chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Hypoaesthesia oral
Clinical narrative: Metal taste in mouth; Slight numbness on upper lip; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20Apr2021 at 11:30 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Mar2021 at 10:30 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the COVID-19 vaccine. On 20Apr2021, the patient experienced metal taste in mouth and slight numbness on upper lip. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome for the events metal taste in mouth and slight numbness on upper lip were unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pain in extremity
Clinical narrative: Muscles were so sore; Body was so sore; Sole was so sore; This is a spontaneous report from a contactable consumer. An 81-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EP7534) via an unspecified route of administration in the left arm on 25Mar2021 (at the age of 81-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 04Mar2021 (at the age of 81-year-old) as a single dose for COVID-19 immunisation. On 26Mar2021, one day after the second dose of vaccine, the patient experienced muscles, body and sole so sore to where she stayed in bed. The effects lasted for 24 hours and then she felt fine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events, muscles, body, and sole sore was recovered on 27Mar2021, after the duration of 24 hours.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Drug ineffective, Suspected COVID-19
Clinical narrative: got both of the Pfizer shots and he was sick as hell with COVID; got both of the Pfizer shots and he was sick as hell with COVID; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 18Aug2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient) via the program. A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (lot number and expiry date unknown) as dose 2, single and; the first dose via an unspecified route of administration on an unspecified date (lot number and expiry date unknown) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The report the patient got both of the Pfizer shots and he was sick with COVID right now. The patient stated that the vaccines didn't take, and his antibodies were very low after the shots. The patient stated, So much for being protected. The outcome of the event was unknown.  The lot number for BNT162B2 was not provided and will be requested during follow-up.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Peripheral coldness, Pruritus, Vein disorder
Clinical narrative: itchy and cold lower legs to feet; itchy and cold lower legs to feet. Felt like no blood flow wasnt getting to my feet. Veins looked like venous veins in lower legs.; Veins looked like venous veins in lower legs.; Felt like no blood flow wasnt getting to my feet.; This is a spontaneous report from a contactable healthcare professional, 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 left arm on 19Apr2021 at 15:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Information on whether the patient received any medication within two weeks of vaccination was reported as not available. Prior to the vaccination, the patient was 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 19Apr2021 at 20:00, the patient experienced itchy and cold lower legs to feet. The patient felt like no blood flow wasnt getting to her feet. Veins looked like venous veins in lower legs. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events itchy and cold lower legs to feet; felt like no blood flow wasnt getting to feet; veins looked like venous veins in lower legs. was resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dry throat, Hypoaesthesia, Musculoskeletal stiffness
Clinical narrative: Dry throat; Numbness in left hand stiff at times; Numbness in left hand stiff at times; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 07Apr2021 at 14:00 (at the age of 42-year-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. The patient received unspecified medication from unknown date for blood pressure and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 14:00, the patient experienced dry throat, and numbness in her left hand stiff at times. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dry throat, and numbness in left hand stiff at times was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspepsia, Flatulence
Clinical narrative: Excessive flatulence unrelated to any dietary factors.; As though gut biome population impacted by immuneresponse resulting in incomplete digestion; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6Z04) via an unspecified route of administration in the left arm on 05Mar2021 at 16:00 (at the age of 69-year-old) as a single dose for COVID-19 immunisation. Medical history included waldenstrom's macroglobulinemia and vertical sleeve gastrectomy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified medications within two weeks of vaccination. The patient had no known allergies. On 08Mar2021, the patient experienced excessive flatulence unrelated to any dietary factors. As though gut biome population impacted by immune response resulting in incomplete digestion. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event excessive flatulence and incomplete digestion were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Lethargy, Muscle mass, Vaccination site pain, Vaccination site swelling
