chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Tenderness
Clinical narrative: Intense shivers; Fever; Arm tenderness; This is a spontaneous report received from a contactable 42-year female consumer (patient) reported for herself that who received the Pfizer vaccine, bnt162b2 (BNT162B2) Solution for injection, unknown dose (Lot number and expiry date was not reported) via an unspecified route of administration on 02Apr2021 as a single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. She was having some side effects. She received the vaccine on Friday. Saturday, she had arm tenderness (on 03Apr2021), yesterday she was fine. At 3am she woke up with intense shivers and a fever. Friends say they got their side effect in the 48 hours. Should I be concerned?. On Sunday she didn't have anything and then this morning she had a fever and chills (on 04Apr2021). She was wanting to know if that was all normal. Provided PMI number and tried to transfer to  but there were calls holding. Cold transferred to PMI due to wait times. Fax to . Transferring agent stated, have a consumer on the line, she received the Pfizer COVID 19 Vaccine this past Friday, on Saturday she has some arm tenderness and then at 3 am this morning she woke up with shivers and fever. Consumer was informed about the role of Pfizer Drug Safety and requested to probe. No further probing could be don as the consumer hung up the call abruptly. Hence limited information available over the call. Outcome of the events was unknown.   No follow up attempts are possible, no further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-2021377881 same reporter/drug, different patient/AE
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Body temperature abnormal, General physical health deterioration, Heart rate increased
Clinical narrative: mild temperature; felt lethargic; her arm is swollen and painful; her arm is swollen and painful/ pain in legs; heart was beating too fast/can feel her heart beating; her hands were shaking; pins and needles in her legs; numbness in hands/fingers; heaviness in arms hands and fingers; small rash; muscle aches; No strength; could not get out of bed; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program.   A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date were not reported), via an unspecified route of administration on 01Apr2021 as dose 1, single for covid-19 immunization. The patient's medical history included tested positive in Jun/Jul, mild diarrhea and pain in abdomen and legs. Concomitant medications were not reported. On an unknown date, the patient experienced mild temperature, felt lethargic, could not get out of bed, her arm was swollen and painful, heart was beating too fast/could feel her heart beating, hands were shaking, pins and needles in her legs, numbness in hands/fingers, heaviness in arms hands and fingers, small rash, muscle aches, and no strength. She stated she had been a bad experience/reaction to the vaccine. She spoke to her doctor today, who told her not to take second shot. The patient underwent lab tests and procedures which included body temperature: abnormal on an unknown date. The outcome of all the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Lethargy, Limb discomfort, Myalgia, Pain in extremity
Clinical narrative: mild temperature; felt lethargic; her arm is swollen and painful; her arm is swollen and painful/ pain in legs; heart was beating too fast/can feel her heart beating; her hands were shaking; pins and needles in her legs; numbness in hands/fingers; heaviness in arms hands and fingers; small rash; muscle aches; No strength; could not get out of bed; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program.   A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date were not reported), via an unspecified route of administration on 01Apr2021 as dose 1, single for covid-19 immunization. The patient's medical history included tested positive in Jun/Jul, mild diarrhea and pain in abdomen and legs. Concomitant medications were not reported. On an unknown date, the patient experienced mild temperature, felt lethargic, could not get out of bed, her arm was swollen and painful, heart was beating too fast/could feel her heart beating, hands were shaking, pins and needles in her legs, numbness in hands/fingers, heaviness in arms hands and fingers, small rash, muscle aches, and no strength. She stated she had been a bad experience/reaction to the vaccine. She spoke to her doctor today, who told her not to take second shot. The patient underwent lab tests and procedures which included body temperature: abnormal on an unknown date. The outcome of all the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral swelling, Rash, Tremor
Clinical narrative: mild temperature; felt lethargic; her arm is swollen and painful; her arm is swollen and painful/ pain in legs; heart was beating too fast/can feel her heart beating; her hands were shaking; pins and needles in her legs; numbness in hands/fingers; heaviness in arms hands and fingers; small rash; muscle aches; No strength; could not get out of bed; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program.   A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date were not reported), via an unspecified route of administration on 01Apr2021 as dose 1, single for covid-19 immunization. The patient's medical history included tested positive in Jun/Jul, mild diarrhea and pain in abdomen and legs. Concomitant medications were not reported. On an unknown date, the patient experienced mild temperature, felt lethargic, could not get out of bed, her arm was swollen and painful, heart was beating too fast/could feel her heart beating, hands were shaking, pins and needles in her legs, numbness in hands/fingers, heaviness in arms hands and fingers, small rash, muscle aches, and no strength. She stated she had been a bad experience/reaction to the vaccine. She spoke to her doctor today, who told her not to take second shot. The patient underwent lab tests and procedures which included body temperature: abnormal on an unknown date. The outcome of all the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Dyspnoea, Malaise
