chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Epistaxis, Headache, Paraesthesia
Clinical narrative: nose bleeds; headache; dizziness; tingly; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA vaccine, Lot number: unknown) via an unspecified route of administration on 18Mar2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine and penicillin allergy. Concomitant medications included bupropion (MANUFACTURER UNKNOWN), paracetamol (TYLENOL) and docosahexaenoic acid, eicosapentaenoic acid, tocopherol (OMEGA 3), all from unknown dates and unknown indications. The patient did not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 19Mar2021, the patient experienced nose bleeds, headache, dizziness and tingly. The adverse event resulted in a visit to the doctors or other healthcare professional office/clinic visit. It was unknown if the patient received treatment for the reported events. The clinical outcome of the events nose bleeds, headache, dizziness and tingly was unknown at the time of this report.   Information on lot/batch number has been requested.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Hot flush, Nausea
Clinical narrative: Lightheaded; Nausea; Hot flush; Fatigue; Chills; This is a spontaneous report received from a contactable pharmacist. A 36-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: ER8270) via an intramuscular route of administration in the left arm the 23Mar2021 at 11:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported and there were no known allergies. The concomitant medications were unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID-19 vaccination. On 23Mar2021 at 12:00, the patient experienced lightheaded, nausea, hot flush, fatigue and chills. The patient did not receive any treatment for the events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the lightheaded, nausea, hot flush, fatigue and chills was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Fever; Chills; Body ache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 17Mar2021 at 19:00(at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food, or other products. Concomitant medication included rosuvastatin (MANUFACTURER UNKNOWN) 40 milligram (mg) for an unknown indication from an unknown date. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5502) via an unspecified route of administration in the left arm on 24Feb2021 at 19:00 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since the vaccination. On 18Mar2021, at 12:00 (17hrs after the vaccination) the patient experienced fever, chills, body aches and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the events fever, chills, body ache and fatigue was resolved on 20Mar2021 at 12:00.   No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: itchy; puffy hives; This is a spontaneous report from a contactable other healthcare professional, the patient. A 30-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER COVID-19 mRNA VACCINE BIONTECH, Lot number: ER2613) via intramuscular in the left arm on 16Mar2021 at 10:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had a history of allergy to Bactrim and Z-pak. The patient did not receive any medication within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER COVID-19 mRNA VACCINE BIONTECH, Lot number: ER6200) via intramuscular in the left arm on 16Feb2021 at 08:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested positive for COVID-19 since having the vaccine. 5 days post vaccination, on 21Mar2021 at 07:00, the patient experienced a series of puffy hives appeared on both of arms (more on the injection arm). The patient applied hydrocortisone cream to the hives and took a Benadryl. In the next day morning on 22Mar2021, the patient woke up with hives all over her chest, neck, some on face, and all down legs and arms. They were itchy but below the surface of the skin. The treatment medications included Benadryl, Pepcid and prednisone for the reported events. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events hives and itchy was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021324091 similar report from same reporter
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Headache, Pain, Skin warm
Clinical narrative: Tender arm; Warm to the touch; Body aches; Headache; Upset stomach; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: ER2613), via an unspecified route of administration in the left arm on 22Mar2021 at 18:15 (at the age of 25-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included birth control. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccine 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021 at 03:00, the patient experienced tender arm, warm to the touch, body aches, headache, and upset stomach with diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the events tenderness, skin warm, general body pain, headache, diarrhea and stomach upset was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Tender arm; Warm to the touch; Body aches; Headache; Upset stomach; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: ER2613), via an unspecified route of administration in the left arm on 22Mar2021 at 18:15 (at the age of 25-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included birth control. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccine 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021 at 03:00, the patient experienced tender arm, warm to the touch, body aches, headache, and upset stomach with diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the events tenderness, skin warm, general body pain, headache, diarrhea and stomach upset was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: This is a spontaneous report received from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route of administration on the left arm on 15Mar2021 at 10:30 (at the age of 33-years-old), as a single dose for COVID-19 immunization. Relevant medical history included asthma and penicillin allergy from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included birth control medication (unspecified) on an unknown date. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 15Mar2021 at 10:45, the patient experienced numbing and tingling sensation on the left arm and left side of face. To date which is one week after the vaccine, tingling and numbing sensation was still felt around mouth. The patient did not receive treatment for the event numbness and tingling. The clinical outcome of the events numbness and tingling was recovered with sequelae on an unknown date. No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: Chills; Headache; Tiredness; Body ache; This is a spontaneous report from a contactable consumer, the patient. A 67-years old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: en6206) via an unspecified route of administration in the left arm on 06Mar2021 at 09:00 (at the age of 67-years-old), as a second single dose for COVID-19 immunisation. The patient's medical history included T2diabeties, high blood pressure and asthma. The patient had allergy to erythromycin. Concomitant medications included insulin (MANUFACTURER UNKNOWN), dulaglutide(TRULICITY), Lisinopril (MANUFACTURER UNKNOWN), Amlopine (MANUFACTURER UNKNOWN) and paracetamol(TYLENOL) were taken for unknown indications received on unknown dates. 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 previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lo t number: el9266), via an unspecified route of administration in the left arm on 13Feb201 at 09:00, for COVID-19 immunisation. On 07Mar2021 at 11:00, the patient experienced chills, headache, tiredness, body ache, continue to experience extreme tiredness where the patient had to lie down various time throughout the day. The was patient had doctor or other healthcare professional office/clinic visit due to the adverse events and patient did not received any treatment for the adverse events. The clinical outcome of chills, headache, tiredness and body ache were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Pain
Clinical narrative: stinging sensation on my legs, also had similar sensations on my torso and back; pain; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727); via unspecified route of administration in the left arm on 20Mar2021 at 12:00(at the age 51-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no allergy to any medications, food, or other products. Concomitant medications included low dose of acetylsalicylic acid (ASPIRIN) and amitriptyline (MANUFACTURER UNKNOWN); both from unknown dates for unknown indications. The patient did not receive any other vaccine within four weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 21Mar2021 at 13:15, approximately 24 hours after the vaccination, the patient experienced stinging sensation on her legs. This had repeated the following two days as well, all at random times during the day, but not after he go to bed. he also had similar sensations on my torso and back. There had been no visible signs at all. The sensations last from 10-60 minutes. The pain is similar, but slightly less than a fire ant bite. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of stinging sensation of legs, torso, back and pain was not recovered. No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Rash
Clinical narrative: Rash and flushing of skin; Flushing of skin; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727), via an unspecified route of administration in the right arm on 23Mar2021 at 08:30 (at the age of 37-years-old), as a single dose for COVID-19 immunisation. Medical history included thalassemia beta, Hashimoto's (thyroid) and allergic to tree nuts. Concomitant medications included magnesium vitamin C (MANUFACTURER UNKNOWN), vitamin B complex (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN) and probiotic nos (MANUFACTURER UNKNOWN); all for unspecified indications from unknown dates. The patient previously received betamethasone (MANUFACTURER UNKNOWN) and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021 at 17:00, the patient experienced rash and flushing of skin. The patient did not receive any treatment for the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the rash and flushing of skin were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Spontaneous nosebleed 2hours after injection; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207), via an unspecified route of administration in the left arm on 23Mar2021 at 16:45 (at the age of 58-years-old), as a single dose for COVID-19 immunisation. The patient did not have any medical history at the time of report. Concomitant medications included low dose acetylsalicylic acid (ASPIRIN), multivitamin and flaxseed oil, all for unknown indication within two weeks of vaccine. The patient did not have any allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 23Mar2021 at 18:45, the patient experienced spontaneous nosebleed 2 hours after injection. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event nosebleed was resolving.