chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Lymphadenopathy, Nausea, Pyrexia
Clinical narrative: Tiredness; Chills; Fever; Doesn't feel good, weak; Lymph node swollen, hurts, can't touch it; Nauseous; Headache; This is a spontaneous report from a contactable consumer (Patient). A 61-year-old female patient received the second dose of BNT162B2 (COMIRNATY Formulation: Solution for injection) via unspecified route of administration as a SINGLE DOSE on 07Apr2021 02:35PM for COVID-19 immunization. The patient had no relevant medical history and family history. Patient received historical vaccine of first dose BNT162B2 (COMIRNATY) via unspecified route of administration in left arm on 17Mar2021 02:35 PM for COVID-19 immunization. Medical history and concomitant medication was not reported. No family history. Patient reported as does not think her medications had anything to do with the events. she takes all the same medications and didn't have any events with the first vaccine. On 07Apr2021 at 14:35 after second vaccine she got headache right after that and still ongoing. On 08Apr2021 lymph node under arm swollen hurts and she can't touch it and still ongoing, she was nauseous around 5 or 6 in evening. On 08Apr2021 2:00 AM she had chills, tiredness, doesn't feel good weak and fever was 100.5 then it went higher and lower. Second shot on Wednesday and she really sick was 25 percent better today. No Prior Vaccinations (within 4 weeks). The outcome of event recovered for Chills, Fever on 09Apr2021, Nauseous on 08Apr0221 and not recovered for Tiredness, Headache, Doesn't feel good, weak, Lymph node swollen, hurts, can't touch it.  No follow-up attempts are needed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Gait disturbance, Transient ischaemic attack
Clinical narrative: affected her balance and walking/out of balance; affected her balance and walking; TIA; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in arm right on 25Mar2021 10:00 (batch/lot number EP6955 and expiry date not reported) at 77 years of age as single dose for covid-19 immunization in a clinic facility and not in military facility. Medical history included Stroke from 2014 and another in Dec2018; the patient had MRI to confirm, ongoing blood thinner (therapy). Concomitant medications included rivaroxaban (XARELTO) taken for blood thinner from Jan2019 and ongoing. The patient previously took first dose of bnt162b2 on 04Mar2021 at 77 year of age for covid-19 immunization and experienced arm soreness, Eliquis for 2.5 years after the first stroke for blood thinner and couldn't deal with Eliquis very well and made her feel like she was dying. The patient had no prior vaccinations (within 4 weeks). On 30Mar2021, the patient experienced TIA (transient ischaemic attack). The patient informed that at first she had nothing then five days after the second dose (30Mar2021), she had a TIA. The TIA that she experienced was so sudden and so alarming. It affected her balance and walking (unspecified date). The patient informed that when she was walking to pick up a stick she felt out of balance. The patient was walking like she was a drunken sailor and was staggering. It was the oddest thing. The patient has not talked to her doctor. The TIA was quick then it was gone. It was scary. The patient did not seek treatment (no treatment received). The outcome of the event TIA was recovered on 30Mar2021, while unknown for the rest of the events. The patient considered that the TIA may have had nothing to do with the shot, it happened 5 days later.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Blood test, Fatigue, Pain, Pain in extremity
Clinical narrative: miscarriage; super tired; super sore; sore arm; This is a spontaneous report from a contactable consumer (patient's husband). A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP7533) via an unspecified route of administration into left arm on 09Apr2021 13:30 (at the age of 39-year-old) as single dose for COVID-19 immunisation. Medical history included ongoing colitis. Concomitant medications included mesalazine (MESALAMINE) taken for colitis from an unspecified start date and ongoing and other unspecified medications. Historical vaccine includes first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6199) into left arm on 19Mar2021 (at the age of 39-year-old) for COVID-19 immunization and patient received first dose of BNT162B2 while pregnant. On 09Apr2021, it was reported that the patient experienced sore arm. On 10Apr2021 she was super tired and super sore. On 11Apr2021, patient reportedly had miscarriage. The mother was 3 weeks pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. The fetal outcome was intrauterine death. The events reportedly resulted to emergency room  visit. The patient underwent lab tests and procedures which included blood test on 11Apr2021 showing she was only 3 weeks pregnant and sonogram: no fetal heartbeat on 11Apr2021. The event miscarriage was treated with 10 pills of Hydrocodone. Outcome of event miscarriage  was unknown while for all other events was not recovered.