chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: broke out all over in a terrible rash; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the parent.  A 19 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization.  The following information was reported: RASH (non-serious), outcome "unknown", described as "broke out all over in a terrible rash".  Additional information: After her second Covid vaccination She broke out in a terrible rash all over her body. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Musculoskeletal stiffness, Nausea, Neck pain
Clinical narrative: fever ( 102.8 ); stiff neck; swollen throat; pains in neck, shoulders, body; pains in neck, shoulders, body; pains in neck, shoulders, body; nauseous; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Oct2021 (Lot number: 30145BA) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "heart disease" (unspecified if ongoing), notes: HEART DISEASE; "Peanuts" (unspecified if ongoing), notes: Peanuts. Concomitant medication(s) included: COREG. The following information was reported: PYREXIA (non-serious) with onset 01Oct2021 20:45, outcome "not recovered", described as "fever ( 102.8 )"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 01Oct2021 20:45, outcome "not recovered", described as "stiff neck"; PHARYNGEAL OEDEMA (non-serious) with onset 01Oct2021 20:45, outcome "not recovered", described as "swollen throat"; NECK PAIN (non-serious), ARTHRALGIA (non-serious), PAIN (non-serious) all with onset 01Oct2021 20:45, outcome "not recovered" and all described as "pains in neck, shoulders, body"; NAUSEA (non-serious) with onset 01Oct2021 20:45, outcome "not recovered", described as "nauseous". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, musculoskeletal stiffness, pharyngeal oedema, neck pain, arthralgia, pain, nausea.  Additional Information: The patient treated was with Tylenol and pain medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received LASARTIN / COREG within 2 weeks of vaccination.The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient been not tested for COVID-19.  Follow-Up (11Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pharyngeal oedema, Pyrexia
Clinical narrative: fever ( 102.8 ); stiff neck; swollen throat; pains in neck, shoulders, body; pains in neck, shoulders, body; pains in neck, shoulders, body; nauseous; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Oct2021 (Lot number: 30145BA) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "heart disease" (unspecified if ongoing), notes: HEART DISEASE; "Peanuts" (unspecified if ongoing), notes: Peanuts. Concomitant medication(s) included: COREG. The following information was reported: PYREXIA (non-serious) with onset 01Oct2021 20:45, outcome "not recovered", described as "fever ( 102.8 )"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 01Oct2021 20:45, outcome "not recovered", described as "stiff neck"; PHARYNGEAL OEDEMA (non-serious) with onset 01Oct2021 20:45, outcome "not recovered", described as "swollen throat"; NECK PAIN (non-serious), ARTHRALGIA (non-serious), PAIN (non-serious) all with onset 01Oct2021 20:45, outcome "not recovered" and all described as "pains in neck, shoulders, body"; NAUSEA (non-serious) with onset 01Oct2021 20:45, outcome "not recovered", described as "nauseous". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, musculoskeletal stiffness, pharyngeal oedema, neck pain, arthralgia, pain, nausea.  Additional Information: The patient treated was with Tylenol and pain medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received LASARTIN / COREG within 2 weeks of vaccination.The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient been not tested for COVID-19.  Follow-Up (11Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: Medium-size green bruises appeared on legs for no reasons on first week after 2nd Pfizer COVID-19 mRNA vaccine. New smaller green bruises formed on week 4 after the shot (again for no obvious reasons); Medium-size green bruises appeared on legs for no reasons on first week after 2nd Pfizer COVID-19 mRNA vaccine. New smaller green bruises formed on week 4 after the shot (again for no obvious reasons); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Sep2021 16:00 (Lot number: FC3184) at the age of 33 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing); "Allergy: Latex" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FC3181, Location of injection: Arm Left, Vaccine Administration Time: 15:30), administration date: 14Aug2021, when the patient was 33 years old, for COVID-19 immunization. The following information was reported: CONTUSION (non-serious) with onset 08Sep2021, outcome "recovered" (2021), CONTUSION (non-serious) with onset Oct2021, outcome "unknown" and all described as "Medium-size green bruises appeared on legs for no reasons on first week after 2nd Pfizer COVID-19 mRNA vaccine. New smaller green bruises formed on week 4 after the shot (again for no obvious reasons)". The event "medium-size green bruises appeared on legs for no reasons on first week after 2nd pfizer covid-19 mrna vaccine. new smaller green bruises formed on week 4 after the shot (again for no obvious reasons)" and "medium-size green bruises appeared on legs for no reasons on first week after 2nd pfizer covid-19 mrna vaccine. new smaller green bruises formed on week 4 after the shot (again for no obvious reasons)" was evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of contusion, contusion.  Additional information: It was reported that, medium-size green bruises appeared on legs for no reasons on first week after 2nd Pfizer COVID-19 mRNA vaccine. New smaller green bruises formed on week 4 after the shot (again for no obvious reasons), though old ones dissolved. Patient received vaccine at Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior and other medications 2 weeks prior to the COVID vaccine. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Myalgia, Paraesthesia
