chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vomiting
Clinical narrative: "I" had a severe headache this morning and it woke "me" up.; And "I" vomited 30 minutes after "I" woke up even though "I" didnt eat anything.; This is a spontaneous report from a contactable nurse. A 22-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 arm left on 14Apr2021 at 15:15(at the age of 22-years-old) as a single dose for COVID-19 immunisation. The patient had no 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 four weeks prior to the vaccination. The patient received birth control pill (unspecified) every day within two weeks of vaccination. The patient previously received first dose BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 18Apr2021 at 06:30, in the morning the patient had severe headache and it woke her up. The patient vomited 30 minutes after she woke up, even though she did not eat anything. The patient asked that are these also the side effects of the vaccine. Therapeutic measures were not taken as a result of the reported events. The adverse events did not result in a visit to the doctors 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. The clinical outcome of the events severe headache and vomited 30 minutes after was recovering 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.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: A day after the vaccination I started itching a little bit in random areas.; Then 72 hours small bumps have been popping up that seem like hives or bug bites.; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EWO162) via an unspecified route of administration in the left arm on 08Apr2021 at 17:00 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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 patient did not receive any other medications in two weeks of vaccination. On 09Apr2021 at 15:00, a day after the vaccination, the patient started experiencing itching a little bit in random areas. Then seventy two hours, small bumps had been popped up that seemed like hives or bug bites. However, the patient had them at random areas of his body. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. No therapeutic measures were  taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of events itching and small bumps like hives were not recovered at this time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chapped lips, Hypersensitivity, Lip haemorrhage, Lip swelling, Mouth swelling
Clinical narrative: Lower mouth gums to cheeks began to swell on both sides; Lip began to swell and cracked and bled; Lip began to swell and cracked and bled; Lip began to swell and cracked and bled; lip swelled like an allergic reaction; This is a spontaneous report from a contactable consumer. A 58-year-old female patient (non pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for Injection; (Batch/Lot Number: ER8731; Expiry date: 31Jul2021), intramuscularly, in left arm on 14Apr2021 at 10:30, as DOSE 1, SINGLE for covid-19 immunization (age at vaccination: 58-years-old). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The patient was allergic to Unpasteurized eggs. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (Batch/Lot Number: EW0165), intramuscularly, in left arm on 06May2021 1:00, as DOSE 2, SINGLE for covid-19 immunization. The patient's concomitant medication was not reported. On 15Apr2021 at 12:00, the patient developed swollen lips and Lips swelled like an allergic reaction. On 16Apr2021 at 05:00, after 2 days of the vaccination the patient's lip began to swell and cracked and bled. On 17Apr2021, 3 days after vaccination her lower mouth gums to cheeks began to swell on both sides. Lips swelled like an allergic reaction and remained swollen for 3 months. Therapeutic measures were taken as a result for the events. The patient received antihistamine treatment for the events. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pain, Pyrexia
Clinical narrative: Low grade fever; Body ache; Chills; Muscle soreness; Extreme tiredness; This is a spontaneous report from a contactable healthcare professional, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 16Apr2021 at 09:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 26Mar2021 at 09:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 15:00, 6 hours after the vaccination, the patient experienced extreme tiredness. On 17Apr2021, 18 hours after the vaccination, the patient experienced low grade fever, body ache, chills and muscle soreness. 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 extreme tiredness, low grade fever, body ache, chills and muscle soreness was resolving 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: Rash, Rash pruritic
Clinical narrative: Sudden spreading rash; small itchy bumps, up vaccine arm and hands.; This is a spontaneous report from a contactable consumer, the patient. A 25-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 14:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included GERD (reported as recovered). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Apr2021 at 00:30, the patient experienced sudden spreading rash, small itchy bumps, up vaccine arm and hands.  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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sudden spreading rash and small itchy bumps, up vaccine arm and hands was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Feeling hot, Nausea, Pain
