chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Swelling
Clinical narrative: Lot of swelling; Large red patch; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 30Mar2021 (Lot Number: EP7534, expiry date: unknown) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 02Apr2021, the patient experienced lot of swelling and large red patch. Patient Stated had the Pfizer vaccine first dose last week and still having the side effects that was not noted on your, any of your material. It's related to a lot of swelling and large red patch after three days of vaccine which apparently is sometimes seen with the Moderna vaccine. But was just trying to find if there is anything need to do and if it's okay for me to still have my second shot in which due date is 20Apr2020. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Musculoskeletal stiffness
Clinical narrative: headaches/sometimes the pain feels intense; feel like a squeezing sensation; neck muscles also sometimes feel very stiff; This is a spontaneous report from a contactable consumer (patient). A 76-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EN6205) via an unspecified route of administration, administered in Arm Left on 03Mar2021 13:00 (at the age of 76-years-old) as DOSE 2, SINGLE for covid-19 immunization. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EL9262) via an unspecified route of administration, administered in arm left on 10Feb2021 at 2PM as DOSE 1, SINGLE for covid-19 immunization. No vaccine was administered within 4 weeks. The patient's medical history included left elbow surgery after traumatic fall in May2018 from an unknown date, physical therapy for neck stiffness from an unknown date and unknown if ongoing, skin allergy to nickel and allergic to ceclor from an unknown date and unknown if ongoing and covid was tested prior vaccination on an unknown date and covid was not tested post vaccination. Concomitant medications included levothyroxine, atorvastatin, hydrochlorothiazide taken for an unspecified indication, start and stop date were not reported. On 04Mar2021 at 03:00 AM the patient reported that for the past six weeks after her second vaccine, she was experiencing daily headaches (which began 12-24 hours after her vaccine) on both the top and back of her head, varying in intensity and duration. She feels like a squeezing sensation, sometimes the pain feels intense. Neither Tylenol nor Ibuprofen really help. Her neck muscles also sometimes feel very stiff when the headache is coming on. No treatment was received for the events. The outcome of the events was reported as not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Headache, Nausea
Clinical narrative: Killer headaches; Dizziness; Nausea; Has been experiencing "killer" headaches. She states that this morning it is "really bad"; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team. A 50-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; batch or lot Number: EW0162) via an unspecified route of administration, administered in right arm on 23Apr2021 morning at 9:30 (at the age of 50-years-old) as dose 1, single dose for covid-19 immunization. The patient medical history included high blood pressure from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported but patient stated took small dose of medication for high blood pressure. On an unspecified date, the patient experienced killer headaches, this morning it is really bad and stated that she is also having dizziness and nausea. Patient received the first dose yesterday but she is experiencing a severe headache. She already took Ibuprofen orally one last night and one this morning, took one 800 mg tablet it's the prescription that she had last year for something else but it helped little but today it got worse. Patient concerned that she had a headache yesterday and this morning it's getting worse, and she took Ibuprofen last night but today it's not helping. She would like to know if it is safe to take Excedrin to treat her symptoms, as she is worried about a potential interaction between it and the vaccine. Response received as there is no information regarding a potential interaction between the vaccine and Excedrin. Spoke from the attached document to let caller know about CDCs considerations that medications used to reduce pain can be taken after vaccination to treat symptoms, but let caller know that it does not specify Excedrin. Referred caller to HCP for further guidance. Unaddressed medical questions referred or forwarded to medical Information. Therapeutic measures were taken as a result of all the events. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthropathy, Blood cholesterol, Pain in extremity, Product use issue, Red blood cell sedimentation rate increased
Clinical narrative: having hand pain; sedimentation rate is high; knees being bad; Product use error; This is a spontaneous report from a Specialty Pharmacy reported on behalf of a 55-years-old female (patient) reported that: A 55-Year-old female patient of an age received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration  (at the age of 56-year-old) on an unspecified date at for COVID-19 immunisation; tofacitinib citrate (XELJANZ XR), at 11 mg, orally, daily from an unspecified date (Batch/Lot number was not reported) to an unspecified date for rheumatoid arthritis.  Medical history included overweight from an unknown date and unknown if ongoing. The patient reported that her cholesterol levels are normal. The patient's concomitant medications were not reported. The patient experienced having hand pain, sedimentation rate is high and knees being bad. The Patient reported that she had been off of xeljanz for over a month due to taking the COVID vaccine Pfizer and being on antibiotics (previously reported adverse event 20Jan2021). The patient reported having hand pain while off of xeljanz, but was not in complete pain (patient did not clarify complete pain). The patient reported that the sedimentation rate is high, knees being bad (patient did not clarify knees being bad), and took knees x-ray. No exact dates or further details were reported. The patient re started the xeljanz on 21Apr2021. The patient reported before xeljanz being upset and cried, was in too much pain, had to take prednisone. The action taken in response to the events for tofacitinib citrate was unknown.  No follow-up attempts are needed. Information of lot/batch number can not be obtained.
