chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Myalgia, Nausea, Pyrexia
Clinical narrative: Chest tightness; Tiredness; Headaches; Joint pain; Low grade fever; Nausea; Swollen lymph nodes in neck; Chills; Muscle pain; This is a spontaneous report from a contactable healthcare professional (patient). A 33-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; Lot Number: EH9899), intramuscular in right arm on 15Dec2020 07:45 at a single dose for an COVID-19 immunization. The vaccine was administered in a hospital. Medical history included celiac disease, allergy, and diagnosed with COVID-19 prior to vaccination. Concomitant medication included fexofenadine hydrochloride for allergy. The patient experienced tiredness, headaches, muscle pain, joint pain, chills, low grade fever, nausea, swollen lymph nodes in neck, and chest tightness on 15Dec2020, 03:00 PM.  No treatment was received for the events. The outcome of the events was not recovered. The events were reported as non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram, Feeling abnormal, Feeling jittery, Hypoaesthesia
Clinical narrative: 15 minutes after vaccination, started to have SOB, numbness on legs and extremities-- > sent to ED for evaluation.  She c/o funny feeling in her mouth and tingling in her arms and legs after vaccination.  She felt short of breath initially, but not at ED.  No rash.  No swelling that she is aware of.  She just doesn't feel right.  States she feels "jittery" and shaky. Received 2 L NS and epi 0.3mg IM x1 and diphenhydramine 25mg IV x-- > symptoms improved. Observed for 4 more hrs in ED.   Discharged home on Epi pen.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Nervousness, Paraesthesia, Sinus tachycardia
Clinical narrative: 15 minutes after vaccination, started to have SOB, numbness on legs and extremities-- > sent to ED for evaluation.  She c/o funny feeling in her mouth and tingling in her arms and legs after vaccination.  She felt short of breath initially, but not at ED.  No rash.  No swelling that she is aware of.  She just doesn't feel right.  States she feels "jittery" and shaky. Received 2 L NS and epi 0.3mg IM x1 and diphenhydramine 25mg IV x-- > symptoms improved. Observed for 4 more hrs in ED.   Discharged home on Epi pen.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Hypertension, Nausea
Clinical narrative: Dizziness; hypertensive to 109/80; nauea, sweating, sent to ED for monitoring; follow up call next day: symptoms resolved.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Pruritus, Urticaria
Clinical narrative: Employee was being monitored post Covid19 vaccination. Approximately 10 minutes after vaccination employee had an allergic reaction and developed Hives all over her body and became itchy with hot flashes. Employee was given 50MG of Benadryl which was effective.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Pain at injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A 54-year-old male patient received the first dose of bnt162b2 (lot number: EH9899), intramuscular on the left arm on 15Dec2020 09:00 at a single dose for immunization. There were no medical history and concomitant medications. The patient have no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 and had not been tested for COVID-19 since the vaccination. On 15Dec2020 18:00, the patient experienced pain at injection site. No treatment was received for the adverse event. Outcome of the event was recovering.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Malaise, Pain, Tachycardia
Clinical narrative: Headache, tachycardia, body aches, malaise, lethargy,
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Myalgia, Nausea
Clinical narrative: Injection site tenderness for 48 hours Myalgias for 72 hours Morning nausea for 4 days post-injection Chills for 48 hours Headache for 72 hours
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Arm pain at site; This is a spontaneous report from a contactable nurse.  A 59-year-old female patient received bnt162b2 (lot number: EH9899), intramuscular on right arm from 16Dec2020 15:45, at an unspecified dose, single, for immunization.  Medical history included hypertension. The patient's concomitant medications were not reported. Patient had other medications the patient received within 2 weeks of vaccination. On 16Dec2020 at 19:45, the patient experienced arm pain at site. Outcome of event was unknown.  Event occurred in a country different from that of the reporter.  This may be a duplicate if the reporter also submitted directly to his/her local agency.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Feeling of body temperature change, Myalgia
Clinical narrative: recipient reported feeling of acute hot/cold feeling 5min after the vaccination, which went away after a few minute. the next day by evening feel fatigue and muscle aches lastly to today Tues. fatigue and muscles aches have improved a little but still feeling under the weather. Denied fever or other reactions
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Dyspnoea, Injection site pruritus, Throat irritation
Clinical narrative: Patient states 20 minutes after receiving the injection she began having a scratchy throat and began having shortness of breath.  She also developed some itching to the site.  She presented to the Emergency Department and noted to have hoarseness but no severe dyspnea.  Patient was given steroids and Benadryl.  Her symptoms did not worsen and she was discharged home.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Patient waited her 15 minute time of observation. She said she felt her throat closing . Moved her into the observation area. Dr.  was present and ordered for 25mg of Benadryl to be administered po. This was given at 16:00. Dr. observed patient for approximately 45 minutes until all symptoms resolved. Patient was allowed to leave at 16:45. Patient was provided with the instructions to please go to the ED if she should have any new symptoms tonight.
