chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Eye swelling, Headache, Nausea
Clinical narrative: I was fine immediately after the vaccine.  At around 9:00 pm on the night of December 23rd I noted that my eyes started to swell.  I had no difficulty  breathing, shortness of breath, closing of the throat at this time.  My husband and I decided to just take a Benadryl 25 mg by mouth and keep the Epipen close by.   I went to bed.  At around 2:30 am on December 24th  I woke up to excruciating pain but with the urge to urinate.   However, I was in so much pain at the time I did not want to get up so I tried to go back to sleep.  At 4:30 am on December 24h in the morning, I decided I needed to get up to go to the bathroom.  I went to ambulate and instantly felt weak in my knees and extremely dizzy.  I made it my bathroom and looked in the mirrors- my face was extremely pale like a sheet of paper white, I was really nauseous, dizzy, felt the urge to have a bowel movement.  I walked to the bathroom.  I was able to void at that time, but the nausea did not go away.  I crawled to my bed and laid back down.  I then still felt intensely nauseous to the point that I was going to pass out and the room was spinning.  I made it back to the bathroom where I threw bile up in the bathroom.  I still had the urge for a bowel movement but was unable to go ( I imagine I was having a vasovagal response).  I went back to my bed and laid down.  I stayed in bed until my husband came down around 8:30.  He told me to drink some fluids and take another benadryl  with some tylenol.  I did both.  I went back to sleep and I woke up about 2.5 hours later.  I was able to go out of the house to get a few things for Christmas, but then about 6 pm went and laid down for bed for the night.  I took another benadryl and more tylenol.   On 12/25/2020 I woke up and was able to do a few things thanks to tylenol and benadryl.  My eyes were still swollen and now my hands and feet were noticeably swollen. I continued with benadryl, tylenol and started taking pepcid 10 mg PO.  By Saturday 12/26/2020, I was able to be more mobile- I was able to walk the dog and clean my car.  However, I still went to bed rather early.  I took another benadryl and tylenol as I still felt swollen and puffy all over.  Up until Monday 12/28/2020 I had a constant headache and felt nausesous with some swelling.  I have not went to a physician to be seen. I have talked to several physicians, as I am an RN and my husband is an ER physcian.  Yesterday 12/29/2020 was the first time I felt normal since the vaccine.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pallor, Peripheral swelling, Vomiting
Clinical narrative: I was fine immediately after the vaccine.  At around 9:00 pm on the night of December 23rd I noted that my eyes started to swell.  I had no difficulty  breathing, shortness of breath, closing of the throat at this time.  My husband and I decided to just take a Benadryl 25 mg by mouth and keep the Epipen close by.   I went to bed.  At around 2:30 am on December 24th  I woke up to excruciating pain but with the urge to urinate.   However, I was in so much pain at the time I did not want to get up so I tried to go back to sleep.  At 4:30 am on December 24h in the morning, I decided I needed to get up to go to the bathroom.  I went to ambulate and instantly felt weak in my knees and extremely dizzy.  I made it my bathroom and looked in the mirrors- my face was extremely pale like a sheet of paper white, I was really nauseous, dizzy, felt the urge to have a bowel movement.  I walked to the bathroom.  I was able to void at that time, but the nausea did not go away.  I crawled to my bed and laid back down.  I then still felt intensely nauseous to the point that I was going to pass out and the room was spinning.  I made it back to the bathroom where I threw bile up in the bathroom.  I still had the urge for a bowel movement but was unable to go ( I imagine I was having a vasovagal response).  I went back to my bed and laid down.  I stayed in bed until my husband came down around 8:30.  He told me to drink some fluids and take another benadryl  with some tylenol.  I did both.  I went back to sleep and I woke up about 2.5 hours later.  I was able to go out of the house to get a few things for Christmas, but then about 6 pm went and laid down for bed for the night.  I took another benadryl and more tylenol.   On 12/25/2020 I woke up and was able to do a few things thanks to tylenol and benadryl.  My eyes were still swollen and now my hands and feet were noticeably swollen. I continued with benadryl, tylenol and started taking pepcid 10 mg PO.  By Saturday 12/26/2020, I was able to be more mobile- I was able to walk the dog and clean my car.  However, I still went to bed rather early.  I took another benadryl and tylenol as I still felt swollen and puffy all over.  Up until Monday 12/28/2020 I had a constant headache and felt nausesous with some swelling.  I have not went to a physician to be seen. I have talked to several physicians, as I am an RN and my husband is an ER physcian.  Yesterday 12/29/2020 was the first time I felt normal since the vaccine.