chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: Nausea; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: EW0172) via an unspecified route of administration in the arm left on an unknown date (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On an unknown date the patient experienced nausea and fatigue. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events nausea and fatigue was unknown at the time of report.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Dizziness
Clinical narrative: Extreme dizziness/disorientation; Extreme dizziness/disorientation; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Apr2021 at 15:00 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included alprazolam (XANAX), hydrocodone (MANUFACTURER UNKNOWN), ibuprofen (ADVIL) and omeprazole (OMEPRAZOL) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 13:30 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. On 26Apr2021 at 18:00, the patient experienced extreme dizziness/disorientation. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme dizziness/disorientation was recovering at the time of reporting.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Peripheral swelling, Pruritus, Rash
Clinical narrative: On day 9 after the injection, April 18, sudden swelling at the site, right arm; on day 9 after the injection, April 18, sudden swelling at the site, right arm; rash on entire body with excessive itching sensation and redness; rash on entire body with excessive itching sensation and redness; rash on entire body with excessive itching sensation and redness; Obvious allergic reaction.; This is a spontaneous report from a contactable healthcare professional, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 09Apr2021 at 11:45 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's disease, hypothyroidism, vitiligo, asthma, hypertension and known allergies to sulfa, latex, adhesives and walnuts. 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 COVID-19 vaccine. Concomitant medications included regular treatment (unspecified), cyanocobalamin (VITAMIN B12) and colecalciferol (VITAMIN D3); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received clindamycin (MANUFACTURER UNKNOWN), amoxicillin; clavulanate potassium (MANUFACTURER UNKNOWN) and experienced drug allergy. On 18Apr2021 at 20:00, day 9 after the injection, the patient experienced sudden swelling at the site, right arm and rash on entire body with excessive itching sensation and redness and obvious allergic reaction. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with diphendydramine hydrochloride (BENADRYL) until the events got resolved. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events experienced sudden swelling at the site, right arm and rash on entire body with excessive itching sensation and redness was recovered on an unknown date in Apr2021.   No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: On day 9 after the injection, April 18, sudden swelling at the site, right arm; on day 9 after the injection, April 18, sudden swelling at the site, right arm; rash on entire body with excessive itching sensation and redness; rash on entire body with excessive itching sensation and redness; rash on entire body with excessive itching sensation and redness; Obvious allergic reaction.; This is a spontaneous report from a contactable healthcare professional, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 09Apr2021 at 11:45 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's disease, hypothyroidism, vitiligo, asthma, hypertension and known allergies to sulfa, latex, adhesives and walnuts. 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 COVID-19 vaccine. Concomitant medications included regular treatment (unspecified), cyanocobalamin (VITAMIN B12) and colecalciferol (VITAMIN D3); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received clindamycin (MANUFACTURER UNKNOWN), amoxicillin; clavulanate potassium (MANUFACTURER UNKNOWN) and experienced drug allergy. On 18Apr2021 at 20:00, day 9 after the injection, the patient experienced sudden swelling at the site, right arm and rash on entire body with excessive itching sensation and redness and obvious allergic reaction. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with diphendydramine hydrochloride (BENADRYL) until the events got resolved. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events experienced sudden swelling at the site, right arm and rash on entire body with excessive itching sensation and redness was recovered on an unknown date in Apr2021.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Myalgia, Pyrexia
Clinical narrative: Low grade fever; Muscle aches; Chills; Brain fog; This is a spontaneous report from a contactable consumer. A 45-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history included seasonal allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. On an unknown date in Apr2021, the patient experienced low grade fever, muscle aches, chills, and brain fog. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events low grade fever, muscle aches, chills, and brain fog were recovered on an unknown date in Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, SARS-CoV-2 test
