chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: hives over my entire body; itching on the trunk of my body that spread to the entire body by that evening.; This is a spontaneous report from a contactable consumer (patient).   A 37-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in arm left on 15Apr2021 15:00 (at the age of 37-year-old) (Batch/Lot Number: EW0158) as dose number unknown, single for COVID-19 immunisation. Medical history included none. No known allergies. The patient's concomitant medications were not reported. No other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced itching on the trunk of my body that spread to the entire body by that evening (medically significant) on 19Apr2021 06:30 with outcome of not recovered, hives over my entire body (medically significant) on 20Apr2021 with outcome of not recovered. Events resulted in Doctor or other healthcare professional office/clinic visit. The clinical course of events was as follows: On Monday 19Apr2021 patient started out with itching on the trunk of his body that spread to the entire body by that evening. He went to the doctor on that day and was told to take an antihistamine Benedryl. The next day as this continued he developed hives over his entire body. After dealing with them for a day he sought medical attention again and was given a steroid shot to counteract the reaction. He was beginning to feel a little better but have a lot of recovery left. COVID was not tested post vaccination.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Vaccination site urticaria
Clinical narrative: Large, red, hot hive around the injection site; Redness spreading to other parts of upper arm; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 17Apr2021 at 15:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to sulfa drugs and COVID-19 (Prior to the vaccination, the patient was diagnosed with COVID-19). Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 27Mar2021 at 15:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient previously also received sulfamethoxazole/trimethoprim (BACTRIM), cefaclor (CECLOR) and amoxicillin sodium (AMOXCIL), for unknown indication from an unknown date and experienced drug allergy. On 18Apr2021 at 12:00, the patient experienced large, red, hot hive around the injection site, with redness spreading to other parts of upper arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/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 large, red, hot hive around the injection site and redness spreading to other parts of upper arm was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin lesion
Clinical narrative: Day 12 I also got a rash on my stomach in one area &some spots on my legs.; 10 days after shot "I" developed a rash on the inside of "my" left forearm. Day 11 it spread further up my arm and also on my right arm. Day 12 "I" also got a rash on my stomach in one area and some spots on "my" legs; This is a spontaneous report from a non-contactable consumer, the patient. A 35-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 07Apr2021 at 10:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome and known allergies to latex and wool. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT) and omeprazole (PRILOSEC); both 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 17Apr2021 at 20:00, 10 days after shot, the patient experienced a rash on the inside of left forearm. On 18Apr2021, on day 11, the rash spread further up her arm and also on her right arm. On 19Apr2021, on day 12, the patient also got a rash on her stomach in one area and some spots on her legs. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any 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 rash on the inside of left forearm, on day 11 it spread further up her arm and also on her right arm, on day 12 she also got a rash on her stomach in one area and some spots on her legs were resolving 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: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Back pain, Chills, Fatigue
Clinical narrative: Left arm muscle pain; Chills; Fever; Weakness; Fatigue; Joint pain in left knee; Headache; Neck and upper back ache; Neck and upper back ache; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: L:er8734E:7/21) via an unspecified route of administration in the left arm on 20Apr2021 at 16:15 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient has no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included escitalopram oxalate (LEXAPRO) and vitamins; for unknown indications, from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: L:er8735E:7/21) via an unspecified route of administration in the left arm on an unknown date in Mar2021 at 16:15 as a single dose for COVID-19 immunisation. On 21Apr2021 at 04:00, the patient experienced left arm muscle pain, weakness, chills, fever, fatigue, joint pain in left knee, headache, neck and upper back ache. 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 left arm muscle pain, weakness, chills, fever, fatigue, joint pain in left knee, headache, neck and upper back ache was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Neck pain, Pyrexia
Clinical narrative: Left arm muscle pain; Chills; Fever; Weakness; Fatigue; Joint pain in left knee; Headache; Neck and upper back ache; Neck and upper back ache; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: L:er8734E:7/21) via an unspecified route of administration in the left arm on 20Apr2021 at 16:15 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient has no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included escitalopram oxalate (LEXAPRO) and vitamins; for unknown indications, from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: L:er8735E:7/21) via an unspecified route of administration in the left arm on an unknown date in Mar2021 at 16:15 as a single dose for COVID-19 immunisation. On 21Apr2021 at 04:00, the patient experienced left arm muscle pain, weakness, chills, fever, fatigue, joint pain in left knee, headache, neck and upper back ache. 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 left arm muscle pain, weakness, chills, fever, fatigue, joint pain in left knee, headache, neck and upper back ache was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Swelling
