chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Herpes virus infection, Inflammation, Pruritus, Rash vesicular
Clinical narrative: Herpes Virus associated vesicular rash on top of left foot, with intense, radiating itchiness, inflammation; Herpes Virus associated vesicular rash on top of left foot, with intense, radiating itchiness, inflammation; Herpes Virus associated vesicular rash on top of left foot, with intense, radiating itchiness, inflammation; Herpes Virus associated vesicular rash on top of left foot, with intense, radiating itchiness, inflammation; redness; This is a spontaneous report from a contactable consumer.   A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EW0187), via an unspecified route of administration in the right arm on 02May2021 as a single dose for COVID-19 vaccination. On an unknown date 03:45 PM the patient received second dose of BNT162B2 (Lot number: EW0176), via an unspecified route of administration in the right arm on 02May2021 as a single dose for COVID-19 vaccination. Medical history included hypothyroidism. Concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine nor any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to or since the vaccination. The patient experienced Herpes Virus associated vesicular rash on top of left foot, with intense, radiating itchiness, inflammation. On 02Jun2021 08:30 PM, intensely itchy area on top of left foot, which she thought was a bug bite. Topical Benadryl (Diphenhydramine) was applied. On 03Jun2021, two small scabs emerged (approx. 5-8mm wide) that looked like abrasion/scab from excessive scratching. 03Jun2021 - 04Jun2021 itchiness subsided. On 05Jun2021, there was visible redness, inflammation and small vesicle formation around two scabbed areas in conjunction with intense radiating itchiness extending beyond areas of visible inflammation. 05Jun2021 - 06Jun2021 inflammation, intense radiating itchiness and formation of new and larger vesicles ultimately forming a 3' rash across top of foot. On 08Jun2021 the patient consulted with primary care physician (PCP): Weeping vesicles and new vesicles formation noted. Antibiotics and topical cream prescribed, and culture performed. On 11Jun2021: second opinion with dermatologist and testing of affected area positive for Herpes virus. Antiviral medication was prescribed. Treatment for the adverse events included Cephalexin, Mupirocin and Valacyclovir. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: breakthrough Covid case; breakthrough Covid case; This is a spontaneous report from a contactable consumer or other non hcp.    A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications was not reported. Patient previously took first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, at single dose for covid-19 immunisation. It was reported that, patient received both doses of Pfizer vaccine (Further not clarified hence captured as Unspecified vaccine) a few months ago and just wanted to call because recently patient had a breakthrough Covid case. It was reported as there was product complaint. The lab tests included test : covid-19, result: positive on unknown date. The outcome of the events was unknown. ~ Follow-up(12Jun2021): Upon follow up, no new information was included.  Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Colitis ulcerative
Clinical narrative: huge flare with her Ulcerative Colitis; This is a spontaneous report from a contactable pharmacist via medical information team.   A female patient of an unspecified age received first dose of BNT16B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date: UN-KNOWN), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included adalimumab (HUMIRA), 160 mg (Then in 2 weeks will go down to 80 mg dose) taken for an unspecified indication from year 2021 and ongoing.   On an unspecified date of Jun2021, the patient experienced huge flare with her ulcerative colitis. Re-porter was concerned about the immune response the patient will receive and her immunity to Covid-19 after her second dose while on the immunosuppressant therapy, or should the patient wait to receive her second dose until she was at her maintenance dose in 4 weeks time. Therapeutic measures were taken as a result of the event with steroids. The outcome of the event was unknown.  Information about batch/lot number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event ulcerative colitis (relapse) and the suspect drug.  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.,Linked Report(s) : US-PFIZER INC-2021707940 Same reporter,patient/ different event, dose
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Pruritus, Vaccination site rash
Clinical narrative: Caller is experiencing eye swelling and rash at the injection site.; Caller is experiencing eye swelling and rash at the injection site.; the itchy burning drives me crazy; This is a spontaneous report from a contactable consumer or other non hcp. A 49-years-old female patient received (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported.The patient's concomitant medications were not reported. The patient experienced caller is experiencing eye swelling and rash at the injection site. (medically significant) on an unspecified date with outcome of unknown , caller is experiencing eye swelling and rash at the injection site (medically significant) on an unspecified date with outcome of unknown , the itchy burning drives me crazy (pruritus) (medically significant) on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of caller is experiencing eye swelling and rash at the injection site. (eye swelling), the itchy burning drives me crazy (pruritus).
