chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Her husband got his first dose on 09Feb2021 and afterwards tested positive for COVID on 13Feb2021; This is a spontaneous report from a contactable consumer. A 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 09Feb2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller reports that her husband got his first dose on 09Feb2021 and afterwards tested positive for COVID on 13Feb2021. She reports that he was instructed to wait 90 days after testing positive to have his second dose but now asking, what was the recommended timing, does he have to start the series over. Caller reports that she has spoken with their healthcare professional but are not getting guidance from him. Confirmed Pfizer COVID vaccine. Spoke from attached documentation. Referred to HCP/Pharm for guidance. Caller reports that she filed a report with DSU last night, no reference number for that encounter. The patient underwent lab test and procedure which included COVID-19 test: Positive on 13Feb2021. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch numbers cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got covid after the first dose of the vaccine; got covid after the first dose of the vaccine; This is a spontaneous report from a non-contactable consumer via Pfizer-sponsored program.  A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported the caller has firsthand knowledge. The patient experienced got Covid after the first dose of the vaccine on an unspecified date. The clinical outcome of the event was unknown. Caller inquired if the patient  is eligible to get second dose of vaccine.     No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Oropharyngeal pain
Clinical narrative: woke up sick; sore throat; This is a spontaneous report from a Pfizer sponsored program COVAX SUPPORT received from a contactable consumer (patient's husband). A female patient of an unspecified age received first dose of bnt162b2 (Pfizer/BioNTech COVID-19 Vaccine), via an unspecified route of administration on 27Mar2021 (Lot number: not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 17Apr2021, the patient woke up sick with sore throat and thus could not go to have the 2nd dose of the vaccine and she was scheduled to have the 2nd dose of vaccine on 17Apr2021. The reporter was asking what they should do and wanted to cancel the appointment. The reporter was referred back to the facility and provided with PMI's (reported) phone number. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness, SARS-CoV-2 test
Clinical narrative: She started to feel sick on 01Apr; she received her first vaccine dose on 31Mar. She started to feel sick on 01Apr and then tested positive for covid.; she received her first vaccine dose on 31Mar. She started to feel sick on 01Apr and then tested positive for covid.; This is a spontaneous report from a contactable consumer. This female consumer (patient) of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on 31Mar2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 01Apr2021, she started to feel sick and then on an unspecified date in Apr2021, she tested positive for covid. She reported that she was scheduled for her second vaccine dose the next day and asked if it was advisable to get the second vaccine dose as planned. The outcome for the events was unknown.  Information on lot number/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: triggered rheumatoid arthritis flare up; This is a spontaneous report from a contactable consumer. A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 intramuscular on 15Apr2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced triggered rheumatoid arthritis flare up in Apr2021 with outcome of unknown. It was reported that within 24 hour after receiving the second does of her COVID-19 vaccine, the patient claimed that the shot triggered rheumatoid arthritis flare up. No other symptoms reported.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: menstruation issue, heavy blood clots, its not even her regular cycle yet.; she is having heavy bleeding for days; This is a spontaneous report from a contactable consumer (patient's Mother) reported for a patient. A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date (age at vaccination was 33 years) at a single dose for Covid-19 immunisation. Medical history and concomitant medication were not reported. The caller called for her daughter who received the first dose of the Pfizer covid vaccine and she was having menstruation issue, heavy blood clots, went to see doctors but they were not sure what's going on. The caller wanted to know if menstruation issue has been reported. Caller stated that she was having heavy bleeding for days and its not even her regular cycle yet.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: possible pericarditis
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Fatigue, Headache, Nausea
Clinical narrative: 7:00 pm feeling tired 8:30 pm forehead warm to touch but thermometer said temp normal. Went to bed. 10:40 pm, cannot sleep, 99.7 temp,  headache, chills, warm, nausea. Brain constantly active therefore unable to distract to go to sleep 2 am head cool to touch,  no covers, very warm 3 am started getting little bursts of sleep 4 am slept, not soundly, until 8 am
