chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain, Somnolence
Clinical narrative: Moderna COVID-19 Vaccine EUA  Day1- none Day2- Injection site: soreness, firmness, and weakness. General symptoms: none Day3- Injection site: bruising, tenderness. General symptoms: fatigue Day4- Injection site: bruising, tenderness. General symptoms: fatigue, body aches, joint pains, difficulty waking in the morning Day5- Injection site: bruising, tenderness. General symptoms: fatigue, body aches, joint pains, difficulty waking in the morning Day6- Injection site: bruising, tenderness. General symptoms: fatigue, body aches, joint pains, difficulty waking in the morning  I am currently on day 6 from getting the Moderna COVID-19 Vaccine and the injection side bruising and tenderness still persist along with the general symptoms of fatigue, body aches, joint pains, and difficulty waking up in the morning.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Myalgia, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable nurse (patient). A 33-year-old female patient received BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) on 22Dec2020 11:30AM at left arm for COVID-19 immunization. The patient had known allergies to sulfa and was currently breastfeeding. The patient had concomitantly received ascorbic acid, honey, melatonin, zinc gluconate (ZARBEE'S ALL NATURAL COUGH SYRUP NIGHTTIME) (reported as " Zarbees elderberry immune syrup") in two weeks. The patient experienced fatigue, myalgias, headache, arm soreness, brain fog at 3:00PM on 22Dec2020. Patient received ibuprofen 400 mg as treatment for the adverse events. The outcome of the events was resolving at the time of reporting. Information on the lot/batch number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Hot flush
Clinical narrative: headache; fatigued; lightheaded/dizzy(the room was spinning); nauseous; chills; hot flashes; This is a spontaneous report from a contactable nurse reported for herself. A 24-year-old adult female patient (pregnant: no) was received the first dose BNT162B2 (brand: Pfizer, Batch/lot number: EK5730) via unspecified rout of administration on left arm on 23Dec2020 13:00 at single dose for COVID-19 immunization. Medical history included asthma, Bipolar Disorder, known allergies: Latex, milk, bananas, blue dye 2&, COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19? :Yes). Concomitant medication in two weeks included lamotrigine (LAMICTAL), fluoxetine hydrochloride (PROZAC), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and ascorbic acid, ferrous fumarate, folic acid, retinol (PRENATAL [ASCORBIC ACID;FERROUS FUMARATE;FOLIC ACID;RETINOL]). No other vaccine in four weeks. After the vaccination patient became lightheaded, dizzy (the room was spinning), nauseous and got chills and hot flashes. After 30minutes or so she began to get a headache while the other symptoms wore off and then became fatigued. Adverse event start date was 23Dec2020 01:00 PM. the most recent COVID-19 vaccine was administered in Hospital. Since the vaccination, the patient has not been tested for COVID-19. Treatment received for the events included ibuprofen (MOTRIN), Meclizine, ondansetron (ZOFRAN) and paracetamol (TYLENOL). Patient was recovering from the events. It was reported as non-serious. No results in death, life threatening, caused/prolonged hospitalization, disabling/Incapacitating nor congenital anomaly/birth defect.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vertigo
Clinical narrative: headache; fatigued; lightheaded/dizzy(the room was spinning); nauseous; chills; hot flashes; This is a spontaneous report from a contactable nurse reported for herself. A 24-year-old adult female patient (pregnant: no) was received the first dose BNT162B2 (brand: Pfizer, Batch/lot number: EK5730) via unspecified rout of administration on left arm on 23Dec2020 13:00 at single dose for COVID-19 immunization. Medical history included asthma, Bipolar Disorder, known allergies: Latex, milk, bananas, blue dye 2&, COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19? :Yes). Concomitant medication in two weeks included lamotrigine (LAMICTAL), fluoxetine hydrochloride (PROZAC), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and ascorbic acid, ferrous fumarate, folic acid, retinol (PRENATAL [ASCORBIC ACID;FERROUS FUMARATE;FOLIC ACID;RETINOL]). No other vaccine in four weeks. After the vaccination patient became lightheaded, dizzy (the room was spinning), nauseous and got chills and hot flashes. After 30minutes or so she began to get a headache while the other symptoms wore off and then became fatigued. Adverse event start date was 23Dec2020 01:00 PM. the most recent COVID-19 vaccine was administered in Hospital. Since the vaccination, the patient has not been tested for COVID-19. Treatment received for the events included ibuprofen (MOTRIN), Meclizine, ondansetron (ZOFRAN) and paracetamol (TYLENOL). Patient was recovering from the events. It was reported as non-serious. No results in death, life threatening, caused/prolonged hospitalization, disabling/Incapacitating nor congenital anomaly/birth defect.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: woke up with mild fever, and severe headache, lasted through the day, was gone upon waking next morning.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, SARS-CoV-2 test negative
