chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash macular, SARS-CoV-2 test
Clinical narrative: My skin started to become itch with red spots; My skin started to become itch with red spots; This is a spontaneous report from a contactable other healthcare professional (patient). A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number and expiry date unknown), via an unspecified route of administration at the left arm on 13Jan2021 09:15 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient reported that her skin started to become itch with red spots on 30Jan2021 14:00. No treatment was received for the events. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included nasal swab: negative on 27Jan2021. The outcome of the events were recovering. Events were reported as non-serious.  Information on the lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: abdominal pain- feels like pulled muscles/like I got kicked in the stomach; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown) solution for injection at the age of 35-years-old, via an unspecified route of administration on 27Jan2021 at 1:15 PM at single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications were reported as none. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not pregnant at the time of vaccination. She did not receive any other vaccine within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was unknown. The patient experienced abdominal pain which felt like she pulled a muscle, like she got kicked in the stomach on 02Feb2021 at 3:00 PM. The patient did not receive any treatment in response to the event. The outcome of the event was not recovered. The event was assessed as non-serious.   Information on the lot/batch number has been requested.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Fatigue, Headache
Clinical narrative: Severe chills; entire body muscle aches; mild nausea; extreme fatigue; mild cough; severe headache; Slight fever; This is a spontaneous report received from a contactable consumer (patient). A 53-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261, expiry date: unknown), via an unspecified route of administration on the left arm, on 21Jan2021 13:00, at single dose, for COVID-19 immunization, at a public health department. Medical history included dermatomyositis (autoimmune disorder). The patient has no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included mycophenolate mofetil (MYCOPHENOLATE). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date: unknown) received at 53 years of age, via an unspecified route of administration on the left arm, on 29Dec2020 09:00, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. On 28Jan2021 at 10:00, the patient experienced severe chills, entire body muscle aches, mild nausea, extreme fatigue, mild cough, severe headache, all lasting several days; and slight fever which lasted for 1 day. The adverse events resulted to physician office visit. The patient underwent lab tests and procedures which included rapid test (nasal swab) on 31Jan2021 with negative result and nasal swab on 01Feb2021 with unknown result (pending). The patient recovered from slight fever on 29Jan2021a at 10:00; and was recovering from severe chills, entire body muscle aches, mild nausea, extreme fatigue, mild cough and severe headache.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, SARS-CoV-2 test
Clinical narrative: Severe chills; entire body muscle aches; mild nausea; extreme fatigue; mild cough; severe headache; Slight fever; This is a spontaneous report received from a contactable consumer (patient). A 53-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261, expiry date: unknown), via an unspecified route of administration on the left arm, on 21Jan2021 13:00, at single dose, for COVID-19 immunization, at a public health department. Medical history included dermatomyositis (autoimmune disorder). The patient has no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included mycophenolate mofetil (MYCOPHENOLATE). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date: unknown) received at 53 years of age, via an unspecified route of administration on the left arm, on 29Dec2020 09:00, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. On 28Jan2021 at 10:00, the patient experienced severe chills, entire body muscle aches, mild nausea, extreme fatigue, mild cough, severe headache, all lasting several days; and slight fever which lasted for 1 day. The adverse events resulted to physician office visit. The patient underwent lab tests and procedures which included rapid test (nasal swab) on 31Jan2021 with negative result and nasal swab on 01Feb2021 with unknown result (pending). The patient recovered from slight fever on 29Jan2021a at 10:00; and was recovering from severe chills, entire body muscle aches, mild nausea, extreme fatigue, mild cough and severe headache.