chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Headache, Pyrexia, Tremor, Vomiting
Clinical narrative: fever; headache; shaking uncontrollably; vomited; pain in my ears; This is a spontaneous report based on the information received by Pharmacy Group. A contactable 56-year-old female consumer (patient) reported that she received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Exp. Date was not reported), via an unspecified route of administration on 13Jun2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration in May2021 at 55 years as Dose 1 single "3 weeks before" for COVID-19 immunization. It was reported that patient received dose 2 of the Pfizer COVID 19 vaccine (site of injection not reported) on Sunday (13Jun2021). The patient had received Dose 1 "3 weeks before" (date not reported). She noted that within several hours "around midnight" on 14Jun2021 she began to experience "a fever" and "a headache" and "shaking uncontrollably" and then 30 minutes later, she "vomited." She also reported "pain in my ears." By 8am on 14Jun2021 these signs/symptoms "subsided." On 15Jun2021, she "kind of felt out it." She did not seek medical attention for any of the effects that she experienced, nor did she contact her healthcare provider about it. The outcome of all events was recovered on an unspecified date in Jun2021.  No further information is expected. Information about lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Positron emission tomogram
Clinical narrative: she had a pet scan and  lymph node illuminated on right arm, not big but could see on pet scan.; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left at the age of 56-year-old on 01Apr2021 (Lot Number: ER8737) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Stage 4 melanoma that went to her bone from 2014, had a pituitary tumor removed in 2014 a month after they removed her ischium bone. The patient's concomitant medications were not reported. The patient previously took Yervoy from 2014 to an unknown date for immunoadsorption therapy, took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on arm right at the age of 56-year-old on 11Mar2021 (Lot number: EN6208) for covid-19 immunisation. Since her second vaccine, she had a pet scan and lymph node illuminated on right arm, not big but could see on pet scan. She had her first vaccine on 11Mar2021, and the second vaccine on 01Apr2021. She got them three weeks apart. She got one in her left arm and one in her right. She just recently had a PET scan. She has a history of cancer, stage 4 melanoma that went to her bone in 2014. Initially they said last week her cancer was okay. Then, they said they wanted her to come in. They don't want to alarm her but want her to get an Ultra Sound. They noticed her lymph node was illuminated on her right arm. It is not very big. She was told they are seeing this with the vaccine. They told her they are seeing this basically all over the countries, on pet scans from people that have had the covid vaccine. They haven't said it's cancer but just a reaction to the vaccine. She got the PET scan a week ago on the 22Jun2021 or the 23Jun2021. She can't feel it, so she doesn't know if it has changed. She doesn't remember which arm she got each one in, but she knows she did alternate arms. The patient underwent lab tests and procedures which included positron emission tomogram: lymph node illuminated on right arm, not big but could see on pet scan on an unknown date (reported as 22Jun2021 or the 23Jun202). The outcome of the event was unknown.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Angiopathy, Erythema, Formication, Pruritus, Rash
Clinical narrative: Several redness and rashes and itch all body every day; Several redness and rashes and itch all body every day; Several redness and rashes and itch all body every day; A lot of thread veins are visible.; It's like an insect crawling inside the skin; Daily life is difficult and very stressful; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 24Apr2021 15:15 (Batch/Lot Number: EW0150) as DOSE 2, SINGLE for covid-19 immunisation, age at vaccination 47 years old. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient received the first dose of BNT162B2 (Lot/batch no: EW0165) on 03Apr2021, 15:00 at Arm Left for covid-19 immunization. Patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and had no other medications the patient received within 2 weeks of vaccination. Patient had been getting several redness, rashes and itch all body every day even 2 months have passed. It's like an insect crawling inside the skin. Also, a lot of thread veins are visible. Patient mentioned that It's been two months and he was not the only one who still has these symptoms. Because of this, daily life is difficult and very stressful (He didn't have any allergies to food or vaccines). Patient had antihistamine injections, took antihistamine pills and medicine for several weeks. However, when he stopped taking the medicine, the symptoms recurred. Physician office was visited. Outcome of the events was not recovered.  Information on batch/lot number was available. Additional information has been requested.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Stress
