chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Blood pressure increased, Blood pressure measurement
Clinical narrative: My blood pressure also went up to 153/103; I had all signs of early stages of Bells Palsy; This is a spontaneous report from a contactable healthcare professional (patient).  A 37-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm left on 22Mar2021 14:45 (Batch/Lot Number: ER2613) as SINGLE DOSE for COVID-19 immunization.  Medical history included low blood pressure. The patient had allergies with orphenadrine (K FLEX).  Concomitant medications included melatonin (MELATONIN) and paracetamol (TYLENOL) both taken from unknown dates and indications, start and stop date were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  On 22Mar2021 15:45 (when the patient was almost home), half of her lips started to go numb on right side. The next morning, the rest of right side of face had went numb. She went to urgent care after work and doctor told her that she had all signs of early stages of Bell's Palsy. Her blood pressure also went up to 153/103 (unit of measure not reported) on 23Mar2021. The patient required doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care for both events. No treatment was also received for both events. She was not diagnosed with COVID-19 prior to vaccination and no tested for COVID-19 since the vaccination. Outcome of the events were not recovered.   Follow up attempts are needed. Further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Palsy Bells cannot be excluded.  The case will be reassessed if additional information becomes available.  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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Cold sweat, Dizziness, Hyperhidrosis, Hypertension
Clinical narrative: Dizziness; clammy kind of feeling; low grade fever; feels kind of sweaty; felt like she was going to pass out; blood pressure was up; This is a spontaneous report from a contactable consumer reported for herself that at the age of 54- year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unknown), via an unspecified route of administration on 15Mar2021 (at the age of 54-year-old), at a single dose for COVID-19 immunisation. Medical history included ongoing asthma. The patient's concomitant medications were not reported. Caller reports that since she received the vaccine on 15Mar2021, on the day of the vaccine, she felt like she was going to pass out and her blood pressure was quite high. Her blood pressure is usually about 120/70 something, but it was 160 or 155/96 on the day of the vaccine. The reporter stated, she has been experiencing a clammy kind of feeling, like she has a low-grade fever and she feels kind of sweaty on 16Mar2021. Caller make the comment that she is in her fifties and she knows what hot flashes feel like-your body gets hot, sweaty, and you get redness on your skin, and your temperature goes up. This feeling is different- she doesn't feel like herself and she doesn't feel right and she is not sure if this is related to the vaccine, but it started after she received the vaccine. The patient underwent lab tests and procedures which included blood pressure measurement: 120/70 on an unspecified date and on 15Mar2021 reported as: 160 or 155/96 on 15Mar2021. The reported events were considered as non-serious by the health authority. The outcome of the events clammy kind of feeling, low grade fever and feels kind of sweaty were not recovered and unknown for other events.  Information for lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, Pyrexia
Clinical narrative: Dizziness; clammy kind of feeling; low grade fever; feels kind of sweaty; felt like she was going to pass out; blood pressure was up; This is a spontaneous report from a contactable consumer reported for herself that at the age of 54- year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unknown), via an unspecified route of administration on 15Mar2021 (at the age of 54-year-old), at a single dose for COVID-19 immunisation. Medical history included ongoing asthma. The patient's concomitant medications were not reported. Caller reports that since she received the vaccine on 15Mar2021, on the day of the vaccine, she felt like she was going to pass out and her blood pressure was quite high. Her blood pressure is usually about 120/70 something, but it was 160 or 155/96 on the day of the vaccine. The reporter stated, she has been experiencing a clammy kind of feeling, like she has a low-grade fever and she feels kind of sweaty on 16Mar2021. Caller make the comment that she is in her fifties and she knows what hot flashes feel like-your body gets hot, sweaty, and you get redness on your skin, and your temperature goes up. This feeling is different- she doesn't feel like herself and she doesn't feel right and she is not sure if this is related to the vaccine, but it started after she received the vaccine. The patient underwent lab tests and procedures which included blood pressure measurement: 120/70 on an unspecified date and on 15Mar2021 reported as: 160 or 155/96 on 15Mar2021. The reported events were considered as non-serious by the health authority. The outcome of the events clammy kind of feeling, low grade fever and feels kind of sweaty were not recovered and unknown for other events.  Information for lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Headache, Optic neuritis, Tremor
