chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: tiredness; Fever; chills; headache; body ache; light headed; dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 23Feb2022 (Lot number: FL3197) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing), notes: other medical history: Diabetes; "fatty liver disease" (unspecified if ongoing), notes: other medical history: fatty liver disease. Concomitant medication(s) included: METFORMIN; CELECOXIB; LISINOPRIL. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 01Apr2021, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 11Mar2021, for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 23Feb2022 14:30, outcome "recovering", described as "tiredness"; PYREXIA (non-serious) with onset 23Feb2022 14:30, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 23Feb2022 14:30, outcome "recovering", described as "chills"; HEADACHE (non-serious) with onset 23Feb2022 14:30, outcome "recovering", described as "headache"; PAIN (non-serious) with onset 23Feb2022 14:30, outcome "recovering", described as "body ache"; DIZZINESS (non-serious) with onset 23Feb2022 14:30, outcome "recovering", described as "light headed"; DIZZINESS (non-serious) with onset 23Feb2022 14:30, outcome "recovering", described as "dizziness". The events "tiredness", "fever", "chills", "headache", "body ache", "light headed" and "dizziness" were evaluated at the physician office visit. Therapeutic measures were taken as a result of fatigue, pyrexia, chills, headache, pain, dizziness, dizziness. Additional information: 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. Treatment received for the adverse event was Tylenol. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Pyrexia
Clinical narrative: She "had a fever but just had it overnight; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 70-year-old female patient received bnt162b2 (BNT162B2), administration date 08Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunization. Relevant medical history included: "She just have "different allergies"" (unspecified if ongoing), notes: She just have "different allergies". The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Manufacturer Unknown), administration date: 18Jan2021, for COVID-19 Immunization, reaction(s): "Had severe reaction (itching arm)"; Bnt162b2 (Dose: 2, Manufacturer Unknown), administration date: 08Feb2021, for COVID-19 Immunization, reaction(s): "Had severe reaction (itching arm)". The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "She "had a fever but just had it overnight". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient stated that she had her first shot on 18Jan2021 and had her second shot on 08Feb2021, and she received her booster shot by 08Oct2021. The patient mentioned that she will be having her second booster dose this 08Mar, as suggested by her healthcare provider. Also stated that, she heard that mixing up vaccines suggest a higher immunity against COVID19. The patient also mentioned that she experienced different side effects after getting the shot. During her first dose, she had severe reaction (itching arm) that lasted 3 weeks. The "second dose was much easier." The patient stated that on her third dose, she "had a fever but just had it overnight." She had antibody test made by her doctor and she got "500". After getting the booster dose, her antibody went "2000 way up." The patient mentioned that her doctor was under clinical trial for COVID19 vaccine and was the one recommending her to get her 2nd booster dose.    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: Blue toe syndrome
Clinical narrative: COVID Toe like symptom (purple toes on left foot); This is a spontaneous report received from 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 right, administration date 04Jan2022 (Lot number: FL3198) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Mild asthma" (unspecified if ongoing); "Heart rhythm issue" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing); "Known allergies: some antibiotics" (unspecified if ongoing); "Known allergies: some sea food" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0175, Location of injection: Arm Left), administration date: 28Apr2021, when the patient was 58 years old, for COVID-19 Immunization, reaction(s): "Low blood platelets count", "Liver enzyme number increase"; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8729, Location of injection: Arm Left), administration date: 07Apr2021, when the patient was 58 years old, for COVID-19 Immunization, reaction(s): "Low blood platelets count", "Liver enzyme number increase". The following information was reported: BLUE TOE SYNDROME (non-serious) with onset 26Feb2022 22:00, outcome "unknown", described as "COVID Toe like symptom (purple toes on left foot)". It was unknown if therapeutic measures were taken as a result of blue toe syndrome.  Additional Information: If other vaccine in four weeks: No. Other medications in two weeks: None. Covid prior vaccination: No. Covid tested post vaccination: No. Patient sated that pictures were taken to be showed to primary doctor for seeking medical treatment/advice.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: having pain in my foot and I was having pain in my shoulder, both shoulders; having pain in my foot and I was having pain in my shoulder, both shoulders; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administration date 01Mar2021 (Batch/Lot number: unknown) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Menopause" (unspecified if ongoing), notes: Verbatim: Menopause; "I take my blood pressure pills" (unspecified if ongoing), notes: I take my blood pressure pills; "arthritis" (unspecified if ongoing), notes: That's what I was taking, not because of the Pfizer, but because of arthritis. The patient took concomitant medications. The following information was reported: ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 2021, outcome "unknown" and all described as "having pain in my foot and I was having pain in my shoulder, both shoulders". Therapeutic measures were taken as a result of arthralgia, pain in extremity.  