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall, Loss of consciousness, Neck pain, Vomiting
Clinical narrative: unconscious for 3-4 minutes; neck pain; dizziness; vomiting; fell down; This is a spontaneous report from a contactable consumer (patient). A 38-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number: Unknown), via an unspecified route of administration on an unspecified date as UNKNOWN DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced on an unspecified date it was reported she would also like to know if this is something she should see a doctor for and what can she take to make the neck pain go away. Caller stated she received the vaccine around 1-2pm it was really crowded and she experienced dizziness around 3 am after receiving the vaccine and she also had vomiting and she fell down. She stated she was unconscious for 3-4 minutes after becoming dizzy and falling down and she did not have these symptoms prior to receiving the vaccine. The clinical outcome of the events were unknown.  Information about batch/Lot number has been requested.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: 2 days after  2 shot severe shortness of breath; This is a spontaneous report from a contactable consumer (Patient). An 84-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection; Lot Number: ep7534), via an unspecified route of administration administered in Arm Left on 23Mar2021 as 2nd dose, single dose for COVID-19 immunization. Age at the time of vaccination was 84 year. Medical history included atrial fibrillation (afib) and allergies (unspecified). The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection; Lot Number: en6203) via an unspecified route of administration, administered in Arm Left on 02Mar2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. Patient did not have other vaccine in four weeks. Patient did not have covid prior vaccination. Patient was not tested with covid post vaccination. 2 days after 2 shot, the patient experienced severe shortness of breath (dyspnoea) on 25Mar2021. Event resulted in Doctor or other healthcare professional office/clinic visit and was treated with prescribed drugs for heart failure. Therapeutic measures were taken as a result of shortness of breath. Seriousness of the event was reported Disabling/Incapacitating. The outcome of the event was recovered with sequelae.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: got COVID-19 after receiving the first vaccine; got COVID-19 after receiving the first vaccine; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE ), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for covid-19 immunization. Medical history and concomitant medications were not reported. The patient was wanting to get the second dose of the COVID vaccine 5 months after receiving the first vaccine. Caller wanted to know if there was any harm in giving the vaccine after five months and if the series needs to be repeated. Caller stated that the patient did not receive the vaccine because the patient got COVID-19 after receiving the first vaccine. The outcome of event was unknown.  Information about batch/lot number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events drug ineffective, suspected COVID-19 and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: my arm hurt worst from my elbow up and seems it has gone to my sides; This is a spontaneous report from a contactable consumer (patient). A consumer (patient) of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration, administered in arm on "215" (not clarified) as 2nd dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 vaccine on "115" (not clarified) for COVID-19 immunization. The patient did not know which way go to try and find this stuff. The patient had a reaction since the patient got the last shot (second dose) of Pfizer. The patient got the first one on "115" (not clarified) and second one on "215" (not clarified). The patient mentioned "since that shot my arm has hurt from my elbow up and it seems that it has gone to my sides or something, the worst part is the arm". The patient just been wondering for a month how to find out if anybody else have this problem. Further the patient stated "am just curious if something else going on but after this one (second shot) happened they been trying to get a steroid shot (treatment) that could helped me but nothing helping, so will call them. All my friends are saying you experience from the shot but I didn't know that. I am trying to find out." The outcome of the event was unknown.  Information about batch/lot number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for Covid 19 vaccine; tested positive for Covid 19 vaccine; This is a spontaneous report from a contactable consumer (patient) and other healthcare professional.   