chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Immunisation
Clinical narrative: I experienced heavy menstruation for 3 weeks after the booster shot; dose received: 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18Nov2021 19:00 (Lot number: FH8030) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Idiopathic Thrombocytopenia Purpura" (unspecified if ongoing), notes: other medical history: Idiopathic Thrombocytopenia Purpura; "acid reflux" (unspecified if ongoing), notes: other medical history: acid reflux; "osteopenia" (unspecified if ongoing), notes: other medical history: osteopenia. Concomitant medication(s) included: TRI-SPRINTEC; MOMETASONE FUROATE; FLORAJEN. Past drug history included: Neomycin, reaction(s): "Known Allergies: Neomycin"; Tetracain, reaction(s): "Known allergies: tetracain". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8734, Location of injection: Arm Right, Vaccine Administration Time: 02:15 PM), administration date: 02Apr2021, when the patient was 40 years old, for COVID-19 Immunization, reaction(s): "I was already menstruating for several days prior to getting the shot"; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0164, Location of injection: Arm Right, Vaccine Administration Time: 02:15 PM), administration date: 23Apr2021, when the patient was 40 years old, for COVID-19 Immunization, reaction(s): "I was already menstruating for several days prior to getting the shot".  The following information was reported: IMMUNISATION (non-serious) with onset 18Nov2021 19:00, outcome "unknown", described as "dose received: 3"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 22Nov2021, outcome "unknown", described as "I experienced heavy menstruation for 3 weeks after the booster shot". Therapeutic measures were not taken as a result of heavy menstrual bleeding.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received within 2 weeks of vaccination: vitamin. Since patient was already menstruating for several days prior to getting the shot, the menstruation ended up lasting for 4 weeks straight. Patient reported that she did not know whether she was recovered because she did not know if next month's period will be affected, but bleeding has stopped as of earlier this week. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Immunisation
Clinical narrative: booster; a symptom of breast soreness; This is a spontaneous report received from a contactable Consumer or other non HCP from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "menopause" (unspecified if ongoing), notes: She compares it to PMS symptom even though she is "well past menopause". The patient's 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), outcome "unknown", described as "booster"; BREAST PAIN (non-serious), outcome "unknown", described as "a symptom of breast soreness".  The lot number for bnt162b2 was not provided and will be requested during follow up..
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: Booster; COVID-19 confirmed by positive COVID-19 test/currently diagnosed positive with Covid-19, currently asymptomatic; COVID-19 confirmed by positive COVID-19 test/currently diagnosed positive with Covid-19, currently asymptomatic; This is a spontaneous report received from a contactable reporter (Physician) from medical information team for a Pfizer sponsored program.  An 80 year-old male patient received bnt162b2 (BNT162B2), administration date 28Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date 15Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date 23Feb2021 (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: IMMUNISATION (medically significant) with onset 28Sep2021, outcome "unknown", described as "Booster"; ASYMPTOMATIC COVID-19 (medically significant) with onset 2021, outcome "not recovered", DRUG INEFFECTIVE (medically significant) with onset 2021, outcome "unknown" and all described as "COVID-19 confirmed by positive COVID-19 test/currently diagnosed positive with Covid-19, currently asymptomatic". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) positive. The reporter wanted to know if the use of nirmatrelvir tablets; ritonavir tablets will require a prescription from a licensed healthcare provider and if Paxlovid has been studied in asymptomatic people.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I took 2 doses and got covid again/ I took both doses of Pfizer and still got COVID-19 second time.; I took 2 doses and got covid again/I took both doses of Pfizer and still got COVID-19 second time.