chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Impaired work ability, Joint stiffness, Lipoprotein increased, Loss of personal independence in daily activities
Clinical narrative: unable to work; right under arm pain; right under arm swelling; Armpits are swollen and very tender. The left armpit originally swelled up a few days after the injection and has remained swollen in the right armpit after one day is swollen and very tender.; Armpits are swollen and very tender. The left armpit originally swelled up a few days after the injection and has remained swollen in the right armpit after one day is swollen and very tender.; Fatigue; body aches and pain; wakes daily in a fog like he took a pain pill and has a look not like a zombie but like he is totally out of it; extreme insomnia; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EN6201) via intramuscular route of administration, administered in arm right on 03Mar2021 (at the age of 42 years-old) as dose 2, single for COVID-19 immunization. Medical history included splenectomy and Augmentin allergy. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number El3247) via intramuscular route of administration, administered in arm left on 09Feb2021 as dose 1, single for COVID-19 immunization and experienced left under arm pain and left under arm swelling. Patient did not take any other vaccine in four weeks prior to immunization. The patient did not have Covid prior vaccination. Covid tested post vaccination on 24Mar2021 was negative. Concomitant medication included botulinum toxin type a (BOTOX) taken on his forehead either 26Feb2021, 27Feb2021 or 28Feb2021. Product name is either Zoman Or Xoman. patient is unable to confirm. The patient taking concomitant products Botox as facial paralyzer. On 04Mar2021 armpits are swollen and very tender. The left armpit originally swelled up a few days after the injection and has remained swollen in the right armpit after one day is swollen and very tender. For the past 7-8 days he has progressively gotten more fatigued. He has had body aches and pain. Also has right under arm pain, right under arm swelling. In Mar2021 patient experienced extreme insomnia, On 20Mar2021 he said he can't work like this. He called out with fatigue last week. He wakes daily in a fog like he took a pain pill and has a look not like a zombie but like he is totally out of. He is seeing a new physician Monday. The outcome of the event unable to work was recovered on 21Mar2021 and right under arm swelling was recovered on 20Mar2021, events right under arm pain was recovering, event foggy feeling in head was unknown and rest of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head normal, Magnetic resonance imaging spinal normal, Magnetic resonance imaging thoracic normal, Night sweats, Pain
Clinical narrative: unable to work; right under arm pain; right under arm swelling; Armpits are swollen and very tender. The left armpit originally swelled up a few days after the injection and has remained swollen in the right armpit after one day is swollen and very tender.; Armpits are swollen and very tender. The left armpit originally swelled up a few days after the injection and has remained swollen in the right armpit after one day is swollen and very tender.; Fatigue; body aches and pain; wakes daily in a fog like he took a pain pill and has a look not like a zombie but like he is totally out of it; extreme insomnia; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EN6201) via intramuscular route of administration, administered in arm right on 03Mar2021 (at the age of 42 years-old) as dose 2, single for COVID-19 immunization. Medical history included splenectomy and Augmentin allergy. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number El3247) via intramuscular route of administration, administered in arm left on 09Feb2021 as dose 1, single for COVID-19 immunization and experienced left under arm pain and left under arm swelling. Patient did not take any other vaccine in four weeks prior to immunization. The patient did not have Covid prior vaccination. Covid tested post vaccination on 24Mar2021 was negative. Concomitant medication included botulinum toxin type a (BOTOX) taken on his forehead either 26Feb2021, 27Feb2021 or 28Feb2021. Product name is either Zoman Or Xoman. patient is unable to confirm. The patient taking concomitant products Botox as facial paralyzer. On 04Mar2021 armpits are swollen and very tender. The left armpit originally swelled up a few days after the injection and has remained swollen in the right armpit after one day is swollen and very tender. For the past 7-8 days he has progressively gotten more fatigued. He has had body aches and pain. Also has right under arm pain, right under arm swelling. In Mar2021 patient experienced extreme insomnia, On 20Mar2021 he said he can't work like this. He called out with fatigue last week. He wakes daily in a fog like he took a pain pill and has a look not like a zombie but like he is totally out of. He is seeing a new physician Monday. The outcome of the event unable to work was recovered on 21Mar2021 and right under arm swelling was recovered on 20Mar2021, events right under arm pain was recovering, event foggy feeling in head was unknown and rest of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Poor quality sleep, Pyrexia, Sinus congestion, Weight decreased
