chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Cold sweat, Fatigue
Clinical narrative: chills; neck and shoulder pain; neck and shoulder pain /  intermittent joint pain in her left elbow, right shoulder, knee, and back; neck and shoulder pain /  intermittent joint pain in her left elbow, right shoulder, knee, and back; fatigued; nausea; cold sweats; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on 27Jan2021 (at the age of 76-years-old) as dose 1, single for covid-19 immunization. The patient medical history included she has pulmonary fibrosis at baseline. Concomitant medications were not reported. It was reported that, patient is 76 y/o female. She received her first dose of the Pfizer Covid vaccine on 27Jan2021. 3 hours after her shot, she started to experience intermittent chills that last about an hour then go away, neck and shoulder pain - was hard to turn her head due to the pain. Then intermittent joint pain in her left elbow, right shoulder, knee, and back. She felt fatigued and had an episode of nausea and cold sweats. She states she has pulmonary fibrosis at baseline. She is concerned that the side effects have been lasting for a while and wants to know if that's normal. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain
Clinical narrative: chills; neck and shoulder pain; neck and shoulder pain /  intermittent joint pain in her left elbow, right shoulder, knee, and back; neck and shoulder pain /  intermittent joint pain in her left elbow, right shoulder, knee, and back; fatigued; nausea; cold sweats; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on 27Jan2021 (at the age of 76-years-old) as dose 1, single for covid-19 immunization. The patient medical history included she has pulmonary fibrosis at baseline. Concomitant medications were not reported. It was reported that, patient is 76 y/o female. She received her first dose of the Pfizer Covid vaccine on 27Jan2021. 3 hours after her shot, she started to experience intermittent chills that last about an hour then go away, neck and shoulder pain - was hard to turn her head due to the pain. Then intermittent joint pain in her left elbow, right shoulder, knee, and back. She felt fatigued and had an episode of nausea and cold sweats. She states she has pulmonary fibrosis at baseline. She is concerned that the side effects have been lasting for a while and wants to know if that's normal. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dysgeusia, Pain, Pyrexia
Clinical narrative: Weird taste/metallic taste in mouth; Fever Less than 100; Chills/Bodyaches; Chills/Bodyaches; This is a spontaneous report received from a contactable consumer (Patient) via in response the Non HCP letter sent in cross referenced case. A 51-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) via an unspecified route of administration at left arm (at the age of 51-year-old) on 23Jan2021 (Lot Number: EL9262) as single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included ibuprofen (ADVIL). No there are not any other products that were taken together with those Indicated above. Patient did not receive any other vaccine prior to this vaccination within 4weeks. Patient did not have any adverse events prior to the vaccination. There were no predisposing factors. The patient did not visit emergency room/ Physician office for the events. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) via an unspecified route of administration at left arm (at the age of 50-year-old) on 02Jan2021 11:30 (Lot Number: EK9231) as single dose for COVID-19 immunisation and patient experienced 30 minutes after vaccine had a really weird taste in mouth for about 2 hours, throwingup/vomiting, fever more than 100, chills, bodyaches, mettalic taste in mouth. After second dose the patient experienced Same symptoms after 2 dose except vomiting i.e weird taste, fever less than 100 and chills/bodyaches on an unspecified date in 2021. The patient underwent lab tests and procedures which included body temperature: less than 100 on an unspecified date in 2021. Outcome of all events was unknown.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hot flush, Pyrexia
Clinical narrative: fever; chills; hot flashes; headache; fatigue; This is a spontaneous report from a contactable consumer or other non hcp (reported for a patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reportedly, event took place after use of product. After second dose of Covid vaccine, on an unspecified date, the patient experienced fever, chills, hot flashes, headache, and fatigue. Outcome of the events were resolved within 48 hours.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 13Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced has a spot the size of a lemon and is angry red on an unspecified date. Outcome of the event was not recovered.  Follow-up (15Feb2021): This is a follow-up spontaneous report from a contactable consumer.  Follow-up (12MAY2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Fatigue, Pain, Pyrexia
