chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: missed the appointment for the second dose and wants to receive the second dose now, more than 42 days after the first one; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed the appointment for the second dose and wants to receive the second dose now, more than 42 days after the first one) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed the appointment for the second dose and wants to receive the second dose now, more than 42 days after the first one). In 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed the appointment for the second dose and wants to receive the second dose now, more than 42 days after the first one) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Tremor
Clinical narrative: Sore arm after both shots; Tired; Couldn't stop shaking; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm after both shots), TREMOR (Couldn't stop shaking) and FATIGUE (Tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced TREMOR (Couldn't stop shaking). On 20-Feb-2021, the patient experienced FATIGUE (Tired). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm after both shots). On 20-Feb-2021, TREMOR (Couldn't stop shaking) had resolved. On 22-Feb-2021, FATIGUE (Tired) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm after both shots) outcome was unknown. Unknown          Concomitant product use was not provided by the reporter. Treatment medication use was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Gait disturbance, Groin pain
Clinical narrative: Pain in her left thigh/left leg was nothing but pain/pain suddenly went into her right leg; Could hardly walk at all; Both of her knees were swollen/big ball in the back of her knee; Pain in her groin; Real bad chills, day and night; Pain in the muscle; Both of her knees hurt; Left leg got cramps; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Left leg got cramps), PAIN IN EXTREMITY (Pain in her left thigh/left leg was nothing but pain/pain suddenly went into her right leg), GAIT DISTURBANCE (Could hardly walk at all), JOINT SWELLING (Both of her knees were swollen/big ball in the back of her knee) and GROIN PAIN (Pain in her groin) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced MUSCLE SPASMS (Left leg got cramps). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in her left thigh/left leg was nothing but pain/pain suddenly went into her right leg), GAIT DISTURBANCE (Could hardly walk at all), JOINT SWELLING (Both of her knees were swollen/big ball in the back of her knee), GROIN PAIN (Pain in her groin), CHILLS (Real bad chills, day and night), MYALGIA (Pain in the muscle) and ARTHRALGIA (Both of her knees hurt). At the time of the report, MUSCLE SPASMS (Left leg got cramps), PAIN IN EXTREMITY (Pain in her left thigh/left leg was nothing but pain/pain suddenly went into her right leg), GAIT DISTURBANCE (Could hardly walk at all), JOINT SWELLING (Both of her knees were swollen/big ball in the back of her knee), GROIN PAIN (Pain in her groin), CHILLS (Real bad chills, day and night), MYALGIA (Pain in the muscle) and ARTHRALGIA (Both of her knees hurt) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102 F.         No relevant concomitant medications were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Muscle spasms, Myalgia, Pain in extremity
Clinical narrative: Pain in her left thigh/left leg was nothing but pain/pain suddenly went into her right leg; Could hardly walk at all; Both of her knees were swollen/big ball in the back of her knee; Pain in her groin; Real bad chills, day and night; Pain in the muscle; Both of her knees hurt; Left leg got cramps; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Left leg got cramps), PAIN IN EXTREMITY (Pain in her left thigh/left leg was nothing but pain/pain suddenly went into her right leg), GAIT DISTURBANCE (Could hardly walk at all), JOINT SWELLING (Both of her knees were swollen/big ball in the back of her knee) and GROIN PAIN (Pain in her groin) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced MUSCLE SPASMS (Left leg got cramps). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in her left thigh/left leg was nothing but pain/pain suddenly went into her right leg), GAIT DISTURBANCE (Could hardly walk at all), JOINT SWELLING (Both of her knees were swollen/big ball in the back of her knee), GROIN PAIN (Pain in her groin), CHILLS (Real bad chills, day and night), MYALGIA (Pain in the muscle) and ARTHRALGIA (Both of her knees hurt). At the time of the report, MUSCLE SPASMS (Left leg got cramps), PAIN IN EXTREMITY (Pain in her left thigh/left leg was nothing but pain/pain suddenly went into her right leg), GAIT DISTURBANCE (Could hardly walk at all), JOINT SWELLING (Both of her knees were swollen/big ball in the back of her knee), GROIN PAIN (Pain in her groin), CHILLS (Real bad chills, day and night), MYALGIA (Pain in the muscle) and ARTHRALGIA (Both of her knees hurt) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102 F.         No relevant concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Pyrexia, Rash