Age: 69.0
Sex: F
Vaccine: FLUA4
Symptoms: Arthralgia, Back pain, Chills, Insomnia, Musculoskeletal stiffness
Clinical narrative: About 7-10 days after the shot, shestarted to feel joint pain, mostly on right hip/left hip, low back and it just got progressively worst and the pain spread to locations on the right shoulder and other parts of the body with prior surgery or medical interventions. The pain was so bad that she could not put on socks and shoes on the feet. There were pain on the left side as well. It was hard to her to sleep at times. Sometimes she had chills and low grade fever (99-100 F) from time to time. She had concern about the stiffness and the severe joint pain. The left leg end up being shorter than the right leg.  She had a rheumatologist, checked her joints for RA with blood works and X-ray. The tests were re-run again to be sure. Dr. had her checked for COVID-19 but it was negative. She will have the antibodies test done this week to be sure that it wasn't something else relating autoimmune disease. She also saw a chiropractor and the diagnosis was that her legs were different lengths and it was her body's natural response to compensate what was happening. Dr. is her acupuncturist, diagnosed her with "heat in her body". She put her on herbs to relieve the "heat".  Before it started, she was diagnosed with fibromyalgia. She was active and functional without medication with low grade pain throughout the day. Now it's severe and chronic. She was also diagnosed with mild arthritis and was getting cortisone injections in the past. However she was active had good quality of life before the shot.
Age: 69.0
Sex: F
Vaccine: FLUA4
Symptoms: Pyrexia, Red blood cell sedimentation rate increased, SARS-CoV-2 test negative, Vitamin B12 normal, Vitamin D
Clinical narrative: About 7-10 days after the shot, shestarted to feel joint pain, mostly on right hip/left hip, low back and it just got progressively worst and the pain spread to locations on the right shoulder and other parts of the body with prior surgery or medical interventions. The pain was so bad that she could not put on socks and shoes on the feet. There were pain on the left side as well. It was hard to her to sleep at times. Sometimes she had chills and low grade fever (99-100 F) from time to time. She had concern about the stiffness and the severe joint pain. The left leg end up being shorter than the right leg.  She had a rheumatologist, checked her joints for RA with blood works and X-ray. The tests were re-run again to be sure. Dr. had her checked for COVID-19 but it was negative. She will have the antibodies test done this week to be sure that it wasn't something else relating autoimmune disease. She also saw a chiropractor and the diagnosis was that her legs were different lengths and it was her body's natural response to compensate what was happening. Dr. is her acupuncturist, diagnosed her with "heat in her body". She put her on herbs to relieve the "heat".  Before it started, she was diagnosed with fibromyalgia. She was active and functional without medication with low grade pain throughout the day. Now it's severe and chronic. She was also diagnosed with mild arthritis and was getting cortisone injections in the past. However she was active had good quality of life before the shot.
Age: 69.0
Sex: F
Vaccine: FLUA4
Symptoms: X-ray limb abnormal
Clinical narrative: About 7-10 days after the shot, shestarted to feel joint pain, mostly on right hip/left hip, low back and it just got progressively worst and the pain spread to locations on the right shoulder and other parts of the body with prior surgery or medical interventions. The pain was so bad that she could not put on socks and shoes on the feet. There were pain on the left side as well. It was hard to her to sleep at times. Sometimes she had chills and low grade fever (99-100 F) from time to time. She had concern about the stiffness and the severe joint pain. The left leg end up being shorter than the right leg.  She had a rheumatologist, checked her joints for RA with blood works and X-ray. The tests were re-run again to be sure. Dr. had her checked for COVID-19 but it was negative. She will have the antibodies test done this week to be sure that it wasn't something else relating autoimmune disease. She also saw a chiropractor and the diagnosis was that her legs were different lengths and it was her body's natural response to compensate what was happening. Dr. is her acupuncturist, diagnosed her with "heat in her body". She put her on herbs to relieve the "heat".  Before it started, she was diagnosed with fibromyalgia. She was active and functional without medication with low grade pain throughout the day. Now it's severe and chronic. She was also diagnosed with mild arthritis and was getting cortisone injections in the past. However she was active had good quality of life before the shot.
