chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in the right leg; This is a spontaneous report from a contactable consumer reported for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, 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 immunization. The patient medical and concomitant medication history were reported. The patient experienced pain in the right from the COVID-19 first shot. The outcome of the event was unknown.   The lot number was not provided. Information on lot number has been requested during follow up.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Somnolence, Vaccination site pain
Clinical narrative: fever; chills; sleepiness; pain in her right arm where she got the shot at.; This is a spontaneous report from a contactable consumer.   A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: SW0167) (at the age of 57-years-old), via an unspecified route of administration, right arm on 02Jul2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On01Jul2021, the patient had experienced severe pain in right arm. On 02Jul2021, the patient had experienced fever, chills and sleepiness. Additional Context: Stated that with the second shot that within three days she had severe chest pains, leg cramps, lightheadedness and swollen lymph nodes. Is for Pfizer Covid shot. Stated that she does not think that she should get the third shot because of the chest pain. No treatment was received in response to the adverse events. On 02Jul2021, the event sleepiness was recovered. On 07Jul2021, the events fever and chills was recovered. At the time of reporting, the event pain in her right arm where she got the shot at was not recovered.  Product details: Stated that the second shot was on 01Aug2021 NDC unknown, expiration unknown and lot SH7485. Stated that it was in the right arm. Stated that the card was hard to read.  No Follow-up attempts are possible. No information is expected further.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Headache, Lymphadenopathy, Muscle spasms
Clinical narrative: severe chest pain; leg cramps; lightheadedness; swollen lymph nodes; headache; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: SH7485, Expiry Date: Unknown) via an unspecified route of administration, administered in arm right on 01Aug2021 (at the age of 57-years-old) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications reported. No investigation assessment was provided. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: SW0167) via an unspecified route of administration, administered in arm right on 02Jul2021 (at the age of 57-years-old) as dose 1, single for COVID-19 vaccination. The patient wanted to report her side effects. Stated with the first shot that she had fever, chills, sleepiness and pain in her right arm, headache where she got the shot on 02Jul2021. On unknown date in Aug2021, the patient stated that within three days of second shot, she had severe chest pain, leg cramps, lightheadedness and swollen lymph nodes. Stated that she does not think that she should get the third shot because of the chest pain. The patient stated that she was having chest pain 2-3 times a week but now she was having it once a week. Mentioned that she had a headache with the second shot in 2021. No treatment was reported for the reported events. The outcome of the events of severe chest pain was recovering; event of lightheadedness was recovered on an unknown date in 2021; and other events was not recovered at the time of reporting.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: FC3183; Expiration Date: Oct2021), dose 1 via an unspecified route of administration on 04Sep2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced itching on Sep2021. Reporter stated, " So, I have my vaccine yesterday actually, I got my first dose yesterday of the Pfizer and I wasn't sure whom to call all the pharmacy are closed and hospital are not giving me any answer so, I am not quite sure too I am having like itching, Is that normal? And itching everywhere. "Should I be worried about that I was reaction with itching? I am not having trouble in breathing, I am not having hives, I am just itching. Outcome of the event was unknown.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy to vaccine, Breath sounds abnormal, Cough, Rhinorrhoea
Clinical narrative: When he coughs she can hear his chest; When he coughs she can hear his chest; He has got real bad runny nose; I get the other allergy reaction; This is a spontaneous report from a contactable consumer or other non HCP (Reporter's grandson). A 15-year-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm on 27Aug2021 at 16:30 (at the age of 15-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included ongoing asthma. The patient had no family medical history relevant to AE. Concomitant medication included salbutamol sulfate (PROAIR [SALBUTAMOL SULFATE]) taken for asthma and unspecified inhaler start and stop date were not reported. It was reported the patient received this concomitant medications since born. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have any events prior vaccinations. The patient got real bad runny nose and get the other allergy reaction on 28Aug2021. On 03Sep2021 in the morning, the patient can breathe, when he coughs she can hear his chest. Like how boogers escape and where they go and that why he sounds like that. The patient not visited emergency room or physician office due to the events. It was reported that the patient born in incubator and there for a month or two diagnosed with asthma. The patient received Benadryl last night for the events. Therapeutic measures were taken as a result of events. The outcome of events was unknown and for event bad runny nose was not recovered  The lot number for the vaccine [BNT162B2], was not provided and will be requested during follow up.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Positive covid test result, PCR, taken Wednesday 01Sep2021. First symptoms Monday 30Aug2021; Positive covid test result, PCR, taken Wednesday 01Sep2021. First symptoms Monday 30Aug2021; This is a spontaneous report from a contactable consumer. This male consumer (patient) reported for himself. A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: UNKNOWN), both doses via intramuscular administered in left arm as dose 2, single on 04Mar2021 and as dose 1, single on 11Feb2021 (at the age of 44-year-old) for covid-19 immunisation. The patient medical history was not reported. No concomitant medications were administered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and received no other medications within 2 weeks of vaccination. Patient had not been diagnosed with COVID-19 prior to vaccination and had been tested since the vaccination. On 30Aug2021, the patient experienced first symptoms and on 01sep2021, he was tested PCR nasal swab resulted positive. Lab tests and procedures which included SARS-COV-2 test: positive on 01Sep2021. No treatment was received for the adverse events. The outcome of events was recovered on unspecified date in Sep2021.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Mass, Pain in extremity
Clinical narrative: sore arm; her arm hurts but its getting worse; can feel a lump in that arm; This is a spontaneous report from a contactable consumer or other non hcp. A 41-years-old female patient received bnt162b2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8735) dose 2 via an unspecified route of administration, administered in Arm Left on 18May2021 as DOSE 2, SINGLE (Age at vacciantion 41-years-old) was for covid-19 immunisation. Medical history included migraine (Migraine). The patient's concomitant medications were not reported. The patient historical vaccine included bnt162b2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8736) via an unspecified route of administration on 27Apr2021 as DOSE 1, SINGLE was for covid-19 immunisation. Patient does not received any vaccine prior to the vaccinations and did not visited emergency Room or physician Office. On an unspecified date, the patient experienced sore arm (pain in extremity), her arm hurts but its getting worse (condition aggravated) (non-serious) and feel a lump in that arm (mass). On an unspecified, date with outcome of unknown. The outcome of the event pain in extremity outcome of not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: My hands will start falling in sleeping; my finger, index finger is numb, my hands is whole numb; I have numbness it won't go away; This is a spontaneous report from a contactable consumer (patient) reported for self. A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 03Sep2021 (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient regrets getting Pfizer shot, it was giving side effect right now. The patient got it on Friday 03Sep2021 and now the patient's hands would start falling in sleeping, the patient's finger, index finger was numb, the patient's hands was whole numb. The patient had numbness it won't go away. The patient wanted to know if the patient had to get the second shot because the second shot was due on 24Sep2021. The patient asked whether to go and get second one and get more side effects. The outcome of the event was not resolved.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac flutter
Clinical narrative: I was having fluttering of my heart and I was feel like, It is been stuck; It's just 5 days or a week ago like, I am experiencing it.; This is a spontaneous report from a contactable consumer (patient herself). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: EW0186, Expiry date, NDC number, UPC number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had experienced i was having fluttering of my heart and i was feel like, it is been stuck; it's just 5 days or a week ago like, i am experiencing it. Caller stated, I don't see LOT# number on my card. It's my name, my date of birth, first dose. Oh Is the number in box on the card, Started with E. It has some letter in it. It is (#). That's what I see under the word Pfizer. Caller stated, do you have to document because I am asking a question, patient had the question about the Covid vaccine. Patient got the 1st shot and didn't show any reaction, but side effect, when came home, I was having fluttering of my heart and I was feel like, It is been stuck and Is it recommended that, You take the 2nd dose after experience that because the patient did not and had not this qualification so, patient's doctor knows about it. It's just 5 days or a week ago like, patient experiencing it. Caller stated, what is that, No. patient consulted the doctor and they didn't gave any medication. The patient did not receive treatment for the adverse event. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, SARS-CoV-2 test