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: miscarriage; super tired; super sore; sore arm; This is a spontaneous report from a contactable consumer (patient's husband). A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP7533) via an unspecified route of administration into left arm on 09Apr2021 13:30 (at the age of 39-year-old) as single dose for COVID-19 immunisation. Medical history included ongoing colitis. Concomitant medications included mesalazine (MESALAMINE) taken for colitis from an unspecified start date and ongoing and other unspecified medications. Historical vaccine includes first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6199) into left arm on 19Mar2021 (at the age of 39-year-old) for COVID-19 immunization and patient received first dose of BNT162B2 while pregnant. On 09Apr2021, it was reported that the patient experienced sore arm. On 10Apr2021 she was super tired and super sore. On 11Apr2021, patient reportedly had miscarriage. The mother was 3 weeks pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. The fetal outcome was intrauterine death. The events reportedly resulted to emergency room  visit. The patient underwent lab tests and procedures which included blood test on 11Apr2021 showing she was only 3 weeks pregnant and sonogram: no fetal heartbeat on 11Apr2021. The event miscarriage was treated with 10 pills of Hydrocodone. Outcome of event miscarriage  was unknown while for all other events was not recovered.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: DVT; This is a spontaneous report from a contactable physician (patient). This 60-year-old male patient received 2nd dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number Ek4176) at single dose via an unknown route in left arm on 18Jan2021 for Covid-19 immunization. Medical history included factor 5 leiden and prior DVT. Patient did not have Covid prior vaccination. Patient had no known allergies. Concomitant drug was not provided. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Eh9899) on 26Dec2020 for Covid-19 immunisation. On 08Mar2021, patient experienced DVT which resulted in doctor or other healthcare professional office/clinic visit. Treatment included blood thinner. Outcome of the event was unknown. Patient did not have Covid tested post vaccination.; Sender's Comments: Based on the information currently available, the event deep vein thrombosis was most likely associated with the patient's underlying medical condition and was unrelated to Bnt162b2 vaccine. Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pain in extremity, Vaccination site cellulitis
Clinical narrative: she have her arm completely swollen to the elbow and it is red with a circle around the injection site. She says that she even developed cellulitis; Still having problems with left arm it still burns, itches, and still has a throbbing pain; Still having problems with left arm it still burns, itches, and still has a throbbing pain; This is a spontaneous report from a contactable consumer (patient). A 73-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number), via an unspecified route of administration, on 09Apr2021 (at the age of 73 years-old) as a single dose for COVID-19 immunization. Historical vaccine information included bnt162b2 (COMIRNATY), 1st dose on an unspecified date and no adverse reaction. The medical history included: acid reflux. Concomitant medications were not reported. She says that she is a healthy person and does exercise, has no weight problems, nothing but acid reflux. The patient reported that she got the second on Friday at 1 pm and now she have her arm completely swollen to the elbow and it is red with a circle around the injection site. She says that she even developed cellulitis and she is not happy about this. Her left arm was on fire, burned, very swollen from the site all the way down to the elbow. That went away, the swelling finally started to go down Tuesday of last week but she is still having problems with left arm it still burns, itches, and still has a throbbing pain.  She has been in the ER twice already and they told her that if the circle around the injection site gets bigger she would need an IV. She has been to the ER 3 days later twice at two different locations.  Caller states she is still having difficulty after getting her second Pfizer shot. She contacted her doctor to let them know because she wants them to document everything. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Migraine
Clinical narrative: Migraine; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm (reported as right and left arm) on 18Mar2021 a little after 07:00 (at the age of 43-years-old) (Batch/Lot Number: EN6208) as SINGLE DOSE for COVID-19 immunisation. Medical history included ongoing migraine since puberty, from around 13-14 years old, has been migraine free for five years; COVID-19 from Dec2020 to an unknown date. Concomitant medications included topiramate (TOPAMAX) taken for migraine from an unspecified start date and ongoing; butalbital, caffeine, paracetamol (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; rizatriptan benzoate (MAXALT) taken for headache, start and stop date were not reported. The patient did not receive other vaccines within 4 weeks prior to vaccination. The patient experienced migraine on 18Mar2021 ever since she received the first dose of COVID-19 vaccine. The patient worked the night before she received her first dose of the Covid-19 vaccine, 17Mar2021 into 18Mar2021; she got the first dose of the Covid-19 vaccine the morning of 18Mar2021, came home, went to sleep, and woke up with a pounding headache around 1 PM on 18Mar2021. The patient considered the event medically significant as she had to get an MRI for it and the event required a physician office visit. The patient underwent lab tests and procedures which included magnetic resonance imaging: found white matter lesions consistent with chronic migraines which was normal for her on 07Apr2021.  