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: 7:00 pm feeling tired 8:30 pm forehead warm to touch but thermometer said temp normal. Went to bed. 10:40 pm, cannot sleep, 99.7 temp,  headache, chills, warm, nausea. Brain constantly active therefore unable to distract to go to sleep 2 am head cool to touch,  no covers, very warm 3 am started getting little bursts of sleep 4 am slept, not soundly, until 8 am
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyskinesia, Fatigue, Hot flush, Hyperhidrosis
Clinical narrative: Total body aches / almost paralysis.  Faint / white as a sheet when tried to get up for bathroom.  Convulsive jerks horribly for several hours (reminded me of how a friend of mine reacted to strong cancer immunotherapy drugs in the hospital).  Tired to the point could barely move or get up for 9 hours.  When tried to get up to let my dogs out 4-6 hours after adverse reactions, almost fainted / had to lie down on the floor at my front door until I could get the strength to move again.  At one point, a hot flash / sweating like I never experienced before (was just after I tried to get up and had to lie on the floor).  Finally could get up and move without so much pain or feeling faint by 6 - 6:30 pm today (the day after getting the shot at 11 am yesterday).  NOTE;  I did drink 2.5 glasses of white wine the evening I got my shot before I felt bad (clearly, not a smart move).  Not sure if that made things worse.  I did take 2 Tylenol Rapid Release 500 mg/each before I went to bed but then didn?t take any more.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Total body aches / almost paralysis.  Faint / white as a sheet when tried to get up for bathroom.  Convulsive jerks horribly for several hours (reminded me of how a friend of mine reacted to strong cancer immunotherapy drugs in the hospital).  Tired to the point could barely move or get up for 9 hours.  When tried to get up to let my dogs out 4-6 hours after adverse reactions, almost fainted / had to lie down on the floor at my front door until I could get the strength to move again.  At one point, a hot flash / sweating like I never experienced before (was just after I tried to get up and had to lie on the floor).  Finally could get up and move without so much pain or feeling faint by 6 - 6:30 pm today (the day after getting the shot at 11 am yesterday).  NOTE;  I did drink 2.5 glasses of white wine the evening I got my shot before I felt bad (clearly, not a smart move).  Not sure if that made things worse.  I did take 2 Tylenol Rapid Release 500 mg/each before I went to bed but then didn?t take any more.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: Chills, sweating, nausea, dizziness, vomiting, fever up to 102
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Chills, sweating, nausea, dizziness, vomiting, fever up to 102
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental exposure to product, Immunisation, Syringe issue, Underdose
Clinical narrative: Per vaccinator,  while attempting to administer vaccination, needle separated from syringe and the vaccine sprayed out. Less than half of the dose was received by the patient. A replacement vaccine dose was administered.   Syringe/needle
Sex: F
Vaccine: COVID19
Symptoms: Tooth extraction
Clinical narrative: yesterday she had a tooth pulled; This is a spontaneous report from a contactable consumer (Patient) via Medical Information Team. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot# unknown), via an unspecified route of administration on 01Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 19Apr2021, patient got her tooth pulled. The dentist prescribed her with antibiotic Z-Pak for five days. The patient was scheduled to receive the second dose on 23Apr2021 and wanted to know if this could interfere with the vaccination. The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 23.0
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Cough, Hyperhidrosis, Loss of consciousness, Skin warm
Clinical narrative: 14:11-vaccine 14:20- passed out, myself and family eased her to the ground, placed her head on a pillow, called for help.  She had a pulse and was breathing.  Warm, diaphoretic.  After propping her legs up, verbally stimulation, she came to quickly, knew her name, where she was.  She quickly was alert and oriented x4. 14:25  120/70, HR 80, 20 RR, we had her drink some juice.  By 1430 she was describing "throat tightness, coughing and had inspiratory wheezing. 14:33, she took 25 mg of PO benadryl from her own E-kit (her SO had it)  Myself , another RN and the PA were watching her closely. 14:36: she still coughing and wheezing, her anxiety was increased, we called EMS and help administer her EPI pen from her E-kit., continued to monitor closely. 14:40- 118/74, HR 80, RR 22, Lungs CTA , anxiety, wheezing , coughing and throat tightness eased up. 14:46:  EMS arrived, patient was talking and answering questions.  Requested to be called "they".   Patient was loaded onto a stretcher by EMS and they transported her to the hospital. SO and Dad were involved in the decision making.