Clinical narrative: the vaccine made me pretty ill; rash; fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (the vaccine made me pretty ill), RASH (rash) and PYREXIA (fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (the vaccine made me pretty ill), RASH (rash) and PYREXIA (fever). At the time of the report, ILLNESS (the vaccine made me pretty ill), RASH (rash) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vaccination site pain
Clinical narrative: Chills for two days post second dose; pain in injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (pain in injection site) and CHILLS (Chills for two days post second dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Lymphedema.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, the patient experienced VACCINATION SITE PAIN (pain in injection site). On 13-Sep-2021, the patient experienced CHILLS (Chills for two days post second dose). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency; NAPROXEN for Pain, at an unspecified dose and frequency and PARACETAMOL for Pain, at an unspecified dose and frequency. On 15-Sep-2021, CHILLS (Chills for two days post second dose) had resolved. At the time of the report, VACCINATION SITE PAIN (pain in injection site) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the site of the injection) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Diabetic, Hypertension, Myositis and Immunocompromised.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced VACCINATION SITE PAIN (Pain at the site of the injection). At the time of the report, VACCINATION SITE PAIN (Pain at the site of the injection) outcome was unknown.            No concomitant medications reported. No treatment reported
Age: 53.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided by the reporter. Treatment medication was not reported.  Vaccine was administered after 4days from first puncture of vial.   Reporter did not allow further contact; Sender's Comments: This report refers to a case of Expired vaccine used for mRNA-1273, Lot# 037C21A with no associated AEs. Causality for this medication error is not applicable.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort
Clinical narrative: minimal discomfort; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (minimal discomfort) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (minimal discomfort). At the time of the report, DISCOMFORT (minimal discomfort) outcome was unknown.            No treatment medication was reported. No Concomitant medication was reported. No lab data was provided.   This case was linked to MOD-2021-329830, MOD-2021-335336 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Decreased appetite, Loss of personal independence in daily activities, Nausea, Vomiting
Clinical narrative: Vomiting; Upset stomach; loss of appetite; she cannot have her on the school campus like that.; Nausea; This is a spontaneous report from a contactable nurse (patient's mother). A 16-year-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 02Aug2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (Bnt162b2, Solution for injection) via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. On 03Aug2021 she started vomiting. On an unspecified date in Aug2021, the patient experienced nausea, upset stomach, loss of appetite, she cannot have her on the school campus like that. She was still felt nauseous like she was going to throw up. Outcome of the events loss of appetite and she cannot have her on the school campus like that were unknown and outcome of rest all events were not resolved.  Follow-up attempts had been completed and no further information was expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Headache, Irritability, Nausea, Sunburn
Clinical narrative: Extreme Flushing of face when active at all. Appears sunburned on face.; Sunburned on face; Headache daily that worsens throughout day.; Nausea; irritability; This is a spontaneous report from a contactable consumer (reported for herself). A 40-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 28Jul2021 at 18:15 (at the age of 40-years-old) as dose 1, single for covid-19 immunisation at Pharmacy. Medical history included impaired gastric emptying, schizophrenia, bipolar disorder, post-traumatic stress disorder and drug hypersensitivity (sulfa allergy), all 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 four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received geodon (ZIPRASIDONE MESILATE) and experienced drug hypersensitivity and paxil (PIROXICAM) and experienced drug hypersensitivity. On 31Jul2021 at 16:30, the patient experienced extreme Flushing of face when active at all. Appears sunburned on face. Headache daily that worsens throughout day. Nausea and irritability. The reporter stated the events result in Doctor's or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events included treatment with ibuprofen and appointment with her PCP (Primary Care Physician). The outcome of the events was not resolved.  This follow-up is being submitted to notify theta the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Discomfort, Headache, Muscle spasms, Musculoskeletal discomfort
