chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood thyroid stimulating hormone, Body height, Chest pain, Disturbance in attention
Clinical narrative: was laying down because was not feeling well/ felt sick; all of a sudden got dizzy/felt like fainting; heart started racing; anxious; could not concentrate; felt like chest hurts; head feels funny; difficult sleeping; felt a lot of fear that something was wrong; This is a spontaneous report from a contactable consumer (patient). A 27-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EW0175) dose 1 via an unspecified route of administration, administered in left arm on 23Apr2021 as FIRST DOSE, SINGLE for COVID-19 immunisation. Medical history included diagnosed with COVID-19 and allergies was none. The patient's concomitant medications were not reported. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On Saturday 01May2021, the patient was laying down because she was not feeling well, all of a sudden she got dizzy and her heart started racing and she felt like fainting. Since then every day had been horrible she felt dizzy, she felt very anxious, she could not concentrate, she felt like her chest hurts and her head feels funny. She had difficult sleeping and she felt a lot of fear that something was wrong with her. She did not feel like herself anymore. The adverse events result in doctor or other healthcare professional office/clinic visit and visit emergency room/department or urgent care. The patient underwent lab tests and procedures which included TSH, CBC, CMP, Thyroid and Vitamin D: unknown in 2021, body height: 5'5 in 2021 not clarified appropriately. Therapeutic measures were taken as a result of events and treatment with Sertraline 50 mg. Outcome of the events was not resolved.  No follow-up attempts are needed. No further information was expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fear, Feeling abnormal, Full blood count, Insomnia
Clinical narrative: was laying down because was not feeling well/ felt sick; all of a sudden got dizzy/felt like fainting; heart started racing; anxious; could not concentrate; felt like chest hurts; head feels funny; difficult sleeping; felt a lot of fear that something was wrong; This is a spontaneous report from a contactable consumer (patient). A 27-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EW0175) dose 1 via an unspecified route of administration, administered in left arm on 23Apr2021 as FIRST DOSE, SINGLE for COVID-19 immunisation. Medical history included diagnosed with COVID-19 and allergies was none. The patient's concomitant medications were not reported. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On Saturday 01May2021, the patient was laying down because she was not feeling well, all of a sudden she got dizzy and her heart started racing and she felt like fainting. Since then every day had been horrible she felt dizzy, she felt very anxious, she could not concentrate, she felt like her chest hurts and her head feels funny. She had difficult sleeping and she felt a lot of fear that something was wrong with her. She did not feel like herself anymore. The adverse events result in doctor or other healthcare professional office/clinic visit and visit emergency room/department or urgent care. The patient underwent lab tests and procedures which included TSH, CBC, CMP, Thyroid and Vitamin D: unknown in 2021, body height: 5'5 in 2021 not clarified appropriately. Therapeutic measures were taken as a result of events and treatment with Sertraline 50 mg. Outcome of the events was not resolved.  No follow-up attempts are needed. No further information was expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Metabolic function test, Palpitations, Thyroid function test, Vitamin D
Clinical narrative: was laying down because was not feeling well/ felt sick; all of a sudden got dizzy/felt like fainting; heart started racing; anxious; could not concentrate; felt like chest hurts; head feels funny; difficult sleeping; felt a lot of fear that something was wrong; This is a spontaneous report from a contactable consumer (patient). A 27-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EW0175) dose 1 via an unspecified route of administration, administered in left arm on 23Apr2021 as FIRST DOSE, SINGLE for COVID-19 immunisation. Medical history included diagnosed with COVID-19 and allergies was none. The patient's concomitant medications were not reported. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On Saturday 01May2021, the patient was laying down because she was not feeling well, all of a sudden she got dizzy and her heart started racing and she felt like fainting. Since then every day had been horrible she felt dizzy, she felt very anxious, she could not concentrate, she felt like her chest hurts and her head feels funny. She had difficult sleeping and she felt a lot of fear that something was wrong with her. She did not feel like herself anymore. The adverse events result in doctor or other healthcare professional office/clinic visit and visit emergency room/department or urgent care. The patient underwent lab tests and procedures which included TSH, CBC, CMP, Thyroid and Vitamin D: unknown in 2021, body height: 5'5 in 2021 not clarified appropriately. Therapeutic measures were taken as a result of events and treatment with Sertraline 50 mg. Outcome of the events was not resolved.  