chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness
Clinical narrative: BP elevated; Light headedness 24 minutes post shot; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El1284), via an unspecified route of administration on 11Jan2021 15:15 at a single dose on right arm for COVID-19 immunization. Medical history included hypothyroidism, systemic mastocytosis and allergies to sulfa. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior to vaccination. The patient previously took fexofenadine hcl (ALLEGRA) and experienced allergies. The patient was administered with first dose of bnt162b2 on 21Dec2020 15:30 on right arm for COVID-19 immunization (lot number: El0140). No other vaccines received in four weeks prior to COVID vaccination. On 11Jan2021 15:39, the patient experienced light headedness 24 minutes post shot and BP (blood pressure) was elevated at 15:45. Patient laid on floor for 15-20 minutes and 49 minutes after shot, she felt so what back to normal with normal BP. No treatment was received for the adverse events. The patient has not been tested for COVID post vaccination. Patient recovered from BP elevated on 11Jan2021 at 16:04, and from light headedness on an unspecified date.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, SARS-CoV-2 test positive
Clinical narrative: 10 days after receiving vaccine patient tested positive for covid via nasal swab; 10 days after receiving vaccine patient tested positive for covid via nasal swab; Mild cold symptoms; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received her first dose of BNT162B2 (lot no. and expiry date were not reported), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of vaccine, and 10 days after receiving vaccine patient tested positive for covid via nasal swab on unspecified date. The patient also experienced mild cold symptoms on unspecified date. The physician would like to know if his patient should receive second dose or if any literature supports second dose after getting covid in between dose. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives all over her body; This is a spontaneous report from a non-contactable consumer.  A female patient of an unspecified age received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced hives all over her body (non-serious) on an unspecified date with an outcome of unknown.    No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Inappropriate schedule of product administration, Pain, Pyrexia
Clinical narrative: Fever; chills; body aches; Date of start of drug: 11Jan2021/ 12Dec2020; This is a spontaneous report from a contactable nurse (patient). A 40-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231, expiration date unknown), intramuscular on the left arm 11Jan2021 at 08:00 at a single dose and the first dose (lot number: Eh9899) via intramuscular on the left arm on 12Dec2020 at 08:00 at a single dose for COVID-19 immunization. Medical history included Known allergies to Latex and 1000 island dressing. The patient is not pregnant. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on 12Dec2020 for COVID-19 immunization and with which the patient experienced fever, chills and body aches. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient has no COVID prior vaccination and no COVID testing post vaccination. The patient experienced fever, chills, and body aches on 11Jan2021 at 20:00, 12 hours post vaccine. The events were resolving.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: few hives/rash; few hives/rash; This is a spontaneous report from a contactable healthcare professional (patient). A 33-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EK9231), via an unspecified route of administration in the left arm on 11Jan2021 at 15:00 at a single dose in the hospital for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not have COVID prior to vaccination. The patient was not pregnant at the time of report. The patient experienced few hives/rash on 11Jan2021 at 18:00, about 2 hours after getting the vaccine. The patient did not receive treatment for the events. The patient was not tested for COVID post vaccination. Outcome of the events was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pain
Clinical narrative: chills; headache; fatigue; fever 101; body aches; This is a spontaneous report from a contactable healthcare professional (patient). A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration in right arm on 09Jan2021 11:00 at single dose for COVID-19 immunization. Medical history included hypothyroidismand arthritis from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID), progesterone and estradiol (DOTTI). The patient previously took ace inhibitors and experienced allergies. The patient had first dose of BNT162B2, via unspecified route of administration on 18Dec2020 11:00 AM, lot number: EK507, in right arm at single dose for COVID-19 immunization. On 09Jan2021 2:30 AM, the patient woke up and experienced chills, fever 101, headache, fatigue and body aches and it lasted most of the day. The patient went back to bed at 8:30 PM and still had fever 100.2 and fatigue but most other symptoms getting better. The patient woke on 10Jan2021 at 4:30 am for work, no fever and some fatigue but that was it. No other reactions since this writing. The outcome of the event fever was recovered on 10Jan2021 and the outcome of the remaining events was recovering. No treatment was given for the events. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: chills; headache; fatigue; fever 101; body aches; This is a spontaneous report from a contactable healthcare professional (patient). A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration in right arm on 09Jan2021 11:00 at single dose for COVID-19 immunization. Medical history included hypothyroidismand arthritis from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID), progesterone and estradiol (DOTTI). The patient previously took ace inhibitors and experienced allergies. The patient had first dose of BNT162B2, via unspecified route of administration on 18Dec2020 11:00 AM, lot number: EK507, in right arm at single dose for COVID-19 immunization. On 09Jan2021 2:30 AM, the patient woke up and experienced chills, fever 101, headache, fatigue and body aches and it lasted most of the day. The patient went back to bed at 8:30 PM and still had fever 100.2 and fatigue but most other symptoms getting better. The patient woke on 10Jan2021 at 4:30 am for work, no fever and some fatigue but that was it. No other reactions since this writing. The outcome of the event fever was recovered on 10Jan2021 and the outcome of the remaining events was recovering. No treatment was given for the events. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Muscle spasms
