chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dyspnoea, Fall, Fatigue, Memory impairment, Pneumonia
Clinical narrative: She fell and had an accident; She fell and had an accident; The hospital was going to send her home, but her A-Fib went off suddenly; she couldn't breathe; they treated her lungs for inflammation; to see if she had pneumonia. She was put on antibiotics; Anxiety; fatigue / She is very fatigued; She has memory issues since hospitalization; She is now stuttering; This is a spontaneous report from a contactable consumer (daughter) An 87-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on an unspecified date (at an unspecified age) as a single dose for COVID-19 immunisation and started to receive palbociclib (IBRANCE) via an unspecified route of administration on an unspecified date to an unspecified date at 100mg, unspecified frequency and via an unspecified route of administration on an unspecified date to an unspecified date at 75mg, unspecified frequency, for an unspecified indication. Medical history included atrial fibrillation (A-Fib) from an unspecified date and unspecified if ongoing. Concomitant medications were not reported. On unspecified dates the patient experienced she fell and had an accident, the hospital was going to send her home, but her A-Fib went off suddenly, she could not breathe, they treated her lungs for inflammation, to see if she had pneumonia. She was put on antibiotics, anxiety, fatigue / she is very fatigued, she has memory issues since hospitalization, and she is now stuttering. The clinical course was reported as follows: "My mother has anxiety and fatigue as her main symptoms. She did go into the hospital recently. She fell and had an accident. My mother got the vaccine a day before the event happened, so not sure if that contributed to the accident. The hospital was going to send her home, but her atrial fibrillation (A-Fib) went off suddenly and she could not breathe. They almost sent her to the intensive care unit (ICU). They got her and her heart rate stabilized. She had difficulty breathing, so they treated her lungs for inflammation. They did a computerized axial tomography (cat) scan of her lungs to see if she had pneumonia. She was put on antibiotics. She went down on the dose of palbociclib from 100mg to 75mg. She was very fatigued. She had adverse events to the antibiotics. She became psychotic on them. She had memory issues since hospitalization. She was now stuttering."  The action taken in response to the events for palbociblib was dose reduced. The clinical outcomes of the events she fell and had an accident, the hospital was going to send her home, but her A-Fib went off suddenly, she could not breathe, they treated her lungs for inflammation, to see if she had pneumonia. She was put on antibiotics, anxiety, fatigue / she is very fatigued, she has memory issues since hospitalization, and she is now stuttering were unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pneumonitis
Clinical narrative: She fell and had an accident; She fell and had an accident; The hospital was going to send her home, but her A-Fib went off suddenly; she couldn't breathe; they treated her lungs for inflammation; to see if she had pneumonia. She was put on antibiotics; Anxiety; fatigue / She is very fatigued; She has memory issues since hospitalization; She is now stuttering; This is a spontaneous report from a contactable consumer (daughter) An 87-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on an unspecified date (at an unspecified age) as a single dose for COVID-19 immunisation and started to receive palbociclib (IBRANCE) via an unspecified route of administration on an unspecified date to an unspecified date at 100mg, unspecified frequency and via an unspecified route of administration on an unspecified date to an unspecified date at 75mg, unspecified frequency, for an unspecified indication. Medical history included atrial fibrillation (A-Fib) from an unspecified date and unspecified if ongoing. Concomitant medications were not reported. On unspecified dates the patient experienced she fell and had an accident, the hospital was going to send her home, but her A-Fib went off suddenly, she could not breathe, they treated her lungs for inflammation, to see if she had pneumonia. She was put on antibiotics, anxiety, fatigue / she is very fatigued, she has memory issues since hospitalization, and she is now stuttering. The clinical course was reported as follows: "My mother has anxiety and fatigue as her main symptoms. She did go into the hospital recently. She fell and had an accident. My mother got the vaccine a day before the event happened, so not sure if that contributed to the accident. The hospital was going to send her home, but her atrial fibrillation (A-Fib) went off suddenly and she could not breathe. They almost sent her to the intensive care unit (ICU). They got her and her heart rate stabilized. She had difficulty breathing, so they treated her lungs for inflammation. They did a computerized axial tomography (cat) scan of her lungs to see if she had pneumonia. She was put on antibiotics. She went down on the dose of palbociclib from 100mg to 75mg. She was very fatigued. She had adverse events to the antibiotics. She became psychotic on them. She had memory issues since hospitalization. She was now stuttering."  The action taken in response to the events for palbociblib was dose reduced. The clinical outcomes of the events she fell and had an accident, the hospital was going to send her home, but her A-Fib went off suddenly, she could not breathe, they treated her lungs for inflammation, to see if she had pneumonia. She was put on antibiotics, anxiety, fatigue / she is very fatigued, she has memory issues since hospitalization, and she is now stuttering were unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Meniere's disease
