chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: I woke up with fever; Severe headache; Eye and neck pain; Eye and neck pain; Body aches; Nausea; Vomited; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the arm right on 06Apr2021 at 14:30(at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer, clotting disorder, MTHFR gene mutation, shellfish allergy and MSG allergy. Concomitant medications included apixaban (ELIQUIS) and levothyroxine sodium (SYNTHROID 112); for unknown indication from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the arm right on 04Mar2021 at 15:00 as a single dose for COVID-19 immunisation. Prior to the 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 07Apr2021 at 05:00, in the morning the patient woke up with fever, severe headache, eye pain, neck pain, body aches, and then nausea. The patient vomited throughout the day violently and took promethazine for the nausea and immediately vomited that up. Before deciding to go the hospital, the patient tried promethazine suppository for nausea and 1 vicodin (these medications prescribed for a surgical procedure) and took them 3 times during the day as vomiting recurred after drug wore off. The medications offered some relief. On 08Apr2021, the patient had low grade headache and body aches and light nausea. 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 promethazine (MANUFACTURER UNKNOWN) and acetaminophen-hydrocodone (VICODIN). The clinical outcome of the events fever, severe headache, eye pain, neck pain, body aches, nausea and vomited were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Developed Ringing in left ear.; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male 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 arm on 26Feb2021 at 12:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no known allergies to medications, food, or other products. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to the 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 15Mar2021, the patient developed ringing in left ear. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the event. The clinical outcome of the event developed ringing in left ear was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Rash, SARS-CoV-2 test
Clinical narrative: Extreme chills; Tiredness; Slight headache; Slight rash; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 24Mar2021 at 10:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, high cholesterol and pacemaker. The patient had no known allergies to food, medications, or other products. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), losartan potassium (LOSARTIN) and metoprolol (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021 at 06:00, the patient experienced extreme chills, tiredness, slight headache and slight rash. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 08Apr2021, the patient underwent lab test which included nasal swab test and tested negative. The clinical outcome of the events extreme chills, tiredness, slight headache and slight rash was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dysphagia, Pharyngeal swelling, Throat tightness
Clinical narrative: Throat seemed tight andhaving problems swallowing; Throat seemed tight andhaving problems swallowing; Burning in lungs; The swelling seemed to have subsided 30minutes later.; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old female patient 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 08Apr2021 at 10:15 (at the age of 55-years-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. Concomitant medications included levothyroxine sodium (THYROXINE) and levothyroxine (MANUFACTURER UNKNOWN); both from an unknown date for unknown indication. The patient previously received sulphur on unknown date for an unspecified indication and experienced drug allergy. Prior to the 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 08Apr2021 at 11:30, the patient experienced throat seemed tight and having problem swallowing, swelling, slight burning in lungs. The patient was traveling so got out of car and drank some water. The swelling seemed to have subsided 30 minutes later. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events throat seemed tight and having problem swallowing, swelling, slight burning in lungs were recovered on 08Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: 101.5 fever; Chills; Body aches; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm left on 06Apr2021 at 09:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and obesity and COVID-19 (Prior to the vaccination, the patient was diagnosed with COVID-19). The patient had no known allergies to medications, food or other products. The patient did not take any concomitant medications. 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 06Apr2021 at 23:00, the patient experienced 101.5 fever, chills, body aches, headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of fever, chills, body aches, headache were resolved on an unknown date in Apr2021.   No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever; severe body aches; chills; fatigue; arm pain; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 05Apr2021 at 09:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no allergies to medications, food, or other products. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (LOESTRIN FE), cetirizine hydrochloride (ZYRTEC) and ibuprofen (ADVIL), all taken for unknown indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 15Mar2021 at 09:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Prior to the 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 06Apr2021 at 01:00, 18 hours after the vaccination, the patient experienced fever, severe body aches, chills, fatigue and pain in arm. Fever and chills subsided after several hours. Fatigue and arm pain continued for about 48 hours after the vaccine was administered. The 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 patient did not receive any treatment for the events. The clinical outcome of the events fever and chills were resolved on an unknown date in Apr2021, while that of severe body aches, fatigue and pain in arm were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Pain in extremity, Peripheral swelling, Vaccination site pain
