chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pain in extremity, Vaccination site pain, Vaccination site swelling
Clinical narrative: Chills; Headache; Pain in arm; Body aches; not feeling good; Feeling bad; Muscle pain in my arm; injection site is pretty sore; a little swelling there; injection site is pretty sore; a little swelling there; Dizziness ; I think that is the pain.; driving me crazy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2) (Lot number: Unknown) at the age of 54 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), for COVID-19 immunization. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Chills"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Pain in arm"; PAIN (non-serious), outcome "unknown", described as "Body aches"; MALAISE (non-serious), outcome "unknown", described as "not feeling good"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Feeling bad"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain in my arm"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious), outcome "unknown" and all described as "injection site is pretty sore; a little swelling there"; DIZZINESS (non-serious), outcome "unknown", described as "Dizziness ; I think that is the pain."; FEELING ABNORMAL (non-serious), outcome "unknown", described as "driving me crazy".  Additional information: Consumer took the second dose (Unspecified Medication) yesterday and you know this is day 2, I am experiencing chills, headache, I think no more side effects. And pain in arm but that is getting better, I know that is getting better. The side effects the chills and headache, how long does it take, like you know, my body aches. Got her second vaccination yesterday and was experiencing some side effects. They are not real bad, the one that is driving her crazy is the headache and the chills. having of course some muscle pain in arm and the injection site is pretty sore and it's getting better and little swelling there and stated that it is not a big deal but troubling with the dizziness and thinks no more side effects and pain in arm but that is getting better. Consumer asked how long it takes for the side effects chills and headache and her body aches.  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: Cutis laxa, Energy increased, Weight, Weight decreased
Clinical narrative: Yesterday, I took 20,000 steps and my second shot feels like I'm on a caffeine buzz of energy.; My leg skin is starting to sag from losing weight quickly; My leg skin is starting to sag from losing weight quickly; This is a spontaneous report received from 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 21Apr2021 10:00 (Lot number: ER8731) at the age of 40 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "HBP" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: PROPOFOL; PROZAC; LISINOPRIL. Vaccination history included: Bnt162b2 (lot number:Er8727, administration time:10:00 AM, vaccine location:Left arm, dose number:1), administration date: 01Apr2021, when the patient was 40 years old, for Covid-19 immunisation, reaction(s): "Increase in energy". The following information was reported: ENERGY INCREASED (non-serious) with onset 21Apr2021, outcome "not recovered", described as "Yesterday, I took 20,000 steps and my second shot feels like I'm on a caffeine buzz of energy."; WEIGHT DECREASED (non-serious), CUTIS LAXA (non-serious) all with onset Apr2021, outcome "unknown" and all described as "My leg skin is starting to sag from losing weight quickly". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information:The patient had Increase in energy, that was a stretch for him to hit 2,500 due to a mixture of pain, fatigue and other concerns over the years. Yesterday(21Apr2021), he took 20,000 steps and his second shot felt him like on a caffeine buzz of energy. He Heard about people had an awful experience, but he had zero pain and aside from the change in energy levels nothing negative. His leg skin was starting to sag from losing weight quickly. He had no known allergies also no other vaccine in four weeks and but received fish as medication in two weeks. No treatment was received for adverse events. He had no COVID-19 prior to vaccination and post the vaccination was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: She feels sick ;if she is positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 13Apr2021 (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: ILLNESS (non-serious) with onset Apr2021, outcome "unknown", described as "She feels sick ;if she is positive".  Additional information: She got her 1st dose last April 13Apr2021. And today she stated she feels sick and now she wants to ask if she will be or she should be tested if she is positive, She is just asking if she needs to be tested because she feels sick today.  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 in extremity
