chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Malaise, Paraesthesia, Somnolence
Clinical narrative: Tingling and pin pricks in hands, neck and feet; having dizziness; Felt like might fall asleep; did not feel well; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 44 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Oct2021 (Lot number: 30130BA, Expiration Date: Nov2021) at the age of 44 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PARAESTHESIA (non-serious) with onset 08Oct2021, outcome "recovering", described as "Tingling and pin pricks in hands, neck and feet"; DIZZINESS (non-serious) with onset 08Oct2021, outcome "recovering", described as "having dizziness"; SOMNOLENCE (non-serious) with onset 08Oct2021, outcome "recovering", described as "Felt like might fall asleep"; MALAISE (non-serious) with onset 08Oct2021, outcome "recovering", described as "did not feel well".  Additional Information: Relatedness of drug to reaction(s)/event(s) Reaction assessed: Tingling and pin pricks in hands, neck and feet   Source of assessment: Primary Source Reporter    Method of assessment: Global Introspection Drug result: Related    Relatedness of drug to reaction(s)/event(s) Reaction assessed: having dizziness and did not feel well   Source of assessment: Primary Source Reporter   Method of assessment: Global Introspection   Drug result: Related    Relatedness of drug to reaction(s)/event(s) Reaction assessed: Felt like might fall asleep   Source of assessment: Primary Source Reporter   Method of assessment: Global Introspection   Drug result: Related    Pfizer Covid Vaccine: Tingling and pin pricks in hands, neck and feet - Related. Pfizer Covid Vaccine: having dizziness and did not feel well - Related. Pfizer Covid Vaccine: Felt like might fall asleep - Related  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: About 18 hours after booster: All of my teeth ache, not just some, all, they ache with no movement and also ache when chewing. Not my gums, not my jaw, but an overall aching of my teeth; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 07Oct2021 13:45 (Lot number: Fe3590) at the age of 45 years as dose 3 (booster) , single for covid-19 immunisation. Relevant medical history included: "Hip bursitis" (unspecified if ongoing); "thyroidectomy" (unspecified if ongoing); "hysterectomy" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "known allergies: Walnuts" (unspecified if ongoing); "known allergies: sulfa medications" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; WELLBUTRIN; SYNTHROID; ADDERALL; ESTRADIOL. Vaccination history included: Bnt162b2 (Previous dose product: covid 19, prev dose brand=Pfizer ,, prev dose brand unknown=False,, prev dose lot number=El9265,, prev dose lot unknown=False,, prev dose administrator route=Intramuscular,, prev dose administration date= 30Jan2021,   , prev dose dose number=2,, prev dose vaccine location=Left arm), administration date: 30Jan2021, when the patient was 45 years old, for COVID-19 IMMUNIZATION; Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer ,, prev dose brand unknown=False,, prev dose lot number=El3246,, prev dose lot unknown=False,, prev dose administrator route=Intramuscular,, prev dose administration date=07Jan2021, prev dose dose number=1,, prev dose vaccine location=Left arm), administration date: 07Jan2021, when the patient was 45 years old, for COVID-19 IMMUNIZATION. The following information was reported: TOOTHACHE (non-serious) with onset 08Oct2021 08:00, outcome "not recovered", described as "About 18 hours after booster: All of my teeth ache, not just some, all, they ache with no movement and also ache when chewing. Not my gums, not my jaw, but an overall aching of my teeth". Therapeutic measures were not taken as a result of toothache.  Additional information: Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.  Follow-up (12Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenopia, Headache, Hypoaesthesia, Muscular weakness, Paraesthesia
Clinical narrative: Tingly-numb on left pinky finger, and tingly on left ring finger, and numb on 1/3 of left palm towards my pinky; headache; left eye (reading eye) was tired.; bedtime tingly left pinky finger/left side of thigh felt tingly; full left hand felt limp; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Sep2021 17:00 (Lot number: 301308A) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "breast cancer", start date: 2015 (unspecified if ongoing); "osteoporosis", start date: 2020 (unspecified if ongoing); "cataract surgery" (unspecified if ongoing); "Monovision" (unspecified if ongoing). Concomitant medication(s) included: LETROZOLE; ALENDRONATE. Past drug history included: Taxol, start date: 2016, for breast cancer, reaction(s): "my feet felt tingly", notes: 5 years ago I had chemo for breast cancer and my feet felt tingly from Taxol/paclitaxel. It felt like that except chemo was multiples worse; Paclitaxel, start date: 2016, for breast cancer, reaction(s): "my feet felt tingly", notes: 5 years ago I had chemo for breast cancer and my feet felt tingly from Taxol/paclitaxel. Vaccination history included: Jj vax, administration date: 12Mar2021, when the patient was 59 years old, for Immunization. The following information was reported: PARAESTHESIA (non-serious) with onset 07Oct2021 23:00, outcome "unknown", described as "bedtime tingly left pinky finger/left side of thigh felt tingly"; MUSCULAR WEAKNESS (non-serious) with onset 07Oct2021 23:00, outcome "unknown", described as "full left hand felt limp"; HYPOAESTHESIA (non-serious) with onset 08Oct2021, outcome "unknown", described as "Tingly-numb on left pinky finger, and tingly on left ring finger, and numb on 1/3 of left palm towards my pinky"; HEADACHE (non-serious) with onset 08Oct2021, outcome "unknown", described as "headache"; ASTHENOPIA (non-serious) with onset 08Oct2021, outcome "unknown", described as "left eye (reading eye) was tired.". Therapeutic measures were not taken as a result of paraesthesia, muscular weakness, hypoaesthesia, headache, asthenopia.   