chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia
Clinical narrative: Had an almost metallic-like taste in my mouth on both my first and second shot.; Slight burning in the arm only after the second dose.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07May2021 11:00 (Batch/Lot number: unknown) at the age of 25 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL. Vaccination history included: Bnt162b2 (Dose 1, Single), for Covid-19 immunization, reaction(s): "metallic-like taste in my mouth". The following information was reported: DYSGEUSIA (non-serious) with onset 07May2021 11:30, outcome "recovered", described as "Had an almost metallic-like taste in my mouth on both my first and second shot."; VACCINATION SITE PAIN (non-serious) with onset 07May2021 11:30, outcome "recovered", described as "Slight burning in the arm only after the second dose.". Therapeutic measures were not taken as a result of dysgeusia, vaccination site pain.  Additional information: The patient had no prior covid vaccination and was not covid tested post vaccination. She had no allergies and did not get other vaccine in four weeks. other medications in two weeks - 10MG Adderall IR. He had an almost metallic-like taste in her mouth on both her first and second shot. Slight burning in the arm only after the second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia, Vaccination site pain
Clinical narrative: Had an almost metallic-like taste in my mouth on both my first and second shot.; Slight burning in the arm only after the second dose.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07May2021 11:00 (Batch/Lot number: unknown) at the age of 25 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL. Vaccination history included: Bnt162b2 (Dose 1, Single), for Covid-19 immunization, reaction(s): "metallic-like taste in my mouth". The following information was reported: DYSGEUSIA (non-serious) with onset 07May2021 11:30, outcome "recovered", described as "Had an almost metallic-like taste in my mouth on both my first and second shot."; VACCINATION SITE PAIN (non-serious) with onset 07May2021 11:30, outcome "recovered", described as "Slight burning in the arm only after the second dose.". Therapeutic measures were not taken as a result of dysgeusia, vaccination site pain.  Additional information: The patient had no prior covid vaccination and was not covid tested post vaccination. She had no allergies and did not get other vaccine in four weeks. other medications in two weeks - 10MG Adderall IR. He had an almost metallic-like taste in her mouth on both her first and second shot. Slight burning in the arm only after the second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: not feeling well after 2nd dose; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  An adult patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "not feeling well after 2nd dose".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Back pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "Back pain". Therapeutic measures were taken as a result of back pain.  Additional information: Reporter would like recommendations on behalf of a patient who is about to start oral steroids but is scheduled to get the second dose of the Pfizer vaccine on 12May. Reporter mentioned that her patient, who received the 1st dose of the Pfizer covid vaccine about 3 weeks ago, was being started on oral steroids meant to help the patient relieve back pain. He is scheduled for the 2nd dose 12May2021. She did not confirm whether the back pain was related to the vaccine or not.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: developed hypertension; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERTENSION (non-serious), outcome "unknown", described as "developed hypertension".  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vertigo
Clinical narrative: vertigo; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Apr2021 11:45 (Batch/Lot number: unknown) at the age of 34 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "preeclampsia while pregnant" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN B COMPLEX; PROBIOTICS. Vaccination history included: Bnt162b2 (After first shot: instant vertigo and nausea which last approximately 5 hours. Product: COVID 19, brand: Pfizer, lot unknown: True, lot unknown reason: Not available/provided to reporter at the time of report completion, administration date: 25Mar2021, administration time: 11:45 AM, dose number: 1, vaccine location: Right arm), administration date: 25Mar2021, when the patient was 34 years old, for COVID-19 Immunization, reaction(s): "instant vertigo", "nausea". The following information was reported: VERTIGO (non-serious) with onset 18Apr2021 07:00, outcome "not recovered", described as "vertigo"; NAUSEA (non-serious) with onset 18Apr2021 07:00, outcome "not recovered", described as "nausea". The events "vertigo" and "nausea" were evaluated at the physician office visit. Therapeutic measures were taken as a result of vertigo, nausea.  Additional information: Facility type vaccine was Pharmacy or Drug Store. No other vaccine in four weeks. Other medications in two weeks included Birth control. After first shot had instant vertigo and nausea which lasted approximately for 5 hours. After second shot vertigo and nausea set in approximately 1.5 hours after shot. Have had constant vertigo since (a little over 3 weeks right now). Treatment received included Allergy meds, medrol pack and physical therapy. There was no Covid prior vaccination. Covid test was not performed post vaccination. The patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Pain