Clinical narrative: Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female 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".  Additional Information: Reporter stated during call that her 2 sisters had sore arms after their Covid Vaccines.  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-2021477215 Same reporter/ drug/ AE, different patient
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Affective disorder, Chills, Feeling hot, Flatulence, Headache
Clinical narrative: Pain at injection site (similar to first vaccine); chills; Headache; body aches; Warm head, face, and neck; cold hands, feet, and nose; Increased flatulence; BMs; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 21Apr2021 17:15 (Lot number: EP7533) at the age of 27 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MIRENA; OLLY RESTFUL SLEEP. Vaccination history included: Bnt162b2 (lot number ER8734, administration time 03:45 PM, vaccine location Right arm, First dose ), administration date: 31Mar2021, when the patient was 27 years old, for COVID-19 IMMUNISATION. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 22Apr2021 07:00, outcome "not recovered", described as "Pain at injection site (similar to first vaccine)"; CHILLS (non-serious) with onset 22Apr2021 07:00, outcome "not recovered", described as "chills"; HEADACHE (non-serious) with onset 22Apr2021 07:00, outcome "not recovered", described as "Headache"; PAIN (non-serious) with onset 22Apr2021 07:00, outcome "not recovered", described as "body aches"; FEELING HOT (non-serious) with onset 22Apr2021 07:00, outcome "not recovered", described as "Warm head, face, and neck; cold hands, feet, and nose"; FLATULENCE (non-serious) with onset 22Apr2021 07:00, outcome "not recovered", described as "Increased flatulence"; AFFECTIVE DISORDER (non-serious) with onset 22Apr2021 07:00, outcome "not recovered", described as "BMs". Therapeutic measures were not taken as a result of vaccination site pain, chills, headache, pain, feeling hot, flatulence, affective disorder.  Additional information: Pain at injection site (similar to first vaccine). Woke up with chills this morning (7:00am), on and off chills throughout the day Headache and body aches Warm head, face, and neck, cold hands, feet, and nose Increased flatulence and BMs. Patient did not receive treatment AE. No covid prior vaccination. No covid tested post vaccination. Known allergies: No, other vaccine was not received in four weeks. Other medications in two weeks Mirena IUD, OLLY Women's Multi, OLLY Xtra Str Slp.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: Pain at injection site (similar to first vaccine); chills; Headache; body aches; Warm head, face, and neck; cold hands, feet, and nose; Increased flatulence; BMs; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 21Apr2021 17:15 (Lot number: EP7533) at the age of 27 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MIRENA; OLLY RESTFUL SLEEP. Vaccination history included: Bnt162b2 (lot number ER8734, administration time 03:45 PM, vaccine location Right arm, First dose ), administration date: 31Mar2021, when the patient was 27 years old, for COVID-19 IMMUNISATION. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 22Apr2021 07:00, outcome "not recovered", described as "Pain at injection site (similar to first vaccine)"; CHILLS (non-serious) with onset 22Apr2021 07:00, outcome "not recovered", described as "chills"; HEADACHE (non-serious) with onset 22Apr2021 07:00, outcome "not recovered", described as "Headache"; PAIN (non-serious) with onset 22Apr2021 07:00, outcome "not recovered", described as "body aches"; FEELING HOT (non-serious) with onset 22Apr2021 07:00, outcome "not recovered", described as "Warm head, face, and neck; cold hands, feet, and nose"; FLATULENCE (non-serious) with onset 22Apr2021 07:00, outcome "not recovered", described as "Increased flatulence"; AFFECTIVE DISORDER (non-serious) with onset 22Apr2021 07:00, outcome "not recovered", described as "BMs". Therapeutic measures were not taken as a result of vaccination site pain, chills, headache, pain, feeling hot, flatulence, affective disorder.  Additional information: Pain at injection site (similar to first vaccine). Woke up with chills this morning (7:00am), on and off chills throughout the day Headache and body aches Warm head, face, and neck, cold hands, feet, and nose Increased flatulence and BMs. Patient did not receive treatment AE. No covid prior vaccination. No covid tested post vaccination. Known allergies: No, other vaccine was not received in four weeks. Other medications in two weeks Mirena IUD, OLLY Women's Multi, OLLY Xtra Str Slp.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dyskinesia, Headache, Illness
