chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Neck pain, Swelling
Clinical narrative: swelling on my right neck; Neck paining; dizzy; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the arm right on 01May2021 at 11:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient did not had take any medications within two weeks of the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number:ER8733 ) via an unspecified route of administration to right arm on 10Apr2021 at 14:00 as a single dose for COVID-19 immunisation. On 02May2021 at 15:00, the patient experienced a swelling on her right neck at the place where beauty bone lies and was paining and making dizzy and causing problem to compute her daily task. Therapeutic measures were not reported. The clinical outcome of the event swelling on right neck, neck paining and dizzy was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Muscle aches; Fever; Headache; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0172) via an unspecified route of administration in the left arm on 06Apr2021 at 14:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as not applicable. The patients past drug name was reported as unknown. Concomitant medications taken within two weeks of vaccination included birth control (unspecified). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. On 28Apr2021 at 07:00, the patient experienced muscle aches, fever and headache. The clinical outcome of the events muscle aches, fever and headache was resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Electric shock sensation
Clinical narrative: Severe Lower back pain; Electric shock kind of feeling in limbs worse in legs and calves; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 28Apr2021 at 12:15 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid (hypothyroidism), generalized anxiety disorder (GAD) and sulfonamide allergy. Concomitant medications included levothyroxine (LEVOTHYROXINE), sertraline (SERTRALINE), biotin (BIOTIN) and MG. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021, the patient experienced severe Lower back pain and electric shock kind of feeling in limbs which was worse in the legs and calves. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event Severe Lower back pain was not recovered/not resolved/ongoing. The clinical outcome of the events severe back pain and electric shock kind of feeling in limbs which was worse in the legs and calves was not resolved at the time of this report   No follow-up attempts are needed; information about lot number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Lacrimation increased
Clinical narrative: Burning eyes; Watery eyes; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 04May2021 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and fibromyalgia. The patient previously had taken sulfa drugs, cephalosporins, keflex, ceclor, yogurt and  latex on unknown dates and experienced allergy. Concomitant medications included cyclobenzaprine hydrochloride (FLEXERIL), metformin (MANUFACTURER UNKNOWN), insulin detemir (LEVEMIR), exenatide (BYDUREON) and dapagliflozin propanediol monohydrate (FARXIGA), all for unknown indications from an unknown dates. Prior to the vaccination, the patient was  not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04May2021 at 16:00, the patient experienced burning eyes and watery eyes. The clinical outcome of the events of watery eyes and burning eyes was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea
Clinical narrative: severe cramping associated with period; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Apr2021(at the age of 27-years-old), as a single dose for COVID-19 immunisation. Medical history included type 1 diabetes mellitus, celiac disease and hypothyroidism. Concomitant medications included insulin lispro (HUMALOG), insulin glargine (LANTUS), levothyroxine sodium (SYNTHROID), spironolactone (MANUFACTURER UNKNOWN) and retinol (MANUFACTURER UNKNOWN); all for unknown indication from unknown date. The past drug history was reported as no. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021,since getting vaccinated, the patient experienced severe cramping associated with period. The clinical outcome of the event severe cramping associated with period was resolving at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: Soreness in small area in right armpit crease; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the arm right on 27Apr2021 at 11:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the arm right on 07Apr2021 at 15:15 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. On 28Apr2021, the patient experienced soreness in small area in right armpit crease (armpit pain). Therapeutic measures were not reported. The clinical outcome of the event soreness in small area in right armpit crease was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node/under arm on the left side; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175), via an unspecified route of administration in the left arm on 28Apr2021 (at the age of 35-years-old), as a single dose for COVID-19 immunisation. Medical history included herpes simplex type II. Concomitant medications included ibuprofen sodium (IBUPROFEN) from unknown date for an unknown indication and valaciclovir hydrochloride (VALTREX) from unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533), via an unspecified route of administration in the left arm on 31Mar2021 (at the age of 35-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Apr2021, the patient experienced swollen lymph node/ under arm on the left side. The clinical outcome of the event swollen lymph node/under arm on the left side was not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: Fever,; Pain in injection arm; Headache; Tiredness; Chills; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 01May2021 at 15:30 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as no. