chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Chills, Headache, Nausea
Clinical narrative: 104F fever; Sharp headache; Nausea; Chills; Stomach pain; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Apr2021 at 12:00 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included sjogren's and achenbach syndrome. The patient did not receive any concomitant medications. The patient had no known allergies. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Apr2021 at 12:00 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Apr2021 at 23:00, the patient experienced 104F fever, sharp headache, nausea, chills and stomach pain. Therapeutic measures were taken as a result of these events and included treatment with TYLENOL and ADVIL. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 23Apr2021, the patient had underwent body temperature test and the result was 104 Fahrenheit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events stomach pain, 104F fever, sharp headache, nausea and chills was recovered on an unknown date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 104F fever; Sharp headache; Nausea; Chills; Stomach pain; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Apr2021 at 12:00 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included sjogren's and achenbach syndrome. The patient did not receive any concomitant medications. The patient had no known allergies. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Apr2021 at 12:00 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Apr2021 at 23:00, the patient experienced 104F fever, sharp headache, nausea, chills and stomach pain. Therapeutic measures were taken as a result of these events and included treatment with TYLENOL and ADVIL. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 23Apr2021, the patient had underwent body temperature test and the result was 104 Fahrenheit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events stomach pain, 104F fever, sharp headache, nausea and chills was recovered on an unknown date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: Tiredness and nausea for about 24 hours; Tiredness and nausea for about 24 hours; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the right arm on 07Apr2021 at 15:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included depression and acid reflux (esophageal). The patient previously used adhesive tape (reported as adhesive bandages) and experienced adhesive tape (reported as adhesive bandages) allergy. Concomitant medications taken within two weeks of vaccination included naproxen sodium (ALEVE) and sertraline hydrochloride (ZOLOFT); both from unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 08:00, the patient experienced tiredness and nausea for about 24 hours. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events tiredness and nausea for about 24 hours was resolved on 09Apr2021.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dysgeusia, Hypertension
Clinical narrative: After about 12 minutes I asked about the metal taste in my mouth; I began to feel light headed so the EMT took my blood pressure which was 200/100 they did nothing for me except monitor my vitals/My blood pressure remained at that high level; This is a spontaneous report from a contactable consumer. This female consumer report for herself.  A (non-pregnant) female patient with unspecified age received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: BNT/ER8733, Expiration date: unknown), via unspecified route, administered in left arm on 26Mar2021 at 13:30 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Past drug events include Magnesium Sulphate induced Drug hypersensitivity.  On 26Mar2021 01:45 PM, 12 minutes after the vaccination, the patient experienced metallic taste in the mouth. Patient began to feel lightheaded so the EMT took her blood pressure which was 200/100 they did nothing for her except monitored her vitals. After taking her vitals multiple times they sent her home and told her to see her doctor. her blood pressure remained at that high level. she has been monitored her blood pressure since then and her average pressure is 135/75. She has not been able to talk to her doctor yet. The patient lab data includes blood pressure monitoring on an unspecified date with readings of 200/100, 135/75 and a high-level reading with unknown value. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Heart rate abnormal, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: fluttering skipping heart; can't catch breath; Numb tingling left arm, both calves numb; dizzy spells; bad temple pain; nausea; swollen; numb lips; blurred vision in left eye; This is a spontaneous report from a contactable consumer. A non- pregnant female patient 48 years old received (Age group 18-64 Years) bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 22Apr2021 17:00 (age at vaccination 47 years) as dose 1, single for covid-19 immunisation. Medical history included Known allergies: Fish (Known allergies: Fish, sensitive to Valium). Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. The patient previously took valium and experienced drug hypersensitivity, Synthroid (take Synthroid daily). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient visited Doctor or other healthcare professional office/clinic visit. On 22Apr2021 17:30 the patient experienced fluttering skipping heart, can't catch breath, numb tingling left arm, both calves numb, dizzy spells, bad temple pain, nausea, swollen, numb lips, blurred vision in left eye. Patient did not receive any treatment for reported events. The outcome of event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Swelling, Vision blurred
