chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: I waited about 30 minutes.  Felt tingly and a bit light headed but cracked it up to being tired from the shot.  I got in my car and about 5 minutes out driving in the middle of traffic,  I felt like I was going to pass out like I had once before with anaphylaxis- at the wheel.  There is no mistaking the feeling.  I could not feel my pulse at all.    Fortunately I had a EpiPin in my car and I was able to jab it in my leg and within a minute or two I had the energy to turn the car around and get back to the folks at site who were wonderful.  I then took benadryl as advised and the EMS were called.  I was taken to site where they gave me a steriod, pepsid and monitored me until I went home later that evening.  I was told to take benadryl for the next 24 hours and I did.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Arthralgia, Condition aggravated, Dysphagia, Full blood count
Clinical narrative: RA flare up. Mild joint pain beginning 3 weeks after Shot 1. Blood tests 3 days  prior to Shot 2  revealed no inflammatory issues/platelet count normal do Rheumatologist approved getting Shot 2.  RA symptoms have continued  and progressively worsened  (today is day 16 following Shot 2. Severity of joint pain has increased as well as number of joint affected.  Over last 3 days,  Experiencing  additional symptoms, including difficulty swallowing and cramps/pain on side of abdomen. Limiting work and daily function.  Blood test on day  10 show normal platelet count and reduced  WBC/absolute monocyte count.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Impaired work ability, Loss of personal independence in daily activities, Monocyte count decreased, Platelet count normal, Rheumatoid arthritis
Clinical narrative: RA flare up. Mild joint pain beginning 3 weeks after Shot 1. Blood tests 3 days  prior to Shot 2  revealed no inflammatory issues/platelet count normal do Rheumatologist approved getting Shot 2.  RA symptoms have continued  and progressively worsened  (today is day 16 following Shot 2. Severity of joint pain has increased as well as number of joint affected.  Over last 3 days,  Experiencing  additional symptoms, including difficulty swallowing and cramps/pain on side of abdomen. Limiting work and daily function.  Blood test on day  10 show normal platelet count and reduced  WBC/absolute monocyte count.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: White blood cell disorder
Clinical narrative: RA flare up. Mild joint pain beginning 3 weeks after Shot 1. Blood tests 3 days  prior to Shot 2  revealed no inflammatory issues/platelet count normal do Rheumatologist approved getting Shot 2.  RA symptoms have continued  and progressively worsened  (today is day 16 following Shot 2. Severity of joint pain has increased as well as number of joint affected.  Over last 3 days,  Experiencing  additional symptoms, including difficulty swallowing and cramps/pain on side of abdomen. Limiting work and daily function.  Blood test on day  10 show normal platelet count and reduced  WBC/absolute monocyte count.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Malaise, Migraine
Clinical narrative: about 10 hours after receiving the vaccine experienced extreme malasia, including sensitive skin, migrane, night sweats for 2 nights.  Also have redness/ swelling/ itching on injection site that appeared after about 36 hours,  4 inches in diameter
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Sensitive skin
Clinical narrative: about 10 hours after receiving the vaccine experienced extreme malasia, including sensitive skin, migrane, night sweats for 2 nights.  Also have redness/ swelling/ itching on injection site that appeared after about 36 hours,  4 inches in diameter
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash erythematous, Rash pruritic, Swelling, Swelling face
Clinical narrative: Rash (redness, swelling, itching) on left arm spreading to wrist, whole face swelling with swollen eyelids and neck, rash on thighs, taking Benadryl, no change
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Anxiety, Dizziness, Faeces discoloured, Heart rate increased
Clinical narrative: Regular - Arm pain.  Adverse - Abdominal pain / pressure, green stools, dizziness, fast heartbeat, anxiousness, irritation, body hyper alert, triggered.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Hypervigilance, Irritability, Pain in extremity
Clinical narrative: Regular - Arm pain.  Adverse - Abdominal pain / pressure, green stools, dizziness, fast heartbeat, anxiousness, irritation, body hyper alert, triggered.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Sluggishness
Clinical narrative: a little sluggish on the second day; arm sore; sore on top of his head appeared back which he observed after getting the shot; This is a spontaneous report from a Pfizer Sponsored Program COVAX US Support via a contactable consumer (patient). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiry was not reported), via an unspecified route of administration on 06Apr2021 (Tuesday) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (Solution for injection, Batch/Lot number and expiry was not reported), via an unspecified route of administration on 15Mar2021 as single dose for covid-19 immunisation. On 07Apr2021, the patient started having arm sore and a little sluggish (on the second day about 24 hours after), and yesterday (09Apr2021) he was fine but the sore on top of his head appeared back which he observed after getting the shot. The outcome for all of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatinine increased, Cerebral infarction, Chills, Diarrhoea, Embolic stroke