Clinical narrative: GI upset; Cramping; Diarrhea; This is a spontaneous report from a contactable healthcare professional. A 39-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 vaccine; unknown lot number and expiration date), via an unspecified route of administration right arm on 05Jan2021 06:30 at a single dose for covid-19 immunization. Medical history included lymphoma and was identified with Covid prior vaccination. The patient has not received other vaccines in four weeks. There were no concomitant medications. The patient previously took acetazolamide (DIAMOX) but had allergies. The patient received her vaccine in a hospital. The patient experienced GI (gastrointestinal) upset, cramping and diarrhea on 05Jan2021 13:00. No treatment was received for the adverse events. The patient has not been tested post vaccination. The outcome of the events was recovered on Jan2021.   The following information on the batch/lot number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Herpes zoster, Pain in extremity, Pain of skin
Clinical narrative: Rash on her right forearm consisting of clusters of vesicles on an erythematous base; rash is consistent with a diagnosis of herpes zoster or shingles; Radiating burning pain down the underside or volar side of her right arm to her wrist; first felt like a bruise; Radiating burning pain down the underside or volar side of her right arm to her wrist; first felt like a bruise; Pain then began to feel more like a bad sunburn with her skin being tender in the same distribution; This is a spontaneous report from a contactable healthcare professional (patient). A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), via an unspecified route of administration in right arm, on 04Jan2021 at 18:15, at a single dose, for COVID-19 immunization. The patient had no medical history and concomitant medications. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The facility where the vaccine was administered was her workplace clinic. On 05Jan2021 at 03:00 PM, the patient developed radiating burning pain down the underside or volar side of her right arm to her wrist (vaccinated arm) that at first felt like a bruise within 24 hours of receiving the vaccine. In Jan2021, the pain then began to feel more like a bad sunburn with her skin being tender in the same distribution. Then on 11Jan2021, the patient developed a rash on her right forearm consisting of clusters of vesicles on an erythematous base. The patient consulted with a dermatologist in her primary care physician who agreed that the rash is consistent with a diagnosis of herpes zoster or shingles. This resulted in doctor or other healthcare professional office or clinic visit. Treatment received for shingles included valacyclovir. Post-vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Erythema, Flushing, Headache
Clinical narrative: Fever of 99.5; Body aches; chills; red face; feeling flushed 5 hours after 1st shot; Headache for next two days; This is a spontaneous report from a contactable other hcp (patient). A 30-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), intramuscular on 15Dec2020 10:00 at single dose (Left arm) for COVID-19 immunization. Medical history included Covid 19. Patient is not pregnant. Patient had no known allergies. Concomitant medication included pseudoephedrine. Facility type vaccine: Hospital. There was no other vaccine in four weeks. On 15Dec2020 15:00, it was reported that patient had Fever of 99.5, body aches, chills, red face, and feeling flushed (5 hours after 1st shot). Temp increased to 100.6 so I took Aleve and I felt better in 30 min. Headache for next two days. After second shot, fever of 99.6 and body aches with chills after 12 hours. Took Aleve and fever was gone felt fine by noon next day. The patient underwent lab tests and procedures which included Nasal Swab: negative on 18Dec2020. Therapeutic measures were taken as a result of fever of 99.5. The outcome of the events was recovered on an unspecified date.  Information about lot/batch number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever of 99.5; Body aches; chills; red face; feeling flushed 5 hours after 1st shot; Headache for next two days; This is a spontaneous report from a contactable other hcp (patient). A 30-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), intramuscular on 15Dec2020 10:00 at single dose (Left arm) for COVID-19 immunization. Medical history included Covid 19. Patient is not pregnant. Patient had no known allergies. Concomitant medication included pseudoephedrine. Facility type vaccine: Hospital. There was no other vaccine in four weeks. On 15Dec2020 15:00, it was reported that patient had Fever of 99.5, body aches, chills, red face, and feeling flushed (5 hours after 1st shot). Temp increased to 100.6 so I took Aleve and I felt better in 30 min. Headache for next two days. After second shot, fever of 99.6 and body aches with chills after 12 hours. Took Aleve and fever was gone felt fine by noon next day. The patient underwent lab tests and procedures which included Nasal Swab: negative on 18Dec2020. Therapeutic measures were taken as a result of fever of 99.5. The outcome of the events was recovered on an unspecified date.  Information about lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenitis
Clinical narrative: Lymphadenitis developed in my axilla and extended down my right chest wall.; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration in the right arm on 08Jan2021 10:45 at a single dose for COVID-19 immunization. There were no medical history. The patient had no known allergies to medications, food, or other products. The patient was not pregnant. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 29Dec2020 at the age of 51 years old for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient experienced lymphadenitis developed in her axilla and extended down her right chest wall on 09Jan2021. No treatment was received for the adverse event. Outcome of the event was recovering.  Information about batch/lot number has been requested.