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Hard swelling at site of injection; Vaccination site redness; This is a spontaneous report received from a contactable consumer, the patient. A 62-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6204) via an unspecified route of administration in the left arm on 08Mar2021 at 14:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included allergy to sulfa drugs. The concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Mar2021, the patient had a 2X2 inch hard red swelling at site of injection (vaccination site swelling and vaccination site erythema), which had appeared about 12 days after first injection. It was reported that it was the first, ever such reaction to a vaccine, either delayed or immediate. The redness began to subside after a few days and there were no other symptoms. The events didn't result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events vaccination site swelling and vaccination site erythema was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash
Clinical narrative: Light pink/red rash around the injection site; Light pink/red rash around the injection site; This is a spontaneous report received from a contactable other health care professional. A 29-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: ER2613), via unspecified route of administration in left arm on 19Mar2021 at 17:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and surgery to fix tendonosis. The patient had no known allergies. The concomitant medication included claritin (LORATADINE), budesonide-formoterol (SYMBICORT), cetirizine (ZYRTEC), paracetamol (TYLENOL) and proair. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6200) via unspecified route of administration in left arm on 26Feb2021 at 16:45 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021 at 19:00, the patient experienced light pink/red rash around the injection site (vaccination site erythema and vaccination site rash). The clinical outcome of the event light pink/red rash was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site mass
Clinical narrative: left arm at the injection sight developed a huge (between golf & tennis ball) itchy bump that was painful to touch; Arm is still a bit tender; This is a spontaneous report from a contactable consumer, the patient. An 18-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208), via an unspecified route of administration in the left arm on 11Mar2021 at 17:15 (at the age of 18-years-old), as a single dose for COVID-19 immunisation. Medical history included asthma. The patient was allergic to dogs, pollen, mould, guinea pigs and dust. Concomitant medication included isotretinoin (CLARAVIS) 40mg; from an unknown date for unspecified indication. The patient did not receive any other vaccines within four weeks prior to the 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. On Saturday, 20Mar2021, the patient developed a huge itchy bump (between golf & tennis ball) on the left arm at the injection sight, that was painful to touch. The arm was still a bit tender and the bump had reduced in size. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events vaccination site lump and pain in arm was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Red Rash on day 4 or day 5.  Both Arms & both upper legs.  Around ankles.; This is a spontaneous report received from contactable consumer, the patient. A 50-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route of administration in the left arm on 12Mar2021 at 11:45 (at the age of 50-years-old), as single dose for COVID-19 immunisation. Medical history included patient was asthmatic. The patient was not allergic to medications, food and other products. Concomitant medication included ventolin(MANUFACTURER UNKNOWN) from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since the vaccination. On 16Mar2021, the patient experienced delayed reaction, red rash on day 4 or day 5, both arms & both upper legs and around ankles. On day 12 still had rash when body heats up shower or working out. The events result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of red rash was not resolved at the time of report.   No follow-up attempts are possible. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Mild-moderate left arm pain; This is a spontaneous report from a contactable consumer, the parent. A 16-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 01Mar2021 at 15:15 (at the age of 16-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. 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 did not receive any other vaccines within four weeks prior to the COVID vaccine. On 23Mar2021 at 22:00, the patient experienced mild to moderate left arm pain. The patient did not receive any treatment for the event. The clinical outcome of event left arm pain was resolving at the time of this report. Information about lot/batch number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Arm (both), chest and leg. Hives; This is a spontaneous report from a contactable consumer, the patient. A 74-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in left arm on 18Mar2021 at 15:30, (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included congestive heart failure. The patient was allergic to medications, food or other products. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in left arm on 25Feb2021 at 15:30, as a single dose for COVID-19 immunisation. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Mar2021, the patient experienced hives over arm (both), chest and leg. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient not received treatment for the reported events. The clinical outcome for event hives were recovering.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Rash