Therapeutic measures were taken as a result of the migraine which included migraine medications topiramate, Butalbital-APAP-Caff and rizatriptan which were not helping; physician changed her medications to a different rescue medication which did not help. The clinical outcome of the event migraine was not recovered (reported as low level of migraine for 4 weeks).  The reporter considered the event migraine as related to the COVID-19 vaccine.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event  and the suspect vaccine BNT162B2
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Dysphagia, Ear discomfort, Fatigue
Clinical narrative: her throat got swollen; burning sensation at the site; tiredness; achiness all over; her throat got red; could not sallow; her lymph nodes in the neck were swollen, they hurt really bad; Her lymph nodes in the neck were swollen, they hurt really bad; had pressure in the ears; ain in the shoulder, back of the head, in the back and in the neck; ain in the shoulder, back of the head, in the back and in the neck; ain in the shoulder, back of the head, in the back and in the neck; ain in the shoulder, back of the head, in the back and in the neck; This is a spontaneous report received from contactable consumer (patient).  A 63-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 27Mar2021 (Batch/Lot number was not reported) as single dose (at the age of 63-year-old) for covid-19 immunisation.  Medical history included COVID-19, she was tested positive for COVID in Jan2021. The patient's concomitant medications were not reported.  On an unspecified date she experienced burning sensation at the site (that went away), later experienced tiredness, achiness all over, and her throat got red and swollen, could not sallow, she felt like getting COVID again after the vaccine. Her lymph nodes in the neck were swollen, they hurt really bad, had pressure in the ears, pain in the shoulder, back of the head, in the back and in the neck. She wanted to know if she should to get the second dose or not, if she can get the shot in the gluteal or other sites. The event her throat got swollen was considered medically significant. The outcome of Vaccination site burning was recovered, of all other events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Lymph node pain, Lymphadenopathy, Neck pain, Pain
Clinical narrative: her throat got swollen; burning sensation at the site; tiredness; achiness all over; her throat got red; could not sallow; her lymph nodes in the neck were swollen, they hurt really bad; Her lymph nodes in the neck were swollen, they hurt really bad; had pressure in the ears; ain in the shoulder, back of the head, in the back and in the neck; ain in the shoulder, back of the head, in the back and in the neck; ain in the shoulder, back of the head, in the back and in the neck; ain in the shoulder, back of the head, in the back and in the neck; This is a spontaneous report received from contactable consumer (patient).  A 63-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 27Mar2021 (Batch/Lot number was not reported) as single dose (at the age of 63-year-old) for covid-19 immunisation.  Medical history included COVID-19, she was tested positive for COVID in Jan2021. The patient's concomitant medications were not reported.  On an unspecified date she experienced burning sensation at the site (that went away), later experienced tiredness, achiness all over, and her throat got red and swollen, could not sallow, she felt like getting COVID again after the vaccine. Her lymph nodes in the neck were swollen, they hurt really bad, had pressure in the ears, pain in the shoulder, back of the head, in the back and in the neck. She wanted to know if she should to get the second dose or not, if she can get the shot in the gluteal or other sites. The event her throat got swollen was considered medically significant. The outcome of Vaccination site burning was recovered, of all other events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal erythema, Pharyngeal swelling, SARS-CoV-2 test positive, Vaccination site pain
Clinical narrative: her throat got swollen; burning sensation at the site; tiredness; achiness all over; her throat got red; could not sallow; her lymph nodes in the neck were swollen, they hurt really bad; Her lymph nodes in the neck were swollen, they hurt really bad; had pressure in the ears; ain in the shoulder, back of the head, in the back and in the neck; ain in the shoulder, back of the head, in the back and in the neck; ain in the shoulder, back of the head, in the back and in the neck; ain in the shoulder, back of the head, in the back and in the neck; This is a spontaneous report received from contactable consumer (patient).  A 63-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 27Mar2021 (Batch/Lot number was not reported) as single dose (at the age of 63-year-old) for covid-19 immunisation.  Medical history included COVID-19, she was tested positive for COVID in Jan2021. The patient's concomitant medications were not reported.  