Clinical narrative: extreme arm pain and swollen at injection site; extreme arm pain and swollen at injection site; collar bone as it was super painful and could feel a lump just above my left collarbone; collar bone as it was super painful and could feel a lump just above my left collarbone; Lethargy; This is a spontaneous report from a contactable Other Health Professional (patient reported for herself). A 30-year-old Adult female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8727, Expiration date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 at 13:30 (at the age of 30-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included Hypothyroidism, Asthma and obesity. The patient had Known allergies to Penicillins and mussels. The patient had no covid prior vaccination. The patient concomitant medications included unspecified medications. The patient had not been tested for covid post vaccination. On an unspecified date in 2021, after the 1st dose of vaccination, the patient experienced extreme arm pain and swollen at injection site, collar bone as it was super painful and could feel a lump just above my left collarbone and Lethargy during those first few hours as well. The patient stated that few days after the first dose thought a dog at work had broken part of her collar bone as it was super painful and could feel a lump just above her left collarbone. Pain eventually stopped and bump did get smaller. The patient received no treatment to treat the events. The patient outcome of the events extreme arm pain and swollen at injection site, collar bone as it was super painful and could feel a lump just above my left collarbone was resolving and the outcome of the event Lethargy was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness
Clinical narrative: Dizziness occurring 3 hours post injection including loss of balance.; Dizziness occurring 3 hours post injection including loss of balance.; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20Apr2021 at 14:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included adult stills disease (AOSD). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included anakinra (KINERET), methotrexate (MANUFACTURER UNKNOWN), duloxetine hydrochloride (CYMBALTA) and bupropion (MANUFACTURER UNKNOWN); all from unknown date for unknown indications and an unknown if ongoing. 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 right arm on 21Mar2021 at 14:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient previously took moxifloxacin hydrochloride (AVELOX) and codeine (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 20Apr2021 at 04:30, the patient experienced dizziness occurring 3 hours post injection including loss of balance. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of reported events. The clinical outcome of events dizziness occurring 3 hours post injection including loss of balance was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Sciatica
Clinical narrative: Sciatica type pain starting from hips and going into legs and feet.; Tingling in legs and feet.; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Apr2021 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications were not reported. On 18Apr2021, the patient experienced sciatica type pain starting from hips and going into legs and feet and tingling in legs and feet. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sciatica type pain starting from hips and going into legs and feet and tingling in legs and feet was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Vomiting; Fever; Arm pain; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration on 19Apr2021 at 10:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On an unknown date in Apr2021, the patient experienced vomiting, fever, arm pain, and tiredness. Since the vaccination, the patient had not been tested for COVID-19. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of reported events which was unspecified. The clinical outcomes of events vomiting, fever, arm pain and tiredness were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus/ringing in ears; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 01Apr2021 at 17:15 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 11Mar2021 at 17:15 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. On 03Apr2021, the patient started having tinnitus/ringing in the ears after receiving the second dose. It had not subsided since then and it was increased quite a bit on occasion. The patient was planning to discuss this with the primary care physician (PCP) this week (at the time of the report). Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event tinnitus/ringing in ears was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rashes / skin reactions on the left side of body (chest and back); This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 07Apr2021 at 14:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN) of 20mg from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: CN6208) via an unspecified route of administration in the left arm on 16Mar2021 at 14:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 08Apr2021, the patient experienced rashes/skin reactions on the left side of body on chest and back. It had been 14 days and the patient still had rashes. Since the vaccination, the patient had not been tested for COVID-19. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken as a result of reported event. The clinical outcome of event rashes/skin reactions on the left side of body on chest and back was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Swelling
Clinical narrative: Pain and swelling in left armpit and that lasted for 3 days; Pain and swelling in left armpit and that lasted for 3 days; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 12:15 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as none. The patient had no known allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included paracetamol (TYLENOL), naproxen sodium (ALEVE), omeprazole (MANUFACTURER UNKNOWN) and alprazolam (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Mar2021 at 12:15 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported that with the first vaccine the patient had no side effects at all. On 16Apr2021 at around 19:00, the following night after second vaccine, the patient experienced pain and swelling in left armpit and that lasted for 3 days. That was the only side effect. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain and swelling in left armpit was resolved on 19Apr2021, after the duration of 3 days.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Swelling on back of arm near shot and soreness; Swelling on back of arm near shot and soreness; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: PFIZEREW0170) via an unspecified route of administration in the left arm on 20Apr2021 at 08:15 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 20Apr2021 at 19:15, the patient experienced swelling on back of arm near shot and soreness. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of reported events. The clinical outcome of event swelling on back of arm near shot and soreness was unknown 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: Dysmenorrhoea, Heavy menstrual bleeding
