chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: 1st shot - high fever, chills, aches lasting 24 hours; 1st shot - high fever, chills, aches lasting 24 hours; 1st shot - high fever, chills, aches lasting 24 hours; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Aug2021 10:00 (Lot number: FC3180) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lyme disease" (unspecified if ongoing); "covid-19" (unspecified if ongoing), notes: prior vaccination. The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), CHILLS (non-serious) all with onset 2021, outcome "recovering" and all described as "1st shot - high fever, chills, aches lasting 24 hours"; PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "1st shot - high fever, chills, aches lasting 24 hours". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, pain.  Additional information: The patient had no known allergies. The patient had COVID prior vaccination and had negative COVID test post vaccination. Facility type vaccine was pharmacy or Drug Store. Patient did not receive other vaccine in four weeks or  other medications in two weeks.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Eating disorder, Exposure via breast milk, Vomiting projectile
Clinical narrative: Received her first dose, she was breastfeeding; had some projectile vomiting; He was vomiting all day; 'he did not take anything all day'; 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 male patient received bnt162b2 (BNT162B2), administration date 30Jul2021 (Lot number: EW0181) 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: EXPOSURE VIA BREAST MILK (non-serious), outcome "unknown", described as "Received her first dose, she was breastfeeding"; VOMITING PROJECTILE (non-serious), outcome "unknown", described as "had some projectile vomiting; He was vomiting all day"; EATING DISORDER (non-serious), outcome "unknown", described as "'he did not take anything all day'". Additional Information: The reporter (mother) received her first dose, she was breastfeeding. and the mother experienced after the first dose some soreness towards her arm and shoulder and she said that her baby also had a reaction from the breastfeeding and had some projectile vomiting." Reporter stated, "So on the first shot that she got, her baby, "he did not take anything all day', he was vomiting all day.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101192775 Mother's case (2 dose)
Age: 50.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Arthropathy, Drug ineffective, Nausea, Pyrexia, SARS-CoV-2 test
Clinical narrative: COVID-19; Small flare on knee; COVID-19; Nausea; Fever; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4098161-00.   A 50 year-old male patient received BNT162B2 (BNT162B2), intramuscular, administration date 31Jul2021 (Batch/Lot number: unknown) at the age of 50 years as dose 1, single and intramuscular, administration date 31Aug2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unknown (cf) for psoriasis. The patient's relevant medical history and concomitant medications were not reported.   The following information was reported: SUSPECTED COVID-19 (medically significant) with onset Nov2021, outcome "recovered" (2021), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19"; ARTHROPATHY (non-serious), outcome "recovering", described as "Small flare on knee"; NAUSEA (non-serious) with onset 2021, outcome "recovering", described as "Nausea"; PYREXIA (non-serious) with onset 2021, outcome "recovered", described as "Fever". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Nov2021) positive. The action taken for adalimumab was unknown.   The reporter considered "small flare on knee", "nausea" and "fever" not related to bnt162b2.   The lot number for bnt162b2 was not provided and will be requested during follow up.   Follow-up (07Dec2021): New information received in a follow-up solicited report based on the information received by Pfizer (Mfr. Control No.: 21K-163-4098161-00). A contactable consumer (patient) reported, which included: Updated information on reporter's Email, onset date, events.; Sender's Comments: Based on the information available in narrative the reported  events of pyrexia and nausea were assessed as related to suspected vaccine BNT162B2, However the event of arthropathy aggravated  was consider not related to suspected vaccine and more likely due to pervious illness.
Age: 50.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Suspected COVID-19
Clinical narrative: COVID-19; Small flare on knee; COVID-19; Nausea; Fever; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4098161-00.   A 50 year-old male patient received BNT162B2 (BNT162B2), intramuscular, administration date 31Jul2021 (Batch/Lot number: unknown) at the age of 50 years as dose 1, single and intramuscular, administration date 31Aug2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unknown (cf) for psoriasis. The patient's relevant medical history and concomitant medications were not reported.   The following information was reported: SUSPECTED COVID-19 (medically significant) with onset Nov2021, outcome "recovered" (2021), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19"; ARTHROPATHY (non-serious), outcome "recovering", described as "Small flare on knee"; NAUSEA (non-serious) with onset 2021, outcome "recovering", described as "Nausea"; PYREXIA (non-serious) with onset 2021, outcome "recovered", described as "Fever". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Nov2021) positive. The action taken for adalimumab was unknown.   The reporter considered "small flare on knee", "nausea" and "fever" not related to bnt162b2.   The lot number for bnt162b2 was not provided and will be requested during follow up.   Follow-up (07Dec2021): New information received in a follow-up solicited report based on the information received by Pfizer (Mfr. Control No.: 21K-163-4098161-00). A contactable consumer (patient) reported, which included: Updated information on reporter's Email, onset date, events.; Sender's Comments: Based on the information available in narrative the reported  events of pyrexia and nausea were assessed as related to suspected vaccine BNT162B2, However the event of arthropathy aggravated  was consider not related to suspected vaccine and more likely due to pervious illness.