Clinical narrative: Hives all over his body where his lymph node is located for the last couple of days; arm pits and groin area were not feeling great; arm pits and groin area were not feeling great; Muscle cramps; Headache; Has been in bed; terrible pain in both feet; This is a spontaneous report from a contactable Consumer or other non-HCP (mother of patient). A 26-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 08Aug2021 (at the age of 26-year-old), as DOSE 1, SINGLE for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient experienced terrible pain in both feet on an unspecified date in Aug2021, muscle cramps and headache on 09Aug2021, arm pits and groin area were not feeling great on 12Aug2021 and hives all over his body where his lymph node is located for the last couple of days on 13Aug2021. The patient had been in bed since Monday 09Aug2021. The clinical details of the events as follows: Caller stated her son who is 26 years old got first Pfizer Covid vaccine on Sunday, 08Aug2021 and has big hives near all lymph node areas of his body, and complaining of terrible pain to both his feet, he was also having other side effects and wanted to know if this was normal after the vaccine, knows they said that the major side effects would occur within 24 hours of the vaccine. Caller stated the patient noticed yesterday, 12Aug2021 his arm pits and groin area were not feeling great, noticed the hives today. Got the vaccine at Walgreens and stated her son has been in bed since Monday, stated he has had a headache and muscle cramps since Monday, 09Aug2021. Unknown anatomical location of injection stated she assumes it was on the left side since he is right-handed. Caller wanted to know if these are side effects reported after taking the Pfizer Covid vaccine and also asked how long these side effects supposed to last: response: In general, local side effects; the ones you get on the arm where you got the shot (such as injection site redness and injection site swelling) were mostly mild-to-moderate in severity and resolved within 1 to 2 days. Side effects that you may experience throughout the rest of your body; (systemic side effects) including fever and chills were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter. Swollen lymph nodes (lymphadenopathy), which generally resolved within 10 days. There was no Investigation Assessment provided. The patient outcome of the events hives near all the lymph node areas on the body, terrible pain in both feet, Headache and Muscle cramps was not resolved and the outcome of the other events was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Urticaria
Clinical narrative: Hives all over his body where his lymph node is located for the last couple of days; arm pits and groin area were not feeling great; arm pits and groin area were not feeling great; Muscle cramps; Headache; Has been in bed; terrible pain in both feet; This is a spontaneous report from a contactable Consumer or other non-HCP (mother of patient). A 26-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 08Aug2021 (at the age of 26-year-old), as DOSE 1, SINGLE for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient experienced terrible pain in both feet on an unspecified date in Aug2021, muscle cramps and headache on 09Aug2021, arm pits and groin area were not feeling great on 12Aug2021 and hives all over his body where his lymph node is located for the last couple of days on 13Aug2021. The patient had been in bed since Monday 09Aug2021. The clinical details of the events as follows: Caller stated her son who is 26 years old got first Pfizer Covid vaccine on Sunday, 08Aug2021 and has big hives near all lymph node areas of his body, and complaining of terrible pain to both his feet, he was also having other side effects and wanted to know if this was normal after the vaccine, knows they said that the major side effects would occur within 24 hours of the vaccine. Caller stated the patient noticed yesterday, 12Aug2021 his arm pits and groin area were not feeling great, noticed the hives today. Got the vaccine at Walgreens and stated her son has been in bed since Monday, stated he has had a headache and muscle cramps since Monday, 09Aug2021. Unknown anatomical location of injection stated she assumes it was on the left side since he is right-handed. Caller wanted to know if these are side effects reported after taking the Pfizer Covid vaccine and also asked how long these side effects supposed to last: response: In general, local side effects; the ones you get on the arm where you got the shot (such as injection site redness and injection site swelling) were mostly mild-to-moderate in severity and resolved within 1 to 2 days. Side effects that you may experience throughout the rest of your body; (systemic side effects) including fever and chills were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter. Swollen lymph nodes (lymphadenopathy), which generally resolved within 10 days. There was no Investigation Assessment provided. The patient outcome of the events hives near all the lymph node areas on the body, terrible pain in both feet, Headache and Muscle cramps was not resolved and the outcome of the other events was unknown at the time of this report.  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: Blood pressure increased, Blood pressure measurement, Chest pain, Chills, Headache
