chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: her arm was sore; her elbow was in a lot of pain; This is a spontaneous report from a contactable other healthcare professional.  A 80-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation solution for injection, Batch/Lot number was not reported), via unspecified route of administration on an unspecified date at the single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation solution for injection, Batch/Lot number was not reported), via unspecified route of administration on an unspecified date at the single dose for COVID-19 immunization. On an unspecified date the patient experienced her arm was sore, her elbow was in a lot of pain. It was reported that patient receiving her second COVID 19 vaccine, she stated she a slight reaction her arm was sore, then she woke up the next morning her elbow was in a lot of pain, no additional information noted. The outcome of events was unknown.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.   Follow-up attempts have been completed and no further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen neck gland; This is a spontaneous report received from a contactable consumer (patient herself). A 66-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL8982) via an unspecified route of administration, on left arm on 20Jan2021 at 10:30 as 1st dose, single for COVID-19 immunization. Medical history included overweight. Concomitant medications included diphenhydramine hydrochloride (BENADRYL) received within 2 weeks of vaccination. The patient previously took ceftriaxone sodium (ROCEFIN) and experienced known allergies. The patient did not receive other vaccine in four weeks. The patient did not had COVID-19 prior vaccination and did not tested COVID-19 post vaccination. On 29Jan2021 at 10:30, the patient experienced swollen neck gland. She did not receive any treatment for the event. The outcome of the event was recovering.  No follow up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Feeling abnormal, Gait disturbance, Headache
Clinical narrative: dizziness; Noticed slight feeling of unbalanced gait; noticed a feeling of "things not quite right"; headache; nausea; decreased appetite; This is a spontaneous report from a contactable nurse reported for herself. A 57-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9265) via Intramuscular route of administration in right arm on 02Feb2021 10:30 and first dose (Lot Number: EL3248) via an Intramuscular in right arm on 11Jan2021 17:30 both at single dose for Covid-19 immunization. The patient medical history was not reported. Concomitant medications included vitamin b complex (SUPER B COMPLEX) 1 DF, ascorbic acid (VIT C) 500mg, colecalciferol (VIT D3) 2000 IU, asa (ASA) 325mg all one tablet daily. No allergies to medications, food, or other products and there were no prior vaccinations within 4 weeks. The patient was not diagnosed with COVID-19 prior to vaccination. The patient not tested with COVID-19 post vaccination. On 02Feb2021, the patient experienced since 2nd vaccine having subtle headache, relieved by taking ASA dose X 1 daily, otherwise so subtle was tolerable, and subtle nausea that only has decreased appetite somewhat (no weight loss) accompanied by slight feeling of dizziness (VS WNL). Beginning 07Feb2021, awakened by severe feeling of dizziness, nausea, then headache. Noticed slight feeling of unbalanced gait, but able to be corrected without difficulty, just noticed a feeling of "things not quite right". Approx 03:00 today, 11Feb2021, awakened with another episode of severe dizziness accompanied by nausea and increased imbalance while walking through home. This time, these symptoms are intermittent, but constant intermittent and not going away, therefore have made an appointment with my PCP today 11Feb2021 at 15:00 to ask for a possible CT of my head d/t worrying about this dizziness to rule out nothing else is wrong since this dizziness w/nausea feeling is becoming persistent. Treatment received for adverse event was unknown. Reporter was assessed event as non-serious. Adverse event result in doctor or other healthcare professional office/clinic visit. The outcome for the events were not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: dizziness; Noticed slight feeling of unbalanced gait; noticed a feeling of "things not quite right"; headache; nausea; decreased appetite; This is a spontaneous report from a contactable nurse reported for herself. A 57-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9265) via Intramuscular route of administration in right arm on 02Feb2021 10:30 and first dose (Lot Number: EL3248) via an Intramuscular in right arm on 11Jan2021 17:30 both at single dose for Covid-19 immunization. The patient medical history was not reported. Concomitant medications included vitamin b complex (SUPER B COMPLEX) 1 DF, ascorbic acid (VIT C) 500mg, colecalciferol (VIT D3) 2000 IU, asa (ASA) 325mg all one tablet daily. No allergies to medications, food, or other products and there were no prior vaccinations within 4 weeks. The patient was not diagnosed with COVID-19 prior to vaccination. The patient not tested with COVID-19 post vaccination. On 02Feb2021, the patient experienced since 2nd vaccine having subtle headache, relieved by taking ASA dose X 1 daily, otherwise so subtle was tolerable, and subtle nausea that only has decreased appetite somewhat (no weight loss) accompanied by slight feeling of