Clinical narrative: Joint ache and tiredness on the next day after vaccination; Joint ache and tiredness on the next day after vaccination; This is a spontaneous report from a contactable other healthcare professional (patient). A 27-years-old female patient (not pregnant) received BNT162B2 (lot number: EK5730) first dose on 18Dec2020 12:45 PM intramuscularly on Left arm at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. No Known allergies to medications, food, or other products. Facility type vaccine was Hospital. Other medications in two weeks was No. Patient experienced Joint ache and tiredness on the next day after vaccination (19Dec2020). Patient had no covid prior vaccination. Patient had covid tested post vaccination on 21Dec2020, Nasal Swab, the result was negative. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment received for the events. The outcome of the events was recovering. The seriousness was reported as no.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: soreness at site of injection; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Dec2020 intramuscularly on right arm at single dose for COVID-19 immunization. Medical history included ongoing Psoriatic arthritis, patient received allergy shots (Unable to provide the names, NDC. Lot, or expiry for the allergy injections she received. It's the regular one for pets (cat and dog dander), trees, mold and dust. No food allergy. Mentions having an allergy to sulfur), unspecified sulfur products-wheezing, rash, itching. Concomitant medications included adalimumab (HUMIRA) and methotrexate, both ongoing for Psoriatic arthritis. She Is having soreness in her arm where she received it and she got it last Thurday (17Dec2020). Today (23Dec2020), she went to get her allergy shots and not sure if she should have waited or if she is missing something in the literature about doing the allergy shots after. It didn't say. She knows that it is the same when she has to get a flu shot she waits about a week to get her allergy shots. Received the vaccine early last Thurday evening and the allergy shots today at 2pm. Received the vaccine through her workplace. The soreness started on Friday morning (18Dec2020) and by Monday afternoon (21Dec2020) and it had gone away. She is just worried because she got the allergy injection today in the same arm that the vaccine was given. Clarifies that the soreness is around the injection site of where the vaccine was given, not where the allergy shots given. Worried that she should have waited and doesn't want to go to bed and wake up with something wrong. States this is her first shot. Unable to provide the names, NDC. Lot, or expiry for the allergy injections she received. It's the regular one for pets (cat and dog dander), trees, mold and dust. No food allergy. Mentions having an allergy to sulfur. Has wheezing airway and the first time was when she was a kid and she got a rash, redness, and itching. The doctor now knows not to prescribe anything with sulfur because the second time was when she was 20 something she had the wheezing. Vaccination Facility Type was Hospital. Vaccine Administered at Military Facility was No. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. No AE(s) require a visit to Emergency Room or physician office. Prior Vaccinations (within 4 weeks prior to the first administration date of the suspect vaccine(s)) was none. The outcome of the event was recovered on 21Dec2020. The seriousness was reported as no.   Information on the Batch/Lot number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pain, Pyrexia
Clinical narrative: Severe body aches; chills; low grade fever 100.7; fatigue; muscle pain; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient (pregnant: no) was received first dose BNT162B2 (brand: Pfizer BioNtech, lot number: EJ1685), via unspecified route of administration at arm right on 17Dec2020 12:30 PM at single dose for COVID-19 immunization. Medical history included Complex Migraines, prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication in two weeks included verapamil, amitriptyline, fish oil, magnesium, vitamin b2 [riboflavin], no other vaccine in four weeks. Patient previous took amoxicillin clavulanic acid (AUGMENTIN), butalbital caffeine paracetamol (FIORICET) and eletriptan hydrobromide (RELPAX) and had allergies to them. Patient experienced severe body aches, chills, low grade fever 100.7, fatigue, muscle pain on 18Dec2020 03:00 AM. the most recent COVID-19 vaccine was administered in Hospital. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for the events. Patient was recovered from the events. It was reported as non-serious. No results in death, life threatening, caused/prolonged hospitalization, disabling/Incapacitating nor congenital anomaly/birth defect.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Somnolence
