chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash all over body; cold hands and feet; numb toes for 8 hours; violent shivering; headache; all body heat went to head and chest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Oct2021 16:45 (Batch/Lot number: unknown) at the age of 22 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "bee stings" (unspecified if ongoing), notes: bee sting; "pineapple" (unspecified if ongoing), notes: pineapple. There were no concomitant medications. Past drug history included: Tramadol, reaction(s): "known allergies: tramadol"; Sassafras, reaction(s): "known allergies: sassafras", notes: sassafras. 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: 05:00 PM), administration date: 28Sep2021, when the patient was 22 years old, for COVID-19 Immunization. The following information was reported: RASH (non-serious) with onset 19Oct2021 20:45, outcome "not recovered", described as "Rash all over body"; PERIPHERAL COLDNESS (non-serious) with onset 19Oct2021 20:45, outcome "not recovered", described as "cold hands and feet"; HYPOAESTHESIA (non-serious) with onset 19Oct2021 20:45, outcome "recovered" (20Oct2021), described as "numb toes for 8 hours"; CHILLS (non-serious) with onset 19Oct2021 20:45, outcome "not recovered", described as "violent shivering"; HEADACHE (non-serious) with onset 19Oct2021 20:45, outcome "not recovered", described as "headache"; FEELING HOT (non-serious) with onset 19Oct2021 20:45, outcome "not recovered", described as "all body heat went to head and chest". Therapeutic measures were not taken as a result of rash, peripheral coldness, hypoaesthesia, chills, headache, feeling hot.  Reported Event: Rash all over body (had it since 4 hours after vaccination), cold hands and feet, numb toes for 8 hours, violent shivering, headache, all body heat went to head and chest. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Device Date: 24Oct2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Malaise, Nausea
Clinical narrative: Nausea; diarrhea; headache; tiredness; not feeling well; Minor pain at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Oct2021 10:30 (Lot number: FE3590) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Chronic pain" (unspecified if ongoing); "high BP" (unspecified if ongoing); "Mitral valve repair" (unspecified if ongoing); "Afib" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "cervical Dustin's" (unspecified if ongoing); "high BMI" (unspecified if ongoing); "high blood fats" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Tegretol, reaction(s): "Allergies"; Flagyl, reaction(s): "Allergies". Vaccination history included: Bnt162b2 (Dose: 2, Batch/Lot No: EW0170, Location of injection: Arm Left, Vaccine Administration Time: 02:15 PM), administration date: 19Apr2021, when the patient was 62 years old, for COVID-19 Immunization; Bnt162b2 (Dose: 1, Batch/Lot No: ER8732, Location of injection: Arm Left, Vaccine Administration Time: 12:30 PM), administration date: 25Mar2021, when the patient was 62 years old, for COVID-19 Immunization. The following information was reported: NAUSEA (non-serious) with onset 20Oct2021 06:00, outcome "recovering", described as "Nausea"; DIARRHOEA (non-serious) with onset 20Oct2021 06:00, outcome "recovering", described as "diarrhea"; HEADACHE (non-serious) with onset 20Oct2021 06:00, outcome "recovering", described as "headache"; FATIGUE (non-serious) with onset 20Oct2021 06:00, outcome "recovering", described as "tiredness"; MALAISE (non-serious) with onset 20Oct2021 06:00, outcome "recovering", described as "not feeling well"; VACCINATION SITE PAIN (non-serious) with onset 20Oct2021 06:00, outcome "recovering", described as "Minor pain at injection site". Therapeutic measures were not taken as a result of nausea, diarrhoea, headache, fatigue, malaise, vaccination site pain.  Additional information: No other vaccine in four weeks. Other medications in two weeks included Lots prescribed, vitamins. No COVID prior vaccination. No COVID tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Nausea; diarrhea; headache; tiredness; not feeling well; Minor pain at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Oct2021 10:30 (Lot number: FE3590) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Chronic pain" (unspecified if ongoing); "high BP" (unspecified if ongoing); "Mitral valve repair" (unspecified if ongoing); "Afib" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "cervical Dustin's" (unspecified if ongoing); "high BMI" (unspecified if ongoing); "high blood fats" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Tegretol, reaction(s): "Allergies"; Flagyl, reaction(s): "Allergies". Vaccination history included: Bnt162b2 (Dose: 2, Batch/Lot No: EW0170, Location of injection: Arm Left, Vaccine Administration Time: 02:15 PM), administration date: 19Apr2021, when the patient was 62 years old, for COVID-19 Immunization; Bnt162b2 (Dose: 1, Batch/Lot No: ER8732, Location of injection: Arm Left, Vaccine Administration Time: 12:30 PM), administration date: 25Mar2021, when the patient was 62 years old, for COVID-19 Immunization. The