Additional information: Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: letrozole, alendronate, store vitamins (various). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. known allergies: no.   No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Gait disturbance, Injection site discomfort
Clinical narrative: he had a fall because his legs gave out; Received booster dose on 06Oct2021, could hardly walk the next day.; Discomfort to injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 76 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 06Oct2021 (Lot number: FF8841) at the age of 76 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Parkinson's disease", start date: 2015 (ongoing), notes: Verbatim: Parkinson's disease, he has a Deep brain stimulator, it was an implant to help with Parkinson's but it made it worse; "Prediabetes" (unspecified if ongoing), notes: Verbatim: Prediabetes; "Remission from Bladder Cancer" (unspecified if ongoing), notes: Verbatim: Remission from Bladder Cancer, Had Infusion therapy.; "Diabetes" (ongoing), notes: Sugar On Metformin; "leukemia" (unspecified if ongoing); "Hodgkins disease" (unspecified if ongoing); "myelomas" (unspecified if ongoing). Concomitant medication(s) included: CARBIDOPA taken for parkinson's disease; METFORMIN taken for diabetes mellitus; ATORVASTATIN; LOSARTAN; DULOXETINE; SILODOSIN. Vaccination history included: Bnt162b2 (Dose:1, single, Lot number:ER8982, Anatomical site of injection: Left arm, Route of administration: Intramuscular), administration date: 28Jan2021, when the patient was 75 years old, for COVID-19 Immunization; Bnt162b2 (Dose:2, single, Lot number:EN6201, Anatomical site of injection: Left arm, Route of administration: Intramuscular), administration date: 18Feb2021, when the patient was 75 years old, for COVID-19 Immunization. The following information was reported: GAIT DISTURBANCE (non-serious) with onset 07Oct2021, outcome "unknown", described as "Received booster dose on 06Oct2021, could hardly walk the next day."; INJECTION SITE DISCOMFORT (non-serious) with onset 07Oct2021, outcome "recovered" (2021), described as "Discomfort to injection site"; FALL (non-serious), outcome "unknown", described as "he had a fall because his legs gave out". Therapeutic measures were not taken as a result of gait disturbance, injection site discomfort.  Additional information: Patient was with Parkinson's and hardly walk but this right now just terrible. He walked once to the bathroom but it was very slow. He uses a walker. No prior vaccination within 4 weeks.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: experienced some arm soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 03Sep2021 (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 "recovered", described as "experienced some arm soreness". Therapeutic measures were taken as a result of pain in extremity.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: had some aches and pain with the 2nd dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (086396). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "not have a spleen." (Unspecified if ongoing), notes: Verbatim: not have a spleen.; "was having a problem with my thumb" (unspecified if ongoing), notes: prescribed Mobic once a day. Concomitant medication(s) included: LETROZOLE. Vaccination history included: Bnt162b2 (1st dose), administration date: Mar2021, for Covid-19 Immunization. The following information was reported: PAIN (non-serious) with onset 2021, outcome "unknown", described as "had some aches and pain with the 2nd dose".  Additional information: Her oncologist told her booster shot since she was taking Ibrance and Letrozole. she was having a problem with her thumb and she was prescribed Mobic once a day. her doctor said she need to wait to get the booster during her week off of Ibrance. Patient husband added that she does not have a spleen. She was ok after the 1st dose but had some aches and pain with the 2nd dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy liver, Blood testosterone, Chills, Dizziness, Heart rate increased
