chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test, Vaccination failure
Clinical narrative: they have tested him yesterday but he started not feeling good on 25Nov2021; they have tested him yesterday but he started not feeling good on 25Nov2021; tired; achy; cold; not feeling good; Caller recently got COVID19 from someone at work; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the parent.  A 55-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Apr2021 (Lot number: EW0167) at the age of 55 years as dose 2, single and administration date 09Apr2021 (Lot number: EW0161) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Nov2021, outcome "unknown" and all described as "they have tested him yesterday but he started not feeling good on 25Nov2021"; EXPOSURE TO SARS-COV-2 (non-serious) with onset Nov2021, outcome "unknown", described as "Caller recently got COVID19 from someone at work"; MALAISE (non-serious) with onset 25Nov2021, outcome "unknown", described as "not feeling good"; FATIGUE (non-serious) with onset 26Nov2021, outcome "unknown", described as "tired"; PAIN (non-serious) with onset 26Nov2021, outcome "unknown", described as "achy"; NASOPHARYNGITIS (non-serious) with onset 26Nov2021, outcome "unknown", described as "cold". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Nov2021) positive.   Patient son got both doses of the vaccine and now had Covid. He took a test yesterday, and on the bottom line was pink and purple, and the top line was pink so that means he had Covid. Stated that on 23Nov2021, a 20-year-old that the patient son worked with got Covid. He notified the people at work, including the patient, and since then several people and their families who had not had the vaccines had gotten Covid. Reporter verified that her son did get both doses of the vaccine but he did not have time to get the booster because he did not meet the age group requirements. Patient had notified his boss that he had Covid. He was just tired and achy right now, so it's not too bad. He started having symptoms of Covid on 26Nov2021, he was very tired and cold. He took a Covid test on 29Nov2021, and it was positive for Covid. AE(s) did not require a visit to Emergency Room or Physician Office. No prior vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine(s). Reporter said there were 3 people with heart problems who had gotten booster dose of the vaccine in the same house, reporter asked how long before they get infected. She also asked if there were some over-the-counter medications that her son could take while he had COVID-19. Reporter also asked if she needed to notify his doctor that he had COVID-19 infection.  Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pain in extremity
Clinical narrative: Sore arm; Dose received 3/ dose number=3; This is a spontaneous report received from a non-contactable reporter (consumer or other non HCP).   A 59-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration site is unknown, administration date on an unknown date in 2021 (Lot number: unknown) at the age of 59 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot Number: Unknown, Anatomical site: Unknown) for COVID-19 immunisation and BNT162b2 (DOSE 2, SINGLE, Lot Number: Unknown, Anatomical site: Unknown) for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset an unknown date in 2021, outcome "unknown", described as "Dose received 3/ dose number=3"; PAIN IN EXTREMITY (non-serious) with onset 01Dec2021, outcome "unknown", described as "Sore arm".   Additional Information: The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Immunisation, Pain, Pain in extremity
Clinical narrative: Moderate to severe headache and body aches, specifically in my left arm and in my lower back; moderate to severe headache and body aches, specifically in my left arm and in my lower back; moderate to severe headache and body aches, specifically in my left arm and in my lower back; moderate to severe headache and body aches, specifically in my left arm and in my lower back; Dose number: 3; This is a spontaneous report received from contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in the left arm, administration date 30Nov2021 at 09:00 (Lot number: FJ8762) at the age of 41 years as dose 3 (booster), single for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not receive any concomitant medications. Vaccination history included: BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 1, SINGLE, Lot Number: ER8730, Anatomical site: Left Arm, Route of administration: unspecified), administration date: 30Mar2021 at 09:00, when the patient was 40 years old, for COVID-19 immunisation and BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 2, SINGLE, Lot Number: EW0162, Anatomical site: left Arm, Route of administration: unspecified), administration date: 20Apr2021 at 09:00, when the patient was 40 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 30Nov2021 at 09:00, outcome "unknown", described as "Dose number: 3"; HEADACHE (non-serious), PAIN (non-serious), PAIN IN EXTREMITY (non-serious), BACK PAIN (non-serious) all with onset 30Nov2021 at 16:00, outcome "recovered" (an unknown date in 2021), and all described as "moderate to severe headache and body aches, specifically in the left arm and in the lower back". Therapeutic measures were not taken as a result of headache, pain, pain in extremity and back pain.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.   No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dyspnoea, Fatigue, Malaise
