chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 at 14:45 as dose 5 (booster), single (Lot number: GJ6742) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Beta lactams" (unspecified if ongoing), notes: Known allergies: Beta lactams. Concomitant medication(s) included: LISINOPRIL. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 3, booster), for Covid-19 immunization; Covid-19 vaccine (Dose 4, booster), for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 19Oct2022 at 06:00, outcome "recovered"; PAIN IN EXTREMITY (non-serious) with onset 19Oct2022 at 06:00, outcome "recovered", described as "Sore arm". Therapeutic measures were not taken as a result of pain in extremity, fatigue.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: my husbands arm was sore/sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team, Program ID.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; manufacturer unknown), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "my husband's arm was sore/sore arm".  Additional information: The caller stated that she had to listen to more than 20 minutes of explanations before she was transferred over. The caller wants to know how many months it will be before she can receive the comirnaty vaccine after receiving the bivalent booster. She did not have any reactions when she got the vaccine. However, her husband's arm was sore. Could it be because she was taking Humira (adalimumab) and she was immunocompromised? The caller stated that she had read the information available online and found out about a new COMINNATY vaccine. She has had all Pfizer COVID-19 vaccines from the primary series leading to the bivalent booster. 4 doses. Does it protect against more strains than the bivalent booster.  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.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; vaccine brand other=Moderna/vaccine brand=Pfizer/BioNTech; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 64 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Lot number: EN5218), in right arm, on 22Feb2021 as dose 2, single (Lot number: EL9264), in right arm and on 28Sep2021 as dose 3 (booster), single (Lot number: 301308A) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Apr2022 as dose 4 (booster), single (Lot number: 066K21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Coronary Artery Disease" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN, start date: 30Jun2017, stop date: 18Oct2022; ALFUZOSIN HCL, start date: 15Jan2017, stop date: 18Oct2022; ASPIRIN 81, start date: 29Jan2007; CETRIZINE; TOPROL, start date: 15Jul2021. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 06Apr2022, outcome "unknown", described as "vaccine brand other=Moderna/vaccine brand=Pfizer/BioNTech"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 incldued Paxlovid.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events vaccination failure, covid-19, and interchange of vaccine products and BNT162B2.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Product leakage, Underdose, Vaccination site haemorrhage, Vaccination site injury
Clinical narrative: the Pfizer BionTech covid-19 vaccine with liquid coming out during administration (potential leakage); the Pfizer BionTech covid-19 vaccine with liquid coming out during administration (potential leakage); Think a vein was nicked in the arm; Bruise on the arm; It look like when took the nedle out the arm there was bleeding; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 71-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 at 12:30 as dose number unknown, single (Lot number: GJ6665) at the age of 71 years, in left deltoid for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation. The following information was reported: CONTUSION (non-serious) with onset 24Oct2022, outcome "unknown", described as "Bruise on the arm"; VACCINATION SITE HAEMORRHAGE (non-serious) with onset 24Oct2022, outcome "unknown", described as "It look like when took the nedle out the arm there was bleeding"; VACCINATION SITE INJURY (non-serious) with onset 24Oct2022, outcome "unknown", described as "Think a vein was nicked in the arm"; PRODUCT LEAKAGE (non-serious), UNDERDOSE (non-serious) all with onset 24Oct2022, outcome "unknown" and all described as "the Pfizer BionTech covid-19 vaccine with liquid coming out during administration (potential leakage)".  Additional information: There was an issue yesterday. Someone received the vaccine yesterday. Reporter is not exactly sure what happened. The patient received the vaccine and think a vein was nicked in the arm and it caused a bruise on the arm. It looked like when took the needle out the arm there was bleeding and clear liquid came out. Wondering if the the vaccine leaked out. He is calling to see if the patient needs to be re-vaccinated. Reporter reporting on Bivalent Covid Vaccine. The manufacturer date is Jul2022 and thinks the expiration date is 12 months after the manufacturer date. On the bottle and box, it only has the manufacturer date. He did not see an expiration.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure, Cardiovascular evaluation
