chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: I didn't feel good; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Event verbatim: I got really sick), administration date: 18Jan2021, for COVID-19 immunization, reaction(s): "sickness", "Hypertension", "Tremor". The following information was reported: MALAISE (non-serious), outcome "unknown", described as "I didn't feel good".  Additional information: The patient wanted to know if the three vaccines were identical or if anything had changed and also didn't knew if the event was a drug reaction or normal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Antibody test, Dizziness, Headache
Clinical narrative: headache; dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 84 year-old patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 20Oct2021 (Lot number: FF8841) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Left Deltoid, EN9581), administration date: 09Feb2021, for Covid-19 immunization; Bnt162b2 (Dose 2, Left Deltoid, EN6200), administration date: 02Mar2021, for Covid-19 immunization.  The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, dizziness.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Pruritus
Clinical narrative: she had severe reaction (itching arm) that lasted 3 weeks; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administration date 08Feb2021 (Batch/Lot number: unknown) as dose 2, single and administration date 18Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "different allergies" (unspecified if ongoing), notes: she just have "different allergies". The patient's concomitant medications were not reported. The following information was reported: PRURITUS (non-serious) with onset 2021, outcome "recovered" (2021), described as "she had severe reaction (itching arm) that lasted 3 weeks". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Caller stated that she had her first booster shot on 18Jan2021 and had her second shot on 08Feb2021, and she received her booster shot by 08Oct2021. Caller mentioned that she will be having her second booster dose this 08Mar, as suggested by her healthcare provider. Caller also stated that she has heard that mixing up vaccines suggest a higher immunity against COVID19. Caller mentioned that for Moderna vaccine, the booster dose in terms of mcg was lessen. Caller also mentioned that she experienced different side effects after getting the shot. During her first dose, caller stated that she had severe reaction (itching arm) that lasted 3 weeks. Caller stated that the second dose was much easier. Caller stated that on her third dose, she had a fever but just had it overnight. Caller mentioned that she had antibody test made by her doctor and she got 500. Caller mentioned that after getting the booster dose, her antibody went 2000 way up. She mentioned that her doctor was under clinical trial for COVID19 vaccine and was the one recommending her to get her 2nd booster dose. Caller verified that she was immunocompromised. Initially provided information from attached CONS-use in immunosuppressed patients. Caller later on clarified that she was not really immunocompromised and she just had different allergies. Caller stated that people from her dermatologist already received their second booster shot. Caller mentioned that she will still get the second booster shot to be on the safe side and will continue to wear n95 masks. Caller also stated that if she will experience any adverse reaction, she will definitely go the emergency room.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, SARS-CoV-2 test
Clinical narrative: cough; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 47 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 09Nov2021 (Lot number: FF2589) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247), administration date: 18Feb2021, when the patient was 46 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 28Jan2021, when the patient was 46 years old, for Covid-19 Immunization. The following information was reported: COUGH (non-serious) with onset 22Feb2022, outcome "unknown", described as "cough". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of cough. Additional Information: Prior vaccination within 4 weeks was reported as unknown. Prior to vaccination, it was unknown the patient was diagnosed with COVID-19 and since the vaccination, the patient has been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Off label use
Clinical narrative: 4th dose of Covid Vaccine; 4th dose of Covid Vaccine; totally exhausted; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 4, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Bnt162b2 (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Bnt162b2 (DOSE 3; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious), outcome "unknown" and all described as "4th dose of Covid Vaccine"; FATIGUE (non-serious), outcome "unknown", described as "totally exhausted".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Omicron; Omicron; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single 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 "Omicron".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200371280 same reporter/product/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chest discomfort