Clinical narrative: 24Mar2021 Went to see Neurologist now have optical neuritis and balance issue.; 24Mar2021 Went to see Neurologist now have optical neuritis and balance issue.; 19Mar2021 headache and shakiness; 19Mar2021 headache and shakiness; This is a spontaneous report from a contactable consumer (patient herself). A 57-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; Lot Number: Er2613), via an unspecified route of administration in the left arm on 18Mar2021 at 10:00 as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis (with no symptoms) and known allergies to Flagel, aspirin, dairy, oats, tomatoes, and garlic. The patient did not have COVID prior to the vaccination. The patient had no other vaccine in four weeks but had other medications in two weeks (unspecified). On 19Mar2021 at 07:00 AM, the patient experienced headache and shakiness. On 24Mar2021, she went to see a Neurologist and now had optical neuritis and balance issue. She was the scheduled an MRI. The patient wanted to know if she should get her second dose. The patient was not COVID tested post-vaccination. The patient received no treatment for the events. Outcome of the events was not recovered.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Chills, Nausea, Ophthalmic migraine, Pain
Clinical narrative: vision loss; Severe Migraine over her right eye; blurriness, can't see out of right eye, very blurry was reported as worsened; Body Aches; Nausea; Chills; This is a spontaneous report from a contactable consumer (patient herself). A 69-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), batch lot number unknown, on 22Mar2021 at 09:15 (at the age of 69-year old) at single dose for COVID-19 Immunization. Relevant medical history was not reported. The patient received first dose of the same vaccine on 01Mar2021, on the left arm. Caller states that she has usually gotten sick with the flu shot. Concomitant medications were not reported. On 22Mar2021 the patient experienced chills. On 23Mar2021 the patient experienced nausea, body aches and severe migraine over her right eye and vision loss. She stated that when she covered her good eye she could not see the couch due to blurriness in the right eye. The patient was treated with ibuprofen and acetaminophen (TYLENOL), used hot packs, cold packs and a hot water bottle.The patient recovered from chills on 23Mar2021, she was recovering from nausea and body aches but was not recovered from severe migraine over right eye and can't see out of right eye, very blurry (reported as worsened).     Information about lot/batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: vision loss; Severe Migraine over her right eye; blurriness, can't see out of right eye, very blurry was reported as worsened; Body Aches; Nausea; Chills; This is a spontaneous report from a contactable consumer (patient herself). A 69-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), batch lot number unknown, on 22Mar2021 at 09:15 (at the age of 69-year old) at single dose for COVID-19 Immunization. Relevant medical history was not reported. The patient received first dose of the same vaccine on 01Mar2021, on the left arm. Caller states that she has usually gotten sick with the flu shot. Concomitant medications were not reported. On 22Mar2021 the patient experienced chills. On 23Mar2021 the patient experienced nausea, body aches and severe migraine over her right eye and vision loss. She stated that when she covered her good eye she could not see the couch due to blurriness in the right eye. The patient was treated with ibuprofen and acetaminophen (TYLENOL), used hot packs, cold packs and a hot water bottle.The patient recovered from chills on 23Mar2021, she was recovering from nausea and body aches but was not recovered from severe migraine over right eye and can't see out of right eye, very blurry (reported as worsened).     Information about lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Menstrual disorder, Off label use, Product use issue
Clinical narrative: bleeding heavily; starting a menstrual cycle within weeks of delivery was highly unusual if exclusively breastfeeding; patient was five weeks postpartum and was exclusively breastfeeding the newborn; patient was five weeks postpartum and was exclusively breastfeeding the newborn; This is a spontaneous report from a contactable consumer(patient) who reported for herself  A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EP7634), in left arm on 18Mar2021 at 15:15 (at 38 years) at single dose for covid-19 immunisation . The patient medical history included five weeks postpartum; concomitant medications were not reported. On 19Mar2021 the patient experienced bleeding heavily and starting a menstrual cycle within weeks of delivery that was highly unusual if exclusively breastfeeding. These events required doctor or other healthcare professional office/clinic visit and were described as follows: patient was five weeks postpartum and was exclusively breastfeeding the newborn. Her body was no longer expelling lochia/blood after the fourth weeks postpartum, however, the day after the vaccine, she began bleeding heavily. This continued on for four days. Her midwife said that ovulation and starting a menstrual cycle within weeks of delivery was highly unusual if exclusively breastfeeding. She didn't attribute to the vaccine until researching on a postpartum message board on What to Expect that there were other anecdotal claims of similar experiences. She would love to speak with someone about what this side effect could possibly mean for her future reproductive health and that if her newborn son.No treatment given; patient was recovering from bleeding heavily and starting a menstrual cycle within weeks of delivery.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021331585 baby case