Clinical narrative: Headache; Chills; Brain fog; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 23Mar2021 at 12:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included testosterone (MANUFACTURER UNKNOWN), for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received morphine (MANUFACTURER UNKNOWN) for unknown indication from an unknown date and experienced drug allergy. On 24Mar2021 at 08:00, the patient experienced headache, chills, brain fog. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 26Mar2021, the patient underwent nasal swab test and the result was negative. The clinical outcome of the event headache, chills, brain fog was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Very mild soreness at injection site; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the arm right on 26Apr2021 at 09:45 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not have any medical history. Concomitant medications were not reported. The patient had no known allergies. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the arm right on 05Apr2021 at 09:45 as a single dose for COVID-19 immunisation.  On 26Apr2021 at 16:00 the patient experienced very mild soreness at injection site and no other side effects. The patient did not receive any treatment for the event. The event did not result in doctor 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 event very mild soreness at injection site was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Hypersensitivity, Somnolence, Throat irritation
Clinical narrative: I had an allergic reaction over night; I was a bit sleepy after getting my vaccine but that seemed normal; my left eye had swole up; throat was scratchy; This is a spontaneous report from a contactable consumer (patient). A 19-years-old non pregnant female patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number was not reported) via an unspecified route of administration on 26Apr2021 13:30 (Age at vaccination was 19 Years) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history included known allergies: I am allergic to a few different types of fruit and also most pets, covid-19 from an unknown date and unknown if ongoing covid prior vaccination. The patient had been diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications the patient received within 2 weeks of vaccination. Concomitant medication was not reported. On 27Apr2021 07:30, it was reported that the patient had an allergic reaction overnight. I was a bit sleepy after getting my vaccine but that seemed normal. I went to bed a little late that night and when I had woken up on the morning of the 27th my left eye had swole up and my throat was scratchy. I took some allergy meds and waited to see if it would help. It got better throughout the day, but the swelling still is not fully gone. Allergy medication had been taken for allergic reaction while no treatment received for rest of the events. The outcome of the events was recovering.  This follow-up was being submitted to notify that the lot/batch number was not available despite the follow-up attempts made. Follow-up attempts completed. No further information was expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Gait inability, Inflammation, Pain in extremity
Clinical narrative: pain in right foot close to knee; not able to walk; ball-kind of inflammation on foot; Pain and burning in right knee (posterior and lateral knee area) with bending impairment; Pain and burning in right knee (posterior and lateral knee area) with bending impairment; This is a spontaneous report from a contactable consumer (patient herself). A 58-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number EW0161), via an unspecified route of administration, administered in Arm Right on 14Apr2021 10:00 (at the age of 58 years old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not known for any allergies. 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 vaccination. The patient did not receive any other medication 2 weeks prior to COVID vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient was not tested for COVID-19. The patient historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number EP7534), via an unspecified route of administration, administered in Arm left on 24Mar2021 10:00 AM as dose 1, single for COVID-19 immunization. On 21Apr2021, the patient experienced pain and burning in right knee (posterior and lateral knee area) with bending impairment, next day patient experienced pain in right foot close to knee and not able to walk, with ball-kind of inflammation on foot. The patient did not receive any treatment for adverse events. The outcome of events was not resolved.  No follow-up attempts are needed. No further information required.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: After getting the 2nd dose, she started to have difficulty in breathing.; This is a spontaneous report from  sponsored program  support from contactable consumer (patient, self-reported) via medical information team. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number and expiry date were not reported), via an unspecified route of administration, on 30Apr2021, as a dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient historical vaccine includes BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a dose 1, single for COVID-19 immunization. On an unspecified date in Apr2021, after receiving the second dose the patient started to have difficulty in breathing. It was reported that she realized it could be a severe allergic reaction as mentioned on the fact sheet, she read about the vaccine. The patient also reported that is over and done with and she went to the hospital, and she does not have any questions at this time. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: armpit was swelling; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). A 49-years-old male patient received bnt162b2 second dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Expiry Date: unknown, Lot number: FW0179) via an unspecified route of administration, administered in Arm Left on 01May2021 10:00 (at the age of 49-years-old) as dose 2, single for COVID-19 immunisation. Medical history includes Mild High Blood pressure from an unknown date and unknown if ongoing no Investigation Assessment. The patient's concomitant medications were not reported. The patient previously took bnt162b2 first dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Expiry Date: unknown, Lot number: ER8729) via an unspecified route of administration, administered in Arm Left on 10Apr2021 10:00 for COVID-19 immunisation, Patient has drug allergy of erythromycin he has no Lot or Expiry number of Erythromycin it has been discarded according to patient. Patient didn't have any prior vaccination (within 4 weeks). On 04May2021 the patient experienced armpit was swelling. Patient was not taken to Emergency room or physician office. Patient didn't receive any treatment for event. The outcome of event was not recovered.    No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Swelling face
Clinical narrative: Experienced puffiness and redness of her face, mainly her cheeks/ Puffing of the face; Experienced puffiness and redness of her face, mainly her cheeks/ Redness; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0164) via an unspecified route of administration, administered in Arm Left on 03May2021 10:00 or 10:30 (at the age of 70-years-old) as dose 1, single for COVID-19 immunization. Medical history included acid reflux (diagnosed years ago), high blood pressure (many years ago), atrial fibrillation (diagnosed 2-3 years ago). Concomitant medications included rivaroxaban (XARELTO) taken for atrial fibrillation; metoprolol (METOPROLOL) taken for hypertension started taking this years ago; losartan (LOSARTAN) taken for hypertension started taking this years ago; hydralazine (HYDRALAZINE) taken for hypertension started taking this years ago; omeprazole (PROTONIX [OMEPRAZOLE]) taken for gastro-esophageal reflux disease; nifedipine (NIFEDIPINE) taken for hypertension she states she stated taking this a long time ago. No investigation assessment was performed. No prior vaccinations (within 4 weeks). On 03May2021 21:00, the patient experienced puffiness and redness of her face, mainly her cheeks/ puffing of the face/ redness. She went to the Emergency room. She asked how long this is expected to last. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chills, Pain
Clinical narrative: body aches; chills; This is a spontaneous report from Pfizer. A contactable Consumer reported for a 69-Years-old female patient that: who received bnt162b2 (BNT162B2) solution for injection, via an unspecified route of administration on an unspecified date aa unknown dose single dose for covid-19 immunisation; palbociclib (IBRANCE), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unknown single for an unspecified indication. The patient medical history and concomitant medications were not reported. On an unspecified date the caregiver verbally stated that the patient had body aches and chills after getting the Covid Vaccine. Outcome of thew events was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bed rest, Contusion, Dizziness, Fall
Clinical narrative: dizziness like "lights out"/ Lightheadedness; her elbow is bruised and sore, and it goes to her wrist or her shoulder; falling backward; room spinning; spent whole day in bed; my arm hurt so bad; swelling in her left wrist, elbow, and shoulder; sore to touch, almost like being bruised "like its in my joints"; discovering "knots" on her left arm, "knots" on her head; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 62-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ECU0161, Expiration date: not reported) via an unspecified route of administration, administered in left arm on 17Apr2021, In the morning between 09:00-10:00 at the age of 62-years-old as single dose for COVID-19 immunization. Patient's had no medical history and concomitant medications. On 29Apr2021, patient experienced discovering knots on her left arm, knots on her head, my arm hurt so bad, swelling in her left wrist, elbow, and shoulder, sore to touch, almost like being bruised like its in my joints, falling backward, room spinning, spent whole day in bed, on an unspecified date, dizziness like lights out, Lightheadedness, her elbow is bruised and sore, and it goes to her wrist or her shoulder. History of all previous immunization with the Pfizer vaccine considered as suspect was none. No additional Vaccines Administered on Same Date of the Pfizer Suspect. Patent did not receive prior Vaccinations within 4 weeks. The outcome of event discovering knots on her left arm was recovered in 29Apr2021, dizziness like lights out, Lightheadedness, her elbow is bruised and sore, and it goes to her wrist or her shoulder was unknown rest events outcome was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Pain in extremity, Skin disorder, Vertigo
