chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Vomiting, Weight, Weight decreased
Clinical narrative: Within an hour of receiving both vaccines, 1 & 2. I had a level 10 migraine.; Each time I through up at least ten times with such force, projectile vomiting.; lost so much weight; This is a spontaneous report received from a contactable consumer (patient).   A 57-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: ER8727) via an unspecified route of administration at right arm on 24Mar2021 (at the age of 57-year-old) as dose 2, single and received first dose via an unspecified route of administration at left arm on 03Mar2021 19:30 (Lot Number: EN6199) (at the age of 57-year-old) as dose 1, single for COVID-19 immunisation. Medical history included Chronic migraines; Mitral valve Prolapse. Concomitant medications included bupropion hydrochloride (BUPROPION HCL XL), atorvastatin, lorazepam, sumatriptan succinate (IMITREX). The patient previously took compazine [prochlorperazine edisylate] and experienced allergy, Known allergies: Compazine. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccine in four weeks. Patient did not have COVID prior vaccination and since vaccination patient has not been tested with COVID-19. The patient experienced events reported as "within an hour of receiving both vaccines, 1 & 2. I had a level 10 migraine, each time I through up at least ten times with such force, projectile vomiting, lost so much weight on 03Mar2021 20:30. Patient reported that within an hour of receiving both vaccines, 1 & 2. She had a level 10 migraine. Each time she through up at least ten times with such force, projectile vomiting. 2 solid days and nights. 3rd day still had a horrible migraine but the vomiting stopped". she lost so much weight that she fell below 100 lbs. Now they are talking about a third vaccine and she was petrified to go through this entire event again. Both times she had to get a telemedicine appointment with her physician because she thought her husband would need to take her to the hospital. She made sure to stay hydrated before the vaccines as well as after the vaccine. The patient underwent lab tests and procedures which included weight: below 100 lbs on 03Mar2021 (I lost so much weight that I fell below 100 lbs). Patient stated that both occasions she received treatment with oral Fiorinal Tablets. Patient visited physician office for the events. Outcome of event vomiting recovered on an unspecified date in 2021 and remaining events was recovering/resolving.   No follow-up attempts are possible; Information about Lot/Batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Fatigue, Feeling of body temperature change, Gait disturbance
Clinical narrative: 18 hours after the vaccine I had uncontrollable shaking, so bad it woke me up, and I could not control my hands or anything else/It was everywhere in my body and I could not stop shaking; I was also very cold but very warm to the touch; every limb and joint hurts; every limb and joint hurts; I'm very tired; fast heartbeat; I seemed to have trouble taking a deep breath; I could barely walk; I could barely hold a glass of water; This is a spontaneous report received from a contactable consumer (patient). A 61-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6207, Expiration date was not reported), via an unspecified route of administration in arm left on 15Apr2021 at 13:30 (at the age of 61-year-old) as a dose 2, single for COVID-19 immunization. The patient's medical history was reported as none, nothing that would affect this. The patient had no known allergies. The patient's concomitant medications in two weeks included ibuprofen (ADVIL [IBUPROFEN]), levothyroxine sodium (SYNTHROID) and atenolol (ATENOLOL), all were taken for an unspecified indication. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6204, Expiration date was not reported), via an unspecified route of administration in arm left on 22Mar2021 at 13:30 (at the age of 61-year-old) as a dose 1, single for COVID-19 immunization. It was reported that, the patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks to the COVID vaccine. No COVID prior vaccination and no COVID tested post vaccination. On 16Apr2021 at 07:15 AM, 18 hours after the vaccine, the patient had uncontrollable shaking, so bad it woke her up and she could not control her hands or anything else. Stated that, it was everywhere in her body and she could not stop shaking. Stated that, she took an Advil and after an hour it diminished. Hours later, she was still shaky and now every limb and joint hurts and she was very tired. Stated that, she also had a fast heartbeat, probably because she was shaking so bad. Stated that, she seemed to have trouble taking a deep breath. Stated that, she could barely hold a glass of water and she could barely walk. She was also very cold but very warm to the touch. Treatment was received for the event 18 hours after the vaccine I had uncontrollable shaking, so bad it woke me up, and I could not control my hands or anything else/It was everywhere in my body and I could not stop shaking while for the other events treatment was not received. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Loss of personal independence in daily activities, Pain in extremity, Tremor