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: J&J COVID-19 Vaccine  I received fever, chills, fatigue, headache 10 hours after getting the vaccine. My fever got as high as 101.5, but now is down to 99.9 (47 hours after vaccination). My fever has gone down due to taking Tylenol every four hours. Chills and headache have gone, but general fatigue is still present.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure decreased, Dizziness, Hyperhidrosis, Loss of consciousness
Clinical narrative: Pt became anxious, sweaty and dizzy. Developed tunnel vision and loss of consciousness. Staff with pt at time of syncopal episode and assisted pt to floor. Pt regain consciousness within 1 minute. Pt placed on stretcher and arrived to med obs at 1558. Vitals obtained. At this time pt states she is feeling normal. At 1611 c/o dizziness and nausea. BP rechecked and notably dropped. Pt placed in the trendelenburg position. BP increased. Nausea and dizziness resolved. Snacks and water given.  Pt left facility 1712, friend driving. Vitals as follows; 1600 BP 107/74 HR 85 RR 22 spo2 98%     1611 BP 97/68 HR 78 RR 20 spo2 100%     1625 BP 109/76 HR RR 18 spo2 99%     1705 BP 95/66 (standing, asymptomatic)
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Syncope, Tunnel vision
Clinical narrative: Pt became anxious, sweaty and dizzy. Developed tunnel vision and loss of consciousness. Staff with pt at time of syncopal episode and assisted pt to floor. Pt regain consciousness within 1 minute. Pt placed on stretcher and arrived to med obs at 1558. Vitals obtained. At this time pt states she is feeling normal. At 1611 c/o dizziness and nausea. BP rechecked and notably dropped. Pt placed in the trendelenburg position. BP increased. Nausea and dizziness resolved. Snacks and water given.  Pt left facility 1712, friend driving. Vitals as follows; 1600 BP 107/74 HR 85 RR 22 spo2 98%     1611 BP 97/68 HR 78 RR 20 spo2 100%     1625 BP 109/76 HR RR 18 spo2 99%     1705 BP 95/66 (standing, asymptomatic)
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Chills, migraines, vomitting, excessive sweating, dizziness, fogginess, fever, weakness, very tired
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Migraine, Pyrexia, Vomiting
Clinical narrative: Chills, migraines, vomitting, excessive sweating, dizziness, fogginess, fever, weakness, very tired
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: 3-31-21 soreness in front of shoulder under bra strap left side (ongoing) 4-2-21 found enlarged lymph node on collar bone on left side, size of a grape but round, painful to touch (ongoing) 4-7-21 2pm developed red itchy welt about five inches below injection site on left arm, about 1inch in diameter.  Hard and hot to the touch. By 5pm there were two welts that were touching, both were about 1inch, making the full size about 1 by 2 inches.  I also started experiencing a burning sensation on my cheeks and forehead.  Be bedtime my entire arm ached from shoulder to wrist, concentrated in welt and feelings of "growing pains" in forearm. 4-8-21 woke to welt growing to have 2.5 inch diameter, growing to 3.5 inch diameter by afternoon.  Had video appt with primary care physician.  She prescribed cordisone cream to be applied 3x per day, aleve or motrin as needed and to watch it.   That is most up to date details at time of posting.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Lymph node pain, Lymphadenopathy
Clinical narrative: 3-31-21 soreness in front of shoulder under bra strap left side (ongoing) 4-2-21 found enlarged lymph node on collar bone on left side, size of a grape but round, painful to touch (ongoing) 4-7-21 2pm developed red itchy welt about five inches below injection site on left arm, about 1inch in diameter.  Hard and hot to the touch. By 5pm there were two welts that were touching, both were about 1inch, making the full size about 1 by 2 inches.  I also started experiencing a burning sensation on my cheeks and forehead.  Be bedtime my entire arm ached from shoulder to wrist, concentrated in welt and feelings of "growing pains" in forearm. 4-8-21 woke to welt growing to have 2.5 inch diameter, growing to 3.5 inch diameter by afternoon.  Had video appt with primary care physician.  She prescribed cordisone cream to be applied 3x per day, aleve or motrin as needed and to watch it.   That is most up to date details at time of posting.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Urticaria
Clinical narrative: 3-31-21 soreness in front of shoulder under bra strap left side (ongoing) 4-2-21 found enlarged lymph node on collar bone on left side, size of a grape but round, painful to touch (ongoing) 4-7-21 2pm developed red itchy welt about five inches below injection site on left arm, about 1inch in diameter.  Hard and hot to the touch. By 5pm there were two welts that were touching, both were about 1inch, making the full size about 1 by 2 inches.  I also started experiencing a burning sensation on my cheeks and forehead.  Be bedtime my entire arm ached from shoulder to wrist, concentrated in welt and feelings of "growing pains" in forearm. 4-8-21 woke to welt growing to have 2.5 inch diameter, growing to 3.5 inch diameter by afternoon.  Had video appt with primary care physician.  She prescribed cordisone cream to be applied 3x per day, aleve or motrin as needed and to watch it.   That is most up to date details at time of posting.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Angina pectoris, Body temperature, Chills, Cold sweat
