chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Swelling, Vaccination site erythema, Vaccination site swelling
Clinical narrative: swollen injection site; red injection site; swollen area underneath armpit area feels like someone is pulling on a stitch type of pain; swollen area underneath armpit area feels like someone is pulling on a stitch type of pain; This is a spontaneous report from a contactable healthcare professional (patient). A 21-year-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration in the right arm on 15Jan2021 15:45 at a single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (LARIN FE). The patient received first dose of BNT162B2 on 28Dec2020 03:15 for covid-19 immunization. On 15Jan2021 08:15, the patient experienced swollen injection site and red injection site. The patient added that swollen area underneath armpit area feels like someone is pulling on a stitch type of pain. The patient has taken Benadryl and Tylenol Friday, Saturday, and Sunday as treatment for the events. The patient is not pregnant. The patient has not tested positive for covid post vaccination. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: nausea; severe headache; This is a spontaneous report from a contactable physician (patient). A 40-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3249, expiration date not reported) via an unspecified route of administration on the left arm on 16Jan2021 14:00 at a single dose for COVID-19 immunization. Medical history included hypothyroidism. Concomitant medications included levothyroxine sodium (LEVOTHYROXINE) and sertraline. On 17Jan2021 05:00 AM, the patient experienced nausea and severe headache. The facility where the vaccine was administered was the workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Patient was not pregnant. Therapeutic measures were taken as a result of the events which included naproxen and acetaminophen (TYLENOL). Outcome of the events was not recovered.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Myalgia, Vaccination site pain
Clinical narrative: muscle aches and discomfort; muscle aches and discomfort; pain was at the injection site; This is a spontaneous report via a Pfizer-sponsored program from a contactable nurse (reporting for herself). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142, expiration date: 31Mar2021), intramuscular in the left arm  on 02Jan2021 at a single dose for COVID-19 immunization.  Medical history was reported none.  The patient's concomitant medications were not reported. The patient previously received the flu vaccine on unspecified date and experienced discomfort. On 02Jan2021, the patient experienced pain at injection site. On 03Jan2021, the patient experienced muscle aches and discomfort. The patient was scheduled for the second dose of the COVID-19 vaccine and reported that she took Aleve after she got the first vaccine and was wondering if she can take Aleve after the second one. She stated that it helped with the pain. She said that she was getting conflicting information and stated that she heard that there have been more symptoms associated with the second vaccine. She wanted to know if it was contraindicated for her to take the Aleve after getting the second dose. The patient described it as discomfort and stated that she gets it with the flu vaccine too. Aleve helped with the discomfort and the ache. She did not pre-medicate. She took it afterward. She stated that she took maybe 1-2 doses of the Aleve the next day and stated that by the end of the next day her pain was fine. The patient clarified pain was at the injection site and was achy. She said that she received the first vaccine on 02Jan2021 in the morning. She noticed the pain later in the day around midafternoon and said that it was gone by the next day. The outcome of the event pain at injection site was recovered on 03Jan2021 while outcome of muscle aches and discomfort was recovered on unspecified date in Jan2021.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness of arm; This is a spontaneous report from a contactable pharmacist (patient). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported) on an unspecified date for COVID-19 immunization and experienced pain in arm/injection site, headache, weakness and fatigue. The patient called to ask if it was true that most people experience increased side effects from second dose. Patient stated that he had no side effects after second dose, other than soreness of arm on an unspecified date. Patient would also like to know the guidance for timing between vaccine and other immunizations (example: flu shot) and how soon after 2nd dose of vaccine are antibodies present. The outcome of the event was unknown.  Information on Lot/Batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia
Clinical narrative: Temperature up to 102.1; body aches; headaches; This is a spontaneous report from a contactable healthcare professional (patient). A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on from 17Jan2021 10:15 at a single dose for COVID-19 immunization. The first dose was received on 27Dec2020 10:00 on the left arm (lot number: EK5730). Medical history included SVT, celiac gluten allergy. Patient was not pregnant at time of vaccination.  Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE). The patient experienced temperature up to 102.1, body aches, and headaches. Events started 10 hours after vaccine on 17Jan2021 20:30. Outcome of the event was recovering. No treatment was received. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  Information about lot/batch number has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Myalgia, Nausea
Clinical narrative: fatigue; dizziness; nausea; muscle soreness; This is a spontaneous report from a contactable consumer. This 28-year-old female consumer (patient, pregnant: No) received 1st dose of BNT162B2 (COVID vaccine) on 15Jan2021 06:15 PM at single dose on Left arm for covid-19 immunization. Medical history was Herniated disc. Known allergies: Steroids and anti-itch creams (unspecific). No other vaccine in four weeks. Concomitant drug was ethinylestradiol/norgestimate (SPRINTEC), Omeprazole. Patient reported experiencing Fatigue, Dizziness, Nausea and muscle soreness for 3 days since receiving the vaccine on 15Jan2021 08:00 PM with outcome was not recovered. No treatment. No COVID prior vaccination. No COVID tested post vaccination.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Rash papular, Rash pruritic
Clinical narrative: raised rash that itched; raised rash that itched; a little feverish; a tiny bit nauseated; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (age: 60; unit: unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced raised rash that itched, a little feverish, a tiny bit nauseated on unspecified date. Rash was approximately 1.5in by 1.5in. Outcome of the events was unknown.   Information about lot/batch has been requested.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Lethargy
Clinical narrative: Feeling very lethargic ("can barely walk"); Feeling very lethargic ("can barely walk"); Severe tiredness; This is a spontaneous report from a contactable consumer. An 82-year-old male patient received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration in Jan2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. In the morning of an unspecified day in Jan2021, the patient was feeling very lethargic. The reporter (patient's wife) stated that they both received the vaccine at 2AM on Saturday and was asking if the event was common. It was also reported that the patient had severe tiredness all of a sudden after receiving the vaccine. The reporter stated that it had been about 55 hours since the shot and she wanted to know if this was a time frame to expect this; stated that it came on so sudden. Outcome of the events was unknown. Case was reported as non-serious.  Information on the lot/batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Inappropriate schedule of product administration, Pain
Clinical narrative: chills and aches in my body and joints; chills and aches in my body and joints; chills and aches in my body and joints; dose 1: 29Dec2020; dose 2: 15Jan2021; This is a spontaneous report from a contactable pharmacist (patient herself). A 36-year-old female patient (non-pregnant) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL0142), via an unspecified route of administration on 15Jan2021 08:15 in right arm at single dose for covid-19 immunization. There were no medical history and concomitant medications. Known allergies was none. The patient previously the first dose of bnt162b2 (lot number: EJ1685) on 29Dec2020 08:00 am in right arm at single dose for covid-19 immunization. Facility type vaccine was hospital. No other vaccine in four weeks were taken and none other medications in two weeks were taken. The patient had no COVID prior vaccination and was not tested COVID post vaccination. Patient experienced chills and aches in her body and joints starting the evening after her shot on 15Jan2021 at 19:00. This continued overnight and until early afternoon (about 3pm). Patient took 3 doses of acetaminophen 500 mg for events. Outcome of chills and aches in her body and joints were recovered in Jan2021.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Fevers 101.5; Nausea; Dizziness; Headache; Body aches; This is a spontaneous report from a contactable Other HCP (patient). A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , intramuscular on 17Jan2021 13:30 at the second single dose (lot number EL0142), intramuscular on 27Dec2020 13:45 at the second single dose (lot number EJ1685) for covid-19 immunisation .  Medical history reported as none.  There were no concomitant medications.  The patient experienced fevers 101.5, nausea, dizziness, headache, body aches on 17Jan2021 22:00. The outcome of events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose decreased, Fatigue
Clinical narrative: fatigue; drops in his blood sugar; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports.  A male patient of an unspecified age (age reported as under 55/under 56 years old) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced some fatigue and drops in his blood sugar after his first vaccine. The patient asked about any information about seizures or Pancreatic (low Blood sugar) issues and fatigue after receiving the vaccine, and wanted to know the additive/ingredients in the Covid 19 vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021071679 same reporter/drug, similar event, different patients
