chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Swelling
Clinical narrative: flu like symptoms; right arm pit (hard and itching) swollen; right arm pit (hard and itching) swollen; fever; swollen lymph; chills; This is a spontaneous report from a contactable healthcare professional (patient). A female patient of an unspecified age (reported as 45, unit unknown) received the first dose ofBNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had question about getting 2nd vaccination/dose. At end of Oct2020/beginning of Nov2020, she was positive for COVID. After a month and 1/2 after COVID19, she got the vaccine. After first vaccination, 18 hours later patient had the flu like symptoms and right arm pit (hard and itching) swollen. She had fever, swollen lymph nodes at 10 or 11 O'clock. Patient had chills, fever, flu like symptoms. 18 days after, the lump was there. Outcome of the events was unknown. Patient was asking if it was okay to get the 2nd shot.  Information of lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature fluctuation
Clinical narrative: temperature of 99.3F, 98.3F, 99.2F, 99.7F; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received his 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 04Jan2021 at single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On Tuesday (05Jan2021), she woke up with a temperature of 99.3F. On Thursday (07Jan2021) evening, she had a temperature of 98.3F, then she took Tylenol and her temperature was back to normal which she noted that her temperature is 97.6F. Yesterday (08Jan2021) at 6pm, she had a temperature of 99.2F and she took Tylenol at 10PM and her temperature was 98.3F. Her temperature today (09Jan2021) was 99.7F and she didn't take Tylenol. The outcome of event was unknown.  Information about lot/batch has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Fatigue
Clinical narrative: Chills; Night Sweats; Body Aches; Dizziness; Headache; fatigue; weakness; joint pain; nausea; This is a spontaneous report from a contactable health care professional, the patient.  A 37-years-old non-pregnant female patient (health care professional) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number:  EK9231),  in the right arm on 30Dec2020 13:00  as a single dose,  for COVID-19 vaccination.  The vaccine was administered at a Pharmacy or Drug Store. Medical History include drug allergy to sulfa. Concomitant medication included Microgestin, Biotin and Prenatal Vitamin. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 31Dec2020 , the patient experienced Chills, Night Sweats, Body Aches, Dizziness, Headache, fatigue, weakness, joint pain, nausea. No treatment was received given for the event. The clinical outcome of Chills, Night Sweats, Body Aches, Dizziness, Headache, fatigue, weakness, joint pain, nausea was recovering.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Night sweats, Pain
Clinical narrative: Chills; Night Sweats; Body Aches; Dizziness; Headache; fatigue; weakness; joint pain; nausea; This is a spontaneous report from a contactable health care professional, the patient.  A 37-years-old non-pregnant female patient (health care professional) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number:  EK9231),  in the right arm on 30Dec2020 13:00  as a single dose,  for COVID-19 vaccination.  The vaccine was administered at a Pharmacy or Drug Store. Medical History include drug allergy to sulfa. Concomitant medication included Microgestin, Biotin and Prenatal Vitamin. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 31Dec2020 , the patient experienced Chills, Night Sweats, Body Aches, Dizziness, Headache, fatigue, weakness, joint pain, nausea. No treatment was received given for the event. The clinical outcome of Chills, Night Sweats, Body Aches, Dizziness, Headache, fatigue, weakness, joint pain, nausea was recovering.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Inappropriate schedule of product administration, Myalgia
Clinical narrative: chills; muscle ache/muscle pain about 10 hours after injection; headache; Dose Number: 2, Date of start of drug: 08Jan2021; This is a spontaneous report received from a contactable physician (who is also the patient). A 59-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ek9231), via an unspecified route of administration in left arm, on 08Jan2021 12:00, at single dose, for COVID-19 immunization, in the hospital. Medical history included polymyalgia rheumatica. The patient has no known allergies. Concomitant medication included methotrexate and folic acid. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: el0140), via an unspecified route of administration in left arm, on 22Dec2020 at 11:00, for COVID-19 immunization. The patient experienced chills, muscle ache, headache, and muscle pain about 10 hours after injection on 08Jan2021 at 22:00. The patient did not receive treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient has not been tested for COVID-19. The outcome of the events chills, muscle ache/muscle pain about 10 hours after injection and headache was recovering.