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Full body hives; This is a spontaneous report from a contactable healthcare professional. A 29-year-old female patient received bnt162b2 (BNT162B2; lot number: EH9899; expiration date: unknown), via an unspecified route of administration on 18Dec2020 08:15 at single dose (on the left arm) for COVID-19 immunization. The patient had no medical history and concomitant medications. The patient has no known allergies. The patient was no pregnant at the time of vaccination. The patient had no other medications the patient received within 2 weeks of vaccination. The patient experienced full body hives on 23Dec2020 06:45 AM. The patient received treatment of Benadryl. The patient also did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not yet been tested for COVID-19 since the vaccination. The outcome of the event was recovering.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Headache, Nausea, Pain
Clinical narrative: About 1am after the vaccine i got a severe headache that lasted about 4 days, my body was super weak and hurting all over. I was nauseated and diarrhea began after about day 3  which lasted about 2 days.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: About 1am after the vaccine i got a severe headache that lasted about 4 days, my body was super weak and hurting all over. I was nauseated and diarrhea began after about day 3  which lasted about 2 days.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Fever 100.2; chills; headache; swollen lymph neck; muscle and joint ache; muscle and joint ache; Tiredness; injection site pain; This is a spontaneous report from a contactable other health professional (patient). A 42-year-old male patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 19Dec2020 at 14:30 at single dose in right arm for covid-19 immunization. Medical history included high blood pressure. Concomitant medication included acetylsalicylic acid (ASPIRIN), amlodipine, benazepril, and multi-vitamin. The patient previously took erythromycin and experienced drug allergy. The patient experienced fever 100.2, chills, headache, swollen lymph neck, muscle and joint ache, tiredness, and injection site pain; all on 20Dec2020 at 14:30. All events were reported as non-serious. The patient didn't receive treatment for  all the events. The outcome of all events was resolved in Dec2020.   Information on the lot/batch number has been requested.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: Fever 100.2; chills; headache; swollen lymph neck; muscle and joint ache; muscle and joint ache; Tiredness; injection site pain; This is a spontaneous report from a contactable other health professional (patient). A 42-year-old male patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 19Dec2020 at 14:30 at single dose in right arm for covid-19 immunization. Medical history included high blood pressure. Concomitant medication included acetylsalicylic acid (ASPIRIN), amlodipine, benazepril, and multi-vitamin. The patient previously took erythromycin and experienced drug allergy. The patient experienced fever 100.2, chills, headache, swollen lymph neck, muscle and joint ache, tiredness, and injection site pain; all on 20Dec2020 at 14:30. All events were reported as non-serious. The patient didn't receive treatment for  all the events. The outcome of all events was resolved in Dec2020.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Pain
Clinical narrative: light-headedness for about an hour after the injection; woke in the middle of the night with body aches; This is a spontaneous report from a non-contactable other health professional. An adult patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot:EM9899) on an unspecified date at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced light-headedness for about an hour after the injection on an unspecified date. It was also reported that the patient woke in the middle of the night with body aches on an unspecified date. The patient was treated with ibuprofen (ADVIL) for the events reported. Outcome of events recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site pruritus, Limb discomfort, Myalgia, Peripheral swelling
Clinical narrative: ARM WAS SORE FROM TIME OF SHOT UNTIL 12/25/20 AM. ON 12/29/20 AT 11 PM EMPLOYEE NOTED ITCHING TO INJECTION SITE. ARM WAS ALSO SWOLLEN AND RED. THIS HAS PROGRESSED TO MUSCCLE PAIN TO ENTIRE RIGHT ARM. EMPLOYEE CALLED PCP WHO OFFEREN NO ADVICE. EMPLOYEE THEN CALL INFECTION PREVENTION NURSE AT HER EIMPLOYMENT (MEDICAL CENTER). IP CONSULTED WITH PHARMACIST WHO ADVISED EMPLOYEE TAKE BENADRYL. IP REVIEW SIGNS TO WATCH FOR-ANAPHYLAXIS AND INFECTION. WAS ADVISED TO COME TO THE ED IF SYMPTOMS WORSEN.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blepharospasm, Fatigue, Lymphadenopathy, Pain in extremity, Pyrexia