Clinical narrative: Fever; Body aches; Weakness; Diarrhea; She vomited once; Fatigue; low grade fever; This is a spontaneous report from a Pfizer-sponsored program. A Contactable consumer reported for a 83-years-old female patient (grandmother) that she received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unknown date, the patient experienced fever (pyrexia) 48 hours ago, and currently the patient was having body aches (pain), weakness (asthenia), diarrhea (diarrhoea) since Saturday. She vomited once (vomiting), fatigue (fatigue), low grade fever (pyrexia) Sunday. On an unspecified date, the patient underwent lab tests and procedures which included sars-cov-2 test: negative. Therapeutic measures were taken as a result of fever (pyrexia), body aches (pain), weakness (asthenia), diarrhea (diarrhoea), she vomited once (vomiting), fatigue (fatigue) and low grade fever (pyrexia). She has been taking Tylenol every day, she has been afebrile since but she still has fatigue and some body aches The reporter wanted to know if the patient could still take the second dose tomorrow. The clinical outcome of the events was Unknown.  Information on the Batch/Lot number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vomiting
Clinical narrative: Fever; Body aches; Weakness; Diarrhea; She vomited once; Fatigue; low grade fever; This is a spontaneous report from a Pfizer-sponsored program. A Contactable consumer reported for a 83-years-old female patient (grandmother) that she received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unknown date, the patient experienced fever (pyrexia) 48 hours ago, and currently the patient was having body aches (pain), weakness (asthenia), diarrhea (diarrhoea) since Saturday. She vomited once (vomiting), fatigue (fatigue), low grade fever (pyrexia) Sunday. On an unspecified date, the patient underwent lab tests and procedures which included sars-cov-2 test: negative. Therapeutic measures were taken as a result of fever (pyrexia), body aches (pain), weakness (asthenia), diarrhea (diarrhoea), she vomited once (vomiting), fatigue (fatigue) and low grade fever (pyrexia). She has been taking Tylenol every day, she has been afebrile since but she still has fatigue and some body aches The reporter wanted to know if the patient could still take the second dose tomorrow. The clinical outcome of the events was Unknown.  Information on the Batch/Lot number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Erythema, Influenza like illness, Muscle spasms, Myalgia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Feb 9, 2021, single dose, for COVID-19 immunisation. Medical history included cholesterol (abnormal blood cholesterol) and asthma. Concomitant medication included Praluent (alirocumab) taken for abnormal blood cholesterol. On an unspecified date, patient experienced myalgia and influenza-like illness, (muscle aches and flu-like symptoms), which she also experienced with Praluent in the past. On Feb 9, 2021, patient experienced severe muscle spasms (like Charlie horses all over her body). This was an immediate, short-term reaction after receiving the COVID-19 vaccine. Her skin and throat turned bright red, and she had difficulty breathing. She needed her asthma pump but had 3 occurrences (one after the other) and required on-site observation for 1.5 hours. She no longer felt that afterwards. She was told to take Benadryl and a couple of puffs of her inhaler before her appointment for the 2nd dose on Mar 2, 2021, and she would be kept for observation. They made a note in her file and advised her primary care physician. At the time of this report, the outcome of events: unknown. Follow-up attempts completed. No further information expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal erythema
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Feb 9, 2021, single dose, for COVID-19 immunisation. Medical history included cholesterol (abnormal blood cholesterol) and asthma. Concomitant medication included Praluent (alirocumab) taken for abnormal blood cholesterol. On an unspecified date, patient experienced myalgia and influenza-like illness, (muscle aches and flu-like symptoms), which she also experienced with Praluent in the past. On Feb 9, 2021, patient experienced severe muscle spasms (like Charlie horses all over her body). This was an immediate, short-term reaction after receiving the COVID-19 vaccine. Her skin and throat turned bright red, and she had difficulty breathing. She needed her asthma pump but had 3 occurrences (one after the other) and required on-site observation for 1.5 hours. She no longer felt that afterwards. She was told to take Benadryl and a couple of puffs of her inhaler before her appointment for the 2nd dose on Mar 2, 2021, and she would be kept for observation. They made a note in her file and advised her primary care physician. At the time of this report, the outcome of events: unknown. Follow-up attempts completed. No further information expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Cheilitis, Mass, Polymerase chain reaction, Sensation of foreign body
Clinical narrative: Rash on the lower left side of the lip; Lump felt below the chin close to the throat and also below the left ear.; Lump felt below the chin close to the throat and also below the left ear.; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: unknown) dose 1 via an unspecified route of administration in right arm on 11Feb2021, 06:45 PM (at the age of 25-year-old) as single dose for COVID-19 immunisation. Medical history and concomitant medications were none. No known allergies. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. On 14Feb2021 05:00 PM, the patient experienced rash on the lower left side of the lip. Lump felt below the chin close to the throat and also below the left ear. Events resulted in Doctor or other healthcare professional office/clinic visit. Received antiviral treatment for events. The patient underwent lab test post vaccination which included Q PCR, on 18Jan2021, result: Negative. The outcome of events was recovering.  Follow-up attempts completed. No further information expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Vaccination site erythema, Vaccination site induration, Vaccination site inflammation, Vaccination site nodule