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: Nervous Anxiety; This is a spontaneous report from a contactable consumer (patient). A 77-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported PFIZER BIONTECH COVID-19 VACCINE; lot number: EL9265; expiration date: unknown) at vaccination age of 77-year-old via an unspecified route of administration in the left arm on 27Jan2021 13:30 at a single dose for covid-19 immunization. The patient's medical history concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior vaccination. The patient previously took naproxen (ALEVE) but had allergies to Aleve. The patient reported that she had nervous anxiety for second day (28Jan2021). The event did not receive treatment. The patient has not been tested for COVID-19 since vaccination. The outcome of the event was not recovered.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Myalgia
Clinical narrative: Quivering muscle pain when attempting to stand and to sit; Thigh muscles still feel quivering and tight/tight and unstudy; This is a spontaneous report from a contactable consumer (patient). A 79 -year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number:EL9262), via an unspecified route of administration (on left arm) on 29Jan2021 (at the age of 79 -years-old), single dose for COVID-19 immunization.  Medical history included Mech. Valve/ Arthritis from an unknown date. Concomitant medication included warfarin, bempedoic acid, hydrochlorothiazide, losartan potassium.  The patient previously took ciprofloxacin and experienced drug allergy. The patient experienced quivering muscle pain when attempting to stand and to sit. Occurring upper thighs in front and under buttocks in rear. Similar feeling across groin area when sitting. Began the 2nd day after vaccine shot on a Sunday. Now, on Wednesday still occurring . however, not as pronounce. I still push myself up from sitting as well as sitting down as thigh muscles still feel quivering and tight and unstudy. No treatment for the adverse events. The outcome of the events was recovering. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The events were assessed as non-serious.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Chest pain, Headache, Nausea, Pyrexia
Clinical narrative: chest pain; loss of smell; fever; headaches; vomiting/nausea; vomiting/nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot number: EL9264), via an unspecified route of administration in the left arm on 30Jan2021 15:45 at a single dose for covid-19 immunization. Medical history included heart problems, migraine, anemia, asthma and unspecified allergies. The patient is not pregnant. The patient's concomitant medications were not reported. On 30Jan2021 19:00, the patient experienced chest pain, loss of smell, fever, headaches, vomiting and nausea. The patient did not receive treatment for the events. The outcome of the events was not recovered.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: chest pain; loss of smell; fever; headaches; vomiting/nausea; vomiting/nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot number: EL9264), via an unspecified route of administration in the left arm on 30Jan2021 15:45 at a single dose for covid-19 immunization. Medical history included heart problems, migraine, anemia, asthma and unspecified allergies. The patient is not pregnant. The patient's concomitant medications were not reported. On 30Jan2021 19:00, the patient experienced chest pain, loss of smell, fever, headaches, vomiting and nausea. The patient did not receive treatment for the events. The outcome of the events was not recovered.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Muscle spasms, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Severe right leg (thigh knee and calf) pain 7 days after vaccine; Severe right leg (thigh knee and calf) pain 7 days after vaccine; Severe back muscle spasm 1 day after injection; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EL1284), via an unspecified route of administration on left arm on 29Dec2020 at 11:30 (at the age of 35years) at single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included allergies: Sulfa. The patient's concomitant medications were not reported. The patient experienced severe back muscle spasm 1 day after injection (30Dec2020). Severe right leg (thigh knee and calf) pain 7 days after vaccine (05Jan2021). There were no treatment given for the events. The events were considered non-serious by the patient as did not results in death, non-life threatening, did not cause/prolong hospitalization, non-disabling/incapacitating and no congenital anomaly/birth defect. The adverse events result in doctor or other healthcare professional office/clinic visit. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The COVID-19 test (nasal swab) on 12Jan2021 was negative. The outcome of the events was recovered for pain in extremity and arthralgia in 2021 and for muscle spasms on an unspecified date.