient experienced nausea , vomiting, chills, diarrhea on an unspecified date. It was stated that Side effects that had been reported with the vaccine. The outcome of the events was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Headache, Malaise, Neck pain
Clinical narrative: vary sore arm; pain in part of the neck; bad headache; Injection site swelling; Injection site redness; Nervousness; Feeling unwell; Arm pain; Vomiting; Her neck hurts; Her hurting shoulder; This is a spontaneous report from contactable consumer. A 79-years old contactable female consumer (patient) reported for herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EW2171), via an unspecified route of administration on 27Apr2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 on 27Mar2021 for covid-19 immunization (first dose and lot number- ER8732). On an unknown date, the patient experienced very sore arm, pain in part of the neck, bad headache, injection site swelling, injection site redness, nervousness, feeling unwell, arm pain and vomiting. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Pain in extremity, Vaccination site erythema, Vaccination site swelling, Vomiting
Clinical narrative: vary sore arm; pain in part of the neck; bad headache; Injection site swelling; Injection site redness; Nervousness; Feeling unwell; Arm pain; Vomiting; Her neck hurts; Her hurting shoulder; This is a spontaneous report from contactable consumer. A 79-years old contactable female consumer (patient) reported for herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EW2171), via an unspecified route of administration on 27Apr2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 on 27Mar2021 for covid-19 immunization (first dose and lot number- ER8732). On an unknown date, the patient experienced very sore arm, pain in part of the neck, bad headache, injection site swelling, injection site redness, nervousness, feeling unwell, arm pain and vomiting. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Kidney infection, Nephrolithiasis
Clinical narrative: Kidney infection; Kidney stones; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer reported for patient.   A patient of unspecified age and gender received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number and expiration date unknown), via unspecified route of administration on 14Mar2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient developed kidney infection and kidney stones and hospitalized after receiving 2nd dose. The outcome of the events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Nausea, Paraesthesia
Clinical narrative: felt nauseous; face numb and tingling; face numb and tingling; This is a spontaneous report received from a contactable consumer (patient reported himself) via Medical Information Team. A 53-year-old male consumer received first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 21Apr2021 as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, "E-transmitting possible duplicate AE (this report may contain additional information not shared prior to transfer to the Medical Information. Caller stated he had already reported this to the previous agent). First dose of Pfizer on 21Apr2021, side effects started, 5 minutes after shot, felt nauseous. 10 minutes later, face numb and tingling and did not last long. He was no longer having side effects, they were all gone that day. He saw his PCP before the second dose and would talk to him". Caller asked whether the small side effects were from the first Pfizer vaccine, should he get the second. Response received included: As noted in the Fact Sheet for Recipients, should not get the Pfizer-BioNTech COVID-19 Vaccine if he had a severe allergic reaction after a previous dose of the vaccine or if he had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason could not be made by Pfizer. He was referred to speak to his healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Healthcare provider would know his health situation and would have access to information that can better help inform this decision". No PQC present. Outcome of the events was recovered on 21Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Laboratory test
Clinical narrative: heart felt funny and her heartrate was 135 to 140; This is a spontaneous report from a contactable consumer (patient's husband) via Medical information Team. A 37-year-old female patient (reporter's wife) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 21Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included anxiety (takes a low dose of Xanax). Concomitant medication(s) included alprazolam (XANAX) taken for an unspecified indication, start and stop date (couple times a month) were not reported. Historical Vaccine included first dose of BNT162B2 for COVID-19 immunisation. The patient experienced heart felt funny and her heartrate was 135 to 140 (non-serious) on Apr2021. The caller stated his wife, got the second dose of the vaccine last Wednesday, 21Apr2021. She ate well and was in good shape. She was 5 foot 4 inches and 135 pounds and has never had any heart issues ever. She wore an apple watch and the morning after the vaccine her heart felt funny and her heartrate was 135 to 140. She has anxiety and takes a low dose of Xanax maybe a couple times a month but did not take anything daily for this. She went to the urgent care and they ran tests and could not figure anything out so they sent her to the emergency room. At the emergency room they ran tests and couldn't figure anything out and weren't seeing anything and said it must be a reaction to the vaccine and said it should go away in a couple days. Now it was going on 8 days and when she woke up her heartrate is about 130. She has contacted her primary care provider and is about ready to go back to the ER. He asked if there is any