Clinical narrative: Felt dizzy as soon as first injection; fast heartbeat; nervous; Muscle ache; Arm hurts; chill on chest up and down; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old male patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 07Oct2021 (Lot number: FC3184) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Kidney replacement transplant" (unspecified if ongoing), notes: Years ago; "Known allergies: Penicillin" (unspecified if ongoing). Family history included: "heart disease" (unspecified if ongoing), notes: 2 Family members died of Heart Disease. The patient took concomitant medications. Past drug history included: Augmentin, reaction(s): "Known allergies: Augmentin". The following information was reported: DIZZINESS (non-serious) with onset 07Oct2021 09:30, outcome "recovered with sequelae", described as "Felt dizzy as soon as first injection"; HEART RATE INCREASED (non-serious) with onset 07Oct2021 09:30, outcome "recovered with sequelae", described as "fast heartbeat"; NERVOUSNESS (non-serious) with onset 07Oct2021 09:30, outcome "recovered with sequelae", described as "nervous"; MYALGIA (non-serious) with onset 07Oct2021 09:30, outcome "recovered with sequelae", described as "Muscle ache"; PAIN IN EXTREMITY (non-serious) with onset 07Oct2021 09:30, outcome "recovered with sequelae", described as "Arm hurts"; CHILLS (non-serious) with onset 07Oct2021 09:30, outcome "recovered with sequelae", described as "chill on chest up and down". The events "felt dizzy as soon as first injection", "fast heartbeat", "nervous", "muscle ache", "arm hurts" and "chill on chest up and down" were 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 dizziness, heart rate increased, nervousness, myalgia, pain in extremity, chills. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient receive other medications within 2 weeks of vaccination. Patient had bathed in rubbing alcohol.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nervousness, Pain in extremity
Clinical narrative: Felt dizzy as soon as first injection; fast heartbeat; nervous; Muscle ache; Arm hurts; chill on chest up and down; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old male patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 07Oct2021 (Lot number: FC3184) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Kidney replacement transplant" (unspecified if ongoing), notes: Years ago; "Known allergies: Penicillin" (unspecified if ongoing). Family history included: "heart disease" (unspecified if ongoing), notes: 2 Family members died of Heart Disease. The patient took concomitant medications. Past drug history included: Augmentin, reaction(s): "Known allergies: Augmentin". The following information was reported: DIZZINESS (non-serious) with onset 07Oct2021 09:30, outcome "recovered with sequelae", described as "Felt dizzy as soon as first injection"; HEART RATE INCREASED (non-serious) with onset 07Oct2021 09:30, outcome "recovered with sequelae", described as "fast heartbeat"; NERVOUSNESS (non-serious) with onset 07Oct2021 09:30, outcome "recovered with sequelae", described as "nervous"; MYALGIA (non-serious) with onset 07Oct2021 09:30, outcome "recovered with sequelae", described as "Muscle ache"; PAIN IN EXTREMITY (non-serious) with onset 07Oct2021 09:30, outcome "recovered with sequelae", described as "Arm hurts"; CHILLS (non-serious) with onset 07Oct2021 09:30, outcome "recovered with sequelae", described as "chill on chest up and down". The events "felt dizzy as soon as first injection", "fast heartbeat", "nervous", "muscle ache", "arm hurts" and "chill on chest up and down" were 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 dizziness, heart rate increased, nervousness, myalgia, pain in extremity, chills. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient receive other medications within 2 weeks of vaccination. Patient had bathed in rubbing alcohol.  No follow-up attempts are possible. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Pain assessment, Vaccination site pain
Clinical narrative: Soreness at injection site (level 2 on scale 1-10); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 12 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 30Oct2021 09:30 (Lot number: FF2593) at the age of 12 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Nephrotic syndrome" (unspecified if ongoing). Concomitant medication(s) included: TACROLIMUS taken for nephrotic syndrome, start date: 2013 (ongoing). Vaccination history included: Bnt162b2 (DOSE:1, prev dose lot number=FH8020, prev dose administrator route=Intra muscular,, prev dose dose number=1,, prev dose vaccine location=Left, arm}], administration time=03:15 PM), administration date: 09Oct2021, when the patient was 12 years old, for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 30Oct2021 20:00, outcome "not recovered", described as "Soreness at injection site (level 2 on scale 1-10)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, patient has not been tested for COVID-19. The patient did not have any known allergies. The patient did not have any family medical history relevant to adverse event.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Slight fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female 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: PYREXIA (non-serious), outcome "unknown", described as "Slight fever".  Additional information: Patient's mother reported that the adverse reaction to the Pfizer COVID Vaccine. While providing information caller stated that her husband and daughter got it. Her husband didn't have symptoms. Her daughter had slight fever. Caller wasn't expecting this at all. Reporter declined to go through a report for her daughter because it was minor.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blister, Pruritus, Scar
