chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: tongue went numb; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number Unknown, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: HYPOAESTHESIA ORAL (non-serious), outcome "unknown", described as "tongue went numb".  Additional information: (Case narrative): The patient was also not the reporter. Reporter seriousness for tongue went numb was provided as unspecified. Is Covid vaccine a Pfizer product: Unspecified. Covid vaccine manufacturer was unspecified. Dates and NDC number for Covid vaccine was unspecified. Reason for no lot number: of Covid vaccine: Complainant does not have the product with them at the time of call. Expiry Date of Covid vaccine was unknown. Other Products were unknown. Additional Context: Agent stated there was a consumer a patient on the line, did not wish to provide demographics, patient got booster shot on 21Jan2022, stated a few minutes after booster shot her lips started to get numb and her throat feels like it is closing and it is hard to swallow. Agent stated the caller was given Benadryl 30 minutes prior to the vaccine but it did not give any effect. Caller confirmed details provided by the transferring agent. Caller mentioned that a nurse told her that her tongue got numb after the booster shot, stated the nurses name was withheld, she was a female, an RN at the Clinic in the procedure center, stated she has no personal details to provide and did not know the nurse personally, product information unknown, no further details known or provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Nasopharyngitis
Clinical narrative: Cold; Chills; temperature of 99°F.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 20 year-old female patient received bnt162b2 (BNT162B2), administration date 25Jan2022 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: NASOPHARYNGITIS (non-serious) with onset Jan2022, outcome "unknown", described as "Cold"; CHILLS (non-serious) with onset Jan2022, outcome "unknown", described as "Chills"; BODY TEMPERATURE INCREASED (non-serious) with onset Jan2022, outcome "unknown", described as "temperature of 99°F.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information:  Consumer reported for his granddaughter (patient) that received the First dose of Pfizer BioNtech vaccine yesterday and ever since the patient has had Cold, Chills and a temperature of 99°F. They went yesterday at 5:00 for the patient to get the vaccine and she has been cold all day. Reporter wants to know if these side effects could be from the vaccine. He also mentioned his 7year old Grandson had received the vaccination as well but he does not have side effects. He would like to know on how to treat the fever, is monitoring and sponge bath every hour enough.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria, Weight
Clinical narrative: Rash/The rash is mostly on her chest, and up her neck and stomach/rash on her neck , chest, and ears.; since the booster she has been breaking out in hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2), administration date 17Dec2021 (Batch/Lot number: unknown) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (First Dose, She was fine with the first and second dose of the COVID vaccine., Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Second dose, She was fine with the first and second dose of the COVID vaccine., Manufacturer unknown), for COVID-19 Immunization. The following information was reported: RASH (non-serious) with onset 17Dec2021, outcome "not recovered", described as "Rash/The rash is mostly on her chest, and up her neck and stomach/rash on her neck , chest, and ears."; URTICARIA (non-serious) with onset 17Dec2021, outcome "not recovered", described as "since the booster she has been breaking out in hives". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash, urticaria.  Additional information: Reporter seriousness for Rash was unspecified. Patient tried to go to doctor and doctor advised to take Benadryl but it didn't work. She doesn't like taking pills. She doesn't have the lot/expiration for the Benadryl. She doesn't know the dates or lot/expirations for any of her vaccines. She doesn't have that information on her at this time. The rash showed up the same week of the COVID booster. She stayed at the place for almost half an hour. The night of the COVID booster, is when she started feeling the rash on her neck , chest, and ears. Sometimes it is worse than other times. Every medication she is on she has been on for a long time. She just doesn't know what she is dealing with.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Illness, Investigation
