chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pruritus, Urticaria
Clinical narrative: hives on  hands and ankles. The hives have gradually spread to all extremities (arms and legs); The hives have gradually spread to all extremities (arms and legs) and are red, hot, and itchy.; The hives have gradually spread to all extremities (arms and legs) and are red, hot, and itchy.; The hives have gradually spread to all extremities (arms and legs) and are red, hot, and itchy.; This is a spontaneous report from a contactable consumer, the patient. A 20-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 30Mar2021 at 17:15 (at the age of 20-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 in Oct2020. The patient did not receive any concomitant medications. The patient had no known allergies to medications, food or other products.  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 30Mar2021 at 19:30, the patient experienced hives on hands and ankles and gradually spread to all extremities (arms and legs) and were red, hot and itchy. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included treatment with Hydroxyzine Pam and Prednisone. The clinical outcome of the event hives, extremities hot feeling of, erythema of extremities and itchy was not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow-up (20Ju2021):Amendment: This follow-up report is being submitted to amend previously reported information: Include in VAERS Block updated as Block 13 and ticked Block 10.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Pain, Pain in extremity
Clinical narrative: arm pain; escalation of Blood Pressure; increased body pain quite a bit; This is a spontaneous report from a contactable consumer, the patient. A 68-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6206), via an unspecified route of administration, administered in Arm Left on 15Mar2021 12:45 as (At the age of 68-years) DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypersensitivity, dermatitis contact, and fibromyalgia all are from an unknown date and unknown if ongoing. Concomitant medication included propranolol; diphenhydramine hydrochloride (BENADRYL); diazepam (VALIUM) taken for an unspecified indication, start and stop date were not reported. The patient also received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: EN6200) via an unspecified route of administration in the left arm on 22Feb2021 at 13:30 (At the age of 67-years-old) as a single dose for COVID-19 immunisation and experienced arm pain and escalation of blood pressure, neomycin and experienced drug hypersensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. Post 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 an unknown date in Mar2021, the patient experienced arm pain for 4-5 days. On an unknown date in Mar2021, the patient noticed an escalation of her blood pressure which was much worse this time and had lasted 2 weeks now, with the patient almost seeking urgent care. On an unknown date in Mar2021, the patient experienced increased body pain which was as a result of past history with fibromyalgia and the pain was much longer than a few days. Increased blood pressure was the most concerning for her. These adverse events resulted in doctor or other healthcare professional office or clinic visit. Therapeutic measures were taken as a result of high blood pressure and included treatment with more consumption of beta blocker which was advised by nurse practitioner (NP). The patient underwent lab tests and procedures which included blood pressure measurement: the escalation of my bp was much worse on has lasted over 2 weeks now on an unknown date . The clinical outcome of the events increased blood pressure, arm pain and body pain were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Muscle spasms, SARS-CoV-2 test, Swollen tongue
Clinical narrative: Initial tongue swelling; Extreme muscle cramping; Terrible joint pain; Extremely exhausted; Shaking; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: unknown, Expiry date: unknown, age at vaccination 54 years) via an unspecified route of administration on 18Mar2021 09:00 on Arm Left as dose 1, single for covid-19 immunisation administered at Pharmacy or Drug Store. The medical history includes IC Hashimoto's IBS. Allergies to food was Latex and shellfish. Concomitant medications within 2 weeks were not reported. The patient did not receive any other vaccines or medication within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID. Since the vaccination, the patient has been tested for COVID-19. On 18Mar2021 09:45 the patient reported, Initial tongue swelling. Extreme muscle cramping, she was out of  rooms and extremities. Terrible joint pain as if she had room Atari arthritis. Extremely exhausted. Shaking. Been to urgent care once and taken by ambulance to ER once. The adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received for the adverse event was Benadryl tongue swelling. Muscle relaxer. Covid prior vaccination was No. Covid tested post vaccination was Yes. The patient underwent lab tests and procedures which included Nasal Swab test result negative on unspecified date. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Initial tongue swelling; Extreme muscle cramping; Terrible joint pain; Extremely exhausted; Shaking; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: unknown, Expiry date: unknown, age at vaccination 54 years) via an unspecified route of administration on 18Mar2021 09:00 on Arm Left as dose 1, single for covid-19 immunisation administered at Pharmacy or Drug Store. The medical history includes IC Hashimoto's IBS. Allergies to food was Latex and shellfish. Concomitant medications within 2 weeks were not reported. The patient did not receive any other vaccines or medication within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID. Since the vaccination, the patient has been tested for COVID-19. On 18Mar2021 09:45 the patient reported, Initial tongue swelling. Extreme muscle cramping, she was out of  rooms and extremities. Terrible joint pain as if she had room Atari arthritis. Extremely exhausted. Shaking. Been to urgent care once and taken by ambulance to ER once. The adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received for the adverse event was Benadryl tongue swelling. Muscle relaxer. Covid prior vaccination was No. Covid tested post vaccination was Yes. The patient underwent lab tests and procedures which included Nasal Swab test result negative on unspecified date. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in left arm; This is a spontaneous report from a non-contactable consumer, the patient. A 49-years-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 10Mar2021 (at the age of 49-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 31Mar2021 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not receive any concomitant medications. The patient did not have known allergies to food, medication or other product. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Mar2021, the patient experienced soreness in left arm with the first shot and it was reported that second shot resulted in much more soreness. The patient did not receive any treatment for the event. 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. The clinical outcome of the event soreness in left arm was not resolved at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Vaccine Facility Information added.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Pain in extremity
Clinical narrative: very little left arm pain on the first vaccine; did notice an escalation of my Blood Pressure on day 2.; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 68-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6200 and expiration date was not reported), first dose via an unspecified route of administration, administered in Arm Left on 22Feb2021 13:30 (at the age of 68 years) as single for covid-19 immunisation. Medical history included fibromyalgia and Known allergies, adhesives, multiple sensitivities from an unknown date and unknown if ongoing. Concomitant medication included propranolol taken for an unspecified indication, start and stop date were not reported; diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported; diazepam (VALIUM) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. The patient previously took neomycin and experienced allergies. On 23Feb2021 09:00 the patient experienced very little left arm pain on the first vaccine and did notice an escalation of my blood pressure on day 2. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood pressure measurement did notice an escalation of my blood pressure on 23Feb2021 (did notice an escalation of my Blood Pressure on day 2). The adverse event was treated with more Beta Blocker. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Periorbital swelling, Swelling of eyelid
Clinical narrative: A lot of swelling in eyelids; Swelling in eyelids and space above eyes/under eye brows.; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ERS734) via an unspecified route of administration in the left arm on 06Apr2021 at 12:00 (at the age of 23-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included loratadine (CLARITINE ALLERGY), omeprazole (MANUFACTURER UNKNOWN) and digestive probiotic (MANUFACTURER UNKNOWN), all taken for unknown indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 15Mar2021 at 12:00 (at the age of 23-years-old), as a single dose for COVID-19 immunisation. 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 07Apr2021, the patient experienced a lot of swelling in eyelids and space above eyes/under eye brows. When the patient woke up the next morning, it had not gone away and was still present before noon of the same 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. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events swelling in eyelids and space above eyes/under eye brows were 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: Arthralgia, Blood pressure decreased, Blood pressure measurement, Dizziness, Fatigue
Clinical narrative: Upper shoulder pain; Neck pain; Decreased blood pressure. Blood pressure dropped to 98/63 and then 85/54. (I'm normally 110/90); Tired; Vertigo; Headache; Dizzy; This is a spontaneous report from a contactable consumer, the patient. A 57-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER 8733) via an unspecified route of administration on the left arm on 31Mar2021 at 09:00, (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included vertigo. The patient had known allergies to diflucan. Concomitant medications included varicella zoster vaccine rge (cho) (SHINGRIX) received on 02Mar2021, estradiol cipionate (ESTRADIOL), progesterone (MANUFACTURER UNKNOWN), gliclazide (CLARITIN), biotin (MANUFACTURER UNKNOWN) and vitamin d nos (MANUFACTURER UNKNOWN) all from an unknown dates, for an unknown indications. 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 31Mar2021 10 minutes after the vaccination patient experienced dizzy and headache, went to medical area at facility. On 03Apr2021 i.e. 3 days after the vaccination the patient experienced vertigo (which I had 2 years go, so I'm familiar with the symptoms), headache, dizzy, neck pain, tired, shoulder pain on right side (I get dizzy when I get up from bed or lie down, or from certain head motions. Will set tired and a headache in the afternoon. Neck/upper shoulder pain on right side) and dropped blood pressure to 98/63 and then 85/54. No therapeutic measures were taken as a result of reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the events vertigo, headache, dizzy, neck pain, shoulder pain on right side, tired and dropped blood pressure was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Neck pain, Vertigo
