chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Anxiety, Cough, Fatigue, Nausea
Clinical narrative: generally was tired; Minor stomach upset on night of 26Nov-27Nov due to believed diet; Feeling nauseous/they believe nausea is a flare up of this; Vomiting; anxiety/chronic anxiety; runny nose; coughing a little; chronic sinus issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 27 year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Has gotten covid in the past., if covid prior vaccination: Yes; "Alcohol" (unspecified if ongoing), notes: Alcohol and cannabis-related use throughout past couple days.; "Nausea" (unspecified if ongoing), notes: History of nausea in the morning due to anxiety; "anxiety" (unspecified if ongoing), notes: History of nausea in the morning due to anxiety; "cannibis use" (unspecified if ongoing), notes: Some recreational CBD or cannibis use. The patient's concomitant medications were not reported. The following information was reported: NAUSEA (non-serious) with onset 25Nov2021 10:00, outcome "recovering", described as "Feeling nauseous/they believe nausea is a flare up of this"; VOMITING (non-serious) with onset 25Nov2021 10:00, outcome "recovering", described as "Vomiting"; ANXIETY (non-serious) with onset 25Nov2021 10:00, outcome "unknown", described as "anxiety/chronic anxiety"; RHINORRHOEA (non-serious) with onset 25Nov2021 10:00, outcome "unknown", described as "runny nose"; COUGH (non-serious) with onset 25Nov2021 10:00, outcome "unknown", described as "coughing a little"; SINUS DISORDER (non-serious) with onset 25Nov2021 10:00, outcome "unknown", described as "chronic sinus issues"; FATIGUE (non-serious) with onset 26Nov2021, outcome "unknown", described as "generally was tired"; ABDOMINAL DISCOMFORT (non-serious) with onset 26Nov2021, outcome "recovered" (27Nov2021), described as "Minor stomach upset on night of 26Nov-27Nov due to believed diet". Therapeutic measures were taken as a result of nausea, vomiting.  Additional information : It was reported that reporter believed unrelated to vaccine but woke up with runny nose, coughing a little, and feeling nauseous and vomiting. Unsure what brand of vaccine and number of doses. It was believed that, been vaccinated for a while now (not recent), but unsure when initially vaccinated. Patient has chronic sinus issues due to tongue size in proportion to mouth. Patient felt nauseous again and believed still due to chronic anxiety. On 27Nov2021 experienced nausea, vomiting still continued and still believed to be due to chronic anxiety. Cannabis related substances (not CBD). It was reported that nausea issue could be exasperated by drinking alcohol the night before and chugged water which may have caused vomiting. Took Dramamine and seemed to improve slightly during the day (based on observation)  The lot number for COVID-19 Vaccine - Manufacturer Unknown was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sinus disorder, Vomiting
Clinical narrative: generally was tired; Minor stomach upset on night of 26Nov-27Nov due to believed diet; Feeling nauseous/they believe nausea is a flare up of this; Vomiting; anxiety/chronic anxiety; runny nose; coughing a little; chronic sinus issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 27 year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Has gotten covid in the past., if covid prior vaccination: Yes; "Alcohol" (unspecified if ongoing), notes: Alcohol and cannabis-related use throughout past couple days.; "Nausea" (unspecified if ongoing), notes: History of nausea in the morning due to anxiety; "anxiety" (unspecified if ongoing), notes: History of nausea in the morning due to anxiety; "cannibis use" (unspecified if ongoing), notes: Some recreational CBD or cannibis use. The patient's concomitant medications were not reported. The following information was reported: NAUSEA (non-serious) with onset 25Nov2021 10:00, outcome "recovering", described as "Feeling nauseous/they believe nausea is a flare up of this"; VOMITING (non-serious) with onset 25Nov2021 10:00, outcome "recovering", described as "Vomiting"; ANXIETY (non-serious) with onset 25Nov2021 10:00, outcome "unknown", described as "anxiety/chronic anxiety"; RHINORRHOEA (non-serious) with onset 25Nov2021 10:00, outcome "unknown", described as "runny nose"; COUGH (non-serious) with onset 25Nov2021 10:00, outcome "unknown", described as "coughing a little"; SINUS DISORDER (non-serious) with onset 25Nov2021 10:00, outcome "unknown", described as "chronic sinus issues"; FATIGUE (non-serious) with onset 26Nov2021, outcome "unknown", described as "generally was tired"; ABDOMINAL DISCOMFORT (non-serious) with onset 26Nov2021, outcome "recovered" (27Nov2021), described as "Minor stomach upset on night of 26Nov-27Nov due to believed diet". Therapeutic measures were taken as a result of nausea, vomiting.  Additional information : It was reported that reporter believed unrelated to vaccine but woke up with runny nose, coughing a little, and feeling nauseous and vomiting. Unsure what brand of vaccine and number of doses. It was believed that, been vaccinated for a while now (not recent), but unsure when initially vaccinated. Patient has chronic sinus issues due to tongue size in proportion to mouth. Patient felt nauseous again and believed still due to chronic anxiety. On 27Nov2021 experienced nausea, vomiting still continued and still believed to be due to chronic anxiety. Cannabis related substances (not CBD). It was reported that nausea issue could be exasperated by drinking alcohol the night before and chugged water which may have caused vomiting. Took Dramamine and seemed to improve slightly during the day (based on observation)  The lot number for COVID-19 Vaccine - Manufacturer Unknown was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Immunisation, Post herpetic neuralgia