Clinical narrative: 1-2 weeks after dose of vaccine, developed nausea, chills, diarrhea. Presented 1 month after vaccine to ED with embolic strokes and new renal failure.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head abnormal, Nausea, Renal failure
Clinical narrative: 1-2 weeks after dose of vaccine, developed nausea, chills, diarrhea. Presented 1 month after vaccine to ED with embolic strokes and new renal failure.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pityriasis rosea, Pyrexia, Rash
Clinical narrative: Pityriasis rosea breakout. april 15 had fever of 102, it went away and by the 21st i have developed a rash  that looks exactly like Pityriasis rosea.  started with one big spot and now is breaking into many.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chest discomfort, Dyspnoea, Erythema, Rash macular
Clinical narrative: had immediate reaction of heavy chest; trouble breathing; tightness in her throat; Her blood pressure went up; her face was red; she had blotches on her arms; This is a spontaneous report received from Pfizer sponsored program COVAX SUPPORT. A contactable consumer (patient) reported a female patient of an unspecified age received BNT162B2 (BNT162B2) (Batch/Lot number was not reported), dose 1, intramuscularly on 09Apr2021 as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 09Apr2021 (reported as this morning), the patient had an immediate reaction of heavy chest, trouble breathing and tight in her throat following her first vaccination. Her blood pressure went up and her face was red and she had blotches on her arms. She stated she was immediately given Benadryl and took a hit from her inhaler and then was given another Benadryl. The patient stated they kept her there for 2 hours to make she would be alright. She stated the symptoms subsided but asked what she should do now. Clinical outcome of the events heavy chest, trouble breathing, tight in her throat, blood pressure went up, face was red and blotches on her arms was resolving.   No follow up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: had immediate reaction of heavy chest; trouble breathing; tightness in her throat; Her blood pressure went up; her face was red; she had blotches on her arms; This is a spontaneous report received from Pfizer sponsored program COVAX SUPPORT. A contactable consumer (patient) reported a female patient of an unspecified age received BNT162B2 (BNT162B2) (Batch/Lot number was not reported), dose 1, intramuscularly on 09Apr2021 as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 09Apr2021 (reported as this morning), the patient had an immediate reaction of heavy chest, trouble breathing and tight in her throat following her first vaccination. Her blood pressure went up and her face was red and she had blotches on her arms. She stated she was immediately given Benadryl and took a hit from her inhaler and then was given another Benadryl. The patient stated they kept her there for 2 hours to make she would be alright. She stated the symptoms subsided but asked what she should do now. Clinical outcome of the events heavy chest, trouble breathing, tight in her throat, blood pressure went up, face was red and blotches on her arms was resolving.   No follow up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: contracted covid in between doses; contracted covid in between doses; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 18Mar2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient contracted COVID -19 in between doses. The patient received the second dose on 08Apr2021 and wanted to know if she needed the second dose again. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Sarcoidosis
Clinical narrative: syptoms that go with sarcoidosis started after getting the vaccine.; This is a spontaneous report from Pfizer-sponsored program,  from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The consumer was asking if any studies were done on sarcoidosis side effects. Clarified if she has this, she said she has not been diagnosed with it yet, but her symptoms point to this. She has taken the  series and states some of the auto-immune symptoms that go with sarcoidosis started after getting the vaccine. Onset 3 weeks ago (Mar2021). The outcome of the event was unknown.    Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: start feeling unwell after a few days, tested positive for COVID; start feeling unwell after a few days, tested positive for COVID; This is a spontaneous report from a contactable Nurse. A female patient of (3 decade) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown) via an unspecified route of administration, administered at an unknown anatomical location on an unknown date at a single dose for covid-19 immunisation. Medical history and concomitant medication were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown) for covid-19 immunisation. On 09Apr2021, patient start feeling unwell after a few days, tested positive for COVID. After the second dose, the patient started feeling unwell after a few days, tested positive for COVID, and a week after still tested positive for COVID. Event took place after use of product. The outcome of the events was unknown.  Information on Lot and Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Headache, Malaise