following information was reported: NAUSEA (non-serious) with onset 20Oct2021 06:00, outcome "recovering", described as "Nausea"; DIARRHOEA (non-serious) with onset 20Oct2021 06:00, outcome "recovering", described as "diarrhea"; HEADACHE (non-serious) with onset 20Oct2021 06:00, outcome "recovering", described as "headache"; FATIGUE (non-serious) with onset 20Oct2021 06:00, outcome "recovering", described as "tiredness"; MALAISE (non-serious) with onset 20Oct2021 06:00, outcome "recovering", described as "not feeling well"; VACCINATION SITE PAIN (non-serious) with onset 20Oct2021 06:00, outcome "recovering", described as "Minor pain at injection site". Therapeutic measures were not taken as a result of nausea, diarrhoea, headache, fatigue, malaise, vaccination site pain.  Additional information: No other vaccine in four weeks. Other medications in two weeks included Lots prescribed, vitamins. No COVID prior vaccination. No COVID tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Triggered photo sensitive migraine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 28 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "History of migraine" (unspecified if ongoing), notes: History of migraine; "unknown gastrointestinal illness" (unspecified if ongoing), notes: unknown gastrointestinal illness. The patient's concomitant medications were not reported. Past drug history included: Topomax, reaction(s): "Allergies: Topomax", notes: Topomax. The following information was reported: MIGRAINE (non-serious) with onset 20Oct2021 08:00, outcome "recovered" (2021), described as "Triggered photo sensitive migraine". Therapeutic measures were taken as a result of migraine.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and taken over the counter Ibuprofen as treatment medication. The prior to vaccination and since the vaccination she did not diagnosed with COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Ear pain
Clinical narrative: tightness in my chest; coughing; ear ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Oct2021 03:00 (Batch/Lot number: unknown) at the age of 38 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "allergies: sulfa" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 03:30 AM), administration date: 27Sep2021, when the patient was 38 years old, for Covid-19 Immunization. The following information was reported: CHEST DISCOMFORT (non-serious) with onset 19Oct2021 18:00, outcome "recovering", described as "tightness in my chest"; COUGH (non-serious) with onset 19Oct2021 18:00, outcome "recovering", described as "coughing"; EAR PAIN (non-serious) with onset 19Oct2021 18:00, outcome "recovered"(2021), described as "ear ache". Therapeutic measures were not taken as a result of chest discomfort, cough, ear pain.  The Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced tightness in my chest and if breathing quickly would cause coughing.  Experienced this for about 12 hours during the following day. Also had an earache that started up within 6 hours of getting the vaccine and went away approximately 24 hours after shot. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (25Nov2021): 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: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Insomnia
Clinical narrative: couldn''t sleep for months; had problems with his heart; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INSOMNIA (non-serious), outcome "unknown", described as "couldn''t sleep for months"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "had problems with his heart".  Additional information: Is report related to a study or programme? No. Is the patient also the reporter? Yes. Is Pfizer Covid 19 Vaccine a Pfizer product? Yes. Caller reporting adverse event for family member and states he took it too, he has problems, he is getting better slowly, there is no way that this vaccine isn't terrible, he has problems too, he couldn't sleep for months, he had a problem with his heart, he went to a cardiologist, there is no way that he can get away with these issues with this vaccine, they are foreign bodies, its expected but its very severe reactions. Caller confirms the product he received is the Pfizer Covid 19 Vaccine. Caller declines to complete safety report, stating he doesn't care, he knew there has to be some side effects, its impossible to give him something like that and be okay, it has to do something, everybody he knows has affected them somehow. Everyone they have talked to has had problems, it's expected. His whole family, they all received the Pfizer and all had problems, had issues.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Menstruation delayed, Menstruation irregular, Pregnancy test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Apr2021 12:00 (Lot number: ER8729) at the age of 26 years as dose 2, single for Covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8732, Location of injection: Arm Right, Vaccine Administration Time: 01:15 PM), administration date: 27Mar2021, when the patient was 26 years old, for COVID-19 immunization. The following information was reported: AMNESIA (non-serious) with onset 17Aug2021 12:00, outcome "unknown", described as "memory loss"; MENSTRUATION DELAYED (non-serious) with onset 17Aug2021 12:00, outcome "unknown", described as "Delayed period"; MENSTRUATION IRREGULAR (non-serious) with onset Oct2021, outcome "unknown", described as "Missed my period". