chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Dry throat, Hyperhidrosis, Nodule, Pain in extremity
Clinical narrative: dry throat; my arm pits started sweating extremely; Left hand was feeling a little heaven; I started having pain in my forearm; my left thigh had  pain and another nodule; my left thigh had  pain and another nodule; This is a spontaneous report from a contactable consumer (patient herself). A 38-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 18Jun2021 01:30 (age at vaccination: 38 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included stroke, clots ,miscarriages and antiphospholipid syndrome. Concomitant medication(s) included levofloxacin (LOVENOX).The patient previously took hydromorphone hcl for hypersensitivity, macrobid [clarithromycin] for hypersensitivity, minocin akne for hypersensitivity, flagyl 250 for hypersensitivity. On 18Jun2021 13:45, the patient experienced dry throat, her arm pits started sweating extremely, left hand was feeling a little heaven, she started having pain in her forearm, her left thigh had pain and another nodule. After 2 mins of taking the first shot she had dry throat, with in 30 mins wait time she experience dry throat, her arm pits started sweating extremely. Left hand was feeling a little heaven that she started having pain in her forearm when she checked there was a dump that was hurting the nurses said it was nothing. But it was hurting she ended up in the emergency room. The doctors explained the nodules are getting inflamed in some people . By 7 pm her left thigh had pain and another nodule. She took Lovenox dose. She still have pain but the nurses and doctors are understanding the pain. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 nor was tested for covid-19 since vaccination. The outcome of all the events was not recovered. The device date was 19Jun2021.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Longer heavier menstruation; This is a spontaneous report from a contactable consumer (patient) reporting for herself. A 37-year-old non-pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), via an unspecified route of administration on 30May2021 15:00 (at the age of 37-years-old) (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. Medical history included Ivf (in vitro fertilization) failure one month prior from an unknown date and unknown if ongoing. The patient had previously known allergies: penicillin. There were no concomitant medications. The patient experienced longer heavier menstruation on 01Jun2021. Patient did not receive any treatment. Patient did not receive any other vaccines within 4 weeks prior and other medications 2 weeks prior to the COVID vaccine. The patient was not tested for covid 19 prior to vaccination and had not been tested post vaccination. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vaccination site pain
Clinical narrative: Later I became nauseous; Headache; Injection site pain; This is a spontaneous report from a contactable consumer, the patient. A 13-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 arm left on 18Jun2021 at 08:00 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported and the patient was allergic to amoxicillin (MANUFACTURER UNKNOWN) .Concomitant medication was not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Jun2021 at 08:00, right after the shot, the patient experienced injection site pain and on 18Jun2021 at 10:00, later in the day (about 3 hours later), the patient became nauseous with a headache. No therapeutic measures were taken for the reported events. The clinical outcome of the event injection site pain, nauseous and headache was not recovered at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Fatigue, Feeling abnormal, Palpitations
Clinical narrative: dizzy spell approx. 20 mins afterinjection/ general lightheaded feeling persisted.; heart palpitations; heavy anxiety culminating in a panic attack; heavy anxiety culminating in a panic attack; brain fog; fatigue; pins & needles in hands and legs; occasional tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the right arm on 24Mar2021 at 09:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included none. Patient had no known allergies. Patient did not receive other medications in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Mar2021 at 09:30 the patient experienced dizzy spell approx. 20 minutes after injection, that passed quickly but a general lightheaded feeling persisted. On an unknown date in 2021, the patient experienced (in next few days started having) heart palpitations and heavy anxiety culminating in a panic attack. palpitations worsened at night, especially when lying down. light headedness, brain fog, heart palpitations, fatigue, pins and needles in hands and legs, occasional tinnitus all persist almost 4 months later. The events resulted in emergency room/department or urgent care. The patient did not receive any treatment for the events. On 26May2021, the patient underwent COVID-19 virus test (Nasal swab) and the result was Negative. The clinical outcome of the events dizzy spell, a general lightheaded feeling, heart palpitations and heavy anxiety culminating in a panic attack, brain fog, heart palpitations, fatigue, pins and needles in hands and legs, occasional tinnitus was not recovered.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Panic attack, Paraesthesia, SARS-CoV-2 test, Tinnitus