Clinical narrative: sick; lost her smell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick"; ANOSMIA (non-serious), outcome "unknown", described as "lost her smell". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up attempts completed. No further information is expected.  Follow-up (28Feb2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovered", described as "swollen lymph nodes".  Additional information: Reporter was stated her sister swollen lymph nodes for 3 months after 1st shot. In May2021 I noticed some hair loss but blamed it on getting older until the fall of 2021 when I noticed more than usual was falling out. Since I already had a 6 mo follow-up appointment with my dermatologist on 01Dec2021. I waited to be checked until then. she could see some disease was going on my scalp so did a biopsy of the scalp. Diagnosis was Lichen Planopilaris. In my research I found cases of hair loss in # after vaccination.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Antibody test, Bacterial test, Blood immunoglobulin G, Blood test, COVID-19
Clinical narrative: one participant reconverted for anti-N IgG between days 90 and 210 after the prime, indicating a breakthrough infection; one participant reconverted for anti-N IgG between days 90 and 210 after the prime, indicating a breakthrough infection; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 21Feb2022, this case now contains all required information to be considered valid.  This is a literature report.  A patient (no qualifiers provided) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "one participant reconverted for anti-N IgG between days 90 and 210 after the prime, indicating a breakthrough infection". The patient underwent the following laboratory tests and procedures: anti-ABD antibodies: unknown results; spike antigen on antibody specificities: unknown results; spike antigen: unknown results; anti-N lgG: unknown results; Plasma samples: unknown results; core needle biopsy: unknown results; Spike protein: unknown results; SARS-CoV-2 reverse-transcription quantitative polymerase chain reaction: unknown results.; Sender's Comments: Based on the information currently available, a lack of efficacy with bnt162b2 vaccine in this patient cannot be completely excluded
Sex: U
Vaccine: COVID19
Symptoms: Diagnostic aspiration, Drug ineffective, Protein total, SARS-CoV-2 test
Clinical narrative: one participant reconverted for anti-N IgG between days 90 and 210 after the prime, indicating a breakthrough infection; one participant reconverted for anti-N IgG between days 90 and 210 after the prime, indicating a breakthrough infection; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 21Feb2022, this case now contains all required information to be considered valid.  This is a literature report.  A patient (no qualifiers provided) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "one participant reconverted for anti-N IgG between days 90 and 210 after the prime, indicating a breakthrough infection". The patient underwent the following laboratory tests and procedures: anti-ABD antibodies: unknown results; spike antigen on antibody specificities: unknown results; spike antigen: unknown results; anti-N lgG: unknown results; Plasma samples: unknown results; core needle biopsy: unknown results; Spike protein: unknown results; SARS-CoV-2 reverse-transcription quantitative polymerase chain reaction: unknown results.; Sender's Comments: Based on the information currently available, a lack of efficacy with bnt162b2 vaccine in this patient cannot be completely excluded
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Loss of consciousness
Clinical narrative: I thought I was going to pass out; rapid heartbeat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 72 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Jan2022 10:30 (Lot number: FK9729) at the age of 72 years as dose 4 (booster), single for covid-19 immunisation. Relevant medical history included: "immunocompromised" (unspecified if ongoing), notes: IgG deficiency; "rheumatoid arthritis" (ongoing), notes: take methotrexate for rheumatoid arthritis; "IgG deficiency" (unspecified if ongoing); "Asthma/COPD" (ongoing); "osteoporosis" (ongoing); "Nerve pain" (ongoing); "Pain/inflammation" (ongoing); "Pain/inflammation" (ongoing); "Weakened immune system" (unspecified if ongoing); "Asthma/COPD" (ongoing). Concomitant medication(s) included: METHOTREXATE taken for rheumatoid arthritis (ongoing); GABAPENTIN taken for neuralgia (ongoing); CELEBREX taken for pain, inflammation (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Time: 7:30 AM, Anatomical site of injection: Upper left arm, Route of administration: Intramuscular, Batch/Lot Number: EN6201), administration date: 10Mar2021, for Covid-19 Immunization, reaction(s): "No adverse event"; Bnt162b2 (Dose: 2, Time: 7:30 AM, Anatomical site of injection: Upper left arm, Route of administration: Intramuscular, Batch/Lot Number: DBP6955), administration date: 31Mar2021, for Covid-19 Immunization, reaction(s): "No adverse event"; Bnt162b2 (Dose: 3, Time: 11:00 AM, Anatomical site of injection: Upper left arm, Route of administration: Intramuscular, Batch/Lot Number: FC3187), administration date: 20Aug2021, for Covid-19 Immunization, reaction(s): "No adverse event". The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 26Jan2022, outcome "recovered" (27Jan2022), described as "I thought I was going to pass out"; HEART RATE INCREASED (non-serious) with onset 26Jan2022, outcome "recovered" (27Jan2022), described as "rapid heartbeat". The patient underwent the following laboratory tests and procedures: heart rate: (26Jan2022) increased, notes: Rapid heartbeat.  