chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Contusion, Erythema, Pain, Peripheral swelling
Clinical narrative: left arm on 25Mar big red spot abd bruise abd hot; left arm on 25Mar big red spot abd bruise abd hot; left arm on 25Mar big red spot abd bruise abd hot; Arm Swelling Reaction; left arm got a large round rash; very painful; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6207, Expiry date: Jul2021) intramuscularly administered in Arm Left on 24Mar2021 15:45, as dose 2, single (at the age of 60-years-old) for COVID-19 immunization. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6203, Expiry date: Jun2021) via Intramuscularly administered in Arm Left on 03Mar2021 15:00 for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included diabetes mellitus, pre-diabetes and hypertension from an unknown date and unknown if ongoing, COVID-19 from 09Mar2021 taken to physician office patient was treated with inhaler Albuterol, patient recovered on 04Apr2021. Concomitant medications included acyclovir sodium (ACYCLOVIR SODIUM) taken for an unspecified indication, start and stop date were not reported; dulaglutide (TRULICITY) taken for Pre-Diabetes from an unspecified start date and ongoing; hctz (HCTZ) taken orally for High Blood Pressure from an unspecified start date and ongoing; lisinopril (LISINOPRIL) taken orally from an unspecified indication from an unspecified start date and ongoing; levothyroxine sodium (SYNTHROID) taken orally from an unspecified indication from an unspecified start date and ongoing. On 24Mar2021 the Patient experienced arm swelling reaction. On 25Mar2021, the patient experienced left arm on 25mar big red spot abd bruise abd hot. On unspecified date in Mar2021 patient experienced left arm got a large round rash, very painful. The patient went to physician office for the events arm swelling reaction, left arm on 25mar big red spot abd bruise abd hot and it was unknown if treatment was received for these events. It took 4-5 days to diminish. The patient underwent lab tests and procedures which included sars-cov-1 test: positive on 09Mar2021. Patient didn't receive any treatment for event arm swelling reaction. The outcome for arm swelling reaction was recovered on unspecified date of Mar2021, for left arm on 25mar big red spot abd bruise abd hot, left arm got a large round rash, very painful was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-1 test
Clinical narrative: left arm on 25Mar big red spot abd bruise abd hot; left arm on 25Mar big red spot abd bruise abd hot; left arm on 25Mar big red spot abd bruise abd hot; Arm Swelling Reaction; left arm got a large round rash; very painful; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6207, Expiry date: Jul2021) intramuscularly administered in Arm Left on 24Mar2021 15:45, as dose 2, single (at the age of 60-years-old) for COVID-19 immunization. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6203, Expiry date: Jun2021) via Intramuscularly administered in Arm Left on 03Mar2021 15:00 for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included diabetes mellitus, pre-diabetes and hypertension from an unknown date and unknown if ongoing, COVID-19 from 09Mar2021 taken to physician office patient was treated with inhaler Albuterol, patient recovered on 04Apr2021. Concomitant medications included acyclovir sodium (ACYCLOVIR SODIUM) taken for an unspecified indication, start and stop date were not reported; dulaglutide (TRULICITY) taken for Pre-Diabetes from an unspecified start date and ongoing; hctz (HCTZ) taken orally for High Blood Pressure from an unspecified start date and ongoing; lisinopril (LISINOPRIL) taken orally from an unspecified indication from an unspecified start date and ongoing; levothyroxine sodium (SYNTHROID) taken orally from an unspecified indication from an unspecified start date and ongoing. On 24Mar2021 the Patient experienced arm swelling reaction. On 25Mar2021, the patient experienced left arm on 25mar big red spot abd bruise abd hot. On unspecified date in Mar2021 patient experienced left arm got a large round rash, very painful. The patient went to physician office for the events arm swelling reaction, left arm on 25mar big red spot abd bruise abd hot and it was unknown if treatment was received for these events. It took 4-5 days to diminish. The patient underwent lab tests and procedures which included sars-cov-1 test: positive on 09Mar2021. Patient didn't receive any treatment for event arm swelling reaction. The outcome for arm swelling reaction was recovered on unspecified date of Mar2021, for left arm on 25mar big red spot abd bruise abd hot, left arm got a large round rash, very painful was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Confusional state, Dyspnoea, Fatigue