Clinical narrative: they are now testing positive for COVID 19; her daughter began to feel bad yesterday; This is a spontaneous report from a contactable consumer (patient's mother) for the patient (daughter).  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 29Aug2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter states that her daughter got her first dose of the vaccine on 29Aug2021. She states that they have not been exposed to anyone with COVID 19 and that they are now testing positive for COVID 19. She states that it has been 8-9 days and she tested positive on Saturday and her daughter tested positive today (06Sep2021). She would like to know if this is because of the vaccine and that they really don't have the virus? She makes an example of when people get the flu shot and then get sick with the flu. She states that it's the same because the vaccine is COVID that they put in their body. She states that her daughter began to feel bad yesterday (05Sep2021). The reporter would like to know if she can still get her second dose of the vaccine now since she has tested positive after the first dose. She also states that this vaccine is the virus so that is why she is testing positive right? She states that the vaccine puts the virus in your body. The patient underwent lab tests and procedures which included sars-cov-2 test: tested positive on 06Sep2021. The outcome of both the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive today for the rapid test; This is a spontaneous report from a Pfizer sponsored program. A Non-contactable consumer reported for a patient (reporter's wife) reported that:   A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on 04Sep2021 as dose 1, single for covid-19 immunization. Patient had no known allergies and no relevant medical history. The patient concomitant medications were not reported. The caller wanted to know that if his wife take  2nd dose since his wife got covid-19 vaccine yesterday and she tested positive today (i.e. 05Sep2021) for the rapid test. The outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain
Clinical narrative: Lymphadenopathy of the left shoulder with pain, Lymphadenopathy of right shoulder.; Lymphadenopathy of the left shoulder with pain, Lymphadenopathy of right shoulder.; This is a spontaneous report from a non-contactable consumer. This 51-year-old male consumer (patient) reported. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: FA7484), dose 2 via an unspecified route of administration, administered in Arm Left on 23Jul2021 (at the age of 51-years-old) as a single dose for covid-19 immunization. Medical history included hypertension, glucose tolerance impaired and pre-diabetic. Concomitant medication(s) included amlodipine besilate, hydrochlorothiazide, valsartan (AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE); losartan; simvastatin. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: PA6780), dose 1 via an unspecified route of administration, administered in Arm Left on 09Jul2021 (at the age of 51-years-old) as a single dose for covid-19 immunization. The patient had no other vaccine within four weeks. 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 27Jul2021, the patient experienced lymphadenopathy of the left shoulder with pain, lymphadenopathy of right shoulder. The patient was hospitalization for the event. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment. Outcome of the event was not recovered, at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Haemorrhage, Headache, Vaccination site erythema
Clinical narrative: Redness and swelling at the injection site; Redness and swelling at the injection site; Irregular non-period-related bleeding the day after the second dose; severe headaches; chills; fatigue; This is a spontaneous report from a non-contactable consumer (Patient). A 49-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: FO8448, and Expiration date: Unknown), via an unspecified route of administration, administered in right arm on 12Aug2021 09:30 (at the age of 49-year-old) as dose 2, single for COVID-19 immunization. The patient medical history was none.  Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (TAYTULLA) (birth control generic for Taytulla).  The patient previously took oral minocycline for acne and experienced hypersensitivity (allergy). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0171, and Expiration date: Unknown), via an unspecified route of administration, administered in right arm on 22Jul2021 (at the age of 49-year-old) as dose 1, single for COVID-19 immunization. The patient received no other vaccine in four weeks. The patient did not have COVID prior vaccination. The patient was not tested for COVID since vaccination. 