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 10Apr2021 at 18:45 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02May2021 at 07:00, the patient experienced fever, pain in injection arm, headache, tiredness, chills and body aches Therapeutic measures were taken as a result of body aches, fever, pain in injection arm, headache, tiredness and chills and included treatment with acetaminophen (TYLENOL) from unknown date. The clinical outcome of the event body aches, fever, pain in arm, headache, tiredness and chills was recovered on an unknown date in May2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever,; Pain in injection arm; Headache; Tiredness; Chills; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 01May2021 at 15:30 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as no. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 10Apr2021 at 18:45 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02May2021 at 07:00, the patient experienced fever, pain in injection arm, headache, tiredness, chills and body aches Therapeutic measures were taken as a result of body aches, fever, pain in injection arm, headache, tiredness and chills and included treatment with acetaminophen (TYLENOL) from unknown date. The clinical outcome of the event body aches, fever, pain in arm, headache, tiredness and chills was recovered on an unknown date in May2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Mass, Pain in extremity, Rash pruritic
Clinical narrative: Hot, Red, Itchy Spot on Arm; Bump as big as a golf ball; Hot, Red, Itchy Spot on Arm/ her arm is redder than heck today. States the red area is a bigger than it was before; Sore Arm; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EW0153), dose 2 via an unspecified route of administration, administered in Arm Left on 27Apr2021 at 11:40 (at the age of 59-years-old) as a DOSE 2, SINGLE for covid-19 immunisation. Medical history included illness, Sick for 1 and a half or 2 weeks from an unknown date and unknown if ongoing, Sick for 1 and a half or 2 weeks. The patient's concomitant medications were not reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EN6199, Expiry Date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 06Apr2021 (at the age of 59-years-old) as a DOSE 1, SINGLE for covid-19 immunisation and Flu vaccine on an unspecified date (at the age of 59-years-old). Additional Vaccines Administered on Same Date of the Pfizer Suspect were None. Prior Vaccinations (within 4 weeks) and AEs following prior vaccinations were None. With Flu Vaccine was Sick for 1 and a half or 2 weeks. Patients Medical History (Including any illness at time of vaccination) was None. The patient experienced sore arm on 27Apr2021 and hot, red, itchy spot on arm, bump as big as a golf ball and hot, red, itchy spot on arm/ her arm is redder than heck today, stated the red area is a bigger than it was before on 28Apr2021. Reporter stated that she got the second shot of the Covid Vaccine on 27Apr2021 and her arm is redder than heck today.  Stated the red area is a bigger than it was before.  She also has a bump there.  Asks if this is normal. Reporter reported her weight as too much. Stated her arm was sore starting on the day of the vaccine.  It has improved. The hot, red, itchy area on her arm has gotten worse.  Stated the red part has gotten bigger; it is about the size of a tennis ball now. Said she still has a bump on her arm that is as big as a golf ball. She Denied any medications, medical conditions, labs, testing, or treatments relevant to these events. Relevant Tests done were None. Reporter seriousness for the events were Unspecified. Outcome of sore arm was recovering and hot, red, itchy spot on arm, bump as big as a golf ball and hot, red, itchy spot on arm/ her arm is redder than heck today, stated the red area is a bigger than it was before was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Bone scan, Computerised tomogram, Malaise, Panic attack
Clinical narrative: feeling bad for four days. i was trying to get a fever. i was at 99.7. i was starting to get into panic mode. on the fifth day i felt normal again; feeling bad for four days. i was trying to get a fever. i was at 99.7. i was starting to get into panic mode. on the fifth day i felt normal again; feeling bad for four days. i was trying to get a fever. i was at 99.7. i was starting to get into panic mode. on the fifth day i felt normal again; This is a spontaneous report from a contactable physician. A 60-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization and palbociclib (IBRANCE), oral from Dec2020 (Batch/Lot number was not reported) and ongoing, at 75 mg daily, cyclic for 14 days on, 14 days off for breast cancer (reported recommended dose 125 mg daily, 21 days on/7 days off). Medical history included breast cancer from an unknown date. Concomitant medication included fulvestrant (FASLODEX) taken for an unspecified indication, since an unknown date. On an unspecified date the patient experienced "feeling bad for four days: she was trying to get a fever. She was at 99.7. She was starting to get into panic mode. On the fifth day she felt normal again". The reported events resolved on an unknown date. On an unknown date the patient underwent lab tests and procedures which included body temperature: 99.7, computerised tomography scan of organs and full body bone scan "looked good". The action taken with palbociclib was unknown at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: feeling bad for four days. i was trying to get a fever. i was at 99.7. i was starting to get into panic mode. on the fifth day i felt normal again; feeling bad for four days. i was trying to get a fever. i was at 99.7. i was starting to get into panic mode. on the fifth day i