A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: EL9269 or EI9269 or E19269), dose 2 via an unspecified route of administration, administered in Arm Right on 12Feb2021 around 7:00pm (at the age of 45 years old) as 2nd dose, single dose for COVID-19 immunization. Medical history included high prolactin, former smoker. No family medical history relevant to adverse events. Concomitant medication(s) included gabapentin (GABAPENTIN) taken for an unspecified indication, gabapentin 300mg, 3 times per day and stopped taking it because she got tired of it and didn't see any improvement. She stopped taking it maybe 2 months ago and had only been taking it not even 3 months, start and stop date were not reported; bromocriptine (BROMOCRIPTINE) taken for high prolactin, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. No additional vaccines administered on same date of the Pfizer suspect. No adverse events following prior vaccinations. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: EL3249, or EI3249, or E13249), dose 1 via an unspecified route of administration, administered in Arm Right on 20Jan2021 around 12:00am as 1st dose, single dose for COVID-19 immunization and experienced pain in arm, dry mouth and little headache. It was reported that patient tested positive for Covid 19 after having both doses of the Covid 19 vaccine. She got vaccinated with first dose on 20Jan2021 and had the second dose on 12 Feb 2021. She got Covid, tested positive for COVID, 24 May 2021. She went back for a test again this Monday, 7 Jun 2021 and it was negative. The patient stated that she went to see her primary care doctor and they told her to report about the vaccine. She stated there was nothing after the second dose. Adverse event did not require a emergency room/physician office visit. Investigation Assessment: Yes. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 24May2021, sars-cov-2 test: negative on 07Jun2021. The clinical outcome of the event tested positive for covid 19 vaccine was recovered on 07Jun2021 and vaccination failure was unknown.  Information about Lot/Batch number requested, additional information requested.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pyrexia
Clinical narrative: woke up very tired; developed fever in the afternoon of that same day that reached 101.5 and remained this high for approximately 5 hours (6-11 pm); mild headache; This is a spontaneous report from a contactable consumer. A 13-year-old male patient received BNT162B2 (Formulation: Solution for injection; Batch/Lot number: Unknown), via an unspecified route of administration on 10Jun2021 as unknown, single dose for covid-19 immunisation. The patient's medical history included arthritis reactive from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 10Jun2021, Thursday, on the day of vaccination, the patient experienced mild headache on the day of vaccination. The patient woke up very tired the following day on 11Jun2021 and stayed home. He developed fever in the afternoon of that same day that reached 101.5 and remained this high for approximately 5 hours (6-11 pm) despite the use of paracetamol. The patient was able to sleep through the night and woke up feeling fine today 12Jun2021, which was the second day after vaccination. The received treatment with paracetamol for fever. The outcome of the events was recovered on 12Jun2021.  Information related to batch/Lot no. was requested.
Age: 44.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cold sweat, Dyspnoea, Feeling cold, Feeling hot, Flushing
Clinical narrative: shortness of breath; wheezing; hot; flushed; cool; clammy; This is a spontaneous report from a contactable nurse received via a sales representative. A 44-years-old female patient received second dose of BNT162B2 (COVID-19 VACCINE-MANUFACTURER UNKNOWN, formulation: Solution for injection, lot number unknown) via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE DOSE for COVID-19 immunisation; infliximab (INFLECTRA, formulation: Powder for injection, lot Number: EJ1527; Expiration Date: Nov2024, after 7th infusion (2nd reload), via an unspecified route of administration from an unspecified date, at an unknown dose for an unspecified indication. Medical history ongoing Ankylosis Spond. Concomitant medication included methotrexate (METHOTREXATE) taken for an unspecified indication from an unspecified start date and ongoing. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), for covid-19 immunisation. It was reported that patient was premedicated with Tylenol and Benadryl, used Humira prior to switching to Inflectra. Patient had received 2nd Covid Vaccination at least two weeks prior. Nurse said it was unknown if it was Pfizer or Moderna, but Pfizer was more commonly available being it came out first. No previous issues with Inflectra until Covid shot, event took place after use of product. On an unspecified date, the patient experienced shortness of breath, wheezing, hot, flushed, cool and clammy. The outcome of reported events was unknown.  Information about lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Wheezing