No follow-up attempts are needed. No further information was expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Gush of blood after period ended/it was fresh red blood with some small clots; This is a spontaneous report from a contactable consumer (patient). A 54-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0176; Expiration Date: Aug2021), dose 2 via an unspecified route of administration, administered in Arm Left on 28Apr2021 08:45 as DOSE 2, SINGLE for covid-19 immunisation (at the age of 54-years). Medical history included asthma (caller has had since she was three years old), crohn's disease (diagnosed in '89, caller states so about 23) and blood pressure measurement. Concomitant medication included losartan (LOSARTAN) (caller has been on for about probably 14-15 years). The patient previously took first dose at the same place, at 8:45 am in her upper left shoulder (LOT number: ER8734, expiration date: Jul2021). Adverse events following prior vaccinations: none that she knows of, she has not had vaccines at all, and has not had a flu shot. To her knowledge, she has never had a pneumonia shot. Other than that, her only vaccines were when she was a kid. The patient experienced gush of blood after period ended/it was fresh red blood with some small clots (she thinks she is perimenopausal where her period is every 6 months or so. Her period started last Tuesday and was normal. She normally does not have any troubles. Yesterday, caller states she had no flow. Today, this morning, none. She did not have a pad. She felt fine and felt good. Around 12 o'clock, she was standing up doing work for her job. She had a gush of blood. She had to sit on the toilet until her husband came home. It just gushed. Caller added it was fresh red blood with some small clots and that it is still pouring. She has a pad on now, but it is still pouring as she speaks.) on 06May2021. The patient did not visited physician office and emergency room. The outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Pain
Clinical narrative: Headache; Foggy brain; Body aches; This is a spontaneous report from a contactable consumer. A 4-decade-old (early 40s) healthy male patient received unknown dose of BNT162B2 (BNT162B2, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced headache, foggy brain and body aches. The outcome of the all the events was reported as unknown.   Reporter does not wish to be contacted for follow-up. No follow-up attempts are possible; information about lot/batch number could not be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: my menstrual cycle on day 8 and ordinarily my mensural cycle is no more than 4 days; This is a spontaneous report from a contactable consumer (Patient). A 53-years old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection Batch/Lot Number: EW0158; Expiration Date: 31Jul2021), dose 2 via an unspecified route of administration on 30Apr2021 as 2nd dose, single, dose 1 via an unspecified route of administration on 08Apr2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, Consumer stated, that am 53 years old, obviously my cycle ordinarily went for about 3-4 days menstrual cycle and it's been onto well over 7 days. The first time this is happened, menstrual cycle on day 8 and ordinarily my mensural cycle is no more than 4 days. I got my second dose, Pfizer shot or vaccine 30Apr2021 and my cycle as the month of May and So this started after my second round of the Pfizer Vaccine, never had it that extended beyond 4 days so this out of the ordinary, little heavier than normal as well. No, none. I don't have any history. Consumer stated, within the past year (as the Lab test was done previous year hence not captured in tab) it have my lab data normally run during the physical. Everything was normal. CBC, my lipids, everything was normal nothing abnormal. The patient experienced my menstrual cycle on day 8 and ordinarily my mensural cycle is no more than 4 days on an unspecified date with outcome of unknown. No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular, Oligomenorrhoea
Clinical narrative: Menstrual Irregularities; Heavy irregular bleeding/Clotting; Period lasting longer then usual with heavy bleeding; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6204, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 13Mar2021 11:45 (at the age of 49-year-old) as dose 1, single for COVID-19 immunization, at pharmacy or drug store. The patient medical history included chronic obstructive pulmonary disease (COPD). Concomitant medications included fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY); fluticasone propionate, salmeterol xinafoate (PROAIR BRONQUIAL); alprazolam (ALPRAZOLAM), Advil, and Multi Vitamins (unspecified). The patient was not pregnant at the time of vaccination. 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 had not been tested for COVID-19. On 23Apr2021, the patient experienced menstrual irregularities, heavy irregular bleeding/clotting, and "period lasting longer then usual with heavy bleeding". No treatment was given for the events. The patient was not hospitalized, or hospitalization was not prolonged due to events. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Pharyngeal swelling