Clinical narrative: dizzy spell approx. 20 mins afterinjection/ general lightheaded feeling persisted.; heart palpitations; heavy anxiety culminating in a panic attack; heavy anxiety culminating in a panic attack; brain fog; fatigue; pins & needles in hands and legs; occasional tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the right arm on 24Mar2021 at 09:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included none. Patient had no known allergies. Patient did not receive other medications in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Mar2021 at 09:30 the patient experienced dizzy spell approx. 20 minutes after injection, that passed quickly but a general lightheaded feeling persisted. On an unknown date in 2021, the patient experienced (in next few days started having) heart palpitations and heavy anxiety culminating in a panic attack. palpitations worsened at night, especially when lying down. light headedness, brain fog, heart palpitations, fatigue, pins and needles in hands and legs, occasional tinnitus all persist almost 4 months later. The events resulted in emergency room/department or urgent care. The patient did not receive any treatment for the events. On 26May2021, the patient underwent COVID-19 virus test (Nasal swab) and the result was Negative. The clinical outcome of the events dizzy spell, a general lightheaded feeling, heart palpitations and heavy anxiety culminating in a panic attack, brain fog, heart palpitations, fatigue, pins and needles in hands and legs, occasional tinnitus was not recovered.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis
Clinical narrative: Hearing problems in left ear; This is a spontaneous report from a contactable consumer, the patient. A 59-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 14Jun2021 at 09:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included dupuytrens disease and osteoarthritis. It was unknown if the patient had known allergies to medications, food or other products. Concomitant medications included magnesium (MANUFACTURER UNKNOWN), ubidecarenone (COQ10), boron (MANUFACTURER UNKNOWN), vitamin d (MANUFACTURER UNKNOWN), vitamin e (MANUFACTURER UNKNOWN) and vitamin b (MANUFACTURER UNKNOWN), all were taken for unknown indication, on an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Jun2021 at 19:00, the patient experienced hearing problems in left ear. The event 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 reported event. The clinical outcome of the event hearing problems in left ear was not resolved at the time of report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Heart rate irregular
Clinical narrative: Rapid heart rate day 2 ,3, and 4 of 90 beats per minute; Heart felt like it was beating very heavy; This is a spontaneous report from a non-contactable consumer, the patient. A 55-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 06May2021 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not receive any medication within 2 weeks of 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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17May2021, the patient experienced rapid heart rate on the days 2 ,3, and 4 which was 90 beats per minute and heart felt like it was beating very heavy. The patient reported that she will not be getting her second dose, she was a perfectly healthy 125 pounds gal and the second dose scared her. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event rapid heart rate and heart felt like it was beating very heavy were resolved on an unknown date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: Tongue swelling about an hour after. Lasted a few hours; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 18May2021 at 12:30 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included essential oils allergy except lavender and penicillin allergy. The patient did not receive any concomitant medications. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) and experienced drug allergy. 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 18May2021 at 13:30, the patient experienced tongue swelling about an hour after. Lasted a few hours. Therapeutic measures were not taken as a result of this event. The adverse event 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 tongue swelling about an hour after. Lasted a few hours was recovered on 18May2021.   The batch/lot numbers for BNT162b2 were not provided and will be requested during follow up.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Slight soreness after vaccination then injection site was normal; Injection site was normal till yesterday when it became very itchy; A hard knot the size of half dollar has developed and site slightly swollen.; This is a spontaneous report from a non-contactable consumer, the patient. A 57-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 09Jun2021 at 15:45 (at the age of 57-years-old), as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy. Concomitant medications were not reported. The patient previously took propylthiouracil (MANUFACTURER UNKNOWN) on unknown date for unspecified indication and experienced drug allergy. 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 17Jun2021, the patient experienced slight soreness after vaccination then injection site was normal till yesterday when it became very itchy and a hard knot the size of half dollar has developed, site is slightly swollen. 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 slight soreness after vaccination then injection site was normal till yesterday when it became very itchy and a hard knot the size of half dollar has developed, site is slightly swollen were unknown at the time of this report.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Insomnia, Pain, Wheezing
