chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pigmentation disorder, Pyrexia, Rash macular
Clinical narrative: had a pigment discoloration on her forehead and hairline; red splotches all over her body; low grade fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team.   A 56-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 56 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 (First dose), for COVID-19 immunization. The following information was reported: PIGMENTATION DISORDER (non-serious), outcome "unknown", described as "had a pigment discoloration on her forehead and hairline"; RASH MACULAR (non-serious), outcome "recovered" (2021), described as "red splotches all over her body"; PYREXIA (non-serious), outcome "unknown", described as "low grade fever".  Additional information: She had the second dose of the Pfizer-BioNTech COVID-19 Vaccine and had a pigment discoloration on her forehead and hairline. She is asking if anyone has reported this and when it could return to normal. The Lot number and expiry dates were not provided. Onset dates for all the events were unspecified. Caller stated that after the second shot, she had red splotches all over her body, and a low-grade fever. Caller stated after the splotches went away, she had pigment discoloration around her forehead, near her hairline. Caller asks, is that a normal effect, and will she get the pigment color back? Caller agreed to be transferred to Medical Information. Caller declined to complete a safety report at this time. Caller stated that she would like to know when her pigmentation will return, and if anyone else has reported pigment discoloration? Investigation Assessment was not provided.  Follow-up attempts completed. No further information is expected.
Age: 33.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Poor quality product administered, Product temperature excursion issue, Pyrexia
Clinical narrative: Fever; Fatigue; Undiluted vial that was thawed from frozen under refrigeration on 22Jun21 and stored at 2C to 8C. The by use date was 21Jul21. The vaccine was administered 9 days after the by use date; Undiluted vial that was thawed from frozen under refrigeration on 22Jun21 and stored at 2C to 8C. The by use date was 21Jul21. The vaccine was administered 9 days after the by use date; This is a spontaneous report from a contactable other HCP via Medical information team. A patient of 33 age and unknown gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: EW0169) via an Intramuscular route of administration on  Right Deltoid on 30Jul2021 as dose 1, single for COVID-19 immunization. The Relevant medical history and concomitant medications were not reported. It was stated that the dose 1 of Pfizer-BioNTech COVID-19 Vaccine was administered to a patient on 30Jul2021.The dose was pulled from an undiluted vial that was thawed from frozen under refrigeration on 22Jun2021 and stored at 2C to 8C. The by use date was 21Jul2021. The vial was thawed at room temperature and diluted before administration on 30Jul2021.Given that the vaccine was administered 9 days after the by use date. The HCP has a concern should dose 1 be re-administered to the patient. On 30Jul2021 at 16:00 , patient experienced fever and fatigue and the outcome for the same was recovered. Patient had received no treatment for the reported events.After vaccine had been administered it was discovered that it was 9 days past the beyond use date. in addition the vial has been @9c for<12 hrs during storage.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  Follow-up (23Sep2021): This is a Follow-up spontaneous report received from a contactable other HCP. This other HCP reported in response to HCP letter sent which included that: Patient age at time of vaccination, Anatomical site of injection, Route of administration, Batch/lot number, onset time of the event.  Follow-up attempts are completed. No further information is expected.  Follow-Up (27Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Fatigue, Pain, Pyrexia