Age: 93.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient's agent claims the patient had a swollen, red arm for 1 week after receiving FluzoneHD.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, SARS-CoV-2 test negative, Tachycardia
Clinical narrative: Shortness of breath, tachycardia in the 120 rate with exertion
Age: 1.75
Sex: M
Vaccine: FLUR4, HIBV, MMR, VARCEL
Symptoms: Lip swelling, Pyrexia, Urticaria
Clinical narrative: Hives all over body, swelling of the lips  fever for first 2 days Benadryl and Prednisolone  outcome - resolved
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Injection site pain, Pain
Clinical narrative: Body aches, joint pain, chills, headache, injection site pain; Body aches, joint pain, chills, headache, injection site pain; Body aches, joint pain, chills, headache, injection site pain; Body aches, joint pain, chills, headache, injection site pain; Body aches, joint pain, chills, headache, injection site pain; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient received bnt162b2 (BNT162B2) lot number and expiration date were not reported, intramuscular (arm right) first dose on 16Dec2020 13:45 at a single dose for immunization.  Medical history included migraine with aura, ovarian cyst and paragard IUD. Concomitant medication included fluconazole (DIFLUCAN), probiotics and famotidine. The patient previously took codeine and experienced drug hypersensitivity. The patient reported adverse events of body aches, joint pain, chills, headache, and injection site pain on 09Dec2020 at 03:45 PM (pending clarification). The patient had not taken any other vaccine in 4 weeks. The events were considered non-serious. The patient recovered from the events body aches, joint pain, chills, headache, and injection site pain on an unspecified date. There was no treatment given due to the events. The patient was not diagnosed with COVID-19 prior to vaccine nor was she tested positive for COVID-19 since vaccination.   No follow-up attempts are possible; Information about batch/lot number cannot be obtained. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Severe Headache ("Felt like someone hit me with a bat in the head"; water/tylenol given; sent to ED - given Toradol; later: chills; resolved per follow-up call prior day.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, SARS-CoV-2 test
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA Headache, body aches and extreme fatigue started on 12/20/2020. I had a doctor appointment on 12/22/20 for a routine visit and I told my doctor about these symptoms that had occurred and he stated that I needed to be tested for COVID since these were symptoms. He also ordered blood work and I had blood drawn. I had informed him at the beginning of the visit of my recent COVID vaccine last week.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Injection site pain, Malaise, Nausea
Clinical narrative: Phizer-BioNtech COVID-19 Vaccine EUA pain at site of infection.  Fatigue, maliaise, dizziness, nausea, low grade fevers
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Phizer-BioNtech COVID-19 Vaccine EUA pain at site of infection.  Fatigue, maliaise, dizziness, nausea, low grade fevers
Age: 77.0
Sex: M
Vaccine: FLUA4, PPV
Symptoms: Pain in extremity
Clinical narrative: PATIENT SAYS ABOUT 3 MONTHS AFTER GETTING THE PNEMOVAX 23 VACCINE HE HAS HAD PAIN IN HIS LEFT ARM STARTING BACK BEHIND THE ARMPIT AND RADIATING DOWN TO ABOUT THE ELBOW. THERE DOESN'T APPEAR TO BE ANY SWELLING AT THE MOMENT. HE SAYS THE PAIN IS RELIEVED WITH OTC PAIN RELIEVERS BUT IT JUST COMES BACK. HE ALSO GOT A FLU SHOT AT THE SAME TIME.  SAYS HE HASN'T HAD THIS KIND OF REACTION TO THE FLU SHOT BEFORE
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Nausea
Clinical narrative: Pt reports joint pain, nausea, headache, fatigued.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Hyperhidrosis, Paraesthesia
Clinical narrative: 25 mins after the vaccination his right arm became tingly ranging from the lower part of the arm to his pinky. fell asleep. He was touching it and could not feel it, like it was "asleep" .  Felt himself get hotter and sweaty. Patient was advised to go to the ER, but refused. Called patient one hour after the event, and they reported that arm started to feel less tingly.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Injection site pain
Clinical narrative: pain at the injection site; felt some numbness; slight headache; This is a spontaneous report from a contactable consumer. A 49-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: unknown), intramuscular on arm left on 16Dec2020 (10:00 AM) at single dose for COVID-19 immunization. The patient's medical history included rheumatoid arthritis and COVID-19. Concomitant medication included secukinumab (COSENTYX) (received within 2 weeks of vaccination). It was reported that prior vaccination, patient diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No known allergies. The patient reported that after a few hours of initial injection she felt pain at the injection site. In addition, she mentioned that she also felt some numbness and had a slight headache on 16Dec2020 (08:00 PM). There was no treatment received for the reported adverse events. The outcome of event was recovered on an unspecified date.  Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Presyncope, Throat irritation
