chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Migraine, Muscle spasms, Nausea, Vaccination site pain
Clinical narrative: Migraine; Nausea; Severe muscle spasms on right side of body; Dizziness; Weakness; Heartbeat elevated 20 bpm; Pain and swelling at injection site; Swelling at injection site; Chills; Vomiting; Loss of appetite; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on an unknown date in Apr2021 at 15:00 (at the age of 43-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on an unknown date in Apr2021 at 15:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient included Polycystic Ovarian Syndrome (PCOS) and chronic inflammation. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. Concomitant medications included metformin (MANUFACTURER UNKNOWN), low-dose naltrexone (MANUFACTURER UNKNOWN) and estradiol (MANUFACTURER UNKNOWN), all taken for an unspecified indication from an unknown date and unknown if ongoing. On an unknown date in Apr2021 at 04:30, 12 hours after the shot, the patient experienced migraine, nausea, severe muscle spasms on right side of the body every 30 seconds, dizziness, weakness, heartbeat elevated 20 beats per minute (bpm), pain and swelling at injection site and chills. On an unknown date in Apr2021, 20 hours after the shot, the patient experienced muscle spasms right side, vomiting, chills, loss of appetite and migraine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events migraine, nausea, severe muscle spasms on right side of body, dizziness, weakness, heartbeat elevated 20 bpm, pain and swelling at injection site, chills, vomiting and loss of appetite was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vomiting
Clinical narrative: Migraine; Nausea; Severe muscle spasms on right side of body; Dizziness; Weakness; Heartbeat elevated 20 bpm; Pain and swelling at injection site; Swelling at injection site; Chills; Vomiting; Loss of appetite; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on an unknown date in Apr2021 at 15:00 (at the age of 43-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on an unknown date in Apr2021 at 15:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient included Polycystic Ovarian Syndrome (PCOS) and chronic inflammation. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. Concomitant medications included metformin (MANUFACTURER UNKNOWN), low-dose naltrexone (MANUFACTURER UNKNOWN) and estradiol (MANUFACTURER UNKNOWN), all taken for an unspecified indication from an unknown date and unknown if ongoing. On an unknown date in Apr2021 at 04:30, 12 hours after the shot, the patient experienced migraine, nausea, severe muscle spasms on right side of the body every 30 seconds, dizziness, weakness, heartbeat elevated 20 beats per minute (bpm), pain and swelling at injection site and chills. On an unknown date in Apr2021, 20 hours after the shot, the patient experienced muscle spasms right side, vomiting, chills, loss of appetite and migraine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events migraine, nausea, severe muscle spasms on right side of body, dizziness, weakness, heartbeat elevated 20 bpm, pain and swelling at injection site, chills, vomiting and loss of appetite was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness
Clinical narrative: Blood pressure went up; Light headed; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 26Apr2021 at 13:00 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history included Barrett's esophagus and allergy to sulfa drugs (sulfonamide allergy). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included potassium chloride (MANUFACTURER UNKNOWN), pantoprazole (MANUFACTURER UNKNOWN) and chlortalidone (CHLORTHALIDONE); for unknown indications from an unknown date and unknown if ongoing. The patient previously received lisinopril (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN) and losartan (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. On 26Apr2021 at 14:00, within 2 hours of getting the second dose the patient's blood pressure went up and felt light headed. For the next 2 days the pressure stayed up and on the 3 days after it came down. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events blood pressure went up was recovered on 29Apr2021; while that of the event felt light headed was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Pyrexia
Clinical narrative: Starting 12 hours following the second dose on 4/23/20201 experienced chills; Starting 12 hours following the second dose on 4/23/20201 experienced chills, significant muscle aches; Starting 12 hours following the second dose on 4/23/20201 fever started which lasted for about 32 hours. The fever was between 99oF and 101.5oF during; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ERZ735) via an unspecified route of administration in the left arm on 23Apr2021 at 11:15 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 02Apr2021 at 10:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021 at 23:15, 12 hours following the second dose, the patient experienced chills, significant muscle aches and fever which lasted for about 32 hours. The fever was between 99oF and 101.5oF during that timeframe. On the same day, the patient underwent body temperature test and the result was between 99 degree Fahrenheit and 101.5 degree Fahrenheit. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of the reported events which included treatment with paracetamol (TYLENOL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, chills, significant muscle aches was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, Dizziness, Dyspnoea, Eye pain
