chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Hypoaesthesia, Menstrual disorder, Muscle spasms
Clinical narrative: Seizures around 7 pm the same day; Cough; Severe congestion; Freezing cold all the time; Muscle spasms; Heart palpitations; Numbness of my hands and feet; Severe tremors in my hands; Dizziness; Weight loss; Menstrual cramps; Has affected my menstrual cycle severely; Loss of appetite; Headaches; Had extreme fatigue; This is a spontaneous report from a contactable consumer (patient). A 31-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0175), via an unspecified route of administration in the left arm on 10Jun2021 at 11:40 as a dose 2, single for COVID-19 immunization (at the age of 31-years-old). Medical history included Known allergies: Soy from an unknown date and unknown if ongoing.There were no concomitant medications. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0173), via an unspecified route of administration in the left arm on 20May2021 at 12:00 as a dose 1, single for COVID-19 immunization (at the age of 31-years-old). The patient did not receive any medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient stated that she had two seizures around 7 pm the same day (10Jun2021 19:00). Since her second dose of Pfizer, 10Jun2021 13:00, she have had extreme fatigue, cough, severe congestion, freezing cold all the time, muscle spasms, heart palpitations, numbness of my hands and feet, severe tremors in my hands, headaches, dizziness, loss of appetite, weight loss, menstrual cramps every day and has affected her menstrual cycle severely. The patient did not receive any treatment. The clinical outcome for the events was not recovered.  Follow-up attempts are completed. No further information is expected
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Palpitations, Seizure, Tremor, Weight decreased
Clinical narrative: Seizures around 7 pm the same day; Cough; Severe congestion; Freezing cold all the time; Muscle spasms; Heart palpitations; Numbness of my hands and feet; Severe tremors in my hands; Dizziness; Weight loss; Menstrual cramps; Has affected my menstrual cycle severely; Loss of appetite; Headaches; Had extreme fatigue; This is a spontaneous report from a contactable consumer (patient). A 31-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0175), via an unspecified route of administration in the left arm on 10Jun2021 at 11:40 as a dose 2, single for COVID-19 immunization (at the age of 31-years-old). Medical history included Known allergies: Soy from an unknown date and unknown if ongoing.There were no concomitant medications. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0173), via an unspecified route of administration in the left arm on 20May2021 at 12:00 as a dose 1, single for COVID-19 immunization (at the age of 31-years-old). The patient did not receive any medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient stated that she had two seizures around 7 pm the same day (10Jun2021 19:00). Since her second dose of Pfizer, 10Jun2021 13:00, she have had extreme fatigue, cough, severe congestion, freezing cold all the time, muscle spasms, heart palpitations, numbness of my hands and feet, severe tremors in my hands, headaches, dizziness, loss of appetite, weight loss, menstrual cramps every day and has affected her menstrual cycle severely. The patient did not receive any treatment. The clinical outcome for the events was not recovered.  Follow-up attempts are completed. No further information is expected
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Thrombosis, Traumatic haemorrhage
Clinical narrative: extremely heavy clots that were dropping out of me in very huge chunks; excessive bleeding; I bled heavily for about an hour it was traumatic; This is a spontaneous report from a contactable other hcp (Patient). A 43-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: ewo179) via an unspecified route of administration (age at vaccination 43-year) Right Arm on 29Apr2021 at 02:00 PM as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No known allergies were reported. Historical vaccine included first dose of BNT162B2 (lot number: ewo158) on 08Apr2021 for COVID-19 immunization; No reaction on exposure to previous Vaccine. 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. List of any other medications the patient received within 2 weeks of vaccination was reported as No. On 10May2021 the patient experienced event reported as "extremely heavy clots that were dropping out of me in very huge chunks, excessive bleeding, she bled heavily for about an hour it was traumatic". The patient reported that "After taking my second dose on my next monthly period cycle I experienced excessive bleeding and extremely heavy clots that were dropping out of me in very huge chunks! I thought I was going to call 911. I bled heavily for about an hour it was traumatic. At this moment I'm doubting if I will take a booster shot because i'm a single Mom living in a shelter with my three kids and my children need me to be alive for them! I was scared that I wouldn't make it through! I thank  that he saved my life!". No treatment was received for the adverse events. The clinical outcome of the events was recovering.  Follow up information has been requested.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid Diagnosis after fully vaccinated with Pfizer; Covid Diagnosis after fully vaccinated with Pfizer; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 18Mar2021 at 10:30 (Batch/Lot Number: EN6198) as dose 2, single, and on 26Feb2021 at 09:30 (Batch/Lot Number: EN6207) as dose 1, single, both at the age of 56-years-old, via an unspecified route of administration, administered in arm left for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication included telmisartan (MICARDIS) taken for an unspecified indication, start and stop dates were not reported. The patient had a Covid diagnosis after (being) fully vaccinated with Pfizer on 04Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 04Aug2021. The outcome of the events was recovering.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Suicidal ideation, Vertigo