Clinical narrative: dizzy; funny feeling on the throat; vasovagal reaction; This is a spontaneous report from a contactable physician. This physician reported similar events for two patients. This is the second of two reports. Only the first case is serious. This case is non-serious. A female patient of an unspecified age (reported as 59, unit unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 22:00 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that she felt dizzy, funny feeling on the throat and ED (emergency department) assessed vasovagal reaction as normal; no rash or major allergic reaction was noted. Outcome of the events was unknown.  Follow-up attempts are completed. The following information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020500236 Same reporter, product, and event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: tingling sensation around the mouth; tingling sensation around the mouth and in her arm; This is a spontaneous report from a contactable physician.  A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch # not provided), via an unspecified route of administration on 17Dec2020 22:00 at SINGLE DOSE as COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. In Dec2020, the patient felt tingling sensation around the mouth and in her arm.  Outcome of the events was unknown.   Information regarding batch number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Pain, Tachycardia
Clinical narrative: Intermittent tachycardia; headache; left shoulder pain, increases when lifting elbow above pectoral; This is a spontaneous report from a contactable nurse, the patient.  A 30-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730), intramuscular in the left arm on 16Dec2020 at 16:45 (at the age of 30-years-old) as a single dose for COVID-19 immunization.   The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) from an unknown date to an unknown date for an unknown indication and experienced drug allergy. On 16Dec2020 at 21:45, the patient experienced intermittent tachycardia, headache, and left shoulder pain (which increased when lifting elbow above pectoral). Therapeutic measures were taken as a result of the intermittent tachycardia, headache, and left shoulder pain and included treatment (self-medicated) with acetaminophen (TYLENOL) and diphenhydramine hydrochloride (BENADRYL). The clinical outcomes of intermittent tachycardia, headache, and left shoulder pain were unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Patient felt lightheaded & dizzy 10 minutes after receiving vaccine. Layed down flat with feet elevated for 10-15 minutes.
Age: 65.0
Sex: F
Vaccine: PPV, TD
Symptoms: Pain, Skin warm, Swelling
Clinical narrative: only had reaction to pcv23, hot to touch swollen, severe pain 2-3 hrs after  injection.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Malaise, Pain in extremity
Clinical narrative: feeling "Sort of dizzy"; arm is sore; just doesn't feel well; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on her left upper arm on 17Dec2020 13:25 at a single dose for covid-19 prevention. The patient's medical history included blood pressure abnormal. Concomitant medications included blood pressure medicine at night. The patient went to the hospital today where she works, to have a vaccine for COVID, and then she drove herself home. After she got home, she decided to rest a bit before her shift at work tonight, she laid down for a little while, and she started feeling sort of dizzy and her arm was sore. She just doesn't feel well. She does not feel like she needs to go to the hospital or anything, but she may need rest. Patient was wondering if these are known side effects of the product. She started feeling the side effects maybe 20 or 25 minutes after getting the vaccine and after she had left the hospital. She was just thinking at the time that it was okay and maybe she just needed rest. She takes blood pressure medicine at night, but she does not think that has anything to do with how she is feeling. Outcome of the events was unknown.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Pruritus, Respiratory tract irritation, Throat irritation
Clinical narrative: Within just over half an hour of receiving it my lungs and throat started burning. Shortly after that my upper lip started to swell. Over night my lip swelled more and my face became itchy.