dizziness (VS WNL). Beginning 07Feb2021, awakened by severe feeling of dizziness, nausea, then headache. Noticed slight feeling of unbalanced gait, but able to be corrected without difficulty, just noticed a feeling of "things not quite right". Approx 03:00 today, 11Feb2021, awakened with another episode of severe dizziness accompanied by nausea and increased imbalance while walking through home. This time, these symptoms are intermittent, but constant intermittent and not going away, therefore have made an appointment with my PCP today 11Feb2021 at 15:00 to ask for a possible CT of my head d/t worrying about this dizziness to rule out nothing else is wrong since this dizziness w/nausea feeling is becoming persistent. Treatment received for adverse event was unknown. Reporter was assessed event as non-serious. Adverse event result in doctor or other healthcare professional office/clinic visit. The outcome for the events were not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Hypersensitivity
Clinical narrative: she had allergic reaction; Rash under her breast is, all over chest, back, and sides and it has moved up into her hairline; fever; achiness; body aches; sore arm; Massive headache; loss of appetite; extremely tired; Chills; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Lot Number: EL9269) via an unspecified route of administration on 06Feb2021 at 12:30 (at the age of 50-year-old) as a 1st dose, single dose in left arm for COVID-19 immunisation in School/Student Health Clinic. The patient's medical history included allergic to sulfa products taken for bad kidney, bladder infections 30 years ago; flu shots every year in the Fall around September or October and experienced soreness in arms, achiness and never had any other reactions and had COVID virus infection back during the end of the year. Concomitant medications were not reported. On 06Feb2021 Saturday night, the patient experienced sore arm and it was hard to lift like when she had flu shots in past. On 07Feb2021 Sunday, the patient experienced fever, achiness, body aches. The patient felt fine on 08Feb2021 Monday. Later on 08Feb2021, she experienced rash under her breast is, all over chest, back, and sides and it has moved up into her hairline. It does not itched, but irritating under her breast. On 09Feb2021, the patient went to urgent care, visited doctor in physician office and told she had allergic reaction and to not get the second dose, it could turn into anaphylaxis. On an unspecified date in Feb2021, the patient experienced massive headache, chills, loss of appetite, and was extremely tired. Patient enquired whether sulfa products is present in the Pfizer Biontech vaccine, as Sulfa is the only medicine she has been allergic to. The patient underwent lab tests and procedures included SARS-CoV-2 antibody test: unknown result on an unknown date. The clinical outcome of all the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Rash, SARS-CoV-2 antibody test
Clinical narrative: she had allergic reaction; Rash under her breast is, all over chest, back, and sides and it has moved up into her hairline; fever; achiness; body aches; sore arm; Massive headache; loss of appetite; extremely tired; Chills; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Lot Number: EL9269) via an unspecified route of administration on 06Feb2021 at 12:30 (at the age of 50-year-old) as a 1st dose, single dose in left arm for COVID-19 immunisation in School/Student Health Clinic. The patient's medical history included allergic to sulfa products taken for bad kidney, bladder infections 30 years ago; flu shots every year in the Fall around September or October and experienced soreness in arms, achiness and never had any other reactions and had COVID virus infection back during the end of the year. Concomitant medications were not reported. On 06Feb2021 Saturday night, the patient experienced sore arm and it was hard to lift like when she had flu shots in past. On 07Feb2021 Sunday, the patient experienced fever, achiness, body aches. The patient felt fine on 08Feb2021 Monday. Later on 08Feb2021, she experienced rash under her breast is, all over chest, back, and sides and it has moved up into her hairline. It does not itched, but irritating under her breast. On 09Feb2021, the patient went to urgent care, visited doctor in physician office and told she had allergic reaction and to not get the second dose, it could turn into anaphylaxis. On an unspecified date in Feb2021, the patient experienced massive headache, chills, loss of appetite, and was extremely tired. Patient enquired whether sulfa products is present in the Pfizer Biontech vaccine, as Sulfa is the only medicine she has been allergic to. The patient underwent lab tests and procedures included SARS-CoV-2 antibody test: unknown result on an unknown date. The clinical outcome of all the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Pain
Clinical narrative: severe headache; body aches; Mild pain at the injection site; This is a spontaneous report from a contactable other healthcare professional via Pfizer Sales Representative. A female patient of an unspecified age received BNT162B2(COMIRNATY, Solution of injection, Batch/Lot Number: was not reported) via an unspecified route of administration on an unspecified date as second dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced severe headache, body aches, mild pain at the injection site on an unspecified date. She experienced a severe headache that lasted 1 week. She also had bad body aches that lasted for about 3 days. Mild pain at the injection site. Outcome of the event was unknown.    No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Flushing, Heart rate, Heart rate increased