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: she got a cold; This is a spontaneous report from a non-contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of bnt162b2 (BNT162B2, also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration on an unspecified date at SINGLE DOSE for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient informed that she had an appointment to receive her second dose of the vaccine tomorrow, but her HCP advised to wait since she got a cold. The outcome of event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This is a spontaneous report from a contactable consumer. A 73-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Feb2021 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The consumer's father received the first dose of Pfizer's vaccine yesterday (02Feb2021). He had diarrhea since last night (02Feb2021). The consumer asked if it was due to the vaccine and how long it will last. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Nausea; sore arm; fever; This is a spontaneous report from a contactable healthcare professional.  A 54-year-old female patient received second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL 3246), via an unspecified route of administration on the right arm on 02Feb2021 08:15 at single dose for COVID-19 immunisation.  Medical history allergies: pcn, latex, wheat/gluten, dairy, soy, corn.  The patient's concomitant medications were not reported.  The patient previously took first dose of BNT162B2 (lot number: EL 3246) on 11Jan2021 06:30 PM on the right arm for covid-19 immunisation; epinephrine and experienced allergies.  At 6:00 PM on 02Feb2021, patient developed fever 99.4 and steadily rose to 101.5 by 9:30 PM; sore arm all day and night, following day much less sore and easier to move.  Fever stayed overnight, down to 100.5 morning on 03Feb2021.  Nausea accompanied fever and still have slight nausea. The patient received no treatment. The outcome of the events was recovering.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: only sore arm; feeling tired; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (reporting for herself). A 76-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration (at the age of 76) single dose on 02Feb2021 for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced only sore arm and feeling tired both on an unspecified date. She has had to take a nap everyday since. The outcome was unknown.    Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: light headedness to the point of feeling like passing out; This is a spontaneous report from a contactable consumer.  A male patient of an unspecified age (Age: 71; Unit: Unknown; as reported) received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 03Feb2021 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced: light headedness to the point of feeling like passing out (non-serious) in Feb2021. The clinical course was reported as follows: The patient reported that during the 15 minutes after receiving the injection, he was fine. Thirty minutes post vaccination, while driving home, the patient experienced light headedness to the point of feeling like passing out. The patient had to pull over on the highway. The feeling lasted about an hour before subsiding. The patient stated that after an hour and a half after receiving the injection, the light headedness was mostly gone. The clinical outcome of the event was recovering.  The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Allergic sinusitis, Ear pain
Clinical narrative: ear pain; allergic sinusitis; This is a spontaneous report from a Pfizer Sponsored Program . A non-contactable consumer reported that a 34-year-old female patient received her second dose of bnt162b2 (BNT162B2 also reported as Pfizer-Biontech covid-19 vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on 02Feb2021 at SINGLE DOSE for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced ear pain and allergic sinusitis on an unspecified date. She already took Tylenol as treatment. The outcome of event was unknown.    No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Condition aggravated, Headache, Pain
Clinical narrative: Fever worsened; arm soreness/achy legs; minor aches and pains; Chills; slight/mild headache; fever of 100 Fahrenheit then 101.6 Fahrenheit; This is a spontaneous report from a contactable consumer.  A 68-year-old male patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3248), via an unspecified route of administration on 02Feb2021 at 09:45 at 68-years-old at a single dose for COVID-19 immunization.  Medical history included type 2 diabetes mellitus from an unknown date and unknown if ongoing.  