Clinical narrative: mild flu like symptoms; A lot of inflammation, large, bright red area that is hot to the touch and has a large hard knot inthe center where injection was given in upper left arm; A lot of inflammation, large, bright red area that is hot to the touch and has a large hard knot inthe center where injection was given in upper left arm; lot of inflammation, large, bright red area that was hot to the touch and has a large hard knot in the center where injection was given in upper left arm; A lot of inflammation, large, bright red area that is hot to the touch and has a large hard knot inthe center where injection was given in upper left arm; hard knot in the center of her left upper arm at the injection site/ hard knot in the center where injection was given in upper left arm; Itching left upper arm; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EM9810) via an unspecified route of administration, administered in upper left arm on 09Feb2021, at 10:30 (at the age of 74-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient had received pneumonia vaccine for immunisation about 5 years ago and had experienced localized inflammation on the arm where injection was administered, which lasted for couple of days. The concomitant medication(s) included romosozumab aqqg (EVENITY [ROMOSOZUMAB AQQG]) 2 weeks before administered of the Pfizer COVID-19 Vaccine, precursor to Prolia. It was reported that the patient experienced mild flu like symptoms and developed inflammation and a hard knot in the center of her left upper arm at the injection site. On night of 09Feb2021, the patient had onset of itching left upper arm. On morning of 10Feb2021, when patient woke up noticed onset of a lot of inflammation, large, bright red area that was hot to the touch and has a large hard knot in the center where injection was given in upper left arm, area was quite large and bright red, about 3 inches in diameter, hot to the touch, the center where she got the vaccine injection was a very large hard knot. Very large hard knot was still there, and was gradually see it spreading, it got a little larger and a little bit lighter. On 10Feb2021, unknown time the patient reported onset of mild flu like symptoms. The patient had been taking antihistamines and Aleve, used all the usual things. On 15Feb2021, the patient had a regular unrelated appointment with her Rheumatologist, who had started her on a course of Prednisone for her inflammation. Patient did not any AE(s) require a visit to emergency room and physician office. No hospitalization. The outcome of mild flu like symptoms was recovered on 11Feb2021 and rest all recovering.   Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site warmth
Clinical narrative: mild flu like symptoms; A lot of inflammation, large, bright red area that is hot to the touch and has a large hard knot inthe center where injection was given in upper left arm; A lot of inflammation, large, bright red area that is hot to the touch and has a large hard knot inthe center where injection was given in upper left arm; lot of inflammation, large, bright red area that was hot to the touch and has a large hard knot in the center where injection was given in upper left arm; A lot of inflammation, large, bright red area that is hot to the touch and has a large hard knot inthe center where injection was given in upper left arm; hard knot in the center of her left upper arm at the injection site/ hard knot in the center where injection was given in upper left arm; Itching left upper arm; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EM9810) via an unspecified route of administration, administered in upper left arm on 09Feb2021, at 10:30 (at the age of 74-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient had received pneumonia vaccine for immunisation about 5 years ago and had experienced localized inflammation on the arm where injection was administered, which lasted for couple of days. The concomitant medication(s) included romosozumab aqqg (EVENITY [ROMOSOZUMAB AQQG]) 2 weeks before administered of the Pfizer COVID-19 Vaccine, precursor to Prolia. It was reported that the patient experienced mild flu like symptoms and developed inflammation and a hard knot in the center of her left upper arm at the injection site. On night of 09Feb2021, the patient had onset of itching left upper arm. On morning of 10Feb2021, when patient woke up noticed onset of a lot of inflammation, large, bright red area that was hot to the touch and has a large hard knot in the center where injection was given in upper left arm, area was quite large and bright red, about 3 inches in diameter, hot to the touch, the center where she got the vaccine injection was a very large hard knot. Very large hard knot was still there, and was gradually see it spreading, it got a little larger and a little bit lighter. On 10Feb2021, unknown time the patient reported onset of mild flu like symptoms. The patient had been taking antihistamines and Aleve, used all the usual things. On 15Feb2021, the patient had a regular unrelated appointment with her Rheumatologist, who had started her on a course of Prednisone for her inflammation. Patient did not any AE(s) require a visit to emergency room and physician office. No hospitalization. The outcome of mild flu like symptoms was recovered on 11Feb2021 and rest all recovering.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dehydration