Sex: F
Vaccine: COVID19, UNK
Symptoms: X-ray
Clinical narrative: having hand pain; sedimentation rate is high; knees being bad; Product use error; This is a spontaneous report from a Specialty Pharmacy reported on behalf of a 55-years-old female (patient) reported that: A 55-Year-old female patient of an age received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration  (at the age of 56-year-old) on an unspecified date at for COVID-19 immunisation; tofacitinib citrate (XELJANZ XR), at 11 mg, orally, daily from an unspecified date (Batch/Lot number was not reported) to an unspecified date for rheumatoid arthritis.  Medical history included overweight from an unknown date and unknown if ongoing. The patient reported that her cholesterol levels are normal. The patient's concomitant medications were not reported. The patient experienced having hand pain, sedimentation rate is high and knees being bad. The Patient reported that she had been off of xeljanz for over a month due to taking the COVID vaccine Pfizer and being on antibiotics (previously reported adverse event 20Jan2021). The patient reported having hand pain while off of xeljanz, but was not in complete pain (patient did not clarify complete pain). The patient reported that the sedimentation rate is high, knees being bad (patient did not clarify knees being bad), and took knees x-ray. No exact dates or further details were reported. The patient re started the xeljanz on 21Apr2021. The patient reported before xeljanz being upset and cried, was in too much pain, had to take prednisone. The action taken in response to the events for tofacitinib citrate was unknown.  No follow-up attempts are needed. Information of lot/batch number can not be obtained.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Tooth disorder
Clinical narrative: has a dental problem and he thinks it was after his 1st dose/root canal; This is a spontaneous report received from a contactable consumer (Patient) or other non-HCP.  A 70-year-old male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was ER8735) via an unspecified route of administration on 11Apr2021 12:00 administered in left arm as a DOSE 1, SINGLE dose for COVID-19 immunization. Co-suspect AMOXICILLIN 3 tablets a day, each tablet was 500 mg from 20Apr2021, taken for infection. Medical history and concomitant medications was not reported. The patient had no relevant family history related to adverse events. included. The caller stated that he was taking amoxicillin till his second dose 04May2021. No Additional Vaccines were Administered (on same date as Pfizer vaccine considered as suspect). The patient had no Prior Vaccination within 4 weeks. On 27Apr2021, the patient experienced has a dental problem and he thinks it was after his 1st dose/root canal. Additional Information included the caller said that he actually had a question regarding the COVID-19 vaccine. He was taking antibiotics right now because of a dental surgery and he had his 1st dose on 11Apr2021 and his 2nd dose appointment is 02MAR2021 and he will be taking antibiotics for this whole week so he is just wondering if this will affect the vaccination. He clarified antibiotic he was taking to amoxicillin. He had a dental problem and he thought it was after his 1st dose. He had one surgery right after the 1st dose but now he needs to have a second dental surgery. The surgery he has had and was having was a root canal. Again, actually he already had the root canal but it was not working very well so he needs to revisit to the clinic to fill it again because he had some infection going on so they did the root canal but they did not complete it. caller says he does not have those to provide since it is in an orange pharmacy bottle. He started taking the amoxicillin on 20Apr2021 and will take until 04May2021. The investigation assessment was not provided. No relevant tests were done. The clinical outcome of event was unknown.  No follow-up attempts are needed; No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Nausea, Sitting disability, Sleep disorder
Clinical narrative: Was asleep and was awakened by severe dizziness and nausea.  Went to bathroom and had numerous sessions of vomiting along with dizziness so bad I couldn?t keep my eyes open and could not sit down or walk. The vomiting was so severe in nature it caused blood vessels to break under the skin of my face.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vein rupture, Vomiting
Clinical narrative: Was asleep and was awakened by severe dizziness and nausea.  Went to bathroom and had numerous sessions of vomiting along with dizziness so bad I couldn?t keep my eyes open and could not sit down or walk. The vomiting was so severe in nature it caused blood vessels to break under the skin of my face.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Injection site swelling, Pyrexia
Clinical narrative: fever, chills, joint pain, injection site swelling
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain