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: headache; arm pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 28-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 18Dec2020 09:30 at a single dose on left arm for COVID-19 immunization. Medical history included Postural orthostatic tachycardia syndrome. Concomitant medication included spironolactone and metoprolol. The patient experienced headache and arm pain on an unspecified date after first dose (reported as "First dose: headache, arm pain"). No treatment received for adverse events. The outcome of the events was recovering. The events were assessed as non-serious. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information on the lot/ batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Headache, Lymph node pain, Myalgia
Clinical narrative: Inject site pain; muscle/joint pain; muscle/joint pain; fever with temperature of 99-100.6 [units unspecified]; under arm lymph node pain; headache; This is a spontaneous report from a contactable healthcare professional. A 41-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; lot number: EL1284; expiration date: unknown), intramuscular left arm on 08Jan2021 08:45 AM at a single dose for covid-19 vaccination. Medical history included asthma, allergies, high blood pressure and gastric sleeve. Concomitant medication included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]), beclometasone dipropionate (QVAR), mometasone furoate (FLONASE), aminobenzoic acid, calcium pantothenate, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride (B-COMPLEX), cyanocobalamin (B-12), colecalciferol (D) and macrogol 3350 (MIRALAX). The patient previously took vancomycin but had allergies. The patient received the first dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; lot number: EK5730; expiration date: unknown) intramuscular left arm on 18Dec2020 07:45 AM at a single dose for covid-19 vaccination. 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 received the most recent COVID-19 vaccine in a hospital. The patient experienced inject site pain, muscle/joint pain, fever with temperature of 99-100.6 [units unspecified], under arm lymph node pain and headache on 09Jan2021 23:30. The events were considered as non-serious. The treatment the patient received for the adverse event were acetaminophen (TYLENOL), fluids, ice packs and magnesium. The patient has not been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included temperature was 99-100.6 [units unspecified] on 09Jan2021. The outcome of the events was recovering.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Inject site pain; muscle/joint pain; muscle/joint pain; fever with temperature of 99-100.6 [units unspecified]; under arm lymph node pain; headache; This is a spontaneous report from a contactable healthcare professional. A 41-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; lot number: EL1284; expiration date: unknown), intramuscular left arm on 08Jan2021 08:45 AM at a single dose for covid-19 vaccination. Medical history included asthma, allergies, high blood pressure and gastric sleeve. Concomitant medication included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]), beclometasone dipropionate (QVAR), mometasone furoate (FLONASE), aminobenzoic acid, calcium pantothenate, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride (B-COMPLEX), cyanocobalamin (B-12), colecalciferol (D) and macrogol 3350 (MIRALAX). The patient previously took vancomycin but had allergies. The patient received the first dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; lot number: EK5730; expiration date: unknown) intramuscular left arm on 18Dec2020 07:45 AM at a single dose for covid-19 vaccination. 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 received the most recent COVID-19 vaccine in a hospital. The patient experienced inject site pain, muscle/joint pain, fever with temperature of 99-100.6 [units unspecified], under arm lymph node pain and headache on 09Jan2021 23:30. The events were considered as non-serious. The treatment the patient received for the adverse event were acetaminophen (TYLENOL), fluids, ice packs and magnesium. The patient has not been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included temperature was 99-100.6 [units unspecified] on 09Jan2021. The outcome of the events was recovering.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing, Vaccination site pain
Clinical narrative: Mild pain at injection site and runny nose/sneezing day after vaccine; Mild pain at injection site and runny nose/sneezing day after vaccine; Mild pain at injection site and runny nose/sneezing day after vaccine; This is a spontaneous report from a contactable pharmacist (patient herself). A 30-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as COVID 19 brand Pfizer, lot Ej1685), via an unspecified route of administration in the left arm on 21Dec2020 12:00 at single dose for Covid-19 immunisation. Medical history included allergy to PCN (rash to PCN as a child). No other vaccine in four weeks prior to Covid-19 vaccine. No Covid-19 prior to vaccination. The patient's concomitant medications were not reported. The patient experienced mild pain at injection site and runny nose/sneezing day after vaccine (22Dec2020). No treatment was given to the patient. The outcome of events was recovered.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Inappropriate schedule of product administration, Pain, Vaccination site erythema
