chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Drug interaction, Gait inability, Headache, Vertigo
Clinical narrative: Headache; Vertigo; Dizziness; prescribed was meclizine/because of his Parkinson's medications she believes it interacted; Couldn't walk/ the medication (meclizine) really affected his walking and so forth; This is a spontaneous report from a contactable consumer reporting for a patient. A 75-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK4176), intramuscular on 12Jan2021, 11:00 at SINGLE DOSE for COVID-19 immunisation, at 75 years old; and started to receive meclizine (expiration date 20Jan2022) via oral route of administration from an unspecified date in 2021 at 25 mg, thrice daily for vertigo. Medical history included ongoing Parkinson's from 2011, and ongoing glaucoma from 2017. No other vaccines administered on the same date. No other vaccines within 4 weeks. The patient's concomitant medication included unspecified lots of medications for Parikinson's from an unspecified date.  The patient experienced headache on 12Jan2021, on the first day; and vertigo on Jan2021 described as on the 4th or 5th day and dizziness on Jan2021. He slept in the chair for 5 days. He could not lay down without having vertigo. The vertigo has slowly gone away but now he is experiencing dizziness. When he tries to stand, he gets quite dizzy. Patient is due to receive his second vaccine tomorrow at the facility. Reporter wanted to know if patient should get the second vaccine. Patient still has very mild headaches off and on. The vertigo has gone away but he believes the dizziness has gotten a little worse. When he goes to stand up or anything, especially after laying down, he gets quite dizzy. They called the doctor's office and his doctor put him on a medication that was supposed to help with the vertigo. But, because of his Parkinson's medications she believes it interacted and did not work with him. He couldn't take it. He couldn't walk (unspecified date in 2021). She clarifies further the medication (meclizine) really affected his walking and so forth. The medication he was prescribed was Meclizine 25mg. He was prescribed to take one tablet by mouth three times daily as needed. She confirms the medication is dispensed in a pharmacy bottle. Patient wanted to know if there is any history of other people having dizziness and vertigo. The action taken for meclizine was unknown. Outcome of the event headache, Couldn't walk/ the medication really affected his walking and so forth, and "prescribed was meclizine/because of his Parkinson's medications she believes it interacted and did not work" was unknown. Outcome of dizziness was not recovered. Outcome of the event vertigo was recovered on an unspecified date in 2021.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Fatigue, Pyrexia
Clinical narrative: Chills; fever and a temperature (unspecified); Tiredness; Weak; This is a spontaneous report from a contactable consumer. An 84-year-old male patient (reporter's husband) received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL9262, expiry date unknown), via an unspecified route of administration on 29Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter and the patient got the vaccine and it was reported that the patient got side effects on 30Jan2021. The patient got lot of chills, had fever and a temperature (unspecified). The patient also had tiredness and was very weak. He had to go to the bed in the afternoon and that was 24 hours later. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Mouth haemorrhage
Clinical narrative: blood in her mouth; metallic taste in her mouth; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced blood in her mouth and metallic taste in her mouth on an unspecified date. It was reported that the patient had a metallic taste in her mouth which she has a strong metallic taste but also has blood in her mouth. She wants to know if that is a side effect. She still has the metallic taste but no longer has blood in her mouth. The patient woke up with blood in her mouth. The patient recovered from blood in her mouth while not recovered from metallic taste in her mouth.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence, Vaccination site pain
Clinical narrative: more tired; left arm/injection arm, had a little bit of pain; little more drowsy than normal; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: PFREL1283; expiry date: 30Apr2021) via an unspecified route of administration on 08Jan2021, at single dose, for COVID-19 immunization. Medical history included pre-diabetic, thyroid disorder and cholesterol abnormal. Concomitant medications included levothyroxine for couple of years for thyroid disorder and rosuvastatin for 30 some odd years for blood cholesterol abnormal. The patient reported that with the first shot, she had side effects she was aware of. On 08Jan2021, she was a little more drowsy than normal. It was nothing severe, but when she was up and awake, she could tell she was more tired. That lasted over 3 days. It wasn't like she couldn't do anything. She just felt more tired than normal. It was different than normal. On 09Jan2021, her left arm, which was her injection arm, had a little bit of pain. She understood that though. It lasted a couple of days. Outcome of the event tired was unknown, while for the other events was recovered on 10Jan2021.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dyspnoea, Fatigue, Feeling cold