Sex: U
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: sleepiness; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A patient (no qualifiers provided) 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: SOMNOLENCE (non-serious), outcome "recovered" (reported as no more than 3 days), described as "sleepiness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101333935 same reporter/drug/AE, different patient; INC-202101333934 same reporter/drug/AE, different patient
Sex: U
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: sleepiness; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A patient (no qualifiers provided) 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: SOMNOLENCE (non-serious), outcome "recovered", described as "sleepiness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101333902 same reporter/drug/AE, different patient;US-PFIZER INC-202101333935 same reporter/drug/AE, different patient
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (other HCP). A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SOMNOLENCE (non-serious), outcome "recovered" (reported as no more than 3 days), described as "sleepiness". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s): US-PFIZER INC-202101333902 same reporter/drug/different patient; US-PFIZER INC-202101333934 same reporter/drug/different patient.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Immunisation, Pain, Pyrexia
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 69 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 09Oct2021 13:15 (Lot number: FE3590) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine inact sag 4v (FLUAD QUAD), administered in arm right, administration date 09Oct2021 (Lot number: 312834) as dose 1, single. Relevant medical history included: "Barrets" (unspecified if ongoing), notes: Barrets; "COPD" (unspecified if ongoing); "HBP" (unspecified if ongoing); "HDL" (unspecified if ongoing); "Melonoma of nose" (unspecified if ongoing), notes: Melonoma of nose; "Melignant Carcinoid Tumor lung" (unspecified if ongoing), notes: Melignant Carcinoid Tumor lung; "Diabetes 2" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient took concomitant medications. Past drug history included: Augmentine, reaction(s): "Known allergies: Augmentine", notes: Known allergies: Augmentine. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: Pfizer, Dose Number: 1, Batch/Lot No: EL9262, Location of injection: Arm Right, Vaccine Administration Time: 12:30 PM), administration date: 01Feb2021, for Covid-19 immunization; Bnt162b2 (Product: COVID 19, Brand: Pfizer, Dose Number: 2, Batch/Lot No: En6202, Location of injection: Arm Right, Vaccine Administration Time: 10:15 AM), administration date: 22Feb2021, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 10Oct2021 01:00, outcome "unknown", described as "Booster"; PYREXIA (non-serious) with onset 10Oct2021 01:00, outcome "recovered with sequelae", described as "fever"; CHILLS (non-serious) with onset 10Oct2021 01:00, outcome "recovered with sequelae", described as "chills"; PAIN (non-serious) with onset 10Oct2021 01:00, outcome "recovered with sequelae", described as "achy"; HEADACHE (non-serious) with onset 10Oct2021 01:00, outcome "recovered with sequelae", described as "headache; pain in back of head". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of immunisation, pyrexia, chills, pain, headache.Additional information: No, the patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Yes, patient received other medications the patient received within 2 weeks of vaccination. Yes, prior to vaccination, patient diagnosed with COVID-19. No, Since the vaccination, has the patient been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 69 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 09Oct2021 13:15 (Lot number: FE3590) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine inact sag 4v (FLUAD QUAD), administered in arm right, administration date 09Oct2021 (Lot number: 312834) as dose 1, single. Relevant medical history included: "Barrets" (unspecified if ongoing), notes: Barrets; "COPD" (unspecified if ongoing); "HBP" (unspecified if ongoing); "HDL" (unspecified if ongoing); "Melonoma of nose" (unspecified if ongoing), notes: Melonoma of nose; "Melignant Carcinoid Tumor lung" (unspecified if ongoing), notes: Melignant Carcinoid Tumor lung; "Diabetes 2" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient took concomitant medications. Past drug history included: Augmentine, reaction(s): "Known allergies: Augmentine", notes: Known allergies: Augmentine. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: Pfizer, Dose Number: 1, Batch/Lot No: EL9262, Location of injection: Arm Right, Vaccine Administration Time: 12:30 PM), administration date: 01Feb2021, for Covid-19 immunization; Bnt162b2 (Product: COVID 19, Brand: Pfizer, Dose Number: 2, Batch/Lot No: En6202, Location of injection: Arm Right, Vaccine Administration Time: 10:15 AM), administration date: 22Feb2021, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 10Oct2021 01:00, outcome "unknown", described as "Booster"; PYREXIA (non-serious) with onset 10Oct2021 01:00, outcome "recovered with sequelae", described as "fever"; CHILLS (non-serious) with onset 10Oct2021 01:00, outcome "recovered with sequelae", described as "chills"; PAIN (non-serious) with onset 10Oct2021 01:00, outcome "recovered with sequelae", described as "achy"; HEADACHE (non-serious) with onset 10Oct2021 01:00, outcome "recovered with sequelae", described as "headache; pain in back of head". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of immunisation, pyrexia, chills, pain, headache.Additional information: No, the patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Yes, patient received other medications the patient received within 2 weeks of vaccination. Yes, prior to vaccination, patient diagnosed with COVID-19. No, Since the vaccination, has the patient been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Gastrointestinal infection, Myalgia, Pyrexia
Clinical narrative: 3 days of fever and muscle aches; muscle aches/1 day of muscle aches; 3 days of intestinal infection (diarrhea); 3 days of intestinal infection (diarrhea); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Oct2021 15:45 (Lot number: FF2590) at the age of 74 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "other medical history= heart" (unspecified if ongoing); "other medical history= Liver" (unspecified if ongoing); "diabetes" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE taken for immunisation, administration date Sep2021; LANTUS; SYNTHROID; HUMALOG; LOSARTAN; ATORVASTATIN. Past drug history included: Amoxicillin for drug allergy; Sulfa for drug allergy. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8730, Location of injection: Arm Left), administration date: 26Mar2021, when the patient was 74 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6200, Location of injection: Arm Right), administration date: 01Mar2021, when the patient was 74 years old, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 07Oct2021, outcome "not recovered", described as "3 days of fever and muscle aches"; MYALGIA (non-serious) with onset 07Oct2021, outcome "not recovered", described as "muscle aches/1 day of muscle aches"; GASTROINTESTINAL INFECTION (non-serious), DIARRHOEA (non-serious) all with onset 07Oct2021, outcome "not recovered" and all described as "3 days of intestinal infection (diarrhea)". Therapeutic measures were not taken as a result of pyrexia, myalgia, gastrointestinal infection, diarrhoea.  Additional information: Facility type Vaccine= Pharmacy or Drug Store. Other medications taken within 4 weeks and two weeks taken was reported under concomitant section. Covid prior vaccination=No and tested post vaccination=No.  Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Blood test, Body temperature, Infectious mononucleosis, Investigation
Clinical narrative: body aches; tested positive for the mononucleosis virus; fever of 102.5; couldn't get out of bed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 12 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 24Sep2021 16:00 (Lot number: FE3592) at the age of 12 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Verbatim: factor V" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII; HPV VACCINE. The following information was reported: PYREXIA (non-serious) with onset 26Sep2021, outcome "recovered" (2021), described as "fever of 102.5"; BEDRIDDEN (non-serious) with onset 26Sep2021, outcome "unknown", described as "couldn't get out of bed"; MONONUCLEOSIS SYNDROME (non-serious) with onset 01Oct2021, outcome "recovering", described as "tested positive for the mononucleosis virus"; PAIN (non-serious), outcome "unknown", described as "body aches". The events "fever of 102.5", "couldn't get out of bed" and "tested positive for the mononucleosis virus" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: She said her daughter By Sunday night, 26Sep2021 was feverish, and couldn't get out of bed. She went to the doctor a couple times. They couldn't figure out what the fevers were connected to. Her daughter tested positive for mono. She hadn't been around anyone they know of. She was not sure if it was related to the vaccine or not. Her daughter still have active mono. Her daughter's fever reached 102.5. Her daughter also had body aches. She couldn't come out of her room for a week. She couldn't lift her head off the pillow. She was back at school, but could not play any sports or activities. The doctor did blood work that next Thursday, and a Strep test that Tuesday after the vaccine. The doctor was looking at every single scenario. Her daughter does have factor V , but she has had no blood clotting issues with it. Prior Vaccinations (within 4 weeks): flu vaccine and HPV.  Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Mononucleosis syndrome, Pain, Pyrexia