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of amnesia, menstruation delayed, menstruation irregular. Additional Information: The patient did not have other medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. I have been experiencing memory loss at times where I forget what I was talking about and what I needed to go get. One big thing that I noticed is that I have had a very delayed period and a few months ago and this month in October I missed my period as well and negative pregnancy test. No treatment received for the event. 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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Insomnia, Limb discomfort, Lymphadenopathy
Clinical narrative: Chills; restless leg the night of the vaccine administration; insomnia; swollen lymph nodes on the side of the injection; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Oct2021 10:15 (Batch/Lot number: unknown) 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: Unknown.), for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown.), for COVID-19 immunization.  The following information was reported: CHILLS (non-serious) with onset 21Oct2021, outcome "recovering", described as "Chills"; LIMB DISCOMFORT (non-serious) with onset 21Oct2021, outcome "recovering", described as "restless leg the night of the vaccine administration"; INSOMNIA (non-serious) with onset 21Oct2021, outcome "recovering", described as "insomnia"; LYMPHADENOPATHY (non-serious) with onset 21Oct2021, outcome "recovering", described as "swollen lymph nodes on the side of the injection". Therapeutic measures were not taken as a result of chills, limb discomfort, insomnia, lymphadenopathy.  Additional Information: Facility type: vaccine Public Health Clinic/Administration facility. No other vaccine in four weeks. No COVID prior to the vaccination. No COVID tested post vaccination. No known allergies. Adverse event: Chills, restless leg the night of the vaccine administration, insomnia, swollen lymph nodes on the side of the injection  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling of body temperature change, Headache, Pain
Clinical narrative: Mild headaches; chills; Fatigue; Body aches; fever; running between hot and cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the parent.  A 37 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose), for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset Aug2021, outcome "recovered" (2021), described as "chills"; FATIGUE (non-serious) with onset Aug2021, outcome "recovered" (2021), described as "Fatigue"; PAIN (non-serious) with onset Aug2021, outcome "recovered" (2021), described as "Body aches"; PYREXIA (non-serious) with onset Aug2021, outcome "recovered" (2021), described as "fever"; FEELING OF BODY TEMPERATURE CHANGE (non-serious) with onset Aug2021, outcome "recovered" (2021), described as "running between hot and cold"; HEADACHE (non-serious), outcome "unknown", described as "Mild headaches".  Additional information: Reporter clarified that her second son, who is 37 years old, after his second dose of Pfizer Covid-19 Vaccine he thought he was running a fever but he did not check his temperature; but was running between hot and cold and having the chills and also experienced fatigue. She also reported that he also had body aches. These events lasted at least 12 hours, the same day, and then the next day he was ok. She thinks that was back in Aug2021 that he had the second dose of Pfizer Covid-19 Vaccine and these events. She only knows that his Pfizer Covid-19 Vaccines were administered at a withheld where he lives in unknown sub-town of withheld, withheld, like withheld or something like that. She wouldn't know any further information to provide for this son, and declined to provide any further information because he is a grown man and she does not know that he would want her to provide that. Caller mentioned her 37 year old son experienced fatigue, mild headaches, chills.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Mild headaches; chills; Fatigue; Body aches; fever; running between hot and cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the parent.  A 37 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose), for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset Aug2021, outcome "recovered" (2021), described as "chills"; FATIGUE (non-serious) with onset Aug2021, outcome "recovered" (2021), described as "Fatigue"; PAIN (non-serious) with onset Aug2021, outcome "recovered" (2021), described as "Body aches"; PYREXIA (non-serious) with onset Aug2021, outcome "recovered" (2021), described as "fever"; FEELING OF BODY TEMPERATURE CHANGE (non-serious) with onset Aug2021, outcome "recovered" (2021), described as "running between hot and cold"; HEADACHE (non-serious), outcome "unknown", described as "Mild headaches".  