chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Rash
Clinical narrative: a mild rash on my forearms and front of my legs; numb tongue; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 18Jan2021 14:30 at a single dose for covid-19 immunisation. Medical history included mild hypertension, elevated cholesterol, allergy to sulfa, allergy to gluten and celiac disease. The patient's concomitant medications were not reported. On 18Jan2021 15:30, patient experienced mild rash on his forearms and front of his legs which was treated with diphenhydramine  (BENADRYL) tablet. The patient also experienced numb tongue on 18Jan2021 15:30 with no treatment received. Outcome of event "mild rash on my forearms and front of my legs" was unknown while for the event "numb tongue" was not recovered.   Information on the Lot/Batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Headache, Vertigo
Clinical narrative: light headed; vertigo; feel flushed; headache; This is a spontaneous report from a contactable healthcare professional reporting for self. This 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=ELC142) via intramuscular on 13Jan2021 08:30 AM (vaccine location=Left arm) at single dose for Covid-19 immunisation. Medical history included allergies: Reactive airway to chemicals/perfumes/smoke. Concomitant medications included calcium carbonate, colecalciferol (VITAMIN D 2000), calcium, fish oil, echinacea purpurea root, olea europaea leaf, sambucus nigra fruit (ELDERBERRY ECHINACEA & OLIVE LEAF). The patient previously received first dose of BNT162B2 (lot number=EJ1685) via intramuscular on 23Dec2020 08:30 AM (vaccine location=Left arm) at single dose for Covid-19 immunisation. No other vaccine in four weeks.  On 13Jan2021, the patient had a headache in the evening and took Ibuprofen before bed. She woke up about 3:30 AM 14Jan2021 to use the bathroom and had vertigo. She carefully maneuvered to the bathroom and back to the bedroom, drank some Powerade and sat on the bed for a bit before she slowly laid back down. She did feel flushed while experiencing the vertigo. She was able to get back to sleep for a few more hours. When she got up about 7:15 am she felt light headed but did not have any more vertigo. Treatment for event headache included Ibuprofen, no treatment received for other events. Patient did not have COVID prior vaccination, did not test COVID post vaccination, patient was not pregnant. The outcome of events was recovered.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Nausea
Clinical narrative: a fever of 101.4; headache; fatigue; severe body aches; chills; nausea; This is a spontaneous report from a contactable other HCP (patient). A 29-year-old female patient received the second dose of bnt162b2 (lot number: EL1283), via an unspecified route of administration in left arm on 17Jan2021 15:00 at single dose for covid-19 immunization. Medical history included attention deficit hyperactivity disorder (ADHD), allergic rhinitis. Concomitant medication included dexamfetamine (DEXTROAMPHETAMINE), cetirizine, and unspecified prenatal multivitam. The patient previously received the first dose of bnt162b2 (lot number: Eh9899), via an unspecified route of administration in left arm on 30Dec2020 10:00 at single dose for covid-19 immunization. Starting 12 hours after 2nd vaccination (18Jan2021 03:00) patient developed severe body aches, chills, nausea. Within 18 hours after vaccination (18Jan2021 09:00) patient had also developed a fever of 101.4, headache, and fatigue. No treatment and pregnant. The outcome of the events was Recovering.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: a fever of 101.4; headache; fatigue; severe body aches; chills; nausea; This is a spontaneous report from a contactable other HCP (patient). A 29-year-old female patient received the second dose of bnt162b2 (lot number: EL1283), via an unspecified route of administration in left arm on 17Jan2021 15:00 at single dose for covid-19 immunization. Medical history included attention deficit hyperactivity disorder (ADHD), allergic rhinitis. Concomitant medication included dexamfetamine (DEXTROAMPHETAMINE), cetirizine, and unspecified prenatal multivitam. The patient previously received the first dose of bnt162b2 (lot number: Eh9899), via an unspecified route of administration in left arm on 30Dec2020 10:00 at single dose for covid-19 immunization. Starting 12 hours after 2nd vaccination (18Jan2021 03:00) patient developed severe body aches, chills, nausea. Within 18 hours after vaccination (18Jan2021 09:00) patient had also developed a fever of 101.4, headache, and fatigue. No treatment and pregnant. The outcome of the events was Recovering.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: have reactions to their recent botox injections; This is a spontaneous report from a non-contactable consumer communicated to a Pfizer colleague. This consumer reported similar events for 2 patients. This is 1st of two reports.   A patient of unspecified age and gender received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had reactions to their recent injections on an unspecified date. Reported as "They provide various services. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021042317 Same reporter/ drug/ event for different patients