Age: 23.0
Sex: U
Vaccine: COVID19
Symptoms: Throat tightness, Wheezing
Clinical narrative: 14:11-vaccine 14:20- passed out, myself and family eased her to the ground, placed her head on a pillow, called for help.  She had a pulse and was breathing.  Warm, diaphoretic.  After propping her legs up, verbally stimulation, she came to quickly, knew her name, where she was.  She quickly was alert and oriented x4. 14:25  120/70, HR 80, 20 RR, we had her drink some juice.  By 1430 she was describing "throat tightness, coughing and had inspiratory wheezing. 14:33, she took 25 mg of PO benadryl from her own E-kit (her SO had it)  Myself , another RN and the PA were watching her closely. 14:36: she still coughing and wheezing, her anxiety was increased, we called EMS and help administer her EPI pen from her E-kit., continued to monitor closely. 14:40- 118/74, HR 80, RR 22, Lungs CTA , anxiety, wheezing , coughing and throat tightness eased up. 14:46:  EMS arrived, patient was talking and answering questions.  Requested to be called "they".   Patient was loaded onto a stretcher by EMS and they transported her to the hospital. SO and Dad were involved in the decision making.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Fever next night lasting overnight, arm sore and swelling for next 5 days, hair is starting to fall out about a week afterwards and is still continuing.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Syringe issue
Clinical narrative: Per vaccinator, while attempting to administer vaccination, the needle retracted prematurely and the vaccine sprayed out. Vaccinator estimated about 2/3rd of the dose was received by the patient, however the patient stated she felt that she did not received even 1/2 of the dose. After some discussion, a replacement vaccine dose was administered.   Syringe/needle was Vanishpoint brand
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Myalgia, Somnolence
Clinical narrative: Muscle aches in legs and arms; tiredness and sleepiness; deep sleep lasting approx 4 hours
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Lymphadenopathy, Pain
Clinical narrative: redness and swelling of injection site. is still present and currently spreads out more every day. It is painful but lessens each day. is slightly itchy.  Swollen lymph nodes. Very swollen in right under arm. Painful to the touch. appeared 2 days ago (4/29/21) Tiredness that went away after 24 hours
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Tenderness
Clinical narrative: redness and swelling of injection site. is still present and currently spreads out more every day. It is painful but lessens each day. is slightly itchy.  Swollen lymph nodes. Very swollen in right under arm. Painful to the touch. appeared 2 days ago (4/29/21) Tiredness that went away after 24 hours
Sex: M
Vaccine: COVID19
Symptoms: Atrioventricular block, Echocardiogram, Heart rate increased, Heart rate irregular, Myocardial infarction
Clinical narrative: So I basically had a heart attack.; I was hospitalized and in fact I had a blockage in my heart; had a severe heart beat; I started to feel symptoms that was irregular then I started having heart beat once in a while.; This is a spontaneous report from a contactable consumer (patient). A 47-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was reported as it says EN6207, is it EN or ER6207) as single dose for covid-19 immunisation. Medical history was None. There were no concomitant medications. The patient stated he took his Covid-19 vaccine and he had some side effects and he thought it was important for Pfizer to know because it ended up leading, him to have a heart, a stent placed in his heart and he never had a history of heart problems and it was after he took the vaccine and he developed the symptoms in which he had a severe heart beat but after he took the vaccine on the very next day actually and he had to and at first, he thought it was the vaccine itself, the side effects. So he did not go the doctor immediately but after few days when he was still having the same side effects. So he had to go the doctor and he was hospitalized and in fact, he had a blockage in his heart and so therefore they had to do stent, put a stent in his heart and he felt like, he never had any heart problem in the past. Never had any issues, it was after he took a first vaccine shot, he started to feel symptoms that was irregular then he started having heart beat once in a while and he put a second, he realized something was wrong. He never had these problems before then he rushed to the doctor to urgent care facility on around 2 am in the morning and he was kept for monitoring for 24 hours and the decision was made to have a stent put in his heart. So he basically had a heart attack. He was reporting this because that was just because he did know for fact, he did not have any of those symptoms prior to taking the vaccine. After he went out reported for the hospital, they had, they had done all the test that they needed to do including and ultrasound of his heart. The patient was hospitalized for "basically had a heart attack" and "had a blockage in his heart" from 03Apr2021 and discharged on 05Apr2021. Therapeutic measures were taken as a result of " basically had a heart attack" and "had a blockage in his heart" included placed a stent in his heart. The outcome of the events was unknown.  Information about the Lot/batch number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Syringe issue, Underdose