Clinical narrative: having her go in for IV hydration; This is a spontaneous report from a non-contactable consumer (patient herself). 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 08Feb2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date in February2021, the patient was going in for iv hydration. Therapeutic measures were taken for the adverse event. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Headache
Clinical narrative: Fever (99.9); fatigue; headache; muscle and joint aches; muscle and joint aches; chills; This is a spontaneous report from a contactable consumer (Patient). A 26-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL 3247) via an unspecified route of administration in arm right on 12Feb2021 10:30 (age at vaccination 26-year-old, Patient non-pregnant at the time of vaccination) as DOSE 2, SINGLE for COVID-19 immunisation at workplace clinic. The patient's medical history was not reported. No other vaccines within 4 weeks PRIOR to the COVID-19 vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient's concomitant medications were not reported. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL3247), via an unspecified route of administration in arm right on 22Jan2021 10:45 AM (age at vaccination 26-year-old) on as DOSE 1, SINGLE for COVID-19 Immunization. The patient experienced Fever (99.9), fatigue, headache, muscle and joint aches and chills on 12Feb2021 22:30. The patient underwent lab tests and procedures which included body temperature (99.9) on 12Feb2021. The outcome of events were recovered on 13Feb2021.  No follow-up attempts are needed. No further information was expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever (99.9); fatigue; headache; muscle and joint aches; muscle and joint aches; chills; This is a spontaneous report from a contactable consumer (Patient). A 26-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL 3247) via an unspecified route of administration in arm right on 12Feb2021 10:30 (age at vaccination 26-year-old, Patient non-pregnant at the time of vaccination) as DOSE 2, SINGLE for COVID-19 immunisation at workplace clinic. The patient's medical history was not reported. No other vaccines within 4 weeks PRIOR to the COVID-19 vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient's concomitant medications were not reported. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL3247), via an unspecified route of administration in arm right on 22Jan2021 10:45 AM (age at vaccination 26-year-old) on as DOSE 1, SINGLE for COVID-19 Immunization. The patient experienced Fever (99.9), fatigue, headache, muscle and joint aches and chills on 12Feb2021 22:30. The patient underwent lab tests and procedures which included body temperature (99.9) on 12Feb2021. The outcome of events were recovered on 13Feb2021.  No follow-up attempts are needed. No further information was expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: she wants to know if her father can take ibuprofen for pain following the covid vaccine; This is a spontaneous report from a contactable consumer or other non-hcp (patient's daughter). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced pain. It was reported that she (patient's daughter) wanted to know if her father can take ibuprofen for pain following the COVID vaccine. The clinical outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: Swollen lymph nodes (size of an orange); high fever; This is a spontaneous report from a contactable physician via Pfizer sales representative.  A patient of an unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), at an unknown route, dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced swollen lymph nodes (size of an orange) and high fever. The outcome of events was unknown.  Follow-up attempts completed. No further information expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Loss of personal independence in daily activities, Pain
Clinical narrative: unable to work the day following both vaccinations; Fever; chills; Body aches; Fatigues; Headache; This is a spontaneous report from a contactable other healthcare professional reporting for herself. A 39-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right (as reported Upper right arm) on 27Jan2021 09:30 (Batch/Lot Number: EL8982) as single dose (at age of 39-years old) for covid-19 immunization. Medical history included hypertension from Aug2012 to an unknown date. Family medical history relevant to AE(s): Hypertension. The patient's concomitant medications were not reported. There were no adverse events prior to vaccinations. The patient previously took first dose of BNT162B2, Solution for injection via unspecified route of administration on 09Jan2021 as single dose for covid-19 immunization and experienced Fever, Chills, Body aches, and Fatigue. The patient experienced fever, chills, body