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Throat tightness, Tongue disorder, Urticaria, Vaccination site pain, Vaccination site ulcer
Clinical narrative: large hive at injection site; scattered hives/smaller hives scattered; tightness in throat; thick feeling tongue; bubbled ulcer looking site on his lower left deltoid; left arm soreness; This is a spontaneous report from a contactable nurse (patient).  A 45-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EK4176), intramuscular on 08Jan2021 at a single dose on the left arm for COVID-19 immunization in the hospital.  Medical history included allergies to penicillin (PCN), sulfa and latex. The patient did not have COVID-19 prior to vaccination. It was unknown if the patient had other vaccines in four weeks. The patient has other medications (unspecified) in two weeks. The patient previously took erythromycin (ERY) on an unspecified date and experienced allergies. The patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: LEK5230) on 18Dec2020 at 08:00 AM via intramuscular route of administration on the right arm at a single dose for COVID-19 immunization and experienced hives, itching and itchy feeling tongue wherein the patient took Benadryl, 20 mg Pepcid and 10 mg of Zyrtec. After the second vaccine the patient experienced scattered hives, with large hive at injection site and smaller hives scattered on an unspecified date in Jan2021. The patient also had tightness in throat and thick feeling tongue also on unspecified dates in Jan2021. The patient took 50 mg Benadryl, 20 mg Pepcid, 10 mg of Zyrtec and albuterol inhaler with spacer four puffs. The patient also has a bubbled ulcer looking site on his lower left deltoid with left arm soreness eight days later both on an unspecified date in Jan2021. The outcome of the events bubbled ulcer looking site on his lower left deltoid and left arm soreness was unknown while the outcome of the other events was recovering. The patient has not been tested for COVID-19 post vaccination.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site urticaria
Clinical narrative: large hive at injection site; scattered hives/smaller hives scattered; tightness in throat; thick feeling tongue; bubbled ulcer looking site on his lower left deltoid; left arm soreness; This is a spontaneous report from a contactable nurse (patient).  A 45-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EK4176), intramuscular on 08Jan2021 at a single dose on the left arm for COVID-19 immunization in the hospital.  Medical history included allergies to penicillin (PCN), sulfa and latex. The patient did not have COVID-19 prior to vaccination. It was unknown if the patient had other vaccines in four weeks. The patient has other medications (unspecified) in two weeks. The patient previously took erythromycin (ERY) on an unspecified date and experienced allergies. The patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: LEK5230) on 18Dec2020 at 08:00 AM via intramuscular route of administration on the right arm at a single dose for COVID-19 immunization and experienced hives, itching and itchy feeling tongue wherein the patient took Benadryl, 20 mg Pepcid and 10 mg of Zyrtec. After the second vaccine the patient experienced scattered hives, with large hive at injection site and smaller hives scattered on an unspecified date in Jan2021. The patient also had tightness in throat and thick feeling tongue also on unspecified dates in Jan2021. The patient took 50 mg Benadryl, 20 mg Pepcid, 10 mg of Zyrtec and albuterol inhaler with spacer four puffs. The patient also has a bubbled ulcer looking site on his lower left deltoid with left arm soreness eight days later both on an unspecified date in Jan2021. The outcome of the events bubbled ulcer looking site on his lower left deltoid and left arm soreness was unknown while the outcome of the other events was recovering. The patient has not been tested for COVID-19 post vaccination.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Dyspnoea, Headache, Malaise