Clinical narrative: "severe" asthma; shortness of breath; Not feeling well; This is a spontaneous report from a contactable consumer or other non hcp. A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and Expiration Date was not reported) via an unspecified route of administration on 12Mar2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced severe asthma, shortness of breath and not feeling well on an unspecified date. It was reported that, patient had severe asthma and her shortness of breath had been more severe. She was scheduled to receive her second dose but she won't be able to make it to her second dose appointment today due to her symptoms. She started a prednisone treatment because of shortness of breath and recurrence severe (not clarified) after the injection, so today as well she was not feeling well, so won't be able to make her second dose appointment. She asked how long can patient wait before getting the second dose without impacting the efficacy of the vaccine and without having to repeat the vaccination series if she didn't make it to her vaccination appointment today and the vaccination series would need to be repeated at a later time, once completed. She asked how to react to the second dose of the vaccine, due to her medical condition and reaction to the first dose and if people with asthma had a stronger reaction to the vaccine. Patient might be receiving the second vaccine. 2 weeks after the injection, patient received treatment with prednisone for severe asthma and shortness of breath. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A patient with unspecified age and gender received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/ lot number: not reported) via an unspecified route of administration on 29Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient took the first dose of Pfizer Vaccine (Covid-19 Vaccine) yesterday on 29Mar2021 and on an unspecified date, patient experienced fever. Patient wanted know if that was COVID-19 or the side effects of vaccine. Patient was informed about Pfizer Medical information department and was provided with the number. Limited information was available over the call as the consumer was not willing to complete the report. Outcome of the event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (husband). A female patient, of an unspecified age, received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Mar 30, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient previously the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, for COVID-19 immunization. Reportedly, patient had a little bit of fever after the Pfizer COVID-19 vaccine the second dose (Mar 30, 2021). She wanted to know if that is alright to take Tylenol. The outcome of the event: unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Body temperature increased, Chills, Condition aggravated, Depression
Clinical narrative: Fever of 102.4. Severe chills. Bodyaches; Fever of 102.4. Severe chills. Bodyaches; Fever of 102.4. Severe chills. Bodyaches; Skin hyper sensitive to touch; Severe pain in area of Liver like when I took Tylenol during covid; Hands and feet feel like blocks of ice but soles of feet feel like on fire; Hands and feet feel like blocks of ice but soles of feet feel like on fire; Bad tummy ache; Muscle weakness; Also, the mild depression & brain fog which has remained since I recovered from having covid from 02Dec-26Jan is even worse now; Also, the mild depression & brain fog which has remained since I recovered from having covid from 02Dec-26Jan is even worse now; Also, the mild depression & brain fog which has remained since I recovered from having covid from 02Dec-26Jan is even worse now; Barely able to function physically & mentally; This is a spontaneous report from a contactable consumer. A 63-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration, administered in Arm Right on 31Mar2021 14:00 as DOSE 1, SINGLE (at the age of 63-year-old) for covid-19 immunisation. Medical history included coeliac disease, autoimmune thyroiditis, gluten sensitivity, covid-19 (I had in Dec & Jan when I had covid for 50 days), feeling abnormal. Concomitant medications included levothyroxine sodium (SYNTHROID).  Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient's 1st Vaccine was received on 31Mar21. The next day on 01Apr2021 06:00, patient's reaction symptoms include several of the symptoms patient had in Dec & Jan when had covid for 50 days. They includes fever of 102.4, severe chills, body aches, skin hyper sensitive to touch, severe pain in area of liver like when patient took Tylenol during covid, hands and feet feel like blocks of ice but soles of feet feel like on fire, bad tummy ache, muscle weakness, barely able to function physically & mentally. Patint'e symptoms were some of the many that patient had when patient was very ill with covid. Also, the mild depression & brain fog which has remained since patient recovered from having covid from 02Dec-26Jan was even worse now. The patient underwent lab tests and procedures which included body temperature increased: 102.4 fahrenheit on 01Apr2021, sars-cov-2 test: positive on Dec2020 symptoms I had in Dec & Jan when I had covid for 50 days. The patient did not received the treatment for events. The outcome of the events was not resolved.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling hot, Hepatic pain, Loss of personal independence in daily activities, Muscular weakness