Clinical narrative: soreness at site of injectio and droziness
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Fever up to 100.4; Headache; Chills; Muscle pains; This is a spontaneous report from a contactable physician (patient). A 57-year-old male patient was received first dose BNT162B2 (reported "Active Drug substance names: COVID 19", lot number: EJ1685), via unspecified route of administration at left arm on 18Dec2020 05:15 PM at single dose for COVID-19 immunization. Medical history included hyperlipidaemia and COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19?:Yes), No known allergies. There are no other medications in two weeks and no other vaccine in four weeks. Patient experienced fever up to 100.4, headache, chills, muscle pains on 19Dec2020 12:00 PM (20Dec2020 00:00). the most recent COVID-19 vaccine was administered in Hospital. Since the vaccination, the patient has not been tested for COVID-19 (COVID was not tested post vaccination). Treatment for the event included paracetamol (TYLENOL). Patient was recovered from the events. It was reported as non-serious. No results in death, life threatening, caused/prolonged hospitalization, disabling/Incapacitating nor congenital anomaly/birth defect.  Pfizer is a marketing authorization holder of COVID 19 vaccine in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of COVID 19 vaccine has submitted the same report to the regulatory authorities.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Heart rate increased, Pharyngeal swelling, Vocal cord disorder
Clinical narrative: Patient reports that about 25 minutes after receiving the vaccine she began to feel like her throat was swollen and the her voice was changed and she had a feeling of pressure on her vocal chords.  She also noted that she seemed to have an increase in heart rate. She took a dose of Benadryl and no further symptoms were experienced.  She reports that these symptoms resolved by next day but she felt extreme fatigue for the next few days.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Chest discomfort, Dizziness, Muscle tightness
Clinical narrative: Patient  received the vaccine, waited 15 minutes and had no difficulties.  He presented back to the injection area with complaints of dizziness, slight chest and neck tightness. BP was slightly elevated.  He was given 2 benadryl an taken to the ED where they monitored him. No further medication intervention needed.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Felt a little achey and a sore arm; This is a spontaneous report from a contactable consumer. An adult female patient of unspecified age was received first dose of BNT162B2 (Brand: Pfizer/BioNTech, lot number: unknown) via unspecified route of administration at single dose for COVID-19 immunization. Medical history and concomitant medication were unknown. It was unknown if other vaccine in four weeks. Patient felt a little achey and a sore arm on 21Dec2020. It was unknown if the patient diagnosed with COVID-19 prior to vaccination, it was unknown if the patient been tested for COVID-19 since the vaccination (unknown covid tested post vaccination). It was unknown if treatment received for the event. Outcome of the events was unknown. It was reported as non-serious. No results in death, life threatening, caused/prolonged hospitalization, disabling/Incapacitating nor congenital anomaly/birth defect.  Information on the Batch/Lot number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain, Vertigo, Vomiting
Clinical narrative: Shaking chills; body aches; nausea; vomiting; vertigo; This is a spontaneous report from a contactable Other-healthcare professional (patient). A 57-year-old female (not pregnant) patient received BNT162B2 (lot number: EH9899) first dose on 17Dec2020 02:00 PM intramuscularly on left arm at single dose for COVID-19 immunization. Medical history included Colon Cancer, Hypothyroidism, Allergic Rhinitis, Weight Loss Surgery, GERD, BPPV. Concomitant medications in two weeks included Levothyroxine, cetirizine hydrochloride (ZYRTEC), Escitalopram, MVI, Calcium, colecalciferol (VIT D3), cyanocobalamin (VIT B12). No Known allergies to medications, food, or other products. Facility type vaccine was Other. No other vaccine in four weeks. Patient experienced Shaking chills, body aches, nausea, vomiting and vertigo on 18Dec2020 03:30 AM. Patient received Zofran, Meclizine, Phenerga as treatment. Patient did not have covid prior vaccination and no covid tested post vaccination. The outcome of the events was recovering. The seriousness was reported as no.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Agitation, Anxiety, Diarrhoea, Dyspnoea exertional
