chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Raised hot injection site, fever 100+, fatigue
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Eating disorder, Fatigue, Irritability, Malaise
Clinical narrative: 13 Nov 2021 2000 Sore arm and irritable, gave 7 mL Tylenol   14 Nov 2021 0930 Extremely fatigued, eating very little except sips of water  1000 Temperature ? 103.5 degrees F (All temporal temps with a minimum of 3 reading values.  Average temp recorded) Tylenol ? 320 mg (2 tablets)  1145 Temperature ? 100.9 degrees F  1510 Noticed rapid respiration and pulse while child sleeping (HR 220+, Resp 40) Temperature ? 106.4 degrees F  1515 Tylenol ? 320 mg (10 mL) Lukewarm bath  1535 Temperature ? 101.0 degrees F  1625 Temperature ? 100.9 degrees F  2010 Temperature ? 102.8 degrees F  2015 Tylenol ? 320 mg (10 mL)  2045 Temperature ? 105.8 degrees F  2100 Temperature ? 103.6 degrees F  2125 Temperature ? 101.1 degrees F  2145 Temperature ? 105.2 degrees   2215 Temperature ? 99.8 degrees F  2235 Temperature ? 101.4 degrees F  2320 Temperature ? 103.1 degrees F  2340 Temperature ? 103.2 degrees F   15 Nov 2021 0020 Temperature ?  103.4 degrees F Tylenol ? 320 mg (10 mL) ? did not stay down, vomited within mins of medication administration and few sips of cool water Appears unwell; puffy eyes, fatigued Sips of water  0024 Vomiting ? water + Tylenol  0050 Temperature ?  104.2  degrees F  0120 Temperature ?  104.1  degrees F Tylenol ? 320 mg (10 mL) readministered   0140 Temperature ?  102.4  degrees F  0530 Temperature ?  normal to touch while sleeping  0915 Temperature ?  99.5  degrees F Tylenol ? 320 mg (10 mL)  1345 Temperature ?  98.3  degrees F  Completely healthy prior to vaccine, including all household members.  No other illness after conclusion of the above reported vaccination reaction.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Periorbital swelling, Vomiting
Clinical narrative: 13 Nov 2021 2000 Sore arm and irritable, gave 7 mL Tylenol   14 Nov 2021 0930 Extremely fatigued, eating very little except sips of water  1000 Temperature ? 103.5 degrees F (All temporal temps with a minimum of 3 reading values.  Average temp recorded) Tylenol ? 320 mg (2 tablets)  1145 Temperature ? 100.9 degrees F  1510 Noticed rapid respiration and pulse while child sleeping (HR 220+, Resp 40) Temperature ? 106.4 degrees F  1515 Tylenol ? 320 mg (10 mL) Lukewarm bath  1535 Temperature ? 101.0 degrees F  1625 Temperature ? 100.9 degrees F  2010 Temperature ? 102.8 degrees F  2015 Tylenol ? 320 mg (10 mL)  2045 Temperature ? 105.8 degrees F  2100 Temperature ? 103.6 degrees F  2125 Temperature ? 101.1 degrees F  2145 Temperature ? 105.2 degrees   2215 Temperature ? 99.8 degrees F  2235 Temperature ? 101.4 degrees F  2320 Temperature ? 103.1 degrees F  2340 Temperature ? 103.2 degrees F   15 Nov 2021 0020 Temperature ?  103.4 degrees F Tylenol ? 320 mg (10 mL) ? did not stay down, vomited within mins of medication administration and few sips of cool water Appears unwell; puffy eyes, fatigued Sips of water  0024 Vomiting ? water + Tylenol  0050 Temperature ?  104.2  degrees F  0120 Temperature ?  104.1  degrees F Tylenol ? 320 mg (10 mL) readministered   0140 Temperature ?  102.4  degrees F  0530 Temperature ?  normal to touch while sleeping  0915 Temperature ?  99.5  degrees F Tylenol ? 320 mg (10 mL)  1345 Temperature ?  98.3  degrees F  Completely healthy prior to vaccine, including all household members.  No other illness after conclusion of the above reported vaccination reaction.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided by the reporter No treatment information provided. The vaccine was initially stored in refrigerator on 16-Sep-2021.   This case was linked to MOD-2021-391855 (Patient Link).