Clinical narrative: Joint pain; Lower back intense pain; Fever; Fatigue; Body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included lisdexamfetamine mesilate (VYVANSE) from unknown date for an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO180) via an unspecified route of administration in the left arm on 19Jul2021 at 17:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. On 11Aug2021 at 10:00, the patient experienced joint pain, lower back intense pain, fever, fatigue and body aches. Since the vaccination, the patient had not been tested for COVID-19. It was unknown if patient received any treatment for the events. The clinical outcome of the events joint pain, lower back intense pain, fever, fatigue, body aches were not resolved at the time of this report.  Follow-up attempts completed. No further information expected.   Amendment: This follow-up report is being submitted to amend previously reported information: 1. Vaccine Facility Information added 2. Final sentence Follow-up attempts completed. No further information expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Chills, Headache, Inappropriate schedule of product administration
Clinical narrative: administration date=29Jul2021; administration date=14Aug2021; extrem chills; body aches; pain in joints; heavy chest; panic attack; nausea; headache; swollen armpits; 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 right, administration date 14Aug2021 12:00 (Batch/Lot number: unknown) at the age of 33 years as dose 2, single for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: Pfizer, Lot unknown: True, Lot unknown reason: Other, Lot unknown reason other: do not have card on me, Administration date: 29Jul2021, Administration time: 03:00 PM, Dose number: 1, Vaccine location: Left arm), administration date: 29Jul2021, when the patient was 33 years old, for Covid-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "administration date=29Jul2021; administration date=14Aug2021"; CHILLS (non-serious) with onset 14Aug2021 20:00, outcome "unknown", described as "extrem chills"; PAIN (non-serious) with onset 14Aug2021 20:00, outcome "unknown", described as "body aches"; ARTHRALGIA (non-serious) with onset 14Aug2021 20:00, outcome "unknown", described as "pain in joints"; CHEST DISCOMFORT (non-serious) with onset 14Aug2021 20:00, outcome "unknown", described as "heavy chest"; PANIC ATTACK (non-serious) with onset 14Aug2021 20:00, outcome "unknown", described as "panic attack"; NAUSEA (non-serious) with onset 14Aug2021 20:00, outcome "unknown", described as "nausea"; HEADACHE (non-serious) with onset 14Aug2021 20:00, outcome "unknown", described as "headache"; SWELLING (non-serious) with onset 14Aug2021 20:00, outcome "unknown", described as "swollen armpits". Additional information Facility type Vaccine was Pharmacy or Drug Store. The patient did not receive any other vaccine in four weeks. The patient did not have Covid prior vaccination. The patient was not Covid tested post vaccination. Adverse event: extrem chills, body aches, pain in joints, heavy chest, panic attack, nausea, headache, swollen armpits  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Panic attack, Swelling
Clinical narrative: administration date=29Jul2021; administration date=14Aug2021; extrem chills; body aches; pain in joints; heavy chest; panic attack; nausea; headache; swollen armpits; 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 right, administration date 14Aug2021 12:00 (Batch/Lot number: unknown) at the age of 33 years as dose 2, single for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: Pfizer, Lot unknown: True, Lot unknown reason: Other, Lot unknown reason other: do not have card on me, Administration date: 29Jul2021, Administration time: 03:00 PM, Dose number: 1, Vaccine location: Left arm), administration date: 29Jul2021, when the patient was 33 years old, for Covid-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "administration date=29Jul2021; administration date=14Aug2021"; CHILLS (non-serious) with onset 14Aug2021 20:00, outcome "unknown", described as "extrem chills"; PAIN (non-serious) with onset 14Aug2021 20:00, outcome "unknown", described as "body aches"; ARTHRALGIA (non-serious) with onset 14Aug2021 20:00, outcome "unknown", described as "pain in joints"; CHEST DISCOMFORT (non-serious) with onset 14Aug2021 20:00, outcome "unknown", described as "heavy chest"; PANIC ATTACK (non-serious) with onset 14Aug2021 20:00, outcome "unknown", described as "panic attack"; NAUSEA (non-serious) with onset 14Aug2021 20:00, outcome "unknown", described as "nausea"; HEADACHE (non-serious) with onset 14Aug2021 20:00, outcome "unknown", described as "headache"; SWELLING (non-serious) with onset 14Aug2021 20:00, outcome "unknown", described as "swollen armpits". Additional information Facility type Vaccine was Pharmacy or Drug Store. The patient did not receive any other vaccine in four weeks. The patient did not have Covid prior vaccination. The patient was not Covid tested post vaccination. Adverse event: extrem chills, body aches, pain in joints, heavy chest, panic attack, nausea, headache, swollen