advice or if anyone else has reported this. He was looking for any information at all on this. The caller stated he already reported this with safety; e-transmitting potential duplicate AE details. The patient underwent lab tests and procedures which included heart rate: 135 to 140 on Apr2021, heart rate: 130 on Apr2021, laboratory test: couldn't figure anything out and weren't seeing an on Apr2021. The outcome of event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 14Apr2021 at single dose, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date after first dose, few days later in Apr2021 patient experienced itching on both of upper thighs. On 17Apr2021, three days later patient got hives three later in certain area, which looks like hives or a rash. Patient was scheduled for her second dose on 05May2021 and patient thinking is it ok to have the second dose, sow her healthcare professional who confirmed its not related to the shot and advised her to proceed with her second dose. The outcome of all the events was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Anger, Arthralgia, Feeling abnormal, Irritability
Clinical narrative: had some "weird" side effects; "really bad achy" joints; feeling "really irritable and angry; feeling "really irritable and angry; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration on 09Apr2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 09Apr2021, the patient experienced had some "weird" side effects, "really bad achy" joints, feeling "really irritable and angry, feeling "really irritable and angry. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Malaise, Muscular weakness
Clinical narrative: muscle pain; joint pain; tiredness; feeling unwell; a little bit of dizziness; losing strength in her hands; fingers are swollen up; achiness and pain are more pronounced than usually; This is a spontaneous report from a contactable other hcp. A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: not reported), dose 2 via an unspecified route of administration on 14Apr2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced muscle pain, joint pain, tiredness, feeling unwell, a little bit of dizziness, losing strength in her hands, fingers are swollen up, achiness and pain are more pronounced than usually. Patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 18Mar2021 and the second dose on 14Apr2021, about 2 and a half weeks ago or 3 she started experieinced side-effects, she had this side-effects in the past also and they include: muscle pain, joint pain, tiredness, feeling unwell, a little bit of dizziness, she's also losing strength in her hands because her fingers are swollen up. She states that this time the achiness and pain are more pronounced than usually. She would like to know if this could possibly be side-effects from the vaccine. She would like to know what are the recommendations. She would like to know how far after vaccination the side-effects were reported (onset). She would like to know how long this side-effects can last. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Peripheral swelling
Clinical narrative: muscle pain; joint pain; tiredness; feeling unwell; a little bit of dizziness; losing strength in her hands; fingers are swollen up; achiness and pain are more pronounced than usually; This is a spontaneous report from a contactable other hcp. A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: not reported), dose 2 via an unspecified route of administration on 14Apr2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced muscle pain, joint pain, tiredness, feeling unwell, a little bit of dizziness, losing strength in her hands, fingers are swollen up, achiness and pain are more pronounced than usually. Patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 18Mar2021 and the second dose on 14Apr2021, about 2 and a half weeks ago or 3 she started experieinced side-effects, she had this side-effects in the past also and they include: muscle pain, joint pain, tiredness, feeling unwell, a little bit of dizziness, she's also losing strength in her hands because her fingers are swollen up. She states that this time the achiness and pain are more pronounced than usually. She would like to know if this could possibly be side-effects from the vaccine. She would like to know what are the recommendations. She would like to know how far after vaccination the side-effects were reported (onset). She would like to know how long this side-effects can last. 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: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive for COVID; This is a spontaneous report from a contactable consumer (Patients wife). A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 15Apr2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced with COVID-19 on 22Apr2021. It was reported that both her husband and his mom have experienced side effects since getting vaccinated. Her mother in-law got her 2nd dose on April 19th and my husband got his 1st dose on 15Apr. She has not been vaccinated and started getting symptoms on 22Apr. Both my husband, me and one of our children have all tested POSITIVE for COVID. On 22Apr2021 the patient underwent lab tests SARS-CoV-2 test: Positive. 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
Symptoms: Peripheral swelling
Clinical narrative: swelling in the arm; This is a spontaneous report from a contactable consumer reported for a female patient (Sister-in-law).  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number and Expiration date was unspecified) 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 provided. On an unspecified date, patient experienced swelling in the arm that needed to be treated with compression. Outcome for the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Kidney infection, Nephrolithiasis