0n 13Aug2021 01:00, the patient experienced irregular non-period-related bleeding the day after the second dose, severe headaches (Moderate to severe headaches), chills, and fatigue for 9 days starting the morning after the 2nd dose of the vaccine. On 14Aug2021, the patient experienced redness and swelling at the injection site for about 3 days. No treatment was given for the event. The outcome of the events was reported as resolved on an unspecified date in 2021.  No follow-up attempts are possible, Information about Lot/Batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Redness and swelling at the injection site; Redness and swelling at the injection site; Irregular non-period-related bleeding the day after the second dose; severe headaches; chills; fatigue; This is a spontaneous report from a non-contactable consumer (Patient). A 49-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: FO8448, and Expiration date: Unknown), via an unspecified route of administration, administered in right arm on 12Aug2021 09:30 (at the age of 49-year-old) as dose 2, single for COVID-19 immunization. The patient medical history was none.  Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (TAYTULLA) (birth control generic for Taytulla).  The patient previously took oral minocycline for acne and experienced hypersensitivity (allergy). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0171, and Expiration date: Unknown), via an unspecified route of administration, administered in right arm on 22Jul2021 (at the age of 49-year-old) as dose 1, single for COVID-19 immunization. The patient received no other vaccine in four weeks. The patient did not have COVID prior vaccination. The patient was not tested for COVID since vaccination. 0n 13Aug2021 01:00, the patient experienced irregular non-period-related bleeding the day after the second dose, severe headaches (Moderate to severe headaches), chills, and fatigue for 9 days starting the morning after the 2nd dose of the vaccine. On 14Aug2021, the patient experienced redness and swelling at the injection site for about 3 days. No treatment was given for the event. The outcome of the events was reported as resolved on an unspecified date in 2021.  No follow-up attempts are possible, Information about Lot/Batch number cannot be obtained.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, SARS-CoV-2 test
Clinical narrative: I had extreme bilateral throbbing leg pain; I had extreme bilateral throbbing leg pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 22-year-old non-pregnant female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EN5318), via intramuscular route administered in left arm on 13Feb2021 at 09:15 AM (22-year-old at the time of vaccination) as dose 1, single for COVID-19 immunization. Medical history included Numbness, tingling, burning, hypersensitive, tourniquet feeling in thigh, cold leg and foot, extreme dull ache pain, pressure in leg, extreme leg weakness and Progressive neurological symptoms over the course of the past 8 months from 17Jan2021 and ongoing. The patient's concomitant medications were not reported. The patient previously took Percocet (PERCOCET [OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE; PARACETAMOL]) and experienced allergies. The patient had not received any vaccine within four weeks. The patient was tested since vaccination. On 13-FEB-2021 12:15, 3 hours after Dose 1 of Pfizer vaccine, the patient experienced extreme bilateral throbbing leg pain. The patient was hospitalised for 3 days. Therapeutic measures were taken for the event using medications. The patient underwent lab tests and procedures which included COVID-19 Nasal Swab testnegative on 01Sep2021. Adverse event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. The outcome of the event was not recovered.; Sender's Comments: The event of Pain in extremity and Pain are assessed as possibly related to the suspect drug BNT162B2  based on strong temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, SARS-CoV-2 test
Clinical narrative: have had a progressively heavy period/i am on currently day 7 of extremely heavy bleeding; This is a spontaneous report from a contactable other health care professional that is nurse (Patient). A 36-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on 25Jan2021 10:15 (at the age of 36 years) as dose2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on 23Dec2020 (at the age of 36 years) as dose1, single for COVID-19 immunization. On an unspecified date the patient experienced a progressively heavy period. Patient was on day 7 of extremely heavy bleeding. she tracked cycle extremely closely, and had for many years, it has been erratic since the second Pfizer vaccine. Prior to vaccination, patient was not diagnosed with Covid-19. Since the vaccination, patient has not been tested for Covid-19. Patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. No treatment was received for adverse events. The patient underwent lab tests and procedures which included Covid test found to be negative on an unspecified date (Nasal Swab). The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Disease recurrence, SARS-CoV-2 test