Clinical narrative: pain in the heart; semi-hallucinatory dreams; 3 day duration: extreme headache; fatigue; nausea and vomiting; nausea and vomiting; diarrhea; chills; cold sweats; fever spiking to 103.9 F; This is a spontaneous report from a contactable consumer (Patient) reporting for herself. A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8727), via an unspecified route of administration, at the age of 64 years, administered on the left arm on 21Mar2021 09:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included atypical homozygous pseudocholinesterese deficiency from an unknown date and unknown if ongoing. Concomitant medications included liothyronine (LIOTHYRONINE) and levothyroxine (LEVOTHYROXINE); both taken for an unspecified indication, start and stop date were not reported. The patient received first dose of COVID vaccine BNT162B2 (lot number: EN6203) on 02Mar2021 09:00 AM on the left arm for COVID-19 immunization. On 21Mar2021 18:00, the patient experienced 3 day duration of extreme headache, fatigue, nausea, vomiting, diarrhea, chills, cold sweats, fever spiking to 103.9 F, pain in the heart and semi-hallucinatory dreams. The patient underwent lab tests and procedures which included body temperature: 103.9 fahrenheit on 21Mar2021. Treatment was not received for the events. The outcome of the events was recovering.   Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: pain in the heart; semi-hallucinatory dreams; 3 day duration: extreme headache; fatigue; nausea and vomiting; nausea and vomiting; diarrhea; chills; cold sweats; fever spiking to 103.9 F; This is a spontaneous report from a contactable consumer (Patient) reporting for herself. A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8727), via an unspecified route of administration, at the age of 64 years, administered on the left arm on 21Mar2021 09:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included atypical homozygous pseudocholinesterese deficiency from an unknown date and unknown if ongoing. Concomitant medications included liothyronine (LIOTHYRONINE) and levothyroxine (LEVOTHYROXINE); both taken for an unspecified indication, start and stop date were not reported. The patient received first dose of COVID vaccine BNT162B2 (lot number: EN6203) on 02Mar2021 09:00 AM on the left arm for COVID-19 immunization. On 21Mar2021 18:00, the patient experienced 3 day duration of extreme headache, fatigue, nausea, vomiting, diarrhea, chills, cold sweats, fever spiking to 103.9 F, pain in the heart and semi-hallucinatory dreams. The patient underwent lab tests and procedures which included body temperature: 103.9 fahrenheit on 21Mar2021. Treatment was not received for the events. The outcome of the events was recovering.   Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: pain in the heart; semi-hallucinatory dreams; 3 day duration: extreme headache; fatigue; nausea and vomiting; nausea and vomiting; diarrhea; chills; cold sweats; fever spiking to 103.9 F; This is a spontaneous report from a contactable consumer (Patient) reporting for herself. A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8727), via an unspecified route of administration, at the age of 64 years, administered on the left arm on 21Mar2021 09:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included atypical homozygous pseudocholinesterese deficiency from an unknown date and unknown if ongoing. Concomitant medications included liothyronine (LIOTHYRONINE) and levothyroxine (LEVOTHYROXINE); both taken for an unspecified indication, start and stop date were not reported. The patient received first dose of COVID vaccine BNT162B2 (lot number: EN6203) on 02Mar2021 09:00 AM on the left arm for COVID-19 immunization. On 21Mar2021 18:00, the patient experienced 3 day duration of extreme headache, fatigue, nausea, vomiting, diarrhea, chills, cold sweats, fever spiking to 103.9 F, pain in the heart and semi-hallucinatory dreams. The patient underwent lab tests and procedures which included body temperature: 103.9 fahrenheit on 21Mar2021. Treatment was not received for the events. The outcome of the events was recovering.   Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: My Vaccination record card I got on the day lists Janssen 1808609 and I filled out a disclosure form on the day for Johnson and Johnson.   But 2 days later I received a txt with a picture of a COVID 19 vaccination record card from hospital  stating I got the first dose of MODERNA 1808609, the CDC logo is blocking the patient number so I cannot provide .  I have tried to contact hospital by calling the number that txt me but it's not a working number. I have called many different hospital numbers that I have been passed to and even tried the school who hosted the vaccine but everyone just passes me on to someone else and says it doesn't fall under them. At this point I do not know which vaccine I have received. I have had no fever or symptoms whatsoever following my shot. I do not know if this means I likely got the moderna short vaccine 1 or I had J&J and was lucky.   I need to know which shot I got so I can travel.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, Tinnitus
Clinical narrative: Fever; chills; fatigue; ringing ears  for two days
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Heart rate increased, Pyrexia