Clinical narrative: Chest tightness; Burning sensation; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team.  A 32 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST DISCOMFORT (non-serious), outcome "unknown", described as "Chest tightness"; BURNING SENSATION (non-serious), outcome "unknown", described as "Burning sensation". Therapeutic measures were taken as a result of chest discomfort, burning sensation.  Additional information: The reporter inquired about side effects of the Pfizer Covid-19 vaccine and reported that he and his wife received their first dose of the vaccine 9 days and was wondering about an adverse effect that had been lasting a few days. It was reported that his wife was experiencing chest tightness and a burning sensation and that his wife had never really had heart burn, but they tried heart burn medicine and that did not help at all. Reporter was looking for information regarding other reports of the occurring and what might be causing it.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Alopecia areata, SARS-CoV-2 test
Clinical narrative: The hair on my scalp and am beginning to lose body hair on my arms, legs, and pubic region.; I have been diagnosed with Alopecia Areata; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Nov2021 (Lot number: 330308D) at the age of 29 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "asthma" (unspecified if ongoing); "Behavioral health" (unspecified if ongoing). Concomitant medication(s) included: LAMICTAL; CITALOPRAM. Past drug history included: Augmentin, reaction(s): "Known allergies: Augmentin". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: FW0170), administration date: 22Apr2021, when the patient was 28 years old, for COVID-19 immunization, reaction(s): "In Sep2021 I noticed a small quarter-sized bald patch on the back of my head."; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8733), administration date: 01Apr2021, when the patient was 28 years old, for COVID-19 immunization.  The following information was reported: ALOPECIA AREATA (non-serious) with onset 2021, outcome "not recovered", described as "I have been diagnosed with Alopecia Areata"; ALOPECIA (non-serious) with onset Dec2021, outcome "not recovered", described as "The hair on my scalp and am beginning to lose body hair on my arms, legs, and pubic region.". The events "i have been diagnosed with alopecia areata" and "the hair on my scalp and am beginning to lose body hair on my arms, legs, and pubic region." were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of alopecia areata, alopecia.  Additional information: In Sep2021 patient noticed a small quarter-sized bald patch on the back of her head. By Dec2021 she had lost approximately 75 percent of her hair and as of Mar2022 she has lost 90 percent of the hair on her scalp and am beginning to lose body hair on my arms, legs, and pubic region. She has been diagnosed with Alopecia Areata, an autoimmune reaction that attacks hair follicles. The patient received treatment for the adverse event with Corticosteroid injections and topical treatments. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No hospitalization Prolonged. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Tachycardia; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date Dec2020 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TACHYCARDIA (non-serious) with onset Dec2020, outcome "unknown", described as "Tachycardia".  Additional information: 1 hour after administration, she experienced tachycardia and never got a second dose. Caller wanted to know if she could get another vaccine (Moderna) as her second dose.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 03Jan2022 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), administration date: 06Apr2021, for COVID-19 Immunization; Bnt162b2 (Dose: 02), administration date: 27Apr2021, for COVID-19 Immunization. The following information was reported: BELL'S PALSY (medically significant) with onset 2022, outcome "unknown", described as "Bell's Palsy". The event "bell's palsy" was evaluated at the emergency room visit. Clinical course: On the morning of 09Mar2022, the patient went to the emergency department at (withheld). The patient got diagnosed with Bell's Palsy. The patient read that the FDA indicated in Dec2020 that patients should be monitored for Bell's Palsy symptoms.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Head titubation, Oesophagogastroduodenoscopy, Torticollis
Clinical narrative: diagnosed with a neurological condition called cervical dystonia; Severe head tremor; dysphagia; This is a spontaneous report received from a contactable reporter (other HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) via an unspecified route of administration on 03Feb2021 (batch/lot number: EN9581) at the age of 44 years old, as DOSE 2, SINGLE for COVID-19 immunization. Relevant medical history included: "Hypothyroid" (unspecified if ongoing). Patient was not diagnosed with COVID prior vaccination. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose, via an unspecified route of administration (batch/lot number: EL3248), as DOSE 1, SINGLE), administration date: 13Jan2021, when the patient was 44 years old, for COVID-19 immunization. Patient did not receive other vaccine in four weeks. The following information was reported: TORTICOLLIS (disability) with onset 01Mar2021, outcome "not recovered" described as "diagnosed with a neurological condition called cervical dystonia"; HEAD TITUBATION (disability) with onset 01Mar2021, outcome "not recovered" described as "Severe head tremor"; DYSPHAGIA (disability) with onset 01Mar2021, outcome "not recovered" described as "dysphagia." The events "diagnosed with a neurological condition called cervical dystonia", "severe head tremor" and "dysphagia" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: esophagogastroduodenoscopy: unknown results, notes: Multiple EGD's. Therapeutic measures were taken as a result of torticollis, head titubation, and dysphagia which included botox injection of back of neck and multiple EGD's (as reported). The patient received the third dose via an unspecified route of administration on 01Sep2021 (batch/lot number: 30130BA) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The patient has not tested for COVID post vaccination.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Investigation, Optic neuritis, Optic neuropathy