Clinical narrative: Unwell feeling; Nausea; painful Rash; Fatigue but restlessness; Fatigue but restlessness; short of breath; muscle pain; joint pain; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 11:45 (Batch/Lot number: unknown) at the age of 29 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MALAISE (non-serious) with onset 30Nov2021 23:45, outcome "not recovered", described as "Unwell feeling"; NAUSEA (non-serious) with onset 30Nov2021 23:45, outcome "not recovered", described as "Nausea"; RASH (non-serious) with onset 30Nov2021 23:45, outcome "not recovered", described as "painful Rash"; FATIGUE (non-serious), RESTLESSNESS (non-serious) all with onset 30Nov2021 23:45, outcome "not recovered" and all described as "Fatigue but restlessness"; DYSPNOEA (non-serious) with onset 30Nov2021 23:45, outcome "not recovered", described as "short of breath"; MYALGIA (non-serious) with onset 30Nov2021 23:45, outcome "not recovered", described as "muscle pain"; ARTHRALGIA (non-serious) with onset 30Nov2021 23:45, outcome "not recovered", described as "joint pain"; CHILLS (non-serious) with onset 30Nov2021 23:45, outcome "not recovered", described as "Chills". Therapeutic measures were not taken as a result of malaise, nausea, rash, fatigue, restlessness, dyspnoea, myalgia, arthralgia, chills.  Additional Information: The patient did not have covid prior to vaccination. The patient did not have covid tested post vaccination. The patient did have known allergies.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Rash, Restlessness
Clinical narrative: Unwell feeling; Nausea; painful Rash; Fatigue but restlessness; Fatigue but restlessness; short of breath; muscle pain; joint pain; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 11:45 (Batch/Lot number: unknown) at the age of 29 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MALAISE (non-serious) with onset 30Nov2021 23:45, outcome "not recovered", described as "Unwell feeling"; NAUSEA (non-serious) with onset 30Nov2021 23:45, outcome "not recovered", described as "Nausea"; RASH (non-serious) with onset 30Nov2021 23:45, outcome "not recovered", described as "painful Rash"; FATIGUE (non-serious), RESTLESSNESS (non-serious) all with onset 30Nov2021 23:45, outcome "not recovered" and all described as "Fatigue but restlessness"; DYSPNOEA (non-serious) with onset 30Nov2021 23:45, outcome "not recovered", described as "short of breath"; MYALGIA (non-serious) with onset 30Nov2021 23:45, outcome "not recovered", described as "muscle pain"; ARTHRALGIA (non-serious) with onset 30Nov2021 23:45, outcome "not recovered", described as "joint pain"; CHILLS (non-serious) with onset 30Nov2021 23:45, outcome "not recovered", described as "Chills". Therapeutic measures were not taken as a result of malaise, nausea, rash, fatigue, restlessness, dyspnoea, myalgia, arthralgia, chills.  Additional Information: The patient did not have covid prior to vaccination. The patient did not have covid tested post vaccination. The patient did have known allergies.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Active menstrual cycle stopped while at time of 1st dose. Cycle has not resumed to date.; This is a spontaneous report received from a contactable reporter (other healthcare professional). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (COMIRNATY), administered in left arm, administration date 09Nov2021 at 10:15 (Lot number: FF2590) at the age of 39 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: codeine, reaction: "Drug allergy". The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 09Nov2021 at 10:15, outcome "not recovered", described as "active menstrual cycle stopped while at time of 1st dose, cycle had not resumed to date". Therapeutic measures were not taken as a result of menstruation irregular.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's cycle was 21 days between an active 7 day flow. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Pain, Pain in extremity