Age: 46.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Disturbance in attention, Headache, Lethargy
Clinical narrative: Rash; fever; severe chills; head ache/head ache lingering 6 days after; joint pain; kidney pain; lethargy; difficulty concentrating; This is a spontaneous report from a contactable nurse. A 46-year-old patient of an unspecified gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), intramuscular on 06Jan2021 at single dose (right arm) for COVID-19 immunization. Medical history included celiac disease and allergies: gluten. The patient's concomitant medications were not reported. On 06Jan2021, the patient experienced rash, fever, severe chills, headache, joint pain, kidney pain, lethargy, and difficulty concentrating. The main symptoms lasted about 48 hours, and headache was lingering 6 days after. There was no therapy for the events. There were no other vaccine in four weeks and no other medications in two weeks. The patient underwent lab tests and procedures which included nasal swab was negative on 06Jan2021, post vaccination. Outcome of event head ache/head ache lingering 6 days after was recovering;  outcome of the rest of events was recovered on 08Jan2021.   Information about Lot/Batch has been requested.
Age: 46.0
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Renal pain, SARS-CoV-2 test
Clinical narrative: Rash; fever; severe chills; head ache/head ache lingering 6 days after; joint pain; kidney pain; lethargy; difficulty concentrating; This is a spontaneous report from a contactable nurse. A 46-year-old patient of an unspecified gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), intramuscular on 06Jan2021 at single dose (right arm) for COVID-19 immunization. Medical history included celiac disease and allergies: gluten. The patient's concomitant medications were not reported. On 06Jan2021, the patient experienced rash, fever, severe chills, headache, joint pain, kidney pain, lethargy, and difficulty concentrating. The main symptoms lasted about 48 hours, and headache was lingering 6 days after. There was no therapy for the events. There were no other vaccine in four weeks and no other medications in two weeks. The patient underwent lab tests and procedures which included nasal swab was negative on 06Jan2021, post vaccination. Outcome of event head ache/head ache lingering 6 days after was recovering;  outcome of the rest of events was recovered on 08Jan2021.   Information about Lot/Batch has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Approx. 2x2: painful, red, warm, raised area at injection site; Approx. 2x2: painful, red, warm, raised area at injection site; Approx. 2x2: painful, red, warm, raised area at injection site; This is a spontaneous report from a contactable nurse (patient herself). A 29-year-old female patient received two doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), first dose on 18Dec2020 (lot number: EK5730) and second dose on 08Jan2021 (lot number: EK9231), both intramuscular in the left arm (injection placed approximately 8" below acromion process, medial side of arm, not into deltoid) at single dose for COVID-19 immunization. Medical history included asthma and covid (reported as "if covid prior vaccination: Yes"). The patient is not pregnant. Concomitant medications included montelukast sodium (SINGULAIR), sertraline hydrochloride (ZOLOFT), and melatonin. The patient previously took phenytoin sodium (DILANTIN) and carbamazepine (TEGRETOL), and both experienced with known allergies. The patient had not tested for COVID post vaccination. The patient experienced approx. 2x2: painful, red, warm, raised area at injection site on 09Jan2021 04:00. No treatment received for these events. The outcome of the events was recovering.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Swelling and itching at injection site; Swelling and itching at injection site; This is a spontaneous report from a contactable pharmacist (patient). A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number:EL1284) via an unspecified route of administration into the left arm on 03Jan2021 12:45 at a single dose for covid-19 immunisation. Medical history included hypothyroidism and hyper cholesterol. The patient's concomitant medications were not reported. The patient experienced swelling and itching at injection site on 11Jan2021 20:00. The patient did not receive treatment and was not pregnant. Outcome of events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: headache; arm pain; This is a spontaneous report from a contactable healthcare professional (reporting for herself) via Pfizer  and Medical information team. A female patient of an unspecified age (Age: 23; Units: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of vaccine today on 11Jan2021 and patient would like to know if she can take Ibuprofen or Tylenol for the headache and arm pain she experienced in Jan2021. The patient stated, "I read on my transact sheet that they say that you are not supposedly to take like ibuprofen before you get the second vaccine. If I have a headache can I take something or should I not?". The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hot flush