Clinical narrative: 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 43 year-old female patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (Batch/Lot number: unknown) at the age of 43 years as dose 2, single for Covid-19 immunisation. 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 immunisation. The following information was reported: OPTIC NEURITIS (medically significant) with onset Apr2021, outcome "not recovered", described as "Bilateral optic neuritis"; OPTIC NEUROPATHY (medically significant) with onset Apr2021, outcome "not recovered", described as "Bilateral optic neuropathy"; HEADACHE (non-serious), outcome "not recovered", described as "Headache"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Doesn't feel good". The events "bilateral optic neuritis" and "bilateral optic neuropathy" were evaluated at the physician office visit and emergency room visit. The event "headache" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: investigation: unknown results. Clinical course of the events was reported as follows: 2.5 weeks after the dose, the patient began having vision problems. She started losing vision in her left eye and then in her right eye so she went to the emergency room in a hospital that specializes in eyes and they told her she has bilateral optic neuropathy and also was diagnosed with bilateral optic neuritis and was even in danger of going blind. The neurologist and other doctors advised her not to take the booster dose. Two months ago, she started having symptoms similar to the first time and called to see if we had any new information about reports of this nature. She has an appointment with the neurologist next 25Mar2022 and would like to know what information Pfizer can provide to her and indicated that her vision problems has not improved. The patient reported that she has had many medical tests and appointments with doctors. It was further reported that that patient was still having problems and can see but is having dark spots, having headaches and vision blurriness. She already went to a neurologist to see if she had another type of disease and they cannot find anything, so even the neurologist told her not to take the booster. She doesn't feel good and feels something is wrong in her eye. She stated that the doctor said they were going to do a report and send it in because she was not getting any better. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Anxiety, Asthenia, Chest discomfort, Chest pain
Clinical narrative: Sharp Chest pain; Conclusion was allergic to something in vaccine; Dose Number:2, 06Aug2021/ Dose Number:1, 02Jan2021; felt like she would die/was not herself; Shortness of breath; Chest tightness; Unable to lie down to sleep; Brain fog; Marked fatigue months; weakness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200398207 (Pfizer).  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Aug2021 11:00 (Lot number: ew0164) at the age of 67 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "hypertension" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "nonhodgkins lymphoma" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder; VALSARTAN & HCTZ; NEXIUM [ESOMEPRAZOLE SODIUM]. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: el3246, Location of injection: Arm Right, Vaccine Administration Time: 11:00 AM, Route of Administration: Intramuscular), administration date: 02Jan2021, when the patient was 66 years old, for COVID-19 immunization. The following information was reported: ANXIETY (non-serious), outcome "recovered", described as "felt like she would die/was not herself"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 06Aug2021, outcome "unknown", described as "Dose Number:2, 06Aug2021/ Dose Number:1, 02Jan2021"; CHEST PAIN (non-serious), outcome "recovered", described as "Sharp Chest pain"; DYSPNOEA (non-serious), outcome "recovered", described as "Shortness of breath"; CHEST DISCOMFORT (non-serious), outcome "recovered", described as "Chest tightness"; SLEEP DISORDER (non-serious), outcome "recovered", described as "Unable to lie down to sleep"; FEELING ABNORMAL (non-serious), outcome "recovered", described as "Brain fog"; FATIGUE (non-serious), outcome "recovered", described as "Marked fatigue months"; ASTHENIA (non-serious), outcome "recovered", described as "weakness"; ALLERGY TO VACCINE (non-serious), outcome "recovered", described as "Conclusion was allergic to something in vaccine". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of anxiety, chest pain, dyspnoea, chest discomfort, sleep disorder, feeling abnormal, fatigue, asthenia, allergy to vaccine.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Feeling abnormal, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: Sharp Chest pain; Conclusion was allergic to something in vaccine; Dose Number:2, 06Aug2021/ Dose Number:1, 02Jan2021; felt like she would die/was not herself; Shortness of breath; Chest tightness; Unable to lie down to sleep; Brain fog; Marked fatigue months; weakness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200398207 (Pfizer).  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Aug2021 11:00 (Lot number: ew0164) at the age of 67 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "hypertension" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "nonhodgkins lymphoma" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder; VALSARTAN & HCTZ; NEXIUM [ESOMEPRAZOLE SODIUM]. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: el3246, Location of injection: Arm Right, Vaccine Administration Time: 11:00 AM, Route of Administration: Intramuscular), administration date: 02Jan2021, when the patient was 66 years old, for COVID-19 immunization. The following information was reported: ANXIETY (non-serious), outcome "recovered", described as "felt like she would die/was not herself"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 06Aug2021, outcome "unknown", described as "Dose Number:2, 06Aug2021/ Dose Number:1, 02Jan2021"; CHEST PAIN (non-serious), outcome "recovered", described as "Sharp Chest pain"; DYSPNOEA (non-serious), outcome "recovered", described as "Shortness of breath"; CHEST DISCOMFORT (non-serious), outcome "recovered", described as "Chest tightness"; SLEEP DISORDER (non-serious), outcome "recovered", described as "Unable to lie down to sleep"; FEELING ABNORMAL (non-serious), outcome "recovered", described as "Brain fog"; FATIGUE (non-serious), outcome "recovered", described as "Marked fatigue months"; ASTHENIA (non-serious), outcome "recovered", described as "weakness"; ALLERGY TO VACCINE (non-serious), outcome "recovered", described as "Conclusion was allergic to something in vaccine". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of anxiety, chest pain, dyspnoea, chest discomfort, sleep disorder, feeling abnormal, fatigue, asthenia, allergy to vaccine.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: Sharp Chest pain; Conclusion was allergic to something in vaccine; Dose Number:2, 06Aug2021/ Dose Number:1, 02Jan2021; felt like she would die/was not herself; Shortness of breath; Chest tightness; Unable to lie down to sleep; Brain fog; Marked fatigue months; weakness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200398207 (Pfizer).  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Aug2021 11:00 (Lot number: ew0164) at the age of 67 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "hypertension" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "nonhodgkins lymphoma" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder; VALSARTAN & HCTZ; NEXIUM [ESOMEPRAZOLE SODIUM]. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: el3246, Location of injection: Arm Right, Vaccine Administration Time: 11:00 AM, Route of Administration: Intramuscular), administration date: 02Jan2021, when the patient was 66 years old, for COVID-19 immunization. The following information was reported: ANXIETY (non-serious), outcome "recovered", described as "felt like she would die/was not herself"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 06Aug2021, outcome "unknown", described as "Dose Number:2, 06Aug2021/ Dose Number:1, 02Jan2021"; CHEST PAIN (non-serious), outcome "recovered", described as "Sharp Chest pain"; DYSPNOEA (non-serious), outcome "recovered", described as "Shortness of breath"; CHEST DISCOMFORT (non-serious), outcome "recovered", described as "Chest tightness"; SLEEP DISORDER (non-serious), outcome "recovered", described as "Unable to lie down to sleep"; FEELING ABNORMAL (non-serious), outcome "recovered", described as "Brain fog"; FATIGUE (non-serious), outcome "recovered", described as "Marked fatigue months"; ASTHENIA (non-serious), outcome "recovered", described as "weakness"; ALLERGY TO VACCINE (non-serious), outcome "recovered", described as "Conclusion was allergic to something in vaccine". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of anxiety, chest pain, dyspnoea, chest discomfort, sleep disorder, feeling abnormal, fatigue, asthenia, allergy to vaccine.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Myocardial infarction
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP reported as a nurse). The reporter is the patient. A 63-year-old female patient received bnt162b2 (BNT162B2), administration date Feb2022 (Batch/Lot number: unknown) at the age of 63 years as dose 2, single for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose1, single), for COVID-19 immunisation. The following information was reported: CHEST PAIN (medically significant) with onset 24Feb2022, outcome "unknown", described as "Chest pain"; MYOCARDIAL INFARCTION (medically significant) with onset 24Feb2022, outcome "unknown", described as "thought patient was having a heart attack". Clinical course: The patient experienced chest pain. The pain began late Feb2022 or early Mar2022, within a few days of her second dose. Sometime around 24Feb2022, she had the first episode, stated should have tracked it better, stated it was either the same day as the second dose or a few days within getting the second dose. The patient stated that the chest pain sometimes persisting and sometimes it worsened, the pain was intermittent, has it in her sleep even, that's scary. Sometimes it was severe and sometimes it was not severe, sometimes severe enough to hold her chest, has not researched anything on any of the vaccines so she thought she was having a heart attack, thought it was weird because it was shortly after her vaccines. She stated that it was important to note that it was happening in her sleep. It was the first thing she wakes up to every morning. Some days, it was severe and some days it was not severe, but it was every day. It was intermittent throughout the day. She got both doses, her symptoms started after the second vaccine. She thought it was the lining of the heart but maybe it was the heart muscle itself or maybe it was both. The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: A possible contribution role of vaccination with bnt162b2 to the onset of chest pain which was suspected as heart attack by the reporter, cannot be excluded. The case will be reassessed should additional information become available. 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.