Clinical narrative: Strong pain in injection arm; Chills; Sweats; Full body aches; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 40 year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administered in left arm, administration date 30Nov2021 at 12:00 (Lot number: 330308BD) at the age of 40 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: PAIN IN EXTREMITY (non-serious) with onset 30Nov2021 at 23:00, outcome "recovering", described as "Strong pain in injection arm"; CHILLS (non-serious) with onset 30Nov2021 at 23:00, outcome "recovering", described as "Chills"; HYPERHIDROSIS (non-serious) with onset 30Nov2021 at 23:00, outcome "recovering", described as "Sweats"; PAIN (non-serious) with onset 30Nov2021 at 23:00, outcome "recovering", described as "Full body aches"; HEADACHE (non-serious) with onset 30Nov2021 at 23:00, outcome "recovering", described as "Headache". Therapeutic measures were taken as a result of pain in extremity, chills, hyperhidrosis, pain and headache which included over the counter (OTC) Advil.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Immunisation, Pain, Vaccination site pain
Clinical narrative: Dose number=3; Pain at site of injection; Chills; Achiness; Tiredness; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP).  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Nov2021 (Lot number: FF8839) at the age of 51 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE Lot number: EN6203 Route of administration: Unspecified.), for COVID-19 immunisation and Bnt162b2 (DOSE 1, SINGLE Lot number: EL3247 Route of administration: Unspecified.), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 30Nov2021, outcome "unknown", described as "Dose number=3"; VACCINATION SITE PAIN (non-serious) with onset 30Nov2021, outcome "not recovered", described as "Pain at site of injection"; CHILLS (non-serious) with onset 30Nov2021, outcome "not recovered", described as "Chills"; PAIN (non-serious) with onset 30Nov2021, outcome "not recovered", described as "Achiness"; FATIGUE (non-serious) with onset 30Nov2021, outcome "not recovered", described as "Tiredness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site pain, chills, pain and fatigue.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures taken as a result of the events and included treatment with TYLENOL.
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Hypoacusis, Immunisation
Clinical narrative: Dose 3; Decreased hearing from the left ear and abnormal hearing in the right ear; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 65 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 2 (MANUFACTURER UNKNOWN), Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 1  (MANUFACTURER UNKNOWN), Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "Dose 3"; HYPOACUSIS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Decreased hearing from the left ear and abnormal hearing in the right ear". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hypoacusis. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Overdose, Product preparation error
Clinical narrative: Patient was given an undiluted (not yet reconstitutued) 0.3 ML dose of COVID vaccine; Patient was given an undiluted (not yet reconstitutued) 0.3 ML dose of COVID vaccine; booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An adult male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Dec2021 11:45 (Lot number: FH8030) as dose 3 (booster), 0.3 ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Simvastatin for myalgias, reaction(s): "Known allergies: Simvastatin". Vaccination history included: Bnt162b2 ([{prev_dose_product=COVID 19,, prev_dose_brand_unknown=True,, prev_dose_brand_name_unknown=COVID19 Vaccine,, prev_dose_lot_unknown=True,, prev_dose_lot_unknown_reason=Not, available/provided to reporter at the, time of report completion,, prev_dose_dose_number=2},), for COVID-19 immunization; Bnt162b2 ({prev_dose_product=COVID 19,, prev_dose_brand_unknown=True,, prev_dose_brand_name_unknown=COVID19 Vaccine,, prev_dose_lot_unknown=True,, prev_dose_lot_unknown_reason=Not, available/provided to reporter at the, time of report completion,, prev_dose_dose_number=1}]), for COVID-19 immunization. The following information was reported: OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious) all with onset 01Dec2021 11:45, outcome "unknown" and all described as "Patient was given an undiluted (not yet reconstitutued) 0.3 ML dose of COVID vaccine"; IMMUNISATION (non-serious) with onset 01Dec2021 11:45, outcome "unknown", described as "booster". Therapeutic measures were not taken as a result of overdose, product preparation error, immunisation and 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.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Immunisation