Clinical narrative: headache; does not feel well; transient global amnesia.; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection, Lot Number was not reported), dose 2nd via an unspecified route of administration on 18Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 25Feb2021 for covid-19 immunisation. Patient was diagnosed with transient global amnesia. Asked if there were reports on patient who also has gotten this side effect, after receiving her second dose she experienced a severe adverse event and was hospitalized. She was released from the hospital on 12Apr2021. She had a reaction for the first dose. With the second dose she just had the headache. She just came out of the hospital and would like to know if that was because of the vaccine. She does not feel well. The outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Grip strength decreased, Peripheral swelling
Clinical narrative: Joint pain; swollen hand, can't close hand, can't grip; swollen hand, can't close hand, can't grip; Slightly swollen middle finger; This is a spontaneous report from a contactable consumer (Patient).     A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection, Lot Number: EP7534) dose 1 via an unspecified route of administration, administered in Arm Left on 10Apr2021 12:30 as single dose for covid-19 immunisation. Medical history included Type 2 Diabetes and high cholesterol. Concomitant medication(s) included Metformin, Atorvastatin and Vitamin D. The patient experienced joint pain, swollen hand, can't close right hand, can't grip. Patient did not have covid prior vaccination and not tested for covid post vaccination. Patient did not have known allergies. The outcome of the event was not recovered.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Mastication disorder, Pyrexia, Swelling face, Trismus
Clinical narrative: could not open her mouth almost like lockjaw; could not chew; face was hot and puffy; face was hot and puffy; might have some fever; This is a spontaneous report from a contactable consumer (Patient himself). An 82-year-old male received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch number: Unknown, ExpirationDate: Unknown) on 30Mar2021 via unspecified route of administration at SINGLE DOSE for COVID-19 Immunization. The patients medical history and concomitant medications were not reported. The patient stated the next morning she could not open her mouth, could not chew, face was hot and puffy, might have some fever also. She took a couple of Aleve, and it went away after couple of days. The patient stated she didn't know for sure if it was related to the Covid-19 vaccine or not. The day that she got the Covid-19 vaccine, later provided as 30Mar2021, she felt fine and never had a sore arm or fever. It was reported that it was almost like lockjaw, that she couldn't brush her teeth or chew. The patient reported that later in the day, the side of her face was all hot and might have been swollen and she took ibuprofen and that the inability to open her mouth went away in a couple of days. The reporter assessed the events as non-serious. The patient reported that she went to the chiropractor a couple of days later and the chiropractor said that he had heard about patients experiencing lockjaw after receiving the Covid-19 vaccine and she looked on Pfizer's website and the AE she experienced was not listed as a side effect. She is just a little concerned as she is scheduled to receive her second dose of the Covid-19 vaccine next week on 20Apr2021. She is afraid that the lockjaw might come back and might be worse. She is just curious if she is the only one that experienced the inability to open her mouth. The patient reported she does not know anyone that had this reaction and it is not listed as a side effect on Pfizer's website. The outcome of the event was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: dizziness; vertigo worse; This is a spontaneous case received from a contactable consumer (patient).  A 73-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), 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. On an unspecified date, within thirty minutes after vaccination, the patient experienced dizziness and vertigo worsened and stated that she read that this could be severe allergic reaction. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Limb discomfort, Pain in extremity