Concomitant medications included metformin (MANUFACTURER UNKNOWN) taken for type 2 diabetes mellitus from an unspecified date to an unspecified date. The patient experienced the following events and outcomes: arm soreness/achy legs (non-serious) on 02Feb2021 with outcome of recovering, minor aches and pains (non-serious) on 02Feb2021 with outcome of recovering, chills (non-serious) on 02Feb2021 with outcome of recovered on 03Feb2021, slight/mild headache (non-serious) on 02Feb2021 with outcome of recovered on an unspecified date, fever of 100 Fahrenheit then 101.6 Fahrenheit (non-serious) on 02Feb2021 (as reported) with outcome of not recovered, fever worsened (non-serious) on an unspecified date with outcome of unknown. The clinical course was reported as follows: The patient reported having aches, pains, chills, a slight headache, and a fever of 100 Fahrenheit in the afternoon and evening on 02Feb2021 (as reported). On the morning of 03Feb2021, the patient reported having a fever of 101.6 Fahrenheit (as reported). The patient also reported a fever of 99.1-99.4 Fahrenheit (the night before the report); then, the next morning had a fever at 100 Fahrenheit and then 101.6 (as reported).The patient further reported that he had arm soreness, upon which the patient put a cold towel on it, and it was a lot better on 03Feb2021. The patient also had a mild headache and took paracetamol (TYLENOL). The patient was concerned about the fever. The patient read to drink liquids and dress lightly; and had been drinking plenty of liquids. The patient reported that his weight was 190-200 lbs. The had minor aches and pains, and he was a little achy in his legs which started on 02Feb2021 as well. At the time of the report, it was about the same. It was worse in the morning but was better now. Then the patient had a small chill the day before and at the time of the report. The patient he turned up the heat, and it went away. The was scheduled for his second dose on 23Feb2021. The doctor recommended the patient to get the vaccine because of his age and having type 2 diabetes. The patient had his diabetes under control with metformin. The patient underwent lab tests and procedures which included body temperature: 99.1 Fahrenheit on 02Feb2021, body temperature: 99.4 Fahrenheit on 02Feb2021, body temperature: 100 Fahrenheit on 02Feb2021, body temperature: 101.6 Fahrenheit on 03Feb2021.  Therapeutic measures were taken as a result of arm soreness/achy legs and slight/mild headache.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever worsened; arm soreness/achy legs; minor aches and pains; Chills; slight/mild headache; fever of 100 Fahrenheit then 101.6 Fahrenheit; This is a spontaneous report from a contactable consumer.  A 68-year-old male patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3248), via an unspecified route of administration on 02Feb2021 at 09:45 at 68-years-old at a single dose for COVID-19 immunization.  Medical history included type 2 diabetes mellitus from an unknown date and unknown if ongoing.  Concomitant medications included metformin (MANUFACTURER UNKNOWN) taken for type 2 diabetes mellitus from an unspecified date to an unspecified date. The patient experienced the following events and outcomes: arm soreness/achy legs (non-serious) on 02Feb2021 with outcome of recovering, minor aches and pains (non-serious) on 02Feb2021 with outcome of recovering, chills (non-serious) on 02Feb2021 with outcome of recovered on 03Feb2021, slight/mild headache (non-serious) on 02Feb2021 with outcome of recovered on an unspecified date, fever of 100 Fahrenheit then 101.6 Fahrenheit (non-serious) on 02Feb2021 (as reported) with outcome of not recovered, fever worsened (non-serious) on an unspecified date with outcome of unknown. The clinical course was reported as follows: The patient reported having aches, pains, chills, a slight headache, and a fever of 100 Fahrenheit in the afternoon and evening on 02Feb2021 (as reported). On the morning of 03Feb2021, the patient reported having a fever of 101.6 Fahrenheit (as reported). The patient also reported a fever of 99.1-99.4 Fahrenheit (the night before the report); then, the next morning had a fever at 100 Fahrenheit and then 101.6 (as reported).The patient further reported that he had arm soreness, upon which the patient put a cold towel on it, and it was a lot better on 03Feb2021. The patient also had a mild headache and took paracetamol (TYLENOL). The patient was concerned about the fever. The patient read to drink liquids and dress lightly; and had been drinking plenty of liquids. The patient reported that his weight was 190-200 lbs. The had minor aches and pains, and he was a little achy in his legs which started on 02Feb2021 as well. At the time of the report, it was about the same. It was worse in the morning but was better now. Then the patient had a small chill the day before and at the time of the report. The patient he turned up the heat, and it went away. The was scheduled for his second dose on 23Feb2021. The doctor recommended the patient to get the vaccine because of his age and having type 2 diabetes. The patient had his diabetes under control with metformin. The patient underwent lab tests and procedures which included body temperature: 99.1 Fahrenheit on 02Feb2021, body temperature: 99.4 Fahrenheit on 02Feb2021, body temperature: 100 Fahrenheit on 02Feb2021, body temperature: 101.6 Fahrenheit on 03Feb2021.  