chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated
Clinical narrative: Autoimmune reaction flare-up, going on 3 weeks; This is a spontaneous report from a non-contactable consumer (patient). A 29-year-old female patient received the first and second doses of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot numbers and expiration dates were not reported) via an unspecified routes of administration on an unspecified dates at single doses for COVID-19 immunisation. Medical history included Ehlers-Danlos Syndrome, Postural Orthostatic Tachycardia Syndrome (POTS) and Mast Cell Activation Syndrome (MCAS). The patient's concomitant medications were not reported. The patient experienced an autoimmune reaction flare-up, going on 3 weeks. No other specific details were provided. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 79.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood magnesium, Blood magnesium decreased, Blood potassium, Blood potassium decreased, Diarrhoea
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number and expiry date were unknown), via an unspecified route of administration on 09Feb2021 (at the age of 79-years) as a single dose for COVID-19 immunization; and liraglutide (VICTOZA), via an unspecified route of administration from 10Feb2021 to an unspecified date at unknown dose, weekly for an unspecified indication. The patient's medical history and concomitant medications were not reported. It was reported that everything was going fine until she had her COVID-19 vaccine on 09Feb2021, and then on 10Feb2021 she had the liraglutide injection. That's when everything went wrong and had to be hospitalized. She is losing her magnesium and her potassium. She had diarrhea, hadn't eaten in 5 weeks, was throwing up, and lost weight. She just can't eat, everything tasted so bland. She is getting better now though. The action taken for liraglutide was unknown. The outcome of the events was recovering. No follow-up attempts are possible; information about the lot number cannot be obtained.
Age: 79.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Feeding disorder, Taste disorder, Vomiting, Weight, Weight decreased
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number and expiry date were unknown), via an unspecified route of administration on 09Feb2021 (at the age of 79-years) as a single dose for COVID-19 immunization; and liraglutide (VICTOZA), via an unspecified route of administration from 10Feb2021 to an unspecified date at unknown dose, weekly for an unspecified indication. The patient's medical history and concomitant medications were not reported. It was reported that everything was going fine until she had her COVID-19 vaccine on 09Feb2021, and then on 10Feb2021 she had the liraglutide injection. That's when everything went wrong and had to be hospitalized. She is losing her magnesium and her potassium. She had diarrhea, hadn't eaten in 5 weeks, was throwing up, and lost weight. She just can't eat, everything tasted so bland. She is getting better now though. The action taken for liraglutide was unknown. The outcome of the events was recovering. No follow-up attempts are possible; information about the lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Nausea, Vomiting
Clinical narrative: blood pressure has also been higher; nausea; vomit; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received first dose of PFIZER-BIONTECH COVID-19 VACCINE (BNT162B2, solution for injection, Batch/Lot number and expiration date were not reported), via an unspecified route of administration on 13Mar2021 as single dose for COVID-19 immunization. Medical history included high blood pressure from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 16Mar2021, the patient started to experience nausea and vomiting, both with an unknown outcome. She has been taking care of herself, drink tea, eat soup, fruits, vegetables and was eating correctly, but she eats and throw up (as reported). Her blood pressure has also been higher lately with outcome of unknown. The patient underwent lab tests and procedures which included higher blood pressure measurement.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site vesicles
Clinical narrative: redness on the injection site; blister on the injection site; This is a spontaneous report from a contactable consumer (reporting for his wife). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were not reported), via an unspecified route of administration on 17Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got redness and blister on the injection site yesterday (18Mar2021). The outcome of the events was unknown.  Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Body temperature, COVID-19, Chills, Headache
