chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Heart rate, Heart rate increased
Clinical narrative: Extreme fatigue; Low grade fever/Body temperature 103.9; Heart rate ranging between 120 to the 140; Chills; This is a spontaneous report from a contactable consumer, the parent. A 14-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 10Jun2021 at 15:30 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. Medical history included reactive airway in childhood. The patient had no known allergies. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration in the left arm on 20May2021 at 15:30 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 10Jun2021, the first night of vaccination, the patient experienced low grade fever and chills. On 11Jun2021, the second day after vaccination, the patient had a temperature of 103.9 with heart rate ranging between 120 to 140. On 12Jun2021, the third day after vaccination, the patient had no fever and palpitation but experienced extreme fatigue. On 13Jun2021, the fourth day, the patient had no symptoms. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever of 103.9 and heart rate ranging between 120 to 140 were resolved on 12Jun2021, while fatigue and chills were resolved on 13Jun2021.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Extreme fatigue; Low grade fever/Body temperature 103.9; Heart rate ranging between 120 to the 140; Chills; This is a spontaneous report from a contactable consumer, the parent. A 14-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 10Jun2021 at 15:30 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. Medical history included reactive airway in childhood. The patient had no known allergies. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration in the left arm on 20May2021 at 15:30 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 10Jun2021, the first night of vaccination, the patient experienced low grade fever and chills. On 11Jun2021, the second day after vaccination, the patient had a temperature of 103.9 with heart rate ranging between 120 to 140. On 12Jun2021, the third day after vaccination, the patient had no fever and palpitation but experienced extreme fatigue. On 13Jun2021, the fourth day, the patient had no symptoms. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever of 103.9 and heart rate ranging between 120 to 140 were resolved on 12Jun2021, while fatigue and chills were resolved on 13Jun2021.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Decreased appetite, Fatigue, Headache
Clinical narrative: she is tired; having nausea; weak; Headache; shoulder pain; body ache; neck pain; She received the vaccine on her left arm and felt some pain; a loss of appetite; wanting to throw up; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), first dose via an unspecified route of administration on left arm on 17Jun2021 (Thursday) single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On unspecified date of 2021 the patient was tired, having nausea, weak, and had headaches. She was just wondering what is going on, how long is that supposed to play a part, she thought it was like 2 days. if this is normal. Patient also experienced shoulder pain as well as body ache and neck pain. Patient also described feeling a loss of appetite sometimes and wanting to throw up. She said that it had been going into the third day already and wants to know if the side effects she have mentioned are normal. The outcome of the events was recovered on unspecified date of 2021.   The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Pain, Pain in extremity, Vomiting
Clinical narrative: she is tired; having nausea; weak; Headache; shoulder pain; body ache; neck pain; She received the vaccine on her left arm and felt some pain; a loss of appetite; wanting to throw up; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), first dose via an unspecified route of administration on left arm on 17Jun2021 (Thursday) single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On unspecified date of 2021 the patient was tired, having nausea, weak, and had headaches. She was just wondering what is going on, how long is that supposed to play a part, she thought it was like 2 days. if this is normal. Patient also experienced shoulder pain as well as body ache and neck pain. Patient also described feeling a loss of appetite sometimes and wanting to throw up. She said that it had been going into the third day already and wants to know if the side effects she have mentioned are normal. The outcome of the events was recovered on unspecified date of 2021.   The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Intense skin rash specially in the face area in the shape of a mask from the forehead to mid cheek area reminiscent of a sunburn. Some in the arms, legs and back as well; This is a spontaneous report from a contactable consumer, the parent. A 12-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via an unspecified route of administration in the arm right on 08Jun2021 at 15:30 (at the age of 12-year-old), as a single dose for COVID-19 immunisation. Medical history included allergy to chemicals (allergic to methyl isobutyl ketone), since unknown date. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the arm left on 03May2021 at 15:30 (at the age of 12-years-old), as a single dose for COVID-19 immunisation. On 10Jun2021 at 06:00, the patient experienced intense skin rash specially in the face area in the shape of a mask from the forehead to mid cheek area reminiscent of a sunburn. Some in the arms, legs and back as well. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of intense skin rash and included treatment with unspecified steroids and unspecified allergy medicine. The clinical outcome of the event intense skin rash specially in the face area in the shape of a mask from the forehead to mid cheek area, arms, legs and back was recovered on an unknown date in Jun2021.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Injection site discomfort, Injection site mass, Pain, Pruritus, Swelling