Clinical narrative: Post Herpetic Neuralgia episode; Following my third Pfizer Covid vaccine, I have experienced increasing episodes. Three in the past 3 days; Third Pfizer Covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  An 84-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 21Oct2021 09:30 (Lot number: FF2593) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Shingles" (unspecified if ongoing), notes: extreme case of shingles to left eye, and nerves surrounding eye 15 years ago; "squamous cell lesion" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, Batch/Lot Number: EL9262, Location of injection: Arm Left), administration date: 02Feb2021, for Covid-19 Immunization; Bnt162b2 (Dose 1, Batch/Lot Number: EL8982, Location of injection: Arm Left), administration date: 22Jan2021, for Covid-19 Immunization; Flu zone hd (other vaccine 4 weeks product: Flu zone HD, date: 01Oct2021, dose number: 1, vaccine location: left arm), administration date: 01Oct2021. The following information was reported: IMMUNISATION (non-serious) with onset 21Oct2021, outcome "unknown", described as "Third Pfizer Covid vaccine"; POST HERPETIC NEURALGIA (non-serious) with onset 28Oct2021, outcome "not recovered", described as "Post Herpetic Neuralgia episode"; CONDITION AGGRAVATED (non-serious) with onset 28Oct2021, outcome "not recovered", described as "Following my third Pfizer Covid vaccine, I have experienced increasing episodes. Three in the past 3 days". Therapeutic measures were not taken as a result of post herpetic neuralgia, condition aggravated.  Additional information: Within a week of my third Pfizer Covid vaccine, I experienced a Post Herpetic Neuralgia episode. An extreme case of shingles to left eye, and nerves surrounding eye 15 years ago led many post herpetic neuralgia episodes for several years, gradually decreasing to 1-3 a year. Following my third Pfizer Covid vaccine, I have experienced increasing episodes. Three in the past 3 days. Have read there may be a connection. known allergies: Unknown. If covid prior vaccination: No. If covid tested post vaccination: No  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Immunisation
Clinical narrative: received booster Covid-19 vaccine shot; sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (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: Covid-19 vaccine (Dose 1), for COVID-19 immunization; Covid-19 vaccine (Dose 2), for COVID-19 immunization.The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "received booster Covid-19 vaccine shot"; ILLNESS (non-serious), outcome "unknown", described as "sick".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pain
Clinical narrative: Booster; had some increase in pain; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 47 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) at the age of 47 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "surgery", start date: 13Oct2021 (unspecified if ongoing). Concomitant medication(s) included: CETIRIZINE; RED YEAST RICE. Past drug history included: Doxycycline, reaction(s): "Allergies". Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "Booster"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "had some increase in pain".  Additional information: Date of event onset was unknown. Patient stated that she has been off the medication since about 2 weeks before her surgery on 13Oct21. She had to stay off for a week after her covid booster too. She has had some increase in pain. Doctor is aware. The patient had allergies to Doxycycline. Medication(s) patient was using at or around the time of the adverse event and dates of therapy. (Exclude medications used to treat event) were Cetirizine, Multivitamin ,Red Yeast Rice.  The lot number for bnt162b2 was not provided and will be requested during follow up.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101686169 Same patient , different drug and event
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Immunisation, Vaccination site pain