Clinical narrative: Upper shoulder pain; Neck pain; Decreased blood pressure. Blood pressure dropped to 98/63 and then 85/54. (I'm normally 110/90); Tired; Vertigo; Headache; Dizzy; This is a spontaneous report from a contactable consumer, the patient. A 57-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER 8733) via an unspecified route of administration on the left arm on 31Mar2021 at 09:00, (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included vertigo. The patient had known allergies to diflucan. Concomitant medications included varicella zoster vaccine rge (cho) (SHINGRIX) received on 02Mar2021, estradiol cipionate (ESTRADIOL), progesterone (MANUFACTURER UNKNOWN), gliclazide (CLARITIN), biotin (MANUFACTURER UNKNOWN) and vitamin d nos (MANUFACTURER UNKNOWN) all from an unknown dates, for an unknown indications. 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 31Mar2021 10 minutes after the vaccination patient experienced dizzy and headache, went to medical area at facility. On 03Apr2021 i.e. 3 days after the vaccination the patient experienced vertigo (which I had 2 years go, so I'm familiar with the symptoms), headache, dizzy, neck pain, tired, shoulder pain on right side (I get dizzy when I get up from bed or lie down, or from certain head motions. Will set tired and a headache in the afternoon. Neck/upper shoulder pain on right side) and dropped blood pressure to 98/63 and then 85/54. No therapeutic measures were taken as a result of reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the events vertigo, headache, dizzy, neck pain, shoulder pain on right side, tired and dropped blood pressure was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Cough, Fatigue, Nausea
Clinical narrative: Painful to lift left arm; Low grade fever; Fatigue; Cough; Slight chills; Chest tightness; Nausea; Arm at the injection site became very sore; 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: EN6204) via an unspecified route of administration in the left on 22Mar2021 at 10:00 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included migraines. Concomitant medications were not reported. The patient previously took Macrobid and experienced drug allergy on an 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 22Mar2021 at 17:00, the patient experienced nausea in the evening following the vaccination and overnight the nausea worsened, arm at the injection site became very sore, developed a low-grade fever, fatigue, cough, slight chills and some chest tightness. On 23Mar2021, in the morning the patient experienced painful to lift left arm and nausea continued. By the following morning, all symptoms were gone. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of events. The clinical outcome of the events nausea, arm at the injection site became very sore, low-grade fever, fatigue, cough, slight chills, some chest tightness and painful to lift left arm were recovered on 23Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: Painful to lift left arm; Low grade fever; Fatigue; Cough; Slight chills; Chest tightness; Nausea; Arm at the injection site became very sore; 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: EN6204) via an unspecified route of administration in the left on 22Mar2021 at 10:00 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included migraines. Concomitant medications were not reported. The patient previously took Macrobid and experienced drug allergy on an 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 22Mar2021 at 17:00, the patient experienced nausea in the evening following the vaccination and overnight the nausea worsened, arm at the injection site became very sore, developed a low-grade fever, fatigue, cough, slight chills and some chest tightness. On 23Mar2021, in the morning the patient experienced painful to lift left arm and nausea continued. By the following morning, all symptoms were gone. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of events. The clinical outcome of the events nausea, arm at the injection site became very sore, low-grade fever, fatigue, cough, slight chills, some chest tightness and painful to lift left arm were recovered on 23Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Lethargy, Pain, Pyrexia
Clinical narrative: 104.4 temp; chills; severe body aches; 1st 48 hours very lethargic, 48 hours later 104.4 temp, severe body aches & chills for 3 days. Tylenol does not help fever.; This is a spontaneous report from a contactable consumer, the patient. A 42-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 03Apr2021 at 12:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications was reported as N/A. 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 03Apr2021, the patient experienced 1st 48 hours very lethargic. On 05Apr2021, 48 hours later,  the patient experienced 104.4 (unspecified units) temperature, severe body aches and chills for 3 days. The events resulted in a visit to the doctors or other healthcare professional office/clinic. Therapeutic measures were taken as a result of the reported events and included treatment with Tylenol which did not help with the fever. The clinical outcome of the events lethargy, body aches and chills was recovering and the outcome of the event fever was not recovered at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Vaginal haemorrhage