Clinical narrative: Burning sensation in left leg; He was at the sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03May2021 14:00 (Lot number: EW0172, Expiration Date: Aug2021) at the age of 57 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot: EW0162, Expiry: Jul2021., Time:14:00 , Anatomical location: Left arm, No reaction), administration date: 12Apr2021, when the patient was 57 years old, for Covid-19 immunization, reaction(s): "No reaction". The following information was reported: BURNING SENSATION (non-serious) with onset 07May2021 03:00, outcome "not recovered", described as "Burning sensation in left leg"; PAIN (non-serious) with onset May2021, outcome "unknown", described as "He was at the sore".  Additional information: The patient was telling the other lady, this morning at 3, he had a burning sensation in his left leg for a couple of seconds that woke him up. He continued that when he got up it happened again. When he got in his truck, it did it again. Every half hour or so it happened. A burning pain near his ankle that he describes as someone got a match to one spot on his leg. And this has occurred since his 2nd dose of the Pfizer COVID vaccine. No visit of Emergency Room and Physician Office. No prior vaccinations within 4 weeks.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: So tired; Body is a little achy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old male patient received bnt162b2 (BNT162B2), administration date 28Apr2021 (Batch/Lot number: unknown) at the age of 28 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: FATIGUE (non-serious), outcome "not recovered", described as "So tired"; PAIN (non-serious), outcome "not recovered", described as "Body is a little achy".  Additional information: Report was not related to a study or programme. Batch/lot number, expiry date and NDC number of vaccine for covid was not provided. Other products were not provided. Patient history was not provided. Investigation assessment was not provided. Patient first dose of the vaccine for Covid last Wednesday. It has been about a week and he is still experiencing side effects. He was looking online and it seems like after the first shot it should be pretty much back to normal after a couple days but he is not feeling that.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Hidradenitis
Clinical narrative: Hidradenitis Supportive, associated with hormones; flare up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "hidradenitis suppertiva" (unspecified if ongoing), notes: I have Hidradenitis Suppertiva, associated with hormones. I have not have flare ups for 3 years. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for Covid-19 immunization.  The following information was reported: HIDRADENITIS (non-serious), outcome "unknown", described as "Hidradenitis Supportive, associated with hormones"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "flare up".  Additional information: I have read about several women having hormonal changes after getting vaccinated. I hope this is research you are pursuing. I have Hidradenitis Supportive, associated with hormones. I have not have flare ups for 3 years. After my second dose of Pfizer, I experienced a flare up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain and soreness/ soreness where he took the shot, in the left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Apr2021 (Batch/Lot number: unknown) at the age of 59 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "pain and soreness/ soreness where he took the shot, in the left arm".  Additional Information: Patient and his wife took their first dose on 28Apr2021. The both had their shot in the left arm and after a while they experienced pain and soreness. Patient's events went away after the second day. Patient experienced some soreness where he took the shot, in the left arm. The patient was fine now.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021524897 Same reporter/product/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Limb discomfort, Peripheral swelling, Vaccination site joint erythema
Clinical narrative: Red arm; swollen warm arm; Red arm; swollen warm arm; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An elderly female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE JOINT ERYTHEMA (non-serious), ERYTHEMA (non-serious) all with onset 04May2021, outcome "unknown" and all described as "Red arm"; PERIPHERAL SWELLING (non-serious), LIMB DISCOMFORT (non-serious) all with onset 04May2021, outcome "unknown" and all described as "swollen warm arm".  Additional information: DR reports patients with side effects of COVID vaccine. DR: One of the things we are seeing is a red, swollen, warm arm that can start even a week later after the shot, but, um, it's not dangerous. The causality was reported as related.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: he felt just a little bad; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "recovered", described as "he felt just a little bad". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information: PT reports family member with side effects of COVID vaccine PT: Well, somebody said that, if I take it, I need to take Tylenol, which would, you know. But, his brother took his first one and he said he felt just a little bad, but he rested and he was fine.  