Clinical narrative: Soreness; Swelling; Swollenness like a lump in the area, it was itchy, very itchy and I have a lump like where the injection site is; Swollenness like a lump in the area, it was itchy, very itchy and I have a lump like where the injection site is; It is like it is a nut right in the injection site; This is a spontaneous report from a contactable consumer (patient). A 45-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Right on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included none. Concomitant medication included multivitamin (Vitamins Nos) for unspecified indication, start and stop dates were not reported. Investigation assessment and prior vaccinations (within 4 weeks) included none. The patient had the Pfizer vaccine on Monday (unspecified date) in right arm and experienced some soreness and some swelling, but at the time of this report patient was experiencing swollenness like a lump in the area, it was itchy, very itchy and had a lump like where the injection site was. So, was real concerned about that, after reading the material that was given to patient about the vaccine, didn't know if should be really concerned because it was like it is a nut right in the injection site. Didn't know if patient should put like a lump compress on it. Consumer was informed about Pfizer Medical Information department and provided with the number. Patient received no treatment for the events. Clinical outcome of events was unknown.  Information on lot/batch number was not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Cough
Clinical narrative: Bronchitis; coughing was so bad; This is a spontaneous report from a contactable consumer or other non hcp (patient). 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 14Jun2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took 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 1, single for covid-19 immunisation and experienced no reaction. On 16Jun2021, the patient experienced bronchitis, coughing was so bad. she was not tested for Covid-19 at her urgent care visit. Reporter stated that, before the vaccine everything was fine. The patient had to go to the urgent care because the coughing was so bad and it was not really letting up at all. Patient was asking what she should do about her symptoms. Therapeutic measures were taken as a result of bronchitis, coughing was so bad. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Oropharyngeal pain, Pain in extremity
Clinical narrative: pain in my throat; chest; down my arms each morning.; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 2 via an unspecified route of administration on Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pain in my throat, chest and down my arms each morning on an unknown date in Mar2021 (In March the patient began experiencing pain in my throat, chest and down my arms each morning. It doesn't last all day and sometimes it lasts longer than others and sometimes it's really bad). The patient underwent lab tests and procedures which included blood test: normal on an unknown date in 2021 (Had an EKG and blood work done and they couldn't find anything), electrocardiogram: normal on an unknown date in 2021 (Had an EKG and blood work done and they couldn't find anything). The patient have been to the ER twice. Outcome of the events was unknown.  Information on batch/lot no. has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Adnexa uteri pain, Arthralgia, Joint swelling, Joint warmth, Loss of personal independence in daily activities
Clinical narrative: right ovary pain mild; nausea; arthritis pain on my feet; itching in the joints; I felt itching in the joints and swelling and heat.; I felt itching in the joints and swelling and heat.; I have arthritis pain on my feet on Saturday. It was so strong I couldn't walk.; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0168) via an unspecified route of administration in the right arm on 18Jun2021 at 08:15 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. The medical history of the patient included polycystic ovary syndrome (PCOS), possibly celiac and gluten sensitivity. The concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 19Jun2021 at 13:00, next day of vaccination, the patient experienced right ovary pain mild. On 20Jun2021, the patient had stronger pain in the ovary. On 21Jun2021, it intensified and had severe ovary pain plus nausea. The patient also had arthritis pain on feet on19Jun2021. It was so strong that she couldn't walk. The patient also felt itching in the joints and swelling and heat. Therapeutic measures were not taken as a result of the events. The adverse event 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, right ovary pain, nausea, arthritis pain on feet, itching in the joints, swelling and heat was not recovered at the time of this report.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pruritus