felt normal again; feeling bad for four days. i was trying to get a fever. i was at 99.7. i was starting to get into panic mode. on the fifth day i felt normal again; This is a spontaneous report from a contactable physician. A 60-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization and palbociclib (IBRANCE), oral from Dec2020 (Batch/Lot number was not reported) and ongoing, at 75 mg daily, cyclic for 14 days on, 14 days off for breast cancer (reported recommended dose 125 mg daily, 21 days on/7 days off). Medical history included breast cancer from an unknown date. Concomitant medication included fulvestrant (FASLODEX) taken for an unspecified indication, since an unknown date. On an unspecified date the patient experienced "feeling bad for four days: she was trying to get a fever. She was at 99.7. She was starting to get into panic mode. On the fifth day she felt normal again". The reported events resolved on an unknown date. On an unknown date the patient underwent lab tests and procedures which included body temperature: 99.7, computerised tomography scan of organs and full body bone scan "looked good". The action taken with palbociclib was unknown at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Hot flush, Lymphadenopathy, Pain in extremity, Pyrexia
Clinical narrative: Hot flashes; mild fever (99.7); sore arm; swollen lymph nodes; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0167) via an unspecified route of administration in the arm left on 02May2021 at 12:00 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included "birth control"(unspecified medication). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0151) via an unspecified route of administration in the arm left on 04Apr2021 at 11:00 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 02May2021 at 13:00, the patient experienced hot flashes, mild fever(99.7), sore arm and swollen lymph nodes. The patient underwent lab test which included body temperature on 02May2021 and resulted with a temperature of 99.7(unspecified units). The clinical outcome of the events hot flashes, fever, sore arm and swollen lymph nodes were not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Malaise
Clinical narrative: I'm not feeling well; This is a spontaneous report from a Pfizer-Sponsored program Pfizer.  Together received from a contactable consumer (patient). A 65-years-old female patient received BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration on an unspecified date, at 65 years of age, (Batch/Lot number was not reported) as single dose for COVID-19 immunization and palbociclib (IBRANCE), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported), at 125 mg for Malignant neoplasm of unspecified site of left female breast. Medical history included breast cancer and chronic obstructive pulmonary disease, both from an unknown date. The patient's concomitant medications were not reported. On an unspecified date, the day after vaccination, the patient was not feeling well. The action taken with palbociclib in response to the event was unknown. At the time of the report the event outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 74.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue
Clinical narrative: pt reported fatigue; This is a spontaneous report from pharmacy received from a contactable Healthcare Professional. A 74-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration on an unspecified date, at 74 years of age, (Batch/Lot number was not reported) as single dose for COVID-19 immunization and palbociclib (IBRANCE), oral from 13Apr2021 and ongoing (Batch/Lot number was not reported), at 125 mg daily day 1-21 of 28 day cycle for breast cancer. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient experienced fatigue. Palbociclib dose was not changed in response to the event. The event outcome was unknown at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Feeling abnormal, Malaise, Sluggishness
Clinical narrative: patient was really not feeling a 100%; still felt low energy; he is tired; feeling sluggish; mind was in a fog. He had brain fog.; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 72-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot Number: EW0153), via an unspecified route of administration on 03May2021 at 14:30 (at the age of 72-year-old) as single dose for COVID-19 immunization. Medical history included diabetic, cancer and thyroid (Levothyroxine or Synthroid 100 mg further not clarified). Concomitant medication included pantoprazole taken for acid reflux, losartan taken for blood pressure, simvastatin taken for blood cholesterol, metformin, ascorbic acid (VITAMIN C ACID), mecobalamin (VITAMIN B12), VITAMIN B COMPLEX, VITAMIN D NOS, antioxidants NOS, adalimumab (HUMIRA), tocopheryl acetate, ubidecarenone (COQ10), fish oil, chondroitin sulfate, glucosamine sulfate (GLUCOSAMINE CHONDROITIN SULFATE) taken for arthritis. Prior Vaccinations (within 4 weeks) was none and the patient did not have any adverse event prior to vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot Number: EW0158), via an unspecified route of administration in right arm on 12Apr2021 at (at the age of 72-year-old) for COVID-19 immunization (his appointment was at 2:53 pm and the vaccine was given within 5 minutes of the appointment). On an unspecified date in May2021, after receiving second dose of BNT162B2, the patient was really not feeling a 100%, still felt low energy, he was tired, feeling sluggish and mind was in a fog (he had brain fog). It was reported that the patient got his second vaccine on 03May2021 and it took him a whole 7 days before he could finally say, he thought he came back to normal but since then and today was Wednesday and today was fifth, he was really not feeling a 100%, he thought he was a 100%, he told he was a 100% Monday, which would had been