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 39 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Jun2021 12:30 (Batch/Lot number: unknown) at the age of 39 years as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included COVID-19, start date: Oct2020 (unspecified if ongoing), he got COVID last year. There were no concomitant medications. The following information was reported DRUG INEFFECTIVE (medically significant) with onset 2021, outcome unknown; SUSPECTED COVID-19 (medically significant) with onset 2021, outcome unknown. The events I took 2 doses and got covid again/ I took both doses of pfizer and still got covid-19 second time, were evaluated at the physician office visit. Therapeutic measures were not taken as a result of drug ineffective, suspected covid-19. Patient took both doses of Pfizer and still got COVID-19 second time. So, even his doctors were puzzled and they were not sure why this happened to him again. Patient was really fit and healthy. There was no lab test. Patient had not taken any treatment other than test (unspecified). Patient had severe symptoms this time. So, he was in touch with the doctor and they are monitoring the situation.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Breakthrough Case; Breakthrough Case; Reason why batch/lot is Unknown: Not available/provided to reporter at the time of report completion Reported Event: Breakthrough Case Awareness Date : 22Dec2021 This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adolescent female patient received bnt162b2 (BNT162B2) (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 Breakthrough Case. No follow-up attempts are possible information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Immunisation, Influenza like illness
Clinical narrative: Booster dose; temperature; Flu like symptoms; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administration date 20Dec2021 (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, After first one, I was little bit tried but I didn't have any flu like symptoms or anything), administration date: 10Apr2021, for COVID-19 Immunization, reaction(s): "Little bit tired"; Bnt162b2 (Dose: 2), administration date: 29Apr2021, for COVID-19 Immunization, reaction(s): "Mild joint pain", "Felt tired". The following information was reported: IMMUNISATION (non-serious) with onset 20Dec2021, outcome "unknown", described as "Booster dose"; BODY TEMPERATURE (non-serious) with onset Dec2021, outcome "unknown", described as "temperature"; INFLUENZA LIKE ILLNESS (non-serious) with onset Dec2021, outcome "unknown", described as "Flu like symptoms"; HEADACHE (non-serious) with onset Dec2021, outcome "unknown", described as "Headache".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Endometriosis, Heavy menstrual bleeding, Immunisation
Clinical narrative: Endometriosis; Period going on for 2 weeks now; Severe period cramping; Booster; 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 received bnt162b2 (BNT162B2), administered in arm left, administration date 10Dec2021 (Lot number: FH8030) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Severe asthma" (unspecified if ongoing), notes: Severe asthma. Concomitant medication(s) included: APRI taken for contraception. Vaccination history included: Bnt162b2 (1st dose, lot number: EN6201, administered in left arm.), administration date: 14Feb2021, when the patient was 33 years old, for COVID-19 immunisation; Bnt162b2 (2nd dose, lot number EN6206, and was given in her left arm., Her second vaccine it happened, but she was due for her period at that time. She was on a different birth control then, and still had periods.), administration date: 07Mar2021, when the patient was 34 years old, for COVID-19 immunisation, reaction(s): "Still had periods". The following information was reported: IMMUNISATION (non-serious) with onset 10Dec2021, outcome "unknown", described as "Booster"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 11Dec2021, outcome "not recovered", described as "Period going on for 2 weeks now"; DYSMENORRHOEA (non-serious) with onset 11Dec2021, outcome "not recovered", described as "Severe period cramping"; ENDOMETRIOSIS (non-serious), outcome "not recovered", described as "Endometriosis". The event "period going on for 2 weeks now" was evaluated at the physician office visit.  Additional information: patient had concomitant therapy. Patient didn't receive other vaccines within 4 weeks prior to vaccination. After the COVID booster, she got a period, and she has had it for 2 weeks now. It occurred the day after the booster. Actually, she doesn't get a period because of her birth control so this is concerning to her. She has had severe period cramping. She has had this period for 2 weeks now. She has actually gotten all 3 vaccines from Pfizer. Her second vaccine it happened, but she was due for her period at that time. She was on a different birth control then, and still had periods.    No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Immunisation, Rash pruritic