Therapeutic measures were taken as a result of arm soreness/achy legs and slight/mild headache.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Fever; aches and pains; headache; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received second dose of BNT162B2 (brand=Pfizer), via an unspecified route of administration (right arm) on 02Feb2021 08:30 at a single dose for COVID-19 immunization at a workplace clinic. Medical history included allergies to macadamia nuts. There were no concomitant medications. No other medications the patient received within 2 weeks of vaccination. Historical vaccine included first dose of BNT162B2 (brand=Pfizer) on 14Jan2021 07:30 AM (vaccine location= left arm). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced fever, aches and pains, headache on 03Feb2021 05:00 AM. No treatment received for the events. The events were reported as non-serious (did not result to death, not life threatening, did not cause/prolong hospitalization, not disabling/incapacitating, and not congenital anomaly/birth defect). Since the vaccination, the patient has not been tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Full blood count, Lipids, Lymphocyte count, Lymphocyte count abnormal
Clinical narrative: white blood cell count was down to 2.3/absolute neutrophils were low/neutropenia; body ache; sore throat; chills; I've haven't had this shift before in lymphocyte; This is a spontaneous report from a contactable healthcare professional.  A 55-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), via an unspecified route of administration on 02Jan2021 at single dose for COVID-19 immunisation.  Medical history included MS and saw neurologist in Nov2020, prior to getting the vaccine and at that time did not have the typical blood work drawn which would have been a CBC and CMP and white blood cell could usually runs in the 3.5-3.7.  Concomitant medication included dimethyl fumarate (TECFIDERA).  The patient previously took TYSABRI and had to be taken off of that in 2010 due to evidence by CBC of bone marrow suppression. The patient had IVIG and experienced myelosuppression. Patient participated in clinical trials with rituximab and took VIOXX before it was removed from the market. The patient really loved VIOXX and used to prescribe it to her patients; first dose of BNT162B2 on 17Dec2020 for COVID-19 immunisation.  A week after the patient got the vaccine, she had a sore throat, chills and body aches.  The patient just went to bed early and was fine.  The patient reported those symptoms through the CDC VAERS site. The patient had blood work drawn on 29Jan2021 and was shocked that the white blood cell count was down to 2.3 and absolute neutrophils were low.  The patient was referred to follow up with a hematologist for the neutropenia. The patient thinks this is not related to the Covid vaccine.  The patient haven't had this shift before in lymphocyte and neutrophil count.  On 29Jan2021, CBC and CMP and that is comprehensive metabolic panel, complete blood count and lipid panel. The patient received no treatment. The outcome of white blood cell count was down to 2.3/absolute neutrophils were low/neutropenia was not recovered and other events was unknown.; Sender's Comments: Based on the information available a causal relationship between reported events and  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Neutropenia, Neutrophil count, Oropharyngeal pain, Pain
Clinical narrative: white blood cell count was down to 2.3/absolute neutrophils were low/neutropenia; body ache; sore throat; chills; I've haven't had this shift before in lymphocyte; This is a spontaneous report from a contactable healthcare professional.  A 55-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), via an unspecified route of administration on 02Jan2021 at single dose for COVID-19 immunisation.  Medical history included MS and saw neurologist in Nov2020, prior to getting the vaccine and at that time did not have the typical blood work drawn which would have been a CBC and CMP and white blood cell could usually runs in the 3.5-3.7.  Concomitant medication included dimethyl fumarate (TECFIDERA).  The patient previously took TYSABRI and had to be taken off of that in 2010 due to evidence by CBC of bone marrow suppression. The patient had IVIG and experienced myelosuppression. Patient participated in clinical trials with rituximab and took VIOXX before it was removed from the market. The patient really loved VIOXX and used to prescribe it to her patients; first dose of BNT162B2 on 17Dec2020 for COVID-19 immunisation.  A week after the patient got the vaccine, she had a sore throat, chills and body aches.  