Additional information: Reporter clarified that her second son, who is 37 years old, after his second dose of Pfizer Covid-19 Vaccine he thought he was running a fever but he did not check his temperature; but was running between hot and cold and having the chills and also experienced fatigue. She also reported that he also had body aches. These events lasted at least 12 hours, the same day, and then the next day he was ok. She thinks that was back in Aug2021 that he had the second dose of Pfizer Covid-19 Vaccine and these events. She only knows that his Pfizer Covid-19 Vaccines were administered at a withheld where he lives in unknown sub-town of withheld, withheld, like withheld or something like that. She wouldn't know any further information to provide for this son, and declined to provide any further information because he is a grown man and she does not know that he would want her to provide that. Caller mentioned her 37 year old son experienced fatigue, mild headaches, chills.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: another tender red mark, similar to injection site, popped up on the opposite arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Oct2021 09:30 (Batch/Lot number: unknown) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), administered in arm right, administration date 18Oct2021 (Batch/Lot number: unknown). Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; MONTELUCAST; BENADRYL; TYLENOL ARTHRITIS. Vaccination history included: Bnt162b2 (Dose Number: 2, Location of injection: Arm Left, Vaccine Administration Time: 09:30 AM), administration date: 12Apr2021, when the patient was 59 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Location of injection: Arm Left, Vaccine Administration Time: 09:30 AM), administration date: 15Mar2021, when the patient was 59 years old, for COVID-19 Immunization. The following information was reported: ERYTHEMA (non-serious) with onset 20Oct2021 18:00, outcome "recovering", described as "another tender red mark, similar to injection site, popped up on the opposite arm". Therapeutic measures were not taken as a result of erythema.  Additional Information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. About 2 days after the vaccine, there was another tender red mark, similar to injection site, popped up on the opposite arm. No covid prior vaccination. Covid was not tested post vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 1.83
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk, Rash
Clinical narrative: developed a severe rash diagnosed as serum sickness 10 days after my 2nd vaccine dose; My 22 month old daughter, whom I am breastfeeding; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the parent.  A 22 month-old female patient was exposed to bnt162b2 (BNT162B2), transmammary administered in arm left, administration date 10Sep2021 11:00 (Lot number: EW0186) as dose 1, single for covid-19 immunisation. The mother of the patient was 32 years old at the time of vaccination. The patient had no relevant medical history. Date of last menstrual period of the mother: 29Mar2021. The mother was 23 weeks pregnant at the time of exposure to bnt162b2. The mother was 23 weeks pregnant at the event onset. The mother is expected to deliver a baby(s) on 27Jan2022. The patient's concomitant medications were not reported. The following information was reported: EXPOSURE VIA BREAST MILK (non-serious) with onset 10Sep2021, outcome "unknown", described as "My 22 month old daughter, whom I am breastfeeding"; RASH (non-serious) with onset 20Sep2021, outcome "unknown", described as "developed a severe rash diagnosed as serum sickness 10 days after my 2nd vaccine dose".  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in extremity
Clinical narrative: sore throat 3 days, 24 hours a day and it is still as last time; my calves are in pain 24 hours a day and they have not changed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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 Number:01), for Covid-19 Immunization; Bnt162b2 (Dose Number:02), for Covid-19 Immunization. The following information was reported: OROPHARYNGEAL PAIN (non-serious), outcome "not recovered", described as "sore throat 3 days, 24 hours a day and it is still as last time"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "my calves are in pain 24 hours a day and they have not changed".  Additional information: The booster it caused me to have a sore throat 3 days, 24 hours a day and it is still as last time. Also the, gives me, my calves are in pain 24 hours a day and they have not changed. I am not a history of Charley horses, I am not a history of sore throats but this is since the time I took your shot and it doesn't get any better.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood pressure measurement, Body temperature, Heart rate, Hyperhidrosis