Clinical narrative: Per vaccinator,  while attempting to administer vaccination, needle prematurely retracted into syringe and the vaccine sprayed out. Less than half of the dose was received by the patient. A replacement vaccine dose was administered per Rph  Syringe/needle was different brand
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Groin pain
Clinical narrative: I am experiencing pain in the folds of my groin area and pain in both hips I just took a hot bath and two Tylenol
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Fatigue, Myocardial infarction, Pain
Clinical narrative: Initially she experienced fever, fatigue, aches, chills.  Then later, several days of tightening chest leading up to heart attack (20 days post vaccine).  Doctor expressed surprise by heart attack.  Not sure if there's a connection, but thought I'd submit.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Initially she experienced fever, fatigue, aches, chills.  Then later, several days of tightening chest leading up to heart attack (20 days post vaccine).  Doctor expressed surprise by heart attack.  Not sure if there's a connection, but thought I'd submit.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth, Vaccination complication
Clinical narrative: Covid arm; Red hot patch near vaccination site
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 8 days after shot, the injection area became red, swollen, itchy, and warm.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hyperaesthesia, Pain
Clinical narrative: Chills, body ache head to toe, sensitive and achy skin, tingly feeling on arms, bottom of feet, fatigue, headache. Had the same symptoms after the first shot and they lasted 48 hours before I started feeling better.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Vaccine positive rechallenge
Clinical narrative: Chills, body ache head to toe, sensitive and achy skin, tingly feeling on arms, bottom of feet, fatigue, headache. Had the same symptoms after the first shot and they lasted 48 hours before I started feeling better.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: received the first dose of Pfizer's COVIDs vaccine on 02Apr2021. On 05Apr2021, he was tested positive for COVID; This is a spontaneous report from a contactable consumer (patient himself) via a medical information team. A 41-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 02Apr2021 (at the age of 41-year-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 05Apr2021, he was tested positive for COVID and was told that he could not receive his second dose until 90 days later. He was supposed to get his second dose this Friday. Caller was wondering if that was true or not. The patient underwent lab test and procedure which included COVID: Positive on 05Apr2021. The outcome of the event was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Injection site swelling, Nausea, Pain
Clinical narrative: Pain,  swelling at injection site.   Nausea,  body aches,  headache,
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature increased, Chills, Dizziness, Fatigue
Clinical narrative: Had no noticeable symptoms until 34 hours after the second dose.  Although, in retrospect, I realize I had some "brain fog" during the day after the injection.  Day after the vaccine:  9pm I went to bed with terrible chills. Could not get warm, nor stop shaking. Awoke in the night needing to use the bathroom. Lifted my head and was so dizzy I began vomiting. Could not get out of bed and walk downstairs to the bathroom. On the day of the vaccine, I was at my normal body temperature of 96.6.  My temperature when I awoke was 102.9.  I was drenched in sweat.  I lay back and tried to sleep.  My breathing was very strange. I was taking deep breaths and as I exhaled my breath came out in squeaks and rattles. It was frightening.  Remained in bed and could not break the fever the next day. Very tired and feeling sick.  Chest hurt if I laughed or coughed due to the severe shivering the night before. That night I had the severe chills again. Still had the fever. Upset stomach. Exhaustion.   The fever continued the next day with some ups and downs - but never down to normal.  I did not feel fully recovered from the vaccine side-effects until about 10 days after the shot.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling cold, Hyperhidrosis, Malaise, Mobility decreased
Clinical narrative: Had no noticeable symptoms until 34 hours after the second dose.  Although, in retrospect, I realize I had some "brain fog" during the day after the injection.  Day after the vaccine:  9pm I went to bed with terrible chills. Could not get warm, nor stop shaking. Awoke in the night needing to use the bathroom. Lifted my head and was so dizzy I began vomiting. Could not get out of bed and walk downstairs to the bathroom. On the day of the vaccine, I was at my normal body temperature of 96.6.  My temperature when I awoke was 102.9.  I was drenched in sweat.  I lay back and tried to sleep.  My breathing was very strange. I was taking deep breaths and as I exhaled my breath came out in squeaks and rattles. It was frightening.  Remained in bed and could not break the fever the next day. Very tired and feeling sick.  Chest hurt if I laughed or coughed due to the severe shivering the night before. That night I had the severe chills again. Still had the fever. Upset stomach. Exhaustion.   The fever continued the next day with some ups and downs - but never down to normal.  I did not feel fully recovered from the vaccine side-effects until about 10 days after the shot.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Respiration abnormal, Tremor, Vomiting