Clinical narrative: Arm underneath painful; Arm underneath swollen; Lymph nodes painful; Lymph nodes swollen; Left arm sore at injection site; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 02Apr2021 at 10:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriatic arthritis. The patient was allergic to sulfa (sulfonamide) and all GERD medications (drug allergy). Concomitant medications included ondansetron (ZOFRAN), vitamin d nos (MANUFACTURER UNKNOWN) and multi vitamin (MANUFACTURER UNKNOWN) all from an unknown date for an unknown indication and unknown if ongoing. The patient previously took polysorbate 80 (MANUFACTURER UNKNOWN), sodium sulfate (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously took SIMPONI ARIA IV (intravenous) 50mg for psoriatic arthritis. 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 for COVID-19. On 03Apr2021 at 16:00, the patient experienced left arm sore at injection site. On 04Apr2021 (24 hours later), the patient's arm underneath and lymph nodes were painful and swollen for 4 days. The events did not result in a visit to  doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of these events. The clinical outcome of the event left arm sore at injection site was resolved on an unspecified date in 2021 while that of the events arm underneath painful, arm underneath swollen, lymph nodes painful and lymph nodes swollen were resolved on an unspecified date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Diarrhoea, Fatigue, Migraine
Clinical narrative: Vomiting; diarrhea; migraine; scalp sensitivity; chest pain; fatigue; body ache; fever; chills; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the arm left on 06Apr2021 at 15:30 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications included salbutamol (ALBUTEROL), budesonide, formoterol fumarate (SYMBICORT). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 16Mar2021 at 16:15 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. The patient previously received amoxycillin (MANUFACTURER UNKNOWN) for unknown indication and experienced drug allergy. Prior to the 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 07Apr2021 at 07:00, the patient experienced vomiting, diarrhoea, migraine, scalp sensitivity, chest pain, fatigue, body ache, fever and chills. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcomes of the events vomiting, diarrhoea, migraine, scalp sensitivity, chest pain, fatigue, body ache, fever and chills were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Skin irritation, Vomiting
Clinical narrative: Vomiting; diarrhea; migraine; scalp sensitivity; chest pain; fatigue; body ache; fever; chills; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the arm left on 06Apr2021 at 15:30 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications included salbutamol (ALBUTEROL), budesonide, formoterol fumarate (SYMBICORT). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 16Mar2021 at 16:15 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. The patient previously received amoxycillin (MANUFACTURER UNKNOWN) for unknown indication and experienced drug allergy. Prior to the 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 07Apr2021 at 07:00, the patient experienced vomiting, diarrhoea, migraine, scalp sensitivity, chest pain, fatigue, body ache, fever and chills. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcomes of the events vomiting, diarrhoea, migraine, scalp sensitivity, chest pain, fatigue, body ache, fever and chills were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Skin wrinkling, Vaccination site discolouration, Vaccination site scar
Clinical narrative: developed a scar - like one would if they were cut, that ended up being 3/4" long x 1/8 wide.; puckered /pulled skin; "slightly discolored from skin around it just likeany other scar would be"; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the arm left on 25Mar2021 at 10:30 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol, hypothyroid, anxiety, depression and was allergic to iodinated contrast agent (injectable contrast dye). The patient received unspecified medications within two weeks of vaccination and it was reported as "they don't all fit". The patient previously received venlafaxine (MANUFACTURER UNKNOWN) for unknown indication and experienced drug allergy. Prior to the 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 26Mar2021 at 21:00, at the injection site, within about 36hrs, the patient had developed a scar - like one would if they were cut, that ended up being 3/4" long x 1/8" wide. It was "puckered" (pulled skin) and slightly discoloured from skin around it just like any other scar would be. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events injection site scar, "puckered" (pulled skin) and slightly discoloured from skin around it was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Lymphadenopathy, Pain in extremity