Clinical narrative: sweat profusely from his head, chest and arms; Started feeling of nausea; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 22 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Oct2021 (Lot number: FF2589, Expiration Date: Dec2021) at the age of 22 years as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HYPERHIDROSIS (non-serious) with onset 21Oct2021, outcome "unknown", described as "sweat profusely from his head, chest and arms"; NAUSEA (non-serious) with onset 21Oct2021, outcome "unknown", described as "Started feeling of nausea". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hyperhidrosis, nausea.  Additional information: While confirming the date of adverse event, Pharmacist added, Immediately, it was immediately right after. The man started to sweat profusely from his head, chest, and arms. We gave the patient orange juice and he started to feel better, orange juice, no medication. Pharmacist also stated, yes, the patient immediately started feeling of nausea and then the sweating it happen like right after he got the shot. He don't know, we asked him if he has suffered from anxiety with vaccine or getting shot, he said no. His heartbeat did not increase so was not a panic attack. When the paramedics came out, they checked his temperature, which was normal, his blood sugar was normal, his heart rate was normal, and his blood pressure was also normal. He has no known drug allergies. He has never had an adverse reaction to any vaccine. He has no underlying conditions and no medications. No other Products and Investigation assessment was reported.  No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: sweat profusely from his head, chest and arms; Started feeling of nausea; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 22 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Oct2021 (Lot number: FF2589, Expiration Date: Dec2021) at the age of 22 years as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HYPERHIDROSIS (non-serious) with onset 21Oct2021, outcome "unknown", described as "sweat profusely from his head, chest and arms"; NAUSEA (non-serious) with onset 21Oct2021, outcome "unknown", described as "Started feeling of nausea". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hyperhidrosis, nausea.  Additional information: While confirming the date of adverse event, Pharmacist added, Immediately, it was immediately right after. The man started to sweat profusely from his head, chest, and arms. We gave the patient orange juice and he started to feel better, orange juice, no medication. Pharmacist also stated, yes, the patient immediately started feeling of nausea and then the sweating it happen like right after he got the shot. He don't know, we asked him if he has suffered from anxiety with vaccine or getting shot, he said no. His heartbeat did not increase so was not a panic attack. When the paramedics came out, they checked his temperature, which was normal, his blood sugar was normal, his heart rate was normal, and his blood pressure was also normal. He has no known drug allergies. He has never had an adverse reaction to any vaccine. He has no underlying conditions and no medications. No other Products and Investigation assessment was reported.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: she developed a fever of 104.8; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st Dose), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset May2021, outcome "unknown", described as "she developed a fever of 104.8". The event "she developed a fever of 104.8" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Attempted transfer from agent (Name withheld) Support (#) has no caller on the line who was calling due to receiving the second dose of Pfizer Covid vaccine back in May and she developed a fever of 104.8. Stated that she went to emergency room and has a bill that the insurance company will not pay. Agent stated that she wanted assistance. Agent provided caller with legal department's fax number. Stated that she did not want the address.  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
Symptoms: Inappropriate schedule of product administration, Psychotic disorder
Clinical narrative: Brief psychotic episode; Patient Drug Start date: 27Aug2021, Dose Number: 1/Dose Number: 2, Date of start of drug: 10Sep2021; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) via regulatory authority (RA). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Sep2021 (Batch/Lot number: unknown) at the age of 34 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Tension headaches" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Overweight" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (dose 1, single, prev dose product= COVID 19, prev dose brand= Pfizer covid 19 vaccine, prev dose vaccine location= Left arm), administration date: 27Aug2021, when the patient was 34 years old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 10Sep2021, outcome "unknown", described as "Patient Drug Start date: 27Aug2021, Dose Number: 1/Dose Number: 2, Date of start of drug: 10Sep2021"; PSYCHOTIC DISORDER (non-serious) with onset 14Sep2021, outcome "recovered" (2021), described as "Brief psychotic episode". The event "brief psychotic episode" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of psychotic disorder.  