chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Periarthritis, SARS-CoV-2 test
Clinical narrative: Severe arm pain about a week after second shot; It got worse and froze my shoulder; Severe brain fog; tiredness all the time; My lymph nodes still swell occasionally; lymph nodes painful/are painful to this day; My immune system was compromised and I was sick all the time.; My immune system was compromised and I was sick all the time.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2021 as dose 2, single (Lot number: EW0158) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "I was diagnosed with Epstein Barr Virus" (unspecified if ongoing); "Known allergies: Sulfur" (unspecified if ongoing), notes: Known allergies: Sulfur. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (lot number: EL9267, dose 1, right arm), administration date: 22Mar2021, when the patient was 55-year-old, for Covid-19 Immunization. The following information was reported: PERIARTHRITIS (disability) with onset 23Apr2021, outcome "recovering", described as "It got worse and froze my shoulder"; IMMUNE SYSTEM DISORDER (disability), ILLNESS (disability) all with onset 23Apr2021, outcome "recovering" and all described as "My immune system was compromised and I was sick all the time."; LYMPHADENOPATHY (disability) with onset 23Apr2021, outcome "recovering", described as "My lymph nodes still swell occasionally"; PAIN IN EXTREMITY (disability) with onset 23Apr2021, outcome "recovering", described as "Severe arm pain about a week after second shot"; FEELING ABNORMAL (disability) with onset 23Apr2021, outcome "recovering", described as "Severe brain fog"; LYMPH NODE PAIN (disability) with onset 23Apr2021, outcome "recovering", described as "lymph nodes painful/are painful to this day"; FATIGUE (disability) with onset 23Apr2021, outcome "recovering", described as "tiredness all the time". The events "severe arm pain about a week after second shot", "it got worse and froze my shoulder", "severe brain fog", "tiredness all the time", "my lymph nodes still swell occasionally", "lymph nodes painful/are painful to this day" and "my immune system was compromised and i was sick all the time." required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of pain in extremity, periarthritis, feeling abnormal, fatigue, lymphadenopathy, lymph node pain, immune system disorder, illness.   Patient also received dose 3, right arm on 01Jul2022 (lot number: FM7753). Patient did not have COVID prior vaccination and was COVID tested post vaccination.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Interchange of vaccine products; Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 31Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 15Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LOVASTATIN, start date: Jan2000, stop date: 28Feb2023; ASPIRIN [ACETYLSALICYLIC ACID]; VITAMIN B12 [CYANOCOBALAMIN]; VITAMIN D 2000. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown"; DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid from 02Mar2023 to 06Mar2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300110661 Same patient, different product, different event;
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: developed severe hives all over her body; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 as dose 4 (booster), single (Lot number: GJ5342) at the age of 12 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mildly allergic to Cat" (unspecified if ongoing); "Mildly allergic to Pollen" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: FJ4991, Location of injection: Arm Left), administration date: 16Jul2022, when the patient was 12-year-old, for COVID-19 IMMUNIZATION; BNT162b2 (Dose Number: 2, Batch/Lot No: FK5618, Location of injection: Arm Left), administration date: 04Dec2021, when the patient was 11-year-old, for COVID-19 IMMUNIZATION; BNT162b2 (Dose Number: 1, Batch/Lot No: PK5127, Location of injection: Arm Left), administration date: 13Nov2021, when the patient was 11-year-old, for COVID-19 IMMUNIZATION. The following information was reported: URTICARIA (disability) with onset 14Nov2022 at 17:00, outcome "not recovered", described as "developed severe hives all over her body". The event "developed severe hives all over her body" required physician office visit. Therapeutic measures were taken as a result of urticaria.  Clinical course: Three-four days after taking the vaccination, patient developed severe hives all over her body. The hives could be controlled by taking 10 mg of generic antihistamine that she has to take every day. After consultations with her pediatrician, allergist and immunologist, (name withheld) was given five-day 15mg/5ml Prednisolone course but that did not help in the long run as she started developing symptoms a week after the treatment ended. Recently she completed six-day course of 4mg Methylprednisolone, and that has not helped either. Failure to take atleast one antihistamine dosage in a day resulted in breakout of hives all over her body. The hives continue to this day, 14Mar2023 - more than four months after she took her last dose of vaccine.