Clinical narrative: Aching pain; Coughing/Very hard to cough; Wheezing; It is like very bothering that I cannot sleep; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient took the vaccine on Wednesday. The patient experienced aching pain, coughing/very hard to cough, wheezing, it is like very bothering that i cannot sleep (non-serious) on an unspecified date. The outcome of events was unknown. It was reported that consumer hung up phone abruptly.  Information on lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash. Looks like bug bites, had lasted over a week and spreading, started on arms and now all over; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old, female patient received the 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 39-year-old) as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on left arm an unknown date (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications include unspecified birth control medications from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date, the patient experienced rash which looked like bug bites, had lasted over a week and spreading, started on arms and now all over. The doctor said it was a reaction to the shots. The event resulted in in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the event rash looked like bug bites, had lasted over a week and spreading, started on arms and now all over was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Continual headache; Fatigue; 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 in the left arm on 16Jun2021 at 14:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included pneumonia, hypothyroidism, polycystic ovaries, pseudotumor cerebri and COVID-19. The patient had unspecified allergies. The patient received unspecified concomitant medications within two weeks of the COVID vaccine. 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 COVID vaccine. On 16Jun2021, at 15:00, the patient experienced continual headache and fatigue. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with unspecified pain medication and rest. The clinical outcome of the events continual headache and fatigue was not recovered at the time of this report.      The batch number for BNT162b2 was not provided and will be requested during follow up.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: after the first dose I just have like slight nausea sort of that for couple of hours; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was unknown, Expiration date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date (at the age of 39-year-old) as dose 1, single for COVID-19 immunization. Medical history was none provided. Concomitant medication(s) included omeprazole (PROTONIX [OMEPRAZOLE]); quetiapine fumarate (SEROQUEL); bupropion hydrochloride (WELLBUTRIN); meloxicam; budesonide (NASOCORT); diphenhydramine hydrochloride (BENADRYL); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and propranolol taken for an unspecified indication, start and stop date were not reported; metoprolol taken for heart medication, start and stop date were not reported and that's like a longer acting one so she only take either one or the other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Reported that family medical history related to adverse event was no reported. Patient reported that she did not remember when she received the first one but the second dose, she received on 09Apr and we have received that one at work. Reported that date of first shot she was trying to find. On an unspecified date, patient experienced after the first dose I just have like slight nausea sort of that for couple of hours. Therapeutic measures (antibiotic) were taken as a result of after the first dose I just have like slight nausea sort of that for couple of hours. The clinical outcome of event was unknown.  Information about lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Hyperhidrosis, Nausea, Vertigo