Clinical narrative: Chest pain on left side- felt like my heart hurt; Very fast heart rate; Increased blood pressure; Body aches; Chills in the morning; Fever; hot flashes; headache; swollen lymph node in the left armpit; This is a spontaneous report from a contactable consumer(Patient). A 46-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FA7484, Expiration date was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 13Aug2021 15:00 (age at vaccination 46 years) as dose 2, single for covid-19 immunisation. Medical history included arthritis, fibromyalgia, pcos, hypothyroidism, allergies: Penicillin. The patient previously took BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0196, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 19Jul2021 04:00 (age at vaccination 46 years) as dose 1, single for covid-19 immunisation. Concomitant medication(s) included lisinopril (LISINOPRIL). 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 did not receive any other vaccines within four weeks prior to the vaccination. On 14Aug2021 08:30 the patient experienced chest pain on left side- felt like my heart hurt, very fast heart rate, increased blood pressure, body aches, chills in the morning, fever in the afternoon , hot flashes in the afternoon , headache , swollen lymph node in the left armpit. The patient underwent lab tests and procedures which included blood pressure measurement was increased on 14Aug2021, heart rate was very fast on 14Aug2021. The patient did not receive any treatment for reported events. The outcome of event was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Hot flush, Lymphadenopathy, Pain
Clinical narrative: Chest pain on left side- felt like my heart hurt; Very fast heart rate; Increased blood pressure; Body aches; Chills in the morning; Fever; hot flashes; headache; swollen lymph node in the left armpit; This is a spontaneous report from a contactable consumer(Patient). A 46-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FA7484, Expiration date was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 13Aug2021 15:00 (age at vaccination 46 years) as dose 2, single for covid-19 immunisation. Medical history included arthritis, fibromyalgia, pcos, hypothyroidism, allergies: Penicillin. The patient previously took BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0196, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 19Jul2021 04:00 (age at vaccination 46 years) as dose 1, single for covid-19 immunisation. Concomitant medication(s) included lisinopril (LISINOPRIL). 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 did not receive any other vaccines within four weeks prior to the vaccination. On 14Aug2021 08:30 the patient experienced chest pain on left side- felt like my heart hurt, very fast heart rate, increased blood pressure, body aches, chills in the morning, fever in the afternoon , hot flashes in the afternoon , headache , swollen lymph node in the left armpit. The patient underwent lab tests and procedures which included blood pressure measurement was increased on 14Aug2021, heart rate was very fast on 14Aug2021. The patient did not receive any treatment for reported events. The outcome of event was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Chest pain on left side- felt like my heart hurt; Very fast heart rate; Increased blood pressure; Body aches; Chills in the morning; Fever; hot flashes; headache; swollen lymph node in the left armpit; This is a spontaneous report from a contactable consumer(Patient). A 46-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FA7484, Expiration date was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 13Aug2021 15:00 (age at vaccination 46 years) as dose 2, single for covid-19 immunisation. Medical history included arthritis, fibromyalgia, pcos, hypothyroidism, allergies: Penicillin. The patient previously took BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0196, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 19Jul2021 04:00 (age at vaccination 46 years) as dose 1, single for covid-19 immunisation. Concomitant medication(s) included lisinopril (LISINOPRIL). 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 did not receive any other vaccines within four weeks prior to the vaccination. On 14Aug2021 08:30 the patient experienced chest pain on left side- felt like my heart hurt, very fast heart rate, increased blood pressure, body aches, chills in the morning, fever in the afternoon , hot flashes in the afternoon , headache , swollen lymph node in the left armpit. The patient underwent lab tests and procedures which included blood pressure measurement was increased on 14Aug2021, heart rate was very fast on 14Aug2021. The patient did not receive any treatment for reported events. The outcome of event was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Cough, Derealisation, Nasal congestion