Clinical narrative: dizziness like "lights out"/ Lightheadedness; her elbow is bruised and sore, and it goes to her wrist or her shoulder; falling backward; room spinning; spent whole day in bed; my arm hurt so bad; swelling in her left wrist, elbow, and shoulder; sore to touch, almost like being bruised "like its in my joints"; discovering "knots" on her left arm, "knots" on her head; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 62-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ECU0161, Expiration date: not reported) via an unspecified route of administration, administered in left arm on 17Apr2021, In the morning between 09:00-10:00 at the age of 62-years-old as single dose for COVID-19 immunization. Patient's had no medical history and concomitant medications. On 29Apr2021, patient experienced discovering knots on her left arm, knots on her head, my arm hurt so bad, swelling in her left wrist, elbow, and shoulder, sore to touch, almost like being bruised like its in my joints, falling backward, room spinning, spent whole day in bed, on an unspecified date, dizziness like lights out, Lightheadedness, her elbow is bruised and sore, and it goes to her wrist or her shoulder. History of all previous immunization with the Pfizer vaccine considered as suspect was none. No additional Vaccines Administered on Same Date of the Pfizer Suspect. Patent did not receive prior Vaccinations within 4 weeks. The outcome of event discovering knots on her left arm was recovered in 29Apr2021, dizziness like lights out, Lightheadedness, her elbow is bruised and sore, and it goes to her wrist or her shoulder was unknown rest events outcome was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Lip blister, Lip erythema, Lip haemorrhage, Lip swelling, Mouth swelling
Clinical narrative: swelling in her mouth, jaws; swelling in her mouth, jaws; blisters on her lips and blistering inside of her mouth; Swollen lips; Redness, blistering/bleeding of the lips; Redness, blistering/bleeding of the lips; Redness, blistering/bleeding of the lips; This is a spontaneous report from a contactable consumer or other non hcp. A 20-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number ER8734; Expiration Date: 31Jul2021), via an unspecified route of administration, administered in the left amr on 16Apr2021 8:45 (age at the time of vaccination was 20-year-old) as dose 2, 0.3 ml single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, there was no other medications the patient received within 2 weeks of vaccination. The medical history included hypersensitivity from an unknown date and unknown if ongoing Verbatim was Allergy. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced swelling in her mouth, jaws on 29Apr2021 swelling in her mouth, jaws, blisters on her lips and blistering inside of her mouth, swollen lips, redness, blistering/bleeding of the lips. the  patient not diagnosed with COVID- 19, and since the vaccination, the patient has not been tested for COVID-19. The patient was treated with A Dexamethasone shot and prescribed 2 medications Prior to vaccination. Therapeutic measures were taken as a result of swelling in her mouth, jaws (swelling face), blisters on her lips and blistering inside of her mouth (oral mucosal blistering), redness, blistering/bleeding of the lips (lip erythema), redness, blistering/bleeding of the lips (lip blister), redness, blistering/bleeding of the lips (lip haemorrhage). Doctor or other healthcare professional of-fice/clinicvisit. The outcome of event swelling in her mouth, jaws was unknown and all other events were not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Oral mucosal blistering, Swelling face
Clinical narrative: swelling in her mouth, jaws; swelling in her mouth, jaws; blisters on her lips and blistering inside of her mouth; Swollen lips; Redness, blistering/bleeding of the lips; Redness, blistering/bleeding of the lips; Redness, blistering/bleeding of the lips; This is a spontaneous report from a contactable consumer or other non hcp. A 20-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number ER8734; Expiration Date: 31Jul2021), via an unspecified route of administration, administered in the left amr on 16Apr2021 8:45 (age at the time of vaccination was 20-year-old) as dose 2, 0.3 ml single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, there was no other medications the patient received within 2 weeks of vaccination. The medical history included hypersensitivity from an unknown date and unknown if ongoing Verbatim was Allergy. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced swelling in her mouth, jaws on 29Apr2021 swelling in her mouth, jaws, blisters on her lips and blistering inside of her mouth, swollen lips, redness, blistering/bleeding of the lips. the  patient not diagnosed with COVID- 19, and since the vaccination, the patient has not been tested for COVID-19. The patient was treated with A Dexamethasone shot and prescribed 2 medications Prior to vaccination. Therapeutic measures were taken as a result of swelling in her mouth, jaws (swelling face), blisters on her lips and blistering inside of her mouth (oral mucosal blistering), redness, blistering/bleeding of the lips (lip erythema), redness, blistering/bleeding of the lips (lip blister), redness, blistering/bleeding of the lips (lip haemorrhage). Doctor or other healthcare professional of-fice/clinicvisit. The outcome of event swelling in her mouth, jaws was unknown and all other events were not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discomfort, Malaise, Pain, Pyrexia
Clinical narrative: I am not feeling great/Discomfort/Not feeling very good; achy; chills; Fever; Discomfort; This is a spontaneous report from a contactable consumer (patient).    A female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine), via an unspecified route of administration on 03May2021 (Batch/Lot number, Expiry Date and NDC number were not reported) as dose 2, single for covid-19 immunisation. Medical history included body ache. Concomitant medications included naproxen sodium (ALEVE) taken for pain. On 04May2021 the patient experienced event reported as: I am not feeling great/discomfort/not feeling very good, achy, chills, fever and discomfort. The patient reported that "I got my second Pfizer Covid 19 vaccine dose yesterday (03May2021) and today on 04May2021 I am not feeling great. I am more achy and I have chills this time. The first dose was like nothing. Is it ok to take Aleve or Alka-Seltzer Plus Cold?" She said she just experienced something minor and has a question.  She said she had the first one done and felt nothing after it. She had her second vaccination yesterday and she was not expecting to feel like she does today. She said it was not terrible, she had a little discomfort. She said they told her she could take something, she did not remember what they said to take, but she did not take that. She said she usually takes Aleve for any kind of body ache. She asked them if she could take Aleve and they said sure. She said she was not feeling very good today and she was out of Aleve. She said she has Alka-Seltzer Plus Cold Medicine which basically covers all the same symptoms, like fever and that. She asked can she take Alka-Seltzer Plus Cold Medicine instead of Aleve. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Pain, Pyrexia, Somnolence
Clinical narrative: I fell asleep for a day; fever; chills; dullness; body ache; This is a spontaneous report from a contactable consumer (patient) via Pfizer Sales Representative. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date after receiving the Pfizer vaccine the patient fell asleep for a day with fever, chills, dullness, and body aches. Reportedly the event manifested after use of the product. Outcome of the event was unknown.  No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable consumer or other non-healthcare professional.   A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 09Apr2021 as dose 1, single for COVID-19 immunisation; doxycycline (DOXYCYCLINE), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose single for melanocytic naevus/have some moles. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced headache. The patient was going to get second Pfizer shot on Friday the 30th. On yesterday, the doctor prescribed with some antibiotics (later clarified as Doxycycline) and patient wanted to know if antibiotics can be taken without it interfering with the Pfizer (Vaccine). Next one (Pfizer COVID Vaccine) was on Friday, 30th. Took one antibiotic last night because it was one every night. Patient just had a headache but did not know if it was coming from that. Took it last night. Had the first shot on April 9, the second shot on April 30th. The antibiotic was for face. Have some moles removed, that was what the antibiotic was for. Still experiencing headache, consumer stated as no. Consumer was unwilling to share further information, hence, product details (NDC#, UPC#) reporter type and other details were unknown. Limited information was available over the call. Outcome of the event was resolved on an unspecified date. The action taken in response to the event for doxycycline was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: skin started to clear prior to starting xeljanz and after first pfizer; This is a spontaneous report from a contactable consumer other hcp (patient). A 71-year-old male 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 an unspecified date as dose 1, single for covid-19 immunization. The patient also received tofacitinib citrate (XELJANZ, Batch/Lot number was not reported, 5 mg, 2x/day), via an unspecified route of administration from 01Apr2021 and ongoing for psoriasis, eczema. The patient medical history included psoriasis, eczema. Concomitant medications were not reported. It was reported that patient is taking xeljanz for off label diagnosis of psoriasis and eczema. no adverse event reported. he reports skin started to clear prior to starting xeljanz and after first Pfizer covid-19 vaccine. he started xeljanz after first vaccine and skin was clearer than it had been in a long time. md aware. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Cough, Dizziness, Fatigue