Clinical narrative: Abnormally heavy periods following first and second doses of this vaccine, with increased cramps, blood flow, and blood clots; Abnormally heavy periods following first and second doses of this vaccine, with increased cramps; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on an unknown date in Mar2021 at 12:30 (at the age of 35-years-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW951) via an unspecified route of administration in the left arm on 08Apr2021 at 13:45 (at the age of 35-years-old), as a single dose for COVID-19 immunisation. Medical history included endometriosis, surgery (the patient was diagnosed with endometriosis, but received surgery in 2009 and have not had adverse symptoms since) and sulfonamide allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not take any concomitant medications. On an unknown date in Mar2021, the patient experienced abnormally heavy periods following the first and second doses of this vaccine, with increased cramps, blood flow, and blood clots. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events abnormally heavy periods following the first and second doses of this vaccine, with increased cramps, blood flow, and blood clots were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Muscle soreness on left arm where vaccine was applied - slight pain when lifting or rotating arm; Muscle soreness on left arm where vaccine was applied - slight pain when lifting or rotating arm; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 20Apr2021 at 14:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications taken within two weeks of vaccination were 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 other vaccines within four weeks prior to the vaccination. On 20Apr2021 at 14:15, the patient experienced muscle soreness on left arm where vaccine was applied - slight pain when lifting or rotating arm. It was unknown whether therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events muscle soreness on left arm where vaccine was applied - slight pain when lifting or rotating arm was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Awoke on Day 2 after vaccine with swelling in my leftarmpit (injection arm).; tenderness in left armpit (injection arm); 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: EW0153) via an unspecified route of administration in the left arm on 19Apr2021 at 13:00 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and sulfonamide allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8733) via an unspecified route of administration in the left arm on 26Mar2021 at 12:30 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. On 21Apr2021 at 05:30,  after vaccination the patient woke up on day 2 with swelling and tenderness in her left armpit (injection arm). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swelling and tenderness in left armpit (injection arm) were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Body aches; Chills; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 19Apr2021 at 10:00 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history included sulfa drugs allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 29Mar2021 at 10:30 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. On 19Apr2021, the patient experienced body aches, chills and fatigue (from 3 days). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events body aches, chills and fatigue were resolving at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain
Clinical narrative: Right Neck Pain.; Could not move the neck up and down or side to side for a day without pain; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 15Apr2021 at 11:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer. The patient previously took tetracycline (MANUFACTURER UNKNOWN) on an unknown date and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included exemestane (MANUFACTURER UNKNOWN) for unknown indication from an unknown date and unknown if ongoing. On 16Apr2021 at 10:00, the patient experienced right neck pain and could not move her neck up and down or side to side for a day without pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events right neck pain and could not move her neck up and down or side to side for a day without pain was resolved on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Pain
Clinical narrative: 25 minutes after I had pain going up my right side neck up carotid, then numbness right face cheek, and lips. Lasted about 20 -30 minutes then went away; 25 minutes after I had pain going up my right side neck up carotid, then numbness right face cheek, and lips. Lasted about 20 -30 minutes then went away; 25 minutes after I had pain going up my right side neck up carotid, then numbness right face cheek, and lips. Lasted about 20 -30 minutes then went away; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 15Apr2021 at 17:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and high cholesterol. The patient had no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included losartan potassium 25 milligram (MANUFACTURER UNKNOWN) for unknown indication from unknown date. 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 15Apr2021 at 18:10, 25 minutes after, the patient had pain going up her right side neck up carotid, then at 18:30, numbness right face cheek, and lips. Lasted about 20 -30 minutes then went away. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events 25 minutes after had pain going up right side neck up carotid, then numbness right face cheek, and lips; lasted about 20 -30 minutes then went away was resolved on 15Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Skin burning sensation