Clinical narrative: unable to work; right under arm pain; right under arm swelling; Armpits are swollen and very tender. The left armpit originally swelled up a few days after the injection and has remained swollen in the right armpit after one day is swollen and very tender.; Armpits are swollen and very tender. The left armpit originally swelled up a few days after the injection and has remained swollen in the right armpit after one day is swollen and very tender.; Fatigue; body aches and pain; wakes daily in a fog like he took a pain pill and has a look not like a zombie but like he is totally out of it; extreme insomnia; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EN6201) via intramuscular route of administration, administered in arm right on 03Mar2021 (at the age of 42 years-old) as dose 2, single for COVID-19 immunization. Medical history included splenectomy and Augmentin allergy. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number El3247) via intramuscular route of administration, administered in arm left on 09Feb2021 as dose 1, single for COVID-19 immunization and experienced left under arm pain and left under arm swelling. Patient did not take any other vaccine in four weeks prior to immunization. The patient did not have Covid prior vaccination. Covid tested post vaccination on 24Mar2021 was negative. Concomitant medication included botulinum toxin type a (BOTOX) taken on his forehead either 26Feb2021, 27Feb2021 or 28Feb2021. Product name is either Zoman Or Xoman. patient is unable to confirm. The patient taking concomitant products Botox as facial paralyzer. On 04Mar2021 armpits are swollen and very tender. The left armpit originally swelled up a few days after the injection and has remained swollen in the right armpit after one day is swollen and very tender. For the past 7-8 days he has progressively gotten more fatigued. He has had body aches and pain. Also has right under arm pain, right under arm swelling. In Mar2021 patient experienced extreme insomnia, On 20Mar2021 he said he can't work like this. He called out with fatigue last week. He wakes daily in a fog like he took a pain pill and has a look not like a zombie but like he is totally out of. He is seeing a new physician Monday. The outcome of the event unable to work was recovered on 21Mar2021 and right under arm swelling was recovered on 20Mar2021, events right under arm pain was recovering, event foggy feeling in head was unknown and rest of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, COVID-19, Fatigue, Feeling abnormal, Insomnia
Clinical narrative: unable to work; right under arm pain; right under arm swelling; Armpits are swollen and very tender. The left armpit originally swelled up a few days after the injection and has remained swollen in the right armpit after one day is swollen and very tender.; Armpits are swollen and very tender. The left armpit originally swelled up a few days after the injection and has remained swollen in the right armpit after one day is swollen and very tender.; Fatigue; body aches and pain; wakes daily in a fog like he took a pain pill and has a look not like a zombie but like he is totally out of it; extreme insomnia; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EN6201) via intramuscular route of administration, administered in arm right on 03Mar2021 (at the age of 42 years-old) as dose 2, single for COVID-19 immunization. Medical history included splenectomy and Augmentin allergy. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number El3247) via intramuscular route of administration, administered in arm left on 09Feb2021 as dose 1, single for COVID-19 immunization and experienced left under arm pain and left under arm swelling. Patient did not take any other vaccine in four weeks prior to immunization. The patient did not have Covid prior vaccination. Covid tested post vaccination on 24Mar2021 was negative. Concomitant medication included botulinum toxin type a (BOTOX) taken on his forehead either 26Feb2021, 27Feb2021 or 28Feb2021. Product name is either Zoman Or Xoman. patient is unable to confirm. The patient taking concomitant products Botox as facial paralyzer. On 04Mar2021 armpits are swollen and very tender. The left armpit originally swelled up a few days after the injection and has remained swollen in the right armpit after one day is swollen and very tender. For the past 7-8 days he has progressively gotten more fatigued. He has had body aches and pain. Also has right under arm pain, right under arm swelling. In Mar2021 patient experienced extreme insomnia, On 20Mar2021 he said he can't work like this. He called out with fatigue last week. He wakes daily in a fog like he took a pain pill and has a look not like a zombie but like he is totally out of. He is seeing a new physician Monday. The outcome of the event unable to work was recovered on 21Mar2021 and right under arm swelling was recovered on 20Mar2021, events right under arm pain was recovering, event foggy feeling in head was unknown and rest of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Pain, Pain in extremity, Peripheral swelling, Swelling