Clinical narrative: body aches; tested positive for the mononucleosis virus; fever of 102.5; couldn't get out of bed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 12 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 24Sep2021 16:00 (Lot number: FE3592) at the age of 12 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Verbatim: factor V" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII; HPV VACCINE. The following information was reported: PYREXIA (non-serious) with onset 26Sep2021, outcome "recovered" (2021), described as "fever of 102.5"; BEDRIDDEN (non-serious) with onset 26Sep2021, outcome "unknown", described as "couldn't get out of bed"; MONONUCLEOSIS SYNDROME (non-serious) with onset 01Oct2021, outcome "recovering", described as "tested positive for the mononucleosis virus"; PAIN (non-serious), outcome "unknown", described as "body aches". The events "fever of 102.5", "couldn't get out of bed" and "tested positive for the mononucleosis virus" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: She said her daughter By Sunday night, 26Sep2021 was feverish, and couldn't get out of bed. She went to the doctor a couple times. They couldn't figure out what the fevers were connected to. Her daughter tested positive for mono. She hadn't been around anyone they know of. She was not sure if it was related to the vaccine or not. Her daughter still have active mono. Her daughter's fever reached 102.5. Her daughter also had body aches. She couldn't come out of her room for a week. She couldn't lift her head off the pillow. She was back at school, but could not play any sports or activities. The doctor did blood work that next Thursday, and a Strep test that Tuesday after the vaccine. The doctor was looking at every single scenario. Her daughter does have factor V , but she has had no blood clotting issues with it. Prior Vaccinations (within 4 weeks): flu vaccine and HPV.  Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Lymphadenopathy, Pain
Clinical narrative: Fever/(100 degrees F); achiness; chills; fatigue; swollen lymph nodes under arm and in collar bone; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Oct2021 14:00 (Lot number: FF2589) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Allrgy: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: BLISOVI 24 FE; ADVIL [IBUPROFEN]. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Vaccine Administration Time: 10:30 AM, Route of Administration: Intramuscular), administration date: 04Mar2021, when the patient was 42 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Vaccine Administration Time: 10:30 AM, Route of Administration: Intramuscular), administration date: 25Mar2021, when the patient was 42 years old, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 13Oct2021 02:30, outcome "recovered" (15Oct2021 02:30), described as "Fever/(100 degrees F)"; PAIN (non-serious) with onset 13Oct2021 02:30, outcome "recovered" (15Oct2021 02:30), described as "achiness"; CHILLS (non-serious) with onset 13Oct2021 02:30, outcome "recovered" (15Oct2021 02:30), described as "chills"; FATIGUE (non-serious) with onset 13Oct2021 02:30, outcome "recovered" (15Oct2021 02:30), described as "fatigue"; LYMPHADENOPATHY (non-serious) with onset 13Oct2021 02:30, outcome "not recovered", described as "swollen lymph nodes under arm and in collar bone". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, pain, chills, fatigue, lymphadenopathy. Additional information: Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. No other vaccine in four weeks. No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever/(100 degrees F); achiness; chills; fatigue; swollen lymph nodes under arm and in collar bone; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Oct2021 14:00 (Lot number: FF2589) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Allrgy: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: BLISOVI 24 FE; ADVIL [IBUPROFEN]. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Vaccine Administration Time: 10:30 AM, Route of Administration: Intramuscular), administration date: 04Mar2021, when the patient was 42 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Vaccine Administration Time: 10:30 AM, Route of Administration: Intramuscular), administration date: 25Mar2021, when the patient was 42 years old, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 13Oct2021 02:30, outcome "recovered" (15Oct2021 02:30), described as "Fever/(100 degrees F)"; PAIN (non-serious) with onset 13Oct2021 02:30, outcome "recovered" (15Oct2021 02:30), described as "achiness"; CHILLS (non-serious) with onset 13Oct2021 02:30, outcome "recovered" (15Oct2021 02:30), described as "chills"; FATIGUE (non-serious) with onset 13Oct2021 02:30, outcome "recovered" (15Oct2021 02:30), described as "fatigue"; LYMPHADENOPATHY (non-serious) with onset 13Oct2021 02:30, outcome "not recovered", described as "swollen lymph nodes under arm and in collar bone". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, pain, chills, fatigue, lymphadenopathy. Additional information: Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. No other vaccine in four weeks. No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: pain all over my body/Body aches; itching; chills; headache; joint pain; vomiting; fatigue; muscle and body aches; diarrhea; 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 (BNT162B2), administered in arm left, administration date 19Aug2021 10:45 (Lot number: Evv0169) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Borderline high bp" (unspecified if ongoing); "known allergies : penicillin" (unspecified if ongoing). Concomitant medication(s) included: TAMSULOSIN. The following information was reported: PAIN (non-serious) with onset 23Aug2021, outcome "not recovered", described as "pain all over my body/Body aches"; PRURITUS (non-serious) with onset 23Aug2021, outcome "not recovered", described as "itching"; CHILLS (non-serious) with onset 23Aug2021, outcome "not recovered", described as "chills"; HEADACHE (non-serious) with onset 23Aug2021, outcome "not recovered", described as "headache"; ARTHRALGIA (non-serious) with onset 23Aug2021, outcome "not recovered", described as "joint pain"; VOMITING (non-serious) with onset 23Aug2021, outcome "not recovered", described as "vomiting"; FATIGUE (non-serious) with onset 23Aug2021, outcome "not recovered", described as "fatigue"; MYALGIA (non-serious) with onset 23Aug2021, outcome "not recovered", described as "muscle and body aches"; DIARRHOEA (non-serious) with onset 23Aug2021, outcome "not recovered", described as "diarrhea". The events "pain all over my body/body aches", "itching", "chills", "headache", "joint pain", "vomiting", "fatigue", "muscle and body aches" and "diarrhea" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, pruritus, chills, headache, arthralgia, vomiting, fatigue, myalgia, diarrhoea.  Additional information: The patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Sep2021 10:45 AM (Lot number: EH0150) at the age of 58 years as dose 2, single for covid-19 immunisation. The patient had not received any other vaccine within 4 weeks. List of any other medications the patient received within 2 weeks of vaccination includes Tamsulosin. Adverse event treatment: medication/ongoing stress exam/heart monitor. Prior to vaccination, the patient was  not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Covid test post vaccination on 12Sep2021: covid test type post vaccination=Nasal Swab, covid test result was Negative. Device Date : 25Oct2021  Follow-up (28Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pruritus, SARS-CoV-2 test, Vomiting
Clinical narrative: pain all over my body/Body aches; itching; chills; headache; joint pain; vomiting; fatigue; muscle and body aches; diarrhea; 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 (BNT162B2), administered in arm left, administration date 19Aug2021 10:45 (Lot number: Evv0169) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Borderline high bp" (unspecified if ongoing); "known allergies : penicillin" (unspecified if ongoing). Concomitant medication(s) included: TAMSULOSIN. The following information was reported: PAIN (non-serious) with onset 23Aug2021, outcome "not recovered", described as "pain all over my body/Body aches"; PRURITUS (non-serious) with onset 23Aug2021, outcome "not recovered", described as "itching"; CHILLS (non-serious) with onset 23Aug2021, outcome "not recovered", described as "chills"; HEADACHE (non-serious) with onset 23Aug2021, outcome "not recovered", described as "headache"; ARTHRALGIA (non-serious) with onset 23Aug2021, outcome "not recovered", described as "joint pain"; VOMITING (non-serious) with onset 23Aug2021, outcome "not recovered", described as "vomiting"; FATIGUE (non-serious) with onset 23Aug2021, outcome "not recovered", described as "fatigue"; MYALGIA (non-serious) with onset 23Aug2021, outcome "not recovered", described as "muscle and body aches"; DIARRHOEA (non-serious) with onset 23Aug2021, outcome "not recovered", described as "diarrhea". The events "pain all over my body/body aches", "itching", "chills", "headache", "joint pain", "vomiting", "fatigue", "muscle and body aches" and "diarrhea" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, pruritus, chills, headache, arthralgia, vomiting, fatigue, myalgia, diarrhoea.  Additional information: The patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Sep2021 10:45 AM (Lot number: EH0150) at the age of 58 years as dose 2, single for covid-19 immunisation. The patient had not received any other vaccine within 4 weeks. List of any other medications the patient received within 2 weeks of vaccination includes Tamsulosin. Adverse event treatment: medication/ongoing stress exam/heart monitor. Prior to vaccination, the patient was  not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Covid test post vaccination on 12Sep2021: covid test type post vaccination=Nasal Swab, covid test result was Negative. Device Date : 25Oct2021  Follow-up (28Oct2021): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Bedridden, Chills, Fatigue, Immunisation, Nausea