Clinical narrative: Chills; Body ache; Fatigue; redness and hot about 1-3 inches below injection site; redness and hot about 1-3 inches below injection site; patient received the second dose in less than 21 days from  the first dose; This is a spontaneous report from a contactable nurse, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EJ0142), intramuscular in the left arm on 05Jan2021 at 08:00 AM (at the age of 53-year-old) as a single dose for COVID-19 immunization. Medical history was none. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19.  There were no concomitant medications. The patient previously received the first dose of BNT162B2 intramuscular on 19Dec2020 at 19:00 PM, lot number: EJ1685 at the age of 53-year-old for COVID-19 immunization in the left arm. The patient did not receive any other vaccines within four weeks prior to the second vaccination (except the first vaccination). On 05Jan2021 at 22:00 PM  the patient experienced chills, body ache, fatigue, redness and hot about 1-3 inches below injection site. The patient took Motrin for chills, body ache, fatigue, redness and hot about 1-3 inches below injection site. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the chills, body ache, fatigue, redness and hot about 1-3 inches below injection site was not recovered.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Chills; Body ache; Fatigue; redness and hot about 1-3 inches below injection site; redness and hot about 1-3 inches below injection site; patient received the second dose in less than 21 days from  the first dose; This is a spontaneous report from a contactable nurse, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EJ0142), intramuscular in the left arm on 05Jan2021 at 08:00 AM (at the age of 53-year-old) as a single dose for COVID-19 immunization. Medical history was none. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19.  There were no concomitant medications. The patient previously received the first dose of BNT162B2 intramuscular on 19Dec2020 at 19:00 PM, lot number: EJ1685 at the age of 53-year-old for COVID-19 immunization in the left arm. The patient did not receive any other vaccines within four weeks prior to the second vaccination (except the first vaccination). On 05Jan2021 at 22:00 PM  the patient experienced chills, body ache, fatigue, redness and hot about 1-3 inches below injection site. The patient took Motrin for chills, body ache, fatigue, redness and hot about 1-3 inches below injection site. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the chills, body ache, fatigue, redness and hot about 1-3 inches below injection site was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Headache
Clinical narrative: Headache; Blood pressure went up; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age (reported as "Age 85: Unit Unknown") received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: not provided), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of COVID-19 vaccine on Wednesday 06Jan2021 and reported that on Friday 08Jan2021, she had a headache and blood pressure went up. Patient asked if these are side effects of the vaccine. Patient stated that someone saw on internet that high blood pressure can be from vaccine. Outcome of the events was unknown.  Information about batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Receives dose #1 of the covid vaccine and contracts covid prior to dose #2; Receives dose #1 of the covid vaccine and contracts covid prior to dose #2; This is a spontaneous report from a contactable physician via Pfizer sales representative. This physician reported similar events for two patients. This is 2nd of two reports.   A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that patient received dose #1 of the COVID vaccine and contracts COVID prior to dose #2 on an unspecified date. The patient underwent lab test which included Covid-19 test in which he/she tested positive on an unknown date. Outcome of the events was unknown.  Information about batch/lot number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. 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 RAs, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-2021012928 Same reporter/drug/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Respiratory disorder, Skin disorder