Clinical narrative: Fever of 102.4. Severe chills. Bodyaches; Fever of 102.4. Severe chills. Bodyaches; Fever of 102.4. Severe chills. Bodyaches; Skin hyper sensitive to touch; Severe pain in area of Liver like when I took Tylenol during covid; Hands and feet feel like blocks of ice but soles of feet feel like on fire; Hands and feet feel like blocks of ice but soles of feet feel like on fire; Bad tummy ache; Muscle weakness; Also, the mild depression & brain fog which has remained since I recovered from having covid from 02Dec-26Jan is even worse now; Also, the mild depression & brain fog which has remained since I recovered from having covid from 02Dec-26Jan is even worse now; Also, the mild depression & brain fog which has remained since I recovered from having covid from 02Dec-26Jan is even worse now; Barely able to function physically & mentally; This is a spontaneous report from a contactable consumer. A 63-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration, administered in Arm Right on 31Mar2021 14:00 as DOSE 1, SINGLE (at the age of 63-year-old) for covid-19 immunisation. Medical history included coeliac disease, autoimmune thyroiditis, gluten sensitivity, covid-19 (I had in Dec & Jan when I had covid for 50 days), feeling abnormal. Concomitant medications included levothyroxine sodium (SYNTHROID).  Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient's 1st Vaccine was received on 31Mar21. The next day on 01Apr2021 06:00, patient's reaction symptoms include several of the symptoms patient had in Dec & Jan when had covid for 50 days. They includes fever of 102.4, severe chills, body aches, skin hyper sensitive to touch, severe pain in area of liver like when patient took Tylenol during covid, hands and feet feel like blocks of ice but soles of feet feel like on fire, bad tummy ache, muscle weakness, barely able to function physically & mentally. Patint'e symptoms were some of the many that patient had when patient was very ill with covid. Also, the mild depression & brain fog which has remained since patient recovered from having covid from 02Dec-26Jan was even worse now. The patient underwent lab tests and procedures which included body temperature increased: 102.4 fahrenheit on 01Apr2021, sars-cov-2 test: positive on Dec2020 symptoms I had in Dec & Jan when I had covid for 50 days. The patient did not received the treatment for events. The outcome of the events was not resolved.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral coldness, Pyrexia, SARS-CoV-2 test, Skin disorder
Clinical narrative: Fever of 102.4. Severe chills. Bodyaches; Fever of 102.4. Severe chills. Bodyaches; Fever of 102.4. Severe chills. Bodyaches; Skin hyper sensitive to touch; Severe pain in area of Liver like when I took Tylenol during covid; Hands and feet feel like blocks of ice but soles of feet feel like on fire; Hands and feet feel like blocks of ice but soles of feet feel like on fire; Bad tummy ache; Muscle weakness; Also, the mild depression & brain fog which has remained since I recovered from having covid from 02Dec-26Jan is even worse now; Also, the mild depression & brain fog which has remained since I recovered from having covid from 02Dec-26Jan is even worse now; Also, the mild depression & brain fog which has remained since I recovered from having covid from 02Dec-26Jan is even worse now; Barely able to function physically & mentally; This is a spontaneous report from a contactable consumer. A 63-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration, administered in Arm Right on 31Mar2021 14:00 as DOSE 1, SINGLE (at the age of 63-year-old) for covid-19 immunisation. Medical history included coeliac disease, autoimmune thyroiditis, gluten sensitivity, covid-19 (I had in Dec & Jan when I had covid for 50 days), feeling abnormal. Concomitant medications included levothyroxine sodium (SYNTHROID).  Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient's 1st Vaccine was received on 31Mar21. The next day on 01Apr2021 06:00, patient's reaction symptoms include several of the symptoms patient had in Dec & Jan when had covid for 50 days. They includes fever of 102.4, severe chills, body aches, skin hyper sensitive to touch, severe pain in area of liver like when patient took Tylenol during covid, hands and feet feel like blocks of ice but soles of feet feel like on fire, bad tummy ache, muscle weakness, barely able to function physically & mentally. Patint'e symptoms were some of the many that patient had when patient was very ill with covid. Also, the mild depression & brain fog which has remained since patient recovered from having covid from 02Dec-26Jan was even worse now. The patient underwent lab tests and procedures which included body temperature increased: 102.4 fahrenheit on 01Apr2021, sars-cov-2 test: positive on Dec2020 symptoms I had in Dec & Jan when I had covid for 50 days. The patient did not received the treatment for events. The outcome of the events was not resolved.