Clinical narrative: Terrible pain in back of neck/ very bad pains back of my neck; Shoulder pain; Headache comes and goes; Little nauseous; Feeling generally unwell; Short of breath; Muscle pain; This is a spontaneous report from a contactable consumer (patient). An 88-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection; lot number: EL3249; expiry date: unknown) via an unspecified route of administration, on 14Jan2021, at a single dose, for COVID-19 immunisation (to protect from the virus). Medical history included COVID-19 and he was in the hospital for 3 or 4 days. He came out 10 days later and it was negative. Other medical history included heart disorder. Concomitant medications included carvedilol (COREG) taken for many years because it strengthens his heart, apixaban (ELIQUIS) as blood thinner, finasteride, furosemide (LASIX), sotalol, spironolactone, and ezetimibe, simvastatin (VYTORIN). The patient received his first vaccination this past Thursday and everything was fine. He woke up the following morning (15Jan2021) with terrible/ very bad pains pain in back of his neck, shoulder and headache. He was a little nauseous, just feeling generally unwell, and short of breath. The headache comes and goes which he controlled with Tylenol. He also had muscle pain on an unspecified date in Jan2021. Tylenol was also taken for events muscle pain, shoulder pain, headache, and terrible pain in back of neck/ very bad pains back of my neck. He was wondering if there is anything, he should know and do about it. Patient underwent an unspecified blood test/ lab works with unknown results. Outcome of the events headache and short of breath was recovering, for event muscle pain was unknown, while for the remaining events was not recovered.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Neck pain
Clinical narrative: Terrible pain in back of neck/ very bad pains back of my neck; Shoulder pain; Headache comes and goes; Little nauseous; Feeling generally unwell; Short of breath; Muscle pain; This is a spontaneous report from a contactable consumer (patient). An 88-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection; lot number: EL3249; expiry date: unknown) via an unspecified route of administration, on 14Jan2021, at a single dose, for COVID-19 immunisation (to protect from the virus). Medical history included COVID-19 and he was in the hospital for 3 or 4 days. He came out 10 days later and it was negative. Other medical history included heart disorder. Concomitant medications included carvedilol (COREG) taken for many years because it strengthens his heart, apixaban (ELIQUIS) as blood thinner, finasteride, furosemide (LASIX), sotalol, spironolactone, and ezetimibe, simvastatin (VYTORIN). The patient received his first vaccination this past Thursday and everything was fine. He woke up the following morning (15Jan2021) with terrible/ very bad pains pain in back of his neck, shoulder and headache. He was a little nauseous, just feeling generally unwell, and short of breath. The headache comes and goes which he controlled with Tylenol. He also had muscle pain on an unspecified date in Jan2021. Tylenol was also taken for events muscle pain, shoulder pain, headache, and terrible pain in back of neck/ very bad pains back of my neck. He was wondering if there is anything, he should know and do about it. Patient underwent an unspecified blood test/ lab works with unknown results. Outcome of the events headache and short of breath was recovering, for event muscle pain was unknown, while for the remaining events was not recovered.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hot flush
Clinical narrative: Hot flashes; chills; This is a spontaneous report received from a non-contactable Nurse.   A 26-year-old female received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK9231 and Expiration date was unspecified) on 30Dec2020 14:00 as single dose, (at 26  years of age), intramuscular left arm for COVID-19 immunisation. Medical history included allergic to shellfish.  Concomitant medication was none.  The Patient is not pregnant.  The patient did not have Covid prior to vaccination.  The patient was not tested post vaccination for Covid.  No other vaccine was taken within four weeks. The patient did not have treatment.  The patient experienced Hot flashes and chills 24hrs after receiving vaccine (31Dec2020 16:00). Outcome of event Hot flashes was recovered and chills  was recovered.   No follow-up attempts are possible. No further information expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Rash, SARS-CoV-2 test, Urticaria