Action taken: unknown, Outcome: unknown, Causality: related   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I had a sore arm; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 42 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SPIRONOLACTONE; NORVASC; METOPROLOL TARTRATE; AMLODIPINE. Past drug history included: Spironolactone for severe muscle cramps in limbs. Vaccination history included: Flu shot, for sore arm/Little worse than a flu shot; Tetanus shot, for sore arm/not as bad as a tetanus shot. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "I had a sore arm".  Additional information: Patient reported that the side effects of spironolactone, also mentioned being maxed out on Norvasc, switching from metoprolol to "get it down", was recently hospitalized and is on amlodipine. Patient stated that they also prescribed spironolactone, but that one caused, causes me severe muscle cramps in limbs and to mix with, patient stopped taking that one. Patient reported that with the first COVID vaccine patient had a sore arm. Little worse than a flu shot, not as bad as a tetanus shot. And then, the second COVID vaccine, patient was a little achy and had to take a warm bath.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vertigo
Clinical narrative: Vertigo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Apr2021 13:00 (Lot number: ER8732) at the age of 53 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Product: COVID 19 , Brand: Pfizer , Lot number: ERS735, Lot unknown: False, Administration Date: 25Mar2021, Administration Time: 02:00PM, Vaccine location: Left arm , Dose number: 1), administration date: 25Mar2021, when the patient was 53 years old, for covid-19 immunization. The following information was reported: VERTIGO (non-serious) with onset 01May2021 23:30, outcome "unknown", described as "Vertigo". The event "vertigo" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vertigo.  Additional information: No other vaccine in four weeks. Vertigo about 10 days after she got the shot. Her husband and she got their shots on the same day, same time. They both got vertigo. They other got vertigo the same time afterward. She never had vertigo before in her life so it was really weird. Hers has calmed down. No covid prior vaccination. Covid was tested post vaccination. No known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Vaccination site erythema
Clinical narrative: she had injected her triceps instead to be in deltoid; Injection site redness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2), administration date 06May2021 (Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 06May2021, outcome "unknown", described as "she had injected her triceps instead to be in deltoid"; VACCINATION SITE ERYTHEMA (non-serious) with onset 06May2021, outcome "unknown", described as "Injection site redness".  Additional Information: It was reported that, medical questions addressed by this program forwarded/referred to Medical Information (Live Operators Only). Customer and/or medical inquiry forwarded or referred to MI.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: fatigue; mild nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administration date 07Apr2021 (Lot number: ER8729) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "fatigue"; NAUSEA (non-serious), outcome "unknown", described as "mild nausea".  Additional information: The patient later received her second dose of the vaccine (lot number: ER8735) on 28Apr2021 at 14:00 and reported that twelve hours later, about 2:00, she woke up and felt okay initially but was then hit with severe nausea few minutes later that lasted 24 hours. She stated that she had Pepto Bismol but did not want to take it and instead drank some ginger tea, which did not help. She would like to know if severe nausea lasting 24 hours after the Pfizer BioNTech COVID-19 vaccine would be considered a severe allergic reaction. She would like to know if any nausea meds, such as Pepto Bismol, would be okay to take to treat the severe nausea she experienced after the second dose of the Pfizer BioNTech COVDI-19 vaccine.  No follow-up attempts needed; No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: allergies; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose No: 1), for Covid-19 immunization. The following information was reported: DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergies".  Additional information: Caller stated that he received his second dose of the Pfizer BioNTech COVID-19 vaccine today and would like to know if it is okay for him to take his seasonal medication for allergies. Response: Let caller know that there is no information regarding a potential interaction between the vaccine and allergy medications. Spoke from attached document to let caller know that during the clinical trials, participants were allowed to take antihistamines for seasonal allergies. Referred caller to HCP for further guidance. Response: Spoke from the attached document regarding CDC's guidance on the use of fever reducing and pain reducing medications like Tylenol after vaccination to treat symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node right on her collarbone; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 (Lot number: ER8735) at the age of 61 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, Manufacturer: unknown), for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 01May2021, outcome "unknown", described as "Swollen lymph node right on her collarbone".  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm: first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 28Mar2021 (Lot number: ER8733) at the age of 49 years as dose 1, 0.3 ml single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ALEVE taken for headache. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 28Mar2021, outcome "recovered" (31Mar2021), described as "sore arm: first dose".  Additional Information; No prior Vaccinations within 4 weeks prior to the first administration date of the suspect vaccine. Not visited emergency room and physician office. No relevant tests provided.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Laziness