Clinical narrative: fever (101*F); chills; body aches; headaches; nausea/queasy; she was still sick; still a little shaky; This is a spontaneous report received from a contactable consumer (patient) via medical information team. A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified rout of administration on 11Mar2021 at a single dose for COVID-19 immunization. The patient's relevant medical history included covid (she had covid last April/May 2020/sick) in 2020, infection in 2020. Concomitant medication was not reported. It was reported as patient received the 1st dose on 11Mar2021 last Thursday and everything went well. A day after, on Friday (12Mar2021), she experienced all symptoms on the fact sheet such as fever (101*F), chills, body aches, headaches, and nausea. Over the weekend she was still sick in Mar2021 but she could feel better everyday. On Monday and Tuesday, some symptoms were still there but most of them were recovering. As of calling, she mentioned she was feeling fine but was still a little shaky and queasy in 2021. She mentioned that she had covid last April/May 2020. It was nothing major, she had no respiratory issues but was still pretty sick with the similar symptoms that she was experiencing now for 10 days. On June2020 she had an antibody test and she was shown to have antibodies. She was asking if there is any data from Pfizer to say that she might not have to receive the 2nd dose as she already has enough antibodies due to her previous infection in 2020. She fears that she might have overmedicated herself as she already had antibodies. Her 2nd dose was on 01Apr2021 and she is concerned that she might experience the same side effects but worse on her 2nd dose. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nausea, Pain, Pyrexia, Tremor
Clinical narrative: fever (101*F); chills; body aches; headaches; nausea/queasy; she was still sick; still a little shaky; This is a spontaneous report received from a contactable consumer (patient) via medical information team. A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified rout of administration on 11Mar2021 at a single dose for COVID-19 immunization. The patient's relevant medical history included covid (she had covid last April/May 2020/sick) in 2020, infection in 2020. Concomitant medication was not reported. It was reported as patient received the 1st dose on 11Mar2021 last Thursday and everything went well. A day after, on Friday (12Mar2021), she experienced all symptoms on the fact sheet such as fever (101*F), chills, body aches, headaches, and nausea. Over the weekend she was still sick in Mar2021 but she could feel better everyday. On Monday and Tuesday, some symptoms were still there but most of them were recovering. As of calling, she mentioned she was feeling fine but was still a little shaky and queasy in 2021. She mentioned that she had covid last April/May 2020. It was nothing major, she had no respiratory issues but was still pretty sick with the similar symptoms that she was experiencing now for 10 days. On June2020 she had an antibody test and she was shown to have antibodies. She was asking if there is any data from Pfizer to say that she might not have to receive the 2nd dose as she already has enough antibodies due to her previous infection in 2020. She fears that she might have overmedicated herself as she already had antibodies. Her 2nd dose was on 01Apr2021 and she is concerned that she might experience the same side effects but worse on her 2nd dose. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate decreased, Pancreatitis
Clinical narrative: her husband got hospitalized yesterday due to his pancreatitis; his heart rate is getting lower; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer. A male patient (consumer's husband) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient was scheduled for his second dose of the vaccine today. Unfortunately, the patient got hospitalized yesterday (15Mar2021) due to his pancreatitis and his heart rate was getting lower. The outcome was unknown.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Vaccination failure
Clinical narrative: and the results came back negative; This is a spontaneous report from a non-contactable consumer. A non-contactable consumer (patient):A female patient of an unspecified age received bnt162b2 (COVID-19 MRNA VACCINE BIONTECH)dose 2 via an unspecified route of administration on 11Feb2021 as SINGLE DOSE for covid-19 immunisation .The patient medical history was not reported.The patient's concomitant medications were not reported. You may not have ever had COVID-19. Talk with your healthcare provider about your test result and the type of test you took to understand what your result means. Some people may take even longer to develop antibodies,and some people who are infected may not ever develop antibodies."and The patient experienced and the results came back negative on an unspecified date with outcome of unknown.