Clinical narrative: Chills; coldness; Heart was beating fast; Palpitations; Headache; Dizzy; Tired/exhausted/feeling of exhaustion; Breathing was not coming on easily; Slight muscle ache; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported by the patient that after she got her vaccine, she was feeling fine. She did have chills and coldness. That was pretty much it. The nurse had asked if her heart was beating fast. She replied that it was, but she thought it was out of excitement or adrenaline. They said to let her doctor know if anything happens. She went home and Friday afternoon the chills were noticed more and her heart felt like it was beating faster. It was 100 beats per minute. She felt palpitations, chills, and headache coming on. The next morning, she felt much better than the night before. A little later that day she was getting tired, exhausted, and had a headache. The night before she felt a little dizzy too. Then the next day her breathing was not coming on easily. She also had a little muscle ache. Each day she is feeling better which is good. But the feeling of exhaustion is still there. The outcome of the event fatigue was not recovered while recovering for the other events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Heart rate increased, Myalgia, Palpitations
Clinical narrative: Chills; coldness; Heart was beating fast; Palpitations; Headache; Dizzy; Tired/exhausted/feeling of exhaustion; Breathing was not coming on easily; Slight muscle ache; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported by the patient that after she got her vaccine, she was feeling fine. She did have chills and coldness. That was pretty much it. The nurse had asked if her heart was beating fast. She replied that it was, but she thought it was out of excitement or adrenaline. They said to let her doctor know if anything happens. She went home and Friday afternoon the chills were noticed more and her heart felt like it was beating faster. It was 100 beats per minute. She felt palpitations, chills, and headache coming on. The next morning, she felt much better than the night before. A little later that day she was getting tired, exhausted, and had a headache. The night before she felt a little dizzy too. Then the next day her breathing was not coming on easily. She also had a little muscle ache. Each day she is feeling better which is good. But the feeling of exhaustion is still there. The outcome of the event fatigue was not recovered while recovering for the other events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain lower, Ageusia, Condition aggravated, Pain, Pain in extremity
Clinical narrative: The pains across his body keeps getting worse, the pains got a little better Saturday but then Saturday night it got pretty bad.; Loss of taste; difficulty talking; Friday night the same thing happened except the pains were a little higher and above his belly button; pain across body; little bit of soreness in left arm; This is a spontaneous report from a contactable consumer (patient). This 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number EL9261, exp. unknown) , intramuscular on left arm on 21Jan2021 08:30 at single  dose covid-19 immunization at a clinic.  Medical history included thyroid disorder from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included levothyroxine 100mcg once a day for thyroid.  The patient experienced little bit of soreness in left arm (non-serious) on 21Jan2021 with outcome of recovered, pain across body (non-serious) on 28Jan2021 20:00 with outcome of recovering , the pains across his body keeps getting worse/the pains got a little better Saturday but then Saturday night it got pretty bad (condition aggravated) (non-serious) on an unspecified date with outcome of unknown, loss of taste (non-serious) on 01Feb2021 with outcome of unknown, difficulty talking (non-serious) on 31Jan2021 with outcome of not recovered , pains were a little higher and above his belly button (non-serious) on 29Jan2021 with outcome of unknown.  The patient underwent lab tests and procedures which included thyroid function test was low on Sep2020 (levothyroxine was changed to 125mcg from 112mcg), thyroid function test was back towards normal but had not quite reached it on Nov2020 (new dose of 100mcg tablet once a day), thyroid function test was unknown on 25Jan2021 but was on 100mcg of levothyroxine once a day.  Therapeutic measures were taken as a result of little bit of soreness in left arm and pain across body included Tylelol (acetaminophen).