Clinical narrative: Several redness and rashes and itch all body every day; Several redness and rashes and itch all body every day; Several redness and rashes and itch all body every day; A lot of thread veins are visible.; It's like an insect crawling inside the skin; Daily life is difficult and very stressful; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 24Apr2021 15:15 (Batch/Lot Number: EW0150) as DOSE 2, SINGLE for covid-19 immunisation, age at vaccination 47 years old. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient received the first dose of BNT162B2 (Lot/batch no: EW0165) on 03Apr2021, 15:00 at Arm Left for covid-19 immunization. Patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and had no other medications the patient received within 2 weeks of vaccination. Patient had been getting several redness, rashes and itch all body every day even 2 months have passed. It's like an insect crawling inside the skin. Also, a lot of thread veins are visible. Patient mentioned that It's been two months and he was not the only one who still has these symptoms. Because of this, daily life is difficult and very stressful (He didn't have any allergies to food or vaccines). Patient had antihistamine injections, took antihistamine pills and medicine for several weeks. However, when he stopped taking the medicine, the symptoms recurred. Physician office was visited. Outcome of the events was not recovered.  Information on batch/lot number was available. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Syncope
Clinical narrative: Fainted; Mom thought maybe dehydration; This is a spontaneous report from a contactable consumer (patient). A 16-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Leg Right on 06Jun2021 10:30 (at the age of 16 years old, not pregnant) (Lot Number: Ew0191) as single dose for covid-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. No any other medications the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (Lot number: Ew0185) in Right arm on 16May2021 10:30 (at the age of 15 years old) for Covid-19 immunization and no events reported. Facility where the most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. On 08Jun2021 at 18:30, the patient fainted in kitchen at night on day 3 after second dose, over 48 hrs after shot. Mom and dad caught her and put her on floor until she came back. Mom thought maybe dehydration so gave pedialyte but didn't know if that was reason. She slowly felt better. No treatment for fainted. The reporter considered the report as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Sore arm, sore and swollen arm at the injection site; Sore arm, sore and swollen arm at the injection site; This is a spontaneous report from a Pfizer sponsored program, received from a contactable consumer (patient). The consumer reported similar events for two patients. This is the first of two reports.   A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and lot number was not reported), dose 1, via an unspecified route of administration, administered in arm on 29Jun2021 (age at vaccination: 63-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took flu shot. On an unknown date, the patient had sore arm, sore and swollen arm at the injection site after her Pfizer Covid-19 Vaccine. The outcome for the events was unknown.  Follow-up attempts are needed; information about lot/batch number has been requested.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac stress test, Chest pain, Computerised tomogram, Dyspnoea, Electrocardiogram
Clinical narrative: Started developing breathlessness/Breathlessness while sleeping, running and biking (active athelete).; chest pain; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 01Apr2021 at 15:00 PM, at patient age of 52-year-old, as single dose (Lot number EW0150) for COVID-19 immunisation. The patient had no COVID prior vaccination. The patient's medical history was none. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any medications within 2 weeks of vaccination. The patient started developing breathlessness, chest pain around 10Apr2021 (10 days after 1st dose). Breathlessness while sleeping, running and biking (active athelete). The patient went to ER on 26Apr2021 unable to breathe. Stress test/EKG, CT Scan of lung, Covid all normal. Breathless still exists during physical activity & sometimes while sleeping. The event onset date was reported as 10Apr2021 at 13:00 PM. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was treated with inhaler for breathlessness. The outcome of the events was not resolved.  COVID was not tested post vaccination. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 08May2021 at 13:00 PM, at patient age of 52-year-old, as single dose (Lot number EW0173) for COVID-19 immunization.