Clinical narrative: Swollen lymph nodes in both elbows; Numbness in right arm; Pain in right arm; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the arm left on 07Apr2021 at 13:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient had no known allergies. Concomitant medications included marajuana (MANAFACTURER UNKNOWN) daily, ibuprofen (MANUFACTURER UNKNOWN) occasionally for an unspecified indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the right arm on an unspecified date as a single dose for COVID-19 immunisation. Prior to the 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 08Apr2021 at 19:00 the patient experienced swollen lymph nodes in both elbows, the right lymph node was about the size of a quarter and was causing numbness and pain throughout the arm. The left was smaller, more like a small grape. The patient did not receive any treatment for the events. The 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 swollen lymph node, pain in arm, numbness in arm was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; Chills; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 07Apr2021 at 15:45 (at the age of 17-year-old) as a single dose for COVID-19 immunisation. Medical history included Crohn's. The patient did not have any allergies to medications, food, or other products. Concomitant medications included infliximab (REMICADE) and levocetirizine dihydrochloride (XYZAL) both for unknown indication from an unknown date. 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 arm left on 17Mar2021 at 15:30 (at the age of 17-year-old) as a single dose for COVID-19 immunisation. Prior to the 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 08Apr2021 at 03:00, the patient experienced fever and chills. No therapeutic measures were taken as a result of the events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever and chills were not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Extreme fatigue; Sore arm at injection site; This is a spontaneous report from a non-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: EW0150) via an unspecified route of administration in the left arm on 07Apr2021 at 09:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history and 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 for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021, the patient experienced extreme fatigue and sore arm at injection site ( vaccination site pain). The events 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 events. The clinical outcome of the events of extreme fatigue and sore arm at injection site were unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Vaccination site mass
Clinical narrative: Sore in arm; Small bump in injection spot; Itchy; This is a spontaneous report from a non-contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the right arm on 06Apr2021 at 15:45 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no known allergies to food, medications, or other products. Concomitant medications included vitamin d nos (VITAMIN D) and birth control; both for unknown indications from unknown dates. Prior to the 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 07Apr2021, the patient experienced sore in arm, small bump in injection spot and itchy. The events 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 events. The clinical outcome of the events sore in arm, small bump in injection spot and itchy was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Rash
Clinical narrative: Rash on chest and right side of neck; Headache; Fever; Chills.; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 07Apr2021 at 16:30 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history included cancer, radiation thyroiditis, crohn's disease and arthritis. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), hydrocodone bitartrate, paracetamol (NORCO), lisinopril dihydrate (LISINOPRIL), levothyroxine (MANUFACTURER UNKNOWN) and meloxicam (MELOXIC); all from unknown date for unknown indication. The patient had no known allergies to medications, food or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 24Mar2021 at 17:00 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Prior to the 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 07Apr2021 at 20:00, the patient experienced rash on chest and right side of neck, headache, fever and chills. it was reported that he was prior cancer patient, right side squamous cell carcinoma resection lymph nodes removed on this side as well as radiation effects. All treatment from 2017-2018, nothing recently. 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 event. The clinical outcome of the events rash, headache, fever and chills was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Inflammation, Influenza, Lethargy
Clinical narrative: slight sore arm; Lethargic; Fever; very low energy; Cough; Flu; feeling of inflammation; Lot of stuffiness; Post nasal drip; This is a spontaneous report from a non-contactable consumer, the patient. A 53-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6202) via an unspecified route of administration in the left arm on 04Mar2021 at 07:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included hyperthyroid. The patient had a history of allergy to sulfa, mold and hornets. the patient received other medications included montelukast (MANUFACTURER UNKNOWN), gabapentin (MANUFACTURER UNKNOWN) and estradiol (ESTROGEN) and vitamins (MANUFACTURE UNKNOWN) for unknown indication within 2 weeks of vaccination. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: el9262) via an unspecified route of administration in the left arm on 10Feb2021 at 15:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. 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 04Mar2021, the patient had experienced slight sore arm, lethargic, fever, loss of energy, cough, flu which was lasted for 32 hours and felt better however, she was feeling of inflammation, lot of stuffiness and post nasal drip. The patient reported that she was not sure if her allergies or shot or shot triggered the excess inflammation in body and she was still fighting it off along with allergies kicking in. The patient did not receive any treatment for the reported events. The 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 event flu was resolving while the outcome of the events slight sore arm, lethargic, fever, loss of energy, cough, feeling of inflammation, lot of stuffiness and post nasal drip was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pain in extremity, Pyrexia, Upper-airway cough syndrome