Clinical narrative: Meniere's disease; patient received the first dose 8 weeks ago; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program.  A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 19Mar2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced Meniere's disease on an unspecified date. It was also reported on 10May2021 that the patient received the first dose 8 weeks ago (as reported) on 19Mar2021. The patient asked her doctors if she can get the second dose,  and they agreed but her other doctor disagreed. The patient was asking if she can get the second dose even if it's been 8 weeks from the first dose. The clinical outcome of Meniere's disease and patient received the first dose 8 weeks ago was unknown.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Musculoskeletal stiffness
Clinical narrative: sharp pain; felt like it was stretched tight or stiff muscle; felt like it was stretched tight or stiff muscle; usual arm pain at injection site; Headache; Chills; Fatigue; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (Patient) reported that a 20-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/ Lot number and expiration date: Not reported) via intramuscular route of administration in left arm on 23Apr2021 15:25 at single dose for covid-19 immunisation. Medical history included diagnosed allergies, compromised immune status, respiratory illness, chromosomal abnormalities, endocrine abnormalities, genetic / (including diabetes) and obesity. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (Solution for injection, Batch/Lot: ED8734) intramuscular (at the age of 20 years) in left arm on 02Apr2021 at 16:30 for covid-19 immunisation and experienced Pain at left arm injection site. The patient experienced the "usual arm pain at injection site which started on 24APR2021 and went away a few days later. On 07MAY2021 having a new pain, that has been persisting since then, it is a sharp pain. On 24Apr2021, the patient experienced headache at 04:00, chills and fatigue at 01:00 or 02:00, Pain in left arm at injection site at 04:00. The patient later stated pain starting at 04:00 pretty similar to normal pain after injection of second dose which was dull and sore and hurt to lift arm. It was the same as the first shot. It cleared up within 3 days. The patient did not notice anything else. Friday, 07May2021, the patient noticed that left arm felt like it was stretched tight or stiff muscle. If patient lifted her arm up in a certain way, very sharp pain near injection site. That has persisted. It did totally go away and restarted as a different type of pain 2 weeks after. After received second vaccine and pain in the injection site. Had sharp sensation near injection site when raising arm. The outcome of usual arm pain at injection site was recovered on 07May2021; sharp pain, headache, chills and fatigue was recovering and felt like it was stretched tight or stiff muscle was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: sharp pain; felt like it was stretched tight or stiff muscle; felt like it was stretched tight or stiff muscle; usual arm pain at injection site; Headache; Chills; Fatigue; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (Patient) reported that a 20-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/ Lot number and expiration date: Not reported) via intramuscular route of administration in left arm on 23Apr2021 15:25 at single dose for covid-19 immunisation. Medical history included diagnosed allergies, compromised immune status, respiratory illness, chromosomal abnormalities, endocrine abnormalities, genetic / (including diabetes) and obesity. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (Solution for injection, Batch/Lot: ED8734) intramuscular (at the age of 20 years) in left arm on 02Apr2021 at 16:30 for covid-19 immunisation and experienced Pain at left arm injection site. The patient experienced the "usual arm pain at injection site which started on 24APR2021 and went away a few days later. On 07MAY2021 having a new pain, that has been persisting since then, it is a sharp pain. On 24Apr2021, the patient experienced headache at 04:00, chills and fatigue at 01:00 or 02:00, Pain in left arm at injection site at 04:00. The patient later stated pain starting at 04:00 pretty similar to normal pain after injection of second dose which was dull and sore and hurt to lift arm. It was the same as the first shot. It cleared up within 3 days. The patient did not notice anything else. Friday, 07May2021, the patient noticed that left arm felt like it was stretched tight or stiff muscle. If patient lifted her arm up in a certain way, very sharp pain near injection site. That has persisted. It did totally go away and restarted as a different type of pain 2 weeks after. After received second vaccine and pain in the injection site. Had sharp sensation near injection site when raising arm. The outcome of usual arm pain at injection site was recovered on 07May2021; sharp pain, headache, chills and fatigue was recovering and felt like it was stretched tight or stiff muscle was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected, Tongue discolouration