Clinical narrative: injection site pain; tiredness; insomnia; headache; muscle and joint pain; muscle and joint pain; nausea; feelling unwell; cough for the first30 minutes; accelerated heartbeat; dizziness; weakness; she experienced pain; swollen lymph nodes; This is a spontaneous report from a Pfizer. A contactable consumer or other non-health care professional (patient) reported for a 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history included covid-19 from an unknown date. The patient's concomitant medications were not reported.  On an unspecified date in 2021, the patient experienced injection site pain, tiredness, insomnia, headache within the first 4 hours, muscle and joint pain, nausea, feeling unwell, cough for the first30 minutes, accelerated heartbeat for the first 30 minutes but did not last, dizziness and weakness for the first 4hours, pain and swollen lymph nodes. Reporter would like to know if this can indicate that they might have prior COVID19 before getting the 1st dose of the vaccine and if there are currently any antibody test used for detecting the COVID19 virus accurately post vaccination that might not give a false positive result. The patient underwent lab tests and procedures on an unknown date which included sars-cov-2 test: positive.  The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Insomnia, Lymphadenopathy, Malaise
Clinical narrative: injection site pain; tiredness; insomnia; headache; muscle and joint pain; muscle and joint pain; nausea; feelling unwell; cough for the first30 minutes; accelerated heartbeat; dizziness; weakness; she experienced pain; swollen lymph nodes; This is a spontaneous report from a Pfizer. A contactable consumer or other non-health care professional (patient) reported for a 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history included covid-19 from an unknown date. The patient's concomitant medications were not reported.  On an unspecified date in 2021, the patient experienced injection site pain, tiredness, insomnia, headache within the first 4 hours, muscle and joint pain, nausea, feeling unwell, cough for the first30 minutes, accelerated heartbeat for the first 30 minutes but did not last, dizziness and weakness for the first 4hours, pain and swollen lymph nodes. Reporter would like to know if this can indicate that they might have prior COVID19 before getting the 1st dose of the vaccine and if there are currently any antibody test used for detecting the COVID19 virus accurately post vaccination that might not give a false positive result. The patient underwent lab tests and procedures on an unknown date which included sars-cov-2 test: positive.  The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: injection site pain; tiredness; insomnia; headache; muscle and joint pain; muscle and joint pain; nausea; feelling unwell; cough for the first30 minutes; accelerated heartbeat; dizziness; weakness; she experienced pain; swollen lymph nodes; This is a spontaneous report from a Pfizer. A contactable consumer or other non-health care professional (patient) reported for a 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history included covid-19 from an unknown date. The patient's concomitant medications were not reported.  On an unspecified date in 2021, the patient experienced injection site pain, tiredness, insomnia, headache within the first 4 hours, muscle and joint pain, nausea, feeling unwell, cough for the first30 minutes, accelerated heartbeat for the first 30 minutes but did not last, dizziness and weakness for the first 4hours, pain and swollen lymph nodes. Reporter would like to know if this can indicate that they might have prior COVID19 before getting the 1st dose of the vaccine and if there are currently any antibody test used for detecting the COVID19 virus accurately post vaccination that might not give a false positive result. The patient underwent lab tests and procedures on an unknown date which included sars-cov-2 test: positive.  The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pain, Pyrexia
Clinical narrative: muscle pain; fever/well last night it was like the whole night with temperature; chills; Headache; Body ache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiration date were not reported), second dose via an unspecified route of administration on 03May2021 as single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as single for covid-19 immunization. On 04May2021, the patient had fever/well last night it was like the whole night with temperature and she woke up with so much pain like body ache, muscle ache and had really bad headache. So, she was just wondering whether she could take Tylenol or what medication she could take. Outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Movement disorder, Myalgia