Age: 86.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blindness, Condition aggravated
Clinical narrative: had worsening vision loss in her eye; had worsening vision loss in her eye; This is a spontaneous report from a contactable consumer (patient) based on the information received by Pfizer. An 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation; pyrimethamine (Tablet, Lot Number: AM0737A; Expiration Date: 31Jul2022) via an unspecified route of administration from an unspecified date and ongoing at 25 mg once daily for toxoplasmosis retinitis. Medical history included toxoplasmosis retinitis (eye infection toxoplasmal), vision loss (Blindness), and an allergy to sulfa medications. Concomitant products were not reported. On an unspecified date, the patient had a second dose of the Covid vaccine. On an unspecified date in Feb2021 (over the last month of 01Mar2021), after starting the products, the patient had worsening vision loss (visual impairment) in her eye within one month of receipt of the second dose of the COVID-19 vaccine. The patient felt the only thing that was new was she had just received the second dose of the Covid vaccine. As of 01Mar2021, the statuses of treatment with pyrimethamine and the worsening of vision loss in her eye were ongoing. An association with pyrimethamine cannot be ruled out. However, the event is confounded by toxoplasmosis retinitis, vision loss, and receipt of the COVID-19 vaccine, which the reporter notes was the only new occurrence. The action taken in response to the events for pyrimethamine was dose not changed. Therapeutic measures were taken as a result of had worsening vision loss in her eye. The outcome of the events was unknown. The reported was considered as other serious (important medical events).  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Nausea, Retching, Vomiting
Clinical narrative: nauseous; could not eat nor drink; threw up; dry heaves; This is a spontaneous report from a non-contactable consumer (patient). A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), via an unspecified route of administration on 17Mar2021 as a single dose for COVID-19 immunization. Medical history included Covid and pneumonia (previously) and had an antibody infusion. The patient's concomitant medications were not reported. The patient received the first dose on 17Mar2021. On 18Mar2021, she experienced side effects that lasted for 2 days. She said she could not get out of bed, felt nauseous, had dry heaves, threw up, and could not eat nor drink. She said she previously had COVID and pneumonia and had an antibody infusion. She wants to know if that was a factor that led her to have these side effects. The patient was told that there is no information whether her history with COVID, and the antibody infusion she received caused the side effects to occur, and to contact her healthcare provider if the side effects continue to bother her. The events resolved on 20Mar2021.   No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Dyspnoea, Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: Diagnosed in ER with 4 subsegmental pulmonary embolisms on 18Mar2021 shown with CT Scan with contrast; Shortness of Breath; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: En5318), via an unspecified route of administration, administered in left arm on 04Feb2021 10:00 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient was not pregnant at the time of report. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: El3249) administered on the left arm on 14Jan2021 10:00 AM for COVID-19 immunization. The patient was diagnosed in Emergency room (ER) with 4 subsegmental pulmonary embolisms on 18mar2021 16:00 shown with CT scan with contrast and experienced shortness of breath on 18Mar2021 16:00. Prior to vaccination, the patient was not diagnosed with COVID. Patient was tested COVID post vaccination. The patient underwent lab tests and procedures which included CT scan with contrast: 4 subsegmental pulmonary embolisms on 18Mar2021, and nasal swab: negative on 14Jan2021. Therapeutic measures were taken as a result of the events and included treatment with apixaban (ELIQUIS). Facility type vaccine was Nursing Home. The event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent case, life threatening illness (immediate risk of death from the event). The outcome of the events were recovering.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache
Clinical narrative: tiredness; headache; just did not feel her self; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient (unknown age) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Unknown) via unknown route of administration on 10Mar2021 at single dose for COVID-19 immunisation. Medical history included immunocompromised condition and severe allergies but not to vaccines. Concomitant medications were not reported. Patient had first dose of the pfizer covid 19 vaccine was on 10Mar2021. patient reported tiredness, headache and just did not feel herself in Mar2021. Caller wanted to know if she should get the second shot. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Paralysis