Clinical narrative: slight sore arm; Lethargic; Fever; very low energy; Cough; Flu; feeling of inflammation; Lot of stuffiness; Post nasal drip; This is a spontaneous report from a non-contactable consumer, the patient. A 53-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6202) via an unspecified route of administration in the left arm on 04Mar2021 at 07:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included hyperthyroid. The patient had a history of allergy to sulfa, mold and hornets. the patient received other medications included montelukast (MANUFACTURER UNKNOWN), gabapentin (MANUFACTURER UNKNOWN) and estradiol (ESTROGEN) and vitamins (MANUFACTURE UNKNOWN) for unknown indication within 2 weeks of vaccination. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: el9262) via an unspecified route of administration in the left arm on 10Feb2021 at 15:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. 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 04Mar2021, the patient had experienced slight sore arm, lethargic, fever, loss of energy, cough, flu which was lasted for 32 hours and felt better however, she was feeling of inflammation, lot of stuffiness and post nasal drip. The patient reported that she was not sure if her allergies or shot or shot triggered the excess inflammation in body and she was still fighting it off along with allergies kicking in. The patient did not receive any treatment for the reported events. The 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 event flu was resolving while the outcome of the events slight sore arm, lethargic, fever, loss of energy, cough, feeling of inflammation, lot of stuffiness and post nasal drip was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: bfever x 1 day after her second covid vaccine injection; This is a spontaneous report from a contactable consumer(patient). A 54-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of injection on 08Apr2021, at 54-year-old, as single dose (Batch/Lot number was not reported) for covid-19 immunisation. The patient medical history included ongoing malignant neoplasm of breast from an unspecified date. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, as single dose (Batch/Lot number was not reported) for covid-19 immunisation. The patient stated that she had a fever x 1 day after her second covid vaccine injection on 09Apr2021. The outcome of events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Thyroid pain, Thyroiditis
Clinical narrative: triggered serious thyroiditis symptoms; painful thyroid, triggered serious thyroiditis symptoms; This is a spontaneous report from a non-contactable consumer or other non HCP (patient). A 44-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown), dose 1 via an unspecified route of administration on 19Apr2021 as dose 1, single for COVID-19 immunization. Medical history included thyroiditis. Concomitant medication was not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, patient has not been tested for COVID-19. On 25Apr2021, the patient experienced painful thyroid and triggered serious thyroiditis symptoms. The outcome of the events was not recovered.   Information of the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pityriasis rubra pilaris, Skin exfoliation
Clinical narrative: the patient's skin totally exfoliated.; patient has been diagnosed with PRP (Pityriasis rubra pilaris).; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced as, the patient's skin totally exfoliated, patient had been diagnosed with prp (pityriasis rubra pilaris) on an unspecified date. Reported as, HCP stated they would love if there was anymore information about any other kind of rash besides urticaria or anaphylaxis. This was not an histamine related reaction with her patient and she had since been diagnosed, which caller did not believe that it is this, patient has been diagnosed with PRP (Pityriasis rubra pilaris). It's so rare and this was from what the biopsy showed by someone else who gave the diagnosis. It was pretty bad. Patient's skin totally exfoliated. No further details provided. It was not a product complaint and no medical information request reported. Outcome of the event were unknown.  Information on the Lot/batch number has been requested.  Follow-up (22Jul2021): New information reported from a contactable Physician in response to Physician outbound call which included: events were coded and the case was considered valid from invalid.  Information on the Lot/batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dry mouth, Oropharyngeal pain, Pharyngeal swelling, Pyrexia
Clinical narrative: Foggy eyesight; Sore throat; Swollen throat; Dry Mouth; Swollen face; Fever; Extreme joint pain; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right upper arm on 01May2021 at 09:15 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was reported as none. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within 4 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 for COVID-19. On 04May2021 at 14:00, the patient experienced foggy eyesight, fever, dry mouth, extreme joint pain, sore throat, swollen face and throat. The clinical outcomes of the events foggy eyesight, fever, dry mouth, extreme joint pain, swollen face and throat, and sore throat were recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Vision blurred