Additional information: Serious: No. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No. Reason why batch/lot is Unknown: Misplaced/discarded. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: Multivitamin with C and Zinc. Reported Event: Brief psychotic episode - no prior history of psychosis or related mental disorders. Did the adverse event result in any of the following: Doctor or other healthcare professional office/clinic visit. Did the adverse event result in any of the following: Emergency room/department or urgent care. Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: No. Device Date: 23Oct2021. If treatment ae: No. Known allergies: No known allergies. Other medical history: tension headaches, anxiety, high cholesterol, overweight.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fevers and chills for 48 hours; Fevers and chills for 48 hours; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Oct2021 09:00 (Batch/Lot number: unknown) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Bee venom" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Penicillin for Allergies to Penicillin, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details), administration date: 20Oct2021, when the patient was 61 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details), administration date: 2021, when the patient was 61 years old, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious), CHILLS (non-serious) all with onset 20Oct2021, outcome "recovering" and all described as "Fevers and chills for 48 hours". Therapeutic measures were not taken as a result of pyrexia, chills. Additional information: Facility where the most recent COVID-19 vaccine was administered was at Hospital The patient didn't received 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, patient had not been tested for COVID-19.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (26Nov2021): 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.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Vision blurred
Clinical narrative: occasional tingling that started a few days after getting the shot and has progressed to a constant tingling in my pinky, ring, and middle finger on both hands; My non-dominant eye was occasionally blurry and progressed to blurry most of the time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) (patient).  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Apr2021 (Lot number: EW0164) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing); "known allergies: yes" (unspecified if ongoing), notes: known allergies: yes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE= 1, Dose lot number= EW0150, Vaccine location= Left arm), administration date: 02Apr2021, when the patient was 61 years old, for Covid-19 immunization. The following information was reported: PARAESTHESIA (non-serious) with onset May2021, outcome "not recovered", described as "occasional tingling that started a few days after getting the shot and has progressed to a constant tingling in my pinky, ring, and middle finger on both hands"; VISION BLURRED (non-serious) with onset May2021, outcome "not recovered", described as "My non-dominant eye was occasionally blurry and progressed to blurry most of the time". The events "occasional tingling that started a few days after getting the shot and has progressed to a constant tingling in my pinky, ring, and middle finger on both hands" and "my non-dominant eye was occasionally blurry and progressed to blurry most of the time" were evaluated at the physician office visit. Therapeutic measures were taken as a result of vision blurred. AE treatment: eye drops for blurry eye Additional information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. Prior to vaccination, was the patient diagnosed with COVID-19? No. Since the vaccination, has the patient been tested for COVID-19? No  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Hypoaesthesia
Clinical narrative: Sharp pains in her right eye; A numbness in the right side of face; This is a spontaneous report received from a 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 right, administration date 23Oct2021 11:00 (Lot number: FF2593) at the age of 70 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Latex" (unspecified if ongoing). Concomitant medication(s) included: LAMOTRIGINE; BUPROPION. Vaccination history included: Bnt162b2 (Dose 1, Single; Batch/Lot No: EP7534; in Arm Right; at 05:00 PM), administration date: Apr2021, when the patient was 69 years old, for COVID-19 immunization; Bnt162b2 (Dose 2, Single; Batch/Lot No: EW0151 in Arm Right; at 05:00 PM), administration date: Apr2021, when the patient was 69 years old, for COVID-19 immunization. The following information was reported: EYE PAIN (non-serious) with onset Oct2021, outcome "not recovered", described as "Sharp pains in her right eye"; HYPOAESTHESIA (non-serious) with onset Oct2021, outcome "not recovered", described as "A numbness in the right side of face". Therapeutic measures were not taken as a result of eye pain, hypoaesthesia. Additional information: Facility where the most recent COVID-19 vaccine was administered reported as Pharmacy or Drug Store. Prior to the 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 four weeks prior to the vaccination. Patient received other medications within two weeks of vaccination. At 11:15 AM, she was experiencing sharp pains in her right eye and numbness in the right side of face. No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Eating disorder
