chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Blood pressure decreased, Blood pressure measurement, Head injury, Loss of consciousness
Clinical narrative: Blood pressure dropped; anaphylactic event; passed out; hit her head; This is a spontaneous report received from contactable reporter(s) (Physician).  A 46-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 46 years for COVID-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: BLOOD PRESSURE DECREASED (medically significant), 10 hrs after the suspect product(s) administration, outcome "unknown", described as "Blood pressure dropped"; ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "anaphylactic event"; LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "passed out"; HEAD INJURY (non-serious), outcome "unknown", described as "hit her head". The events "blood pressure dropped", "anaphylactic event", "passed out" and "hit her head" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: Decreased, notes: Patient's blood pressure dropped to 60 ten hours after the second dose was given.  Clinical course: Patients other condition was reported as no. Other products and investigations reported as unknown. Patient's blood pressure dropped to 60 ten hours after the second dose was given, passed out, hit her head, and taken to ER. Given fluids at the ER. Reporter thought it was an anaphylactic event. Reporter assumed that the patient was fine as reporter trying to figure out if patient should get boosted or not. Patient doesn't have any other comorbidities.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received. Sender's Comments: Based on the available reported information, the causal association between the events and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), in Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Lone atrial fibrillation" (ongoing), notes: currently managed; "Hypothyroidism" (unspecified if ongoing). Concomitant medications included: ASPIRIN [ACETYLSALICYLIC ACID], start date: Mar2003 (ongoing); LEVOTHYROXINE, start date: Jan2017 (ongoing); LISINOPRIL taken for hypertension, start date: Jan2017 (ongoing). The following information was reported: PAIN (non-serious) with onset 2022, outcome "recovering", described as "Body aches"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "COVID-19"; PYREXIA (non-serious) with onset 2022, outcome "recovering", described as "Fever". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (06Nov2022) Negative; (09Nov2022) Positive; (10Nov2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of pyrexia, pain. Clinical course: The patient reported that he completed his course of treatment with Paxlovid on 05Nov2022 and tested negative for COVID on 06Nov2022. He did not experience any symptoms of COVID other than fatigue as of 04Nov2022. On the evening of 08Nov2022, the patient began to feel congested and took a COVID test on the morning of 09Nov202, at which time he tested positive. He experienced a modest cough and fairly heavy congestion during this "rebound" phase, although he did not experience any fever or body aches as he had with the first infection during the prior week. The patient did a follow-up test in the morning of 10Nov2022, and the result was again positive for COVID.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; 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 (COMIRNATY), on 02Dec2021 at 13:00 as dose 2, single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1. single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Stem cell recepient ALL leukemia" (unspecified if ongoing), notes: Stem cell recepient ALL leukemia; "Allogenic Transplant patient 2014", start date: 2014 (unspecified if ongoing), notes: Allogenic Transplant patient 2014; "Butter" (unspecified if ongoing); "dairy" (unspecified if ongoing); "soy oil" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Coediene, reaction(s): "allergy".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported COVID-19, which is considered as ineffectiveness of the vaccine BNT162B2, and the administration of BNT162B2, as the efficacy of a vaccine varies individually and may be affected by different factors including drug potency.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure decreased, Blood pressure measurement, Head discomfort, Heart rate