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Started developing breathlessness/Breathlessness while sleeping, running and biking (active athelete).; chest pain; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 01Apr2021 at 15:00 PM, at patient age of 52-year-old, as single dose (Lot number EW0150) for COVID-19 immunisation. The patient had no COVID prior vaccination. The patient's medical history was none. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any medications within 2 weeks of vaccination. The patient started developing breathlessness, chest pain around 10Apr2021 (10 days after 1st dose). Breathlessness while sleeping, running and biking (active athelete). The patient went to ER on 26Apr2021 unable to breathe. Stress test/EKG, CT Scan of lung, Covid all normal. Breathless still exists during physical activity & sometimes while sleeping. The event onset date was reported as 10Apr2021 at 13:00 PM. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was treated with inhaler for breathlessness. The outcome of the events was not resolved.  COVID was not tested post vaccination. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 08May2021 at 13:00 PM, at patient age of 52-year-old, as single dose (Lot number EW0173) for COVID-19 immunization.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Tonsillitis, Uvulitis
Clinical narrative: The uvula was inflamed; Had inflamed tonsils; This is a spontaneous report from a contactable consumer or other non hcp. A 61-years-old female patient received second dose of BNT162B2 (BNT162B2, Solution for injection), via an unspecified route of administration in Arm Right on 11Mar2021 12:00 (Age at the time of vaccination: 61-years-old) (Batch/Lot number was not reported) as single for covid-19 immunization. The patient's medical history included anxiety and known allergies: sensitivities; both unknown if ongoing and ongoing childhood tonsillitis. The patient's concomitant medications were not reported. Historical vaccine included patient received first dose of BNT162B2 (BNT162B2, Solution for injection), via an unspecified route of administration on an unknown date (Batch/Lot number was not reported) as single for covid-19 immunization. Prior to vaccination, the patient diagnosed with COVID-19 and since the vaccination, the patient been tested for COVID-19 was mentioned as no. On 15Jun2021 09:00 AM, the uvula was inflamed, felt it trying to swallow when she woke up a few months after the second injection. Soon after the second injection in 2021, she had inflamed tonsils. Both went away later that day. The patient did not received any treatment. The outcome both the events was recovered on unspecified date in Jun2021.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Extreme joint pain; This is a spontaneous report from a contactable consumer (patient) from the Pfizer sponsored program. An 88-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20May2021 (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced extreme joint on an unspecified date. The patient was scheduled to receive her second dose on 10Jun2021; however, the physician of the patient had advised the patient not to take her second dose for three weeks until she was okay. The patient was now feeling better and wanted to know if she could take her second dose on 30Jun2021. The outcome of event was recovering.  Information about lot/batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Echocardiogram, Fatigue, Feeling abnormal, Illness
Clinical narrative: Felt physically sick after both of the shots; The next day after both shots she was feeling ill; Extremely fatigued and wiped out; Felt bad and was on the couch for 2 days; This is a spontaneous report from a contactable consumer or other non-HCP. A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6198), via an unspecified route of administration, administered in Right Arm on 05Mar2021 as DOSE 1, SINGLE (at the age of: 69-year-old) for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient felt physically sick after both of the shots. The next day after both shots she was feeling ill. On an unspecified date the patient experienced extremely fatigued and wiped out and felt bad and was on the couch for 2 days. AE require a visit to Physician Office. Prior Vaccinations (within 4 weeks) If applicable, no other vaccinations within four weeks prior to the first administration date of the suspect vaccine was administered. The patient underwent lab tests and procedures which included computerised tomogram: negative, echocardiogram: unknown on 24Jun2021, magnetic resonance imaging: negative on 18Jun2021, mammogram: negative on 19Jun2021, ultrasound scan: unknown on 24Jun2021. The outcome of event the next day after both shots she was feeling ill was unknown while outcome of rest all event was recovered on an unspecified date.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Mammogram, Ultrasound scan