Clinical narrative: starting on 14Aug, have lost sense of smell and taste. Went for a covid test on 15Aug, which came back negative.; starting on 14Aug, have lost sense of smell and taste. Went for a covid test on 15Aug, which came back negative.; Second and third week after first dose, feeling unwell, constant cough, congestion.; Second and third week after first dose, feeling unwell, constant cough, congestion.; Second and third week after first dose, feeling unwell, constant cough, congestion.; Constant feeling of having a fever without having an elevated temperature; This is a spontaneous report received from a contactable consumer or other non hcp. A 51-years-old male patient received first 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 27Jul2021 13:00 (age at vaccination 51years old) as single dose for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks and Other medications in two weeks prior to the COVID vaccine. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing Allergies: PCN. The patient's concomitant medications were not reported. Since the vaccination, the patient had been tested for COVID-19. The patient experienced constant feeling of having a fever without having an elevated temperature on 31Jul2021 16:00, and second and third week after first dose, feeling unwell, constant cough, congestion on Aug2021, starting on 14aug, have lost sense of smell and taste. went for a covid test on 15aug, which came back negative on 14Aug2021. The patient underwent lab tests and procedures which included sarscov-2 test: negative on 15Aug2021. The patient did not receive any treatment for the adverse events. The clinical outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: starting on 14Aug, have lost sense of smell and taste. Went for a covid test on 15Aug, which came back negative.; starting on 14Aug, have lost sense of smell and taste. Went for a covid test on 15Aug, which came back negative.; Second and third week after first dose, feeling unwell, constant cough, congestion.; Second and third week after first dose, feeling unwell, constant cough, congestion.; Second and third week after first dose, feeling unwell, constant cough, congestion.; Constant feeling of having a fever without having an elevated temperature; This is a spontaneous report received from a contactable consumer or other non hcp. A 51-years-old male patient received first 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 27Jul2021 13:00 (age at vaccination 51years old) as single dose for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks and Other medications in two weeks prior to the COVID vaccine. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing Allergies: PCN. The patient's concomitant medications were not reported. Since the vaccination, the patient had been tested for COVID-19. The patient experienced constant feeling of having a fever without having an elevated temperature on 31Jul2021 16:00, and second and third week after first dose, feeling unwell, constant cough, congestion on Aug2021, starting on 14aug, have lost sense of smell and taste. went for a covid test on 15aug, which came back negative on 14Aug2021. The patient underwent lab tests and procedures which included sarscov-2 test: negative on 15Aug2021. The patient did not receive any treatment for the adverse events. The clinical outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Pain
Clinical narrative: experienced shortness of breath; pain all over his body; This is a spontaneous report from a Pfizer- sponsored program via a contactable consumer (patient's partner/wife). A 48-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 14Aug2021 at 15:00 hours as DOSE 1, SINGLE (at the age of 48-years-old) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced shortness of breath, and pain all over his body on 14Aug2021. The patient underwent lab tests and procedures which included pulse rate: 68 on 14Aug2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Mass, Rash macular, Skin burning sensation
Clinical narrative: headache; mall red raised bumps all over body, primarily on legs, spots inched and burned.; mall red raised bumps all over body, primarily on legs, spots inched and burned.; mall red raised bumps all over body, primarily on legs, spots inched and burned.; This is a spontaneous report from a contactable consumer. This 14-year-old male consumer (patient) reported for himself that: A 14-year-old male patient received first dose of bnt162b2 (BNT162B2, solution for injection, Lot number was not reported) dose 1 via an unspecified route of administration, administered in the right arm on 07Aug2021 at 13:00 (at the age of 14-year-old) as dose 1, single for COVID-19 immunisation at pharmacy or drug store. Medical history included headaches and covid-19. Concomitant medication(s) included ibuprofen (IBUPROFEN) taken for headache, start and stop date were not reported and paracetamol (TYLENOL) taken