Clinical narrative: 3rd dose; some arm pain that occurred at injection site.; slightly light headed right after the vaccine in the first 20 minutes; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 45 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 30Nov2021 14:00 (Batch/Lot number: unknown) at the age of 45 years 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 Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: Mar2021, when the patient was 44 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: Mar2021, when the patient was 44 years old, for COVID-19 immunization. The following information was reported IMMUNISATION (non-serious) with onset 30Nov2021 14:00, outcome unknown; VACCINATION SITE PAIN (non-serious) with onset 30Nov2021, outcome recovering; DIZZINESS (non-serious) with onset 30Nov2021, outcome recovered (30Nov2021). Therapeutic measures were not taken as a result of vaccination site pain, dizziness.  The reporter stated that the person had some arm pain that occurred at injection site. Sounds mild-moderate. persisted mild the morning after. Also felt slightly lightheaded right after the vaccine in the first 20 minutes, and that dissipated. The patient had no known allergies and other medical history. The patient had no COVID prior vaccination and not tested for COVID post vaccination. No other vaccine in four weeks and no other medications in two weeks prior to dose 3 (booster).  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Arthralgia, Diarrhoea, Headache, Immunisation, Muscle spasms
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 29Nov2021 17:45 (Batch/Lot number: unknown) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm left, administration date 29Nov2021 (Batch/Lot number: unknown) as dose 1, single. Relevant medical history included: "Type 1 diabetes" (unspecified if ongoing); "similar reaction to TB test" (unspecified if ongoing), notes: Had similar reaction to TB test at 15 years old. Concomitant medication(s) included: HUMALOG taken for type 1 diabetes mellitus; SKYLA. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 11:15 AM), administration date: 11Mar2021, when the patient was 33 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 11:15 AM), administration date: 01Apr2021, when the patient was 33 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 29Nov2021 17:45, outcome "unknown", described as "dose number=3"; MUSCLE SPASMS (non-serious) with onset 30Nov2021 14:00, outcome "not recovered", described as "Full body muscle spasms"; NAUSEA (non-serious) with onset 30Nov2021 14:00, outcome "not recovered", described as "extreme nausea"; DIARRHEA (non-serious) with onset 30Nov2021 14:00, outcome "not recovered", described as "diarrhea"; MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 30Nov2021 14:00, outcome "not recovered" and all described as "intense muscle and joint pain"; HEADACHE (non-serious) with onset 30Nov2021 14:00, outcome "not recovered", described as "piercing headache". Therapeutic measures were not taken as a result of muscle spasms, nausea, diarrhea, myalgia, arthralgia, headache. Additional information: Prior to vaccination, the patient was not diagnosed with covid-19 and post vaccination, the patient had not been tested for covid-19. The patient did not receive any other vaccine in four weeks. The patient experienced full body muscle spasms, extreme nausea, diarrhea, intense muscle and joint pain, piercing headache on 30Nov2021 14:00 which had been going on for 48 hours and did not seem to be calming down yet. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Myalgia, Nausea
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 29Nov2021 17:45 (Batch/Lot number: unknown) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm left, administration date 29Nov2021 (Batch/Lot number: unknown) as dose 1, single. Relevant medical history included: "Type 1 diabetes" (unspecified if ongoing); "similar reaction to TB test" (unspecified if ongoing), notes: Had similar reaction to TB test at 15 years old. Concomitant medication(s) included: HUMALOG taken for type 1 diabetes mellitus; SKYLA. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 11:15 AM), administration date: 11Mar2021, when the patient was 33 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 11:15 AM), administration date: 01Apr2021, when the patient was 33 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 29Nov2021 17:45, outcome "unknown", described as "dose number=3"; MUSCLE SPASMS (non-serious) with onset 30Nov2021 14:00, outcome "not recovered", described as "Full body muscle spasms"; NAUSEA (non-serious) with onset 30Nov2021 14:00, outcome "not recovered", described as "extreme nausea"; DIARRHEA (non-serious) with onset 30Nov2021 14:00, outcome "not recovered", described as "diarrhea"; MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 30Nov2021 14:00, outcome "not recovered" and all described as "intense muscle and joint pain"; HEADACHE (non-serious) with onset 30Nov2021 14:00, outcome "not recovered", described as "piercing headache". Therapeutic measures were not taken as a result of muscle spasms, nausea, diarrhea, myalgia, arthralgia, headache. Additional information: Prior to vaccination, the patient was not diagnosed with covid-19 and post vaccination, the patient had not been tested for covid-19. The patient did not receive any other vaccine in four weeks. The patient experienced full body muscle spasms, extreme nausea, diarrhea, intense muscle and joint pain, piercing headache on 30Nov2021 14:00 which had been going on for 48 hours and did not seem to be calming down yet. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen and very tender lymph nodes in my left underarm; Swollen and very tender lymph nodes in my left underarm; dose number=3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Nov2021 15:00 (Lot number: 30145BA) at the age of 58 years as dose 3, (booster) single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SYNTHROID and multi vitamins. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EWO175, Location of injection: Arm Left, Vaccine Administration Time: 01:45 PM), administration date: 29Apr2021, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EWO158, Location of injection: Arm Left, Vaccine Administration Time: 01:45 PM), administration date: 08Apr2021, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 26Nov2021 15:00, outcome "unknown", described as "dose number=3"; LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious) all with onset 28Nov2021, outcome "recovered" (2021) and all described as "Swollen and very tender lymph nodes in my left underarm". Therapeutic measures were not taken as a result of lymph node pain, lymphadenopathy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Headache, Immunisation, Off label use, Pain, Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 48 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Dec2021 11:00 (Lot number: FF8841) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), administered in arm left, administration date 01Dec2021 (Batch/Lot number: unknown) for immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot Number: EL3248, Route of Administration: Intramuscular, Anatomical Location: Left arm, Time of Administration: 11:00), administration date: 16Mar2021, when the patient was 47 years old, for COVID-19 immunization; Bnt162b2 (DOSE 1, SINGLE, Lot Number: EL3247, Route of Administration: Intramuscular, Anatomical Location: Left arm, Time of Administration: 10:00), administration date: 23Feb2021, when the patient was 47 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021 11:00, outcome "unknown", described as "Dose received 3/dose number = 3"; PAIN (non-serious) with onset 01Dec2021 22:00, outcome "unknown", described as "Body pain"; HEADACHE (non-serious) with onset 01Dec2021 22:00, outcome "unknown", described as "Headache"; PAIN IN EXTREMITY (non-serious) with onset 01Dec2021 22:00, outcome "unknown", described as "Left arm pain"; PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 01Dec2021, outcome "unknown" and all described as "Product use for unapproved combination". Therapeutic measures were not taken as a result of pain, headache, pain in extremity. Additional Information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Product use issue
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 48 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Dec2021 11:00 (Lot number: FF8841) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), administered in arm left, administration date 01Dec2021 (Batch/Lot number: unknown) for immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot Number: EL3248, Route of Administration: Intramuscular, Anatomical Location: Left arm, Time of Administration: 11:00), administration date: 16Mar2021, when the patient was 47 years old, for COVID-19 immunization; Bnt162b2 (DOSE 1, SINGLE, Lot Number: EL3247, Route of Administration: Intramuscular, Anatomical Location: Left arm, Time of Administration: 10:00), administration date: 23Feb2021, when the patient was 47 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021 11:00, outcome "unknown", described as "Dose received 3/dose number = 3"; PAIN (non-serious) with onset 01Dec2021 22:00, outcome "unknown", described as "Body pain"; HEADACHE (non-serious) with onset 01Dec2021 22:00, outcome "unknown", described as "Headache"; PAIN IN EXTREMITY (non-serious) with onset 01Dec2021 22:00, outcome "unknown", described as "Left arm pain"; PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 01Dec2021, outcome "unknown" and all described as "Product use for unapproved combination". Therapeutic measures were not taken as a result of pain, headache, pain in extremity. Additional Information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatinine, Blood creatinine decreased, Body temperature, Headache, Immunisation