Clinical narrative: right after he got the Covid vaccine he went to the ER and his heart was working at 25% capacity. Now his heart is only down to 10%. He's going to die from this thing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A 59-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 reporter is very upset because her brother (patient) aged 59 have had severe issues after getting the Pfizer BioNTech Covid 19 vaccine. Her brother was healthy as a horse, climbing ladder every day, never sick and heart trouble doesn't run in the family. Her brother received Pfizer BioNTech Covid 19 vaccine, immediately got sick after getting it . She initially thought his heart was messed up from a heart break, which sounds crazy but it was true.  Maybe it was because his girlfriend is dying of kidney failure.  She then found out right after he got the Covid vaccine he went to the emergency room and his heart was working at 25% capacity. Now his heart is only down to 10%. He's going to die from this thing. When he told her she started crying, he gave her his vaccination card and said she should have it in case she has to sue us after he dies.  She told him that Pfizer isn't liable for anything and they could be injecting dirt into people and there would be no repercussions. Outcome of the event was not recovered.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Full blood count, Investigation, SARS-CoV-2 test
Clinical narrative: I received the vaccine on 08Sep. I have asymptomatic but then I tested positive 16Oct; I received the vaccine on 08Sep. I have asymptomatic but then I tested positive 16Oct; 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 49-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose number unknown (booster), single (Lot number: GH9694) at the age of 49 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for hypertension. Vaccination history included: Covid-19 vaccine ("DOSE X; MANUFACTURER UNKNOWN" (where X=1, 2, or number unknown)), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11Sep2022, outcome "unknown" and all described as "I received the vaccine on 08Sep. I have asymptomatic but then I tested positive 16Oct". The patient underwent the following laboratory tests and procedures: Full blood count: (unspecified date) short CBC and long CBC; lab work: (unspecified date) Unknown results; SARS-CoV-2 test: (16Oct2022) Positive; (unspecified date) Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course included Patient received the vaccine on 08Sep2022. Patient had asymptomatic but then tested positive 16Oct2022. She became symptomatic on 11Sep2022. Patient had Covid in Sep2022. Patient came down with Covid positive and symptomatic and sick a few days after getting the bivalent vaccine and patient originally called Pfizer just to ask the question about going forward like if they thought whatever the booster available again for immunocompromised people. Patient came down with Covid positive and symptomatic and sick few days after getting the bivalent vaccine. Patient had surgery on Friday so patient had lab work. Patient had a short CBC and long CBC, patient had a lot of labs. Patient had a PCR, COVID PCR. Patient did actually on day 5, the first day that she tested positive was actually day 5 of symptoms. Patient was really sick before testing positive and took the Paxlovid.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: EW0150), in right arm and on 03May2021 as dose 2, single (Lot number: EW0170) at the age of 43 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's" (unspecified if ongoing); "Multiple Sclerosis" (unspecified if ongoing); "IBS" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Feb2019. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. COVID 19 Treatment included PAXLOVID from 24Oct2022.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Lip swelling, Polymerase chain reaction, Pruritus
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: EW0150), in right arm and on 03May2021 as dose 2, single (Lot number: EW0170) at the age of 43 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's" (unspecified if ongoing); "Multiple Sclerosis" (unspecified if ongoing); "IBS" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Feb2019. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. COVID 19 Treatment included PAXLOVID from 24Oct2022.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: The patient has just been treated for pneumonia, it looks like this was diagnosed 10Oct; This is a spontaneous report received from contactable reporter(s) (Nurse).  An 8-year-old female patient received BNT162b2 (BNT162B2), on 17Dec2021 as dose 2, single (Lot number: FK5618, Expiration Date: 31Dec2021, NDC: 59267105504) at the age of 8 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (NDC: 59267105504, LOT: FK5127, EXP: 28Feb2022), administration date: 29Nov2021, when the patient was 7-year-old, for covid- 19 immunisation. The following information was reported: PNEUMONIA (hospitalization, medically significant) with onset 10Oct2022, outcome "unknown", described as "The patient has just been treated for pneumonia, it looks like this was diagnosed 10Oct". The patient was hospitalized for pneumonia (start date: 10Oct2022, discharge date: 16Oct2022, hospitalization duration: 6 day(s)). Therapeutic measures were taken as a result of pneumonia.  