Clinical narrative: "hot flashes" in the middle of the night. She also mentioned that the same thing happened last night.; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unknown route of administration on 09Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient said she received the 1st dose of the bnt162b2 last Saturday. However, she said that after receiving the 1st dose of the vaccine, she started to experience "hot flashes" in the middle of the night. She also mentioned that the same thing happened last night. Patient wanted to know if this was normal. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity, Pyrexia
Clinical narrative: sore arm; She is experiencing a temperature of 100.5 F; This is a spontaneous report from a contactable consumer reported for herself. A female patient of an unspecified age (reported as 63, unit unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown), via an unspecified route of administration on 10Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received first dose on Sunday. She is experiencing a temperature of 100.5 F and a sore arm today on 11Jan2021. The patient would like to know what she should do. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Feeling abnormal, Headache, Inappropriate schedule of product administration
Clinical narrative: brain fog; intense headache; muscle aches; stomach pain; fatigue; 2nd dose on 06Jan2021; This is a spontaneous report from a contactable healthcare professional (patient). A 27-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), intramuscular left arm on 06Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included milk allergy. Patient was not pregnant. There were no concomitant medications. The patient took the 1st dose of BNT162B2 on 23Dec2020 15:30 (left arm). The patient experienced 5 days ongoing brain fog, intense headache, muscle aches, stomach pain, and fatigue on 06Jan2021 21:00. Outcome of the events of brain fog, headache, muscles aches, stomach pain and fatigue was not recovered. No treatment was given for the events. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: brain fog; intense headache; muscle aches; stomach pain; fatigue; 2nd dose on 06Jan2021; This is a spontaneous report from a contactable healthcare professional (patient). A 27-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), intramuscular left arm on 06Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included milk allergy. Patient was not pregnant. There were no concomitant medications. The patient took the 1st dose of BNT162B2 on 23Dec2020 15:30 (left arm). The patient experienced 5 days ongoing brain fog, intense headache, muscle aches, stomach pain, and fatigue on 06Jan2021 21:00. Outcome of the events of brain fog, headache, muscles aches, stomach pain and fatigue was not recovered. No treatment was given for the events. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  Information on the lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Musculoskeletal stiffness, Myalgia, Pruritus
Clinical narrative: Right side neck stiffness; small area on lower left arm itching (no rash); tenderness right side sternum and pec muscle; tenderness right side sternum and pec muscle; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EJ1686), via an unspecified route of administration in left arm on 11Jan2021 07:15 in a hospital at a single dose for COVID-19 immunization. Medical history included known allergies with CT contrasting agent, walnuts, pecans, patient also has high blood pressure, pre-diabetes, and depressive disorder. Concomitant medications included hydrochlorothiazide and lisinopril. The patient previously took (promethazine hydrochloride) REGAN and carbomer and experienced allergies. The patient experienced right side neck stiffness, small area on lower left arm itching (no rash), tenderness right side sternum and pec muscle on 11Jan2021 19:30. The patient was not pregnant. The patient does not have COVID prior vaccination. Patient was not tested for COVID post vaccination. No treatment was received for the adverse event. The outcome of the events was recovering.