Clinical narrative: 1.5 inch in diameter, round swelling; 1.5 inch in diameter, round swelling and, itching and sore to touch (slightly forward); 1.5 inch in diameter, round swelling and, itching and sore to touch (slightly forward); This is a spontaneous report from a contactable consumer, the patient. A 65-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 19Apr2021 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included mild hypertension (HTN). It was unknown whether the patient had any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included lisinopril (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), valaciclovir (VALACYCLOVIR) and acetylsalicylic acid (ASPIRIN); all from unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Apr2021 at 21:00, the patient experienced a 1.5 inch in diameter, round swelling and, itching and sore to touch (slightly forward). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events a 1.5 inch in diameter, round swelling and, itching and sore to touch (slightly forward) was unknown 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: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Headache, Pain, Urticaria
Clinical narrative: Headache; Facial redness; Hives; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 21Apr2021 at 13:15 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included lumbar radiculopathy and known allergies to sulfa and food- onions. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included bupropion (MANUFACTURER UNKNOWN), oxybutynin (MANUFACTURER UNKNOWN), biotin (MANUFACTURER UNKNOWN), naproxen sodium (NAPROXEN) and ammonium chloride, diphenhydramine hydrochloride, menthol, sodium citrate (BENADRYL); all for unknown indications, since unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Apr2021 at 13:15, the patient experienced headache, facial redness, hives and body aches. The events did not result in 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. Therapeutic measures were not taken for the reported events. The clinical outcome of the event headache, facial redness, hives and body aches was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: After receiving my second dose I had severe body chills in the middle of the night between 1am - 3am.; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the left arm on 20Apr2021 at 09:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the left arm on 31Mar2021 at 09:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation and experienced no adverse events. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Apr2021 at 01:00, after receiving the second dose, the patient experienced severe body chills in the middle of the night between 01:00 - 03:00. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe body chills in the middle of the night between 01:00 -03:00 was resolved on 21Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Headache, Pain in extremity, Rash
Clinical narrative: Soreness in arm; Headache; Backache; Stomachache; Rash; This is a spontaneous report from a contactable consumer. A 58-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 17Apr2021 at 11:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included transverse myelitis. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 24Mar2021 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. On 18Apr2021, the patient experienced soreness in arm, headache, backache, stomachache and rash. 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 soreness in arm, headache, backache, stomachache and rash was resolving at the time of the report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Body temperature, Fatigue, Headache
Clinical narrative: Fatigue; Headache; Fever 100.2F; Nausea; Stomachache; Abdominal pain; Cramps on arm, leg and back left side; Running nose; Sore throat; Thirsty; Finger ache, like arthritis symptoms mostly left side.; Body ache; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the arm left on 19Apr2021 at 13:00(at the age of 45-years-old) as a single dose for COVID-19 immunisation. The medical history included asthma and allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications were not reported. On 19Apr2021 at 19:30, the patient experienced fatigue, headache, fever 100.2 F, nausea, stomachache, abdominal pain close to ovaries location, cramps on arm, leg and back left side, running nose, sore throat, thirsty, finger ache like arthritis symptoms mostly left side and body ache. On 19Apr2021, the patient underwent body temperature test and the result was found to be 100.2 Fahrenheit. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, headache, fever 100.2 F, nausea, stomachache, abdominal pain, cramps on arm, leg and back left side, running nose, sore throat, thirsty, finger ache like arthritis and body ache were recovering at the time of this report.    No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Nausea, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: Fatigue; Headache; Fever 100.2F; Nausea; Stomachache; Abdominal pain; Cramps on arm, leg and back left side; Running nose; Sore throat; Thirsty; Finger ache, like arthritis symptoms mostly left side.; Body ache; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the arm left on 19Apr2021 at 13:00(at the age of 45-years-old) as a single dose for COVID-19 immunisation. The medical history included asthma and allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications were not reported. On 19Apr2021 at 19:30, the patient experienced fatigue, headache, fever 100.2 F, nausea, stomachache, abdominal pain close to ovaries location, cramps on arm, leg and back left side, running nose, sore throat, thirsty, finger ache like arthritis symptoms mostly left side and body ache. On 19Apr2021, the patient underwent body temperature test and the result was found to be 100.2 Fahrenheit. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, headache, fever 100.2 F, nausea, stomachache, abdominal pain, cramps on arm, leg and back left side, running nose, sore throat, thirsty, finger ache like arthritis and body ache were recovering at the time of this report.    No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea, Thirst