Clinical narrative: heavy limbs; when trying to hit keyboard with pinky, it hurts; Brain fog; wrist pains in both arms/when you are moving it (trying to type on key board) feels like wrist is going to break; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 02Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 02Apr2021 patient experienced brain fog, wrist pains in both arms/when you are moving it and feels like wrist is going to break and when trying to hit keyboard with pinky, it hurts. Heavy limbs were observed on 03Apr2021. She told her family doctor, she had moments since getting vaccine. She is getting this daily and asks when It is going away. She just wanted to make sure this falls into the classification of Joint and muscle pain. Her doctor said, in a week, tell me how she was feeling. After she got vaccine on 02Apr2021 and experienced experiencing heavy limbs and wrist pain on the 3rd. The wrist pains she was still experiencing in Left side, injections site, it's extremely sensitive, clipping my dogs harness on is bad and she never had arthritis and don't know. Asked Is there a stretch that she should try. The outcome of the event was not recovered for wrist pain and other outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: she develops high temperature; This is a spontaneous report received from a Pfizer sponsored program COVAX US Support. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on 09Mar2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had a knee surgery last Wednesday (31Mar2021) and developed high temperature on an unspecified date. The outcome of the event was unknown. The patient was due for her second dose on 09Apr2021.    No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: She has a migraine currently; This is a spontaneous report from a non-contactable consumer (patient) via medical information team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that normally, she takes sumatriptan for migraines. The patient was going to get her second dose of vaccine that morning (as of reporting time). She had a migraine currently. She wanted to know that it would affect the vaccine if she takes her medication and how long she should wait to take her medication after the vaccination. The outcome of migraine was unknown at the reporting time.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Caller tested positive for covid; This is a spontaneous report received from a contactable consumer (reporting on herself). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and Expiry date was not reported), via an unspecified route of administration on 02Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient tested positive for covid today (Apr2021). Patient was asking will she be able to receive her second Pfizer Covid vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: She is experiencing a metallic taste is her mouth for weeks; This is a spontaneous report received from a contactable consumer (reporting on herself). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number and Expiry date was not reported), via an unspecified route of administration in left arm on 19Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 for COVID-19 immunization. The patient reported that since Mar2021, was experiencing a metallic taste is her mouth for weeks and wants to know if it's going to go away or it is permanent. Side effects after your second shot may be more intense than the ones you experienced after your first shot. These side effects are normal signs that your body was building protection and should go away within a few days. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19
Clinical narrative: Caller diagnosed with COVID 19 after 1st Pfizer vaccine dose.; lost my sense of taste and smell; lost my sense of taste and smell; This is a spontaneous report from a contactable consumer via Medical Information Team.  A 28-year-old male 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 26Mar2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient was diagnosed with COVID 19 after 1st Pfizer vaccine dose, states that received his 1st Pfizer vaccine dose on 26Mar2021 and then lost his sense of taste (ageusia) and smell (anosmia) and got diagnosed with COVID 19 on 02Apr2021 results on 04Apr2021. Patient Got clearance, this past Thursday (08Apr2021) or Friday (09Apr2021), that it was ok to leave Isolation 2nd vaccine dose is on 16Apr2021. Is it ok for me to get the 2nd dose? The outcome of the event covid-19 was recovered while for other events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Malaise
Clinical narrative: Caller stated he had covid and had a horrible 5 days in the hospital and was scared; Sick a little bit, recovering fine; Drug ineffective; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0153, Expiration date: 31Jul2021), via an unspecified route of administration on 09Apr2021at single dose for COVID-19 immunization. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6205, Expiration date: 30Jun2021), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient stated him and his wife had received both their vaccines. He stated his second one was this past friday. Patient was very happy they were able to receive the Pfizer vaccine. Patient stated he was a little bit sick, recovering, fine. Everything is so far so good. The patient further stated he had covid and had a horrible 5 days in the hospital and was scared. Patient declined a Safety report. The patient stated he did not have an email and declined to provide his address. The patient did not state further information for the report. Patient wanted to know if the expiry date on his covid 19 vaccination card meant he had to go get another vaccine after the expiration. The patient stated he would like to be transferred to regulatory authority to make sure of these expiration dates. The outcome of the events was resolving.