Sex: M
Vaccine: COVID19
Symptoms: Gingival swelling, Oropharyngeal discomfort, Pharyngeal inflammation, Pruritus, Sinus disorder
Clinical narrative: nose tickling; spasming in sinuses; unusual side effects with throat; swollen gums; breathing was inflamed; This is a spontaneous report from a non-contactable consumer.  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jan2021 at single dose for covid-19 immunisation. Medical history included Lyme's disease, inflammation/high sed rate (inflammation/high sed rate).  The patient's concomitant medications were not reported.  The patient received vaccine last Saturday and within an hour developed nose tickling, spasming in sinuses, unusual side effects with throat, not sore throat and not swollen lymph nodes, swollen gums, breathing was inflamed for a few days.  He states its "not anything like anaphylaxis." The outcome of the event was breathing was inflamed was not resolved, while the outcome of the other events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: I developed a headache; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3246 and expiration date not provided), via an unspecified route of administration (left arm) first dose on 10Jan2021 17:00 at single dose for covid-19 immunisation. The patient's medical history included Anemia, Chronic Rhinitis, Rheumatoid Arthritis, Osteoarthritis, Kidney Disease Stage 3, and Gerd. The patient's concomitant medication included fexofenadine hydrochloride (ALLEGRA), rosuvastatin calcium (CRESTOR), prednisone, darbepoetin alfa (ARANESP), and clopidogrel. The patient previously took Phenergan and ACE inhibitors; both experienced allergies. On 16Jan2021 18:30, the patient developed a headache.  The patient did not received treatment for the event. The outcome of the event was unknown.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Left axillary lymphadenopathy; This is a spontaneous report from a contactable physician (patient). A 42-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142) solution for injection, via an unspecified route of administration on left arm on 16Jan2021 09:00 at a single dose for Covid-19 immunization. Medical history was reported as none. Patient has no known allergies. There were no concomitant medications. Patient was not pregnant. The patient received the first dose on 28Dec2020 (lot number: EK5730). Patient did not receive other vaccine in four weeks. Patient has no other medications in two weeks. The patient experienced left axillary lymphadenopathy on 17Jan2021 21:00. Patient did not receive any treatment. Patient was not diagnosed with Covid-19 prior to vaccination. Patient has not been tested for Covid-19 after vaccination. Outcome of the event was recovered.  No follow-up activities are needed. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Palpitations, Sleep disorder
Clinical narrative: I woke up early 14Jan2021 with some minor heart palpitations/they got more frequent and lasted longer (had one about every hour and half and they lasted 20 to 30 minutes); I woke up early 14Jan2021 with some minor heart palpitations/they got more frequent and lasted longer (had one about every hour and half and they lasted 20 to 30 minutes); just fatigued the rest of the day; This is a spontaneous report from a contactable consumer. A 73-year-old male patient received the first dose  of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3246), via an unspecified route of administration in the left arm on 13Jan2021 12:45 at a single dose for covid-19 immunization. The patient's medical history included borderline prehypertension from an unknown date and unknown if ongoing. Concomitant medication included dexlansoprazole (DEXILANT) and enalapril maleate (ENALAPRIL MALEATE). The patient previously took anticoagulant citrate dextrose and experienced drug hypersensitivity. After the patient received the vaccine, the patient felt OK, just fatigued the rest of the day, nothing out of the ordinary for a vaccination. Patient woke up early in 14Jan2021, 06:00 with some minor heart palpitations. As the day progressed, they got more frequent and lasted longer (had one about every hour and half and they lasted 20 to 30 minutes). By the evening of 14Jan2021 he told his wife about the problem. In the morning of 15Jan2021 it's still occurring but not as frequently, but they did last just as long. By evening they were less frequent and lasting quite a bit shorter (10 to 15 minutes). On 16Jan2021, it only happened about a dozen times and lasted less than 5 minutes. On 17Jan2021, he only had a couple of occurrences. Today (18Jan2021), by 12:45 PM, patient  have had only 2 occurrences. The outcome of the events was recovering. The patient did not have Covid prior to vaccination and was not tested positive prior and post vaccination.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Headache