Clinical narrative: Blepharospasm of left eye about 5 min after lasted about 1 min; Sore arm; Tired; felt feverish; Swollen left supraclavicular lymph node; This is a spontaneous report from a contactable physician (patient). A 44-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/lot no: Ek9231), via an unspecified route of administration on 23Dec2020 at 16:30 at single dose in left arm for covid-19 immunization. Medical history included migraine from an unknown date.  Concomitant medication included sumatriptan, colecalciferol (VIT D3). The patient previously took cephalosporin and experienced allergies. The patient experienced blepharospasm of left eye about 5 min after lasted about 1 min, sore arm, tired, felt feverish, and swollen left supraclavicular lymph node; all on 24Dec2020 at 10:00. All events were reported as non-serious. The patient didn't receive treatment for all the events. The outcome of all events was not resolved.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Pain
Clinical narrative: Blepharospasm of left eye about 5 min after lasted about 1 min; Sore arm; Tired; felt feverish; Swollen left supraclavicular lymph node; This is a spontaneous report from a contactable physician (patient). A 44-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/lot no: Ek9231), via an unspecified route of administration on 23Dec2020 at 16:30 at single dose in left arm for covid-19 immunization. Medical history included migraine from an unknown date.  Concomitant medication included sumatriptan, colecalciferol (VIT D3). The patient previously took cephalosporin and experienced allergies. The patient experienced blepharospasm of left eye about 5 min after lasted about 1 min, sore arm, tired, felt feverish, and swollen left supraclavicular lymph node; all on 24Dec2020 at 10:00. All events were reported as non-serious. The patient didn't receive treatment for all the events. The outcome of all events was not resolved.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blepharospasm, Fatigue, Lymphadenopathy, Pain in extremity, Pyrexia
Clinical narrative: Left supraclavicular lymphadenopathy and general fullness to supraclavicular area.   This was initially noticed Dec 25 and worsened but is now stable. It?s not yet resolving.  The area is mildly achy but there is no tenderness.  I?m a physician. I didn?t seek care yet. If it lasts longer than ~10 days I will.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Pain
Clinical narrative: Left supraclavicular lymphadenopathy and general fullness to supraclavicular area.   This was initially noticed Dec 25 and worsened but is now stable. It?s not yet resolving.  The area is mildly achy but there is no tenderness.  I?m a physician. I didn?t seek care yet. If it lasts longer than ~10 days I will.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Little soreness in her arm; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received bnt162b2 (lot number and expiry date were unknown), via an unspecified route of administration on unspecified date in Dec2020 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter got the COVID vaccine yesterday, maybe, caller is not exactly sure, now states she thinks it was Tuesday or Wednesday, but caller is not sure. She has a little soreness in her arm on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymph node pain, Lymphadenopathy, Lymphoedema
Clinical narrative: Swollen, tender lymph node; Swollen, tender lymph node; Arm soreness; Fatigue\tiredness; Brief headache; This is a spontaneous report from a contactable consumer (patient herself).  This 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK5730), via an unspecified route of administration, at single dose on 18Dec2020 at 09:15 AM for COVID-19 immunisation. Vaccine location was deltoid left. The patient was vaccinated at hospital, age at vaccination 66-year-old. The patient did not have a relevant medical history. Relevant concomitant medications included hypertensive medications and hypothyroid medications. The patient is a therapist that works in the hospital. She stated she has not been overly exposed to Covid. On 18Dec2020, after receiving vaccination, the patient complained of fatigue and brief headache. On 19Dec2020, she felt arm soreness. On 21Dec2020, she noticed swollen lymph node in her neck right by the clavicle, she stated it was tender that there was a couple of teaspoons of fluid surrounding it in that area. She stated it was on the side of the body where she received the vaccination, left deltoid. The patient had recovered from 'fatigue/tiredness' on 19Dec2020, from 'brief headache' on 18Dec2020 and from 'arm soreness' on unknown date in Dec2020. The patient had not recovered from the event 'swollen, tender lymph node'.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020513276 Same reporter, drug and event; different patients