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 as dose 4 (booster), single (Lot number: GJ3275) at the age of 60 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: ER2613), in right arm, on 08Apr2021 as dose 2, single (Lot number: EW0151), in left arm and on 11Nov2021 as dose 3 (booster), single (Lot number: FH8028), in right arm for covid-19 immunisation. The patient's relevant medical history included: "PVCs" (unspecified if ongoing); "PACs" (unspecified if ongoing); "hx histoplasmosis with multiple nodules both lungs" (unspecified if ongoing); "chronic cough" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Positive, notes: Tested positive for Covid 5 days after finishing paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 05Mar2023 to 09Mar2023.; Sender's Comments: The efficacy of a product varies from one patient to another and can be affected by different factors; however, based on the temporal association and available information, a causal relationship between the events and suspect vaccine cannot be completely excluded.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Paxlovid for COVID 19 Treatment; Paxlovid for COVID 19 Treatment; This is a spontaneous report received from contactable reporter (consumer). The reporter is the patient.  An 80-year-old female patient (not pregnant) received BNT162b2, BNT162b2 OMI BA.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 80 years, in left arm for COVID-19 immunisation; BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL9263), in left arm, on 18Feb2021 as dose 2, single (Lot number: EN6201), in left arm and on 14Oct2021 as dose 3 (booster), single (Lot number: FF3590), in left arm for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Paxlovid for COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, COVID-19. Paxlovid was given from 27Feb2023 to 03Mar2023 for COVID-19 treatment. Clinical course: The patient has no known allergies.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Hemiparesis, Laboratory test, Muscle disorder, Muscular weakness
Clinical narrative: ride sided muscle weakness; nerve pain; muscle weakness; she has muscle issues; Weakness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2), in Aug2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 01, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: HEMIPARESIS (medically significant), outcome "unknown", described as "ride sided muscle weakness"; NEURALGIA (non-serious), outcome "unknown", described as "nerve pain"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "muscle weakness"; MUSCLE DISORDER (non-serious), outcome "unknown", described as "she has muscle issues"; ASTHENIA (non-serious), outcome "unknown", described as "Weakness". The patient underwent the following laboratory tests and procedures: lab work: Normal, notes: HCP says is normal.  Clinical course: The caller stated she had muscle issues, ride sided muscle weakness, nerve pain and muscle weakness. She was querying if these were possible side effects. Caller stated she was desperate to find answers, these symptoms may not have anything to do with the vaccine, but she was looking at everything. Caller stated she received her Primary dose #2 in Aug2021. It had been 10 months and she had lab work done to which the HCP says was normal. About 5 months after receiving her 2nd primary vaccine dose, she started to have these symptoms. She stated little things started happening about 5 months after the vaccine. She was asking if there was a diagnosis that was found that would help his HCP look in the right direction that was anything related to muscle weakness, muscle wasting, muscle atrophy and anything to do with nerve damage. Caller was 64 and states she was healthy until she was 62 years old. She got two of the vaccines and 3-4 months after she got it, started having issues. Unknown if anything to do with the vaccine. Trying to figure out going on with her. Doctor asked what changed. She was at her wits in and had been dealing with this for 10 months. She just wanted someone to listen to her who can give some advice. She declined to continue with safety report as she wanted to speak to someone who can answer her questions. Reporter later clarified issues she was questioning was having muscle issues and, nerve issues, nerve pain. She was mainly having muscle issues. She was also having weakness and muscle weakness.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia
Clinical narrative: ride sided muscle weakness; nerve pain; muscle weakness; she has muscle issues; Weakness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2), in Aug2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 01, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: HEMIPARESIS (medically significant), outcome "unknown", described as "ride sided muscle weakness"; NEURALGIA (non-serious), outcome "unknown", described as "nerve pain"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "muscle weakness"; MUSCLE DISORDER (non-serious), outcome "unknown", described as "she has muscle issues"; ASTHENIA (non-serious), outcome "unknown", described as "Weakness". The patient underwent the following laboratory tests and procedures: lab work: Normal, notes: HCP says is normal.  