Clinical narrative: 18 hours after the vaccine I had uncontrollable shaking, so bad it woke me up, and I could not control my hands or anything else/It was everywhere in my body and I could not stop shaking; I was also very cold but very warm to the touch; every limb and joint hurts; every limb and joint hurts; I'm very tired; fast heartbeat; I seemed to have trouble taking a deep breath; I could barely walk; I could barely hold a glass of water; This is a spontaneous report received from a contactable consumer (patient). A 61-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6207, Expiration date was not reported), via an unspecified route of administration in arm left on 15Apr2021 at 13:30 (at the age of 61-year-old) as a dose 2, single for COVID-19 immunization. The patient's medical history was reported as none, nothing that would affect this. The patient had no known allergies. The patient's concomitant medications in two weeks included ibuprofen (ADVIL [IBUPROFEN]), levothyroxine sodium (SYNTHROID) and atenolol (ATENOLOL), all were taken for an unspecified indication. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6204, Expiration date was not reported), via an unspecified route of administration in arm left on 22Mar2021 at 13:30 (at the age of 61-year-old) as a dose 1, single for COVID-19 immunization. It was reported that, the patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks to the COVID vaccine. No COVID prior vaccination and no COVID tested post vaccination. On 16Apr2021 at 07:15 AM, 18 hours after the vaccine, the patient had uncontrollable shaking, so bad it woke her up and she could not control her hands or anything else. Stated that, it was everywhere in her body and she could not stop shaking. Stated that, she took an Advil and after an hour it diminished. Hours later, she was still shaky and now every limb and joint hurts and she was very tired. Stated that, she also had a fast heartbeat, probably because she was shaking so bad. Stated that, she seemed to have trouble taking a deep breath. Stated that, she could barely hold a glass of water and she could barely walk. She was also very cold but very warm to the touch. Treatment was received for the event 18 hours after the vaccine I had uncontrollable shaking, so bad it woke me up, and I could not control my hands or anything else/It was everywhere in my body and I could not stop shaking while for the other events treatment was not received. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye pain, Headache, Hypoaesthesia, Joint range of motion decreased
Clinical narrative: Numb face within 20 min of 2nd injection lasted two hours; swelling of finger joints, not able to bend a couple fingers for about 6 hours day after 2nd injection; not able to bend a couple fingers for about 6 hours day after 2nd injection; chills; severe muscle aches; headache in eyes and head; headache in eyes and head; This is a spontaneous report from a contactable consumer. This 65-year-old female consumer (patient) reported. A 65-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 2 via an unspecified route of administration, administered in Arm Left on 15Apr2021 10:45 (at the age of 65-years-old) as a single dose for covid-19 immunization; methocarbamol (METHOCARBAMOL), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unknown (750) for an unspecified indication; losartan (LOSARTAN), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 50 mg for an unspecified indication. Medical history included hypertension, asthma, drug hypersensitivity, milk allergy. Concomitant medications in two weeks included hydrocodone. The patient previously took percodan [acetylsalicylic acid;oxycodone hydrochloride] and experienced drug hypersensitivity, ultram [paracetamol;tramadol hydrochloride] and experienced drug hypersensitivity. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration administered in Arm Left on 25Mar2021 10:45 (at the age of 65-years-old) as a single dose for covid-19 immunization. The patient had allergies with percodan penicillin ultram, milk. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 15Apr2021 11:15, the patient experienced numb face within 20 min of 2nd injection lasted two hours, swelling of finger joints, not able to bend a couple fingers for about 6 hours day after 2nd injection, chills and severe muscle aches, headache in eyes and head. The patient received treatment with anti-inflammatory. Outcome of the event was recovering, at the time of this report. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Myalgia
Clinical narrative: Numb face within 20 min of 2nd injection lasted two hours; swelling of finger joints, not able to bend a couple fingers for about 6 hours day after 2nd injection; not able to bend a couple fingers for about 6 hours day after 2nd injection; chills; severe muscle aches; headache in eyes and head; headache in eyes and head; This is a spontaneous report from a contactable consumer. This 65-year-old female consumer (patient) reported. A 65-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 2 via an unspecified route of administration, administered in Arm Left on 15Apr2021 10:45 (at the age of 65-years-old) as a single dose for covid-19 immunization; methocarbamol (METHOCARBAMOL), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unknown (750) for an unspecified indication; losartan (LOSARTAN), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 50 mg for an unspecified indication. Medical history included hypertension, asthma, drug hypersensitivity, milk allergy. Concomitant medications in two weeks included hydrocodone. The patient previously took percodan [acetylsalicylic acid;oxycodone hydrochloride] and experienced drug hypersensitivity, ultram [paracetamol;tramadol hydrochloride] and experienced drug hypersensitivity. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration administered in Arm Left on 25Mar2021 10:45 (at the age of 65-years-old) as a single dose for covid-19 immunization. The patient had allergies with percodan penicillin ultram, milk. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 15Apr2021 11:15, the patient experienced numb face within 20 min of 2nd injection lasted two hours, swelling of finger joints, not able to bend a couple fingers for about 6 hours day after 2nd injection, chills and severe muscle aches, headache in eyes and head. The patient received treatment with anti-inflammatory. Outcome of the event was recovering, at the time of this report. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Feeling abnormal, Feeling of body temperature change, Influenza like illness, Nausea, Pain in extremity
Clinical narrative: tingly; Severely sore arm; foggy; hazy; hot & cold; Flu like symptoms; Vomit; Nausea; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection Batch/Lot number: Unknown), via an unspecified route of administration in left arm on 09Apr2021 at 17:00 (at the age of 51 years old, not pregnant at the time of vaccination) as dose 1, single for covid-19 immunisation; diphenhydramine hydrochloride (BENADRYL), start and stop date and dose were not reported for an unspecified indication. Medical history included gastrooesophageal reflux disease, hiatus hernia, laryngopharyngeal reflux, endometriosis, arthritis, bulged discs, carpal tunnel syndrome. The patient had known allergies to penicillin. Concomitant medications in two weeks included lansoprazole, ondansetron, acetylsalicylic acid, caffeine, paracetamol, salicylamide (EXCEDRIN [ACETYLSALICYLIC ACID; CAFFEINE; PARACETAMOL; SALICYLAMIDE]), Sin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 10Apr2021 at 06:00 patient experienced, days 1-3 severely sore arm, days 1-5 very foggy, hazy, tingly, on an unspecified date in Apr2021, days 3-6 flu like symptoms, vomit, nausea, hot and cold like she had 10 benadryl. The patient did not received treatment due to the events. The action taken in response to the events for diphenhydramine hydrochloride was unknown. The outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Paraesthesia, Vision blurred, Vomiting
Clinical narrative: tingly; Severely sore arm; foggy; hazy; hot & cold; Flu like symptoms; Vomit; Nausea; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection Batch/Lot number: Unknown), via an unspecified route of administration in left arm on 09Apr2021 at 17:00 (at the age of 51 years old, not pregnant at the time of vaccination) as dose 1, single for covid-19 immunisation; diphenhydramine hydrochloride (BENADRYL), start and stop date and dose were not reported for an unspecified indication. Medical history included gastrooesophageal reflux disease, hiatus hernia, laryngopharyngeal reflux, endometriosis, arthritis, bulged discs, carpal tunnel syndrome. The patient had known allergies to penicillin. Concomitant medications in two weeks included lansoprazole, ondansetron, acetylsalicylic acid, caffeine, paracetamol, salicylamide (EXCEDRIN [ACETYLSALICYLIC ACID; CAFFEINE; PARACETAMOL; SALICYLAMIDE]), Sin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 10Apr2021 at 06:00 patient experienced, days 1-3 severely sore arm, days 1-5 very foggy, hazy, tingly, on an unspecified date in Apr2021, days 3-6 flu like symptoms, vomit, nausea, hot and cold like she had 10 benadryl. The patient did not received treatment due to the events. The action taken in response to the events for diphenhydramine hydrochloride was unknown. The outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue discomfort
Clinical narrative: Burned tongue; This is a spontaneous report from a contactable consumer (patient). A 28-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was ER8730 and expiration date was not reported), via an unspecified route of administration, administered in left arm on 26Mar2021 11:00 AM (Age at vaccination was 28 year) as DOSE 1, SINGLE for covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history was reported as none. Concomitant medication included sertraline (in two weeks). The patient did not have known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Patient was not tested for COVID-19 since vaccination. The patient did not take any other vaccine in four weeks. On 01Apr2021 at 12:00 pm, the patient experienced burned tongue.Therapeutic measures were not taken. The outcome of event was recovered with sequelae.  No follow-up attempts is possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Headache, Nausea, Pain