Clinical narrative: Lymph node pain under arm
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Peripheral swelling, Swelling, Weight increased
Clinical narrative: Swelling occurred particularly in my  extremities but very bad I?m my legs.  Dissipated after about two weeks. Was several pounds of water gain I believe. Also had a headache that was pretty intense a couple of days.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Chest discomfort, Chest pain, Dizziness, Dyspnoea
Clinical narrative: Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Medium
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Hyperhidrosis, Hypoaesthesia, Tremor
Clinical narrative: Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Medium
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspepsia, Echocardiogram normal, Electrocardiogram normal, Heart rate increased, Insomnia
Clinical narrative: Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Medium
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test normal, Muscle fatigue, Muscular weakness, Nausea, Syncope
Clinical narrative: Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Medium
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat irritation
Clinical narrative: Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Medium
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dyspnoea, Injection site pain, Pruritus, Tachycardia
Clinical narrative: Moderna COVID-19 Vaccine EUA administered.  Observed at facility for 30mins, with nly soreness at injection site present.  Itchiness, Urticaria, tachycardia, and shortness of breath/wheezing developed approximately 45min-1hr after administration of vaccination and slowly got progressively worse.  Minimal relief of symptoms after taking 50mg liquid Benedryl PO and prescribed rescue Albuterol Inhaler.  Epi pen administered and symptoms improved, other than minor itching.  Medical evaluation obtained at urgent care center for anaphylactic reaction.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Wheezing
Clinical narrative: Moderna COVID-19 Vaccine EUA administered.  Observed at facility for 30mins, with nly soreness at injection site present.  Itchiness, Urticaria, tachycardia, and shortness of breath/wheezing developed approximately 45min-1hr after administration of vaccination and slowly got progressively worse.  Minimal relief of symptoms after taking 50mg liquid Benedryl PO and prescribed rescue Albuterol Inhaler.  Epi pen administered and symptoms improved, other than minor itching.  Medical evaluation obtained at urgent care center for anaphylactic reaction.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Flushed / Sweating-Severe
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Menstruation irregular
Clinical narrative: And this month I start to spotting couple of days and now stopped again; I suppose to have period on march 20th after first shot. After my first and 2nd shot, I totally missed my period.; This is a spontaneous report from a contactable consumer, the patient. A 44-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 on 07Mar2021 at 10:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation and 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 28Mar2021 at 10:00 (at the age of 44-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. The patient did not receive any other medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 22Mar2021, the patient reported that she was suppose to have period on March 20th.  After her first and 2nd shot, she totally missed her period and on an unknown date in Apr2021, she start to spotting couple of days and now stopped again. The 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event suppose to have period on march 20th, after her first and 2nd shot, she totally missed her period and she start to spotting couple of days and now stopped again was not resolved 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.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Pregnancy test
Clinical narrative: Patient not had a menstrual period since receiving the first dose of the vaccine; This is a spontaneous report from a contactable consumer, the patient. A 30-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 05Apr2021, at 10:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity and hypertension. Patient had no known allergies. 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 medication taken within two weeks of vaccination was not reported. On 05Apr2021, the patient did not have a menstrual period since receiving the first dose of the vaccine and patient feel perfectly fine with no other side effects. In Apr2021, over the last 3 weeks (as reported), the patient underwent pregnancy tests and the result was negative. Therapeutic measures were not taken as a result of the event. 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 patient not had a menstrual period since receiving the first dose of the vaccine was not resolved 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.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Pruritus, Vaccination site bruising