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Speech disorder, Thyroid function test
Clinical narrative: The pains across his body keeps getting worse, the pains got a little better Saturday but then Saturday night it got pretty bad.; Loss of taste; difficulty talking; Friday night the same thing happened except the pains were a little higher and above his belly button; pain across body; little bit of soreness in left arm; This is a spontaneous report from a contactable consumer (patient). This 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number EL9261, exp. unknown) , intramuscular on left arm on 21Jan2021 08:30 at single  dose covid-19 immunization at a clinic.  Medical history included thyroid disorder from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included levothyroxine 100mcg once a day for thyroid.  The patient experienced little bit of soreness in left arm (non-serious) on 21Jan2021 with outcome of recovered, pain across body (non-serious) on 28Jan2021 20:00 with outcome of recovering , the pains across his body keeps getting worse/the pains got a little better Saturday but then Saturday night it got pretty bad (condition aggravated) (non-serious) on an unspecified date with outcome of unknown, loss of taste (non-serious) on 01Feb2021 with outcome of unknown, difficulty talking (non-serious) on 31Jan2021 with outcome of not recovered , pains were a little higher and above his belly button (non-serious) on 29Jan2021 with outcome of unknown.  The patient underwent lab tests and procedures which included thyroid function test was low on Sep2020 (levothyroxine was changed to 125mcg from 112mcg), thyroid function test was back towards normal but had not quite reached it on Nov2020 (new dose of 100mcg tablet once a day), thyroid function test was unknown on 25Jan2021 but was on 100mcg of levothyroxine once a day.  Therapeutic measures were taken as a result of little bit of soreness in left arm and pain across body included Tylelol (acetaminophen).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Headache
Clinical narrative: Bad headache; This is a spontaneous report from a contactable consumer (patient).  A 74-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL8920, expiry date unknown), via an unspecified route of administration on 19Jan2021 at a single dose for COVID-19 immunization.  Medical history included COVID from Nov2020 to an unknown date. The patient's concomitant medications were not reported. The patient stated that she had a very slight case of COVID in Nov2020 and her family doctor told her about three weeks ago that she needed to get the vaccine. However, he did not tell the patient that she needed to wait 90 days from when she had COVID (as reported). So, she got the Pfizer vaccine about two months and a week after she had COVID itself. Ever since about five days after she had the vaccine, on an unspecified date in Jan2021, she came down with a bad headache and have had a headache since that day. She is on day nine of a headache and this is the headache that require medication. It is not the headache that you think is going way because it has not. She wanted to know if she got the headache because she got the vaccine too soon after having COVID. The patient got medicine for the headache because she had to go to the emergency room for the event. She had blood work done on an unspecified date but had unknown results. The outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine
Clinical narrative: Migraines came full blown; Excruciating headaches; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age (reported as Age: 39, Unit: Unknown) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 15Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Family history includes her mom having history of migraines. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Dec2020 for COVID-19 immunization and experienced Tingling, throbbing, and pressure on the top and back of her head. The patient received the second of the vaccine on 15Jan2021 and stated the migraines came full blown on an unspecified date in 2021. She also reported experiencing excruciating headaches on an unspecified date in 2021, in which she called off work today and has visited urgent care. The patient stated that she does not have a history of migraines. She wanted to know the percentages of people who have experienced headaches in both age groups. She also stated that her mom has a history of migraines. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was a little sore; This is a spontaneous report from a contactable consumer (patient's sister). A female patient of unspecified age received BNT162B2 (COVID vaccine), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had the COVID vaccine and her arm was a little sore but that's all. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Nasopharyngitis, Pain