Clinical narrative: Felt physically sick after both of the shots; The next day after both shots she was feeling ill; Extremely fatigued and wiped out; Felt bad and was on the couch for 2 days; This is a spontaneous report from a contactable consumer or other non-HCP. A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6198), via an unspecified route of administration, administered in Right Arm on 05Mar2021 as DOSE 1, SINGLE (at the age of: 69-year-old) for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient felt physically sick after both of the shots. The next day after both shots she was feeling ill. On an unspecified date the patient experienced extremely fatigued and wiped out and felt bad and was on the couch for 2 days. AE require a visit to Physician Office. Prior Vaccinations (within 4 weeks) If applicable, no other vaccinations within four weeks prior to the first administration date of the suspect vaccine was administered. The patient underwent lab tests and procedures which included computerised tomogram: negative, echocardiogram: unknown on 24Jun2021, magnetic resonance imaging: negative on 18Jun2021, mammogram: negative on 19Jun2021, ultrasound scan: unknown on 24Jun2021. The outcome of event the next day after both shots she was feeling ill was unknown while outcome of rest all event was recovered on an unspecified date.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got COVID; got COVID; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number was not reported) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The reporter stated that: her sister in law got COVID and then passed it to her and their kids, it was clarified that her sister-in-law had Pfizer COVID-19 vaccine. The patient outcome of the event was unknown.  The information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling hot, Hypoaesthesia, Nerve injury, Pain
Clinical narrative: tingling/numbess up jaw below his nipple, starting in his chest. Small localized to around the artery, below my jaw line, creeping cheek, ear towards top of my head; tingling/numbess up jaw below his nipple, starting in his chest. Small localized to around the artery, below my jaw line, creeping cheek, ear towards top of my head; States hot; pain; uncomfortable; damage to nerves; It is hard to differentiate that sensation; This is a spontaneous report from a contactable consumer or other non healthcare professional. A adult male patient in his 60's received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 03May2021 (Batch/Lot Number: EW0170; Expiration Date: Aug2021) as dose 2, single for covid-19 immunisation. Medical history included, sinus congestion from an unknown date and unknown if ongoing rarely takes Sudafed for sinus congestion. The patient's concomitant medications were not reported. The patient previously took bnt162b2 for covid-19 immunisation and experienced adverse event, sudafed 12 hour for sinus congestion. The patient experienced tingling or numbness up the jaw below his nipple, starting in his chest. small localized to around the artery, below the jaw line, creeping cheek, ear towards top of the head states hot feeling, pain, uncomfortable feeling and damage to nerves on 2021 with outcome of not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Sensory loss
Clinical narrative: tingling/numbess up jaw below his nipple, starting in his chest. Small localized to around the artery, below my jaw line, creeping cheek, ear towards top of my head; tingling/numbess up jaw below his nipple, starting in his chest. Small localized to around the artery, below my jaw line, creeping cheek, ear towards top of my head; States hot; pain; uncomfortable; damage to nerves; It is hard to differentiate that sensation; This is a spontaneous report from a contactable consumer or other non healthcare professional. A adult male patient in his 60's received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 03May2021 (Batch/Lot Number: EW0170; Expiration Date: Aug2021) as dose 2, single for covid-19 immunisation. Medical history included, sinus congestion from an unknown date and unknown if ongoing rarely takes Sudafed for sinus congestion. The patient's concomitant medications were not reported. The patient previously took bnt162b2 for covid-19 immunisation and experienced adverse event, sudafed 12 hour for sinus congestion. The patient experienced tingling or numbness up the jaw below his nipple, starting in his chest. small localized to around the artery, below the jaw line, creeping cheek, ear towards top of the head states hot feeling, pain, uncomfortable feeling and damage to nerves on 2021 with outcome of not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: Hands were getting more tingling; This is a spontaneous report from a contactable consumer or other non healthcare professional. This consumer reporting for a patient. This is one of 2 reports: A 7 decades-old (60 s as reported) male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on 03May2021 as dose 2, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The patient experienced hands were getting more tingling as versed to going away on an unspecified date in May2021. The outcome of the event was reported as unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Illness