Clinical narrative: feel prickly; both arms broke out in raised hives and rash; both arms broke out in raised hives and rash; This is a spontaneous report from a contactable consumer (patient). A 49-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration on the left arm on 14Jan2021 at 13:00 at a single dose for COVID-19 Immunization. Medical history included severe asthma, depression, anxiety, sinus problems, and known allergies with Penicillin and intravenous (IV) iodine. Concomitant medications included duloxetine hydrochloride (CYMBALTA) and aripiprazole (ABILIFY).  The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. About 15 minutes after the shot, on 14Jan2021 at 1330 hours, the patient started to feel prickly and both arms broke out in raised hives and rash. Treatment for the events included intramuscular (IM) 50mg Benadryl. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included nasal swab: negative on 14Nov2020. The events resolved in Jan2021.   Information on the lot/batch number has been requested.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Feeling abnormal, Headache, Somnolence, Vomiting
Clinical narrative: non stop vomiting; headache; eyes hurt; cloudy feeling in my head; done nothing but Sleep; This is a spontaneous report from a contactable consumer (reporting for herself).  A non-pregnant 19-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 15Jan2021 12:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) for COVID-19 immunizatio.  The patient experienced non-stop vomiting, headache, eyes hurt, cloudy feeling in my head and done nothing but sleep on 15Jan2021 14:00.  There was no treatment received for the events.  The outcome of the events was not recovered.    The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Widespread enlarged lymph nodes; Fatigue; Loss of appetite; This is a spontaneous report from a contactable healthcare professional (patient). A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on left arm on 02Jan2021 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient is not pregnant at the time of vaccination. The patient had no known allergies. The patient had no COVID prior vaccination. No other vaccine administered in four weeks and no other medications in two weeks. On 09Jan2021, the patient experienced widespread enlarged lymph nodes, fatigue and loss of appetite. The events resulted in doctor office/clinic and emergency room/department or urgent care visit. The treatment of the events included "Antibiotics to date". The patient was COVID-19 tested post vaccination on 07Jan2021, the COVID-19 test type post vaccination was Nasal Swab with negative result. The outcome of the events was not recovered.  Information about Lot/Batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold
Clinical narrative: chills/major chills and could not warm up; was cold all night; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in the right arm on 11Jan2021 15:00 at single dose for COVID-19 immunisation. Medical history included allergies to sulfa. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included citalopram, topiramate, zinc, and ergocalciferol (VIT D). On 12Jan2021 07:00, the patient started having chills in the morning that was gradually increasing throughout day. At 6:00pm, that patient had major chills and could not warm up. The patient got into the bed with numerous covers. She was cold all night. The last time she woke up was at 3:00am, and then when she woke at 6:00am, and she was fine. No treatment was received for feeling cold. Clinical outcome of the events was recovered on an unspecified date.  Information about lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: typical site reaction at the time of injection/The spot was raised and turned bright red; typical site reaction at the time of injection/The spot was raised and turned bright red; typical site reaction at the time of injection/my arm was sore; I felt lethargic; hot to the touch; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK9231) intramuscular on 08Jan2021 10:30 AM at single dose on the left arm for COVID-19 immunization. Patient is not pregnant. Medical history included unknown allergies(reported as "Known allergies: yes"). There were no other medical history. No COVID prior vaccination. Concomitant medications (Other medications in two weeks) included ibuprofen (ADVIL [IBUPROFEN]), fexofenadine hydrochloride (ALLEGRA 24 HOUR), diphenhydramine hydrochloride (BENADRYL) and montelukast sodium (SINGULAIR). No other vaccine in four weeks. Facility type vaccine is Hospital. The patient had a typical site reaction at the time of injection on 16Jan2021 09:00 AM. The spot was raised and turned bright red, and her arm was sore. The patient felt lethargic. After a few days those symptoms went away. The spot on her arm disappeared. Eight days later, the spot on her arm reappeared. It was bigger, bright red, and hot to the touch. Patient's arm felt sore again and she had lethargy again. A doctor confirmed it was not cellulitis. No treatment was given for the events. The events resulted in Doctor or other healthcare professional office/clinic visit. Patient was not tested for COVID-19 since the vaccination. Outcome of the events was recovering (as reported).