Clinical narrative: Legs were weak; Left arm hurt (where the application was made); Headache; Eyes hurting; Little dizzy; Tired; A lump under arm pit; Tingling left arm and chest; Difficulty to breathe (like anxiety, but it was not); Feel a pinch on back with some pain; Lump under arm pit hurting; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 23Apr2021 at 20:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19: Yes). The patient had no known allergies. Concomitant medications included ascorbic acid (VIT C), vitamin b nos (VITAMIN B), colecalciferol (VIT D3) and fish oil (OMEGA 3); all for an unknown indication, from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 23Apr2021 at 20:30 on the first day of vaccination, left arm hurt for the patient (where the application was made), then the patient experienced  headache, eyes were hurting, little dizzy and tired. On 24Apr2021 on second day of vaccination, his left arm hurt, he also felt dizzy, tired and legs were weak. In Apr2021 on third (25Apr2021), fourth(26Apr2021) and fifth day(27Apr2021) of vaccination the patient's  left arm hurt, legs were weak, a lump under his arm pit was hurting, he felt tingling in his left arm and chest and experienced difficulty to breathe (like anxiety, but it was not) and on sixth (28Apr2021) and seventh day (29Apr2021) of vaccination, the lump under his arm pit was hurting, he felt tingling in his left arm and chest, and found it difficult to breathe. The patient also , felt a pinch on his back. The tingling sensation was bothering him. It felt like when you applied a bengay (hot and cold, but with some pain). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events left arm hurt (where the application was made), headache, eyes hurting, little dizzy, tired, legs were weak, lumps under arm pit hurting, felt a pinch on back with some pain, tingling left arm, a lump under arm pit and chest and difficulty to breathe (like anxiety, but it was not) was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Muscular weakness, Nerve compression, Paraesthesia
Clinical narrative: Legs were weak; Left arm hurt (where the application was made); Headache; Eyes hurting; Little dizzy; Tired; A lump under arm pit; Tingling left arm and chest; Difficulty to breathe (like anxiety, but it was not); Feel a pinch on back with some pain; Lump under arm pit hurting; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 23Apr2021 at 20:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19: Yes). The patient had no known allergies. Concomitant medications included ascorbic acid (VIT C), vitamin b nos (VITAMIN B), colecalciferol (VIT D3) and fish oil (OMEGA 3); all for an unknown indication, from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 23Apr2021 at 20:30 on the first day of vaccination, left arm hurt for the patient (where the application was made), then the patient experienced  headache, eyes were hurting, little dizzy and tired. On 24Apr2021 on second day of vaccination, his left arm hurt, he also felt dizzy, tired and legs were weak. In Apr2021 on third (25Apr2021), fourth(26Apr2021) and fifth day(27Apr2021) of vaccination the patient's  left arm hurt, legs were weak, a lump under his arm pit was hurting, he felt tingling in his left arm and chest and experienced difficulty to breathe (like anxiety, but it was not) and on sixth (28Apr2021) and seventh day (29Apr2021) of vaccination, the lump under his arm pit was hurting, he felt tingling in his left arm and chest, and found it difficult to breathe. The patient also , felt a pinch on his back. The tingling sensation was bothering him. It felt like when you applied a bengay (hot and cold, but with some pain). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events left arm hurt (where the application was made), headache, eyes hurting, little dizzy, tired, legs were weak, lumps under arm pit hurting, felt a pinch on back with some pain, tingling left arm, a lump under arm pit and chest and difficulty to breathe (like anxiety, but it was not) was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Legs were weak; Left arm hurt (where the application was made); Headache; Eyes hurting; Little dizzy; Tired; A lump under arm pit; Tingling left arm and chest; Difficulty to breathe (like anxiety, but it was not); Feel a pinch on back with some pain; Lump under arm pit hurting; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 23Apr2021 at 20:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19: Yes). The patient had no known allergies. Concomitant medications included ascorbic acid (VIT C), vitamin b nos (VITAMIN B), colecalciferol (VIT D3) and fish oil (OMEGA 3); all for an unknown indication, from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 23Apr2021 at 20:30 on the first day of vaccination, left arm hurt for the patient (where the application was made), then the patient experienced  headache, eyes were hurting, little dizzy and tired. On 24Apr2021 on second day of vaccination, his left arm hurt, he also felt dizzy, tired and legs were weak. In Apr2021 on third (25Apr2021), fourth(26Apr2021) and fifth day(27Apr2021) of vaccination the patient's  left arm hurt, legs were weak, a lump under his arm pit was hurting, he felt tingling in his left arm and chest and experienced difficulty to breathe (like anxiety, but it was not) and on sixth (28Apr2021) and seventh day (29Apr2021) of vaccination, the lump under his arm pit was hurting, he felt tingling in his left arm and chest, and found it difficult to breathe. The patient also , felt a pinch on his back. The tingling sensation was bothering him. It felt like when you applied a bengay (hot and cold, but with some pain). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events left arm hurt (where the application was made), headache, eyes hurting, little dizzy, tired, legs were weak, lumps under arm pit hurting, felt a pinch on back with some pain, tingling left arm, a lump under arm pit and chest and difficulty to breathe (like anxiety, but it was not) was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Body aches; Severe headache; Chills; Sweating; When breaking a fever after taking tylenol but when Tylenol wore off, "I"  would spike 103 fever.; Exhausted/slept most all day.; Slept most all day but choppy sleep because could not get comfortable due to body aches.; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 28Apr2021 at 12:15(at the age of 43-years-old) as a single dose for COVID-19 immunisation. The medical history included bipolar, depression and anxiety. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The concomitant medications included venlafaxine (MANUFACTURER UNKNOWN), lithium (MANUFACTURER UNKNOWN) and clonazepam (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient also had taken morphine (MANUFACTURER UNKNOWN) on an unknown date and experienced allergy. On 29Apr2021 at 02:30, the patient experienced body aches, severe headache, chills, sweating when breaking a fever after taking tylenol, but when tylenol wore off, the patient's fever would spike to 103 and exhausted. The patient slept most all the day but it was a choppy sleep because she could not get comfortable due to body aches. On the same day, the patient underwent body temperature test and the result was found to be 103 (units unspecified). The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of fever which included treatment with paracetamol (TYLENOL). The patient did not receive any treatment for the events body aches, severe headache, chills, sweating, exhausted and slept most all the day but it was a choppy sleep. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body aches, severe headache, chills, sweating, fever, exhausted and slept most all the day but was a choppy sleep were resolving at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Pain, Pyrexia
Clinical narrative: Body aches; Severe headache; Chills; Sweating; When breaking a fever after taking tylenol but when Tylenol wore off, "I"  would spike 103 fever.; Exhausted/slept most all day.; Slept most all day but choppy sleep because could not get comfortable due to body aches.; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 28Apr2021 at 12:15(at the age of 43-years-old) as a single dose for COVID-19 immunisation. The medical history included bipolar, depression and anxiety. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The concomitant medications included venlafaxine (MANUFACTURER UNKNOWN), lithium (MANUFACTURER UNKNOWN) and clonazepam (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient also had taken morphine (MANUFACTURER UNKNOWN) on an unknown date and experienced allergy. On 29Apr2021 at 02:30, the patient experienced body aches, severe headache, chills, sweating when breaking a fever after taking tylenol, but when tylenol wore off, the patient's fever would spike to 103 and exhausted. The patient slept most all the day but it was a choppy sleep because she could not get comfortable due to body aches. On the same day, the patient underwent body temperature test and the result was found to be 103 (units unspecified). The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of fever which included treatment with paracetamol (TYLENOL). The patient did not receive any treatment for the events body aches, severe headache, chills, sweating, exhausted and slept most all the day but it was a choppy sleep. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body aches, severe headache, chills, sweating, fever, exhausted and slept most all the day but was a choppy sleep were resolving at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Asthenia, Diarrhoea, Headache, Pain
Clinical narrative: also has diarrhea and headache which started a couple of months ago with xeljanz,; also has diarrhea and headache which started a couple of months ago with xeljanz; she has been in a lot of pain and sometimes has no energy, not sure if xeljanz is working at it should be.; she has been in a lot of pain and sometimes has no energy, not sure if xeljanz is working at it should be.; This is a spontaneous report from a contactable other hcp. A 66-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation, tofacitinib citrate (XELJANZ XR), oral from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 11 mg, daily (once) for psoriatic arthropathy. The patient medical history and concomitant medications were not reported. Historical vaccine BNT162B2 1st dose COVID-19 immunization. On an unspecified date the patient experienced also has diarrhea and headache which started a couple of months ago with xeljanz. she has been in a lot of pain and sometimes has no energy, not sure if xeljanz is working at it should be. Outcome of the event was diarrhoea, pain, asthenia was unknown, headache was recovering. The action taken in response to the for tofacitinib citrate was not applicable.  No follow up attempts are possible, information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Discomfort, Heart rate increased, Pulmonary pain