Clinical narrative: she has an itchy rash; BOOSTER; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program.  A 75-year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU VACCINE) (Batch/Lot number: unknown). Relevant medical history included: "Rheumatoid arthritis" (ongoing); "Psoriasis" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTUERER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTUERER UNKNOWN), for COVID-19 immunisation. The following information was reported: RASH PRURITIC (non-serious) with onset 2021, outcome "unknown", described as "she has an itchy rash"; IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "BOOSTER". The action taken for influenza vaccine was unknown.  Additional information: The patient stated that she had an itchy rash that she received after her flu shot and her covid vaccine booster. Action taken with Enbrel with Reusable Autoinjector was reported as unknown for the event rash pruritic. The causal relationship between the event rash pruritic and Enbrel, Reusable Autoinjector was not provided by the consumer. The reporter declined consent to contact.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Immunisation
Clinical narrative: Booster shot; her blood sugar level were high; my blood sugar was up like I never seen it like 240; it stayed up there and then today, two hours after eating was at 150; that's not normal for me; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (002191). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 21Dec2021 (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) with onset 21Dec2021, outcome "unknown", described as "Booster shot"; BLOOD GLUCOSE INCREASED (non-serious) with onset 21Dec2021, outcome "unknown", described as "her blood sugar level were high; my blood sugar was up like I never seen it like 240; it stayed up there and then today, two hours after eating was at 150; that's not normal for me". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient received her booster shot yesterday it's that her blood sugar level was high. She wanted to know if this is a common side effect and inquired that is this something you will be able to help with. Consumer stated that got the shot yesterday and then sometime yesterday her blood sugar was up like she never seen it like 240 (further not clarified), that's got to be wrong but it stayed up there and then today, two hours after eating was at 150 which she guess is not enough to kill her but that's not normal for me.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Immunisation, Swelling
Clinical narrative: where they cut me open also swelled up really bad; confusion; booster; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 22Dec2021 (Lot number: FE8839) at the age of 61 years as dose 3 (booster), single for COVID-19 immunization. Relevant medical history included: "Stroke" (unspecified if ongoing); "brain bleed" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "severe ruined disc" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Known allergies: remeron, reaction: "known allergies: Remeron"; Known allergies: clonidine, reaction: "Known allergies: clonidine"; Known allergies: doxycycline, reaction: "known allergies: doxycycline". Vaccination history included: Bnt162b2 (Dose Number: 2, lot number: El00187, vaccine location: Right arm), administration date: 10Jun2021, when the patient was 60 years old, for covid 19 immunization; Bnt162b2 (Dose Number: 1, lot number: El00177,  vaccine location: Left arm), administration date: 12May2021, when the patient was 60 years old, for covid 19 immunization, reactions: "swelling", "gum swelling", "teeth were pulled". The following information was reported: IMMUNISATION (hospitalization) with onset 22Dec2021, outcome "unknown", described as "booster"; SWELLING (hospitalization), outcome "not recovered", described as "where they cut me open also swelled up really bad"; CONFUSIONAL STATE (hospitalization), outcome "not recovered", described as "confusion". The events "where they cut me open also swelled up really bad" and "confusion" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of swelling, confusional state which included pain medicine. Clinical course: My reaction was that I had swelled up everywhere that I had any injury. My teeth have been pulled and my gums all swelled up, I had arthritis all through my bones and I swelled up all through that. I had recently been in the hospital and I have a brain bleed and where they cut me open also swelled up really bad and yes that was after I was already healed. I don't know what was in it that made me swell but I sure did swell. I am still not for sure what all my confusion is caused from whether it is all the swelling the brain bleed or what.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Drug ineffective, Exposure to SARS-CoV-2, Headache, Pain