Clinical narrative: she is been indolent for a month; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization, reaction(s): "had a little reaction after the first dose of the vaccine". The following information was reported: LAZINESS (non-serious), outcome "unknown", described as "she is been indolent for a month".  Additional information: The patient had both doses of the Pfizer BioNTech covid vaccine and need to report side effects. Patient had a little reaction after the first dose of the vaccine. But the second dose of the vaccine really kicked, patient had been an invalid for a month since getting the second dose. After getting second dose she stated she hab been indolent for a mont  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abnormal faeces, Diarrhoea, Faeces discoloured, Faeces hard
Clinical narrative: Problem with my stomach; Colour of my bowl now just like green grass it got me to smell like a cow; bowl is a hard it is no more a soft, it is less running; Bowel run like diarrhea; Colour of my bowl now just like green grass it got me to smell like a cow; bowl is a hard it is no more a soft, it is less running; Colour of my bowl now just like green grass; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 25Mar2021 09:05 (Lot number: EP6955) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for hypertension; ATORVASTATIN taken for blood cholesterol; METFORMIN; GABAPENTIN. Vaccination history included: Bnt162b2 (1st dose, Batch/lot number: FN6215, Anatomical injection: right arm injection, Time the Vaccination: 09:15), administration date: 04Mar2021, when the patient was 66 years old, for COVID-19 immunization. The following information was reported: ABNORMAL FAECES (non-serious), FAECES HARD (non-serious) all with onset Apr2021, outcome "unknown" and all described as "Colour of my bowl now just like green grass it got me to smell like a cow; bowl is a hard it is no more a soft, it is less running"; FAECES DISCOLOURED (non-serious) with onset Apr2021, outcome "unknown", described as "Colour of my bowl now just like green grass"; ABDOMINAL DISCOMFORT (non-serious), outcome "not recovered", described as "Problem with my stomach"; DIARRHOEA (non-serious) with onset Apr2021, outcome "not recovered", described as "Bowel run like diarrhoea". The event "bowel run like diarrhoea" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of abnormal faeces, faeces discoloured, abdominal discomfort, faeces hard. Therapeutic measures were taken as a result of diarrhoea.  Additional Information: It was reported that History of all previous immunization with the Pfizer vaccine considered as suspect was reported was not reported. Family Medical History Relevant to AE(s) was not reported. The patient did not administer additional vaccines. The patient had no prior vaccinations (within 4 weeks) and no AE(s) following prior vaccinations. The foot got an Antigout. There was a burning in patient foot. The patient took some sugar pills to that Metformin. The patient had problem with stomach. It was not worsened but its same as every day, had this problem 3-4 times a day. The patient stated the second dose was received in his right arm as an injection on 25Mar2021. Patient stated he went to the doctor yesterday and his doctor told him to take Imodium for diarrhoea.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021514881 same reporter/drug, event / different patient
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient in her 30's received bnt162b2 (BNT162B2), administered in arm (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "diagnosed allergies" (unspecified if ongoing); "compromised immune status" (unspecified if ongoing); "respiratory illness" (unspecified if ongoing); "genetic / chromosomal abnormalities" (unspecified if ongoing); "endocrine abnormalities" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick".  Additional Information: Patient got the second dose and patient's mom said patient only became ill with the first dose, not the second dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness
Clinical narrative: First dose: blood pressure rose within 30 minutes, light headed for 5 minutes; First dose: blood pressure rose within 30 minutes, light headed for 5 minutes; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 (Batch/Lot number: unknown) at the age of 40 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: NASONEX. The following information was reported: BLOOD PRESSURE INCREASED (non-serious) with onset 01Apr2021, outcome "unknown", DIZZINESS (non-serious) with onset 01Apr2021, outcome "recovered" (01Apr2021) and all described as "First dose: blood pressure rose within 30 minutes, lightheaded for 5 minutes". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of blood pressure increased, dizziness. Additional information: Facility type vaccine was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received OTC Nasonex medications within 2 weeks of vaccination. After First dose blood pressure rose within 30 minutes and lightheaded for 5 minutes. The patient dont have a history of high blood pressure, it's always been in the normal/excellent range. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Inappropriate schedule of product administration, Lymphadenopathy