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: A few hours following the vaccine, patient started to feel sore at injection site and in upper extremities, but symptoms were mild and manageable.; A few hours following the vaccine, patient started to feel sore at injection site and in upper extremities, but symptoms were mild and manageable.; sore muscles; fatigue; headache; low-grade fever; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VCACINE; Lot Number: EP6955, Expiration date: Not reported), via an unspecified route of administration in left arm, on 31Mar2021 at 13:00 (at the age of 24-years-old) as dose 2, single for COVID-19 immunization in a workplace clinic. Medical history included chronic migraines. The patient had known allergies to sulfa drugs and avocado. Concomitant medications/any other medications received by the patient within 2 weeks of vaccination included amitriptyline, propranolol and diclofenac potassium (CAMBIA); all were taken for migraine. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VCACINE; Lot Number: EL3247, Expiration date: Not reported), via an unspecified route of administration in left arm, on 10Mar2021 at 13:00 (at the age of 24-years-old) as dose 1, single for COVID-19 immunization and experienced sore muscles (around injection site and neck), mild headache and fatigue. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. A few hours following the vaccination on 31Mar2021 at 15:00, patient started to have some mild symptoms where the patient felt the soreness at injection site and in upper extremities. The patient also experienced sore muscles, fatigue and headache that got worse as the day went on and also had a low-grade fever for a little under a half-hour, but the symptoms were mild and manageable. Symptoms continued on the following morning/next day on 01Apr2021. These symptoms improved with rest and the patient has avoided rescue medication for migraines (Cambia) as the product was an NSAID, however under normal conditions, would have dosed to prevent a migraine following observation of headache and sore muscles. No treatment was received by the patient for these events. The outcome of these events was recovering at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: A few hours following the vaccine, patient started to feel sore at injection site and in upper extremities, but symptoms were mild and manageable.; A few hours following the vaccine, patient started to feel sore at injection site and in upper extremities, but symptoms were mild and manageable.; sore muscles; fatigue; headache; low-grade fever; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VCACINE; Lot Number: EP6955, Expiration date: Not reported), via an unspecified route of administration in left arm, on 31Mar2021 at 13:00 (at the age of 24-years-old) as dose 2, single for COVID-19 immunization in a workplace clinic. Medical history included chronic migraines. The patient had known allergies to sulfa drugs and avocado. Concomitant medications/any other medications received by the patient within 2 weeks of vaccination included amitriptyline, propranolol and diclofenac potassium (CAMBIA); all were taken for migraine. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VCACINE; Lot Number: EL3247, Expiration date: Not reported), via an unspecified route of administration in left arm, on 10Mar2021 at 13:00 (at the age of 24-years-old) as dose 1, single for COVID-19 immunization and experienced sore muscles (around injection site and neck), mild headache and fatigue. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. A few hours following the vaccination on 31Mar2021 at 15:00, patient started to have some mild symptoms where the patient felt the soreness at injection site and in upper extremities. The patient also experienced sore muscles, fatigue and headache that got worse as the day went on and also had a low-grade fever for a little under a half-hour, but the symptoms were mild and manageable. Symptoms continued on the following morning/next day on 01Apr2021. These symptoms improved with rest and the patient has avoided rescue medication for migraines (Cambia) as the product was an NSAID, however under normal conditions, would have dosed to prevent a migraine following observation of headache and sore muscles. No treatment was received by the patient for these events. The outcome of these events was recovering at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Bladder discomfort, Chest discomfort, Dyspnoea
Clinical narrative: Fever; chest pain, tighness in chest; shoulder, back, neck pain, body aches; shoulder, back, neck pain, body aches; shoulder, back, neck pain, body aches; headache and muscle spasms; headache and muscle spasms; This made it difficult for her to hold her bladder; short of breath; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6202, Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 01Apr2021 09:30 (at the age of 59 years old) as Dose 2, Single for covid-19 immunisation. Medical history included High Blood Pressure and Asthma from an unknown date and unknown if ongoing. No concomitant medications were reported. Historical vaccine included first dose of bnt162b2 (COMIRNATY, Solution, for injection batch/Lot Number EM9809, Expiry date was not reported) via an unspecified route of administration, administered in Arm Left as Dose 1, Single for covid-19 immunisation. The patient had not tested COVID post vaccination. The patient had not received any other vaccine within 4 weeks. On 01Apr2021,(at 21:30) the patient experienced, ever, chest pain, tightness in chest, shoulder, back, neck pain, body aches, headache and muscle spasms, this made it difficult for her to hold her bladder and short of breath. As a treatment patient received Toradol through her intravenous site and sodium chloride flush. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests and procedures which included blood culture: negative on 02Apr2021, blood culture: normal on 02Apr2021, body temperature: 102 on unspecified date, body temperature: 103 on unspecified date, electrocardiogram: normal on 02Apr2021, x-ray: normal on 02Apr2021. The outcome for the events was unknown.  No follow up attempts are possible. No further information is expected