Clinical narrative: Tightness to breath without any sign of cough; Pain; My skin was very hot but I did not run a fever; I became very nauseous; Chills; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on the left arm on 07Apr2021 at 12:30 (at the age of 56-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 concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration on the left arm on 17Mar2021 at 13:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. On 15Apr2021 at 20:00, the patient was very nauseous and experienced chills one week after the shot. He also experienced pain, tightness to breath without any sign of cough and skin was very hot. His skin was very hot but he did not run a fever. The chills were awful and he never lost his taste or smell. The events did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. No 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 very nauseous, chills, pain, tightness to breath without any sign of cough and skin was very hot 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.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash macular
Clinical narrative: skin problems for 2 months.  Red spots and itches on both arms and legs..; itches on both arms and legs.   I am taking Bernadryl everyday to ease the itches but i still have itches and reddish skins; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266) via an unspecified route of administration in the left arm on 14Feb2021 at 00:00(at the age of 77-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to apple(fruit allergy) and other fruits. 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 levothyroxine sodium (MANUFACTURER UNKNOWN) from an unknown date for unknown indication and unknown if ongoing. On 27Feb2021, the patient experienced red spots and itches on both arms and legs and the patient reported that he has skin problems for two months, she was taking benadryl everyday to ease the itches but still had itches and reddish skins. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with benadryl(MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events red spots and itches on both arms and legs was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fall, Feeling hot, Limb discomfort, Malaise
Clinical narrative: If I lay down at night it pain on the left shoulder; Arm was hurting a lot and was hot; feeling really bad; She would fall back on the couch or whatever; Whole lot of pain in my left arm; it's just so sore that I can't lift it up, place close; Whole lot of pain in my left arm; it's just so sore that I can't lift it up, place close; This is a spontaneous report from a contactable consumer or other non hcp.    A 63-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 30Mar2021 (Batch/Lot Number: ER8732; Expiration Date: 31Jul2021) as 2nd dose, single for covid-19 immunisation. Medical history included hypertension, blood cholesterol, depression, thyroid disorder, seasonal allergy. Concomitant medication(s) included clonidine hydrochloride (CLONIDINE HCL) taken for hypertension; amlodipine (AMLODIPINE) taken for hypertension; atorvastatin (ATORVASTATIN) taken for blood cholesterol; doxepin (DOXEPIN) taken for depression, anxiety; ezetimibe (EZETIMIBE) taken for blood cholesterol; gabapentin (GABAPENTIN) taken for depression, anxiety; lamotrigine (LAMOTRIGINE) taken for depressed mood; levothyroxine (LEVOTHYROXINE) taken for thyroid disorder; hydrochlorothiazide, lisinopril (LISINOPRIL/HYDROCHLOROTHIAZIDE) taken for hypertension; montelukast (MONTELUKAST) taken for seasonal allergy; quetiapine (QUETIAPINE) taken for depression; sertraline (SERTRALINE) taken for depression; metoprolol (METOPROLOL) taken for hypertension.  It was Reported that, The patient experienced whole lot of pain in my left arm; it's just so sore that can't lift it up, place close on 30Mar2021 with outcome of not recovered, if  lay down at night it pain on the left shoulder on an unspecified date with outcome of unknown, arm was hurting a lot and was hot on an unspecified date with outcome of unknown , feeling really bad on an unspecified date with outcome of unknown , she would fall back on the couch or whatever on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of whole lot of pain in my left arm; it's just so sore that i can't lift it up, place close (limb discomfort), if i lay down at night it pains on the left shoulder (arthralgia).  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: If I lay down at night it pain on the left shoulder; Arm was hurting a lot and was hot; feeling really bad; She would fall back on the couch or whatever; Whole lot of pain in my left arm; it's just so sore that I can't lift it up, place close; Whole lot of pain in my left arm; it's just so sore that I can't lift it up, place close; This is a spontaneous report from a contactable consumer or other non hcp.    