Clinical course: It was reported that the patient had no real issues with the first three doses. The patient had a rapid heart beat with the fourth dose. Patient had were a rapid heartbeat that started about 5 hours after the shot. It intensified a couple hours later. That started within a few hours of the injection. It continued for several hours becoming very rapid to the point that the patient thought that he/she was going to pass out. That lasted about half an hour then back to just a fast beat but tolerable. By the next day it was normal. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Specific relevant test for thromboembolic events with thrombocytopenia was reported as None . No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Spontaneous penile erection
Clinical narrative: penis got hard when Pfizer gave the vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SPONTANEOUS PENILE ERECTION (non-serious), outcome "unknown", described as "penis got hard when Pfizer gave the vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Nail discolouration, Pain in extremity, Raynaud's phenomenon, SARS-CoV-2 test
Clinical narrative: Bilateral  8 toes, except big toe is bluish red; Bilateral 8 toes, except big toe is/swollen; Bilateral 8 toes, except big toe is/burning feeling; Bilateral 8 toes, except big toe is/painful; Looks like Raynaud's phenomenon.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 (Lot number: FH8030) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VIT B12; ADVIL. Past drug history included: Metoclopramide, reaction(s): "known allergies: Metoclopramide", notes: known allergies: Metoclopramide. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0172, Location of injection: Arm Left), administration date: 03May2021, when the patient was 50 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0153, Location of injection: Arm Left), administration date: 12Apr2021, when the patient was 50 years old, for COVID-19 Immunization. The following information was reported: NAIL DISCOLOURATION (non-serious) with onset Dec2021, outcome "recovering", described as "Bilateral  8 toes, except big toe is bluish red"; SWELLING (non-serious) with onset Dec2021, outcome "recovering", described as "Bilateral 8 toes, except big toe is/swollen"; BURNING SENSATION (non-serious) with onset Dec2021, outcome "recovering", described as "Bilateral 8 toes, except big toe is/burning feeling"; PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "recovering", described as "Bilateral 8 toes, except big toe is/painful"; RAYNAUD'S PHENOMENON (non-serious) with onset Dec2021, outcome "recovering", described as "Looks like Raynaud's phenomenon.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of nail discolouration, swelling, burning sensation, pain in extremity, raynaud's phenomenon.  Additional information: It was reported that she had bilateral 8 toes, except big toe is bluish red, swollen, burning feeling and painful looks like Raynauds Phenomenon. No other vaccine in four weeks. other medications in two weeks included Vit B12, Advil as needed. No covid prior vaccination, she had covid tested post vaccination. AE treatment included Advil and Atenolol. No other medical history and no hospitalization prolonged.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Bilateral  8 toes, except big toe is bluish red; Bilateral 8 toes, except big toe is/swollen; Bilateral 8 toes, except big toe is/burning feeling; Bilateral 8 toes, except big toe is/painful; Looks like Raynaud's phenomenon.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 (Lot number: FH8030) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VIT B12; ADVIL. Past drug history included: Metoclopramide, reaction(s): "known allergies: Metoclopramide", notes: known allergies: Metoclopramide. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0172, Location of injection: Arm Left), administration date: 03May2021, when the patient was 50 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0153, Location of injection: Arm Left), administration date: 12Apr2021, when the patient was 50 years old, for COVID-19 Immunization. The following information was reported: NAIL DISCOLOURATION (non-serious) with onset Dec2021, outcome "recovering", described as "Bilateral  8 toes, except big toe is bluish red"; SWELLING (non-serious) with onset Dec2021, outcome "recovering", described as "Bilateral 8 toes, except big toe is/swollen"; BURNING SENSATION (non-serious) with onset Dec2021, outcome "recovering", described as "Bilateral 8 toes, except big toe is/burning feeling"; PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "recovering", described as "Bilateral 8 toes, except big toe is/painful"; RAYNAUD'S PHENOMENON (non-serious) with onset Dec2021, outcome "recovering", described as "Looks like Raynaud's phenomenon.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of nail discolouration, swelling, burning sensation, pain in extremity, raynaud's phenomenon.  Additional information: It was reported that she had bilateral 8 toes, except big toe is bluish red, swollen, burning feeling and painful looks like Raynauds Phenomenon. No other vaccine in four weeks. other medications in two weeks included Vit B12, Advil as needed. No covid prior vaccination, she had covid tested post vaccination. AE treatment included Advil and Atenolol. No other medical history and no hospitalization prolonged.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Headache, Nausea, Pyrexia