Clinical narrative: Was extremely dizzy immediately after in first 10 minutes; Headache; Bad fatigue lasted a week; Bruised at injection site; Had some itching on back and base of skull; This is a spontaneous report from a contactable consumer, the patient. A 50-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 20Apr2021 at 12:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included PIDDS (primary immune deficiency syndrome), allergy to oranges (fruit allergy), allergy to milk and a lot of environmental allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the vaccination. Concomitant medications included clonazepam (MANUFACTURER UNKNOWN); for unknown indication from unknown date and unknown if ongoing. On 20Apr2021 at 12:15, immediately after in first 10 minutes the patient was extremely dizzy, had headache, bad fatigue that lasted a week. The patient experienced bruise at injection site, had some itching on back and base of skull. 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 extremely dizzy, headache and bad fatigue lasted a week were recovered on an unknown date in Apr2021; while that of the events bruised at injection site, some itching on back and base of skull were 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.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Fatigue, Heart rate, Heart rate increased
Clinical narrative: Heart rate was 125; Feeling fatigue; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old male 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 30Apr2021 at 15:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies. 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-19 vaccine. Concomitant medications included amoxicillin (MANUFACTURER UNKNOWN) and doxycycline (MANUFACTURER UNKNOWN); both for unknown indications from unknown dates and 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 on an unknown date (at the age of 22-years-old) as a single dose for COVID-19 immunisation. On 30Apr2021 at 15:15, after injection, the patient's heart rate was 125 (unit unspecified) and blood pressure was 114/68 (unit unspecified). The patient's heart rates were staying between 93 and117 bpm. The patient was also feeling fatigue. The patient was very healthy before second shot. It was reported that no health issues. 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 heart rate was 125 and feeling fatigue was not resolved 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.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Diarrhoea, Headache, Hypoaesthesia
Clinical narrative: I have had a headache; my joint are killing me; numbness occurred right away in my arms and hands; Very lethargic; weak; Starting at 11pm I have had severe diarrhea and vomiting; Starting at 11pm I have had severe diarrhea and vomiting that hasnt stopped; This is a spontaneous report from a contactable consumer, the patient. A 48-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 30Apr2021 at 11:45 (at the age of 48-year-old), as a single dose for COVID-19 immunisation. Medical history included known allergies to latex and abs whole wheat. 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 sertraline (MANUFACTURER UNKNOWN) and estradiol (MANUFACTURER UNKNOWN); both for unspecified indication from unknown date and unknown if ongoing. On 30Apr2021 at 23:00, the patient experienced severe diarrhea and vomiting that had not stopped. On same day at 23:45, the patient experienced headache and patient's joints were killing her, numbness occurred right away in her arms and hands, felt very lethargic and weak. 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 severe diarrhea and vomiting that had not stopped, headache, joints were killing her, numbness occurred right away in her arms and hands, very lethargic and weak was not resolved 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.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Vomiting
Clinical narrative: I have had a headache; my joint are killing me; numbness occurred right away in my arms and hands; Very lethargic; weak; Starting at 11pm I have had severe diarrhea and vomiting; Starting at 11pm I have had severe diarrhea and vomiting that hasnt stopped; This is a spontaneous report from a contactable consumer, the patient. A 48-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 30Apr2021 at 11:45 (at the age of 48-year-old), as a single dose for COVID-19 immunisation. Medical history included known allergies to latex and abs whole wheat. 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 sertraline (MANUFACTURER UNKNOWN) and estradiol (MANUFACTURER UNKNOWN); both for unspecified indication from unknown date and unknown if ongoing. On 30Apr2021 at 23:00, the patient experienced severe diarrhea and vomiting that had not stopped. On same day at 23:45, the patient experienced headache and patient's joints were killing her, numbness occurred right away in her arms and hands, felt very lethargic and weak. 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 severe diarrhea and vomiting that had not stopped, headache, joints were killing her, numbness occurred right away in her arms and hands, very lethargic and weak was not resolved 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.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dehydration, Dry mouth, Dry skin, Dyspnoea