armpits  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: He is having swelling in his armpit on the arm where the shot was administered; It's severely sore/swelling in his armpit on the arm where the shot was administered; This is a spontaneous report from contactable consumer (Patient's Parent), reported for a 18-year-old male Patient. An 18-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 13Aug2021 (Lot number: Unknown) at the age of 18 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VYVANSE; TRILEPTAL; TRAZODONE. The following information was reported: VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "He is having swelling in his armpit on the arm where the shot was administered"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "It's severely sore/swelling in his armpit on the arm where the shot was administered".Therapeutic measures were taken as a result of vaccination site swelling, vaccination site pain.  Additional information: Reporter stated, "My son went this past Friday to get the COVID Pfizer shot (Pfizer BioNTech COVID-19 Vaccine) and he is having swelling in his armpit on the arm where the shot was administered. How long can we expect this? Because he is in high school and he has weight training and we don't know what to do as far as the class and it's severely sore." Reporter was informed about Pfizer Medical Information Department and offered the number. Reporter was provided with the number of Pfizer Medical Information Department and was requested to select option timings as 8 am to 8 pm on Monday to Friday. Reporter was informed about the role of Pfizer Drug Safety Department and requested to probe Name of the vaccine: Pfizer BioNTech COVID-19 Vaccine. LOT#: Reporter stated, "All I see is his name, his date of birth, Pfizer the date and Pharmacy. When confirmed that there is no LOT#, consumer stated, "No." Reporter Type: Reporter stated, "No, I am not (hence captured as consumer or other non-health professional in tab)."Anatomical site of administration: Reporter stated, "Right Arm." Other medical condition and Concomitant medications: Reporter stated, "Yes, he is taking other medications." Name of medication : Reporter stated, "He is taking Vyvanse, Trileptal, 'Trazodone' that's it (Medicine name not further clarified hence not captured in tab).Treatment : Reporter stated, "Ice and Ibuprofen."  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Muscle disorder, Nausea, Pain in extremity
Clinical narrative: Felt like the muscle was 'hardening' around the injection site; arm pain really bad; joints ached, strange kinda asymmetrical pains; nauseated; I have no evergy; Vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Aug2021 13:00 (Batch/Lot number: unknown) at the age of 41 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Migraines" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "anaplasmosis" (unspecified if ongoing), notes: several years. Concomitant medication(s) included: PRAZOSIN; TOPIRAMATE; BUPROPION; RAMELTEON. Vaccination history included: Bnt162b2 (1st Dose, time: 13:00, Location: Arm Left), administration date: 14Jul2021, when the patient was 41 years old, for COVID-19 Immunization, reaction(s): "oddly pleasant", "My neck Felt Warm And fuzzy", "I Felt High", "Some arm Pain". The following information was reported: MUSCLE DISORDER (non-serious) with onset 11Aug2021 18:00, outcome "not recovered", described as "Felt like the muscle was 'hardening' around the injection site"; PAIN IN EXTREMITY (non-serious) with onset 11Aug2021 18:00, outcome "not recovered", described as "arm pain really bad"; ARTHRALGIA (non-serious) with onset 11Aug2021 18:00, outcome "not recovered", described as "joints ached, strange kinda asymmetrical pains"; NAUSEA (non-serious) with onset 11Aug2021 18:00, outcome "not recovered", described as "nauseated"; ASTHENIA (non-serious) with onset 11Aug2021 18:00, outcome "not recovered", described as "I have no evergy"; VOMITING (non-serious) with onset 11Aug2021 18:00, outcome "not recovered", described as "Vomiting". Therapeutic measures were not taken as a result of muscle disorder, pain in extremity, arthralgia, nausea, asthenia, vomiting.  Additional information: Patient did not had covid prior vaccination. Patient was not tested post vaccination for covid. Patient didn't had any allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination and since the vaccination the patient was not diagnosed and tested for COVID-19.  