Clinical narrative: headaches get worse at night; headache; This is a spontaneous report from a contactable consumer. A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on left upper arm on 16Jan2021 14:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included anticoagulant therapy from an unknown date and unknown if ongoing. Concomitant medication included rivaroxaban (XARELTO). The patient had the first dose of the vaccine on 16Jan2021. He has had a headache that has come and gone and after taking over the counter medication they seem to have eased up a little. Saturday night was pretty bad and Sunday night he took Excedrin before he went to sleep and when he woke up he took another half and that seemed to keep it at bay. He took two halves today and it seems to be holding the headache back. He stated it feels more like an allergy headache, the left side of his temple by his left eye is where it radiates from. He asked if other people got headaches and how long do the headaches typically last and will they eventually go away. He reported his headaches were getting lighter, but the headaches get worse at night. The patient also stated when they give the shot they don't discuss the side effects. He said they give you a sheet that lists the side effects but he stated that 25% of people having headaches is pretty significant and this should be highlighted on the sheet. He said he took 1/2 of an Equate Headache Relief caplet, and then took another 1/2 of the Equate Headache Relief caplet later. He said he tried regular Tylenol (clarified as Equate brand Acetaminophen 500mg), and the Equate Acetaminophen 500mg didn't do anything for his headache. He stated he didn't have the Equate Acetaminophen 500mg box, any longer. Therapeutic measures were taken as a result of headache (headache). The outcome of the event headache was recovering while the event headaches get worse at night was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea most of the day; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in left arm on 11Jan2021 at 18:45 at a single dose for COVID-19 immunization in a hospital.  Medical history included hypertension and stress. The patient has no known allergies. Concomitant medications included atorvastatin, ezetimibe, amlodipine, and irbesartan.  On 17Jan2021 at 13:00, the patient experienced nausea most of the day. The patient did not receive other vaccine in four weeks. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not received treatment for the event. The patient recovered from nausea in Jan2021.   Information on the batch/lot number has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Middle insomnia, Vaccination site pain
Clinical narrative: Diarrhea; Upset stomach/stomach was jumping around; she woke up during the night after her stomach was jumping around yesterday; her arm was not real sore, which she was surprised. She says that if she touches the injection site she can feel it; This is a spontaneous report received from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: unknown), via an unspecified route of administration in the left arm, on 16Jan2021 11:30, at single dose, for COVID-19 immunization. Medical history included ablation and watchmen procedure (successful) both in 2020, atrial fibrillation (A-fib) and sensitive stomach. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN 81 mg, lot number: NAA80DX, expiry date: Aug2021). The patient reported that she had her first dose of the vaccine this past Saturday (16Jan2021), and she did not have adverse events, but she was having some upset stomach on 17Jan2021 and diarrhea on 18Jan2021 and would like to know if this could be a side effect. She stated she woke up during the night of 17Jan2021 after her stomach was jumping around. She stated she has a sensitive stomach, anyway, normally; and her arm was not real sore, which she was surprised. She said that if she touches the injection site, she can feel it (pending clarification), but it is not throbbing, aching, or swollen. She stated that she was not sure if it could be the spaghetti they had for dinner, but this morning (18Jan221) she had some diarrhea. When asked about treatment, she said she didn't take anything for this because she doesn't like to take medicine, and if it is from the vaccine it should go away in a day or so but her diarrhea stayed about the same and has not gotten any better or worse. She also noticed the paperwork that said don't take Ibuprofen, Aspirin, or blood thinners, and mentioned she takes baby aspirin every day, she wanted to know if that was okay. The outcome of the event diarrhea was not recovered; and the remaining events was unknown.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Gait disturbance