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Swollen, tender lymph node; Swollen, tender lymph node; Arm soreness; Fatigue\tiredness; Brief headache; This is a spontaneous report from a contactable consumer (patient herself).  This 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK5730), via an unspecified route of administration, at single dose on 18Dec2020 at 09:15 AM for COVID-19 immunisation. Vaccine location was deltoid left. The patient was vaccinated at hospital, age at vaccination 66-year-old. The patient did not have a relevant medical history. Relevant concomitant medications included hypertensive medications and hypothyroid medications. The patient is a therapist that works in the hospital. She stated she has not been overly exposed to Covid. On 18Dec2020, after receiving vaccination, the patient complained of fatigue and brief headache. On 19Dec2020, she felt arm soreness. On 21Dec2020, she noticed swollen lymph node in her neck right by the clavicle, she stated it was tender that there was a couple of teaspoons of fluid surrounding it in that area. She stated it was on the side of the body where she received the vaccination, left deltoid. The patient had recovered from 'fatigue/tiredness' on 19Dec2020, from 'brief headache' on 18Dec2020 and from 'arm soreness' on unknown date in Dec2020. The patient had not recovered from the event 'swollen, tender lymph node'.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020513276 Same reporter, drug and event; different patients
Age: 35.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Feeling hot, Lip swelling, Swelling face, Swollen tongue
Clinical narrative: Almost immediately felt a rush of heat.  Cooled down and felt okay. Within 30 minutes, became tachycardic and short of breath.  Was unable to complete a full sentence.  Facial, lip and tongue swelling noted.  Rapid Response was called.  IV Solumedrol, IV Pepcid, Iv Benadryl and IV Normal Saline bolus given with positive results.  *Patient states previous sensitivity to IV Reglan.*
Age: 35.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Tachycardia
Clinical narrative: Almost immediately felt a rush of heat.  Cooled down and felt okay. Within 30 minutes, became tachycardic and short of breath.  Was unable to complete a full sentence.  Facial, lip and tongue swelling noted.  Rapid Response was called.  IV Solumedrol, IV Pepcid, Iv Benadryl and IV Normal Saline bolus given with positive results.  *Patient states previous sensitivity to IV Reglan.*
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Intranasal hypoaesthesia, Nasal congestion, Nasopharyngitis
Clinical narrative: Diarrhea; Numbness in the nose; Cold; his nose is kind of plugged/ clogged but there was nothing; This is a spontaneous report from a contactable consumer (patient himself). A 36-year-old male patient received his first dose of bnt162b2 (BNT162B2 also reported as Covid 19 Vaccine. Lot EL0140), via an unspecified route of administration in the right arm (reported as right shoulder) on 22Dec2020 at single dose for Covid-19 immunisation. Medical history was none.  There were no concomitant medications.  The patient experienced diarrhea on 22Dec2020. He informed that it appeared 2-3 minutes right after receiving the vaccine, however he though that it couldn't be from the vaccine, he does not think it would go through him that quickly. He seemed it was coincidental to him, he had the diarrhea even before leaving the observation. He also had numbness in the nose as well, it started on the same day. He clarified it was not really numbness but he can feel it almost. The cold also started after the vaccine, its like his nose is kind of plugged/ clogged but there was nothing. The outcome of event Diarrhea, cold was recovered on 22Dec2020; for Numbness in the nose was not recovered; for his nose is kind of plugged/ clogged but there was nothing was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Instillation site pain, Myalgia, Pyrexia
Clinical narrative: Chills; Low grade fever of a 100; Tenderness at the site; Muscle pain; This is a spontaneous report from a contactable nurse (patient).  A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date unknown), via an unspecified route of administration on the right deltoid on 23Dec2020 11:30 at a single dose for COVID-19 vaccination. Medical history included borderline diabetes.  Concomitant medication included meloxicam. The patient experienced chills, low grade fever of a 100, ache at the injection site, tenderness at the site, muscle pain on 23Dec2020 14:00. Outcome of the events was unknown. Patient took TYLENOL for as treatment for the events.  Information about lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: Pain in right shoulder joint.  Difficulty with range of motion and limited range of motion with right shoulder due to pain.  Applying ice, heat and taking advil around the clock. Scheduling appointment to have it evaluated.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: feeling sore arm/arm soreness; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the 2nd of 2 reports.   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in arm, on an unspecified date, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced feeling sore arm/arm soreness the same day he got the shot on an unspecified date. The outcome of the event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020513266 Same reporter, drug and event; different patients