Clinical narrative: Within two days of vaccine, shortness of breath on light exertion (talking, walking), ?revved up? like on steroid or medrol. Anxiety, increased resting HR, abdominal cramping, diarrhea, agitation, palpitations, fatigue, dazed, premenstrual spotting.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Heart rate increased, Metrorrhagia, Palpitations
Clinical narrative: Within two days of vaccine, shortness of breath on light exertion (talking, walking), ?revved up? like on steroid or medrol. Anxiety, increased resting HR, abdominal cramping, diarrhea, agitation, palpitations, fatigue, dazed, premenstrual spotting.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Pain in extremity
Clinical narrative: Temp 103, and very sore arm for 3 days; Temp 103, and very sore arm for 3 days; This is a spontaneous report from a contactable nurse reported for herself (patient). A 57-year-old female patient (pregnant: no) was received BNT162B2 (brand: Pfizer, Lot number: unknown) via unspecified route of administration on 19Dec2020 10:30 AM at single dose for COVID-19 immunization. Medical history included COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19?:Yes). Concomitant medication in two weeks of vaccination included simvastatin, acetylsalicylic acid (BABY ASPIRIN), docusate sodium (COLACE) and fish oil (FISH OIL OMEGA 3). no other vaccine within 4 weeks prior to the COVID vaccine. Patient used took ciprofloxacin (CIPRO) and had allergy. Patient experienced temp 103, and very sore arm for 3 days on 20Dec2020 02:00 AM. the most recent COVID-19 vaccine was administered in Hospital. Since the vaccination, the patient has not been tested for COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Treatment received for the events included ibuprofen. Patient was recovered from the events in Dec2020. It was reported as non-serious. No results in death, life threatening, caused/prolonged hospitalization, disabling/Incapacitating nor congenital anomaly/birth defect.  Information on the lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Pallor, Paraesthesia oral, Throat irritation
Clinical narrative: 12/28/20 called to observation area at 12:05.  she had already waited 15 minutes after vaccine.  reports tingling top of tongue, tingling ums, back of mouth/throat scratchy.  12:10 states no change,  12:12 rapid response and supervisor arrived - talked with her.  decided to not go to ER unless worse, agreed will not go back to work or leave for home until sx resolved.  12:20 states gum tingling decreasing.  12:30 states sx resolved - left observation with instruction to return if sx. 12/29/20 came to vaccine area at 1045 to report injection site with 1" redness, firm to touch.  blanches, tender w/ pressing outer edge redness.  arm size unchanged, noted when got up this morning.  states sore, able to move arm.  1050 evaluated by rapid response and nursing supervisor.  states otherwise feeling ok, no sx.  supervisor drew circle around redness.  suggested ice/anti-histamine.  talked with her - to wait 30 minutes, to contact PCP if spreads.  1130 states no change, decided to RTW
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injected limb mobility decreased, Injection site pain
Clinical narrative: Severe arm pain at injection site.; No swelling but can barely move arm; Chills; fatigue; moderate headache; This is a spontaneous report from a non-contactable nurse (patient). A 27-year-old non-pregnant female patient receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration at left arm on 22Dec2020 at 10:00 AM at single dose for COVID-19 immunization at pharmacy or drug store. Medical history was none and there was no known allergies.  Concomitant medication included oxybutynin hydrochloride (OXYBUTYNIN) and birth control received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe arm pain at injection site, there was no swelling but can barely move arm, chills and fatigue and moderate headache, all on 22Dec2020 at 09:00 PM. There was no treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination,  the patient had not been tested for COVID-19. The outcome of the events was not resolved.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: He was diagnosed with COVID 19; He was diagnosed with COVID 19; This is a spontaneous report from a contactable consumer (front line hospital worker) reporting for himself, received via a Pfizer sales representative. This male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date in Dec2020, at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in Dec2020, after vaccination, the patient was diagnosed with COVID 19 with unknown outcome.  Information on the lot/batch number has been requested.