Clinical course: The caller stated she had muscle issues, ride sided muscle weakness, nerve pain and muscle weakness. She was querying if these were possible side effects. Caller stated she was desperate to find answers, these symptoms may not have anything to do with the vaccine, but she was looking at everything. Caller stated she received her Primary dose #2 in Aug2021. It had been 10 months and she had lab work done to which the HCP says was normal. About 5 months after receiving her 2nd primary vaccine dose, she started to have these symptoms. She stated little things started happening about 5 months after the vaccine. She was asking if there was a diagnosis that was found that would help his HCP look in the right direction that was anything related to muscle weakness, muscle wasting, muscle atrophy and anything to do with nerve damage. Caller was 64 and states she was healthy until she was 62 years old. She got two of the vaccines and 3-4 months after she got it, started having issues. Unknown if anything to do with the vaccine. Trying to figure out going on with her. Doctor asked what changed. She was at her wits in and had been dealing with this for 10 months. She just wanted someone to listen to her who can give some advice. She declined to continue with safety report as she wanted to speak to someone who can answer her questions. Reporter later clarified issues she was questioning was having muscle issues and, nerve issues, nerve pain. She was mainly having muscle issues. She was also having weakness and muscle weakness.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 92-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "enlarged prostate" (unspecified if ongoing). Concomitant medication(s) included: FINASTERIDE, start date: 01Jan2020; DOXAZOSIN, start date: 01Jan2020. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient had no known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19-2
Symptoms: Chills, Cough, Feeling cold
Clinical narrative: chills/tremendous chills; has been coughing for a couple of day; he was really cold when he came to bed. He was really freezing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "sinus issues" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown Manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Unknown Manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 3 (Booster), Unknown Manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 4 (Booster), Unknown Manufacturer), for Covid-19 immunization. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "chills/tremendous chills"; COUGH (non-serious), outcome "unknown", described as "has been coughing for a couple of day"; FEELING COLD (non-serious), outcome "unknown", described as "he was really cold when he came to bed. He was really freezing".  Additional information: Wife of patient called and wanted to know if chills was a side effect of the Pfizer COVID-19 Vaccine 3rd booster dose. Patient received the vaccine at 9:30AM and had extreme chills that night. Caller had to turn up the heat at night and put extra blankets on the patient. Caller mentioned that the patient has been coughing for a couple of days maybe due to the allergy season. Caller mentioned that the patient has sinus issues during allergy season. Further reported that husband was given the third booster of the Pfizer shot and she doesn't know if her husband is getting a side effect but her husband had tremendous chills last night. Which her husband doesn't normally have. Had the shot at 9:30 in the morning then at midnight, 1am, or 2am he was really cold when he came to bed. He was really freezing. Thought it was a side effect because it was kind of unusual.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac neoplasm unspecified, Computerised tomogram, Hepatic mass, Immune system disorder, Inguinal mass
Clinical narrative: Sarcoidosis; she has nodules all in her lungs, liver, heart, spleen and her groin; Her immune system has gone crazy; she has nodules all in her lungs, liver, heart, spleen and her groin; she has nodules all in her lungs, liver, heart, spleen and her groin; she has nodules all in her lungs, liver, heart, spleen and her groin; she has nodules all in her lungs, liver, heart, spleen and her groin; advanced stage of lymph node swelling and nodules; She has rashes everywhere; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "She doesn't drink, smoke or anything" (unspecified if ongoing); "She doesn't drink, smoke or anything" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SARCOIDOSIS (medically significant), outcome "unknown"; CARDIAC NEOPLASM UNSPECIFIED (medically significant), PULMONARY MASS (non-serious), HEPATIC MASS (non-serious), SPLEEN DISORDER (non-serious), INGUINAL MASS (non-serious), outcome "unknown" and all described as "she has nodules all in her lungs, liver, heart, spleen and her groin"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "Her immune system has gone crazy"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "advanced stage of lymph node swelling and nodules"; RASH (non-serious), outcome "unknown", described as "She has rashes everywhere". The patient underwent the following laboratory tests and procedures: Computerised tomogram: everything is growing like crazy all over her body; D-dimer test: went through the roof; 1.69 cm lining around her heart, notes: 1.69 cm lining around her heart; Magnetic resonance imaging: everything is growing like crazy all over her body; Positron emission tomogram: everything is growing like crazy all over her body. Additional information: It was reported that the CDC and VAERS has reported many, many cases of Sarcoidosis after taking the Pfizer Covid vaccine and the patient has it all over the place and she is a healthy person. She doesn't drink, smoke or anything. Her immune system has gone crazy, she has nodules all in her lungs, liver, heart, spleen and her groin. Her doctors have said that this was most definitely caused by the vaccine. The patient has advanced stage of lymph node swelling and nodules. The doctor said there is no cure and once you get it your done and you could die from it. The patient's D-dimer test went through the roof. She has nodules 1.7cm on her lungs, on her lymph nodes, her heart and spleen. In her groin. She has rashes everywhere and they want to put her on medication and she could die.