Clinical narrative: flushing; rapid heart rate; elevated blood pressure; This is a spontaneous report from a contactable consumer. A non-pregnant female(Age: 72, Unit: Unknown) patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9265), via an unspecified route of administration on arm Left on 16Feb2021 09:00 AM at single dose for COVID-19 immunization. The patient medical history included Asthma, high cholesterol. The patient had allergies to PCN, Ativan, Zofran, Prednisone. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccines in four weeks. The patient Concomitant medications included Rosuvastatin, Cetirizine Hydrochloride, Albuterol inh. On 16Feb2021 09:00 AM, Five minutes after injection, the patient experienced some flushing, rapid heart rate, elevated blood pressure. The events resulted in Emergency room/department or urgent care. The patient did not receive any treatment for the events. The outcome of the events was recovered.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Rash, SARS-CoV-2 test, Visual impairment
Clinical narrative: dizziness; seeing spots; rash on face, arms. upper back; This is a spontaneous report from a contactable consumer.   A 20-years-old (non pregnant) female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number=PF12EREL9207; Expiration date: UNKNOWN), via an unspecified route of administration in Right arm on 16Feb2021 at 02:30 PM as single dose for COVID-19 immunizations. Medical history includes known allergies to foods-bananas, pineapple. The patient had COVID prior vaccination. The patient previously received the first dose of BNT162b2 on an unknown date for COVID-19 immunisation. The patient did not receive any other vaccines in four weeks. It was unknown if COVID tested post vaccination. Concomitant medication (other medications in two weeks) included ethinylestradiol, levonorgestrel (ALTAVERA) (MANUFACTURER UNKNOWN), sertraline taken for unspecified indication at unspecified dose from an unspecified date and unknown if ongoing.   On 16Feb2021 at 11:45 PM patient experienced dizziness, seeing spots and rash on face, arm and up-per back. Patient received benedryl as a treatment for the adverse events. The outcome of the events dizziness, seeing spots and rash on face, arm and upper back was reported as not recovered.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Very severe joint pain in both knees; This is a spontaneous report from a contactable consumer (Patient). A 91-year-old male patient received first dose of BNT162B2 (Pfizer COVID-19 Vaccine, solution for injection, Lot Number: EL9269), via an unspecified route of administration, administered in left arm on 16Feb2021 at 17:15 (at the age of 91-years) as single dose for COVID-19 immunisation. Medical history included cardiac failure from an unknown date and unknown if ongoing. Patient had no known allergies. Patient did not have COVID prior vaccination. Patient did not receive any other vaccine within four weeks of vaccination. Patient received unspecified medications within two weeks prior vaccination. The concomitant medication(s) were not reported. On 17Feb2021 at 08:00 (next day of vaccination), patient experienced very severe joint pain in both knees. Patient did not receive any treatment for the event. Patient not tested for COVID post vaccination. The outcome of the event was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: took the Pfizer vaccine before I know that I have COVID; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced took the Pfizer vaccine before I know that I have COVID on an unspecified date. It was reported that the patient took the vaccine and stated that after a few days, the PCR results showed that he has COVID and that was '5 days' ago (not clarified). The patient was asking if when can he do the second shot and if he needed to start from the first shot over or just continue with the second shot. The patient also stated that he took the vaccination because when he did the first rapid test, it was negative but when the PCR came up, it was positive. So, he stated that he took it at the same time while he has COVID. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: 4 hours after injection, my ears started buzzing (tinnitus) and it's been constant since.; This is a spontaneous report from a contactable consumer (Patient). A 74-years-old non pregnant female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 11Jan2021 at 13:30 as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included atrial fibrillation from 2012 to an unknown date, 1 afib episode in 2012 requiring emergency treatment in hospital 5 hrs, hypersensitivity, rubber sensitivity. Concomitant medications included cyanocobalamin (B-12), Nattokinase (NATTOKINASE); omega-3 fatty acids (OMEGA-3 FATTY ACIDS), Xantofyl (LUTEIN). The patient previously took methylisothiazolinone and experienced drug hypersensitivity. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Jan2021 17:30, The patient experienced 4 hours after injection, my ears started buzzing and it's been constant since. No treatment was received for the adverse event. The outcome of the events was not resolved.  Information about lot/Batch number has been requested. .