Clinical narrative: Chills, Sweats, Dizziness, Nausea and Vertigo lasted for 3 Days. Dizziness still occurring currently after a week of vaccine; Chills, Sweats, Dizziness, Nausea and Vertigo lasted for 3 Days. Dizziness still occurring currently after a week of vaccine; Chills, Sweats, Dizziness, Nausea and Vertigo lasted for 3 Days. Dizziness still occurring currently after a week of vaccine; Chills, Sweats, Dizziness, Nausea and Vertigo lasted for 3 Days. Dizziness still occurring currently after a week of vaccine; Chills, Sweats, Dizziness, Nausea and Vertigo lasted for 3 Days. Dizziness still occurring currently after a week of vaccine; This is a spontaneous report from a non-contactable healthcare professional. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 14Jun2021 at 10:00 (at the age of 40-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 24May2021 at 14:45 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included multivitamins, lysine (MANUFACTURER UNKNOWN), biotin (MANUFACTURER UNKNOWN), glutathione (MANUFACTURER UNKNOWN) and vitamin d nos (VITAMIN D) all for an unknown indication on an unknown date. The patient previously received fexofenadine HCL (MANUFACTURER UNKNOWN) on an unspecified date for an unknown indication and experienced drug allergy. On an unknown date in 2021, the patient experienced Chills, Sweats, Dizziness, Nausea and Vertigo lasted for 3 Days. Dizziness still occurring currently after a week of vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of all the events except dizziness was recovered on an unknown date in 2021, after the duration of 3 days; dizziness was recovering at the time of reporting.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Limb discomfort, Musculoskeletal chest pain, Neck pain, Shoulder injury related to vaccine administration
Clinical narrative: shoulder injury related to vaccine administration; experiencing is shoulder pain it goes down in to my arm some goes down in to my back and lower part of my ribs and some going to my neck; experiencing is shoulder pain it goes down in to my arm some goes down in to my back and lower part of my ribs and some going to my neck; experiencing is shoulder pain it goes down in to my arm some goes down in to my back and lower part of my ribs and some going to my neck; experiencing is shoulder pain it goes down in to my arm some goes down in to my back and lower part of my ribs and some going to my neck; This is a spontaneous report from a contactable consumer via Team. This consumer reported for a patient (reporter's friend) that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated that his friend and he has been experiencing the same symptoms and they have been going on long term after having the vaccine. The reporter and his friend experiencing shoulder pain it goes down in to arm some goes down in to back and lower part of ribs and some going to neck. Reporter been trying physical therapies. Reporter have been trying Chiropractic to help with it. Reporter have been trying Tylenol and Ibuprofen and it gives very mild relief. The patient was referring SIRVA meaning to shoulder injury related to vaccine administration. He stated that he was really hoping that it was not SIRVA. Therapeutic measures were taken as a result of experiencing was shoulder pain it goes down in to my arm some goes down in to my back and lower part of my ribs and some going to my neck. The outcome of the events was unknown.  Follow-up attempts are completed. Batch/lot number not available.
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Pain
Clinical narrative: feel like little thing is swollen in armpit goes to neck/ I can feel that, like a little swelling and pain in arm pit, under armpit, close to neck; I am already hurting; feel like little thing is swollen in armpit goes to neck/ I can feel that, like a little swelling and pain in arm pit, under armpit, close to neck; This is a spontaneous report from a contactable consumer. This consumer reported that: An unspecified age and gender patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported, Solution for injection), dose 1 via an unspecified route of administration, on 16-JUN-2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced a feel like little thing is swollen in armpit goes to neck/ I can feel that, like a little swelling and pain in arm pit, under armpit, close to neck and I am already hurting in Jun2021. The patient further stated that there is a thing, site, where I took the vaccine, I can feel that, like a little swelling and pain in my arm pit, under my armpit and close to my neck. I think it is a swollen node. The outcome of events is unknown.  Information on the lot/batch number has been requested.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Insomnia, Pain of skin, Rash
Clinical narrative: got like Brutal pain in the areas; hard to sleeping; got a like a rash, close to my under arm and on my lower back on the right side and it is lot of red/not directly on the arm pit, the rash close to it; getting lot of pain around the rash; Red dots, dark red and then the area around it turn orange or light red; painful like a burn on both of my arm pits more toward the back with 2 of those dots almost in the back going toward my back bone kind of in the middle; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A 76-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EC8302), dose 2 via an unspecified route of administration on 17Feb2021 (at the age of 76years old) as dose 2, single for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine patient received BNT162B2 (Batch/Lot Number: EK4176), dose 1 via an unspecified route of administration on 27Jan2021 (at the age of 76years old) as dose 1, single for Covid-19 immunisation and had no side effects after the first dose of the vaccine. After 2nd dose, the patient reported no other side effects at this time