Clinical narrative: Fever; Weakness in her head; Blood pressure was down/blood pressure went down to 80; Her heart rate went down; every time she got down, she was definitely ill; she couldn't even lift her head or lift her arms; she couldn't even lift her head or lift her arms; she couldn't even lift her head or lift her arms; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  An 83-year-old female patient received BNT162b2 (BNT162B2), 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: PYREXIA (non-serious), outcome "unknown", described as "Fever"; ASTHENIA (non-serious), outcome "unknown", described as "Weakness in her head"; BLOOD PRESSURE DECREASED (non-serious), outcome "unknown", described as "Blood pressure was down/blood pressure went down to 80"; HEART RATE DECREASED (non-serious), outcome "unknown", described as "Her heart rate went down"; ILLNESS (non-serious), outcome "unknown", described as "every time she got down, she was definitely ill"; HYPOKINESIA (non-serious), HEAD DISCOMFORT (non-serious), LIMB DISCOMFORT (non-serious), outcome "unknown" and all described as "she couldn't even lift her head or lift her arms". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The caller was calling on behalf her mom that had received 4 doses of the Pfizer-BioNTech COVID 19 Vaccine. However in these previous shots, her mom had fever, weakness in her head and also her blood pressure was down. She wanted to know if this have been reported in order to make a decision if her mom can receive the bivalent formulation. Every time she got down, she was definitely ill and it means her blood pressure went down to 80 and her heart rate went down and then it was like, she couldn't even lift her head or lift her arms or anything like that and it lasted like a 24 hours period and the caller wanted to even get her the booster (Unspecified Booster Shot) but too scared of it. So, it wasn't like it was a single incident, it was every time she got the Pfizer Vaccine. NDC number of COVID-19 Vaccine: Unknown  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201293434 same patient/drug/event; different dose;US-PFIZER INC-202201293435 same patient/drug/event; different dose;US-PFIZER INC-202201293433 same patient/drug/event; different dose;
Sex: F
Vaccine: COVID19
Symptoms: Heart rate decreased, Hypokinesia, Illness, Limb discomfort, Pyrexia
Clinical narrative: Fever; Weakness in her head; Blood pressure was down/blood pressure went down to 80; Her heart rate went down; every time she got down, she was definitely ill; she couldn't even lift her head or lift her arms; she couldn't even lift her head or lift her arms; she couldn't even lift her head or lift her arms; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  An 83-year-old female patient received BNT162b2 (BNT162B2), 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: PYREXIA (non-serious), outcome "unknown", described as "Fever"; ASTHENIA (non-serious), outcome "unknown", described as "Weakness in her head"; BLOOD PRESSURE DECREASED (non-serious), outcome "unknown", described as "Blood pressure was down/blood pressure went down to 80"; HEART RATE DECREASED (non-serious), outcome "unknown", described as "Her heart rate went down"; ILLNESS (non-serious), outcome "unknown", described as "every time she got down, she was definitely ill"; HYPOKINESIA (non-serious), HEAD DISCOMFORT (non-serious), LIMB DISCOMFORT (non-serious), outcome "unknown" and all described as "she couldn't even lift her head or lift her arms". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The caller was calling on behalf her mom that had received 4 doses of the Pfizer-BioNTech COVID 19 Vaccine. However in these previous shots, her mom had fever, weakness in her head and also her blood pressure was down. She wanted to know if this have been reported in order to make a decision if her mom can receive the bivalent formulation. Every time she got down, she was definitely ill and it means her blood pressure went down to 80 and her heart rate went down and then it was like, she couldn't even lift her head or lift her arms or anything like that and it lasted like a 24 hours period and the caller wanted to even get her the booster (Unspecified Booster Shot) but too scared of it. So, it wasn't like it was a single incident, it was every time she got the Pfizer Vaccine. NDC number of COVID-19 Vaccine: Unknown  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201293434 same patient/drug/event; different dose;US-PFIZER INC-202201293435 same patient/drug/event; different dose;US-PFIZER INC-202201293433 same patient/drug/event; different dose;
Sex: U
Vaccine: COVID19-2
Symptoms: Myocardial infarction
Clinical narrative: Massive heart attack: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP), Program ID:  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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 (medically significant), outcome "unknown", described as "Massive heart attack".  Clinical course: The caller also mentioned that one of his friends took the shot and had a massive heart attack. They also recently found out they have stage 4 cancer of the prostate. Caller said that he called Pfizer because of a problem with the approved Comirnaty. Caller stated that he hasn't seen a bottle or label for Comirnaty, but over Labor Day weekend it went Bivalent. Caller said that instead of putting 2 in front of it, they used Bivalent. Most people don't know what the word Bivalent means. Caller said they said it is for two different variants, but it isn't, it's for 5 different variants. Caller stated that bivalent means double the dose and basically Pfizer doubled the dose over Labor Day weekend, and then RSV started. The information on Product strength and count size dispensed, Additional lot numbers, Packaging sealed and intact was not willing to verify or clarify any information provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Died; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP), Program ID:   A male patient received BNT162b2 (BNT162B2), 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 "Died". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course: The patient (boy) got the vaccine and died afterwards.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Died