Clinical narrative: booster; the vaccine may not be working; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 22Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "immunocompromised" (unspecified if ongoing), notes: Caller reports history of her and her husband being slightly immunocompromised. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization; Bnt162b2 (Dose 2, first two doses where she and her husband both experienced side effects with the second dose being even stronger. She did report mild tenderness at the injection site.), for Covid-19 immunization, reaction(s): "mild tenderness at the injection site".  The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "the vaccine may not be working".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101706398 same reporter/drug/AE with different patient
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Since receiving the vaccine I have numbness on my side and down my right arm. The numbness goes all the way to my thumb and fingers; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.   A 57-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 18Sep2021 at 14:15 (Lot number: Unknown) at the age of 57 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing) and "High blood pressure" (unspecified if ongoing), notes: HBP.  Concomitant medications included: COLCHICINE; INSULIN and LISINOPRIL. Vaccination history included:  Bnt162b2 (DOSE 1, SINGLE, Lot Number: UNKNOWN, Route of administration: Unspecified, Anatomical site: left arm, Administration Time: 14:15), administration date: 26Aug2021, when the patient was 57 years old, for COVID-19 immunisation.  The following information was reported: HYPOAESTHESIA (non-serious) with onset 01Oct2021, outcome "not recovered" and described as "Since receiving the vaccine the patient had numbness on side and down right arm. The numbness went all the way to the thumb and fingers". Therapeutic measures were not taken as a result of hypoaesthesia.  Additional Information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Redness, in a circular pattern around injection site, measuring 3 inches by 2.5 inches.; Swelling, in a circular pattern around injection site, measuring 3 inches by 2.5 inches.; Itching, in a circular pattern around injection site, measuring 3 inches by 2.5 inches.; Indurated, in a circular pattern around injection site, measuring 3 inches by 2.5 inches.; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 07Nov2021 at 14:00 (Lot number: 33026BD) at the age of 42 years as dose 1, single for COVID-19 immunisation and the patient also received bnt162b2 (BNT162B2), administered in right arm, administration date 28Nov2021 at 14:00 (Lot number: FH8027) at the age of 42 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PRURITUS (non-serious) and VACCINATION SITE INDURATION (non-serious), all with onset unknown date in Nov2021, outcome "unknown" and all described as "redness, swelling, itching and indurated in a circular pattern around the injection site, measuring 3 inches by 2.5 inches". It was unknown if therapeutic measures were taken as a result of vaccination site erythema, vaccination site swelling, vaccination site pruritus and vaccination site induration.  Additional Information: Reaction began 72 post injection. There was no drainage and no streaking with pain even with light pressure. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Eyelid oedema, Immunisation, Pruritus, Urticaria
Clinical narrative: Edema of upper eyelids; Itchy, red skin on face, neck, hands and left arm; Red skin on face, neck, hands and left arm; Hives on tops of hands and on neck.; Dose received: 3; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.   A 53-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 29Nov2021 at 18:30 (Lot number: UNKNOWN) at the age of 53 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Palsy Bells" (unspecified if ongoing), notes: Bells Palsy at age 23; "Iodine contrast media allergy" (unspecified if ongoing), notes: Possibly iodine (when used for imaging) and "Shellfish allergy" (unspecified if ongoing), notes: may have a sensitivity to shellfish. Concomitant medications included: VITAMIN D, MULTI-VITAMIN and NUTRAFOL. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: UNKNOWN, Anatomical site: Left arm), administration date: 14Apr2021, when the patient was 53 years old, for COVID-19 immunisation and BNT162b2 (DOSE 2, SINGLE, Lot number: UNKNOWN, Anatomical site: Left arm), administration date: 05May2021, when the patient was 53 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 29Nov2021 at 18:30, outcome "unknown", described as "Dose received: 3"; EYELID OEDEMA (non-serious) with onset 30Nov2021 at 16:30, outcome "not recovered", described as "Edema of upper eyelids"; PRURITUS (non-serious) with onset 30Nov2021 at 16:30, outcome "not recovered", described as "Itchy, red skin on face, neck, hands and left arm"; ERYTHEMA (non-serious) with onset 30Nov2021 at 16:30, outcome "not recovered", described as "Red skin on face, neck, hands and left arm"; URTICARIA (non-serious) with onset 30Nov2021 at 16:30, outcome "not recovered", described as "Hives on tops of hands and on neck". Therapeutic measures were not taken as a result of eyelid oedema, pruritus, erythema and urticaria.  Additional Information: 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 COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. Symptoms developed 22 hours after booster shot. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Immunisation, Oral herpes, Pain, SARS-CoV-2 test