Sex: F
Vaccine: COVID19
Symptoms: Metrorrhagia
Clinical narrative: She noticed that she got breakthrough bleeding, when she just got her menstruation last week; This is a spontaneous report from a contactable healthcare professional, the patient.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 16Dec2020 at 17:00 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  On an unknown date in Dec2020, the patient noticed that she had breakthrough bleeding and she just had her period last week. The stated that she was very regular when it came to her period. The clinical outcome of the breakthrough bleeding was unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Oral herpes
Clinical narrative: developing a cold sore (herpes simplex type 1) the following morning/She usually develop a cold sore with an illness; developing a cold sore (herpes simplex type 1) the following morning/She usually develop a cold sore with an illness; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of bnt162b2 (lot number and expiration date were not reported), via an unspecified route of administration on the right arm on 16Dec2020 16:15 at a single dose for immunization. The patient's medical history included cold sore and celiac disease. The patient was not pregnant. Concomitant medication included cetirizine hydrochloride (ZYRTEC). The patient reported that it was not necessarily an adverse event but she noticed that she was developing a cold sore (herpes simplex type 1) the following morning on 17Dec2020 10:00. She usually develop a cold sore with an illness. She also typically take valacyclovir to treat but opted not to take it (did not want to interfere with the vaccine and body developing antibodies). No treatment was received for the events. The patient was not diagnosed with COVID-19 prior to vaccination neither had been tested for COVID-19 post vaccination. Outcome of the events was recovering. The events was considered non-serious.  Information on lot/batch number has been requested.; Sender's Comments: Based on the information currently provided, cold sore (herpes simplex type 1) onset more likely represents the recurrence of the underlying herpes viral infection.  Currently no biological plausibility indicated the event is attributed to the vaccine use.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Rash erythematous, Rash papular
Clinical narrative: Red raised rash 48 hours after Extreme nausea and dizziness; Red raised rash 48 hours after Extreme nausea and dizziness; Red raised rash 48 hours after Extreme nausea and dizziness; This is a spontaneous report from a contactable healthcare professional.  A non-pregnant 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly on 15Dec2020 15:45 at a single dose for COVID-19 immunization.  Medical history included ulcerative colitis, hypothyroidism, allergies: sulfites. sulfa.  Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), dhea (MANUFACTURER UNKNOWN), levothyroxine, liothyronine (NP THYROID), progesterone (MANUFACTURER UNKNOWN), fluoxetine hydrochloride (PROZAC), levothyroxine sodium (SYNTHROID), bupropion hydrochloride (WELLBUTRIN).  On 15Dec2020, the patient experienced red raised rash 48 hours after extreme nausea and dizziness.  No treatment was received from 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: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Hyperhidrosis, Presyncope, Vomiting
Clinical narrative: Client started to feel faint about 10 minutes after she had the vaccine administered. She informed the nurse. Her blood pressure was 100/62 hr 58. She sat for a few minutes and then vomited. She had bcome very diaphoretic. Her bp was 146/100 and hr was 96. She was responsive and she refused a shot of Benadryl. We called for an ambulance. We continued to monitor her bp and hr. Her husband arrived. She left with her husband. Her last bp was 136/100 hr was 70 ab she was not longer diapheretic. He husband took her to the ER. I spoke to patient today at (9:10 am. The ER doctor told her she had a vasovagal incident. He told her she can get the second dose if she is in a supine position with monitoring.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Dizziness, Electrocardiogram, Hyperhidrosis, Loss of consciousness
Clinical narrative: Client started to feel faint about 10 minutes after she had the vaccine administered. She informed the nurse. Her blood pressure was 100/62 hr 58. She sat for a few minutes and then vomited. She had bcome very diaphoretic. Her bp was 146/100 and hr was 96. She was responsive and she refused a shot of Benadryl. We called for an ambulance. We continued to monitor her bp and hr. Her husband arrived. She left with her husband. Her last bp was 136/100 hr was 70 ab she was not longer diapheretic. He husband took her to the ER. I spoke to patient today at (9:10 am. The ER doctor told her she had a vasovagal incident. He told her she can get the second dose if she is in a supine position with monitoring.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pallor, Paraesthesia, Somnolence, Syncope, Tilt table test
Clinical narrative: Client started to feel faint about 10 minutes after she had the vaccine administered. She informed the nurse. Her blood pressure was 100/62 hr 58. She sat for a few minutes and then vomited. She had bcome very diaphoretic. Her bp was 146/100 and hr was 96. She was responsive and she refused a shot of Benadryl. We called for an ambulance. We continued to monitor her bp and hr. Her husband arrived. She left with her husband. Her last bp was 136/100 hr was 70 ab she was not longer diapheretic. He husband took her to the ER. I spoke to patient today at (9:10 am. The ER doctor told her she had a vasovagal incident. He told her she can get the second dose if she is in a supine position with monitoring.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Client started to feel faint about 10 minutes after she had the vaccine administered. She informed the nurse. Her blood pressure was 100/62 hr 58. She sat for a few minutes and then vomited. She had bcome very diaphoretic. Her bp was 146/100 and hr was 96. She was responsive and she refused a shot of Benadryl. We called for an ambulance. We continued to monitor her bp and hr. Her husband arrived. She left with her husband. Her last bp was 136/100 hr was 70 ab she was not longer diapheretic. He husband took her to the ER. I spoke to patient today at (9:10 am. The ER doctor told her she had a vasovagal incident. He told her she can get the second dose if she is in a supine position with monitoring.