Additional information:The patient has just been treated for pneumonia, it looked like this was diagnosed 10Oct, and it looks like she was hospitalized on 10Oct thru 16Oct. There was no treatment mentioned for the hospitalization in the note.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event: "Pneumonia" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Lack of Efficacy/Test Nasal Swab -Positive; Lack of Efficacy/Test Nasal Swab -Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 at 16:00 as dose 4 (booster), single (Lot number: GJ2524 (also reported as GJ2529)) at the age of 60 years intramuscular, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Lot number: EL3248), as dose 2, single (Lot number: EL3248) and as dose 3 (booster), single (Lot number: FF8841) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyrodism" (unspecified if ongoing); "Known allergies: Penicillian" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Oct2022, outcome "recovering" and all described as "Lack of Efficacy/Test Nasal Swab -Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Oct2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Lymphadenopathy, Pain in extremity, Paraesthesia, Rash
Clinical narrative: Rash head to toe; Lymph node swelling; On and off arm spiking pain near shot area; Have had a tingly, prickly feeling in left arm; Hand and thumb numb; Hand and thumb numb and stinging hurt; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Apr2021 at 15:00 as dose 2, single (Lot number: EW0161) at the age of 53 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot Number: ER8732; Anatomical location: Arm Left; Vaccine Administration Time: 12:00 PM), administration date: 30Mar2021, when the patient was 53-year-old, for COVID-19 immunisation. The following information was reported: HYPOAESTHESIA (non-serious) with onset 15Sep2022, outcome "not recovered", described as "Hand and thumb numb"; PAIN IN EXTREMITY (non-serious) with onset 15Sep2022, outcome "not recovered", described as "Hand and thumb numb and stinging hurt"; PARAESTHESIA (non-serious) with onset 15Sep2022, outcome "not recovered", described as "Have had a tingly, prickly feeling in left arm"; LYMPHADENOPATHY (non-serious) with onset 15Sep2022, outcome "not recovered", described as "Lymph node swelling"; VACCINATION SITE PAIN (non-serious) with onset 15Sep2022, outcome "not recovered", described as "On and off arm spiking pain near shot area"; RASH (non-serious) with onset 15Sep2022, outcome "not recovered", described as "Rash head to toe". The events "rash head to toe", "lymph node swelling", "on and off arm spiking pain near shot area", "have had a tingly, prickly feeling in left arm", "hand and thumb numb" and "hand and thumb numb and stinging hurt" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash, lymphadenopathy, vaccination site pain, paraesthesia, hypoaesthesia, pain in extremity.  Additional information: The patient did not receive other vaccines within four weeks and other medications in two weeks prior to COVID vaccine. The patients had early symptoms-rash head to toe, lymph node swelling, and on and off arm spiking pain near shot area, last 2 month, have had a tingly, prickly feeling in left arm throughout every day, sometimes sitting, sometime laying, sometimes standing, makes hand and thumb numb and stinging hurt. Treatment included Chiropractic making sure not pinched nerve in neck. The patient had no known allergies and other medical history. The patient had no COVID prior vaccination. Since the vaccination, the patient had been tested negative for COVID-19.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Rash head to toe; Lymph node swelling; On and off arm spiking pain near shot area; Have had a tingly, prickly feeling in left arm; Hand and thumb numb; Hand and thumb numb and stinging hurt; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Apr2021 at 15:00 as dose 2, single (Lot number: EW0161) at the age of 53 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot Number: ER8732; Anatomical location: Arm Left; Vaccine Administration Time: 12:00 PM), administration date: 30Mar2021, when the patient was 53-year-old, for COVID-19 immunisation. The following information was reported: HYPOAESTHESIA (non-serious) with onset 15Sep2022, outcome "not recovered", described as "Hand and thumb numb"; PAIN IN EXTREMITY (non-serious) with onset 15Sep2022, outcome "not recovered", described as "Hand and thumb numb and stinging hurt"; PARAESTHESIA (non-serious) with onset 15Sep2022, outcome "not recovered", described as "Have had a tingly, prickly feeling in left arm"; LYMPHADENOPATHY (non-serious) with onset 15Sep2022, outcome "not recovered", described as "Lymph node swelling"; VACCINATION SITE PAIN (non-serious) with onset 15Sep2022, outcome "not recovered", described as "On and off arm spiking pain near shot area"; RASH (non-serious) with onset 15Sep2022, outcome "not recovered", described as "Rash head to toe". The events "rash head to toe", "lymph node swelling", "on and off arm spiking pain near shot area", "have had a tingly, prickly feeling in left arm", "hand and thumb numb" and "hand and thumb numb and stinging hurt" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash, lymphadenopathy, vaccination site pain, paraesthesia, hypoaesthesia, pain in extremity.  