Clinical narrative: right ovary pain mild; nausea; arthritis pain on my feet; itching in the joints; I felt itching in the joints and swelling and heat.; I felt itching in the joints and swelling and heat.; I have arthritis pain on my feet on Saturday. It was so strong I couldn't walk.; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0168) via an unspecified route of administration in the right arm on 18Jun2021 at 08:15 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. The medical history of the patient included polycystic ovary syndrome (PCOS), possibly celiac and gluten sensitivity. The concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 19Jun2021 at 13:00, next day of vaccination, the patient experienced right ovary pain mild. On 20Jun2021, the patient had stronger pain in the ovary. On 21Jun2021, it intensified and had severe ovary pain plus nausea. The patient also had arthritis pain on feet on19Jun2021. It was so strong that she couldn't walk. The patient also felt itching in the joints and swelling and heat. Therapeutic measures were not taken as a result of the events. The adverse event 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, right ovary pain, nausea, arthritis pain on feet, itching in the joints, swelling and heat was not recovered at the time of this report.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: Fever; Chills; Nausea; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 77-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EL1284; Expiration Date: Apr2021) (at the age of 77-years-old) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 07Jan2021, the patient experienced fever, chills and nausea. There was no treatment received for reported events. The clinical outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Lymphadenopathy
Clinical narrative: swollen lymph nodes; nose bleeds; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration on 21Apr2021 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient was not reported. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration on 21Mar2021 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Apr2021, the patient experienced swollen lymph nodes and nose bleeds. 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 event(s). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of swollen lymph nodes and nose bleeds were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush
Clinical narrative: Extreme and intense hot flashes resumed within two days of receiving first vaccine; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 52-year-old non-pregnant female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0150 and expiration date was not reported), via an unspecified route of administration, in Right Arm on 02Apr2021 08:30 (at the age of 52-years-old) as dose 1, single for covid-19 immunisation. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6205 and expiration date was not reported), via an unspecified route of administration in Left Arm on 23Apr2021 8:30 (at the age of 52-years-old), as dose 2, single for covid-19 immunisation. The patient medical history included Heart from an unknown date and unknown if ongoing. The patient concomitant medications included acetylsalicylic acid (BAYER ASPIRIN, 325 MG) by oral route of administration taken for Heart from an unspecified start date and ongoing. Patient had no known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination. Since the vaccination, the patient has not been tested for Covid-19. The patient did not received treatment for adverse events. On 03Apr2021, the patient experienced extreme and intense hot flashes resumed within two days of receiving first vaccine. The outcome of the event was not recovered.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Feeling abnormal
Clinical narrative: About 10 minutes after she felt like she had sun burn all over her body and side. The feeling was described as hot with face, legs, and arms burning.; feeling really warm; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). An 81-years-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, at the age of vaccination 81 years), dose 1 via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. She received the first dose of the Pfizer BioNtech covid 19 vaccine on 17Feb2021. About 10 minutes 17Feb2021 after she felt like she had sun burn all over her body and side. The feeling was described as hot with face, legs, and arms burning, feeling really warm. The outcome of events was recovering.  Information on the lot/batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nausea
Clinical narrative: nauseous; sick; This is a spontaneous report from a contactable consumer or other non health care professional (Patient). 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 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient wanted to call and report her reaction to the Pfizer Biontech Covid 19 vaccine. The patient reported that she had a little bit of reaction to the first shot, she was nauseous and sick on an unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia, Urticaria
Clinical narrative: Fever; Hives; Chills; severe body aches; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 45-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration in arm left on 18Jun2021 at 12:00 (at the age of 45-years-old) as dose 2, single for COVID-19 immunisation. The medical history of the patient included LBS, Gastroperesis diverticulosis disease and chronic fatigue syndrome. The patient was allergic to Alpha-gal. The concomitant medications of the patient included linaclotide (LINZESS) and alprazolam (XANAX). The patient previously received first dose of BNT162B2 (solution for injection, Batch/Lot number: UNKNOWN) as single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient not been tested with covid-19. On 18Jun2021 at 22:00, the patient experienced hives, chills, severe body aches and also experienced fever on 19Jun2021 at 04:00. The patient underwent lab tests and procedures which included fever: 101-102 on an unspecified date and fever: 102.5 on 19Jun2021. Therapeutic measures were taken as a result of hives and fever that included rotated Tylenol and ibuprofen to reduce fever and Benadryl for hives. The outcome of all the events was reported as not resolved.  Information about lot/batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Dysgeusia, Eating disorder, Taste disorder