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: a low grade fever; she is swollen under her armpit, which is very sore; she is swollen under her armpit, which is very sore; headache; body aches; tiredness; This is a spontaneous report from Pfizer sponsored program support. A contactable 55-year-old female consumer (patient) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE; Solution for injection; Lot Number: Unknown), via an unspecified route of administration on 10Apr2021 as single dose for COVID-19 immunization. Patient had historical vaccine first dose of BNT162B2 (at 55-year-old) for COVID-19 immunization. The patient medical history was not reported. Patient concomitant medications included paracetamol (TYLENOL); ibuprofen, diphenhydramine citrate (IBU-PROFEN,DIPHENHYDRAMINE CITRATE). On 11Apr2021, the patient experienced headache, body aches, tiredness and on 13Apr2021, patient experienced a low grade fever, she is swollen under her armpit, which is very sore. Patient reports on Sunday, 24 hours after administration, she started experiencing a headache, body aches, and tiredness. She reports today, 3 days later, she has a low grade fever and she is swollen under her armpit, which is very sore. She called to ask how long she typically experience the side effects after her second dose of the vaccine given on Saturday afternoon, 10Apr2021. She was feeling a terrible headache, achiness, arm sore and feeling exhausted with low grade fever and she is taking Tylenol and Ibuprofen, she wanted to know how long she will take these medications. There was no PQC. There were unaddressed medical questions referred or forwarded to Medical Information. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: a low grade fever; she is swollen under her armpit, which is very sore; she is swollen under her armpit, which is very sore; headache; body aches; tiredness; This is a spontaneous report from Pfizer sponsored program support. A contactable 55-year-old female consumer (patient) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE; Solution for injection; Lot Number: Unknown), via an unspecified route of administration on 10Apr2021 as single dose for COVID-19 immunization. Patient had historical vaccine first dose of BNT162B2 (at 55-year-old) for COVID-19 immunization. The patient medical history was not reported. Patient concomitant medications included paracetamol (TYLENOL); ibuprofen, diphenhydramine citrate (IBU-PROFEN,DIPHENHYDRAMINE CITRATE). On 11Apr2021, the patient experienced headache, body aches, tiredness and on 13Apr2021, patient experienced a low grade fever, she is swollen under her armpit, which is very sore. Patient reports on Sunday, 24 hours after administration, she started experiencing a headache, body aches, and tiredness. She reports today, 3 days later, she has a low grade fever and she is swollen under her armpit, which is very sore. She called to ask how long she typically experience the side effects after her second dose of the vaccine given on Saturday afternoon, 10Apr2021. She was feeling a terrible headache, achiness, arm sore and feeling exhausted with low grade fever and she is taking Tylenol and Ibuprofen, she wanted to know how long she will take these medications. There was no PQC. There were unaddressed medical questions referred or forwarded to Medical Information. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: she had "some reactions" to her first vaccine dose. "Like when I had Covid I was sick for 2-3 days; This is a spontaneous report from a contactable consumer (patient herself). A female patient of unspecified aged received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient had "some reactions" to her first vaccine dose. "Like when I had Covid I was sick for 2-3 days and then after Tuesday night I was fine". Patient wanted to know she would take the second shot after having side effects to the first. Patient reports that she already spoke with safety and was transferred to PMI for her question. No reference number for that encounter. As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. The outcome of the event was recovered.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Loss of consciousness
Clinical narrative: she also fainted; her blood pressure drops drastically on Sunday morning; This is a spontaneous report from a non-contactable consumer.  A consumer reported that a 94-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown) on an unknown date at a single dose for COVID-19 immunization. Medical history and concomitant drugs were not reported. The consumer reported that the patient had the vaccine on 'Saturday' and on Sunday morning her blood pressure drops drastically, they called the doctor, she was under in doctor's hand, she called the doctor again today, she also fainted. The consumer was questioning if it can in very extreme cases cause the blood pressure to go havoc. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Headache, Illness, Pyrexia, SARS-CoV-2 test