other than red dots, dark red and then the area around it turned orange or light red and its painful like a burn on both of my arm pits more toward the back with 2 of those dots almost in the back going toward his backbone kind of in the middle in Jun2021. When he tried to sleep, he lay on it and wait an hour before the pain goes away. On 14Jun2021, the patient got a like a rash, close to his under arm and on my lower back on the right side and it was lot of red, it was not directly on the arm pit, the rash close to it. On 14Jun2021, the patient got the brutal pain in the areas and had hard to sleeping, and that was why he used this medication cream NEOSPORIN (start date: 17Jun2021), and it didn't do the great result. He was getting lot of pain around the rash and it was turning red, and it had red dot, he thought it will help but it didn't help. The patient didn't think it was serious, but it was getting painful. The patient also took ASPIRIN, it was a very low dose, he told to reduce with the pain, its 81 mg and confirmed it as treatment to treat the adverse effect. Therapeutic measures (NEOSPORIN and ASPIRIN) for all the events except hard to sleeping. The outcome for got a like a rash, close to my under arm and on my lower back on the right side and it is lot of red/not directly on the arm pit, the rash close to it; red dots, dark red and then the area around it turn orange or light red; and getting lot of pain around the rash was not recovered; and for rest all was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: got like Brutal pain in the areas; hard to sleeping; got a like a rash, close to my under arm and on my lower back on the right side and it is lot of red/not directly on the arm pit, the rash close to it; getting lot of pain around the rash; Red dots, dark red and then the area around it turn orange or light red; painful like a burn on both of my arm pits more toward the back with 2 of those dots almost in the back going toward my back bone kind of in the middle; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A 76-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EC8302), dose 2 via an unspecified route of administration on 17Feb2021 (at the age of 76years old) as dose 2, single for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine patient received BNT162B2 (Batch/Lot Number: EK4176), dose 1 via an unspecified route of administration on 27Jan2021 (at the age of 76years old) as dose 1, single for Covid-19 immunisation and had no side effects after the first dose of the vaccine. After 2nd dose, the patient reported no other side effects at this time other than red dots, dark red and then the area around it turned orange or light red and its painful like a burn on both of my arm pits more toward the back with 2 of those dots almost in the back going toward his backbone kind of in the middle in Jun2021. When he tried to sleep, he lay on it and wait an hour before the pain goes away. On 14Jun2021, the patient got a like a rash, close to his under arm and on my lower back on the right side and it was lot of red, it was not directly on the arm pit, the rash close to it. On 14Jun2021, the patient got the brutal pain in the areas and had hard to sleeping, and that was why he used this medication cream NEOSPORIN (start date: 17Jun2021), and it didn't do the great result. He was getting lot of pain around the rash and it was turning red, and it had red dot, he thought it will help but it didn't help. The patient didn't think it was serious, but it was getting painful. The patient also took ASPIRIN, it was a very low dose, he told to reduce with the pain, its 81 mg and confirmed it as treatment to treat the adverse effect. Therapeutic measures (NEOSPORIN and ASPIRIN) for all the events except hard to sleeping. The outcome for got a like a rash, close to my under arm and on my lower back on the right side and it is lot of red/not directly on the arm pit, the rash close to it; red dots, dark red and then the area around it turn orange or light red; and getting lot of pain around the rash was not recovered; and for rest all was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Breast mass, Breast pain
Clinical narrative: She thought it may be mass on her breast because  there is pain right under her breast; there's nothing wrong with her; She thought it may be mass on her breast because  there is pain right under her breast; there's nothing wrong with her; This is a spontaneous report received from a contactable consumer (Patient's friend). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTEHC COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration, administered in Arm Left on an unspecified date as unknown single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient thought it may be mass on her breast because there is pain right under her breast; there's nothing wrong with her. It was reported that, patient got her mammogram because she thought it may be mass on her breast because there was pain right under her breast and there was nothing wrong with her but she was having these symptoms on left side where she got the shot. The outcome of events was unknown.   The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021442419 same reporter/ product, different patient