Additional information: The patient did not receive other vaccines within four weeks and other medications in two weeks prior to COVID vaccine. The patients had early symptoms-rash head to toe, lymph node swelling, and on and off arm spiking pain near shot area, last 2 month, have had a tingly, prickly feeling in left arm throughout every day, sometimes sitting, sometime laying, sometimes standing, makes hand and thumb numb and stinging hurt. Treatment included Chiropractic making sure not pinched nerve in neck. The patient had no known allergies and other medical history. The patient had no COVID prior vaccination. Since the vaccination, the patient had been tested negative for COVID-19.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Jul2022 at 00:15 as dose 4 (booster), single (Lot number: FP7135) at the age of 48 years, in left 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: patient received Paxlovid as treatment of COVID-19.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Cough, Fatigue, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Jul2022 at 00:15 as dose 4 (booster), single (Lot number: FP7135) at the age of 48 years, in left 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: patient received Paxlovid as treatment of COVID-19.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Sinus operation
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Jul2022 at 00:15 as dose 4 (booster), single (Lot number: FP7135) at the age of 48 years, in left 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: patient received Paxlovid as treatment of COVID-19.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Temperature; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient received BNT162b2 (BNT162B2), on 29Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 56 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid" (ongoing), notes: Thyroid; "Anxiety" (ongoing); "Cholesterol" (ongoing); "Asthma" (ongoing). Concomitant medication(s) included: SYNTHROID oral taken for thyroid disorder, start date: 2015 (ongoing); SERTRALINE oral taken for anxiety, start date: 2013 (ongoing); ATORVASTATIN oral taken for blood cholesterol, start date: 2021 (ongoing); PROAIR [SALBUTAMOL SULFATE] taken for asthma (ongoing); TRELEGY taken for asthma, start date: 2021 (ongoing). Vaccination history included: BNT162b2 (Dose 1, Anatomical site of injection: upper arm, Route of administration: intramuscular, Batch/Lot number: Pfizer EN6207), administration date: 31Mar2021, for Covid-19 immunization; BNT162b2 (Dose 2, Anatomical site of injection: upper arm, Route of administration: intramuscular, Batch/Lot number: Pfizer EW0158), administration date: 14Apr2021, for Covid-19 immunization, reaction(s): "Dose 1: 31Mar2021/ Dose 2: 14Apr2021". The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Temperature"; PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "body aches".
Sex: F
Vaccine: COVID19
Symptoms: Body height, Fatigue, Headache, Weight
Clinical narrative: normal fatigue; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (ongoing). Concomitant medication(s) included: SYMBICORT taken for asthma. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization, reaction(s): "normal fatigue, headache", "normal fatigue, headache"; Bnt162b2 (Dose 2), for COVID-19 immunization, reaction(s): "normal fatigue, headache", "normal fatigue, headache". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "normal fatigue"; HEADACHE (non-serious), outcome "unknown". 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.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Glycosylated haemoglobin
Clinical narrative: blood sugar was averaging 200 or even up to 300 after a vaccine or booster; 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 62-year-old female patient received BNT162b2 (BNT162B2), on 30Jul2021 as dose 2, single (Lot number: FA7484), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Severe osteoporosis", start date: 2020, stop date: 2021. The patient's family history included: "type 2 diabetic" (unspecified if ongoing), notes: Both parents were adult onset type 2 diabetes. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus; GLIPIZIDE taken for diabetes mellitus. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; lot number: EW0191, in the left arm), administration date: 09Jul2021, when the patient was 62-year-old, for COVID-19 immunisation, reaction(s): "blood sugar was averaging 200 or even up to 300 after a vaccine or booster"; Flu shot (This was years ago and she does not have a manufacturer, lot or expiration), for immunization. The following information was reported: BLOOD GLUCOSE INCREASED (medically significant) with onset 2021, outcome "unknown", described as "blood sugar was averaging 200 or even up to 300 after a vaccine or booster". The patient underwent the following laboratory tests and procedures: Blood glucose: (2021) High, notes: each time she had a Pfizer COVID-19 vaccine or booster, she always had high blood sugars; (2021) averaging 200 or even up to 300, notes: blood sugar was averaging 200 or even up to 300 after a vaccine or booster; Glycosylated haemoglobin: (2021) 9; (2021) 6.6; (2021) 6.4.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Ear discomfort, Feeling abnormal