Clinical narrative: how do you know this is the vaccine and not I didn't catch the virus; how do you know this is the vaccine and not I didn't catch the virus; husband exposed to her; Fever; Aching; Chills; Headache; Lung pain; 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 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (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), SUSPECTED COVID-19 (medically significant) all with onset 21Dec2021, outcome unknown; EXPOSURE TO SARS-COV-2 (non-serious) with onset 21Dec2021, outcome unknown; PYREXIA (non-serious) with onset 21Dec2021, outcome unknown; PAIN (non-serious) with onset 21Dec2021, outcome unknown; CHILLS (non-serious) with onset 21Dec2021, outcome unknown; HEADACHE (non-serious) with onset 21Dec2021, outcome unknown; PULMONARY PAIN (non-serious) with onset 21Dec2021, outcome unknown.  The patient reported I have all this side effect I took the vaccine. Yesterday I have fever, aching, chills, headache, lung pain, all that ho do you know this is the vaccine and not I didn't catch the virus? My husband is work he expose to me, he expose to his coworkers, they working at home how can we assume all this symptoms are from the vaccine.   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pulmonary pain, Pyrexia, Suspected COVID-19
Clinical narrative: how do you know this is the vaccine and not I didn't catch the virus; how do you know this is the vaccine and not I didn't catch the virus; husband exposed to her; Fever; Aching; Chills; Headache; Lung pain; 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 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (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), SUSPECTED COVID-19 (medically significant) all with onset 21Dec2021, outcome unknown; EXPOSURE TO SARS-COV-2 (non-serious) with onset 21Dec2021, outcome unknown; PYREXIA (non-serious) with onset 21Dec2021, outcome unknown; PAIN (non-serious) with onset 21Dec2021, outcome unknown; CHILLS (non-serious) with onset 21Dec2021, outcome unknown; HEADACHE (non-serious) with onset 21Dec2021, outcome unknown; PULMONARY PAIN (non-serious) with onset 21Dec2021, outcome unknown.  The patient reported I have all this side effect I took the vaccine. Yesterday I have fever, aching, chills, headache, lung pain, all that ho do you know this is the vaccine and not I didn't catch the virus? My husband is work he expose to me, he expose to his coworkers, they working at home how can we assume all this symptoms are from the vaccine.   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Neuralgia
Clinical narrative: booster in Jun; I'm still dealing with mass nerve pain in my shoulder all around where I received my shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Jun2021 (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, I got my covid shot and booster in Jun.), administration date: Jun2021, for COVID-19 Immunization, reaction(s): "I'm still dealing with mass nerve pain in my shoulder all around where I received my shots."; Bnt162b2 (Dose 2, Single, I got my covid shot and booster in Jun.), administration date: Jun2021, for COVID-19 Immunization, reaction(s): "I'm still dealing with mass nerve pain in my shoulder all around where I received my shots.".  The following information was reported: IMMUNISATION (non-serious) with onset Jun2021, outcome "unknown", described as "booster in Jun"; NEURALGIA (non-serious) with onset 2021, outcome "not recovered", described as "I'm still dealing with mass nerve pain in my shoulder all around where I received my shots".  Additional information: The pharmacist told to exercise shoulder.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: thinks he may have covid; thinks he may have covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2), 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 DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Dec2021, outcome unknown. Reporter believed had at least started vaccination course as of Dec2020 but not sure of the current vaccination course status.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Immunisation, Influenza like illness, Pain, Pyrexia
Clinical narrative: Flu like symptoms; aches; Drowsiness; fever; dose received: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 20Dec2021 11:45 (Lot number: FH8027) at the age of 27 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, brand=Pfizer), administration date: 16Feb2021, when the patient was 26 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, brand=Pfizer), administration date: 26Jan2021, when the patient was 26 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 20Dec2021 11:45, outcome "unknown", described as "dose received: 3"; INFLUENZA LIKE ILLNESS (non-serious) with onset 20Dec2021 22:00, outcome "recovering", described as "Flu like symptoms"; PAIN (non-serious) with onset 20Dec2021 22:00, outcome "recovering", described as "aches"; SOMNOLENCE (non-serious) with onset 20Dec2021 22:00, outcome "recovering", described as "Drowsiness"; PYREXIA (non-serious) with onset 20Dec2021 22:00, outcome "recovering", described as "fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of influenza like illness, pain, somnolence, pyrexia.  