Clinical narrative: Dehydration; incredibly irritating dryness, dry mouth; incredibly irritating dryness, dry mouth, dry skin; Bloody nose; Gastrointestinal issues; Stomach pains; Difficulty breathing; Congestion; Muscle pains/ Sore muscles; Feet pain; This is a spontaneous report from a contactable consumer, the patient. A 17-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 28Apr2021 at 15:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. The medical history included aspergers syndrome(ASD), attention-deficit hyperactivity disorder (ADHD), depression and anxiety. It was unknown whether the patient had any allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The concomitant medications included citalopram (MANUFACTURER UNKNOWN), lisdexamfetamine (MANUFACTURER UNKNOWN) and bupropion (MANUFACTURER UNKNOWN), all for unknown indications from unknown dates and unknown if on going. On 29Apr2021, the patient experienced dehydration, incredibly irritating dryness, dry mouth, dry skin, bloody nose, gastrointestinal issues, stomach pains, difficulty breathing, congestion, muscle pains, sore muscles and feet pain. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dehydration, incredibly irritating dryness, dry mouth, dry skin, bloody nose, gastrointestinal issues, stomach pains, difficulty breathing, congestion, muscle pains, sore muscles and feet pain were not resolved 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.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Gastrointestinal disorder, Myalgia, Nasal congestion, Pain in extremity
Clinical narrative: Dehydration; incredibly irritating dryness, dry mouth; incredibly irritating dryness, dry mouth, dry skin; Bloody nose; Gastrointestinal issues; Stomach pains; Difficulty breathing; Congestion; Muscle pains/ Sore muscles; Feet pain; This is a spontaneous report from a contactable consumer, the patient. A 17-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 28Apr2021 at 15:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. The medical history included aspergers syndrome(ASD), attention-deficit hyperactivity disorder (ADHD), depression and anxiety. It was unknown whether the patient had any allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The concomitant medications included citalopram (MANUFACTURER UNKNOWN), lisdexamfetamine (MANUFACTURER UNKNOWN) and bupropion (MANUFACTURER UNKNOWN), all for unknown indications from unknown dates and unknown if on going. On 29Apr2021, the patient experienced dehydration, incredibly irritating dryness, dry mouth, dry skin, bloody nose, gastrointestinal issues, stomach pains, difficulty breathing, congestion, muscle pains, sore muscles and feet pain. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dehydration, incredibly irritating dryness, dry mouth, dry skin, bloody nose, gastrointestinal issues, stomach pains, difficulty breathing, congestion, muscle pains, sore muscles and feet pain were not resolved 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.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Blood glucose, Blood glucose increased, Hyperaesthesia teeth, Insulin resistance
Clinical narrative: Swollen glands below the jaw; Extreme sensitivity of the teeth in the back or the mouth on top and bottom of both sides; Severe acne on lower half of the face; High blood sugar/insulin resistance; High blood sugar/insulin resistance; painful soreness in the throat on the upper right side; This is a spontaneous report from a contactable consumer, the patient. A 48-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 11Apr2021 at 12:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included type 1 diabetes and celiac disease. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included insulin lispro (HUMALOG), pramlintide acetate (SYMLIN), bupropion (MANUFACTURER UNKNOWN) and escitalopram (MANUFACTURER UNKNOWN); all for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 12:00, the patient experienced swollen glands below the jaw, extreme sensitivity of the teeth in the back or the mouth on top and bottom of both sides, severe acne on lower half of the face, high blood sugar and insulin resistance, painful soreness in the throat on the upper right side. 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 events. Since the vaccination, the patient had been tested for COVID-19. On 25Apr2021, the patient underwent test for COVID-19 via nasal swab and the result was negative. The clinical outcome of the events swollen glands below the jaw, extreme sensitivity of the teeth in the back or the mouth on top and bottom of both sides, severe acne on lower half of the face, high blood sugar and insulin resistance, painful soreness in the throat on the upper right side was resolving 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.