Clinical narrative: throat was swollen; allergy; he could not breathe; This is a spontaneous report from a contactable consumer. This consumer reported events for 2 patients. This is the first of 2 reports. A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that his friend (patient) after second dose and 9 days later, his throat was swollen and he ended up in the hospital 3 times because he could not almost breathe. He went to the ER and he put some injection for allergy and he was getting better but now in the process to figure out why he had that reaction. He was in the middle with the doctor with the allergist trying to find out what caused him that reaction they still have not given the answer about what caused the reaction in him. The events was considered serious medically significant. Outcome of the events was recovering.  No follow-up attempts are needed. Information on lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021534586 same reporter/drug, different patients/events
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Dizziness postural, Fatigue, Gait disturbance
Clinical narrative: intermittent dizziness which led to temporary instability in standing; intermittent dizziness which led to temporary instability in standing; instability in standing; generalized muscle stiffness around the neck/shoulder/upper back area; low grade fever; develop low grade fever, fatigue and generalized muscle and joint aches; develop low grade fever, fatigue and generalized muscle and joint aches; generalized muscle and joint aches; patient developed palpitation and nervousness; patient developed palpitation and nervousness; difficulty falling asleep; mild arm pain; This is a spontaneous report from a contactable Pharmacist. A 36-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an intramuscular route of administration in left arm on 11May2021 at 16:30 (age at vaccination 36-year-old) as single dose for COVID-19 immunization. The patient's medical history was not reported. List of any other medications the patient was not received within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to 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. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an intramuscular route of administration in left arm on 20Apr2021 (age at vaccination 36-year-old) at single dose for COVID-19 immunization. On 11May2021 after the injection, patient developed mild arm pain around 21:00, after the injection. On 11May2021 around 23:00, patient developed palpitation and nervousness, which led to difficulty falling asleep for that night. The next day on 12May2021 morning patient experienced generalized muscle stiffness around the neck/shoulder/upper back area. On 12May2021 patient started to develop low grade fever, fatigue and generalized muscle and joint aches. These symptoms are ongoing. On 13May2021 patient additionally developed intermittent dizziness which led to temporary instability in standing. The instability in standing recovered. The dizziness still ongoing. The patient did not receive any treatment for adverse event. The outcome of event intermittent dizziness which led to temporary instability in standing was recovered on 13May2021 and the outcome of all other event was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Musculoskeletal stiffness, Myalgia, Nervousness, Pain in extremity
Clinical narrative: intermittent dizziness which led to temporary instability in standing; intermittent dizziness which led to temporary instability in standing; instability in standing; generalized muscle stiffness around the neck/shoulder/upper back area; low grade fever; develop low grade fever, fatigue and generalized muscle and joint aches; develop low grade fever, fatigue and generalized muscle and joint aches; generalized muscle and joint aches; patient developed palpitation and nervousness; patient developed palpitation and nervousness; difficulty falling asleep; mild arm pain; This is a spontaneous report from a contactable Pharmacist. A 36-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an intramuscular route of administration in left arm on 11May2021 at 16:30 (age at vaccination 36-year-old) as single dose for COVID-19 immunization. The patient's medical history was not reported. List of any other medications the patient was not received within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to 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. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an intramuscular route of administration in left arm on 20Apr2021 (age at vaccination 36-year-old) at single dose for COVID-19 immunization. On 11May2021 after the injection, patient developed mild arm pain around 21:00, after the injection. On 11May2021 around 23:00, patient developed palpitation and nervousness, which led to difficulty falling asleep for that night. The next day on 12May2021 morning patient experienced generalized muscle stiffness around the neck/shoulder/upper back area. On 12May2021 patient started to develop low grade fever, fatigue and generalized muscle and joint aches. These symptoms are ongoing. On 13May2021 patient additionally developed intermittent dizziness which led to temporary instability in standing. The instability in standing recovered. The dizziness still ongoing. The patient did not receive any treatment for adverse event. The outcome of event intermittent dizziness which led to temporary instability in standing was recovered on 13May2021 and the outcome of all other event was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia
Clinical narrative: intermittent dizziness which led to temporary instability in standing; intermittent dizziness which led to temporary instability in standing; instability in standing; generalized muscle stiffness around the neck/shoulder/upper back area; low grade fever; develop low grade fever, fatigue and generalized muscle and joint aches; develop low grade fever, fatigue and generalized muscle and joint aches; generalized muscle and joint aches; patient developed palpitation and nervousness; patient developed palpitation and nervousness; difficulty falling asleep; mild arm pain; This is a spontaneous report from a contactable Pharmacist. A 36-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an intramuscular route of administration in left arm on 11May2021 at 16:30 (age at vaccination 36-year-old) as single dose for COVID-19 immunization. The patient's medical history was not reported. List of any other medications the patient was not received within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to 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. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an intramuscular route of administration in left arm on 20Apr2021 (age at vaccination 36-year-old) at single dose for COVID-19 immunization. On 11May2021 after the injection, patient developed mild arm pain around 21:00, after the injection. On 11May2021 around 23:00, patient developed palpitation and nervousness, which led to difficulty falling asleep for that night. The next day on 12May2021 morning patient experienced generalized muscle stiffness around the neck/shoulder/upper back area. On 12May2021 patient started to develop low grade fever, fatigue and generalized muscle and joint aches. These symptoms are ongoing. On 13May2021 patient additionally developed intermittent dizziness which led to temporary instability in standing. The instability in standing recovered. The dizziness still ongoing. The patient did not receive any treatment for adverse event. The outcome of event intermittent dizziness which led to temporary instability in standing was recovered on 13May2021 and the outcome of all other event was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Vaginal haemorrhage
Clinical narrative: menstrual cycle came which lasted 8-10 days of heavy bleeding; experianced spotting; This is a spontaneous report from a contactable consumer (mother). A 17-years-old female patient received BNT162B2 (BNT162B2, solution for injection, batch/lot number: EW0164, expiration date: Aug2021) dose 1 via an unspecified route of administration, administered in Deltoid Left on 24Apr2021 as DOSE 1, SINGLE for COVID-19 immunisation (at the age of 17-years-old). The patient's medical history included nuts allergy and muscle spasms from an unknown date and unknown if ongoing Concomitant medication included ascorbic acid (C-VITAMIN) taken for an unspecified indication, start and stop date were not reported, chlorophyll (CHLOROPHYLL) taken for an unspecified indication, start and stop date were not reported. after the first dose her daughter experienced spotting (on 25Apr2021) for 4 days and then her menstrual cycle came which lasted 8-10 days of heavy bleeding (30Apr2021). it was so excessive bleeding that patient had to change pads a lot. Caller stated it has slowed down since yesterday. The patient usually only spots the day before she gets her period. When the patient came on her cycle, she bled heavy and could not go to work and was changing her pad every 1-2 hours. The caller had the patient take an iron pill. The patient's period finally eased up on day 10 and started slowing down. Today, 13May2021 the patient only had to change her pad once. The patient's second dose is due the 20May2021.  The outcome of event spotting was unknown, whereas the event heavy bleeding was recovering.  No follow-up attempts are possible. No further information was expected.