Clinical narrative: Chills, fever, elevated heart rate, headache lasting overnight.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Rash, Rash pruritic
Clinical narrative: Two days after injection sight swollen and red. Four days after injection rash started to develop on my back and continued to cover my whole body except face. Very itchy. Day 5 rash continues but seems to have peaked.  Treating with Benadryl.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Flushing, Muscular weakness, Nausea, Swollen tongue
Clinical narrative: Body flush like when getting CT scan dye,  leg weakness,, nausea,, swollen tongue, feeling like throat closed over difficulty breathing. Happened immediately after getting J & J covid vaccine.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Body flush like when getting CT scan dye,  leg weakness,, nausea,, swollen tongue, feeling like throat closed over difficulty breathing. Happened immediately after getting J & J covid vaccine.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza like illness, Pyrexia
Clinical narrative: Flu like symptoms,fatigue, fever,really bad chills from 430 pm till the next am
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Pallor, Syncope
Clinical narrative: Pt reported feeling dizzy and light headed.  He laid down with feet up with cold pack.  He felt better after about 10 minutes and he sat up.  He then fainted within about 5-10 minutes.  We again got him safely to the ground with feet up and cold pack. He remained pale and dizzy for about 10 minutes.  He then sat up and left after about 20 more minutes after reporting that he felt better.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Influenza like illness, Myalgia, Pain
Clinical narrative: Flu-like symptom(s): Serious body ache, increased body temperature, muscle soreness.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Pain, Vomiting
Clinical narrative: nausea; dizziness; pain; severe headache/splitting headache; throwing up; This is a spontaneous report from a contactable nurse. A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 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. The patient experienced nausea, dizziness, pain, severe headache/ splitting headache, throwing up. She was sent to the hospital, for 24 to 48 hours treated with i.v medications. She was scared about getting her next vaccination. The events outcome was unknown.   Information on the Lot number and Batch number has been requested.; Sender's Comments: Assuming a plausible drug-events temporal association, the company cannot completely exclude a causal association between all the reported, serious events and BNT162b2 administration. The impacts 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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Computerised tomogram, Facial paralysis, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: 4/6/21 I awoke with symptoms of numbness/paralysis on left side of face limited to  upper lip and cheek area and both eyes would not stop watering. Movements to drink or make facial expressions were limited due to the numbness.  Because I have sensitive skin  I thought I may have had some type of reaction to something. So I waited to see if it would clear up through the day. I was not experiencing any other symptoms. By that evening it was apparent that I was not getting better and possibly getting worse because I began to experience some noticeable drooping in my cheek area. I decided to call my doctor in the morning. Because I am currently out of town, my home doctor suggested I see a local ER to rule out a stroke and determine if I was experiencing Bell's Palsy. I went to an ER clinic on 4/7/21
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased, Paralysis, Sensitive skin
Clinical narrative: 4/6/21 I awoke with symptoms of numbness/paralysis on left side of face limited to  upper lip and cheek area and both eyes would not stop watering. Movements to drink or make facial expressions were limited due to the numbness.  Because I have sensitive skin  I thought I may have had some type of reaction to something. So I waited to see if it would clear up through the day. I was not experiencing any other symptoms. By that evening it was apparent that I was not getting better and possibly getting worse because I began to experience some noticeable drooping in my cheek area. I decided to call my doctor in the morning. Because I am currently out of town, my home doctor suggested I see a local ER to rule out a stroke and determine if I was experiencing Bell's Palsy. I went to an ER clinic on 4/7/21
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever, body aches, headache, chills
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching throughout body.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Patient reported having mild lip swelling Patient seen by medical team and refused medical transport and signed AMA form Patient stated symptoms improved and will take benadryl at home
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Electrocardiogram, Feeling hot, Nausea
Clinical narrative: Lightheaded, slight nauseau, feeling of heat
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Started with a headache that progressively got worse. Severe fatigue. Fever and the chills.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Fever, chills, severe muscle pain...all over. Severe headache.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Severe  (LOUD) constant Tinnitus
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Severe flu like symptoms