Clinical narrative: Severe nausea; severe headache; fever; couldn't get out of bed; Weak Lasted 72 hours; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Jan2022 17:15 (Lot number: FK9729) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 2, single, product=COVID 19, brand=Pfizer, lot number=EW0179, administration date=28Jun2021, administration time=10:00 AM, vaccine location=Left arm), administration date: 28Jun2021, when the patient was 55 years old, for COVID-19 immunization; Bnt162b2 (dose 1, single, product=COVID 19, brand=Pfizer, lot number=EW1077, administration date=07Jun2021, administration time=10:00 AM, vaccine location=Left arm), administration date: 07Jun2021, when the patient was 55 years old, for COVID-19 immunization. The following information was reported: NAUSEA (non-serious) with onset 29Jan2022 12:00, outcome "recovering", described as "Severe nausea"; HEADACHE (non-serious) with onset 29Jan2022 12:00, outcome "recovering", described as "severe headache"; PYREXIA (non-serious) with onset 29Jan2022 12:00, outcome "recovering", described as "fever"; BEDRIDDEN (non-serious) with onset 29Jan2022 12:00, outcome "recovering", described as "couldn't get out of bed"; ASTHENIA (non-serious) with onset 29Jan2022 12:00, outcome "recovered" (01Feb2022 12:00), described as "Weak Lasted 72 hours". Therapeutic measures were not taken as a result of nausea, headache, pyrexia, bedridden, asthenia.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications in two weeks. The patient had no known allergies. Facility type vaccine: Pharmacy or Drug Store.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: 1st dose some hair was falling out, then the 2nd dose she lost almost all her hair; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  An adolescent female patient received bnt162b2 (BNT162B2) (Lot number: fj4184) as dose 1, single and (Lot number: 123002) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "1st dose some hair was falling out, then the 2nd dose she lost almost all her hair".  Additional information: Prior to the vaccine the patient was a healthy teenager.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis, Sinusitis
Clinical narrative: She feels all congested, like she has a sinus infection.; She feels all congested, like she has a sinus infection.; I have cold something like that; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Feb2022 (Batch/Lot number: unknown) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, with the first 2 doses of the Pfizer COVID-19 Vaccine and she had no side effects at all), for Covid-19 Immunization, reaction(s): "had no side effects at all"; Bnt162b2 (Dose: 2, with the first 2 doses of the Pfizer COVID-19 Vaccine and she had no side effects at all), for Covid-19 Immunization, reaction(s): "had no side effects at all". The following information was reported: SINUSITIS (non-serious), NASAL CONGESTION (non-serious) all with onset Feb2022, outcome "unknown" and all described as "She feels all congested, like she has a sinus infection."; NASOPHARYNGITIS (non-serious) with onset Feb2022, outcome "unknown", described as "I have cold something like that". Therapeutic measures were taken as a result of sinusitis, nasal congestion, nasopharyngitis.  Additional information: Reporter stated that, patient received the booster dose yesterday 01Feb2022. Patient had no side effects at all with the first 2 doses of the Pfizer COVID-19 vaccine but now she feels all congested like she has a sinus infection. Patient didn't take prior vaccination since last Apr. Patient didn't receive other medicines before in her life. Therapeutic measures were taken as a result of sinusitis, nasal congestion and nasopharyngitis with Mucinex and Tylenol.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Some type of skin rash (big red/purple lesions all over neck and chest); This is a spontaneous report received from contactable consumer. The reporter is the patient.  A 42 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 16Dec2021 20:30 (Lot number: FL3197) at the age of 41 years as dose 1, single and administered in arm left, administration date 21Jan2022 08:30 (Lot number: FJ6369) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Antiphopholipid Syndrome" (unspecified if ongoing). Concomitant medications  included: WARFARIN; SERTRALINE.  The following information was reported: RASH (non-serious) with onset 26Dec2021 07:00, outcome "not recovered", described as "Some type of skin rash (big red/purple lesions all over neck and chest)". The event "some type of skin rash (big red/purple lesions all over neck and chest)" was evaluated at the physician office visit. Therapeutic measures were taken as a result of rash.  Additional information: some type of skin rash (big red/purple lesions all over neck and chest) appeared 10 days after 1st dose and also again 10 days after 2nd dose. Prior to vaccination, the patient was not diagnosed with COVID-19, and since the vaccination, has not been tested for COVID-19. The were no known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Joint Pain in Fingers; This is a spontaneous report received from a contactable Consumer via system.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Family history included: "Joint Pain in Fingers" (unspecified if ongoing), notes: Brother also got Joint Pain in Fingers but no neurological issues. The patient's concomitant medications were not reported.  The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "Joint Pain in Fingers".  The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain, Fatigue, Lymphadenopathy, Myalgia