Additional information: No investigation Assessment was done. On confirming the treatment for the adverse event (Tylenol): Consumer stated, yes, but she also was taking another medication. Once before patient was taking another medication. Patient was taking Meloxicam (Further clarifications unknown). Patient was taking that for pain and that was when patient got the first vaccine. That's what patient was taking, not because of the vaccine but because of arthritis. Patient was taking that for pain, like patient said she was having pain in her foot and was having pain in shoulder, both shoulders. Patient was having pain in shoulders as well but it wasn't the pain that patient was having now. (Further clarifications unknown) patient didn't start having the pain till she took that second Pfizer dose. But she didn't look at it as nothing because she just thought it was just normal because it was off and on and patient weren't taking Tylenols like that either but now with this here was different. Vaccination facility details: at the hospital where patient work at.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Autoimmune dermatitis, Rash
Clinical narrative: autoimmune condition as the rash is now spreading and becoming painful; the rash is now spreading and becoming painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 11May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Testosterone, notes: Prior used Testostorone cream as prescribed by doctor past year or 2 without side effects. Vaccination history included: Bnt162b2 (1st Dose), administration date: Apr2021, for Covid-19 immunization. The following information was reported: AUTOIMMUNE DERMATITIS (non-serious), outcome "unknown", described as "autoimmune condition as the rash is now spreading and becoming painful"; RASH (non-serious), outcome "unknown", described as "the rash is now spreading and becoming painful".  Additional Information: The patient had prior to vaccination used Testosterones cream as prescribed by doctor for the past year or two without any side effects. After the second Covid-19 shot started experiencing a rash in the groin exactly where patient applied the testosterones cream which had to stop. I'm convinced that the Covid-19 shot has caused some autoimmune condition as the rash was now spreading and becoming painful.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Lichenoid keratosis, SARS-CoV-2 test
Clinical narrative: Lichenoid Dermatitis/Lichen Planus spreading over torso and extremities; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 21Apr2021 (Lot number: EP7533) at the age of 38 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8734), administration date: 02Apr2021, when the patient was 38 years old, for Covid-19 immunization. The following information was reported: LICHENOID KERATOSIS (non-serious) with onset Nov2021, outcome "not recovered", described as "Lichenoid Dermatitis/Lichen Planus spreading over torso and extremities". The event "lichenoid dermatitis/lichen planus spreading over torso and extremities" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lichenoid keratosis.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Adverse event did not require a visit to Doctor or other healthcare professional office/clinic visit. The treatment received for the adverse event included Steroid cream and antihistamine. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has been tested for COVID-19. No Known allergies. The patient also received BNT162B2 (Lot number: FH8027) on 16Feb2022 as dose 3, (booster) single for covid-19 immunisation.  No follow-up attempts are possible. No further information is expected.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Weight
Clinical narrative: First Vaccine: A little achy; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program. The reporter is the patient.  A 85 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 10Feb2021 (Lot number: EN6203) at the age of 85 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "pacemaker" (ongoing); "Bovine Valve Implant" (unspecified if ongoing); "Abdominal Aneurysm with 2 Stents" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: PAIN (non-serious), outcome "recovered", described as "First Vaccine: A little achy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain. Additional information: The patient stated that he was pleased to tell Pfizer, he was 86 years (at the time of report) old and he had both shots and also had the first booster shot and those 3 shots he had no reaction whatsoever. The patient stated the route of administration was arm intramuscular. The patient stated again, he is 86 years old and has had all 3 shots, with no reaction, whatsoever, except the first time he was a little achy, but he took an aspirin and the achiness went away. The patient stated with the second, he was a little itchy, but he took a Benadryl and it knocked out the itchiness from the second shot and he has been fine ever since. The patient stated the very minor side effects he experienced were transient and they didn't last. The patient was using Heart Medication as concomitant medication. The patient mentioned that he was taking Covid 19 Vaccine to prevent dying.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200341941 same patient, product, different dose
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Hypoaesthesia, Neck pain, Pain in extremity