Clinical narrative: Had no noticeable symptoms until 34 hours after the second dose.  Although, in retrospect, I realize I had some "brain fog" during the day after the injection.  Day after the vaccine:  9pm I went to bed with terrible chills. Could not get warm, nor stop shaking. Awoke in the night needing to use the bathroom. Lifted my head and was so dizzy I began vomiting. Could not get out of bed and walk downstairs to the bathroom. On the day of the vaccine, I was at my normal body temperature of 96.6.  My temperature when I awoke was 102.9.  I was drenched in sweat.  I lay back and tried to sleep.  My breathing was very strange. I was taking deep breaths and as I exhaled my breath came out in squeaks and rattles. It was frightening.  Remained in bed and could not break the fever the next day. Very tired and feeling sick.  Chest hurt if I laughed or coughed due to the severe shivering the night before. That night I had the severe chills again. Still had the fever. Upset stomach. Exhaustion.   The fever continued the next day with some ups and downs - but never down to normal.  I did not feel fully recovered from the vaccine side-effects until about 10 days after the shot.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Urticaria
Clinical narrative: Headache, fever about 8 hours after injection.  Lasted until 10am next  day.  Broke out in hives 5 days after injection - lasted 13 days
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Malaise, Visual impairment
Clinical narrative: The patient was sitting in the waiting area following her vaccination when shortly after receiving the vaccine, her mother flagged us down and said that she lost her vision. She was describing feeling unwell. I had her lay down on the floor in the immunization booth and her mother elevated her legs. I asked her to describe her symptoms and she said that she just saw all white. I asked if she wanted me to check her blood pressure and I had her sit up on the floor and it was low around 75/53 with a pulse of 53 but not sure how accurate it was since she was sitting on the floor. She fluctuated from starting to feel better and feeling unwell again and her vision going out again. I asked if they wanted me to call 911 and her mother said she wasn't sure what to do, if she should take her to an urgent care. I said that it would be best if she was seen in an emergency room where they can better respond to this kind of situation. The patient was able to get up and walk with her mother's assistance. I was going to help walk her out but she said that she was okay walking out with her mother's help. About 10 minutes later, I called the patient to see how she was doing. Her mother said that she was doing okay and that they were on their way to the hospital just to make sure that she was checked and everything was okay.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site hypoaesthesia, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, numbness, and itching around injection site of left arm.  Has been hurting since day of injection, but noticed other side effects listed today, Saturday May 1, 2021.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Confusional state, Echocardiogram, Electrocardiogram ambulatory, Fatigue
Clinical narrative: Fatigue, tachycardia, brain fog: memory loss, confusion,
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Tachycardia
Clinical narrative: Fatigue, tachycardia, brain fog: memory loss, confusion,
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Malaise, Nausea, Pain, Pain in extremity
Clinical narrative: FEVER, CHILLS, BODY ACHES, NASUEA....DIDNT FEEL GOOD ENOUGH TO CHECK FEVER FRO SEVERAL HOURS  . WHEN FINALLY CHECKED IT AROUND 2 AM IT WAS 100.9   UNSURE IF THIS WAS THE HIGH OR LOW OR WHAT.......ALSO VERY SORE ARM BUT THAT WAS SAME AS FIRST DOSE ( 04/06/2021........)  ADVERSE REACTION WAS ONLY ON 2ND DOSE ( 04/27/2021)
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER, CHILLS, BODY ACHES, NASUEA....DIDNT FEEL GOOD ENOUGH TO CHECK FEVER FRO SEVERAL HOURS  . WHEN FINALLY CHECKED IT AROUND 2 AM IT WAS 100.9   UNSURE IF THIS WAS THE HIGH OR LOW OR WHAT.......ALSO VERY SORE ARM BUT THAT WAS SAME AS FIRST DOSE ( 04/06/2021........)  ADVERSE REACTION WAS ONLY ON 2ND DOSE ( 04/27/2021)
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chest discomfort, Dyspnoea, Electrocardiogram ambulatory, Electrocardiogram normal
Clinical narrative: First vaccine dose 3/26/21 First health event 4/7/21:  pre-syncope and palpitations Second vaccine dose 4/16/21 4/18/21: strange heart feelings on any exertion, pre-syncope, weakness, malaise, winded by even walking the dog, hands turn purple, weird thump/click in chest, visual changes (seeing colors or spots, greying of vision, migraine-like hallucinations), shortness of breath  Episodes like the one described on 4/18 daily, especially in the morning and on exertion until now, 5/1/21  Seen in the ER on 4/19/21 and 5/1/21. EKGs normal, CBC and metabolic panel largely normal. Holter monitor 4/21/21-4/26/21 placed by healthcare Center; hasn't been read yet.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Full blood count normal, Malaise, Metabolic function test, Palpitations