Follow-up (27Sep2021)This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Felt like the muscle was 'hardening' around the injection site; arm pain really bad; joints ached, strange kinda asymmetrical pains; nauseated; I have no evergy; Vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Aug2021 13:00 (Batch/Lot number: unknown) at the age of 41 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Migraines" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "anaplasmosis" (unspecified if ongoing), notes: several years. Concomitant medication(s) included: PRAZOSIN; TOPIRAMATE; BUPROPION; RAMELTEON. Vaccination history included: Bnt162b2 (1st Dose, time: 13:00, Location: Arm Left), administration date: 14Jul2021, when the patient was 41 years old, for COVID-19 Immunization, reaction(s): "oddly pleasant", "My neck Felt Warm And fuzzy", "I Felt High", "Some arm Pain". The following information was reported: MUSCLE DISORDER (non-serious) with onset 11Aug2021 18:00, outcome "not recovered", described as "Felt like the muscle was 'hardening' around the injection site"; PAIN IN EXTREMITY (non-serious) with onset 11Aug2021 18:00, outcome "not recovered", described as "arm pain really bad"; ARTHRALGIA (non-serious) with onset 11Aug2021 18:00, outcome "not recovered", described as "joints ached, strange kinda asymmetrical pains"; NAUSEA (non-serious) with onset 11Aug2021 18:00, outcome "not recovered", described as "nauseated"; ASTHENIA (non-serious) with onset 11Aug2021 18:00, outcome "not recovered", described as "I have no evergy"; VOMITING (non-serious) with onset 11Aug2021 18:00, outcome "not recovered", described as "Vomiting". Therapeutic measures were not taken as a result of muscle disorder, pain in extremity, arthralgia, nausea, asthenia, vomiting.  Additional information: Patient did not had covid prior vaccination. Patient was not tested post vaccination for covid. Patient didn't had any allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination and since the vaccination the patient was not diagnosed and tested for COVID-19.  Follow-up (27Sep2021)This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Dizziness, Dyspnoea, Feeling cold
Clinical narrative: shortness of breath; chest pressure/tightness; chest pressure/tightness; dizziness; I started shivering a lot and felt like I was freezing; I started shivering a lot and felt like I was freezing; my body was covered in goosebumps and couldn't stop shaking; my body was covered in goosebumps and couldn't stop shaking; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Aug2021 20:00 (Lot number: FC3181) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "pre diabetes" (unspecified if ongoing); "chronic back pain" (unspecified if ongoing); "year'round allergies (sinus allergies)" (unspecified if ongoing); "Known allergies: Cherries" (unspecified if ongoing); "Known allergies: grapefruit (sensitivity)" (unspecified if ongoing); "Known allergies: peanuts (mild allergic reaction)" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing). Concomitant medication(s) included: HYDROCODONE. Past drug history included: Lipitor, reaction(s): "Known allergies: Lipitor". The following information was reported: DYSPNOEA (non-serious) with onset 18Aug2021 20:30, outcome "recovered with sequelae", described as "shortness of breath"; CHEST DISCOMFORT (non-serious), CHEST DISCOMFORT (non-serious) all with onset 18Aug2021 20:30, outcome "recovered with sequelae" and all described as "chest pressure/tightness"; DIZZINESS (non-serious) with onset 18Aug2021 20:30, outcome "recovered with sequelae", described as "dizziness"; CHILLS (non-serious), FEELING COLD (non-serious) all with onset 18Aug2021 20:30, outcome "recovered with sequelae" and all described as "I started shivering a lot and felt like I was freezing"; PILOERECTION (non-serious), TREMOR (non-serious) all with onset 18Aug2021 20:30, outcome "recovered with sequelae" and all described as "my body was covered in goosebumps and couldn't stop shaking". Therapeutic measures were not taken as a result of dyspnoea, chest discomfort, chest discomfort, dizziness, chills, feeling cold, piloerection, tremor.  Additional information: Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine.The patient received any other medications within 2 weeks of vaccination was Hydrocone 10/325mg, Multivitamin supplement. known allergies are penicillin, lipitor, cherries, grapefruit (sensitivity), peanuts (mild allergic reaction) latex.  Follow-Up (27Aug2021): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Piloerection, Tremor