On an unspecified date she experienced burning sensation at the site (that went away), later experienced tiredness, achiness all over, and her throat got red and swollen, could not sallow, she felt like getting COVID again after the vaccine. Her lymph nodes in the neck were swollen, they hurt really bad, had pressure in the ears, pain in the shoulder, back of the head, in the back and in the neck. She wanted to know if she should to get the second dose or not, if she can get the shot in the gluteal or other sites. The event her throat got swollen was considered medically significant. The outcome of Vaccination site burning was recovered, of all other events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear discomfort, Ear swelling, Eating disorder, Fatigue, Insomnia
Clinical narrative: her throat got swollen; burning sensation at the site; tiredness; achiness all over; her throat got red; could not sallow; her lymph nodes in the neck were swollen, they hurt really bad; Her lymph nodes in the neck were swollen, they hurt really bad; had pressure in the ears; ain in the shoulder, back of the head, in the back and in the neck; ain in the shoulder, back of the head, in the back and in the neck; ain in the shoulder, back of the head, in the back and in the neck; ain in the shoulder, back of the head, in the back and in the neck; This is a spontaneous report received from contactable consumer (patient).  A 63-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 27Mar2021 (Batch/Lot number was not reported) as single dose (at the age of 63-year-old) for covid-19 immunisation.  Medical history included COVID-19, she was tested positive for COVID in Jan2021. The patient's concomitant medications were not reported.  On an unspecified date she experienced burning sensation at the site (that went away), later experienced tiredness, achiness all over, and her throat got red and swollen, could not sallow, she felt like getting COVID again after the vaccine. Her lymph nodes in the neck were swollen, they hurt really bad, had pressure in the ears, pain in the shoulder, back of the head, in the back and in the neck. She wanted to know if she should to get the second dose or not, if she can get the shot in the gluteal or other sites. The event her throat got swollen was considered medically significant. The outcome of Vaccination site burning was recovered, of all other events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle tightness, Myalgia, Pain, SARS-CoV-2 test, Skin mass
Clinical narrative: her throat got swollen; burning sensation at the site; tiredness; achiness all over; her throat got red; could not sallow; her lymph nodes in the neck were swollen, they hurt really bad; Her lymph nodes in the neck were swollen, they hurt really bad; had pressure in the ears; ain in the shoulder, back of the head, in the back and in the neck; ain in the shoulder, back of the head, in the back and in the neck; ain in the shoulder, back of the head, in the back and in the neck; ain in the shoulder, back of the head, in the back and in the neck; This is a spontaneous report received from contactable consumer (patient).  A 63-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 27Mar2021 (Batch/Lot number was not reported) as single dose (at the age of 63-year-old) for covid-19 immunisation.  Medical history included COVID-19, she was tested positive for COVID in Jan2021. The patient's concomitant medications were not reported.  On an unspecified date she experienced burning sensation at the site (that went away), later experienced tiredness, achiness all over, and her throat got red and swollen, could not sallow, she felt like getting COVID again after the vaccine. Her lymph nodes in the neck were swollen, they hurt really bad, had pressure in the ears, pain in the shoulder, back of the head, in the back and in the neck. She wanted to know if she should to get the second dose or not, if she can get the shot in the gluteal or other sites. The event her throat got swollen was considered medically significant. The outcome of Vaccination site burning was recovered, of all other events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Streptococcus test, Throat tightness, Vaccination site pain
Clinical narrative: her throat got swollen; burning sensation at the site; tiredness; achiness all over; her throat got red; could not sallow; her lymph nodes in the neck were swollen, they hurt really bad; Her lymph nodes in the neck were swollen, they hurt really bad; had pressure in the ears; ain in the shoulder, back of the head, in the back and in the neck; ain in the shoulder, back of the head, in the back and in the neck; ain in the shoulder, back of the head, in the back and in the neck; ain in the shoulder, back of the head, in the back and in the neck; This is a spontaneous report received from contactable consumer (patient).  A 63-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 27Mar2021 (Batch/Lot number was not reported) as single dose (at the age of 63-year-old) for covid-19 immunisation.  Medical history included COVID-19, she was tested positive for COVID in Jan2021. The patient's concomitant medications were not reported.  On an unspecified date she experienced burning sensation at the site (that went away), later experienced tiredness, achiness all over, and her throat got red and swollen, could not sallow, she felt like getting COVID again after the vaccine. Her lymph nodes in the neck were swollen, they hurt really bad, had pressure in the ears, pain in the shoulder, back of the head, in the back and in the neck. She wanted to know if she should to get the second dose or not, if she can get the shot in the gluteal or other sites. The event her throat got swollen was considered medically significant. The outcome of Vaccination site burning was recovered, of all other events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Blood pressure measurement, Dizziness, Headache