Clinical narrative: light headed/ when he got out of bed that he was lightheaded; wobbly on my feet; where he had knee surgery he always has pain but there was additional pain/ Clarified that the pain from knee surgery is joint pain; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL1284, expiration date not reported) via an unspecified route of administration on the left arm on 11Jan2021 at a single dose for COVID-19. Medical history included knee surgery from 2010. There were no concomitant medications. The patient reported, "After I got my first dose of the vaccine, I felt light headed, wobbly on my feet, and had additional pain where I had knee surgery in the past. Is this normal?" He had a question about vaccine which he got last Monday 11Jan2021. Stated that he had no symptoms when he got the shot. On 11Jan2021, he was light headed and wobbly on his feet. Stated that where he had knee surgery he always has pain but there was additional pain. Stated that the symptoms lasted 4.5 days and went away. Wondered if anyone else had experienced this. Stated that he called his doctor and the CDC. Stated that this is his first shot. Clarified that the pain from knee surgery is joint pain. Stated that he had knee surgery the last time in 2010. Stated that when he got out of bed that he was lightheaded. Stated that it lasted Tuesday into early Saturday. Stated that lightheaded (dizzy) and wobbly on his feet resolved on Saturday morning. No treatment was received for the events. Outcome of the events 'light headed/ when he got out of bed that he was lightheaded' and wobbly on my feet was recovered on 16Jan2021, while recovering for the other event.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Body temperature, Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: woke with myalgias (left-sided) and significant pain left axilla.; woke with myalgias (left-sided) and significant pain left axilla.; swollen axilla and golf-ball sized lymphadenopathy; swollen axilla and golf-ball sized lymphadenopathy; mild fever (100.4) in AM; This is a spontaneous report from a contactable physician who reported for herself. A 43-year-old female patient received her second single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot number EL1283) Intramuscularly at left arm 15:15 on 17Jan2021 for Covid-19 immunization. Patient received her fist shot (Lot number EI0142) intramuscularly at left arm 06:45 PM on 27Dec2020. The patient had a medical history included factor V leiden, and Hashimotos thyroiditis. Patient had no known allergies. Concomitant medications included rivaroxaban (XARELTO), levothyroxine, rizatriptan benzoate (MAXALT). No other vaccines were taken within four weeks. 12 hours post vaccine (around 04:00 AM on 18Jan2021), patient woke with myalgias (left-sided) and significant pain left axilla. It was noted swollen axilla and golf-ball sized lymphadenopathy. Also, she had mild fever (100.4) in AM. The patient had no COVID prior vaccination and had no COVID tested post vaccination. The outcome of the events was unknown.  Amendment: This follow-up report is being submitted to amend previously reported information: Laboratory test "mild fever (100.4)" as "Body Temperature" updated in lab data section in Patient tab.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: woke with myalgias (left-sided) and significant pain left axilla.; woke with myalgias (left-sided) and significant pain left axilla.; swollen axilla and golf-ball sized lymphadenopathy; swollen axilla and golf-ball sized lymphadenopathy; mild fever (100.4) in AM; This is a spontaneous report from a contactable physician who reported for herself. A 43-year-old female patient received her second single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot number EL1283) Intramuscularly at left arm 15:15 on 17Jan2021 for Covid-19 immunization. Patient received her fist shot (Lot number EI0142) intramuscularly at left arm 06:45 PM on 27Dec2020. The patient had a medical history included factor V leiden, and Hashimotos thyroiditis. Patient had no known allergies. Concomitant medications included rivaroxaban (XARELTO), levothyroxine, rizatriptan benzoate (MAXALT). No other vaccines were taken within four weeks. 12 hours post vaccine (around 04:00 AM on 18Jan2021), patient woke with myalgias (left-sided) and significant pain left axilla. It was noted swollen axilla and golf-ball sized lymphadenopathy. Also, she had mild fever (100.4) in AM. The patient had no COVID prior vaccination and had no COVID tested post vaccination. The outcome of the events was unknown.  Amendment: This follow-up report is being submitted to amend previously reported information: Laboratory test "mild fever (100.4)" as "Body Temperature" updated in lab data section in Patient tab.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity
Clinical narrative: arm pain; redness; This is a spontaneous report from a contactable other healthcare professional (patient) and a consumer (husband). A 68-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Dec2020 at a single dose for covid-19 immunization. The patient's medical history included a heart attack 20 years ago; coronary artery disease and autoimmune deficiency (ATS) from an unknown date. Concomitant medication included clopidogrel bisulfate (PLAVIX), warfarin sodium (COUMADIN). The patient experienced arm pain and redness on an unspecified date with outcome of recovered.    Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blister, Burning sensation, Facial pain, Lip blister, Oral mucosal blistering