Clinical narrative: First vaccine dose 3/26/21 First health event 4/7/21:  pre-syncope and palpitations Second vaccine dose 4/16/21 4/18/21: strange heart feelings on any exertion, pre-syncope, weakness, malaise, winded by even walking the dog, hands turn purple, weird thump/click in chest, visual changes (seeing colors or spots, greying of vision, migraine-like hallucinations), shortness of breath  Episodes like the one described on 4/18 daily, especially in the morning and on exertion until now, 5/1/21  Seen in the ER on 4/19/21 and 5/1/21. EKGs normal, CBC and metabolic panel largely normal. Holter monitor 4/21/21-4/26/21 placed by healthcare Center; hasn't been read yet.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Presyncope, Skin discolouration, Visual impairment
Clinical narrative: First vaccine dose 3/26/21 First health event 4/7/21:  pre-syncope and palpitations Second vaccine dose 4/16/21 4/18/21: strange heart feelings on any exertion, pre-syncope, weakness, malaise, winded by even walking the dog, hands turn purple, weird thump/click in chest, visual changes (seeing colors or spots, greying of vision, migraine-like hallucinations), shortness of breath  Episodes like the one described on 4/18 daily, especially in the morning and on exertion until now, 5/1/21  Seen in the ER on 4/19/21 and 5/1/21. EKGs normal, CBC and metabolic panel largely normal. Holter monitor 4/21/21-4/26/21 placed by healthcare Center; hasn't been read yet.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Lip swelling. treated with Solumedro, Pepcid and Benadryl
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Nausea
Clinical narrative: Patient woke today, 5/1/21, with severe pain in left shoulder and chest to the point of being nauseated. No known cause.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, Hypoaesthesia
Clinical narrative: Bell's palsy/Facial droop; facial numbness; This is a spontaneous report from a contactable other health care professional. A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered in Arm Left on 04Mar2021 (at the age of 68-years-old) (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included diabetes, Blood pressure, cholesterol. Concomitant medications included insulin glargine (LANTUS) taken for diabetes mellitus; insulin lispro (HUMALOG) taken for diabetes mellitus; amlodipine besilate (NORVASC) taken for blood pressure abnormal; lisinopril (LISINOPRIL) taken for blood pressure abnormal; atorvastatin (LIPITOR [ATORVASTATIN]) taken for blood cholesterol; start and stop dates were not reported. On 22Mar2021, the patient experienced Bell's palsy/facial droop, and facial numbness. The outcome of the events was not recovered. The patient received treatment for the events: Nurse Practitioner stated, "She was given by the emergency room. She was treated with Prednisone. 20mg, tablet, 3 tablet one time in a day, oral. Bell's palsy. She was also given Valtrex. 1gm, oral, tablet, 3 times a day."  Information about lot/batch number has been requested.; Sender's Comments: Based on the temporal association, a possible contributory role of bnt162b2 to the development of Bell's palsy/facial droop cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: developed shingles on face beginning 3 days after vaccine
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: Itching  Pain/soreness in arm
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Eye irritation, Ocular hyperaemia
Clinical narrative: Redness cheeks & eyes... burning sensation on eyes
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site haemorrhage
Clinical narrative: Excessive bleeding at injection site.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Dizziness, Electrocardiogram, Heart rate increased
Clinical narrative: Heart rate shot up to 170. Felt dizzy, lightheaded, weak like I was about to fall and nausea. Was taken to E.R. was given 2 bags of I.V. fluids then released to go home. It's now almost 3 months since the vaccine and I still have all the symptoms.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Heart rate shot up to 170. Felt dizzy, lightheaded, weak like I was about to fall and nausea. Was taken to E.R. was given 2 bags of I.V. fluids then released to go home. It's now almost 3 months since the vaccine and I still have all the symptoms.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Abdominal neoplasm, Abdominal pain upper, Asthenia, Computerised tomogram abnormal
Clinical narrative: One week after the first vaccine I started feeling bloated, got stomach cramps, and constipation and lasted for about a week. After the second dose, a week or two later, I started feeling bloated, weak, had body aches, stomach cramps and was constipated and lasted for about 2 weeks.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Constipation, Hepatic neoplasm, Pain
Clinical narrative: One week after the first vaccine I started feeling bloated, got stomach cramps, and constipation and lasted for about a week. After the second dose, a week or two later, I started feeling bloated, weak, had body aches, stomach cramps and was constipated and lasted for about 2 weeks.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Computerised tomogram normal, Dizziness, Electrocardiogram normal, Impaired driving ability
Clinical narrative: Started feeling extremely dizzy and shaking while driving home. Felt the need to pull over, but didn?t have time before losing consciousness. Ended up crashing car and being flown via life flight to a hospital trauma unit. Fortunately for seat belts and air bags, no serious injuries had occurred.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Road traffic accident, Tremor