The patient just went to bed early and was fine.  The patient reported those symptoms through the CDC VAERS site. The patient had blood work drawn on 29Jan2021 and was shocked that the white blood cell count was down to 2.3 and absolute neutrophils were low.  The patient was referred to follow up with a hematologist for the neutropenia. The patient thinks this is not related to the Covid vaccine.  The patient haven't had this shift before in lymphocyte and neutrophil count.  On 29Jan2021, CBC and CMP and that is comprehensive metabolic panel, complete blood count and lipid panel. The patient received no treatment. The outcome of white blood cell count was down to 2.3/absolute neutrophils were low/neutropenia was not recovered and other events was unknown.; Sender's Comments: Based on the information available a causal relationship between reported events and  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count
Clinical narrative: white blood cell count was down to 2.3/absolute neutrophils were low/neutropenia; body ache; sore throat; chills; I've haven't had this shift before in lymphocyte; This is a spontaneous report from a contactable healthcare professional.  A 55-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), via an unspecified route of administration on 02Jan2021 at single dose for COVID-19 immunisation.  Medical history included MS and saw neurologist in Nov2020, prior to getting the vaccine and at that time did not have the typical blood work drawn which would have been a CBC and CMP and white blood cell could usually runs in the 3.5-3.7.  Concomitant medication included dimethyl fumarate (TECFIDERA).  The patient previously took TYSABRI and had to be taken off of that in 2010 due to evidence by CBC of bone marrow suppression. The patient had IVIG and experienced myelosuppression. Patient participated in clinical trials with rituximab and took VIOXX before it was removed from the market. The patient really loved VIOXX and used to prescribe it to her patients; first dose of BNT162B2 on 17Dec2020 for COVID-19 immunisation.  A week after the patient got the vaccine, she had a sore throat, chills and body aches.  The patient just went to bed early and was fine.  The patient reported those symptoms through the CDC VAERS site. The patient had blood work drawn on 29Jan2021 and was shocked that the white blood cell count was down to 2.3 and absolute neutrophils were low.  The patient was referred to follow up with a hematologist for the neutropenia. The patient thinks this is not related to the Covid vaccine.  The patient haven't had this shift before in lymphocyte and neutrophil count.  On 29Jan2021, CBC and CMP and that is comprehensive metabolic panel, complete blood count and lipid panel. The patient received no treatment. The outcome of white blood cell count was down to 2.3/absolute neutrophils were low/neutropenia was not recovered and other events was unknown.; Sender's Comments: Based on the information available a causal relationship between reported events and  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest discomfort, Cough, Electrocardiogram, Feeling abnormal
Clinical narrative: a little cough; sore throat; runny nose; a bit of pressure in chest; fever; her heart was beating fast; Granddaughter had covid virus and passed to caller/she tested positive for COVID 19/she was diagnosed with COVID; she was feeling bad; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248, expiry date: 30Apr2021), via an unspecified route of administration at the right arm on 24Jan2021 07:15 at a single dose for COVID-19 immunization. The patient's medical history included diabetic. The patient's concomitant medications were not reported. It was reported that the patient's granddaughter had COVID virus and passed to the patient. The 2nd dose appointment scheduled for 14Feb2021. Patient stated she had the first dose of the Pfizer COVID 19 vaccine on 24Jan2021 at 0715AM in the right arm. After that, she found out she got infected with COVID 19. On 01Feb2021, she tested positive for COVID 19. On 28Jan2021 (also reported as on 28Jan20201 or 29Jan2021), she was feeling bad. Her little granddaughter had COVID virus (was infected at the school) and passed it on to her. Now she has been going to different places checking it out and she went to urgent care because her heart was beating fast on 02Feb2021. She had an electrocardiogram and her lungs were okay on an unspecified date. They told her was eligible to get an infusion but she doesn't know what it is. The urgent care clinic told her she could get the infusion but then she can't get the second dose of the Pfizer COVID 19 vaccine. She wants to ask if this is true. She was being offered a monoclonal antibody infusion. When ask if this is the first time to call, she stated she called once before right after she found out that she had the COVID 19 infection to ask if she could still