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: lost their babies; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP), Program ID:  A female patient received BNT162b2 (BNT162B2), 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: ABORTION SPONTANEOUS (medically significant), outcome "unknown", described as "lost their babies".  Clinical course: caller reported that he is reporting that the Pfizer COVID 19 Vaccine is causing cancer to everyone. The caller mentioned there were four girls who got the vaccine, and three of them lost their babies. The caller also mentioned that one of his friends took the shot and had a massive heart attack. They also recently found out they have stage 4 cancer of the prostate. The caller also mentioned that (withheld), after getting the shot, had COVID twice already. The caller also mentioned that a boy got the vaccine and died afterwards.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19-2
Symptoms: Abortion spontaneous
Clinical narrative: lost their babies; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP), Program ID: A female patient received BNT162b2 (BNT162B2), 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: ABORTION SPONTANEOUS (medically significant), outcome "unknown", described as "lost their babies".  Clinical course: The report was related to a study or program. The caller mentioned there were four girls who got the vaccine, and three of them lost their babies. The caller also mentioned that one of his friends took the shot and had a massive heart attack. They also recently found out they have stage 4 cancer of the prostate. The caller also mentioned that after getting the shot, had COVID twice already. Caller said that he called Pfizer because of a problem with the approved Comirnaty. Caller stated that he had not seen a bottle or label for Comirnaty, but over Labor Day weekend it went Bivalent. Caller said that instead of putting 2 in front of it, they used Bivalent. Most people did not know what the word Bivalent means. Caller said they said it was for two different variants, but it isn't, it was for 5 different variants. Caller stated that bivalent means double the dose and basically Pfizer doubled the dose over Labor Day weekend, and then RSV started. The information on Product strength and count size dispensed, Additional lot numbers, Packaging sealed and intact was not willing to verify or clarify any information provided. There was a product complaint to report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: lost their babies; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown).  A female patient received BNT162b2 (BNT162B2), 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: ABORTION SPONTANEOUS (medically significant), outcome "unknown", described as "lost their babies".  Clinical course: The Reporter stated that he is reporting that the Pfizer COVID 19 Vaccine is causing cancer to everyone. The Reporter mentioned there were four girls who got the vaccine, and three of them lost their babies. The Reporter also mentioned that one of his friends took the shot and had a massive heart attack. They also recently found out they have stage 4 cancer of the prostate. The Reporter also mentioned that (withheld), after getting the shot, had COVID twice already. The Reporter also mentioned that a boy got the vaccine and died afterwards. The Reporter states that Pfizer did not put out much, but according to Pfizer's own numbers they killed 110,000 plus people. Reporter states that he has not seen a bottle or label for Comirnaty, but over special weekend it went Bivalent. Reporter says that instead of putting 2 in front of it, they used Bivalent. Most people don't know what the word Bivalent means. Reporter says they say it is for two different variants, but it is not, it is for 5 different variants. Reporter states that bivalent means double the dose and basically Pfizer doubled the dose over special weekend, and then (withheld) started.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pruritus