Clinical narrative: lost partial vision in my right eye which has been determined to be a AION; blood pressure elevated; weak; dizzy; nauseated; fever; headache; This is a spontaneous report from a contactable consumer (patient). This 71- year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EN6208), via an unspecified route of administration, on 11Mar2021 at 16:00 (at the age of 71-years-old) as a single dose for COVID-19 vaccination, in left arm. The facility where COVID-19 vaccine was administered was Public Health Clinic facility. Historical vaccine included: bnt162b2 (COMIRNATY, Solution for injection, Lot number EN6200) dose 1 on 18Feb2021 04:00 PM, for covid-19 immunization, left arm. No known allergies. The medical history included: Blood pressure abnormal. Concomitant medications included: Prozac, Inderal, Atorvastatin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Mar2021 09:00 am, Day after 2nd injection, she felt weak, dizzy, nauseated, fever, blood pressure elevated and had an extremely severe headache. That evening I lost partial vision in my right eye, which has been determined to be AION. Vision has not returned at one month out. Event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Treatment included: Blood pressure monitoring and return 13Apr2021. The clinical outcome of the events was not recovered. The patient was not tested for COVID-19 after the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Optic ischaemic neuropathy, Pyrexia
Clinical narrative: lost partial vision in my right eye which has been determined to be a AION; blood pressure elevated; weak; dizzy; nauseated; fever; headache; This is a spontaneous report from a contactable consumer (patient). This 71- year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EN6208), via an unspecified route of administration, on 11Mar2021 at 16:00 (at the age of 71-years-old) as a single dose for COVID-19 vaccination, in left arm. The facility where COVID-19 vaccine was administered was Public Health Clinic facility. Historical vaccine included: bnt162b2 (COMIRNATY, Solution for injection, Lot number EN6200) dose 1 on 18Feb2021 04:00 PM, for covid-19 immunization, left arm. No known allergies. The medical history included: Blood pressure abnormal. Concomitant medications included: Prozac, Inderal, Atorvastatin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Mar2021 09:00 am, Day after 2nd injection, she felt weak, dizzy, nauseated, fever, blood pressure elevated and had an extremely severe headache. That evening I lost partial vision in my right eye, which has been determined to be AION. Vision has not returned at one month out. Event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Treatment included: Blood pressure monitoring and return 13Apr2021. The clinical outcome of the events was not recovered. The patient was not tested for COVID-19 after the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Gait disturbance, Immobile, Investigation, Pain in extremity
Clinical narrative: immobile for a day; cannot walk; sore arm; weakness; This is a spontaneous report from a contactable consumer (patient).  A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 15Feb2021 (at the age of 77-years old) (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation. Medical history included Hashimoto's disease from an unknown date and unknown if ongoing, Diagnosed 35 years ago, hypermobility syndrome from an unknown date and unknown if ongoing, Diagnosed 20 years ago, "anomia" (unspecified) from an unknown date and unknown if ongoing, Diagnosed 25 years ago, and thyroid high from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) taken for thyroid disorder, start and stop date were not reported; levothyroxine sodium (SYNTHROID) taken for thyroid disorder, start and stop date were not reported; and diazepam (VALIUM) taken for an unspecified indication, start and stop date were not reported. The patient experienced immobile for a day on an unspecified date, cannot walk from kitchen to the other room on an unspecified date, she is so weak which lasted one day and was bearable on 15Feb2021, and sore arm on an unspecified date. The patient underwent lab tests and procedures which included investigation: has antibodies, they are there but not very strong on an unknown date. The clinical outcome of the events immobile, gait disturbance and pain in extremity was unknown; asthenia was recovered on an unknown date Feb2021 (lasted one day).   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021409340 Same patient, different dose and event
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Pain, Pyrexia