Age: 1.25
Sex: M
Vaccine: COVID19
Symptoms: Exposure via breast milk, Rash
Clinical narrative: vaccine exposure via breast milk; Rashes on the face; This is a spontaneous report from a contactable consumer (mother). This consumer reported information for both mother (herself) and infant. This is the infant case.  A 15-month-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EW0169), via transmammary route, on 07May2021 (at the age of 15-months-old) as a single dose for COVID-19 immunisation. The patient had no medical history or concomitant medications. The patient experienced vaccine exposure via breast milk on 07May2021 and rashes on the face in May2021. It was reported that the rashes on the face started one to two days after the vaccine dose. The clinical course was reported as follows: The mother stated she only breastfed at night and her son had woken up three times with rashes on his face in the morning. She stated that there have had no changes to the infant or the mother's diets or anything else, except the vaccine. The rash was still going on at the time of reporting on 13May2021 and the patient woke up on 13May2021 with rashes as well. The patient experienced rashes three times so far. It was reported that after a few hours, the rash goes away, gets better throughout the day, and is worse when waking up but, by evening time, it is gone. The mother stated that no treatment was sought for the patient because the rash does end up going away. On 13May2021, was the third time the rash had occurred, so the mother was going to observe how the day went and call the pediatrician if see needs to. Other than the rashes, the patient acts fine. The clinical outcome of vaccine exposure via breast milk and rashes on the face was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021542489 same reporter/drug, different patient/event
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Gastrointestinal pain, Headache, Investigation, Vertigo
Clinical narrative: severe burning in my chest and my intestine; severe burning in my chest and my intestine; Vertigo; Headache; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 71-years-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number EW0176, expiration date unspecified), via an unspecified route of administration, administered in arm right on 07May2021 as single dose for covid-19 immunization (71 year when vaccinated) at a pharmacy. Medical history included osteoporosis from an unknown date. The patient's concomitant medications were not reported. On 07May2021, the patient experienced slight headache few hours after the shot. On an unknown date couple of days later the patient had severe burning in my chest and my intestine and had a really severe headache and had vertigo pretty bad. The patient reports of going to doctor tomorrow and wanted to have some Prednisone to calm all this down also wanted to make sure it will not be going to interfere if the patient decide to take the second shot in the next 3weeks. I has been a week since the first dose and was concerned because patient is not well. The patient was is treated with Tylenol 500mg sometime take 1 or 2. The outcome of the events was reported as unknown at the time of report.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Skin infection
Clinical narrative: skin infection; This is a spontaneous report from a contactable Pharmacist reported for a female patient. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced skin infection. The patient already got the 1st dose and would like to confirm if it's true that she cannot take antibiotics for her skin infection that she experienced after 1st dose. Patient asking if when she can take the 2nd dose. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Scratch, Skin papilloma, Urticaria
Clinical narrative: Warts on her stomach; Welts on her stomach'she has welts on her legs; Having itching and scratching.; Having itching and scratching.; This is a spontaneous report from a contactable consumer (reported for herself). A 57-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0179/Batch number was not reported, Expiration Date: 31Aug2021), via an unspecified route of administration, in right arm on 14May2021 at 09:30 (at the age of 57-years-old) as dose 2, 30 ug, single for covid-19 immunisation at Hospital. The patient medical history included asthma from 2020 and ongoing (States she was diagnosed around this time in 2020), ongoing hypersensitivity Stated that she has a lot of allergies and spinal laminectomy from 21Aug2019 to an unknown date. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0169/Batch number was not reported, Expiration Date: 31Aug2021), via an unspecified route of administration, in right arm on 23Apr2021 (at the age of 57-years-old) as dose 1, 30 ug, single for covid-19 immunisation at Hospital. On an unspecified date, the patient received historical vaccine Influenza (States her arm swelled up after the flu shot in either 2007 or 2008. No date or Lot number known). The patient did not receive any other vaccines within four weeks prior to the vaccination. It was reported that she noticed warts on her stomach and welts on her stomach she has welts on her legs on 16May2021, it went away but later they popped up in the legs. She went tanning the next day after the vaccine. She is having itching and scratching. Her Dr informed her that she can take zyrtec 4 times a day for it. Her doctor told her that she has this reported from others with the pfizer covid vaccine. AE not requiring to visiting emergency room and physician office. Therapeutic measures were taken as a result of event with zyrtec 4 times a day. The outcome of events warts on her stomach and welts on her stomach she has welts on her legs was resolved on 17May2021 and outcome of other events was unknown.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, SARS-CoV-2 test, Taste disorder