Clinical narrative: moderate vertigo; depression severe enough/significant depression; depression severe enough to have daily suicidal thoughts; This is a spontaneous report from a contactable other healthcare professional (patient). A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown), via an unspecified route of administration on 16Apr2021 as dose 2, single for covid-19 immunization. Medical history included thyroid and; mild anxiety. There were no known allergies. Concomitant medication included bupropion hydrochloride (WELLBUTRIN) taken for thyroid, hormone replacement therapy (HRT), and mild anxiety from 2001. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) on an unspecified date for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. Prior to vaccination, the patient was not diagnosed with Covid-19. The patient was not pregnant at the time of vaccination and at the time of the events. The patient experienced moderate vertigo approx. 2 weeks after the second dose in 30Apr2021, which lasted for several hours. The patient took scopolamine for the vertigo. The patient informed that she has been taking Wellbutrin for 20 years for mild anxiety; and she has never had problems with depression, but for "about 6 weeks" on an unspecified date in 2021, she had depression severe enough to have daily suicidal thoughts which was very bizarre for her. The patient further stated that she experienced significant depression "approx. 4 months" after the second dose. No treatment was received for depression. The patient recovered from vertigo on 30Apr2021. The outcome of the other remaining events was recovering. Since the vaccination, the patient has not been tested for Covid-19.  The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: A causal relationship between BNT162B2 and the reported events cannot be excluded based on  temporal association. 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 RAs, Ethics Committees, and Investigators, as appropriate .
Sex: F
Vaccine: COVID19
Symptoms: Arthropod bite, Impaired healing, Pain
Clinical narrative: her daughter got a bug bite and much longer than normal to heal; bug bite; complaining of pain; This is a spontaneous report from a contactable consumer (patient's mother). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received 1 dose of the Pfizer COVID 19 vaccine but her mother cancelled the second appointment and states that they would not receiving it. Patient got a bug bite and it took much longer than normal to heal. She did hours of meditation for healing. She was in pain from a bug bite and reporter relays that patient was complaining of pain that she never had before. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Illness
Clinical narrative: shortness of breath/ having trouble breathing; he was extremely ill and sick in bed for 3.5 weeks; chest pressure; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient himself) reported that a 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Jun2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date after vaccination, the patient was extremely ill and sick in bed for 3 and a half weeks within a week of getting the second shot. He was having trouble breathing, chest pressure, and had shortness of breath. He went to the emergency room (ER) for his symptoms. He didn't feel any better after that so he also went to urgent care. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Hyperpyrexia, Pain, Pyrexia
Clinical narrative: have a fever/104/Now keeps 107 F; whole body is aching and warm; pain in her arm/My arm is still hurting where I got the shot; headache; Backache; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 03Aug2021 (Lot Number: EW0180) as 0.3 mL single for COVID-19 immunization. Medical history included positive for COVID-19 from Mar2021 to an unknown date. The patient's concomitant medications were not reported. On 03Aug2021, the patient has a fever. The first time she came to know it was 104, but now keeps 107 degree Fahrenheit. On 03Aug2021, she experienced headache, whole body is aching and warm, arm is still hurting where she got the shot. Took the vaccine at 9 or 10 and an hour after that she had a pain in her arm, headache and back ache around 10:15 or 11 yesterday. No treatment received for fever and body aches. Events did not require a visit to Emergency Room or Physician Office. Outcome of events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: have a fever/104/Now keeps 107 F; whole body is aching and warm; pain in her arm/My arm is still hurting where I got the shot; headache; Backache; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 03Aug2021 (Lot Number: EW0180) as 0.3 mL single for COVID-19 immunization. Medical history included positive for COVID-19 from Mar2021 to an unknown date. The patient's concomitant medications were not reported. On 03Aug2021, the patient has a fever. The first time she came to know it was 104, but now keeps 107 degree Fahrenheit. On 03Aug2021, she experienced headache, whole body is aching and warm, arm is still hurting where she got the shot. Took the vaccine at 9 or 10 and an hour after that she had a pain in her arm, headache and back ache around 10:15 or 11 yesterday. No treatment received for fever and body aches. Events did not require a visit to Emergency Room or Physician Office. Outcome of events was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot number: unknown) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot number: unknown) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. It was reported on an unspecified date the patient tested positive for covid-19 after patient had been fully vaccinated. Reporter further stated that the symptoms were mild. The majority of the illness was around 3-4 days, though reporter believe that the patient who got covid-19 was still recovering. The patient was recovering from the events.