chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia
Clinical narrative: Fatigue; Dry mouth; Slight fever; Clamminess; Pain in upper right arm; Joints became stiff; Itchy on right arm/hand; Headache; Dizziness; Nauseated; Could not sleep; Feeling tingling throughout right side; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the right arm on 16Apr2021 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome with diarrhea (IBS-D), high blood pressure, sciatica (Sciatic Nerve Lower Back Pain), scoliosis, laryngopharyngeal reflux (silent reflux), gastroesophageal reflux disease (GERD), gastroparesis and food allergy (gelatin). The patient previously took vibramycin, doxycycline, tetracycline and flagyl and experienced allergy to these medications. Prior to the vaccination, the patient was no 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. Concomitant medications included metoprolol succinate ER (MANUFACTURER UNKNOWN), pantoprazole sodium sesquihydrate (pantoprazole sodium) (MANUFACTURER UNKNOWN) and tramadol (MANUFACTURER UNKNOWN) all for unknown indication from an unknown date. On 16Apr2021, 15 minutes after the shot she felt fine. 30 minutes after the shot she started feeling tingling throughout her right side, along with pain in her upper right arm. 45 minutes after the shot her joints became stiff and she started becoming itchy on her right arm/hand. 60 minutes after the shot she started getting a headache and dizziness. 90 minutes after the shot she got nauseated. She could not sleep that night because of the dizziness. On 17Apr2021, next day all of the same symptoms plus fatigue, dry mouth and a slight fever with clamminess. Two days after the shot no more tingling, less pain in the arm, joints were a little looser, still had a headache, some dizziness, and still had a dry mouth. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the events feeling tingling throughout right side was resolved on 18Apr2021. The clinical outcome of the events joints became stiff, dizziness, could not sleep, pain in upper right arm was resolving and that of itchy on right arm/hand, headache, nauseated, fatigue, dry mouth, slight fever and clamminess was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Severe lower backpain; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Apr2021 at 10:00, 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. On 17Apr2021 at 23:45, the patient experienced severe lower backpain. The patient had no known history of back pain. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe lower backpain was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives on chest, left arm, and stomach; Some itchiness on the arm; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male 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 06Apr2021 at 16:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and high blood pressure. The patient was not allergic to medications, food, or other products. Concomitant medications included insulin (MANUFACTURER UNKNOWN) taken for unknown indication from unspecified date, unknown if ongoing. 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 14Apr2021 at 20:00, the patient experienced hives on chest, left arm and stomach, with some itchiness on the arm. These 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 which included treatment with application of cooling ointment on skin. The clinical outcome of the events hives and itchiness were resolved on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: I am having vaginal bleeding, started with spotting on 11Apr, turned to mostly bright red blood on 12Apr, heavier on 13Apr, no change on 14Apr; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient herself). A 58-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0153), dose 1 via an unspecified route of administration, administered in Arm Left on 06Apr2021 15:00 (03:00 pm) as dose 1, single (at age of 58-years old) for covid-19 immunization. The patient's medical history included known allergies: allergic to sulfa drugs and patient had an adverse reaction to Non-steroidal anti-inflammatory drugs (NSAIDs). The patient had menopausal. The patient's concomitant medication/other medications in two weeks included unspecified medication. The patient had no other vaccine in four weeks. The patient had no covid prior vaccination. The patient was not covid tested post vaccination. The patient stated, she was post-menopausal. She was having vaginal bleeding, started with spotting on 11Apr2021, turned to mostly bright red blood on 12Apr2021, heavier on 13Apr2021, no change on 14Apr2021 (today). The event resulted in doctor or other healthcare professional office/clinic visit. The patient not received treatment for the adverse event. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pain in extremity
Clinical narrative: My hands and fingers ache really bad; My hands and fingers ache really bad; Have a burning sensation; 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 left arm on 16Apr2021 at 11:00 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. The medical history included aortic valve replacement, asthma, celiacs and allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included amlodipine (MANUFACTURER UNKNOWN), losartan potassium (LOSARTIN), levothyroxine (MANUFACTURER UNKNOWN), folic acid (MANUFACTURER UNKNOWN) and vitamin d nos (MANUFACTURER UNKNOWN), all from unknown dates and for unspecified indications. On 17Apr2021, the patient's hands and fingers ache really bad and had a burning sensation. Therapeutic measures were not taken as a result of 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events hands and fingers ache really bad and had a burning sensation was not recovered at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lump on left side of collarbone ( lymph node).; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 17Apr2021 at 10:15 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was not allergic to medications, food, or other products. The patient received unspecified medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on an unknown date in Mar2021 at 10:30 (at the age of 55-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 4 weeks prior to the vaccination. On 18Apr2021 at 17:00, the patient experienced lump on left side of collarbone (lymph node).The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the event. The clinical outcome of the event lump on left side of collarbone (lymph node) was not resolved 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: Nerve compression, Vein disorder