Clinical narrative: COVID-19 test / PCR nasal swab test was positive; COVID-19; Headache; Fever of 99.0; Ill; This is a spontaneous report from a contactable consumer (patient) and nurse. A 48-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) at age 48-years old, the first dose via intramuscular route of administration in the left arm on Jan2021 08:00 (Batch/Lot Number: EL3248) as a single dose, then at age 48-years old the second dose via intramuscular route of administration in the left arm on 02Feb2021 16:45 (Batch/Lot Number: EL3248) as a single dose for COVID-19 immunization at a workplace clinic. Medical history was not reported. The patient did not have COVID-19 prior to receiving the BNT162B2 vaccination. Concomitant medications were not reported. On 08Apr2021, the patient reported he was ill. On 09Apr2021, the patient began to experience headache and a fever of 99.0. On 12Apr2021, COVID-19 test (PCR nasal swab test) was positive. The events resulted in a doctor or other healthcare professional office/clinic visit. Treatment was reported as unknown. The outcome of events vaccine failure, COVID-19 test positive, illness, headache and fever was recovering
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination failure
Clinical narrative: COVID-19 test / PCR nasal swab test was positive; COVID-19; Headache; Fever of 99.0; Ill; This is a spontaneous report from a contactable consumer (patient) and nurse. A 48-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) at age 48-years old, the first dose via intramuscular route of administration in the left arm on Jan2021 08:00 (Batch/Lot Number: EL3248) as a single dose, then at age 48-years old the second dose via intramuscular route of administration in the left arm on 02Feb2021 16:45 (Batch/Lot Number: EL3248) as a single dose for COVID-19 immunization at a workplace clinic. Medical history was not reported. The patient did not have COVID-19 prior to receiving the BNT162B2 vaccination. Concomitant medications were not reported. On 08Apr2021, the patient reported he was ill. On 09Apr2021, the patient began to experience headache and a fever of 99.0. On 12Apr2021, COVID-19 test (PCR nasal swab test) was positive. The events resulted in a doctor or other healthcare professional office/clinic visit. Treatment was reported as unknown. The outcome of events vaccine failure, COVID-19 test positive, illness, headache and fever was recovering
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 test / PCR nasal swab test was positive; COVID-19; Headache; Fever of 99.0; Ill; This is a spontaneous report from a contactable consumer (patient) and nurse. A 48-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) at age 48-years old, the first dose via intramuscular route of administration in the left arm on Jan2021 08:00 (Batch/Lot Number: EL3248) as a single dose, then at age 48-years old the second dose via intramuscular route of administration in the left arm on 02Feb2021 16:45 (Batch/Lot Number: EL3248) as a single dose for COVID-19 immunization at a workplace clinic. Medical history was not reported. The patient did not have COVID-19 prior to receiving the BNT162B2 vaccination. Concomitant medications were not reported. On 08Apr2021, the patient reported he was ill. On 09Apr2021, the patient began to experience headache and a fever of 99.0. On 12Apr2021, COVID-19 test (PCR nasal swab test) was positive. The events resulted in a doctor or other healthcare professional office/clinic visit. Treatment was reported as unknown. The outcome of events vaccine failure, COVID-19 test positive, illness, headache and fever was recovering
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: Symptoms were chills, headache, bodyaches, fever of 100.3; Symptoms were chills, headache, bodyaches, fever of 100.3; Symptoms were chills, headache, bodyaches, fever of 100.3; Symptoms were chills, headache, bodyaches, fever of 100.3; This is a spontaneous report from a contactable consumer (patient) communicated to a Pfizer sales representative. A 45-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported),2nd dose via an unspecified route of administration on 09Apr2021 as SINGLE DOSE for COVID-19 immunization. The patient medical history not reported. On an unspecified date, the patient received first dose of bnt162b2 for COVID-19 immunization and concomitant medications were not reported. On an unspecified date the patient experienced symptoms like chills, headache, body aches, fever of 100.3. The patient underwent lab tests and procedures which included body temperature (fever): 100.3. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Hypersensitivity, SARS-CoV-2 test
Clinical narrative: tested positive for covid; tested positive for covid; Reaction to vaccine; This is a spontaneous report from a Pfizer sponsored program  via the consumer (patient). A male patient of an unspecified age received unspecified dose number of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number and expiry was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had reaction to vaccine, went to urgent care and tested positive for covid with lab tests SARS-COV-2 test. The outcome to the events was unknown. Information about batch/lot number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Dyspnoea
Clinical narrative: difficulty breathing; chills; This is a spontaneous report from a contactable consumer (patient) via Medical Information team. A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on 23Mar2021 (at the age of 65-years-old) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced chills on 23Mar2021 and difficulty breathing on 26Mar2021 at 04:00. She wanted to know how long the breathing difficulty lasts and about the second dose vaccination. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Agitation, Anxiety, Blood test, Chest X-ray, Chest discomfort