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Had covid/tested positive; Had covid/tested positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 21K-163-4078537-00.  A male patient received bnt162b2 (BNT162B2), intramuscular, administration date 02Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Sep2021, outcome "recovered", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Had covid/tested positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The action taken for adalimumab was unknown.  Clinical Course: Reported as, Reporter and her husband both had covid with coughing, aches and pains. They tested positive before the second dose.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid with mild cold like symptoms.; Tested positive for Covid with mild cold like symptoms.; Tested positive for Covid with mild cold like symptoms.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male patient received bnt162b2 (BNT162B2), administration date 10Nov2021 16:45 (Lot number: FF8841) as dose 3 (booster), single, administration date 10Feb2021 (Lot number: EL3247) as dose 2, single and administration date 20Jan2021 (Lot number: EL3247) as dose 1, single 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), NASOPHARYNGITIS (non-serious) all with onset 05Mar2022, outcome "recovered" and all described as "Tested positive for Covid with mild cold like symptoms.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Mar2022) positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19, nasopharyngitis. The patient did not had covid prior vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure, Vitamin B12 decreased
Clinical narrative: POCT Covid 19 Antigen test  positive; POCT Covid 19 Antigen test positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 31Jan2021 12:00 (Lot number: EN5318) at the age of 49 years as dose 2, single and administered in arm left, administration date 11Jan2021 12:00 (Lot number: EL3246) as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies:Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Jan2022, outcome "unknown" and all described as "POCT Covid 19 Antigen test  positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (08Jan2022) positive, notes: Nasal Swab; vitamin b12 decreased: (Jul2021) low.  Clinical course:No other vaccine in four weeks  No follow-up attempts are possible. No further information is expected; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events  and suspect drug BNT162B2 cannot be excluded.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Fatigue, Flushing, General physical health deterioration, Hyperhidrosis
Clinical narrative: POCT Covid 19 Antigen test  positive; POCT Covid 19 Antigen test positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 31Jan2021 12:00 (Lot number: EN5318) at the age of 49 years as dose 2, single and administered in arm left, administration date 11Jan2021 12:00 (Lot number: EL3246) as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies:Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Jan2022, outcome "unknown" and all described as "POCT Covid 19 Antigen test  positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (08Jan2022) positive, notes: Nasal Swab; vitamin b12 decreased: (Jul2021) low.  Clinical course:No other vaccine in four weeks  No follow-up attempts are possible. No further information is expected; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events  and suspect drug BNT162B2 cannot be excluded.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypertension, Iron deficiency anaemia, Migraine with aura, Pain, Paraesthesia
Clinical narrative: POCT Covid 19 Antigen test  positive; POCT Covid 19 Antigen test positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 31Jan2021 12:00 (Lot number: EN5318) at the age of 49 years as dose 2, single and administered in arm left, administration date 11Jan2021 12:00 (Lot number: EL3246) as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies:Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Jan2022, outcome "unknown" and all described as "POCT Covid 19 Antigen test  positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (08Jan2022) positive, notes: Nasal Swab; vitamin b12 decreased: (Jul2021) low.  Clinical course:No other vaccine in four weeks  No follow-up attempts are possible. No further information is expected; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events  and suspect drug BNT162B2 cannot be excluded.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Postural orthostatic tachycardia syndrome, Pyrexia, SARS-CoV-2 test, Sjogren's syndrome, Vitamin B12
Clinical narrative: POCT Covid 19 Antigen test  positive; POCT Covid 19 Antigen test positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 31Jan2021 12:00 (Lot number: EN5318) at the age of 49 years as dose 2, single and administered in arm left, administration date 11Jan2021 12:00 (Lot number: EL3246) as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies:Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Jan2022, outcome "unknown" and all described as "POCT Covid 19 Antigen test  positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (08Jan2022) positive, notes: Nasal Swab; vitamin b12 decreased: (Jul2021) low.  Clinical course:No other vaccine in four weeks  No follow-up attempts are possible. No further information is expected; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events  and suspect drug BNT162B2 cannot be excluded.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vitamin B12 decreased