A 63-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 30Mar2021 (Batch/Lot Number: ER8732; Expiration Date: 31Jul2021) as 2nd dose, single for covid-19 immunisation. Medical history included hypertension, blood cholesterol, depression, thyroid disorder, seasonal allergy. Concomitant medication(s) included clonidine hydrochloride (CLONIDINE HCL) taken for hypertension; amlodipine (AMLODIPINE) taken for hypertension; atorvastatin (ATORVASTATIN) taken for blood cholesterol; doxepin (DOXEPIN) taken for depression, anxiety; ezetimibe (EZETIMIBE) taken for blood cholesterol; gabapentin (GABAPENTIN) taken for depression, anxiety; lamotrigine (LAMOTRIGINE) taken for depressed mood; levothyroxine (LEVOTHYROXINE) taken for thyroid disorder; hydrochlorothiazide, lisinopril (LISINOPRIL/HYDROCHLOROTHIAZIDE) taken for hypertension; montelukast (MONTELUKAST) taken for seasonal allergy; quetiapine (QUETIAPINE) taken for depression; sertraline (SERTRALINE) taken for depression; metoprolol (METOPROLOL) taken for hypertension.  It was Reported that, The patient experienced whole lot of pain in my left arm; it's just so sore that can't lift it up, place close on 30Mar2021 with outcome of not recovered, if  lay down at night it pain on the left shoulder on an unspecified date with outcome of unknown, arm was hurting a lot and was hot on an unspecified date with outcome of unknown , feeling really bad on an unspecified date with outcome of unknown , she would fall back on the couch or whatever on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of whole lot of pain in my left arm; it's just so sore that i can't lift it up, place close (limb discomfort), if i lay down at night it pains on the left shoulder (arthralgia).  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Menstrual disorder
Clinical narrative: I started my period after receiving the vaccine and it has last for two weeks now and is not stopping. My period is never irregular; My cramps are bad as well; This is a spontaneous report from a contactable consumer (patient). A 34-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: ER8732) via an unspecified route of administration on 07Apr2021 at 10:45 (at the age of 34 years old) in left arm as dose 1, single for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. No known allergies were reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had not received any other vaccine within 4 weeks or any other medication within 2 weeks. The patient had her period cycle a week before the vaccine and it was normal. Then on 08Apr2021 at 10:00, she started with period after receiving the vaccine and it had last for two weeks and was not stopping. Her period was never irregular. Her cramps were bad as well which was not for her menstrual cycle. Patient did not receive any treatment for the events. The outcome of both the events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Hypersensitivity, Ocular hyperaemia, Periorbital swelling
Clinical narrative: right eyelid puffy, itchy, red - comes and goes; right eyelid puffy, itchy, red - comes and goes; right eyelid puffy, itchy, red - comes and goes; Thought it was allergic reaction to makeup but it's only on the one eye and it comes and goes; This is a spontaneous report from a contactable consumer or other non hcp. A 47-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 02Mar2021 14:30 (Batch/Lot Number: EN-9809) as dose 1, single and received second dose via an unspecified route of administration, administered in Arm Left on 23Mar2021 14:30 (Batch/Lot Number: EN-6208) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included bupropion hydrochloride (WELLBUTRIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The patient did not receive any treatment for the adverse events. On Mar2021 the patient experienced right eyelid puffy, itchy, red - comes and goes and thought it was allergic reaction to makeup but its only on the one eye and it comes and goes. The outcome of all the events was unknown. No follow-up attempts are possible. No further information is expected.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: hives; This is a spontaneous report from a contactable consumer (patient herself). A 68-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), via an unspecified route of administration in her upper arm on an unspecified date (doesn't recall the date, either end of March or beginning of April, Batch/Lot number was not reported) as a single dose for immunization. Medical history included high blood pressure and takes half a pill. Concomitant medications also included vitamins. It was reported that the patient had a reaction to PREVNAR 13 years ago and was considering the Pfizer COVID 19 vaccine. She wanted to know any similar ingredients. She had the Pfizer PREVNAR 13 pneumonia booster years ago on an unspecified date and 2-3 weeks after the vaccine she got hives for 2 months. It wouldn't go away and they were just in the low extremity, stomach and upper legs and her behind and nowhere else. She went to a couple of different doctors and a dermatologist and one didn't think it was hives and one said it was and gave her some medicine to take and put on it and it helped taking it away, it was hives. It was the last booster she got and they wanted her to get a booster for tetanus and she said "I don't think so." She had no idea what was in the PREVNAR 13 that might also be in the COVID vaccine. Patient asked if she can speak to someone to help her make a decision, she doesn't want to get it and get a reaction. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Flushing, Headache, Pruritus