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Lymphadenopathy, Magnetic resonance imaging, Positron emission tomogram, Pulmonary mass
Clinical narrative: Sarcoidosis; she has nodules all in her lungs, liver, heart, spleen and her groin; Her immune system has gone crazy; she has nodules all in her lungs, liver, heart, spleen and her groin; she has nodules all in her lungs, liver, heart, spleen and her groin; she has nodules all in her lungs, liver, heart, spleen and her groin; she has nodules all in her lungs, liver, heart, spleen and her groin; advanced stage of lymph node swelling and nodules; She has rashes everywhere; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "She doesn't drink, smoke or anything" (unspecified if ongoing); "She doesn't drink, smoke or anything" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SARCOIDOSIS (medically significant), outcome "unknown"; CARDIAC NEOPLASM UNSPECIFIED (medically significant), PULMONARY MASS (non-serious), HEPATIC MASS (non-serious), SPLEEN DISORDER (non-serious), INGUINAL MASS (non-serious), outcome "unknown" and all described as "she has nodules all in her lungs, liver, heart, spleen and her groin"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "Her immune system has gone crazy"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "advanced stage of lymph node swelling and nodules"; RASH (non-serious), outcome "unknown", described as "She has rashes everywhere". The patient underwent the following laboratory tests and procedures: Computerised tomogram: everything is growing like crazy all over her body; D-dimer test: went through the roof; 1.69 cm lining around her heart, notes: 1.69 cm lining around her heart; Magnetic resonance imaging: everything is growing like crazy all over her body; Positron emission tomogram: everything is growing like crazy all over her body. Additional information: It was reported that the CDC and VAERS has reported many, many cases of Sarcoidosis after taking the Pfizer Covid vaccine and the patient has it all over the place and she is a healthy person. She doesn't drink, smoke or anything. Her immune system has gone crazy, she has nodules all in her lungs, liver, heart, spleen and her groin. Her doctors have said that this was most definitely caused by the vaccine. The patient has advanced stage of lymph node swelling and nodules. The doctor said there is no cure and once you get it your done and you could die from it. The patient's D-dimer test went through the roof. She has nodules 1.7cm on her lungs, on her lymph nodes, her heart and spleen. In her groin. She has rashes everywhere and they want to put her on medication and she could die.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Sarcoidosis, Spleen disorder
Clinical narrative: Sarcoidosis; she has nodules all in her lungs, liver, heart, spleen and her groin; Her immune system has gone crazy; she has nodules all in her lungs, liver, heart, spleen and her groin; she has nodules all in her lungs, liver, heart, spleen and her groin; she has nodules all in her lungs, liver, heart, spleen and her groin; she has nodules all in her lungs, liver, heart, spleen and her groin; advanced stage of lymph node swelling and nodules; She has rashes everywhere; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "She doesn't drink, smoke or anything" (unspecified if ongoing); "She doesn't drink, smoke or anything" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SARCOIDOSIS (medically significant), outcome "unknown"; CARDIAC NEOPLASM UNSPECIFIED (medically significant), PULMONARY MASS (non-serious), HEPATIC MASS (non-serious), SPLEEN DISORDER (non-serious), INGUINAL MASS (non-serious), outcome "unknown" and all described as "she has nodules all in her lungs, liver, heart, spleen and her groin"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "Her immune system has gone crazy"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "advanced stage of lymph node swelling and nodules"; RASH (non-serious), outcome "unknown", described as "She has rashes everywhere". The patient underwent the following laboratory tests and procedures: Computerised tomogram: everything is growing like crazy all over her body; D-dimer test: went through the roof; 1.69 cm lining around her heart, notes: 1.69 cm lining around her heart; Magnetic resonance imaging: everything is growing like crazy all over her body; Positron emission tomogram: everything is growing like crazy all over her body. Additional information: It was reported that the CDC and VAERS has reported many, many cases of Sarcoidosis after taking the Pfizer Covid vaccine and the patient has it all over the place and she is a healthy person. She doesn't drink, smoke or anything. Her immune system has gone crazy, she has nodules all in her lungs, liver, heart, spleen and her groin. Her doctors have said that this was most definitely caused by the vaccine. The patient has advanced stage of lymph node swelling and nodules. The doctor said there is no cure and once you get it your done and you could die from it. The patient's D-dimer test went through the roof. She has nodules 1.7cm on her lungs, on her lymph nodes, her heart and spleen. In her groin. She has rashes everywhere and they want to put her on medication and she could die.