Clinical narrative: Muscle weakness/Tingling, weakness, and heaviness in my left arm and hand; Tingling in face and body/Tingling in my left arm and hand/Tingling and clinching in my jaw (both).; chills; some shortness of breath; some confusion; fatigue; heaviness in my left arm and hand.; clinching in my jaw (both); This is a spontaneous report from a contactable other healthcare professional (patient). A 46-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: ER2613, expiration date was not reported) via an unspecified route of administration, in left arm, on 17Mar2021 08:00 (at the age of 46-years-old), at dose 1, single for covid-19 immunization from hospital. Medical history included covid-19 on 21Jan2021 and continued with some long-haul symptoms since diagnosis (shortness of breath), acid reflux and constipation. Concomitant medications included azithromycin (Z-PAK); hydroxyzine hydrochloride (VISTARIL); fexofenadine hydrochloride (ALLEGRA); lansoprazole (PREVACID); bupropion hydrochloride (WELLBUTRIN); xylometazoline hydrochloride (NASAL SPRAY II). The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient has not been tested with covid-19 since the vaccination. The patient experienced muscle weakness/weakness in left arm and hand, tingling in face and body/tingling in left arm and hand/tingling and clinching in jaw (both), chills, some shortness of breath, some confusion, fatigue and heaviness in left arm and hand on 17Mar2021 08:30. The reporter assessed the case as non-serious. No treatment was received for the events. The patient underwent lab tests and procedures which included covid-19: positive on 21Jan2021. The outcome of the events was recovering.  Follow-up #1 (27Mar2021): New information received from the same contactable other healthcare professional (patient) which includes: medical history details (shortness of breath, onset date for covid-19), concomitant drug details (Prevacid), reaction data (muscle weakness, some shortness of breath)  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Muscle tightness, Muscular weakness, Paraesthesia
Clinical narrative: Muscle weakness/Tingling, weakness, and heaviness in my left arm and hand; Tingling in face and body/Tingling in my left arm and hand/Tingling and clinching in my jaw (both).; chills; some shortness of breath; some confusion; fatigue; heaviness in my left arm and hand.; clinching in my jaw (both); This is a spontaneous report from a contactable other healthcare professional (patient). A 46-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: ER2613, expiration date was not reported) via an unspecified route of administration, in left arm, on 17Mar2021 08:00 (at the age of 46-years-old), at dose 1, single for covid-19 immunization from hospital. Medical history included covid-19 on 21Jan2021 and continued with some long-haul symptoms since diagnosis (shortness of breath), acid reflux and constipation. Concomitant medications included azithromycin (Z-PAK); hydroxyzine hydrochloride (VISTARIL); fexofenadine hydrochloride (ALLEGRA); lansoprazole (PREVACID); bupropion hydrochloride (WELLBUTRIN); xylometazoline hydrochloride (NASAL SPRAY II). The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient has not been tested with covid-19 since the vaccination. The patient experienced muscle weakness/weakness in left arm and hand, tingling in face and body/tingling in left arm and hand/tingling and clinching in jaw (both), chills, some shortness of breath, some confusion, fatigue and heaviness in left arm and hand on 17Mar2021 08:30. The reporter assessed the case as non-serious. No treatment was received for the events. The patient underwent lab tests and procedures which included covid-19: positive on 21Jan2021. The outcome of the events was recovering.  Follow-up #1 (27Mar2021): New information received from the same contactable other healthcare professional (patient) which includes: medical history details (shortness of breath, onset date for covid-19), concomitant drug details (Prevacid), reaction data (muscle weakness, some shortness of breath)  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: Sore arm; nausea; body aches; Chills; fever; headache; This is a spontaneous report received from a contactable consumer or other non HCP. A 33-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sore arm, nausea, body aches, chills, fever, headache on an unspecified date. The clinical outcome of the event was unknown.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Sore arm; nausea; body aches; Chills; fever; headache; This is a spontaneous report received from a contactable consumer or other non HCP. A 33-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sore arm, nausea, body aches, chills, fever, headache on an unspecified date. The clinical outcome of the event was unknown.