Clinical narrative: hearing loss; my left ear felt clogged; I developed the feeling of being underwater; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ME" (unspecified if ongoing); "CFS" (unspecified if ongoing); "Known allergies Yes; IV Contrast for CT scans" (unspecified if ongoing). Concomitant medication(s) included: SHINGRIX, on 06Sep2022 as dose 2, single; FLU [INFLUENZA VACCINE], on 06Sep2022 as dose number unknown, single. Vaccination history included: Covid-19 vaccine (DOSE: 4, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE: 3, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE: 2, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE: 1, Unknown manufacturer), for COVID-19 immunization; Shringrx (DOSE: 1). The following information was reported: FEELING ABNORMAL (disability) with onset 17Sep2022, outcome "not recovered", described as "I developed the feeling of being underwater"; DEAFNESS (disability, medically significant) with onset 17Sep2022, outcome "not recovered", described as "hearing loss"; EAR DISCOMFORT (disability) with onset 17Sep2022, outcome "not recovered", described as "my left ear felt clogged". The events "hearing loss", "my left ear felt clogged" and "i developed the feeling of being underwater" required physician office visit. Therapeutic measures were taken as a result of deafness, ear discomfort, feeling abnormal. Clinical course: 15 minutes after the vaccination left ear felt clogged. Patient developed the feeling of being underwater, and noticed hearing loss. Treatment inlcuded prednisone and ear cleaning. Patient had no covid prior vaccination. Patient had no covid tested post vaccination.   The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Fatigue, Nausea, Pyrexia, Vomiting
Clinical narrative: Very nauseous; Vomiting; Fever; Very fatigued; Bloody mucus from my nasal; This is a spontaneous report received from contactable reporter (consumer). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Apr2021 as dose 2, single (Lot number: EW0158) at the age of 63 years, in right arm for COVID-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing); "Sjogren's" (unspecified if ongoing); "Rheumatoid arthritis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (lot number: EN6203, administered in right arm as dose 1, single), administration date: 20Mar2021, when the patient was 63-year-old, for COVID-19 immunisation. The following information was reported: NAUSEA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Very nauseous"; VOMITING (non-serious) with onset 2021, outcome "recovered" (2021); PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Fever"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Very fatigued"; EPISTAXIS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Bloody mucus from my nasal".  Additional information: With her second shot, the patient was very nauseous, vomited, with fever, very fatigued, and with bloody mucus nasally. These lasted 10 days. She has no COVID prior to vaccination and was not tested for COVID post vaccination. She received BNT162b2 (BNT162B2), on 28Aug2021 as dose 3 (booster), single (Lot number: FC3184), in right arm for COVID-19 immunisation.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201256368 same patient and drug, different dose and events;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 27-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5, on 29Sep2022 at 19:00 as dose 4 (booster), single (Lot number: GJ3277) at the age of 26 years, in left arm for covid-19 immunisation; BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), on 19Apr2021 as dose 1, single (Lot number: EW0164), on 11May2021 as dose 2, single (Lot number: EW0173) and on 02Dec2021 at 08:00 as dose 3 (booster), single (Lot number: FJ8762) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication included multivitamin from 01Jul2022 to 25Oct2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Covid-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 and included treatment with Paxlovid.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 45 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: ER8727), in left arm, on 13Apr2021 as dose 2, single (Lot number: EW0162), in left arm and on 14Oct2021 as dose 3 (booster), single (Lot number: FC3181), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing); "I am on a immune suppressant." (unspecified if ongoing), notes: Other Medical History: I am on a immune suppressant. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (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 vaccination failure, covid-19 and treatment included Paxlovid.