Clinical narrative: Neck pain; Vaginal bleeding with moderate clots; This is a spontaneous report from a contactable other hcp (Patient). A 31-years-old no pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation, Solution for injection, Batch/Lot Number: EN6207) via an unspecified route of administration, administered in Arm left on 07Apr2021 at 08:30 at the age of (31-years-old) as a dose 2, single for covid-19 immunisation. Medical history of patient included none. Prior to vaccination, the patient was not affected with covid. The patient was not been tested positive for covid after post vaccination. The patient did not receive any other vaccines within four weeks of vaccination. The patient was not taken any other medications within two weeks of vaccination. There were no concomitant medications. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation, Solution for injection, Batch/Lot Number: EW0150) via an unspecified route of administration, administered in Arm left on 17Mar2021 at 08:30 at the age of (31-years-old) as a dose 1, single for covid-19 immunisation. It was reported that on an unspecified date in Apr2021 at 12:00 PM the patient experienced neck pain and Vaginal bleeding with moderate clots for 3 hrs and vaccination occurred at 8:30 am, moderate bleeding came suddenly at 12 pm and continue nonstop until 3pm, even spreading through her pants. Nothing like this had ever happened to her. Patient menstrual cycle is 28 days regular one, with the heavy day being the second day and never this way. This bleeding came one week prior of her next expected cycle and it only lasted for those three hours with subsequent spotting. No treatment received. The patient was recovered from the events in 2021.  No follow up attempts are possible; information about lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Lip swelling, Myalgia
Clinical narrative: Rash not at injection site; Facial swelling; Lip swelling; Fatigue; joint pain; Muscle aches; Headache; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Epb955) via an unspecified route of administration in the left arm on 07Apr2021 at 14:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included polymorphic light eruption, deaf in left ear since birth, vitreous gel detachment, epiretinal membrane, polycystic ovarian syndrome, COVID-19 on unknown dates, latex allergy, caffeine allergy (coffee), allergy to plants (chamomile and cilantro), vegetable allergy (cucumbers and rutabaga), spice allergy (cumin) and allergy to wasp stings (wasps). The patient received unspecified medications within two weeks of vaccination for unknown indications on unknown dates. The patient previously received codeine (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Apr2021 at 15:30, the patient experienced rash not at injection site, facial and lip swelling, fatigue, joint pain, muscle ache and headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events rash not at injection site, facial and lip swelling, fatigue, joint pain, muscle ache and headache were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling face
Clinical narrative: Rash not at injection site; Facial swelling; Lip swelling; Fatigue; joint pain; Muscle aches; Headache; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Epb955) via an unspecified route of administration in the left arm on 07Apr2021 at 14:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included polymorphic light eruption, deaf in left ear since birth, vitreous gel detachment, epiretinal membrane, polycystic ovarian syndrome, COVID-19 on unknown dates, latex allergy, caffeine allergy (coffee), allergy to plants (chamomile and cilantro), vegetable allergy (cucumbers and rutabaga), spice allergy (cumin) and allergy to wasp stings (wasps). The patient received unspecified medications within two weeks of vaccination for unknown indications on unknown dates. The patient previously received codeine (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Apr2021 at 15:30, the patient experienced rash not at injection site, facial and lip swelling, fatigue, joint pain, muscle ache and headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events rash not at injection site, facial and lip swelling, fatigue, joint pain, muscle ache and headache were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysgeusia
Clinical narrative: Metallic taste in mouth 5 min post injection.  Duration of about 5 minutes.; Feeling slightly dizzy 5 min post injection. Duration of approximately 5 min.; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration on 07Apr2021(at the age of 50-year-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. On 07Apr2021, within 5 minutes of receiving the vaccine the patient experienced metallic taste in mouth and felt slight dizzy for a duration of about 5 minutes. The metallic taste feeling was similar to what was experienced before vomiting, but without nausea. The clinical outcome of the event metallic taste and dizzy was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Uterine pain
Clinical narrative: Burning uterine pain; Burning uterine pain; This is a spontaneous report from a non-contactable consumer, the patient. A 27-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 12:30 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any medication within two weeks of vaccination. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 16:45, the patient experienced burning uterine pain. 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, emergency room/department or urgent care. The clinical outcome of the event burning uterine pain was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Migraine, Pyrexia