Age: 58.0
Sex: M
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Pain at the injection site; This is a spontaneous report from a contactable Other Health Professional (patient) via Pfizer sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain at the injection site after Covid 19 vaccine on an unspecified date with outcome of unknown. Information on the Batch/Lot number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Lightheadedness; This is a spontaneous report from a contactable Nurse (patient). A 60-year-old female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1284), intramuscularly in arm left on 23Dec2020 16:30 at single dose for COVID-19 immunization. The patient medical history was not reported.  Concomitant medication the patient received within 2 weeks of vaccination included colecalciferol (VIT D3), smilax aristolochiifolia (SARSAPARILLA), ascorbic acid (VIT C), dioscorea villosa (WILD YAM), multi collagen protein.  The patient previously took codeine and experienced allergies: Codeine.  The patient experienced lightheadedness on 23Dec2020 17:15 with outcome of recovered in Dec2020. Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Identification of the case safety report: Serious: No; Seriousness criteria-Results in death: No; Seriousness criteria-Life threatening: No; Seriousness criteria-Caused/prolonged hospitalization: No; Seriousness criteria-Disabling/Incapacitating: No; Seriousness criteria-Congenital anomaly/birth defect: No.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Pain
Clinical narrative: I begin chilling the next day after I received the vaccine and started running a low grade fever of 100.5-body aches, headache, fatigue and pain in the arm where I received vaccine x 2 days.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I begin chilling the next day after I received the vaccine and started running a low grade fever of 100.5-body aches, headache, fatigue and pain in the arm where I received vaccine x 2 days.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Fatigue, Malaise
Clinical narrative: Tiredness; Chills; mild joint pain; Nausea; feeling unwell; he hasn't eaten; threw up; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration by injection once in the left arm, near shoulder on 18Dec2020 at single dose for COVID-19 immunization.  Medical history included asthma from 2009 and ongoing (Has asthma but he has no breathing symptoms, no runny nose, no dry cough, no shortness of breath, no COVID symptoms).  There were no concomitant medications.  The patient experienced tiredness on 20Dec2020 with outcome of not recovered, chills on 20Dec2020 with outcome of recovered on 20Dec2020, mild joint pain on 20Dec2020 with outcome of recovered on 20Dec2020, nausea on 20Dec2020 with outcome of not recovered, feeling unwell on 20Dec2020 with outcome of not recovered, he hasn't eaten in Dec2020 with outcome of unknown, threw up in Dec2020 with outcome of unknown. No runny nose, cough or anything. Investigation Assessment: No. The patient took the COVID vaccine and was having mild symptoms, which he wished to report, and he was seeking recommendations. He had the print out thing given with all the symptoms that may happen, he had tiredness, chills, mild joint pain, nausea, and feeling unwell. He was a COVD tester, which is why he got it last week. This is not his first date of symptoms. Nausea: He threw up Sunday and Monday, was nauseous on Tuesday, is nauseous now but feels better, he missed work on Monday, he went for 2 hours yesterday and was sent home, he didn't go in today, but is feeling more normal, but has been perpetually nauseous since Sunday, like 24/7, in the middle of the night, middle of day, for no reason. He ate yesterday, he hasn't eaten today, because he feels nauseous. States feeling unwell goes along with nausea, he can't separate the two. What kind of medicine should he take, like over the counter or Pedialyte. What would a person potentially take if they were nauseous. Pedialyte, fluid or something. States this is Pfizer, he guesses any guidance is medical. Information on the Lot/batch number has been requested.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Tiredness; Chills; mild joint pain; Nausea; feeling unwell; he hasn't eaten; threw up; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration by injection once in the left arm, near shoulder on 18Dec2020 at single dose for COVID-19 immunization.  Medical history included asthma from 2009 and ongoing (Has asthma but he has no breathing symptoms, no runny nose, no dry cough, no shortness of breath, no COVID symptoms).  There were no concomitant medications.  