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Hot itchy rash at injection site. Super hot to touch. Round ish rash that is purple red
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Hot itchy rash at injection site. Super hot to touch. Round ish rash that is purple red
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Eye pain, Gait disturbance, Headache
Clinical narrative: The following morning my Entire body aching, muscles and joints very weak hard to walk for hours. Intense headache and eye pain with extreme light sensitivity. Fever of 102.5 for hours. Eventually after about 8 hours my stomach began to hurt nauseous. And fever dropped to 101.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Nausea, Pain, Photophobia, Pyrexia
Clinical narrative: The following morning my Entire body aching, muscles and joints very weak hard to walk for hours. Intense headache and eye pain with extreme light sensitivity. Fever of 102.5 for hours. Eventually after about 8 hours my stomach began to hurt nauseous. And fever dropped to 101.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pain in extremity, Toothache
Clinical narrative: Very Sore Arm. Headache, Teeth ache, extreme fatigue an muscle ache.  Lasted for 2 1/2 days
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: This was my second dose of the Moderna vaccine.  I had no reactions other than a slightly sore shoulder after the first dose. After the second it was exactly the same until about 5 days after when I developed an itchy, swollen, hot, rash on my arm around the injection site.  Now on day 2 it has roughly doubled in size, and is incredibly annoying! I am using ice blocks and calamine lotion to try and reduce the itching and heat its giving off.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: This was my second dose of the Moderna vaccine.  I had no reactions other than a slightly sore shoulder after the first dose. After the second it was exactly the same until about 5 days after when I developed an itchy, swollen, hot, rash on my arm around the injection site.  Now on day 2 it has roughly doubled in size, and is incredibly annoying! I am using ice blocks and calamine lotion to try and reduce the itching and heat its giving off.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Blood pressure increased, Burning sensation, Cold sweat
Clinical narrative: 3/13/2021 began having right forearm wrist was sensitive to touch and skin clammy. 3/14/2021 still clammy in both hands. 3/15/2021 whole body clammy and sticky. Both shins and ankles had burning sensation. 3/17/2021 both ankles painful mostly at night. 3/18/2021 both ankles, shins and legs painful all day. Unable to sleep at night. 3/19/2021 left work early due to nauseated, headache and pain and burning both legs. Blood pressure elevated. 3/20/2021 head pounding and elevated rate and nauseated. Went to ER for continued leg/shins burning and pain. ABI was normal. Diagnosed with neuropathy. 3/23/2021 blood pressure elevated due to pain 3/24/2021 pain to legs and shins continue below know. pain scale 5. 3/26/2021 pain to legs and shins pain scale 7 3/27/2021 pain to legs and shins pain scale 3 3/29/2021 burning and sensitive legs. Sensitivity now present in both arms.  3/30/2021 burning to forearms and legs 4/1/2021 pain scale 3 burning pain to forearms and legs. 4/4/2021 improved pain  4/5/2021 tingling resumed to legs and calves. Pain scale 4. 4/6/2021 sensitive/burning bilateral forearm and wrist and bilateral legs. 4/7/2021 left leg burning more and feels warm. Back ache began 4/8/2021 both legs still burning and tingling. Heart rate elevated. Back pain continues.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Heart rate increased, Hyperaesthesia, Hyperhidrosis
Clinical narrative: 3/13/2021 began having right forearm wrist was sensitive to touch and skin clammy. 3/14/2021 still clammy in both hands. 3/15/2021 whole body clammy and sticky. Both shins and ankles had burning sensation. 3/17/2021 both ankles painful mostly at night. 3/18/2021 both ankles, shins and legs painful all day. Unable to sleep at night. 3/19/2021 left work early due to nauseated, headache and pain and burning both legs. Blood pressure elevated. 3/20/2021 head pounding and elevated rate and nauseated. Went to ER for continued leg/shins burning and pain. ABI was normal. Diagnosed with neuropathy. 3/23/2021 blood pressure elevated due to pain 3/24/2021 pain to legs and shins continue below know. pain scale 5. 3/26/2021 pain to legs and shins pain scale 7 3/27/2021 pain to legs and shins pain scale 3 3/29/2021 burning and sensitive legs. Sensitivity now present in both arms.  3/30/2021 burning to forearms and legs 4/1/2021 pain scale 3 burning pain to forearms and legs. 4/4/2021 improved pain  4/5/2021 tingling resumed to legs and calves. Pain scale 4. 4/6/2021 sensitive/burning bilateral forearm and wrist and bilateral legs. 4/7/2021 left leg burning more and feels warm. Back ache began 4/8/2021 both legs still burning and tingling. Heart rate elevated. Back pain continues.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability, Insomnia, Nausea, Neuropathy peripheral, Pain in extremity