Clinical narrative: shortness of breath; chest pressure/tightness; chest pressure/tightness; dizziness; I started shivering a lot and felt like I was freezing; I started shivering a lot and felt like I was freezing; my body was covered in goosebumps and couldn't stop shaking; my body was covered in goosebumps and couldn't stop shaking; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Aug2021 20:00 (Lot number: FC3181) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "pre diabetes" (unspecified if ongoing); "chronic back pain" (unspecified if ongoing); "year'round allergies (sinus allergies)" (unspecified if ongoing); "Known allergies: Cherries" (unspecified if ongoing); "Known allergies: grapefruit (sensitivity)" (unspecified if ongoing); "Known allergies: peanuts (mild allergic reaction)" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing). Concomitant medication(s) included: HYDROCODONE. Past drug history included: Lipitor, reaction(s): "Known allergies: Lipitor". The following information was reported: DYSPNOEA (non-serious) with onset 18Aug2021 20:30, outcome "recovered with sequelae", described as "shortness of breath"; CHEST DISCOMFORT (non-serious), CHEST DISCOMFORT (non-serious) all with onset 18Aug2021 20:30, outcome "recovered with sequelae" and all described as "chest pressure/tightness"; DIZZINESS (non-serious) with onset 18Aug2021 20:30, outcome "recovered with sequelae", described as "dizziness"; CHILLS (non-serious), FEELING COLD (non-serious) all with onset 18Aug2021 20:30, outcome "recovered with sequelae" and all described as "I started shivering a lot and felt like I was freezing"; PILOERECTION (non-serious), TREMOR (non-serious) all with onset 18Aug2021 20:30, outcome "recovered with sequelae" and all described as "my body was covered in goosebumps and couldn't stop shaking". Therapeutic measures were not taken as a result of dyspnoea, chest discomfort, chest discomfort, dizziness, chills, feeling cold, piloerection, tremor.  Additional information: Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine.The patient received any other medications within 2 weeks of vaccination was Hydrocone 10/325mg, Multivitamin supplement. known allergies are penicillin, lipitor, cherries, grapefruit (sensitivity), peanuts (mild allergic reaction) latex.  Follow-Up (27Aug2021): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Swelling
Clinical narrative: next morning little swelling around collar bone and noticed a knot; 10 or 11 that next morning she noticed a little smaller knot noticeable a little painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Aug2021 18:00 (Lot number: FC3181, Expiration Date: 31Oct2021) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (ongoing). Concomitant medication(s) included: AMLODIPINE taken for hypertension (ongoing); TRIAMTERENE taken for hypertension (ongoing). Vaccination history included: Bnt162b2 (DOSE 1, Expiry Date: 30Sep2021), administration date: 17Jul2021, when the patient was 47 years old, for COVID-19 immunization. The following information was reported: SWELLING (non-serious) with onset 11Aug2021, outcome "not recovered", described as "next morning little swelling around collar bone and noticed a knot"; PAIN (non-serious) with onset 11Aug2021, outcome "not recovered", described as "10 or 11 that next morning she noticed a little smaller knot noticeable a little painful". Therapeutic measures were not taken as a result of swelling, pain.  Follow-up (19Aug2021): This is a Follow up spontaneous report from a contactable consumer. This 47-Year-old female consumer (patient) reported for herself that she is having a side effect from the last shot of the Pfizer COVID vaccine.She noticed she is having a little swelling around her collar bone area. It is a small little knot. It is a little painful . She wanted to know if that is normal.   Additional information:No History of all previous immunization with the Pfizer vaccine considered as suspect.No Additional Vaccines Administered on Same Date of the Pfizer Suspect.Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine.Patient's Medical History (including any illness at time of vaccination):  Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and no obesity.No List of other relevant diagnostic and confirmatory test results for event(s), for example, from blood tests, cerebrospinal fluid culture, bacterial sero-type, diagnostic imaging, (e.g., chest X-ray, MRI)    Follow-Up (01Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Nodule, Swelling, Tenderness