Clinical narrative: Burning skin sensation, all over body lasted about 6 hours; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 20Apr2021 at 08:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes (diabetic). The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included insulin (MANUFACTURER UNKNOWN) since an unknown date, for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine.   On an unknown date in Apr2021, the patient experienced burning skin sensation, all over body which lasted about 6 hours. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported event. The clinical outcome of the event burning skin sensation, all over body lasted about 6 hours was recovered on an unknown date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Large swollen lymph node on left collarbone; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the  left arm on 16Apr2021 at 12:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient was allergic to adhesive. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), lamotrigine (LAMICTAL), doxycycline (MANUFACTURER UNKNOWN) and tretinoin (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 25Mar2021 at 16:00 (at the age of 49-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 20Apr2021 at 13:00, the patient experienced large swollen lymph node on left collarbone. The patient stated that, the swollen lymph node was warm and painful to the touch. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event large swollen lymph node on left collarbone was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears; 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: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in Mar2021 at 13:00 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. Medical history included Hashimoto's thyroiditis and breast cancer. The patient did not have any allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included levothyroxine sodium (SYNTHROID), letrozole (MANUFACTURER UNKNOWN), vitamin d nos (MANUFACTURER UNKNOWN) and cyanocobalamin (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in Mar2021 at 13:00 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. On 07Apr2021, the patient experienced ringing in ears about 10 days after the second shot. Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event ringing in ears was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Intermittent bouts of paresthesia from the left shoulder to the left elbow but most often over the deltoid. It felt like icy hot cream on the skin; This is a spontaneous report from a contactable nurse, the patient. A 60-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 01Apr2021 at 09:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, vitamin d deficiency, vitamin b12 deficiency, coeliac disease (possible celiac), arthritis. The patient allergic to penicillin, adhesive tape and deodorant allergy (an unknown ingredient in sure deodorant). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine sodium (MANUFACTURER UNKNOWN), vitamin d nos (MANUFACTURER UNKNOWN) and estradiol (MANUFACTURER UNKNOWN), all taken for unknown indication for unknown date and unknown if ongoing. On 01Apr2021 at 10:00, 1 hour after the vaccination, the patient had intermittent bouts of paraesthesia from the left shoulder to the left elbow but most often over the deltoid. It felt like "icy" hot cream on the skin. It lasted anywhere from 5 minutes to a couple hours at that time and occurring a few times per day. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event intermittent bouts of paresthesia from the left shoulder to the left elbow was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE RIGHT ARM; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the right arm on an unknown date in Apr2021 at 15:00 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date the patient experienced sore right arm. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore right arm was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased
Clinical narrative: Temp 101.9 and 102.6; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the arm left on 21Apr2021 at 09:15 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included Factor V Leiden carrier. It was unknown whether the patient was pregnant at the time of vaccination. Concomitant medications included paracetamol (TYLENOL) and cetirizine hydrochloride (ZYRTEC) for unknown indication from an unknown date. It was unknown whether the patient was allergic to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 21Apr2021, at 10:00 the patient had temperature of  101.9 (Unspecified units) and 102.6 (Unspecified units). The event resulted in emergency room/department visit or urgent care. Therapeutic measures were taken as a result of the event and included treatment with diphenhydramine hydrochloride (BENADRYL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event Temp 101.9 and 102.6 was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Mild but constant tinnitus not affecting hearing.; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the right arm on an unknown date in Mar2021 at 17:30 (at the age of 64-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the right arm on 11Apr2021 at 15:00 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. On an unknown date in Apr2021, the patient experienced mild but constant tinnitus which was not affecting hearing. The adverse event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event mild but constant tinnitus was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Pain
Clinical narrative: dizziness; nausea; headache; soreness; This is a spontaneous report from a contactable consumer. A 30-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20Apr2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were reported as unknown. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19 and also unknown if the patient was pregnant at the time of vaccination. It was unknown if the patient had any allergies to medications, food, or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 31Mar2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. On 20Apr2021 at 21:00, the patient experienced dizziness, nausea, headache, and soreness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizziness, nausea, headache, and soreness was recovering at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.