Clinical narrative: He then said that his tongue has been white for a while now after receiving the vaccine.; He said it was a miracle that the vaccine helped clear up the awful fungus; This is a spontaneous report from a Pfizer sponsored program COVAX US support reported from a non-contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 11May2021 as second dose, single for COVID-19 immunization. Medical history included fungal infection from 2020 (from 1 year) and prescribed with creams but did not help at all. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as first dose, single for COVID-19 immunization. The patient said it was a miracle that the vaccine helped to clear up the awful fungus in May2021. The patient also said that his tongue has been white for a while now after receiving the vaccine in May2021. The patient wanted to know about the ingredients of the vaccine which helped his fungus to clear up. The outcome of the event tongue has been white was unknown at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Decreased immune responsiveness
Clinical narrative: two shots didn't seem to give her a robust immune response; This is a spontaneous report from a non-contactable consumer (patient) via Medical Information Team. A female patient of an unspecified age received first and second doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot numbers and expiration dates were not reported), both via an unspecified routes of administration on unspecified dates at first dose, single and second dose, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included unspecified immunosuppressive medications (injection). The patient was interested in knowing if Pfizer was conducting a clinical trial in patients who were immunocompromised taking a third dose of the Covid-19 vaccine because the patient stated that the two shots didn't seem to give her a robust immune response. After a lab test, the patient asked the antibodies range at a lab company and they estimated that they usually saw results between 15-16 thousand but hers was low compared to that, and for the first dose the result was almost undetectable. She also stated that immunocompromised people have an inadequate response to the double vaccination and low antibodies, that's why she's wondering it was being investigated. 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: Inappropriate schedule of product administration, Seizure
Clinical narrative: seizure; patient missed second dose appointment due to hospitalization; This is a spontaneous report from a non-contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced seizure on an unspecified date, which required hospitalization. It was also reported that the patient missed second dose appointment due to hospitalization on an unspecified date. The patient reported that she received first dose before the hospitalization. The clinical outcome of seizure and patient missed second dose appointment due to hospitalization was unknown. The reporter (patient) assessed the causality between the event and BNT162B2 as unrelated (reported as: nothing to do with seizure).  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on an implied chronological connection to the vaccine, a causal relationship between event seizure and  BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Illness, Influenza like illness, Pain, Pyrexia
Clinical narrative: entire body ached; running a fever but did not check his temperature; it was kind of like a sick day where he got nothing productive done; experienced small amount of pain at the injection site of left shoulder that was bypassed by his having felt achy the entire day like flu-like achy; experienced small amount of pain at the injection site of left shoulder that was bypassed by his having felt achy the entire day like flu-like achy; experienced small amount of pain at the injection site of left shoulder that was bypassed by his having felt achy the entire day like flu-like achy; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). A 58-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection) via an unspecified route of administration, administered in Arm Left on 02Apr2021 around 13:00-13:30 (Batch/Lot Number: EP7533, Expiration date: Unknown) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included, had positive COVID-19 test from exposure that occurred between best guess 25Nov2021-30Nov2020. Had no symptoms and had digital thermometer was periodically taking temperature even though had no symptoms, works from home-took test because it was close by at the apartment complex, but was completely asymptomatic. Acute Bronchitis as a child from an unknown date and unknown if ongoing. Other vaccine