Clinical narrative: had a metallic taste in her mouth; that it is interfering with her eating; lost 10  pounds; Everything tastes awful; This is a spontaneous report from a contactable consumer(patient) via medical information team. A 68-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection, lot number: EW0150) via an unspecified route of administration, administered in Arm Right on 06Apr2021 (at the age of 68-year-old) as dose 2, single for COVID-19 vaccination. Medical history included ongoing rheumatoid arthritis (reported as about 9 years ago it became pronounced enough that she needed medication), ongoing hypothyroidism (reported as she did not get diagnosed until 6 or 7 years ago), ongoing atrial fibrillation (reported as she had that since she was 24) and COVID-19. The patient's concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Additional vaccines administered on same date of the Pfizer Suspect was reported as none. Prior Vaccinations (within 4 weeks) was reported as none. Patient family medical history was reported as none. Historical vaccine included bnt162b2 (Solution for injection, lot number: EN6207) via an unspecified route of administration, administered in arm right as dose 1, single on 13Mar2021 (at the age of 68-year-old) for Covid-19 immunization and experienced metallic taste in mouth. The patient had Covid and she lost her sense of taste and smell, but it was coming back. Patient had the second vaccine on 06Apr2021, and the metallic taste got so severe to the point she could barely eat. The reporter stated metallic taste got worse within a week of getting the second dose. Everything tastes awful. She had lost 10 pounds. Patient was wondered if Pfizer had any information about it and if anything, they learned can help her to get over this. Patient just continued to lose weight. Patient had Covid, but she was told she had no antibodies in her blood. On unknown date in 2021, the patient experienced a metallic taste in her mouth that it was interfering with her eating, lost 10 pounds, everything tastes awful. Patient had regular bloodwork because of her arthritis and doctor sent her to an ENT doctor who did a CT scan of her sinuses to see if there was anything wrong that could affect her smell and taste. Outcome for event lost 10 pounds was not recovered while unknown for rest of the event.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Weight, Weight decreased
Clinical narrative: had a metallic taste in her mouth; that it is interfering with her eating; lost 10  pounds; Everything tastes awful; This is a spontaneous report from a contactable consumer(patient) via medical information team. A 68-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection, lot number: EW0150) via an unspecified route of administration, administered in Arm Right on 06Apr2021 (at the age of 68-year-old) as dose 2, single for COVID-19 vaccination. Medical history included ongoing rheumatoid arthritis (reported as about 9 years ago it became pronounced enough that she needed medication), ongoing hypothyroidism (reported as she did not get diagnosed until 6 or 7 years ago), ongoing atrial fibrillation (reported as she had that since she was 24) and COVID-19. The patient's concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Additional vaccines administered on same date of the Pfizer Suspect was reported as none. Prior Vaccinations (within 4 weeks) was reported as none. Patient family medical history was reported as none. Historical vaccine included bnt162b2 (Solution for injection, lot number: EN6207) via an unspecified route of administration, administered in arm right as dose 1, single on 13Mar2021 (at the age of 68-year-old) for Covid-19 immunization and experienced metallic taste in mouth. The patient had Covid and she lost her sense of taste and smell, but it was coming back. Patient had the second vaccine on 06Apr2021, and the metallic taste got so severe to the point she could barely eat. The reporter stated metallic taste got worse within a week of getting the second dose. Everything tastes awful. She had lost 10 pounds. Patient was wondered if Pfizer had any information about it and if anything, they learned can help her to get over this. Patient just continued to lose weight. Patient had Covid, but she was told she had no antibodies in her blood. On unknown date in 2021, the patient experienced a metallic taste in her mouth that it was interfering with her eating, lost 10 pounds, everything tastes awful. Patient had regular bloodwork because of her arthritis and doctor sent her to an ENT doctor who did a CT scan of her sinuses to see if there was anything wrong that could affect her smell and taste. Outcome for event lost 10 pounds was not recovered while unknown for rest of the event.  Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness in pointer finger, back and arm on the right side where vaccine was administered.; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO187) via an unspecified route of administration in the right arm on an unknown date in Jun2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an unspecified route of administration in the right arm on 16May2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Jun2021, the patient experienced numbness in pointer finger, back and arm on the right side where vaccine was administered. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. The clinical outcome of the event numbness in pointer finger, back and arm on the right side was unknown at the time of this report.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Contusion, Platelet count increased, Pruritus