Clinical narrative: Severe nausea; Upper abdominal pain; Headache; Fever; Chill; Pain all over body; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8735) via an unspecified route of administration in the left arm on 17Apr2021 at 10:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. 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 4 weeks prior to the COVID-19 vaccine. Concomitant medications included colecalciferol (VITAMIN D3) for an unknown indication from an unknown start date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8732) via an unspecified route of administration in the left arm on 27Mar2021 at 10:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. On 17Apr2021 at 23:00, the patient experienced severe nausea, upper abdominal pain, headache, fever, chill and pain all over body. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events severe nausea, upper abdominal pain, headache, fever, chill and pain all over body were recovering at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Severe nausea; Upper abdominal pain; Headache; Fever; Chill; Pain all over body; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8735) via an unspecified route of administration in the left arm on 17Apr2021 at 10:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. 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 4 weeks prior to the COVID-19 vaccine. Concomitant medications included colecalciferol (VITAMIN D3) for an unknown indication from an unknown start date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8732) via an unspecified route of administration in the left arm on 27Mar2021 at 10:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. On 17Apr2021 at 23:00, the patient experienced severe nausea, upper abdominal pain, headache, fever, chill and pain all over body. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events severe nausea, upper abdominal pain, headache, fever, chill and pain all over body were recovering at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Neuralgia, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the right arm on 19Apr2021 at 10:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, exercise-induced asthma and known allergies to sulfa, tomatoes, dust mites, and ragweed. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fluoxetine hydrochloride (PROZAC), meloxicam (MANUFACTURER UNKNOWN), bupropion hydrochloride (WELLBUTRIN) and trazodone (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 29Mar2021 at 10:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient previously received chlorhexidine gluconate (HIBICLENS), ciprofloxacin hydrochloride (CIPROFLOXACIN) and levofloxacin (LEVAQUIN) on unknown dates for unknown indications and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Apr2021 at 11:00, the patient experienced pain between scapulae and ribs and it felt like nerve pain, a light tingling sensation in arms, muscle aches, bad headache and chills. 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 pain between scapulae and ribs, nerve pain, light tingling sensation in arms, muscle aches, bad headache and chills were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the right arm on 19Apr2021 at 10:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, exercise-induced asthma and known allergies to sulfa, tomatoes, dust mites, and ragweed. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fluoxetine hydrochloride (PROZAC), meloxicam (MANUFACTURER UNKNOWN), bupropion hydrochloride (WELLBUTRIN) and trazodone (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 29Mar2021 at 10:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient previously received chlorhexidine gluconate (HIBICLENS), ciprofloxacin hydrochloride (CIPROFLOXACIN) and levofloxacin (LEVAQUIN) on unknown dates for unknown indications and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Apr2021 at 11:00, the patient experienced pain between scapulae and ribs and it felt like nerve pain, a light tingling sensation in arms, muscle aches, bad headache and chills. 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 pain between scapulae and ribs, nerve pain, light tingling sensation in arms, muscle aches, bad headache and chills were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Dizziness, Eye pruritus, Fatigue
Clinical narrative: Hives on eyelids; Itchy eyes; Muscle soreness; Joint pain; Fever; Sweats; Mild headache; Sore arm; Tired; Dizziness; Nauseous; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 15Apr2021 at 12:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included Graves' disease. The patient previously took methocarbamol (MANUFACTURER UNKNOWN) and cyclobenzaprine (MANUFACTURER UNKNOWN) for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included citalopram (MANUFACTURER UNKNOWN), vitamin d nos (VITAMIN D) and selenium sulfide (SELENIUM); all taken from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 12:30, immediately after the vaccine, patient experienced dizziness and nauseous; 7 hours post vaccination at 19:30 experienced, mild headache, sore arm and tired. On 16Apr2021 at 04:30, 16 hours post vaccination, the patient experienced fever, sore arm, tiredness and sweats; 24 hours post vaccination at 12:30, experienced itchy eyes,  hives on eyelids, mild headache, muscle soreness and joint pain. The patient also reported that 48-96 hours after the vaccination, she had hives on eyelids, itchy eyes and joint pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 16Apr2021 at 04:30, the patient underwent body temperature test and the result was 100.6 (unspecified units). 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 event dizziness, nauseous, mild headache, sore arm, tired, fever, sweats, hives on eyelids, itchy eyes, muscle soreness and joint pain was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Myalgia, Nausea, Pain in extremity