Clinical narrative: shortness of breath; wheezing; hot; flushed; cool; clammy; This is a spontaneous report from a contactable nurse received via a sales representative. A 44-years-old female patient received second dose of BNT162B2 (COVID-19 VACCINE-MANUFACTURER UNKNOWN, formulation: Solution for injection, lot number unknown) via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE DOSE for COVID-19 immunisation; infliximab (INFLECTRA, formulation: Powder for injection, lot Number: EJ1527; Expiration Date: Nov2024, after 7th infusion (2nd reload), via an unspecified route of administration from an unspecified date, at an unknown dose for an unspecified indication. Medical history ongoing Ankylosis Spond. Concomitant medication included methotrexate (METHOTREXATE) taken for an unspecified indication from an unspecified start date and ongoing. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), for covid-19 immunisation. It was reported that patient was premedicated with Tylenol and Benadryl, used Humira prior to switching to Inflectra. Patient had received 2nd Covid Vaccination at least two weeks prior. Nurse said it was unknown if it was Pfizer or Moderna, but Pfizer was more commonly available being it came out first. No previous issues with Inflectra until Covid shot, event took place after use of product. On an unspecified date, the patient experienced shortness of breath, wheezing, hot, flushed, cool and clammy. The outcome of reported events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Migraine
Clinical narrative: I got tired; She felt headache on right side of her head/getting migraines but only on the right side of my head; This is a spontaneous report from a contactable female consumer (patient) reported for herself via Pfizer Sponsored Program. A female patient of unspecified age received first dose of BNT162B2 (Pfizer covid-19 vaccine, Solution for Injection, Lot number: Unknown, Expiration date: Unknown), via an unspecified route on 22May2021, as a single dose for covid-19 immunization. Medical history included anaphylactic reaction which patient got before in her life. The patient concomitant medications were not reported. On an unknown date after first dose, patient got tired and started getting migraines but only on the right side of the head. The clinical outcome of the migraine was gone away and fatigue was unknown. Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chest pain, Diarrhoea, Dyspnoea, Heart rate
Clinical narrative: Shortness of breath because of my heart issue; Lot of diarrhea; Severe stomach pain; Severe pain in my chest with heart racing; Little bit of pain in my chest, nothing like a couple of hours after I got the vaccine, it was very severe in my chest and heart racing; Severe pain in my chest with heart racing; Little bit of pain in my chest, nothing like a couple of hours after I got the vaccine, it was very severe in my chest and heart racing; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date as 1st dose, single dose for Covid-19 immunization. Medical history included heart failure. The patient's concomitant medications were not reported. The patient took the first vaccine last week and due for the second one on 25Jun2021. On an unknown date, the patient had severe pain in chest with heart racing. The patient had a heart failure and a lot of other things that were issues with heart. The patient had severe stomach pain, a lot of diarrhea (reported as on Friday, Saturday, Sunday and Monday and a few days this week, just a few days). The patient stated it seems to be okay (reported as Today). On an unknown date, the patient experienced a little bit of pain in chest that the patient had normally but nothing like a couple of hours after the patient got the vaccine. It was reported that it was very severe in chest and like the heart racing and some, the patient also had shortness of breath because of heart issue but this was even more. The outcome of events severe pain in my chest with heart racing (chest pain and heartbeats increased) was recovering while unknown for rest of the events.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Shortness of breath because of my heart issue; Lot of diarrhea; Severe stomach pain; Severe pain in my chest with heart racing; Little bit of pain in my chest, nothing like a couple of hours after I got the vaccine, it was very severe in my chest and heart racing; Severe pain in my chest with heart racing; Little bit of pain in my chest, nothing like a couple of hours after I got the vaccine, it was very severe in my chest and heart racing; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date as 1st dose, single dose for Covid-19 immunization. Medical history included heart failure. The patient's concomitant medications were not reported. The patient took the first vaccine last week and due for the second one on 25Jun2021. On an unknown date, the patient had severe pain in chest with heart racing. The patient had a heart failure and a lot of other things that were issues with heart. The patient had severe stomach pain, a lot of diarrhea (reported as on Friday, Saturday, Sunday and Monday and a few days this week, just a few days). The patient stated it seems to be okay (reported as Today). On an unknown date, the patient experienced a little bit of pain in chest that the patient had normally but nothing like a couple of hours after the patient got the vaccine. It was reported that it was very severe in chest and like the heart racing and some, the patient also had shortness of breath because of heart issue but this was even more. The outcome of events severe pain in my chest with heart racing (chest pain and heartbeats increased) was recovering while unknown for rest of the events.  Information on the lot/batch number has been requested.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19, UNK, UNK, UNK