Clinical narrative: taste and smell started changing/ things started smelling weird and tasting weird again; taste and smell started changing/ things started smelling weird and tasting weird again; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9267), dose 2 via an unspecified route of administration, administered in left arm on 01Apr2021, as 0.3 ml single dose for COVID-19 immunisation. Medical history included COVID-19 from Dec2020 to Dec2020. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6206), administered in left arm on an unknown date, as single dose for COVID-19 immunisation and after she had taste and smell went away and came back different. She was not able to smell bad smells like trash, boiled eggs, dog droppings or bowel movements or any other nasty smells. Post covid 1 month her smell started to return some and somewhat go back to normal. After the first dose of the vaccine, she was able to smell thing but not tell what it was. After received her second dose of the Pfizer COVID 19 vaccine, a couple of days, might be two days later things on 03Apr2021, patient started to notice that her taste and smell started changing/ weird again and now (at the time of report) she could not smell nasty smells and other things have changed. She stated it started with her toothpaste, the mint started smelling weird, and then bananas started smelling weird, chicken started smelling weird, charred, rancid smell. She noticed first with her toothpaste and the taste of chicken and bananas. She did see her primary care doctor for something else and she brought it up but they did not seem to know anything. She knew that everything was still ongoing and being studi changed of taste ed but it was just frustrated because she concerned about it went back to normal. The patient underwent lab tests and procedures which included COVID-19 test: negative on 06May2021. Outcome of the events was not resolved.  Follow up attempts are needed. Further information has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea
Clinical narrative: Diarrhea; joint pain; This is a spontaneous report from a contactable consumer (patient)   A 40-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), solution for injection: Lot/Batch number: EW0158) via an unspecified route of administration on 07Apr2021 at 09:30 am on the left arm as single dose for COVID-19 immunisation. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), solution for injection: Lot/Batch number: EW0167) via an unspecified route of administration on 28Apr2021 at 09:20 am on the left arm as single dose for COVID-19 immunisation. Medical history included IBS, Pencillin and Sulpha allergy. The patient's concomitant medications were not reported. Patient's other vaccine within four weeks prior the vaccination was none. Other medications in two weeks prior vaccination was none. Covid prior vaccination was none. The patient was not tested for Covid post vaccination. The patient developed diarrhoea two days after receiving her first vaccine. It did not improve by the time of the second vaccine and continued. Only other reaction was joint pain that lasted 24 hours. The patient stated that she had no other symptoms and noticed the diarrhoea started after consuming dairy. The patient stated that the diarrhoea continued with no other symptoms. The patient stated that she noticed that diarrhoea was worse after certain foods. The patient stated that she cut out dairy and gluten and only have diarrhoea when she ate those things. The patient stated that she had stopped dairy, but still had some diarrhoea and removed gluten. The patient stated that she did not had diarrhoea since removal of gluten. The patient did not take any treatment medication for the events. The outcome of the events was resolving.  Follow-up (15Jun2021): This is a follow up-spontaneous report from a contactable consumer. This consumer (patient) reported in response to consumer letter sent via follow-up letter which included: second dose information obtained, Event diarrhoea clinical information was obtained.  Follow-up attempts were completed. No further information is expected
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Vomiting