Additional information: The patient had no known allergies.The patient did not receive any other vaccine in four weeks.The patient did not receive any other medications in two weeks.The patient was not diagnosed with COVID-19 prior and post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Flu like symptoms; aches; Drowsiness; fever; dose received: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 20Dec2021 11:45 (Lot number: FH8027) at the age of 27 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, brand=Pfizer), administration date: 16Feb2021, when the patient was 26 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, brand=Pfizer), administration date: 26Jan2021, when the patient was 26 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 20Dec2021 11:45, outcome "unknown", described as "dose received: 3"; INFLUENZA LIKE ILLNESS (non-serious) with onset 20Dec2021 22:00, outcome "recovering", described as "Flu like symptoms"; PAIN (non-serious) with onset 20Dec2021 22:00, outcome "recovering", described as "aches"; SOMNOLENCE (non-serious) with onset 20Dec2021 22:00, outcome "recovering", described as "Drowsiness"; PYREXIA (non-serious) with onset 20Dec2021 22:00, outcome "recovering", described as "fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of influenza like illness, pain, somnolence, pyrexia.  Additional information: The patient had no known allergies.The patient did not receive any other vaccine in four weeks.The patient did not receive any other medications in two weeks.The patient was not diagnosed with COVID-19 prior and post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Hyperhidrosis, Immunisation
Clinical narrative: High fever; chills; shaking; headache; muscle aches; sweating; dose received: 3; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Dec2021 (Lot number: FE3594) at the age of 38 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: 1, Batch/Lot No: EL3247, brand=Pfizer), administration date: 09Mar2021, when the patient was 38 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, brand=Pfizer), administration date: 30Mar2021, when the patient was 38 years old, for Covid-19 immunization. The following information was reported IMMUNISATION (non-serious) with onset 20Dec2021, outcome unknown, described as dose received 3; PYREXIA (non-serious) with onset 21Dec2021, outcome recovered (2021); CHILLS (non-serious) with onset 21Dec2021, outcome recovered (2021); TREMOR (non-serious) with onset 21Dec2021, outcome recovered (2021); HEADACHE (non-serious) with onset 21Dec2021, outcome recovered (2021); MYALGIA (non-serious) with onset 21Dec2021, outcome recovered (2021); HYPERHIDROSIS (non-serious) with onset 21Dec2021, outcome recovered (2021). Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, tremor, headache, myalgia, and hyperhidrosis.  The patient did not receive any other vaccines in four weeks. Covid prior vaccination and covid tested post vaccination was reported as no.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Tremor
Clinical narrative: High fever; chills; shaking; headache; muscle aches; sweating; dose received: 3; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Dec2021 (Lot number: FE3594) at the age of 38 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: 1, Batch/Lot No: EL3247, brand=Pfizer), administration date: 09Mar2021, when the patient was 38 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, brand=Pfizer), administration date: 30Mar2021, when the patient was 38 years old, for Covid-19 immunization. The following information was reported IMMUNISATION (non-serious) with onset 20Dec2021, outcome unknown, described as dose received 3; PYREXIA (non-serious) with onset 21Dec2021, outcome recovered (2021); CHILLS (non-serious) with onset 21Dec2021, outcome recovered (2021); TREMOR (non-serious) with onset 21Dec2021, outcome recovered (2021); HEADACHE (non-serious) with onset 21Dec2021, outcome recovered (2021); MYALGIA (non-serious) with onset 21Dec2021, outcome recovered (2021); HYPERHIDROSIS (non-serious) with onset 21Dec2021, outcome recovered (2021). Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, tremor, headache, myalgia, and hyperhidrosis.  The patient did not receive any other vaccines in four weeks. Covid prior vaccination and covid tested post vaccination was reported as no.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Mass, Pain
Clinical narrative: Lumps in her body caused by the calcifilaxis became inflamed and very painful.; Lumps in her body caused by the calcifilaxis became inflamed and very painful.; Lumps in her body caused by the calcifilaxis became inflamed and very painful.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a program (005570).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included calcifilaxis (unspecified if ongoing); calcium restricted (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included Bnt162b2 (First Dose), for COVID-19 Immunization. The following information was reported PAIN (non-serious), INFLAMMATION (non-serious), MASS (non-serious), outcome unknown. Therapeutic measures were taken as a result of pain, inflammation, mass.  My sister has calcifilaxis and is calcium restricted. She said that after her second shot, the lumps in her body caused by the calcifilaxis became inflamed and very painful. So much so, that she had to have surgery to remove some of them.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Headache, Immunisation, Nausea