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Headache, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: I am having side effects, is that COVID?; I woke up with 102 fever; probably the sweat; Everything aches, still aches; Light Headache; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EL9262 Expiration Date: not reported), via an unspecified route of administration on 08Feb2021 at 14:00 as second dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On unspecified date of Feb2021, at the middle of the night, the patient reported to know to have side effects. The patient had none initially but she woke up on unspecified date of Feb2021 with 102 fever, probably the sweat, everything aches, still aches and Light headache. The patient further reported that she was having side effects and asking if that was COVID. Outcome of the event "everything aches, still aches " was not recovered and unknown for all other events.  No follow up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: I am having side effects, is that COVID?; I woke up with 102 fever; probably the sweat; Everything aches, still aches; Light Headache; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EL9262 Expiration Date: not reported), via an unspecified route of administration on 08Feb2021 at 14:00 as second dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On unspecified date of Feb2021, at the middle of the night, the patient reported to know to have side effects. The patient had none initially but she woke up on unspecified date of Feb2021 with 102 fever, probably the sweat, everything aches, still aches and Light headache. The patient further reported that she was having side effects and asking if that was COVID. Outcome of the event "everything aches, still aches " was not recovered and unknown for all other events.  No follow up attempts are possible. No further information is expected.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Muscle spasms
Clinical narrative: Severe cramp, left leg on 18Feb2021 atleast 4 separate times in afternoon followed by cramps both legs simultaneously with warm feeling right toes lasting abt1hr.Cramps lasted approx.3-5 Min.each time; Severe cramp, left leg on 18Feb2021 atleast 4 separate times in afternoon followed by cramps both legs simultaneously with warm feeling right toes lasting abt1hr.Cramps lasted approx.3-5 Min.each time; This is a spontaneous report from a contactable consumer (patient). An 82-years-old male patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN5318) administered in right arm via an unknown route of administration on 14Feb2021 at 09:45 am as SINGLE DOSE for covid-19 immunization. Medical history included diabetes mellitus. Concomitant medications in two weeks included Esomeprazole (ESOMEPRAZOLE), Simvastatin (SIMVASTATIN), Ramipril (RAMIPRIL), Amlodipine (AMLODIPINE). Prior vaccination, patient was not diagnosed with covid. On 18Feb2021 at 15:30 pm, the patient experienced severe cramp, left leg at least 4 separate times in afternoon followed by cramps both legs simultaneously with warm feeling right toes lasting about 1 hr.  cramps lasted approximately 3-5 minutes each time. The outcome of the events was unknown. No other vaccine was received in four weeks. Post vaccination, the patient was not tested for covid. The patient had known allergies only to Typhus vaccine many years ago.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Lymphadenopathy, Malaise
Clinical narrative: swelling/ pain in area of left armpit lymph node; Fatigue; General malaise; pain in arm where injection occurred; Headache; Chills; aches; This is a spontaneous report from a contactable consumer (patient).   This 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247), via an unknown route in the left deltoid, on 08Feb2021 15:15 (at the age of 43-year-old) at single dose for COVID-19 immunisation, administered at Workplace clinic. No relevant medical history were provided. Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247), administered via an unknown route in the left deltoid, on 20Jan2021 14:00 (at the age of 43-year-old) at single dose and developed swelling/pain in armpit of injection arm on 21Jan2021; flu shot last vaccination was annual flu shot in Sep/Oct2020 with no side effects. The patient did not have a relevant concomitant medications. No other vaccine was received in four weeks. On 08Feb2021 at 18:30, the patient developed pain in arm where injection occurred, headache, chills, aches, fatigue and general malaise. On 09Feb2021 at 18:00, the patient developed swelling/pain in area of left armpit lymph node. The events did not require physician office visit/emergency room visit. The patient was not hospitalized for the events. The patient had recovered from 'headache', 'chills', 'aches', 'fatigue', and 'general malaise' on 10Feb2021. The patient had recovered from 'pain in arm where injection occurred' on unknown date in 2021 while the patient had recovered from 'swelling/ pain in area of left armpit lymph node' on 15Feb2021.  