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle spasms, Neck pain, Pyrexia
Clinical narrative: Fever; chest pain, tighness in chest; shoulder, back, neck pain, body aches; shoulder, back, neck pain, body aches; shoulder, back, neck pain, body aches; headache and muscle spasms; headache and muscle spasms; This made it difficult for her to hold her bladder; short of breath; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6202, Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 01Apr2021 09:30 (at the age of 59 years old) as Dose 2, Single for covid-19 immunisation. Medical history included High Blood Pressure and Asthma from an unknown date and unknown if ongoing. No concomitant medications were reported. Historical vaccine included first dose of bnt162b2 (COMIRNATY, Solution, for injection batch/Lot Number EM9809, Expiry date was not reported) via an unspecified route of administration, administered in Arm Left as Dose 1, Single for covid-19 immunisation. The patient had not tested COVID post vaccination. The patient had not received any other vaccine within 4 weeks. On 01Apr2021,(at 21:30) the patient experienced, ever, chest pain, tightness in chest, shoulder, back, neck pain, body aches, headache and muscle spasms, this made it difficult for her to hold her bladder and short of breath. As a treatment patient received Toradol through her intravenous site and sodium chloride flush. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests and procedures which included blood culture: negative on 02Apr2021, blood culture: normal on 02Apr2021, body temperature: 102 on unspecified date, body temperature: 103 on unspecified date, electrocardiogram: normal on 02Apr2021, x-ray: normal on 02Apr2021. The outcome for the events was unknown.  No follow up attempts are possible. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: headaches; fever; fatigue; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient's mother) reported for a 25-year-old female patient that:  A 25-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number; Unknown), via an unspecified route of administration as dose 1, single on an unspecified date for covid-19 immunisation. Medical history included headaches (but increases water intake and they have resolved) from an unknown date and unknown if ongoing. Concomitant medication included tofacitinib citrate (XELJANZ; Tablet) at 10 mg taken for an unspecified indication from 26Sep2020 to an unspecified stop date. Reported patient use to get headaches but increases water intake and they have resolved. Patient received Covid-19 vaccine yesterday and has been experiencing headache, fever and fatigue on unspecified date. At the time of this report, 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: Hypersensitivity, Rash
Clinical narrative: rash all over her body; developed a severe rash all over her body and had a systemic reaction; This is a spontaneous report from a non-contactable physician (reported behalf of one of his patients) received from a regulatory authority. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The physician reported that he had one female patient, which this happened about 2 weeks ago, that had the second dose of the Pfizer Covid 19 Vaccine and after 5 days the patient developed a severe rash all over her body and had a systemic reaction on an unspecified date. Reporter stated that the patient was taken to the ER and was treated and now was doing fine and the patient took Prednisone. Reporter stated the patient's son called him and the patient's son stated he called Pfizer to report the adverse events and Pfizer stated that the primary care provider should order some lab tests for the patient, which he was not aware of. Reporter stated he just wanted to see what lab tests he should order for this allergic reaction as he was unsure and felt bad because the patient's son called him, and the reporter was not aware of this and with the doctor promoting the vaccine he felt he should find out. The outcome of the events was recovered on an unspecified date.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: increased allergies; This is a spontaneous report from Pfizer sponsored program via a contactable consumer (patient, self-reported).  A male patient of an unspecified age received 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 unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that he was scheduled for his 2nd Pfizer vaccine this weekend. His allergies were kicking in (increased allergies) and would like to know if it was ok to take claritin. 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: Burning sensation, Chills, Decreased appetite, Dry skin, Fatigue