for headache, start and stop date were not reported. Patient reported past drug event as ibuprofen for known allergies as not until now ibuprofen. Patient was not received any other vaccine four weeks prior vaccination. On 18Aug2021 at 07:00 the patient experienced headache, shortly after developed small red raised bumps all over body, primarily on legs, spots inched and burned. Reported stated that took ibuprofen in the morning for a headache on 8/18. The same thing happened to mother. Since vaccination patient not tested for covid-19. The case assessed as non-serious by the reporter. Therapeutic measures were taken as a result of the events with with Otc Zyrtec. Waiting to see if paediatrician visit w. The clinical outcome of the events was reported as recovered with sequel on an unspecified date of 2021.   Follow-up attempts are completed. No further information is expected
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Severe nosebleed less than 24 hours after vaccine; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 25 year old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 17Aug2021 14:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine included dose 1 via an unspecified route of administration, administered in Arm Left on 26Jul2021 14:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported; olive leaf [olea europaea leaf] (OLIVE LEAF [OLEA EUROPAEA LEAF]) taken for an unspecified indication, start and stop date were not reported; turmeric [curcuma longa rhizome] (TURMERIC [CURCUMA LONGA RHIZOME]) taken for an unspecified indication, start and stop date were not reported; docosahexaenoic acid (DHA) taken for an unspecified indication, start and stop date were not reported.  The patient experienced severe nosebleed less than 24 hours after vaccine causing epistaxis on 18Aug2021 08:00 with outcome of unknown.    Information on the Batch/Lot number has been requested.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Pain, Pain in extremity, Vaccination site pain
Clinical narrative: arm started hurting and he couldn't move it and it kept going out; arm started hurting and he couldn't move it and it kept going out; just had a sting and a pain in the injection site; just had a sting and a pain in the injection site; soreness; This is a spontaneous report from a contactable consumer (patient) reported that. A 59-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), dose 2 via an unspecified route of administration on 25Mar2021 (at the age of 59 years old) as dose 2, single for on an unspecified indication. The patient medical history was not reported. There were no concomitant medications. On 21Jun2021, the patient experienced arm started hurting and he couldn't move it and it kept going out. The patient had the arm sting (25Mar2021) and pain at the injection site ((25Mar2021)), he was just having that and soreness (unknown date in 2021). But then on 21Jun2021 his arm went out and he guesses that he is not able to use the muscle in his arm and it just goes out on him. Like if he does something, sometimes he will reach out to open the door and it completely goes out. The sting and the pain started the day he received the injection, the COVID vaccine, and that was 25Mar2021 and that has been lasting from then up until 21Jun2021 when his arm started going out. He still has a little still that sting and it will be sore as well. He confirms that this is ongoing but now his arm goes out and sometimes he can't move it out. He says the sting and pain has gotten somewhat better. The outcome of the event arm started hurting and he couldn't move it and it kept going out was not recovered and the event just had a sting and a pain in the injection site outcome was recovering, and the event soreness was unknown.  Information on the lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Headache, Myalgia, Pain, Palpitations
Clinical narrative: Within a hour heart palpitations have started; pain in kidney area; later evening body ache; muscle ache; fever; headache; extreme drowsiness; noise in ear; pain behind ear; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration in left arm on 12Aug2021 at 12:00 (At the age of 40-year-old) as single dose for COVID-19 immunization. Medical history of the patient included Graves disease, allergy to latex. Patient received concomitant/other medications [unspecified] in two weeks. Patient did not receive any other vaccine in four weeks. Patient did not have COVID prior vaccination and was not tested for covid post vaccination. Patient previously took Flagyl on an unspecified date and experienced allergy. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration in left arm on 22Jul2021 at 12:00 as single dose for COVID-19 immunization. On 12Aug2021 at 13:15 within an hour patient experienced heart palpitations have started and pain in kidney area, later evening body ache, muscle ache, fever, headache, extreme drowsiness waking up with headache, pain behind ear and noise in ear. Patient did not receive any treatment in response to the evets. Outcome of the events were Recovering.  Information on the Lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Renal pain, Somnolence, Tinnitus