Clinical narrative: exhaustion and brain fog have remained for almost two weeks; Swollen glands under right armpit and both sides of neck/ chin; exhaustion and brain fog have remained for almost two weeks; Dose 1 on 02Apr2021 and Dose 2 on 04Apr2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 04Apr2021 (Lot number: EIN0151) at the age of 38 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Antibiotics, reaction(s): "known allergies: antibiotics". Vaccination history included: Bnt162b2 (dose 1, lot number= FR8734, vaccine location= Left arm), administration date: 02Apr2021, when the patient was 38 years old, for COVID-19 Immunization, reaction(s): "Swollen glands under left armpit". The following information was reported: FEELING ABNORMAL (non-serious), FATIGUE (non-serious) all with onset 04Apr2021, outcome "not recovered" and all described as "exhaustion and brain fog have remained for almost two weeks"; LYMPHADENOPATHY (non-serious) with onset 04Apr2021, outcome "not recovered", described as "Swollen glands under right armpit and both sides of neck/ chin"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 04Apr2021, outcome "unknown", described as "Dose 1 on 02Apr2021 and Dose 2 on 04Apr2021". The events "exhaustion and brain fog have remained for almost two weeks", "swollen glands under right armpit and both sides of neck/ chin" and "exhaustion and brain fog have remained for almost two weeks" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of feeling abnormal, lymphadenopathy, fatigue.  Additional Information: It was reported that no other vaccines were given in four weeks. The patient did not have Covid prior vaccination. The patient had not tested for Covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Acne, Blood pressure increased, Blood pressure measurement
Clinical narrative: blood pressure again increased; acne outbreak on forehead for the past two weeks; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  40 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Apr2021 (Batch/Lot number: unknown) at the age of 40 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: NASONEX. Vaccination history included: Bnt162b2 (Dose number: 1, Vaccine location: Left arm), administration date: 01Apr2021, when the patient was 40 years old, for COVID-19 Immunisation, reaction(s): "Blood pressure rose", "Light headed". The following information was reported: BLOOD PRESSURE INCREASED (non-serious) with onset 22Apr2021 13:15, outcome "recovered" (2021), described as "blood pressure again increased"; ACNE (non-serious) with onset 22Apr2021 13:15, outcome "unknown", described as "acne outbreak on forehead for the past two weeks". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of blood pressure increased, acne.   Additional information included: The patient did not receive other vaccine in four weeks. Other medications in two weeks included OTC Nasonex. Second dose: blood pressure again increased, this time within 5 minutes of taking shot, and lasted for 90 minutes. The next day, blood pressure again rose for a few hours in the morning. Returned to normal and hasn't been an issue since. In addition, acne outbreak on forehead for the past two weeks. I don't have a history of high blood pressure, it's always has been in the normal/excellent range. The patient did not receive any treatment for AE. The patient was not diagnosed with Covid-19 prior to vaccination. The patient has not been tested for Covid-19 post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain in extremity, Painful respiration
Clinical narrative: The process of breathing is painful, which includes her arms hurting and it hurts to breathe when she takes more than a shallow breath, after the first vaccine; The process of breathing is painful, which includes her arms hurting and it hurts to breathe when she takes more than a shallow breath, after the first vaccine; Difficult to sleep, as breathing is painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03May2021 10:00 (Batch/Lot number: unknown) at the age of 27 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAINFUL RESPIRATION (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 03May2021, outcome "not recovered" and all described as "The process of breathing is painful, which includes her arms hurting and it hurts to breathe when she takes more than a shallow breath, after the first vaccine"; INSOMNIA (non-serious) with onset 03May2021, outcome "not recovered", described as "Difficult to sleep, as breathing is painful". Additional information: The patient reconfirmed that she was calling about the Pfizer Covid 19 vaccine, got her vaccine yesterday. The patient was calling to report her symptoms, because her parents were concerned for her, and they wanted her to make this call. when patient takes a deep breath, or more than a shallow breath, her arms hurt a lot and it hurts to breathe. Patient reclarified that her lungs and chest do not hurt, but it was the entire process of breathing that was painful. Caller reclarified that it was the process of breathing was painful, which includes her arms hurting and it hurts to breathe when she takes more than a shallow breath. Difficult to sleep, as breathing was painful at night. The patient stated that the number was handwritten, and she thinks the letters were EW or they could be BN, followed by the numbers 0170. No History of all previous immunization with the Pfizer vaccine considered as suspect. No additional Vaccines Administered on Same Date of the Pfizer Suspect. Events did not require a visit to emergency room or physician office. No prior vaccinations (within 4 weeks). No events following prior vaccinations. No patient medical history (including any illness at time of vaccination). No relevant tests.