Symptoms: Product administered at inappropriate site, Pruritus, Urticaria, Urticaria chronic
Clinical narrative: first dose in left leg; chronic urticaria; began waking up feeling itchy like I had been bitten by bed bugs or mosquitos; would be covered from head to toe in hives and wheals at all times of the day and night; This is a spontaneous report from a contactable consumer. A 34-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EP753A, Expiry date was not reported), via an unspecified route of administration Left leg on 15Mar2021 11:15, as 1st dose, single dose and the patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EP7533, expiry date was not reported), via an unspecified route Left Arm on 05Apr2021 11:15, as 2nd dose, single dose for COVID-19 immunization. The patient's medical history included anxiety and depression from an unspecified date and unknown if ongoing. Concomitant medication reported was finasteride, 1 mg, 1x/week for unspecified indication. Patient did not have any know allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient reporting adverse side effects of chronic urticaria following my first and second COVID-19 vaccination on 15Mar2021 and 05Apr2021. Following first and second COVID-19 vaccination, the patient experienced adverse side effects of chronic urticaria on 24Mar2021. The following week after first vaccine, on 24Mar2021, he began waking up feeling itchy like he had been bitten by bed bugs or mosquitos. Over the next two months, his condition only worsened where she would be covered from head to toe in hives and wheals at all times of the day and night. He visited with a dermatologist and an allergist and was prescribed numerous antihistamines and corticosteroids such as prednisone to try to control his chronic hives. After consultation with his allergist, he was prescribed Xolair/omalizumab as a last resort to controlling his chronic urticaria. Prior to his covid vaccination he had never experienced anything like chronic urticaria and his condition has only worsened since his second vaccination. Patient was treated with Antihistamines, prednisone, Xolair. The outcome of event was not recovered.   Follow-up attempts are possible. Further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021709306 similar report from same reporter
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19, UNK, UNK, UNK
Symptoms: Arthropod bite, Blood test, Drug dependence, Drug effect less than expected, Urticaria
Clinical narrative: first dose in left leg; chronic urticaria; began waking up feeling itchy like I had been bitten by bed bugs or mosquitos; would be covered from head to toe in hives and wheals at all times of the day and night; This is a spontaneous report from a contactable consumer. A 34-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EP753A, Expiry date was not reported), via an unspecified route of administration Left leg on 15Mar2021 11:15, as 1st dose, single dose and the patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EP7533, expiry date was not reported), via an unspecified route Left Arm on 05Apr2021 11:15, as 2nd dose, single dose for COVID-19 immunization. The patient's medical history included anxiety and depression from an unspecified date and unknown if ongoing. Concomitant medication reported was finasteride, 1 mg, 1x/week for unspecified indication. Patient did not have any know allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient reporting adverse side effects of chronic urticaria following my first and second COVID-19 vaccination on 15Mar2021 and 05Apr2021. Following first and second COVID-19 vaccination, the patient experienced adverse side effects of chronic urticaria on 24Mar2021. The following week after first vaccine, on 24Mar2021, he began waking up feeling itchy like he had been bitten by bed bugs or mosquitos. Over the next two months, his condition only worsened where she would be covered from head to toe in hives and wheals at all times of the day and night. He visited with a dermatologist and an allergist and was prescribed numerous antihistamines and corticosteroids such as prednisone to try to control his chronic hives. After consultation with his allergist, he was prescribed Xolair/omalizumab as a last resort to controlling his chronic urticaria. Prior to his covid vaccination he had never experienced anything like chronic urticaria and his condition has only worsened since his second vaccination. Patient was treated with Antihistamines, prednisone, Xolair. The outcome of event was not recovered.   Follow-up attempts are possible. Further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021709306 similar report from same reporter
