chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Pulmonary embolism
Clinical narrative: bilateral pulmonary Emboli Infarct; she went on A-fib; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 75-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 as dose number unknown (booster), single (Lot number: G13722) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (ongoing), notes: Blood pressure high. Concomitant medication(s) included: LISINOPRIL taken for hypertension; ATORVASTATIN taken for hypertension; CHLORTHALIDONE taken for hypertension. Past drug history included: Estradiol patch, notes: Estradiol patch (Suspect captured as per verbatim conservatively) 0.05milligrams and she is down that for 25 years. Vaccination history included: Covid-19 vaccine (Primary series of immunization complete, unknown manufacturer), for COVID-19 immunization.  The following information was reported: PULMONARY EMBOLISM (medically significant), outcome "unknown", described as "bilateral pulmonary Emboli Infarct"; ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "she went on A-fib". Therapeutic measures were taken as a result of pulmonary embolism, atrial fibrillation.  Clinical course: Reporter (Physician) stated, I have a patient. I am a Family medicine doctor, patient who had a Pfizer vaccine on 01Nov2022 and she had a developed a DDT (Event captured as per verbatim) several days later with bilateral pulmonary Emboli Infarct and so just wanted to add that to your database. Medical Conditions and Regular medications: Reporter stated, she does yes she has high blood pressure and high blood pressure medication she takes. You want the list of the meds? Lisinopril 20 milligrams, Atorvastatin 20 milligrams and she takes Chlorthalidone 25milligrams. Reporter stated, then she also was on Estradiol patch (Suspect captured as per verbatim conservatively) 0.05 milligrams and she is down that for 25 years. Treatment: Reporter stated, she is currently on Eliquis blood thinner, and we stopped her estrogen patch (Estradiol Patch) and she is also on metoprolol because she went on A-fib (Event captured conservatively as per verbatim).; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events (PULMONARY EMBOLISM, ATRIAL FIBRILLATION) and BNT162B2. Based on known drug safety profile, there is reasonable possibility of causal association between the event and BNT162B2. 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: 16.0
Sex: M
Vaccine: MENB
Symptoms: Urticaria
Clinical narrative: hives; This is a spontaneous report received from contactable reporter(s) (Physician) from medical information team and a sales representative.  A 16-year-old male patient received meningococcal group b Rlp2086 (TRUMENBA), on 13Jun2022 as dose 1, single (Lot number: ER2622) at the age of 16 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URTICARIA (non-serious) with onset 13Jun2022, outcome "unknown", described as "hives".  Additional information: Physician asked if there is any data on pre-medicating with Benadryl for patients who have had mild reactions (hives).
Sex: M
Vaccine: PNC20, PPV
Symptoms: Arthralgia, Arthritis, Injection site induration, Injection site swelling, Joint range of motion decreased
Clinical narrative: injection site swelling; serious pain in the right hand and the right shoulder; serious pain in the right hand and the right shoulder; shoulders are inflamed; cannot write/his whole right shoulder is almost inoperable; injection site turned like into rock almost; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 18Oct2022 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 INDURATION (non-serious) with onset 2022, outcome "unknown", described as "injection site turned like into rock almost"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset Oct2022, outcome "unknown", described as "cannot write/his whole right shoulder is almost inoperable"; PAIN IN EXTREMITY (non-serious) with onset Oct2022, outcome "unknown", ARTHRALGIA (non-serious) with onset Oct2022, outcome "not recovered" and all described as "serious pain in the right hand and the right shoulder"; ARTHRITIS (non-serious) with onset Oct2022, outcome "unknown", described as "shoulders are inflamed"; VACCINATION SITE SWELLING (non-serious) with onset 18Oct2022, outcome "not recovered", described as "injection site swelling".  Additional information: The patient mentioned that he was experiencing a serious pain in the right hand and the right shoulder. He felt like if he didn't even have a right arm. His shoulders were inflamed. He was right-handed and he cannot write. His injection site turned like into rock almost and his whole shoulder has been in pain for over a month now while since the 18Oct2022 and 19Oct2022 his whole right shoulder was almost inoperable.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: PNC20, PPV
Symptoms: Loss of personal independence in daily activities, Pain in extremity, Vaccination site induration, Vaccination site swelling