Sex: F
Vaccine: COVID19
Symptoms: Thyroid disorder
Clinical narrative: Patient diagnosed with Thyroid Condition; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), in Oct2021 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 Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization.  The following information was reported: THYROID DISORDER (non-serious), outcome "not recovered", described as "Patient diagnosed with Thyroid Condition". Therapeutic measures were taken as a result of thyroid disorder.  Additional information: It was reported that patient received a medication as treatment for thyroid condition. It was unknown if patient had covid prior vaccination. It was also unknown if patient was covid tested post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19-2
Symptoms: Body height, Fatigue, Vaccination site pain, Weight, Wrong product administered
Clinical narrative: experiencing fatigue and injection site pain after receiving fourth dose of COVID-19 vaccine; experiencing fatigue and injection site pain after receiving fourth dose of COVID-19 vaccine; Wrong vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 34-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Lot number: 6JS342) for covid-19 immunisation. The patient didn't receive BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for COVID-19 Immunization.  The following information was reported: FATIGUE (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "experiencing fatigue and injection site pain after receiving fourth dose of COVID-19 vaccine"; WRONG PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "Wrong vaccine administered". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The female patient approximately 157 pounds, 5'1",experienced fatigue and injection site pain after receiving fourth dose of COVID-19 vaccine. Event took place after use of product.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: I had your vaccine and I was wondering if it was designed to help the liver? I felt that along with what I would say kinda felt like C-Type ketamine; 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 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: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "I had your vaccine and I was wondering if it was designed to help the liver? I felt that along with what I would say kinda felt like C-Type ketamine".  Additional information: The patient had vaccine and was wondering if it was designed to help the liver? The patient felt that along with what patient would say kinda felt like C-Type ketamine. The patient don't think it necessarily prevents infection but highly decreases the amount of deaths from the illness. The patient think COVID is kind a overrated, but the patient thought it was a good vaccine. The patient though it was genetic engineering and safe too.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Right upper arm where two of the injections were given stay sore; along with pain on occasion traveling down my arm into my right thumb; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient.  A 66-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Jan2021 as dose 1, single (Batch/Lot number: unknown), on 26Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 20Aug2021 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. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "Right upper arm where two of the injections were given stay sore"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "along with pain on occasion traveling down my arm into my right thumb". Therapeutic measures were taken as a result of vaccination site pain, pain in extremity.  Additional information: It was reported that the patient have had 2 vaccines for COVID that were Pfizer on dates 04Jan2021 and 26Jan2021. Then two Pfizer boosters on 20Aug2021 and 01Oct2022. Her right upper arm where two of the injections were given stay sore along with pain on occasion traveling down my arm into my right thumb. That had been ongoing for quite awhile and thought it was her side sleeping but bought a spinal alignment pillow and it still persisted. The pain was not severe but was there.   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.
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Nerve conduction studies, SARS-CoV-2 test, Vaccination site discomfort
Clinical narrative: Right upper arm where two of the injections were given stay sore; along with pain on occasion traveling down my arm into my right thumb; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient.  A 66-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Jan2021 as dose 1, single (Batch/Lot number: unknown), on 26Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 20Aug2021 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. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "Right upper arm where two of the injections were given stay sore"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "along with pain on occasion traveling down my arm into my right thumb". Therapeutic measures were taken as a result of vaccination site pain, pain in extremity.  Additional information: It was reported that the patient have had 2 vaccines for COVID that were Pfizer on dates 04Jan2021 and 26Jan2021. Then two Pfizer boosters on 20Aug2021 and 01Oct2022. Her right upper arm where two of the injections were given stay sore along with pain on occasion traveling down my arm into my right thumb. That had been ongoing for quite awhile and thought it was her side sleeping but bought a spinal alignment pillow and it still persisted. The pain was not severe but was there.   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.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for covid virus; tested positive for covid virus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male 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; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history 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 "tested positive for covid virus". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  Clinical course: Caller mentioned that he just tested positive for covid virus and he was asking how long before he can get up his B4 booster shot after he had covid.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.