No Follow-up attempts are possible. No further Information expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: swelling/ pain in area of left armpit lymph node; Fatigue; General malaise; pain in arm where injection occurred; Headache; Chills; aches; This is a spontaneous report from a contactable consumer (patient).   This 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247), via an unknown route in the left deltoid, on 08Feb2021 15:15 (at the age of 43-year-old) at single dose for COVID-19 immunisation, administered at Workplace clinic. No relevant medical history were provided. Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247), administered via an unknown route in the left deltoid, on 20Jan2021 14:00 (at the age of 43-year-old) at single dose and developed swelling/pain in armpit of injection arm on 21Jan2021; flu shot last vaccination was annual flu shot in Sep/Oct2020 with no side effects. The patient did not have a relevant concomitant medications. No other vaccine was received in four weeks. On 08Feb2021 at 18:30, the patient developed pain in arm where injection occurred, headache, chills, aches, fatigue and general malaise. On 09Feb2021 at 18:00, the patient developed swelling/pain in area of left armpit lymph node. The events did not require physician office visit/emergency room visit. The patient was not hospitalized for the events. The patient had recovered from 'headache', 'chills', 'aches', 'fatigue', and 'general malaise' on 10Feb2021. The patient had recovered from 'pain in arm where injection occurred' on unknown date in 2021 while the patient had recovered from 'swelling/ pain in area of left armpit lymph node' on 15Feb2021.  No Follow-up attempts are possible. No further Information expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Influenza, Urticaria
Clinical narrative: 1-2 days afterwards he was experiencing hives, chills, flu symptoms; 1-2 days afterwards he was experiencing hives, chills, flu symptoms; 1-2 days afterwards he was experiencing hives, chills, flu symptoms; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a male Patient. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Formulation: Solution for injection,Batch/Lot number was not reported), via an unspecified route of administration on 12Feb2021 at 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced 1-2 days afterwards he was experiencing hives, chills, flu symptoms. Verbatim and Event Description included 12Feb2021 was his first dose of the covid vaccine, 1-2 days afterwards he was experiencing hives, chills, flu symptoms. He is looking for advice about how to treat the symptoms and if he should take the second dose. He would not provide anything but his phone number. Read ISI, long hold in a phone queue, AE for reaction to the vaccine faxed to a company. CEP 159558. The outcome of events were unknown.   Information on the lot batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis, Erythema, Pruritus, Urticaria
Clinical narrative: Hives and itchy on entire body; skin is red and inflamed but not swollen; skin is red and inflamed but not swollen; itchy on entire body; This is a spontaneous report from a contactable consumer. A 36-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9269), dose 2 via an unspecified route of administration, administered in Arm Left on 13Feb2021 06:00 as 2ND DOSE, SINGLE for covid-19 immunisation. Patient was not pregnant at time of vaccination. Medical history included former diagnosis of hashimoto's, penicillin and all varieties of antibiotics in this category, penicillin and all varieties of antibiotics and allergic to dairy and whey, ginger from an unknown date and unknown if ongoing. Concomitant medications included hydrochlorothiazide (HYDROCHLOROTHIAZIDE) and sertraline hydrochloride (SERTRALINE HYDROCHLORIDE) both taken for an unspecified indication, start and stop date were not reported. The patient previously received 1st dose on 17Jan2021 for covid-19 immunisation. On 16Feb2021, the patient experienced hives and itchy on entire body and skin is red and inflamed but not swollen. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not tested positive for covid. No treatment received for events. Outcome for the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Chills, Headache