Clinical narrative: migraine; vomiting; fever; chills; fatigue; joint pain; This is a spontaneous report from a contactable other healthcare professional, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the arm left on 30Mar2021 at 10:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any concomitant medications. 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 30Mar2021 at 15:00, the patient experienced migraine, vomiting, fever, chills, fatigue and joint pain. 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. The clinical outcome of the events migraine vomiting, fever, chills, fatigue and joint pain was recovered on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: migraine; vomiting; fever; chills; fatigue; joint pain; This is a spontaneous report from a contactable other healthcare professional, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the arm left on 30Mar2021 at 10:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any concomitant medications. 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 30Mar2021 at 15:00, the patient experienced migraine, vomiting, fever, chills, fatigue and joint pain. 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. The clinical outcome of the events migraine vomiting, fever, chills, fatigue and joint pain was recovered on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Hypoaesthesia, Nausea
Clinical narrative: Arm/shoulder pain; Arm/shoulder pain; Swelling at injection site; Numbness/tingling sensation radiating down arm; Numbness/tingling sensation radiating down arm; Mild headache; Nausea; Body aches; Chills; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 06Apr2021 at 11:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient did not receive any concomitant medications. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 16Mar2021 (at the age of 28-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 COVID vaccine. On 06Apr2021 at 20:00, the patient experienced arm/shoulder pain and swelling at injection site. Numbness/tingling sensation radiating down arm. Additionally, mild headache, nausea, body aches, chills and no fever. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the reported events. The clinical outcome of the events arm/shoulder pain and swelling at injection site, numbness/tingling sensation radiating down arm, mild headache, nausea, body aches, chills and no fever were resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Paraesthesia, Vaccination site swelling
Clinical narrative: Arm/shoulder pain; Arm/shoulder pain; Swelling at injection site; Numbness/tingling sensation radiating down arm; Numbness/tingling sensation radiating down arm; Mild headache; Nausea; Body aches; Chills; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 06Apr2021 at 11:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient did not receive any concomitant medications. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 16Mar2021 (at the age of 28-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 COVID vaccine. On 06Apr2021 at 20:00, the patient experienced arm/shoulder pain and swelling at injection site. Numbness/tingling sensation radiating down arm. Additionally, mild headache, nausea, body aches, chills and no fever. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the reported events. The clinical outcome of the events arm/shoulder pain and swelling at injection site, numbness/tingling sensation radiating down arm, mild headache, nausea, body aches, chills and no fever were resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Illness, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: No voice; Really sick; Fever; Sore throat; This is a spontaneous report from a contactable consumer (patient). A 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number was not reported) via an unspecified route of administration on 05Apr2021 at 16:00 (at the age of 41-year-old) as dose number unknown, single for COVID-19 immunization. Medical history included asthma and hypothyroidism and COVID-19 on 31Oct2020 and unknown if ongoing. Patient received unspecified medications (concomitant medications) within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 (unknow result). It was reported that after receiving the dose of vaccine she was really sick with fever and sore throat on day 1 and 2 (on 08Apr2021 at 23:00). Day 3 sore throat was worse and woke up day 4 (on 09Apr2021) and had no voice. It was unknown if the patient received any treatment. On 31Oct2020, the patient underwent lab tests and procedures which included PCR Covid test (nasal swab) which was positive on 31Oct2020. The reporter assessed the events as non-serious. The outcome of the events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Ear pain, Gingival oedema, Pain in jaw
Clinical narrative: Pain in right ear; Swollen gums in lower right quadrant of mouth; Extreme pain in jaw; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 01Apr2021 at 09:45 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not included. The patient had no allergies. 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 02Apr2021 at 08:00, the patient experienced pain in right ear, swollen gums in lower right quadrant of mouth and extreme pain in jaw (ruled out as dental issue). The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with antibiotics prophylactically. The clinical outcome of pain in right ear, swollen gums in lower right quadrant of mouth and extreme pain in jaw was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Pruritus, Rash, Swelling