aches, fatigues, and headache on 27Jan2021 19:45. On unknown date, the patient was unable to work the day following both vaccinations. Side effects began 6-8 hours after the vaccine administration. Therapeutic measures were taken as a result of fever, and headache: treatment included Tylenol for fever/Headache. The patient was not admitted to hospital. It was reported that, were any of the events above considered serious due to being Life-threatening, or due to persistent or significant disability/incapacity or any other reason? IF yes, note the below which event/s and seriousness criteria: Unable to work the day following both vaccinations (unspecified information). Adverse events did not require Emergency room or Physician office visit. The patient was not deceased. A reasonable possibility that the event was related to suspect product/s reported as yes. The outcome of the events Fever, Chills, Body aches, and Fatigue was recovering while the outcome of the event unable to work the day following both vaccinations was unknown.  Follow-up attempts completed. No further information expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: unable to work the day following both vaccinations; Fever; chills; Body aches; Fatigues; Headache; This is a spontaneous report from a contactable other healthcare professional reporting for herself. A 39-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right (as reported Upper right arm) on 27Jan2021 09:30 (Batch/Lot Number: EL8982) as single dose (at age of 39-years old) for covid-19 immunization. Medical history included hypertension from Aug2012 to an unknown date. Family medical history relevant to AE(s): Hypertension. The patient's concomitant medications were not reported. There were no adverse events prior to vaccinations. The patient previously took first dose of BNT162B2, Solution for injection via unspecified route of administration on 09Jan2021 as single dose for covid-19 immunization and experienced Fever, Chills, Body aches, and Fatigue. The patient experienced fever, chills, body aches, fatigues, and headache on 27Jan2021 19:45. On unknown date, the patient was unable to work the day following both vaccinations. Side effects began 6-8 hours after the vaccine administration. Therapeutic measures were taken as a result of fever, and headache: treatment included Tylenol for fever/Headache. The patient was not admitted to hospital. It was reported that, were any of the events above considered serious due to being Life-threatening, or due to persistent or significant disability/incapacity or any other reason? IF yes, note the below which event/s and seriousness criteria: Unable to work the day following both vaccinations (unspecified information). Adverse events did not require Emergency room or Physician office visit. The patient was not deceased. A reasonable possibility that the event was related to suspect product/s reported as yes. The outcome of the events Fever, Chills, Body aches, and Fatigue was recovering while the outcome of the event unable to work the day following both vaccinations was unknown.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Pyrexia
Clinical narrative: joint pain; dull headache that ran down spine; chills; fever; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, after the second dose of cold vaccine, the patient experienced joint pain, dull headache that ran down spine, chills, and fever. The patient recovered from the events, which resolved within 48 hours, on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: she had diarrhea; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a female patient (reporter's daughter's-in-law mother) of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 08Feb2021 (Age at the time of vaccination was not provided) as DOSE 1, SINGLE for an unspecified indication. The medical history included irritable bowel syndrome from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The reporter was asking how she can get an appointment for her daughter's-in-law mother. After the first dose yesterday, the patient had diarrhoea on 08Feb2021 but according to the caller this was normal because she had Irritable Bowel Syndrome even before she got the vaccine, and she ate bacon that night that might cause the diarrhoea. The outcome of the event was reported as unknown.  Follow-up attempts completed. No further information expected. Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Influenza like illness
Clinical narrative: Pain in underarm; flu like symptoms; This is a spontaneous report from a contactable physician via Pfizer sales representative. This physician reported for self that:  From: (Name) Reporter Name: (Name), MD Reported by: Physician Reporter Contact Information: (address withheld)  Patient Name: (Name) Description of Event: The patient experience pain in underarm for 3 days after 2nd dose of the vaccine as well as flu like symptoms for 24 hours. Name of Product: COVID 19 vaccine Awareness Date: 9Feb2021 Country of Occurrence: United States Event took place after use of product.  Information on the lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: fever; experienced a headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable male consumer (patient) reported for himself. A male patient of an unspecified age received bnt162b2 (Pfizer Covid-19 Vaccine: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 10Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date of Feb2021 patient experienced fever and headache. He took Advil and Benadryl after. He wants to know if he still needs to take the second dose. The outcome of the event was unknown.  