Clinical narrative: Itchy head, which progressed to other parts of the body in the following days; Bumps all over body; Some discomfort with breathing when taking a deep breath; This is a spontaneous report from a contactable consumer (relative). A female patient of an unspecified age (reported as "Pt age: 25", unit: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: not provided), via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 31Dec2020, patient experienced itchy head, which progressed to other parts of the body in the following days. The patient also experienced bumps all over body and some discomfort with breathing when taking a deep breath. Outcome of the events was not recovered (reported as "ongoing").  Information on the lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Dizziness, Fatigue, Pain in extremity, Palpitations
Clinical narrative: My heart rate, I was like in AFib; very high fever of 103; dizzy, light headed; arms sore; exhausted like an extreme fatigue; palpitations; This is a spontaneous report from a contactable consumer (patient).  A 38-year-old female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9899), via an unspecified route of administration on 30Dec2020 at 38-years-old at a single dose for COVID-19 immunization.  Medical history included blood clotting disorder from an unknown date and unknown if ongoing.  The patient experienced the following events and outcomes: my heart rate, I was like in AFib (medically significant) on 31Dec2020 with outcome of recovering, very high fever of 103 (non-serious) on 31Dec2020 with outcome of unknown, dizzy, light headed (non-serious) on 31Dec2020 with outcome of unknown, arms sore (non-serious) on 31Dec2020 with outcome of unknown, exhausted like an extreme fatigue (non-serious) on 31Dec2020 with outcome of not recovered, palpitations (non-serious) on 31Dec2020 with outcome of not recovered.  The clinical course was reported as follows: The patient stated, "the day after the shot I got a very high fever of 103. I was dizzy, lightheaded. My heart rate I was like in AFib, it was going from 60s to 50s all over the place. And this was the next day after the vaccination. That evening nothing my arms was just sore. But the next day all of these side effects just started in and even still today I just feel so exhausted like an extreme fatigue and I am still getting like palpitations." The patient stated, "So I went to urgent care and they check my vitals and stuff and when they wanted me to send me to the hospital. But I told them I will get a ride and I go by myself just because I didn't want, capable of an ambulance ride and I ended up just going home because I couldn't get a hold up anybody. So, I came home and took my blood thinner medication because I do have blood clotting disorder."  In regard to the outcomes of the events, the patient stated, "I am not experiencing all of them still definitely my heart is much better. I am still getting palpitations but nothing near how it was that first day. I am experiencing extreme fatigue."
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: My heart rate, I was like in AFib; very high fever of 103; dizzy, light headed; arms sore; exhausted like an extreme fatigue; palpitations; This is a spontaneous report from a contactable consumer (patient).  A 38-year-old female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9899), via an unspecified route of administration on 30Dec2020 at 38-years-old at a single dose for COVID-19 immunization.  Medical history included blood clotting disorder from an unknown date and unknown if ongoing.  The patient experienced the following events and outcomes: my heart rate, I was like in AFib (medically significant) on 31Dec2020 with outcome of recovering, very high fever of 103 (non-serious) on 31Dec2020 with outcome of unknown, dizzy, light headed (non-serious) on 31Dec2020 with outcome of unknown, arms sore (non-serious) on 31Dec2020 with outcome of unknown, exhausted like an extreme fatigue (non-serious) on 31Dec2020 with outcome of not recovered, palpitations (non-serious) on 31Dec2020 with outcome of not recovered.  The clinical course was reported as follows: The patient stated, "the day after the shot I got a very high fever of 103. I was dizzy, lightheaded. My heart rate I was like in AFib, it was going from 60s to 50s all over the place. And this was the next day after the vaccination. That evening nothing my arms was just sore. But the next day all of these side effects just started in and even still today I just feel so exhausted like an extreme fatigue and I am still getting like palpitations." The patient stated, "So I went to urgent care and they check my vitals and stuff and when they wanted me to send me to the hospital. But I told them I will get a ride and I go by myself just because I didn't want, capable of an ambulance ride and I ended up just going home because I couldn't get a hold up anybody. So, I came home and took my blood thinner medication because I do have blood clotting disorder."  In regard to the outcomes of the events, the patient stated, "I am not experiencing all of them still definitely my heart is much better. I am still getting palpitations but nothing near how it was that first day. I am experiencing extreme fatigue."