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever, chills, body aches, head aches back of the head
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vials were used to provide 38 doses; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No vial went any temperature excursions.  On 12-Nov-2021, all vaccines were administered within 2 hours.  Some of patient received booster dose on 1-Nov-2021, 05-Nov-2021, 11-Nov-2021 and 12-Nov-2021. Till 19-Nov-2021, there were no adverse reactions to the vaccine.  As of 19 Nov 2021, there were no adverse reactions to the vaccine reported by the list below. We spoke with some that received the vaccine during these dates and some identified common side effects after the vaccine (ex: sore arm, etc.) and only lasted for a few hours but no more than 24 hours for 1st dose, 2nd dose and Booster.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Nov-2021: Follow up information received on 18 Nov 2021 included suspect administration date. On 19-Nov-2021: Follow-up information received on 19 Nov 2021  included about patients details On 19-Nov-2021: Significant Follow up received on 19 Nov 2021 appended (Second reporter Information was updated)
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Muscle spasms, Nausea
Clinical narrative: Loss of balance; Dissiness; Nausea; Charlie horse in legs; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8027) via an unspecified route of administration in the left arm on 15Nov2021 at 18:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, heart disease and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included alfuzosin hydrochloride (XATRAL) and metformin (MANUFACTURER UNKNOWN); both for unknown indications from unknown dates and unknown if on going. On 15Nov2021, the patient experienced loss of balance, dizziness, nausea and charlie hoarse in legs. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events loss of balance, dizziness, nausea and charlie hoarse in legs was not recovered at the time of report.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation
Clinical narrative: Pain in left armpit and surrounding area; Dose received 3; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8030), via an unspecified route of administration in the left arm on 16Nov2021 at 11:45 (at the age of 57-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. 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. The patient received unspecified medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206), via an unspecified route of administration in the left arm on 14Mar2021 at 15:00 (at the age of 56-year-old), and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FR8730), via an unspecified route of administration in the left arm on 05Apr2021 at 10:00 (at the age of 56-year-old); both as single dose for COVID-19 immunisation. On 18Nov2021 at 22:00, the patient experienced pain in left armpit and surrounding area. The pain in left armpit and surrounding area did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the pain in left armpit and surrounding area. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pain in left armpit and surrounding area was not resolved at the time of this report.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Immunisation, Muscle spasms, Nausea
Clinical narrative: Nausea; Vomiting; Headache; Joint pain; Muscle cramping; The patient received a third/booster dose; This is a spontaneous report from a contactable health care professional, the patient. A 50-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the left arm on 18Nov2021 at 07:00(at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history includes thyroid condition. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient received unspecified medications within two weeks of vaccination. The patient previously received diphenhydramine; paracetamol; phenylpropanolamine hydrochloride (BENADRYL) and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in left arm on 25Jan2021 at 12:00 (at the age of 49-years-old) as a single dose and also second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the left arm on 15Feb2021 at 12:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation.  On 18Nov2021 at 22:00, the patient experienced nausea, vomiting, headache, joint pain and muscle cramping. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, vomiting, headache, joint pain and muscle cramping were resolving at the time of this report.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Nausea; Vomiting; Headache; Joint pain; Muscle cramping; The patient received a third/booster dose; This is a spontaneous report from a contactable health care professional, the patient. A 50-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the left arm on 18Nov2021 at 07:00(at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history includes thyroid condition. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient received unspecified medications within two weeks of vaccination. The patient previously received diphenhydramine; paracetamol; phenylpropanolamine hydrochloride (BENADRYL) and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in left arm on 25Jan2021 at 12:00 (at the age of 49-years-old) as a single dose and also second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the left arm on 15Feb2021 at 12:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation.  On 18Nov2021 at 22:00, the patient experienced nausea, vomiting, headache, joint pain and muscle cramping. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, vomiting, headache, joint pain and muscle cramping were resolving at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation, Nausea, Pain