Clinical narrative: booster; Dizziness; Headache; fever; nausea; restless legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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 (unknown manufacturer), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; DIZZINESS (non-serious), outcome "unknown", described as "Dizziness"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; PYREXIA (non-serious), outcome "unknown", described as "fever"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; RESTLESS LEGS SYNDROME (non-serious), outcome "unknown", described as "restless legs". Relevant laboratory tests and procedures are available in the appropriate section.  Additional info: It was reported that, Symptoms occurred within 12 hours of the vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Restless legs syndrome
Clinical narrative: booster; Dizziness; Headache; fever; nausea; restless legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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 (unknown manufacturer), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; DIZZINESS (non-serious), outcome "unknown", described as "Dizziness"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; PYREXIA (non-serious), outcome "unknown", described as "fever"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; RESTLESS LEGS SYNDROME (non-serious), outcome "unknown", described as "restless legs". Relevant laboratory tests and procedures are available in the appropriate section.  Additional info: It was reported that, Symptoms occurred within 12 hours of the vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Diabetes mellitus, Dysgeusia, Glycosylated haemoglobin, Headache
Clinical narrative: Headache; metallic taste when drinking; diabetic/blood glucose at 875 and A1C greater than 15; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2, administered in arm left, administration date 08Apr2021 14:30 (Lot number: EN6955) at the age of 58 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "R/Arthritis" (unspecified if ongoing); "Ankyloding spondylitis" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Nitro, reaction(s): "allergies". Vaccination history included: Bnt162b2 (Dose Number: 1, Lot No: EN6240; Arm Left; 02:45 PM), administration date: 08Mar2021, when the patient was 58 years old, for Covid-19 immunization. The following information was reported: HEADACHE (prolonged hospitalization, life threatening) with onset 16Apr2021 12:15, outcome "not recovered", described as "Headache"; DYSGEUSIA (prolonged hospitalization, life threatening) with onset 16Apr2021 12:15, outcome "not recovered", described as "metallic taste when drinking"; DIABETES MELLITUS (prolonged hospitalization, life threatening) with onset 16Apr2021 12:15, outcome "not recovered", described as "diabetic/blood glucose at 875 and A1C greater than 15". The events "headache", "metallic taste when drinking" and "diabetic/blood glucose at 875 and a1c greater than 15" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood glucose: (16Apr2021) 875; glycosylated haemoglobin: (16Apr2021) greater than 15. Therapeutic measures were taken as a result of diabetes mellitus. Clinical course: Headache, metallic taste when drinking with led to him in the ER with blood glucose at 875 and A1C greater than 15. He was not a diabetic before this and now he is. Now he has to take insulin. Vaccine received during existing hospitalization.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Immunisation, Suspected COVID-19
Clinical narrative: she has covid is 70years old good health both covid shots and booster.; she has covid is 70years old good health both covid shots and booster.; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a program (005570).  A 70-year-old female patient 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; IMMUNISATION (medically significant), outcome unknown, described as booster. The patient was informed she has covid, she was 70years old good health both covid shots and booster, with cold like symptoms and would to know if any treatment available to help recover and availability at this time.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Herpes zoster, Immunisation, Lymphadenopathy