Clinical narrative: Probably after 12 hours,  veins/nerves started pulling up near shoulder and jaws; Probably after 12 hours,  veins/nerves started pulling up near shoulder and jaws; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Mar2021 at 08:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included fenofibrate (MANUFACTURER UNKNOWN) and simvastatin (MANUFACTURER UNKNOWN) all from an unknown date from an unspecified indication. On 17Mar2021 at 20:00, the patient experienced probably after 12 hours, veins/nerves started pulling up near shoulder and jaws. Patient stated that he took a hot shower and slept, when he woke up after 4 hours, it became much better. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events probably after 12 hours, veins/nerves started pulling up near shoulder and jaws was recovered on an unspecified date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site urticaria, SARS-CoV-2 test, Urticaria
Clinical narrative: Hive like bumps on face (mainly around the forehead and cheeks), on chest,; and a little bit around the site of the shot; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old non-pregnant female patient 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 18Mar2021 at 14:15 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any other medication within two weeks of vaccination. On 19Mar2021 at 07:00, the patient experienced hive like bumps on face (mainly around the forehead and cheeks), on chest, and a little bit around the site of the shot. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On 08Apr2021, the patient gave nasal swab for SARS-CoV-2 PCR test and the result was negative. The clinical outcome of the event hive like bumps on face (mainly around the forehead and cheeks), on chest, and a little bit around the site of the shot was recovered on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Small lump under skin in back of neck left side; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the arm left on 12Apr2021 at 12:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies .The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 22Mar2021 at 11:00 (at the age of 64-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 15Apr2021 the patient experienced small lump under skin in back of neck left side. Therapeutic measures were not taken as a result of the 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 small lump under skin in back of neck left side was 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: Headache, Hepatitis C antibody
Clinical narrative: A very slight headache starting approximately 4 hours post vaccination.; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: CN6206) via an unspecified route of administration in the right arm on 16Mar2021 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. 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 16Mar2021 at 16:00, approximately 4 hours post vaccination, the patient experienced a very slight headache. Additionally on 20Mar2021, four days after vaccination, the patient donated blood, which was a regular occurrence for him. On an unknown date in 2021, he received word back from his donation that he had a reactive result on the anti-HCV screening. Extra testing indicated that this result was a false positive and that he did not show any reactivity to the anti-HCV test. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event slight headache was resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Blurred vision; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male 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 15Apr2021 at 12:15 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and dronedarone hydrochloride (MULTAQ). On 15Apr2021 at 12:45, the patient experienced blurred vision. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event blurred vision was not resolved at the time of this report. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Terrible headache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 09Apr2021 at 12:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included Rheumatoid Arthritis (RA) and posterior uveitis. The patient was allergic to penicillin. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN) and rosuvastatin calcium (CRESTOR) all were from unknown date and for unspecified indication. The patient previously took doxycycline (MANUFACTURER UNKNOWN), ciprofloxacin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 19Mar2021 at 12:15 (at the age of 43-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 09Apr2021 at 15:00, after the second dose of vaccination the patient experienced terrible headache and fatigue. 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 the result of adverse events.  The clinical outcome of the events terrible headache and fatigue were not recovered at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Sore arm - 4 days after injection; Sore shoulder - 4 days after injection; This is a spontaneous report received from a contactable consumer, the patient. A 56-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0161) via an unspecified route of administration in the left arm on 15Apr2021 at 11:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient included diabetes. The patient did not had any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metformin (MANUFACTURER UNKNOWN) for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 19Apr2021, the patient had sore arm and shoulder 4 days after injection. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of the events sore arm  and shoulder  were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Headache, Lymph node pain, Lymphadenopathy