Clinical narrative: Feeling of skin being "itchy" from the inside; Flushing of skin all over body but no rash; Chills; Headache; This is a spontaneous report received from a contactable other healthcare professional (patient). A 44-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/lot number: Not Reported, Expiry Date: Not Reported), via an unspecified route of administration, administered in Arm Left on 22Apr2021 (at the age of 44-year-old) at 09:15 as dose 1, single for COVID-19 immunisation at Clinic/facility. The patient was not pregnant at the time of vaccination. The patient medical history included systemic lupus erythematosus, nephritis, raynaud's phenomenon, psoriasis, psoriatic arthritis, type 2 diabetes mellitus. The patient concomitant medication(s) included bupropion hydrochloride (WELLBUTRIN), naltrexone (NALTREXONE), Plaquenil, and Effexor XR taken for an unspecified indication, start and stop date were not reported. The patient received this medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient previously took sulfonamide and experienced drug hypersensitivity (known allergies Sulfa based medications). On 22Apr2021 at 10:30, the patient experienced, feeling of skin being itchy from the inside, flushing of skin all over body but no rash, chills, and headache. The patient did not receive any treatment for the reported events. Outcome of the event was not recovered.   No follow-up attempts are needed. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary mass, Axillary pain, Musculoskeletal discomfort
Clinical narrative: when I touch I had a little bump on my arm pit; I was having pain on my shoulder, on my arm pit; I was having pain on my shoulder, on my arm pit.; But later a week I had a little thing on my neck on my shoulder.; This is a spontaneous report from a contactable consumer or other non healthcare professional (patient).      A 39-years-old female received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0153) via an unspecified route of administration administered in Arm Left on 12Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced when I touch, I had a little bump on my arm pit, I was having pain on my shoulder, on my arm pit, but later a week I had a little thing on my neck on my shoulder on an unspecified date. It was reported that, a week after vaccination, patient had a little thing on neck and shoulder. The patient was having pain on shoulder and arm pit. It was reported that the patient had when touched had a little bump on arm pit. The patient was a little worried because, she was scheduled for a mammography and was also scheduled for second dose of vaccination on 02May2021. Patient wanted to know, how long was it going to stay there and how long the bump was to appear on the arm pit, (did not have any pain there). Arm pit next to breast, so was little worried. Therapeutic measures taken as a result of the events included Advil. The outcome of the events was unknown.  No follow up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain
Clinical narrative: same pain on neck and shoulder; same pain on neck and shoulder; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced same pain on neck and shoulder. The outcome of the events was unknown.    No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Feeling hot, Ocular hyperaemia, Rash, Rash erythematous
Clinical narrative: Woke up with a one-sided facial rash (right side); one-sided facial rash (right side) redness; one-sided facial rash (right side) warmth; one-sided facial rash (right side) was blotchy; Left eye was red near the water line; My left eye had mild swelling.; Red bumps that were itchy on right arm; Red bumps that were itchy on my right arm.; This is a spontaneous report from a contactable nurse, the patient. A 24-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 09Apr2021 at 09:45 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included increased skin sensitivity, hives (frequently got hives, do not know source) and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. It was unknown if patient was pregnant at the time of vaccination. Concomitant medications included amphetamine sulfate (MANUFACTURER UNKNOWN), escitalopram oxalate (LEXAPRO) and buspirone (MANUFACTURER UNKNOWN); all taken for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) and experienced drug allergy. On 11Apr2021 at 09:45, the patient woke up with a one-sided facial rash (right side), redness, warmth, and was blotchy. Her left eye was red near the water line and had mild swelling. The patient also had red bumps that were itchy on her right arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No 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 events one-sided facial rash (right side), redness, warmth, was blotchy, the left eye was red near the water line and had mild swelling and red bumps that were itchy on right arm was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Rash papular, Rash pruritic
