chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Hypoaesthesia, Skin abrasion, Swelling
Clinical narrative: abrasions to my chest and left leg.; swelling; dramatically decreasedsensitivity to pain.; after receiving the vaccine Ifell; This is a spontaneous report received from a contactable consumer, the patient. A 42-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 01Apr2021 at 12:45 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were reported as no. The patient had no known allergies. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. 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 02Apr2021 at 08:00, the patient experienced decreased sensitivity to pain, abrasions to chest, fall and left leg swelling. The patient reported that he experienced dramatically decreased sensitivity to pain and while jogging on morning after receiving the vaccine he fell and suffered abrasions on his chest and left leg. Despite clearly visible abrasions and swelling he experienced no pain at all. 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 fall, swelling, abrasions to chest and left leg and decreased sensitivity to pain were unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Neck pain, Pain in extremity
Clinical narrative: arm soreness; sharp stabbing pains in lower neck; sharp stabbing pains in lower neck and upper back; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot Number: ER 8730) in the left arm on 31Mar2021 at 15:30 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as no health issues and the patient was very athletic and fit. The patient did not receive any vaccination in four weeks. The patient did not receive any other medications in two weeks. The patient did not have a history of allergies to medications, food, or other products. 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 31Mar2021, post-vaccination, the patient experienced arm soreness, sharp stabbing pains in lower neck and sharp stabbing pains in upper back. The patient reported that initially, she experienced immediate arm soreness. The patient awakened in the middle of the night with sharp stabbing pains in lower neck and upper back. The pain was intense which prevented movement and necessitated contacting physician who prescribed meloxicam and Flexeril. Pain remained intense on second day after the vaccine and persisted on third day but, was considerably improved. The event resulted in doctor or other healthcare professional office/clinic visit. Patient received meloxicam and Flexeril as treatment. The clinical outcome of the events arm soreness, sharp stabbing pains in lower neck and upper back was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste in mouth within 1 minuteof getting the shot.; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 02Apr2021 at 16:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Concomitant medications included calcium (MANUFACTURER UNKNOWN) and Prenatal Vitamins (MANUFACTURER UNKNOWN) for unknown indication. Medical history was 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 COVID-19 vaccine. On 02Apr2021 at 16:31, the patient had experienced metallic taste in mouth with in one minute of getting the shot. Adverse event 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 metallic taste in mouth within 1 minute of getting the shot was unknown at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Muscle spasms, Nausea
Clinical narrative: Hand, calves, foot muscle cramping/  severe cramping in chest and back; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 56-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 19Mar2021 at 10:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer, kidney infarcts possibly due to aromatose inhibitors and was on blood thinners for the same. Concomitant medications included rivaroxaban (XARELTO) and exemestane (MANUFACTURER UNKNOWN) from an unknown date. The patient had no known allergies to medications, food or other products. 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 vaccine. On 28Mar2021 the patient experienced hand, calves, foot muscle cramping, severe cramping in chest and back. The patient experienced nausea on 28Mar2021. The patient underwent MRI contrast procedure on an unknown date and had no issues and the result was unknown. The adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events cramps and nausea were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Malaise
Clinical narrative: Injection site pain; Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever; Injection site redness; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old male 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 30Mar2021 at 16:30 as a single dose for COVID-19 immunisation. Medical history included diabetes, rectal cancer treated and in remission, appendectomy, facial bones fracture from a car accident. The patient previously took Metformin and experienced drug allergy. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), aspirin (MANUFACTURER UNKNOWN), sitagliptin phosphate (JANUVIA) and pioglitazone hydrochloride (PIOGLI) all from an unknown date for an unknown indication. 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 an unknown date in Mar2021 at 16:30 the patient experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site redness, nausea and feeling unwell. The patient did not receive any treatment for the events. The clinical outcome of the events injection site pain, tiredness, headache, muscle pain, chills. joint pain, fever, injection site redness, nausea and feeling unwell were not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Injection site pain; Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever; Injection site redness; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old male 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 30Mar2021 at 16:30 as a single dose for COVID-19 immunisation. Medical history included diabetes, rectal cancer treated and in remission, appendectomy, facial bones fracture from a car accident. The patient previously took Metformin and experienced drug allergy. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), aspirin (MANUFACTURER UNKNOWN), sitagliptin phosphate (JANUVIA) and pioglitazone hydrochloride (PIOGLI) all from an unknown date for an unknown indication. 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 an unknown date in Mar2021 at 16:30 the patient experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site redness, nausea and feeling unwell. The patient did not receive any treatment for the events. The clinical outcome of the events injection site pain, tiredness, headache, muscle pain, chills. joint pain, fever, injection site redness, nausea and feeling unwell were not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Erythema, Feeling hot, Lymphadenopathy, Vaccination site lymphadenopathy
Clinical narrative: Armpit pain; Hot to touch; large red looking welt approx 4-5 inches width; swollen lymph nodes armpit; swollen lymph nodes at site of injection; This is a spontaneous report from a contactable consumer, the patient. A 57-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 arm left on 31Mar2021 at 10:00 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. The patient medical history included diabetes. Patient received other medication in 2 weeks which included dulaglutide (TRULICITY) for unknown indication and start date. The patient did not report any allergy to food, medication and other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021, 16 hours after 2nd vaccine, the patient woke at night with armpit pain, swollen lymph nodes armpit and at site of injection, hot to touch with large red-looking welt approx. 4-5 inches width. Three days later, still swollen at site, warm to touch with welt look and slight expansion of redness area. 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 outcomes of the events armpit pain, hot to touch, large red-looking welt approx. 4-5 inches width, swollen lymph nodes armpit, swollen lymph nodes at site of injection were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Peripheral swelling
Clinical narrative: swelling on flank/side boob; swollen armpit/swelling on flank/side boob; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 23Mar2021 at 15:00 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included Crohn's disease. Concomitant medications included birth control, doxycycline (MANUFACTURER UNKNOWN) and ustekinumab (STELARA) all on an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 09Mar2021 at 15:00 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. The patient previously took Amoxicillin and Sulfa antibiotics and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 06:15 the patient experienced swollen armpit. On 02Apr2021, armpit swelling continued and in addition experienced swelling on flank/side boob. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events swollen armpit and breast swelling was not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Malaise, Myalgia
Clinical narrative: Muscle pain; Headache; Chills; Joint pain; Nausea; Feeling unwell; 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: EN6207) via an unspecified route of administration in the left arm on 31Mar2021 at 09:45 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, thyroid disorder, high cholesterol and COVID-19 all from unknown date. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), venlafaxine (MANUFACTURER UNKNOWN), vitamin d2 (MANUFACTURER UNKNOWN) and telmisartan (MANUFACTURER UNKNOWN) all for unknown indication and from unknown date. The patient previously received codeine and experienced allergy.  Prior to the vaccination, the patient was 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 vaccine.  On 01Apr2021 (day after vaccination) at 04:00 the patient experienced muscle pain, headache, chills, joint pain, nausea and feeling unwell. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event chills, muscle pain, headache, joint pain, nausea and feeling unwell was not recovered 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: Nausea
Clinical narrative: Muscle pain; Headache; Chills; Joint pain; Nausea; Feeling unwell; 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: EN6207) via an unspecified route of administration in the left arm on 31Mar2021 at 09:45 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, thyroid disorder, high cholesterol and COVID-19 all from unknown date. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), venlafaxine (MANUFACTURER UNKNOWN), vitamin d2 (MANUFACTURER UNKNOWN) and telmisartan (MANUFACTURER UNKNOWN) all for unknown indication and from unknown date. The patient previously received codeine and experienced allergy.  Prior to the vaccination, the patient was 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 vaccine.  On 01Apr2021 (day after vaccination) at 04:00 the patient experienced muscle pain, headache, chills, joint pain, nausea and feeling unwell. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event chills, muscle pain, headache, joint pain, nausea and feeling unwell was not recovered at the time of this report   No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Foaming at mouth, Hiccups, Salivary hypersecretion