Information about Lot/Batch Number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: Caller is starting to get a stomach ache; This is spontaneous report received from a consumer via Pfizer-sponsored program Pfizer First Connect. A contactable female patient (Consumer) of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 09Feb2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took famotidine. It was reported that, the patient (caller) received first dose this morning, 2 days before vaccination she stopped taking Famotidine. The patient said that before she took the COVID vaccine this morning on 09Feb2021, about 5 hours ago, she did not take her Famotidine. It had been about four hours since the vaccine and the patient wanted to know if it was okay to take Famotidine. The patient started to get a stomach ache without medication on 09Feb2021. She remembered one pharmacist telling her that the Famotidine/Antacid hinders in the absorption of medications you can take. That was the reason she did not take it. She wanted to make sure that the vaccine would be absorbed completely by her body. Not taking her medication was voluntary on her part. She was afraid that it would hinder any absorption of the vaccine. She was calling to see if she can resume taking her medication. "She wants/needs to take it now". She was calling to see if it would affect the absorption of the vaccine. She was wondering can she resume it. From what she knew, the vaccine was absorbed by the muscle and not the stomach, she asked if that was true. She read that part, and the nurse who injected her said that the vaccine was absorbed by the muscle in the body, not directly from the stomach. She was not in the medical field, but her assumption was that since both medications were absorbed differently, there would be no interaction. The patient clarified that the Famotidine was a prescription. The outcome of the event was unknown.  Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: experienced a headache; fever; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (Patient) reported that. A male patient of an unspecified age received BNT162B2 (COMIRNATY; Formulation: Solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration, on 10Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced a headache and fever. Therapeutic measures were taken for events with Advil and Benadryl. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Feeling drunk, Loss of personal independence in daily activities
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A patient, of an unspecified age and gender, received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Patient felt "drunk" next morning after the vaccination. Unable to "get out of bed." Recovered by afternoon and able to go for a run. Event took place after use of product. Patient: fully recovered on an unspecified date. No follow-up attempts possible. Information about lot/batch number cannot be obtained.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Lung disorder
Clinical narrative: On the first dose I smoked weed and it made my lungs feel strange.; This is a spontaneous report from a contactable other hcp (Patient). A 30-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via intramuscular route of administration (age at vaccination 30-year) in Left Arm on 27Jan2021 at 05:00 PM as dose 1, single for COVID-19 immunization. Reported medical history was none. Concomitant medication includes other medications received in two weeks; medicines were unspecified. The patient received no other vaccine in four weeks. Reported facility type vaccine was Nursing Home/Senior Living Facility. No COVID prior vaccination was reported. The patient not tested COVID post vaccination. On an unspecified date the patient experienced on the first dose he smoked weed and it made his lungs feel strange. The clinical outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This is a spontaneous report from a contactable other health care professional. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, Reporter stated that a nurse (Patient) at the vaccination site had a fever after the second shot of Pfizer vaccine. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dyspnoea, Headache, Joint swelling
Clinical narrative: breathing issues; back of hand swelling; Ankle swelling; knuckle swelling; Headache; Muscle pain; Joint pain; chills; This is a spontaneous report from a contactable consumer (Patient). An unspecified age of male patient received first dose of bnt162b2(PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 27Jan2021 as a single dose COVID-19 immunization. The patient medical history and concomitant medications were not reported. He had the first shot on the 27Jan2021, and then starting on the 28Jan2021, he started getting Headache, muscle pains, chills, and joint pains in all joints in his body. Then, he started having breathing issues. He couldn't breathe very well. He came out of that. He has back of the hand and ankle swelling. His knuckles are swelled up. He is supposed to get the second dose 21Feb2021. He would prefer just to get over to Medical Information. The outcome of the events was unknown.   Information on the Batch/Lot number has been requested.  Follow-up (14MAY2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Peripheral swelling, Swelling