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Food allergy, Granuloma, Reaction to preservatives
Clinical narrative: Disseminated Granuloma annular; My entire body was covered by the lesions; Leaving my skin damaged in many places; became allergic to many food and preservatives; became allergic to many food and preservatives; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient) from the Pfizer-sponsored program. A 73-year-old female patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (Manufacturer: Pfizer, lot number and expiration date unknown), and influenza vaccine (FLU VACCINE VII) both via unspecified routes of administration on an unspecified date in 2015 (reported as 6 years ago) at a single dose for immunization. The patient's medical history and concomitant medications were not reported. 6 years ago, after simultaneously receiving a Flu vaccine and a Pneumonia vaccine administered by a local pharmacy, the patient developed Disseminated Granuloma annular. It took almost 9 months, until the lesions fully came out. The patient's entire body was covered by the lesions, but her face. It took almost 1 year for the lesions to fade, leaving her skin damaged in many places. She became allergic to many foods, as well as preservatives in foods and drugs. The patient is 73-years-old and was asking if the COVID Vaccine is for her. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: Bells Palsy; This is a spontaneous report from a contactable Other HCP (patient).   A 63-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Lot # EL1284) intramuscular at single dose at left arm on 29Dec2020 16:30 for Covid-19 immunisation, administered at hospital.  Medical history included hypertension, thyroid disorder, high cholesterol, fibromyalgia, allergy to sulfur drugs and codeine. The patient was not pregnant. The patient had not experienced Covid-19 prior vaccination. The patient previously took codeine and experienced drug hypersensitivity. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine.  The patient experienced bells palsy on 11Jan2021. The event resulted in Emergency room/department or urgent care. The event bells palsy has been treated with steroids. Post vaccination, the patient has been not tested for COVID-19. The outcome of event was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of bells palsy cannot be excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Condition aggravated, Fatigue, Hunger, Mental fatigue
Clinical narrative: Felt brain fatigue; Felt very hungry before dinner; On 07Jan, after breakfast I suddenly felt tired, so took a nap; During the whole day I took three naps; Had sore arm; Between 15-30 min after injection, I felt light arrhythmia twice and I tried to do deeper breath to control it. About 1.5 hours after injection, in between my pull-up exercises I felt light arrhythmia; his legs were shaking which had never happened before; This is a spontaneous report from a  contactable consumer reporting for himself.  A 56-years-old male patient  received the first dose of bnt162b2 (BNT162B2; Lot # EL0140) vaccine , in the right arm on 05Jan2021 16:00 at single dose for Covid-19 immunisation .  The patient medical history and concomitant medications were not reported.  The patient experienced light arrhythmia  on 05Jan2021 16:30 with outcome of recovered , his legs were shaking which had never happened before on 05Jan2021 with outcome of unknown, had sore arm  on 06Jan2021 with outcome of recovered; felt brain fatigue  on 07Jan2021 with outcome of recovered ,  , felt very hungry before dinner  on 07Jan2021 with outcome of recovered , on 07Jan, after breakfast  felt tired, so took a nap  on 07Jan2021 with outcome of recovered , during the whole day i took three naps  on 07Jan2021 with outcome of recovered.   Course of the event: Between 15-30 min after injection, the patient felt light arrhythmia twice and  tried to do deeper breath to control it. About 1.5 hours after injection, in between his pull-up exercises he felt light arrhythmia 2-3 times, and after doing the third set of pull-ups his legs were shaking which had never happened before.  Next morning the patient  woke up a couple hours later than his normal time. Noting that the night before he went to bed one hour earlier for no reason. When semi-waking up, he had a strong arrhythmia, followed by a couple more light ones. In the past arrhythmia did occur to him when he was very stressed or very tired, but had not have it for a few years.  The patient had sore arm but tolerable. On 07Jan2021, after breakfast the patient suddenly felt tired, so took a nap. During the whole day he took three naps, which he had never done before. No arrhythmia though. The patient felt brain fatigue, but physically no problem. He felt very hungry before dinner, same as the day before, but not in other days.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence, Tremor
Clinical narrative: Felt brain fatigue; Felt very hungry before dinner; On 07Jan, after breakfast I suddenly felt tired, so took a nap; During the whole day I took three naps; Had sore arm; Between 15-30 min after injection, I felt light arrhythmia twice and I tried to do deeper breath to control it. About 1.5 hours after injection, in between my pull-up exercises I felt light arrhythmia; his legs were shaking which had never happened before; This is a spontaneous report from a  contactable consumer reporting for himself.  A 56-years-old male patient  received the first dose of bnt162b2 (BNT162B2; Lot # EL0140) vaccine , in the right arm on 05Jan2021 16:00 at single dose for Covid-19 immunisation .  The patient medical history and concomitant medications were not reported.  The patient experienced light arrhythmia  on 05Jan2021 16:30 with outcome of recovered , his legs were shaking which had never happened before on 05Jan2021 with outcome of unknown, had sore arm  on 06Jan2021 with outcome of recovered; felt brain fatigue  on 07Jan2021 with outcome of recovered ,  , felt very hungry before dinner  on 07Jan2021 with outcome of recovered , on 07Jan, after breakfast  felt tired, so took a nap  on 07Jan2021 with outcome of recovered , during the whole day i took three naps  on 07Jan2021 with outcome of recovered.   Course of the event: Between 15-30 min after injection, the patient felt light arrhythmia twice and  tried to do deeper breath to control it. About 1.5 hours after injection, in between his pull-up exercises he felt light arrhythmia 2-3 times, and after doing the third set of pull-ups his legs were shaking which had never happened before.  Next morning the patient  woke up a couple hours later than his normal time. Noting that the night before he went to bed one hour earlier for no reason. When semi-waking up, he had a strong arrhythmia, followed by a couple more light ones. In the past arrhythmia did occur to him when he was very stressed or very tired, but had not have it for a few years.  The patient had sore arm but tolerable. On 07Jan2021, after breakfast the patient suddenly felt tired, so took a nap. During the whole day he took three naps, which he had never done before. No arrhythmia though. The patient felt brain fatigue, but physically no problem. He felt very hungry before dinner, same as the day before, but not in other days.