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tiredness; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date (reported last Thursday), the patient experienced tiredness. The outcome of the event was not recovered/not resolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Swelling face, Swelling of eyelid
Clinical narrative: eye had swelled up; eyelid had swollen and underneath her eyelid, her face was swollen; eyelid had swollen and underneath her eyelid, her face was swollen; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date, NDC and UPC number was unknown), via an unspecified route of administration on 13Jun2021 (Sunday) as dose number unknown, single (at the age of 60-years-old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 15Jun2021, probably about Tuesday, patient eye swelled up, eyelid had swollen and underneath her eyelid, her face was swollen. Patient talked with her doctor and she just want to see what she needs to do. The outcome of all the events was unknown.  Information on the lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Induration, Vaccination site pain
Clinical narrative: Induration; Redness; Injection site pain; warmth; This is a spontaneous report from a contactable other hcp (patient). A 42-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration in arm left on 18Jun2021 at 19:00 (at the age of 42-years-old) as dose 2, single for COVID-19 immunisation. The medical history of the patient included osteoarthritis. The concomitant medications of the patient included ascorbic acid (VIT C). The relevant past drug history was reported as no. The patient was not pregnant at the time of vaccination. The patient previously received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration in arm left on 28May2021 at 19:00 (at the age of 42-years-old) as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient not been tested with covid-19. On 19Jun2021 at 07:45, the patient experienced induration, redness, injection site pain and warmth. Therapeutic measures were taken as a result of events that included patient took Motrin 200mg, Tylenol. The outcome of the events was reported as not resolved.  Information on the lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint range of motion decreased, Mobility decreased, Pain in extremity
Clinical narrative: Shoulder pain; Arm still hurts; Can't throw a ball or move my arm quickly; with limited range of motion at times; This is a spontaneous report from a contactable consumer (patient). A 53-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via intramuscular route of administration in the right arm/shoulder on 25Feb2021 at 15:00 (Batch/Lot Number: EN6202, at age 53-years-old at vaccination) as a single dose for COVID-19 immunisation at a civic center (non-military facility). Medical history included diabetes mellitus from 2017 and ongoing, hypertension from 2017 and ongoing. There was no known allergies. The patient did not have COVID-19 prior to vaccination. The concomitant medication taken within two weeks of the BNT162B2 vaccine were unspecified. There was no other vaccine taken within four weeks of vaccination. On 25Feb2021 at 15:00, the patient received the first dose of the BNT162B2 vaccine. On 26Feb2021 at 07:00, the patient experienced shoulder pain, arm hurting and cant throw a ball or move my arm quickly. Clinical course: The first vaccine shot was given high up on the right shoulder. The pain started within 24hrs and never went away. It hurts off and on with limited range of motion at times. The pain stops her from doing normal things. She can't throw a ball or move her arm quickly. On 18Mar2021 at 15:00, she received the second shot in the left arm, which was sore the next few days and then went back to normal, but the right arm where she received the first shot still aches. The right arm still aches like this for about 5 months. It was hurting less now but still certain movements cause pain and she still cannot move her arm to throw anything. It does however feel better than a month ago (4 months after the first shot). The patient didn't seek medical attention because of the cost and was just hoping it would heal. The arm still hurts. She cannot throw without a popping sound inside the muscle. Certain movements are very painful and she has to be careful how she moves it. Seriousness criteria was reported as persistent, significant disability and incapacity. No treatment was received. The patient did not test for COVID-19 post vaccination. The outcome of events shoulder pain, arm hurting and can't throw a ball or move arm quickly, limited range of motion at times  was not recovered.   Follow-up attempts are completed: no further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Pityriasis rosea