Clinical narrative: The patient received the third/boster dose of BNT162b2; After getting the COVID booster shot, patient experienced "splitting headache; Aches; Nausea; This is a spontaneous report from a contactable consumer. An adult female patient of unknown age, received third (BOOSTER) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 18Nov2021 as a single dose for COVID-19 immunisation. It was unknown if the patient was pregnant at the time of vaccination. The medical history included drug allergy (unspecified drug) and it was unknown whether the patient had any other medical history. It was also unknown, if patient had any known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. It was unknown if the patient received any other concomitant medications within two weeks prior to the vaccination. Previously, the patient had received two doses of COVID-19 vaccine (MANUFACTURER UNKNOWN) via an unspecified route of administration, on unspecified dates, as a single dose for COVID-19 immunisation. On 18Nov2021, after getting the COVID-19 booster shot, the patient experienced splitting headache, aches and nausea and had an awful night. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events splitting headache, aches and nausea was unknown at the time of this report.  The batch/lot numbers for BNT162b2 were not provided and will be requested during follow up.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Sudden pain below the left chest.While having that symptom, feel pain when having a deep breath or a big smile.; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30145BA) via an unspecified route of administration in the left arm on 08Oct2021 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. 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. The patient did not receive any concomitant medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 3184 [as reported] ) via an unspecified route of administration in the left arm on 17Sep2021 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. On an unknown date in Nov2021 at 09:00, the patient experienced sudden pain below the left chest. It was reported that while having that symptom, the patient feels felt pain when having a deep breath or a big smile. After 10-15 minutes, the symptom was gone. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sudden pain below the left chest while having that symptom, felt pain when having a deep breath or a big smile was not resolved at the time of this report.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Hypersomnia, SARS-CoV-2 test, Sluggishness
Clinical narrative: Shortness of breath; Tiredness; Sluggishness; I was sleeping a lot; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0818) via an unspecified route of administration in the left arm on 27Jun2021 at 12:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19.The patient did not take any other medications within two weeks of vaccination. On 28Jun2021, the patient experienced shortness of breath, tiredness, sluggishness and was sleeping a lot. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in Aug2021, the patient underwent nasal swab test and the result was negative. The clinical outcome of the events shortness of breath, tiredness, sluggishness and was sleeping a lot were resolved on an unknown date in 2021.The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181) via an unspecified route of administration in the left arm on 18Jul2021 at 12:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia areata
Clinical narrative: Quarter size bald patch (alopecia areata ) on left side of scalp; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 28Oct2021 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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. Concomitant medication taken within two weeks of vaccination included multivitamin (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 20Nov2021, the patient experienced quarter size bald patch (alopecia areata) on left side of scalp. The patient had no previous history of "AA" (alopecia areata). It was reported that the patient had a dermatologist appointment the next day of this report so it was unknown if treatment would be available at that time. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event quarter size bald patch (alopecia areata) on left side of scalp was unknown at the time of this report.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Immunisation, Lymphadenitis
Clinical narrative: Very severe headache that would not go away.; Fever; Chills; All over body pain; Extremely inflamed lymph node; Extreme fatigue; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received third (BOOSTER) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 19Nov2021 at 08:00(at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included Hashimoto's disease, high blood pressure, high cholesterol. The patient was allergic to scallops. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID), rosuvastatin calcium (CRESTOR), estradiol (ESTROGEN), multivitamin (MANUFACTURER UNKNOWN) and homeopathics nos (ZICAM); all for an unknown indication from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Mar2021 at 10:30(at the age of 48-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Apr2021 at 10:30(at the age of 48-years-old) as a single dose for COVID-19 immunisation. On 19Nov2021 at 19:00 the patient experienced very severe headache that would not go away, fever, chills, all over body pain, extremely inflamed lymph node, extreme fatigue.  Severe symptoms lasted longer than 24 hours. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events very severe headache that would not go away, fever, chills, all over body pain, extremely inflamed lymph node, extreme fatigue was not resolved at the time of this report.  The batch/lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Very severe headache that would not go away.; Fever; Chills; All over body pain; Extremely inflamed lymph node; Extreme fatigue; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received third (BOOSTER) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 19Nov2021 at 08:00(at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included Hashimoto's disease, high blood pressure, high cholesterol. The patient was allergic to scallops. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID), rosuvastatin calcium (CRESTOR), estradiol (ESTROGEN), multivitamin (MANUFACTURER UNKNOWN) and homeopathics nos (ZICAM); all for an unknown indication from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Mar2021 at 10:30(at the age of 48-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Apr2021 at 10:30(at the age of 48-years-old) as a single dose for COVID-19 immunisation. On 19Nov2021 at 19:00 the patient experienced very severe headache that would not go away, fever, chills, all over body pain, extremely inflamed lymph node, extreme fatigue.  Severe symptoms lasted longer than 24 hours. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events very severe headache that would not go away, fever, chills, all over body pain, extremely inflamed lymph node, extreme fatigue was not resolved at the time of this report.  The batch/lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Amenorrhoea, Feeling abnormal, Hot flush, Menopause