Clinical narrative: getting worse; painful rash over the neck and shoulders.; his arm started hurting; Rash; left side of his neck is in excruciating pain; Left arm is going numb; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200348601 (Pfizer), US-PFIZER INC-202200354082 (Pfizer).  A 76 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Jan2022 11:00 (Lot number: F0611) at the age of 76 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, date: 27Dec2021, Lot: FJ8957, Expiration: Unknown), administration date: 27Dec2021, when the patient was 76 years old, for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 20Jan2022, outcome "not recovered", described as "his arm started hurting"; RASH (non-serious) with onset 20Jan2022, outcome "not recovered", described as "Rash"; NECK PAIN (non-serious) with onset 20Jan2022, outcome "not recovered", described as "left side of his neck is in excruciating pain"; HYPOAESTHESIA (non-serious) with onset 20Jan2022, outcome "not recovered", described as "Left arm is going numb"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "getting worse"; ARTHRALGIA (non-serious), outcome "unknown", described as "painful rash over the neck and shoulders.". The events "his arm started hurting", "rash", "left side of his neck is in excruciating pain" and "left arm is going numb" were evaluated at the physician office visit and emergency room visit.  Additional information: Patient got the second dose of the Pfizer Covid-19 vaccine. As soon as he got the second dose, his arm started hurting. He developed a rash on his left side, the left side of his neck was in excruciating pain and it was getting worse. It has been 6 weeks. His left arm was going numb and getting worse. He was on insurance and they only pay for 80%. His second dose was 6 weeks ago on 20Jan2022. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as None. Prior Vaccinations (within 4 weeks), Medical History, Family Medical History Relevant to AE was reported as None.  Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: getting worse; painful rash over the neck and shoulders.; his arm started hurting; Rash; left side of his neck is in excruciating pain; Left arm is going numb; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200348601 (Pfizer), US-PFIZER INC-202200354082 (Pfizer).  A 76 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Jan2022 11:00 (Lot number: F0611) at the age of 76 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, date: 27Dec2021, Lot: FJ8957, Expiration: Unknown), administration date: 27Dec2021, when the patient was 76 years old, for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 20Jan2022, outcome "not recovered", described as "his arm started hurting"; RASH (non-serious) with onset 20Jan2022, outcome "not recovered", described as "Rash"; NECK PAIN (non-serious) with onset 20Jan2022, outcome "not recovered", described as "left side of his neck is in excruciating pain"; HYPOAESTHESIA (non-serious) with onset 20Jan2022, outcome "not recovered", described as "Left arm is going numb"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "getting worse"; ARTHRALGIA (non-serious), outcome "unknown", described as "painful rash over the neck and shoulders.". The events "his arm started hurting", "rash", "left side of his neck is in excruciating pain" and "left arm is going numb" were evaluated at the physician office visit and emergency room visit.  Additional information: Patient got the second dose of the Pfizer Covid-19 vaccine. As soon as he got the second dose, his arm started hurting. He developed a rash on his left side, the left side of his neck was in excruciating pain and it was getting worse. It has been 6 weeks. His left arm was going numb and getting worse. He was on insurance and they only pay for 80%. His second dose was 6 weeks ago on 20Jan2022. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as None. Prior Vaccinations (within 4 weeks), Medical History, Family Medical History Relevant to AE was reported as None.  Follow-up attempts are completed. No further information is expected.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Second Vaccine: A little Itchy; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program. The reporter is the patient.  A 86 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 03Mar2021 (Lot number: EN6203) at the age of 86 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Pacemaker" (ongoing); "Bovine valve implant" (unspecified if ongoing); "Abdominal Aneurysm with 2 Stents" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Suspect Products: Pfizer Covid 19 Vaccine, First Dose: 10Feb2021 Lot: EN6203), administration date: 10Feb2021, when the patient was 85 years old, for Covid-19 immunization, reaction(s): "First Vaccine: A little achy". The following information was reported: PRURITUS (non-serious) with onset Mar2021, outcome "recovered", described as "Second Vaccine: A little Itchy". Therapeutic measures were taken as a result of pruritus.  Additional information: It was reported that, he had both shots and also had the first booster shot and those 3 shots he had no reaction whatsoever. Caller states the route of administration was arm intramuscular. Caller states again, he has had all 3 shots, with no reaction, whatsoever, except the first time he was a little achy, but he took an aspirin and the achiness went away. Caller states with the second, he was a little itchy, but he took a Benadryl and it knocked out the itchiness from the second shot and he has been fine ever since.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200341897 same patient, product, different dose
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein, C-reactive protein increased, Red blood cell sedimentation rate decreased, Red blood cell sedimentation rate increased, Therapeutic response unexpected