Clinical narrative: Hives on eyelids; Itchy eyes; Muscle soreness; Joint pain; Fever; Sweats; Mild headache; Sore arm; Tired; Dizziness; Nauseous; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 15Apr2021 at 12:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included Graves' disease. The patient previously took methocarbamol (MANUFACTURER UNKNOWN) and cyclobenzaprine (MANUFACTURER UNKNOWN) for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included citalopram (MANUFACTURER UNKNOWN), vitamin d nos (VITAMIN D) and selenium sulfide (SELENIUM); all taken from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 12:30, immediately after the vaccine, patient experienced dizziness and nauseous; 7 hours post vaccination at 19:30 experienced, mild headache, sore arm and tired. On 16Apr2021 at 04:30, 16 hours post vaccination, the patient experienced fever, sore arm, tiredness and sweats; 24 hours post vaccination at 12:30, experienced itchy eyes,  hives on eyelids, mild headache, muscle soreness and joint pain. The patient also reported that 48-96 hours after the vaccination, she had hives on eyelids, itchy eyes and joint pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 16Apr2021 at 04:30, the patient underwent body temperature test and the result was 100.6 (unspecified units). 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 event dizziness, nauseous, mild headache, sore arm, tired, fever, sweats, hives on eyelids, itchy eyes, muscle soreness and joint pain was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Urticaria
Clinical narrative: Hives on eyelids; Itchy eyes; Muscle soreness; Joint pain; Fever; Sweats; Mild headache; Sore arm; Tired; Dizziness; Nauseous; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 15Apr2021 at 12:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included Graves' disease. The patient previously took methocarbamol (MANUFACTURER UNKNOWN) and cyclobenzaprine (MANUFACTURER UNKNOWN) for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included citalopram (MANUFACTURER UNKNOWN), vitamin d nos (VITAMIN D) and selenium sulfide (SELENIUM); all taken from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 12:30, immediately after the vaccine, patient experienced dizziness and nauseous; 7 hours post vaccination at 19:30 experienced, mild headache, sore arm and tired. On 16Apr2021 at 04:30, 16 hours post vaccination, the patient experienced fever, sore arm, tiredness and sweats; 24 hours post vaccination at 12:30, experienced itchy eyes,  hives on eyelids, mild headache, muscle soreness and joint pain. The patient also reported that 48-96 hours after the vaccination, she had hives on eyelids, itchy eyes and joint pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 16Apr2021 at 04:30, the patient underwent body temperature test and the result was 100.6 (unspecified units). 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 event dizziness, nauseous, mild headache, sore arm, tired, fever, sweats, hives on eyelids, itchy eyes, muscle soreness and joint pain was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Myalgia, Pyrexia
Clinical narrative: Had a fever in 12 hours; temperature: 98F to 100F; Tiredness; Muscle pain; This is a spontaneous report from a non-contactable consumer. A 30-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration on 17Apr2021 at 11:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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 17Apr2021, the patient had a fever in 12 hours, temperature 98F to 100F, which lasted for 12 hours and was fully recovered after 36 hours. On an unknown date in Apr2021, the patient experienced tiredness and muscle pain. On 17Apr2021, the patient underwent body temperature and the result was 98 to 100 Fahrenheit. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever was resolved on an unknown date in Apr2021 (also reported duration of 36 hours) and for the events tiredness and muscle pain were resolved on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: Fever 103 degrees; Rigors; Severe body aches/Muscle pain; Severe body aches/Muscle pain; Fatigue; Nausea; Anorexia; Severe Headache; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 16Apr2021 at 15:00 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included autoimmune disease, fibromyalgia, migraines, paroxysmal atrial fibrillation, gastroesophageal reflux disease (GERD), hypercholesterolemia, anemia of chronic disease, cerebrovascular accident (CVA) and brain aneurysm. The patient had no known drug 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 medications included omeprazole (PRILOSEC), famotidine (PEPCID), aluminium hydroxide, magnesium hydroxide, simeticone (MYLANTA), progesterone (PROMETRIUM) and estradiol (MANUFACTURER UNKNOWN); all for an 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: ER8730) via an unspecified route of administration in the left arm on 24Mar2021 at 14:30 (at the age of 60-year-old), as a single dose for COVID-19 immunisation. On 17Apr2021 at 04:00, the patient experienced fever 103 degrees, rigors, chills, severe body aches/muscle pain, fatigue, nausea, anorexia and severe headache. 