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Achy Joints; This is a spontaneous report from a non-contactable consumer (patient). A 40-year-old female patient received BNT162B2 (FIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6204), via an unspecified route of administration on 03Mar2021 11:00 (at the age of 40-years-old) as dose 1, single for COVID-19 immunization. Medical history included ongoing hypothalesemia, asthma and allergy to Percocet. Concomitant medications included cetirizine hydrochloride (ZYRTEC), beclometasone dipropionate (QVAR) and lorazepam (ATIVAN). The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced achy joints in Mar2021. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for this event. The clinical outcome of achy joints was recovered in Mar2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: rash on neck area/itching; 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), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the Covid-19 vaccine on Saturday morning and noticed the day prior (24Mar2021) that she has a rash on the neck area where the throat is and travelling up to Adam's apple, it's a pretty good size rash. The patient applied Benadryl gel on it for the itching as it was unbearable. The patient stated she is a senior and she has a healthcare person who comes in to care for her. The patient then asked what she should do. The outcome of the event was unknown.   No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasopharyngitis, Rash
Clinical narrative: from 7-14 days after the first shot, she developed a small rash (irritated rash) on her neck and arm which has since resolved and recently a cough like a cold.; from 7-14 days after the first shot, she developed a small rash (irritated rash) on her neck and arm which has since resolved and recently a cough like a cold.; from 7-14 days after the first shot, she developed a small rash (irritated rash) on her neck and arm which has since resolved and recently a cough like a cold.; This is spontaneous report from a contactable consumer (patient). A 65-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history included respiratory problems from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. On unspecified date, the patient took first dose of Pfizer COVID vaccine about 3 weeks ago and had no problems afterwards but states anywhere from 7-14 days after the first shot, she developed a small rash (irritated rash) on her neck and arm which has since resolved and recently a cough like a cold. Patient states she applied antiitch topically to her rash. States she was due for her second shot today. States she read that if she experienced a rash then she shouldn't get the second shot. The outcome of events was unknown.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash developed in left armpit.Rash stayed predominantly in arm pit, but a few spots on upper arm and chest over the next couple days; This is a spontaneous report from a contactable consumer. A 56-years-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 20Mar2021 08:30 as (at the age of 56 years old) dose 1, single for covid-19 immunization. Medical history included tongue cancer metastatic from 2017 to 2017 (diagnosed/treated 2017), spleen disorder from 2017 to 2017 spleen removed. The patient's concomitant medications were not reported. The patient had not received any other vaccine within 4 weeks. It was reported unknown if patient taken any medication 2 weeks prior to vaccination. Patient had no known allergies. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 24Mar2021 four days after vaccine the patient experienced rash developed in left armpit, rash stayed predominantly in arm pit, but a few spots on upper arm and chest over the next couple days. Upon follow-up (01Apr2021) it was questioned to confirm awareness date that reporter became aware of the adverse events in this report as this effects regulatory reporting timelines for report # Submitted on 29Mar2021. This awareness date is the date reporter became aware of the occurrence of the reported events. It was reported that, if you are the patient in the case, your awareness date would be the date that you became aware you were experiencing the reported events. If you are not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events. This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If you learned of these events from another Pfizer colleague, please provide the date that the first Pfizer colleague became aware of the events reported, as regulatory reporting due dates are calculated based on the first day that a Pfizer colleague became aware of the adverse events was 29Mar2021 as per the response. Therapeutic measures were taken as a result of rash developed in left armpit, rash stayed predominantly in arm pit, but a few spots on upper arm and chest over the next couple days included with Steroids-oral & topical. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered.  Follow-up (01Apr2021): This is a follow-up spontaneous report in response to mail trail sent regarding the confirmation of below mentioned query. This report included that: Awareness date confirmed.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Eye pain, Fatigue