Clinical narrative: elevated CRP; Pain free in legs; elevated CRP, which she later clarified as C-Reactive Protein, and ESR sedimentation rate; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administration date 21Nov2021 (Batch/Lot number: unknown) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Multiple Sclerosis" (unspecified if ongoing); "Diabetic" (unspecified if ongoing); "multiple bleeding stomach polyps" (unspecified if ongoing), notes: multiple bleeding stomach polyps.; "Erythema Nodosum" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "Osteopenia" (unspecified if ongoing); "Rheumatoid arthritis" (unspecified if ongoing), notes: She continues to experience arthritis. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, she maybe had chills when she woke up in the night and just put an extra blanket and went back to sleep and had no ill effect), administration date: Jan2021, when the patient was 60 years old, for COVID-19 immunization, reaction(s): "Chills"; Bnt162b2 (DOSE 2, The CRP has been going up back in Jun2021), administration date: Feb2021, when the patient was 60 years old, for COVID-19 immunization, reaction(s): "CRP has been going up". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 25Nov2021, outcome "not recovered", described as "Pain free in legs"; C-REACTIVE PROTEIN INCREASED (non-serious) with onset 29Dec2021, outcome "unknown", described as "elevated CRP"; RED BLOOD CELL SEDIMENTATION RATE INCREASED (non-serious) with onset Nov2021, outcome "unknown", described as "elevated CRP, which she later clarified as C-Reactive Protein, and ESR sedimentation rate". Relevant laboratory tests and procedures are available in the appropriate section. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dysarthria, Pyrexia, SARS-CoV-2 test, Tremor
Clinical narrative: Shaking violently; Could barely speak; Temperature began to rise, stopping at 99.9; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Feb2022 15:00 (Lot number: FMO698) at the age of 29 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Dairy" (unspecified if ongoing), notes: Verbatim: Known allergies: Dairy; "COVID-19" (unspecified if ongoing), notes: If Covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EWO217, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 02Aug2021, when the patient was 29 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EWO180, Location of injection: Arm Right, Vaccine Administration Time: 02:30 PM), administration date: 12Jul2021, when the patient was 29 years old, for COVID-19 immunization. The following information was reported: TREMOR (non-serious) with onset 27Feb2022 03:00, outcome "recovered" (Feb2022), described as "Shaking violently"; DYSARTHRIA (non-serious) with onset 27Feb2022 03:00, outcome "recovered" (Feb2022), described as "Could barely speak"; PYREXIA (non-serious) with onset 27Feb2022 03:00, outcome "recovered" (Feb2022), described as "Temperature began to rise, stopping at 99.9". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tremor, dysarthria, pyrexia.  Additional information: 14 hours after my 3rd shot (booster) I woke up at 3am shaking violently, so badly patient could barely speak. Patient did not have a fever at the time (97.9). This lasted for 30 minutes. Shortly after the tremors stopped, patient noticed that my temperature began to rise, stopping at 9.9. No other vaccine in four weeks. Yes Covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Menorrhagia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 15Dec2021 (Batch/Lot number: unknown) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "thyroid" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Concomitant medication(s) included: SYNTHROID. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details), administration date: 06May2021, when the patient was 41 years old, for COVID-19 immunization, reaction(s): "Prev dose administration date: 05May2021, prev dose dose number:  1/Prev dose administration date: 06May2021, prev dose dose number: 2"; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details), administration date: 05May2021, when the patient was 41 years old, for COVID-19 immunization. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 22Dec2021, outcome "recovered with sequelae" (Jan2022), described as "Menorrhagia". The event "menorrhagia" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of heavy menstrual bleeding.  Additional information: Patient did not receive any other vaccines within 4weeks prior to COVID vaccine and since the vaccination patient has not been tested for COVID 19. Device date:28Feb2022.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 53.0
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Influenza like illness, Pain in extremity
Clinical narrative: Achy back, legs like flu; Achy back, legs like flu; Achy back, legs like flu; 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), administered in arm, administration date 30Nov2021 (Lot number: FF8841) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "headache" (unspecified if ongoing). Concomitant medication(s) included: FISH OIL (ongoing); ADVIL taken for headache; FLINTSTONES (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Site and Route of injection:, Anatomical site of injection: arm, Batch/Lot number: EW0161), administration date: 19Apr2021, when the patient was 53 years old, for Covid-19 Immunization; Bnt162b2 (Dose 2, Site and Route of injection:, Anatomical site of injection: arm, Batch/Lot number: EW0173, odd feeling of having fluid in my armpit), administration date: 10May2021, when the patient was 53 years old, for Covid-19 Immunization, reaction(s): "odd feeling of having fluid in my armpit". The following information was reported: BACK PAIN (non-serious), PAIN IN EXTREMITY (non-serious), INFLUENZA LIKE ILLNESS (non-serious) all with onset 01Dec2021, outcome "recovered" and all described as "Achy back, legs like flu". Therapeutic measures were not taken as a result of back pain, pain in extremity, influenza like illness. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: blurry vision/eyesight is blurry; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VISION BLURRED (non-serious), outcome "unknown", described as "blurry vision/eyesight is blurry". The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Eye pain