Clinical narrative: chest/lung pain/discomfort when taking a breath; chest/lung pain/discomfort when taking a breath; chest/lung pain/discomfort when taking a breath; Periodic fast heartbeat; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 15Apr2021 at 11:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included sarcoidosis affecting lungs, relapsing polychondritis and bipolar type II. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 15Apr2021 at 11:00, the patient had periodic fast heart beat from time of injection over 24-hours period. On 15Apr2021 at 15:00, about 4 hours after injection, the patient experienced chest/lung pain/discomfort when taking a breath. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chest/lung pain/discomfort when taking a breath was resolved on an unknown date in Apr2021 and of the event periodic fast heartbeat was resolved on 16Apr2021.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Injection site erythema, Swelling
Clinical narrative: Little redness; Allergic reaction on her arm, swelling; Allergic reaction on her arm, swelling; This is a spontaneous report from a contactable consumer. This consumer reported for her wife that:  A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown, Expiry Date: unknown), via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE for covid-19 immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported.Historical vaccine include the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown, Expiry Date: unknown), via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for covid-19 immunisation.The patient experienced little redness, allergic reaction on her arm, swelling, allergic reaction on her arm, swelling on an unspecified date. It was reported that the patient took the shot of the Pfizer Covid-19 Vaccine, had an allergic reaction on her arm, swelling and asked how to get the swelling down, and for information about the Pfizer Covid-19 Vaccine. Reporter did not have the agency vaccine record card at the time of the call. Product: PFIZER-BIONTECH COVID-19 VACCINE. Question: The reporter stated his wife, got the second dose of the vaccine on Tuesday of this week and after the shot had a little reaction to it. Had a knot on her arm and a little redness so they put ice on it and the ice made it throb after 10 minutes. Asked how do they get the swelling down, do they put ice on it. agency- did not obtain more info or warm transfer because the reporter declined reporting this at this time because he needed to get in touch with a doctor before it starts raining there; stated will report later; e-transmitting details. Response: Referred to HCP for treatment recommendations. The outcome of events were unknown.  Follow-up (30Apr2021): New information include in response to this follow-up spontaneous report received from a contactable reporter. This reporter reported that: Clinical information updated.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Erythema, Headache, Nausea, Peripheral swelling
Clinical narrative: "I had little bit of a  Headache the first day.Then I noticed a  swollen area, like a red swollen bump, below where I got my shot in my left arm; Her arm is red; It also feels like the caller was punched under her arms and in her chest, its very tender; Caller states that yesterday was worse with nausea and no vomiting; I had little bit of a Headache the first day.Then I noticed a  swollen area, like a red swollen bump, below where I got my shot in my left arm; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0175), via an unspecified route of administration in left arm on 27Apr2021 (at the age of 55-year-old) as dose 2, single for COVID-19 immunization. Medical history included thyroid cancer from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Previously patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: ER8737), via an unspecified route of administration in arm left on 06Apr2021 (at the age of 55-year-old) as dose 1, single for COVID-19 immunization. On 27Apr2021, the patient had little bit of a headache the first day. On 29Apr2021, then noticed a swollen area, like a red swollen bump, below where she got her shot in her left arm, very tender under both arms, more so under her left arm. The patient reported that her arm is red and swollen below the shot site, like a big goose egg. It also feels like she was punched under her arms and in her chest, its very tender. The caller thought it was weird that this showed up so late after receiving the vaccine. Patient states that on 29Apr2021 was worse with nausea and no vomiting. The caller's blood pressure was taken in her left arm on 29Apr2021 and then the goose egg appeared. The patient wanted to know whether she can take some benedryl and something for the pain or do she just need to ride it out. The outcome of headache, nausea was reported as unknown and swollen arm, erythema, tenderness was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: "I had little bit of a  Headache the first day.Then I noticed a  swollen area, like a red swollen bump, below where I got my shot in my left arm; Her arm is red; It also feels like the caller was punched under her arms and in her chest, its very tender; Caller states that yesterday was worse with nausea and no vomiting; I