Clinical narrative: elevated BP; 102 fever; severe uncontrolled chills lasting 3 hours; headache lasting 5 days; This is a spontaneous report from a contactable other healthcare professional (patient, self-reporting). A 51-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: en6200, expiration date was not reported), via an intramuscular route of administration in arm left on 18Feb2021 at 07:15 as single dose for COVID-19 immunisation (at the age of 51years and the patient was not pregnant) at Hospital. The patient had medical history of COVID-19. Concomitant medication included ibuprofen and acetaminophen taken for an unspecified indication, start and stop date were not reported (both as other medications in two weeks). Tested covid prior vaccination. No other vaccine in four weeks, no covid tested post vaccination and no known allergies. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ek9231, expiration date was not reported), via an intramuscular route of administration in arm left on 28Jan2021 at 16:00 as single dose for COVID-19 immunisation. On 18Feb2021 at 21:00, the patient had 102 fever, severe uncontrolled chills lasting 3 hours, headache lasting 5 days and elevated BP (blood pressure). No treatment was given for these events. The patient underwent lab tests and procedures which included blood pressure with result elevated and body temperature as 102, both on 18Feb2021 at 21:00. The outcome for all events was not recovered.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: elevated BP; 102 fever; severe uncontrolled chills lasting 3 hours; headache lasting 5 days; This is a spontaneous report from a contactable other healthcare professional (patient, self-reporting). A 51-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: en6200, expiration date was not reported), via an intramuscular route of administration in arm left on 18Feb2021 at 07:15 as single dose for COVID-19 immunisation (at the age of 51years and the patient was not pregnant) at Hospital. The patient had medical history of COVID-19. Concomitant medication included ibuprofen and acetaminophen taken for an unspecified indication, start and stop date were not reported (both as other medications in two weeks). Tested covid prior vaccination. No other vaccine in four weeks, no covid tested post vaccination and no known allergies. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ek9231, expiration date was not reported), via an intramuscular route of administration in arm left on 28Jan2021 at 16:00 as single dose for COVID-19 immunisation. On 18Feb2021 at 21:00, the patient had 102 fever, severe uncontrolled chills lasting 3 hours, headache lasting 5 days and elevated BP (blood pressure). No treatment was given for these events. The patient underwent lab tests and procedures which included blood pressure with result elevated and body temperature as 102, both on 18Feb2021 at 21:00. The outcome for all events was not recovered.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscle pain in her lower right side of back; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A female patient of age 70 (unspecified unit)received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot number: Unknown) via an unspecified route of administration on 20Feb2021 as 1st dose, single for COVID-19 immunization on 20Feb2021. The patient medical history and concomitant medications were not reported. On 23Feb2021, (3 days later), the patient experienced muscle pain in her lower right side of back. Caller asking if symptom has been reported? Also, if it's okay to take Acetaminophen.   E-TRANSMITING, AE Noted while documenting after caller was disconnected. The seriousness of the event was reported as non-serious. The clinical outcome of the event was unknown.  Follow-up information was received on 06Apr2021: Case closure was added in the narrative  Information on the lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain in extremity
Clinical narrative: soreness in the arm; woozy; headache; This is a spontaneous report from a contactable consumer. This 74-year-old male consumer reported that he received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient received both doses of Pfizer's COVID vaccine and had soreness in the arm. The first night, he felt kind of woozy and as the day went on, he got better. He took some Tylenol and started feeling better every day. The patient stated he experienced a headache a couple days ago, but it was nothing serious. The outcome of the event woozy was reported as recovering. The outcome of events soreness in the arm and headache was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Feeling abnormal
Clinical narrative: wiped out; low grade fever ranging from 100-100.5°F; she had left arm injection site pain; chills; knee and ankle pain; she felt wiped out the next day; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expiry Date: unknown), via unknown route of administration on 10Feb2021, as 1st dose, single for Covid-19 immunisation. Medical history included Covid-19 in the month of Aug2020 (minus loss of taste and smell). Concomitant medications were not reported. After vaccination, on an unspecified date, the patient had experienced left arm injection site pain, chills, low grade fever ranging from 100-100.5'F, knee and ankle pain, and she felt wiped out the next day. In Aug2020 she has tested positive for COVID antibodies and she has been donating convalescent plasma. She had underwent lab test which included SARS-CoV-2 antibody test: positive in Aug2020, body temperature: low grade fever ranging from 100-100.5'F on an unspecified date. The outcome of events was unknown.   Information about lot/batch no has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 antibody test, Vaccination site pain