Clinical narrative: face, neck, ear, chest, and shoulder turned red.; Skin Rash; Rash areasfelt hot; This is a spontaneous report from a contactable consumer, the patient. A 49-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204), via an unspecified route of administration in the left arm on 23Mar2021 at 12:45 (at the age of 49-years-old), as a single dose for COVID-19 immunisation. The patient medical history included Hashimotos, Sjogrens syndrome (Sjogrens), systemic lupus erythematosus (Lupus), and polymorphous disorder. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was allergic to morphine, prednisone and some antibiotics(unspecified). Concomitant medications included levothyroxine (25mg) (MANUFACTURER UNKNOWN), sertraline (25mg) (MANUFACTURER UNKNOWN) for unknown indications and from an unknown date. The patient also received ADVIL 2 days before the vaccination on 21Mar2021. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021 at 12:45, within a couple of minutes of vaccination patients face, neck, ear, chest, and shoulder turned red. The patient developed rash in some areas and also felt hot in those areas. It was reported that this lasted an hour at that severity and when it started to improve, patient left home. The areas were red but not as bright and they didnt feel as hot. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events skin red and rash was not recovered; while that of the event hot feeling was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen lymph nodes : left armpit, breast; right neck above an below collar bone and into armpit. Above collarbone is a hard nodule with swollen line over collarbone that radiates toward armpit; Swollen lymph nodes: Very painful.; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route on the right arm on 12Mar2021 16:30 (at the age of 60-year-old) as a single dose, for COVID-19 immunisation. Medical history included mitral valve prolapse, Penicillin allergy, Sulfa allergy, contrast agents allergy and shellfish allergy. Concomitant medications included atenolol (MANUFACTURER UNKNOWN), rosuvastatin (MANUFACTURER UNKNOWN), cranberry pills (MANUFACTURER UNKNOWN) and b complex (MANUFACTURER UNKNOWN) for unknown indication from unknown date. The patient previously took cefaclor monohydrate (CECLOR)and cefalexin monohydrate (KEFLEX) for unspecified indication from unknown dates and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 15Mar2021, the patient experienced swollen lymph nodes from left armpit, breast, right neck above and below collar bone into armpit (lymph nodes cervical swollen). There was a hard nodule with swollen line over collarbone which radiated toward armpit and was very painful (lymph node pain). The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure was taken as a result of event and included the treatment with X-ray with CT scan to follow (No details to confirm if patient underwent these investigations). The clinical outcome of events lymph nodes cervical swollen and lymph node pain was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: migraine-like headache; This is a spontaneous report from a contactable other health care professional, the patient. A 62-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6208) via an unspecified route of administration in the left arm on 08MAR2021 at 10:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. The patient had unspecified past medical history. 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 received unspecified medications within 2 weeks of vaccination. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced migraine like headache within a few days after the shot on 11Mar2021 at 14:00. It was reported that the patient never gets headaches before. The adverse event did not result in doctor or other healthcare professional office or clinic visit or emergency room visit. The patient had not received any treatment for the event. The clinical outcome of the event migraine like headache was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Breaking out in a rash, it itches. All over my arms and chest; This is a spontaneous report received from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in the left arm on 23Mar2021 at 13:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant past medical history. Concomitant medications were not reported.  The patient did not have any allergies to medications, food, or other products. 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 did not receive any other vaccines within four weeks prior to the vaccination. On 23Mar2021 at 17:00, the patient experienced breaking out rash, it itches all over arms and chest. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event breaking out rash itches all over arms and chest was not resolved.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable healthcare professional, the patient. A 40-Year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8727) via an unspecified route of administration in right arm on 23Mar2021 at 12:45 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. Concomitant medication was not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: En6198) via an unspecified route of administration in right arm on 02Mar2021 at 12:45 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 23Mar2021 at 15:45, the patient experienced diarrhea which began after he got the vaccine, before he ate anything. It was mostly liquid. The patient did not receive any treatment for events. The clinical outcome of event diarrhea was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: APACHE II score, AST/ALT ratio, Alanine aminotransferase increased, Alpha-1 anti-trypsin, Antinuclear antibody