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Nov2021 12:15 (Lot number: FF2550) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "sulfa" (unspecified if ongoing), notes: known allergies: Sulfa; "Prolactinoma" (unspecified if ongoing); "Diabetes Insipidus" (unspecified if ongoing); "Migraine" (unspecified if ongoing); "PTSD" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Known allergies: Pcn" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN; DDAVP; LEXAPRO; LEVOTHROID. Past drug history included: Morphine, reaction(s): "known allergies: Morphine", notes: known allergies: morphine; Codeine, reaction(s): "known allergies: Codeine", notes: known allergies: codeine; Ceftin, reaction(s): "known allergies: Ceftin", notes: known allergies: ceftin. Vaccination history included: Bnt162b2 (Dose 2, Lot Number: EW158), administration date: 14Apr2021, when the patient was 55 years old, for Covid-19 Immunization; Bnt162b2 (Dose 1, Lot Number: EN6207), administration date: 24Mar2021, when the patient was 55 years old, for Covid-19 Immunization; Prevnair13, reaction(s): "known allergies: Prevnar 13". The following information was reported: IMMUNISATION (non-serious) with onset 30Nov2021 12:15, outcome "unknown", described as "Booster"; LYMPHOCYTE COUNT DECREASED (non-serious) with onset 01Dec2021, outcome "not recovered", described as "low lymphocytes"; BLOOD CREATININE DECREASED (non-serious) with onset 01Dec2021, outcome "not recovered", described as "low creatinine"; PYREXIA (non-serious) with onset 01Dec2021, outcome "not recovered", described as "fever 102"; VOMITING (non-serious) with onset 01Dec2021, outcome "not recovered", described as "vomiting"; NAUSEA (non-serious) with onset 01Dec2021, outcome "not recovered", described as "nausea"; HEADACHE (non-serious) with onset 01Dec2021, outcome "not recovered", described as "severe headache". The events "low lymphocytes", "low creatinine", "fever 102", "vomiting", "nausea" and "severe headache" 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 lymphocyte count decreased, blood creatinine decreased, pyrexia, vomiting, nausea, headache.  Additional information: The AE resulted in Doctor or other healthcare professional office/clinic visit. Received AE treatment with zofran, labwork, covid test. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had been tested for COVID-19 post vaccination (result: pending).  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphocyte count, Lymphocyte count decreased, Nausea, Pyrexia, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Nov2021 12:15 (Lot number: FF2550) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "sulfa" (unspecified if ongoing), notes: known allergies: Sulfa; "Prolactinoma" (unspecified if ongoing); "Diabetes Insipidus" (unspecified if ongoing); "Migraine" (unspecified if ongoing); "PTSD" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Known allergies: Pcn" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN; DDAVP; LEXAPRO; LEVOTHROID. Past drug history included: Morphine, reaction(s): "known allergies: Morphine", notes: known allergies: morphine; Codeine, reaction(s): "known allergies: Codeine", notes: known allergies: codeine; Ceftin, reaction(s): "known allergies: Ceftin", notes: known allergies: ceftin. Vaccination history included: Bnt162b2 (Dose 2, Lot Number: EW158), administration date: 14Apr2021, when the patient was 55 years old, for Covid-19 Immunization; Bnt162b2 (Dose 1, Lot Number: EN6207), administration date: 24Mar2021, when the patient was 55 years old, for Covid-19 Immunization; Prevnair13, reaction(s): "known allergies: Prevnar 13". The following information was reported: IMMUNISATION (non-serious) with onset 30Nov2021 12:15, outcome "unknown", described as "Booster"; LYMPHOCYTE COUNT DECREASED (non-serious) with onset 01Dec2021, outcome "not recovered", described as "low lymphocytes"; BLOOD CREATININE DECREASED (non-serious) with onset 01Dec2021, outcome "not recovered", described as "low creatinine"; PYREXIA (non-serious) with onset 01Dec2021, outcome "not recovered", described as "fever 102"; VOMITING (non-serious) with onset 01Dec2021, outcome "not recovered", described as "vomiting"; NAUSEA (non-serious) with onset 01Dec2021, outcome "not recovered", described as "nausea"; HEADACHE (non-serious) with onset 01Dec2021, outcome "not recovered", described as "severe headache". The events "low lymphocytes", "low creatinine", "fever 102", "vomiting", "nausea" and "severe headache" 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 lymphocyte count decreased, blood creatinine decreased, pyrexia, vomiting, nausea, headache.  Additional information: The AE resulted in Doctor or other healthcare professional office/clinic visit. Received AE treatment with zofran, labwork, covid test. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had been tested for COVID-19 post vaccination (result: pending).  