Clinical narrative: She added the bottoms of her feet feel fiery and dry; I can't stay up too long; She has chills, feeling tired, itching, hands are feeling numb and on fire, and no appetite since receiving her second dose.; She has chills, feeling tired, itching, hands are feeling numb and on fire, and no appetite since receiving her second dose; She has chills, feeling tired, itching, hands are feeling numb and on fire, and no appetite since receiving her second dose; She has chills, feeling tired, itching, hands are feeling numb and on fire, and no appetite since receiving her second dose; She has chills, feeling tired, itching, hands are feeling numb and on fire, and no appetite since receiving her second dose; She has chills, feeling tired, itching, hands are feeling numb and on fire, and no appetite since receiving her second dose; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EP6955) via an unspecified route of administration on 26Mar2021 as dose 2, single for covid-19 immunisation. Medical history included She had an allergy to Penicillin. She was having the same symptoms as if she was reacting to Penicillin, She had gained some weight. The patient's concomitant medications takes medications every day, details not provided. Previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot no.: EN6206) at left arm on 05Mar2021 as dose 1, single for covid-19 immunisation. The patient experienced chills, feeling tired, itching, hands are feeling numb and on fire, and no appetite since receiving her second dose on 26Mar2021. She added the bottoms of her feet feel fiery and dry, I can't stay up too long on an unspecified date. Patient did not any AE(s) require a visit to:  emergency room, physician office. The outcome of the event for dry skin and feeling abnormal was unknown and rest all were not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Pruritus
Clinical narrative: She added the bottoms of her feet feel fiery and dry; I can't stay up too long; She has chills, feeling tired, itching, hands are feeling numb and on fire, and no appetite since receiving her second dose.; She has chills, feeling tired, itching, hands are feeling numb and on fire, and no appetite since receiving her second dose; She has chills, feeling tired, itching, hands are feeling numb and on fire, and no appetite since receiving her second dose; She has chills, feeling tired, itching, hands are feeling numb and on fire, and no appetite since receiving her second dose; She has chills, feeling tired, itching, hands are feeling numb and on fire, and no appetite since receiving her second dose; She has chills, feeling tired, itching, hands are feeling numb and on fire, and no appetite since receiving her second dose; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EP6955) via an unspecified route of administration on 26Mar2021 as dose 2, single for covid-19 immunisation. Medical history included She had an allergy to Penicillin. She was having the same symptoms as if she was reacting to Penicillin, She had gained some weight. The patient's concomitant medications takes medications every day, details not provided. Previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot no.: EN6206) at left arm on 05Mar2021 as dose 1, single for covid-19 immunisation. The patient experienced chills, feeling tired, itching, hands are feeling numb and on fire, and no appetite since receiving her second dose on 26Mar2021. She added the bottoms of her feet feel fiery and dry, I can't stay up too long on an unspecified date. Patient did not any AE(s) require a visit to:  emergency room, physician office. The outcome of the event for dry skin and feeling abnormal was unknown and rest all were not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: fever for about 2 days; headache; chills the first night; This is a spontaneous report from a contactable consumer (Patient). This is part one of two reports. A 62-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: er8732) via an unspecified route of administration in the left arm on 26Mar2021 at 08:45 (at the age of 62-year-old) as dose 2, single for COVID-19 immunization. The Patient's Medical history included drug hypersensitivity from an unknown date and unknown if ongoing Gradual swelling over days due apparently to some inactive ingredients of some medications, seasonal allergy from an unknown date and unknown if ongoing hay fever, cough variant asthma from an unknown date and unknown if ongoing mild, cough-variant asthma. The patient had no food allergies. The patient received other medications in two weeks which included vitamin b complex (VITAMIN B [VITAMIN B COMPLEX]) taken for an unspecified indication, start and stop date were not reported. multivitamin (MANAFACTURER UNKNOWN), Nutritional yeast (MANAFACTURER UNKNOWN), turmeric (MANAFACTURER UNKNOWN) all from an unknown date for an unspecified indication. Previously patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number: en6199 and Expiry date was not reported), via an unspecified route of administration in the left arm on 05Mar2021 (at the age of 62-year-old) as dose 1, single for COVID-19 immunization and experienced headache. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since, the vaccination the patient had not been tested for COVID-19. On 26Mar2021 at 20:00, the patient experienced chills, fever, headache. Chills the first night and fever for about 2 days, headache starting the first night and lasting on and off for 8 days so far, often mild but sometimes moderate. Patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever, chills, and headache was resolving at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing, Throat irritation, Vaccination site bruising, Vaccination site erythema