Clinical narrative: eye pain; lightheaded; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "clipped aneurysm", start date: 2010 (unspecified if ongoing), notes: I have a clipped aneurysm since 2010. The patient's concomitant medications were not reported. The following information was reported: EYE PAIN (non-serious) with onset Feb2022, outcome "not recovered", described as "eye pain"; DIZZINESS (non-serious) with onset Feb2022, outcome "not recovered", described as "lightheaded".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: occasional diarrhea; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program (051529).  A 58 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN , MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "occasional diarrhea".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein, Chills, Red blood cell sedimentation rate decreased
Clinical narrative: chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administration date Jan2021 (Batch/Lot number: unknown) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Multiple Sclerosis" (unspecified if ongoing), notes: She has Multiple Sclerosis and is diabetic; "diabetic" (unspecified if ongoing), notes: She has Multiple Sclerosis and is diabetic; "multiple bleeding stomach polyps" (unspecified if ongoing); "Erythema Nodosum" (unspecified if ongoing), notes: She also has Erythema Nodosum; "Osteoporosis" (unspecified if ongoing), notes: She has Osteoporosis now and it was Osteopenia; "Osteopenia" (unspecified if ongoing), notes: She has Osteoporosis now and it was Osteopenia; "She continues to experience arthritis" (unspecified if ongoing); "spot on the legs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "chills". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: hives; burning rash covering the torso/ neck; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 24Feb2022 (Batch/Lot number: unknown) at the age of 48 years as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown; Manufacturer unknown.), for Covid-19 immunization. The following information was reported: URTICARIA (non-serious), outcome "recovering", described as "hives"; RASH (non-serious), outcome "recovering", described as "burning rash covering the torso and neck". Therapeutic measures were not taken as a result of urticaria, rash.  Additional information: The patient had hives the following day after given booster shot by the weekend they had a burning rash covering the torso and neck.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Incontinence
Clinical narrative: incontinence; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization. The following information was reported: INCONTINENCE (non-serious), outcome "unknown", described as "incontinence".  Additional information: Patient got booster and had bad side effects including incontinence.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Body height, Erythema, Joint range of motion decreased, Pain in extremity
Clinical narrative: It is all red underneath his armpit, below his armpit, under his arm; Underneath his armpit, is like a ball, it''s like swollen underneath; His is still swollen and he is still like; he cannot really move his arm all the way to the top; I just knew that, he said my arm was sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 52 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 25Feb2022 19:15 (Batch/Lot number: unknown) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN taken for hypertension. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 04Apr2021, when the patient was 51 years old, for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), administration date: May2021, when the patient was 51 years old, for COVID-19 immunization. The following information was reported: ERYTHEMA (non-serious), outcome "not recovered", described as "It is all red underneath his armpit, below his armpit, under his arm"; AXILLARY MASS (non-serious), outcome "unknown", described as "Underneath his armpit, is like a ball, it''s like swollen underneath"; SWELLING (non-serious), outcome "not recovered", described as "His is still swollen and he is still like"; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "not recovered", described as "he cannot really move his arm all the way to the top"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "I just knew that, he said my arm was sore". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Prior vaccinations (within 4 weeks): Reporter stated, "No, not before 4 weeks but he has taken his other shots. He took around 04Apr and the other was taken in May of this year and they were both Pfizer(further not clarified)."  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Weight
Clinical narrative: It is all red underneath his armpit, below his armpit, under his arm; Underneath his armpit, is like a ball, it''s like swollen underneath; His is still swollen and he is still like; he cannot really move his arm all the way to the top; I just knew that, he said my arm was sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 52 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 25Feb2022 19:15 (Batch/Lot number: unknown) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN taken for hypertension. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 04Apr2021, when the patient was 51 years old, for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), administration date: May2021, when the patient was 51 years old, for COVID-19 immunization. The following information was reported: ERYTHEMA (non-serious), outcome "not recovered", described as "It is all red underneath his armpit, below his armpit, under his arm"; AXILLARY MASS (non-serious), outcome "unknown", described as "Underneath his armpit, is like a ball, it''s like swollen underneath"; SWELLING (non-serious), outcome "not recovered", described as "His is still swollen and he is still like"; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "not recovered", described as "he cannot really move his arm all the way to the top"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "I just knew that, he said my arm was sore". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Prior vaccinations (within 4 weeks): Reporter stated, "No, not before 4 weeks but he has taken his other shots. He took around 04Apr and the other was taken in May of this year and they were both Pfizer(further not clarified)."  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm was sore; 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 received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 25Feb2022 (Batch/Lot number: unknown) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Blood cholesterol" (unspecified if ongoing), notes: Verbatim: Cholesterol. Concomitant medication(s) included: SIMVASTATIN taken for blood cholesterol. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for covid 19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2022, outcome "unknown", described as "Arm was sore".  Additional information: It was reported that she only had the reactions for just say Saturday and her arm was sore, Yesterday very little but she was okay. No Prior vaccinations (within 4 weeks).  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pruritus, SARS-CoV-2 test
Clinical narrative: both my hands started to get itchy, burning; both my hands started to get itchy, burning; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 21Jan2021 15:15 (Lot number: EL0142) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing); "DMII" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "covid" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient took concomitant medications. The following information was reported: PRURITUS (non-serious), BURNING SENSATION (non-serious) all with onset 08Dec2021 07:00, outcome "recovered" and all described as "both my hands started to get itchy, burning". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pruritus, burning sensation.  Additional information: At Public Health Clinic/Veterans Administration facility the vaccine was administered. No other vaccine was administered in four weeks. Other medications were administered in two weeks. The day after having the Booster both her hands started to get itchy, burning. She took Benadryl to get relief. Patient had covid prior vaccination. Patient had covid tested post vaccination. Patient had known allergies.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: extremely sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date 2021 (Batch/Lot number: unknown) as dose 2, single and administration date 2021 (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: ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "extremely sick".  Additional information: Reporter stated she became extremely sick from her first 2 shots of the Comirnaty vaccine. The patient later took booster dose of bnt162b2 (COMIRNATY) last Friday and got extremely sick again from that. She mentioned she had stopped breathing but good thing she had an EpiPen. She mentioned that she felt like every bone in her body had been hit by a truck to the site of the road and that she also had low grade fever.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: my shoulder was sore, just like when i got the 1st and 2nd doses; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 10May2021 08:00 (Lot number: EW0167) at the age of 30 years as dose 1, single and intramuscular, administered in arm, administration date 01Jun2021 (Lot number: EW0191) as dose 2,single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "my shoulder was sore, just like when i got the 1st and 2nd doses".  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Audiogram, Magnetic resonance imaging, Pain in extremity, Pyrexia
Clinical narrative: arm sore; little fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administration date 29Jan2021 (Lot number: EN9581) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "hypertension" (ongoing), notes: Also family had history of Just normal hypertension; "Thyroid" (ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder (ongoing); VALSARTAN taken for hypertension (ongoing).  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 29Jan2021, outcome "unknown", described as "arm sore"; PYREXIA (non-serious) with onset 29Jan2021, outcome "recovered" (2021), described as "little fever". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Caller states the mom mentioned that the patient experienced body itching after the first dose of the Covid-19 vaccine.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 15 year-old male patient received bnt162b2 (BNT162B2), administration date 28Jan2022 (Lot number: 33130BA, Expiration Date: 31May2022) at the age of 15 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: PRURITUS (non-serious) with onset Jan2022, outcome "unknown", described as "Caller states the mom mentioned that the patient experienced body itching after the first dose of the Covid-19 vaccine.".   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin lesion
Clinical narrative: Sores produced al! over her body after receiving the injection; The reaction was accompanied by itching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient. Other Case identifier(s): 2020SA044245.  A 78 year-old female patient (not pregnant) 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: SKIN LESION (non-serious), outcome "unknown", described as "Sores produced al! over her body after receiving the injection"; PRURITUS (non-serious), outcome "unknown", described as "The reaction was accompanied by itching".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.