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 fever 103 degrees, rigors, chills, severe body aches/muscle pain, fatigue, nausea, anorexia and severe headache was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: Fever 103 degrees; Rigors; Severe body aches/Muscle pain; Severe body aches/Muscle pain; Fatigue; Nausea; Anorexia; Severe Headache; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 16Apr2021 at 15:00 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included autoimmune disease, fibromyalgia, migraines, paroxysmal atrial fibrillation, gastroesophageal reflux disease (GERD), hypercholesterolemia, anemia of chronic disease, cerebrovascular accident (CVA) and brain aneurysm. The patient had no known drug 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 medications included omeprazole (PRILOSEC), famotidine (PEPCID), aluminium hydroxide, magnesium hydroxide, simeticone (MYLANTA), progesterone (PROMETRIUM) and estradiol (MANUFACTURER UNKNOWN); all for an 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: ER8730) via an unspecified route of administration in the left arm on 24Mar2021 at 14:30 (at the age of 60-year-old), as a single dose for COVID-19 immunisation. On 17Apr2021 at 04:00, the patient experienced fever 103 degrees, rigors, chills, severe body aches/muscle pain, fatigue, nausea, anorexia and severe headache. 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 fever 103 degrees, rigors, chills, severe body aches/muscle pain, fatigue, nausea, anorexia and severe headache was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Intense hives occurred 5h post injection on scalp, arms, legs, neck, and most severely on the lower abdomen.; This is a spontaneous report from a contactable healthcare professional, the patient. A 41-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 right arm on 18Apr2021 at 12:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included allergic to deodorant, laundry detergents and had been exposed to PEG in lab environment. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 18Apr2021 at 17:00, 5 hours post injection, the patient experienced intense hives on scalp, arms, legs, neck and most severely on the lower abdomen and there was no injection site reaction nor any other side effects. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether therapeutic measures were 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 intense hives on scalp, arms, legs, neck, and most severely on the lower abdomen were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pyrexia, Sinus congestion
Clinical narrative: My entire body, other than my face, chest and tops of my feet felt like I had a sunburn when touched or clothes rubbed against my skin. There was no rash and my skin looked normal.; Chills; Fever; Nausea; Extreme sinus blockage; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 50-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 16Apr2021 at 16:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's thyroiditis, stage 2 kidney disease and high blood pressure. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN) and dicycloverine (DICYCLOMINE); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 23Mar2021 at 16:15 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Apr2021 at 12:00, the patient experienced her entire body, other than her face, chest and tops of her feet felt like she had a sunburn when touched or clothes rubbed against her skin. The patient reported that there was no rash and her skin looked normal. The patient also experienced chills, fever, nausea, extreme sinus blockage and fatigue. The events did not result in doctor or other health care 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 felt like she had a sunburn when touched or clothes rubbed against her skin, chills, fever, nausea, extreme sinus blockage and fatigue were resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Skin burning sensation
Clinical narrative: My entire body, other than my face, chest and tops of my feet felt like I had a sunburn when touched or clothes rubbed against my skin. There was no rash and my skin looked normal.; Chills; Fever; Nausea; Extreme sinus blockage; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 50-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 16Apr2021 at 16:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's thyroiditis, stage 2 kidney disease and high blood pressure. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN) and dicycloverine (DICYCLOMINE); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 23Mar2021 at 16:15 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Apr2021 at 12:00, the patient experienced her entire body, other than her face, chest and tops of her feet felt like she had a sunburn when touched or clothes rubbed against her skin. The patient reported that there was no rash and her skin looked normal. The patient also experienced chills, fever, nausea, extreme sinus blockage and fatigue. The events did not result in doctor or other health care 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 felt like she had a sunburn when touched or clothes rubbed against her skin, chills, fever, nausea, extreme sinus blockage and fatigue were resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Nausea, Vomiting
Clinical narrative: Severe nausea; Vomiting; Diarrhea; Chills; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 17Apr2021 at 15:30 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. The patient had known allergy to nuts. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Apr2021, the patient experienced severe nausea and vomiting and diarrhea starting at 09:00, and on the same day the patient also experienced chills. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe nausea, vomiting, diarrhea and chills was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.