Clinical narrative: low grade temp; soreness in arm; feeling achy; feeling weak; felt like a bad cold; chills; threw up in his sleep; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient started to received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiry date unknown), via an unspecified route of administration at the left arm on 29Jan2021 14:35 at a single dose for COVID-19 immunization. The patient's medical history included to go to sleep, opens up the prostate and prostate cancer. The patient's family history included prostate cancer (father and brother). The patient's concomitant medications included ongoing tamsulosin to opens up the prostate and plantago ovata (METAMUCIL). After the vaccine, patient felt fine on Saturday and Sunday then last night (31Jan20201) he threw up in his sleep, it startled him and woke him up. Then he got up again at 0600AM on 01Feb2021 to take a leak and reported feeling achy; weak feeling like he had a bad cold; and he took his temperature which was 96.9 (unit unknown) which seems normal for him. He took it again and it was 98.4 (unit unknown). The patient reported that he was fine for 2 days then felt the effects. He threw up in middle of night, achy weakness, chills, low grade temp. He had soreness in arm on an unspecified date. The guy that gave the shot said his arm got sore for about 24hrs and the patient took Tylenol. Patient was asking if he should be concerned the symptoms started more than 36hours after getting the 1st dose. He was asking if these can be reaction to vaccine or if he needs to get tested for COVID.He was scheduled to receive the second dose on 20Feb2021. The outcome of the event 'threw up in his sleep' was recovered on 31Jan2021; feeling achy, feeling weak, felt like a bad cold, and chills were recovering; and the outcome of the other events was unknown. The vaccination facility type was hospital.  Information on the lot/batch number has been requested.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vomiting
Clinical narrative: low grade temp; soreness in arm; feeling achy; feeling weak; felt like a bad cold; chills; threw up in his sleep; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient started to received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiry date unknown), via an unspecified route of administration at the left arm on 29Jan2021 14:35 at a single dose for COVID-19 immunization. The patient's medical history included to go to sleep, opens up the prostate and prostate cancer. The patient's family history included prostate cancer (father and brother). The patient's concomitant medications included ongoing tamsulosin to opens up the prostate and plantago ovata (METAMUCIL). After the vaccine, patient felt fine on Saturday and Sunday then last night (31Jan20201) he threw up in his sleep, it startled him and woke him up. Then he got up again at 0600AM on 01Feb2021 to take a leak and reported feeling achy; weak feeling like he had a bad cold; and he took his temperature which was 96.9 (unit unknown) which seems normal for him. He took it again and it was 98.4 (unit unknown). The patient reported that he was fine for 2 days then felt the effects. He threw up in middle of night, achy weakness, chills, low grade temp. He had soreness in arm on an unspecified date. The guy that gave the shot said his arm got sore for about 24hrs and the patient took Tylenol. Patient was asking if he should be concerned the symptoms started more than 36hours after getting the 1st dose. He was asking if these can be reaction to vaccine or if he needs to get tested for COVID.He was scheduled to receive the second dose on 20Feb2021. The outcome of the event 'threw up in his sleep' was recovered on 31Jan2021; feeling achy, feeling weak, felt like a bad cold, and chills were recovering; and the outcome of the other events was unknown. The vaccination facility type was hospital.  Information on the lot/batch number has been requested.
Age: 24.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: A few days later I got covid; A few days later I got covid; This is a spontaneous report from a contactable consumer (patient). A 24-year-old patient of an unspecified gender received the first dose of bnt162b2 (BNT162B2, lot number unknown), via an unspecified route of administration (at the age of 24-years-old) on 19Jan2021 at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated "I got the vaccine (Unspecified Vaccine) on 19Jan (complete date not clarified); and then a few days later (in 2021) I got COVID and my mom also got COVID so I was wondering do I still; can I still get the second vaccine and how long should I wait from having covid to get the second vaccine?" The outcome of the events was unknown.  Information on the batch/lot number has been requested.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Visual field defect
Clinical narrative: can't see straight; dizzy; This is a spontaneous report from a contactable consumer (patient).  A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9264 and expiration date not provided), via an unspecified route of administration first dose on 29Jan2021 at single dose for Covid-19 immunization.  The patient's medical history included ongoing high blood pressure. The patient's concomitant medications included unspecified blood pressure medication. It was reported that patient had first shot on Friday 29Jan2021 and everything was fine, it was the easiest shot has ever had. On Sunday 31Jan2021, the patient started getting dizzy. The patient had to hold on to the wall to balance himself. The patient was dizzy again today. The patient doesn't know if it is a coincident or a side effect. It probably started about 40 hours after the vaccine. The patient stated that he was currently miles from home, and he was going to start driving, but he can't see straight. The outcome of the events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm was sore at the place/soreness in the arm around his injection site; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported) via an unspecified route of administration on 31Jan2021 14:15 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  Patient got the shot on 31Jan2021 at 1415 and everything was fine and it didn't hurt at all. Then this morning (01Feb2021) at 0600 - 0700 AM, he noticed his arm was sore at the place, also reported as soreness in the arm around his injection site. He was asking if he can take anything. He mentioned he has a bottle of acetaminophen and was asking if he can take it. The outcome of the event was unknown.   