Clinical narrative: unable to work; right under arm pain; right under arm swelling; Armpits are swollen and very tender. The left armpit originally swelled up a few days after the injection and has remained swollen in the right armpit after one day is swollen and very tender.; Armpits are swollen and very tender. The left armpit originally swelled up a few days after the injection and has remained swollen in the right armpit after one day is swollen and very tender.; Fatigue; body aches and pain; wakes daily in a fog like he took a pain pill and has a look not like a zombie but like he is totally out of it; extreme insomnia; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EN6201) via intramuscular route of administration, administered in arm right on 03Mar2021 (at the age of 42 years-old) as dose 2, single for COVID-19 immunization. Medical history included splenectomy and Augmentin allergy. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number El3247) via intramuscular route of administration, administered in arm left on 09Feb2021 as dose 1, single for COVID-19 immunization and experienced left under arm pain and left under arm swelling. Patient did not take any other vaccine in four weeks prior to immunization. The patient did not have Covid prior vaccination. Covid tested post vaccination on 24Mar2021 was negative. Concomitant medication included botulinum toxin type a (BOTOX) taken on his forehead either 26Feb2021, 27Feb2021 or 28Feb2021. Product name is either Zoman Or Xoman. patient is unable to confirm. The patient taking concomitant products Botox as facial paralyzer. On 04Mar2021 armpits are swollen and very tender. The left armpit originally swelled up a few days after the injection and has remained swollen in the right armpit after one day is swollen and very tender. For the past 7-8 days he has progressively gotten more fatigued. He has had body aches and pain. Also has right under arm pain, right under arm swelling. In Mar2021 patient experienced extreme insomnia, On 20Mar2021 he said he can't work like this. He called out with fatigue last week. He wakes daily in a fog like he took a pain pill and has a look not like a zombie but like he is totally out of. He is seeing a new physician Monday. The outcome of the event unable to work was recovered on 21Mar2021 and right under arm swelling was recovered on 20Mar2021, events right under arm pain was recovering, event foggy feeling in head was unknown and rest of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Borrelia test negative, Computerised tomogram normal, Electrocardiogram normal, Herpes simplex test negative
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EK8730), dose 1 via an unspecified route of administration, on 27Mar2021 at 12:15 PM (at the age of 63-year-old), in left arm as dose 1, single for COVID-19 immunization. Patient also received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: GR8734), via an unspecified route of administration, on unspecified date (at the age of 63-year-old), in left arm as dose 2, single for COVID-19 immunization. Medical history included Pancreatitis, shingles, kidney cancer and some antibiotics from an unknown start and stop dates. The patient previously took lamisil and experienced drug hypersensitivity. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The other medications received within 2 weeks of vaccination included Vitamins. The COVID prior vaccination reported as no and not tested post vaccination. On 22Apr2021 08:00 the patient experienced bell's palsy. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures taken with Regiment of prednisone, facial nerve stimulation. The clinical outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EK8730), dose 1 via an unspecified route of administration, on 27Mar2021 at 12:15 PM (at the age of 63-year-old), in left arm as dose 1, single for COVID-19 immunization. Patient also received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: GR8734), via an unspecified route of administration, on unspecified date (at the age of 63-year-old), in left arm as dose 2, single for COVID-19 immunization. Medical history included Pancreatitis, shingles, kidney cancer and some antibiotics from an unknown start and stop dates. The patient previously took lamisil and experienced drug hypersensitivity. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The other medications received within 2 weeks of vaccination included Vitamins. The COVID prior vaccination reported as no and not tested post vaccination. On 22Apr2021 08:00 the patient experienced bell's palsy. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures taken with Regiment of prednisone, facial nerve stimulation. The clinical outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 81.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, Insomnia, Pain in extremity, Rash
Clinical narrative: people who have received the Pfizer Covid vaccine having shingles after the dose/Shingles on left arm, lasted 10 days; The initial case was missing the following minimum criteria: unspecified number of patients. Upon receipt of follow-up information on 02Aug2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer.  A 81-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration of left arm on 29Mar2021 14:00 (Batch Number: ER8727, Lot Number EN6205) DOSE 2, SINGLE for covid-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration of left arm on 06Mar2021 13:00 as DOSE 1, SINGLE for covid-19 immunisation. Caller was a patient who was calling to ask if the Pfizer covid vaccine causes shingles, because she has been experiencing side effects since receiving the vaccine on 29Mar2021, and since April developed shingles and continued pain to injection site. Caller stated that she wants to ensure that it gets reported since information has been found online of other people who have received the Pfizer Covid vaccine having shingles after the dose. Shingles on left arm, lasted 10 days. Began on 07Apr2021 after pain in left arm for a few months. Patient visited physician office. Therapeutic measures were taken as a result of shingles. The patient received treatment Famciclovir 500 Mg 3perday x 7days. The outcome of the event was recovering.  Follow-up attempts completed. No further information expected.; Sender's Comments: Shingles on left arm, lasted 10 days. Began on 07Apr2021 after pain in left arm for a few months.