Clinical narrative: severe generalized burning type pain; occasional pruritus in my feet, hands, extremities, & occasionally in the abdomen & back.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "SLE" (unspecified if ongoing); "other autoimmune diseases" (unspecified if ongoing). Concomitant medication(s) included: CELLCEPT [MYCOPHENOLATE MOFETIL] taken for autoimmune disorder; BENLYSTA subcutaneous taken for autoimmune disorder. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: unknown), for COVID-19 Immunization, reaction(s): "severe generalized burning type pain", "occasional pruritus in my feet, hands, extremities, & occasionally in the abdomen & back"; Bnt162b2 (DOSE 2, SINGLE, Lot number: unknown), for COVID-19 Immunization, reaction(s): "severe generalized burning type pain", "occasional pruritus in my feet, hands, extremities, & occasionally in the abdomen & back". The following information was reported: PAIN (non-serious), outcome "unknown", described as "severe generalized burning type pain"; PRURITUS (non-serious), outcome "unknown", described as "occasional pruritus in my feet, hands, extremities, & occasionally in the abdomen & back.". Therapeutic measures were taken as a result of pain, pruritus.  Additional information: It was also reported that symptoms occurred 6-7 days after the injection on both occasions. Patient had minimal symptoms with the 2nd, 3rd and 4th doses. These symptoms are unresponsive to OTC meds, partially responsive to oxycodone, & usually require short term use of prednisone.   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: Asthenia, Blood pressure decreased, Blood pressure measurement, Head discomfort, Heart rate
Clinical narrative: Fever; Weakness in her head; Weakness in her head; Blood pressure was down/blood pressure went down to 80; Her heart rate went down; She couldn't even lift her head or lift her arms; Every time she got down, she was definitely ill; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  An 83-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (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: Bnt162b2 (DOSE 1), for COVID-19 immunization, reaction(s): "Weakness in her head", "Blood pressure was down/blood pressure went down to 80", "Weakness in her head", "Her heart rate went down", "Every time she got down, she was definitely ill", "She couldn't even lift her head or lift her arms", "Fever"; Bnt162b2 (DOSE 2), for COVID-19 immunization, reaction(s): "Weakness in her head", "Blood pressure was down/blood pressure went down to 80", "Weakness in her head", "Her heart rate went down", "Every time she got down, she was definitely ill", "She couldn't even lift her head or lift her arms", "Fever". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever"; ASTHENIA (non-serious), HEAD DISCOMFORT (non-serious), outcome "unknown" and all described as "Weakness in her head"; BLOOD PRESSURE DECREASED (non-serious), outcome "recovered", described as "Blood pressure was down/blood pressure went down to 80"; HEART RATE DECREASED (non-serious), outcome "recovered", described as "Her heart rate went down"; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "recovered", described as "She couldn't even lift her head or lift her arms"; ILLNESS (non-serious), outcome "recovered", described as "Every time she got down, she was definitely ill". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201293068 Same patient, drug, and events; different dose;US-PFIZER INC-202201293433 same patient/drug/event; different dose;
Sex: F
Vaccine: COVID19
Symptoms: Heart rate decreased, Illness, Joint range of motion decreased, Pyrexia
Clinical narrative: Fever; Weakness in her head; Weakness in her head; Blood pressure was down/blood pressure went down to 80; Her heart rate went down; She couldn't even lift her head or lift her arms; Every time she got down, she was definitely ill; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  An 83-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (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: Bnt162b2 (DOSE 1), for COVID-19 immunization, reaction(s): "Weakness in her head", "Blood pressure was down/blood pressure went down to 80", "Weakness in her head", "Her heart rate went down", "Every time she got down, she was definitely ill", "She couldn't even lift her head or lift her arms", "Fever"; Bnt162b2 (DOSE 2), for COVID-19 immunization, reaction(s): "Weakness in her head", "Blood pressure was down/blood pressure went down to 80", "Weakness in her head", "Her heart rate went down", "Every time she got down, she was definitely ill", "She couldn't even lift her head or lift her arms", "Fever". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever"; ASTHENIA (non-serious), HEAD DISCOMFORT (non-serious), outcome "unknown" and all described as "Weakness in her head"; BLOOD PRESSURE DECREASED (non-serious), outcome "recovered", described as "Blood pressure was down/blood pressure went down to 80"; HEART RATE DECREASED (non-serious), outcome "recovered", described as "Her heart rate went down"; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "recovered", described as "She couldn't even lift her head or lift her arms"; ILLNESS (non-serious), outcome "recovered", described as "Every time she got down, she was definitely ill". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201293068 Same patient, drug, and events; different dose;US-PFIZER INC-202201293433 same patient/drug/event; different dose;