prior to COVID vaccine with in 4 weeks was reported as second dose of Shingrix Vaccine shot, 2 weeks and 1 day prior to first Pfizer COVID-19 Vaccine. Lot/NDC/Expiry: Unknown, caller does not have this information on hand, unknown if lost the paperwork. Shingrix Vaccine second dose vaccine hurt a lot, but he was fully recovered from the Shingrix Vaccine and feeling fine by the time he got the first Pfizer COVID-19 Vaccine. Shingrix Vaccine first dose caller thinks was administered on 30Dec2020 or 31Dec2020: Lot/NDC/Expiry: Unknown, caller does not have this information on hand, unknown if lost the paperwork. The patient's concomitant medications were not reported. On 03Apr2021, when he woke up, the patient experienced, entire body ached, it was kind of like a sick day where he got nothing productive done. He experienced small amount of pain at the injection site of left shoulder that was bypassed by his having felt achy the entire day like flu-like achy and fever. Especially the first time because he didn't take any medication with the first dose side effects and was probably running a fever but did not check his temperature but was definitely running a fever the next day. The outcome of the events entire body ached, it was kind of like a sick day where he got nothing productive done. He experienced small amount of pain at the injection site of left shoulder that was bypassed by his having felt achy the entire day like flu-like achy was recovered on 04Apr2021 and fever was recovered on 05Apr2021.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: entire body ached; running a fever but did not check his temperature; it was kind of like a sick day where he got nothing productive done; experienced small amount of pain at the injection site of left shoulder that was bypassed by his having felt achy the entire day like flu-like achy; experienced small amount of pain at the injection site of left shoulder that was bypassed by his having felt achy the entire day like flu-like achy; experienced small amount of pain at the injection site of left shoulder that was bypassed by his having felt achy the entire day like flu-like achy; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). A 58-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection) via an unspecified route of administration, administered in Arm Left on 02Apr2021 around 13:00-13:30 (Batch/Lot Number: EP7533, Expiration date: Unknown) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included, had positive COVID-19 test from exposure that occurred between best guess 25Nov2021-30Nov2020. Had no symptoms and had digital thermometer was periodically taking temperature even though had no symptoms, works from home-took test because it was close by at the apartment complex, but was completely asymptomatic. Acute Bronchitis as a child from an unknown date and unknown if ongoing. Other vaccine prior to COVID vaccine with in 4 weeks was reported as second dose of Shingrix Vaccine shot, 2 weeks and 1 day prior to first Pfizer COVID-19 Vaccine. Lot/NDC/Expiry: Unknown, caller does not have this information on hand, unknown if lost the paperwork. Shingrix Vaccine second dose vaccine hurt a lot, but he was fully recovered from the Shingrix Vaccine and feeling fine by the time he got the first Pfizer COVID-19 Vaccine. Shingrix Vaccine first dose caller thinks was administered on 30Dec2020 or 31Dec2020: Lot/NDC/Expiry: Unknown, caller does not have this information on hand, unknown if lost the paperwork. The patient's concomitant medications were not reported. On 03Apr2021, when he woke up, the patient experienced, entire body ached, it was kind of like a sick day where he got nothing productive done. He experienced small amount of pain at the injection site of left shoulder that was bypassed by his having felt achy the entire day like flu-like achy and fever. Especially the first time because he didn't take any medication with the first dose side effects and was probably running a fever but did not check his temperature but was definitely running a fever the next day. The outcome of the events entire body ached, it was kind of like a sick day where he got nothing productive done. He experienced small amount of pain at the injection site of left shoulder that was bypassed by his having felt achy the entire day like flu-like achy was recovered on 04Apr2021 and fever was recovered on 05Apr2021.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing in ears; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program.  A 55-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot no: ENU204), first dose via an unspecified route of administration, administered in right arm on 30Mar2021 11:00 as single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient took the first Covid vaccine on 30Mar2021 and had Covid virus back before then on the 07Mar2021. On an unknown date in 2021, the patient experienced ringing in ears (tinnitus). The patient stated that the ringing in ears was worsened. Dates for has not had second dose; was at day 42 and wants to take it. Since patient has had the vaccine, he noticed ringing in the ears or either it made it worse and is not sure if it's side effect or not. patient has not had the second dose and is at day 42 and wants to take it but wants to know if there is any information about a short term flare up about the ringing in ears or anyone else reporting ringing in ears. At the time of this report event outcome was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle twitching, Paraesthesia