Clinical narrative: Having cold sores for an extensive period of time.; Extremely painful; Unable to eat; Dose received 3/ dose number=3; This is a spontaneous report received from a contactable reporter(s) (other healthcare professional). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 08Oct2021 (Lot number: FF8839) at the age of 44 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Allergic reaction to antibiotics" (unspecified if ongoing), notes: Known allergies: QUINOLONES. Concomitant medications were not reported. Past drug history included: Levaquin, reaction(s): "Drug allergy"; Quinone, reaction(s): "Drug allergy". Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot Number: EL9261, Anatomical Location: Left arm), administration date: 01Jan2021, when the patient was 43 years old, for COVID-19 immunisation and BNT162b2 (DOSE 2, SINGLE, Lot Number: EN6201, Anatomical Location: Left arm), administration date: 09Feb2021, when the patient was 43 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 08Oct2021, outcome "unknown", described as "Dose received 3/ dose number=3"; ORAL HERPES (non-serious) with onset 04Nov2021, outcome "recovering", described as "Having cold sores for an extensive period of time"; PAIN (non-serious) with onset 04Nov2021, outcome "recovering", described as "Extremely painful"; FEEDING DISORDER (non-serious) with onset 04Nov2021, outcome "recovering", described as "Unable to eat". The events "Having cold sores for an extensive period of time, extremely painful and unable to eat" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of oral herpes, pain and feeding disorder.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Therapeutic measures were taken as a result of oral herpes, pain and feeding disorder and included treatment with unspecified medication. Since the vaccination, the patient had been tested for COVID-19.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Mucous stools, Myalgia
Clinical narrative: Mucoid stools; Muscle pain; This is a spontaneous report received from a non-contactable reporter (nurse). The reporter is the patient.  A 28 year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in right arm, administration date 30Nov2021 at 10:00 (Lot number: unknown) at the age of 28 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Allergic reaction to analgesics" (unspecified if ongoing), notes: known allergies: Nsaids. Concomitant medications included: FLU SHOT taken for Immunisation in the left arm, start date: an unknown date in 2021, stop date: an unknown date in 2021.  The following information was reported: MUCOUS STOOLS (non-serious) with onset 01Dec2021 at 12:00, outcome "recovering", described as "Mucoid stools"; MYALGIA (non-serious) with onset 01Dec2021 at 12:00, outcome "recovering", described as "Muscle pain". Therapeutic measures were not taken as a result of mucous stools and myalgia.  Additional Information:  The patient received other vaccine within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Pyrexia
Clinical narrative: Fever; Fatigue; Back ache; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration on an unknown date (Lot number: EL3247), at the age of 27 years as dose 1 and also the patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration on an unknown date (Lot number: EP6955), at the age of 27 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 15Nov2021, outcome "recovering", described as "Fever"; FATIGUE (non-serious) with onset 15Nov2021, outcome "recovering", described as "Fatigue"; BACK PAIN (non-serious) with onset 15Nov2021, outcome "recovering", described as "Back ache". Therapeutic measures were not taken as a result of pyrexia, fatigue and back pain.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Immunisation