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; This is a spontaneous report from a contactable nurse. A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 03Aug2021 (Lot Number: EW0179) as dose 1, single for COVID-19 immunization. The patient's medical and concomitant medications were not reported. The patient broke out in hives on 03Aug2021. The patient took Benadryl which resolved the hives and at the time of report, she was better and not having any symptoms. The pharmacist then asked recommendation for the second vaccine. Outcome of the event was recovered on 04Aug2021.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died; This is a spontaneous report from a contactable healthcare professional via medical information team and via a Pfizer-sponsored program. A 55-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in May2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The healthcare professional reported that they were definitely seeing a rise in COVID and that a 55-year-old guy died in their hospital the other day (unspecified date), he was vaccinated in May with Pfizer. It was unknown if an autopsy was done.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious event Death cannot be totally excluded. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, concomitant medications and dates of vaccination.This case will be reassessed once additional information is available.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.; Reported Cause(s) of Death: died
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Dizziness; Flu like symptoms; Body ache; Weakness; Chills; Fever; Fatigue; Headache; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 17Jul2021(at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not receive any medication within two weeks of vaccination. The patient previously received first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via an unspecified route of administration in the left arm on 26Jun2021 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Jul2021 the patient experienced dizziness, weakness, chills, fever, flu like symptoms, body ache, fatigue and headache, which took a few days to recover. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the event dizziness, weakness, chills, fever, flu like symptoms, body ache, fatigue and headache were resolved on an unknown date in 2021.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: Dizziness; Flu like symptoms; Body ache; Weakness; Chills; Fever; Fatigue; Headache; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 17Jul2021(at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not receive any medication within two weeks of vaccination. The patient previously received first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via an unspecified route of administration in the left arm on 26Jun2021 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Jul2021 the patient experienced dizziness, weakness, chills, fever, flu like symptoms, body ache, fatigue and headache, which took a few days to recover. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the event dizziness, weakness, chills, fever, flu like symptoms, body ache, fatigue and headache were resolved on an unknown date in 2021.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for covid infection; This is a spontaneous report from a contactable consumer.  A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 22Jul2021 (Batch/Lot Number: FA7484) as dose 1, single (at the age of 44 years old) for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient got the first dose of the Pfizer BioNTech Covid-19 Vaccine last 22Jul2021 and tested positive for covid infection last 30Jul2021. She is scheduled to have her second dose on 12Aug2021. The patient asked if she should she get the second vaccine dose on 12Aug021 or does she need to wait. She took the covid test on Friday 30Jul2021 in the ER. She was not admitted into the hospital she was sent back home the same day. The positive result was notified to her on Sunday 01Aug2021. It was 2 tests actually done, they did a rapid and a test that was sent off for which the results would come in 2-3 days. Rapid test result was actually negative, but because of the symptoms she was experiencing they decided to do the other nasal swab test and sent it off. She was at work on Friday and felt like she was hit by a bus or run over. Her muscles were aching, she had a head cold but without the symptoms in the head, the inside of her nostril and the back of the throat was raw and everything even while breathing felt raw. It felt horrible. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Paraesthesia oral