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Pain at the injection site roughly 14 hours later; This is a spontaneous report from a contactable healthcare professional. A 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Dec2020 16:45 in left arm at single dose for COVID-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. On 22Dec2020 06:00, the patient experienced pain at the injection site roughly 14 hours later from vaccination. No treatment was given to the patient for the event. The patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and has not received other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The facility where the most recent COVID-19 vaccine was administered was in the workplace clinic. The outcome of event was recovered on unspecified date. The event was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.  Information on the lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Headache, Heart rate irregular
Clinical narrative: Within minutes, developed palpitations, got extremely dizzy and light headed, nauseated. Pulse was found to be irregular.  Within few hours developed fever, chills, headache, muscle aches.   Today is day 2, still having chills, headache, weakness, muscle pain and palpitations still ongoing. Light headed on sitting up  Right arm extremely sore,   Taking tylenol and motrin (1g and 800 q8hr)
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain in extremity, Palpitations, Pyrexia
Clinical narrative: Within minutes, developed palpitations, got extremely dizzy and light headed, nauseated. Pulse was found to be irregular.  Within few hours developed fever, chills, headache, muscle aches.   Today is day 2, still having chills, headache, weakness, muscle pain and palpitations still ongoing. Light headed on sitting up  Right arm extremely sore,   Taking tylenol and motrin (1g and 800 q8hr)
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Cold sore; This is a spontaneous report from a contactable healthcare professional. A 38-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot, expiry unspecified), via an unspecified route of administration on 22Dec2020 at single dose (at left arm) for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 25Dec2020, the patient experienced cold sore. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no therapy was received for the event. The patient was not diagnosed with Covid-19 prior to vaccination and since the vaccination, the patent had not been tested for Covid-19. Outcome of event was recovering.  Information about Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration in 22Dec2020 at a single dose as COVID vaccine. The patient's medical history and concomitant medications were not reported. Patient had the COVID vaccine on evening, 22Dec2020, and around 5:45am, morning of 24Dec2020, patient started having some diarrhea. Patient was wondering if that was a known side effect of the product. The outcome of the event diarrhea was unknown.   Information on the lot/batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis acneiform, Eyelid rash, Rash, Rash pustular
Clinical narrative: I started to develop like little pimples; I have rash down the back of neck, along the bridge of my nose, eyebrows and eyelids, on my chin, around my mouth and down my chest; more of pustule but like a rash; allergies; This is a spontaneous report from a contactable consume.  A 31-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EH9899) the first dose on 22Dec2020 at single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications.  Patient reported for primary/prescribing healthcare professional details included that actually did it through her county, her county health department so it wasn't specifically a doctor. She was priorities due to her job duty. She was a social worker. Due to the environment where she worked, she had high risk of exposure. She believed that 20Jan2021 was the second dose. Patient received the COVID 19 vaccine on 22December2020 early in the morning around 9 AM and around 6 hours later she started to develop like little pimples which she thought were associated with wearing a mask an N95 however it progressively the rash progressively got worse and now she had rash down the back of neck, along the bridge of her nose, eyebrows and eyelids, on her chin, around her mouth and nose and down her chest. What she saw was were worse pimple that was actually it was more of pustule but like a rash. Patient did try topical for allergies, Cortisol cream and it did not help and she just spoke to a doctor telephonically. She was going to take oral Benadryl but she recommended that should first contact or see a medical Professional in person to them to asses so just the topical. Outcome of events was not resolved.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Pyrexia
Clinical narrative: Chills, fever, and pain under left axilla.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose decreased
Clinical narrative: her blood sugar is going below to 90; This is a spontaneous report from a contactable consumer. A female patient received BNT162B2 on unknown date (reported as Tuesday) single dose for COVID-19 immunization.  Medical history was not provided. Concomitant drug included ongoing insulin pump. The patient reported her blood sugar was going below to 90. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Limb discomfort, Nausea