Clinical narrative: fluttering skipping heart; can't catch breath; Numb tingling left arm, both calves numb; dizzy spells; bad temple pain; nausea; swollen; numb lips; blurred vision in left eye; This is a spontaneous report from a contactable consumer. A non- pregnant female patient 48 years old received (Age group 18-64 Years) bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 22Apr2021 17:00 (age at vaccination 47 years) as dose 1, single for covid-19 immunisation. Medical history included Known allergies: Fish (Known allergies: Fish, sensitive to Valium). Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. The patient previously took valium and experienced drug hypersensitivity, Synthroid (take Synthroid daily). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient visited Doctor or other healthcare professional office/clinic visit. On 22Apr2021 17:30 the patient experienced fluttering skipping heart, can't catch breath, numb tingling left arm, both calves numb, dizzy spells, bad temple pain, nausea, swollen, numb lips, blurred vision in left eye. Patient did not receive any treatment for reported events. The outcome of event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Sneezing
Clinical narrative: Allergies are acting up; Sneezing; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: not provided), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Medical history included allergies. The patient's concomitant medications were not reported. On an unknown date, the patient reported her allergies were acting up and she did not know if she was allowed to take Zyrtec. She has not taken Zyrtec yet, she just didn't know if she could take Zyrtec before or after the second dose of Pfizer Covid-19 Vaccine. She was just being cautious, didn't want to take Zyrtec if she shouldn't. She knows you can't take like a Tylenol or anything like that. If it was not fine to take Zyrtec she just won't take the Zyrtec. Allergies are acting up further described as sneezing and the usual allergies. The patient was getting her second dose of Pfizer Covid-19 Vaccine today, and was not sure who to call. The patient was not received treatment for the events. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Disturbance in attention, Headache, Impaired quality of life, Tinnitus
Clinical narrative: I was experiencing hearing loss; Extreme ringing in ears; Started after my first dose its making my life unberable; Having hard time consentrating at work; Headache; Extreme vertigo; Upon Follow up #2 (PRD19AUG2021/SRD 19AUG2021) case was considered valid suspect product "BNT162B2" was added.  This is a spontaneous report from a contactable consumer. A 32-years-old male patient received BNT162B2 (BNT162B2, Formulation: Solution for Injection, Batch/Lot Number: EW0150, Expiration date: 04May2021) dose 1 via unknown route of administration, administered in Arm Left on 05Apr2021 (at the age of 32-years-old) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient had past drug therapy with unspecified drug. Concomitant medication included excedrine (CAFFEINE; PARACETAMOL) dose of 300mg once a day for headache on 04May2021. The patient stated that he was experiencing hearing loss after getting the Pfizer shot (Unspecified shot) on 05Apr2021. The patient received treatment for the event. He illness before the time of vaccine having extreme ringing in the ears does not stop started after my first dose it's making my life unbearable having hard time concentrating at work used up all my sick time because of because of this also get headaches and extreme Vertigo. The patient reported that reported issue occurred after taking Pfizer product. The outcome of the event I was experiencing hearing loss was not recovered and other events was unknown.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: I was experiencing hearing loss; Extreme ringing in ears; Started after my first dose its making my life unberable; Having hard time consentrating at work; Headache; Extreme vertigo; Upon Follow up #2 (PRD19AUG2021/SRD 19AUG2021) case was considered valid suspect product "BNT162B2" was added.  This is a spontaneous report from a contactable consumer. A 32-years-old male patient received BNT162B2 (BNT162B2, Formulation: Solution for Injection, Batch/Lot Number: EW0150, Expiration date: 04May2021) dose 1 via unknown route of administration, administered in Arm Left on 05Apr2021 (at the age of 32-years-old) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient had past drug therapy with unspecified drug. Concomitant medication included excedrine (CAFFEINE; PARACETAMOL) dose of 300mg once a day for headache on 04May2021. The patient stated that he was experiencing hearing loss after getting the Pfizer shot (Unspecified shot) on 05Apr2021. The patient received treatment for the event. He illness before the time of vaccine having extreme ringing in the ears does not stop started after my first dose it's making my life unbearable having hard time concentrating at work used up all my sick time because of because of this also get headaches and extreme Vertigo. The patient reported that reported issue occurred after taking Pfizer product. The outcome of the event I was experiencing hearing loss was not recovered and other events was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Nausea, Pruritus, Pyrexia
Clinical narrative: Fever; Chills; Nausea; Chest tightness for almost 2 hours thatwas coming and going and felt likepressure on chest,; Squeezing chest; Welts; bumpy rash that looks like bug bites on  lower  back,upper back, both legs, chest and on  face; bumpy rash that looks like bug bites that are itchy, on  lower back, upper back, both legs, chest and on face; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 18Apr2021 at 11:30 (at the age of 55-year-old) as a single dose for COVID-19 immunization. Patient did not have any medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any medication within two weeks of vaccination. The patient did not have allergies to medications, food, or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 28Mar2021 at 12:30 (at the age of 55-year-old) as a single dose for COVID-19 immunization. Post second vaccination, the patient had fever and chills and nausea the next morning, second night had chest tightness for almost 2 hours that was coming and going and felt like pressure on chest, was not hard to breathe but was like squeezing chest, 2nd day had welts and bumpy rash that looks like bug bites that are itchy, on lower back, upper back, both legs, chest and on face. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, chills, nausea, chest tightness for almost 2 hours, felt like pressure on chest, was not hard to breathe but was like squeezing chest, welts and bumpy rash that looks like bug bites that are itchy, on lower back, upper back, both legs, chest and on face was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Fever; Chills; Nausea; Chest tightness for almost 2 hours thatwas coming and going and felt likepressure on chest,; Squeezing chest; Welts; bumpy rash that looks like bug bites on  lower  back,upper back, both legs, chest and on  face; bumpy rash that looks like bug bites that are itchy, on  lower back, upper back, both legs, chest and on face; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 18Apr2021 at 11:30 (at the age of 55-year-old) as a single dose for COVID-19 immunization. Patient did not have any medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any medication within two weeks of vaccination. The patient did not have allergies to medications, food, or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 28Mar2021 at 12:30 (at the age of 55-year-old) as a single dose for COVID-19 immunization. Post second vaccination, the patient had fever and chills and nausea the next morning, second night had chest tightness for almost 2 hours that was coming and going and felt like pressure on chest, was not hard to breathe but was like squeezing chest, 2nd day had welts and bumpy rash that looks like bug bites that are itchy, on lower back, upper back, both legs, chest and on face. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, chills, nausea, chest tightness for almost 2 hours, felt like pressure on chest, was not hard to breathe but was like squeezing chest, welts and bumpy rash that looks like bug bites that are itchy, on lower back, upper back, both legs, chest and on face was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chillblains, Erythema, Foot deformity, Pain in extremity, Sensitive skin
Clinical narrative: Most of the toes have developed the "COVID toes"/chilblains reaction within a week of receiving the vaccine.; Reddened areas on toes that are very sore and sensitive to any pressure.; There are reddened areas on toes that are very sore and sensitive to any pressure.; Most of the toes have developed the "COVID toes"/chilblains reaction within a week of receiving the vaccine.; Sensitive to any pressure; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 13:30 (at the age of 27-years-old), as a single dose for COVID-19 immunisation. Medical history included chilblains. The patient did not have any allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included multivitamins (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 17Apr2021, the patient experienced most of the toes had developed the "COVID toes"/chilblains reaction within a week of receiving the vaccine. It was reported that patient had a chronic chilblains-like condition (no diagnosis was done, not sure what type of doctor to consult to figure it out, just based on symptoms) that had not flared for over a year, so the patient thought there was a connection. The reaction in the toes was the exact same as what would happen when her "regular chilblains" flared up. There were reddened areas on toes that were very sore and sensitive to any pressure. No itching. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events most of the toes had developed the "COVID toes"/chilblains reaction within a week of receiving the vaccine, reddened areas on toes that were very sore and sensitive to any pressure were not resolved at the time of this report.    No follow-up attempts are needed; information about lot number cannot be obtained.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Experienced ringing in ear; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the right arm on 26Mar2021 at 01:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously took sulfamethoxazole/trimethoprim (BACTRIM), vancomycin (MANUFACTURER UNKNOWN) and cefaclor (CECLOR) for unknown indication on an unknown dates and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 26Mar2021, the patient experienced ringing in ear. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were not taken as a result of reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of ringing in ear was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Vaccination site pain
Clinical narrative: Horrible headache that made the patient unable to do anything but lay down; Injection site soreness, hurt but could still use arm; Swollen lymph nodes in armpit on the side of injection; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 21Apr2021 at 15:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety and panic disorder. The patient did not have any allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included sertraline hydrochloride (ZOLOFT), multivitamin (MANUFACTURER UNKNOWN), colecalciferol (VITAMIN D3), levocetirizine dihydrochloride (XYZAL) and cobamamide (VITAMIN B12), all for unspecified indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 31Mar2021 at 15:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. On 22Apr2021 at 03:30, the patient experienced horrible headache that made her unable to do anything but lay down, injection site soreness which hurt but she could still use her arm and swollen lymph nodes in armpit on the side of injection. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events horrible headache that made the patient unable to do anything but lay down, injection site soreness, hurt but could still use arm and swollen lymph nodes in armpit on the side of injection was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage, Vulvovaginal burning sensation, Vulvovaginal erythema, Vulvovaginal pain