Clinical narrative: Caller states she started having "a headache, chills that started last night at 11pm, I am also tired and weak."; Caller states she started having "a headache, chills that started last night at 11pm, I am also tired and weak."; Caller states she started having "a headache, chills that started last night at 11pm, I am also tired and weak."; she has a flu; eyeballs hurt; her joints and muscles hurt; her joints and muscles hurt; she had no energy/ I am also tired and weak."; She was cold around 11:something pm; This is a spontaneous report received from contactable consumer. A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6298) via intramuscular, administered in Arm Left on 27Mar2021 11:00 (age at vaccination 63-years-old) as dose 1, single for covid-19 immunisation. Medical history included lupus-like syndrome from 2008 to an unknown date and it is in remission now, ongoing kidney diseases maybe from 2 year ago or 3 years ago, deteriorated discs in the neck and the back from 2010 and ongoing. The patient concomitant medications were not reported. On 28Mar2021 23:00, patient stated that she started having a headache, chills that started last night at 11pm, I am also tired and weak, she has a flu, eyeballs hurt, her joints and muscles hurt, she had no energy/ I am also tired and weak. She was cold around 11 something pm. She was weak, she had no energy at all. Reporter asked are these normal side effects of the vaccine. No treatment was received. No other vaccine was received prior to vaccination with in four weeks. No ae prior to vaccination. she does not even get the flu shot. Outcome of the event cold was unknown and other events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Myalgia, Nasopharyngitis
Clinical narrative: Caller states she started having "a headache, chills that started last night at 11pm, I am also tired and weak."; Caller states she started having "a headache, chills that started last night at 11pm, I am also tired and weak."; Caller states she started having "a headache, chills that started last night at 11pm, I am also tired and weak."; she has a flu; eyeballs hurt; her joints and muscles hurt; her joints and muscles hurt; she had no energy/ I am also tired and weak."; She was cold around 11:something pm; This is a spontaneous report received from contactable consumer. A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6298) via intramuscular, administered in Arm Left on 27Mar2021 11:00 (age at vaccination 63-years-old) as dose 1, single for covid-19 immunisation. Medical history included lupus-like syndrome from 2008 to an unknown date and it is in remission now, ongoing kidney diseases maybe from 2 year ago or 3 years ago, deteriorated discs in the neck and the back from 2010 and ongoing. The patient concomitant medications were not reported. On 28Mar2021 23:00, patient stated that she started having a headache, chills that started last night at 11pm, I am also tired and weak, she has a flu, eyeballs hurt, her joints and muscles hurt, she had no energy/ I am also tired and weak. She was cold around 11 something pm. She was weak, she had no energy at all. Reporter asked are these normal side effects of the vaccine. No treatment was received. No other vaccine was received prior to vaccination with in four weeks. No ae prior to vaccination. she does not even get the flu shot. Outcome of the event cold was unknown and other events was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: When he came home from work, he ran a fever of 102.9F.; This is a spontaneous report from a contactable consumer or other non hcp (parent). This consumer reported for a 30-year-male (Son) Patient. A 30-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced when he came home from work, he ran a fever of 102.9f. The patient underwent lab tests and procedures which included body temperature: 102.9 Fahrenheit on an unspecified date. The clinical outcome of the event was unknown at the time of vaccination.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Tenderness
Clinical narrative: swollen gland in my neck; some tenderness in my neck glands but it was not swollen as much; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received first dose of 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 08Mar2021 18:30 as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, patient had her first dose on 08Mar2021 and a few hours later she had swollen gland in her neck on an unspecified date in Mar2021. The next morning when she woke up it was gone. However a couple of days ago she noticed some tenderness in her neck glands but it was not swollen as much. She was not sure if it was related to some yard work that she was doing and/or allergies. Consumer stated, she was calling to find out if it was okay to get her second vaccine because her glands were a little tender and swollen a little bit when she took the first shot. The outcome of both the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot been obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pain in jaw