Clinical narrative: My left under arm was tender beginning Wednesday afternoon. Thursday morning, my left under arm was swollen with a noticeable knot; My left under arm was tender beginning Wednesday afternoon. Thursday morning, my left under arm was swollen with a noticeable knot; My left under arm was tender beginning Wednesday afternoon. Thursday morning, my left under arm was swollen with a noticeable knot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Aug2021 11:30 (Lot number: Ew0171) at the age of 43 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: NODULE (non-serious), TENDERNESS (non-serious), SWELLING (non-serious) all with onset 18Aug2021 14:00, outcome "not recovered" and all described as "My left under arm was tender beginning Wednesday afternoon. Thursday morning, my left under arm was swollen with a noticeable knot". The event "my left under arm was tender beginning wednesday afternoon. thursday morning, my left under arm was swollen with a noticeable knot", "my left under arm was tender beginning wednesday afternoon. thursday morning, my left under arm was swollen with a noticeable knot" and "my left under arm was tender beginning wednesday afternoon. thursday morning, my left under arm was swollen with a noticeable knot" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of nodule, tenderness, swelling.  Additional information: Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No history of drug allergy.  Follow-up (31Aug2021): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Pruritus, Vaccination site erythema, Vaccination site pain
Clinical narrative: Next day- Pain and redness; Next day- Pain and redness; Same day- pain on the injection area.; Next 10-12 days: Itchy, swelling and redness on the injection area.; Next 10-12 days: Itchy, swelling and redness on the injection area.; Next 10-12 days: Itchy, swelling and redness on the injection area.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Aug2021 11:30 (Lot number: FA7485) at the age of 26 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "White eggs" (unspecified if ongoing); "known allergies: Nuts" (unspecified if ongoing); "known allergies: Wheat" (unspecified if ongoing); "known allergies: Soybean" (unspecified if ongoing); "known allergies: Sesame Seed" (unspecified if ongoing); "known allergies: Shrimps" (unspecified if ongoing); "known allergies: Scallops" (unspecified if ongoing); "known allergies: Salmon" (unspecified if ongoing); "known allergies: Mite" (unspecified if ongoing); "known allergies: mold" (unspecified if ongoing); "known allergies: pollen" (unspecified if ongoing). Concomitant medication(s) included: BIOTIN; VITAMIN C [ASCORBIC ACID]. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 06Aug2021 13:00, outcome "recovered" (Aug2021), described as "Same day- pain on the injection area."; PAIN (non-serious), ERYTHEMA (non-serious) all with onset 07Aug2021, outcome "recovered" (Aug2021) and all described as "Next day- Pain and redness"; PRURITUS (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset Aug2021, outcome "recovered" (Aug2021) and all described as "Next 10-12 days: Itchy, swelling and redness on the injection area.".   Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination included Biotin, Vitamins, Vitamin C. 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 (01Sep2021): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected. Reporter's Comments: ~~~
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Next day- Pain and redness; Next day- Pain and redness; Same day- pain on the injection area.; Next 10-12 days: Itchy, swelling and redness on the injection area.; Next 10-12 days: Itchy, swelling and redness on the injection area.; Next 10-12 days: Itchy, swelling and redness on the injection area.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Aug2021 11:30 (Lot number: FA7485) at the age of 26 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "White eggs" (unspecified if ongoing); "known allergies: Nuts" (unspecified if ongoing); "known allergies: Wheat" (unspecified if ongoing); "known allergies: Soybean" (unspecified if ongoing); "known allergies: Sesame Seed" (unspecified if ongoing); "known allergies: Shrimps" (unspecified if ongoing); "known allergies: Scallops" (unspecified if ongoing); "known allergies: Salmon" (unspecified if ongoing); "known allergies: Mite" (unspecified if ongoing); "known allergies: mold" (unspecified if ongoing); "known allergies: pollen" (unspecified if ongoing). Concomitant medication(s) included: BIOTIN; VITAMIN C [ASCORBIC ACID]. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 06Aug2021 13:00, outcome "recovered" (Aug2021), described as "Same day- pain on the injection area."; PAIN (non-serious), ERYTHEMA (non-serious) all with onset 07Aug2021, outcome "recovered" (Aug2021) and all described as "Next day- Pain and redness"; PRURITUS (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset Aug2021, outcome "recovered" (Aug2021) and all described as "Next 10-12 days: Itchy, swelling and redness on the injection area.".   Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination included Biotin, Vitamins, Vitamin C. 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 (01Sep2021): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected. Reporter's Comments: ~~~