Clinical narrative: Foggy eyesight; Sore throat; Swollen throat; Dry Mouth; Swollen face; Fever; Extreme joint pain; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right upper arm on 01May2021 at 09:15 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was reported as none. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within 4 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 for COVID-19. On 04May2021 at 14:00, the patient experienced foggy eyesight, fever, dry mouth, extreme joint pain, sore throat, swollen face and throat. The clinical outcomes of the events foggy eyesight, fever, dry mouth, extreme joint pain, swollen face and throat, and sore throat were recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Pains in armpit; Swollen lymph node in armpit; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0172) via an unspecified route of administration in the arm left on 03May2021 at 09:00(at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR) and loratadine (CLARITIN) from unknown dates and for unknown indications. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8729)  via an unspecified route of administration in the arm left on 12Apr2021 at 09:00 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Prior to the 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 05May2021 at 08:00, the patient experienced pains in armpit and  swollen lymph node in armpit. The clinical outcome of the event pains in armpit and  swollen lymph node in armpit were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Menstruation irregular, Pyrexia
Clinical narrative: Started another period, and bled for a full 5 days/ breakthrough bleeding; Fever; Chills; Shivering; Headache; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 23Apr2021 at 14:30 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history and 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 for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient experienced fever, chills, shivering, headache and fatigue for about two days. On 03May2021 the patient experienced irregular menstruation. She was on last 2 days of period while vaccination and after 10 days of the vaccine, started another period and bled for a full 5 days. The blood was somewhat thinner than it is in a usual period. She had rarely had such breakthrough bleeding in between her cycle and felt was likely a side effect of the vaccine. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event fever, chills, shivering, headache and fatigue was recovered on an unknown date in 2021; while that of irregular menstruation was unknown at the time of report.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Menstrual cycle was early by 3 weeks; This is a spontaneous report from a non- contactable consumer, the patient. A 16-year-old non-pregnant female patient 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 27April2021 at 15:00 (16-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies. The patient did not receive any other medications within two 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. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 06May2021, nine days after vaccination, the patient experienced a menstrual cycle, which was early by 3 weeks. No therapeutic measures were taken for the adverse event. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event was unknown 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: Blood glucose increased, Dizziness, Fatigue, Feeling abnormal, Headache
Clinical narrative: Extreme nauseous feeling; Extreme tiredness; Extreme tiredness/fatigue/feverish feeling with no fever; Extreme tiredness/fatigue/feverish feeling with no fever; headaches; foggy feeling; Dizziness; High glucose; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient 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 30Apr2021 at 09:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included type 1 diabetes, diabetic retinopathy and gastroparesis. Concomitant medications included insulin lispro (HUMALOG), ascorbic acid (VITAMIN C), calcium citrate; cholecalciferol (CALCIUM CITRATE + D) and Xa (MANUFACTURER UNKNOWN); all for unknown indications on unknown dates. The patient previously received codeine (MANUFACTURER UNKNOWN) for unknown indication on unknown date and experienced drug allergy. Prior to the 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 30Apr2021 at 15:30, 6 hours after shot, the patient experienced dizziness. Everyday since first shot, the patient experienced high glucose everyday, extreme nauseous feeling, extreme tiredness/fatigue/ feverish feeling with no fever, some dizziness throughout the day, headaches and foggy feeling. 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. The clinical outcome of the events of dizziness, high glucose everyday, extreme nauseous feeling, extreme tiredness/fatigue/feverish feeling with no fever, headaches and foggy feeling were not recovered at the time of this report.   No follow-up attempts are needed; information about lot number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Extreme nauseous feeling; Extreme tiredness; Extreme tiredness/fatigue/feverish feeling with no fever; Extreme tiredness/fatigue/feverish feeling with no fever; headaches; foggy feeling; Dizziness; High glucose; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient 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 30Apr2021 at 09:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included type 1 diabetes, diabetic retinopathy and gastroparesis. Concomitant medications included insulin lispro (HUMALOG), ascorbic acid (VITAMIN C), calcium citrate; cholecalciferol (CALCIUM CITRATE + D) and Xa (MANUFACTURER UNKNOWN); all for unknown indications on unknown dates. The patient previously received codeine (MANUFACTURER UNKNOWN) for unknown indication on unknown date and experienced drug allergy. Prior to the 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 30Apr2021 at 15:30, 6 hours after shot, the patient experienced dizziness. Everyday since first shot, the patient experienced high glucose everyday, extreme nauseous feeling, extreme tiredness/fatigue/ feverish feeling with no fever, some dizziness throughout the day, headaches and foggy feeling. 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. The clinical outcome of the events of dizziness, high glucose everyday, extreme nauseous feeling, extreme tiredness/fatigue/feverish feeling with no fever, headaches and foggy feeling were not recovered at the time of this report.   No follow-up attempts are needed; information about lot number cannot be obtained.