Information on about lot/batch number has been requested.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Right arm was barely sore where injection administered; This is a spontaneous report from a contactable consumer (patient).  A 78-year-old male patient received first dose of BNT162B2 (Lot number: EL0142), via an unspecified route of administration on 11Jan2021 17:05 at single dose in the right arm for vaccination. Medical history included eye vitamin/To maintain good eye health, eye disorder, Heart supplement, heart disorder and he had his last annual physical with Pneumocystis pneumonia (PCP) in Oct2020. He had his flu shot in Sep2020. Concomitant medication included ramipril taken for probably at least 15 years, started in his 60s; atorvastatin taken for probably at least 15 years, started in his 60s. He believes this is the generic product for Pfizer Lipitor; acetylsalicylic acid (ASPIRIN CHILDREN) taken for probably at least 15 years, started in his 60s; ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (AREDS) (also reported as "Advanced Retinol Eye Study Disease") for eye vitamin/To maintain good eye health; bioflavonoids nos, lecithin, quercetin, ubidecarenone (CO-Q-10 PLUS) taken for probably at least 15 years, started in his 60s for Heart supplement; and unspecified multivitamin taken daily and probably taken all his life, all ongoing. This patient reported he was administered his first dose of Pfizer COVID-19 vaccine on 11Jan2021. There were no side effects; his right arm was barely sore where injection administered on 11Jan2021. Onset probably about 19:05-20:05 and he had recovered completely by the next morning when he woke. He had no discomfort during the night, no pain or throbbing, he felt very normal the next morning. He clarified that he has no medical conditions, no flu or illnesses of any other kind. He had his last annual physical with PCP in Oct2020; he has a twice yearly check-up with the Cardiologist that will be coming up soon. Stated that today is the 21st day and he is scheduled to get his second dose at 3:00pm. He asked how the incremental immunity builds up percentage wise after getting the first and second dose of Pfizer COVID-19 vaccine. He asked if there is any restriction or limitation on taking products like Tylenol, Advil or Aspirin before getting the Pfizer COVID-19 Vaccine; and if those products are ok to use to potentially treat side effects from the Pfizer COVID-19 Vaccine such as if patient has sore arm or something; and how soon after the second dose side effects can kick in-he believes the briefing documents he was given for the Pfizer COVID-19 Vaccine said 2-14 days. He asked this particularly because he has an hour drive home after this second dose and wanted to know what to anticipate before attempting to drive home. His wife thought someone told her not to take any Tylenol, Advil or Aspirin before getting the Pfizer COVID-19 Vaccine which they had not heard of elsewhere, and saw no mention of that in the briefing documents given for the Pfizer COVID-19 Vaccine. The with outcome of the event was recovered on 12Jan2021.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal pruritus, Pain in extremity, Sneezing, Swelling face
Clinical narrative: Itchy nose; Sneezing; sore arm; Swollen face; This is a spontaneous report from a contactable consumer. An 84-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported) at age 84 years (as reported), via an unspecified route of administration on 25Jan2021 at single dose for COVID-19 immunization. Medical history included ongoing blood pressure high. Concomitant medication included warfarin sodium (COUMADIN). The patient previously received shingles vaccine (believes it was more than four weeks before getting the COVID vaccine). It was reported that the day after (26Jan2021), the patient experienced sore arm like everyone else. The sore arm has gone away, but does not know what day it went away. The day after the vaccine the patient had a swollen face (26Jan2021) and today it is worse; it is more swollen. On 01Feb2021, the patient experienced an itchy nose and sneezing. The outcome of the event sore arm was recovered on an unspecified date, the event swollen face was not recovered, while unknown for the events itchy nose and sneezing.  Information on Lot/Batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid; This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982 and expiry date: Apr2021), via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunization. Medical history was reported as none.  There were no concomitant medications. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient stated, "I received the vaccine on 20Jan2021, Pfizer at my work at (Facility name) and then I just tested positive for COVID on 20Jan2021. So, how will that effect my second dose?" When asked about treatment, the patient stated, "I do not know. Is Tylenol also considered as a treatment?" And when asked about causality, the patient stated, "I think so, I mean I do not want to rule that out, but maybe." The outcome of the event was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever; Chills; Aches and pains; hurting all over; Headache like my head was going to explode; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL3302; expiration date: unknown) at vaccination age of 74-year-old via an unspecified route of administration on 19Jan2021 at a single dose for covid-19 immunization. Medical history included type 2 diabetes, autoimmune thyroid disease and complex migraine (migraine chronic, complex migraine). The patient's concomitant medications were not reported. The patient reported that last Friday (29Jan2021, also reported as two weeks later), she got a fever, chills, aches and pains. She was hurting all over and she had a headache like her head was going to explode. So, she wanted to know could that be a delayed reaction to the shot (vaccine). The patient mentioned that treatment for the problems included acetaminophen, butalbital, and caffeine (FIORICET). The outcome of the events was unknown.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Nasopharyngitis, Rhinorrhoea, Sinus congestion
Clinical narrative: runny nose; cough; sinus congestion; Cold; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283, expiry date was not reported) (at 66 years of age), via an unspecified route of administration in the left arm on 12Jan2021 (at approximately noon) at a single dose for COVID-19 immunization. Medical history included blood cholesterol abnormal. Concomitant medication included simvastatin for cholesterol. The patient has no any other vaccines within four weeks prior to the covid vaccine. The patient got the first dose of the vaccine and he is due to get the second dose tomorrow. However, he has a cold. He does not have a fever; but he has a runny nose and a cough, both on an unknown date. He wanted to know if it was safe for him to get the vaccine; or if not, if it is delayed, how long. He commented that he did not know what to do. Patient has had the cold for ten days. It was getting better, but not rapidly getting better. He had been taking cold medicine as treatment which was not prescribed, it was over the counter. The time of onset for cold was at bedtime like ten days ago (22Jan2021), at around bedtime started to feel the drainage. On 01Feb2021, it was reported that the patient was due for his second dose of the vaccine tomorrow but he has a cold. He has no fever but has a cough and sinus congestion. The outcome of cold was recovering while unknown for runny nose, cough and sinus congestion. Therapeutic measure was taken as a result of cold with the use of cold medicine (unspecified).
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Pain in extremity
Clinical narrative: terrible pain in leg and can hardly walk; terrible pain in leg and can hardly walk; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown, reported as EL926S or EL9265), intramuscular (arm right) on 29Jan2021 at SINGLE DOSE for COVID-19 immunisation, at 84 years old. The patient's medical history included "nerve pain, neuropathy". Family history included Parkinson's (child). The patient previously received the first dose (arm left) of BNT162B2 (lot number ELO140) on 07Jan2021 for COVID-19 immunisation and experienced Slept the whole day. Concomitant medication included pregabalin (LYRICA) from an unspecified date for "nerve pain, neuropathy". No other vaccines were given the same day. It was reported that for COVID vaccine, there was a terrible pain in leg and can hardly walk on 30Jan2021. The pain in the legs was reported as getting worse. The adverse events did not require visit to the Emergency Room or Physician Office. Outcome of the event was not recovered.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: a little bit of soreness in the arm at the injection site; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration in the arm on 21Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no side effects aside from a little bit of soreness in the arm at the injection site in Jan2021 with outcome of unknown.  Information on the batch/lot number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscles in arm hurting; This is a spontaneous report from a contactable consumer (reporting for herself). A 68-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiration date: May2021), via an unspecified route of administration in her right arm from 21Dec2020 07:15 to 21Dec2020 07:15 at SINGLE DOSE for COVID-19 immunization. There was no medical history and concomitant medications reported. In Dec2020, the patient experienced that the muscles in her arm started hurting. The outcome of the event was not recovered.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Pain in extremity