Clinical narrative: Swollen Lymph Nodes; Pain in Left Axilla/ Breast; Pain in Left Axilla/ Breast; mild muscle aches; fatigue; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Jan2022 11:30 (Lot number: FJ5682) at the age of 60 years as dose 2 (booster), single for covid-19 immunisation. Relevant medical history included: "Osteopenia" (unspecified if ongoing); "Elevated BP" (unspecified if ongoing). Concomitant medication(s) included: PROZAC; LISINOPRIL; CALCIUM;VITAMIN D. Vaccination history included: Janssen covid 19 (Dose Number: 1, Batch/Lot No: 045A21A, Location of injection: Arm Left, administration date=17May2021), administration date: 17May2021, when the patient was 59 years old, for Covid-19 immunization, reaction(s): "no adverse events". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 01Feb2022, outcome "recovering", described as "Swollen Lymph Nodes"; AXILLARY PAIN (non-serious), BREAST PAIN (non-serious) all with onset 01Feb2022, outcome "recovering" and all described as "Pain in Left Axilla/ Breast"; MYALGIA (non-serious) with onset 01Feb2022, outcome "recovering", described as "mild muscle aches"; FATIGUE (non-serious) with onset 01Feb2022, outcome "recovering", described as "fatigue". Therapeutic measures were not taken as a result of lymphadenopathy, axillary pain, breast pain, myalgia, fatigue.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient not been tested with covid-19. The patient had no known allergies.   No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Hypoaesthesia, Nasopharyngitis, Pain
Clinical narrative: body aches a lot; I had my vaccine; I have a concern about my face, I feel my face numb; feeling very tired; cough; have a cold; cough with phlegm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 48 year-old male patient received bnt162b2 (BNT162B2), administration date 27Jan2022 (Batch/Lot number: unknown) at the age of 48 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: HYPOAESTHESIA (non-serious) with onset 08Feb2022, outcome "unknown", described as "I had my vaccine; I have a concern about my face, I feel my face numb"; FATIGUE (non-serious) with onset 2022, outcome "unknown", described as "feeling very tired"; COUGH (non-serious) with onset 2022, outcome "unknown", described as "cough"; NASOPHARYNGITIS (non-serious) with onset 2022, outcome "unknown", described as "have a cold"; PRODUCTIVE COUGH (non-serious) with onset 2022, outcome "unknown", described as "cough with phlegm"; PAIN (non-serious), outcome "unknown", described as "body aches a lot".  Additional information: The patient stated that he had a question, he had his vaccine the 27th last month the 27 and he had a concern about his face. he felt his face numb so, he wants to make sure, if this is like a symptom for the vaccine. he asked if his symptoms are related to vaccination and to make sure if he should go to the doctor, he stated since Friday he have been feeling very tired, he had some cough and cold, a cough with phlegm and body aches a lot, yesterday he felt on his face like it was kind of going numb and it felt like that throughout the day, but this morning he woke up and felt it a little better, I no longer feel that same symptom on his face.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Productive cough
Clinical narrative: body aches a lot; I had my vaccine; I have a concern about my face, I feel my face numb; feeling very tired; cough; have a cold; cough with phlegm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 48 year-old male patient received bnt162b2 (BNT162B2), administration date 27Jan2022 (Batch/Lot number: unknown) at the age of 48 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: HYPOAESTHESIA (non-serious) with onset 08Feb2022, outcome "unknown", described as "I had my vaccine; I have a concern about my face, I feel my face numb"; FATIGUE (non-serious) with onset 2022, outcome "unknown", described as "feeling very tired"; COUGH (non-serious) with onset 2022, outcome "unknown", described as "cough"; NASOPHARYNGITIS (non-serious) with onset 2022, outcome "unknown", described as "have a cold"; PRODUCTIVE COUGH (non-serious) with onset 2022, outcome "unknown", described as "cough with phlegm"; PAIN (non-serious), outcome "unknown", described as "body aches a lot".  