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19, UNK, UNK, UNK
Symptoms: Urticaria chronic
Clinical narrative: first dose in left leg; chronic urticaria; began waking up feeling itchy like I had been bitten by bed bugs or mosquitos; would be covered from head to toe in hives and wheals at all times of the day and night; This is a spontaneous report from a contactable consumer. A 34-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EP753A, Expiry date was not reported), via an unspecified route of administration Left leg on 15Mar2021 11:15, as 1st dose, single dose and the patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EP7533, expiry date was not reported), via an unspecified route Left Arm on 05Apr2021 11:15, as 2nd dose, single dose for COVID-19 immunization. The patient's medical history included anxiety and depression from an unspecified date and unknown if ongoing. Concomitant medication reported was finasteride, 1 mg, 1x/week for unspecified indication. Patient did not have any know allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient reporting adverse side effects of chronic urticaria following my first and second COVID-19 vaccination on 15Mar2021 and 05Apr2021. Following first and second COVID-19 vaccination, the patient experienced adverse side effects of chronic urticaria on 24Mar2021. The following week after first vaccine, on 24Mar2021, he began waking up feeling itchy like he had been bitten by bed bugs or mosquitos. Over the next two months, his condition only worsened where she would be covered from head to toe in hives and wheals at all times of the day and night. He visited with a dermatologist and an allergist and was prescribed numerous antihistamines and corticosteroids such as prednisone to try to control his chronic hives. After consultation with his allergist, he was prescribed Xolair/omalizumab as a last resort to controlling his chronic urticaria. Prior to his covid vaccination he had never experienced anything like chronic urticaria and his condition has only worsened since his second vaccination. Patient was treated with Antihistamines, prednisone, Xolair. The outcome of event was not recovered.   Follow-up attempts are possible. Further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021709306 similar report from same reporter
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, COVID-19, SARS-CoV-2 test positive
Clinical narrative: No/Blood test: Positive/Since the vaccination, has the patient been tested for COVID-19?:Yes; This is a spontaneous report from a contactable physician.  A 17-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), an unspecified route of administration, administered in Right Arm on 13Jun2021 at 12:00 as 1st Dose, Single Dose for COVID-19 immunization. The patient's medical history included None. The patient had no known allergies. The patient's concomitant medications were not reported. Since the vaccination, the patient has tested for COVID-19.It was Unknown, if patient diagnosed with COVID-19 prior to vaccination. On 13Jun2021, after 1st Dose of vaccination, the patient underwent a covid test type post vaccination=Blood test, covid test name post vaccination, covid test result=Positive. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Congenital anomaly or birth defect]no days hospitalization: 4. The patient underwent lab tests and procedures which included blood test was positive on 13Jun2021 Blood test,sars-cov-2 test positive: positive on 13Jun2021 [{covid test type post vaccination was Blood test, covid test name post vaccination=covid test date was 13Jun/2021,covid test result was Positive. The outcome for the events was recovered/resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Lymph node pain, Lymphadenopathy, Pain
Clinical narrative: Mild body aches; Headache; Swollen lymph node in right armpit the size of 1/2 orange and some pressure and mild pain.; Swollen lymph node in right armpit the size of 1/2 orange and some pressure and mild pain.; This is a spontaneous report received from a contactable consumer (patient).  A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number  EW0161 and expiration date: 31JUL2021) via intramuscular, on right arm, on 11Jun2021 at 17:00, (at the age of 56-year-old), as 2ND DOSE, SINGLE DOSE for covid-19 immunization at Pharmacy or Drug Store. The patient medical history was not reported. The patient is not pregnant at the time of vaccination. The patient had no concomitant medications. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number:EW0151 and expiration date: not reported)  via intramuscular, on Left arm, on 21May2021 at 17:35,(at the age of 56-year-old) as 1ST DOSE, SINGLE DOSE  for covid-19 immunization. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine.The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. After the vaccination patient has not been tested for COVID-19. It was reported that on 12Jun2021, the patient spent the afternoon at a hot (90 degrees) and sunny festival. The patient came home and watched TV for several more hours of no symptoms. The patient noticed the swollen lymph node described as swollen lymph node in right armpit the size of 1/2 orange and some pressure and mild pain as the patient went to bed on 12Jun2021 at 19:00. On 13Jun2021, the next day, it was more painful and increased in pain, the 3rd day the patient finally took an ibuprofen. On 15Jun2021 at 17:15, it seemed to lessen in pain without drugs but the patient will probably take another dose to sleep. On 13Jun2021, the patient experienced mild body aches and headache. The patient underwent lab tests and procedures which included body temperature: 97.8 on 11Jun2021 and 98.8 on 12Jun2021. Therapeutic measures taken in response to the event headache included administration of Excedrin, 1 pill by mouth on 13Jun2021 and ibuprofen by mouth on 15Jun2021 and ongoing lymph node in right armpit the size of 1/2 orange and some pressure and mild pain. It was reported that the ibuprofen helped. No treatment was given for the event mild body aches. Outcome of the event Swollen lymph node in right armpit the size of 1/2 orange, and some pressure and mild pain was recovering and the events mild body aches and headache recovered in Jun2021.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: headache; nausea; This is a spontaneous report from a contactable consumer (patient's mother). A 15-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number  and expiration date: not reported), via an unspecified route of administration, on an unspecified date as 2ND DOSE, SINGLE DOSE for covid-19 immunization .The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiration date: not reported) via an unspecified route of administration, on an unspecified date, as 1ST DOSE, SINGLE DOSE for covid-19 immunization and no reaction was reported.  The patient experienced headache and nausea on 12Jun2021. The outcome of events was unknown.  Information on the lot number/batch number has been requested.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: He got covid after the first dose.; He got covid after the first dose.; This is a spontaneous report from a contactable pharmacist reporting for a patient via Pfizer-sponsored program. A 47-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in Jan2021 as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient got the first dose in Jan2021 and he got covid after the first dose on an unspecified date in 2021. The patient wanted to know if he could get the second shot now. The patient underwent lab tests and procedures which included covid-19 (SARS-CoV-2 test): positive on an unspecified date in 2021. The outcome of events was reported as unknown.   Information related to batch/ lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Exposure to SARS-CoV-2, Illness
Clinical narrative: Caller said with Covid people were getting sick; sick; cough/ he still has cough; This is a spontaneous report from a contactable male consumer (patient). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date were not reported) via unspecified route of administration on 03Mar2021 as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Previously patient took first dose of BNT162B2 for COVID-19 immunization. It was reported that he received the 2nd dose of the Pfizer COVID Vaccine on 03Mar2021. Two weeks later, he developed a cough in Mar2021 that was still persistent by the time of the call. He mentioned that he did not have a cough prior to the vaccine and was certain that his prolonged cough was caused by the vaccine. He received his vaccine He was asking if this had been reported and for what to do about it. Again, stated that he took his last shot at a Health Facility. It was the Pfizer last shot on 3Mar2021. He developed a cough 2 weeks later and now it was 14Jun2021 and he still had cough. Patient said with Covid people were getting sick. Patient stated that he was trying to find out what to do about the cough. When caller was advised to consult with primary healthcare professional, caller said that physicians did not know how to treat the cough. It was a vigorous cough. Caller wanted to know if we had seen a cough like this that went on this long and what to do about it. He was taking treatment with cough drops and cough medicine, still coughing, but nothing was working. At the time of report, the outcome of event cough was not resolved, whereas unknown for other events.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pruritus
Clinical narrative: I'm pregnant; Itching; This is a spontaneous report from a contactable consumer(patient) via Medical Information Team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 10Jun2021 as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Caller received her first dose on 10Jun2021 and had itching, that started several hours after the dose. She took Benadryl. She was pregnant. She wanted to know whether she can get the second dose. Serious was reported as no. Outcome of the events was unknown.  Information on lot/batch has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Asthenia, Dizziness, Palpitations