Clinical narrative: next to nose below right eye had the feeling of something burning/getting a feeling on face below her eye, it felt like a burning sensation; like an irritant on skin; hurt, next to my nose and as the night went on it stayed there, moving lower today; getting little red blister or some type of little things/like a little blister pustule thing, now inside lip/blisters started forming down her cheek, she can feel them still forming; getting little red blister or some type of little things/like a little blister pustule thing, now inside my lip/the blisters are down to her mouth now and there is even one inside her lip; getting little red blister or some type of little things/like a little blister pustule thing, now inside my lip/the blisters are down to her mouth now and there is even one inside her lip; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration on 17Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The caller was a retired nurse who reported that she got the covid vaccine yesterday afternoon on 17Jan2021. She reported that about 30 minutes after getting the vaccine on 17Jan2021 she noticed "that next to my nose below right eye I had the feeling of something burning, like an irritant on my skin, like jalapeno pepper juice or something. It hurt, next to my nose and as the night went on it stayed there, moving lower today and getting little red blister or some type of little things. I looked in the mirror, and it's like a little blister pustule thing, now inside my lip". Caller stated that she was trying to decide if she needs to go to Urgent Care. Caller states that she got home after getting the COVID vaccine, she was there for 15 minutes for observation and then within a half hour of her getting home afterwards, she started getting a feeling on her face below her eye, it felt like a burning sensation, like jalapeno pepper juice, like an irritant type burning. Caller states that little by little, blisters started forming down her cheek, she can feel them still forming. Caller states that the blisters are down to her mouth now and there is even one inside her lip. Caller was wondering if this vaccine triggered a shingles outbreak in her, even though she has never had shingles before. But caller stated that she knew people can pop out with shingles after something like this, but she was just speculating, she did not know for sure that it is shingles. The outcome of the events was unknown. This case reported as non-serious.  Information on the LOT/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Skin irritation
Clinical narrative: next to nose below right eye had the feeling of something burning/getting a feeling on face below her eye, it felt like a burning sensation; like an irritant on skin; hurt, next to my nose and as the night went on it stayed there, moving lower today; getting little red blister or some type of little things/like a little blister pustule thing, now inside lip/blisters started forming down her cheek, she can feel them still forming; getting little red blister or some type of little things/like a little blister pustule thing, now inside my lip/the blisters are down to her mouth now and there is even one inside her lip; getting little red blister or some type of little things/like a little blister pustule thing, now inside my lip/the blisters are down to her mouth now and there is even one inside her lip; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration on 17Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The caller was a retired nurse who reported that she got the covid vaccine yesterday afternoon on 17Jan2021. She reported that about 30 minutes after getting the vaccine on 17Jan2021 she noticed "that next to my nose below right eye I had the feeling of something burning, like an irritant on my skin, like jalapeno pepper juice or something. It hurt, next to my nose and as the night went on it stayed there, moving lower today and getting little red blister or some type of little things. I looked in the mirror, and it's like a little blister pustule thing, now inside my lip". Caller stated that she was trying to decide if she needs to go to Urgent Care. Caller states that she got home after getting the COVID vaccine, she was there for 15 minutes for observation and then within a half hour of her getting home afterwards, she started getting a feeling on her face below her eye, it felt like a burning sensation, like jalapeno pepper juice, like an irritant type burning. Caller states that little by little, blisters started forming down her cheek, she can feel them still forming. Caller states that the blisters are down to her mouth now and there is even one inside her lip. Caller was wondering if this vaccine triggered a shingles outbreak in her, even though she has never had shingles before. But caller stated that she knew people can pop out with shingles after something like this, but she was just speculating, she did not know for sure that it is shingles. The outcome of the events was unknown. This case reported as non-serious.  Information on the LOT/Batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Muscular weakness, Nausea