Clinical narrative: could not get her legs to work; her arm was sore; Dizzy/ Dizziness was reported as worsened; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN5318) intramuscular on the right arm on 27Jan2021 15:30 at a single dose for COVID-19 immunization. Medical history included peritoneal dialysis from Apr2020 and diabetes (diagnosed about 30 years ago) both ongoing; blood thinner, 2 stents a and a balloon from Dec2020 and high blood sugar. There was no family medical history. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN) for stents, insulin detemir (LEVEMIR) for diabetes, insulin aspart (NOVOLOG) for high blood sugar during the day and clopidogrel bisulfate (PLAVIX) as blood thinner all were ongoing. The patient stated that her arm was sore on 27Jan2021 and that was no big deal. She said that she got so dizzy and was walking like a drunk. Dizziness was reported as worsened. Patient said that last night (31Jan2021) she tried to get to the bathroom, but she could not get her legs to work. She said that her husband had to lead her to the bathroom with a walker and when she was done, she could not get back to bed. She was scared to death last night when her legs would not work. She said that she thought her symptoms would just go away. What should she do about her symptoms? The facility where the vaccine was administered was in a clinic. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of Pfizer suspect. The events did not require a visit to physician office or Emergency Room. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No relevant tests done. Outcome of the events was not recovered.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Peripheral swelling, Vaccination site erythema
Clinical narrative: Arm swollen and turned red 3 inches above and below injection site; Arm swollen and turned red 3 inches above and below injection site; arm swollen and turned red 3 inches above and below injection site. She said it does not hurt, but just feels kind of heavy; This is a spontaneous report from a contactable consumer. A 76-year-old female patient received BNT162B2 (lot number: EN5318), intramuscular on 25Jan2021 08:30 at single dose in the right arm for Prevention. Medical history included diabetes diagnosed 10 years ago, acid reflux and cholesterol, all on unknown dates. Concomitant medication included esomeprazole sodium (NEXIUM) taking for 10 years for Acid Reflux, ongoing metformin for diabetes, "Sarxigo" taking for about 3 years for diabetes and unspecified cholesterol medication. On 26Jan2021 09:30, the patient experienced arm swollen and turned red 3 inches above and below injection site. She said it does not hurt, but just feels kind of heavy. The flu shot did that to her too, but not as bad. Flu shot turned her arm red this year also. She got it in Oct2020. She also got in the right arm in the muscle. She would like to know if she will she be safe to take second dose of BNT162B2. The patient did not receive any other vaccines within four weeks prior to the vaccination. The outcome of the events was not recovered.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Myalgia, Pain, Pyrexia
Clinical narrative: Covid vaccine first dose--flu like symptoms (body aches, headache, muscle aches, light fever); Covid vaccine first dose--flu like symptoms (body aches, headache, muscle aches, light fever); Covid vaccine first dose--flu like symptoms (body aches, headache, muscle aches, light fever); Covid vaccine first dose--flu like symptoms (body aches, headache, muscle aches, light fever); Covid vaccine first dose--flu like symptoms (body aches, headache, muscle aches, light fever); This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient received first single dose of BNT162B2 (Solution for injection, batch/lot number and expiration date not reported), intramuscular administered to left arm on 04Jan2021 14:00 for COVID-19 immunization. Vaccination Facility Type: Hospital. Medical history included migraine. Patient had medication for them, but has not had any migraines in a long time. The patient's concomitant medications were not reported. There were no other vaccines given the same day. Patient had no problems with vaccines in past. The patient had questions about the side effects of the Covid vaccine. On 04Jan2021 when she got the first dose, later that day (a few hours after the shot) the patient experienced flu like symptoms (body aches, headache, muscle aches, and light fever). Had the headache for about 4 days with the first dose. All this lasted about 4 days. They cleared up and she was fine. The patient wanted to know if anyone reported any of this or prolonged symptoms. Patient was unable to provide seriousness criteria when queried, only states that it was very frustrating, it's not life threatening, but she was at home versus being at work. No investigation assessment/relevant tests performed. The patient recovered from the events on an unspecified date in Jan2021. The reporter considered the events as related to the Covid vaccine.  Information about lot number and expiry date for the suspect product will be requested in follow-up attempts.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Pruritus, Rash, Skin disorder, Urticaria
Clinical narrative: a little bit of itching; kind of hives; uncomfortable at times, at his feet, and ankles; he has rashes; terrible skin; This is a spontaneous report from a contactable consumer (reporting for himself). A 79-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiration date: unknown), via an unspecified route of administration from 09Jan2021 to 09Jan2021 at single dose for COVID-19 immunization. The patient's medical history Ablation surgery. The patient's concomitant medications were not reported. On an unspecified date, the patient had a little bit of itching, kind of hives, he did not break out, he was uncomfortable at times, at his feet, and ankles. The patient has rashes, and terrible skin. The outcome of the events was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site mass