Clinical narrative: I couldn't move for about 4 hours, I was slight paralyzed laying on the floor; IV (intravenous) by needle; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received bnt162b2 (BNT162B2), dose 2 intravenous (at the age of 78-years-old), administered in Deltoid Left (reported as left shoulder) on 15Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included none. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration (at the age of 78-years-old), administered on 22Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient stated, "I received my second Pfizer shot (captured as Unspecified medication) on Monday (15Mar2021) and on Monday night (15Mar2021) I woke up on the floor and I couldn't move for about 4 hours, now finally got back into the bed by 5 o'clock in the morning and I was slight paralyzed laying on the floor and I felt it. You may did know about this because it is probably related to the vaccine. They have improved drastically (events), after yesterday I tried to get some sleep because I laid on the floor for 4 hours, but today I feel alright." The route of administration was "IV (intravenous) by needle." No treatment received for the events. The outcome of the events "I couldn't move for about 4 hours, I was slight paralyzed laying on the floor" was recovered on an unspecified date. The event Paralyzed was considered as serious (medically significant).  Information about Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Basal cell carcinoma
Clinical narrative: Basal Cell carcinoma on face; This is a spontaneous report via Pfizer from a contactable consumer. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was due to get second dose next Tuesday and had a procedure to remove a basal cell carcinoma from her face this past Monday. She would like to know if she will be able to get second dose. She has not gotten an antibiotic since Monday. She would like to know if getting an antibiotic will interfere with getting second dose. On 15Mar2021, the patient had the procedure done to remove basal cell carcinoma on face which was found post 1st COVID vaccine and would like to know if that procedure will jeopardize the efficacy of vaccine. The outcome of the event was unknown.  Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Glaucoma
Clinical narrative: severe Glaucoma; This is a spontaneous report received from a Pfizer Sponsored Program. A contactable consumer reported (for herself) a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the first dose on 25Feb2021 and due for the second dose by 18Mar2021. The patient stated over the call that that they were experiencing heavy rain and she won't be able to drive to the facility because she has severe Glaucoma (noted in 2021). She wanted to know if she can reschedule the second dose on a later date. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myocardial infarction
Clinical narrative: heart attack; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 31Jan2021 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The consumer wanted to schedule her second dose since she missed her second dose due to heart attack two weeks after the first dose. She was taking heart medications (unspecified). The outcome of the event was unknown.    Information about the Lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Instillation site pain, Myocardial infarction, Vaccination site pain
Clinical narrative: heart attack; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 31Jan2021 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The consumer wanted to schedule her second dose since she missed her second dose due to heart attack two weeks after the first dose. She was taking heart medications (unspecified). The outcome of the event was unknown.    Information about the Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Lip disorder, Nasal discomfort, Pruritus
Clinical narrative: the inside of her nose got all sore and itchy; the inside of her nose got all sore and itchy; red skin with tiny bumps outside her nostrils and upper lip down to the corners of her mouth; red skin with tiny bumps outside her nostrils and upper lip down to the corners of her mouth; This is a spontaneous report received from a contactable other healthcare professional (herself).   A 70-years-old female patient received first dose of first bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not included) via an unspecified route of administration on 06Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date in Mar2021 the patient experienced the inside of her nose got all sore and itchy and red skin with tiny bumps outside her nostrils and upper lip down to the corners of her mouth. The reporter classified the events as non-serious. The outcome of the events was unknown.  Information on LOT/BATCH number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Peripheral swelling
Clinical narrative: now her left arm is a little swollen after the vaccine; This is a spontaneous report received from a contactable consumer (Patient). A 83-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection), via an unspecified route of administration on an unspecified date of Mar2021 as single dose for COVID-19 immunization. Medical history included high blood pressure and Her right arm was a little swollen before the vaccine (had car accident that can cause the arm swelling). The patient's concomitant medications were not reported. It was reported that patient received the second dose of the Pfizer vaccine yesterday (Mar2021) and patient's left arm was a little swollen after the vaccine. For high blood pressure, doctor changed her medication last week. The outcome of the event was unknown.  Information about batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: his arm hurt really badly; This is a spontaneous report from a contactable consumer, the Patient via Pfizer sponsored program. A male patient of an unspecified age was tested positive on December 2021. The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number and Expiration date were Unknown) via an unspecified route of administration on 11Mar2021 as single dose for COVID-19 immunisation. Medical history included covid-19 from Dec2020. The patient's concomitant medications were not reported. On 11Mar2021 (the day of vaccination) patient said three hours after getting the first dose of the vaccine his arm hurt really badly. The patient was thinking not to get the second dose because he doesn't want to experience that again. Lab test included sars-cov-2 test: positive on DEC2020. The outcome of events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: little bumps all over her body that started on her hand after the first dose.  