Age: 81.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: people who have received the Pfizer Covid vaccine having shingles after the dose/Shingles on left arm, lasted 10 days; The initial case was missing the following minimum criteria: unspecified number of patients. Upon receipt of follow-up information on 02Aug2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer.  A 81-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration of left arm on 29Mar2021 14:00 (Batch Number: ER8727, Lot Number EN6205) DOSE 2, SINGLE for covid-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration of left arm on 06Mar2021 13:00 as DOSE 1, SINGLE for covid-19 immunisation. Caller was a patient who was calling to ask if the Pfizer covid vaccine causes shingles, because she has been experiencing side effects since receiving the vaccine on 29Mar2021, and since April developed shingles and continued pain to injection site. Caller stated that she wants to ensure that it gets reported since information has been found online of other people who have received the Pfizer Covid vaccine having shingles after the dose. Shingles on left arm, lasted 10 days. Began on 07Apr2021 after pain in left arm for a few months. Patient visited physician office. Therapeutic measures were taken as a result of shingles. The patient received treatment Famciclovir 500 Mg 3perday x 7days. The outcome of the event was recovering.  Follow-up attempts completed. No further information expected.; Sender's Comments: Shingles on left arm, lasted 10 days. Began on 07Apr2021 after pain in left arm for a few months.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Abdominal pain, Blood test, Dyspepsia, Eating disorder
Clinical narrative: 4/14 - Fatigue, extreme muscle pain at injection site; 4/24 - Pancreatitis, continued pain at injection site (steroids, low fat diet); 5/14 - Hair loss; 6/5 - TSH 8, Hypothyroidism, hair loss, anemia (125mcg Synthroid, iron supplementation); 9/5 - Hair loss (TSH normal, MCHC low, continued thyroid hormone and dietary supplementation); Present - Physicians do NOT recommend booster or further vaccination at present, will monitor CBC with Diff, CMP, and other labs for further treatment needs.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Food intolerance, Neuralgia, Pain in extremity, Pancreatitis, Vaccination site pain
Clinical narrative: 4/14 - Fatigue, extreme muscle pain at injection site; 4/24 - Pancreatitis, continued pain at injection site (steroids, low fat diet); 5/14 - Hair loss; 6/5 - TSH 8, Hypothyroidism, hair loss, anemia (125mcg Synthroid, iron supplementation); 9/5 - Hair loss (TSH normal, MCHC low, continued thyroid hormone and dietary supplementation); Present - Physicians do NOT recommend booster or further vaccination at present, will monitor CBC with Diff, CMP, and other labs for further treatment needs.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Amylase abnormal, Anaemia, Blood immunoglobulin G, Blood thyroid stimulating hormone increased
Clinical narrative: 4/14 - Fatigue, extreme muscle pain at injection site; 4/24 - Pancreatitis, continued pain at injection site (steroids, low fat diet); 5/14 - Hair loss; 6/5 - TSH 8, Hypothyroidism, hair loss, anemia (125mcg Synthroid, iron supplementation); 9/5 - Hair loss (TSH normal, MCHC low, continued thyroid hormone and dietary supplementation); Present - Physicians do NOT recommend booster or further vaccination at present, will monitor CBC with Diff, CMP, and other labs for further treatment needs.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Differential white blood cell count, Double stranded DNA antibody, Fatigue, Full blood count abnormal, Glycosylated haemoglobin
Clinical narrative: 4/14 - Fatigue, extreme muscle pain at injection site; 4/24 - Pancreatitis, continued pain at injection site (steroids, low fat diet); 5/14 - Hair loss; 6/5 - TSH 8, Hypothyroidism, hair loss, anemia (125mcg Synthroid, iron supplementation); 9/5 - Hair loss (TSH normal, MCHC low, continued thyroid hormone and dietary supplementation); Present - Physicians do NOT recommend booster or further vaccination at present, will monitor CBC with Diff, CMP, and other labs for further treatment needs.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypothyroidism, Injection site pain, Lipase abnormal, Mean cell haemoglobin concentration decreased, Metabolic function test
Clinical narrative: 4/14 - Fatigue, extreme muscle pain at injection site; 4/24 - Pancreatitis, continued pain at injection site (steroids, low fat diet); 5/14 - Hair loss; 6/5 - TSH 8, Hypothyroidism, hair loss, anemia (125mcg Synthroid, iron supplementation); 9/5 - Hair loss (TSH normal, MCHC low, continued thyroid hormone and dietary supplementation); Present - Physicians do NOT recommend booster or further vaccination at present, will monitor CBC with Diff, CMP, and other labs for further treatment needs.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pancreatitis, SARS-CoV-2 antibody test