Clinical narrative: Started feeling extremely dizzy and shaking while driving home. Felt the need to pull over, but didn?t have time before losing consciousness. Ended up crashing car and being flown via life flight to a hospital trauma unit. Fortunately for seat belts and air bags, no serious injuries had occurred.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Large, bright red, swollen rash at injection site appeared approximately 12 hours after receiving the second dose (no rash reaction to first dose). Rash is approximately five inches in diameter, mildly itchy, and skin is hot to the touch. The arm was extremely sore and tender the following day, but now four days post-injection the pain has dissipated but the large bright rash remains. I will wait one week and if it has not cleared up or reduced in size by then, I will seek medical care.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Large, bright red, swollen rash at injection site appeared approximately 12 hours after receiving the second dose (no rash reaction to first dose). Rash is approximately five inches in diameter, mildly itchy, and skin is hot to the touch. The arm was extremely sore and tender the following day, but now four days post-injection the pain has dissipated but the large bright rash remains. I will wait one week and if it has not cleared up or reduced in size by then, I will seek medical care.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Patient received Moderna dose #2 today as the shown on the vaccine card.  He received Moderna on 4/1/2021. The patient actually received Pfizer for his dose #1 per record. The patient was notified of the error and advised that he does not need to get another dose of Pfizer. He reported feeling well and no presence of adverse symptoms at this time. A new vaccine record will be mailed to the patient.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site discolouration, Injection site erythema, Injection site swelling
Clinical narrative: Patient presented to the pharmacy with redness and swelling below the injection site. She had some discoloration/bruising at the injection site.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Cardiac function test normal, Computerised tomogram abnormal, Limb discomfort, Pulmonary embolism
Clinical narrative: Blood clot on 2/9/2021, just thought it was a severe calf cramp and took ibuprofen for several days until the calf felt somewhat better.  Went to ER on 3/20 for dual pulmonary embolisms.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis, Ultrasound Doppler abnormal
Clinical narrative: Blood clot on 2/9/2021, just thought it was a severe calf cramp and took ibuprofen for several days until the calf felt somewhat better.  Went to ER on 3/20 for dual pulmonary embolisms.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Heavy period bleeding this also happened when I received this first vaccination
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Pain in extremity, Rash erythematous
Clinical narrative: Large red rash on arm that is hard and hot to touch. Painful as well .
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site streaking, Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen , pain full lymph nodes in right armpit. Also some infection like red streaking  moving distally down arm.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Chills, Dyspnoea, Fatigue, Headache
Clinical narrative: Immediately had drop in blood pressure, increased heart rate to 150 from 65, throat constriction and hard to breathe for 5mins. 2 hours post vaccine headache, fatigue which peaked 12 hours post vaccine. 12 hours post vaccine high fever, chills, strong body aches, pain, nausea for 6 hours. Progressively got better over 48 hours.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Immediate post-injection reaction, Nausea, Pain, Pyrexia
Clinical narrative: Immediately had drop in blood pressure, increased heart rate to 150 from 65, throat constriction and hard to breathe for 5mins. 2 hours post vaccine headache, fatigue which peaked 12 hours post vaccine. 12 hours post vaccine high fever, chills, strong body aches, pain, nausea for 6 hours. Progressively got better over 48 hours.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Immediately had drop in blood pressure, increased heart rate to 150 from 65, throat constriction and hard to breathe for 5mins. 2 hours post vaccine headache, fatigue which peaked 12 hours post vaccine. 12 hours post vaccine high fever, chills, strong body aches, pain, nausea for 6 hours. Progressively got better over 48 hours.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Vomiting
Clinical narrative: * Extreme headache, extreme nausea, vomiting, tiredness * Benedryl and Tylenol * Three days
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Muscle twitching, Tremor