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Electrocardiogram, Headache, Polymerase chain reaction
Clinical narrative: On August 13 patient went to a concert and experienced chills; headache; shortness of breath; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 28Mar2021 (Lot number: EP6955) at the age of 30 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: CHILLS (non-serious) with onset 13Aug2021, outcome "recovered" (Aug2021), described as "On August 13 patient went to a concert and experienced chills"; HEADACHE (non-serious) with onset 13Aug2021, outcome "recovered" (Aug2021), described as "headache"; DYSPNOEA (non-serious) with onset 13Aug2021, outcome "recovered" (Aug2021), described as "shortness of breath". The events "on august 13 patient went to a concert and experienced chills", "headache" and "shortness of breath" 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 chills, headache, dyspnoea.  Additional information:Testing for PCR done in that day and EKG on 16th. All test results normal. Found out she has high glucose linked to stress.The patient receive any other vaccines within 4 weeks prior to the COVID vaccine was Unknown. Prior to vaccination, was the patient diagnosed with COVID-19 was Unknown. Since the vaccination, has the patient been tested for COVID-19 was Unknown.  Follow-Up (31Aug2021): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Chest pain, Disorientation, Dizziness, Pain
Clinical narrative: lightheadedness/Dizziness; chest pain; disorientation; tachycardia; blood pressure swings; generalized pain; I have had POTS like symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Apr2021 08:30 (Lot number: EP7533) at the age of 28 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sleep apnoea syndrome" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 26Apr2021, outcome "not recovered", described as "lightheadedness/Dizziness"; CHEST PAIN (non-serious) with onset 26Apr2021, outcome "not recovered", described as "chest pain"; DISORIENTATION (non-serious) with onset 26Apr2021, outcome "not recovered", described as "disorientation"; TACHYCARDIA (non-serious) with onset 26Apr2021, outcome "not recovered", described as "tachycardia"; BLOOD PRESSURE ABNORMAL (non-serious) with onset 26Apr2021, outcome "not recovered", described as "blood pressure swings"; PAIN (non-serious) with onset 26Apr2021, outcome "not recovered", described as "generalized pain"; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (non-serious) with onset 26Apr2021, outcome "not recovered", described as "I have had POTS like symptoms".The events "lightheadedness/dizziness", "chest pain", "disorientation", "tachycardia", "blood pressure swings", "generalized pain" and "i have had pots like symptoms" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, chest pain, disorientation, tachycardia, blood pressure abnormal, pain, postural orthostatic tachycardia syndrome.  Additional information: The reporter stated that dose 2, information included, Product:COVID 19,Brand: Pfizer,Lot number: EW 0179,Lot unknown: False, Administration date:10May2021,Administration time: 08:00 AM,Dose number: 2,Vaccine location: Left arm.For the past 14 weeks following my vaccination I have had POTS like symptoms. Dizziness, lightheadedness, chest pain, disorientation, tachycardia, blood pressure swings, generalized pain, and more. No history of these issues prior to the vaccine.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.The patient did not receive any other medications within 2 weeks of vaccination.Prior to vaccination,the patient was not diagnosed with COVID-19.Since the vaccination,the patient has been tested for COVID-19.  Follow-Up (31Aug2021): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Postural orthostatic tachycardia syndrome, SARS-CoV-2 test, Tachycardia