Clinical narrative: 4/14 - Fatigue, extreme muscle pain at injection site; 4/24 - Pancreatitis, continued pain at injection site (steroids, low fat diet); 5/14 - Hair loss; 6/5 - TSH 8, Hypothyroidism, hair loss, anemia (125mcg Synthroid, iron supplementation); 9/5 - Hair loss (TSH normal, MCHC low, continued thyroid hormone and dietary supplementation); Present - Physicians do NOT recommend booster or further vaccination at present, will monitor CBC with Diff, CMP, and other labs for further treatment needs.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: a sore arm after receiving the second shot of the vaccine; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, batch/lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medication were not reported. The patient stated that she had a sore arm after receiving the second shot of the vaccine. The second dose hurt more than the first. She generally had a sore arm with the flu shot. The outcome of event was unknown.  Follow-up attempts were completed. No further information was expected.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ear discomfort, Feeling hot, Head discomfort, Tinnitus
Clinical narrative: Exacerbation of the tinnitus, with a new, louder sound in both ears; caused panic attacks; with tinnitus, the back of my neck has been stiff since the shot; This is a spontaneous report from a contactable consumer (patient). A 31-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 22Mar2021 10:00 (Lot Number: EN6204) as single dose (at the age of 31 years old) for COVID-19 immunisation. Medical history included tinnitus (I had very mild pre-existing tinnitus). There were no concomitant medications. The vaccine was administered at Hospital. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021 20:00, the patient experienced exacerbation of the tinnitus, with a new, louder sound in both ears; caused panic attacks; with tinnitus, the back of my neck has been stiff since the shot. The outcome of the events was not recovered. The events required a visit to the emergency room and a visit to the physician's office. Therapeutic measures were taken as a result of the events included IV steroids, anxiolytics. The clinical course was reported as follows: "I had very mild pre-existing tinnitus. On 27Mar, five days after receiving the first shot, I noticed exacerbation of the tinnitus, with a new, louder sound in both ears. New tinnitus got worse for about a week. Tinnitus became so loud it severely interfered with my daily life, and caused panic attacks. Checked into the ER, received IV steroids, had no effect on the tinnitus. The volume started to go down after about 10 days from onset. Now, 2.5 months from the shot, I still have the new tinnitus, and while it seems to be slowly improving over time, healing is non-linear, with a lot of tinnitus spikes and variability in volume. Together with tinnitus, the back of my neck has been stiff since the shot. Consulted with PCP, the best explanation he gave me is neuroinflammation following an excessive immune response to the vaccine".   Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: Exacerbation of the tinnitus, with a new, louder sound in both ears; caused panic attacks; with tinnitus, the back of my neck has been stiff since the shot; This is a spontaneous report from a contactable consumer (patient). A 31-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 22Mar2021 10:00 (Lot Number: EN6204) as single dose (at the age of 31 years old) for COVID-19 immunisation. Medical history included tinnitus (I had very mild pre-existing tinnitus). There were no concomitant medications. The vaccine was administered at Hospital. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021 20:00, the patient experienced exacerbation of the tinnitus, with a new, louder sound in both ears; caused panic attacks; with tinnitus, the back of my neck has been stiff since the shot. The outcome of the events was not recovered. The events required a visit to the emergency room and a visit to the physician's office. Therapeutic measures were taken as a result of the events included IV steroids, anxiolytics. The clinical course was reported as follows: "I had very mild pre-existing tinnitus. On 27Mar, five days after receiving the first shot, I noticed exacerbation of the tinnitus, with a new, louder sound in both ears. New tinnitus got worse for about a week. Tinnitus became so loud it severely interfered with my daily life, and caused panic attacks. Checked into the ER, received IV steroids, had no effect on the tinnitus. The volume started to go down after about 10 days from onset. Now, 2.5 months from the shot, I still have the new tinnitus, and while it seems to be slowly improving over time, healing is non-linear, with a lot of tinnitus spikes and variability in volume. Together with tinnitus, the back of my neck has been stiff since the shot. Consulted with PCP, the best explanation he gave me is neuroinflammation following an excessive immune response to the vaccine".   Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Musculoskeletal stiffness, Panic attack, Tinnitus