Clinical narrative: Fatigue; Headache; Fever 100.2F; Nausea; Stomachache; Abdominal pain; Cramps on arm, leg and back left side; Running nose; Sore throat; Thirsty; Finger ache, like arthritis symptoms mostly left side.; Body ache; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the arm left on 19Apr2021 at 13:00(at the age of 45-years-old) as a single dose for COVID-19 immunisation. The medical history included asthma and allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications were not reported. On 19Apr2021 at 19:30, the patient experienced fatigue, headache, fever 100.2 F, nausea, stomachache, abdominal pain close to ovaries location, cramps on arm, leg and back left side, running nose, sore throat, thirsty, finger ache like arthritis symptoms mostly left side and body ache. On 19Apr2021, the patient underwent body temperature test and the result was found to be 100.2 Fahrenheit. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, headache, fever 100.2 F, nausea, stomachache, abdominal pain, cramps on arm, leg and back left side, running nose, sore throat, thirsty, finger ache like arthritis and body ache were recovering at the time of this report.    No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Periorbital oedema
Clinical narrative: Periorbital edema; Dose 1: 30Mar2021, Dose 2: 16Apr2021 (duration between the doses is 17 days); This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in left arm on 16Apr2021 at 17:15 (at the age of 50-years-old) as a single dose for COVID-19 immunisation (inappropriate schedule of vaccine administered). Medical history included tonsil cancer from which the patient was recovering. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included atorvastatin 40mg (MANUFACTURER UNKNOWN) taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in left arm on 30Mar2021 at 17:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. On 19Apr2021 at 16:00, the patient experienced periorbital edema. The event resulted in emergency room/department visit or urgent care. Therapeutic measures were taken as a result of the event which included treatment with methylprednisolone (MANUFACTURER UNKNOWN) 4mg. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event periorbital edema was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: developed a high fever. Day 10 high fever came back. Has been high for 6 days now. 102-104.5 F; This is a spontaneous report from a contactable consumer (patient).   A 57-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm left on 06Apr2021 13:30 (at the age of 57-year-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation, administered at Pharmacy or drug store.  Medical history included: dermatitis contact Known allergies: perfumed soaps and detergents, grasses tree pollen, Known allergies: Perfumed soaps and detergents, grasses tree pollen. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 16Mar2021 13:30 (at the age of 57-year-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. No other vaccine in four weeks. No other vaccine received on the same date. The patient experienced developed a high fever, day 10 high fever came back, has been high for 6 days now, 102-104.5 f (medically significant) on 17Apr2021 22:30 with outcome of not recovered. The clinical course of events was as follows: Day 2 after second dose, developed a high fever. Day 10 high fever came back. Has been high for 6 days now. 102-104.5 F. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received: IVs, Blood work performed in Apr2021 with unknown results, COVID was tested post vaccination: covid test type post vaccination: Nasal Swab, covid test name post vaccination: BiNax Now and PCR, covid test date: 12Apr2021, covid test result: Negative. COVID test date: 14Apr2021, covid test type post vaccination: Nasal Swab, covid test name post vaccination: BiNax Now, covid test result: Negative  The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Feeling hot, Hyperhidrosis, Pain
Clinical narrative: Chills; Extremely achy; Rash on leg that flared up again and burned; Rash on leg that flared up again and burned; Felt very feverish; Got very hot; Sweaty; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old 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 20Apr2021 at 17:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levonorgestrel (NORTREL) for birth control from unknown date and unknown if its ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 30Mar2021 at 17:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 21Apr2021 at 14:00, the patient experienced chills and couldn't get warm for about 4 hours. On 21Apr2021, the patient was extremely achy and had a rash on leg that hadn't bothered for several days and again had a flare up and burned. The patient finally was able to warm up but felt very feverish and then got very hot and sweaty. The patient felt much better by 20:00. 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, extremely achy, rash on leg that flared up again and burned, feverish, got very hot and sweaty was recovered on 21Apr2021 at 20:00.