Clinical narrative: they both experienced a loss of appetite and are still experiencing it a week later; cannot eat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 33 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 15Oct2021 (Lot number: FF8841) at the age of 33 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DECREASED APPETITE (non-serious) with onset 16Oct2021, outcome "not recovered", described as "they both experienced a loss of appetite and are still experiencing it a week later"; EATING DISORDER (non-serious) with onset 16Oct2021, outcome "not recovered", described as "cannot eat".  Additional information: The caller and patient both received their first dose of the Pfizer BioNTech Covid 19 vaccine on Friday. The next day they both experienced a loss of appetite and was still experiencing it a week later. He states sometimes he gets hungry and eats but then throws it up. Caller asked if these are the side effects of vaccine. Report was not related to a study or programme. Caller states he was calling about the Pfizer vaccine and states his son took the vaccine a week ago and is fine and had no adverse events but the caller and his wife also had their vaccine and both have no appetite and cannot eat. Caller asking if this is normal.   Follow-up attempts are completed. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 26 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Oct2021 (Lot number: 30125BA) at the age of 26 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Epileptic seizure" (unspecified if ongoing); "Disabled" (unspecified if ongoing); "Traumatic brain injury" (unspecified if ongoing), notes: Epileptic seizure due to traumatic brain injury. Concomitant medication(s) included: VIMPAT taken for epilepsy. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Batch/lot number: 30125BA, Dosage text: unable to provide, administered to right arm), administration date: 14Sep2021, when the patient was 26 years old, for COVID-19 Immunization, reaction(s): "Erythema", "Hot to touch".  The following information was reported: HEADACHE (non-serious) with onset Oct2021, outcome "recovering", described as "Headache".  Additional information: The patient had no other vaccines the same day and no problem with vaccines in past. The patient had no history of previous immunization with the Pfizer vaccine considered as suspect. The patient had no additional Vaccines Administered on Same Date of the Pfizer Suspect. Went for the second vaccine on 05Oct2021 and had a headache for a couple of days, 2-3 days, and it was better. Caller states she had questioned if it could have been a reaction because of his medication, Vimpact. No further details provided.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Malaise, Polymerase chain reaction
Clinical narrative: I didn't feel well with nonspecific symptoms; Got a very unusual headache; Patient Drug Start date: 26Jan2021, Dose Number: 2/Patient Drug Start date: 08Jan2021, Dose Number: 1; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 26Jan2021 11:00 (Lot number: EL3248) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "asthma" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: FLU, administration date 12Oct2021. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL0140, Location of injection: Arm Right, Vaccine Administration Time: 11:00 AM, Route of Administration: Intramuscular), administration date: 08Jan2021, when the patient was 63 years old, for COVID-19 immunization. The following information was reported: MALAISE (non-serious) with onset Jan2021, outcome "unknown", described as "I didn't feel well with nonspecific symptoms"; HEADACHE (non-serious) with onset Jan2021, outcome "unknown", described as "Got a very unusual headache"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset Jan2021, outcome "unknown", described as "Patient Drug Start date: 26Jan2021, Dose Number: 2/Patient Drug Start date: 08Jan2021, Dose Number: 1". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: On 12Oct2021 patient received other vaccine 4 weeks product was Flu (lot number IDK, vaccine location: Right arm). Facility where the most recent COVID-19 vaccine was administered was pharmacy or Drug Store. Patient subsequently developed a bad sinus infection but had a negative COVID test, nasal pcr. they went away for 4 days to an isolated place so no more testing was done, but there was good chance we both had a mild case of breakthrough COVID. patient didn't feel well with nonspecific symptoms and got a very unusual headache for 2 days. they treated her sinus infection with 2 courses of antibiotics. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient had not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.