Clinical narrative: booster; Chills; fever; aches; sore arm; dizzy; nausea; the very swollen arm pit; developed a single shingle on the back of my leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (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 (First Dose), for Covid-19 Immunization, reaction(s): "I had the first shot with mild symptoms"; Bnt162b2 (Second Dose), for Covid-19 Immunization, reaction(s): "The second shot was fairly bad". The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "booster"; CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Chills"; PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "fever"; PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "aches"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "sore arm"; DIZZINESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "dizzy"; NAUSEA (non-serious) with onset 2021, outcome "recovered" (2021), described as "nausea"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "recovered" (2021), described as "the very swollen arm pit"; HERPES ZOSTER (non-serious) with onset 2021, outcome "unknown", described as "developed a single shingle on the back of my leg".  Additional information: A few days later patient was fine however approximately 10 days later she developed a single shingle on the back of her leg.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: booster; Chills; fever; aches; sore arm; dizzy; nausea; the very swollen arm pit; developed a single shingle on the back of my leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (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 (First Dose), for Covid-19 Immunization, reaction(s): "I had the first shot with mild symptoms"; Bnt162b2 (Second Dose), for Covid-19 Immunization, reaction(s): "The second shot was fairly bad". The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "booster"; CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Chills"; PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "fever"; PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "aches"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "sore arm"; DIZZINESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "dizzy"; NAUSEA (non-serious) with onset 2021, outcome "recovered" (2021), described as "nausea"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "recovered" (2021), described as "the very swollen arm pit"; HERPES ZOSTER (non-serious) with onset 2021, outcome "unknown", described as "developed a single shingle on the back of my leg".  Additional information: A few days later patient was fine however approximately 10 days later she developed a single shingle on the back of her leg.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19;  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a program, other case identifier(s) 21K-163-4204896-00.  A 38 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Apr2021 (Batch/Lot number: unknown) at the age of 38 years as dose 2, single, and intramuscular, administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; HUMIRA, subcutaneous (Batch/Lot number: unknown) for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported DRUG INEFFECTIVE (medically significant) with onset 13Nov2021, outcome unknown, COVID-19 (medically significant) with onset 13Nov2021, outcome recovered (2021). The patient underwent the following laboratory tests and procedures sars-cov-2 test (13Nov2021) positive. The action taken for HUMIRA was unknown.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of COVID-19 virus test positive after vaccination with HUMIRA 40MG/0.4ML was no reasonable possibility. The reporter's causality for the event(s) of COVID-19 virus test positive after vaccination with PFIZER BIONTECH COVID-19 VACCINE was possible.  The lot number for bnt162b2 was not provided and will be requested during follow up. Based on the information in the case report, a possible causal relationship between the events Drug ineffective, Covid-19, and suspect drug BNT162B2 cannot be excluded.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Chills, Fatigue, Headache, Immunisation
Clinical narrative: Fever; Chills; I lost consciousness; Arrhythmia; Booster; Tiredness; Arm was sore; Little bit of headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non healthcare professional). The reporter is the patient.  A 35 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 21Dec2021 (Lot number: FE3594) at the age of 35 years as DOSE NUMBER UNKNOWN (BOOSTER), SINGLE for covid-19 immunization. The patient had no relevant medical history. The patient had no any other vaccinations within 4 weeks. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 21Dec2021, outcome "unknown", described as "Booster"; LOSS OF CONSCIOUSNESS (medically significant) with onset 22Dec2021, outcome "unknown", described as "I lost consciousness"; ARRHYTHMIA (medically significant) with onset 22Dec2021, outcome "unknown", described as "Arrhythmia"; FATIGUE (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "Tiredness"; PYREXIA (non-serious) with onset 22Dec2021, outcome "unknown", described as "Fever"; CHILLS (non-serious) with onset 22Dec2021, outcome "unknown", described as "Chills"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Arm was sore"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Little bit of headache". Therapeutic measure ibuprofen was taken as a result of pyrexia, pain in extremity, headache.  No follow-up attempts are possible. No further information is expected.