Clinical narrative: Next morning splitting headache woke me up at 5 am. Took Advil. 3 hours later still headache w/nausea.; Next morning splitting headache woke me up at 5 am. Took Advil. 3 hours later still headache w/nausea.; 3 hours later woke up with sweats.; Few hours after dose fatigue.; In the evening, leg weakness and achy all over.; In the evening, leg weakness and achy all over.; This is a spontaneous report from a contactable nurse (patient). This 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 16Jan2021 09:15 AM at single dose for covid-19 immunisation. Medical history was unknown. Concomitant medications were none. The patient experienced few hours after dose fatigue at 02:00 PM on 16Jan2021. In the evening of 16Jan2021, the patient had leg weakness and achy all over. Next morning on 17Jan2021, splitting headache woke the patient up at 5 am. The patient took Advil as treatment for headache. 3 hours later the patient still had headache with nausea. 3 hours later she woke up with sweats. Then she started feeling better. The patient woke up this morning slight headache only and resolved on own couple hours later. No treatment was received for the events except headache. The patient had no other vaccine in four weeks or other medications in two weeks. The patient had no covid tested post vaccination, no known allergies. Outcome of all events was recovered.   Information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Next morning splitting headache woke me up at 5 am. Took Advil. 3 hours later still headache w/nausea.; Next morning splitting headache woke me up at 5 am. Took Advil. 3 hours later still headache w/nausea.; 3 hours later woke up with sweats.; Few hours after dose fatigue.; In the evening, leg weakness and achy all over.; In the evening, leg weakness and achy all over.; This is a spontaneous report from a contactable nurse (patient). This 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 16Jan2021 09:15 AM at single dose for covid-19 immunisation. Medical history was unknown. Concomitant medications were none. The patient experienced few hours after dose fatigue at 02:00 PM on 16Jan2021. In the evening of 16Jan2021, the patient had leg weakness and achy all over. Next morning on 17Jan2021, splitting headache woke the patient up at 5 am. The patient took Advil as treatment for headache. 3 hours later the patient still had headache with nausea. 3 hours later she woke up with sweats. Then she started feeling better. The patient woke up this morning slight headache only and resolved on own couple hours later. No treatment was received for the events except headache. The patient had no other vaccine in four weeks or other medications in two weeks. The patient had no covid tested post vaccination, no known allergies. Outcome of all events was recovered.   Information on the lot/batch number has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Heart rate, Heart rate increased, Pain in extremity
Clinical narrative: Arm pain happened 4 hours after vaccination.; Dizziness; weakness; heart rate went to 140 30 minutes after the shot. Heart rate went down 1 hour after; This is a spontaneous report from a contactable consumer. This 25-year-old female consumer (patient) reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunization on 18Jan2021 at 13:00.  Relevant history and concomitant drugs were unknown. No known allergies. No other medical history. The patient received her first dose of BNT162B2 on unknown date. The patient experienced dizziness and weakness on 18Jan2021 at 01:45 pm. The heart rate went to 140 30 minutes after the shot. Heart rate went down 1 hour later, but she was still having dizziness. The patient also had arm pain 4 hours after vaccination on 18Jan2021. No treatment was received. The outcome of event was recovering.  The patient did not receive any other vaccine in four weeks. The patient did not have COVID infection prior vaccination. The patient did have COVID test post vaccination.   Information about Lot/Batch number is requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Fatigue
Clinical narrative: felt very tired; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via unspecified route of administration on 13Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of COVID vaccine on 13Jan2021 and was scheduled to receive second dose on 02Feb2021. In Jan2021, the patient felt very tired after first dose. The patient informed that she usually walks two miles per day and since the first dose of vaccine she has only been able to walk one mile. The patient informed that she was able to walk two miles yesterday. The patient informed that she was set up for major dental work to include implant capping of two teeth and cancelled her appointment for today. The patient wanted to know if she should put off having her dental work done until after the second dose of the vaccine as she has another appointment scheduled for next Monday. The patient informed that she went to her rheumatologist for blood workup and she can only have blood work done on one arm. The patient wanted to know how long does she have to wait after second dose to have blood work drawn in same arm. The outcome of the event felt very tired was unknown.  Follow-up activities are possible, information on the batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Oropharyngeal pain, Pain