Clinical narrative: POCT Covid 19 Antigen test  positive; POCT Covid 19 Antigen test positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 31Jan2021 12:00 (Lot number: EN5318) at the age of 49 years as dose 2, single and administered in arm left, administration date 11Jan2021 12:00 (Lot number: EL3246) as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies:Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Jan2022, outcome "unknown" and all described as "POCT Covid 19 Antigen test  positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (08Jan2022) positive, notes: Nasal Swab; vitamin b12 decreased: (Jul2021) low.  Clinical course:No other vaccine in four weeks  No follow-up attempts are possible. No further information is expected; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events  and suspect drug BNT162B2 cannot be excluded.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Crohn's disease, Diarrhoea
Clinical narrative: This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4301543-00 (AbbVie), US-PFIZER INC-202200403588 (RA). A 41-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 15Mar2021 (Batch/Lot number: unknown) at the age of 40 years as dose 1, single, intramuscular, administration date 19Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 18Feb2022 (Batch/Lot number: unknown) as dose 3 (booster), single for Covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1158187) at citrate free for crohn's disease. Relevant medical history included: "Moderate to severe adult crohn's disease" (unspecified if ongoing). The patient's concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The following information was reported: CROHN'S DISEASE (medically significant), outcome "recovered", described as "more crohn's pain"; ABDOMINAL DISTENSION (medically significant), outcome "recovering", described as "Bloating"; DIARRHOEA (medically significant), outcome "recovering", described as "Diarrhea". The action taken for adalimumab was unknown. Additional information: The reporter's causality for the event(s) of bloating, diarrhea and crohn's pain with HUMIRA (ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of more crohn's pain after Covid-19 vaccine with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's assessment of the causal relationship of the bloating, diarrhea and crohn's pain with the suspect product Pfizer BioNTech Covid-19 Vaccine was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter's causality for the event(s) of more crohn's pain after Covid-19 vaccine with Pfizer BioNTech Covid-19 Vaccine was a reasonable possibility. 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 possible contributory role of the suspect vaccine BNT162B2 to reported event of  abdominal distention, diarrhea and crohn's disease aggravated cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid; Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single 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 10Mar2022, outcome "unknown" and all described as "Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Mar2022) positive, notes: tested positive for Covid 19. Therapeutic measures were taken as a result of drug ineffective, covid-19.Clinical information: The patient was treated with 100 mg of ritonavir and 2 tablets of nirmatrelvir 150mg each. No Other Products. No Patient History.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac infection, Immune system disorder
Clinical narrative: Severe heart inflammation; Bodies with weak immune systems; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  An adolescent patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for Covid-19 immunization. The following information was reported: CARDIAC INFECTION (death, medically significant), outcome "fatal", described as "Severe heart inflammation"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "Bodies with weak immune systems". The patient date of death was unknown. The reported cause of death was inflammation. Additional information: Two teenagers died from the second shot. Severe heart inflammation on autopsy. Bodies with weak immune systems often don't react as fiercely as stronger ones. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Severe heart inflammation
Sex: U
Vaccine: COVID19
Symptoms: Cardiac infection, Immune system disorder
Clinical narrative: Severe heart inflammation on autopsy; Bodies with weak immune systems; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  An adolescent patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. 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. The following information was reported: CARDIAC INFECTION (death, medically significant), outcome "fatal", described as "Severe heart inflammation on autopsy"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "Bodies with weak immune systems". The patient date of death was unknown. The reported cause of death was cardiac infection. Clinical course: Two teenagers died from the second shot. Severe heart inflammation on autopsy. Bodies with weak immune systems often don't react as fiercely as stronger ones.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Severe heart inflammation on autopsy