Clinical narrative: had twitching and tingling sensations all over his body, mostly in his legs, thighs, calves, ankles, and occasionally in his lower and upper arm as well as his fingers; big finger twitch/had twitching and tingling sensations all over patient body, mostly in his legs, thighs, calves, ankles, and occasionally in his lower and upper arm as well as his fingers; This is a spontaneous report from a non-contactable consumer (patients wife) via medical information team.  A 49-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date were not reported) via unspecified route of administration on 23Mar2021 (at the age of 49-year-old) as 2nd dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reportedly, patient received historical vaccine first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date were not reported) via unspecified route of administration on 02Mar2021 as 1st dose, single for COVID-19 immunization. Reportedly, on an unspecified date in Mar2021 (48 hours after the second dose) patient experienced very big finger twitch. On an unknown date (Within last 2 or 3 days) patient had twitching and tingling sensations all over patient body, mostly in his legs, thighs, calves, ankles, and occasionally in his lower and upper arm as well as his fingers. Reporter wanted to know if it was related to the vaccine. Reporter stated that while they were researching about it, they saw that bells palsy has also been reported with the use of the vaccine. Reporter also said that there were some people who had the same reaction as patient after receiving the vaccine. Reporter mentioned that patient was from (place name withheld), and they said that they heard about an existence of a Bells Palsy-like symptoms there. With that, reporter wanted to know if there was any information about neurological side effects or something similar to Bells Palsy that may be associated with the vaccine. Reporter also wanted to know what they should tell the doctor once they meet up with him or if there was any additional information from Pfizer that she could tell their doctor to help rule out what patient had. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Joint stiffness, Musculoskeletal stiffness, Neck pain
Clinical narrative: She couldn't turn her neck and her shoulder and collar bone and her chest hurt and it's getting worse; She couldn't turn her neck and her shoulder and collar bone and her chest hurt and it's getting worse; her right arm was sore from her shoulder to her neck to the top of her chest on the right side / her chest hurt and it's getting worse; right arm was sore from her shoulder to her neck to the top of  her chest on the right side; right arm was sore from her shoulder to her neck to the top of  her chest on the right side; right arm was sore from her shoulder to her neck to the top of  her chest on the right side; This is a spontaneous report from a contactable consumer or other non hcp from United States. The following was Reported by patient herself.   A 59-years-old female patient received bnt162b2 (bnt162b2), dose 2 via an unspecified route of administration, administered in Arm Right on 24Apr2021 15:00 (Batch/Lot number was not reported, Expiry Date: Unknown) as single dose (at the age of 59-years-old) for covid-19 immunization.  The patient previously took first dose on 03APR2021 via an unspecified route of administration, administered in Arm Right (Batch/Lot number was not reported, Expiry Date: Unknown) as single dose for covid-19 immunization. With the first Covid 19 vaccine she just had a sore arm (on 04Apr2021) the day after she received her vaccine. The soreness only lasted a day. Medical history included covid-19 from 11Mar2021 to an unknown date, ongoing arthritis, ongoing type 2 sugar diabetes, ongoing high blood pressure and ongoing lower lumbar sciatica. Patient reported that she had the Covid 19 virus on 11Mar2021. The patient's concomitant medications were not reported. When probing concomitant medications caller reports she takes her regular medications, nothing new has been prescribed. She declines to provide her medications for the report. Patient has no history of prior vaccinations (within 4 weeks). No other events were reported following prior vaccinations. Next day of receiving second dose on, 25Apr2021 her right arm was sore from her shoulder to her neck to the top of her chest on the right side. It's gotten worse since then. She couldn't turn her neck and her shoulder and collar bone (on 25Apr2021). Patient also complained of chest hurt which was reportedly getting worsened. There was no emergency room nor physician office visit for events. The outcome of events was not recovered.  No relevant tests were done. No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Reason for no lot number: The caller reports the vaccine record card does not have an NDC/Lot/Expiry for either dose.