Between doses she noticed more bumps on small of back and chest. After the second dose they came out on her arms, entire back, torso, legs, a few on her forehead; itches really really bad; This is a spontaneous report from a contactable consumer or other non hcp. A 52-year-old female patient received bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration on an unspecified date as SINGLE DOSE, dose 2 via an unspecified route of administration on 18Mar2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. She received the second dose on 18 March 2021. She reports breaking out in little bumps all over her body that started on her hand after the first dose. Between doses she noticed more bumps on small of back and chest. After the second dose they came out on her arms, entire back, torso, legs, a few on her forehead.f It itches really really bad. She took some Benadryl and this morning there is still a little itchiness. The action taken in response to the event for bnt162b2 was not applicable. Therapeutic measures were taken as a result of little bumps all over her body that started on her hand after the first dose. Between doses she noticed more bumps on small of back and chest. after the second dose they came out on her arms, entire back, torso, legs, a few on her forehead, itches really really bad. The outcome of the event little bumps all over her body that started on her hand after the first dose. between doses she noticed more bumps on small of back and chest. after the second dose they came out on her arms, entire back, torso, legs, a few on her forehead was unknown and itches really really bad was not recovered.  Information about the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: dizziness; headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown), via an unspecified route of administration on 18Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 18Mar2021, the patient experienced dizziness and headache. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Hyperhidrosis
Clinical narrative: breathing problems; sweating; chills; feeling very exhausted; This is a spontaneous report received from a contactable consumer (patient). A 92-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on an unknown date in Mar2021 at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date in Mar2021, the patient experienced breathing problems, sweating, chills and is feeling very exhausted. The events were considered as non-serious. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Laryngospasm
Clinical narrative: spasms around the trachea & back of the throat; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Product: PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiry date was not reported), via an unspecified route of administration on Mar2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced spasms around the trachea & back of the throat. Caller asking if symptoms have been reported. The outcome of the event was unknown.  Information about the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cardiac disorder, Pulmonary thrombosis, SARS-CoV-2 test, Vaccination failure
Clinical narrative: blood clots in the lungs; certain cardiac problems; On 05MAR2021, he tested positive to COVID; On 05MAR2021, he tested positive to COVID; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 15Jan2021 (Batch/Lot number was not reported), first dose via an unspecified route of administration on 25Dec2020 (reported as 25Dec2021; Batch/Lot number was not reported); both as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 05Mar2021, he tested positive to COVID. It's now been 16 days he has COVID. He stated he has blood clots in the lungs and certain cardiac problems on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 05Mar2021. The outcome of the events was unknown.  No further follow up excepted. Batch/lot number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: blood clots in the lungs; certain cardiac problems; On 05MAR2021, he tested positive to COVID; On 05MAR2021, he tested positive to COVID; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 15Jan2021 (Batch/Lot number was not reported), first dose via an unspecified route of administration on 25Dec2020 (reported as 25Dec2021; Batch/Lot number was not reported); both as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 05Mar2021, he tested positive to COVID. It's now been 16 days he has COVID. He stated he has blood clots in the lungs and certain cardiac problems on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 05Mar2021. The outcome of the events was unknown.  No further follow up excepted. Batch/lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Bacteraemia, Bacterial test, Blood pressure measurement, Body temperature, Hypertension
Clinical narrative: her temperature started spiking she had 105 temperature; high blood pressure; she had some bacteria in her blood; she got really sick; This is a spontaneous report from a contactable consumer. This consumer reporter a female patient of unspecified age that who received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 11Mar2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Consumer stated that his wife had the COVID shot last week Thursday and she wasn't running and tempura or anything like that. Than all of a sudden Friday she got really sick on 12Mar2021. Then she stopped a Pharmacy cause they have a little Doctor station there. All of a sudden her temperature started spiking she had 105 temperature and high blood pressure, had to take her immediately to the hospital with an ambulance. She tested negative for COVID-19. They found out she had some bacteria in her blood. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pyrexia, SARS-CoV-2 test