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Swollen glands below the jaw; Extreme sensitivity of the teeth in the back or the mouth on top and bottom of both sides; Severe acne on lower half of the face; High blood sugar/insulin resistance; High blood sugar/insulin resistance; painful soreness in the throat on the upper right side; This is a spontaneous report from a contactable consumer, the patient. A 48-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 11Apr2021 at 12:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included type 1 diabetes and celiac disease. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included insulin lispro (HUMALOG), pramlintide acetate (SYMLIN), bupropion (MANUFACTURER UNKNOWN) and escitalopram (MANUFACTURER UNKNOWN); all for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 12:00, the patient experienced swollen glands below the jaw, extreme sensitivity of the teeth in the back or the mouth on top and bottom of both sides, severe acne on lower half of the face, high blood sugar and insulin resistance, painful soreness in the throat on the upper right side. 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 events. Since the vaccination, the patient had been tested for COVID-19. On 25Apr2021, the patient underwent test for COVID-19 via nasal swab and the result was negative. The clinical outcome of the events swollen glands below the jaw, extreme sensitivity of the teeth in the back or the mouth on top and bottom of both sides, severe acne on lower half of the face, high blood sugar and insulin resistance, painful soreness in the throat on the upper right side was resolving 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.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Back pain, Lymph node pain
Clinical narrative: My right arm pit area is throbbing/ It even goes into my back & under my arm a little too.; My right arm pit area is throbbing. Its like my lymph nodes are being applied pressure to them; My right arm pit area is throbbing/ It even goes into my back & under my arm a little too.; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the right arm on 24Apr2021 at 10:00 (at the age of 45-year-old), as a single dose for COVID-19 immunisation. Medical history included lyme disease. The patient had no known allergies. 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-19 vaccine. Concomitant medications included estradiol (MANUFACTURER UNKNOWN) and montelukast sodium (SINGULAIR); both for unknown indication from an unknown date and unknown if ongoing. On 28Apr2021, the patient's arm pit area was throbbing and felt like lymph nodes were being applied pressure to them. It even went into the back and under arm a little too. 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 arm pit area is throbbing, lymph nodes were being applied pressure to them, even went into back and under arm a little too was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Meniere's disease, Vertigo
Clinical narrative: meniere's disease; dizziness; vertigo; This is a spontaneous report from a contactable other hcp (nurse). A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; batch or lot number was not reported) via an unspecified route of administration on an unspecified date (at the age of 57-years-old) as dose number unknown, single dose for covid-19 immunization. Patient received tofacitinib citrate (XELJANZ XR) tablet via orally from unspecified date in 2019 (Batch/Lot number was not reported; Expiration Date: 30Jan2023) to an unspecified date, at 11 mg, 1 daily for rheumatoid arthritis. The patient's medical history and concomitant medications were not reported. On unspecified date, the patient experienced dizziness, vertigo and Meniere's disease. Reporter stated behind one week on therapy (Xelianz XR) due to receiving covid vaccine. Patient reported currently being tested for vertigo and meniere's by ENT. The action taken for tofacitinib citrate was unknown. The outcome of the event dizziness was not recovered and for remaining events it was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the event Meniere's disease and the administration of the vaccine cannot be excluded.The impact of this report on the benefit/risk profile of the product is evaluated as part of procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Joint swelling, Lymph node pain, Lymphadenopathy, Pain in extremity