Clinical narrative: Hands were getting more tingling; This is a spontaneous report from a contactable consumer or other non healthcare professional. This consumer reporting for a patient. This is one of 2 reports: A 7 decades-old (60 s as reported) male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on 03May2021 as dose 2, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The patient experienced hands were getting more tingling as versed to going away on an unspecified date in May2021. The outcome of the event was reported as unknown.  Information on the lot/batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cough, Dyspnoea, Hypokinesia
Clinical narrative: breathless; Can't walk 5 steps; dry cough; chest pain; This is a spontaneous report from a contactable consumer (patient) reported for herself. A non-pregnant 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8729), via an unspecified route of administration, administered in Arm Left on 30Apr2021 12:00 (at age of 64 years old) as single dose for COVID-19 immunisation. Medical history included Diabetic, high blood pressure, known_allergies: Amocicillin, zestril, Peanuts. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13May2021, The patient Can't walk 5 steps without breathless, dry cough, little chest pain. Serious was NO. The adverse event result in: Doctor or other healthcare professional office/clinic visit. No Treatment. The outcome of the events was Not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: 101-102.3 temp for over 12 hours; severe muscle aches; headache; fatigue; Vertigo sti ll ongoing; This is a spontaneous report from a contactable consumer.   Female consumer (patient) reported for herself. A 50-year-old female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: unknown), via an unspecified route of administration on 17Jun2021 as a single dose for COVID-19 immunisation. The patient received first dose on 27May2021 as a single dose for COVID-19 immunisation. Medical history included Hashimoto Thyroiditis, Interstitial Cystitis, Migraines and History of Vertigo. The patient's concomitant medications included Levothyroxine on 01Jan2018 for Hypothyroidism (ongoing), Amitriptyline, Topiramate on 01Jan2016 for Migraine (Ongoing), Aimovig on 1Jan2019 for Migraine (ongoing). On 18Jun2021, the patient had 101-102.3 temperature for over 12 hours, severe muscle aches, headache, fatigue and vertigo. The patient experienced the same events on the first and second vaccine doses. The outcome of the events was resolved  Information on the lot/batch, further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: 101-102.3 temp for over 12 hours; severe muscle aches; headache; fatigue; Vertigo sti ll ongoing; This is a spontaneous report from a contactable consumer.   Female consumer (patient) reported for herself. A 50-year-old female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: unknown), via an unspecified route of administration on 17Jun2021 as a single dose for COVID-19 immunisation. The patient received first dose on 27May2021 as a single dose for COVID-19 immunisation. Medical history included Hashimoto Thyroiditis, Interstitial Cystitis, Migraines and History of Vertigo. The patient's concomitant medications included Levothyroxine on 01Jan2018 for Hypothyroidism (ongoing), Amitriptyline, Topiramate on 01Jan2016 for Migraine (Ongoing), Aimovig on 1Jan2019 for Migraine (ongoing). On 18Jun2021, the patient had 101-102.3 temperature for over 12 hours, severe muscle aches, headache, fatigue and vertigo. The patient experienced the same events on the first and second vaccine doses. The outcome of the events was resolved  Information on the lot/batch, further information has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Dizziness, Fatigue, Feeling abnormal, Heart rate increased
Clinical narrative: Heart Rate went really fast; Felt odd, like whole body was vibrating; Lightheadedness; Tired; Caller has not received second dose of the Pfizer Covid Vaccine; This is a spontaneous report from a contactable consumer (patient) to Pfizer sponsored program support. A 55-years old female received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, (Lot Number: EP7533 expiry date was not reported) dose 1 via an unspecified route of administration at arm Left on 02Apr2021 (at the age of 55-years-old) as a single dose for covid-19 immunisation. Medical history included ongoing thyroiditis (she was diagnosed in her 20's), ongoing fibromyalgia (she was diagnosed about 5 years ago), ongoing asthma (she has had this condition on and off for 5-6 years). The patient's concomitant medications were not reported. caller mentioned that she had the tDAP vaccine last year in June or July and had no adverse events. States she has never had an adverse reaction to a vaccine On 02Apr2021 light-headedness and tired, on 03Apr2021 the patient