Clinical narrative: AST 916; ALT 1865; TB peaked at 5.5; AP 134; jaundice; headache; chills; acholic stools; dark urine; This is a spontaneous report from a contactable physician on behalf of patient. A 59-year-old male patient of received bnt162b2 (Pfizer COVID 19, formulation: solution for injection Batch/Lot number was not reported), via an unspecified route of administration on 08Feb2021 (at the age of 59-year-old) as dose 2, single for COVID-19 immunisation. Medical history included sleep apnoea syndrome. The patient had no allergies. Concomitant medications were not reported. The patient previously took 1st dose of BNT162B2 for COVID-19 immunisation. Prior to the vaccination the patient was not diagnosed with COVID-19. It was unknown whether the patient received any other vaccine within four weeks prior to the COVID vaccine. The clinical course of the events was reported as: on an unknown date in Feb2021, the patient experienced jaundice and went to the physician. The reporter stated that first saw him on 25Feb2021. His initial presentation included headache and chills. He completed the second Phizer COVID vaccination on 08 Feb2021. He never had abdominal pain but he did develop icteric sclera, jaundice, acholic stools and dark urine. A workup included a negative viral hep panel including two HAV IgM (anti Hepatitis A virus immunoglobulin M), negative ANA (Antinuclear antibody), A1AT (Alpha-1 anti-trypsin) and a normal CT (Computerised tomogram) with normal GB (Generalised bullous) and bile ducts. TB (Tuberculosis) peaked at 5.5 with AST (aspartate transaminase) 916, ALT (alanine transaminase) 1865. He began to feel better the last week of Feb 2021 and repeat labs on 10Mar2021 showed TB 1.3 AST 29 ALT 102 ap 134. It was unclear if this was an infectious process that was not captured but the reporter worried enough that this could be related to the vaccine he received 1.5 weeks earlier enough to send this report. Since the vaccination the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment. The outcome of the events was recovering.  Information regarding the lot/ batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event increased AST, ALT and TB test positive and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities,  Committees, and Investigators, as appropriate.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Aspartate aminotransferase increased, Blood alkaline phosphatase increased, Blood immunoglobulin M, Chills, Chromaturia
Clinical narrative: AST 916; ALT 1865; TB peaked at 5.5; AP 134; jaundice; headache; chills; acholic stools; dark urine; This is a spontaneous report from a contactable physician on behalf of patient. A 59-year-old male patient of received bnt162b2 (Pfizer COVID 19, formulation: solution for injection Batch/Lot number was not reported), via an unspecified route of administration on 08Feb2021 (at the age of 59-year-old) as dose 2, single for COVID-19 immunisation. Medical history included sleep apnoea syndrome. The patient had no allergies. Concomitant medications were not reported. The patient previously took 1st dose of BNT162B2 for COVID-19 immunisation. Prior to the vaccination the patient was not diagnosed with COVID-19. It was unknown whether the patient received any other vaccine within four weeks prior to the COVID vaccine. The clinical course of the events was reported as: on an unknown date in Feb2021, the patient experienced jaundice and went to the physician. The reporter stated that first saw him on 25Feb2021. His initial presentation included headache and chills. He completed the second Phizer COVID vaccination on 08 Feb2021. He never had abdominal pain but he did develop icteric sclera, jaundice, acholic stools and dark urine. A workup included a negative viral hep panel including two HAV IgM (anti Hepatitis A virus immunoglobulin M), negative ANA (Antinuclear antibody), A1AT (Alpha-1 anti-trypsin) and a normal CT (Computerised tomogram) with normal GB (Generalised bullous) and bile ducts. TB (Tuberculosis) peaked at 5.5 with AST (aspartate transaminase) 916, ALT (alanine transaminase) 1865. He began to feel better the last week of Feb 2021 and repeat labs on 10Mar2021 showed TB 1.3 AST 29 ALT 102 ap 134. It was unclear if this was an infectious process that was not captured but the reporter worried enough that this could be related to the vaccine he received 1.5 weeks earlier enough to send this report. Since the vaccination the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment. The outcome of the events was recovering.  Information regarding the lot/ batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event increased AST, ALT and TB test positive and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities,  Committees, and Investigators, as appropriate.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Congenital absence of bile ducts, Faeces pale, Generalised bullous fixed drug eruption, Headache