Clinical narrative: Chills; Headache; Muscle pain; Fatigue; Loss of appetite; Injection site redness; Injection site redness, swelling, and pain; Injection site redness, swelling, and pain; Dose received 3; This is a spontaneous report received from a contactable reporter (other healthcare professional). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administered in left arm, administration date 28Nov2021 at 11:45 (Lot number: FJ1620) at the age of 60 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Hashimoto's disease" (unspecified if ongoing), notes: Hashimotos and "Hypertension" (unspecified if ongoing). Concomitant medications included: CYTOMEL; LEVOXYL and RAMIPRIL. Vaccination history included: BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 2, SINGLE, Lot number: EP6955, Anatomical location: left arm, Administration time: 15:00, Route of administration: intramuscular), administration date: 24Mar2021, and BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 1, SINGLE, Lot number: EL3248, Anatomical location: left arm, Administration time: 14:00, Route of administration: intramuscular), administration date: 03Mar2021; both administered when the patient was 59 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 28Nov2021 at 11:45, outcome "unknown", described as "Dose received 3"; CHILLS (non-serious), HEADACHE (non-serious), MYALGIA (non-serious), FATIGUE (non-serious), DECREASED APPETITE (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious), all with onset 29Nov2021 at 06:00, outcome "recovering", all described as "Chills, headache, muscle pain, fatigue, loss of appetite, injection site redness, swelling, and pain". Therapeutic measures were taken as a result of chills, headache, myalgia, fatigue, decreased appetite, vaccination site erythema, vaccination site swelling and vaccination site pain and included treatment with ADVIL.  Additional Information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Chills; Headache; Muscle pain; Fatigue; Loss of appetite; Injection site redness; Injection site redness, swelling, and pain; Injection site redness, swelling, and pain; Dose received 3; This is a spontaneous report received from a contactable reporter (other healthcare professional). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administered in left arm, administration date 28Nov2021 at 11:45 (Lot number: FJ1620) at the age of 60 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Hashimoto's disease" (unspecified if ongoing), notes: Hashimotos and "Hypertension" (unspecified if ongoing). Concomitant medications included: CYTOMEL; LEVOXYL and RAMIPRIL. Vaccination history included: BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 2, SINGLE, Lot number: EP6955, Anatomical location: left arm, Administration time: 15:00, Route of administration: intramuscular), administration date: 24Mar2021, and BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 1, SINGLE, Lot number: EL3248, Anatomical location: left arm, Administration time: 14:00, Route of administration: intramuscular), administration date: 03Mar2021; both administered when the patient was 59 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 28Nov2021 at 11:45, outcome "unknown", described as "Dose received 3"; CHILLS (non-serious), HEADACHE (non-serious), MYALGIA (non-serious), FATIGUE (non-serious), DECREASED APPETITE (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious), all with onset 29Nov2021 at 06:00, outcome "recovering", all described as "Chills, headache, muscle pain, fatigue, loss of appetite, injection site redness, swelling, and pain". Therapeutic measures were taken as a result of chills, headache, myalgia, fatigue, decreased appetite, vaccination site erythema, vaccination site swelling and vaccination site pain and included treatment with ADVIL.  Additional Information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation, Lymphadenopathy, Nausea, Pain
Clinical narrative: Swollen lymph nodes in left arm; Nausea; Headache; Body aches; Dose number:3; This is a spontaneous report received from a non-contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received  bnt162b2 (BNT162B2), administered in left arm, administration date 28Nov2021 (Lot number: 33030BD) at the age of 23 years as dose 3, single for COVID-19 immunisation. Relevant medical history included: "None". Concomitant medications were not reported. Vaccination history included: bnt162b2 (BNT162B2, DOSE 1, SINGLE, Lot Number: EN6207, Route of administration: Unspecified, Anatomical site: left arm), administration date: 01Apr2021 when the patient was 23 years old and bnt162b2 (BNT162B2, DOSE 2, SINGLE, Lot Number: EW0164, Route of administration: Unspecified, Anatomical site: left arm), administration date: 20Apr2021, when the patient was 23 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 28Nov2021, outcome "unknown", described as "Dose received: 3"; LYMPHADENOPATHY (non-serious), NAUSEA (non-serious), HEADACHE (non-serious) and PAIN (non-serious) all with onset 29Nov2021, outcome "recovering" and all described as "Swollen lymph nodes in left arm, nausea, headache and body aches". Therapeutic measures were not taken as a result of lymphadenopathy, headache, nausea and pain.  Additional Information: The patient's known allergies were reported as not applicable. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Dizziness, Fatigue, Immunisation, Nausea