Clinical narrative: injection site swelling; serious pain in the right hand and the right shoulder; serious pain in the right hand and the right shoulder; shoulders are inflamed; cannot write/his whole right shoulder is almost inoperable; injection site turned like into rock almost; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 18Oct2022 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 INDURATION (non-serious) with onset 2022, outcome "unknown", described as "injection site turned like into rock almost"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset Oct2022, outcome "unknown", described as "cannot write/his whole right shoulder is almost inoperable"; PAIN IN EXTREMITY (non-serious) with onset Oct2022, outcome "unknown", ARTHRALGIA (non-serious) with onset Oct2022, outcome "not recovered" and all described as "serious pain in the right hand and the right shoulder"; ARTHRITIS (non-serious) with onset Oct2022, outcome "unknown", described as "shoulders are inflamed"; VACCINATION SITE SWELLING (non-serious) with onset 18Oct2022, outcome "not recovered", described as "injection site swelling".  Additional information: The patient mentioned that he was experiencing a serious pain in the right hand and the right shoulder. He felt like if he didn't even have a right arm. His shoulders were inflamed. He was right-handed and he cannot write. His injection site turned like into rock almost and his whole shoulder has been in pain for over a month now while since the 18Oct2022 and 19Oct2022 his whole right shoulder was almost inoperable.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: PNC20, PPV
Symptoms: Arthralgia, Injection site induration, Injection site pain, Injection site swelling, Muscle strain
Clinical narrative: injection site swelling; serious pain in the right hand and the right shoulder; serious pain in the right hand and the right shoulder; shoulders are inflamed; cannot write/his whole right shoulder is almost inoperable; injection site turned like into rock almost; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 18Oct2022 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 INDURATION (non-serious) with onset 2022, outcome "unknown", described as "injection site turned like into rock almost"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset Oct2022, outcome "unknown", described as "cannot write/his whole right shoulder is almost inoperable"; PAIN IN EXTREMITY (non-serious) with onset Oct2022, outcome "unknown", ARTHRALGIA (non-serious) with onset Oct2022, outcome "not recovered" and all described as "serious pain in the right hand and the right shoulder"; ARTHRITIS (non-serious) with onset Oct2022, outcome "unknown", described as "shoulders are inflamed"; VACCINATION SITE SWELLING (non-serious) with onset 18Oct2022, outcome "not recovered", described as "injection site swelling".  Additional information: The patient mentioned that he was experiencing a serious pain in the right hand and the right shoulder. He felt like if he didn't even have a right arm. His shoulders were inflamed. He was right-handed and he cannot write. His injection site turned like into rock almost and his whole shoulder has been in pain for over a month now while since the 18Oct2022 and 19Oct2022 his whole right shoulder was almost inoperable.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: PNC20, PPV
Symptoms: Muscular weakness, Pain, Product administered at inappropriate site, Pyrexia
Clinical narrative: injection site swelling; serious pain in the right hand and the right shoulder; serious pain in the right hand and the right shoulder; shoulders are inflamed; cannot write/his whole right shoulder is almost inoperable; injection site turned like into rock almost; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 18Oct2022 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 INDURATION (non-serious) with onset 2022, outcome "unknown", described as "injection site turned like into rock almost"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset Oct2022, outcome "unknown", described as "cannot write/his whole right shoulder is almost inoperable"; PAIN IN EXTREMITY (non-serious) with onset Oct2022, outcome "unknown", ARTHRALGIA (non-serious) with onset Oct2022, outcome "not recovered" and all described as "serious pain in the right hand and the right shoulder"; ARTHRITIS (non-serious) with onset Oct2022, outcome "unknown", described as "shoulders are inflamed"; VACCINATION SITE SWELLING (non-serious) with onset 18Oct2022, outcome "not recovered", described as "injection site swelling".  Additional information: The patient mentioned that he was experiencing a serious pain in the right hand and the right shoulder. He felt like if he didn't even have a right arm. His shoulders were inflamed. He was right-handed and he cannot write. His injection site turned like into rock almost and his whole shoulder has been in pain for over a month now while since the 18Oct2022 and 19Oct2022 his whole right shoulder was almost inoperable.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Had a sore arm(where the injection site was); Had a sore arm(where the injection site was); 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 female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history included: "Guillain-Barre Syndrome", start date: 2006 (unspecified if ongoing), notes: The caller states she Guillain-Barre Syndrome(GBS) 16 years ago following a case of shingles; "shingles" (unspecified if ongoing), notes: The caller states she Guillain-Barre Syndrome(GBS) 16 years ago following a case of shingles; "Peripheral neuropathy" (unspecified if ongoing), notes: She developed Peripheral neuropathy in her feet after having Guillain-Barre Syndrome(GBS).; "Exposure to COVID-19" (unspecified if ongoing), notes: Caller has been Exposed 2 time to COVID19 and never got it. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as Had a sore arm(where the injection site was).  Additional information: Patient states she has had the Pfizer COVID vaccine primary series 1 and 2 and 2 previous booster doses from Pfizer. She had No side effects from the 1st dose and with the 2nd dose she Had a sore arm (where the injection site was) and the 2nd booster dose she experienced fatigue. I don't get the shingles shots, flu shots or pneumonia shots. Because they have the virus in them.  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-202201357266 same patient, different dose/event;US-PFIZER INC-202201357265 same patient, different dose/event;