Clinical narrative: Exacerbation of the tinnitus, with a new, louder sound in both ears; caused panic attacks; with tinnitus, the back of my neck has been stiff since the shot; This is a spontaneous report from a contactable consumer (patient). A 31-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 22Mar2021 10:00 (Lot Number: EN6204) as single dose (at the age of 31 years old) for COVID-19 immunisation. Medical history included tinnitus (I had very mild pre-existing tinnitus). There were no concomitant medications. The vaccine was administered at Hospital. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021 20:00, the patient experienced exacerbation of the tinnitus, with a new, louder sound in both ears; caused panic attacks; with tinnitus, the back of my neck has been stiff since the shot. The outcome of the events was not recovered. The events required a visit to the emergency room and a visit to the physician's office. Therapeutic measures were taken as a result of the events included IV steroids, anxiolytics. The clinical course was reported as follows: "I had very mild pre-existing tinnitus. On 27Mar, five days after receiving the first shot, I noticed exacerbation of the tinnitus, with a new, louder sound in both ears. New tinnitus got worse for about a week. Tinnitus became so loud it severely interfered with my daily life, and caused panic attacks. Checked into the ER, received IV steroids, had no effect on the tinnitus. The volume started to go down after about 10 days from onset. Now, 2.5 months from the shot, I still have the new tinnitus, and while it seems to be slowly improving over time, healing is non-linear, with a lot of tinnitus spikes and variability in volume. Together with tinnitus, the back of my neck has been stiff since the shot. Consulted with PCP, the best explanation he gave me is neuroinflammation following an excessive immune response to the vaccine".   Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue, Feeling abnormal, Headache
Clinical narrative: low grade fever; fatigue; intermittent head aches; some upset stomach; diarrhea; a foggy/spacey feeling in my head; Arm pain near injection; This is a spontaneous report from a contactable other HCP (patient). A 39-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL9267), via an unspecified route of administration, administrated in Right arm on 22Feb2021 13:00 (age at the time of vaccination 39-years-old), as a single dose for COVID-19 immunization. The patient's medical history included hypothyroidism, and hyperthyroidism, Hypothyroidism subsequent to radioactive thyroid ablation for Hyperthyroidism. The patient's concomitant medications included Levothyroxine Sodium (for many years). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL9265), via an unspecified route of administration, administrated in Right arm on 29Jan2021 14:00 (age at the time of vaccination 39-years-old), as a single dose for COVID-19 immunization. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. Patient had no known allergies. On 22Feb2021 20:00, the patient experienced Arm pain near injection; on 23Feb2021 low grade fever, fatigue, intermittent head aches, some upset stomach, diarrhea, and a foggy/spacey feeling in my head. Patient did not received treatment as a result of adverse events. The outcome for all the events was not recovered.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: low grade fever; fatigue; intermittent head aches; some upset stomach; diarrhea; a foggy/spacey feeling in my head; Arm pain near injection; This is a spontaneous report from a contactable other HCP (patient). A 39-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL9267), via an unspecified route of administration, administrated in Right arm on 22Feb2021 13:00 (age at the time of vaccination 39-years-old), as a single dose for COVID-19 immunization. The patient's medical history included hypothyroidism, and hyperthyroidism, Hypothyroidism subsequent to radioactive thyroid ablation for Hyperthyroidism. The patient's concomitant medications included Levothyroxine Sodium (for many years). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL9265), via an unspecified route of administration, administrated in Right arm on 29Jan2021 14:00 (age at the time of vaccination 39-years-old), as a single dose for COVID-19 immunization. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. Patient had no known allergies. On 22Feb2021 20:00, the patient experienced Arm pain near injection; on 23Feb2021 low grade fever, fatigue, intermittent head aches, some upset stomach, diarrhea, and a foggy/spacey feeling in my head. Patient did not received treatment as a result of adverse events. The outcome for all the events was not recovered.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue, Feeling abnormal, Migraine