Clinical narrative: lightheadedness/Dizziness; chest pain; disorientation; tachycardia; blood pressure swings; generalized pain; I have had POTS like symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Apr2021 08:30 (Lot number: EP7533) at the age of 28 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sleep apnoea syndrome" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 26Apr2021, outcome "not recovered", described as "lightheadedness/Dizziness"; CHEST PAIN (non-serious) with onset 26Apr2021, outcome "not recovered", described as "chest pain"; DISORIENTATION (non-serious) with onset 26Apr2021, outcome "not recovered", described as "disorientation"; TACHYCARDIA (non-serious) with onset 26Apr2021, outcome "not recovered", described as "tachycardia"; BLOOD PRESSURE ABNORMAL (non-serious) with onset 26Apr2021, outcome "not recovered", described as "blood pressure swings"; PAIN (non-serious) with onset 26Apr2021, outcome "not recovered", described as "generalized pain"; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (non-serious) with onset 26Apr2021, outcome "not recovered", described as "I have had POTS like symptoms".The events "lightheadedness/dizziness", "chest pain", "disorientation", "tachycardia", "blood pressure swings", "generalized pain" and "i have had pots like symptoms" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, chest pain, disorientation, tachycardia, blood pressure abnormal, pain, postural orthostatic tachycardia syndrome.  Additional information: The reporter stated that dose 2, information included, Product:COVID 19,Brand: Pfizer,Lot number: EW 0179,Lot unknown: False, Administration date:10May2021,Administration time: 08:00 AM,Dose number: 2,Vaccine location: Left arm.For the past 14 weeks following my vaccination I have had POTS like symptoms. Dizziness, lightheadedness, chest pain, disorientation, tachycardia, blood pressure swings, generalized pain, and more. No history of these issues prior to the vaccine.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.The patient did not receive any other medications within 2 weeks of vaccination.Prior to vaccination,the patient was not diagnosed with COVID-19.Since the vaccination,the patient has been tested for COVID-19.  Follow-Up (31Aug2021): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: PNC13
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: itchiness and redness all over the arm where the product was injected; itchiness and redness all over the arm where the product was injected; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from a sales representative.  A patient (no qualifiers provided) received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), administered in arm (Batch/Lot number: unknown) as DOSE NUMBER UNKNOWN, SINGLE for immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 26Jul2021, outcome "unknown" and all described as "itchiness and redness all over the arm where the product was injected".  Additional information: it was reported that the reporter was not 100% sure if the events were related to the Prevnar 13 but at the 6 month mark, the patient experienced more itchiness and redness all over the arm where the product was injected.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Nausea, Swelling face
Clinical narrative: my eyes started to have a fair amount of swelling; Some swelling above my cheek bones; Nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Aug2021 10:15 (Lot number: FA7484) at the age of 36 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "hypermobile Ehlers Danlos Syndrome" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: BACLOFEN; TIZANIDINE; MELOXICAM; CANNABIS. Past drug history included: Amoxicillin, reaction(s): "Known allergy: Amoxicillin"; Ceclor, reaction(s): "Known allergy: Ceclor".  The following information was reported: EYE SWELLING (non-serious) with onset 19Aug2021 15:00, outcome "not recovered", described as "my eyes started to have a fair amount of swelling"; SWELLING FACE (non-serious) with onset 19Aug2021 15:00, outcome "not recovered", described as "Some swelling above my cheek bones"; NAUSEA (non-serious) with onset 19Aug2021 15:00, outcome "not recovered", described as "Nausea". Therapeutic measures were not taken as a result of eye swelling, swelling face, nausea.  Additional information: Other medications in two weeks: Baclofen, Tizanidine, Meloxicam, Med Cannabis. If other vaccine in four weeks: No. If Covid prior vaccination: No. If Covid tested post vaccination: No. Adverse event: Normal response for the first 24 hours. At about 36 hours eyes started to have a fair amount of swelling below the brows covering eye lids. Some swelling above cheek bones, nausea.  Follow-up attempts are completed. No further information is expected.