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Illness, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: Dose 1: 29Jul2022; dose 2: 13Sep2022; Sick; Coughing; Fever of 99.1; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 4-year-old female patient received BNT162b2 (BNT162B2), on 13Sep2022 as dose 2 (maroon cap), single (Batch/Lot number: unknown) at the age of 4 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1 (MAROON CAP), SINGLE, Lot number: unknown), administration date: 29Jul2022, when the patient was 4-year-old, for COVID-19 immunization. The following information was reported: COUGH (non-serious) with onset 2022, outcome "unknown", described as "Coughing"; PYREXIA (non-serious) with onset 2022, outcome "unknown", described as "Fever of 99.1"; ILLNESS (non-serious) with onset 2022, outcome "unknown", described as "Sick"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 13Sep2022, outcome "unknown", described as "Dose 1: 29Jul2022; dose 2: 13Sep2022". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller asked about the ability to receive a third dose of the Maroon cap for her 4-year-old. She mentioned that her child had received the two doses of the vaccine, but had difficulty locating a pharmacy that would give the third dose. She had called multiple pharmacies in and around her state but had not had any success. She was curious if there was a limited quantity available or why she might be having issues. She then asked if there was a reason why her son should not get a third dose. She mentioned during the conversation that both her son and daughter had received the Pfizer vaccine this year and later got sick. Her daughter was coughing with a fever of 99.1 and was pulled out of school. Her son had the same thing.   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-202201357132 same reporter/drug, different patient/AE.;
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I am sure you could do but I am just kind of curious why it attacked my right arm that way. It did not do it the first time I got the booster last year which was the regular booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Nov2021 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: PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "unknown", described as "I am sure you could do but I am just kind of curious why it attacked my right arm that way. It did not do it the first time I got the booster last year which was the regular booster". Therapeutic measures were taken as a result of pain in extremity.  Additional information: Consumer stated, "I was sent an email to Pfizer regarding what happened after I just took the update vaccine booster (Later confirmed as Pfizer COVID-19 vaccine hence, captured as COVID-19 vaccine Booster). I just took it at the beginning of, middle of November and within about an hour after getting the vaccine or the booster, I was getting put in my left arm because I have lot of hardware in my right upper arm on my humerus. There is 2 plates and a bunch of screws (Intent: History). Well everything was fine after about an hour so, my right arm started really hurting, really bad and I thought okay, it will pass but around 5'o clock I got the vaccine around 11'o clock that morning around 5' o clock, I have couldn't take anymore, so I though well, let me take a couple of Advil (Suspect captured Conservatively) whatever see it going to help, which it did temporarily but then it right back, hurting me again and I was about to go to the ER, Are you think that was really was amazing. I am sure you could do but I am just kind of curious why it attacked my right arm that way. It did not do it the first time I got the booster last year which was the regular booster but this time (incomplete sentence)." Limited information available over the call.  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): PFIZER INC-202201353257 same patient, different vaccine dose/partial same event;
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Cough, Illness, Pyrexia
Clinical narrative: coughing; fever of 99.1; sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), in 2022 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 1, Unknown Manufacturer), for COVID-19 immunization.  The following information was reported: COUGH (non-serious) with onset 2022, outcome "unknown", described as "coughing"; PYREXIA (non-serious) with onset 2022, outcome "unknown", described as "fever of 99.1"; ILLNESS (non-serious) with onset 2022, outcome "unknown", described as "sick". Relevant laboratory tests and procedures are available in the appropriate section.  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-202201356566 same reporter/drug, different patient/AE.;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; 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 female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Guillain-Barre Syndrome(GBS)" (unspecified if ongoing); "shingles" (unspecified if ongoing); "Peripheral neuropathy in her feet" (unspecified if ongoing); "Exposed 2x to COVID 19" (unspecified if ongoing), notes: Caller has been Exposed 2x to COVID 19 and never got it. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "sore arm"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown".  