get the second shot. She did report at that time that she had gotten the first dose and then tested positive for COVID 19 and she previously provided product information including the lot number from her vaccine card. She added that her heart has been going very fast and has been having fever on 02Feb2021 for two or three days. It is not as high today as it was before. She does want to get the second dose. The first dose helped her so much. On 04Feb2021 (reported as yesterday), she was checked at urgent care because of heart concern and a bit of pressure in chest. Patient stated she only had a little cough, sore throat and runny nose, but she hasn't experienced any other symptoms on an unspecified date. The patient's weight was 54.43 kg on 01Feb2021. The outcome of the events "fever" and "her heart was beating fast" was recovering, while the outcome of the other events was unknown. Patient was scheduled to receive her second dose on 14Feb2021.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Oropharyngeal pain, Pyrexia, Rhinorrhoea, SARS-CoV-2 antibody test
Clinical narrative: a little cough; sore throat; runny nose; a bit of pressure in chest; fever; her heart was beating fast; Granddaughter had covid virus and passed to caller/she tested positive for COVID 19/she was diagnosed with COVID; she was feeling bad; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248, expiry date: 30Apr2021), via an unspecified route of administration at the right arm on 24Jan2021 07:15 at a single dose for COVID-19 immunization. The patient's medical history included diabetic. The patient's concomitant medications were not reported. It was reported that the patient's granddaughter had COVID virus and passed to the patient. The 2nd dose appointment scheduled for 14Feb2021. Patient stated she had the first dose of the Pfizer COVID 19 vaccine on 24Jan2021 at 0715AM in the right arm. After that, she found out she got infected with COVID 19. On 01Feb2021, she tested positive for COVID 19. On 28Jan2021 (also reported as on 28Jan20201 or 29Jan2021), she was feeling bad. Her little granddaughter had COVID virus (was infected at the school) and passed it on to her. Now she has been going to different places checking it out and she went to urgent care because her heart was beating fast on 02Feb2021. She had an electrocardiogram and her lungs were okay on an unspecified date. They told her was eligible to get an infusion but she doesn't know what it is. The urgent care clinic told her she could get the infusion but then she can't get the second dose of the Pfizer COVID 19 vaccine. She wants to ask if this is true. She was being offered a monoclonal antibody infusion. When ask if this is the first time to call, she stated she called once before right after she found out that she had the COVID 19 infection to ask if she could still get the second shot. She did report at that time that she had gotten the first dose and then tested positive for COVID 19 and she previously provided product information including the lot number from her vaccine card. She added that her heart has been going very fast and has been having fever on 02Feb2021 for two or three days. It is not as high today as it was before. She does want to get the second dose. The first dose helped her so much. On 04Feb2021 (reported as yesterday), she was checked at urgent care because of heart concern and a bit of pressure in chest. Patient stated she only had a little cough, sore throat and runny nose, but she hasn't experienced any other symptoms on an unspecified date. The patient's weight was 54.43 kg on 01Feb2021. The outcome of the events "fever" and "her heart was beating fast" was recovering, while the outcome of the other events was unknown. Patient was scheduled to receive her second dose on 14Feb2021.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Weight
Clinical narrative: a little cough; sore throat; runny nose; a bit of pressure in chest; fever; her heart was beating fast; Granddaughter had covid virus and passed to caller/she tested positive for COVID 19/she was diagnosed with COVID; she was feeling bad; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248, expiry date: 30Apr2021), via an unspecified route of administration at the right arm on 24Jan2021 07:15 at a single dose for COVID-19 immunization. The patient's medical history included diabetic. The patient's concomitant medications were not reported. It was reported that the patient's granddaughter had COVID virus and passed to the patient. The 2nd dose appointment scheduled for 14Feb2021. Patient stated she had the first dose of the Pfizer COVID 19 vaccine on 24Jan2021 at 0715AM in the right arm. After that, she found out she got infected with COVID 19. On 01Feb2021, she tested positive for COVID 19. On 28Jan2021 (also reported as on 28Jan20201 or 29Jan2021), she was feeling bad. Her little granddaughter had COVID virus (was infected at the school) and