Clinical narrative: Kidney infection; Kidney stones; This is a spontaneous report from a contactable consumer. This contactable consumer reported for a patient that stating that received second dose of bnt162b2 (BNT162B2; formulation: solution for injection; Lot number and expiration date were not reported) via an unspecified route of administration, on an unknown as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Consumer reported that two of my relatives developed kidney infection and kidney stones and hospitalization after receiving second dose.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Erythema, Vaccination site erythema, Vaccination site injury, Vaccination site pruritus
Clinical narrative: the area was getting bigger and becoming itchy and then last night it was hurting when I lifted my arm up; the area was getting bigger and becoming itchy and then last night it was hurting when I lifted my arm up; the area was getting bigger and becoming itchy and then last night it was hurting when I lifted my arm up; the red area started to "spread like rash ( around where the injection was); the red area started to "spread like rash ( around where the injection was); a little red spot; This is a spontaneous report received from a contactable consumer. This consumer reported for herself (patient) that dose 2 via an unspecified route of administration on 24Apr2021 as SINGLE DOSE for covid-19 immunisation .The patient medical history was not reported the patient's concomitant medications were not reported.The patient experienced a little red spot on 25Apr2021 , the red area started to "spread like rash around where the injection was on 26Apr2021,the red area started to "spread like rash around where the injection was on 26Apr2021,the area was getting bigger and becoming itchy and then last night it was hurting when I lifted my arm up the area was getting bigger and becoming itchy and then last night it was hurting when I lifted my arm up on the area was getting bigger and becoming itchy and then last night it was hurting when I lifted my arm up on 27Apr2021 Therapeutic measures were taken as a result of a little red spot (the red area started to "spread like rash the red area started to spread like rash the area was getting bigger and becoming itchy and then last night it was hurting when I lifted my arm up the area was getting bigger and becoming itchy and then last night it was hurting when I lifted my arm up , the area was getting bigger and becoming itchy and then last night it was hurting when I lifted my arm up The events were assessed as Non serious by health authority and 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: Vaccination site rash
Clinical narrative: the area was getting bigger and becoming itchy and then last night it was hurting when I lifted my arm up; the area was getting bigger and becoming itchy and then last night it was hurting when I lifted my arm up; the area was getting bigger and becoming itchy and then last night it was hurting when I lifted my arm up; the red area started to "spread like rash ( around where the injection was); the red area started to "spread like rash ( around where the injection was); a little red spot; This is a spontaneous report received from a contactable consumer. This consumer reported for herself (patient) that dose 2 via an unspecified route of administration on 24Apr2021 as SINGLE DOSE for covid-19 immunisation .The patient medical history was not reported the patient's concomitant medications were not reported.The patient experienced a little red spot on 25Apr2021 , the red area started to "spread like rash around where the injection was on 26Apr2021,the red area started to "spread like rash around where the injection was on 26Apr2021,the area was getting bigger and becoming itchy and then last night it was hurting when I lifted my arm up the area was getting bigger and becoming itchy and then last night it was hurting when I lifted my arm up on the area was getting bigger and becoming itchy and then last night it was hurting when I lifted my arm up on 27Apr2021 Therapeutic measures were taken as a result of a little red spot (the red area started to "spread like rash the red area started to spread like rash the area was getting bigger and becoming itchy and then last night it was hurting when I lifted my arm up the area was getting bigger and becoming itchy and then last night it was hurting when I lifted my arm up , the area was getting bigger and becoming itchy and then last night it was hurting when I lifted my arm up The events were assessed as Non serious by health authority and outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropod bite, Back disorder, Rash, Urticaria
Clinical narrative: rash on both of her legs and back; one leg looks like a mosquito bite with hives around it; one leg looks like a mosquito bite with hives around it; she also had a patch on her back; This is a spontaneous report from a contactable consumer (reported for herself) via Medical information team.  A 72-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 08Apr2021 (at the age of 72-years) as SINGLE DOSE for covid-19 immunization. Medical history included: lot of drug allergies and to antibiotics. The patient's concomitant medications were not reported. On an unspecified date in Apr2021, the patient experienced a rash on both of her legs and back. The rash looks like if blood was to come to the top of the skin and it has dots around the rash. Also reported that one leg looks like a mosquito bite with hives around it and she also had a patch on her back. She was scheduled for the second dose tomorrow and would like to know if she should receive it. She had a lot of drug allergies and to antibiotics that she was afraid she might have a worse reaction with dose two. Caller reported that when she takes the flu shot she has to take it in two doses instead of one seven days apart at a hospital due to her allergy. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood glucose, Blood glucose increased, Fall, Speech disorder