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: Chills; Extremely achy; Rash on leg that flared up again and burned; Rash on leg that flared up again and burned; Felt very feverish; Got very hot; Sweaty; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old 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 20Apr2021 at 17:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levonorgestrel (NORTREL) for birth control from unknown date and unknown if its ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 30Mar2021 at 17:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 21Apr2021 at 14:00, the patient experienced chills and couldn't get warm for about 4 hours. On 21Apr2021, the patient was extremely achy and had a rash on leg that hadn't bothered for several days and again had a flare up and burned. The patient finally was able to warm up but felt very feverish and then got very hot and sweaty. The patient felt much better by 20:00. 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, extremely achy, rash on leg that flared up again and burned, feverish, got very hot and sweaty was recovered on 21Apr2021 at 20:00.   No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Decreased appetite, Headache
Clinical narrative: chills; Body ache; Fever of 102; Severe headache; Joint pain; Loss of appetite; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 20Apr2021 at 10:30 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient had no  relevant medical history andknown 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. Concomitant medications included escitalopram oxalate (LEXAPRO), lamotrigine (LUPIN) and birth control medication; all from unknown dates for unknown indications and unknown if ongoing. On 21Apr2021 at 03:00, the patient experienced chills, body ache, fever of 102, severe headache, joint pain and loss of appetite.  On 21Apr2021,  the patient underwent body temperature test and the result was 102 (unspecified units). 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, chills, body ache, fever of 102, severe headache, joint pain and loss of appetite 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: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: chills; Body ache; Fever of 102; Severe headache; Joint pain; Loss of appetite; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 20Apr2021 at 10:30 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient had no  relevant medical history andknown 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. Concomitant medications included escitalopram oxalate (LEXAPRO), lamotrigine (LUPIN) and birth control medication; all from unknown dates for unknown indications and unknown if ongoing. On 21Apr2021 at 03:00, the patient experienced chills, body ache, fever of 102, severe headache, joint pain and loss of appetite.  On 21Apr2021,  the patient underwent body temperature test and the result was 102 (unspecified units). 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, chills, body ache, fever of 102, severe headache, joint pain and loss of appetite 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: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Severe headache; Nausea; Vomit; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 30Mar2021 at 18:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to shrimp. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any concomitant medications. On 21Apr2021 at 09:00, the patient experienced severe headache, nausea and vomit. 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 omeprazole (MANUFACTURER UNKNOWN) and ibuprofen (MANUFATURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe headache, nausea and vomit was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Insomnia, Nausea, Panic reaction
Clinical narrative: Shortness of breath; Sleeplessness; Nausea; Panicky feeling; Headache; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 17Apr2021 at 13:00 (at the age of 46-year-old), as a single dose for COVID-19 immunisation. Medical history included reactive airway and high blood pressure. The patient was not aware of any allergies to food, medications or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and fluticasone propionate (FLOVENT); all for an unknown indication from unknown date and unknown if ongoing. On 18Apr2021, at 18:00, the patient experienced shortness of breath, sleeplessness, nausea, panicky feeling and 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 shortness of breath, sleeplessness, nausea, panicky feeling and headache was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Eye irritation, Eye pruritus, Eyelid margin crusting
Clinical narrative: Eyes itching, burning and mild crusting; Eyes itching, burning and mild crusting; Eyes itching, burning and mild crusting; This is a spontaneous report from a contactable other healthcare professional, the patient. A 39-year-old male 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 05Apr2021 at 16:45 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included herniated disc's, rheumatoid arthritis and known allergy to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medication. The patient did not take any concomitant medication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 05Apr2021 at 20:45, the patient experienced eyes itching, burning and mild crusting. No tests just in person diagnosis. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with eye lubricant and azelastine and also reported that azelastine was given for the mild crusting. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events eyes itching, burning and mild crusting was not resolved 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: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia, SARS-CoV-2 test