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blood electrolytes, Blood electrolytes abnormal
Clinical narrative: Electrolyte that was not normal 0.9; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 76-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Hyponatremia" (unspecified if ongoing); "TIA" (unspecified if ongoing); "cardiacally impaired" (unspecified if ongoing). Concomitant medication(s) included: ALPRAZOLAM; GABAPENTIN; LOVENOX [LEVOFLOXACIN]. Vaccination history included: BNT162b2;BNT162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), administration date: 01Oct2022, when the patient was 75-year-old, for Covid-19 Immunization; Covid-19 vaccine (Primary immunization series completed; unknown manufacturer), for Covid-19 Immunization. The following information was reported: BLOOD ELECTROLYTES ABNORMAL (non-serious), outcome "unknown", described as "Electrolyte that was not normal 0.9". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: the patient was given again the bivalent dose on 10Nov2022 which was almost one month apart from the last booster on 01Oct2022. The pharmacist reported that the patient was on 23 medications or whatever the pharmacist told. She was diagnosed with EBA (not clarified), depression, cardiacaly impaired, hypothyroidism, TIA, history of hyponatremia. Her electrolyte was not normal.  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: Arthralgia, Back pain, Blood pressure measurement, Hypertension, Illness
Clinical narrative: Blood clots in Lungs; Peripheral Neuropathy; High Blood Pressure; horrific back & amp; leg pain; horrific back & amp; leg pain; Neck, Shoulder's, arms, and hands Pain.; Neck, Shoulder's, arms, and hands Pain.; Neck, Shoulder's, arms, and hands Pain.; Neck, Shoulder's, arms, and hands Pain.; have been sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team, Program ID: The reporter is the patient.  A 79-year-old female patient received BNT162b2 (BNT162B2), on 04Dec2021 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: ILLNESS (non-serious) with onset 04Dec2021, outcome "unknown", described as "have been sick"; PULMONARY EMBOLISM (hospitalization, medically significant), outcome "unknown", described as "Blood clots in Lungs"; NEUROPATHY PERIPHERAL (hospitalization, medically significant), outcome "unknown", described as "Peripheral Neuropathy"; HYPERTENSION (hospitalization), outcome "unknown", described as "High Blood Pressure"; PAIN IN EXTREMITY (hospitalization), BACK PAIN (hospitalization), outcome "unknown" and all described as "horrific back & amp; leg pain"; NECK PAIN (hospitalization), ARTHRALGIA (hospitalization), PAIN IN EXTREMITY (hospitalization), PAIN IN EXTREMITY (hospitalization), outcome "unknown" and all described as "Neck, Shoulder's, arms, and hands Pain.". The events "blood clots in lungs", "peripheral neuropathy", "high blood pressure", "horrific back & amp; leg pain" and "neck, shoulder's, arms, and hands pain." required physician office visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 202. Additional information: Comirnaty, Pfizer-BioNTech COVID-19 Vaccine, mRNA [Monovalent and/or Bivalent]. Patient inquired asking for Company Doctor's advice on what kind of medicine shot she can get to combat the Pfizer Booster Shot she got on 04Dec2021 and have been sick since then. She has been to about 7 Doctors and hospital with High Blood Pressure (202), Blood clots in Lungs, Peripheral Neuropathy, horrific back & amp; leg pain. And constant Neck, Shoulder's, arms, and hands Pain. She was slowly dieing and no one can seem to help her.   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: Neck pain, Neuropathy peripheral, Pain in extremity, Pulmonary embolism
Clinical narrative: Blood clots in Lungs; Peripheral Neuropathy; High Blood Pressure; horrific back & amp; leg pain; horrific back & amp; leg pain; Neck, Shoulder's, arms, and hands Pain.; Neck, Shoulder's, arms, and hands Pain.; Neck, Shoulder's, arms, and hands Pain.; Neck, Shoulder's, arms, and hands Pain.; have been sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team, Program ID: The reporter is the patient.  