had little bit of a Headache the first day.Then I noticed a  swollen area, like a red swollen bump, below where I got my shot in my left arm; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0175), via an unspecified route of administration in left arm on 27Apr2021 (at the age of 55-year-old) as dose 2, single for COVID-19 immunization. Medical history included thyroid cancer from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Previously patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: ER8737), via an unspecified route of administration in arm left on 06Apr2021 (at the age of 55-year-old) as dose 1, single for COVID-19 immunization. On 27Apr2021, the patient had little bit of a headache the first day. On 29Apr2021, then noticed a swollen area, like a red swollen bump, below where she got her shot in her left arm, very tender under both arms, more so under her left arm. The patient reported that her arm is red and swollen below the shot site, like a big goose egg. It also feels like she was punched under her arms and in her chest, its very tender. The caller thought it was weird that this showed up so late after receiving the vaccine. Patient states that on 29Apr2021 was worse with nausea and no vomiting. The caller's blood pressure was taken in her left arm on 29Apr2021 and then the goose egg appeared. The patient wanted to know whether she can take some benedryl and something for the pain or do she just need to ride it out. The outcome of headache, nausea was reported as unknown and swollen arm, erythema, tenderness was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Itching of injection site; Fever; Redness and swelling of injection site; Redness and swelling of injection site; Severe fatigue; Severe headache; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 28Apr2021 at 10:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and chronic migraines. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vortioxetine hydrobromide (TRINTELLIX), lurasidone hydrochloride (LATUDA), ethinylestradiol/norgestimate (TRI-SPRINTEC) and modafinil (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 03Apr2021 at 14:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 28Apr2021 at 11:30, on the day of injection, the patient experienced redness and swelling of injection site, severe fatigue and headache. On 29Apr2021, day after injection, the patient experienced fever, severe headache, redness and swelling of injection site. On 30Apr2021, two days after injection, the patient experienced mild headache, redness, swelling, and itching of injection site. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events redness and swelling of injection site, severe fatigue and headache, fever and itching of injection site was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Itching of injection site; Fever; Redness and swelling of injection site; Redness and swelling of injection site; Severe fatigue; Severe headache; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 28Apr2021 at 10:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and chronic migraines. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vortioxetine hydrobromide (TRINTELLIX), lurasidone hydrochloride (LATUDA), ethinylestradiol/norgestimate (TRI-SPRINTEC) and modafinil (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 03Apr2021 at 14:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 28Apr2021 at 11:30, on the day of injection, the patient experienced redness and swelling of injection site, severe fatigue and headache. On 29Apr2021, day after injection, the patient experienced fever, severe headache, redness and swelling of injection site. On 30Apr2021, two days after injection, the patient experienced mild headache, redness, swelling, and itching of injection site. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events redness and swelling of injection site, severe fatigue and headache, fever and itching of injection site was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Skin disorder
Clinical narrative: Large rash covering my entire torso and both upper thighs; Severe itching; Hundreds of bumps like chicken pox; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 24Apr2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included 10 Days post diagnostic laparoscopy and known allergy to wheat. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. On 25Apr2021, the patient experienced large rash covering the entire torso and both upper thighs, severe itching and hundreds of bumps like chicken pox. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with unspecified steroid gel and antihistamine. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events large rash covering the entire torso and both upper thighs, severe itching and hundreds of bumps like chicken pox were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dysarthria, Dysstasia, Feeling abnormal, Tremor