Clinical narrative: her temperature started spiking she had 105 temperature; high blood pressure; she had some bacteria in her blood; she got really sick; This is a spontaneous report from a contactable consumer. This consumer reporter a female patient of unspecified age that who received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 11Mar2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Consumer stated that his wife had the COVID shot last week Thursday and she wasn't running and tempura or anything like that. Than all of a sudden Friday she got really sick on 12Mar2021. Then she stopped a Pharmacy cause they have a little Doctor station there. All of a sudden her temperature started spiking she had 105 temperature and high blood pressure, had to take her immediately to the hospital with an ambulance. She tested negative for COVID-19. They found out she had some bacteria in her blood. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This is a spontaneous report from a contactable consumer (patient's wife) via a Pfizer sponsored program. A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration), via an unspecified route of administration on 11Feb2021 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient's wife called on behalf of her husband. Both got their first dose of the vaccine on 11Feb2021. The following day on 12Feb2021, the patient (husband) had a stroke, but the patient's wife said it was not related to the vaccine and the patient had been in the hospital for the last 5 weeks. The wife was already done with the 2nd dose, but the patient was not yet done with his 2nd dose. The patient's wife wanted to know if the patient could still get the 2nd dose of the vaccine or if the patient needed to start from scratch since he was unable to take the 2nd shot on the scheduled date. Outcome of the event was unknown. The event was assessed as serious (hospitalization).   Information on the lot/batch number has been requested.; Sender's Comments: The company considered there is no plausible mechanism implicating suspect vaccine BNT162B2 to the event stroke based on the product's known safety profile. The patient had been in the hospital for the last 5 weeks and the event is most likely due to the patient's underlying conditions.
Sex: M
Vaccine: COVID19
Symptoms: Pancreatitis
Clinical narrative: He also mentioned that he has been in the hospital for the past days due to pancreatitis.; This is a spontaneous report received from Pfizer sponsor program. A contactable male consumer (patient) of an unspecified age  received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 05Mar2021, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient has been in the hospital for the past days due to pancreatitis. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Nausea, Pain, Screaming, Sensory loss
Clinical narrative: the person who put in the shot injected it into her nerve; she can't feel her arm or fingers yet; She screamed unbelievable; nauseous; pain; It blew up like a balloon; This is a spontaneous report from a non-contactable consumer (patient) via a Medical Information Team. A female patient of an unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection) on an unspecified date at 8:00 AM, administered in an unspecified arm via unspecified route of administration at a single dose for COVID-19 immunization. The patient medical history and concomitant medication were not reported. States her daughter received the first dose of the Pfizer covid vaccine today at 8:00 am, the person who put in the shot injected it into her nerve on an unspecified date. She screamed unbelievable on an unspecified date. EMT was there and told her that the woman put it in her nerve. It blew up like a balloon, she can't feel her arm or fingers yet on an unspecified date.  Not sure what arm. She didn't ask her daughter. The EMT said if she gets a hematoma to go to the hospital. She was nauseous and in pain on an unspecified date. Outcome of events was unknown.     No follow-up attempts are possible as the reporter was non-contactable.
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: the person who put in the shot injected it into her nerve; she can't feel her arm or fingers yet; She screamed unbelievable; nauseous; pain; It blew up like a balloon; This is a spontaneous report from a non-contactable consumer (patient) via a Medical Information Team. A female patient of an unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection) on an unspecified date at 8:00 AM, administered in an unspecified arm via unspecified route of administration at a single dose for COVID-19 immunization. The patient medical history and concomitant medication were not reported. States her daughter received the first dose of the Pfizer covid vaccine today at 8:00 am, the person who put in the shot injected it into her nerve on an unspecified date. She screamed unbelievable on an unspecified date. EMT was there and told her that the woman put it in her nerve. It blew up like a balloon, she can't feel her arm or fingers yet on an unspecified date.  Not sure what arm. She didn't ask her daughter. The EMT said if she gets a hematoma to go to the hospital. She was nauseous and in pain on an unspecified date. Outcome of events was unknown.     No follow-up attempts are possible as the reporter was non-contactable.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure congestive