Clinical narrative: developed pityriasis rosea patch a couple of week after getting the vaccine.; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0182) via an unspecified route of administration in the left arm on 08May2021 at 14:00(at the age of 19-years-old) as a single dose for COVID-19 immunisation. The patient medical history was reported as none. Patient had no known allergies to food, medications or other products. Concomitant medication was not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8735) via an unspecified route of administration in the left arm on 17Apr2021 at 14:00(at the age of 19-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 24May2021, the patient experienced a pityriasis rosea patch a couple of weeks after getting the vaccine. There was no other changed in lifestyle nor any new medication. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event developed pityriasis rosea patch was recovering, at the time of this report.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling in the arm that received the dose; Numbness and tingling in the arm that received the dose; This is a spontaneous report from a contactable consumer (patient's wife) reported for a male patient (husband) that a 41-year-old male patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: EW0187, Expiration date: not reported), via an unspecified route of administration in upper left arm on 29May2021 as single dose for COVID-19 immunisation at pharmacy and received second dose of BNT162B2 on 19Jun2021. The patient's medical history was reported as none. Concomitant medications were not reported. On an Unspecified date in 2021, after the first dose, the patient experienced numbness and tingling in the arm that received the dose which has not gone away. The reporter report a side effect that 'after' her husband (patient) receiving the second dose of the Pfizer vaccine (COVID 19 Vaccine) yesterday, she have the card in front of her so she have the number of the LOT that was administered both the first time and the second time. He actually had the side effect from the first dose as well so, she wanted to report for both the shots." The outcome of the events was not recovered.  Follow-up attempts are needed. Information on Lot/Batch number was available, additional information has been requested.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: Running a 101+ Fever; Running a 101 and half fever; Arm hurts, site of the injection hurts; Severe headache at the base of his skull; Arm hurts, site of the injection hurts; This is a spontaneous report form a contactable consumer. This consumer (patient wife) reported for a 41-year-old male patient that.  A 41-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VAC-CINE, solution for injection, Batch/Lot Number: EW0196), via an unspecified route of administration, administered in Arm Left on 19Jun2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (solution for injection, Batch/Lot Number: EW0187), via an unspecified route of administration, administered in Arm Left on an 29May2021, as DOSE 1, SINGLE for covid-19 immunization and experienced Numbness and tingling in the arm. The patient experienced running a 101 plus fever, running a 101 and half fever, arm hurts, site of the injection hurts, severe headache at the base of his skull, and arm hurts, site of the injection hurts on Jun2021. Reporter stated He was running a 101 plus Fever at this time and he got it yesterday and his arm hurts but that was obviously normal, the site of the injection hurts but that was normal for any vaccine. But he was running a 101 and half fever and a severe headache at the base of his skull." For the side effects he took Excedrin Migraine on the day of this report in morning (stated as this morning). That Excedrin was a brand over the counter medication, which specialize in Migraine headache." Dosage: Reporter stated, "she thinks it is 500 mg but I am sure, it is an recommended dose for adults." Frequency was stated as "2, that is the recommended dose. Reporter wanted to know does Pfizer recommend any further action if the symptoms do not abate. The patient underwent lab tests and procedures which included body temperature: 101 and half on Jun2021. The outcome of events was unknown.  Follow-up attempts were completed. No further information was expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chromaturia
Clinical narrative: Dose 2: pale red urine color; This is a spontaneous report from a contactable consumer. A 35-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 18Jun2021 (age at vaccination 35 years) as dose 2, single for covid-19 immunisation. Medical history included headache from an unknown date and unknown if ongoing (Occurred in the evening on Monday or Tuesday before the vaccine, he was not really sure. He states maybe 6:14-6:15pm for onset. Complete recovery the same day). Concomitant medication included paracetamol (TYLENOL) taken for headache, start and stop date were not reported. The patient previously took dose 1 bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0186) on 28May2021 (age at vaccination 35 years) left arm dose 1 single for covid-19 immunization. The patient experienced dose 2: pale red urine colour on 18Jun2021. Reporter stated, He was seeing his urine colour as red after the vaccine. He was having the problem still today. Every time when he passes urine, he sees the colour red. Red colour urine has been ongoing since Friday night. He was not sure if what he was experiencing is a normal side effect of the vaccine. he has seen this before when he has had a beet root, but for the past two days he has never had a beet root. The outcome of event was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.