Additional information: The patient stated that he had a question, he had his vaccine the 27th last month the 27 and he had a concern about his face. he felt his face numb so, he wants to make sure, if this is like a symptom for the vaccine. he asked if his symptoms are related to vaccination and to make sure if he should go to the doctor, he stated since Friday he have been feeling very tired, he had some cough and cold, a cough with phlegm and body aches a lot, yesterday he felt on his face like it was kind of going numb and it felt like that throughout the day, but this morning he woke up and felt it a little better, I no longer feel that same symptom on his face.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Her husband got his dose and all he was tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "recovered", described as "Her husband got his dose and all he was tired".  Additional information: The reporter reported that her husband got his dose and all he was tired, he took a nap and he was fine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: I do have pain in the bottom of my arm like in my armpit area; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 11Feb2022 (Lot number: FK9896) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Interchange of vaccine products" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (Dose 1, single), for COVID-19 immunization; Moderna covid-19 vaccine (Dose 2, single), for COVID-19 immunization. The following information was reported: AXILLARY PAIN (non-serious), outcome "unknown", described as "I do have pain in the bottom of my arm like in my armpit area".  Additional information: Consumer stated, I got my Booster of Pfizer but I don't know how, I am getting because my actual 2 Covid Vaccines being Moderna. Would that give me any side effects because I do have pain in the bottom of my arm like in my armpit area.   No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Circumstance or information capable of leading to medication error, Dizziness, Dyslexia, Epistaxis
Clinical narrative: when she blows her nose it bleeds more than it normally would/ Sometimes the bleeding is heavy and sometimes not; she was on blood thinner; little sick; little dizzy; she was sore with first shot, but that didn't last long; dyslexic; weak; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Dec2021 (Lot number: FJ8762) at the age of 69 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "blood thinner" (unspecified if ongoing); "blood disorder" (unspecified if ongoing), notes: She is still taking Warfarin; "thyroid problem" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: WARFARIN taken for blood disorder (ongoing); LEVOTHYROXINE taken for thyroid disorder (ongoing); HYDROCHLOROTHIAZIDE taken for hypertension (ongoing); ROSUVASTATIN taken for blood cholesterol increased (ongoing). Vaccination history included: Flu shot. The following information was reported: EPISTAXIS (medically significant), outcome "unknown", described as "when she blows her nose it bleeds more than it normally would/ Sometimes the bleeding is heavy and sometimes not"; CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "she was on blood thinner"; ILLNESS (non-serious), outcome "unknown", described as "little sick"; DIZZINESS (non-serious), outcome "unknown", described as "little dizzy"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "she was sore with first shot, but that didn't last long"; DYSLEXIA (non-serious), outcome "unknown", described as "dyslexic"; ASTHENIA (non-serious), outcome "unknown", described as "weak". Patient took levothyroxine, Rosuvastatin and Hydrochlorothiazide for a long time. She was still taking her blood thinners and noticed when she blows her nose it bleeds more than it normally would since taking Covid vaccine. Sometimes the bleeding was heavy and sometimes not. She had flu shot more than 4 weeks prior to getting Covid vaccine, with the first flu shot she ever got, she got sick and had to go ER. That was the first time she took the flu shot. She got very sick.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pain in extremity
Clinical narrative: when she blows her nose it bleeds more than it normally would/ Sometimes the bleeding is heavy and sometimes not; she was on blood thinner; little sick; little dizzy; she was sore with first shot, but that didn't last long; dyslexic; weak; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Dec2021 (Lot number: FJ8762) at the age of 69 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "blood thinner" (unspecified if ongoing); "blood disorder" (unspecified if ongoing), notes: She is still taking Warfarin; "thyroid problem" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: WARFARIN taken for blood disorder (ongoing); LEVOTHYROXINE taken for thyroid disorder (ongoing); HYDROCHLOROTHIAZIDE taken for hypertension (ongoing); ROSUVASTATIN taken for blood cholesterol increased (ongoing). Vaccination history included: Flu shot. The following information was reported: EPISTAXIS (medically significant), outcome "unknown", described as "when she blows her nose it bleeds more than it normally would/ Sometimes the bleeding is heavy and sometimes not"; CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "she was on blood thinner"; ILLNESS (non-serious), outcome "unknown", described as "little sick"; DIZZINESS (non-serious), outcome "unknown", described as "little dizzy"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "she was sore with first shot, but that didn't last long"; DYSLEXIA (non-serious), outcome "unknown", described as "dyslexic"; ASTHENIA (non-serious), outcome "unknown", described as "weak". Patient took levothyroxine, Rosuvastatin and Hydrochlorothiazide for a long time. She was still taking her blood thinners and noticed when she blows her nose it bleeds more than it normally would since taking Covid vaccine. Sometimes the bleeding was heavy and sometimes not. She had flu shot more than 4 weeks prior to getting Covid vaccine, with the first flu shot she ever got, she got sick and had to go ER. That was the first time she took the flu shot. She got very sick.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage, Vaccination site pain, Wrong technique in product usage process
Clinical narrative: experienced arm soreness for the next couple of days; person who injected the needle (i.e., vaccine) did it "wrong" or "at an angle"; person who injected the needle (i.e., vaccine) did it "wrong" or "at an angle" and made the arm bleed slightly; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (173415). The reporter is the patient.  A 37 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was unknown and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "experienced arm soreness for the next couple of days"; WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious), outcome "unknown", described as "person who injected the needle (i.e., vaccine) did it "wrong" or "at an angle""; VACCINATION SITE HAEMORRHAGE (non-serious), outcome "unknown", described as "person who injected the needle (i.e., vaccine) did it "wrong" or "at an angle" and made the arm bleed slightly". Additional information: When receiving the first dose, the person who injected the needle (i.e., vaccine) did it "wrong" or "at an angle" and made the arm bleed slightly: "went it at an angle"/"stabbed me a little"; experienced arm soreness for the next couple of days. Other medications, family history, social history were unknown.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke after taking the vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke after taking the vaccine". Clinical Course: The reporter mentioned that her daughter got Covid but got over it. She said that her daughter doesn't want to be vaccinated because they don't trust the vaccine since she heard that her neighbour had a stroke after taking the vaccine. However, their company is requiring them to be vaccinated. The reporter wants to know the ingredients of the vaccine so they would know what to tell their allergist.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Hypoaesthesia, Insomnia, Lymphadenopathy
Clinical narrative: severe pain; Right arm swelling; redness; hand numbness and tingling; hand numbness and tingling; right axillary lymph node enlargement; insomnia due to pain; insomnia due to pain; severe fatigue; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 14Feb2022 04:30 (Lot number: FJ6369) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "tachycardia" (unspecified if ongoing); "GERD" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: PROTONIX [OMEPRAZOLE]; PROPRANOLOL; VITAMIN D [COLECALCIFEROL]. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: E43246, Location of injection: Arm Left), administration date: 13Jan2021, when the patient was 48 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EH9899, Location of injection: Arm Left), administration date: 23Dec2020, when the patient was 48 years old, for Covid-19 immunization. No other vaccine in four weeks. The following information was reported: PAIN (medically significant) with onset 15Feb2022 07:00, outcome "recovering", described as "severe pain"; PERIPHERAL SWELLING (non-serious) with onset 15Feb2022 07:00, outcome "recovering", described as "Right arm swelling"; ERYTHEMA (non-serious) with onset 15Feb2022 07:00, outcome "recovering", described as "redness"; HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious) all with onset 15Feb2022 07:00, outcome "recovering" and all described as "hand numbness and tingling"; LYMPHADENOPATHY (non-serious) with onset 15Feb2022 07:00, outcome "recovering", described as "right axillary lymph node enlargement"; INSOMNIA (non-serious), PAIN (non-serious) all with onset 15Feb2022 07:00, outcome "recovering" and all described as "insomnia due to pain"; FATIGUE (non-serious) with onset 15Feb2022 07:00, outcome "recovering", described as "severe fatigue". Due to the events the patient missed 2 days of work so far. No covid prior vaccination. No covid tested post vaccination. Therapeutic measures were taken as a result of pain, peripheral swelling, erythema, hypoaesthesia, paraesthesia, lymphadenopathy, insomnia, pain, fatigue included Tylenol , Ibuprofen, Benadryl ice packs.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on current available information, there is reasonable possibility of causal association between the event pain and the suspect drug BNT162B2