Additional information: She stated she has had the Pfizer COVID vaccine primary series 1&2 and 2 previous booster doses from Pfizer. She had no side effects from the 1st dose and with the 2nd dose she Had a sore arm (where the injection site was) and the 2nd booster dose she experienced fatigue. She called her neurologist after her first dose of Pfizer. There was news that the J&J covid vaccine was said to cause GBS, she was panicky and looked up info, mostly males. So she continued with the Pfizer vaccines. Caller has been Exposed 2x to COVID 19 and never got it.   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-202201356556 same patient, different dose/event;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: fatigue; 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 female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Guillain-Barre Syndrome(GBS)" (unspecified if ongoing); "shingles" (unspecified if ongoing); "Peripheral neuropathy in her feet" (unspecified if ongoing); "Exposed 2x to COVID 19" (unspecified if ongoing), notes: Caller has been Exposed 2x to COVID 19 and never got it. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "sore arm"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown".  Additional information: She stated she has had the Pfizer COVID vaccine primary series 1&2 and 2 previous booster doses from Pfizer. She had no side effects from the 1st dose and with the 2nd dose she Had a sore arm (where the injection site was) and the 2nd booster dose she experienced fatigue. She called her neurologist after her first dose of Pfizer. There was news that the J&J covid vaccine was said to cause GBS, she was panicky and looked up info, mostly males. So she continued with the Pfizer vaccines. Caller has been Exposed 2x to COVID 19 and never got it.   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-202201356556 same patient, different dose/event;
Age: 66.0
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) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 05Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 20Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "hypertensive" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergy: amoxicillin, reaction(s): "Known allergy: Amoxicillin", notes: Known allergy: Amoxicillin.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Dec2022) Positive, notes: tested positive 3 days after Paxlovid course; (Dec2022) Negative, notes: negatives right after course completed. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Paxlovid treatment start from 26Nov2022 to 30Nov2022.  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: COVID-19, Drug ineffective
Clinical narrative: I was one week away from getting my next booster when I contacted Covid. I am now taking Paxlovid.; I was one week away from getting my next booster when I contacted Covid. I am now taking Paxlovid.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A 67-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; BNT162b2 (BNT162B2), 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: "my immune system is compromised" (unspecified if ongoing), notes: my immune system is compromised; "I do not have a spleen" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (non-serious), COVID-19 (non-serious), outcome "unknown" and all described as "I was one week away from getting my next booster when I contacted Covid. I am now taking Paxlovid.". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course details: The patient was one week away from getting her next booster when she contacted Covid. She received Pfizer shots from the get-go. Now taking Paxlovid. The patient was on day two of this medication and believe it was helping. The patient wanted to say thank you for hard work and dedication.  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.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Swelling face
Clinical narrative: Swelling in the face, jaw and lymph nodes; Swelling in the face, jaw and lymph nodes; This is a spontaneous report received from contactable reporter(s) (Nurse). Other Case identifier(s): 2022NVX-000004257 (Novavax).  A 75-year-old female patient received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SWELLING FACE (non-serious), LYMPHADENOPATHY (non-serious), outcome "unknown" and all described as "Swelling in the face, jaw and lymph nodes".  Additional information: It was also reported that on 17Nov2022, it was reported that a patient started treatment on an unspecified date in Feb2021 with Pfizer BioNTech COVID-19 Vaccine (tozinameran) at dose 1 and dose 2 for COVID-19 immunisation. It was reported that the patient had swelling in the face, jaw and lymph nodes.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: General physical health deterioration, Inflammation
Clinical narrative: My health has a fairly deteriorated since vaccination; Severe inflammatory reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 45-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: GENERAL PHYSICAL HEALTH DETERIORATION (non-serious), outcome "unknown", described as "My health has a fairly deteriorated since vaccination"; INFLAMMATION (non-serious), outcome "unknown", described as "Severe inflammatory reaction". The events "my health has a fairly deteriorated since vaccination" and "severe inflammatory reaction" required physician office visit.  Additional information: 45-year-old female and long distance hiker and backpacker patient. Patient had a severe inflammatory reaction to the Pfizer vaccines. Patient health has a fairly deteriorated since vaccination. Patient have seen many highly rated doctors who are perplexed. Patient would like to offer her self as a subject. Patient seeking research that patient can participate in that might help illuminate what happened to patient and save others from such outcomes.  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: Dyspnoea, Headache, Hyperhidrosis