Clinical narrative: Monday night was up all night with severe cramps & began vomiting; Monday night was up all night with severe cramps & began vomiting; This is spontaneous report from a contactable consumer. A 14-years-old (Adolescent 12-17 Years) non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EW0173) intramuscularly, administered in right arm, on 13May2021 (Thursday) at 16:00 (at the age of 14-year-old), as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient had no known allergies. It was reported that, patient started period on 15May2021, Friday night on schedule. On 17May2021, at 10:00 AM, the patient had started experiencing severe cramps on Monday at school. It was reported that patient never had cramps before and has been having periods for 14 months. It was reported that Monday night was up all night with severe cramps and began vomiting. And still experienced cramping on Tuesday morning with vomiting. No treatment was received. The outcome of the menstrual cramps severe was resolved on 18May2021. The outcome of the event vomiting was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Concussion, Confusional state, Fatigue, Inappropriate schedule of product administration, Migraine
Clinical narrative: Start Date/Time: [Pfizer] 02May2021 01:00 PM/ Start Date/Time: [Pfizer] 18Apr2021 01:45 PM; Fever; Vomiting; Mild confusion; Extreme exhaustion; Body aches; Second dose brought back all concussion symptoms; Migraine; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 16-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via intramuscular, administered in right arm on 02May2021 13:00 (Age at Time of Vaccination: 16 years) (Batch/Lot number was not reported) as dose 2, single, the patient previously took first dose of bnt162b2 via intramuscular, administered in right arm on 11Apr2021 01:00 pm for covid-19 immunization. The patient medical history included attention deficit hyperactivity disorder (ADHD) and hypersensitivity. The patient concomitant medications included methylphenidate taken for attention deficit hyperactivity disorder, cetirizine hydrochloride (ZYRTEC) taken for hypersensitivity from Jan2021 and ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient received first dose on 18apr2021 and second dose on 02may2021 which led to (inappropriate schedule of product administration). The patient said Second dose brought back all concussion symptoms. Migraine, mild confusion, extreme exhaustion on 02May2021, 8:30 PM, vomiting at 9:30 PM. Body aches and fever on 03May2021, 8:00 PM and lasted for 7 days. The event migraine was reported as serious (disability). The patient received treatment for fever with Motrin. The outcome of the event inappropriate schedule of product administration was unknown and other events were resolved on an unspecified date on 2021.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Start Date/Time: [Pfizer] 02May2021 01:00 PM/ Start Date/Time: [Pfizer] 18Apr2021 01:45 PM; Fever; Vomiting; Mild confusion; Extreme exhaustion; Body aches; Second dose brought back all concussion symptoms; Migraine; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 16-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via intramuscular, administered in right arm on 02May2021 13:00 (Age at Time of Vaccination: 16 years) (Batch/Lot number was not reported) as dose 2, single, the patient previously took first dose of bnt162b2 via intramuscular, administered in right arm on 11Apr2021 01:00 pm for covid-19 immunization. The patient medical history included attention deficit hyperactivity disorder (ADHD) and hypersensitivity. The patient concomitant medications included methylphenidate taken for attention deficit hyperactivity disorder, cetirizine hydrochloride (ZYRTEC) taken for hypersensitivity from Jan2021 and ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient received first dose on 18apr2021 and second dose on 02may2021 which led to (inappropriate schedule of product administration). The patient said Second dose brought back all concussion symptoms. Migraine, mild confusion, extreme exhaustion on 02May2021, 8:30 PM, vomiting at 9:30 PM. Body aches and fever on 03May2021, 8:00 PM and lasted for 7 days. The event migraine was reported as serious (disability). The patient received treatment for fever with Motrin. The outcome of the event inappropriate schedule of product administration was unknown and other events were resolved on an unspecified date on 2021.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Discomfort, Lymphadenopathy
Clinical narrative: she got her second dose, and the lymph nodes under her left arm got bigger, and the lymph nodes under her right arm also grew; she got her second dose, and the lymph nodes under her left arm got bigger, and the lymph nodes under her right arm also grew; She stated this was not comfortable; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: Not provided) via an unspecified route, administered in arm on an unspecified date as dose 2, single for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the first dose of the vaccine on 16Feb2021 and noticed swelling in her lymph nodes after the first dose but got the second dose 3 weeks later and was still having this swelling. She stated she talked to the doctor when it didn't go away for a month and he said give it a week or two. After that he said to send pictures and said give it another month but now it has been 3 months. She stated that everyone else to whom she spoked to that experienced told that it would be resolved in a couple of weeks. She stated this was not comfortable. She asked how long swollen lymph nodes was supposed to lasted. She stated she put in a message to her doctor again today. No investigation assessment was reported. The outcome of the events was unknown.  