Clinical narrative: wiped out; low grade fever ranging from 100-100.5°F; she had left arm injection site pain; chills; knee and ankle pain; she felt wiped out the next day; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expiry Date: unknown), via unknown route of administration on 10Feb2021, as 1st dose, single for Covid-19 immunisation. Medical history included Covid-19 in the month of Aug2020 (minus loss of taste and smell). Concomitant medications were not reported. After vaccination, on an unspecified date, the patient had experienced left arm injection site pain, chills, low grade fever ranging from 100-100.5'F, knee and ankle pain, and she felt wiped out the next day. In Aug2020 she has tested positive for COVID antibodies and she has been donating convalescent plasma. She had underwent lab test which included SARS-CoV-2 antibody test: positive in Aug2020, body temperature: low grade fever ranging from 100-100.5'F on an unspecified date. The outcome of events was unknown.   Information about lot/batch no has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Chills, Dysgeusia, Hot flush
Clinical narrative: Metallic taste in mouth; Chills/hot spells; nausea; vomiting; body aches; hip and back pain; sharp pain in left upper chest; Chills/hot spells; This is a spontaneous report received from a non-contactable Other-HCP. A 40-Year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EN9581 and Expiration date not reported) via an unspecified route of administration, in Arm right, on 13Feb2021 at 02:30 PM (at the age of 40 years) as 2nd dose, single for COVID-19 immunisation. The patient medical history included Known allergies was reported as pseudoephedrine, Cephalexin, eggs, melon and concomitant medications included Multivitamin, St Johns Wort (medications in two weeks). Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL3246 and Expiration date not reported) via an unspecified route of administration, in Right arm, on 23Jan2021 at 02:30 PM as 1st dose, single for covid-19 immunisation. The patient didn't receive any other vaccine in four weeks. There was no covid prior vaccination. The patient was covid tested post vaccination. On 13Feb2021, at 02:45 PM, the patient had experienced Metallic taste in mouth and feeling hot initially, Chills/hot spells, nausea, vomiting, body aches, hip and back pain, sharp pain in left upper chest. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests which includes Rapid Antigen Nasal Swab test post vaccination on 15Feb2021 with the result of negative, on 17Feb2021 with the result of negative, on 19Feb2021 with the result of negative, on 22Feb2021 with the result of negative, PCR Nasal Swab test on 24Feb2021 with the result of pending. There was no treatment received for AE. Outcome of the events was reported as Recovered with lasting effects.  No follow up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, SARS-CoV-2 test, Vomiting
Clinical narrative: Metallic taste in mouth; Chills/hot spells; nausea; vomiting; body aches; hip and back pain; sharp pain in left upper chest; Chills/hot spells; This is a spontaneous report received from a non-contactable Other-HCP. A 40-Year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EN9581 and Expiration date not reported) via an unspecified route of administration, in Arm right, on 13Feb2021 at 02:30 PM (at the age of 40 years) as 2nd dose, single for COVID-19 immunisation. The patient medical history included Known allergies was reported as pseudoephedrine, Cephalexin, eggs, melon and concomitant medications included Multivitamin, St Johns Wort (medications in two weeks). Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL3246 and Expiration date not reported) via an unspecified route of administration, in Right arm, on 23Jan2021 at 02:30 PM as 1st dose, single for covid-19 immunisation. The patient didn't receive any other vaccine in four weeks. There was no covid prior vaccination. The patient was covid tested post vaccination. On 13Feb2021, at 02:45 PM, the patient had experienced Metallic taste in mouth and feeling hot initially, Chills/hot spells, nausea, vomiting, body aches, hip and back pain, sharp pain in left upper chest. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests which includes Rapid Antigen Nasal Swab test post vaccination on 15Feb2021 with the result of negative, on 17Feb2021 with the result of negative, on 19Feb2021 with the result of negative, on 22Feb2021 with the result of negative, PCR Nasal Swab test on 24Feb2021 with the result of pending. There was no treatment received for AE. Outcome of the events was reported as Recovered with lasting effects.  No follow up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Headache, Nausea, Retching