Clinical narrative: cellulitis; kind of tired and achy; kind of tired and achy; She had a headache; felt kind of off; slight fever; This is a spontaneous report from a contactable consumer, the patient. A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 04Apr2021 at 12:30 (Batch/Lot Number: EP7533) as a single dose (at the age of 50 years-old) for COVID-19 immunisation. Medical history included allergies (unspecified) from an unknown date.  There were no concomitant medications.  The patient experienced vaccination site cellulitis on 11Apr2021, tired and achy and headache on 05Apr2021, and "felt off" and fever on an unknown date in Apr2021. The clinical course is as follows: the patient received bnt162b2 on 04Apr2021. She felt kind of tired and achy and had a headache the next day (05Apr2021) and for a few days. She "felt kind of off".  On 11Apr2021, she developed a spot on her arm where she received the first dose of the COVID vaccine. Her arm was itchy where she got the vaccine, and she developed a big red hot lump. The patient noticed an itch on her arm, and when she scratched it, she noticed a big red lump and it was hot to the touch. She also had a slight fever. She called her doctor, and the doctor thinks it is cellulitis, so they gave her antibiotics. The patient reported her headache is somewhere in between ongoing and recovered completely, her headache is off and on. Her arm was itchy where she got the vaccine, and she developed a big red hot lump: It is not as red anymore. It is still hot. Everything else is still the same. The patient stated she has allergies, she is not sure if that comes into play. The patient was inquiring if taking the antibiotic will interfere with the COVID vaccine and if was okay to take antibiotics with the vaccine as everything that she has read online about the COVID vaccine, says that she should not take an antibiotic for this. She was concerned that she should not be taking the antibiotic, because she does not want the antibiotic to interfere with the COVID vaccine. Therapeutic measures were taken as a result of vaccination site cellulitis and included unspecified antibiotics. The clinical outcome of the event vaccination site cellulitis (arm was itchy where she got the vaccine, and she developed a big red hot lump), achy, feeling off, fever and headache was unknown. The clinical outcome of the patient tired was recovering.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site cellulitis
Clinical narrative: cellulitis; kind of tired and achy; kind of tired and achy; She had a headache; felt kind of off; slight fever; This is a spontaneous report from a contactable consumer, the patient. A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 04Apr2021 at 12:30 (Batch/Lot Number: EP7533) as a single dose (at the age of 50 years-old) for COVID-19 immunisation. Medical history included allergies (unspecified) from an unknown date.  There were no concomitant medications.  The patient experienced vaccination site cellulitis on 11Apr2021, tired and achy and headache on 05Apr2021, and "felt off" and fever on an unknown date in Apr2021. The clinical course is as follows: the patient received bnt162b2 on 04Apr2021. She felt kind of tired and achy and had a headache the next day (05Apr2021) and for a few days. She "felt kind of off".  On 11Apr2021, she developed a spot on her arm where she received the first dose of the COVID vaccine. Her arm was itchy where she got the vaccine, and she developed a big red hot lump. The patient noticed an itch on her arm, and when she scratched it, she noticed a big red lump and it was hot to the touch. She also had a slight fever. She called her doctor, and the doctor thinks it is cellulitis, so they gave her antibiotics. The patient reported her headache is somewhere in between ongoing and recovered completely, her headache is off and on. Her arm was itchy where she got the vaccine, and she developed a big red hot lump: It is not as red anymore. It is still hot. Everything else is still the same. The patient stated she has allergies, she is not sure if that comes into play. The patient was inquiring if taking the antibiotic will interfere with the COVID vaccine and if was okay to take antibiotics with the vaccine as everything that she has read online about the COVID vaccine, says that she should not take an antibiotic for this. She was concerned that she should not be taking the antibiotic, because she does not want the antibiotic to interfere with the COVID vaccine. Therapeutic measures were taken as a result of vaccination site cellulitis and included unspecified antibiotics. The clinical outcome of the event vaccination site cellulitis (arm was itchy where she got the vaccine, and she developed a big red hot lump), achy, feeling off, fever and headache was unknown. The clinical outcome of the patient tired was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Eye haemorrhage, Eye swelling, Eyelid pain, Ocular hyperaemia
Clinical narrative: her eye completely swollen and red like she had a little blood vessel burst; eye completely swollen; eye completely swollen and red; little pain in the lower eyelid; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 08Apr2021 at 13:00 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 08Apr2021 (the night of the vaccination), the patient experienced a little pain in the lower eyelid. On 09Apr2021 (the next day), her eye was completely swollen and red like she had a little blood vessel burst. The clinical outcome of "eye completely swollen and red like she had a little blood vessel burst" and "little pain in the lower eyelid" was unknown.  Information on the lot/batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Balance disorder, Chills, Confusional state, Feeling abnormal