Clinical narrative: Woke up with a one-sided facial rash (right side); one-sided facial rash (right side) redness; one-sided facial rash (right side) warmth; one-sided facial rash (right side) was blotchy; Left eye was red near the water line; My left eye had mild swelling.; Red bumps that were itchy on right arm; Red bumps that were itchy on my right arm.; This is a spontaneous report from a contactable nurse, the patient. A 24-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 09Apr2021 at 09:45 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included increased skin sensitivity, hives (frequently got hives, do not know source) and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. It was unknown if patient was pregnant at the time of vaccination. Concomitant medications included amphetamine sulfate (MANUFACTURER UNKNOWN), escitalopram oxalate (LEXAPRO) and buspirone (MANUFACTURER UNKNOWN); all taken for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) and experienced drug allergy. On 11Apr2021 at 09:45, the patient woke up with a one-sided facial rash (right side), redness, warmth, and was blotchy. Her left eye was red near the water line and had mild swelling. The patient also had red bumps that were itchy on her right arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No 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 events one-sided facial rash (right side), redness, warmth, was blotchy, the left eye was red near the water line and had mild swelling and red bumps that were itchy on right arm was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: This is a spontaneous report from contactable consumer or other non-HCP. A 38-year-old (non-pregnant) female received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), at the vaccination age of 38, via an unspecified route of administration on Apr 1, 2021, at 11:00, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient has not tested for COVID-19. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. No medications received within 2 weeks of vaccination. On Apr 2, 2021, patient experienced excessive nose bleeds; with outcome of recovered on an unspecified date in Apr 2021. No follow-up attempts needed. Information about lot/batch number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Headache, Hypersensitivity
Clinical narrative: acute vesiculobullous eczema appeared on both hands and left foot; headache; allergy reactions appeared on both of my thighs and legs; This is a spontaneous report from a contactable consumer. This 32-year-old female consumer (patient) reported for herself that.  A 32-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0161), dose 2 via an unspecified route of administration, administered in Arm Left on 16Apr2021 12:45 as (At the age of 32-years) dose 2, single for covid-19 immunisation. Medical history included, Known allergies: quinolone antibiotic (probably). There were no concomitant medications. Patient was not pregnant at the time of vaccination. No other vaccine in four weeks. No Other medications in two weeks. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 26Mar2021 11:00 Am as (At the age of 32-years) dose 1, single for covid-19 immunisation. The patient experienced acute vesiculobullous eczema appeared on both hands and left foot, headache, and allergy reactions appeared on both of my thighs and legs on 20Apr2021 10:00. It was reported that patient had headache until 48hours after she got his 2nd dose. After 72hours, allergy reactions appeared on both of his thighs and legs. Also, acute vesiculobullous eczema appeared on both hands and left foot. It has been 3 days and is not getting better. Patient did not receive any treatment for events. The outcome of event was not recovered at the time of report.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: sore arm.; This is a spontaneous report from a contactable consumer (patient).  An elderly male patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date (around 2013-2014) (Batch/Lot number was not reported) as dose number unknown, single for an immunization.  Medical history included Low thyroid and possible atrial fibrillation. Concomitant medications included levothyroxine (LEVOTHYROXINE); ascorbic acid, biotin, boron, calcium, chromium, copper, folic acid, ginseng nos, iodine, magnesium, manganese, menadione, molybdenum, nicotinic acid, pantothenic acid, phosphorus, potassium, potassium chloride, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon, thiamine, tocopherol, vitamin b12 nos, vitamin d nos, xantofyl, zinc (MATURE MULTIVITAMINS); ascorbic acid, rosa canina fruit (VITAMIN C & ROSEHIP); chondroitin sulfate sodium, glucosamine hydrochloride (GLUCOSAMINE/CHONDROITIN); vitamin d3 (VITAMIN D3); and acetylsalicylic acid (ASPIRIN (E.C.)) all taken for an unspecified indications and therapy dates. The patient previously received his tetanus and diphtheria booster in 2007 at the age of 63-years-old that caused a sore arm.  Then, he had shingles vaccine in 2012 at the age of 68-years-old and also caused a sore arm. The patient then had his pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) also reported as PREVNAR-23 vaccine in 2013 or 2014 and caused a sore arm. Outcome of the event was unknown.   