Clinical narrative: low grade fever; fatigue; intermittent head aches; some upset stomach; diarrhea; a foggy/spacey feeling in my head; Arm pain near injection; This is a spontaneous report from a contactable other HCP (patient). A 39-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL9267), via an unspecified route of administration, administrated in Right arm on 22Feb2021 13:00 (age at the time of vaccination 39-years-old), as a single dose for COVID-19 immunization. The patient's medical history included hypothyroidism, and hyperthyroidism, Hypothyroidism subsequent to radioactive thyroid ablation for Hyperthyroidism. The patient's concomitant medications included Levothyroxine Sodium (for many years). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL9265), via an unspecified route of administration, administrated in Right arm on 29Jan2021 14:00 (age at the time of vaccination 39-years-old), as a single dose for COVID-19 immunization. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. Patient had no known allergies. On 22Feb2021 20:00, the patient experienced Arm pain near injection; on 23Feb2021 low grade fever, fatigue, intermittent head aches, some upset stomach, diarrhea, and a foggy/spacey feeling in my head. Patient did not received treatment as a result of adverse events. The outcome for all the events was not recovered.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Genital herpes, Herpes zoster
Clinical narrative: an outbreak of Shingles; an outbreak of Shingles; This is a spontaneous report from a contactable consumer (Patient). A non-pregnant female patient 63-year-old received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0158), dose 2 via an unspecified route of administration, administered in Arm Left on 09Apr2021 at 13:15 (at the age of 63-year-old) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. Patient had no known allergies. The patient's concomitant medications were not reported.  Historical vaccine included bnt162b2 (Batch/Lot Number: EN6207) dose 1 via an unspecified route of administration, administered in Arm right on 18Mar2021 at 13:15 (at the age of 63-year-old) as dose 1, single for covid-19 immunisation and experienced 3 outbreaks of genital herpes. The patient experienced an outbreak of shingles on 24May2021 at 16:00.   Therapeutic measures were taken as a result of an outbreak of shingles. Treatment drug included 1 gm Valacyclovir per day. The patient received no other vaccine in four weeks. The patient reported that she had Shingrix shots on 14Sep and 13Nov2020. She was also on a suppressive dose 1g per day of Valacyclovir and the Shingles still broke through. She was getting very concerned about this. The only change in her lifestyle was the 2 covid shots. Patient was not covid prior vaccination. Patient did not test covid post vaccination.The outcome of the events were not recovered.   No follow up attempts are possible. No further information expected.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Disease recurrence, Herpes zoster
Clinical narrative: an outbreak of Shingles; an outbreak of Shingles; This is a spontaneous report from a contactable consumer (Patient). A non-pregnant female patient 63-year-old received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0158), dose 2 via an unspecified route of administration, administered in Arm Left on 09Apr2021 at 13:15 (at the age of 63-year-old) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. Patient had no known allergies. The patient's concomitant medications were not reported.  Historical vaccine included bnt162b2 (Batch/Lot Number: EN6207) dose 1 via an unspecified route of administration, administered in Arm right on 18Mar2021 at 13:15 (at the age of 63-year-old) as dose 1, single for covid-19 immunisation and experienced 3 outbreaks of genital herpes. The patient experienced an outbreak of shingles on 24May2021 at 16:00.   Therapeutic measures were taken as a result of an outbreak of shingles. Treatment drug included 1 gm Valacyclovir per day. The patient received no other vaccine in four weeks. The patient reported that she had Shingrix shots on 14Sep and 13Nov2020. She was also on a suppressive dose 1g per day of Valacyclovir and the Shingles still broke through. She was getting very concerned about this. The only change in her lifestyle was the 2 covid shots. Patient was not covid prior vaccination. Patient did not test covid post vaccination.The outcome of the events were not recovered.   No follow up attempts are possible. No further information expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Arthralgia, Induration, Lymphadenopathy, Ultrasound scan