Clinical narrative: "Swollen limpth nodes"; Burning mouth; Legs hurt below knee; Headache; Body felt like heavy/led; Very tired; Arm muscle hurts; Under arm the gland is very tender.; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on 17Apr2021 at 09:15 (at the age of 75-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medications within two weeks prior to the COVID-19 vaccination. The patient previously received codeine (MANUFACTURER UNKNOWN) and experienced a drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the right arm on an unknown date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 18Apr2021 at 08:30, the patient experienced "swollen limpth nodes", burning mouth, her legs hurt below the knee, headache, "body felt like heavy/led", very tired, her arm muscle hurt and she reported that she was on the third day after vaccine and was still tired and under arm the gland was very tender. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events "swollen limpth nodes", burning mouth, legs hurt below knee, headache, "body felt like heavy/led", very tired, arm muscle hurts and under arm the gland was very tender were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Oral discomfort, Pain in extremity
Clinical narrative: "Swollen limpth nodes"; Burning mouth; Legs hurt below knee; Headache; Body felt like heavy/led; Very tired; Arm muscle hurts; Under arm the gland is very tender.; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on 17Apr2021 at 09:15 (at the age of 75-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medications within two weeks prior to the COVID-19 vaccination. The patient previously received codeine (MANUFACTURER UNKNOWN) and experienced a drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the right arm on an unknown date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 18Apr2021 at 08:30, the patient experienced "swollen limpth nodes", burning mouth, her legs hurt below the knee, headache, "body felt like heavy/led", very tired, her arm muscle hurt and she reported that she was on the third day after vaccine and was still tired and under arm the gland was very tender. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events "swollen limpth nodes", burning mouth, legs hurt below knee, headache, "body felt like heavy/led", very tired, arm muscle hurts and under arm the gland was very tender were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Sensory disturbance, Tinnitus
Clinical narrative: Ringing in my ears\a high pitched sound like the zing of a high tension wire; Physical sensation; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received unknown dose number of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 06Apr2021 at 10:45 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications within 2 weeks of vaccination. The patient previously received ampicillin and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in Apr2021 the patient experienced ringing in ears-a high pitched sound like the zing of a high tension wire and she clapped hands and her left ear rang loudly, which was both a sound and a physical sensation. Since the vaccination, the patient had not been tested for COVID-19. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events ringing in ears and physical sensation were not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Fatigue, Herpes zoster, Rash erythematous, Skin burning sensation
Clinical narrative: Started seeing blisters; Diagnosed with shingles by the typical skin presented in lower abdomen, right side of the waist and the back area at waist level; More and larger red rash surfaced; felt burning on the skin in lower abdomen; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 07Apr2021 at 12:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included a mild degree of diabetes which was under control and the patient had no autoimmune diseases, was a non-smoker and was not an alcohol user. The patient had no allergies to medications, food, or other products. Concomitant medications included metformin (MANUFACTURER UNKNOWN) taken from an unknown date. 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 11Apr2021 at 20:00, after the first dose, the patient felt burning on the skin in lower abdomen with fatigue. On 12Apr2021 and 13Apr2021, the following 2 days, the affected areas grew wider and spread to the right and her back; more and larger red rash surfaced. On 14Apr2021, the patient started seeing blisters, so went to see a doctor, and told her it might have resulted from the first dose. On 14Apr2021, the patient was diagnosed with shingles by the typical skin presented in lower abdomen, right side of the waist and the back area at waist level. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with valacyclovir 1 gm three times a day for seven days. On 15Apr2021, the patient read an Israel report which came up indicating shingles events having a possible link to the vaccine and the patient wanted to know if she could skip the second dose which was scheduled on 05May2021. Her shingles would not be fully recovered before the second dose and she wanted to know what was the maximum interval allowed between dose 1 and dose 2 to maintain the desired efficacy. She also asked if skipping the second dose would impact Pfizer upcoming variants boost dose on efficacy. She also asked if she can receive other company's second dose or a booster if she planned to skip Pfizer's second dose. The clinical outcome of the events burning on the skin in lower abdomen with fatigue, red rash, blisters and shingles were not resolved 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: Fatigue, Tinnitus, Urticaria