Sex: U
Vaccine: COVID19
Symptoms: Respiratory tract congestion
Clinical narrative: patient experience slight congestion; This is a spontaneous report from a contactable physician (patient) via Pfizer Sales Representative. A patient of unspecified age and gender received bnt162b2 via an unspecified route of administration on an unspecified date at single dose for administration of Covid-19 vaccine.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced slight congestion on an unspecified date with outcome of unknown. Event took place after use of product. Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Hypoaesthesia
Clinical narrative: episodes of facial and head numbness and heaviness, lasting 15-30 min or so; isolated to the side of injection site; episodes of facial and head numbness and heaviness, lasting 15-30 min or so; isolated to the side of injection site; This is a spontaneous report from a contactable physician. A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: 0E51685), intramuscularly in the left arm, on 17Dec2020 at 09:00 (at the age of 41-years-old) at a single dose for COVID-19 immunization. The patient had no medical history. Concomitant medications, taken within two weeks of vaccination, included zinc (MANUFACTURER UNKNOWN), quercetin (MANUFACTURER UNKNOWN), and multivitamins (MANUFACTURER UNKNOWN). The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced episodes of facial and head numbness and heaviness, lasting 15-30 minutes or so; isolated to the side of injection site on 17Dec2020 at 22:15. No therapeutic measures were taken as a result of the events. The clinical outcome of episodes of facial and head numbness and heaviness, lasting 15-30 minutes or so; isolated to the side of injection site was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information expected.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dyspnoea, Gaze palsy, Influenza virus test negative, SARS-CoV-2 test negative
Clinical narrative: Patient had severe headache, felt like throat was closing + hard to catch her breath. Went to E.R., they gave her Benadryl + Zofran + tested her for COVID19 + Flu which were both negative. E.R. physician said Adverse reaction to vaccine. Pt. felt better after an hour of Benadryl + Zofran + was D/C
Sex: U
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Rash, Vaccination complication
Clinical narrative: non-anaphylactic allergy reactions to the Pfizer BioNTech COVID-19 vaccine; Rash; Mild swelling of the throat; This is a spontaneous report from a non-contactable pharmacist. This pharmacist reported same events for 2 patients. This report is for 1st of 2 patient.   A patient of unspecified age and gender received BNT162B2 via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization, propylene glycol via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. On 17Dec2020 at 2:50 pm, PharmD, Clinical Pharmacy Manager, shared with the reporter that two employees had non-anaphylactic allergy reactions to the Pfizer BioNTech COVID-19 vaccine, this patient is one of them. She reported rash and mild swelling of the throat. They suspect it was a reaction to propylene glycol and will be doing skin testing. The action taken in response to the event for propylene glycol was unknown. The outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020501257 same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Rash, Vaccination complication
Clinical narrative: Rash; mild swelling of the throat; non-anaphylactic allergy reactions; This is a spontaneous report from a non-contactable pharmacist. This pharmacist reported same events for two patients. This is 2nd of two reports.   A patient of unspecified age and gender received BNT162B2 via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization, propylene glycol via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. On 17Dec2020 at 2:50 pm, PharmD, Clinical Pharmacy Manager, shared with the reporter that two employees had non-anaphylactic allergy reactions to the Pfizer BioNTech COVID-19 vaccine, this patient is one of them. She reported rash and mild swelling of the throat. They suspect it was a reaction to propylene glycol and will be doing skin testing. The action taken in response to the event for propylene glycol was unknown. The outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020501256 same reporter/drug/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Injection site pain
Clinical narrative: Little pain at the injection site; Felt flush afterwards; This is a spontaneous report from a non-contactable nurse.  This nurse reported similar events for two patients.  This is the first of two reports.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK5730), via an unspecified route of administration on 16Dec2020 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  In Dec2020, the patient experienced little pain at the injection site and felt flush afterwards. The outcome of the events was unknown.    No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020501389 same reporter/drug/event, different patient.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: 5 days after immunization, patient reported left lateral arm redness, pain & warmth.