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: She couldn't turn her neck and her shoulder and collar bone and her chest hurt and it's getting worse; She couldn't turn her neck and her shoulder and collar bone and her chest hurt and it's getting worse; her right arm was sore from her shoulder to her neck to the top of her chest on the right side / her chest hurt and it's getting worse; right arm was sore from her shoulder to her neck to the top of  her chest on the right side; right arm was sore from her shoulder to her neck to the top of  her chest on the right side; right arm was sore from her shoulder to her neck to the top of  her chest on the right side; This is a spontaneous report from a contactable consumer or other non hcp from United States. The following was Reported by patient herself.   A 59-years-old female patient received bnt162b2 (bnt162b2), dose 2 via an unspecified route of administration, administered in Arm Right on 24Apr2021 15:00 (Batch/Lot number was not reported, Expiry Date: Unknown) as single dose (at the age of 59-years-old) for covid-19 immunization.  The patient previously took first dose on 03APR2021 via an unspecified route of administration, administered in Arm Right (Batch/Lot number was not reported, Expiry Date: Unknown) as single dose for covid-19 immunization. With the first Covid 19 vaccine she just had a sore arm (on 04Apr2021) the day after she received her vaccine. The soreness only lasted a day. Medical history included covid-19 from 11Mar2021 to an unknown date, ongoing arthritis, ongoing type 2 sugar diabetes, ongoing high blood pressure and ongoing lower lumbar sciatica. Patient reported that she had the Covid 19 virus on 11Mar2021. The patient's concomitant medications were not reported. When probing concomitant medications caller reports she takes her regular medications, nothing new has been prescribed. She declines to provide her medications for the report. Patient has no history of prior vaccinations (within 4 weeks). No other events were reported following prior vaccinations. Next day of receiving second dose on, 25Apr2021 her right arm was sore from her shoulder to her neck to the top of her chest on the right side. It's gotten worse since then. She couldn't turn her neck and her shoulder and collar bone (on 25Apr2021). Patient also complained of chest hurt which was reportedly getting worsened. There was no emergency room nor physician office visit for events. The outcome of events was not recovered.  No relevant tests were done. No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Reason for no lot number: The caller reports the vaccine record card does not have an NDC/Lot/Expiry for either dose.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: itching where her bra hooks; pain under left breast; Under the caller's left breast it is tender to touch; it feels like it would have something on her skin.; The caller didn't even want to touch her skin.; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6200), via an unspecified route, (left arm at the top) on 05Mar2021 09:00 (at the age of 66-year-old) and the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: EL9267 and Unknown NDC and expiration date), via an unspecified route, on 11Feb2021 as single dose for COVID-19 immunization. The patient was 66-years-old at the time of vaccination. Vaccination Facility Type was hospital. History of all previous immunization with the Pfizer vaccine considered as suspect was first dose of the covid vaccine. No prior Vaccinations (within 4 weeks), No AE(s) following prior vaccinations, No family Medical History Relevant to AE. Patient relevant medical history included renal cell carcinoma from 2001 to an unknown date had renal cell carcinoma in 2001 and had to get 1/3 of her kidney removed, diabetes, thyroid, stomach. The patient concomitant medication(s) included acebutolol hydrochloride (ACEBUTOLOL HYDROCHLORIDE) taken for blood pressure measurement, (200 mg, 1x/day); losartan potassium (LOSARTAN POTASSIUM) taken for blood pressure measurement (100 mg, 1x/day (once a day in the mornin), amlodipine besilate (AMLODIPINE BESILATE) taken for blood pressure measurement (5 mg, 1x/day (once a day in the afternoon), metformin hydrochloride (METFORMIN HYDROCHLORIDE) taken for diabetes mellitus (500 mg (at night, one tablet), pantoprazole sodium (PANTOPRAZOLE SODIUM) taken for gastric ulcer (40 mg (in the morning ), levothyroxine sodium (LEVOTHYROXINE SODIUM) taken for thyroid disorder (0.125 mg (1 tablet once in the morning), allopurinol (ALLOPURINOL) taken for renal cancer (300 mg); linagliptin (TRAJENTA) taken for diabetes mellitus (5 mg, 1x/day); chlorpropamide (CHLORPROPAMIDE) taken for diabetes mellitus, 10 mg (once at night), start and stop date for all were not reported. The patient experienced itching where her bra hooks, pain under left breast, under the caller's left breast it was tender to touch, it felt like it would have something on her skin, the caller didn't even want to touch her skin. On 11May2021, the patient underwent lab tests and procedures which included x-ray was not have the results yet. No any AE(s) required a visit to emergency room. Events required physician office visit (primary care provider). The outcome of event for itching where her bra hooks, pain under left breast was recovering and for under the caller's left breast it was tender to touch, it felt like it would have something on her skin, the caller didn't even want to touch her skin was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Pain in extremity