The patient experienced tiredness on 20Dec2020 with outcome of not recovered, chills on 20Dec2020 with outcome of recovered on 20Dec2020, mild joint pain on 20Dec2020 with outcome of recovered on 20Dec2020, nausea on 20Dec2020 with outcome of not recovered, feeling unwell on 20Dec2020 with outcome of not recovered, he hasn't eaten in Dec2020 with outcome of unknown, threw up in Dec2020 with outcome of unknown. No runny nose, cough or anything. Investigation Assessment: No. The patient took the COVID vaccine and was having mild symptoms, which he wished to report, and he was seeking recommendations. He had the print out thing given with all the symptoms that may happen, he had tiredness, chills, mild joint pain, nausea, and feeling unwell. He was a COVD tester, which is why he got it last week. This is not his first date of symptoms. Nausea: He threw up Sunday and Monday, was nauseous on Tuesday, is nauseous now but feels better, he missed work on Monday, he went for 2 hours yesterday and was sent home, he didn't go in today, but is feeling more normal, but has been perpetually nauseous since Sunday, like 24/7, in the middle of the night, middle of day, for no reason. He ate yesterday, he hasn't eaten today, because he feels nauseous. States feeling unwell goes along with nausea, he can't separate the two. What kind of medicine should he take, like over the counter or Pedialyte. What would a person potentially take if they were nauseous. Pedialyte, fluid or something. States this is Pfizer, he guesses any guidance is medical. Information on the Lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: positive rapid COVID testing positive/COVID-19 PCR test positive; positive rapid COVID testing positive/COVID-19 PCR test positive; This is a spontaneous report from a contactable nurse (patient herself). A 42-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, Expiration date: Mar2021), intramuscularly at site of right deltoid at 08:00 on 16Dec2020 at single dose for COVID-19 immunization. Medical history included ongoing high blood pressure. The patient received a flu shot in Oct2020. The patient's concomitant medications were not reported. The patient was tested positive for rapid COVID-19 testing on 21Dec2020 and was also positive for COVID-19 PCR test on 22Dec2020. No treatments after positive testing and patient was not hospitalized. The outcome of events was not recovered.; Sender's Comments: The reported  "tested positive for rapid COVID-19 testing" after 4 days of immunization with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) is considered related to BNT162B2 administration.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Pyrexia
Clinical narrative: soreness at the injection site; slight fever; tiredness; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced soreness at the injection site, slight fever and tiredness on 22Dec2020. The outcome of events was recovered in Dec2020.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Myalgia
Clinical narrative: Mild symptoms such as muscle soreness; This is a spontaneous report from a Pfizer-sponsored program. A contactable physician (patient himself) reported that a 31-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot# EJ1685), via intramuscular on 17Dec2020 20:00 in right arm at single dose for routine vaccination. There were no medical history and concomitant medications. Vaccination facility type was hospital, not a military facility. No additional vaccines were administered on same date of the Pfizer suspect.  Prior Vaccinations (within 4 weeks) was none. Event following prior vaccinations was none. Relevant test was not tested. Patient was calling about COVID vaccine. He got the vaccine last Thursday and experienced mild symptoms such as muscle soreness around 6 am on Friday, 18Dec2020. On Sunday, his family became symptomatic and got tested for COVID and tested positive. He wanted to know if the COVID vaccine could produce false positive and if he can get the second dose. Caller did provide medical information's number and patient would need to be transferred over. There was no prescriber. It was given as routine from the hospital that he worked at. ER (emergency room) or physician's office required was none. Outcome of event was recovering.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: Just letting you know it felt like a bad flu shot, sore enough to avoid sleeping on, but it went away after a few days :) thank you for your hard work, let?s hope after Jan 20 you can do your jobs without restriction.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling cold, Insomnia, Malaise, Nausea
Clinical narrative: felt weak; Nauseated; unable to sleep; was sick for about 2 hours; got so cold and couldn't get warm/felt cold to her bones; This is a spontaneous report from a contactable consumer (patient herself). A 64-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on 21Dec2020 at single dose for covid-19 immunisation. There were no medical history and concomitant medications.  Investigation assessment was no. Caller received the Covid-19 vaccine Monday (21Dec2020). She was sick for 2 hours yesterday (22Dec2020). She got so cold and couldn't get warm, after a while she felt better. She felt cold to her bones. Today (23Dec2020) she felt weak and was nauseated. She worked at hospital. She was a tech at the hospital. She was a frontline worker. When a vial became available, she was given the vaccine. She was also unable to sleep last night (22Dec2020). She was up most of the night.  She clarified that when she said she was sick for about 2 hours she was referring to being cold. Outcome of cold was recovered on 22Dec2020, and outcome of other events were unknown.   Information on the lot/batch number has been requested.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Tachycardia
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Pain in extremity