Clinical narrative: itching and bruising all over her legs; itching and bruising all over her legs; This is a spontaneous report from a contactable consumer or other non-HCP. A 21-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Left Arm on 24May2021 as DOSE 1, SINGLE (at the age of: 21-year-old) for covid-19 immunization. Medical history and Family Medical History Relevant to AE(s) reported as none. There were no concomitant medications. Vaccine was not Administered at Military Facility. No Additional Vaccines Administered on Same Date of Suspect. On an unspecified date of May2021, the patient experienced itching and bruising all over her legs. The patient underwent lab tests and procedures which included blood test: normal on 14Jun2021, platelet count increased: 14Jun2021 on 14Jun2021 she later clarified and mentioned the PTT was a little elevated, but nothing concerning. Patient had her blood test done a week ago from Monday, clarified as last Monday. She further explained, a bunch of test were done and there was nothing concerning. The blood test came back normal. The platelets and all that was checked. However, she later clarified and mentioned the PTT was a little elevated, but nothing concerning. The outcome of all event was recovering.  Follow-up (20Aug2021): 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 have been completed and no further information is expected.  No follow-up attempts are possible. Information about lot/batch no cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash under both arms and in elbow 'crease'; This is a spontaneous report from a non-contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Jun2021 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis. Concomitant medication included mesalazine (MESALAMINE) taken within two weeks of vaccination. The patient previously took ciprofloxacin (CIPRO) and experienced drug allergy. The patient previously also 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 an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Jun2021, the patient experienced rash under both arms and in elbow 'crease'. Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event rash under both arms and in elbow 'crease' was resolved on an unknown date in Jun2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Condition aggravated, Illness, Rash, Rash macular
Clinical narrative: rash; still has hives on her legs; I was sick on Saturday (19Jun2021) but worse on Sunday; splotches; did not have the energy to get up; really sick; 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 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) dose 2 via an unspecified route of administration on 18Jun2021 as DOSE 2, SINGLE for covid-19 immunization. The patient medical history was not reported.  The patient's concomitant medications were not reported. Historical vaccine included dose 1 received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on unspecified date as DOSE 1, SINGLE for covid-19 immunization and had nauseous and sick as reactions. On an unknown date, patient stated that, I had a little bit of reaction to the first shot, I was nauseous and sick.  I had vaccination on second last Friday 18Jun2021, was observed for 15 minutes and did not make a connection at first, but the next day, I was really sick. I started getting splotches on me. I was sick on Saturday 19Jun2021 but worse on Sunday 20Jun2021, I did not have the energy to get up.  I still have the rash today 21Jun2021. I still have hives on my legs. I just need to report it. I hope it goes away. The outcome of all events was reported as an unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: rash; still has hives on her legs; I was sick on Saturday (19Jun2021) but worse on Sunday; splotches; did not have the energy to get up; really sick; 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 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) dose 2 via an unspecified route of administration on 18Jun2021 as DOSE 2, SINGLE for covid-19 immunization. The patient medical history was not reported.  The patient's concomitant medications were not reported. Historical vaccine included dose 1 received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on unspecified date as DOSE 1, SINGLE for covid-19 immunization and had nauseous and sick as reactions. On an unknown date, patient stated that, I had a little bit of reaction to the first shot, I was nauseous and sick.  I had vaccination on second last Friday 18Jun2021, was observed for 15 minutes and did not make a connection at first, but the next day, I was really sick. I started getting splotches on me. I was sick on Saturday 19Jun2021 but worse on Sunday 20Jun2021, I did not have the energy to get up.  I still have the rash today 21Jun2021. I still have hives on my legs. I just need to report it. I hope it goes away. The outcome of all events was reported as an unknown.   Information on the lot/batch number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Heart racing; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0176) via an unspecified route of administration in the left arm on 21Jun2021 at 14:30(at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Concomitant medications included emtricitabine, tenofovir alafenamide fumarate, bictegravir sodium (BIKTARVY) for unknown indication from an unknown start date. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 21Jun2021 at 22:45, the patient experienced heart racing. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event heart racing was not recovered at the time of this report.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Influenza like illness, Pyrexia