Clinical narrative: Sever muscle and joint pain from waist through hips and thighs to knees.; Sever muscle and joint pain from waist through hips and thighs to knees.; Numbness and tingling from knees to toes / Toes and tops of feet going completely numb; Tingling from knees to toes; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 19Sep2021 13:00 (Lot number: 301358A) at the age of 45 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Recent Cervical cancer", start date: Jul2021 (unspecified if ongoing), notes: Recent Cervical cancer, just completed treatments in July.; "known allergies: Most fresh fruits" (unspecified if ongoing); "known allergies: most fresh vegetables" (unspecified if ongoing); "known allergies: some nuts" (unspecified if ongoing), notes: known allergies: some nuts, NOT including peanuts; "if covid prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST SODIUM; ADDERALL; TOPIRAMATE; LANSOPRAZOL. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FC3182, Vaccine Administration Time: 12:00 PM), administration date: 29Aug2021, when the patient was 45 years old, for COVID-19 Immunization. The following information was reported: MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 19Sep2021 17:00, outcome "not recovered" and all described as "Sever muscle and joint pain from waist through hips and thighs to knees."; HYPOAESTHESIA (non-serious) with onset 19Sep2021 17:00, outcome "not recovered", described as "Numbness and tingling from knees to toes / Toes and tops of feet going completely numb"; PARAESTHESIA (non-serious) with onset 19Sep2021 17:00, outcome "not recovered", described as "Tingling from knees to toes". Therapeutic measures were not taken as a result of myalgia, arthralgia, hypoaesthesia, paraesthesia.  Since the vaccination,  patient has not been tested for COVID.. case assessed as non serious and patient was not hospitalized.  Follow-Up (11Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration, Skin exfoliation
Clinical narrative: blood blister; red spots in my mouth; red blotch on my left hand that later turned brown; The brown skin on my hand pealed off; The brown skin on my hand pealed off; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Apr2021 14:50 (Lot number: ERE730) at the age of 76 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing); "hypertension" (ongoing); "known allergies: some foods" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL taken for hypertension (ongoing); CHLORTHALIDON taken for hypertension (ongoing); LOSARTAN taken for hypertension (ongoing); POTASSIUM; PULMICORT taken for asthma (ongoing); VENTOLIN [SALBUTAMOL] taken for asthma (ongoing). Past drug history included: Amoxicillin, reaction(s): "drug allergy: Amoxicillin"; Iodine, reaction(s): "known allergies:iodine internal". Vaccination history included: Bnt162b2 (lot number=EL9266, lot unknown=False, administration date=04Mar2021, administration time=14:40, dose number=1, vaccine location=Left arm , route of administration=intramuscular), administration date: 04Mar2021, when the patient was 76 years old, for Covid-19 immunization. The following information was reported: BLOOD BLISTER (non-serious) with onset 06Aug2021, outcome "recovered" (Aug2021), described as "blood blister"; ORAL MUCOSAL BLISTERING (non-serious) with onset 06Aug2021, outcome "recovered" (Aug2021), described as "red spots in my mouth"; RASH MACULAR (non-serious) with onset 06Aug2021, outcome "recovered" (Aug2021), described as "red blotch on my left hand that later turned brown"; SKIN EXFOLIATION (non-serious), SKIN DISCOLOURATION (non-serious) all with onset 06Aug2021, outcome "recovered" (Aug2021) and all described as "The brown skin on my hand pealed off". The events "blood blister", "red spots in my mouth", "red blotch on my left hand that later turned brown" and "the brown skin on my hand pealed off" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of blood blister, oral mucosal blistering, rash macular, skin exfoliation.  Additional information : It was reported that, 4 months after the second shot, she got a blood blister and many red spots in my mouth. She also got a red blotch on my left hand that later turned brown. No other vaccine in four weeks. She experienced an event that caused several blisters and many red spots in the roof of my mouth. she also have a red circle on my wrist (left) that later turned brown, and then the skin pealed off and new skin appeared under this location. These symptoms lasted for a week. By the time she was able to see her doctor. The symptoms were gone and he could not explain the event.  Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Swelling of face - around both eyes, right cheek, right jawline, right ear lobe; This is a spontaneous report received from 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 27Sep2021 14:30 (Lot number: 301458A) at the age of 74 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "hypercholesteremic" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; ATORVASTATIN; CENTRUM SILVER WOMEN 50+. The following information was reported: SWELLING FACE (non-serious) with onset 27Sep2021 14:30, outcome "not recovered", described as "Swelling of face - around both eyes, right cheek, right jawline, right ear lobe". Therapeutic measures were taken as a result of swelling face treatment with diphenhydramine self-administered.  Additional Information: No other vaccine in four weeks. Facility type Vaccine was Pharmacy or Drug Store. No Covid prior vaccination. Covid not tested post vaccination. No known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Fever 100.2 F; sore arm; sore muscles (whole body); exhaustion; 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 (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 15:00 (Lot number: EP6955) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "celiac" (unspecified if ongoing); "Hashimoto's" (unspecified if ongoing); "Ulcerative colitis" (unspecified if ongoing); "Known allergy: Pollen" (unspecified if ongoing); "Known allergy: dander" (unspecified if ongoing); "Known allergy: mold" (unspecified if ongoing). Concomitant medication(s) included: ADVAIR; VALSARTAN; NP THYROID. Vaccination history included: Bnt162b2 (Dose number =1,, product=COVID 19, brand: Pfizer, COV-19 Vax, lot number: EN6203, administration time: 15.00, vaccine location = Left arm), administration date: 02Mar2021, when the patient was 66 years old, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 23Mar2021, outcome "recovered" (2021), described as "Fever 100.2 F"; PAIN IN EXTREMITY (non-serious) with onset 23Mar2021, outcome "recovered" (2021), described as "sore arm"; MYALGIA (non-serious) with onset 23Mar2021, outcome "recovered" (2021), described as "sore muscles (whole body)"; FATIGUE (non-serious) with onset 23Mar2021, outcome "recovered" (2021), described as "exhaustion". The patient underwent the following laboratory tests and procedures: body temperature: (23Mar2021) 100.2 Fahrenheit. Therapeutic measures were not taken as a result of pyrexia, pain in extremity, myalgia, fatigue.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The event was not required no prolonged hospitalization. The patient did not have covid prior vaccination and did not test covid post vaccination. Prior to vaccination the patient was not diagnosed with COVID-19 and, since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: Began my menstrual cycle 5 days after the vaccine. This was 8 days prior to when my menstrual cycle should have begun.; Heavy bleeding; cramping; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2, Solution for injection), administered in arm right, administration date 27Sep2021 (Lot number: 301358A) at the age of 38 years 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: MENSTRUAL DISORDER (non-serious) with onset 02Oct2021, outcome "unknown", described as "Began my menstrual cycle 5 days after the vaccine. This was 8 days prior to when my menstrual cycle should have begun."; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 02Oct2021, outcome "unknown", described as "Heavy bleeding"; DYSMENORRHOEA (non-serious) with onset 02Oct2021, outcome "unknown", described as "cramping". The events "began my menstrual cycle 5 days after the vaccine. this was 8 days prior to when my menstrual cycle should have begun.", "heavy bleeding" and "cramping" were evaluated at the physician office visit.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Myalgia, Pyrexia
Clinical narrative: Pain in all joints and muscles; Pain in all joints and muscles; Chills; low fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Oct2021 11:45 (Lot number: Ff2589) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Sulpha" (unspecified if ongoing), notes: Known allergies: Sulpha, penicillin; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Sulpha, penicillin; "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?: Yes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Lot Number: EW0198, Vaccine location: Right Arm , Administration time: 13:00), administration date: 30Aug2021, when the patient was 59 years old, for COVID-19 Immunization. The following information was reported: ARTHRALGIA (non-serious), MYALGIA (non-serious) all with onset 03Oct2021 05:00, outcome "unknown" and all described as "Pain in all joints and muscles"; CHILLS (non-serious) with onset 03Oct2021 05:00, outcome "unknown", described as "Chills"; PYREXIA (non-serious) with onset 03Oct2021 05:00, outcome "unknown", described as "low fever". Therapeutic measures were not taken as a result of arthralgia, myalgia, chills, pyrexia.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected...