Clinical narrative: know some people, 3 people that she knows are experiencing the same side effects like what she's having./ a little red marks that turned into water blisters; As itchy little red marks; The blisters will leak out and will turn into a black scar.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 48 year-old female patient (unknown if pregnant) 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: BLISTER (non-serious), outcome "unknown", described as "know some people, 3 people that she knows are experiencing the same side effects like what she's having./ a little red marks that turned into water blisters"; PRURITUS (non-serious), outcome "unknown", described as "As itchy little red marks"; SCAR (non-serious), outcome "unknown", described as "The blisters will leak out and will turn into a black scar.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blister, Blister rupture, Burning sensation, Erythema, Pruritus
Clinical narrative: itchy little red marks scattered over arm and legs that turned into blisters and it's extremely big and red itchy one; itchy little red marks scattered over arm and legs that turned into blisters and it's extremely big and red itchy one; a little red marks that turned into water blisters; blister is burning; The blisters will leak out; The blisters will leak out and will turn into a black scar / mark on body...know some people, 3 people that she knows are experiencing the same side effects; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ERYTHEMA (non-serious), PRURITUS (non-serious), outcome "unknown" and all described as "itchy little red marks scattered over arm and legs that turned into blisters and it's extremely big and red itchy one"; BLISTER (non-serious), outcome "unknown", described as "a little red marks that turned into water blisters"; BURNING SENSATION (non-serious), outcome "unknown", described as "blister is burning"; BLISTER RUPTURE (non-serious), outcome "unknown", described as "The blisters will leak out"; SCAR (non-serious), outcome "unknown", described as "The blisters will leak out and will turn into a black scar / mark on body...know some people, 3 people that she knows are experiencing the same side effects".  Additional Information: Reporter (Female, 48 Years) stated she had both of the Pfizer Covid19 shots and she experienced little red marks that turned into water blisters, and she wants to know what can be done about it. She described it as itchy little red marks scattered over her arm and legs that turned into blisters and it's extremely big and red itchy one. The blisters will leak out and will turn into a black scar. And as we speak one blister is burning, she also added that she know some people, 3 people that she knows are experiencing the same side effects like what she's having. Reporter stated that Pfizer need to look into some serious side effects because this is not good. This side effects of the vaccine will have a mark on her body and all we can do was refer them back to their HCP.  Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Scar
Clinical narrative: itchy little red marks scattered over arm and legs that turned into blisters and it's extremely big and red itchy one; itchy little red marks scattered over arm and legs that turned into blisters and it's extremely big and red itchy one; a little red marks that turned into water blisters; blister is burning; The blisters will leak out; The blisters will leak out and will turn into a black scar / mark on body...know some people, 3 people that she knows are experiencing the same side effects; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ERYTHEMA (non-serious), PRURITUS (non-serious), outcome "unknown" and all described as "itchy little red marks scattered over arm and legs that turned into blisters and it's extremely big and red itchy one"; BLISTER (non-serious), outcome "unknown", described as "a little red marks that turned into water blisters"; BURNING SENSATION (non-serious), outcome "unknown", described as "blister is burning"; BLISTER RUPTURE (non-serious), outcome "unknown", described as "The blisters will leak out"; SCAR (non-serious), outcome "unknown", described as "The blisters will leak out and will turn into a black scar / mark on body...know some people, 3 people that she knows are experiencing the same side effects".  Additional Information: Reporter (Female, 48 Years) stated she had both of the Pfizer Covid19 shots and she experienced little red marks that turned into water blisters, and she wants to know what can be done about it. She described it as itchy little red marks scattered over her arm and legs that turned into blisters and it's extremely big and red itchy one. The blisters will leak out and will turn into a black scar. And as we speak one blister is burning, she also added that she know some people, 3 people that she knows are experiencing the same side effects like what she's having. Reporter stated that Pfizer need to look into some serious side effects because this is not good. This side effects of the vaccine will have a mark on her body and all we can do was refer them back to their HCP.  Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site swelling