Clinical narrative: she has experienced pain in her shoulder blades; she has experienced pain in her jaw; and has had a headache; This is a spontaneous report from a contactable consumer. A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP6955; Expiration Date: 30Jun2021), via an unspecified route of administration on 22Mar2021 at the age of the 51-year-old as dose 1, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. On Mar2021 patient experienced pain in her shoulder blades, jaw, and has had a headache. Taking Advil helps the pain go away but it comes back. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vaccination site pain
Clinical narrative: Dose 1 had only very mild symptoms (mild fever (99 F); Dose 1 had only very mild symptoms (injection site soreness day after); This is a spontaneous report from a non-contactable consumer (patient himself). A 60-years-old male patient received first dose of bnt162b2 (Solution injection; Batch/Lot Number: EN6208), via an unspecified route of administration, administered in Arm Left on 06Mar2021 at 01:15 (at the age of 60-years-old) as single dose for covid-19 immunisation. Medical history included moderate hypertension. Patient had no known allergies. The patient's concomitant medications were not reported. Patient did not receive any other vaccine in four weeks. Patient was not diagnosed with covid prior vaccination. Patient was not tested for covid post vaccination. Patient reported that he experienced only very mild symptoms of injection site soreness day after and mild fever (99 F) 4 days after dose 1. All the dose 1 symptoms resolved on their own without treatment. The patient underwent lab tests and procedures which included body temperature which was 99 fahrenheit. The outcome of the events was recovered on unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Headache, Muscular weakness, Peripheral swelling
Clinical narrative: intense swelling in hands and feet making it difficult to walk/grasp; intense swelling in hands and feet making it difficult to walk/grasp; intense swelling in hands and feet making it difficult to walk/grasp; hives on legs/hives covered most all of body to include face and neck; mild fatigue; headache; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3248; Expiration Date: Apr2021), via an unspecified route of administration on 23Mar2021 08:00 as dose 2, single for COVID-19 immunization. Medical history included ongoing Scalp disorder. Concomitant medication included ongoing topical steroid for scalp. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient experienced mild fatigue and headache on an unspecified date in Mar2021, hives on legs/hives covered most all of body to include face and neck on 26Mar2021 and intense swelling in hands and feet making it difficult to walk/grasp on 27Mar2021. It was reported that morning of 26Mar2021, began to notice hives on legs. By end of day 26Mar2021, hives covered most all of body, went to urgent care, and began taking Benadryl to no effect. By morning 27Mar2021, hives covered all of body to include face and neck, intense swelling in hands and feet making it difficult to walk/grasp. Returned to urgent care, no life-threatening danger, received prescription strength antihistamine which helped reduce symptoms. Morning 29Mar2021, back to regular fatigue and mild swelling, no hives. Outcome of event mild fatigue was not resolved; Outcome headache was unknown. Event hives on legs/hives covered most all of body to include face and neck was resolved on 29Mar2021; intense swelling in hands and feet making it difficult to walk/grasp was resolving.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: intense swelling in hands and feet making it difficult to walk/grasp; intense swelling in hands and feet making it difficult to walk/grasp; intense swelling in hands and feet making it difficult to walk/grasp; hives on legs/hives covered most all of body to include face and neck; mild fatigue; headache; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3248; Expiration Date: Apr2021), via an unspecified route of administration on 23Mar2021 08:00 as dose 2, single for COVID-19 immunization. Medical history included ongoing Scalp disorder. Concomitant medication included ongoing topical steroid for scalp. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient experienced mild fatigue and headache on an unspecified date in Mar2021, hives on legs/hives covered most all of body to include face and neck on 26Mar2021 and intense swelling in hands and feet making it difficult to walk/grasp on 27Mar2021. It was reported that morning of 26Mar2021, began to notice hives on legs. By end of day 26Mar2021, hives covered most all of body, went to urgent care, and began taking Benadryl to no effect. By morning 27Mar2021, hives covered all of body to include face and neck, intense swelling in hands and feet making it difficult to walk/grasp. Returned to urgent care, no life-threatening danger, received prescription strength antihistamine which helped reduce symptoms. Morning 29Mar2021, back to regular fatigue and mild swelling, no hives. Outcome of event mild fatigue was not resolved; Outcome headache was unknown. Event hives on legs/hives covered most all of body to include face and neck was resolved on 29Mar2021; intense swelling in hands and feet making it difficult to walk/grasp was resolving.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Hedaches; Fever; General soreness and aching across entire body; A little soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 25Mar2021 at approximately 8:30 (at the age of 32-year-old) (Lot Number: EK5730) as dose 2, single for COVID-19 immunization. Medical history included high blood pressure. The patient's concomitant medications included lisinopril for unknown indication, start and stop date not provided. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 04Mar2021 (at the age of 32-year-old) (Lot Number: EJ1685) as dose 1, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced besides a little soreness at injection site on Thursday 25Mar2021 and had hedaches, fever of 100.1-100.5, general soreness and aching across entire body (not just at site of injection) symptoms subsided after 36 hours on 26Mar2021 (reported as between 24 -36 hours after taking vaccination and between 8 to 9:30). The patient received treatment with ibuprofen (ADVIL) for fever. The outcome of event pain was recovered and the outcome of other events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Inappropriate schedule of product administration, Insomnia
Clinical narrative: had my second Covid vaccination Pfizer 6 days ago in my left shoulder and my left shoulder is really hurting it, it's radiating into my scapula and having trouble slee; had my second Covid vaccination Pfizer 6 days ago in my left shoulder and my left shoulder is really hurting it, it's radiating into my scapula and having trouble slee; Weakness so bad she can hardly get out of bed and; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported for herself that. A female patient of an unspecified age received (BNT162B2, formulation: Solution for injection, Lot Number: EN6207), via an unspecified route of administration, administered in Arm Left on 22Mar2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included High blood pressure from an unknown date and unknown if ongoing. Concomitant medications included lisinopril taken for blood pressure measurement, start and stop date were not reported. Historical vaccine included (BNT162B2, formulation: Solution for injection, Lot Number: EN6201), via an unspecified route of administration on 17Mar2021 as dose 1 single for covid-19 immunisation. It was reported stated she had her second Covid vaccination Pfizer 6 days ago in she left shoulder and she left shoulder is really hurting it, it's radiating into she scapula and having trouble sleeping, weakness so bad she can hardly get out of bed and go to the bathroom on 22Mar2021. She just wondered if there is something she could or should do about that. The clinical outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021329823 similar report from same reporter
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure increased, Blood pressure measurement, Dyspnoea, Peripheral swelling
Clinical narrative: Elevated blood pressure; shortness of breath; swelling in feet; aching joints; This is a spontaneous report from a contactable consumer. A 70-years-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: EN6202), dose 1 via an unspecified route of administration, administered in Arm Right on 26Feb2021 08:30 as dose 1, single, dose 2 via an unspecified route of administration, administered in Arm Left on 19Mar2021 (Batch/Lot Number: EN6207) as dose 2, single for covid-19 immunisation (at the age of 70 years). Medical history included allergies from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID 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 14Mar2021 05:00 PM patient experienced Elevated blood pressure, shortness of breath, swelling in feet, aching joints. When confirmed that the side effects happened with the first shot and confirmed the side effects from the second dose, consumer stated, I am having same problem except it's little worst. The patient was not received treatment. The adverse event result in any doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Cyanosis, Feeling hot, Influenza like illness