at 4:00 the day of his second shot. He was still feeling low even with his vitamins (Unspecified Medications), he took his vitamins, and he was just okay for a few hours. The patient stated that he wanted to feel 100 percent, and he tried to go in the open air and sunshine to feel better. He stated that he felt alright in the morning, and he described various vitamins that he was taking. Reclarified, the patient described that he felt like he was dragging on and on. The patient stated that he went back and forth in how he feels. He stated for the past two days, even with his vitamins, he was alright in the morning, but then felt like he was dragging, later in the day. The patient did not take any treatment for events. The patient stated that he was improving, but so slowly. No emergency/physician room visit due to events. No relevant tests. The outcome of the events was resolving.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Sluggishness
Clinical narrative: a mild headache; but she is still dragging on energy and is still fatigued.; dragging on her feet; mild pain in the left arm; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 30Apr2021 at 14:00 (at the age of 56-year-old) as a single for COVID-19 immunisation at pharmacy. The patients Medical history and concomitant medications were not reported . No investigation assessment. No family medical history relevant to adverse was reported. Vaccine Administered at Facility was reported as no. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No vaccines administered on same date of the Pfizer suspect. Report not related to a study or programme. Reporter gave consent to contact. No previous immunization with the Pfizer vaccine considered as suspect. on 30Apr2021, the patient experienced mild pain in the left arm, and on 01May2021, she experienced a mild headache, but she was still dragging on energy and was still fatigued, dragging on her feet. It was reported that, a 56-year-old female patient who received her 1st dose of the Pfizer COVID Vaccine on 30Apr2021. She experienced mild pain in the left arm, a mild headache, and tiredness. It was going to be 2 weeks tomorrow, but she was still dragging on energy and is still fatigued. She mentioned that she can do her daily routine and was getting the proper amount of sleep but every morning she just feels fatigued and dragging on her feet. She texts with her doctor and they mentioned that they have also observed this in patients lasting for about 4 to 6 weeks. She was due for her 2nd dose on 21May2021. She was asking if it was normal for her to have the fatigue for this long. Patient asked, was it normal for her to still have fatigue 2 weeks later. Patient stated it kind of went away that following Monday and then it came back, and she has been dragging this week more noticeably, it will be 2 weeks tomorrow. No treatment was received for the events. No adverse event required a visit to emergency room or physician office. No relevant tests were performed. No product quality complaint was reported. The outcome of event mild pain in the left arm was resolved on 01May2021 and mild headache was resolved on 03May2021,outcome of the events but she was still dragging on energy and was still fatigued and dragging on her feet was reported as Not resolved .   No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer (patient, reported for self). A 66-year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot/Batch number: UNKNOWN), via unspecified route of administration as dose number unknown, single for COVID-19 immunization. The patient medical history was not reported. The patient had received Ibrance (100 mg) taken for an unspecified indication and unknown if ongoing. The patient reported, "I got the Covid 19 Vaccine. I did not have any side effects, except for a sore arm." The event was non-serious. The outcome of the event sore arm was unknown.  Information on the lot/batch number has been requested.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Eye disorder, Pain in extremity
Clinical narrative: Right eye had light streaks; Soreness in arm; This is a spontaneous report from a contactable consumer (patient mother). A 13-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration in Arm Left on 17May2021 (Batch/Lot Number: EW0171, Age at the vaccination: 13-years-old) as single for covid-19 immunization. The patient medical history and family history was reported as none. Concomitant medication included multivitamin (he had been taking forever, it was a generic Flinstone brand). The patient was healthy before vaccination. History of all previous immunization with the Pfizer vaccine considered as suspect, additional vaccines administered on same date of the Pfizer suspect if applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect and prior vaccinations (within 4 weeks) if applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was reported as none. Consumer stated that her 13-year-old son had the vaccine yesterday and today he had regular soreness in the arm and things like that. For an hour today, he had, she does not know, like he would see light streaks in his right eye. Reporter added that her son was given the shot in his left arm. He had the light streaks in his right eye, not his left eye. His left eye was fine, and the right eye was doing that. It slowly started dissipating and he would see it when he looked down and to the right. He would see it and it slowly went away. First, it was all of the eye. He was panicking because he thought he was going blind. She did tests without his glasses on, with lights off. He could see better with lights off so maybe it was light sensitivity. Right eye had light streaks: started about 30 minutes ago, or within the last couple of hours. It completely went away. Reporter added that soreness in arm started yesterday. He had the shot probably about 6 or 5:30 when he got it. By about 8, he started feeling soreness in the arm. He still has soreness today. Just a little bit worse than it was yesterday. She guesses it was from getting stiff overnight. The outcome of event Right eye had light streaks recovered on 18May2021 whereas, for other event not recovered.  