Clinical narrative: aches and pain in her shoulder and neck; had exceptionally felt like she wanted to go to bed and nap; She was not able to sleep and did not get up until 10 today; painful and hard; She stated to move her hair even to the touch it is painful; definitely something abnormal; Her hands, mainly her right, and ankles are swollen; Her hands, mainly her right, and ankles are swollen; congested in her chest; she is feeling a little confused; horrendous lumps on her head (some the size of a quarter, some a half dollar; fever; Excruciating pain in my head; peculiar neck pain/ aches and pain in her shoulder and neck; swelling of my arms and hands; Felt Achy; Felt off balance; chills; This is a spontaneous report from a contactable consumer reporting for herself.  A 68-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation  .  Medical history included thyroid mass (Diagnosed over 5 years ago. She never got a biopsy of it) , pelvic mass , cardiac disorder (Diagnosed when she was 49 or 50) , cardiac pacemaker insertion.   The patient's concomitant medications were not reported.  The patient experienced horrendous lumps on her head (some the size of a quarter, some a half dollar on an unspecified date with outcome of unknown , felt off balance  on 12Apr2021 with outcome of not recovered , peculiar neck pain/ aches and pain in her shoulder and neck  on 13Apr2021 with outcome of unknown , aches and pain in her shoulder and neck on an unspecified date with outcome of unknown , had exceptionally felt like she wanted to go to bed and nap  on an unspecified date with outcome of unknown , she was not able to sleep and did not get up until 10 today  on an unspecified date with outcome of unknown , painful and hard  on an unspecified date with outcome of unknown , she stated to move her hair even to the touch it is painful  on an unspecified date with outcome of unknown , definitely something abnormal  on an unspecified date with outcome of unknown , her hands, mainly her right, and ankles are swollen  on an unspecified date with outcome of unknown , congested in her chest  on an unspecified date with outcome of unknown , she is feeling a little confused  on an unspecified date with outcome of unknown , chills  on 12Apr2021 with outcome of recovered , fever  on an unspecified date with outcome of unknown , felt achy  on 12Apr2021 with outcome of not recovered , excruciating pain in my head  on 13Apr2021 with outcome of not recovered , swelling of my arms and hands  on 12Apr2021 with outcome of recovered.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Joint swelling, Mass, Mobility decreased
Clinical narrative: aches and pain in her shoulder and neck; had exceptionally felt like she wanted to go to bed and nap; She was not able to sleep and did not get up until 10 today; painful and hard; She stated to move her hair even to the touch it is painful; definitely something abnormal; Her hands, mainly her right, and ankles are swollen; Her hands, mainly her right, and ankles are swollen; congested in her chest; she is feeling a little confused; horrendous lumps on her head (some the size of a quarter, some a half dollar; fever; Excruciating pain in my head; peculiar neck pain/ aches and pain in her shoulder and neck; swelling of my arms and hands; Felt Achy; Felt off balance; chills; This is a spontaneous report from a contactable consumer reporting for herself.  A 68-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation  .  Medical history included thyroid mass (Diagnosed over 5 years ago. She never got a biopsy of it) , pelvic mass , cardiac disorder (Diagnosed when she was 49 or 50) , cardiac pacemaker insertion.   The patient's concomitant medications were not reported.  The patient experienced horrendous lumps on her head (some the size of a quarter, some a half dollar on an unspecified date with outcome of unknown , felt off balance  on 12Apr2021 with outcome of not recovered , peculiar neck pain/ aches and pain in her shoulder and neck  on 13Apr2021 with outcome of unknown , aches and pain in her shoulder and neck on an unspecified date with outcome of unknown , had exceptionally felt like she wanted to go to bed and nap  on an unspecified date with outcome of unknown , she was not able to sleep and did not get up until 10 today  on an unspecified date with outcome of unknown , painful and hard  on an unspecified date with outcome of unknown , she stated to move her hair even to the touch it is painful  on an unspecified date with outcome of unknown , definitely something abnormal  on an unspecified date with outcome of unknown , her hands, mainly her right, and ankles are swollen  on an unspecified date with outcome of unknown , congested in her chest  on an unspecified date with outcome of unknown , she is feeling a little confused  on an unspecified date with outcome of unknown , chills  on 12Apr2021 with outcome of recovered , fever  on an unspecified date with outcome of unknown , felt achy  on 12Apr2021 with outcome of not recovered , excruciating pain in my head  on 13Apr2021 with outcome of not recovered , swelling of my arms and hands  on 12Apr2021 with outcome of recovered.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Peripheral swelling, Pyrexia, Respiratory tract congestion