Clinical narrative: pain returned worse; enlarged lymph node under my left arm; lump in my breast; lost a patch of hair the size of a 1/2 dollar coin; This is a spontaneous report from a contactable other hcp (patient). A 62-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EL0140), via an unspecified route of administration in arm left on 05Jan2021 at 14:00 (at the age of 62-years-old) as dose 2, single for COVID-19 immunisation. The medical history of the patient included included breast cancer and breast biopsy. The patient had no known allergies. The concomitant medications of the patient included sertraline (SERTRALINE) 100mg 1 x per day and atorvastatin (ATORVASTATIN) 10 mg both taken for an unspecified indication start and stop date were not reported. The patient was not pregnant at the time of vaccination. The patient previously received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EL0140), via an unspecified route of administration in arm left on 25Jan2021 at 15:15 (at the age of 62-years-old) as single dose for COVID-19 immunisation. 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. Since the vaccination, the patient was tested negative with covid-19. The patient reported that after the first vaccine it started with severe site pain, left arm, radiated to her scapula through to the front of her shoulder where it was difficult to move her arm. It felt better before the second vaccine, however, after the second vaccine (on 08Jan2021 at 08:00), the pain returned worse and still with her including an enlarged lymph node under her left arm and then found a lump in her breast. She had to have a breast biopsy where a benign growth was removed. As of her Oct where she had a breast MRI her breasts were clear from any growths. In addition, on the left side of her scalp she have lost a patch of hair the size of a 1/2 dollar coin. All those symptoms are on the left side of her body the same side in which she had the vaccine. The events resulted in physician office visit. The patient underwent lab tests and procedures whichbreast MRI: unknown on an unspecified date and Nasal Swab PCR : negative on 04Jan2021. Therapeutic measures were taken as a result of events that included cortisone injections and anti-inflammatories. The outcome of the events was reported as not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Breast mass, Lymphadenopathy, Magnetic resonance imaging, Pain
Clinical narrative: pain returned worse; enlarged lymph node under my left arm; lump in my breast; lost a patch of hair the size of a 1/2 dollar coin; This is a spontaneous report from a contactable other hcp (patient). A 62-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EL0140), via an unspecified route of administration in arm left on 05Jan2021 at 14:00 (at the age of 62-years-old) as dose 2, single for COVID-19 immunisation. The medical history of the patient included included breast cancer and breast biopsy. The patient had no known allergies. The concomitant medications of the patient included sertraline (SERTRALINE) 100mg 1 x per day and atorvastatin (ATORVASTATIN) 10 mg both taken for an unspecified indication start and stop date were not reported. The patient was not pregnant at the time of vaccination. The patient previously received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EL0140), via an unspecified route of administration in arm left on 25Jan2021 at 15:15 (at the age of 62-years-old) as single dose for COVID-19 immunisation. 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. Since the vaccination, the patient was tested negative with covid-19. The patient reported that after the first vaccine it started with severe site pain, left arm, radiated to her scapula through to the front of her shoulder where it was difficult to move her arm. It felt better before the second vaccine, however, after the second vaccine (on 08Jan2021 at 08:00), the pain returned worse and still with her including an enlarged lymph node under her left arm and then found a lump in her breast. She had to have a breast biopsy where a benign growth was removed. As of her Oct where she had a breast MRI her breasts were clear from any growths. In addition, on the left side of her scalp she have lost a patch of hair the size of a 1/2 dollar coin. All those symptoms are on the left side of her body the same side in which she had the vaccine. The events resulted in physician office visit. The patient underwent lab tests and procedures whichbreast MRI: unknown on an unspecified date and Nasal Swab PCR : negative on 04Jan2021. Therapeutic measures were taken as a result of events that included cortisone injections and anti-inflammatories. The outcome of the events was reported as not resolved.  No follow-up attempts are possible. No further information is expected.