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Feeling abnormal, Pain in extremity
Clinical narrative: Tired; Dizzy; unstable; shoulder/injection site pain; shoulder/injection site pain; Arm pain; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 15Jan2021 (at the age of 83-years-old) at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced shoulder/injection site pain and arm pain in Jan2021 and tired, dizzy, and unstable on 16Jan2021. The clinical course was reported as follows: The patient initially experienced shoulder/injection site pain and arm pain. On the next day after vaccination, she felt tired, dizzy and unstable. The day after was much better and on the fourth day after vaccination, she was back to normal. The clinical outcome of shoulder/injection site pain, arm pain, tired, dizzy, and unstable was recovered on 18Jan2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Tired; Dizzy; unstable; shoulder/injection site pain; shoulder/injection site pain; Arm pain; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 15Jan2021 (at the age of 83-years-old) at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced shoulder/injection site pain and arm pain in Jan2021 and tired, dizzy, and unstable on 16Jan2021. The clinical course was reported as follows: The patient initially experienced shoulder/injection site pain and arm pain. On the next day after vaccination, she felt tired, dizzy and unstable. The day after was much better and on the fourth day after vaccination, she was back to normal. The clinical outcome of shoulder/injection site pain, arm pain, tired, dizzy, and unstable was recovered on 18Jan2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Lip swelling, Oral disorder, Paraesthesia
Clinical narrative: inside of her mouth felt weird; hands starting to tingle and felt a bit numb; hands starting to tingle and felt a bit numb; lower lip started swelling up; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration (left arm) on 01Jan2021 (10:45) at single dose for Covid-19 immunization. Medical history included Hashimoto's thyroiditis, uveitis, and known allergy to some antibiotics, artificial preservatives, artificial colors, many foods like egg, gluten. Concomitant medications included levothyroxine sodium (SYNTHROID), bimatoprost (LUMIGAN), timolol, and vitamin D3; all taken on unspecified dates for an unspecified indication. The patient previously took Benadryl and Aspirin and experienced allergy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that an hour after the vaccine (01Jan2021 11:45), the patient's lower lip started swelling up. Then it got worse and the inside of her mouth felt weird on 18Jan2021 (11:45AM). The patient's hands starting to tingle and felt a bit numb on 18Jan2021 (11:45 AM) (as reported-pending clarification). The adverse events resulted in Emergency room/department or urgent care. The patient was treated with Prednisone 40mg. The outcome of event lip swelling was unknown; while the outcome of other events was recovered on an unspecified date in Jan2021. The patient has not been tested for COVID-19 since the vaccination.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: her husband's skin is breaking out; This is a spontaneous report from a contactable consumer (patient's wife) via Pfizer-sponsored program. An 82-year-old male patient received single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on 14Jan2021 as Covid-19 Vaccine. The patient's medical history and concomitant medications were not reported. The patient's skin was breaking out (onset date not reported). He took a medicine: diphenhydramine for relief. Reporter was advised by their doctor that his husband can't take the second dose and caller was asking what their option was and asking why he can't take the second dose. The outcome of event was unknown.  Information about lot number and expiry date for the suspect product will be requested in follow-up attempts.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Pyrexia
Clinical narrative: chills; generalized mild myalgia; low fever of 37.9C; This is a spontaneous report from a non-contactable Pharmacist (patient). A 33-years-old male patient received the second dose of bnt162b2 (BNT162B2) , lot number EL3302, via an unspecified route of administration from 18Jan2021 at 19:30 (at the age of 33-years-old)  in the left arm as a SINGLE DOSE for COVID-19 vaccination.  Historical vaccination included bnt162b2 (BNT162B2) COVID-19 vaccination, lot number EK5730 on 28Dec2020 at 03:15 PM, dose number 1. The patient medical history was not reported.  There were no concomitant medications.  The patient has no known allergies. The patient received the vaccine at a hospital. On 18Jan2021 at 22:00, the patient experienced chills, generalized mild myalgia and low fever of 37.9C. Treatment for the events included acetaminophen 1000mg. The patient underwent lab tests and procedures which included body temperature: 37.9 centigrade on 18Jan2021 low fever of 37.9C.  Outcome of the chills , generalized mild myalgia and low fever of 37.9C  was  recovered in Jan2021. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal rigidity, Fatigue, Feeling abnormal, Headache, Paraesthesia oral