Clinical narrative: difficulty breathing; chills; This is a spontaneous report from a contactable consumer (patient) via Medical Information team. A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on 23Mar2021 (at the age of 65-years-old) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced chills on 23Mar2021 and difficulty breathing on 26Mar2021 at 04:00. She wanted to know how long the breathing difficulty lasts and about the second dose vaccination. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Cough, Dyspnoea, Electrocardiogram, Emphysema
Clinical narrative: difficulty breathing; chills; This is a spontaneous report from a contactable consumer (patient) via Medical Information team. A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on 23Mar2021 (at the age of 65-years-old) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced chills on 23Mar2021 and difficulty breathing on 26Mar2021 at 04:00. She wanted to know how long the breathing difficulty lasts and about the second dose vaccination. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypersensitivity, Hypopnoea, Influenza, Investigation, Oropharyngeal pain
Clinical narrative: difficulty breathing; chills; This is a spontaneous report from a contactable consumer (patient) via Medical Information team. A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on 23Mar2021 (at the age of 65-years-old) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced chills on 23Mar2021 and difficulty breathing on 26Mar2021 at 04:00. She wanted to know how long the breathing difficulty lasts and about the second dose vaccination. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pulmonary function test, SARS-CoV-2 test, Vital signs measurement, Wheezing
Clinical narrative: difficulty breathing; chills; This is a spontaneous report from a contactable consumer (patient) via Medical Information team. A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on 23Mar2021 (at the age of 65-years-old) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced chills on 23Mar2021 and difficulty breathing on 26Mar2021 at 04:00. She wanted to know how long the breathing difficulty lasts and about the second dose vaccination. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure normal, Blood test normal, Chest X-ray abnormal, Chills, Dyspnoea
Clinical narrative: difficulty breathing; chills; This is a spontaneous report from a contactable consumer (patient) via Medical Information team. A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on 23Mar2021 (at the age of 65-years-old) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced chills on 23Mar2021 and difficulty breathing on 26Mar2021 at 04:00. She wanted to know how long the breathing difficulty lasts and about the second dose vaccination. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immediate post-injection reaction
Clinical narrative: difficulty breathing; chills; This is a spontaneous report from a contactable consumer (patient) via Medical Information team. A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on 23Mar2021 (at the age of 65-years-old) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced chills on 23Mar2021 and difficulty breathing on 26Mar2021 at 04:00. She wanted to know how long the breathing difficulty lasts and about the second dose vaccination. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Blood sodium, Blood sodium decreased, Body temperature, Cough, Eyelid disorder
Clinical narrative: can not walk, or eat by himself needs help; his sputum is thick and brown; low platelets; Elevated liver enzymes; low sodium and unstable phenotypes; rashes all over his body; fever of 100.8 next day friday the 9th woke up with a 104 temp; headache; coughing and his sputum is thick and brown; felt like flue symptoms; extreme body ache; his eyes are unable to open for most times; can not walk, or eat by himself needs help; This is a spontaneous report from a contactable consumer (parent). A 23-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number and expiry date were not reported), via an unspecified route of administration on 08Apr2021, as single dose for COVID-19 immunization. Patient medical and concomitant medications were not re-ported. On 08Apr2021, patient same day developed a fever of 100.8 next day friday the 9th woke up with a 104 temp and ever since (5 days) has had a fever, rashes all over his body, today he started coughing and his sputum is thick and brown, felt like flu symptoms within an hour, extreme body ache, his eyes are unable to open for most times, cannot walk, or eat by himself needs help and headache. Also reported his condition was low platelets, elevated liver enzymes, low sodium and un-stable phenotypes. Treatment received at hospital includes cortisone, paracetamol (TYLENOL), ceftriaxone sodium (ROCEPHIN) and azithromycin. On 08Apr20212 underwent body temperature measurement and result was fever of 100.8 next day friday the 9th woke up with a 104 temp, on unknown date low sodium and unstable phenotypes was done and result was low sodium, underwent liver enzymes test and result was elevated liver enzymes, had platelet count test and result was low platelets and had sputum test and result was sputum is thick and brown. The outcome of the events was un-known.  Information on the lot/batch number has been requested.