Clinical narrative: exterior vaginal pain; I have intense redness and a big purplish looking mark that burns and is tender to the touch; I have intense redness and a big purplish looking mark that burns and is tender to the touch; I have intense redness and a big purplish looking mark that burns and is tender to the touch; This is a spontaneous report from a contactable consumer (patient). A 43-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0164) via an unspecified route of administration, administered in Arm Right on 20Apr2021 16:30 (at the age of 43 years old) as dose 2, single for COVID-19 immunisation at hospital. Medical history included celiac disease, allergy to gluten, and corn. Concomitant medication(s) received within two weeks included calcium (CALCIUM), colecalciferol (VITAMIN D 3), curcuma longa (TURMERIC [CURCUMA LONGA]), cetirizine hydrochloride (ZYRTEK), all taken for an unspecified indication, start and stop date were not reported. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8733) via an unspecified route of administration, administered in Arm Right on 30Mar2021 15:15 (at the age of 43 years old) as single for COVID-19 immunisation. Patient did not received other vaccine within four weeks of COVID vaccine. Patient did not have COVID prior to vaccination. The patient experienced exterior vaginal pain, i have intense redness and a big purplish looking mark that burns and is tender to the touch on 22Apr2021 11:00. Reported as, "Approx 40 hours after injection patient had exterior vaginal pain. The entire exterior vaginal area was tender to the touch, so clothing was irritating, sitting uncomfortable and wiping really hurt. Patient wouldn't have thought that this was a side effect except for the fact that his 18 year old daughter had the same vaginal pain come on at the same time and they got the vaccine together. Patient have intense redness and a big purplish looking mark that burns and was tender to the touch. It lines the left side opening of my vagina". No treatment were given for the adverse events. Patient was not tested for COVID post vaccination. Outcome of all the events were not recovered.  No follow-up attempts are possible, no further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Limb discomfort, Nausea, Pain
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the right arm on 21Apr2021 at 14:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included Guillain barre syndrome from an unknown date in 2019, known allergies to shellfish and penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ibuprofen (MANUFACTURER UNKNOWN) as needed for an unknown indication from an unknown date and unknown if ongoing. The patient previously received hydromorphone hydrochloride (DILAUDID) and iodine (MANUFACTURER UNKNOWN) and experienced drug allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 31Mar2021 at 13:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine.  On 21Apr2021 at 22:00, the patient experienced fever up to 101.9 (unspecified units), nausea, chills, body aches, pain in arm and legs felt heavy-like walking through water when trying to move. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever up to 101.9 (unspecified units), nausea, chills, body aches, pain in arm and legs felt heavy-like walking through water when trying to move were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the right arm on 21Apr2021 at 14:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included Guillain barre syndrome from an unknown date in 2019, known allergies to shellfish and penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ibuprofen (MANUFACTURER UNKNOWN) as needed for an unknown indication from an unknown date and unknown if ongoing. The patient previously received hydromorphone hydrochloride (DILAUDID) and iodine (MANUFACTURER UNKNOWN) and experienced drug allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 31Mar2021 at 13:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine.  On 21Apr2021 at 22:00, the patient experienced fever up to 101.9 (unspecified units), nausea, chills, body aches, pain in arm and legs felt heavy-like walking through water when trying to move. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever up to 101.9 (unspecified units), nausea, chills, body aches, pain in arm and legs felt heavy-like walking through water when trying to move were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Insomnia, Renal pain
Clinical narrative: Sat., chills began; Woke middle of the night with pain in Kidneys Fri a.m., pain got worse after 12 a.m.; Finding it impossible to sleep in bed or really rest; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ew0164) via an unspecified route of administration in the left arm on 21Apr2021 at 10:30 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. The medical history included diabetes type II. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included metformin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN) and pioglitazone (MANUFACTURER UNKNOWN), all from unknown dates and for unknown indications. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ep6955) via an unspecified route of administration in the left arm on 31Mar2021 at 10:15 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. On 23Apr2021 at 02:45, the patient woke in middle of the night with pain in kidneys and found it impossible to sleep in bed or really rest. On 24Apr2021 after 00:00, the pain got worse and chills began. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain in kidneys, pain got worse, chills and finding it impossible to sleep in bed or really rest were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage, Vulvovaginal burning sensation, Vulvovaginal erythema, Vulvovaginal pain
Clinical narrative: vaginal pain; redness and burning pain especially when urine hits the affected area; redness and burning pain especially when urine hits the affected area; white spots; This is a spontaneous report from a contactable consumer. An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for Injection, Lot number: EW0164) dose 2 via an unknown route of administration, administered in Arm Right on 20Apr2021 04:30 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medication was not reported. Approximately 40 hours after injection, Patient experienced, I had exterior vaginal pain. The entire exterior vaginal area was tender to the touch, so clothing was irritating, sitting uncomfortable and wiping really hurt. I wouldn't have thought that this was a side effect except for the fact that my 18-year-old daughter had the same vaginal pain come on at the same time and we got the vaccine together. I have intense redness and a big purplish looking mark that burns and is tender to the touch. It lines the left side opening of my vagina. My daughter also has redness and burning pain especially when urine hits the affected area. She has white spots instead of the dark red purplish mark that I have. We are two days out from noticing these vaginal symptoms with no relief yet. All events on 22Apr2021 11:00 AM. Since it is a weekend, we are just watching it but debating if we need to see a healthcare professional if our symptoms remain come Monday. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever; Headache; Chills; Body aches; Lack of strength and energy; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 19Apr2021 at 12:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included benazepril (MANUFACTURER UNKNOWN) from unknown date for unspecified indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN8727) via an unspecified route of administration in the right arm on 29Mar2021 at 12:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. On 20Apr2021 at 09:00, the patient experienced fever, chills, body aches and headache which began the morning after second dose and lasted until the evening the following day on 22Apr2021. Fever and headache remained until morning of 23Apr2021. The patient was still experiencing lack of strength and energy at the time of this report. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as the result of events. The clinical outcome of the events chills and body aches were resolved with sequelae (also reported resolved with lasting effects) on 22Apr2021; while that of fever and headache were resolved with sequelae (also reported resolved with lasting effects) on 23Apr2021. The clinical outcome of the event lack of strength and energy was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Resting heart rate went from 65-75 BPM to 80-100 BPM with peaks of 130 BPM; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 40-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot number: EW0162) via an unspecified route of administration in the left arm on 18Apr2021 at 11:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included hyperthyroidism. Known allergies were reported as not applicable. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 18Apr2021 at 12:00, the patient experienced resting heart rate which went from 65-75 BPM to 80-100 BPM with peaks of 130 BPM. This was continued on and off for five days. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination the patient had not been tested for COVID-19. The clinical outcome of the event of resting heart rate went from 65-75 BPM to 80-100 BPM with peaks of 130 BPM was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Neck pain, Pruritus, Urticaria
Clinical narrative: Neck pain; Hives in left leg; Itchy; Headache; Joint pain in left knee, right thumb and right wrist; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER 8731) via an unspecified route of administration in the left arm on 19Apr2021 (at the age of 53-years-old) as single dose for COVID-19 immunisation. The patient had history of known allergies to penicillin (MANUFACTURER UNKNOWN). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. On 22Apr2021, the patient experienced hives in her left leg, itchy, headache, neck pain, joint pain in left knee, right thumb and right wrist. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of event hives in left leg, itchy, headache, neck pain, joint pain in left knee, right thumb and right wrist were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Visual impairment
Clinical narrative: Vision changes/ could not read words or numbers/ can't see faces or details of objects; Not been able to go about daily life normally; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 12Apr2021 at 13:15 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included fingolimod hydrochloride (GILENYA) for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the right arm on 23Mar2021 at 14:15 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. On 12Apr2021, the patient experienced vision changes basically similar to when stare at the sun/bright light and then see a dark blob. It was reported that first few days the patient could not read words or numbers and she could read them now but still fuzzy. The patient could not see faces or details of objects still and eye doctor found nothing wrong, and neurologist said it was not a neurological issue. The patient had never experienced eye issues like this before and there was no conclusive evidence (no macular edema). The patient had not been able to go about her daily life normally. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events vision changes/ could not read words or numbers/ can't see faces or details of objects and not been able to go about daily life normally was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasal congestion, Wheezing
Clinical narrative: Chesty cough; Stuff nose; Wheezing; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old, non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route on 18Apr2021 at 13:15 in the left arm (at the age of 42-years-old) as single dose for COVID-19 immunisation. The medical history of the patient included eosinophilic pneumonia. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included inhalers from an unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccination within 4 weeks of COVID vaccine. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route on 28Mar2021 at 12:15 (at the age of 42-years-old) in the left arm as single dose for COVID-19 immunisation. On 21Apr2021, at 12:00 hours, the patient experienced chesty cough and stuff nose at night wheezing. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events of chesty cough, stuff nose and wheezing were recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Diagnosed with shingles 15 days after first covid 19 vaccine dose; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. On an unknown date the patient experienced diagnosed with shingles 15 days after first COVID-19 vaccine dose. Therapeutic measures were taken as a result of the event and included treatment with valacyclovir. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event diagnosed with shingles 15 days after first COVID-19 vaccine dose was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.