Clinical narrative: swelling in arm at the injection area; under my arm it is sore it feels heavy; 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 3 (booster), 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; Bnt162b2 (Dose 2, Single), for COVID-19 Immunization. The following information was reported: VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "swelling in arm at the injection area"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "under my arm it is sore it feels heavy".  Additional Information: Patient received booster shot on the 07. There was swelling in arm at the injection area, but the thing was under arm it was sore it feels heavy. Reporter seriousness for all events was unspecified.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Body height, Investigation, Night sweats, Tremor, Weight
Clinical narrative: had night sweat in the middle of night; shaking where she is like drenched she wake up in the middle of night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 81 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 04Oct2021 (Lot number: 301558A) at the age of 81 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE) (Batch/Lot number: unknown) as unk unk, single; denosumab (PROLIA) (Batch/Lot number: unknown). The patient's relevant medical history was not reported. Concomitant medication(s) included: METOPROLOL; BISOPROLOL; AMLODIPINE; HYDROCHLOROTHIAZIDE; VITAMIN D [VITAMIN D NOS]; ZOLOFT; FLECAINIDE; XARELTO. Vaccination history included: Bnt162b2 (First dose), for Covid-19 immunization; Bnt162b2 (Second dose), for Covid-19 immunization. The following information was reported: NIGHT SWEATS (non-serious) with onset 04Oct2021, outcome "not recovered", described as "had night sweat in the middle of night"; TREMOR (non-serious) with onset 04Oct2021, outcome "not recovered", described as "shaking where she is like drenched she wake up in the middle of night". The events "had night sweat in the middle of night" and "shaking where she is like drenched she wake up in the middle of night" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. The action taken for denosumab was unknown. Therapeutic measures were not taken as a result of night sweats, tremor.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Started pain; my arm is hurting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) at the age of 55 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: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Started pain; my arm is hurting". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Hyperhidrosis, Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 48-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot#  FC3183), at the age of 48, in right deltoid, on Sep 4, 2021, at 08:00, single dose, for COVID-19 immunisation. No medical history or concomitant medications reported. The patient experienced hyperhidrosis (sweats), felt hot (got really hot and is hot all the time), dizziness (kind of had like a dizzy feeling since these vaccines, still been able to go on, but feels weird in her head) and pain in extremity (underarm feels sore; knows it's normal with the swelling on the side where she got the vaccines), onset Sep 2021, with outcome of not recovered. Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A male patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient experienced peripheral swelling ("swollen arms; 4 months ago when I got my shot; arms still swollen"), onset 2021, with outcome of not recovered. Additional information:  Patient got the Pfizer shot (unspecified shot) and his arms swelled-up (ongoing). "4 months ago when I got my shot, my arm almost swelled; and my arms still swollen." Further probing could not be done due to poor connectivity. Limited information available over the call. Expiry date of unspecified shot: Unknown. Follow-up attempts completed. Information about batch/lot number cannot be obtained. No further information expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Vaccination site pain
Clinical narrative: Unable to sleep on left side with both vaccines for one night.; Injection site pain vaccination #1; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Dec2020 08:00 (Lot number: EH9889) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroid" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: SYNTHROID. The following information was reported: INSOMNIA (non-serious), outcome "recovering", described as "Unable to sleep on left side with both vaccines for one night."; VACCINATION SITE PAIN (non-serious), outcome "recovering", described as "Injection site pain vaccination #1".  Additional Information: Facility type vaccine was Pharmacy or Drug Store. No other vaccine in four weeks. Other medications in two weeks was Synthroid. No covid prior vaccination. Not covid tested post vaccination.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101341429 same reporter/patient/product, different dose/event.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lacrimation increased, Pain, Pain in extremity, Tinnitus