Clinical narrative: was tired and slept more than usual; was tired and slept more than usual; Soreness in left arm; This is a spontaneous report from a contactable consumer reported for himself.  A 71-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 22Dec2020 13:50 at single dose for covid-19 immunisation. There were no medical history or concomitant medications.  The patient got it at 1:50 pm, and got home and was really tired, so he said he was going to bed at 6pm and woke up at 7:30 feeling pretty refreshed.  He then told himself, if he didn't get up, he wouldn't sleep at night, so he got up until 11:00 and slept until 8am.  The patient was tired and slept more than usual on 22Dec2020 at 16:00. The only side effect was that he got a little bit more rest than normal.  The other side effect is he got soreness in left arm and it was pretty sore unspecified date in Dec2020.  He did not have any headaches or anything else.  He was pretty satisfied. The outcome of the events was tired and slept more than usual was recovering while for other event was unknown. Information on lot/batch number has been requested.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Pain, Poor quality sleep, Pruritus
Clinical narrative: rash on his forearm by his elbow/He said that the rash is also on the back of his of calf; injection site soreness; a little achy; tired; itching; could not sleep well; This is a spontaneous report from a contactable consumer (reporter).  A 50-year-old male patient received bnt162b2 (BNT162B2, lot number EK5734), via an unspecified route of administration on 18Dec2020 18:30 at single dose for COVID-19 immunization.  Medical history included asthma. He said that he took no other medication except for a multivitamin and his asthma medication. The patient said that within 5 hours of receiving the vaccine, he was a little achy and had injection site soreness. He said that he felt a little tired on Friday (18Dec2020) and Saturday (19Dec2020), but by Sunday (20Dec2020) it was gone. He said that starting Monday (21Dec2020), he noticed a rash on his forearm by his elbow. He said that his skins was normally sensitive and dry. He thought maybe it was not the vaccine and said that he used hand sanitizer that may have bothered it. He said that the rash was on the back of his tricep now though. He said that the rash was also on the back of his of calf. He said that it was itching. He stated that he treated it with triamcinolone cream for rash from his kid and it did not do anything. He said that he was following up with this primary care physician about this. He stated that it was so itchy and he could not sleep well. The outcome of the event tired was recovered on 20Dec2020 while for other events was unknown.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on his forearm by his elbow/He said that the rash is also on the back of his of calf; injection site soreness; a little achy; tired; itching; could not sleep well; This is a spontaneous report from a contactable consumer (reporter).  A 50-year-old male patient received bnt162b2 (BNT162B2, lot number EK5734), via an unspecified route of administration on 18Dec2020 18:30 at single dose for COVID-19 immunization.  Medical history included asthma. He said that he took no other medication except for a multivitamin and his asthma medication. The patient said that within 5 hours of receiving the vaccine, he was a little achy and had injection site soreness. He said that he felt a little tired on Friday (18Dec2020) and Saturday (19Dec2020), but by Sunday (20Dec2020) it was gone. He said that starting Monday (21Dec2020), he noticed a rash on his forearm by his elbow. He said that his skins was normally sensitive and dry. He thought maybe it was not the vaccine and said that he used hand sanitizer that may have bothered it. He said that the rash was on the back of his tricep now though. He said that the rash was also on the back of his of calf. He said that it was itching. He stated that he treated it with triamcinolone cream for rash from his kid and it did not do anything. He said that he was following up with this primary care physician about this. He stated that it was so itchy and he could not sleep well. The outcome of the event tired was recovered on 20Dec2020 while for other events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: test positive for COVID-19; test positive for COVID-19; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Dec2020 at single dose in left arm for covid-19 immunization. There was none medical history or concomitant medications. The reporter reported that she got the vaccine on the 20Dec2020 and found out Monday (21Dec2020) that she was exposed to someone who was positive so they used a rapid test post exposure on the 22Dec2020 that the result was positive for COVID-19. She reported she knew that the vaccine would not have given her COVID, and it was likely she had it before she got the vaccine and didn't know she had it because she didn't have symptoms. The outcome was unknown.  Information about lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Musculoskeletal stiffness, Neck pain, Swelling
Clinical narrative: Sore left arm the day of the vaccination near the site. Throughout the next morning I felt a progressively worsening sore neck, that evolved into a stiff neck by early afternoon. My neck is a bit swollen, on the same side I received the vaccination (Left).