A 79-year-old female patient received BNT162b2 (BNT162B2), on 04Dec2021 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: ILLNESS (non-serious) with onset 04Dec2021, outcome "unknown", described as "have been sick"; PULMONARY EMBOLISM (hospitalization, medically significant), outcome "unknown", described as "Blood clots in Lungs"; NEUROPATHY PERIPHERAL (hospitalization, medically significant), outcome "unknown", described as "Peripheral Neuropathy"; HYPERTENSION (hospitalization), outcome "unknown", described as "High Blood Pressure"; PAIN IN EXTREMITY (hospitalization), BACK PAIN (hospitalization), outcome "unknown" and all described as "horrific back & amp; leg pain"; NECK PAIN (hospitalization), ARTHRALGIA (hospitalization), PAIN IN EXTREMITY (hospitalization), PAIN IN EXTREMITY (hospitalization), outcome "unknown" and all described as "Neck, Shoulder's, arms, and hands Pain.". The events "blood clots in lungs", "peripheral neuropathy", "high blood pressure", "horrific back & amp; leg pain" and "neck, shoulder's, arms, and hands pain." required physician office visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 202. Additional information: Comirnaty, Pfizer-BioNTech COVID-19 Vaccine, mRNA [Monovalent and/or Bivalent]. Patient inquired asking for Company Doctor's advice on what kind of medicine shot she can get to combat the Pfizer Booster Shot she got on 04Dec2021 and have been sick since then. She has been to about 7 Doctors and hospital with High Blood Pressure (202), Blood clots in Lungs, Peripheral Neuropathy, horrific back & amp; leg pain. And constant Neck, Shoulder's, arms, and hands Pain. She was slowly dieing and no one can seem to help her.   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: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Mx: 68 degree F, Min: 76 degree F: Duration of excursion: Approx 24 hrs; Mx: 68 degree F, Min: 76 degree F: Duration of excursion: Approx 24 hrs; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Lot number: GJ6738, Expiration Date: 31Jul2023) 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: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), outcome "unknown" and all described as "Mx: 68 degree F, Min: 76 degree F: Duration of excursion: Approx 24 hrs".  Additional information: The date of shipment arrived at customer at 28Oct2022 and the number of product unit impacted was 1. The fridge was stored at 2-8 degree C. Maximum temperature was reported as 68 degree F and minimum temperature was 78 degree F. The temperature excursion occurred for approximately 24 hours.
Sex: U
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (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 (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: DEAFNESS (medically significant) with onset 2022, outcome "not recovered", described as "Terrible ear loss".  Additional information: Since patient got 3rd dose COVID vaccine patient was experiencing terrible ear loss, it has been 3 and half month now, Patient cannot stand it anymore it is like a nightmare, what should patient do?  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, SARS-CoV-2 test
Clinical narrative: tested positive for COVID.; tested positive for COVID.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Nov2022, outcome "unknown" and all described as "tested positive for COVID.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Nov2022) Negative; (09Nov2022) Positive.  Clinical course: The patient had the Comirnaty bivalent booster vaccine on 06Sep2022. This was his fifth total vaccine (3rd booster). All vaccines were Pfizer. Last night on 08Nov2022 he developed cough, headache, low grade fever and chills. He tested negative on rapid antigen test last night, and on repeated testing this morning (09Nov2022) he tested positive for COVID. He is following up with his primary care physician. This is being reported as a breakthrough COVID infection 2 months s/p the Comirnaty bivalent booster vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Fall, Mobility decreased
Clinical narrative: I'm confined to a wheelchair, not working anymore...I have zero mobility and I was falling a lot.; I'm confined to a wheelchair, not working anymore...I have zero mobility and I was falling a lot.; my symptoms are getting progressively worse; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NUS2022US243422_NS (NOVARTIS).  A 48-year-old male patient received BNT162b2 (BNT162B2), 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: MOBILITY DECREASED (disability), FALL (disability), outcome "unknown" and all described as "I'm confined to a wheelchair, not working anymore...I have zero mobility and I was falling a lot."; CONDITION AGGRAVATED (disability), outcome "unknown", described as "my symptoms are getting progressively worse".  Additional information: Patient reports I got my COVID shot and 3 months later this happens. My symptoms are getting progressively worse. I'm confined to a wheelchair, not working anymore. I have zero mobility and I was falling a lot.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Rotator cuff syndrome, Tendonitis