Clinical narrative: Two weeks after the 2nd dose, "I" had 4 days of low grade fever; Chills; Fatigue; Headache; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Apr2021 at 13:00 (at the age of 47-year-old), as a single dose for COVID-19 immunisation. Medical history included essential tremors and high blood pressure. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included propranolol (MANUFACTURER UNKNOWN), primidone (MANUFACTURER UNKNOWN) and hydrochlorothiazide (MANUFACTURER UNKNOWN); all for an unspecified indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Mar2021 at 13:00 (at the age of 47-year-old), as a single dose for COVID-19 immunisation. On an unknown date in Apr2021, two weeks after the second dose, the patient had 4 days of low-grade fever, chills, fatigue and headache. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination patient had been tested for COVID-19. On 15Apr2021, the patient underwent COVID-19 test via nasal swab and tested negative. The clinical outcome of the events low-grade fever, chills, fatigue and headache was resolved on an unknown date in Apr2021, after the duration of 4 days.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dyspnoea, Fatigue, Headache
Clinical narrative: Strong headache; Chills; Diarrhea; Vomiting; Muscle aches; Extremely tired; Some mild difficulty breathing; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 14Mar2021 at 09:30 (at the age of 63-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 07Apr2021 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included COPD (chronic obstructive pulmonary disease) and COVID-19 (Prior to the vaccination, the patient was diagnosed with COVID-19). The patient had no known allergies. Concomitant medications included phenylephrine (MANUFACTURER UNKNOWN), for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 14Mar2021 at 19:30, 10 hours after receiving injection, the patient experienced strong headache, chills, diarrhea, vomiting, muscle aches, extremely tired and some mild difficulty breathing. Lasted about 30 hours then all symptoms went away. The patient had same symptoms after his second shot but only lasted about 10 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/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 of headache, chills, diarrhea, vomiting, muscle aches, extremely tired and some mild difficulty breathing was recovered on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vomiting
Clinical narrative: Strong headache; Chills; Diarrhea; Vomiting; Muscle aches; Extremely tired; Some mild difficulty breathing; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 14Mar2021 at 09:30 (at the age of 63-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 07Apr2021 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included COPD (chronic obstructive pulmonary disease) and COVID-19 (Prior to the vaccination, the patient was diagnosed with COVID-19). The patient had no known allergies. Concomitant medications included phenylephrine (MANUFACTURER UNKNOWN), for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 14Mar2021 at 19:30, 10 hours after receiving injection, the patient experienced strong headache, chills, diarrhea, vomiting, muscle aches, extremely tired and some mild difficulty breathing. Lasted about 30 hours then all symptoms went away. The patient had same symptoms after his second shot but only lasted about 10 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/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 of headache, chills, diarrhea, vomiting, muscle aches, extremely tired and some mild difficulty breathing was recovered on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dyspnoea, Heart rate increased
Clinical narrative: Within minutes of vaccine I felt burning in back of through,  difficulty taking deep breathe, and rapid heart beat.; Within minutes of vaccine I felt burning in back of through,  difficulty taking deep breathe, and rapid heart beat; Within minutes of vaccine I felt burning in back of through,  difficulty taking deep breathe, and rapid heart beat; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 21Apr2021 at 09:45 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), paracetamol (TYLENOL), ibuprofen (ADVIL) and estradiol (ESTROGEN) taken 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: EP7533) via an unspecified route of administration in the left arm on 21Apr2021 at 09:45 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On 21Apr2021, within minutes of vaccine, the patient experienced burning in back of through, difficulty taking deep breath, and rapid heartbeat. The events did not result in a visit to the doctors or other healthcare professional office/clinic, 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 within minutes of vaccine the patient felt burning in back of through, difficulty taking deep breathe, and rapid heartbeat was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Biopsy bone marrow, Dizziness, Haemoglobin, Haemoglobin decreased, Headache
Clinical narrative: Hgb low; Woozy; Headache; This is a spontaneous report from a contactable consumer (Patient). An 87-year-old male patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration in Feb2021 as dose 2, single for covid-19 immunization. Patient received ruxolitinib phosphate (JAKAFI), oral from 18Oct2019 (Batch/Lot number was not reported) and ongoing, at 10 mg, 2x/day for myelofibrosis. Medical history included ongoing essential thrombocythemia. Concomitant medications included furosemide (LASIX [FUROSEMIDE]), levothyroxine sodium (SYNTHROID), cyclosporine (CYCLOSPORINE) taken for an unspecified indication, start and stop date were not reported. The patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. On an unspecified date in 2021, the patient experienced Hgb low, woozy and headache. The patient underwent lab tests and procedures which included biopsy bone marrow result was unknown and haemoglobin was low on an unspecified date. The clinical outcome of the event Hgb low was not recovered and events woozy and headache was recovered in unspecified date in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.