Clinical narrative: aches and pain in her shoulder and neck; had exceptionally felt like she wanted to go to bed and nap; She was not able to sleep and did not get up until 10 today; painful and hard; She stated to move her hair even to the touch it is painful; definitely something abnormal; Her hands, mainly her right, and ankles are swollen; Her hands, mainly her right, and ankles are swollen; congested in her chest; she is feeling a little confused; horrendous lumps on her head (some the size of a quarter, some a half dollar; fever; Excruciating pain in my head; peculiar neck pain/ aches and pain in her shoulder and neck; swelling of my arms and hands; Felt Achy; Felt off balance; chills; This is a spontaneous report from a contactable consumer reporting for herself.  A 68-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation  .  Medical history included thyroid mass (Diagnosed over 5 years ago. She never got a biopsy of it) , pelvic mass , cardiac disorder (Diagnosed when she was 49 or 50) , cardiac pacemaker insertion.   The patient's concomitant medications were not reported.  The patient experienced horrendous lumps on her head (some the size of a quarter, some a half dollar on an unspecified date with outcome of unknown , felt off balance  on 12Apr2021 with outcome of not recovered , peculiar neck pain/ aches and pain in her shoulder and neck  on 13Apr2021 with outcome of unknown , aches and pain in her shoulder and neck on an unspecified date with outcome of unknown , had exceptionally felt like she wanted to go to bed and nap  on an unspecified date with outcome of unknown , she was not able to sleep and did not get up until 10 today  on an unspecified date with outcome of unknown , painful and hard  on an unspecified date with outcome of unknown , she stated to move her hair even to the touch it is painful  on an unspecified date with outcome of unknown , definitely something abnormal  on an unspecified date with outcome of unknown , her hands, mainly her right, and ankles are swollen  on an unspecified date with outcome of unknown , congested in her chest  on an unspecified date with outcome of unknown , she is feeling a little confused  on an unspecified date with outcome of unknown , chills  on 12Apr2021 with outcome of recovered , fever  on an unspecified date with outcome of unknown , felt achy  on 12Apr2021 with outcome of not recovered , excruciating pain in my head  on 13Apr2021 with outcome of not recovered , swelling of my arms and hands  on 12Apr2021 with outcome of recovered.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: aches and pain in her shoulder and neck; had exceptionally felt like she wanted to go to bed and nap; She was not able to sleep and did not get up until 10 today; painful and hard; She stated to move her hair even to the touch it is painful; definitely something abnormal; Her hands, mainly her right, and ankles are swollen; Her hands, mainly her right, and ankles are swollen; congested in her chest; she is feeling a little confused; horrendous lumps on her head (some the size of a quarter, some a half dollar; fever; Excruciating pain in my head; peculiar neck pain/ aches and pain in her shoulder and neck; swelling of my arms and hands; Felt Achy; Felt off balance; chills; This is a spontaneous report from a contactable consumer reporting for herself.  A 68-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation  .  Medical history included thyroid mass (Diagnosed over 5 years ago. She never got a biopsy of it) , pelvic mass , cardiac disorder (Diagnosed when she was 49 or 50) , cardiac pacemaker insertion.   The patient's concomitant medications were not reported.  The patient experienced horrendous lumps on her head (some the size of a quarter, some a half dollar on an unspecified date with outcome of unknown , felt off balance  on 12Apr2021 with outcome of not recovered , peculiar neck pain/ aches and pain in her shoulder and neck  on 13Apr2021 with outcome of unknown , aches and pain in her shoulder and neck on an unspecified date with outcome of unknown , had exceptionally felt like she wanted to go to bed and nap  on an unspecified date with outcome of unknown , she was not able to sleep and did not get up until 10 today  on an unspecified date with outcome of unknown , painful and hard  on an unspecified date with outcome of unknown , she stated to move her hair even to the touch it is painful  on an unspecified date with outcome of unknown , definitely something abnormal  on an unspecified date with outcome of unknown , her hands, mainly her right, and ankles are swollen  on an unspecified date with outcome of unknown , congested in her chest  on an unspecified date with outcome of unknown , she is feeling a little confused  on an unspecified date with outcome of unknown , chills  on 12Apr2021 with outcome of recovered , fever  on an unspecified date with outcome of unknown , felt achy  on 12Apr2021 with outcome of not recovered , excruciating pain in my head  on 13Apr2021 with outcome of not recovered , swelling of my arms and hands  on 12Apr2021 with outcome of recovered.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.