Clinical narrative: she had a rash with itching; she had a rash with itching; a lump, swelling, that lasted for about 4 to 5 days; a lump, swelling, that lasted for about 4 to 5 days; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown and expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 03Mar2021 at 11:15 as DOSE 1 (age at vaccination:74 years), SINGLE for covid-19 immunisation (Reason for no lot number: of Pfizer covid vaccine: Other: Provides lot number as EN62 OC or OR for the first vaccine. She is unsure because it is handwritten). Medical history included ongoing rheumatoid arthritis (Diagnosed 10 years ago, ongoing malignant melanoma (Diagnosed about 6 years ago. It is the most serious form of skin cancer), covid-19 from Jan2021 to an unknown date First week of January. Concomitant medications included levothyroxine sodium (SYNTHROID) (She has been taking it for 30 years. Took one the morning of the vaccination) and escitalopram oxalate (LEXAPRO) (Started taking this 20 years ago). The patient experienced she had a rash with itching, a lump, swelling, that lasted for about 4 to 5 days on 04Mar2021. The day after the first vaccine she had a rash with itching and a lump, swelling, that lasted for about 4 to 5 days, she recovered completely on an unknown date in Mar2021.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Condition aggravated, Palpitations
Clinical narrative: I had heart palpitations a couple a night.; heart palpations was reported as worsened; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 37-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: ER8727, patient was 37-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Right on 20Mar2021 at 10:30 as single dose for covid-19 immunisation. There were no medical history and concomitant medications reported. It was reported that patient wants to know are there any reports about the vaccine giving people heart palpitations. she has had heart palpitations and before when she would get sick, she would have one every once in a while. Caller states she had them a couple a night for the first week. Caller states then they got worse this week after the vaccination. I went to my doctors and had a physical. All my blood work, everything is fine. My doctor didn't say anything about it and told me to get the 2nd dose. She said nothing can happen to your heart if you have a normal and healthy heart. Reported that patient got the Pfizer vaccine on 20Mar2021, no 30Mar2021, she's due for her second one on the 20Apr2021. No blood pressure issues, good cholesterol, she's healthy. Caller states the heart palpitations are every night, about two times a night, and she thought she was overlooking, and thought it was a side effect, but they are more frequent now than it was before. Stated it is like four times now or more. Caller states they are happening during the daytime too. No history of previous immunizations with the Pfizer vaccine considered as suspect. No additional Vaccines administered on same date of the Pfizer Suspect. No prior Vaccinations within 4 weeks. No AE(s) following prior vaccinations. On 21Mar2021, the patient experienced i had heart palpitations a couple a night, heart palpations was reported as worsened. It was reported that reporter seriousness for heart palpations was Unspecified. No AE(s) require a visit to emergency room and physician office. The patient underwent lab tests and procedures which included blood test resulted as normal on 12Apr2021. The outcomes of events were not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Muscle discomfort, Thyroid mass
Clinical narrative: muscular discomfort; a nodule with multiple nodules appeared in the thyroid isthmus; This is a spontaneous report from a contactable other hcp.    A female patient of an unspecified age received bnt162b2 (BNT162B2 Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose, dose 2 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation.  Medical history included covid-19 from Jul2020 lymphadenopathy, phlebitis. The patient's concomitant medications were not reported.  The patient experienced muscular discomfort, a nodule with multiple nodules appeared in the thyroid isthmus on an unspecified date with outcome of unknown.    Follow-up (19Apr2021): This follow-up report is for reporter mother. No new safety information is provided in the F/U source document.  During conversation for INT00208789 she reported that her mother had the same AE after her second dose of Pfizer-BioNTech COVID-19 Vaccine. Thyroid nodules. Her mother is 72 and had lung cancer. No more information was provided.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Proposed response:  In clinical studies, adverse reactions in participants 16 years of age and older included lymphadenopathy (0.3%). Dose 1 through 30 days after Dose 2, reports of lymphadenopathy were imbalanced with notably more cases in the Pfizer-BioNTech COVID-19 Vaccine group (64) vs. the placebo group (6), which is plausibly related to vaccination. Published safety and final efficacy results from the Phase 2/3 part of the ongoing, placebo-controlled, pivotal study reported a total of 64 vaccine recipients (0.3%) and 6 placebo recipients (<0.1%) reported an event of lymphadenopathy. This included 26 male participants (0.3%) and 38 female participants (0.4%). In cases where location was specified, AEs of lymphadenopathy occurred in the arm and neck region (in axillary, left axillary, left para clavicular, left supra clavicular, bilateral cervical, or unspecified lymph nodes). Most lymphadenopathy events were reported within 2 to 4 days after vaccination (15 events were reported =8 days after vaccination, including 1 event reported 98 days after). The average duration of these events was approximately 10 days, with 11 events ongoing at the time of the data cutoff.