Clinical narrative: tendonitis of upper biceps tendon of left shoulder; rotator cuff impingement syndrome of left shoulder; left shoulder pain/ Chronic pain in right shoulder; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 57-year-old female patient received BNT162b2 (BNT162B2), on 26Apr2021 as dose 2, single (Lot number: EW0164) at the age of 56 years intramuscular, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "Essential hypertension", start date: 22Sep2020 (ongoing); "Mixed hyperlipidemia", start date: 03Sep2020 (ongoing), notes: Hyperlipidemia; "Hypertension", start date: 03Sep2020 (ongoing); "Diabetes mellitus", start date: 03Sep2020 (ongoing), notes: Diabetes mellitus (HCC-CMS) (Chronic); "Osteoarthritis of left glenohumeral joint", start date: 02Feb2021 (ongoing); "Nontraumatic incomplete tear of left rotator cuff", start date: 02Feb2021 (ongoing); "Allergy to Sulfa" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR oral, start date: 01Jun2021 (ongoing); CALCIUM CARBONATE AND VITAMIN D3 oral; MELOXICAM oral; ASCORBIC ACID oral; NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) oral taken for urinary tract disorder, start date: 08Feb2021 (ongoing); NORVASC oral taken for essential hypertension, start date: 22Sep2020 (ongoing). Past drug history included: Losartan. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot no: ER2613, Route of Administration: Intramuscular, Anatomical site: Right deltoid), administration date: 31Mar2021, for COVID-19 Immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 13Sep2021, outcome "not recovered", described as "left shoulder pain/ Chronic pain in right shoulder"; ROTATOR CUFF SYNDROME (non-serious) with onset 25Feb2022, outcome "not recovered", described as "rotator cuff impingement syndrome of left shoulder"; TENDONITIS (non-serious), outcome "not recovered", described as "tendonitis of upper biceps tendon of left shoulder".  Additional information: No any relevant test done. Specific relevant test for thromboembolic events with thrombocytopenia was reported as none.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Drug ineffective, Dysphonia, Feeling abnormal
Clinical narrative: covid; covid; difficulty hearing; headaches; hoarseness; no energy; brain fog; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 64-year-old female patient received BNT162b2 (BNT162B2), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid"; HYPOACUSIS (non-serious), outcome "unknown", described as "difficulty hearing"; HEADACHE (non-serious), outcome "unknown", described as "headaches"; DYSPHONIA (non-serious), outcome "unknown", described as "hoarseness"; ASTHENIA (non-serious), outcome "unknown", described as "no energy"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "brain fog".   The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: She then tested positive for "covid" in Oct.  Clinical course: She then tested positive for "covid" in Oct (date unknown) and xeljanz xr stopped for 2 weeks (dates unknown) per md. Unknown if adverse effects from missed doses. Continues with lingering effects from "covid": hoarseness, no energy, difficulty hearing, brain fog and headaches. Reports she resumed xeljanz xr 1 or 2 weeks ago. Md aware. No additional information or details were disclosed by the patient.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoacusis, SARS-CoV-2 test
Clinical narrative: covid; covid; difficulty hearing; headaches; hoarseness; no energy; brain fog; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 64-year-old female patient received BNT162b2 (BNT162B2), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid"; HYPOACUSIS (non-serious), outcome "unknown", described as "difficulty hearing"; HEADACHE (non-serious), outcome "unknown", described as "headaches"; DYSPHONIA (non-serious), outcome "unknown", described as "hoarseness"; ASTHENIA (non-serious), outcome "unknown", described as "no energy"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "brain fog".   The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: She then tested positive for "covid" in Oct.  Clinical course: She then tested positive for "covid" in Oct (date unknown) and xeljanz xr stopped for 2 weeks (dates unknown) per md. Unknown if adverse effects from missed doses. Continues with lingering effects from "covid": hoarseness, no energy, difficulty hearing, brain fog and headaches. Reports she resumed xeljanz xr 1 or 2 weeks ago. Md aware. No additional information or details were disclosed by the patient.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out.
Sex: M
Vaccine: UNK
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: excessive pain and swelling at injection site after injection of PCV20; excessive pain and swelling at injection site after injection of PCV20; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A male patient received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (MANUFACTURER: PFIZER), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious), outcome "recovering" and all described as "excessive pain and swelling at injection site after injection of PCV20".  Additional information: the excessive pain and swelling at injection site, after injection of PCV20, started to resolve four to five days later.  The information on the batch/lot number for pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received.