Clinical narrative: Headache; Chills; sick; weak; cannot get out of bed; could not move her left arm; left arm swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2) (Lot number: EW0175) 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, Anatomical location-left arm., Lot# Number-ER8734, Left Arm was swollen and hurt from first one and could not move it for a week), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headache"; CHILLS (non-serious), outcome "unknown", described as "Chills"; ILLNESS (non-serious), outcome "unknown", described as "sick"; ASTHENIA (non-serious), outcome "unknown", described as "weak"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "cannot get out of bed"; DYSKINESIA (non-serious), outcome "unknown", described as "could not move her left arm"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "left arm swollen".  Additional information: It was reported that, every since she got the second vaccine yesterday morning that she has been sick. Stated that she will not be doing that again to herself. Stated that she heard one was supposed to get it every year. Stated that she has headache and cannot move arm. Stated that it was not worth it. Stated that she has an autoimmune disease so she was weak anyway. Had chills, sick, weak and cannot get out of bed. Stated she knew these were risks. Stated that she does not think enough research was done because it was an emergency vaccine. Stated that she got talked into it by family. Stated that nothing helps the headache and she was taking Excedrin. Stated that with the first vaccine that her left arm was swollen and hurt from first one and could not move it for a week. Stated that it got better. Provided the first vaccine lot of ER8734 and the second vaccine lot of EW0175. Clarified that it was for the Covid 19 vaccine.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Peripheral swelling
Clinical narrative: Headache; Chills; sick; weak; cannot get out of bed; could not move her left arm; left arm swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2) (Lot number: EW0175) 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, Anatomical location-left arm., Lot# Number-ER8734, Left Arm was swollen and hurt from first one and could not move it for a week), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headache"; CHILLS (non-serious), outcome "unknown", described as "Chills"; ILLNESS (non-serious), outcome "unknown", described as "sick"; ASTHENIA (non-serious), outcome "unknown", described as "weak"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "cannot get out of bed"; DYSKINESIA (non-serious), outcome "unknown", described as "could not move her left arm"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "left arm swollen".  Additional information: It was reported that, every since she got the second vaccine yesterday morning that she has been sick. Stated that she will not be doing that again to herself. Stated that she heard one was supposed to get it every year. Stated that she has headache and cannot move arm. Stated that it was not worth it. Stated that she has an autoimmune disease so she was weak anyway. Had chills, sick, weak and cannot get out of bed. Stated she knew these were risks. Stated that she does not think enough research was done because it was an emergency vaccine. Stated that she got talked into it by family. Stated that nothing helps the headache and she was taking Excedrin. Stated that with the first vaccine that her left arm was swollen and hurt from first one and could not move it for a week. Stated that it got better. Provided the first vaccine lot of ER8734 and the second vaccine lot of EW0175. Clarified that it was for the Covid 19 vaccine.  No follow-up attempts are possible. No further information is expected.
Sex: F
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).  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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore Arm".  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-2021477197 Same reporter/ drug/ AE, different patient
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle contractions involuntary, Vaccination site pain
Clinical narrative: mild muscle contractions in one leg (left); pain in the site of injection; 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 right, administration date 01Apr2021 10:30 (Lot number: ER8134) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "hypothyrodism" (unspecified if ongoing); "Ostopenia" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; ATORVASTATIN; CALCIUM; MAGNESIUM. The following information was reported: MUSCLE CONTRACTIONS INVOLUNTARY (non-serious), outcome "recovered", described as "mild muscle contractions in one leg (left)"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain in the site of injection". The event "mild muscle contractions in one leg (left)" was evaluated at the physician office visit. Additional information: The patient received dose 2 of BNT162B2 (Lot number: EW0172) on 22Apr2021 administered on right arm. The patient had no other vaccine in four weeks. Patient had no COVID prior vaccination and was not COVID tested post vaccination.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021476965 same patient/reporter/event, different vaccine dose