Clinical narrative: breathing issues; back of hand swelling; Ankle swelling; knuckle swelling; Headache; Muscle pain; Joint pain; chills; This is a spontaneous report from a contactable consumer (Patient). An unspecified age of male patient received first dose of bnt162b2(PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 27Jan2021 as a single dose COVID-19 immunization. The patient medical history and concomitant medications were not reported. He had the first shot on the 27Jan2021, and then starting on the 28Jan2021, he started getting Headache, muscle pains, chills, and joint pains in all joints in his body. Then, he started having breathing issues. He couldn't breathe very well. He came out of that. He has back of the hand and ankle swelling. His knuckles are swelled up. He is supposed to get the second dose 21Feb2021. He would prefer just to get over to Medical Information. The outcome of the events was unknown.   Information on the Batch/Lot number has been requested.  Follow-up (14MAY2021): Follow-up attempts completed. No further information expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Peripheral swelling
Clinical narrative: pain in the ankle joint; there is visible swelling in the left foot and pain; there is visible swelling in the left foot and pain; This is a spontaneous report from a non-contactable consumer (patient). A 35-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9269), via an unspecified route of administration on 05Feb2021 at 17:45 (35-year-old) as dose 2, single for COVID-19 immunisation at hospital. The patient medical history and concomitant medications were not reported. The patient had no known allergies. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3246), via an unspecified route of administration on 13Jan2021 at 12:45 (35-year-old) as dose 1, single for COVID-19 immunisation at hospital. Prior to the vaccination, the patient was not had COVID-19. Since the vaccination, unknown if the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient communicated in an informal setting that he had pain in the ankle joint 1 week after taking dose 1 and again 1 week after dose 2. However, after dose 2, there was visible swelling in the left foot and pain, and he had to go to the ER on 10Feb2021. Patient was wondering if this was a reaction to the vaccine. The adverse event was resulted in emergency room/department or urgent care. The patient had received treatment was unknown. The outcome of the events was reported as not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Itchy hands, 4 inch itchy raised rash on opposite arm vaccine was given; This is a spontaneous report from a contactable other hcp. A 47-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6201, Expiration date was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 13Feb2021 08:00 (age at vaccination 47 years) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. Patient had allergic to anti-nausea medicine.Concomitant medication(s) included methylphenidate hydrochloride (RITALIN). The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EI8982, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 23Jan2021 09:00 as dose 1, single for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced itchy hands, 4 inch itchy raised rash on opposite arm vaccine was given on 13Feb2021 08:30. Patient visited emergency room for reported events. Patient received treatment of Medication and cream. The patient was recovering from events.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Hypoacusis
Clinical narrative: hard of hearing; This is a spontaneous report received from a non-contactable consumer (patient) via Pfizer-sponsored program COVAX US Support. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 09Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took Tylenol for bad shoulder. Patient reported that usually took Tylenol daily for bad shoulder. Had 2nd dose of covid vaccine yesterday and would like to know if he can take Tylenol again. Clarified had not taken Tylenol since vaccine. He mentioned being hard of hearing and to speaking. Not clarified if he was hard of hearing before or after vaccine. The clinical outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Headache, Pain, Rhinorrhoea
Clinical narrative: Dry cough; Headache; Very mild runny nose; Body aches; Chills at 3:00am and other random; This is a spontaneous report received from a contactable consumer or other non hcp. A 33-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration in Arm Left on 05Feb2021 04:30 (age at vaccination 33years old) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient did not have known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included elderberry [sambucus nigra] (ELDERBERRY [SAMBUCUS NIGRA]) taken for an unspecified indication, start and stop date were not reported. Since the vaccination, the patient had not been tested positive for COVID-19. The patient experienced that on 12Feb2021 20:00 he had dry cough, headache, very mild runny nose, body aches, chills. The patient did not receive any treatment for the adverse events. The clinical outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.