Clinical narrative: her fingernails were turning purple at some point; She has a knot near her injection site, right next to it. The knot has gotten bigger. The knot is hot, swollen, hard, and very red. The knot has doubled in size.; She has a knot near her injection site, right next to it. The knot has gotten bigger. The knot is hot, swollen, hard, and very red. The knot has doubled in size.; She has a knot near her injection site, right next to it. The knot has gotten bigger. The knot is hot, swollen, hard, and very red. The knot has doubled in size./She also felt hot to touch; She has a knot near her injection site, right next to it. The knot has gotten bigger. The knot is hot, swollen, hard, and very red. The knot has doubled in size.; The knot has gotten bigger/Clarified that the knot is not super raised, but it is swollen. The knot is expanding outward, it is spreading across her arm; She had flu like symptoms; Fever; She had chills, shivers and was shaking; She had chills, shivers and was shaking; She also felt hot to touch; This is a spontaneous report from a contactable consumer (patient). A 25-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EP6955) via an unspecified route of administration, administered in Arm Right (right bicep area) on 26Mar2021 11:00 (at the age of 25-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included she was allergic to penicillin. The patient's concomitant medications were not reported. Previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN6204) at right bicep area (Right arm as dose 1, single on 05Mar2021 at 11:00 (at the age of 25-year-old) for covid-19 immunisation. The patient experienced she had flu like symptoms on 26Mar2021 21:30 and fever, she had chills, shivers and was shaking on 26Mar2021, she also felt hot to touch on 26Mar2021, she has a knot near her injection site, right next to it. the knot has gotten bigger. the knot is hot, swollen, hard, and very red (Her chills, shivers and shaking was the main problem for her, freezing. She also felt hot to touch). the knot has doubled in size; was reported as worsened, about 13 hours later, the knot has gotten bigger/clarified that the knot is not super raised, but it is swollen. the knot is expanding outward, it is spreading across her arm on 27Mar2021, her fingernails were turning purple at some point on an unspecified date. Patient did not any AE(s) require a visit to emergency room and physician office. The outcome of the event Flu like symptoms, chills, shivers and was shaking, She also felt hot to touch was recovered on 28Mar2021 and Fever recovered on 26Mar2021, outcome for her fingernails were turning purple at some point was unknown and rest all event were not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor, Vaccination site erythema, Vaccination site reaction, Vaccination site swelling
Clinical narrative: her fingernails were turning purple at some point; She has a knot near her injection site, right next to it. The knot has gotten bigger. The knot is hot, swollen, hard, and very red. The knot has doubled in size.; She has a knot near her injection site, right next to it. The knot has gotten bigger. The knot is hot, swollen, hard, and very red. The knot has doubled in size.; She has a knot near her injection site, right next to it. The knot has gotten bigger. The knot is hot, swollen, hard, and very red. The knot has doubled in size./She also felt hot to touch; She has a knot near her injection site, right next to it. The knot has gotten bigger. The knot is hot, swollen, hard, and very red. The knot has doubled in size.; The knot has gotten bigger/Clarified that the knot is not super raised, but it is swollen. The knot is expanding outward, it is spreading across her arm; She had flu like symptoms; Fever; She had chills, shivers and was shaking; She had chills, shivers and was shaking; She also felt hot to touch; This is a spontaneous report from a contactable consumer (patient). A 25-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EP6955) via an unspecified route of administration, administered in Arm Right (right bicep area) on 26Mar2021 11:00 (at the age of 25-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included she was allergic to penicillin. The patient's concomitant medications were not reported. Previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN6204) at right bicep area (Right arm as dose 1, single on 05Mar2021 at 11:00 (at the age of 25-year-old) for covid-19 immunisation. The patient experienced she had flu like symptoms on 26Mar2021 21:30 and fever, she had chills, shivers and was shaking on 26Mar2021, she also felt hot to touch on 26Mar2021, she has a knot near her injection site, right next to it. the knot has gotten bigger. the knot is hot, swollen, hard, and very red (Her chills, shivers and shaking was the main problem for her, freezing. She also felt hot to touch). the knot has doubled in size; was reported as worsened, about 13 hours later, the knot has gotten bigger/clarified that the knot is not super raised, but it is swollen. the knot is expanding outward, it is spreading across her arm on 27Mar2021, her fingernails were turning purple at some point on an unspecified date. Patient did not any AE(s) require