Sex: U
Vaccine: COVID19
Symptoms: Hot flush, Injection site pain
Clinical narrative: Little pain at the injection site; Felt flush afterwards; This is a spontaneous report from a non-contactable nurse.  This nurse reported similar events for two patients.  This is the second of two reports.  A patient of unspecified age and gender received the BNT162B2 (BNT162B2; also reported as PFIZER COVID-19 VACCINE; Lot number: EK5730), via an unspecified route of administration on 16Dec2020 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. On an unspecified date in Dec2020, the patient experienced little pain at the injection site and felt flush afterwards. The outcome of the events was unknown.    No follow-up attempts are possible. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020501372 same reporter/drug/event, different patient
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Lymphadenopathy, Pharyngeal hypoaesthesia
Clinical narrative: Throat numbness; Lymph node swelling; Felt flush; This is a spontaneous report from a non-contactable consumer. A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK5730), via an unspecified route of administration in the right arm, on 17Dec2020 at 15:15 (at the age of 28-years-old) at a single dose for COVID-19 immunization. The patient had no medical history or concomitant medications. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced throat numbness, lymph node swelling, and felt flush on 17Dec2020 at 15:15. The events were reported as non-serious. Therapeutic measures were taken as a result of the events, which included treatment with diphenhydramine hydrochloride (BENADRYL). The clinical outcome of throat numbness, lymph node swelling, and felt flush was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Sore injection site; This is a spontaneous report from a non-contactable healthcare professional.  A 29-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EH9899), intramuscular into the left arm on 17Dec2020 at 06:15 as single dose for COVID-19 immunization.  There was no medical history.  The patient's concomitant medications were not reported.  The patient experienced sore injection site on 17Dec2020, at  14:00. The event was reported as non-serious. The outcome of sore injection site was recovered in Dec2020.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Malaise, Nausea, Upper-airway cough syndrome
Clinical narrative: Fatigue; nausea; stomach ache; malaise; post-nasal drip; This is a spontaneous report from a contactable healthcare professional.  A 30-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the left arm on 17Dec2020 15:00 at a single dose for COVID-19 immunization.  Medical history included COVID-19 (prior to vaccination).  Concomitant medication included sulfamethoxazole, trimethoprim (BACTRIM) and escitalopram (MANUFACTURER UNKNOWN).  The patient had no known allergies or other medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  On 18Dec2020 03:00, the patient experienced fatigue, nausea, stomach ache, malaise and post-nasal drip.  No treatment was received for the events.  The outcome of the events was recovering.    The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Paraesthesia oral, Pharyngeal paraesthesia
Clinical narrative: Strong medicine taste in the back of my mouth within 5 mins of injection. Over the next hour after the injection, the taste got stronger; Over the next hour after the injection, the taste got stronger and lead to a tingling sensation in the back of my throat and tongue; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received bnt162b2 (BNT162B2) Lot number: FH9899, via an unspecified route of administration on the right arm, first dose on 17Dec2020 08:15 at a single dose for immunization. Medical history included glucose-6-phosphate dehydrogenase deficiency (G6PD), gastrooesophageal reflux disease (GERD) and allergies to Sulfa which is contraindicated for G6PD. Concomitant medication included famotidine and cetirizine. The patient previously took methylcobalamin and quinine (which is contraindicated for G6PD), and experienced drug hypersensitivity on both. On 17Dec2020 at 08:30 AM, the patient experienced strong medicine taste in the back of her mouth within 5 mins of injection. Over the next hour after the injection, the taste got stronger and lead to a tingling sensation in the back of her throat and tongue. These 2 symptoms are still present 22 hrs after receiving the vaccination. The medicine taste and tingling has decreased from strong to mild over the 22 hours. She mentioned that she did not have Covid prior vaccination nor did she tested positive post vaccination. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The events were reported as non-serious. No treatment received and the patient was recovering from the 'Strong medicine taste' and 'Strong medicine taste'.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Patient c/o lightheadedness, dizziness & nausea about 4 hour after receiving vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Diagnostic procedure, Laboratory test, Pain, Pyrexia