Clinical narrative: still have a round red circle and a black and blue mark where she got the injection/Round circle on arm/ Black and blue mark on arm; sneeze; scratchy throat; runny nose; still have a round red circle and a black and blue mark where she got the injection; This is a spontaneous report from a contactable consumer or other non hcp.   A 57-years-old female patient received first dose bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: ER8732), via an unspecified route of administration, administered in Arm Right on 29Mar2021 09:15 (at the age of 57-years-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had her first shot on 29Mar2021 and experienced around circle on her arm and scratchy throat. The patient still had the circle on her arm and it had already been 8 days and patient was not sure how long it was supposed to last. scratchy throat was about the same or a little bit better. Over the weekend, Patient started to sneeze a lot and had a runny nose. Patient did not know if these were side effects because she was totally fine last week and prior to the shot. The sneezing started last week or early weekend. Patient confirmed that she was not sneezing a lot as of now. As of yesterday, the sneezing had not been as severe the sneezing was not all day long. The outcome of still have a round red circle and a black and blue mark where she got the injection was not recovered, recovering from vaccination site bruising, Otcome of the events scratchy throat and runny nose and sneeze was unknown.  Follow up (06April2021): This is a follow up spontaneous report received from a contactable consumer included: Age, additional events, event onset date and narrative information were updated.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Rash
Clinical narrative: felt like there was something that was surrounding her breath and on her skin; She has rashes on her arms and at the back; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) reported that:  A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 21Jan2021 as dose 1, single for covid-19 immunization and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 11Feb2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medication was not reported. On an unspecified date, she had rashes on her arms and at the back. She felt like there was something that was surrounding her breath and on her skin she mentioned that she was going to get an examination and see what it was. Patient said she had these experiences after she took the vaccine. 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: Pyrexia
Clinical narrative: "I took vaccine of Pfizer, was it yesterday at 9:15 and I was okay but now after 2 or 3 hours I got a fever."; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date it was reported that, patient took the Pfizer vaccine at 9:15, patient was fine but currently after 2 or 3 hours patient got a fever. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Epistaxis, Lip dry
Clinical narrative: she was bending down and had a heavy nose bleed from one nostril; lips and mouth were dry; lips and mouth were dry; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 83-years-old female patient received 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 03Mar2021 as dose 1, single for COVID-19 immunization. Medical history included ongoing epistaxis. The patient concomitant medications were not reported. It was reported that the day that she received her first vaccine on 03Mar2021, she was bending down and had a heavy nosebleed from one nostril. She had nose bleeds in the past but was not sure if this one might have been triggered from the vaccine. She also mentioned that her lips and mouth were dry. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Pain, Vaccination site swelling
Clinical narrative: Lymph node (under armpit) tenderness; swelling; very mild pain; This is a spontaneous report from a contactable consumer. This 38-year-old female consumer (patient) reported that.   A 38-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8730), dose 2 via an unspecified route of administration, administered in Arm Left on 02Apr2021 12:30 as (At the age of 38-years) dose 2, single for covid-19 immunisation. Medical history included, Mild Hypertension, and seasonal allergies from an unknown date and unknown if ongoing. List of any other medications the patient received within 2 weeks of vaccination included Losartan, Montelukast, Hydrochlorothiazide, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) all are taken for an unspecified indication, start and stop date were not reported. Patient was not diagnosed with COVID-19 Prior to vaccination. Patient was not tested for COVID-19 Since the vaccination. No Allergies to medications, food, or other products were reported. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6207), dose 1 via an unspecified route of administration, administered in Arm Left on 12Mar2021 12:30 PM as dose 1, single for covid-19 immunisation. The patient experienced lymph node (under armpit) tenderness, swelling, and very mild pain on 04Apr2021 03:00. Patient did not receive any tenement for events. The outcome of event was not recovered.  information about lot/batch number is available.  No follow-up attempts are needed. No further information is expected.