Clinical narrative: Tiredness; headache; felt out of it; tingling tongue and lips; tingling tongue and lips; body spasms in abdomen throughout the night; This is a spontaneous report from a contactable other healthcare professional, the patient.  A 44-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL3248, via an unspecified route of administration on 18Jan2021 at 10:15 (at the age of 44-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included Fluoxetine hydrochloride (PROZAC), valaciclovir hydrochloride (VALTREX), Cetirizine hydrochloride (ZYRTEC ALLERGY) all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took iodine and experienced drug allergy. On 18Jan2021 at 12:00, the patient experienced tiredness, felt out of it, tingling tongue and lips, headache, body spasms in abdomen throughout the night. The patient did not receive any treatment for the events. The clinical outcomes of tiredness, felt out of it, tingling tongue and lips, headache, body spasms in abdomen throughout the night were recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: arm soreness; headache; fatigue; This is a spontaneous report from a contactable consumer (patient). A 65-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 12Jan2021 09:00 at a single dose in the left arm for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no COVID prior to vaccination. The patient had no other vaccine in four weeks. On 12Jan2021, the patient experienced arm soreness, headache, and fatigue. No treatments received in response to the events reported. The patient was not tested for COVID post vaccination. The patient recovered from the events arm soreness, headache, and fatigue in Jan2021.   Information about Lot/Batch number is requested.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: started chills after few hours of vaccination; bodyache; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 46-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration on 29Dec2020 at 11:15 at a single dose for COVID-19 Immunization. Medical history included COVID-19 prior vaccination. The patient had no known allergies. Concomitant medications included atorvastatin (ATORVASTATIN) and multivitamins. The patient had no other vaccine in four weeks. The patient had not tested for COVID post-vaccination. The patient started having chills after a few hours of vaccination and body ache on 29Dec2020. No treatment administered for the events. The events resolved on an unspecified date.    Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Has early signs of covid; tested positive on covid; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer. A female patient of an unspecified age received 2 doses of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient reported that she has early signs of covid. She tested positive for covid n unspecified date.  Information on the Batch/Lot number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: She tested positive for COVID-19 following the first dose; She tested positive for COVID-19 following the first dose; This is a spontaneous report from a contactable healthcare professional. A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1686, expiration date:Mar2021), via an unspecified route of administration (left arm) on 12Jan2021 at a single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient was asking when she can receive the second dose of the COVID vaccine if she tested positive for COVID-19 following the first dose. She received the first dose of the vaccine on 12Jan2021 and tested positive for COVID-19 on 14Jan2021. The patient underwent lab tests and procedures which included POC rapid COVID test: two negative tests on unspecified date, before getting the vaccine, she is tested twice weekly for work, and positive on 14Jan2021. The outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Lymphadenopathy, Pain
Clinical narrative: tired; fever; chills; aches/achy; swollen lymph node under arm; This is a spontaneous report from a contactable other hcp. This report was received via a sales representative. A 29-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown), via an unspecified route of administration on 16Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported.  The patient's concomitant medications were not reported. It is reported that 13 hours after administration on 16Jan2021, patient experienced fever of 101.9 (degree), chills, aches, swollen lymph node under arm. One day later on 17Jan2021, patient was tired and achy. Outcome of the events was unknown. Information on the lot/batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: tired; fever; chills; aches/achy; swollen lymph node under arm; This is a spontaneous report from a contactable other hcp. This report was received via a sales representative. A 29-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown), via an unspecified route of administration on 16Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported.  The patient's concomitant medications were not reported. It is reported that 13 hours after administration on 16Jan2021, patient experienced fever of 101.9 (degree), chills, aches, swollen lymph node under arm. One day later on 17Jan2021, patient was tired and achy. Outcome of the events was unknown. Information on the lot/batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Accidental exposure to product, Contusion, Exposure via skin contact, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Patient's arm was sore and bruised; some of the fluid dripped down her arm/"all of the vaccine came out and dripped down to her wrist"; some of the fluid dripped down her arm/"all of the vaccine came out and dripped down to her wrist"; some of the fluid dripped down her arm/"all of the vaccine came out and dripped down to her wrist"; it hit the bone/ it was given in bone; it hit the bone and after the nurse pulled back the needle, some of the fluid dripped down my arm; "it hit the bone"/When it was given it felt like cracking in her bone; patient's arm was sore and bruised; This is a spontaneous report from a contactable nurse.  