a visit to emergency room and physician office. The outcome of the event Flu like symptoms, chills, shivers and was shaking, She also felt hot to touch was recovered on 28Mar2021 and Fever recovered on 26Mar2021, outcome for her fingernails were turning purple at some point was unknown and rest all event were not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: her fingernails were turning purple at some point; She has a knot near her injection site, right next to it. The knot has gotten bigger. The knot is hot, swollen, hard, and very red. The knot has doubled in size.; She has a knot near her injection site, right next to it. The knot has gotten bigger. The knot is hot, swollen, hard, and very red. The knot has doubled in size.; She has a knot near her injection site, right next to it. The knot has gotten bigger. The knot is hot, swollen, hard, and very red. The knot has doubled in size./She also felt hot to touch; She has a knot near her injection site, right next to it. The knot has gotten bigger. The knot is hot, swollen, hard, and very red. The knot has doubled in size.; The knot has gotten bigger/Clarified that the knot is not super raised, but it is swollen. The knot is expanding outward, it is spreading across her arm; She had flu like symptoms; Fever; She had chills, shivers and was shaking; She had chills, shivers and was shaking; She also felt hot to touch; This is a spontaneous report from a contactable consumer (patient). A 25-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EP6955) via an unspecified route of administration, administered in Arm Right (right bicep area) on 26Mar2021 11:00 (at the age of 25-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included she was allergic to penicillin. The patient's concomitant medications were not reported. Previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN6204) at right bicep area (Right arm as dose 1, single on 05Mar2021 at 11:00 (at the age of 25-year-old) for covid-19 immunisation. The patient experienced she had flu like symptoms on 26Mar2021 21:30 and fever, she had chills, shivers and was shaking on 26Mar2021, she also felt hot to touch on 26Mar2021, she has a knot near her injection site, right next to it. the knot has gotten bigger. the knot is hot, swollen, hard, and very red (Her chills, shivers and shaking was the main problem for her, freezing. She also felt hot to touch). the knot has doubled in size; was reported as worsened, about 13 hours later, the knot has gotten bigger/clarified that the knot is not super raised, but it is swollen. the knot is expanding outward, it is spreading across her arm on 27Mar2021, her fingernails were turning purple at some point on an unspecified date. Patient did not any AE(s) require a visit to emergency room and physician office. The outcome of the event Flu like symptoms, chills, shivers and was shaking, She also felt hot to touch was recovered on 28Mar2021 and Fever recovered on 26Mar2021, outcome for her fingernails were turning purple at some point was unknown and rest all event were not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Nausea, Pain in extremity, Pyrexia
Clinical narrative: fever; nausea; sore arm; This is a spontaneous report from a contactable consumer or other non hcp.   A 75-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included covid-19 from Dec2020 to an unknown date. The patient's concomitant medications were not reported. The Consumer reports that she administered with the first dose of the Pfizer's COVID-19 vaccine on Saturday, and they developed side effects after the administration of the vaccine. experienced fever, nausea and a sore arm after the administration of the first dose of the vaccine. The Consumer reports that the last 2 weeks she started to have the symptoms for COVID-19 infection again and she performed laboratory tests that denied having an infection for COVID-19 and Flu. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Headache, Pain in extremity
Clinical narrative: low grade temp; arm sore; fatigue; fever/temp above 100.3; bad headache; her back, neck, shoulder and hips are gone; This is a spontaneous report from a contactable nurse (patient). A (Age: 65; Unit: Unknown) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 vaccine, on an unspecified date, as a single dose for COVID-19 immunization. On an unspecified date, the patient experienced low grade temp, arm sore, fatigue, fever/temp above 100.3, bad headache, and her back, neck, shoulder and hips are gone. On an unspecified date, the patient underwent lab tests and procedures which included Body temperature: 100.3. Caller wanted to know what test she can do that can tell if she has any protection after the second dose. The outcome of the event low grade temp, sore arm was recovered on an unspecified date; and all other events were unknown.  No follow up attempts are possible. Information about lot/batch number cannot be requested.