Clinical narrative: feeling weak; falling; is not talking coherently mostly; measure of her blood sugar and it was 300 mg/dl; This is a spontaneous report from a contactable consumer (patient daughter). A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 27Apr2021 as SINGLE DOSE for covid-19 immunization. Medical history included: reporter recalls: that her mother had covid 19 over 3 months ago and she had almost the same symptoms although that time it was more GI problems like diarrhea. She mentions that her mother is also diabetic. The patient's concomitant medications were not reported. In Apr2021 after the vaccination patient experienced some side effects as the patient was feeling weak, falling sometimes and was not talking coherently mostly when asked questions. It was also reported that they took a measure of her blood sugar and it was 300 mg/dl. In Apr2021 the patient underwent lab tests and procedures which included blood glucose: 300 mg/dl. The outcome of events was unknown.  Reporter asked since her mother had side effects after the first dose of the vaccine, should she get the second dose. Response: As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Dry skin, Erythema, Pruritus
Clinical narrative: hand palm felt itching; red dry skin; red dry skin; This is a spontaneous report from a Pfizer-Sponsored program received from a contactable consumer (patient). A male patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced hand palm felt itching (non-serious) on an unspecified date with outcome of unknown, red dry skin(non-serious) on an unspecified date with outcome of unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Nausea, Pain in extremity
Clinical narrative: sore arm; nausea; feeling tired; dizzy; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received second 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 (friday morning) at single dose for COVID-19 immunization. The patient previously took 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 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. She also stated she had the following side effects after her first dose of the vaccine: arm soreness, tired, chills, fever, body aches and pain for 2-3 days and then went away. She reported after second dose that evening she expereinced sore arm, nausea and feeling tired. On Saturday and Sunday, she reports feeling tired and dizzy. Today, she was no longer tired but still had dizziness. What should she do. Was dizziness reported. Was nausea reported. Were blood pressure changes reported. Patient stated she had already reported but received no report number. The outcome of the event feeling tired was recovered and not recovered for dizziness. The outcome of the other events was unknown.  Response: Spoke from the Fact Sheet for Recipients: what are the risks of the pfizer-biontech covid-19 vaccine? who should not get the pfizer-biontech covid-19 vaccine? what should i do about side effects? Revised: 06April2021. Spoke from the PI: Table 2: Study 2  Frequency and Percentages of Participants with Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Each Dose  Participants 18-55 Years of Age Safety Population*; 6.2 Post Authorization Experience. Stated I have no information about blood pressure changes as a side effect. Revised: 06Apr2021 Spoke from the attached side effect document. Referred caller to HCP.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Axillary pain, Limb discomfort, Pain in extremity, Peripheral swelling
Clinical narrative: Her arm was swollen all the way down to her wrist; part under her arm pit was very sore and swollen; extremely painful and relaxing by her side was uncomfortable; extremely painful and relaxing by her side was uncomfortable; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A 52-years-old female patient received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE; Formulation: solution for injection; Batch/Lot Number was ER8731; Expiration date: Unknown), via an unspecified route of administration in Arm Right on 14Apr2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant was not reported.   On an unspecified date, The patient stated she is calling regarding the Pfizer COVID19 vaccine and has some questions about that. Got the shot about 3 weeks ago and her arm was swollen. The part under her arm pit was very sore and swollen. It did not turn red. She had swelling in her armpit area, for 3-4 days it was very swollen, her arm was swollen all the way down to her wrist and really painful right underneath her arm, The part under her arm pit was very sore and swollen. It did not turn red. Even to put deodorant on was extremely painful and relaxing her arm by her side was uncomfortable.    The patient would like to know whether she should get the next dose of the Pfizer COVID vaccine after the side effects she had from the 1st dose. She had called the doctor and they said that it happens sometimes. Does not know if she should get the second shot. Confirmed that the shot was the first dose of the COVID vaccine. Is signed up for the second shot 05May2021. She had COVID and does not want to get it again. Do not want to spread to others.  On an unspecified date the patient underwent lab tests and procedures which included antibody test: positive for antibodies, sars-cov-2 test was negative. Had tested negative when she thought she had it and got an antibody test a few weeks later that was positive for antibodies. There is no product complaint to report. Yes, there is a medical information request.  No follow-up attempts are needed. No further information is expected.