No follow-up attempts are needed, information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Sore arm at the injection; Body aches (widespread); Low-grade fever (100.3); Headache; This is a spontaneous report from a contactable consumer or other non Health care professional (Patient). A 39-year-old non pregnant old female patient received bnt162b2 (BNT162B2 Formulation; solution for injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 21Apr2021 at 14:00 as DOSE NUMBER UNKNOWN, SINGLE (at the age of 39-year-old) for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered. The patient was not pregnant at the time of vaccination. Medical history included prolonged complex migraine, fibromyalgia, generalized anxiety and Allergies to medications, food, or other products (Allergies to medications, food, or other products: Doxycycline, Celebrex)-all from an unknown date and unknown if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications (other medications the patient received within 2 weeks of vaccination) included sertraline hcl, bupropion hydrochloride, naltrexone hydrochloride (CONTRAVE), nortriptyline and nabumetone; all taken for an unspecified indication, start and stop date were not reported. The patient previously took celebrex and doxycycline and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Apr2021 at 20:00, the patient experienced sore arm at the injection site, body aches (widespread), low-grade fever (100.3) and headache. All side effects gone 30 hrs post vaccination. Since the vaccination, the patient had not tested for covid-19. No treatment received for the events. The outcome of event reported as recovered on unknown date of Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Lymphadenopathy
Clinical narrative: Extreme fatigue; Severe swelling of left arm pit lymph nodes; Headaches; Joint pain in shoulders, knees and neck; Dizziness; Extreme fatigue, severe swelling of left arm pit lymph nodes, minor swelling of right arm out lymph nodes, headaches, joint pain in shoulders, knees and neck, dizziness,; This is a spontaneous report from a contactable consumer or other non healthcare professional.  A 47 year old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 19Apr2021 15:30 (Batch/Lot Number: Er8731) as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine included bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 31Mar2021 5:45 (Batch/Lot Number: Ep6955 ) as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included diabetes mellitus from an unknown date and unknown if ongoing , pain from an unknown date and unknown if ongoing , hypertension from an unknown date and unknown if ongoing , blood cholesterol increased from an unknown date and unknown if ongoing , sleep apnoea syndrome from an unknown date and unknown if ongoing , depression from an unknown date and unknown if ongoing. Concomitant medication(s) included gabapentin (GABAPENTIN) taken for an unspecified indication, start and stop date were not reported; metformin hcl (METFORMIN HCL) taken for an unspecified indication, start and stop date were not reported; pravastatin (PRAVASTATIN) taken for an unspecified indication, start and stop date were not reported; ramipril (RAMIPRIL) taken for an unspecified indication, start and stop date were not reported.  The patient experienced extreme fatigue on 20Apr2021 18:30 with outcome of not recovered , severe swelling of left arm pit lymph nodes causing lymphadenopathy on 20Apr2021 18:30 with outcome of not recovered, headache on 20Apr2021 18:30 with outcome of not recovered , joint pain in shoulders, knees and neck causing arthralgia on 20Apr2021 18:30 with outcome of not recovered , dizziness on 20Apr2021 18:30 with outcome of not recovered, extreme fatigue, severe swelling of left arm pit lymph nodes, minor swelling of right arm out lymph nodes, headache, joint pain in shoulders, knees and neck, dizziness, and peripheral swelling on 20Apr2021 18:30 with outcome of not recovered.    No follow-up attempts are needed; No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Extreme fatigue; Severe swelling of left arm pit lymph nodes; Headaches; Joint pain in shoulders, knees and neck; Dizziness; Extreme fatigue, severe swelling of left arm pit lymph nodes, minor swelling of right arm out lymph nodes, headaches, joint pain in shoulders, knees and neck, dizziness,; This is a spontaneous report from a contactable consumer or other non healthcare professional.  A 47 year old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 19Apr2021 15:30 (Batch/Lot Number: Er8731) as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine included bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 31Mar2021 5:45 (Batch/Lot Number: Ep6955 ) as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included diabetes mellitus from an unknown date and unknown if ongoing , pain from an unknown date and unknown if ongoing , hypertension from an unknown date and unknown if ongoing , blood cholesterol increased from an unknown date and unknown if ongoing , sleep apnoea syndrome from an unknown date and unknown if ongoing , depression from an unknown date and unknown if ongoing. Concomitant medication(s) included gabapentin (GABAPENTIN) taken for an unspecified indication, start and stop date were not reported; metformin hcl (METFORMIN HCL) taken for an unspecified indication, start and stop date were not reported; pravastatin (PRAVASTATIN) taken for an unspecified indication, start and stop date were not reported; ramipril (RAMIPRIL) taken for an unspecified indication, start and stop date were not reported.  