Clinical narrative: headache; excessive sweating profusely dripping off of my face; shortness of breath; 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), on 30Nov2022 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: HYPERHIDROSIS (non-serious) with onset 2022, outcome "unknown", described as "excessive sweating profusely dripping off of my face"; HEADACHE (non-serious) with onset 2022, outcome "not recovered"; DYSPNOEA (non-serious) with onset 2022, outcome "unknown", described as "shortness of breath".  Additional information: the patient reported that "I received the Pfizer influenza vaccine via Excel clinical research. I got my shot on 30Nov2022. About 5 hours later I had a headache that has not stopped and it is 05Dec. Also I've had excessive sweating profusely dripping off of my face and shortness of breath. I contacted Excel clinical research on the day after 01Dec and told them I was having symptoms. I was told that I would have to wait until 24 hours to be able to be seen by a doctor. 3 days later it's unchanged.  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: Hypoaesthesia, Limb injury, Thermal burn
Clinical narrative: hurt my arm; arm went numb a little one burned for a while; arm went numb a little one burned for a while; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A 45-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: LIMB INJURY (non-serious), outcome "unknown", described as "hurt my arm"; HYPOAESTHESIA (non-serious), THERMAL BURN (non-serious), outcome "unknown" and all described as "arm went numb a little one burned for a while".  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: Heavy menstrual bleeding, Uterine leiomyoma
Clinical narrative: heavy menstruation; fibroids; 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), in Nov2021 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: HEAVY MENSTRUAL BLEEDING (non-serious), outcome "not recovered", described as "heavy menstruation"; UTERINE LEIOMYOMA (non-serious), outcome "not recovered", described as "fibroids". The event "heavy menstruation" required emergency room visit.  Additional information: The patient suffered from fibroids and heavy menstrual cycles. The last time she took the booster (Nov2021). Her period was so heavy that she almost had to go to the ER. Super plus tampon every 30-40 minutes for two 48 hours. This happened for two months. For this reason, she could not take the new booster due to excessive bleeding.  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: Psychotic disorder
Clinical narrative: Psychosis after the administration of the first dose; This is a literature report for the following literature source(s):   A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, 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: PSYCHOTIC DISORDER (medically significant), outcome "recovered", described as "Psychosis after the administration of the first dose". Therapeutic measures were taken as a result of psychotic disorder.  Clinical course: A new case of psychosis after the administration of the first dose of the mRNA-based COVID-19 vaccine and worsening of psychotic symptoms after receiving the second dose. Hallucinations and delusions were presented within four weeks and resolved in three days after the administration of antipsychotics.; Sender's Comments: As per the available information the causality of the event psychotic disorder with the suspect can not be ruled out completely. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Ras, Ethics committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202201355347 Same article/drug/patient and different event;
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypertension, Insomnia
Clinical narrative: HBP; trouble sleeping; headaches; This is a spontaneous report received from a contactable reporter(s) (Physician). Other Case identifier(s): EC-2022-115296 (RA).  A 68-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; lenvatinib mesilate (LENVIMA), (Batch/Lot number: unknown) at 20 mg. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed, unknown manufacturer), for COVID-19 immunization.  The following information was reported: HYPERTENSION (non-serious), outcome "unknown", described as "HBP"; INSOMNIA (non-serious), outcome "unknown", described as "trouble sleeping"; HEADACHE (non-serious), outcome "unknown", described as "headaches". The action taken for lenvatinib mesilate was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died because of the drug; 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: DEATH (death, medically significant), outcome "fatal", described as "died because of the drug". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical information: In regard to the Pfizer Covid-19 Vaccine and stated that there are millions of people who died because of this drug, and as well that (name) died because of the drug. - Submitted Manual AE Form because there is specific person mentioned who died because of the drug/vaccine  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Death
Sex: U