Clinical narrative: I woke up this morning and I still feel a little abnormal.; I had severe tremoring throughout my entire body.; I could not stand up and my speak was extremely slurred as my jaw was tremoring too.; I could not stand up and my speak was extremely slurred as my jaw was tremoring too.; It was like my entire body was shivering uncontrollably but I did not even feel like I had the chills.; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 29Apr2021 at 10:45 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 09Apr2021 at 12:15 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021 at 23:45, the patient had severe tremoring throughout his entire body. He could not stand up and his speech was extremely slurred as his jaw was tremoring too. It was like his entire body was shivering uncontrollably but the patient did not even feel like he had the chills. It came on very suddenly as he got into bed 13 hours after getting the vaccine. The first 10 minutes were very frightening and intense, the next 5 were rather mild then they suddenly went away. The patient woke up on 30Apr2021, in the morning of the day of report and still felt a little abnormal. The patient had very miniscule tremoring in his arms and hands. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events had severe tremoring throughout his entire body; he could not stand up and his speech was extremely slurred as his jaw was tremoring too; it was like his entire body was shivering uncontrollably but the patient did not even feel like he had the chills; it came on very suddenly as he got into bed 13 hours after getting the vaccine; the first 10 minutes were very frightening and intense, the next 5 were rather mild then they suddenly went away; the patient woke up in the morning of the day of report and still felt a little abnormal; had very miniscule tremoring in his arms and hands resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Gastrooesophageal reflux disease
Clinical narrative: Severe heartburn and acid reflux beginning 2 days following the first vaccine; Severe heartburn and acid reflux beginning 2 days following the first vaccine; This is a spontaneous report from a non-contactable consumer, the patient. A 21-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 30Mar2021 at 10:00 (at the age of 21-years-old) and the second dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 20Apr2021 at 10:00 (at the age of 21-years-old)) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 01Apr2021 at 12:00, 2 days following the first vaccine, the patient experienced severe heartburn and acid reflux beginning and symptoms were still present but were being managed with omeprazole. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with omeprazole (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe heartburn and acid reflux beginning 2 days following the first vaccine was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Moderate-to-moderately severe axillary lymphatic swelling.; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) in the right arm on 03Apr2021 (at the age of 22-years-old) and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW8735) in the arm right on 24Apr2021 (at the age of 22-year-old) both as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 04Apr2021, the patient experienced moderate-to-moderately severe axillary lymphatic swelling. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the event. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event moderate-to-moderately severe axillary lymphatic swelling was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report received from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, NDC number and Expiry date are not provided), via an unspecified route of administration on 09Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included a history of severe acid reflux it is all up in her throat, inflamed vocal cords and lots of mucous production from unspecified date, which she had both before and after receiving the vaccine. She states she is also dealing with her sinuses from unspecified date. The patient's concomitant medications were not reported. The patient previously took sulfa, Macrobid medications and experienced allergy on unspecified date. She is allergic to sulfur and Macrobid and the reaction to that is anaphylaxis on an unspecified date. The patient previously took sulfur and states that she has had a bad reaction from the sulfur that had her burning and swelling and the itching and anaphylaxis on an unspecified date. The patient previously took Macrobid (clarithromycin, NDC number and Expiry date are not provided) and she had Burning, swelling, itching, flushed, and anaphylaxis to Macrobid on an unspecified date. She wanted to know if that would cause her to have a reaction to the vaccine? Stated it is not a good reaction such as feeling flushed, burning and itching all over and a rash. She clarified that she did not have a reaction to the first COVID-19 Vaccine. She had these reactions before to the sulfur and Macrobid. She states that the events mentioned above did not come from the vaccine. She states that she already had these symptoms before she took the first vaccine. She is already on medication for that stuff for the allergies, severe acid reflux, and the inflamed mucus in her vocals. She states that before she has the second one, she wanted to know if those medications are in the second vaccine? On an unspecified date in 2021, the patient experienced headache after the first dose of the vaccine. The reporter was calling about the Pfizer COVID-19 Vaccine. She wants to find out information about the vaccine. She states she took the first vaccine. She wants to know if it's safe for her to get the second dose of the vaccine with her ongoing symptoms. She asked, Would the second vaccine cause any problems, or would she have any serious reaction from the second shot due to the fact that she already has these symptoms? The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.