Clinical narrative: strange feeling in tongue; Dry mouth; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW8733) via an unspecified route of administration in the left arm on 06May2021 at 11:15 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included minor depression and acid reflux (esophageal). The patient was allergic to penicillin and sulpha drugs. Concomitant medications included venlafaxine (MANUFACTURER UNKNOWN) and omeprazole (MANUFACTURER UNKNOWN), both taken for unspecified indications from unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17May2021, the patient experienced strange feeling in tongue and dry mouth which were continuing at the time of this report. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as the result of events. The clinical outcome of the events strange feeling in tongue and dry mouth were not resolved at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: developed a large welt on her arm at the injection site with small amount of pain, redness and swelling; She started out having a small red area where the vaccine was given/developed a large welt on her arm at the injection site with small amount of pain, redness and swelling; painful/developed a large welt on her arm at the injection site with small amount of pain, redness and swelling; developed a large welt on her arm at the injection site with small amount of pain, redness and swelling; This is a spontaneous report from a contactable consumer or other non hcp. A 47-year-old female patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot Number: EW0168) as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's husband is reporting in regards to his wife. He states that she received the first dose of the Pfizer COVID 19 vaccine two days ago. She started out having a small red area where the vaccine was given. He reports that it has continued to get larger and is now about 2.5 inches around. He described the area as a welt and relays that it is somewhat painful. He states that they are concerned because it continues to get larger. He states that he had the Moderna vaccine and that he had bad side effects of fever and couldn't use his arm for 3 days because it hurt. He states that he hadn't heard about side effects with Pfizer so he was worried. With regards to Treatment, Consumer stated, "No, not yet because we just noticed it today it got bigger from last night to today it got little bigger so that's why I called and they said that was one of the side effect of the Pfizer. So you know, she said to let it go another day and its getting any bigger or anything hurts some more to take her either to her doctor or to the emergency.". The event welts was assessed as serious-medically significant. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Rash, Urticaria
Clinical narrative: she had swelling of her lower lips; She had rashes and hives that lasted for 25 days/She got rashes all over the body; Hives; This is a spontaneous report from a contactable consumer or other non-HCP. A 24-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 27Apr2021 as DOSE 2, SINGLE for covid-19 immunization. Historical vaccine included first dose of BNT162B2 (COMIRNATY, Solution injection, Lot number/Expiration date: Unknown) for covid-19 immunization and she did not have an issue with the first dose. The patient's medical history and concomitant medications were not reported. On 23Jul2021 the patient experienced she had swelling of her lower lips. On 27Apr2021 the patient experienced she had rashes and hives that lasted for 25 days/she got rashes all over the body and hives. The outcome of event she had swelling of her lower lips was unknown. The outcome of rest all events was recovered on an unspecified date of 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: Arm pain and dizziness; Arm pin and dizziness; This is a spontaneous report from a non-contactable consumer, the patient. A 15-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the left arm on 04Aug2021 at 10:15 (at the age of 15-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medications included aciclovir (ACYCLOVIR) for cold sores from unknown date and unknown if ongoing and fluticasone propionate (FLONASE), ketotifen fumarate (ZADITOR) and fexofenadine hydrochloride (ALLEGRA); all for unspecified indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 04Aug2021 at 10:45, the patient experienced arm pain and dizziness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of arm pain and included treatment with Advil. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events arm pain and dizziness was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Urticaria
Clinical narrative: Hives from head to toe including palms of her hands; Bruises; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP6955), via an unspecified route of administration in left arm on 27Mar2021 (also reported as 06Mar2021) (at the age of 49 years), as dose 2, single, for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medication included sertraline hydrochloride (ZOLOFT). The patient previously received the first dose of BNT162B2 (Lot Number: EP6199) on 06Mar2021 at 10:00 AM (at the age of 49 years) for COVID-19 immunization (left arm). The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. The patient was not administered with other vaccine in four weeks. The most recent COVID-19 vaccine was administered in a pharmacy or drug store facility. On 29Mar2021 at 09:30 AM (about 48 hours after second vaccination), the patient broke out in hives from head to toe including palms of her hands. Hives lasted 8 days. Hives erupted so violently they left bruises behind (2021). The patient received a steroid shot, took oral steroids, cetirizine hydrochloride (ZYRTEC), and diphenhydramine hydrochloride (BENADRYL) but nothing helped. The adverse events resulted in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient considered the events as non-serious. The patient had not been tested for COVID-19 post vaccination. The patient recovered from "Hives from head to toe including palms of her hands" on 07Apr2021; and from the other event in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: contracted Covid 19; contracted Covid 19; This is a spontaneous report from a non-contactable consumer (patient). A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported), via an unspecified route of administration in arm left in Apr2021 (at the age of 43-year-old) as dose 2, single dose and BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported), via an unspecified route of administration in arm left in Mar2021 (at the age of 43-year-old) as dose 1, single dose for COVID-19 immunisation was in clinic. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. After 4 months being fully vaccinated with the Pfizer/BioNtech vaccine, she contracted COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit. Patient did not receive treatment in response to the events. The patient underwent lab tests and procedures which included PCR-COVID Test (nasal swab): positive on 03Aug2021. Outcome of the event was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a non-contactable consumer. An adult female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not available), on unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was unknown if prior to vaccination the patient was diagnosed with COVID-19. On Jul2021 the patient experienced breakthrough symptomatic COVID-19 infection as confirmed by positive COVID-19 polymerase chain reaction (PCR) test. The patient had been tested for COVID-19 since the vaccination. The patient underwent lab test and procedure which included: COVID-19 PCR test nasal swab (positive) on Jul2021. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Diabetes mellitus
Clinical narrative: Diabetic; This is a spontaneous report from a non-contactable consumer (patient's friend). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiration date were unknown) as dose 1, single and via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiration date were unknown) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was diabetic on an unspecified date. The reporter, who was calling for a friend, wanted to know if there were any clinical trials for a third Covid shot. The patient had both doses of the Pfizer shot and he was diabetic. The outcome of the event was unknown.  No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Diabetes mellitus
Clinical narrative: Diabetes; This is a spontaneous report from a non-contactable consumer (patient). A 76-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (lot number and expiry date: unknown) as dose 2, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 for COVID-19 immunisation. The patient developed diabetes on an unspecified date. Patient would like to enroll in Covid booster trial. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Laboratory test, Pleural effusion, X-ray
Clinical narrative: bilateral pleural effusions; This is a spontaneous report from a contactable consumer (patient). This is the first of two reports. This report concerns events occurred after the first dose of BNT162B2. A 75-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283), administered in the right arm on 12Jan2021  at dose 1, single for COVID-19 immunisation, at the age of 75-years-old. Medical history and concomitant medications were reported as none. Family medical history relevant to the adverse events was none. The patient previously received shingles vaccine and flu vaccine for immunisation and he did fine, no adverse events occurred. Additional vaccines administered on same date of BNT162b2 and prior vaccinations (within 4 weeks) were none. Patient wanted to report some side effects that he did not know if they were from the vaccine, but they seemed to be. He stated that company would get the 3rd shot in the near future, and if he got the same symptoms again, he wanted it to be on the record. Patient had his first shot on 12Jan2021, and on 22Jan2021, after taking the shot, for several days or a week or so he had trouble breathing or getting enough oxygen. It took a while for the fluid to build up; probably 3-4 days later, he was having trouble walking back and forth in house with his breathing. He went to the emergency room (ER), and he was diagnosed with bilateral pleural effusions, which was something he had never had before. They drained a liter and a half of fluid out of his chest cavity. Patient was treated in the ER and released. Treatments included draining fluid, several CT scans, x-rays, and tests of all different kinds in 2021, the whole procedure took about 6 months. They did a lot of examining trying to figure out what it was, but they never figured it out. Patient stated being it was after his first dose and again after the second dose, they figured it was the vaccine. Patient stated that if there was a booster shot and he got the same problem he would be 99% sure that the vaccine was what caused the pleural effusions and fluid. The adverse events required a visit to the ER, no admission to hospital. They wanted him to stay overnight but they figured it would be best not to; the events also required a physician office visit. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101000025 same patient/SD, different AE/dose
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). An unspecified age female patient received an unknown dose of BNT162B2 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. In 2021, patient got COVID and was in bed for about 5 days. The test of COVID-19 had done with result was positive on an unspecified date. Female patient approximately age 50. The outcome of bedridden was recovered in 2021. The outcome of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: developed it (blood clots) and died; This is a spontaneous report from a Pfizer-sponsored program from a non-contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient developed it (blood clots) and died on an unspecified date. It was not reported if an autopsy was performed.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: developed it (blood clots) and died