Clinical narrative: AST 916; ALT 1865; TB peaked at 5.5; AP 134; jaundice; headache; chills; acholic stools; dark urine; This is a spontaneous report from a contactable physician on behalf of patient. A 59-year-old male patient of received bnt162b2 (Pfizer COVID 19, formulation: solution for injection Batch/Lot number was not reported), via an unspecified route of administration on 08Feb2021 (at the age of 59-year-old) as dose 2, single for COVID-19 immunisation. Medical history included sleep apnoea syndrome. The patient had no allergies. Concomitant medications were not reported. The patient previously took 1st dose of BNT162B2 for COVID-19 immunisation. Prior to the vaccination the patient was not diagnosed with COVID-19. It was unknown whether the patient received any other vaccine within four weeks prior to the COVID vaccine. The clinical course of the events was reported as: on an unknown date in Feb2021, the patient experienced jaundice and went to the physician. The reporter stated that first saw him on 25Feb2021. His initial presentation included headache and chills. He completed the second Phizer COVID vaccination on 08 Feb2021. He never had abdominal pain but he did develop icteric sclera, jaundice, acholic stools and dark urine. A workup included a negative viral hep panel including two HAV IgM (anti Hepatitis A virus immunoglobulin M), negative ANA (Antinuclear antibody), A1AT (Alpha-1 anti-trypsin) and a normal CT (Computerised tomogram) with normal GB (Generalised bullous) and bile ducts. TB (Tuberculosis) peaked at 5.5 with AST (aspartate transaminase) 916, ALT (alanine transaminase) 1865. He began to feel better the last week of Feb 2021 and repeat labs on 10Mar2021 showed TB 1.3 AST 29 ALT 102 ap 134. It was unclear if this was an infectious process that was not captured but the reporter worried enough that this could be related to the vaccine he received 1.5 weeks earlier enough to send this report. Since the vaccination the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment. The outcome of the events was recovering.  Information regarding the lot/ batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event increased AST, ALT and TB test positive and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities,  Committees, and Investigators, as appropriate.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Jaundice, Tuberculin test positive, Tuberculosis
Clinical narrative: AST 916; ALT 1865; TB peaked at 5.5; AP 134; jaundice; headache; chills; acholic stools; dark urine; This is a spontaneous report from a contactable physician on behalf of patient. A 59-year-old male patient of received bnt162b2 (Pfizer COVID 19, formulation: solution for injection Batch/Lot number was not reported), via an unspecified route of administration on 08Feb2021 (at the age of 59-year-old) as dose 2, single for COVID-19 immunisation. Medical history included sleep apnoea syndrome. The patient had no allergies. Concomitant medications were not reported. The patient previously took 1st dose of BNT162B2 for COVID-19 immunisation. Prior to the vaccination the patient was not diagnosed with COVID-19. It was unknown whether the patient received any other vaccine within four weeks prior to the COVID vaccine. The clinical course of the events was reported as: on an unknown date in Feb2021, the patient experienced jaundice and went to the physician. The reporter stated that first saw him on 25Feb2021. His initial presentation included headache and chills. He completed the second Phizer COVID vaccination on 08 Feb2021. He never had abdominal pain but he did develop icteric sclera, jaundice, acholic stools and dark urine. A workup included a negative viral hep panel including two HAV IgM (anti Hepatitis A virus immunoglobulin M), negative ANA (Antinuclear antibody), A1AT (Alpha-1 anti-trypsin) and a normal CT (Computerised tomogram) with normal GB (Generalised bullous) and bile ducts. TB (Tuberculosis) peaked at 5.5 with AST (aspartate transaminase) 916, ALT (alanine transaminase) 1865. He began to feel better the last week of Feb 2021 and repeat labs on 10Mar2021 showed TB 1.3 AST 29 ALT 102 ap 134. It was unclear if this was an infectious process that was not captured but the reporter worried enough that this could be related to the vaccine he received 1.5 weeks earlier enough to send this report. Since the vaccination the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment. The outcome of the events was recovering.  Information regarding the lot/ batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event increased AST, ALT and TB test positive and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities,  Committees, and Investigators, as appropriate.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Headache, Myalgia, Oropharyngeal pain
Clinical narrative: thinks he has COVID 19 now; Fever; Headache; muscle aches; Chills; Sore throat; Runny nose; Upset stomach; This is a spontaneous report from a contactable consumer. A 26-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 16Mar2021 (at the age of 26-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Patient had no medical history. The patient concomitant medications were not reported. Prior Vaccinations (within 4 weeks) was none. The patient experienced thinks he has covid 19 now on an unspecified date. On 19Mar2021, he started to have a fever, headache, muscle aches, chills, sore throat, runny nose and an upset stomach that are still persisting today. The patient experienced thinks he has covid 19 now on an unspecified date, Adds the patient is really concerned, and thinks he has COVID 19 now. He even went so far as to get an appointment for the test. It was reported that he got the first dose of the Pfizer COVID 19 vaccine on Tuesday 16MAR2021 at unknown time in an unknown arm. Caller added they were wondered with all of these symptoms should he get a COVID 19 test as suggested to call Pfizer. Patient had not visited physician office. Time the vaccination was given was unknown. History of all previous immunization with the Pfizer vaccine considered as suspect was none. The outcome of thinks he has covid was unknown and other events were not recovered.