Clinical narrative: Mouth filled with foam; Hiccuped; Whole mouth was filled with a very thick, veryfoamy saliva; This is a spontaneous report from a contactable other healthcare professional, the patient. A 39-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 02Apr2021 at 14:00 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no allergies to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. 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 02Apr2021 at 15:30, one hour after receiving the vaccine, the patient experienced mouth filled with foam, hiccuped, felt the mouth was filled with saliva and when she looked in the mirror the whole mouth was filled with a very thick, very foamy saliva. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events mouth filled with foam, hiccuped and whole mouth was filled with a very thick, very foamy saliva was resolved with lasting effects on 02Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Lump on collarbone or neck; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old, non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in left arm on 01Apr2021 at 14:00 (at an age of 50-year-old) as single dose for COVID-19 immunisation. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route in left arm on 14Mar2021 at 16:00 hours as single dose for COVID-19 immunisation. The patient had known allergy to Morphine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19.Post the vaccination, the patient was not tested for COVID-19. On 02Apr2021 the patient had lump on collarbone/neck. 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 for the event of lump on collarbone or neck was not resolved at the time of this report.   No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Lymphadenopathy, Pain in extremity
Clinical narrative: lymph nodes were swollen frommy shoulder to collar bone; my shoulder still is incredibly sore; Felt tired; soreness in my arm.; This is a spontaneous report from a non-contactable consumer, the patient. A 30-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 right arm on 26Mar2021 at 13:00(at the age of 30-year-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. 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 26Mar2021 within the same day, the patient felt tired and soreness in arm and on 30Mar2021 four days later at 07:00, the patient experienced swollen lymph nodes in shoulder to collar bone and shoulder soreness, which was incredible. 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 events tiredness, soreness in arm, swollen lymph nodes and shoulder soreness were not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Lymph node pain
Clinical narrative: Felt a strange sensation in left neck, faceand sinus; Tonsils are sore; feel a strange sensation in my left neck, face and sinus.; This is a spontaneous report from a contactable consumer, the patient. A 39-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the arm right on 02Apr2021 at 12:45 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to nuts of all kinds and swimming fish (not shellfish) allergy. Patient received other medications in two weeks which included paracetamol (TYLENOL), guaifenesin (MUCINEX), ibuprofen (ADVIL), paracetamol; acetylsalicylic acid; caffeine (EXCEDERINE) all from an unknown date for an unspecified indication. The 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. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021 at 13:30, the patient experienced a strange sensation in his left neck, face and sinus. It was subtle. More alarming was that his tonsils were soar. And this had gotten progressively worse as the day had gone on. 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. Clinical outcome of neck strange feeling, lymph node pain, feeling strange was not recovered at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Vomiting
Clinical narrative: Vomiting; Massive headache; Incredibly tired; Sore right arm; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the right arm on 31Mar2021 at 14:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient was not allergic to food, medications, or other products. The patient did not receive any medications within two weeks prior to the COVID-19 vaccine.  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 31Mar2021, after about 3 hours from the first dose of vaccine, the patient was incredibly tired and slept. The event of incredibly tired was not that bad. The patient woke up for a little while and then went back to sleep again. On 01Apr2021 at around 06:15, the patient woke up with a massive headache. He took a couple of ibuprofen and tried to relax. About fifteen minutes later, at 06:30, the patient could tell he was about to vomit and did. He kept vomiting for about the next 20 minutes or so till there was nothing left. He slowly sipped water for the next hour. After that he had no adverse reactions. The patient stated that, he had not vomited in at least the past 7 years and that episode of vomiting was violent and also stated he could not control that. On the same day, in the evening, the patient only had a slight sore right arm and episode of tiredness. On 02Apr2021, after vomiting the patient slept for the next five or so hours. His arm was still slightly sore but really did not bother him. After around 2 PM (about 24 hours later), he had felt totally fine. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the events of tiredness, vomiting and sore right arm. The clinical outcome of the event tiredness, headache, vomiting and sore right arm were resolved in 02Apr2021. No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache
Clinical narrative: Extreme fatigue; Dizziness; Headache; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8732) via an unspecified route of administration in the left arm on 01Apr2021 at 13:15 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19, sleep apnea, hypotension, history of CA (cardiac arrest), penicillin (Pcn) allergy and sulfonamide (sulfa) allergy. The patient received unspecified medications as concomitants within two weeks of vaccination. The patient previously took emycin and iodine and experienced allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 05:00, the patient experienced dizziness, extreme fatigue and headache. The patient did not receive any treatment for the reported 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 dizziness, extreme fatigue and headache were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Sore left arm; Headache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 37-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 02Apr2021 at 09:30 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included type II diabetes mellitus and COVID-19 on an unknown date. The patient was allergic to codeine (MANUFACTURER UNKNOWN). Concomitant medications included insulin glargine (BASAGLAR) and novalog (MANUFACTURER UNKNOWN) both from an unknown date for an unknown indication. 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 02Apr2021 at 19:00 the patient experienced sore left arm, headache and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events sore left arm, headache and fatigue were recovering at time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus
Clinical narrative: Itching on torso and back; Pins and needles on torso and back; This is a spontaneous report from a contactable consumer, the patient. A 16-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 01Apr2021 at 11:30 (at the age of 16-years-old), as a single dose for COVID-19 immunisation. Medical history included asthma and penicillin 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 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. On 03Apr2021 at 01:00, the patient experienced itching on torso and back and pins and needles on torso and back. 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 itching on torso and back and pins and needles on torso and back was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Vaccination site pain
Clinical narrative: Head ache; Moderate injection site pain; Pain when raising arm above horizontal; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male 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 02Apr2021 at 15:15 (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 COVID-19 vaccination. On 03Apr2021 at 08:00, the patient experienced headache, moderate injection site pain and pain when raising arm above horizontal. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events headache, moderate injection site pain and pain when raising arm above horizontal was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Musculoskeletal stiffness, Nausea, Pain, Pain in extremity
Clinical narrative: Body aches; sore/stiff arm; Low grade fever,; Slight nausea; Tired; sore/stiff arm; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration at the left arm on 31Mar2021 at 12:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity, anxiety and depression. The patient had received other medications (unspecified) within 2 weeks of vaccination. The patient did not have any allergies to food, medications, or other products. 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 medications or vaccines within 4 weeks prior to the vaccination. On 31Mar2021 at 13:00, the patient had experienced low grade fever, slight nausea, body aches, tired and sore/stiff arm. The patient did not receive any treatment for the reported events. Adverse 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 low grade fever, slight nausea, body aches, tired and sore/stiff arm was resolved on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Body aches; sore/stiff arm; Low grade fever,; Slight nausea; Tired; sore/stiff arm; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration at the left arm on 31Mar2021 at 12:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity, anxiety and depression. The patient had received other medications (unspecified) within 2 weeks of vaccination. The patient did not have any allergies to food, medications, or other products. 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 medications or vaccines within 4 weeks prior to the vaccination. On 31Mar2021 at 13:00, the patient had experienced low grade fever, slight nausea, body aches, tired and sore/stiff arm. The patient did not receive any treatment for the reported events. Adverse 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 low grade fever, slight nausea, body aches, tired and sore/stiff arm was resolved on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Migraine