Clinical narrative: Had a stroke on my left side; Had a stroke on my left side; This is a spontaneous report from a contactable consumer (Patient).  A 34-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 08Aug2021 15:30 at the age of 34-year-old as dose 1, single for covid-19 immunisation from pharmacy or drug store. Medical history included stroke (blockage), aneurism and patient had no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid prior to vaccination. The patient had a stroke on my left side on 27Aug2021 21:30 which result in emergency room/department or urgent care. The patient was hospitalized for the event for 3 days and had disability or permanent damage. Patient was treated with unspecified medicines in response to the event. The patient underwent lab tests and procedures which included covid test (nasal swab) was negative on 28Aug2021. The outcome of the event was recovering.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Headache, Lymphadenopathy, Nausea
Clinical narrative: Severe headache; fever; body aches; severe anxiety; nausea; dizziness; swollen glands; This is a spontaneous report received from a contactable consumer(patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number was unknown and expiry date was not reported) via an unspecified route of administration, on 04Sep2021 13:00, at the Left arm, at the age of 38-year-old, at dose 2, single for covid-19 immunisation in a pharmacy or drug store. The patient's medical history includes fibromyalgia, postural orthostatic tachycardia syndrome, and anxiety. Concomitant medications in two weeks include diphenhydramine hydrochloride (BENADRYL), ibuprofen, cetirizine hydrochloride (ZYRTEC), colecalciferol (VITAMIN D), and multivitamin (unspecified). The patient previously took cymbalta, phenergan and oxycodone hydrochloride, paracetamol (PERCOCET) and experienced allergies. The patient did not receive other vaccines in two weeks. The patient is not pregnant at the time of vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date were not reported) via an unspecified route of administration, on 14Aug2021 12:30 at the right arm, at dose 1, single, for covid-19 immunisation. The patient did not have prior COVID vaccination. On 07Sep2021, the patient experienced severe headache, fever, body aches, severe anxiety, nausea, dizziness, swollen gland resulted in Emergency room/department or urgent care. The patient underwent nasal swab post vaccination in Sep2021 but the result was unknown. The patient received treatment in response to the events which included fluids, anti-nausea medication, pain reliever. The outcome of the events was not recovered.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Severe headache; fever; body aches; severe anxiety; nausea; dizziness; swollen glands; This is a spontaneous report received from a contactable consumer(patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number was unknown and expiry date was not reported) via an unspecified route of administration, on 04Sep2021 13:00, at the Left arm, at the age of 38-year-old, at dose 2, single for covid-19 immunisation in a pharmacy or drug store. The patient's medical history includes fibromyalgia, postural orthostatic tachycardia syndrome, and anxiety. Concomitant medications in two weeks include diphenhydramine hydrochloride (BENADRYL), ibuprofen, cetirizine hydrochloride (ZYRTEC), colecalciferol (VITAMIN D), and multivitamin (unspecified). The patient previously took cymbalta, phenergan and oxycodone hydrochloride, paracetamol (PERCOCET) and experienced allergies. The patient did not receive other vaccines in two weeks. The patient is not pregnant at the time of vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date were not reported) via an unspecified route of administration, on 14Aug2021 12:30 at the right arm, at dose 1, single, for covid-19 immunisation. The patient did not have prior COVID vaccination. On 07Sep2021, the patient experienced severe headache, fever, body aches, severe anxiety, nausea, dizziness, swollen gland resulted in Emergency room/department or urgent care. The patient underwent nasal swab post vaccination in Sep2021 but the result was unknown. The patient received treatment in response to the events which included fluids, anti-nausea medication, pain reliever. The outcome of the events was not recovered.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: 6VAX-F, PNC13, RV5
Symptoms: Haematemesis, Thrombosis, Vomiting
Clinical narrative: Haematemesis; vomiting; This is a spontaneous report based on the information received by Pfizer from MSD (Manufacturer Control No: MCM-002637). A contactable other HCP reported for a 2-month-old patient of an unspecified gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date as single dose for prophylaxis; diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), hib vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (VAXELIS), route of administration, start and stop date, batch/lot number and dose were not reported for prophylaxis; rotavirus vaccine live reassort oral 5v (ROTATEQ), route of administration, start and stop date, batch/lot number and dose were not reported for prophylaxis. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced haematemesis on 17Aug2021, vomiting on 17Aug2021. On 17Aug2021, the patient experienced vomiting, and the vomit had visible blood clots (Hematemesis). The patient was admitted to the hospital and was hospitalized for one day on an unknown date. The outcome of the events was recovered on an unspecified date. The reporter assessed the causal relationship between Vaxelis and the reported event of vomit had visible blood clots as not related.  