passed it on to her. Now she has been going to different places checking it out and she went to urgent care because her heart was beating fast on 02Feb2021. She had an electrocardiogram and her lungs were okay on an unspecified date. They told her was eligible to get an infusion but she doesn't know what it is. The urgent care clinic told her she could get the infusion but then she can't get the second dose of the Pfizer COVID 19 vaccine. She wants to ask if this is true. She was being offered a monoclonal antibody infusion. When ask if this is the first time to call, she stated she called once before right after she found out that she had the COVID 19 infection to ask if she could still get the second shot. She did report at that time that she had gotten the first dose and then tested positive for COVID 19 and she previously provided product information including the lot number from her vaccine card. She added that her heart has been going very fast and has been having fever on 02Feb2021 for two or three days. It is not as high today as it was before. She does want to get the second dose. The first dose helped her so much. On 04Feb2021 (reported as yesterday), she was checked at urgent care because of heart concern and a bit of pressure in chest. Patient stated she only had a little cough, sore throat and runny nose, but she hasn't experienced any other symptoms on an unspecified date. The patient's weight was 54.43 kg on 01Feb2021. The outcome of the events "fever" and "her heart was beating fast" was recovering, while the outcome of the other events was unknown. Patient was scheduled to receive her second dose on 14Feb2021.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dysgeusia, Headache
Clinical narrative: weakness; Headache; metallic taste in her mouth; This is a spontaneous report from a contactable consumer (patient) via Pfizer Sales Representative.  A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2), lot number not reported, via an unspecified route of administration from an unspecified date as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache, metallic taste in her mouth, weakness after 2nd dose of vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vertigo
Clinical narrative: Caller had symptoms like vertigo and nausea after the 1st dose; Caller had symptoms like vertigo and nausea after the 1st dose; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on an unspecified date, at a single dose,  COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient experienced symptoms like vertigo and nausea after the 1st dose. She wanted to know what to take or to do. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm sore; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of unspecified age received first dose of BNT162B2 (Pfizer CoVid-19 Vaccine), via an unspecified route of administration on 02Feb2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had arm sore on Feb2021 after receiving first dose yesterday (02Feb2021). She was asking if she can take Tylenol. The outcome of the event was unknown.  Information about batch/lot number has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Tested positive for Covid; Really bad headache; Shooting pain; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer sales representative.  A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# not provided), via an unspecified route of administration on 26Jan2021 at SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had really bad headache with shooting pain exactly one week after COVID vaccine (noted on 02Feb2021). The patient also tested positive for COVID one week later on 03Feb2021. Outcome of the events were unknown.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: They both had COVID after the 15th, after the first shot; This is a spontaneous report from a contactable consumer (patient's wife) via a Pfizer-sponsored program. This consumer (wife) reported similar events for herself and her husband. This is 2nd of 2 reports.   A 68-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3249, expiry date not reported), via an unspecified route of administration on 15Jan2021 at single dose for COVID-19 immunization. Medical history included blood pressure measurement. Concomitant medications were not reported. The wife reported that on 25Jan2021, she and her husband both had COVID after the 15th, after the first shot. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on 25Jan2021. She reported that they were done with quarantine that day, 03Feb2021. Therapeutic measure was taken as a result of the event that included Zepac. And then, her husband took an additional like a steroid. She did not know what he took. But they both took Zepac and their doctor prescribed Zepac, and then her husband took a steroid too. Clinical outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021111355 same reporter/product, events, different patients.