Clinical narrative: 3/13/2021 began having right forearm wrist was sensitive to touch and skin clammy. 3/14/2021 still clammy in both hands. 3/15/2021 whole body clammy and sticky. Both shins and ankles had burning sensation. 3/17/2021 both ankles painful mostly at night. 3/18/2021 both ankles, shins and legs painful all day. Unable to sleep at night. 3/19/2021 left work early due to nauseated, headache and pain and burning both legs. Blood pressure elevated. 3/20/2021 head pounding and elevated rate and nauseated. Went to ER for continued leg/shins burning and pain. ABI was normal. Diagnosed with neuropathy. 3/23/2021 blood pressure elevated due to pain 3/24/2021 pain to legs and shins continue below know. pain scale 5. 3/26/2021 pain to legs and shins pain scale 7 3/27/2021 pain to legs and shins pain scale 3 3/29/2021 burning and sensitive legs. Sensitivity now present in both arms.  3/30/2021 burning to forearms and legs 4/1/2021 pain scale 3 burning pain to forearms and legs. 4/4/2021 improved pain  4/5/2021 tingling resumed to legs and calves. Pain scale 4. 4/6/2021 sensitive/burning bilateral forearm and wrist and bilateral legs. 4/7/2021 left leg burning more and feels warm. Back ache began 4/8/2021 both legs still burning and tingling. Heart rate elevated. Back pain continues.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Sticky skin
Clinical narrative: 3/13/2021 began having right forearm wrist was sensitive to touch and skin clammy. 3/14/2021 still clammy in both hands. 3/15/2021 whole body clammy and sticky. Both shins and ankles had burning sensation. 3/17/2021 both ankles painful mostly at night. 3/18/2021 both ankles, shins and legs painful all day. Unable to sleep at night. 3/19/2021 left work early due to nauseated, headache and pain and burning both legs. Blood pressure elevated. 3/20/2021 head pounding and elevated rate and nauseated. Went to ER for continued leg/shins burning and pain. ABI was normal. Diagnosed with neuropathy. 3/23/2021 blood pressure elevated due to pain 3/24/2021 pain to legs and shins continue below know. pain scale 5. 3/26/2021 pain to legs and shins pain scale 7 3/27/2021 pain to legs and shins pain scale 3 3/29/2021 burning and sensitive legs. Sensitivity now present in both arms.  3/30/2021 burning to forearms and legs 4/1/2021 pain scale 3 burning pain to forearms and legs. 4/4/2021 improved pain  4/5/2021 tingling resumed to legs and calves. Pain scale 4. 4/6/2021 sensitive/burning bilateral forearm and wrist and bilateral legs. 4/7/2021 left leg burning more and feels warm. Back ache began 4/8/2021 both legs still burning and tingling. Heart rate elevated. Back pain continues.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Urticaria, Wheezing
Clinical narrative: hives, wheezing, hx of compromised lungs. Benadryl and EpiPen administered. Hives on left and right side of neck and anterior chest
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Choking sensation, Muscle tightness
Clinical narrative: hives, wheezing, hx of compromised lungs. Benadryl and EpiPen administered. Hives on left and right side of neck and anterior chest
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: I developed a rash on my arm exactly one week after vaccination. It was a big red spot around the site of the shot. Started out the size of a quarter. It was hot to the touch and very red and swollen and grew the next day. I went to the doctor and they took measurements and pictures. It went away in about two days. I found out I was pregnant at that time.  Due Date 9/25/2021 First Pregnancy
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Facial paralysis, Paraesthesia
Clinical narrative: face feels very heavy/Nose and cheeks being squeezed tightly/hard to move muscles in face; tingling; feel pressure like being squeezed from outside in and inside out; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, in left arm, on 24Mar2021 12:45 (at the age of 37-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history included polycystic ovarian syndrome (PCOS), and patient was a new mother (baby was almost 2 months old). Patient had no known allergies. No COVID prior vaccination, and no COVID tested post vaccination. Concomitant medication included daily vitamin. On 24Mar2021 13:00 (also reported as 30 min after vaccine), patient's face started to feel pressure like being squeezed from outside in and inside out. It got worse following hour. Patient had no issues breathing yet (2 hours post vaccine) but face felt very heavy. Sometimes patient had tingling, nose and cheeks being squeezed tightly, and it was hard to move muscles in face. Otherwise patient felt ok. No treatment received for events. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Feeling cold, Headache, Hypoaesthesia
Clinical narrative: Client received the 1st dose of Moderna COVID vaccine lot # 041B21A, expiration date 5/6/21 at 12PM. At 12:03PM, EMTs  received a report from client that she was feeling dizzy, mild headache and a little shaky.  Vitals were taken-blood pressure:140/90, pulse:91 and oxygen 99%.  PHN came to find client sitting upright in chair, alert and oriented x4, able to provide medical history of hypertension. Client reports she has never had any reactions to any vaccine. Client medication is Telmisartan and client reports taking her medication this morning and that her blood pressure is usually 120/80 when taking medication. Client reports to PHN that she is feeling more dizzy, PHN and EMTs transfer client to gravity chair. Offer client water and offer to call 9-1-1, patient declines and calls husband.  At 12:09pm  client reports feeling cold and shakiness is worse. Cover client with disposable blanket. Another nurse joined to assist. At 12:11PM vitals were taken oxygen 98%, blood pressure: 146/78 and pulse: 85. At 12:16PM client drank half a bottle of water and reports dizziness improving and no shortness of breath.  