Clinical narrative: Chills; Left arm pain; other random pains; sudden eye tearing; Tinnitus; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Jan2021 08:30 (Lot number: EL1283) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroid" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EH9889, Location of injection: Left arm, Vaccine Administration Time: 08:00 AM), administration date: 31Dec2020, when the patient was 60 years old, for Covid-19 immunization, reaction(s): "Injection site pain". The following information was reported: CHILLS (non-serious), outcome "recovered", described as "Chills"; TINNITUS (non-serious) with onset Jan2021, outcome "recovered" (22Jan2021), described as "Tinnitus"; PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "Left arm pain"; PAIN (non-serious), outcome "recovering", described as "other random pains"; LACRIMATION INCREASED (non-serious), outcome "recovering", described as "sudden eye tearing". Therapeutic measures were taken as a result of lacrimation increased.  Additional Information: Facility type Vaccine: Pharmacy or Drug Store.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101341429 same reporter/patient/product, different dose/event.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I have been sick all week; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Lot number: FE3592) 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: ILLNESS (non-serious), outcome "unknown", described as "I have been sick all week".  Additional information: The patient took the Pfizer vaccine. The patient was given a pamphlet when she got it and because she have been sick all week.    Follow-up: Follow-up attempts completed. No further information expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Magnetic resonance imaging, Pain, Pain in extremity, Periarthritis
Clinical narrative: the problem is Adhesive Capsulitis; Soreness in the left arm; Developed into restricted motion of the left shoulder plus pain of motion; Developed into restricted motion of the left shoulder plus pain of motion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Apr2021 09:30 (Lot number: ER8733) at the age of 64 years as dose 2, single and administered in arm left, administration date 29Mar2021 09:30 (Lot number: ER8734) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PERIARTHRITIS (non-serious) with onset Apr2021, outcome "not recovered", described as "the problem is Adhesive Capsulitis"; PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "not recovered", described as "Soreness in the left arm"; PAIN (non-serious), JOINT RANGE OF MOTION DECREASED (non-serious) all with onset Apr2021, outcome "not recovered" and all described as "Developed into restricted motion of the left shoulder plus pain of motion". The events "the problem is adhesive capsulitis", "soreness in the left arm", "developed into restricted motion of the left shoulder plus pain of motion" and "developed into restricted motion of the left shoulder plus pain of motion" were 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 periarthritis. Therapeutic measures were taken as a result of pain in extremity, pain, joint range of motion decreased. Additional Information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, X-ray
Clinical narrative: the problem is Adhesive Capsulitis; Soreness in the left arm; Developed into restricted motion of the left shoulder plus pain of motion; Developed into restricted motion of the left shoulder plus pain of motion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Apr2021 09:30 (Lot number: ER8733) at the age of 64 years as dose 2, single and administered in arm left, administration date 29Mar2021 09:30 (Lot number: ER8734) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PERIARTHRITIS (non-serious) with onset Apr2021, outcome "not recovered", described as "the problem is Adhesive Capsulitis"; PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "not recovered", described as "Soreness in the left arm"; PAIN (non-serious), JOINT RANGE OF MOTION DECREASED (non-serious) all with onset Apr2021, outcome "not recovered" and all described as "Developed into restricted motion of the left shoulder plus pain of motion". The events "the problem is adhesive capsulitis", "soreness in the left arm", "developed into restricted motion of the left shoulder plus pain of motion" and "developed into restricted motion of the left shoulder plus pain of motion" were 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 periarthritis. Therapeutic measures were taken as a result of pain in extremity, pain, joint range of motion decreased. Additional Information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Gait disturbance, Inappropriate schedule of product administration, Joint stiffness, Rash macular