Clinical narrative: Headache Chills Nausea Arm soreness
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: muscle soreness at the injection site; This is a spontaneous report from a contactable physician reported for self. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose in Dec2020 for COVID-19 immunization. Medical history and concomitant medication were not reported. She reported muscle soreness at the injection site after use of product in Dec2020. The outcome of event was unknown.   Information about lot/batch number are requested.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: was exposed to COVID; This is a spontaneous report from a contactable consumer reporting for herself. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the Pfizer vaccination COVID on the 23Dec2020 at work in the hospital. On the 25Dec2020, Christmas day, she was exposed to COVID by her niece and her niece's husband who hosted the party. They tested positive for COVID on 26Dec2020. Her niece's husband was completely asymptomatic. The consumer asked how soon after receiving the vaccination she started building up the immunity. She realized it was a two dose series, but did she have immunities building up after the first dose? The event outcome was unknown.  Information on the lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Headache, Seizure
Clinical narrative: Patient received the Pfizer-BioNTech vaccine at around 1:30pm on 12/29/20. After about 15 minutes, she complaints of headache, lightheadedness, weakness, shivering , shaking. and want to lie down. she was taken into a room where she lay down and then had seizures which lasted about 20 seconds.   After she was stabilized and received supplemental oxygen, she was transfered to the ER by the EMT at approximately around 2:05pm
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Patient received the Pfizer-BioNTech vaccine at around 1:30pm on 12/29/20. After about 15 minutes, she complaints of headache, lightheadedness, weakness, shivering , shaking. and want to lie down. she was taken into a room where she lay down and then had seizures which lasted about 20 seconds.   After she was stabilized and received supplemental oxygen, she was transfered to the ER by the EMT at approximately around 2:05pm
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID; positive for COVID; positive for COVID/asymptomatic; This is a spontaneous report from a contactable nurse reporting for herself.   A female patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2) at single dose on 18Dec2020 for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported.   She was tested positive for COVID, through the rapid COVID test on 27Dec2020. She stated being asymptomatic and being scheduled for her 2nd dose on 08Jan2021. She asked can she still receive the 2nd dose of the vaccine or should she repeat the vaccination series. The outcome of event was unknown.    Information on the Lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with suspected vaccine in this patient cannot be completely excluded.  Further information like confirmative COVID 19 Nucleic acid/ PCR test are needed for full medical assessment.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Syncope
Clinical narrative: Vasovagal syncope while sitting upright in chair.  Leaned back, legs raised, cool cloth to neck/face.  Regained consciousness within ~15 seconds.  No injury, no sequelae.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Pain, Pain in extremity, Pyrexia
Clinical narrative: mild sore arm for about 2-3 days; feeling a little more achy; had a low grade fever of 100; a bit of a headache; I don't feel very ill just a little under the weather; This is a spontaneous report from a contactable nurse, who is also the patient.  This female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. In Dec2020, the patient experienced mild sore arm for about 2-3 days and about a week out she started feeling a little more achy and she had a low grade fever of 100 and a bit of a headache but she didn't feel very ill just a little under the weather. The outcome of the events was unknown.  The information on the lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Oropharyngeal pain
Clinical narrative: Sore throat and pain at sight
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain
Clinical narrative: I have got ache/I have body ache so bad; I am not feeling right; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot, expiry unspecified), via an unspecified route of administration on Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. In Dec2020, the patient experienced ache and have body ache so bad and was not feeling right after getting Covid-19 shot yesterday (as reported). The patient was asking if they can take a regular pain reliever like Tylenol or Advil to help to ease the pain. There was no lot and expiration date information since it was in the patient's bag right now and will check on this. Outcome of the events was unknown.  Lot/Batch and Expiration date has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: Nausea, Diarrhea; Nausea, Diarrhea; This is a spontaneous report from a non-contactable Nurse (patient).  A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot ek5730) intramuscular in left arm on 21Dec2020 at 16:00 at single dose for COVID-19 immunisation.  The patient medical and concomitant medications were not reported.  On 22Dec2020 the patient experienced nausea and diarrhea (non-serious).Patient was treated with loperamide hydrochloride (IMODIUM). Outcome of the events was recovered in Dec2020. No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram normal, Dysphagia, Enlarged uvula, Oropharyngeal pain, Petechiae