Clinical narrative: fever; chills; fatigue; pain at injection site; booster; nausea; Lay down; 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 (COMIRNATY), administration date 01Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:01), for Covid-19 immunization; Bnt162b2 (Dose:02), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 01Nov2021, outcome "unknown", described as "booster"; PYREXIA (non-serious) with onset 02Nov2021, outcome "unknown", described as "fever"; CHILLS (non-serious) with onset 02Nov2021, outcome "not recovered", described as "chills"; FATIGUE (non-serious) with onset 02Nov2021, outcome "unknown", described as "fatigue"; VACCINATION SITE PAIN (non-serious) with onset 02Nov2021, outcome "unknown", described as "pain at injection site"; NAUSEA (non-serious) with onset Nov2021, outcome "not recovered", described as "nausea"; BEDRIDDEN (non-serious) with onset Nov2021, outcome "not recovered", described as "Lay down".  Additional information: Patient reported being shivering despite cashmere sweater, puffy jacket and blanket. On 03Nov2021 patient was still experiencing chills and severe nausea causing him to lay down.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: fever; chills; fatigue; pain at injection site; booster; nausea; Lay down; 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 (COMIRNATY), administration date 01Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:01), for Covid-19 immunization; Bnt162b2 (Dose:02), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 01Nov2021, outcome "unknown", described as "booster"; PYREXIA (non-serious) with onset 02Nov2021, outcome "unknown", described as "fever"; CHILLS (non-serious) with onset 02Nov2021, outcome "not recovered", described as "chills"; FATIGUE (non-serious) with onset 02Nov2021, outcome "unknown", described as "fatigue"; VACCINATION SITE PAIN (non-serious) with onset 02Nov2021, outcome "unknown", described as "pain at injection site"; NAUSEA (non-serious) with onset Nov2021, outcome "not recovered", described as "nausea"; BEDRIDDEN (non-serious) with onset Nov2021, outcome "not recovered", described as "Lay down".  Additional information: Patient reported being shivering despite cashmere sweater, puffy jacket and blanket. On 03Nov2021 patient was still experiencing chills and severe nausea causing him to lay down.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Infection
Clinical narrative: I am infected with vocal 3 days ago; Sick; 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), administration date Mar2021 (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: INFECTION (non-serious) with onset 2021, outcome "unknown", described as "I am infected with vocal 3 days ago"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "Sick".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 82 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 01Jan2021 12:40 (Lot number: EJ1685, Expiration Date: 31Mar2021) at the age of 82 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Medullary thyroid cancer", start date: 01Sep2004 (ongoing), notes: Sep2004 Thyroid diagnosis monitored twice year with blood work and scans once year; "Breast cancer", start date: Apr2004 (unspecified if ongoing), notes: Mastectomy No treatment; "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for hypertension, start date: 2005 (ongoing); VITAMIN D 2000, start date: 2005 (ongoing); CRESTOR, start date: 2005 (ongoing); SYNTHROID, start date: 2004 (ongoing).The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "sore arm".  Additional information: Prior vaccine in four weeks: None  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Biopsy liver, Blood alkaline phosphatase, Blood alkaline phosphatase increased, Blood bilirubin, Blood bilirubin increased
Clinical narrative: Pfizer COVID vaccine causing elevated alkaline phosphatase, bilirubin , and transaminases Mine were incidentally found to be elevated; Pfizer COVID vaccine causing elevated alkaline phosphatase, bilirubin , and transaminases Mine were incidentally found to be elevated; Pfizer COVID vaccine causing elevated alkaline phosphatase, bilirubin , and transaminases Mine were incidentally found to be elevated; Liver disorder; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD ALKALINE PHOSPHATASE INCREASED (non-serious), BLOOD BILIRUBIN INCREASED (non-serious), TRANSAMINASES INCREASED (non-serious), outcome "unknown" and all described as "Pfizer COVID vaccine causing elevated alkaline phosphatase, bilirubin , and transaminases Mine were incidentally found to be elevated"; LIVER DISORDER (non-serious), outcome "unknown", described as "Liver disorder". The patient underwent the following laboratory tests and procedures: biopsy liver: unknown result; blood alkaline phosphatase: elevated, notes: after my initial series; then trended down; blood bilirubin: elevated, notes: after my initial series; then trended down; transaminases: elevated, notes: after my initial series; then trended down  Additional information: Facility type for vaccine noted as school or student health clinic. The patient was incidentally found to be elevated alkaline phosphatase, bilirubin and transaminases 5 months after his initial series, then trended down until August. The patient got the booster on 01Oct2021 (after which he had significant myalgias, fatigue, and some nausea) and they went even higher and now were not coming down. All other causes/etiologies had been ruled out with a complete workup. Next step was liver biopsy which was on Monday.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101587485 similar report from same reporter