experienced heart rate went really fast, felt odd, like whole body was vibrating, caller has not received second dose of the pfizer covid vaccine (circumstance or information capable of leading to medication error). Caller stated she never reported her symptoms when they occurred, she only told her doctor about them. Caller Stated that within minutes of getting the vaccine she had light-headedness. She went home, was tired, and went to sleep, Stated the next day she felt like her body was vibrating, said that is when her heart rate started, stated it lasted probably more than a week, sometimes it would be beating so fast it would wake her up in the middle of the night. Caller was afraid that she will feel the same way with the second dose of the Pfizer Covid Vaccine. The outcome of the event circumstance or information capable of leading to medication error was unknown and other outcome of the events was recovered on an unspecified date Apr2021.  Information on batch/lot numbers are available. Further information has been requested.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives, after first vaccine; This is a spontaneous report received from a contactable consumer (patient). An 85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6202), via an unspecified route of administration, administered in left arm (left shoulder), on 12Mar2021 12:00 (at the age of 85-year-old), DOSE 1, single for COVID-19 immunization. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID 19 and since the vaccination, the patient had not been tested for COVID 19. The patient had no illness at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. On 30Mar2021 20:00, the patient experienced hives, after first vaccine. They (patient and his wife) had Chinese takeout food and he developed hives. When he broke out in hives, he talked to his doctor about getting the second vaccine, and his doctor told him to delay, the second dose, until the hives cleared up. Patient stated the hives cleared up overnight. The patient did go to the doctor for his hives. The relevant tests were none. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: ER8734), via an unspecified route of administration, administered in left arm (left shoulder), on 16Apr2021 12:00 PM, as DOSE 2, single for COVID-19 immunization, at 35 days, after the first vaccine. The outcome of the event was resolved, on 31Mar2021.  Follow up needed, further information has been requested.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Poor quality product administered, Product temperature excursion issue
Clinical narrative: second dose: arm pain; second dose: headache; They both received an email that the vaccine was invalid due to freezer storage beyond recommended date; They both received an email that the vaccine was invalid due to freezer storage beyond recommended date; This is a spontaneous report form a contactable consumer. This 36-year-old female consumer reported for a 32-year-old male patient (reporter's boyfriend) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, batch/lot number: EW0186, expiration date: 31Aug2021) via an unspecified route of administration, administered in left arm on 07Jun2021 at 14:58 as single dose for COVID-19 immunization. Patient's medical history (including any illness at time of vaccination) was none. There was no family medical history relevant to AE but cancer runs in his family but there has not been any scares or anything with him. The patient had no prior vaccinations (within 4 weeks). There were no AE following prior vaccinations. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, batch/lot number: EW0167, expiration date: 31Aug2021) via an unspecified route of administration, administered in left arm (upper) on 16May2021 at as dose 1, single for COVID-19 immunization and experienced headache and pain the arm. It was reported that patient received an email that the vaccine was invalid due to freezer storage beyond recommended date and administered on 07Jun2021 at 14:58. The email indicated that the facility had reached out to the center and it was recommended that they take a third dose. The reporter stated that her boyfriend had taken the first and second dose at the same exact date and time. The reporter stated that, when the patient had the second dose, the patient had pain in the arm and a little headache. The patient not visited to emergency room and physician office. No treatment medications were received for the adverse events. The outcome of the events was unknown.  Follow up information has been requested.; Sender's Comments: Linked Report(s) : 2021814858 same reporter, dose, drug and event, different patient.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Wheezing