Clinical narrative: Hives; Fatigue; Ringing in ears; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 17Apr2021 at 02:45 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included allergy to nuts. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID), esomeprazole (NEXIUM), sertraline hydrochloride (ZOLOFT), atorvastatin calcium (LIPITOR) and fexofenadine hydrochloride (ALLEGRA); all for unknown indications from unknown dates and unknown if ongoing. On 19Apr2021 at 02:30, the patient experienced hives, fatigue and ringing in ears. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events hives, fatigue and ringing in ears were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Feeling tired; Upper body aches; Headache; This is a spontaneous report from a contactable consumer, the parent. A 16-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 17Apr2021 at 11:00 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Patient did not receive any other medication within two weeks of vaccination. The patient had no allergies to medications, food, or other products. 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 27Mar2021 at 11:15 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. On 18Apr2021 at 12:00, the patient experienced feeling tired, upper body aches and headache. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were taken as a result of feeling tired, upper body aches and headache and included treatment with ADVIL from an unknown start date to an unknown stop date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events feeling tired, upper body aches and headache were recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: sore shoulder; This is a spontaneous report from a contactable consumer. A 46-year-old male patient 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 in Apr2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if patient receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. On 19Apr2021 at 09:11, the patient experienced sore shoulder. The patient did not receive any treatment for the event. Since the vaccination, it was unknown if the patient had been tested for COVID-19. The clinical outcome of the event shoulder soreness was recovered on an unknown date in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained; no further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Cyanosis, Hypoaesthesia, Pain in extremity, Peripheral swelling
Clinical narrative: Fingers on both hands are blue and are painful.; Fingers on both hands are blue and are painful; Left leg swollen; Fingers on both hands are blue and are painful. No feeling; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 20Mar2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 10Apr2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included human immunodeficiency virus (HIV). The patient had no known allergies to food, medication or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Mar2021, the patient experienced fingers on both hands were blue and were painful, no feeling and left leg was swollen. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fingers on both hands were blue and were painful, no feeling and left leg was swollen was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasal congestion, Oropharyngeal pain, Pain
Clinical narrative: Headaches; little bit of congestion; sore throat; body aches; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the right arm on 01Apr2021 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021, the patient experienced headaches, little bit of congestion, sore throat and body aches. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. On 17Apr2021, the patient underwent COVID-19 PCR, nasal swab test and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events headaches, little bit of congestion, sore throat and body aches 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: Dizziness, Headache, Heart rate increased, Neck pain, Nerve compression
Clinical narrative: elevated heart rate occurred/ notice additional elevated heart rate occurring while just sitting; body aches and soreness with continual nerve twitches thru-out body: neck, back, calves and right hand fore finger/ sharpness of needle like pain in calves, fore finger, neck and back; Pinch nerve with tingling in right hand forefinger, back, neck and legs (calves)/ with continual nerve twitches thru-out body: neck, back, calves and right hand fore finger; sharp pinch in neck; slight dizziness (1 hour afterward); headache; sore arm in left (injection site); tingle right finger/ Pinch nerve with tingling in right hand forefinger, back, neck and legs (calves)/ continual tingles in neck, back, calves; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 13Apr2021 at 09:00 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no allergies to medications, food, or other products. The patient did not take any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 11:00, the patient experienced at slight dizziness (1 hour afterward) headache, sore arm in left (injection site), sharp pinch in neck and tingle right finger. On 14Apr2021 the patient experienced  pinch nerve with tingling in right hand forefinger, back, neck and legs (calves). On 15Ap2021 and 16Apr2021 she had continual tingles in neck, back, calves. On 17Apr2021 patient had elevated heart rate, body aches and soreness with continual nerve twitches thru-out body, neck, back, calves and right-hand fore finger. On 18Apr2021 she noticed additional elevated heart rate occurring while just sitting, same symptoms, sharpness of needle like pain in calves, fore finger, neck and back. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event slight dizziness (1 hour afterward) headache, sore arm in left (injection site), sharp pinch in neck and tingle right finger, pinch nerve with tingling in right hand forefinger, back, neck and legs (calves), continual tingles in neck, back and calves, elevated heart rate, body aches and soreness with continual nerve twitches thru-out body, neck, back, calves and right-hand fore finger and additional elevated heart rate occurring while just sitting, same symptoms, sharpness of needle like pain in calves, fore finger, neck and back was not resolved at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Vaccination site pain