Clinical narrative: Woke up with at 3:30am with extremely sore throat, swollen uvula, could not swallow, multiple scattered petechiae on soft and hard palate. Afraid of angioedema or delayed acute anaphylaxis. Paramedics called. Treated at Facility with IV dexamethasone,  diphenhydramine, Pepcid. Swelling resolved in 2 hours. Petechiae still present.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: nausea, dizziness, and headache; nausea, dizziness, and headache; nausea, dizziness, and headache; This is a spontaneous report from a contactable consumer (patient). This 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced nausea, dizziness, and headache. Clinical outcome of the events was unknown at time of this report.   Information on the Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Oral herpes
Clinical narrative: I have a cold sore; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program Pfizer First Connect.  A female consumer of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in Dec2020 at single dose for COVID-19 immunisation. Medical history included cold sores (treated with VALTREX). Past drug history included VALTREX for cold sores. The consumer inquired regarding medication to take over because she took the vaccine. So, the consumer was calling because she had the Covid vaccine on Wednesday (as reported) and developed cold sores and she said she normally took VALTREX and she wanted to know if it was still safe to take VALTREX after receiving the vaccine (she wanted to make sure it was not going to compromise the efficacy of the vaccine). The outcome of the event was unknown. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in arm; This is a spontaneous report from a contactable consumer (patient's cousin). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in Dec2020 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The patient previously took aspirin and was allergic to it. The consumer stated that the patient was administered the new COVID19 Vaccine a few days prior to the report and she experienced pain in arm in Dec2020 that lasted for 2 days. The outcome of the event was recovered in Dec2020.  Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Left arm in pain, cannot lift arm. Burning up with fever, 102.1. Took 2 Tylenol fever went away.  Arm is tender to touch.  Very painful arm.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Taste disorder
Clinical narrative: metallic taste; This is a spontaneous report from a contactable physician (patient). A 41-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Dec2020 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced metallic taste on 19Dec2020. It was reported as "He got the Covid-19 vaccine 10 days ago (19Dec2020) and now he's experiencing altered taste specifically, metallic taste for 10 days now". Outcome of event was not recovered.    Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: pain in her arm (injection site); This is a spontaneous report from a contactable consumer received via Medical Information Team.  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced pain in her arm (injection site) on an unspecified date. The patient outcome of the event was unknown.    Information on Lot/Batch has been requested.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate decreased, Heart rate increased, Hyperhidrosis, Oxygen saturation decreased, Pallor
Clinical narrative: Resident started shaking approximately 7 minutes after the vaccine was given, diaphoretic, pale, HR 134, unable to obtain BP, O2 sat 95% on RA, good breath sounds, then she started to audibly wheeze approx 20 seconds, then no breath present, Pharmacist gave first dose of Epi in left thigh. Resident had a HR of 41 and O2 dropping in the low 80s high 70s. She remained there for approx 3-4 minutes then took a deep breath and O2 up to 90's. She was placed on oxygen and monitored closed for the enxt 4 hours
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor, Wheezing
Clinical narrative: Resident started shaking approximately 7 minutes after the vaccine was given, diaphoretic, pale, HR 134, unable to obtain BP, O2 sat 95% on RA, good breath sounds, then she started to audibly wheeze approx 20 seconds, then no breath present, Pharmacist gave first dose of Epi in left thigh. Resident had a HR of 41 and O2 dropping in the low 80s high 70s. She remained there for approx 3-4 minutes then took a deep breath and O2 up to 90's. She was placed on oxygen and monitored closed for the enxt 4 hours