MSD Company comment: Hematemesis was assessed as serious (hospitalization). Considering the current knowledge of the vaccine and the existence of alternative explanations (co-suspect vaccinations administered the same day), the causal relationship between Vaxelis and Haematemesis is assessed as not related.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained. No further information is expected.; Sender's Comments: Haematemesis and vomiting are considered as unrelated to Prevenar 13;  a possibly contributory role of oral rotavirus vaccine live in triggering gastrointestinal reactions might not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: upper lip swelling; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FC3184), via an unspecified route of administration on 04Sep2021, as dose 1, single for COVID-19 immunization. The patient's medical history included upper lip swelling after taking a pill and eating Kiwi fruit. Concomitant medications were not reported. On 07Sep2021, 3 days after first dose of vaccine, the patient had reaction and her upper lip was swollen. The clinical outcome of the event was unknown.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Fatigue, SARS-CoV-2 test
Clinical narrative: postive COVID results; postive COVID results; loss of taste & smell; loss of taste & smell; severe head congestion; fatigue; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional. A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP6955) intramuscularly, administered in left arm on 26Mar2021 11:30 (at the age of 51-year-old) as dose 2, single and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3248) intramuscularly, administered in left arm on 05Mar2021 11:30 as dose 1, single for covid-19 immunisation. Patient had known allergies to sulfa. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient's concomitant medications were not reported. On 29Aug2021 the patient had positive covid results, loss of taste & smell, severe head congestion, fatigue. The case is serious and patient visited to doctor or other healthcare professional office/clinic. The patient underwent lab tests and procedures which included sars-cov-2 test (nasal swab) result was positive on 31Aug2021. No treatment received for the events. Outcome of the events were resolving.  The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL3248 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL3248, fill lot EL3231, and the formulated drug product lot EL3224. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EP6955 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EP6955, fill lot EP6954, and the formulated drug product lot EP6953. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  No follow-up attempts possible. No further information expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Upper respiratory tract congestion, Vaccination failure
Clinical narrative: postive COVID results; postive COVID results; loss of taste & smell; loss of taste & smell; severe head congestion; fatigue; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional. A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP6955) intramuscularly, administered in left arm on 26Mar2021 11:30 (at the age of 51-year-old) as dose 2, single and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3248) intramuscularly, administered in left arm on 05Mar2021 11:30 as dose 1, single for covid-19 immunisation. Patient had known allergies to sulfa. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient's concomitant medications were not reported. On 29Aug2021 the patient had positive covid results, loss of taste & smell, severe head congestion, fatigue. The case is serious and patient visited to doctor or other healthcare professional office/clinic. The patient underwent lab tests and procedures which included sars-cov-2 test (nasal swab) result was positive on 31Aug2021. No treatment received for the events. Outcome of the events were resolving.  The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL3248 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL3248, fill lot EL3231, and the formulated drug product lot EL3224. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EP6955 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EP6955, fill lot EP6954, and the formulated drug product lot EP6953. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  No follow-up attempts possible. No further information expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Exposure to SARS-CoV-2, Headache, Nasal congestion, Pyrexia