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Pyrexia, Vaccination site pain
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101312630. A 42 year-old female patient received bnt162b2 (COMIRNATY) (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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "I was just a little sore around the injection site from the first dose"; PYREXIA (non-serious), outcome "unknown", described as "had a fever"; CHILLS (non-serious), outcome "unknown", described as "chills"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "a general feeling that I had been hit by a truck for 24-36 hours". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Fatigue, Gingival swelling, Headache
Clinical narrative: No Menstrual yet (late); Vertigo; Dizziness; Headache; Tongue and gum swelling; gum swelling; Fever; Fever blisters in my mouth; Fever blisters in my mouth; Tiredness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Sep2021 14:45 (Lot number: FD0809) at the age of 38 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FD0809, Location of injection: Arm Left, Vaccine Administration Time: 3:00 PM,Dose Number: 1, Batch/Lot No: FD0809, Location of injection: Arm Left, Vaccine Administration Time: 3:00 PM), administration date: 09Sep2021, when the patient was 38 years old, for COVID-19 immunization, reaction(s): "Injection site pain", "No Menstrual yet (late)", "Vertigo", "Dizziness", "Headache", "Tongue and gum swelling", "Tongue and gum swelling", "Fever"; Bnt162b2 (Dose Number: 1, Batch/Lot No: FD0809, Location of injection: Arm Left, Vaccine Administration Time: 3:00 PM), administration date: 09Sep2021, when the patient was 38 years old, for Covid-19 Immunization, reaction(s): "Fever blisters in my mouth", "Injection site pain".  The following information was reported: MENSTRUATION DELAYED (non-serious) with onset 2021, outcome "not recovered", described as "No Menstrual yet (late)"; VERTIGO (non-serious) with onset 2021, outcome "not recovered", described as "Vertigo"; DIZZINESS (non-serious) with onset 2021, outcome "not recovered", described as "Dizziness"; HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "Headache"; SWOLLEN TONGUE (non-serious) with onset 2021, outcome "not recovered", described as "Tongue and gum swelling"; GINGIVAL SWELLING (non-serious) with onset 2021, outcome "not recovered", described as "gum swelling"; PYREXIA (non-serious) with onset 2021, outcome "not recovered", described as "Fever"; ORAL HERPES (non-serious), ORAL MUCOSAL BLISTERING (non-serious) all with onset 2021, outcome "not recovered" and all described as "Fever blisters in my mouth"; FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "Tiredness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstruation delayed, vertigo, dizziness, headache, swollen tongue, gingival swelling, pyrexia, oral herpes, oral mucosal blistering, fatigue.  Additional information: The patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. No  other medications the patient received within 2 weeks of vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101302213 same reporter/patient/product, different dose/event.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: No Menstrual yet (late); Vertigo; Dizziness; Headache; Tongue and gum swelling; gum swelling; Fever; Fever blisters in my mouth; Fever blisters in my mouth; Tiredness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Sep2021 14:45 (Lot number: FD0809) at the age of 38 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FD0809, Location of injection: Arm Left, Vaccine Administration Time: 3:00 PM,Dose Number: 1, Batch/Lot No: FD0809, Location of injection: Arm Left, Vaccine Administration Time: 3:00 PM), administration date: 09Sep2021, when the patient was 38 years old, for COVID-19 immunization, reaction(s): "Injection site pain", "No Menstrual yet (late)", "Vertigo", "Dizziness", "Headache", "Tongue and gum swelling", "Tongue and gum swelling", "Fever"; Bnt162b2 (Dose Number: 1, Batch/Lot No: FD0809, Location of injection: Arm Left, Vaccine Administration Time: 3:00 PM), administration date: 09Sep2021, when the patient was 38 years old, for Covid-19 Immunization, reaction(s): "Fever blisters in my mouth", "Injection site pain".  The following information was reported: MENSTRUATION DELAYED (non-serious) with onset 2021, outcome "not recovered", described as "No Menstrual yet (late)"; VERTIGO (non-serious) with onset 2021, outcome "not recovered", described as "Vertigo"; DIZZINESS (non-serious) with onset 2021, outcome "not recovered", described as "Dizziness"; HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "Headache"; SWOLLEN TONGUE (non-serious) with onset 2021, outcome "not recovered", described as "Tongue and gum swelling"; GINGIVAL SWELLING (non-serious) with onset 2021, outcome "not recovered", described as "gum swelling"; PYREXIA (non-serious) with onset 2021, outcome "not recovered", described as "Fever"; ORAL HERPES (non-serious), ORAL MUCOSAL BLISTERING (non-serious) all with onset 2021, outcome "not recovered" and all described as "Fever blisters in my mouth"; FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "Tiredness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstruation delayed, vertigo, dizziness, headache, swollen tongue, gingival swelling, pyrexia, oral herpes, oral mucosal blistering, fatigue.  Additional information: The patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. No  other medications the patient received within 2 weeks of vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101302213 same reporter/patient/product, different dose/event.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Pyrexia