Clinical narrative: After the COVID-19 shot "I" haven't had a period at all; I've got brain fog; Ive got hot flashes; Ive got thinning hair; Early onset menopause/ I havent had a period at all / got full-blown menopause; Received the vaccine on the left leg; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left leg on 05Jun2021 at 16:15(at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the vaccination. Concomitant medications included cetirizine (MANUFACTURER UNKNOWN), multivitamin (unspecified) and probiotic (unspecified); all for an unknown indication from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15May2021 at 16:15(at the age of 51-years-old) as a single dose for COVID-19 immunisation. On 11Aug2021, the patient experienced early onset menopause. The patient had absolutely no symptoms and her periods were absolutely regular and she reported she was mad about the age but still to go from zero symptoms to full on menopause (meta-paws) right after, seemed too much of a coincidence. The patient had been completely regular, no hot flashes but after the COVID-19 shot, she hasn't had a period at all. She had brain fog, hot flashes, thinning of hair, full-blown menopause and she did not have any warning or symptoms beforehand. The events resulted in doctor or other healthcare professional office/clinic visit. It was unclear if therapeutic measures were taken as a result of events. It was also reported that the patient had appointments coming up. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events early onset menopause, after the COVID-19 shot haven't had a period at all, got brain fog, hot flashes, thinning hair, full-blown menopause was not recovered at the time of this report.   The batch/lot numbers for BNT162b2 were not provided and will be requested during follow up.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site
Clinical narrative: After the COVID-19 shot "I" haven't had a period at all; I've got brain fog; Ive got hot flashes; Ive got thinning hair; Early onset menopause/ I havent had a period at all / got full-blown menopause; Received the vaccine on the left leg; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left leg on 05Jun2021 at 16:15(at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the vaccination. Concomitant medications included cetirizine (MANUFACTURER UNKNOWN), multivitamin (unspecified) and probiotic (unspecified); all for an unknown indication from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15May2021 at 16:15(at the age of 51-years-old) as a single dose for COVID-19 immunisation. On 11Aug2021, the patient experienced early onset menopause. The patient had absolutely no symptoms and her periods were absolutely regular and she reported she was mad about the age but still to go from zero symptoms to full on menopause (meta-paws) right after, seemed too much of a coincidence. The patient had been completely regular, no hot flashes but after the COVID-19 shot, she hasn't had a period at all. She had brain fog, hot flashes, thinning of hair, full-blown menopause and she did not have any warning or symptoms beforehand. The events resulted in doctor or other healthcare professional office/clinic visit. It was unclear if therapeutic measures were taken as a result of events. It was also reported that the patient had appointments coming up. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events early onset menopause, after the COVID-19 shot haven't had a period at all, got brain fog, hot flashes, thinning hair, full-blown menopause was not recovered at the time of this report.   The batch/lot numbers for BNT162b2 were not provided and will be requested during follow up.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain
Clinical narrative: Extreme Tenderness in my ribs. It's hurts to bend or touch, lay down.; This is a spontaneous report from a contactable other healthcare professional, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8030) via an unspecified route of administration in the left arm on 20Nov2021 at 17:15 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included acne and sulfa allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included spironolactone (MANUFACTURER UNKNOWN) for an unknown indication, from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received paracetamol; oxycodone hydrochloride; oxycodone terephthalate (PERCOCET) and experienced drug allergy. On 21Nov2021 at 08:00, the patient experienced extreme tenderness in her ribs; it hurt to bend, touch or lay down. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event extreme tenderness in ribs; it hurt to bend, touch or lay down was resolving at the time of this report.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Malaise, Nausea
Clinical narrative: Tiredness; Headache; Nausea; Decreased appetite; Arm pain; Feeling unwell; This is a spontaneous report from a non-contactable consumer, the patient. A 15-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2590) via an unspecified route of administration in the left arm on 18Nov2021 at 14:15 (at the age of 15-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and had no known allergies. 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. Concomitant medications were not reported. On 19Nov2021 at 09:30, the patient experienced tiredness, headache, nausea, decreased appetite, arm pain and feeling unwell. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events tiredness, headache, nausea, decreased appetite, arm pain and feeling unwell were not recovered at the time of this report.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Tiredness; Headache; Nausea; Decreased appetite; Arm pain; Feeling unwell; This is a spontaneous report from a non-contactable consumer, the patient. A 15-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2590) via an unspecified route of administration in the left arm on 18Nov2021 at 14:15 (at the age of 15-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and had no known allergies. 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. Concomitant medications were not reported. On 19Nov2021 at 09:30, the patient experienced tiredness, headache, nausea, decreased appetite, arm pain and feeling unwell. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events tiredness, headache, nausea, decreased appetite, arm pain and feeling unwell were not recovered at the time of this report.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Biliary colic, Immunisation