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: died from clots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (death, medically significant), outcome "fatal", described as "died from clots". The patient date of death was unknown. Reported cause of death: "died from clots". It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300112856 same reporter, drug and event, different patient;US-PFIZER INC-202300112854 same reporter, drug and event, different patient;; Reported Cause(s) of Death: died from clots
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: died from heart attacks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (death, medically significant), outcome "fatal", described as "died from heart attacks". The patient date of death was unknown. Reported cause of death: "died from heart attacks". It was unknown if an autopsy was performed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300112858 same reporter, product, event; different patient;; Reported Cause(s) of Death: died from heart attacks
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: died from heart attacks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (death, medically significant), outcome "fatal", described as "died from heart attacks". The patient date of death was unknown. Reported cause of death: "died form heart attacks". It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300112857 same reporter, product, event; different patient;; Reported Cause(s) of Death: died form heart attacks
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: They found her with her mouth just open, just dead; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "They found her with her mouth just open, just dead". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. ; Reported Cause(s) of Death: They found her with her mouth just open, just dead
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfur" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received nirmatrelvir, ritonavir (PAXLOVID) from 07Mar2023 to 12Mar2023. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antibody test, COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Patient received the Moderna shots before Pfizer COVID-19 vaccine bivalent shot; 3rd time patient had Covid was in Dec2022,; 3rd time patient had Covid was in Dec2022,; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 74-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation.  Patient received the 2 Moderna shots, caller unknown the specific name of product, just knows it was the Moderna original 2 shot series. Then patient had either 1 or 2 boosters that caller thinks were also Moderna. Then the patient received Pfizer COVID-19 vaccine bivalent shot in either late Sep2022 or early Oct2022. The patient's relevant medical history included: "COVID" (unspecified if ongoing), notes: 1st time patient had Covid was prior to patient receiving the Modera shots or the Pfizer COVID-19 vaccine bivalent shot.; "COVID" (unspecified if ongoing), notes: 2nd time patient had Covid was after patient received the 2 Moderna shots, was 8 or 9 months later.; "anemia", start date: Mar2022 (unspecified if ongoing), notes: diagnosed early last year. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "3rd time patient had Covid was in Dec2022,"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Patient received the Moderna shots before Pfizer COVID-19 vaccine bivalent shot". The patient underwent the following laboratory tests and procedures: Antibody test: no autoimmune disease, notes: test recently and found patient has no autoimmune disease.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Also experienced tingling in his body; Numbness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team, Program ID:  A 21-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious), outcome "unknown", described as "Also experienced tingling in his body"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "Numbness".  Additional information: Reporter stated, "Yes mostly tingling and some numbness in his left leg below his knee and his foot, lots of tingling and his still have it."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Nov2022 at 12:00 as dose 5 (booster), single (Lot number: 021H22A), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicill" (unspecified if ongoing), notes: known allergies: Penicill. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Death