Clinical narrative: joints are stiff; burning in my legs; red spot the size of a baseball; can barely move; administration date=04Oct2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Oct2021 14:30 (Batch/Lot number: unknown) at the age of 52 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "sleep apnoea" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; LINZESS; LEVOTHYROXINE; FLUOXETINE; VIT D [VITAMIN D NOS]. Past drug history included: Biaxin, reaction(s): "known allergies: Biaxin"; Claritin, reaction(s): "known allergies: Claritin". Vaccination history included: Bnt162b2 (Dose number: 1, Dose administration date: May2021, Dose administration time: 07:00PM, Dose vaccine location=Right arm), administration date: May2021, for covid-19 immunization, reaction(s): "Severe itching", "rash on right arm from elbow to wrist that spread to left arm", "Blotches all over top of both legs". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 04Oct2021 14:30, outcome "unknown", described as "administration date=04Oct2021"; JOINT STIFFNESS (non-serious) with onset 05Oct2021 08:00, outcome "not recovered", described as "joints are stiff"; BURNING SENSATION (non-serious) with onset 05Oct2021 08:00, outcome "not recovered", described as "burning in my legs"; RASH MACULAR (non-serious) with onset 05Oct2021 08:00, outcome "not recovered", described as "red spot the size of a baseball"; GAIT DISTURBANCE (non-serious) with onset 05Oct2021 08:00, outcome "not recovered", described as "can barely move". Therapeutic measures were not taken as a result of joint stiffness, burning sensation, rash macular, gait disturbance.  Additional information: First rash on right arm from elbow to wrist that spread to left arm. Blotches all over top of both legs. Severe itching to where I wanted to tear my skin off so far, second injection, I have a red spot the size of a baseball on my left arm, burning in my legs both times and it's extremely difficult for me to get out of bed in the mornings as my joints are stiff and I can barely move. The patient received no other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Neck pain
Clinical narrative: soreness in neck; hands and feet were on fire/burning sensation; 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 left, administration date 06Oct2021 (Lot number: FF2588, Expiration Date: Dec2021) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "car accident", start date: Dec2020 (unspecified if ongoing), notes: she had a car accident 9.5 months ago in Dec2020; "carpal tunnel" (unspecified if ongoing), notes: She had carpal tunnel in both hands due to the accident; "swelling" (unspecified if ongoing), notes: She had swelling previously. The patient's concomitant medications were not reported. The following information was reported: BURNING SENSATION (non-serious) with onset 06Oct2021 22:30, outcome "not recovered", described as "hands and feet were on fire/burning sensation"; NECK PAIN (non-serious) with onset 08Oct2021, outcome "recovering", described as "soreness in neck".  Additional information: She did not initially have any reaction like within a couple minutes or hours after the vaccine. It wasn't until later that evening she started to experience reactions. The injection site was on left arm. Towards the evening she started to have side effects. Her hands and feet were on fire and it hasn't stopped. That was the first day. The second day she had the same symptoms, but then had issue where her neck was very sore. The burning sensation continued through the night. Initially she didn't have the soreness of the neck.  Time the vaccination was given between 6:00PM and 6:30PM. No any AEs prior vaccinations (within 4 weeks) and following prior vaccinations.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Insomnia, Pain in extremity, Vaccination site pain
Clinical narrative: trouble sleeping, didn't sleep very well; Aches pains in legs; where he got the vaccination, his arm was very, very sore; could hardly even lift his arm for a whole day; severe chills, couldn't get warm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Sep2021 11:00 (Batch/Lot number: unknown) at the age of 72 years as dose 3, single for covid-19 immunisation. Relevant medical history included: "Knee replacement" (unspecified if ongoing), notes: Verbatim: Knee replacement. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2), for Covid-19 Immunization; Bnt162b2 (Dose 1), for Covid-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 28Sep2021, outcome "recovered" (29Sep2021), described as "severe chills, couldn't get warm"; INSOMNIA (non-serious), outcome "recovered", described as "trouble sleeping, didn''t sleep very well"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Aches pains in legs"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "where he got the vaccination, his arm was very, very sore; could hardly even lift his arm for a whole day".  Additional information: The caller confirms he had the first two Pfizer vaccinations over 6 months ago and then had the booster shot the Tuesday before last. He states. He went in and got the vaccination and everything was fine. That evening he started to get really severe chills, he couldn't get warm. Also, that night he had trouble sleeping. He states he didn't sleep very well because he had aches and pains in both legs. Weight: his weight fluctuates between 165-170lbs. He mentions also where he got the vaccination, his arm was very, very sore. He could hardly even lift his arm for a whole day.  When probed for the outcome of his symptoms, the caller verifies everything is gone. He mentions he still has a little aches and pains. He clarifies further his chills went away the second day. The second night he still had aches and pains in his legs. Follow-up attempts completed. No further information is expected. lot/batch number is not available despite the follow-up attempts made.