Clinical narrative: her right hand started twitching shaking uncontrollably; her right hand started twitching and shaking uncontrollably; Her temperature also started rising but did not reach above 100*F; This is a spontaneous report from a contactable consumer (Parent). This consumer (patients mother) reported for a 16-year-old female patient (daughter).  A 16-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via unspecified route of administration in left arm on 19Apr2021 (at the age of 16-year-old) for SINGLE DOSE for COVID-19 immunization. She received Pfizer vaccine on 19Apr2021 in left arm and within 2 minutes of receiving it left arm, her right hand started twitching and shaking uncontrollably on an unspecified date. The nurse and the fire department were with her and monitored her for 45 minutes until they suggested her to contact her primary care provider and go to the hospital. In those 45 minutes her right arm started twitching with her hand twitching more. It started going up and down with a flopping motion. Her temperature also started rising but did not reach above 100*F on an unspecified date. She was observed by several doctors in the hospital and was given Adavan (Ativan) for her symptoms which did not subside. She was dismissed from the hospital and was given Adavan (Ativan) again in the hopes that her symptoms would subside in the morning. This morning, only her right hand was still twitching. She is right-handed and could not use her right hand at all as she could not hold a pencil at all, which caused her to be absent from school today. She mentioned that her daughter was healthy, athletic, and had no underlying conditions. Her twin sister also had the vaccine yesterday and experienced nothing but nausea last night with some of the listed side effects. She is asking if there has been reports of this. Waiting to hear from hospital she may need to see a neurologist. Outcome of the event reported as recovering.   Response: Referenced PI Section 6 and Section 18 LAB-1457-7.0 Revised: 06 April 2021  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Developed tinnitus in both ears the day after the injection, and it has continued (now 3 days post injection). It is a low grade buzzing or humming sound.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Headache, chills, fatigue, sore arm, joint and muscle pain (slept almost all day 5/1)
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence
Clinical narrative: Headache, chills, fatigue, sore arm, joint and muscle pain (slept almost all day 5/1)
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Restlessness
Clinical narrative: Weakness / restless feeling in muscle at the injection site. Delayed onset
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Underdose
Clinical narrative: When the shot was being administered, the person who gave me the shot squeezed my shoulder and put the needle in while still squeezing. When the needle was pulled out, I felt liquid run down my arm and the person who administered the shot wiped it up. I'm not sure if this is normal or if I was not given the complete dose of the shot. I want to know if I should get my second dose administered again just in case. It has been 4 hours since I got the shot and my only symptom so far is a sore shoulder.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: Period affected - heavier bleeding and off timeline for my cycle
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Vomiting
Clinical narrative: patient passed out roughly five minutes after receiving covid dose 1, he was sitting in his chair, did not hit his head. After this, he immediately regained consciousness, vomited, and then immediately "felt a lot better" Patient stayed for 15 minutes and then left under supervision of his father
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Menstrual disorder
Clinical narrative: Constantly night hot flashes . missed two months of menstruation
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Oral discomfort, Pharyngeal swelling
Clinical narrative: Mouth inside cheeks inside lip area., raw thicker,, slight burning on left side corner of the lips and inside left side to upper.  Worst started April 30 with immediate swelling including change in throat. Took Hydroxizine. The throat got better aware of inside mouth swollen.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blister, Cheilitis, Rash, Rash pruritic, Skin burning sensation
Clinical narrative: Mouth inside cheeks inside lip area., raw thicker,, slight burning on left side corner of the lips and inside left side to upper.  Worst started April 30 with immediate swelling including change in throat. Took Hydroxizine. The throat got better aware of inside mouth swollen.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Skin exfoliation, Stomatitis, Swelling face
Clinical narrative: Mouth inside cheeks inside lip area., raw thicker,, slight burning on left side corner of the lips and inside left side to upper.  Worst started April 30 with immediate swelling including change in throat. Took Hydroxizine. The throat got better aware of inside mouth swollen.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Stomatitis
Clinical narrative: Mouth inside cheeks inside lip area., raw thicker,, slight burning on left side corner of the lips and inside left side to upper.  Worst started April 30 with immediate swelling including change in throat. Took Hydroxizine. The throat got better aware of inside mouth swollen.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Condition aggravated, Head injury, Seizure
Clinical narrative: 2nd time submitting this because first submission said error; doing another report just in case. Patient got vaccine and said felt anxious then started having a seizure for 2-5 seconds pt said they had history of this prior but has been a while. I was near patient and able to slightly guide patient down but head did slightly hit floor. Patient woke up and said they were fine . Had patient stay an extra 30 minutes and gave ice pack and water and left the store after ensure they felt fine.