Sex: M
Vaccine: COVID19
Symptoms: Liver disorder, Transaminases, Transaminases increased
Clinical narrative: Pfizer COVID vaccine causing elevated alkaline phosphatase, bilirubin , and transaminases Mine were incidentally found to be elevated; Pfizer COVID vaccine causing elevated alkaline phosphatase, bilirubin , and transaminases Mine were incidentally found to be elevated; Pfizer COVID vaccine causing elevated alkaline phosphatase, bilirubin , and transaminases Mine were incidentally found to be elevated; Liver disorder; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD ALKALINE PHOSPHATASE INCREASED (non-serious), BLOOD BILIRUBIN INCREASED (non-serious), TRANSAMINASES INCREASED (non-serious), outcome "unknown" and all described as "Pfizer COVID vaccine causing elevated alkaline phosphatase, bilirubin , and transaminases Mine were incidentally found to be elevated"; LIVER DISORDER (non-serious), outcome "unknown", described as "Liver disorder". The patient underwent the following laboratory tests and procedures: biopsy liver: unknown result; blood alkaline phosphatase: elevated, notes: after my initial series; then trended down; blood bilirubin: elevated, notes: after my initial series; then trended down; transaminases: elevated, notes: after my initial series; then trended down  Additional information: Facility type for vaccine noted as school or student health clinic. The patient was incidentally found to be elevated alkaline phosphatase, bilirubin and transaminases 5 months after his initial series, then trended down until August. The patient got the booster on 01Oct2021 (after which he had significant myalgias, fatigue, and some nausea) and they went even higher and now were not coming down. All other causes/etiologies had been ruled out with a complete workup. Next step was liver biopsy which was on Monday.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101587485 similar report from same reporter
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Immunisation, Nasal congestion
Clinical narrative: Booster dose of the Pfizer Covid vaccine; that night I felt congestion; little dizzy that evening; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date 09Nov2021 (Lot number: FH8030, Expiration Date: 31May2022) 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), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 09Nov2021, described as "Booster dose of the Pfizer Covid vaccine"; NASAL CONGESTION (non-serious) with onset 09Nov2021, described as "that night I felt congestion"; DIZZINESS (non-serious) with onset Nov2021, described as "little dizzy that evening".  Clinical course: She received the booster dose of the Pfizer Covid vaccine on 09Nov2021, and that night she felt congestion and a little dizzy that evening, but she was fine then.  Additional information: She thought was it unusual to get congestion a side effects of the vaccine?, because the way she felt, was more after she received the flu shot, and she did not go there to get the flu shot, but she felt like her side effects felt like the flu vaccine, she went back to them, and they did not have an answer. She was fine then. She just wondering if they gave her the flu vaccine instead. It has been in the news a lot lately, where the pharmacist over diluted the vile, or they gave the wrong thing.  No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: deleted event I pulled back a little do you think I received the whole dose of the vaccine coded to LLT underdose and LLT vaccination error.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure measurement, Chronic obstructive pulmonary disease
Clinical narrative: COPD; anxiety is high; 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 67 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "disabled", start date: 1991 (ongoing), notes: disabled; "high blood pressure" (ongoing); "COPD" (ongoing); "she has started smoking again" (unspecified if ongoing), notes: she has started smoking again; "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: NEURIVAS; OXYCODONE taken for anxiety. Past drug history included: Chantix, notes: starting Chantix in the "90s", has "used it many times" and it "worked". She specified taking Chantix and stopping it because of the way she felt when taking her coffee in the morning. The following information was reported: CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "unknown", described as "COPD"; ANXIETY (non-serious), outcome "unknown", described as "anxiety is high". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of anxiety.  Additional Information: she mentioned she got the Pfizer virus shot and did not get the virus, states she has COPD. States her anxiety is high.  The lot number for bnt162b2 was not provided and will be requested during follow up.