Clinical narrative: elevated heart rate occurred/ notice additional elevated heart rate occurring while just sitting; body aches and soreness with continual nerve twitches thru-out body: neck, back, calves and right hand fore finger/ sharpness of needle like pain in calves, fore finger, neck and back; Pinch nerve with tingling in right hand forefinger, back, neck and legs (calves)/ with continual nerve twitches thru-out body: neck, back, calves and right hand fore finger; sharp pinch in neck; slight dizziness (1 hour afterward); headache; sore arm in left (injection site); tingle right finger/ Pinch nerve with tingling in right hand forefinger, back, neck and legs (calves)/ continual tingles in neck, back, calves; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 13Apr2021 at 09:00 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no allergies to medications, food, or other products. The patient did not take any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 11:00, the patient experienced at slight dizziness (1 hour afterward) headache, sore arm in left (injection site), sharp pinch in neck and tingle right finger. On 14Apr2021 the patient experienced  pinch nerve with tingling in right hand forefinger, back, neck and legs (calves). On 15Ap2021 and 16Apr2021 she had continual tingles in neck, back, calves. On 17Apr2021 patient had elevated heart rate, body aches and soreness with continual nerve twitches thru-out body, neck, back, calves and right-hand fore finger. On 18Apr2021 she noticed additional elevated heart rate occurring while just sitting, same symptoms, sharpness of needle like pain in calves, fore finger, neck and back. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event slight dizziness (1 hour afterward) headache, sore arm in left (injection site), sharp pinch in neck and tingle right finger, pinch nerve with tingling in right hand forefinger, back, neck and legs (calves), continual tingles in neck, back and calves, elevated heart rate, body aches and soreness with continual nerve twitches thru-out body, neck, back, calves and right-hand fore finger and additional elevated heart rate occurring while just sitting, same symptoms, sharpness of needle like pain in calves, fore finger, neck and back was not resolved at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: Red spots on stomach and upper front of body; This is a spontaneous report from a contactable consumer, the patient. A 53-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 06Apr2021 at 12:30 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included high allergic reaction to poison Ivy exposure. The patient previously received paracetamol (TYLENOL) on an unspecified date for an unknown indication and experienced drug allergy.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included losartan (MANUFACTURER UNKNOWN) from an unknown date, for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 (Thursday) at 05:00, the patient woke up with lots of red spots on stomach and upper front of body.  No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event red spots on stomach and upper front of body was recovering at the time for this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: This is a spontaneous report from a contactable nurse. An 89-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249) 0.3 mL via intramuscular route of administration in the left arm on 19Feb2021 (at the age of 89-years-old) as a single dose for COVID-19 immunisation. Medical history included Congestive Heart Failure (CHF), tricuspid and mitral valve regurgitation, hyperlipidemia, hypertension, Gastroesophageal Reflux Disease (GERD), osteopenia, chronic dorsalgia, chronic lumbago, left partial lobectomy related to blastomycosis in 1967 and hysterectomy. The patient was allergic to iodine contrast media and iodine containing multivitamin. Concomitant medications included paracetamol (ACETAMINOPHEN), amitriptyline (MANUFACTURER UNKNOWN), butalbital, caffeine, paracetamol (FIORICET), colecalciferol, calcium phosphate (CALCIUM+D), hydrocodone, paracetamol (APAP;HYDROCODONE), furosemide (MANUFACTURER UNKNOWN), meloxicam (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN), iron (MANUFACTURER UNKNOWN), potassium (MANUFACTURER UNKNOWN), simvastatin (MANUFACTURER UNKNOWN), cyanocobalamin (VITAMIN B12), senna alexandrina (SENNA) and multivitamins (MANUFACTURER UNKNOWN), all the above taken daily and alendronate sodium (FOSAMAX), taken once weekly; all the medications were taken for unspecified 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 27Feb2021, after the second immunisation, the patient experienced zoster rash left mid T-spine, wrapping to under axilla and under breast. Care required 4 weekly visits and antibiotic, until rash was resolved. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and included treatment with lidoderm pain patch; cellulitis occurred under patch/zoster which included treatment with oral antibiotic and monitoring. The clinical outcome of the event zoster rash was resolved on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.