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Abnormally heavy menstrual bleeding; This is a spontaneous report received from a contactable consumer (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0198), intramuscular in left arm on 24Jul2021 05:00 PM as dose 1, single for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was reported as pharmacy or drug store. The patient's medical history was reported as none. The patient was not diagnosed with COVID-19 prior to vaccination. No know allergies were reported. The patient did not receive any other concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Aug2021 the patient experienced abnormally heavy menstrual bleeding reported as non-serious. No treatment was received due to the event. The patient had not been tested for COVID-19 since the vaccination. The outcome of the event was resolving.  Follow-up (10Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthropathy, Joint range of motion decreased, Limb mass
Clinical narrative: Right shoulder, large hard lump; Shoulder is now very painful, aching; Shoulder is now popping; Very hard to move shoulder; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 29Mar2021 at 08:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included arthritis, depression, anxiety and panic disorder. The patient was not aware of any known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 20Apr2021, the patients' right shoulder had large hard lump that was still there (at the time of reporting). Her shoulder was very painful, aching, popping and very hard to move shoulder. The events did not result in doctor or other health care professional office or clinic visit, emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events large hard lump on right shoulder, shoulder was very painful, aching, popping and very hard to move shoulder was not resolved at the time of this report.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: experiencing shingles; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program COVAX US Support. An unspecified age of male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not provided) via an unspecified route of administration on 18May2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 on an unspecified date for covid-19 immunization. The patient experienced shingles on an unspecified date in 2021. The outcome of the event was not resolved.
Sex: U
Vaccine: COVID19
Symptoms: Antibody test, Immunodeficiency
Clinical narrative: Immunocompromised; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot numbers were not reported), via unspecified routes of administration, on unspecified dates, as dose 1, single, and then as dose 2, single, for COVID-19 immunization; and adalimumab (HUMIRA), via an unspecified route of administration, on an unspecified date, at an unspecified dose and frequency, for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient had both doses of the Pfizer COVID-19 shot and was immunocompromised on an unspecified date because the patient takes adalimumab. The patient did a test to check the antibodies and the patient had none on an unspecified date. The patient wanted to know why there wasn't a trial for people on adalimumab (HUMIRA). The outcome of the event was unknown.  No follow-up attempts are possible; information about lot or batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Elevated BPM every now and again after vaccine. Not all the time but when resting, heart BPM has increased to 90 bpm or higher. This has never occurred prior to the first dose.; This is a spontaneous report from a non-contactable consumer. This 30-year-old Female Consumer (patient) reported for herself that: A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID VACCINE; Solution for injection, Batch/Lot Number: EW0177), dose 1 via an unspecified route of administration, administered in Arm Right on Jul2021 at 18:00 PM (at 30-years age) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and patient concomitant medications were not reported. 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. The patient experienced Elevated bpm every now and again after vaccine. Not all the time but when resting, heart bpm has increased to 90 bpm or higher. this has never occurred prior to the first dose on an unspecified date. The patient underwent lab tests and procedures which included heart rate: >90 or higher on an unspecified date. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the event. The outcome of event was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient contracted COVID-19 in Jul2021; Patient contracted COVID-19 in Jul2021; This is a spontaneous report from a non-contactable consumer (Patient). A 77-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported ), via an unspecified route of administration on Feb2021 (Age at vaccination: 77 years) as dose number unknown, single for covid-19 immunisation. Patient did not received other vaccines in four weeks. Other medications received in 2 weeks were unknown. Patient did not have COVID prior vaccination. Patient tested COVID post vaccination. The patient medical history and concomitant medications were not reported. The patient contracted covid-19 in Jul2021. Treatment performed was unknown. The patient underwent lab tests and procedures which included sars-cov-2 test which was positive in Jul2021 Covid test type post vaccination was Unknown. The outcome of the event was recovered in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No fur-ther information is expected.