Clinical narrative: Shortness of breath; Coughing; Wheezing; This is a spontaneous report from a contactable physician via a sales representative. A female patient in her early thirties received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as dose number unknown, single for COVID-19 immunization. Medical history included ongoing ulcerative colitis from an unknown date. The patient's concomitant medications were not reported. The patient experienced coughing, wheezing and shortness of breath on an unspecified date. The outcome of the event was unknown. The physician has referred the patient to a Pulmonologist  Information on the Batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Bone densitometry, Dizziness, Limb discomfort, Pain in extremity
Clinical narrative: arm sore; Arm discomfort; dizziness; This is a spontaneous report from a contactable consumer (patient) based on the information receive by Pfizer. This case is one of the two reports with first dose information. A 77-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation or prophylaxis. Medical history included ongoing osteoporosis, intervertebral disc protrusion, nerve compression (4th disc slipped on 5th disc and pinched a nerve) from 2018 to an unknown date; hypoaesthesia (numbness in feet); substance-usage history was significant for surgery to bone pressing on nerve causing numbness in feet from an unknown date and unknown if ongoing; spinal laminectomy on 27Jun2018 for 4th disc slipped on 5th disc and pinched a nerve, removed bone pressing on nerve causing numbness in feet. The patient's concomitant medications were not reported. The patient previously took Fosamax for osteoporosis and teeth were clear after one year of therapy; Forteo for bone density decreased and experienced shaking, tremor (drug body shook left to right). The patient experienced arm sore, arm discomfort on an unspecified date and dizziness on 02Apr2021 with duration just a few minutes also less than an hour. The patient underwent lab tests and procedures which included bone densitometry of -3.6 n/a in 2018, and -3.5 n/a on Jun2020. Clinical outcome of the event dizziness was recovered on 02Apr2021 and it was unknown for other events.  Follow-up attempts are needed. Further information is requested.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear injury, Loss of personal independence in daily activities, Nausea, Pain in extremity
Clinical narrative: Sore arm; Vertigo, which was quite severe; Pretty severe with nausea and vomiting; Pretty severe with nausea and vomiting; Eight weeks of dizziness; Unable to drive a vehicle; Vestibular nerve was inflamed in one ear; Ringing in the ear, tinnitus; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age (in her 50s) received bnt162b2 (formulation: solution for injection; Batch/Lot number: not reported; Expiry date: not reported; NDC number: not reported), dose 2 via an unknown route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 as dose 1 single for COVID-19 immunisation on an unknown date. Patient said she was not on medications and had no health conditions at all, she was healthy and normal. The patient experienced sore arm, vertigo, pretty severe with nausea and vomiting, eight weeks of dizziness, unable to drive a vehicle, vestibular nerve was inflamed in one ear, ringing in the ear, tinnitus. Patient stated that nine days after the second dose, after not having any other symptoms, except a sore arm, there was vertigo, which was quite severe. And about ten hours later it was pretty severe with nausea and vomiting, and everything, went into close to eight weeks of dizziness, four of those weeks unable to drive a vehicle, it was really in one ear, all on an unknown date. Actually, and the audiologist said that she had seen patients who lost their hearing from the vaccine, that the vestibular nerve was inflamed, and following that, the dizziness, subsided after eight weeks, now it was ringing in the ear, she thought they call it tinnitus. She stated that she was normal in weight, thin, healthy person and never had issues with vertigo or anything like that. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Vertigo, Vomiting
Clinical narrative: Sore arm; Vertigo, which was quite severe; Pretty severe with nausea and vomiting; Pretty severe with nausea and vomiting; Eight weeks of dizziness; Unable to drive a vehicle; Vestibular nerve was inflamed in one ear; Ringing in the ear, tinnitus; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age (in her 50s) received bnt162b2 (formulation: solution for injection; Batch/Lot number: not reported; Expiry date: not reported; NDC number: not reported), dose 2 via an unknown route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 as dose 1 single for COVID-19 immunisation on an unknown date. Patient said she was not on medications and had no health conditions at all, she was healthy and normal. The patient experienced sore arm, vertigo, pretty severe with nausea and vomiting, eight weeks of dizziness, unable to drive a vehicle, vestibular nerve was inflamed in one ear, ringing in the ear, tinnitus. Patient stated that nine days after the second dose, after not having any other symptoms, except a sore arm, there was vertigo, which was quite severe. And about ten hours later it was pretty severe with nausea and vomiting, and everything, went into close to eight weeks of dizziness, four of those weeks unable to drive a vehicle, it was really in one ear, all on an unknown date. Actually, and the audiologist said that she had seen patients who lost their hearing from the vaccine, that the vestibular nerve was inflamed, and following that, the dizziness, subsided after eight weeks, now it was ringing in the ear, she thought they call it tinnitus. She stated that she was normal in weight, thin, healthy person and never had issues with vertigo or anything like that. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was sore; This is a spontaneous report from a non-contactable other healthcare professional. A adult female patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date patient experienced arm was sore. The outcome for the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Cough, Depressed mood, Diarrhoea, Dizziness
Clinical narrative: Sadness; Congestion; Really bad diarrhea; Kidney pain; Dizziness; Cough; Headache; Thirst; Difficulty sleeping; Neck pain; I have burning in the back of my neck; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional.  A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0191 Expiration date: unknown) dose 1 via an unspecified route of administration, administered in Arm Right on 06Jun2021 11:00 (at the age of 55-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. patient did not received any other medication within 4 weak Prior to Vaccinations. The patient experienced neck pain, headache, thirst, depressed mood, cough, and difficulty sleeping on 06Jun2021, have burning in the back of the neck on Jun2021, Really bad diarrhea, Dizziness, kidney pain, on 07Jun2021, Sadness, Congestion on 08Jun2021.neck pain: Caller states neck pain was almost immediate after vaccine.She believes this pain resolved about a week later. when probed for the outcome, the caller explains she was okay right now. She feels she has recovered completely, Burning in the back of the neck started about two to three days after the vaccine, Headache: was almost immediate and resolved about maybe two weeks later, Thirst: Was almost immediate. She was drinking a lot of water.The thirst resolved maybe 2 weeks later. She has been hydrating on and off with Gatorade, Powerade and of course water, diarrhea: lasted about a week and a half, Cough: Was almost immediate. It was about maybe three hours after the vaccine, Dizziness: Resolved probably about two weeks later. The outcome of event Neck pain, Headache, Thirst, Sadness, Dizziness Recovered on Jun2021, outcome of burning in the back of my neck, recovered on 12Jun2021, while outcome of event Kidney pain, Congestion, Cough, Difficulty sleeping not recovered, outcome of other events was unknown     No follow-up attempts are possible. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021820899 similar report from same reporter
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Nasal congestion, Neck pain, Renal pain
Clinical narrative: Sadness; Congestion; Really bad diarrhea; Kidney pain; Dizziness; Cough; Headache; Thirst; Difficulty sleeping; Neck pain; I have burning in the back of my neck; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional.  A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0191 Expiration date: unknown) dose 1 via an unspecified route of administration, administered in Arm Right on 06Jun2021 11:00 (at the age of 55-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. patient did not received any other medication within 4 weak Prior to Vaccinations. The patient experienced neck pain, headache, thirst, depressed mood, cough, and difficulty sleeping on 06Jun2021, have burning in the back of the neck on Jun2021, Really bad diarrhea, Dizziness, kidney pain, on 07Jun2021, Sadness, Congestion on 08Jun2021.neck pain: Caller states neck pain was almost immediate after vaccine.She believes this pain resolved about a week later. when probed for the outcome, the caller explains she was okay right now. She feels she has recovered completely, Burning in the back of the neck started about two to three days after the vaccine, Headache: was almost immediate and resolved about maybe two weeks later, Thirst: Was almost immediate. She was drinking a lot of water.The thirst resolved maybe 2 weeks later. She has been hydrating on and off with Gatorade, Powerade and of course water, diarrhea: lasted about a week and a half, Cough: Was almost immediate. It was about maybe three hours after the vaccine, Dizziness: Resolved probably about two weeks later. The outcome of event Neck pain, Headache, Thirst, Sadness, Dizziness Recovered on Jun2021, outcome of burning in the back of my neck, recovered on 12Jun2021, while outcome of event Kidney pain, Congestion, Cough, Difficulty sleeping not recovered, outcome of other events was unknown     No follow-up attempts are possible. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021820899 similar report from same reporter