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pain in extremity, Vision blurred
Clinical narrative: Blurry vision; Really tired; Arm a little sore; Headache; Achy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), administration date 21Apr2021 (Lot number: ER8735) at the age of 51 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: CITALOPRAM taken for anxiety; DIAZEPAM. Vaccination history included: Bnt162b2 (First dose, lot: EP6955), administration date: 31Mar2021, when the patient was 51 years old, for COVID-19 immunization. The following information was reported: VISION BLURRED (non-serious) with onset 21Apr2021, outcome "not recovered", described as "Blurry vision"; FATIGUE (non-serious) with onset 21Apr2021, outcome "recovering", described as "Really tired"; PAIN (non-serious) with onset Apr2021, outcome "recovering", described as "Achy"; PAIN IN EXTREMITY (non-serious) with onset 21Apr2021, outcome "recovering", described as "Arm a little sore"; HEADACHE (non-serious) with onset 21Apr2021, outcome "recovering", described as "Headache".  Additional information: The blurry vision started about an hour after both shots. The patient had a headache on 21Apr2021 and on 22Apr2021 morning.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm after first dose of the vaccine; This is a spontaneous report received from a contactable consumer. The reporter is the parent.  A 29-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 2021 (Batch/Lot number: unknown) 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: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "sore arm after first dose of the vaccine". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The first dose was administered 3 weeks prior (as reported). The reporter stated that with the first one, his arm was sore the day he got the vaccine and then the day after he was fine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, SARS-CoV-2 antibody test
Clinical narrative: Flu-like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 02Apr2021 (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: INFLUENZA LIKE ILLNESS (non-serious) with onset 04Apr2021, outcome "recovered" (07Apr2021), described as "Flu-like symptoms". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Fatigue, Headache, Nausea
Clinical narrative: menstrual cramps but no period; Exhaustion; nausea; headache for 3 days after 1st dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Mar2021 (Lot number: ER877) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "bipolar type 2" (unspecified if ongoing); "asthma" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies:Penicillin,. Concomitant medication(s) included: ZYPREXA; LAMICTAL; OTREXUP; CELEBREX; B12 [CYANOCOBALAMIN]; D3. Past drug history included: Erythromycin, reaction(s): "Known allergies:erythromycin", notes: Known allergies:erythromycin; Zithromax, reaction(s): "Known allergies:Zithromax", notes: Known allergies:Zithromax; Vancomycin, reaction(s): "Known allergies: Vancomycin", notes: Known allergies:vancomycin; Duracef, reaction(s): "Known allergies:Duracef", notes: Known allergies:duracef; Darvocet, reaction(s): "Known allergies:Darvocet", notes: Known allergies:darvoset; Amoxicillin, reaction(s): "Known allergies: Amoxicillin", notes: Known allergies:amoxicillin. The following information was reported: DYSMENORRHOEA (non-serious) with onset 28Mar2021, outcome "recovered", described as "menstrual cramps but no period"; FATIGUE (non-serious) with onset 28Mar2021, outcome "recovered", described as "Exhaustion"; NAUSEA (non-serious) with onset 28Mar2021, outcome "recovered", described as "nausea"; HEADACHE (non-serious) with onset 28Mar2021, outcome "recovered" (31Mar2021), described as "headache for 3 days after 1st dose". Therapeutic measures were not taken as a result of dysmenorrhoea, fatigue, nausea, headache.  Additional information: The patient did not received any other vaccine in four weeks. The patient did not had covid prior vaccination and not covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Vertigo
Clinical narrative: a few bouts of vertigo; After my second dose the tinnitus did not worsen; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19), administration date 16Apr2021 (Batch/Lot number: unknown) at the age of 44 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "GERD" (unspecified if ongoing); "Sleep apnea" (unspecified if ongoing); "obesity" (unspecified if ongoing); "Known allergies: Pollens only" (unspecified if ongoing); "existing tinnitus" (ongoing). Concomitant medication(s) included: FAMOTIDINE; CETIRIZINE; GLUCOSAMINE; CHONDROITIN. Vaccination history included: Bnt162b2 (Dose 1; Lot number: EN6204, Administration time: 10:45 AM, Vaccine location: Left arm), administration date: 20Mar2021, when the patient was 44 years old, for COVID-19 Immunisation, reaction(s): "worsening of my existing tinnitus". The following information was reported: VERTIGO (non-serious), outcome "not recovered", described as "a few bouts of vertigo"; TINNITUS (non-serious), outcome "not recovered", described as "After my second dose the tinnitus did not worsen". The events "a few bouts of vertigo" and "after my second dose the tinnitus did not worsen" were evaluated at the physician office visit. Therapeutic measures were taken as a result of vertigo, tinnitus. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested for COVID-19 since vaccination. The patient received nasal steroids as a treatment for the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: persistent nasty taste in my mouth; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 80 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12Apr2021 (Lot number: ER8727, Expiration Date: 31Jul2021) at the age of 80 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: TASTE DISORDER (non-serious) with onset 12Apr2021, outcome "unknown", described as "persistent nasty taste in my mouth".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Headache; sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as single dose for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headache"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: It was reported that my realtor just had her second dose of the vaccine and mentioned she had a headache and sore arm the day after the vaccine  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: general tiredness; transient Left arm soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Apr2021 (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: FATIGUE (non-serious) with onset Apr2021, outcome "recovered", described as "general tiredness"; PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "recovered", described as "transient Left arm soreness". Therapeutic measures were not taken as a result of fatigue, pain in extremity. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, it was unknown if the patient has been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: This is a spontaneous report received from contactable consumer or other non-HCP (patient). A 73-year-old male patient received the 1st dose of  BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# ER8732), in left arm, on Mar 27, 2021, at 11:00, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had muscle spasms/right hand severe cramps/left hand severe cramps, onset Mar 27, 2021, with outcome of recovered (Mar 27, 2021), and leg cramps onset Mar 28, 2021, with outcome of recovered (Apr 1, 2021). Additional Information: The reporter stated he received his first shot Mar 27, 2021, at 11:00. At 20:20 while in the shower, he experienced severe right hand cramping. It faded away. A while after, his left hand experienced severe cramping. He experienced debilitating cramps. He never felt this in his lifetime. 2-3 days later he had cramps in his legs. The patient reported this to the clinic and they told him to drink Gatorade. The reporter also added he has type O blood. No follow-up attempts possible. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pain all over her body; This is a spontaneous report received from a non-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. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: PAIN (non-serious), outcome "recovered", described as "Pain all over her body".  Additional information: The reporter stated that he was looking for apartments and the sellers broker mentioned she experienced pain all over her body following the second dose of her Pfizer vaccine and it lasted about a day.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pain in extremity
Clinical narrative: Deathly sick; Arm is massive, sore, throbbing; 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) (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: ILLNESS (non-serious), outcome "unknown", described as "Deathly sick"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm is massive, sore, throbbing". Therapeutic measures were taken as a result of illness, pain in extremity.  Additional information: The patient was told to take some Advil. Patient stated she will take the Advil and will sleep for a day. If it is still sore tomorrow she will go the hospital.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain, Pain in extremity