Clinical narrative: Dose received 3; Pain in stomach; Pain in stomach and gall bladder; This is a spontaneous report from a contactable pharmacist, the patient. A 35-year-old male patient received third (booster) dose of COVID-19 VACCINE-MANUFACTURER UNKNOWN, Lot Number: UNKNOWN, via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included influenza vaccine (FLU VACCINE) for immunisation on an unknown date (within four weeks prior to the COVID vaccine). The patient previously received first dose of covid-19 vaccine (MANUFACTURER UNKNOWN, Lot Number: UNKNOWN), and second dose of covid-19 vaccine (MANUFACTURER UNKNOWN, Lot Number: UNKNOWN); both on unknown dates for COVID-19 immunisation. On 20Nov2021 at 13:30, the patient experienced pain in stomach and gall bladder. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain in stomach and gall bladder was not resolved at the time of this report.    The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Polymenorrhoea
Clinical narrative: period every 2 weeks for event frequent periods; period every 2 weeks for event frequent periods; This is a spontaneous report from a non-contactable consumer, the patient. A 16-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2588) via an unspecified route of administration in the left arm on 23Sep2021 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. It was reported that the patient did not know of any known allergies. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the left arm on 26Aug2021 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Oct2021, the patient experienced period every 2 weeks and very heavy. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event period every 2 weeks and very heavy was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Immunisation, Nausea, Pain
Clinical narrative: Nausea; vomiting; body aches; chills; fevers; diarrhea; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a non-contactable nurse, the patient. A 24-year-old non-pregnant female patient received the third dose (BOOSTER DOSE) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Nov2021 at 08:45 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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 sertraline (MANUFACTURER UNKNOWN) and birth control (Unspecified). The patient previously took vancomycin (MANUFACTURER UNKNOWN), hydrocodone (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Dec2020 at 18:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 21Jan2021 at 18:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation.  On 19Nov2021 at 23:00, the patient experienced nausea, vomiting, body aches, chills, fevers and diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with ondansetron (ZOFRAN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, vomiting, body aches, chills, fevers and diarrhea was resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Nausea; vomiting; body aches; chills; fevers; diarrhea; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a non-contactable nurse, the patient. A 24-year-old non-pregnant female patient received the third dose (BOOSTER DOSE) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Nov2021 at 08:45 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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 sertraline (MANUFACTURER UNKNOWN) and birth control (Unspecified). The patient previously took vancomycin (MANUFACTURER UNKNOWN), hydrocodone (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Dec2020 at 18:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 21Jan2021 at 18:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation.  On 19Nov2021 at 23:00, the patient experienced nausea, vomiting, body aches, chills, fevers and diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with ondansetron (ZOFRAN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, vomiting, body aches, chills, fevers and diarrhea was resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy
Clinical narrative: Very Swollen lymph nodes  in armpit on side of injection; A third (booster) dose of BNT162b2 is administered subsequent to the initial 2 dose regimen of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Nov2021 at 16:45 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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 gabapentin (MANUFACTURER UNKNOWN) taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 4Feb2021 at 12:00 (at the age of 32-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Mar2021 at 12:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 19Nov2021 at 20:00, the patient experienced very swollen lymph nodes in armpit on side of injection. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event very swollen lymph nodes in armpit on side of injection was resolving at the time of this report.     The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; tired; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 15Apr2021 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines. The patient had no known allergies. 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. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration on 25Mar2021(at the age of 59-years-old) as a single dose for COVID-19 immunisation. On 15Apr2021, the patient experienced sore arm and tired. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore arm and tired was resolved on an unknown date in 2021.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Vaccination failure
Clinical narrative: got the vaccinegot shingles/suspected vaccination failure; got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the Shingles vaccine and got shingles any way and the patient stated god awful. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown at the time of reporting.