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Condition aggravated, Feeling drunk, Headache, Myalgia
Clinical narrative: mild headache/splitting headache; soreness/muscle soreness in the posterior chain (shoulder, back, traps); lack of of energy; "like having too much to drink and achy" and is currently ramping up; "like having too much to drink and achy" and is currently ramping up; This is a spontaneous report from a contactable other healthcare professional (patient).  An adult male patient of an unspecified age (Age: 28; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration from an unspecified date to an unspecified date as SINGLE DOSE for COVID-19 immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 23Dec2020 for COVID-19 immunization and the patient experienced mild headache and soreness, muscle soreness in the posterior chain (shoulder, back, traps), splitting headache, lack of energy.  Upon receiving second dose of the vaccine, the patient experienced  same symptoms, mild headache and soreness, muscle soreness in the posterior chain (shoulder, back, traps), splitting headache, lack of energy, and additionally stated "like having too much to drink and achy" and is currently ramping up. The outcome of the events was unknown.  Information about batch/lot number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Inappropriate schedule of product administration, Off label use, Pain
Clinical narrative: Profusely sweat; Body aches; Chills; Get hives on my face and chest; Had a low grade fever. 100.2 F; Dose Number:1/ Date of start of drug: 21Dec2020/ Dose Number:2/ Date of start of drug: 08Jan2021; Dose Number:1/ Date of start of drug: 21Dec2020/ Dose Number:2/ Date of start of drug: 08Jan2021; This is a spontaneous report from a contactable nurse (patient). A 24-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ELO140), intramuscularly on left arm at 20:00 on 08Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included cefalexin monohydrate (LEXIPRON), lisdexamfetamine mesilate (VYVANSE) and medication for birth control. The patient previously took Keflex and experienced drug allergy, first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: BLO140), intramuscularly on left arm at 06:00 AM on 21Dec2021 for COVID-19 immunization. An hour after the vaccination at 21:00 on 08Jan2021, the patient started to profusely sweat and get body aches and chills. The patient then started to get hives on her face and chest. The patient took Tylenol and Benadryl which helped the hives. The patient also had a low grade fever 100.2 F. The events were reported as non-serious. The outcome of events sweating, generalized aching, chills, hives and low grade fever was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Urticaria
Clinical narrative: Profusely sweat; Body aches; Chills; Get hives on my face and chest; Had a low grade fever. 100.2 F; Dose Number:1/ Date of start of drug: 21Dec2020/ Dose Number:2/ Date of start of drug: 08Jan2021; Dose Number:1/ Date of start of drug: 21Dec2020/ Dose Number:2/ Date of start of drug: 08Jan2021; This is a spontaneous report from a contactable nurse (patient). A 24-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ELO140), intramuscularly on left arm at 20:00 on 08Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included cefalexin monohydrate (LEXIPRON), lisdexamfetamine mesilate (VYVANSE) and medication for birth control. The patient previously took Keflex and experienced drug allergy, first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: BLO140), intramuscularly on left arm at 06:00 AM on 21Dec2021 for COVID-19 immunization. An hour after the vaccination at 21:00 on 08Jan2021, the patient started to profusely sweat and get body aches and chills. The patient then started to get hives on her face and chest. The patient took Tylenol and Benadryl which helped the hives. The patient also had a low grade fever 100.2 F. The events were reported as non-serious. The outcome of events sweating, generalized aching, chills, hives and low grade fever was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Crying, Fatigue, Malaise
Clinical narrative: Chills; fatigue; muscle aches so bad it made me cry; muscle aches so bad it made me cry; pain everywhere even clothes against my skin hurt/it was all I could do to physically get to bed, which hurt with every step; temp of 99.7; malaise; profound sleepiness; Arm pain at injection site; Arm pain at injection site; This is a spontaneous report from a contactable Physician reported for herself. A 33-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular at Left arm on 08Jan2021 09:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included reported as none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient historic vaccine included the first dose of BNT162B2 on 18Dec2020 08:00 AM intramuscular at Left arm for covid-19 immunization. The patient experienced Chills, fatigue, muscle aches so bad it made her cry, pain everywhere even clothes against her skin hurt, temperature of 99.7, malaise, profound sleepiness, and it was all she could do to physically get to bed, which hurt with every step. Arm pain at injection site for 2 days now, could not sleep on that side, adverse event start date was provided as 08Jan2021 09:00 AM. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pain in extremity, Pyrexia, Somnolence