A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (lot number: EL3248), via an unspecified route of administration in the left arm, on 16Jan2021 08:15 at SINGLE DOSE for COVID-19 immunization. Patient had no relevant medical history.  The patient's concomitant medications were not reported. The patient stated that during vaccination last Saturday(16Jan2021), "it hit the bone". The nurse pulled back the needle and after that some of the fluid dripped down her arm. Then it was further reported that it was given in bone and "all of the vaccine came out and dripped down to her wrist". Hence, they wanted to know if patient should get it re-administered or get another half dose. Patient's arm was sore and bruised, the first day was so sore but it was getting better. When it was given it felt like cracking in her bone and she thought the needle broke. After the nurse withdrew the needle, she was told it was not broken but said the needle must have gone to the bone. The outcome of event "patient's arm was sore and bruised" was recovering whereas the outcome of all other events was unknown.   No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skeletal injury, Underdose, Wrong technique in product usage process
Clinical narrative: Patient's arm was sore and bruised; some of the fluid dripped down her arm/"all of the vaccine came out and dripped down to her wrist"; some of the fluid dripped down her arm/"all of the vaccine came out and dripped down to her wrist"; some of the fluid dripped down her arm/"all of the vaccine came out and dripped down to her wrist"; it hit the bone/ it was given in bone; it hit the bone and after the nurse pulled back the needle, some of the fluid dripped down my arm; "it hit the bone"/When it was given it felt like cracking in her bone; patient's arm was sore and bruised; This is a spontaneous report from a contactable nurse.  A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (lot number: EL3248), via an unspecified route of administration in the left arm, on 16Jan2021 08:15 at SINGLE DOSE for COVID-19 immunization. Patient had no relevant medical history.  The patient's concomitant medications were not reported. The patient stated that during vaccination last Saturday(16Jan2021), "it hit the bone". The nurse pulled back the needle and after that some of the fluid dripped down her arm. Then it was further reported that it was given in bone and "all of the vaccine came out and dripped down to her wrist". Hence, they wanted to know if patient should get it re-administered or get another half dose. Patient's arm was sore and bruised, the first day was so sore but it was getting better. When it was given it felt like cracking in her bone and she thought the needle broke. After the nurse withdrew the needle, she was told it was not broken but said the needle must have gone to the bone. The outcome of event "patient's arm was sore and bruised" was recovering whereas the outcome of all other events was unknown.   No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site extravasation, Product use issue
Clinical narrative: Patient's arm was sore and bruised; some of the fluid dripped down her arm/"all of the vaccine came out and dripped down to her wrist"; some of the fluid dripped down her arm/"all of the vaccine came out and dripped down to her wrist"; some of the fluid dripped down her arm/"all of the vaccine came out and dripped down to her wrist"; it hit the bone/ it was given in bone; it hit the bone and after the nurse pulled back the needle, some of the fluid dripped down my arm; "it hit the bone"/When it was given it felt like cracking in her bone; patient's arm was sore and bruised; This is a spontaneous report from a contactable nurse.  A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (lot number: EL3248), via an unspecified route of administration in the left arm, on 16Jan2021 08:15 at SINGLE DOSE for COVID-19 immunization. Patient had no relevant medical history.  The patient's concomitant medications were not reported. The patient stated that during vaccination last Saturday(16Jan2021), "it hit the bone". The nurse pulled back the needle and after that some of the fluid dripped down her arm. Then it was further reported that it was given in bone and "all of the vaccine came out and dripped down to her wrist". Hence, they wanted to know if patient should get it re-administered or get another half dose. Patient's arm was sore and bruised, the first day was so sore but it was getting better. When it was given it felt like cracking in her bone and she thought the needle broke. After the nurse withdrew the needle, she was told it was not broken but said the needle must have gone to the bone. The outcome of event "patient's arm was sore and bruised" was recovering whereas the outcome of all other events was unknown.   No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, SARS-CoV-2 test positive