Clinical narrative: Within a hour heart palpitations have started; pain in kidney area; later evening body ache; muscle ache; fever; headache; extreme drowsiness; noise in ear; pain behind ear; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration in left arm on 12Aug2021 at 12:00 (At the age of 40-year-old) as single dose for COVID-19 immunization. Medical history of the patient included Graves disease, allergy to latex. Patient received concomitant/other medications [unspecified] in two weeks. Patient did not receive any other vaccine in four weeks. Patient did not have COVID prior vaccination and was not tested for covid post vaccination. Patient previously took Flagyl on an unspecified date and experienced allergy. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration in left arm on 22Jul2021 at 12:00 as single dose for COVID-19 immunization. On 12Aug2021 at 13:15 within an hour patient experienced heart palpitations have started and pain in kidney area, later evening body ache, muscle ache, fever, headache, extreme drowsiness waking up with headache, pain behind ear and noise in ear. Patient did not receive any treatment in response to the evets. Outcome of the events were Recovering.  Information on the Lot/batch number has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Gait inability, Myalgia, Pain in extremity
Clinical narrative: stated that her right hip was in extreme pain; stated that her right leg was in extreme pain; stated that she was unable to walk overnight; stated that she pushed through it and continued to walk until she was limping; stated that she was not able to bear weight on her right leg; muscle pain; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 2 via an unspecified route of administration on 11Feb2021 as DOSE 2, SINGLE for covid-19 immunization.The patient medical history was not reported.The patient's concomitant medications were not reported.On an unspecified date the patient experienced stated that her right hip was in extreme pain, stated that her right leg was in extreme pain, stated that she was unable to walk overnight, stated that she was unable to walk overnight, stated that she pushed through it and continued to walk until she was limping, stated that she was not able to bear weight on her right leg, muscle pain, Stated that she walks almost three miles a day and has had no health issues, two weeks after the last vaccine her right hip and leg were in extreme pain and she was unable to walk overnight, she asked for X-rays because the pain was not going away which was two months of not being able to put weight on legs. Clarified that only one leg was affected and that was the right leg. The patient underwent lab tests and procedures which included x-ray: everything was intact on 2021. The outcome of event was unknown.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow-up.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Weight bearing difficulty
Clinical narrative: stated that her right hip was in extreme pain; stated that her right leg was in extreme pain; stated that she was unable to walk overnight; stated that she pushed through it and continued to walk until she was limping; stated that she was not able to bear weight on her right leg; muscle pain; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 2 via an unspecified route of administration on 11Feb2021 as DOSE 2, SINGLE for covid-19 immunization.The patient medical history was not reported.The patient's concomitant medications were not reported.On an unspecified date the patient experienced stated that her right hip was in extreme pain, stated that her right leg was in extreme pain, stated that she was unable to walk overnight, stated that she was unable to walk overnight, stated that she pushed through it and continued to walk until she was limping, stated that she was not able to bear weight on her right leg, muscle pain, Stated that she walks almost three miles a day and has had no health issues, two weeks after the last vaccine her right hip and leg were in extreme pain and she was unable to walk overnight, she asked for X-rays because the pain was not going away which was two months of not being able to put weight on legs. Clarified that only one leg was affected and that was the right leg. The patient underwent lab tests and procedures which included x-ray: everything was intact on 2021. The outcome of event was unknown.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder
Clinical narrative: She already received the first and second dose of the Pfizer COVID 19 and she will be having her eye surgery; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, 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, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, consumer received the first and second dose of the Pfizer COVID 19 Vaccine and she will be having her eye surgery next Wednesday. The outcome of event was unknown.  The batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.