Clinical narrative: Chills; fatigue; muscle aches so bad it made me cry; muscle aches so bad it made me cry; pain everywhere even clothes against my skin hurt/it was all I could do to physically get to bed, which hurt with every step; temp of 99.7; malaise; profound sleepiness; Arm pain at injection site; Arm pain at injection site; This is a spontaneous report from a contactable Physician reported for herself. A 33-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular at Left arm on 08Jan2021 09:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included reported as none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient historic vaccine included the first dose of BNT162B2 on 18Dec2020 08:00 AM intramuscular at Left arm for covid-19 immunization. The patient experienced Chills, fatigue, muscle aches so bad it made her cry, pain everywhere even clothes against her skin hurt, temperature of 99.7, malaise, profound sleepiness, and it was all she could do to physically get to bed, which hurt with every step. Arm pain at injection site for 2 days now, could not sleep on that side, adverse event start date was provided as 08Jan2021 09:00 AM. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Chills; fatigue; muscle aches so bad it made me cry; muscle aches so bad it made me cry; pain everywhere even clothes against my skin hurt/it was all I could do to physically get to bed, which hurt with every step; temp of 99.7; malaise; profound sleepiness; Arm pain at injection site; Arm pain at injection site; This is a spontaneous report from a contactable Physician reported for herself. A 33-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular at Left arm on 08Jan2021 09:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included reported as none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient historic vaccine included the first dose of BNT162B2 on 18Dec2020 08:00 AM intramuscular at Left arm for covid-19 immunization. The patient experienced Chills, fatigue, muscle aches so bad it made her cry, pain everywhere even clothes against her skin hurt, temperature of 99.7, malaise, profound sleepiness, and it was all she could do to physically get to bed, which hurt with every step. Arm pain at injection site for 2 days now, could not sleep on that side, adverse event start date was provided as 08Jan2021 09:00 AM. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood glucose, Blood pressure measurement, Dizziness, Fatigue
Clinical narrative: Dizziness; Tired; Weakness; Not feeling good; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), via an unspecified route of administration, on 10Jan2021 at 11:00, at a single dose, for COVID-19 immunization. The patient's medical history included vertigo-like dizziness (gets dizzy sometimes, every now and then). The patient's concomitant medication included dimenhydrinate (DRAMAMINE) for vertigo-like dizziness. The patient had the COVID-19 shot this morning at 11 o'clock (10Jan2021), it's been 8 hours now. The patient was asking if it was safe to take anything or could she take dimenhydrinate. It's been 8 hours since the patient had the vaccine and she only wanted to know if she can take dimenhydrinate because she was having dizziness around 7:30 PM. The patient was tired and did not want to hold, so warm call transfer was not attempted. The patient was about to call her pharmacist as soon as she was referred back to her healthcare professional and disconnected before she was offered the survey. Further that day, the patient reported that she was fine - meaning she had no reaction except felt dizzy around 7:30 or so (around 8 hours after administration). The patient looked at one of the complications and it could be dizziness and weakness, but she just felt a little dizzy and she gets like that sometime. That day (10Jan2021), the patient checked her blood pressure and blood sugar and they were both fine. The patient was just wondering if she could take the half of dimenhydrinate (reason of call). On paraphrasing the concern, the patient reported that she gets dizzy (vertigo-like dizziness) sometimes and she never takes a whole dimenhydrinate; she takes half of one and for this instance, the patient thought she would take half but she wanted to talk to Pfizer medical information first. In response to further questions, the patient stated that 8-10 minutes, she was not feeling good - patient can't do that (answering questions) and just needed some help. Limited information was available over the call as the patient was not willing to proceed with the questions. The events were considered non-serious. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Dizziness; Tired; Weakness; Not feeling good; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), via an unspecified route of administration, on 10Jan2021 at 11:00, at a single dose, for COVID-19 immunization. The patient's medical history included vertigo-like dizziness (gets dizzy sometimes, every now and then). The patient's concomitant medication included dimenhydrinate (DRAMAMINE) for vertigo-like dizziness. The patient had the COVID-19 shot this morning at 11 o'clock (10Jan2021), it's been 8 hours now. The patient was asking if it was safe to take anything or could she take dimenhydrinate. It's been 8 hours since the patient had the vaccine and she only wanted to know if she can take dimenhydrinate because she was having dizziness around 7:30 PM. The patient was tired and did not want to hold, so warm call transfer was not attempted. The patient was about to call her pharmacist as soon as she was referred back to her healthcare professional and disconnected before she was offered the survey. Further that day, the patient reported that she was fine - meaning she had no reaction except felt dizzy around 7:30 or so (around 8 hours after administration). The patient looked at one of the complications and it could be dizziness and weakness, but she just felt a little dizzy and she gets like that sometime. That day (10Jan2021), the patient checked her blood pressure and blood sugar and they were both fine. The patient was just wondering if she could take the half of dimenhydrinate (reason of call). On paraphrasing the concern, the patient reported that she gets dizzy (vertigo-like dizziness) sometimes and she never takes a whole dimenhydrinate; she takes half of one and for this instance, the patient thought she would take half but she wanted to talk to Pfizer medical information first. In response to further questions, the patient stated that 8-10 minutes, she was not feeling good - patient can't do that (answering questions) and just needed some help. Limited information was available over the call as the patient was not willing to proceed with the questions. The events were considered non-serious. The outcome of the events was unknown.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort
Clinical narrative: There was only mild discomfort with the first dose.; This is a spontaneous report from a contactable healthcare professional (patient herself). A 21-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date not reported), via an unspecified route of administration in the right arm on 21Dec2020 11:30 at single dose for COVID-19 immunisation. Medical history was none. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included aminobenzoic acid, biotin, choline bitartrate, cyanocobalamin, folic acid, inositol, iodine, iron, nicotinamide, pantothenic acid, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine hydrochloride, zinc (HAIRVITE), and ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE). The patient experienced that there was only mild discomfort with the first dose on Dec2020. No therapeutic measure was taken as a result of the event. Clinical outcome of the event was unknown.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: 1st - minimal pain right deltoid area at vaccination site; This is a spontaneous report from a contactable consumer (patient herself). A 35-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Flo140, expiry date: 31Mar2021), via an unspecified route of administration in the right arm on 18Dec2020 12:00 at single dose for COVID-19 immunisation. Medical history included hypothyroidism. Concomitant medications included levothyroxine, vitamin c (ascorbic acid) (VITAMIN C), and colecalciferol (VITAMIN D). The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. The patient experienced 1st - minimal pain right deltoid area at vaccination site on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 27Dec2020. Clinical outcome of the event was unknown.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Pruritus, Urticaria