Clinical narrative: Body aches; fatigue; sore throat; chills; This is a spontaneous report from a contactable nurse who reported for herself. A 44-year-old female patient received her second single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot number EL9261) at her right arm 08:30 AM on 17Jan2021 for Covid-19 immunization. The patient received her first shot (lot number EL0140) at right arm 08:30AM on 27Dec2020. The patient had a medical history included asthma, anxiety, hyperlipidemia. Patient had no known allergies. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), duloxetine, salbutamol (ALBUTEROL), rosuvastatin calcium (CRESTOR), and montelukast sodium (SINGULAIR). 06:30 PM on 17Jan2021, the patient experienced body aches, fatigue, sore throat, and chills. No treatment was received for the events. The outcome of the events was not resolved at the time of reporting. Patient had no COVID prior vaccination and had not COVID tested post vaccination.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: facial swelling; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received second dose of bnt162b2 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration in left arm om 11Jan2021 09:30 at single dose for COVID-19 immunization. Medical history included seasonal allergies and urinary incontinence from an unknown date and unknown if ongoing.  Concomitant medication included cetirizine, atenolol (NORTELOL) and oxybutynin. The patient was previously vaccinated with first dose of BNT162B2 (lot number: EH9899) via unspecified route in right arm ,on 22Dec2020 09:30 AM, for COVID-19 immunization. The patient was not pregnant. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced facial swelling on 11Jan2021 18:00 treated with diphenyhydramine (self administered). The outcome of the event was recovered on unspecified date.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot # EH9199) via an unspecified route of administration in left arm on 26Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sore arm on an unspecified date with outcome of unknown.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Splitting trident occipital headache/ Dull ache in frontal skull region; This is a spontaneous report from a contactable other healthcare professional (patient). A 34-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK5730, expiration date not reported) via an unspecified route of administration on the left arm on 23Dec2020 16:00 at a single dose for COVID-19 immunization. Medical history included asthma, rheumatoid arthritis, Raynaud's and allergies: latex, nickel, erythromycin. Concomitant medication included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]), mometasone furoate (FLONASE [MOMETASONE FUROATE]), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), colecalciferol (VITAMIN D [COLECALCIFEROL]) and multivitamin. On 24Dec2020, 1 day post 1st injection the patient had splitting trident occipital headache - lasted 24 hrs. Dull ache in frontal skull region two days after that. No treatment was received. The facility where the vaccine was administered was the workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Ultrasound chest, Ultrasound scan
Clinical narrative: Lymph node swelling noticed in the left clavicle area/swollen lymph node around her left clavicle; Lymph node swelling noticed in the left clavicle area/Did hurt at the beginning; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 18Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 03Jan2021, the patient experienced lymph node swelling noticed in the left clavicle area. No pain now but did hurt at the beginning "for a few days." The patient stated her doctor did an ultrasound of both sides of chest and both clavicle areas: unknown result. The patient was asking if this has been reported in other patients. The patient stated, "I have read everything on lymph edema, I want some specific information regarding the swollen lymph node around my left clavicle. I am really concerned because nobody can tell me anything. I am a nurse and if this is normal side effect from the vaccine then tell me or do I need to get a biopsy for lymphoma?". The outcome of the events was recovered in Jan2021.  Information on the Batch/Lot number has been requested.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Pulsating muscle back pain; This is a spontaneous report from a contactable consumer (patient).  An 83-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231, expiration date unknown), via an unspecified route of administration in the right arm on 12Jan2021 at 11:00 AM at  a single dose for COVID-19 immunization.  Medical history included advanced prostate cancer and penicillin allergies. The patient had no COVID prior to vaccination.  Concomitant medications included prednisone, amlodipine, losartan, and enzalutamide (XTANDI) given on unknown dates for unspecified indications. Patient has not had other vaccine in four weeks. On 12Jan2021 at 15:00, the patient  experienced pulsating muscle back pain. The patient has not been tested for COVID post vaccination. Therapeutic measures were taken as a result of the event  which included  unspecified OTC medicine. The outcome of the event was recovering.