Clinical narrative: nausea/there was nothing in my stomach to throw up (dry heaving); nausea/there was nothing in my stomach to throw up (dry heaving); she hasn't been able to eat today.; Moderately severe headache; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6200, Expiration Date: 30Jun2021) via intramuscular route in left arm on 23Feb2021 at 10:30 (at the age of 65-years-old) as 2ND DOSE, SINGLE for covid-19 immunisation. Previous vaccine included first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL9265, Expiration Date: 31May2021), administered in left arm on 02Feb2021 10:00 for covid-19 immunisation. After first dose, she had a little sore arm but no problem. Medical history included atrial septal defect diagnosed about 10-12 years ago approximately. The patients concomitant medications were unknown. On 23Feb2021, about 18:00, the patient started getting headache. The next morning on 24Feb2021 at 03:00 AM, woke up with a terrible headache and nausea, took 200mg ibuprofen with no effect. At 13:00 took 650mg of acetaminophen. Headache gradually subsided and was gone by about 18:00 on 24Feb2021. At around 8 or 9 it was much worse and nausea but there was nothing in her stomach to throw up (dry heaving). For the headache she had a hard time staying up and needed to lay down all the time. She hasn't been able to eat today. She took Advil early in the morning and it did nothing, she took one 200mg, LOT: ME2776A, EXP: September 2021. She says that she took Tylenol 325mg, she took two of them, LOT P120074, with EXP April 2023, the UPC must have been on an outer box that was discarded. She says that the Tylenol she took a few hours ago and helped a little. She got the vaccine she was told if she had a little headache or fever to take some Tylenol or Advil, but she has normal headaches off and on, one or so a week, which she usually takes Excedrin for that and it works, she has never had Tylenol. She says she would like to know if there might be a reason not to take Aspirin for this, and also if it doesn't get better in x amount of days, when should she seek medical care? She says reading through the paperwork she thinks it would be two days. She gets headaches occasionally. Excedrin Migraine is that ok to take for this the patient asked. Usually, Tylenol does not work for her. Ibuprofen did not help, did not make it go away. The outcome of the event for sever headache was recovered and for other events it was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Vaccination site swelling
Clinical narrative: swelling at the injection site; pain in arm; headache; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, on 21Feb2021 (Lot Number and expiration date was not reported) as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient reported that she had swelling at the injection site, pain, and headache. She also reported she did not have any fever, stated that she had a headache and a swelling where they gave a shot, her arm swelled and that was about it. She had a lot of pain first day she could not even lift her arm and a day after she mean at night, and then it got a little bit better next day and she still had a pain she was lifting and moving her arm, left arm. All the events occurred on an unknown date in 2021. She was scheduled to get her second dose of the vaccine on 19Mar2021. The outcome of the event pain in arm was resolving and all other events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain in extremity, Tremor
Clinical narrative: arm hurt; pain in back of neck and same side of shoulder; pain in / same side of shoulder / elbow is throbbing; shaking; This is a spontaneous report from a contactable consumer. A 38 (unit: unknown) female received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as 1st dose single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. On 19Feb2021 15:35 patient seemed fine, arm hurt, starting on Monday (15Feb2021) or Tuesday (16Feb2021) pain in back of neck and same side of shoulder. Pain was so bad yesterday that she was shaking, similar to pain in labor. Even her elbow is throbbing. Doctor prescribed Flexeril, its giving some relief to make pain bearable. Chiropractor said that pain level is too severe to treat, and it should be reported to Pfizer.  Before receiving the vaccine, had a wisdom tooth infection, full body rash from a staph infection from tooth infection spreading but before the vaccine. She did one month of amoxicillin, and one month of Bactrim. It was questioned whether the shooting pain in her neck a reported side effect of the vaccine. The outcome of the events was recovered.   Information on the lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.