Clinical narrative: Itchiness, hives, wilts, abdominal pain; Itchiness, hives, wilts, abdominal pain; Itchiness, hives, wilts, abdominal pain; Itchiness, hives, wilts, abdominal pain; This is a spontaneous report from a contactable nurse (patient). A 30-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown unable to locate or read the details) via an unspecified route of administration at Left arm on 23Dec2020 14:15 at single dose covid-19 immunization. Facility type vaccine was Hospital. No known allergies and no other medical history. Concomitant medication included ascorbic acid, calcium pantothenate, cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol palmitate, riboflavin, thiamine mononitrate (PRENATAL VITAMINS), colecalciferol (VITAMIN D). No other vaccine in four weeks. The patient experienced itchiness, hives, wilts, abdominal pain on 01Jan2021 23:45. The events resulted in Doctor or other healthcare professional office/clinic visit. No covid prior vaccination and covid was not tested post vaccination. Treatment Benadryl was received for the events. The outcome of the events was recovered in Jan2021.  Information about lot/batch number request.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Chills, Diarrhoea, Headache
Clinical narrative: Headache; body aches; joint pain; chills; fever; general malaise; dental pain; soreness at injection site; pain; Loose stools; Stomach upset; Dose Number:1/ Date of start of drug: 21Dec2020/ Dose Number:2/ Date of start of drug: 07Jan2021; Dose Number:1/ Date of start of drug: 21Dec2020/ Dose Number:2/ Date of start of drug: 07Jan2021; This is a spontaneous report from a contactable Other healthcare professional (patient). A 21-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EL0140), via an unspecified route of administration on left arm at 09:45 AM on 07Jan2021 at single dose for COVID-19 immunization. Medical history reported as none. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) and Women's Daily Multivitamin, Hair Vits. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EL0140), on right arm at 11:30 AM on 21Dec2020 for COVID-19 immunization and experienced only mild discomfort. The patient experienced headache, body aches, joint pain, chills, fever, general malaise, dental pain, pain and soreness at injection site, loose stools, and stomach upset at 21:30 on 07Jan2021. The events were reported as non-serious. The patient did not receive any treatment for events. The outcome of events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the had not patient been tested for COVID-19.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Malaise, Off label use, Pain, Pyrexia
Clinical narrative: Headache; body aches; joint pain; chills; fever; general malaise; dental pain; soreness at injection site; pain; Loose stools; Stomach upset; Dose Number:1/ Date of start of drug: 21Dec2020/ Dose Number:2/ Date of start of drug: 07Jan2021; Dose Number:1/ Date of start of drug: 21Dec2020/ Dose Number:2/ Date of start of drug: 07Jan2021; This is a spontaneous report from a contactable Other healthcare professional (patient). A 21-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EL0140), via an unspecified route of administration on left arm at 09:45 AM on 07Jan2021 at single dose for COVID-19 immunization. Medical history reported as none. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) and Women's Daily Multivitamin, Hair Vits. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EL0140), on right arm at 11:30 AM on 21Dec2020 for COVID-19 immunization and experienced only mild discomfort. The patient experienced headache, body aches, joint pain, chills, fever, general malaise, dental pain, pain and soreness at injection site, loose stools, and stomach upset at 21:30 on 07Jan2021. The events were reported as non-serious. The patient did not receive any treatment for events. The outcome of events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the had not patient been tested for COVID-19.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Toothache, Vaccination site pain
Clinical narrative: Headache; body aches; joint pain; chills; fever; general malaise; dental pain; soreness at injection site; pain; Loose stools; Stomach upset; Dose Number:1/ Date of start of drug: 21Dec2020/ Dose Number:2/ Date of start of drug: 07Jan2021; Dose Number:1/ Date of start of drug: 21Dec2020/ Dose Number:2/ Date of start of drug: 07Jan2021; This is a spontaneous report from a contactable Other healthcare professional (patient). A 21-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EL0140), via an unspecified route of administration on left arm at 09:45 AM on 07Jan2021 at single dose for COVID-19 immunization. Medical history reported as none. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) and Women's Daily Multivitamin, Hair Vits. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EL0140), on right arm at 11:30 AM on 21Dec2020 for COVID-19 immunization and experienced only mild discomfort. The patient experienced headache, body aches, joint pain, chills, fever, general malaise, dental pain, pain and soreness at injection site, loose stools, and stomach upset at 21:30 on 07Jan2021. The events were reported as non-serious. The patient did not receive any treatment for events. The outcome of events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the had not patient been tested for COVID-19.