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Hyperhidrosis, Oxygen saturation decreased, Posture abnormal, Tremor
Clinical narrative: Resident started shaking approximately 7 minutes after the vaccine was given, diaphoretic, pale, HR 134, unable to obtain BP, O2 sat 95% on RA, good breath sounds, then she started to audibly wheeze approx 20 seconds, then no breath present, Pharmacist gave first dose of Epi in left thigh. Resident had a HR of 41 and O2 dropping in the low 80s high 70s. She remained there for approx 3-4 minutes then took a deep breath and O2 up to 90's. She was placed on oxygen and monitored closed for the enxt 4 hours
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Wheezing
Clinical narrative: Resident started shaking approximately 7 minutes after the vaccine was given, diaphoretic, pale, HR 134, unable to obtain BP, O2 sat 95% on RA, good breath sounds, then she started to audibly wheeze approx 20 seconds, then no breath present, Pharmacist gave first dose of Epi in left thigh. Resident had a HR of 41 and O2 dropping in the low 80s high 70s. She remained there for approx 3-4 minutes then took a deep breath and O2 up to 90's. She was placed on oxygen and monitored closed for the enxt 4 hours
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate decreased, Heart rate increased, Hyperhidrosis, Oxygen saturation decreased, Pallor
Clinical narrative: Anaphylaxis.  The patient started shaking and sweating and wheezing  5 to 15 minutes after receiving the vaccine, HR 104, BP normal, O2sat was 95%. After 1 minute she O2sat started dropping and she slid down the chair. EpiPen 0.3mg was given. O2sat kept dropping after the Epipen shot to 83. 1 minute after EpiPen was given, she took the first deep breath. Then Oxygen was given and her O2sat returned to 95% after 4 to 5 minutes. 911 was called and then canceled as the patient vital signs were in the normal range and were monitored by nurses in the nursing home facility.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor, Wheezing
Clinical narrative: Anaphylaxis.  The patient started shaking and sweating and wheezing  5 to 15 minutes after receiving the vaccine, HR 104, BP normal, O2sat was 95%. After 1 minute she O2sat started dropping and she slid down the chair. EpiPen 0.3mg was given. O2sat kept dropping after the Epipen shot to 83. 1 minute after EpiPen was given, she took the first deep breath. Then Oxygen was given and her O2sat returned to 95% after 4 to 5 minutes. 911 was called and then canceled as the patient vital signs were in the normal range and were monitored by nurses in the nursing home facility.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Hyperhidrosis, Oxygen saturation decreased, Posture abnormal, Tremor
Clinical narrative: Anaphylaxis.  The patient started shaking and sweating and wheezing  5 to 15 minutes after receiving the vaccine, HR 104, BP normal, O2sat was 95%. After 1 minute she O2sat started dropping and she slid down the chair. EpiPen 0.3mg was given. O2sat kept dropping after the Epipen shot to 83. 1 minute after EpiPen was given, she took the first deep breath. Then Oxygen was given and her O2sat returned to 95% after 4 to 5 minutes. 911 was called and then canceled as the patient vital signs were in the normal range and were monitored by nurses in the nursing home facility.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Wheezing
Clinical narrative: Anaphylaxis.  The patient started shaking and sweating and wheezing  5 to 15 minutes after receiving the vaccine, HR 104, BP normal, O2sat was 95%. After 1 minute she O2sat started dropping and she slid down the chair. EpiPen 0.3mg was given. O2sat kept dropping after the Epipen shot to 83. 1 minute after EpiPen was given, she took the first deep breath. Then Oxygen was given and her O2sat returned to 95% after 4 to 5 minutes. 911 was called and then canceled as the patient vital signs were in the normal range and were monitored by nurses in the nursing home facility.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: patient received expired Pentacel, no AE; Initial information regarding an unsolicited valid non-serious case was received from an other healthcare professional via Global Medical Information via call-center (reference number- 00378864) and transmitted to Sanofi on 02-Dec-2020.  This case is linked to case 2020SA347741 (same reporter).  This case involves a four-month-old male patient who was administered with 0.5 mL dose of expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number UJ021AAA and expiry date: 31-Oct-2020 (also reported as 21-Oct-20)) once via an unknown route in the left thigh for prophylactic vaccination in error (expired product administered) on 27-Nov-2020.  Medical history, past medical treatment, vaccination, and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE for prophylactic vaccination.  This was an actual medication error case due to expired vaccine used (latency: same day).  The reporter would like to know if the patient must be revaccinated.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.