Clinical narrative: He had not been experiencing any issues or symptoms of his chronic illnesses, but within 1 day had CHF symptoms and died; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history included chronic kidney disease, Congestive heart failure (CHF), hypertension, diabetes mellitus. The concomitant drugs included other unspecified medications in two weeks. There were no covid prior vaccination, and no covid tested post vaccination. The patient had not been experiencing any issues or symptoms of his chronic illnesses, but within 1 day had CHF symptoms and died in Mar2021, which resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), died. The patient was hospitalized for 1 days. Treatment was received. The patient died in Mar2021.  The event was listed as complication of Covid 19 vaccination. It was not reported if an autopsy was performed.   Information on the lot/batch number has been requested.; Reported Cause(s) of Death: He had not been experiencing any issues or symptoms of his chronic illnesses, but within 1 day had CHF symptoms and died
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 antibody test, Suspected COVID-19
Clinical narrative: It is possible that I got covid infection/had flu like symptoms; It is possible that I got covid infection/had flu like symptoms; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 01Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was scheduled for the second dose today 23Mar2021. The patient had flu like symptoms with the first vaccination that seem eerily to close to COVID, and this was about 2 and a half weeks after the first dose. The patient stated that it was possible that he got COVID infection on 19Mar2021 and recovered. The patient went to get tested for the antibodies and it came back negative on an unspecified date. The testing place told him to get the rapid COVID test and if it came back negative, he should take the second dose of the vaccine. The patient was asking if he can take the second dose if he has or had COVID infection in between doses. The outcome of the events was recovered.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Blood potassium, Blood potassium increased, Chest pain
Clinical narrative: Potassium was too high; chest pain; This is a spontaneous report from A contactable consumer (patient's wife) reported that a male patient of an unspecified age (husband) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 25Feb2021 (batch/lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The consumer was calling on behalf of her husband. Her husband got his first dose (25Feb2021) and his second dose schedule was on 18Mar2021. It's just that the patient missed his second dose and didn't make it because he's in the hospital because his potassium was too high and having chest pain on an unspecified date, was planning for a reschedule for his second dose. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Fatigue, Limb discomfort, Malaise
Clinical narrative: tiredness; wooziness; not feeling that great 2 days; The heaviness in her left arm was more prevalent after getting the 2 shots; This is a spontaneous report from a contactable consumer. A 88-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The Patient's medical history included, she was bitten by a bad tick 2 years ago and she ran another blood test, Bell's Palsy, left arm that would become sore when she picked up something heavy. The patient's concomitant medications were not reported. The patient experienced tiredness, wooziness, not feeling that great 2 days, the heaviness in her left arm was more prevalent after getting the 2 shots on an unspecified date.  The patient underwent lab tests and procedures which included blood test for everything: everything returned fine on unspecified date. The outcome of the events was unknown.     Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Fatigue, Pyrexia, SARS-CoV-2 test
Clinical narrative: She is experiencing extreme fatigue and is still experiencing a fever; She is experiencing extreme fatigue and is still experiencing a fever; This is a spontaneous report from a contactable consumer. A 76-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient's historical vaccine included at the age of 76 received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19. On 2021, The patient reported she is experiencing extreme fatigue and is still experiencing a fever. Patient has received both doses of the Pfizer BioNTech Covid vaccine. After the first dose she experienced fatigue. However, after the second dose on 4Feb2021 she had a "fairly large response." She is still dealing with these side effects over six weeks later. She is experiencing extreme fatigue and is still experiencing a fever. Her temperature is usually normal in the morning and then raises to 100.5 to 101.2 in the evening. She has already seen her HCP several times and they have no recommendations. She has been tested for Covid and different viruses but they've all been negative. She's had a chest Xray, urinanalysis, put on antibiotics just incase there was something latent. She has had blood work done several times, her WBC was 5.4 and was only slightly anemic. Her doctor may start her on iron supplements. The patient underwent lab tests and procedures which included, body temperature: 100.5 to 101.2 on 2021 (100.5 to 101.2 in the evening), body temperature: normal in the morning on 2021, sars-cov-2 test: negative on 2021, urine analysis: unknown on 2021, viral test: negative on 2021 and x-ray: unknown on 2021 (She's had a chest Xray) and white blood cell count: 5.4 (Her doctor may start her on iron supplements). The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was unknown.  Information on the lot/batch number has been requested.