Follow-up attempts are needed; information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid between my first and second shot; Tested positive for Covid between my first and second shot; This is a spontaneous report from a contactable consumer, the patient. A 35-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: and expiration date was not reported) via an unspecified route of administration on 24Mar2021 (at the age of 35 years) as single dose, for COVID-19 immunization. The patient medical history and concomitant medication was not reported. On an unspecified date 2021 she experienced tested positive for COVID between her first and second shot.  Patient had COVID test and result was positive. Caller wants to know if she needs to wait to take the 2nd dose or if the 2nd dose is necessary. The outcome of both events were unknown.  Medical Information YES: Customer and/or medical inquiry forwarded or referred to MI  No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: FEVER; Chills; headache; It knocked on my but; she felt exhausted/she's still really tired; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection), dose 2 via an unspecified route of administration on 02May2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took bnt162b2 for covid-19 immunisation and cosentyx. The patient experienced fever, chills, headache, it knocked on my but, still really tired. Patient reported she received her second dose a Pfizer COVID-19 vaccine this past Sunday 02May, the day after taking her cosentyx dose, it knocked me on my but, she went on to explain she experienced fever, chills, headache, and she felt exhausted she reported her symptoms are improving but she's still really tired and having some chills headache. In addition she mentioned she took care passed a dose of her cousin takes a few days late because she forgot to take it and she felt a tingling in her scalp, reported this fully resolved after she took the dose. She also mentioned that she does continue to experience an itch as yet warning sign before her next maintenance dose is due. Outcome of exhaustion was unknown and for all other the events it was recovering.   Information on the lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Menstruation delayed, Ultrasound scan, Urine analysis
Clinical narrative: Missing my period; Menstrual cycle is three weeks late; This is a spontaneous report from a contactable Consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number: ER8736, expiry date: 02Jul2021) via unspecified route of administration on 01May2021 as DOSE 1, SINGLE in left arm for COVID-19 immunisation (at the age of 43 years). The patient's medical history and concomitant medication was not reported. The patient reported that she met a Gynecologist because I was missing my period, so when I went in I did a urine test but he also did an ultrasound so in conclusion, I was not pregnant on both tests but my menstrual cycle has been three weeks late that's why I went in and I am on top of it's a Copper-T called Paragard it's a birth control. So I am having it for 12 years and I am never really missed the period until I took the Pfizer which is two weeks ago and I wanted you to see, like Is it common with  other women that are they calling in seeing that there periods are irregular because I want to report mine that is three weeks late and I am not pregnant and I am 43 years old and I don't take any drug and I do not take any prescription drug and this is like the first of its kind for me, I usually have regular period because of the Copper-T there is like a hormones in it or any drug. So this was the only thing that I did different. I do exercise. I am fit. No high blood pressure. No low blood pressure. I just wanted to report that if there is anybody like me that are calling in?. When paraphrased the concern: Consumer further stated, "My last menstrual cycle was on 31Mar2021 and it's already 18 so in conclusion I am 3 weeks late on my menstrual cycle and the only thing I did different was taking the Pfizer shot so this Saturday would be my second shot for the COVID-19 the Pfizer shot but I am not gonna take it now because I still haven't had my period yet at all and I am wondering and my doctor. He told me to come back in two months. So you know it's kind of strange. When Probed for the date of the first COVID-19 Shot: Consumer Stated, 01May21. When Probed for the date of the second COVID-19 Shot: Consumer Stated, 22May2021 coming up this week. Well I am freaking to take it because I have not got my period yet and I am thinking that it was the Pfizer that has only changed in first as drug and as eating wise and exercise nothing is changed, Well I actually thought I was pregnant I was 43 years old, so I went in right away because I don't what was happening and I want to know if any other women has been experiencing I guess missing their cycle?. The outcome of events was unknown.  Follow-up attempts are completed. No further information was expected.