The patient experienced extreme fatigue on 20Apr2021 18:30 with outcome of not recovered , severe swelling of left arm pit lymph nodes causing lymphadenopathy on 20Apr2021 18:30 with outcome of not recovered, headache on 20Apr2021 18:30 with outcome of not recovered , joint pain in shoulders, knees and neck causing arthralgia on 20Apr2021 18:30 with outcome of not recovered , dizziness on 20Apr2021 18:30 with outcome of not recovered, extreme fatigue, severe swelling of left arm pit lymph nodes, minor swelling of right arm out lymph nodes, headache, joint pain in shoulders, knees and neck, dizziness, and peripheral swelling on 20Apr2021 18:30 with outcome of not recovered.    No follow-up attempts are needed; No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Low grade fever; fatigue; Low grade fever, fatigue, loss of appetite, nausea, achy body and two small shingles like rashes, and the sore arm, all from the first shot.; achy body; two small shingles like rashes; Loss of appetite; Headache; sore arm; Muscle Aches; This is a spontaneous report from a contactable consumer (patient). A 54-years-old female patient received first dose of bnt162b2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on 12Apr2021 at 12:00 (at the age of 54-years-old) as single dose for covid-19 immunisation. Medical history included autoimmune issues and covid-19. Patient had no known allergies. Concomitant medications included ibuprofen. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Apr2021, patient experienced low grade fever, muscle Aches, fatigue, loss of appetite, nausea, achy body and two small shingles like rashes, headache, and the sore arm, all from the first shot. Therapeutic measures were not taken due to the events. Since the vaccination, has the patient been tested for COVID-19. The outcome of all the events was recovering.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Rash
Clinical narrative: Low grade fever; fatigue; Low grade fever, fatigue, loss of appetite, nausea, achy body and two small shingles like rashes, and the sore arm, all from the first shot.; achy body; two small shingles like rashes; Loss of appetite; Headache; sore arm; Muscle Aches; This is a spontaneous report from a contactable consumer (patient). A 54-years-old female patient received first dose of bnt162b2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on 12Apr2021 at 12:00 (at the age of 54-years-old) as single dose for covid-19 immunisation. Medical history included autoimmune issues and covid-19. Patient had no known allergies. Concomitant medications included ibuprofen. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Apr2021, patient experienced low grade fever, muscle Aches, fatigue, loss of appetite, nausea, achy body and two small shingles like rashes, headache, and the sore arm, all from the first shot. Therapeutic measures were not taken due to the events. Since the vaccination, has the patient been tested for COVID-19. The outcome of all the events was recovering.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Haematuria, Pain, Sleep disorder
Clinical narrative: Experienced some pain in my left side; I passed a urinary clot like a blood clot; It could be a urinary tract infection; I just passed the blood clot; felt really bad like he had no energy and slept on and off for 10 hours; felt really bad like he had no energy and slept on and off for 10 hours; felt really bad like he had no energy and slept on and off for 10 hours; I passed a urinary clot like a blood clot; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 62-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Right shoulder on 15Apr2021 (at the age of 62 years) (Batch/Lot Number: EU00162) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included High Blood Pressure from 2010 to an unknown date. The Concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 on 20Mar2021 (at the age of 62 years) for covid-19 immunisation. Patient received the second dose of the Pfizer BioNTech Covid-19 vaccine on 15Apr2021, on 22Apr2021 he experienced pain in his left side and had no energy. This morning he passed a blood clot in his urine. He did not have any symptoms before, he was not sure if this is something that you have previously observed or heard maybe there is something in the past. He knew there are some issues with the vaccines like people were getting blood clots (further clarification unknown). Also, he was not sure if it was urinary clot, I was not sure if I was late, but it was just coincidental that it was after a week he got my shot. Patient stated, he guesses like he was in bed all day yesterday and today (not specified), he felt better but he just passed the blood clot, so he would say it was persisting. Stated, I was treating it now as a UTI infection until I find out otherwise, no such medications that he was taking. Stated yesterday, 22Apr2021, he experienced pain on his left side; felt really bad like he had no energy and slept on and off for 10 hours. He was reaching out to Pfizer to see if this has occurred with other people. The patient received the treatment for the event I passed a urinary clot like a blood clot. The clinical outcome of the event was unknown at the time of report.  No follow-up attempts are possible. No further information is expected.