PHN educate client about speaking to provider about reaction and discussion about next dose. Client also reports headache is better and able to have a conversation. At 12:17PM retake vitals blood pressure: 158/100, oxygen:96%, and pulse:83. client reports headache is worse, no chest pain, no blurred vision, no dizziness reported. At 12:23PM vitals taken-blood pressure 160/84, oxygen 98% and pulse 71. Client alert and oriented x 4 and still feeling cold. Client reports feeling chest pain and dizziness, PHN called 911 at 12:26PM.  At 12:29PM client reports feeling numbness in both of her legs-pulse, motor, sensation intact in both legs, alert and oriented x 4, client reports no shortness of breath.  Fire Department arrived at 12:30PM and assumed care. Client's husband arrived shortly after.  Client left facility via stretcher with paramedics at approximately 12:43PM. At 12:59PM security notified PHN that client declined transport via ambulance.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Nervousness
Clinical narrative: Client received the 1st dose of Moderna COVID vaccine lot # 041B21A, expiration date 5/6/21 at 12PM. At 12:03PM, EMTs  received a report from client that she was feeling dizzy, mild headache and a little shaky.  Vitals were taken-blood pressure:140/90, pulse:91 and oxygen 99%.  PHN came to find client sitting upright in chair, alert and oriented x4, able to provide medical history of hypertension. Client reports she has never had any reactions to any vaccine. Client medication is Telmisartan and client reports taking her medication this morning and that her blood pressure is usually 120/80 when taking medication. Client reports to PHN that she is feeling more dizzy, PHN and EMTs transfer client to gravity chair. Offer client water and offer to call 9-1-1, patient declines and calls husband.  At 12:09pm  client reports feeling cold and shakiness is worse. Cover client with disposable blanket. Another nurse joined to assist. At 12:11PM vitals were taken oxygen 98%, blood pressure: 146/78 and pulse: 85. At 12:16PM client drank half a bottle of water and reports dizziness improving and no shortness of breath.  PHN educate client about speaking to provider about reaction and discussion about next dose. Client also reports headache is better and able to have a conversation. At 12:17PM retake vitals blood pressure: 158/100, oxygen:96%, and pulse:83. client reports headache is worse, no chest pain, no blurred vision, no dizziness reported. At 12:23PM vitals taken-blood pressure 160/84, oxygen 98% and pulse 71. Client alert and oriented x 4 and still feeling cold. Client reports feeling chest pain and dizziness, PHN called 911 at 12:26PM.  At 12:29PM client reports feeling numbness in both of her legs-pulse, motor, sensation intact in both legs, alert and oriented x 4, client reports no shortness of breath.  Fire Department arrived at 12:30PM and assumed care. Client's husband arrived shortly after.  Client left facility via stretcher with paramedics at approximately 12:43PM. At 12:59PM security notified PHN that client declined transport via ambulance.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Erythema, Feeling abnormal, Swelling face
Clinical narrative: I had an allergic reaction (anaphylactic) after both shots, Doses 1: I had taken Claritin the night before, I received the vaccine at 4:00 PM and I had red, hot and inflammation on my face 11 min before the shot, they let me in observation for 30 min. Doses 2: it was at 9:15 Am, I had taken Claritin the night before and 1 Benadryl 30 min before shot, I took another Benadryl just before vaccination and had allergic reaction (mild red, hot, and inflammation on my face) just few seconds after second shot, they let me in observation for 30 min. 3 hours after second shot, I had again allergic reaction: red, hot, and inflammation on my face, I took 2 Benadryl.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Loss of consciousness, Malaise, Speech disorder
Clinical narrative: 20 minutes after receiving vaccine patient walked up to pick up counter to tell someone she did not feel well- sweating and headache.  Patient could not speak and passed out.  EMS was called and responded.  Vitals checked out ok. Patient was not transported.  Patient's  mom was called and came to pharmacy. Patient rode home with mom.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Hyperhidrosis, Pallor
Clinical narrative: At 1314 client receive his first shot of moderna vaccine. At 1319 client complained of feeling fainting, hot and sweeting. Noted client to be pale and diaphoretic. 1320 BP 60/? HR 46, 02 sat 92% on RA, RR 18, sitting, still diaphoretic. 1324 BP 90/? HR 55, 02 sat 95% on RA lying down. 1329, BP 120/80, HR 55, 02 sat 97% on RA. 1331 HR 60 lying down. 1334 BP 118/88,HR 60, 02 sat 97%on RA lying down. 1335, HR 64, 02 sat 97% on RA. at this time client said he has not eaten all day, worked last night, smooks cigarete and has the same reaction with blood draws. 1339 BP 130/70, HR 62. Client verbalized feeling good and that all symtompts has resolved. No further treatment is needed as standing BP aws 138/70 with no dizziness at this time. Total treatment time was 30min. Client left at 1349. Wife will be driving client home.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Symptoms developed over 2 days then subsided. On day 5 after the second shot symptoms returned and were worse.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient given second Covid-19 Pfizer dose 14 days after the first dose