Clinical narrative: Sore arm after the first dose of the Covid Vaccine; Felt Cold after the First Dose of the Vaccine; This is a spontaneous report from a contactable consumer or other non hcp (Patient herself). A 70-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: ER8734), via an unspecified route of administration, administered in left arm on 01Apr2021 (age at the time of vaccination was 70-years-old) as 1st dose, single for COVID-19 immunization. Medical history included herpes from 1970 to an unknown date. Patient had been treated for Herpes on and off since the 1970s. Patient had undergone 3 surgeries in 2016 for knee revision. Patient had shingles three times in her life and received her shingles vaccine 3 years ago. Family history included that her husband had heart valve replacement in 2016. The patient's concomitant medications were not reported. On 02Apr2021, the patient experienced sore arm and felt cold after the first dose of the vaccine. The outcome felt cold was recovered on 02Apr2021 and sore arm was recovered on an unspecified date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: a little bit of hives on hand; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0182), via an unspecified route of administration on an unspecified date as second, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  Historical vaccine included 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 as first, single dose for COVID-19 immunization and experienced rash on legs and arm. The patient experienced a little bit of hives on hand on an unspecified date. Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021537812 same patient, different event, different dose of vaccine
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dizziness, Head titubation, Hypoaesthesia, Pain in jaw
Clinical narrative: Left arm numbness; hand tingling; left jaw pain; Left side of face and scalp began to burn; Internal tremor of the brain; dizziness; This is a spontaneous report from a contactable consumer reported for herself. A 40-years-old non-pregnant female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE,: solution for injection, Batch/Lot Number: Er8730 and Expiration date was not reported), via an unspecified route of administration, in right arm (age at vaccination 40-year-old) as 2nd dose, single for covid-19 immunisation and patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE,: solution for injection, Batch/Lot Number: En6208 and Expiration date was not reported), via an unspecified route of administration, administered in right arm on 19Mar2021 09:45 AM for covid-19 immunisation. Medical history included hypervitaminosis, migraines, and prior to vaccination, patient was diagnosed with COVID-19. The patient was allergic to Levaquin. Concomitant medications that patient received within 2 weeks of vaccination included ferrous citrate (IRON [FERROUS CITRATE]). Facility where the most recent COVID-19 vaccine was administered in hospital. Patient did not receive any other vaccines within 4 weeks previous to the COVID vaccine. Prior to vaccination, patient became now not diagnosed with COVID-19. Patient underwent laboratory test which includes nasal Swab Pcr, covid test on 11May2021 and the result was pending. On 09Apr2021 10:00 the patient experienced left arm numbness 5 minutes after injection, hand tingling, left jaw pain. Left side of face and scalp began to burn one day after injection. Internal tremor of the brain and dizziness. Treatment was received for all event as medical supervision from hospital staff. Since the vaccination, the patient was not tested for COVID-19. The outcome of events was not recovered.    No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, SARS-CoV-2 test
Clinical narrative: Left arm numbness; hand tingling; left jaw pain; Left side of face and scalp began to burn; Internal tremor of the brain; dizziness; This is a spontaneous report from a contactable consumer reported for herself. A 40-years-old non-pregnant female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE,: solution for injection, Batch/Lot Number: Er8730 and Expiration date was not reported), via an unspecified route of administration, in right arm (age at vaccination 40-year-old) as 2nd dose, single for covid-19 immunisation and patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE,: solution for injection, Batch/Lot Number: En6208 and Expiration date was not reported), via an unspecified route of administration, administered in right arm on 19Mar2021 09:45 AM for covid-19 immunisation. Medical history included hypervitaminosis, migraines, and prior to vaccination, patient was diagnosed with COVID-19. The patient was allergic to Levaquin. Concomitant medications that patient received within 2 weeks of vaccination included ferrous citrate (IRON [FERROUS CITRATE]). Facility where the most recent COVID-19 vaccine was administered in hospital. Patient did not receive any other vaccines within 4 weeks previous to the COVID vaccine. Prior to vaccination, patient became now not diagnosed with COVID-19. Patient underwent laboratory test which includes nasal Swab Pcr, covid test on 11May2021 and the result was pending. On 09Apr2021 10:00 the patient experienced left arm numbness 5 minutes after injection, hand tingling, left jaw pain. Left side of face and scalp began to burn one day after injection. Internal tremor of the brain and dizziness. Treatment was received for all event as medical supervision from hospital staff. Since the vaccination, the patient was not tested for COVID-19. The outcome of events was not recovered.    No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Vaccination site pain