Clinical narrative: Has a small, walnut sized lump on her left arm where the injection was; having increased arthritis pain; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (lot EL3247) via an unspecified route of administration in the left arm on 23Jan2021 at a single dose for COVID-19 immunization. Medical history included Covid prior to getting the first shot (has had Covid). Concomitant medications were not reported. It was reported that the patient has a small, walnut sized lump on her left arm where the injection was on Jan2021 that has been there for about a week. She wanted to know what to do about the lump and if she should get the second shot. It was also reported that she's having increased arthritis pain on 2021. She's going to a state on 28Feb2021 and would have second shot on 23Feb2021 and she needed a negative Covid test 72 hours prior to going. She wanted to know how would she get a negative Covid test. The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Emotional disorder, Heart rate, Heart rate increased, Nervousness
Clinical narrative: got upset; pulse faster than normal; Nervous; Worried; This is a spontaneous report from a non-contactable consumer (patient). An 80-year-old patient of an unspecified gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: Unknown), via an unspecified route of administration on 2021 at a single dose for COVID-19 immunization. Medical history included hypertension. Concomitant medication included rosuvastatin calcium (CRESTOR) and unspecified blood pressure medication (the patient takes 40 mg and then with that, the doctor gave patient, it started with Hydro something and that kind of eliminate the salts from your body when you urinate a little bit more). The patient has hypertension and got upset and had a pulse faster than normal. The patient pulled over the vehicle and drive through and 'drive a mile' but then in about 10 minutes it started again but it seems like a 'fall down' and the patient got real nervous and patient was still nervous. The patient is 80 years old. The patient said he/she did not know he/she got home and the patient took a Benadryl as treatment.  The patient got home, nervous and can breath all right, just nervous. The patient mentioned being in good health and everything and was just worried about himself/herself. The outcome of the event pulse faster than normal was recovering; nervous was not recovered; outcome for all other events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: welts and rash on back and chest with second shot; welts and rash on back and chest with second shot; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9265, expiration date: May2021), via an unspecified route of administration on 29Jan2021 at single dose for COVID-19 immunisation. Medical history included ablation surgery from an unknown date about two to three months ago. The patient's concomitant medications include an unspecified blood pressure medicine. The patient previously received the first dose of BNT162B2 (lot number: EL3248, expiration date: Apr2021) on 09Jan2021 for COVID-19 immunization and experienced had a little bit of itching, kind of hives, uncomfortable at times, has rashes, terrible skin. On 30Jan2021, Saturday evening, it was reported that the patient experienced welts and rash on back and chest with second shot and were probably worse on Sunday, he doesn't know if it is better today or not, perhaps it is a little better. The outcome of the events was recovering.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching/both arms near her wrist area only were itching like crazy/her back was itchy; two red welts, almost like hives on her body; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN5318, expiry date: not reported), via an unspecified route of administration at left upper arm on 28Jan2021 17:30 at SINGLE DOSE for COVID-19 immunisation. The patient had no prior vaccinations within 4 weeks. Medical history included ongoing macular degeneration and thyroid disorder. Concomitant medications included levothyroxine for thyroid and ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (AREDS). The patient got the vaccine on Thursday 28Jan2021. Thursday and Friday she was fine. However, Saturday morning (30Jan2021) when she woke up she had two red welts, almost like hives on her body and a little bit of itching. Then, the wee hours of yesterday morning (Sunday morning) both arms near her wrist area only were itching like crazy. She was calling to see if it would be okay to take Benadryl for the itching. No one she has called yet has been able to answer her question. She tried contacting the hospital where she got the vaccine. The patient further reported that she noticed the two red welts like hives on her body on Saturday in the morning (30Jan2021) when she woke up, exact time not specified. This has gone away. It went away sometime yesterday (31Jan2021). These were also itchy. She noticed the inside of her arm by the wrist area in the early morning hours yesterday were extremely itchy. She thought for sure she would wake up with red welts but there wasn't any. Her arms are fine. Now, her back was itchy. Her back now was the only thing now really itching. She placed Cortisone cream on her back and it helped. Her back was still a little itchy, but not as bad. The patient scheduled for her second dose on 18Feb2021. Therapeutic measures were taken as a result of itching/both arms near her wrist area only were itching like crazy/her back was itchy. On 31Jan2021, the patient recovered from "two red welts, almost like hives on her body" and was recovering from itching.