Clinical narrative: 16 hours after 2nd shot (4 am on 6/19) fever of 102.; Felt flu like symptoms; This is a spontaneous report from a non-contactable consumer, the parent. A 15-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0178) via an unspecified route of administration in the arm left on 18Jun2021 at 12:00 (at the age of 15-year-old), as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient had no known allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0180) via an unspecified route of administration in the arm left on 27May2021 at 11:45 (at the age of 15-year-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Jun2021 at 04:00, 16 hours after second shot, the patient experienced fever of 102. "Acetaminophen used very 4-6 hours until 9:15pm then took ibuprofen and fever finally broke at 11:30ish pm on 6/19". The patient felt flu like symptoms all day. The patient still ate, drank lots of fluids, had popsicles as reported by the parent. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of fever and flu like symptoms which included treatment with acetaminophen (MANUFCATURER UNKNOWN) every 4-6 hours until 21:15, then took ibuprofen (MANUFCATURER UNKNOWN). The clinical outcome of the events felt flu like symptoms was recovered on 19Jun2021 and fever of 102 was recovered on 19Jun2021 at 23:30.   No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal faeces, Faeces discoloured, Pain in extremity
Clinical narrative: Black stool; Very strong odoured stool; sharp pain in right arm; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0183) via an unspecified route of administration in left arm on 20Jun2021 at 08:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included asthma and high blood pressure. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medications within two weeks of the vaccination. The patient previously received isopropyl alcohol and experienced anaphylaxis. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. On 21Jun2021 at 23:15, the patient experienced black and very strong odor stool and also had a sharp pain in right arm. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events black and very strong odor stool and sharp pain in right arm was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Fatigue, Myalgia, Pain in extremity
Clinical narrative: Severe muscle pain in lower back and shoulders/Site injection arm pain in the form of muscle soreness; Severe joint pain in lower back and shoulders; injection site arm pain; fatigue; Stimulated immune response (more than normal) of arthritis already diagnosed between L4 and L5 of the spine; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0150) via an unspecified route of administration in the left arm on 20Jun2021 at 16:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included arthritis and possible degenerative disc disease. Concomitant medications included duloxetine hydrochloride (CYMBALTA), ethinylestradiol, levonorgestrel (AVIANE), cetirizine hydrochloride (ZYRTEC) and omeprazole (PRILOSEC); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously took Ceclor and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Jun2021, at 08:00 the patient experienced severe muscle and joint pain in her lower back and shoulders, stimulated immune response (more than normal) of arthritis already diagnosed between L4 and L5 of the spine, injection site arm pain in the form of fatigue and muscle soreness. 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 of severe muscle and joint pain in her lower back and shoulders, stimulated immune response (more than normal) of arthritis already diagnosed between L4 and L5 of the spine, injection site arm pain in the form of fatigue and muscle soreness were not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Headache, Hypoaesthesia, Muscle fatigue
Clinical narrative: Severe muscle fatigue in arms and legs; numbness and tingling started in feet and hands; tingling started in feet and hands, tingling in thighs; vibration in chest replaced by pain in same spot; painful joints, wrists; short lived headaches on right temple; This is a spontaneous report from a contactable consumer (patient). A 41-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Solution for injection, lot number: EW0182) via an unspecified route of administration, administered in Arm Right on 19May2021 at 11:45 (at the age of 41-year-old) as dose 1, single for COVID-19 immunisation. The patient had no medical history. The patient's concomitant medications included Multi vitamin, vitamin D, B12, C and probiotic (other medications within 2 weeks of vaccination). Allergies to medications, food, or other products were reported as no. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. On 22May2021 at 10:00, the patient experienced severe muscle fatigue in arms and legs on day 4 after shot and on an unknown date May2021 (reported as 10 days after shot), the patient experienced numbness and tingling started in feet and hands, tingling in thighs, vibration in chest replaced by pain in same spot, painful joints and wrists, short lived headaches on right temple. The patient did not receive treatment for the adverse events. Since the vaccination the patient was not tested for COVID-19. Outcome of the events were recovering.  Follow-up attempts completed. No further information expected.