Clinical narrative: having aches and a fever of 100.2 so far; having aches and a fever of 100.2 so far; This is a spontaneous report from a contactable consumer (patient's wife).  A male patient of an unspecified age received the bnt162b2 (BNT162B2; Lot Number, Expiration Date, NDC and UPC: unknown), via an unspecified route of administration on 17Dec2020 at 11:30 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. On 17Dec2020, the patient experienced: having aches and a fever of 100.2 so far.  The patient underwent lab tests and procedures which included body temperature: 100.2 on 17Dec2020.  The clinical outcome of the events was unknown.  The batch/lot numbers for the vaccine, BNT162B2, were not provided and will be requested during follow up.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Diagnostic procedure, Laboratory test, Pyrexia
Clinical narrative: Fevers throughout the night of the date received, up to 101.5; This is a spontaneous report from a contactable healthcare professional. A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the left arm, on 17Dec2020 at 20:00 (at the age of 43-years-old) at a single dose for COVID-19 immunization. Medical history included hypothyroidism and COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications, taken within two weeks of vaccination, included levothyroxine (MANUFACTURER UNKNOWN). The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced fevers throughout the night of the date received, up to 101.5 on 17Dec2020. The event was reported as non-serious. The patient underwent lab tests and procedures, which included body temperature: 101.5 on 17Dec2020. No therapeutic measures were taken as a result of the event. The clinical outcome of fevers throughout the night of the date received, up to 101.5 was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain
Clinical narrative: About 20 minutes post vaccine, right sided chest pain, intercostal.  Injection was in right arm; This is a spontaneous report from a contactable nurse and a non contactable physician. A 37-year-old female patient received bnt162b2 (reported as COVID-19 Vaccine, Pfizer, Solution for injection, lot no. and expiry date was unknown), via an unspecified route of administration (right arm) on 17Dec2020 13:30 at a single dose for COVID 19 immunization. The patient medical history was not reported. No allergies to medications, food, or other products. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Not pregnant at the time of vaccination. The hospital was where the most recent COVID-19 vaccine was administered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included sertraline, fish oil, colecalciferol (VITAMIN D), lactobacillus acidophilus (PROBIOTIC), and unspecified vitamin. About 20 minutes post vaccine, the patient experienced right sided chest pain, intercostal. The injection was in right arm on 17Dec2020 13:45 with outcome of recovered. There was no treatment received for the event. The event was considered as non-serious (did not result in death, was not life threatening, did not cause/prolong hospitalization, not disabling/incapacitating, congenital anomaly/birth defect.  Information on the lot/batch number has been requested.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: mild headache; This is a spontaneous report from a non-contactable nurse. A 25-year-old male patient received bnt162b2 (BNT162B2, Lot number: EH9899), via an unspecified route of administration on 18Dec2020 at single dose for immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history and concomitant medications were not reported. The patient previously took amoxicillin and experienced allergies. The patient experienced sudden onset of mild headache approximately 10 minutes after receiving vaccine on 18Dec2020. The most recent COVID-19 vaccine was administered in the hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. There was no treatment for the event. The outcome of the event was unknown.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Injection site reaction, Vertigo
Clinical narrative: Injection site reaction and vertigo.; Injection site reaction and vertigo.; This is a spontaneous report from a contactable pharmacist. A 63-year-old patient of an unspecified gender received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot EH9899), intramuscular on 17Dec2020 10:30 at single dose (left arm) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products. On 17Dec2020, at 10:30, the patient experienced injection site reaction and vertigo. The patient was administered at the hospital. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no treatment received for the events. It was unknown if the patient was diagnosed with Covid-10 prior to vaccination and it was unknown if the patient had been tested for Covid-19 since the vaccination. Outcome of events was recovered on an unspecified date.