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Lymphadenopathy
Clinical narrative: lymph nodes under her arms on her neck; feels like a person who has her monthly cycle; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), for COVID-19 IMMUNISATION. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "lymph nodes under her arms on her neck"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "feels like a person who has her monthly cycle". The events "lymph nodes under her arms on her neck" and "feels like a person who has her monthly cycle" were evaluated at the physician office visit.  Additional information: A 70 year old women after her 2nd dose of the vaccine she has lymph nodes under her arms on her neck and feels like a person who has her monthly cycle. She wants to know how long this was going to last. She has never had this happen in her life. She did go to her doctor who told her to call us.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Feeling abnormal, Ophthalmological examination, Pain
Clinical narrative: Didn't feel good; Achy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Mar2021 10:00 (Lot number: EN6204, Expiration Date: 30Jun2021) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: She has had asthma since childhood.; "Diabetes mellitus" (unspecified if ongoing), notes: Diabetes; "Over weight" (unspecified if ongoing), notes: Over weight; "Polycystic kidney disease" (unspecified if ongoing), notes: Polycystic kidney disease; "Covid-19", start date: Dec2020 (unspecified if ongoing), notes: She had COVID back in December. It was bad and she was in the hospital and almost died.; "surgeries" (unspecified if ongoing), notes: had all her surgeries. She can not find the one with all her surgeries. . Family history included: "Chronic lymphocytic leukaemia" (unspecified if ongoing); "Stage 4 kidney failure" (unspecified if ongoing), notes: Stage 4 kidney failure. The patient's concomitant medications were not reported.  The following information was reported: FEELING ABNORMAL (non-serious) with onset 09Mar2021, outcome "recovered" (Mar2021), described as "Didn't feel good"; PAIN (non-serious) with onset 09Mar2021, outcome "recovered" (Mar2021), described as "Achy". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: information for Chronic lymphocytic leukemia reported as She had a thing where she ended up tearing her rotator cuff and blowing a disk and had to have surgery. They accidentally found in preop test that she had cancer. She would say she was diagnosed approximately 12 years ago. She got the first COVID shot and had pretty mild side effects. She had heard people with COVID reacted pretty bad. She just did not feel good and was achy, started when she woke up the next morning, 09Mar2021. She got the shot at 10AM and was fine that day. She woke up the next day with it.  No follow-up attempts are possible. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen lymph nodes like under his arm and just a little bit of tenderness; Swollen lymph nodes like under his arm and just a little bit of tenderness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the parent.  A 17-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02May2021 (Lot number: EW0167) at the age of 17 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergies" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, Lot number: EW0158), for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset May2021, outcome "unknown" and all described as "Swollen lymph nodes like under his arm and just a little bit of tenderness". Therapeutic measures were taken as a result of lymphadenopathy, lymph node pain.  Additional information: Reporter stated, It was the second shot that the patient got on Sunday (Clarified as 02May). The patient received the Pfizer vaccine, and he had the swollen lymph nodes like under his arm and just a little bit of tenderness and the reporter was just wondering how long the effect last or have to look anything in addition to that. Treatment in response to event was reported as he was given Tylenol yesterday, 500 mg tablet, once a day.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: a super painful headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 04May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose, Single), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset May2021, outcome "unknown", described as "a super painful headache".  Additional information: Patient took the 2nd dose yesterday (04May2021) and can't remember the exact date of the 1st dose, he just said 3 weeks ago and was experiencing a super painful headache. He was asking if he can take some Advil.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.