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Nov2021 12:15 (Lot number: FF2550) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "sulfa" (unspecified if ongoing), notes: known allergies: Sulfa; "Prolactinoma" (unspecified if ongoing); "Diabetes Insipidus" (unspecified if ongoing); "Migraine" (unspecified if ongoing); "PTSD" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Known allergies: Pcn" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN; DDAVP; LEXAPRO; LEVOTHROID. Past drug history included: Morphine, reaction(s): "known allergies: Morphine", notes: known allergies: morphine; Codeine, reaction(s): "known allergies: Codeine", notes: known allergies: codeine; Ceftin, reaction(s): "known allergies: Ceftin", notes: known allergies: ceftin. Vaccination history included: Bnt162b2 (Dose 2, Lot Number: EW158), administration date: 14Apr2021, when the patient was 55 years old, for Covid-19 Immunization; Bnt162b2 (Dose 1, Lot Number: EN6207), administration date: 24Mar2021, when the patient was 55 years old, for Covid-19 Immunization; Prevnair13, reaction(s): "known allergies: Prevnar 13". The following information was reported: IMMUNISATION (non-serious) with onset 30Nov2021 12:15, outcome "unknown", described as "Booster"; LYMPHOCYTE COUNT DECREASED (non-serious) with onset 01Dec2021, outcome "not recovered", described as "low lymphocytes"; BLOOD CREATININE DECREASED (non-serious) with onset 01Dec2021, outcome "not recovered", described as "low creatinine"; PYREXIA (non-serious) with onset 01Dec2021, outcome "not recovered", described as "fever 102"; VOMITING (non-serious) with onset 01Dec2021, outcome "not recovered", described as "vomiting"; NAUSEA (non-serious) with onset 01Dec2021, outcome "not recovered", described as "nausea"; HEADACHE (non-serious) with onset 01Dec2021, outcome "not recovered", described as "severe headache". The events "low lymphocytes", "low creatinine", "fever 102", "vomiting", "nausea" and "severe headache" 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 lymphocyte count decreased, blood creatinine decreased, pyrexia, vomiting, nausea, headache.  Additional information: The AE resulted in Doctor or other healthcare professional office/clinic visit. Received AE treatment with zofran, labwork, covid test. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had been tested for COVID-19 post vaccination (result: pending).  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Immunisation, Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A female patient received bnt162b2 (BNT162B2) (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 1, SINGLE lot no EL3247), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE lot no EM9810), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), BACK PAIN (non-serious), ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "know since I had the booster shot my knee is hurting, my leg is hurting and my back is hurting". Additional information: LOT# (first & second shot): Consumer stated, "Yes you know what, yes, the first one is EL3247. The second one is EM9810." Treatment: Consumer stated, "No, there is nothing I can take. After this, I am going to take a nap because I am tired. And my booster by the way was the date of my booster was 29Nov2021 (further not clarified)." Date of vaccination for First and Second shot: Consumer stated, "Ok, the first shot was 21Jan2021 (unclear) University. Second shot was 12Feb2021 and the booster was 29Oct2021 (further not clarified)." No prior to vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Sluggishness
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 46-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 20Oct2021 (Batch/Lot number: unknown) (at the age of 46-years) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Verbatim: Hypertension. Concomitant medication(s) included: LISINOPRIL taken for hypertension. Vaccination history included: Bnt162b2 (DOSE 1), administration date: 07Apr2021, when the patient was 46 years old, for COVID-19 immunization; Bnt162b2 (DOSE 2), administration date: 19Apr2021, when the patient was 46 years old, for COVID-19 immunization, reaction(s): "fatigue", "I felt symptoms of flu", "I was feeling too low and after that subsided", "Inappropriate schedule of vaccine administered". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Experiencing like serious chronic fatigue"; PAIN (non-serious), outcome "unknown", described as "pain"; SLUGGISHNESS (non-serious), outcome "unknown", described as "It was really hard just getting that on my work day feeling really sluggish and fatigued". Additional information: Patient stated, I had a questionnaire for feedback after I took both vaccinations and also the booster and I wanted to report the feeling of chronic fatigue after taking the second Pfizer vaccine and also currently, the booster which I took on 20Oct2021 and I have been experiencing like serious chronic fatigue. My energy came back early July and that was when I was approved to take the booster. So, I just recently on 20Oct2021, I took it and from that I had the same I felt symptoms of flu symptoms I was feeling too low and after that subsided like the second one, I took and then after it, this lingering effect from it and there was a little bit of pain before the fatigue. So, like it was really hard just getting that on my workday feeling really sluggish and fatigued. Patient also stated that, "I do not have, I just know that it was the Pfizer vaccine, but I do not have my vaccine card in front of me and also stated "So, the first time, the first, initial were both in my left arm and the last one I just had in my right arm." Treatment: Patient stated, "No, I did not take any treatment. I only take Vitamins, I take one a day Vitamins previously before vaccinations and still after, that is the part of my everyday regimen to take my one a day, vitamins." The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: Linked Report(s) : US-PFIZER INC-202101721037 same patient and drug, different event separated in time.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Product administered to patient of inappropriate age, Underdose