Clinical narrative: Dizziness; Heart racing; Weakness; This is a spontaneous report from a contactable other healthcare professional (nurse). A female patient of unspecified age received BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for Injection) via an unspecified route on 10Mar2021, as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 10Mar2021, within ten or fifteen minutes of taking the dose, patient experienced dizziness then She came home and her heart rate was raising and she had weakness and dizziness. She also mentioned that she was negative for antibodies. She called where she got the vaccine and they said to keep monitoring and talk to her healthcare provider. Patient wanted to know if her adverse events have been reported as a side effect or are, they sign of an allergic reaction. She also wanted to know if she should take the second dose of the vaccine. She said that she has consulted her doctor and she was advised to get the second dose of the vaccine and wanted to know if it is ok to get the vaccine 3-4 months after the first dose. The patient underwent lab test and procedure which included antibodies test negative on an un-known date. The clinical outcome of the events was unknown.  Follow-up attempts are needed; Information about batch/ lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: Itch/ the caller experienced itching on both arms; she had a sore arm; This is a spontaneous report received from contactable consumer (patient) via a Pfizer sponsored program COVAX US Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) via an unspecified route of administration on 03Jun2021 as 1st dose single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received flu shot. It was reported that the patient received her first dose of Pfizer-BioNTech COVID-19 Vaccine on 03Jun2021 (Thursday), and her second dose was scheduled for 24Jun2021. The patient stated, she just wanted to check in because she did find had no real reaction, the shot was like a flu shot. On 05Jun2021, at first the patient experienced a sore arm and then that went away. The patient stated both her arms started to itch which was on Saturday 05Jun2021 (reported as two days later). Arm itching had stopped. The clinical outcome of the evets was recovered on an unknown date in Jun2021.  Information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site bruising, Vaccination site inflammation, Vaccination site pain, Vaccination site swelling
Clinical narrative: and still complaining of pain and inflammation at the injection site; And still complaining of pain and inflammation at the injection site; Swelling at the injection site; she could put a "gel on it for bruising and swelling. She is wondering if she can smear some of that on the site; She has a lot of joint pain; This is a spontaneous report from a contactable consumer (patient's friend) via medical information team. A female patient in her 50's received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), second dose via an unspecified route of administration on an unspecified date as a Single Dose for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Historical vaccination included previously received dose 1 bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunization. Report is not related to a study or programme. It was reported that the reporter called on the behalf of her "dear friend who is a female in her 50s". The reporter stated that the patient received the 2nd dose of the Pfizer vaccine on Thursday, and she spoke to her this morning and she still complaining of pain and inflammation at the injection site. The patient has been using cold compress. The reporter stated it was strange because she has been applying a cold compress to lessen the pain and inflammation, but as soon as she stops, it comes back, and it does not even seem to go away. The reporter wanted to know how long the patient would "have to go through this." The reporter stated that the patient was reluctant to call, she says she does not like to call about "every little thing" however the reporter stated its "not a little of a thing" and wanted to call and see if she could help provide answers to her friend. The reporter would like to know if there was anything the patient can use for the pain and swelling at the injection site. She stated she was unsure if she could put a "gel on it for" bruising and swelling. She was wondering if she can smear some of that on the site. The reporter was sure the patient had it because the patient had a lot of joint pain. Maybe with that would alleviate it in addition to the cold compress. That could probably help her. "Advised caller Pfizer does not provide any recommendations regarding the management or treatment of potential adverse events/reactions/symptoms that a patient/consumer may experience". The events were treated with cold compress. The outcome of the events vaccination site pain and vaccination site Inflammation was reported as not recovered and for other events reported as unknown.  No follow-up attempts are possible. No further information is expected.