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: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching in her ear, "like something was crawling in my ear; This is a spontaneous report from a contactable pharmacist, the patient. A 49-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number EW0185), dose 1 via an unspecified route of administration, administered in arm right on 16May2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 18May2021, she stared feeling itching in her ear like something was crawling in her ear and on 19May2021, when coming home from work, she went to the emergency room for the itching in her ear. The emergency room staff looked in her ear and didn't see anything. The emergency room staff flushed her ear and gave her an antibiotic ear drop to use three times daily. she got the prescription for the ear drops on 19May2021 at night and started using them. The outcome of the event was recovered on 21May2021.   Follow-up attempts are needed; information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction, Illness
Clinical narrative: I got this one yesterday and I have been sick ever since; I am having an reaction, and then I 'discage' then up and then I open; This is a spontaneous report from a contactable consumer (the patient reported for self). A patient of an unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on 21May2021 (reported as "yesterday") as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had earlier received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), via an unspecified route of administration on an unknown date (Batch/Lot number was ER8731) as dose 1, single for COVID-19 immunization and had no problem. The patient stated, "This is serious, I have just taken a shot yesterday  (not clear) over the place for the COVID Vaccine and I am having an reaction, and then I 'discage' then up and then I open, so what do I do?. I took my second one, the first one was not like this, that was cool and not I got this one yesterday and I have been sick ever since. I am just trying to find out why do I feel like this because my first shot everything was fine, I had no problem (incomplete sentence)." Reason for no lot number: of COVID 19 Vaccine, the patient stated "Oh my first one, this is my first one that I understand it's ER8731, but I can't understand the second whoever wrote this, the lady who gave me the shot." No further probing was done as the consumer was unwilling to share any further information and was not able to understand the call handler. Limited information available over the call. The events were non-serious. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Oedema peripheral
Clinical narrative: Had severe hip and lower back pain; Had severe hip and lower back pain; Had edematous feet and ankles; This is a spontaneous report from a contactable Nurse (patient). A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6200), via an unspecified route of administration in right upper arm  on 24Feb2021 at 13:30 (at the age of 69 years old) as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received Shingles vaccine and experienced symptoms feeling heat. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive additional vaccines on same date of the Pfizer Suspect. On 26Feb2021, two days after receiving the first dose patient experienced severe hip and lower back pain, an inflammatory like response, had edematous feet and ankles. When it was time for the patient to receive the second dose Pfizer Covid 19 Vaccine, the sever hip and lower back pain and the edematous feet and ankles kind of disappeared and it was okay after the third week.  She considered not getting the second dose Pfizer Covid 19 Vaccine because of the symptoms, but then the symptoms disappeared.  She said she needed to finish the remainder.  She would say she pretty much recovered, pretty much almost totally recovered. Had edematous feet and ankles seemed like recovered from it. She didn't have swollen feet or ankles after that. The hip pain and back pain ended up going, called primary physician and ended up going to a person who specializes in hip issues. No family medical history relevant to adverse events was provided and no relevant tests were performed. The events resulted in a visit to physician office. The outcome of the events was recovered on an unspecified date in Mar2021.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Back pain, Fatigue
Clinical narrative: Kind of tired after first shot; Stomach was kind of irritated; Back hurts a little bit more; This is a spontaneous report from a contactable consumer (patient himself). A 61-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8731), via an unspecified route of administration, administered in right arm on 12May2021 (age at vaccination: 61 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included pain pump which was removed on an unknown date in 2015 at hospital. It was 16.5mg per day plus outside medicine. They were supposed to remove pain pump, but they let it run dry, he was regurgitating for 5 days, every 30 minutes. They got the pump out because he started getting tremors, and that's what gave him the memory loss. It was helping the pain quite a bit that's the only thing it was doing in the back. When they took the pump out, they left a piece of the catheter in one of the discs, he could feel that more than ever. They had him in like an outpatient for people that abuse drugs, he was just there to get the pump out. The patient had