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: arm feels sore and heavy; arm feels sore and heavy; This is a spontaneous report from a contactable nurse (patient). A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that arm felt sore and heavy on an unspecified date after vaccination. The outcome was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: the arm was quite sore; This is a spontaneous report from a contactable consumer (patient's friend). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, expiration date: Mar2021), via an unspecified route of administration on an unspecified date at single dose in arm for covid-19 immunization. The patient's medical history was and concomitant medications were not reported. The patient was a frontline healthcare worker, the patient said the arm was quite sore (far more than expected) after vaccination, but no problem after an hour or so. The outcome of the event was resolved.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: head ache; sore arm; This is spontaneous report from a contactable nurse (patient). A 43-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot #: lot number Eh9899), via an unspecified route of administration on 22Dec2020 at single dose for immunization. Medical history was none. The patient's concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The patient experienced head ache after 24 hours, sore arm on 23Dec2020 18:00 with outcome of unknown. Patient didn't receive treatment for events. The report is considered non-serious.  Information on Lot/ Batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: Slight alteration in smell. Smells are not as pungent and some smells are different then what they should be.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Malaise, Oropharyngeal pain
Clinical narrative: lymphadenopathy in left lower neck area above clavicle/swelling of lymph nodes; sick; sore throat; This is spontaneous report from a contactable other-healthcare professional (patient). A 45-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot #: lot number Eh9899), via an unspecified route of administration on 16Dec2020 19:00 at single dose at left arm for immunization. Medical history included known allergies/shellfish. The patient's concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 21Dec2020 07:00 AM, the patient experienced lymphadenopathy in left lower neck area above clavicle. Patient had never had this before but had felt sick since patient took the vaccine mainly the first day but sore throat not sure if related, then the swelling of lymph nodes. Patient didn't receive treatment for events. Outcome of events was not recovered. The report is considered non-serious.
Sex: F
Vaccine: UNK
Symptoms: Bronchitis, Cough, Dyspnoea, SARS-CoV-2 test
Clinical narrative: 2 years ago I got the adult vax. 2 days later I because short of breath so i used my nebulizer machine. I told my doctor and he told me there was alot of flu going around. I also had bruising at the injection site.  the next year I spoke with my doctor and he gave me the regular flu shot. 5 days later i started experiencing shortness of breath again so i used my nebulizer machine. I also had some coughing as well. i spoke with my MD and he tested me for COVID and gave me a prednisone pack and diagnosed me with bacteria bronchitis  . prior to 2017 I have not had any shortness of breath.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Fatigue, Pain, Pain in extremity
Clinical narrative: Arm soreness; slight aches; slight fatigue; Large lump (lymph node maybe) under arm pit left arm; This is a spontaneous report from a contactable other health professional (patient). A 47-year-old male patient received first dose of BNT162B2 (Lot number: Eh9899) intramuscularly in left arm on 21Dec2020 10:00 at single dose for COVID-19 immunization. Medical history included COVID-19 from an unknown date and unknown if ongoing (COVID prior vaccination: Yes). There were no concomitant medications. The patient experienced arm soreness, slight aches, slight fatigue, large lump (lymph node maybe) under arm pit left arm all on 23Dec2020 03:00 AM. Treatment was not received. The patient underwent lab tests and procedures which included COVID test: COVID on an unspecified date. The outcome of events was not resolved. Facility where the most recent COVID-19 vaccine was administered in hospital. Prior to vaccination, the patient was diagnosed with COVID-19.
Age: 43.0
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: pain that worsened at injection site; pain that worsened at injection site; This is a spontaneous report from a non-contactable consumer (patient). A 43-year-old patient of an unspecified gender received BNT162B2 via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain that worsened at injection site over time on an unspecified date with outcome of unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Dehydration, Dry mouth, Injection site pain, Laboratory test
Clinical narrative: dry mouth; my arm is sore at the injection site; my temperature is also slightly above baseline; It feels like I am dehydrated; my arm is sore at the injection site; This is spontaneous report from a contactable other health professional (Patient). A 32-year-old male patient received first dose of BNT162B2 (lot number: EJ1685), via an unspecified route of administration in left arm on 22Dec2020 17:45 at single dose for COVID-19 immunization. Medical history included psychiatric history, partially empty selle tursica, no other major Illnesses. Concomitant medication included testosterone, emtricitabine, tenofovir disoproxil fumarate (TRUVADA) for prevention. On 23Dec2020 09:00 AM, the patient was experiencing a dry mouth. This was unique because he never had this problem but his arm is sore at the injection site and he had a dry mouth, his temperature is also slightly above baseline, but not significantly. It felt like he was dehydrated but he was drinking lots of water. He had about 3/4 of a gallon today and his mouth was still dry. Almost like a cotton mouth feeling but very mild. It was only 3/10 on how bad it's bothering him. Treatment was not received. The patient underwent lab tests and procedures which included body temperature: slightly above baseline on an unspecified date. The outcome of events was not resolved.