Clinical narrative: Arm was a little sore just where the shot was / Caller confirms if was after both vaccines; This is a spontaneous report received from a contactable female consumer (patient). A 66-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EN6207 and Expiration date not reported), via an unspecified route of administration in left arm on 16Mar2021 (at the age of 66-year-old) at a single dose for COVID-19 immunisation in clinic. Medical history included ongoing Tumor Induced Osteomalacia from Jul2019 and surgery in Feb2021 (but they told her to hold off on the vaccine until 3 weeks after the surgery, so she did). The patient was been working on a diagnosis for 6 years, about 2.5 years ago she went to NIH and they diagnosed her, so maybe 2019, Jul 2019, and she's been going for labs every 3 months and that's why she noticed such a difference in the labs. Concomitant medication included calcitrol (CALCITROL) 0.5mcg every morning and every night by mouth and then when that blood work came back because her calcium level was elevated, they had reduced it to 0.25mcg every morning and every night taking it for 2.5 years. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not experienced any adverse event prior vaccination. Blood work was performed in Jan2021, results were unknown. On 16Mar2021, after vaccination the patient experienced arm was just a little sore. Patient stated she didn't do nothing that she noticed, her arm was a little sore just where the shot was, it was just like a normal shot. Patient stated only if she touched it, it felt like a shot. It was the day of the shot, maybe even the day after, she didn't pay attention to it. Patient confirmed if was after both vaccines. She stated it wasn't a whole sore arm, just the spot they gave it to her, if she didn't touch it, it didn't hurt. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain in left arm injection site/pretty similar to normal pain after injection which was dull and sore and hurt to lift arm; This is a spontaneous report from a consumer (patient) from a Pfizer sponsored program COVAX US support. A 20-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: ER8734), via intramuscularly in left arm on 02Apr2021 at 16:30 (at the age of 20-years-old) as 1st dose single for COVID-19 immunisation. Patient medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic, chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. Patient had no family medical history. Patient had no concomitant medications. No adverse event following prior vaccination. Patient was not administered with additional vaccines on same date of the pfizer suspect. On 02Apr2021at 22:00-23:00, patient experienced pain in left arm injection site. As reported, patient had a pretty similar to normal pain after injection which was dull and sore and hurt to lift arm. No ER (emergency room) or physician's office required. The outcome of events was resolving.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: This is a spontaneous report from a contactable nurse via a COVID sponsored Program. A 59-year-old non-pregnant (at the vaccination) female patient received BNT162B2 (COVID-19 VACCINE, solution for injection, Lot number and Expiration date:Unknown), via an unspecified route of administration on an unspecified date as an unknown, single dose for COVID-19 immunisation. It was reported that on Oct2020, the patient started to received treatment with Xeljanz XR, tablet, at 11mg daily orally for rheumatoid arthritis, psoriatic arthritis. The patient medical history included ongoing rheumatoid arthritis, and ongoing psoriatic arthropathy. The patient concomitant medications were not reported. On an unspecified date, patient fell after taking the COVID19 vaccine on Xeljanz XR. The reporter stated that she was not dizzy when asked. She was running. The patient treating doctor was aware and gave the patient instructions to pause Xeljanz while taking COVID vaccines. The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Fibromyalgia
Clinical narrative: fibromyalgia pain; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received second dose of COMIRNATY (Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on unspecified date as SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose of COMIRNATY (Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on unknown date as SINGLE DOSE for COVID-19 immunisation. On unspecified date the patient experienced, Fibromyalgia pain came back once after her 2nd covid shot (Pfizer). She just had one episode. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.