Clinical narrative: Moderate migraine headache; Achy joints; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6206) in the right arm on 11Mar2021 at 13:00 (at the age of 65-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8782) in the right arm on 01Apr2021 at 08:15 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, hypertension (HTN), osteoarthritis, migraine (since menopause migraines were infrequent), knee replacement, arthritis and menopause. The patient had codeine allergy and seasonal allergy. The concomitant medications were taken by the patients (unspecified) within two weeks prior to COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19 vaccine. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On an unknown date in Mar2021 after first vaccination, the patient experienced moderate migraine headache and achy joints, which lasted for 2 days. On an unknown date in Apr2021 after second vaccination, the patient had recurrence of migraine headache for 3 days and achy joints for 2 days.  As the symptoms recurred the patient believed it was caused by the vaccine. The patient had a history of migraine and arthritis but these episodes did not follow normal triggers. No other effects were noted but the patient wanted to report the events for record purpose. Additional medical attention was not requested as the patient had called on day 4. The adverse events did not result in a visit to the doctors or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient received treatment with unspecified medications for the reported events. It was also reported that the episodes of migraine headache and achy joints did not respond to treatment medications as quickly as usual. The clinical outcome of the event moderate migraine headache and achy joints were resolved on an unknown date. No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Fatigue, Nausea, Pain
Clinical narrative: Arm pain at injection site; Fever 100.8 max; Nausea; Vomiting; Diarrhea; Fatigue; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 3248) via an unspecified route of administration in the arm right on 30Mar2021 at 09:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to clindamycin (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the arm right on 09Mar2021 (at the age of 39-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 01Apr2021, the patient experienced arm pain at injection site, fever 100.8 max, nausea, vomiting, diarrhea, fatigue and body aches. 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 events. The clinical outcome of the events arm pain at injection site, fever 100.8 max, nausea, vomiting, diarrhea, fatigue and body aches were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain, Vomiting
Clinical narrative: Arm pain at injection site; Fever 100.8 max; Nausea; Vomiting; Diarrhea; Fatigue; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 3248) via an unspecified route of administration in the arm right on 30Mar2021 at 09:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to clindamycin (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the arm right on 09Mar2021 (at the age of 39-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 01Apr2021, the patient experienced arm pain at injection site, fever 100.8 max, nausea, vomiting, diarrhea, fatigue and body aches. 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 events. The clinical outcome of the events arm pain at injection site, fever 100.8 max, nausea, vomiting, diarrhea, fatigue and body aches were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes in neck opposite side of injection; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 01Apr2021 at 10:15 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient received unspecified medication within two weeks of vaccination. The patient had no known allergies to medications, food or other products. 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 01Apr2021 at 20:00, the patient experienced swollen lymph nodes in neck opposite side of injection. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event swollen lymph nodes was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headache; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included ADHD and depression. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and lamotrigine (LAMICTAL); both from unknown date for unspecified indication. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 an unknown date, the patient experienced headache and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events headache and fatigue were recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pain
Clinical narrative: Hives or red rash torso, front and back, down arms and groin - not itchy; Fever; Body aches; Chills; Fatigue; Headache; This is a spontaneous report from a contactable other healthcare professional, the patient. A 61-year-old 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 left arm on 30Mar2021 at 13:00(at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included moderate and controlled asthma and environmental allergy. Concomitant medications included allergy shots taken monthly. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number:EN6205) via an unspecified route of administration in the left arm on 10Mar2021 (at the age of 61-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 30Mar2021 at 16:00 the patient experienced  within 3 hours of Pfizer booster(second dose), chills, headache, fatigue. The patient woke up on 31Mar2021 with fever(100.2), exhaustion, body aches, chills, headache. The patient woke up on 01Apr2021 with red rash/hives all over her torso, front and back, down her arms, and in groin which was not itchy. All other symptoms continued. The next day, 02Apr2021 was same as the last day. On 03Apr2021 the patient experienced the first day without  headache, chills, fever, exhaustion and hives were fading. Therapeutic measures were taken as a result of the reported adverse events and included treatment with Tylenol, 650 mg every 4 hours started on 30March2021 to 02Apr2021(4 days). Lab test included body temperature on 30Mar2021 and the result was 100.2. The clinical outcome of the events headache, chills, fever and exhaustion was recovered on 03Apr2021. The clinical outcome of the events hives and body aches were recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.