dementia, but he was surprised that he can remember his address and driver's license; that his memory is coming back quite a bit. Surgery on shoulder, fell right on that shoulder a week after surgery on shoulder, allergic to about 15 different medicines mostly the heavier ones like the muscle relaxants, 100 percent disabled, had 8 ulcers, stomach sometimes flares and back pain. Some of the shots he had from pain management were like epidural. The patient's concomitant medications were not reported. On an unknown date in May2021, the patient experienced kind of tired after first shot, stomach was kind of irritated and back hurts a little bit more. He didn't have blood work. He said he would have to terminate pain management if he was not comfortable with this. The patient said that he was unsure if this was related to the shot. It might not have been the shot. The kind of tiredness was more the issue because he already has back problems before, has a compression, broke. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Dysphonia, Influenza like illness, Pain in extremity
Clinical narrative: First dose: Started losing voice; First dose: The next day felt like had the flu; First dose: Arm started hurting; It is a hoarse voice; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: EW0176), via an unspecified route of administration, administered in Right upper arm on 28Apr2021 (appointment at 12:20) as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient never had allergies. Patient received first dose Pfizer Covid Vaccine earlier this month. On 28Apr2021, patient's arm was sore for a few days which she had noticed on the second day after receiving the first dose Pfizer Covid Vaccine. The next day on 29Apr2021, the patient felt like flu (not stomach flu) which didn't last long, just like a day or two. More like an achy and pain and kind of headache. Patient was losing voice on 30Apr2021. Patient had contributed this to being lethargic from receiving the Pfizer Covid Vaccine, thought it was par for the course. It was a hoarse voice, but the patient had to work to get it out. Patient got her lungs listened by a nurse a couple days ago, and lungs seemed to sound good. Outcome of the events "first dose: the next day felt like had the flu, it is a hoarse voice and first dose: arm started hurting" was unknown, while for event "first dose: started losing voice" was not recovered.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, SARS-CoV-2 antibody test
Clinical narrative: She felt fatigue for a few days, after both vaccines; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9264), via an unspecified route of administration in left arm (high up on shoulder) on 05Feb2021 at 12:07PM (at the age of 70 years) as first dose, single for COVID-19 immunization. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6202), via an unspecified route of administration in left arm on 26Feb2021 at 13:44 (at the age of 70 years) as second dose, single for COVID-19 immunization. Family history included her sister had Psoriasis, and she also got a Spike Protein antibody test. Medical history included thyroid and psoriasis from Jan2020 and ongoing. The patient was taking thyroid pills and because of medication it (thyroid) was okay. She also had psoriasis but she did not take any medicine for it sometime she used a cream but she did not take any medicine for it. The patient previously took Otezla (start date: unspecified, stop date: 28Dec2020) for psoriasis. It was reported that she took it for a month in Dec2020. The patient's concomitant medications were not reported. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. It was reported that she never had pain with the first one, she couldn't even feel the first one. On 05Feb2021, the patient felt fatigue for a few days, after the vaccine. AE did not require emergency room or physician office. Patient stated that she had regular Covid antibody tests on an unspecified in the past and they were negative. She did not clarify if those other tests were before or after her vaccines. The outcome of event was recovered on an unspecified date in 2021.  Information on the lot/batch number has been requested.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Fatigue, Headache, Malaise
Clinical narrative: Dizziness; Tiredness; Stomach pain; Headache; Feeling sick; This is a spontaneous report received from a contactable consumer(patient). A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 25May2021 15:00 (at the age of 44-year-old) as DOSE 1, SINGLE for covid-19 immunization. Medical history included gastritis from an unknown date and unknown if ongoing. Patient said he had bad gastritis for a while and cyclic vomiting syndrome from an unknown date and unknown if ongoing. It was reported that patient has cyclic vomiting syndrome adult, which was diagnosed two months ago. Patient concomitant medications were not reported. He got no other vaccinations in the four weeks prior to getting his Pfizer coronavirus vaccine shot. On 26May2021 the patient experienced dizziness, tiredness, stomach pain, headache and feeling sick. The patient got his first dose of the shot, he is not sure what it was, yesterday, and he is having some side effects that are common, he would like to know how long they will last. He later clarified that the shot was the Pfizer coronavirus vaccine. Patient said he doesn't have his vaccine card with him to provide NDC/LOT/EXP from it, his vaccination was at 3PM. He said his side effects were basic dizziness, tiredness, stomach pain, headache, and feeling sick. His side effects started next morning when he woke up. Patient just took pills for stomach pain and let it pass. Therapeutic measures were taken as a result of stomach pain. Outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected. Information on the batch number not available.