Clinical narrative: May have been exposed to somebody have COVID; still having the symptoms; Fever; I had got like low grade fever like in 90, 99; Stuffy nose; runny nose; Stuffy nose; runny nose; Headache; This is a spontaneous report from a contactable consumer. A 52-years-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: FC3182), dose 1 via an unspecified route of administration, administered in Arm Left on 03Sep2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included edema and multiple sclerosis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Caller is a consumer inquiring about testing positive for Covid after receiving the Pfizer Covid-19 vaccine. Caller reports she received Pfizer Covid-19 vaccine on Friday and was exposed to Covid-19 infection Tuesday. Caller states I am showing symptoms and just thought it was a reaction to the vaccine. Caller asks can I go get a Covid test or will be affected. Caller reports her symptoms include low grade fever, head cold, stuffy nose, and headache. Consumer stated, I am got this Pfizer vaccine on Friday and I just found that probably on Tuesday, I may have been exposed to somebody has COVID and I still having the symptoms and I got to have some side effect like fever all that I am just wondering if I needed to go get tested. When paraphrased the concern, Consumer stated, I work in kindergarten class and we just got to know one of our kid in the class tested positive probably Tuesday and on Saturday I started showing my symptoms, but I thought it was from my shot I got on Friday. The patient received treatment with Tylenol. The patient underwent lab tests and procedures which included body temperature: 90 on 04Sep2021, body temperature: 99 on 04Sep2021, sars-cov-2 test: positive on 07Sep2021. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: May have been exposed to somebody have COVID; still having the symptoms; Fever; I had got like low grade fever like in 90, 99; Stuffy nose; runny nose; Stuffy nose; runny nose; Headache; This is a spontaneous report from a contactable consumer. A 52-years-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: FC3182), dose 1 via an unspecified route of administration, administered in Arm Left on 03Sep2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included edema and multiple sclerosis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Caller is a consumer inquiring about testing positive for Covid after receiving the Pfizer Covid-19 vaccine. Caller reports she received Pfizer Covid-19 vaccine on Friday and was exposed to Covid-19 infection Tuesday. Caller states I am showing symptoms and just thought it was a reaction to the vaccine. Caller asks can I go get a Covid test or will be affected. Caller reports her symptoms include low grade fever, head cold, stuffy nose, and headache. Consumer stated, I am got this Pfizer vaccine on Friday and I just found that probably on Tuesday, I may have been exposed to somebody has COVID and I still having the symptoms and I got to have some side effect like fever all that I am just wondering if I needed to go get tested. When paraphrased the concern, Consumer stated, I work in kindergarten class and we just got to know one of our kid in the class tested positive probably Tuesday and on Saturday I started showing my symptoms, but I thought it was from my shot I got on Friday. The patient received treatment with Tylenol. The patient underwent lab tests and procedures which included body temperature: 90 on 04Sep2021, body temperature: 99 on 04Sep2021, sars-cov-2 test: positive on 07Sep2021. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: The vax does not work; On an unspecified date, the patient experienced the vax does not work.; This is a spontaneous report from a Pfizer-sponsored program Corporate Social Media Platforms. A non-contactable consumer reported for a patient. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported NT162B2), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced the vax does not work. The clinical outcome for the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: declared Covid+; declared Covid+; This is a spontaneous report from a non-contactable consumer (patient), from Pfizer-sponsored program.  A patient of unspecified age and gender received first dose of 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 1, single and second dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 03Sep2021,the patient's PCR result declared Covid positive, felt sick moderately. The patient thought it's not a huge problem thanks to vaccination of 2 BioNTech. The patient always wear mask and throw/change daily. Even if tested positive somehow. The patient had big headache and little nose ache and was quarantined now at home. The patient underwent lab tests which included SARS-Cov-2 test: Covid+ on 03Sep2021. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Feeling abnormal, SARS-CoV-2 test
Clinical narrative: I was fully vaccinated and I have become positive for Covid 19; I was fully vaccinated and I have become positive for Covid 19; Wish I could get antibody infusion. I feel pretty awful.; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that:  A patient (age and gender unspecified) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on unspecified date as dose 2, and dose 1, single for covid-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. It was reported that the patient was fully vaccinated and become positive for Covid-19. On an unspecified date, the patient  become positive for Covid 19. The patient wish that they get antibody infusion and also feel pretty awful. The outcome of events was unknown.  No Follow-up attempts are possible. No information is expected further.