Clinical narrative: positive for COVID; positive for COVID; This is a spontaneous report from a Pfizer Sponsored Program from a contactable consumer (patient). A 52-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EH9899, on 28Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient took the first dose of the Pfizer COVID Vaccine on 28Dec2020. After that he showed positive for COVID. He was scheduled for the second dose today (18Jan2021). He had taken a COVID test and tested positive for COVID. He was trying to re-schedule an appointment. They told him to contact his doctor, which he did. His doctor had suggested that he took the second booster on 24Jan2021, instead of today. The patient took a covid test Last Friday (15Jan2021) and tested positive also, He didn't believe the results so he tested again today (18Jan2021) and the result was also positive. Both tests were rapid tests. What made him take the test, the following Wednesday, he had a dry cough. He took OTC cough medicine and it stopped the dry cough. No other symptoms, not coughing today. The outcome of the events was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Headache, Lethargy, Pain in extremity
Clinical narrative: positive for COVID; positive for COVID; cough; She felt lethargic and had a dull headache; She felt lethargic and had a dull headache; Her arm hurt the night of the vaccine and the following day; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program, Pfizer First Connect. This consumer (patient) reported similar events for two patients (patient's husband and patient). This is the first of two reports.   A 72-years-old female patient received first dose of bnt162b2 (BNT162B2, Lot EH9899), via an unspecified route of administration on 04Jan2021 at single dose for covid-19 immunisation. Medical history included cholesterol. Concomitant medication included pravastatin sodium (PRAVACOR) for cholesterol, levothyroxine sodium (SYNTHROID), she had been taking both at least 10 years and were ongoing. The patient experienced her arm hurt the night of the vaccine and the following day since 04Jan2021. She had been tested a few times. Tested and then came to local area. Quarantined for two weeks and test were negative. She had COVID testing on 11Jan2021 and got results were 13Jan2021. She experienced positive for covid on 11Jan2021, cough and she felt lethargic and had a dull headache on 06Jan2021, she had a mild case, did not have a fever, she went to the walk in clinic, had lungs checked, her oxygen level was normal, she had been testing normal, she did not have any severe symptoms of the COVID, she got post nasal drip and She started azithromycin on 11Jan2021. The patient was such a careful person. When she went to the supermarket, she wore a shield, mask, and gloves. She did not socialize, was home body. She had no idea how she got it. She did call her internist when she found out she had it. The patient underwent lab tests and procedures which included oxygen level: normal in Jan2021, oxygen level: good on an unknown date, COVID test: negative on an unknown date, COVID test: positive on 11Jan2021, lung checked: clear in Jan2021, testing: normal in Jan2021. The even outcome was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Upper-airway cough syndrome
Clinical narrative: positive for COVID; positive for COVID; cough; She felt lethargic and had a dull headache; She felt lethargic and had a dull headache; Her arm hurt the night of the vaccine and the following day; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program, Pfizer First Connect. This consumer (patient) reported similar events for two patients (patient's husband and patient). This is the first of two reports.   A 72-years-old female patient received first dose of bnt162b2 (BNT162B2, Lot EH9899), via an unspecified route of administration on 04Jan2021 at single dose for covid-19 immunisation. Medical history included cholesterol. Concomitant medication included pravastatin sodium (PRAVACOR) for cholesterol, levothyroxine sodium (SYNTHROID), she had been taking both at least 10 years and were ongoing. The patient experienced her arm hurt the night of the vaccine and the following day since 04Jan2021. She had been tested a few times. Tested and then came to local area. Quarantined for two weeks and test were negative. She had COVID testing on 11Jan2021 and got results were 13Jan2021. She experienced positive for covid on 11Jan2021, cough and she felt lethargic and had a dull headache on 06Jan2021, she had a mild case, did not have a fever, she went to the walk in clinic, had lungs checked, her oxygen level was normal, she had been testing normal, she did not have any severe symptoms of the COVID, she got post nasal drip and She started azithromycin on 11Jan2021. The patient was such a careful person. When she went to the supermarket, she wore a shield, mask, and gloves. She did not socialize, was home body. She had no idea how she got it. She did call her internist when she found out she had it. The patient underwent lab tests and procedures which included oxygen level: normal in Jan2021, oxygen level: good on an unknown date, COVID test: negative on an unknown date, COVID test: positive on 11Jan2021, lung checked: clear in Jan2021, testing: normal in Jan2021. The even outcome was unknown.