Clinical narrative: Not feeling ok; Arm was still a little sore; His wife had the second dose Saturday and reported soreness stronger than the first time and body ached a little bit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  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 (First dose), for COVID-19 immunization, reaction(s): "Not feeling ok", "soreness stronger than the first time and body ached a little bit", "yesterday her arm was still a  little sore but today she is better". The following information was reported: PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "His wife had the second dose Saturday and reported soreness stronger than the first time and body ached a little bit"; MALAISE (non-serious), outcome "unknown", described as "Not feeling ok"; PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "Arm was still a little sore".  Additional Information: The reporter reported the event for his wife. Separate case created for the reporter and his mother. The reporter stated that his wife had the second dose on Saturday and reported soreness stronger than the first time and body ached a little bit, not feeling ok , nothing major, The reporter also stated that yesterday her arm was still a  little sore but today she is better.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain, Pain in extremity
Clinical narrative: soreness in the arm and pain in the legs; body ached a little bit; not feeling ok; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  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: Covid-19 vaccine (Dose 1), for Covid-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "soreness in the arm and pain in the legs"; PAIN (non-serious), outcome "unknown", described as "body ached a little bit"; MALAISE (non-serious), outcome "unknown", described as "not feeling ok".  Additional information: Caller stated his wife had the second dose Saturday and reported soreness stronger than the first time and body ached a little bit, not feeling ok , nothing major, Caller stated yesterday her arm was still a  little sore but today she is better. Caller reported his mother got the second dose on Saturday and reported about the same as his wife noting soreness in the arm and pain in the legs stating it is gone now  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Inappropriate schedule of product administration, Investigation, Magnetic resonance imaging, Migraine
Clinical narrative: Severe unrelenting migraine; nausea; vertigo; dose number:1;administration date:11Mar2021/dose number:2;administration date:28Mar2021; Severe right side abdominal pain, deep; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Mar2021 12:00 (Lot number: En6647) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hashimoto's disease" (unspecified if ongoing); "cholecystectomy" (unspecified if ongoing), notes: Levaquin and scopolamine; "hypoglycemia" (unspecified if ongoing); "Allergies to Levaquin" (unspecified if ongoing); "Choke" (unspecified if ongoing); "gastric sleeve" (unspecified if ongoing); "Mc hernia repairs" (unspecified if ongoing); "impure metals" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; ELETRIPTAN; ESCITALOPRAM; TRAZODONE. Past drug history included: Levaquin, reaction(s): "Drug allergy"; Scopolamine. Vaccination history included: Bnt162b2 (Dose 1, lot number: En6349 (Arm left)), administration date: 11Mar2021, for covid-19 immunisation. The following information was reported: ABDOMINAL PAIN (non-serious) with onset 22Apr2021 01:00, outcome "not recovered", described as "Severe right side abdominal pain, deep"; MIGRAINE (non-serious) with onset 29Apr2021 05:00, outcome "not recovered", described as "Severe unrelenting migraine"; NAUSEA (non-serious) with onset 29Apr2021 05:00, outcome "not recovered", described as "nausea"; VERTIGO (non-serious) with onset 29Apr2021 05:00, outcome "not recovered", described as "vertigo"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 22Apr2021 01:00, outcome "unknown", described as "dose number:1;administration date:11Mar2021/dose number:2;administration date:28Mar2021". The event "severe right side abdominal pain, deep" was evaluated at the physician office visit. The events "severe unrelenting migraine", "nausea" and "vertigo" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of abdominal pain, migraine, nausea, vertigo.  Additional information: It was reported that Severe right side abdominal pain, deep. Not relieved by anything. Severe unrelenting migraine for 4 weeks straight and now 3 days of unrelenting vertigo and nausea. Patient received hydration, tests, mri, medicine. 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 the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vertigo
Clinical narrative: Severe unrelenting migraine; nausea; vertigo; dose number:1;administration date:11Mar2021/dose number:2;administration date:28Mar2021; Severe right side abdominal pain, deep; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Mar2021 12:00 (Lot number: En6647) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hashimoto's disease" (unspecified if ongoing); "cholecystectomy" (unspecified if ongoing), notes: Levaquin and scopolamine; "hypoglycemia" (unspecified if ongoing); "Allergies to Levaquin" (unspecified if ongoing); "Choke" (unspecified if ongoing); "gastric sleeve" (unspecified if ongoing); "Mc hernia repairs" (unspecified if ongoing); "impure metals" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; ELETRIPTAN; ESCITALOPRAM; TRAZODONE. Past drug history included: Levaquin, reaction(s): "Drug allergy"; Scopolamine. Vaccination history included: Bnt162b2 (Dose 1, lot number: En6349 (Arm left)), administration date: 11Mar2021, for covid-19 immunisation. The following information was reported: ABDOMINAL PAIN (non-serious) with onset 22Apr2021 01:00, outcome "not recovered", described as "Severe right side abdominal pain, deep"; MIGRAINE (non-serious) with onset 29Apr2021 05:00, outcome "not recovered", described as "Severe unrelenting migraine"; NAUSEA (non-serious) with onset 29Apr2021 05:00, outcome "not recovered", described as "nausea"; VERTIGO (non-serious) with onset 29Apr2021 05:00, outcome "not recovered", described as "vertigo"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 22Apr2021 01:00, outcome "unknown", described as "dose number:1;administration date:11Mar2021/dose number:2;administration date:28Mar2021". The event "severe right side abdominal pain, deep" was evaluated at the physician office visit. The events "severe unrelenting migraine", "nausea" and "vertigo" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of abdominal pain, migraine, nausea, vertigo.  Additional information: It was reported that Severe right side abdominal pain, deep. Not relieved by anything. Severe unrelenting migraine for 4 weeks straight and now 3 days of unrelenting vertigo and nausea. Patient received hydration, tests, mri, medicine. 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 the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Feeling abnormal, Somnolence
Clinical narrative: Tired; Wanted to sleep; Feeling blah; No energy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Apr2021 (Lot number: EW0161) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, Start time: 11.00, left arm injection, Vaccine Lot Number: ER8732), administration date: 27Mar2021, when the patient was 73 years old, for COVID-19 immunization, reaction(s): "severe right hand cramping/left hand experienced severe cramping/cramps in his legs". The following information was reported: FATIGUE (non-serious) with onset 18Apr2021, outcome "recovered" (19Apr2021), described as "Tired"; SOMNOLENCE (non-serious) with onset 18Apr2021, outcome "recovered" (19Apr2021), described as "Wanted to sleep"; FEELING ABNORMAL (non-serious) with onset 18Apr2021, outcome "recovered" (19Apr2021), described as "Feeling blah"; ASTHENIA (non-serious) with onset 18Apr2021, outcome "recovered" (19Apr2021), described as "No energy".  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Walking aid user
Clinical narrative: stated that he is on crutches; stated that he cannot walk; 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: WALKING AID USER (non-serious), outcome "unknown", described as "stated that he is on crutches"; GAIT INABILITY (non-serious), outcome "unknown", described as "stated that he cannot walk".  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Investigation, Neuralgia, Pain
Clinical narrative: skin paresthesia; nerve pain; Extreme fatigue; Chills; Body aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 14:00 (Lot number: Ew0161) at the age of 44 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hashimoto's thyroiditis" (unspecified if ongoing), notes: Other medical history: Hashimoto's thyroiditis. The patient's concomitant medications were not reported. Past drug history included: Singulair, reaction(s): "Allergy: Singulair". Vaccination history included: Bnt162b2 (Product: COVID 19, Lot unknown: False, Dose number: 1 , dose product: COVID 19, dose brand: Pfizer , dose brand unknown: False, dose lot number: Ep6955, dose lot unknown: False, dose administration time: 01:30 PM, dose vaccine location: Right arm), administration date: 24Mar2021, when the patient was 44 years old, for COVID-19 immunisation. The following information was reported: FATIGUE (non-serious) with onset 15Apr2021 12:00, outcome "recovered" (Apr2021), described as "Extreme fatigue"; CHILLS (non-serious) with onset 15Apr2021 12:00, outcome "recovered" (Apr2021), described as "Chills"; PAIN (non-serious) with onset 15Apr2021 12:00, outcome "recovered" (Apr2021), described as "Body aches"; PARAESTHESIA (non-serious), outcome "unknown", described as "skin paresthesia"; NEURALGIA (non-serious), outcome "unknown", described as "nerve pain". The events "skin paresthesia" and "nerve pain" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, chills, pain. Therapeutic measures were taken as a result of paraesthesia, neuralgia.  Additional Information: After the first 2 doses I had skin paresthesia/nerve pain So frequently I had to be tested for MS which was negative. There was no other vaccine taken in four weeks. After the booster toradol and steroid shots used as the treatment drug for the event skin paresthesia/nerve pain. hospital type facility vaccine. There was no covid prior vaccine. There was no covid tested post vaccination.  Follow-up attempts are completed. No further information is expected.