Clinical narrative: The lymph nodes in my left armpit swelled and severely hurt.; The lymph nodes in my left armpit swelled and severely hurt.; My entire arm from my neck to my wrist swelled as well.; My entire arm from my neck to my wrist swelled as well.; The left side of my left breast is also swollen.; My arm is still very swollen and painful.; My entire arm from my neck to my wrist swelled as well.; This is a spontaneous report from a contactable consumer, the patient. A 39-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 26Apr2021 at 13:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included type 1 diabetic (type 1 diabetes mellitus), anxiety, depression and penicillin 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. Concomitant medications included rosuvastatin (MANUFACTURER UNKNOWN), ubidecarenone (COQ), insulin human injection / isophane (HUMULIN N), insulin lispro (HUMALOG) and venlafaxine (MANUFACTURER UNKNOWN); all for an unknown indication from unknown date and unknown if ongoing. The patient previously took codeine (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 05Apr2021 at 13:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. On 27Apr2021 at 08:00, the patient's lymph nodes in left armpit swelled and severely hurt. Over the course of 2 days, the patient's entire arm from neck to wrist swelled as well. The left side of the left breast was also swollen. Over 5 days after the vaccine, the patient's arm was still very swollen and painful. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether therapeutic measures were 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 lymph nodes in left armpit swelled and severely hurt, entire arm from neck to wrist swelled as well, left side of the left breast was swollen breast is swollen, arm was very swollen and painful were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Swelling
Clinical narrative: The lymph nodes in my left armpit swelled and severely hurt.; The lymph nodes in my left armpit swelled and severely hurt.; My entire arm from my neck to my wrist swelled as well.; My entire arm from my neck to my wrist swelled as well.; The left side of my left breast is also swollen.; My arm is still very swollen and painful.; My entire arm from my neck to my wrist swelled as well.; This is a spontaneous report from a contactable consumer, the patient. A 39-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 26Apr2021 at 13:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included type 1 diabetic (type 1 diabetes mellitus), anxiety, depression and penicillin 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. Concomitant medications included rosuvastatin (MANUFACTURER UNKNOWN), ubidecarenone (COQ), insulin human injection / isophane (HUMULIN N), insulin lispro (HUMALOG) and venlafaxine (MANUFACTURER UNKNOWN); all for an unknown indication from unknown date and unknown if ongoing. The patient previously took codeine (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 05Apr2021 at 13:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. On 27Apr2021 at 08:00, the patient's lymph nodes in left armpit swelled and severely hurt. Over the course of 2 days, the patient's entire arm from neck to wrist swelled as well. The left side of the left breast was also swollen. Over 5 days after the vaccine, the patient's arm was still very swollen and painful. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether therapeutic measures were 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 lymph nodes in left armpit swelled and severely hurt, entire arm from neck to wrist swelled as well, left side of the left breast was swollen breast is swollen, arm was very swollen and painful were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Peripheral swelling
Clinical narrative: Leg swelling, legs from the knee down swell up really bad; Hard of hearing; This is a spontaneous report from a contactable consumer or other non hcp.  A 71-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 25Mar2021 (Age at vaccination 71 years old) (Batch/Lot Number: EW6199) as DOSE 1, SINGLE for covid-19 immunisation, warfarin (WARFARIN), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history was not reported. Concomitant medication(s) included simvastatin (SIMVASTATIN) taken for an unspecified indication, start and stop date were not reported.  Consumer sated, "she hard of hearing. Oh I had a reaction to both of the Pfizer shots, patient had her first on 25Mar2021 and the only thing that and she did not related to vaccination or the shot, she had leg swelling and it was about a week after she had the shot and both of her legs from the knee down swell up really bad and she just kind of passed it off with activity and all that and she went to her doctor and he put him on Lasix 40 mg on the 26th of April and went some blood work and it hasn't done anything (further clarification unknown) they are like, they look like logs. So, she have not got in touch with him but that started about a week after, she had nothing else, they are still swollen, there is no pain, they are just huge and like 'tree stuff'. Therapeutic measures were taken as a result of leg swelling, legs from the knee down swell up really bad (peripheral swelling). Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.