Clinical narrative: deceased; stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from legal division.  An adult female patient received BNT162b2 (BNT162B2), on 09Sep2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE NUMBER UNKNOWN, SINGLE), administration date: 03Mar2021, for COVID-19 immunisation, reaction(s): "Stroke". The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset Sep2021, outcome "unknown", described as "stroke"; DEATH (death, medically significant), outcome "fatal", described as "deceased". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course: On or about (date) 03Mar2021, 09Sep2021 plaintiff was injured by the following product. On 03Mar2021, Decedent (Name withheld) received a dose of Defendants Pfizer/Pharmacia SARS-Covid2 for protection Covid-19 and (Name withheld) had multiple strokes thereafter. First, on 04Mar2021 just a day after the 03Mar2021 vaccine; then (Name withheld) received another dose on 09Sep2021 (also reported as 09Sep2020) and she and she had more strokes shortly after in Sept, Oct and Nov2021.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: deceased
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 37 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Onions" (unspecified if ongoing); "sun allergy" (unspecified if ongoing); "Cancer survivor. Finished chemo", stop date: Apr2022, notes: Cancer survivor. Finished chemo in Apr2022.; "Cancer survivor. Finished chemo" (unspecified if ongoing), notes: Cancer survivor. Finished chemo in Apr2022. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Mar2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Mar2023) Positive, notes: Tested positive on 03Mar and started Paxlovid in the evening; (08Mar2023) Negative, notes: Finished the last set of pills on morning of 08Mar and tested negative; (10Mar2023) Negative, notes: Tested negative again on 10Mar; (12Mar2023) Positive, notes: Tested positive again on 12Mar. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid rebound. Tested positive on 03Mar and started Paxlovid in the evening. Finished the last set of pills on morning of Mar8 and tested negative. Tested negative again on 10Mar with no symptoms. On 12Mar, started coughing and sneezing. Tested positive again on 12Mar. Symptoms worsened on 13Mar and 14Mar.
Sex: M
Vaccine: COVID19
Symptoms: Lung transplant
Clinical narrative: patient is on the lung transplant list; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LUNG TRANSPLANT (medically significant), outcome "unknown", described as "patient is on the lung transplant list".  Clinical Course: The patient said that he had his first Pfizer shot in 2021 and he never got the second one. He said he had to get it immediately because he is on the lung transplant list. He said that he had to have this stuff done. The patient provided the information for vaccine appointment. The patient started ranting because we cannot provide the phone number and then he hung up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cerebral disorder
Clinical narrative: Caller mentioned that she thinks the COVID booster shot that she received 2 years ago messed up her brain.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for Covid-19 Immunization. The following information was reported: CEREBRAL DISORDER (non-serious), outcome "unknown", described as "Caller mentioned that she thinks the COVID booster shot that she received 2 years ago messed up her brain.".  Additional information: Reporter mentioned that she thinks the COVID booster shot that she received 2 years ago messed up her brain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I was vaccinated with the Pfizer COVID vaccine on 30Mar2021 and 20Apr2021 / COVID-19 Jul2021; I was vaccinated with the Pfizer COVID vaccine on 30Mar2021 and 20Apr2021 / COVID-19 Jul2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 20Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2021, outcome "unknown" and all described as "I was vaccinated with the Pfizer COVID vaccine on 30Mar2021 and 20Apr2021 / COVID-19 Jul2021". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.Name of Product (both commercial and generic names, if known), ritonavir (paxlovid).  Clinical information: No any other product(s) that were taken together with those indicated above. Paxlovid works great for me with no side effects. In 24 hours my symptoms subside and in 7 days I test negative. This drug is a life saver for me. I don't take my regular medications while on Paxlovid because it does not work well with my meds. I was vaccinated with the Pfizer COVID vaccine on 30Mar2021 and 20Apr2021. I have not had any boosters to date.
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Thrombosis
Clinical narrative: Diagnosed with blood clots; DVT; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; Unknown Manufacturer), for COVID-19 Immunisation. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "Diagnosed with blood clots"; DEEP VEIN THROMBOSIS (medically significant), outcome "unknown", described as "DVT". Therapeutic measures were taken as a result of thrombosis, deep vein thrombosis. Clinical course: Patient confirmed if the DVTs which patient experienced was related to the recent vaccine booster. She took Eliquis which was very expensive. He was healthy, very active adult. Medical inquiry was not forwarded to MI.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300110492 same reporter/drug/event, different patient;