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: died yesterday because of cancer; 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: NEOPLASM MALIGNANT (death, medically significant), outcome "fatal", described as "died yesterday because of cancer". The patient date of death was 05Dec2022. Reported cause of death: "died yesterday because of cancer". It was not reported if an autopsy was performed. Clinical course: The reporter stated that the patient died yesterday because of cancer, and he has friends who had heart attacks and all kinds of cancer. He mentioned death for everybody who pushed that vaccine. He said it's a depopulation method.  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 yesterday because of cancer
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: We all got Covid, even after immunizations.; We all got Covid, even after immunizations.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "We all got Covid, even after immunizations.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: unknown results. Clinical course: The reporter was annoyed and stated that they didn't think there has been enough testing, etc done. In addition, he didn't believe the claims. They all got Covid, even after immunizations". Patient received Pfizer COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Feeding tube user, Injury, Wheelchair user
Clinical narrative: severe injury; stomachache; wheelchair; having only to be able to take food through the feeding tube; This is a spontaneous report received from a non-contactable reporter(s) (Nurse), Program ID: (004756).  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: INJURY (medically significant), outcome "unknown", described as "severe injury"; ABDOMINAL PAIN UPPER (medically significant), outcome "unknown", described as "stomachache"; WHEELCHAIR USER (medically significant), outcome "unknown", described as "wheelchair"; FEEDING TUBE USER (medically significant), outcome "unknown", described as "having only to be able to take food through the feeding tube".  Clinical course: Caller is a former nurse who is asking our exact location in the withheld and the last name initial and said call is being tape. She is asking personally if I have taken the Pfizer COVID 19 kill shot that is killing, destroying, meaning disabling millions across the world. She wants to specifically report and talk about a very specific case. That is withheld who is in the United States, she was a participant in the Pfizer COVID 19 trial and her severe injury results in her being in a wheelchair, having only to be able to take food through the feeding tube. She's been recorded as having a stomachache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely 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: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Erythema, Feeling abnormal, Peripheral swelling, Skin warm
Clinical narrative: bump on arm, size of silver dollar; red; hot; little off; I chilly; Initial information received on 30-Nov-2022 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case involves a 60-year-old female patient who experienced bump on arm, size of silver dollar, red, hot, little off and I chilly after receiving vaccine diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 28-Nov-2022, the patient received suspect diphtheria-2/tetanus/5 AC pertussis vaccine suspension for injection at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (immunisation).  On an unknown date the patient developed a non-serious bump on arm, size of silver dollar (peripheral swelling), red (erythema), hot (feeling hot), little off (feeling abnormal), i chilly (chills), (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken: Not applicable.  Ice, Ibuprofen as necessary as corrective treatment was received for the events (bump on arm, size of silver dollar, red, hot). It was not reported if the patient received a corrective treatment for the events (little off, I chilly).  Outcome: Recovered / Resolved on an unknown date for all the events.; Sender's Comments:  US-SA-2022SA487992:
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: day 6 of the flu and it is horrible; Initial information was received on 30-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age and gender patient who experienced day 6 of the flu and it is horrible after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (unknown formulation) (lot number, expiry date, strength, frequency was unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient had a non-serious event day 6 of the flu and it is horrible (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: I did get sick a week later; Initial information was received on 04-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a non-health-care professional.  This case involves an unknown age and unknown gender patient who had an event, "i did get sick a week later" after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation).     On an unknown date the patient developed a non-serious event of I did get sick a week later (illness) (unknown latency) following the administration of influenza vaccine.  No lab data were reported.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment.  Outcome: Unknown.
Sex: U
Vaccine: FLUX
Symptoms: Cough, Influenza
Clinical narrative: Cough; had the worst case of the flu; Initial information received on 04-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves adult patient of unknown gender who experienced cough and had the worst case of the flu after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site for flu (influenza).  On an unknown date, the patient developed non-serious event of cough and the worst case of the flu (influenza) (unknown latency) following the administration of influenza vaccine.  No lab data was reported.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the events (Cough, had the worst case of the flu).  Outcome: Unknown for both events.