Clinical narrative: High fever; Dizziness; Nausea; Fatigue to the point of falling asleep while sitting up; Fatigue to the point of falling asleep while sitting up; Swelling and pain in left armpit/ axial region so much so that my bras don't fit properly; Pain in left armpit/ axial region so much so that my bras don't fit properly; Dose received 3; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 29Nov2021 at 15:30 (Lot number: unknown) at the age of 39 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: PCN. Concomitant medications included: METFORMIN, HYDROXYZINE and BIRTH CONTROL. Vaccination history included: BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 2, SINGLE, Lot number: UNKNOWN, Anatomical site: Left arm, Administration time: 12:00, Route of administration: unspecified), administration date: 26Apr2021, and BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 1, SINGLE, Lot number: UNKNOWN, Anatomical site: Left arm, Administration time: 12:00, Route of administration: unspecified), administration date: 06Apr2021, both when the patient was 38 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 29Nov2021 at 15:30, outcome "unknown", described as "Dose received 3"; PYREXIA (non-serious) with onset 30Nov2021 at 06:00, outcome "not recovered", described as "High fever"; DIZZINESS (non-serious) with onset 30Nov2021 at 06:00, outcome "not recovered", described as "Dizziness"; NAUSEA (non-serious) with onset 30Nov2021 at 06:00, outcome "not recovered", described as "Nausea"; FATIGUE (non-serious), SOMNOLENCE (non-serious), SWELLING (non-serious), AXILLARY PAIN (non-serious) all with onset 30Nov2021 at 06:00, outcome "not recovered", and all described as "Fatigue to the point of falling asleep while sitting up". The events "High fever", "Dizziness", "Nausea", "Fatigue to the point of falling asleep while sitting up", "Swelling and pain in left armpit/ axial region so much so that my bras don't fit properly" and "Pain in left armpit/ axial region so much so that my bras don't fit properly" were evaluated at the physician office visit. It was unknown whether therapeutic measures were taken as a result of pyrexia, dizziness, nausea, fatigue, somnolence, swelling and axillary pain.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence, Swelling
Clinical narrative: High fever; Dizziness; Nausea; Fatigue to the point of falling asleep while sitting up; Fatigue to the point of falling asleep while sitting up; Swelling and pain in left armpit/ axial region so much so that my bras don't fit properly; Pain in left armpit/ axial region so much so that my bras don't fit properly; Dose received 3; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 29Nov2021 at 15:30 (Lot number: unknown) at the age of 39 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: PCN. Concomitant medications included: METFORMIN, HYDROXYZINE and BIRTH CONTROL. Vaccination history included: BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 2, SINGLE, Lot number: UNKNOWN, Anatomical site: Left arm, Administration time: 12:00, Route of administration: unspecified), administration date: 26Apr2021, and BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 1, SINGLE, Lot number: UNKNOWN, Anatomical site: Left arm, Administration time: 12:00, Route of administration: unspecified), administration date: 06Apr2021, both when the patient was 38 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 29Nov2021 at 15:30, outcome "unknown", described as "Dose received 3"; PYREXIA (non-serious) with onset 30Nov2021 at 06:00, outcome "not recovered", described as "High fever"; DIZZINESS (non-serious) with onset 30Nov2021 at 06:00, outcome "not recovered", described as "Dizziness"; NAUSEA (non-serious) with onset 30Nov2021 at 06:00, outcome "not recovered", described as "Nausea"; FATIGUE (non-serious), SOMNOLENCE (non-serious), SWELLING (non-serious), AXILLARY PAIN (non-serious) all with onset 30Nov2021 at 06:00, outcome "not recovered", and all described as "Fatigue to the point of falling asleep while sitting up". The events "High fever", "Dizziness", "Nausea", "Fatigue to the point of falling asleep while sitting up", "Swelling and pain in left armpit/ axial region so much so that my bras don't fit properly" and "Pain in left armpit/ axial region so much so that my bras don't fit properly" were evaluated at the physician office visit. It was unknown whether therapeutic measures were taken as a result of pyrexia, dizziness, nausea, fatigue, somnolence, swelling and axillary pain.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.