Clinical narrative: fever; felt a litte bad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2021US163876.  A 58 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 58 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt a litte bad".  Additional information: It was reported that Patient stated that he had fever for few days and felt a little bad after his second COVID-19 vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Oropharyngeal pain
Clinical narrative: I feel really bad; Sore throat; Chills; Fever; Headache; Fatigue; 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 Sep2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose no: 1), for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset Sep2021, outcome "unknown", described as "I feel really bad"; OROPHARYNGEAL PAIN (non-serious) with onset Sep2021, outcome "unknown", described as "Sore throat"; CHILLS (non-serious) with onset Sep2021, outcome "unknown", described as "Chills"; PYREXIA (non-serious) with onset Sep2021, outcome "unknown", described as "Fever"; HEADACHE (non-serious) with onset Sep2021, outcome "unknown", described as "Headache"; FATIGUE (non-serious) with onset Sep2021, outcome "unknown", described as "Fatigue".  Additional Information: When probed for the concern, consumer stated, "he took the Pfizer second shot and feel really bad since then, patient had sore throat, chills, fever headache and fatigue. And asked was the sore throat a side effect of the vaccine?". Patient also wanted to know whether he should take booster dose. Response was provided, consumer was informed Pfizer Medical Information Department for the concern. Upon follow-up consumer also reported in response to Non-HCP telephonic  and asked, 'how many people had died because of the vaccine?', consumer stated he was doing alright now. Consumer does not want to continue with the follow up process with the pharmacovigilance team. Consumer does not wish to be contacted any further.  Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I feel really bad; Sore throat; Chills; Fever; Headache; Fatigue; 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 Sep2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose no: 1), for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset Sep2021, outcome "unknown", described as "I feel really bad"; OROPHARYNGEAL PAIN (non-serious) with onset Sep2021, outcome "unknown", described as "Sore throat"; CHILLS (non-serious) with onset Sep2021, outcome "unknown", described as "Chills"; PYREXIA (non-serious) with onset Sep2021, outcome "unknown", described as "Fever"; HEADACHE (non-serious) with onset Sep2021, outcome "unknown", described as "Headache"; FATIGUE (non-serious) with onset Sep2021, outcome "unknown", described as "Fatigue".  Additional Information: When probed for the concern, consumer stated, "he took the Pfizer second shot and feel really bad since then, patient had sore throat, chills, fever headache and fatigue. And asked was the sore throat a side effect of the vaccine?". Patient also wanted to know whether he should take booster dose. Response was provided, consumer was informed Pfizer Medical Information Department for the concern. Upon follow-up consumer also reported in response to Non-HCP telephonic  and asked, 'how many people had died because of the vaccine?', consumer stated he was doing alright now. Consumer does not want to continue with the follow up process with the pharmacovigilance team. Consumer does not wish to be contacted any further.  Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Body temperature, Body temperature increased, Chills
Clinical narrative: Chills; Feeling weak; Shaking; His temperature is higher; He is been bed ever since received booster shot; Running Fever about 102 Degrees; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Lot number: FE3592) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TYLENOL. Vaccination history included: Bnt162b2 (FIRST DOSE, Lot number, Administration date, Administration time and Vaccine location: Unspecified), for COVID-19 immunization; Bnt162b2 (SECOND DOSE, Lot number, Administration date, Administration time and Vaccine location: Unspecified), for COVID-19 immunization. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Chills"; ASTHENIA (non-serious), outcome "unknown", described as "Feeling weak"; TREMOR (non-serious), outcome "unknown", described as "Shaking"; BODY TEMPERATURE INCREASED (non-serious), outcome "unknown", described as "His temperature is higher"; BEDRIDDEN (non-serious), outcome "unknown", described as "He is been bed ever since received booster shot"; PYREXIA (non-serious), outcome "unknown", described as "Running Fever about 102 Degrees". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Administration time of booster dose was 02:00 PM. Vaccine location was unspecified. Facility type Vaccine was unspecified. The patient had not received any other vaccine within 4 weeks. The patient had not covid prior vaccination. The patient had not covid tested post vaccination. Number and Expiry Date of BioNTech Covid-19 Vaccine was unknown. Treatment for AE was unknown. He was running fever about 102 Degrees, it started about 2 o clock this afternoon up until then he was fine.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: Chills; Feeling weak; Shaking; His temperature is higher; He is been bed ever since received booster shot; Running Fever about 102 Degrees; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Lot number: FE3592) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TYLENOL. Vaccination history included: Bnt162b2 (FIRST DOSE, Lot number, Administration date, Administration time and Vaccine location: Unspecified), for COVID-19 immunization; Bnt162b2 (SECOND DOSE, Lot number, Administration date, Administration time and Vaccine location: Unspecified), for COVID-19 immunization. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Chills"; ASTHENIA (non-serious), outcome "unknown", described as "Feeling weak"; TREMOR (non-serious), outcome "unknown", described as "Shaking"; BODY TEMPERATURE INCREASED (non-serious), outcome "unknown", described as "His temperature is higher"; BEDRIDDEN (non-serious), outcome "unknown", described as "He is been bed ever since received booster shot"; PYREXIA (non-serious), outcome "unknown", described as "Running Fever about 102 Degrees". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Administration time of booster dose was 02:00 PM. Vaccine location was unspecified. Facility type Vaccine was unspecified. The patient had not received any other vaccine within 4 weeks. The patient had not covid prior vaccination. The patient had not covid tested post vaccination. Number and Expiry Date of BioNTech Covid-19 Vaccine was unknown. Treatment for AE was unknown. He was running fever about 102 Degrees, it started about 2 o clock this afternoon up until then he was fine.  No follow-up attempts are possible. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Malaise, Pain in extremity, Pyrexia
Clinical narrative: Pain in arm; I feeling tired; High fever last night on day of vaccination; Feeling under the weather; Bit weak; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  An 82-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Oct2021 16:00 (Lot number: 30130BA) at the age of 82 years as dose 3 (booster), single for covid-19 immunization. Relevant medical history included: "Weakened immune system" (unspecified if ongoing). Concomitant medication(s) included: B12 [CYANOCOBALAMIN] taken for supplementation therapy, start date: 1980 (ongoing). Vaccination history included: Bnt162b2 (First dose, Lot Number: EL3249, Time: 2pm, Anatomical site of Injection: left arm, Route of administration: Intramuscular, Expiry date: 31May2021), administration date: 15Jan2021, when the patient was 82 years old, for Covid-19 immunization, reaction(s): "sore arm"; Bnt162b2 (Second dose, Route of administration: Intramuscular, Lot Number: EM9810, Time: 3pm, Anatomical site of Injection: left arm, Batch/Lot number: EM9810), administration date: 06Feb2021, when the patient was 82 years old, for Covid-19 immunization, reaction(s): "sore arm". The following information was reported: PYREXIA (non-serious) with onset 01Oct2021 23:00, outcome "recovered" (02Oct2021 08:00), described as "High fever last night on day of vaccination"; PAIN IN EXTREMITY (non-serious) with onset 02Oct2021, outcome "recovered" (02Oct2021), described as "Pain in arm"; FATIGUE (non-serious) with onset 02Oct2021, outcome "recovered" (02Oct2021), described as "I feeling tired"; ASTHENIA (non-serious) with onset Oct2021, outcome "recovered" (02Oct2021), described as "Bit weak"; MALAISE (non-serious) with onset 01Oct2021, outcome "recovered" (02Oct2021), described as "Feeling under the weather". Therapeutic measures were not taken as a result of pyrexia, pain in extremity, fatigue.  Additional information: The patient had high fever last night after taking booster and pain in arm and was feeling tired its almost over now. The patient woke up at midnight 1-2 o'clock and had the high fever. The patient did not receive any prior vaccinations to Covid vaccine. No relevant lab tests were performed. The patient did not receive treatment for fever and just rested.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Peripheral swelling, Pruritus