Clinical narrative: a 40-year old male patient that was given the orange cap formulation Comirnaty vaccine as his booster dose; a 40-year old male patient that was given the orange cap formulation Comirnaty vaccine as his booster dose; a 40-year old male patient that was given the orange cap formulation Comirnaty vaccine as his booster dose; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 40 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), UNDERDOSE (non-serious) all with onset 2021, outcome "unknown" and all described as "a 40-year old male patient that was given the orange cap formulation Comirnaty vaccine as his booster dose".  Additional info- A patient, male, he is 40 years old and he received the booster dose of Pfizer COVID vaccine but instead of the adult dose he was given paediatric dose."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dysgeusia, Fatigue, Headache
Clinical narrative: Fever 103; chills; headache; metallic taste; fatigue; dose number: 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Dec2021 09:30 (Lot number: FH8030) at the age of 70 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Dupytrens Disease" (unspecified if ongoing), notes: Dupytrens Disease; "Sleep Apnea" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8725, Location of injection: Arm Left, Vaccine Administration Time: 11:15 AM), administration date: 25Mar2021, when the patient was 69 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6201, Location of injection: Arm Left, Vaccine Administration Time: 11:30 AM), administration date: 04Mar2021, when the patient was 69 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021 09:30, outcome "unknown", described as "dose number: 3"; PYREXIA (non-serious) with onset 03Dec2021 08:15, outcome "recovering", described as "Fever 103"; CHILLS (non-serious) with onset 03Dec2021 08:15, outcome "recovering", described as "chills"; HEADACHE (non-serious) with onset 03Dec2021 08:15, outcome "recovering", described as "headache"; DYSGEUSIA (non-serious) with onset 03Dec2021 08:15, outcome "recovering", described as "metallic taste"; FATIGUE (non-serious) with onset 03Dec2021 08:15, outcome "recovering", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, headache, dysgeusia, fatigue.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pyrexia
Clinical narrative: Fever 103; chills; headache; metallic taste; fatigue; dose number: 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Dec2021 09:30 (Lot number: FH8030) at the age of 70 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Dupytrens Disease" (unspecified if ongoing), notes: Dupytrens Disease; "Sleep Apnea" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8725, Location of injection: Arm Left, Vaccine Administration Time: 11:15 AM), administration date: 25Mar2021, when the patient was 69 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6201, Location of injection: Arm Left, Vaccine Administration Time: 11:30 AM), administration date: 04Mar2021, when the patient was 69 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021 09:30, outcome "unknown", described as "dose number: 3"; PYREXIA (non-serious) with onset 03Dec2021 08:15, outcome "recovering", described as "Fever 103"; CHILLS (non-serious) with onset 03Dec2021 08:15, outcome "recovering", described as "chills"; HEADACHE (non-serious) with onset 03Dec2021 08:15, outcome "recovering", described as "headache"; DYSGEUSIA (non-serious) with onset 03Dec2021 08:15, outcome "recovering", described as "metallic taste"; FATIGUE (non-serious) with onset 03Dec2021 08:15, outcome "recovering", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, headache, dysgeusia, fatigue.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Immunisation, Pyrexia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 01Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included Covid-19 vaccine (Dose number unknown, Manufacturer unknown), for Covid-19 immunization. The following information was reported IMMUNISATION (non-serious) with onset 01Dec2021, outcome unknown; ILLNESS (non-serious) with onset 02Dec2021, outcome unknown; PYREXIA (non-serious) with onset 02Dec2021, outcome unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  No follow-up attempts are possible. No further information is expected.  Follow-up on 08Dec2021 included this follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Immunisation
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: Covid-19 vaccine (Dose: 1, MANUFACTURER: UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (Dose : 2, MANUFACTURER: UNKNOWN), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Brain fog". The lot number for bnt162b2 was not provided and will be requested during follow up.