Clinical narrative: he felt terrible pain in his shoulder, groin and knees.; he felt terrible pain in his shoulder, groin and knees.; he felt terrible pain in his shoulder, groin and knees.; couldn't get in and out of his car/couldn't separate his legs; Pain in his hamstring muscle under the glutes; walking slower; arthritis; he doesn't have the strength; This is a spontaneous report from a contactable consumer (patient). This 76-years-old male contactable consumer (patient) reported for himself that: A 76-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number not reported) via an unspecified route, administered on an unknown date (age at vaccination 76 years) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications was not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number not reported) via an unspecified route, administered on an unknown date as DOSE 1, SINGLE for COVID-19 immunization. On an unspecified date, the patient experienced he felt terrible pain in his shoulder, groin and knees, couldn't get in and out of his car/couldn't separate his legs, Pain in his hamstring muscle under the glutes, walking slower, arthritis and he doesn't have the strength. It was reported that, the patient stated they already reported AE to previous agent. Caller says he got the Pfizer shot. About 3-4 weeks after his 2nd dose, he felt terrible pain in his shoulder, groin and knees. At first he waited it out. His HCP said it could be related to his immune system and directed him to a physical therapist. Caller says he couldn't get in and out of his car and couldn't separate his legs but was helped to subside with physical therapy. His shoulders only hurt when he lays down to sleep and gets up to urinate at night, he doesn't have the strength, his shoulder pain subsides during day. Pain in his hamstring muscle under the glutes. Seems to be the tendon on both muscles. He was in pretty good shape before getting the vaccine, now he is walking slower. The patient stated that he went to an Orthopedic doctor, who said that the caller has arthritis, and that the Corona shot works on people's immune system and that these kinds of pains can be expected, but he informed the caller to start Physical Therapy. Patient has been going to see a Physical Therapist and they have been helping him. The patient stated that he could not even get in or out of his car, he could not separate or move his legs, but the Physical Therapist went to work on the caller's tendons, and caller states that he is about 85% better, but the knee pain comes and goes, and the shoulders are only hurting when he lays down at night and first thing in the morning, but after he has been moving around for an hour or so, then he was good. The patient received physiotherapy as treatment. The outcome of the events was unknown.  Information about lot/batch number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Cystitis bacterial, Dysstasia, Nausea, Pyrexia, Tremor
Clinical narrative: fevering; Bladder infection/Bacterial infection; has the shakes; doesn't feel like standing in line for the vaccine today.; Nausea; Vomiting; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on 13Apr2021 as dose 1, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  On an unspecified date the patient experienced fevering, bladder infection/bacterial infection, has the shakes, doesn't feel like standing in line for the vaccine today, nausea, vomiting on 04May2021. The first dose of the Pfizer Covid vaccine on 13Apr2021 and is due to take the second dose today 04May2021. wants to know if delaying taking the vaccine one day because she has a bacterial infection and want to take one day to make this nausea go away. If I wait, will it affect the vaccine working on me. The caller has a bladder infection and is on antibiotics. wants to know if she can take the vaccine a day later the caller has been vomiting today and fevering and has the shakes from the bacterial infection and doesn't feel like standing in line for the vaccine today. Therapeutic measures were taken as a result of bladder infection/bacterial infection antibiotic treatment. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: fevering; Bladder infection/Bacterial infection; has the shakes; doesn't feel like standing in line for the vaccine today.; Nausea; Vomiting; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on 13Apr2021 as dose 1, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  On an unspecified date the patient experienced fevering, bladder infection/bacterial infection, has the shakes, doesn't feel like standing in line for the vaccine today, nausea, vomiting on 04May2021. The first dose of the Pfizer Covid vaccine on 13Apr2021 and is due to take the second dose today 04May2021. wants to know if delaying taking the vaccine one day because she has a bacterial infection and want to take one day to make this nausea go away. If I wait, will it affect the vaccine working on me. The caller has a bladder infection and is on antibiotics. wants to know if she can take the vaccine a day later the caller has been vomiting today and fevering and has the shakes from the bacterial infection and doesn't feel like standing in line for the vaccine today. Therapeutic measures were taken as a result of bladder infection/bacterial infection antibiotic treatment. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.