Clinical narrative: My arm is swollen and it's red; My arm is swollen and it's red; rest part is bigger than my hand and it feels like burning and itchy sensation; rest part is bigger than my hand and it feels like burning and itchy sensation; 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 30Sep2021 (Lot number: FF8841) 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, reaction(s): "didn't have any reactions"; Bnt162b2 (Dose: 2), for Covid-19 immunization, reaction(s): "didn't have any reactions". The following information was reported: PERIPHERAL SWELLING (non-serious), ERYTHEMA (non-serious) all with onset 2021, outcome "unknown" and all described as "My arm is swollen and it's red"; BURNING SENSATION (non-serious), PRURITUS (non-serious) all with onset 2021, outcome "unknown" and all described as "rest part is bigger than my hand and it feels like burning and itchy sensation".  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itchiness on left arm continues to this day (04Oct2021); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Jun2021 (Lot number: EW01716) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]. Vaccination history included: Bnt162b2 (Dose 1, lot number EW0176, vaccine location Left arm), administration date: 15May2021, for Covid-19 immunization.  The following information was reported: PRURITUS (non-serious) with onset 2021, outcome "not recovered", described as "Itchiness on left arm continues to this day (04Oct2021)". Therapeutic measures were not taken as a result of pruritus.  Additional information: The patient was not pregnant at the time of vaccination. Prior to vaccination, was not diagnosed with COVID-19. The patient does not have any known allergies.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received albuterol within 2 weeks of vaccination.  Since the vaccination, Patient was not tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Pruritus, Swelling
Clinical narrative: My toes on my right foot got itchy. Now they are inflamed and swollen.; My toes on my right foot got itchy. Now they are inflamed and swollen; My toes on my right foot got itchy. Now they are inflamed and swollen; 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 25Sep2021 17:00 (Lot number: Fr3183) at the age of 74 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "RA" (unspecified if ongoing), notes: I have RA. On zeljanz for a year, stopped taking few days before vaccine and eight days afterward; "Allergy" (unspecified if ongoing). Concomitant medication(s) included: XELJANZ. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: En6207, Location of injection: Arm Left), administration date: 20Mar2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: En6200, Location of injection: Arm Left), administration date: 26Feb2021, for COVID-19 immunization. The following information was reported: PRURITUS (non-serious) with onset 29Sep2021, outcome "not recovered", described as "My toes on my right foot got itchy. Now they are inflamed and swollen."; INFLAMMATION (non-serious), SWELLING (non-serious) all with onset 29Sep2021, outcome "not recovered" and all described as "My toes on my right foot got itchy. Now they are inflamed and swollen". Therapeutic measures were not taken as a result of pruritus, inflammation, swelling.  Additional information: It was reported that patient's toes on her right foot got itchy. Now they were inflamed and swollen. She dad never had anything like it before. Facility where the most recent COVID-19 vaccine administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Zeljanz within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Malaise
Clinical narrative: feel unwell; all the joints in my body started to ache; headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Sep2021 14:00 (Lot number: 30145BA) at the age of 40 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; ECHINACEA. Past drug history included: Sulfa, reaction(s): "Known allergy:Sulfa". The following information was reported: MALAISE (non-serious) with onset 28Sep2021 17:30, outcome "not recovered", described as "feel unwell"; ARTHRALGIA (non-serious) with onset 28Sep2021 17:30, outcome "not recovered", described as "all the joints in my body started to ache"; HEADACHE (non-serious) with onset 28Sep2021 17:30, outcome "not recovered", described as "headache". The events "feel unwell", "all the joints in my body started to ache" and "headache" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of malaise, arthralgia, headache.  Follow-up attempts are completed. No further information is expected
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Blood test, Pruritus, Rash, Skin test
Clinical narrative: After the first dose she developed a rash on her torso; hives; itching; 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 74 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 13Jan2021 (Lot number: EL3249) at the age of 73 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Eczema" (unspecified if ongoing), notes: Verbatim: Eczema, Diagnosed since she was a child. There were no concomitant medications. The following information was reported: PRURITUS (non-serious) with onset 2021, outcome "unknown", described as "itching"; RASH (non-serious) with onset 16Jan2021, outcome "unknown", described as "After the first dose she developed a rash on her torso"; URTICARIA (non-serious) with onset 2021, outcome "unknown", described as "hives". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient received second and third dose of Pfizer covid-19 vaccine.  No follow-up attempts are possible. No further information is expected.