Sex: F
Vaccine: PNC13
Symptoms: Ear infection, Infection, Sinusitis
Clinical narrative: double ear infection; double ear infection; sinus infection; This is a spontaneous report from a contactable pharmacist. A 44-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number: DJ7721, expiration date 31Jul2022), via an unspecified route of administration on 29Oct2020 at 0.5 mL, single for immunization. There were no medical history and concomitant medications. On 12Nov2020, two weeks later the patient developed the double ear infection and also experienced sinus infection on Nov2020. She had to go to the Emergency room for the double ear infection. So, the pharmacist said it was serious in her opinion. The sinus infection went away, but then she got the second double ear infection. The patient got the Prevnar 13 vaccine because she was getting a cochlear implant, and it was recommended by the surgeon. The patient said nothing else had changed except that she got the vaccine two weeks to the day of the side effects. The outcome of the event sinus infection was recovered while not recovered for the double ear infection.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: The association between the event lack of effect (ear infection) with PREVNAR 13 can not be fully excluded.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, Headache, Pain in extremity, SARS-CoV-2 test positive
Clinical narrative: she tested positive for the covid virus; she tested positive for the covid virus; her arm barely hurt (injection site); This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number unknown), via an unspecified route of administration in the arm on 02Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received her first Pfizer covid vaccine dose on 02Jan2021. She gets tested regularly at work. On 04Jan2021, she tested positive for the Covid virus. She had a headache, not feeling great on Friday, after she was diagnosed with the Covid virus, but no symptoms before. No side effects from vaccine, other than her arm barely hurt (injection site) in Jan2021. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Palpitations
Clinical narrative: 8 minutes after being vaccinated pt had extreme anxiety with heart palpitations. Hx of passing out after shots, vitals - nl. Exam - unremarkable Plan observe and home. Unlikely to be allergic Rx
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Injection site rash, Injection site swelling, Lymph node pain
Clinical narrative: 8 minutes after being vaccinated pt had extreme anxiety with heart palpitations. Hx of passing out after shots, vitals - nl. Exam - unremarkable Plan observe and home. Unlikely to be allergic Rx
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Coagulopathy, Fibrin D dimer increased, Injection site pain
Clinical narrative: Clotting event; Fibrin D dimer high; chest pains; Little injection site soreness; This is a spontaneous report from a contactable consumer reporting for himself. A male patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer -BioNTech), via an unspecified route of administration in the arm, on 22Dec2020, at single dose, for COVID-19 immunisation. Medical history was none. Concomitant medications were not reported. The patient experienced fibrin d dimer high in Jan2021 with outcome of unknown, clotting event on 03Jan2021 with outcome of unknown, chest pains on 03Jan2021 with outcome of unknown, little injection site soreness on 22Dec2020 with outcome of unknown. The events fibrin D dimer high and clotting event caused patient's hospitalization in Jan2021. The patient underwent lab tests and procedures which included fibrin d dimer: high in Jan2021. The patient was vaccinated on 22Dec2020 close to the evening and had a normal response with a little soreness in the arm at the injection site. Then on 03Jan2021, he reported to be having chest pains that he never had before and went to the emergency department (ED) due to a clotting event. Upon blood work, they discovered that his D-dimer was elevated and was really high for his age. He mentioned that he had no history and no issues with this whatsoever before. He received the 2nd dose on 11Jan2021.   The information on the lot/batch number has been requested.
Age: 80.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Chest scan, Computerised tomogram head, Headache, Magnetic resonance imaging
Clinical narrative: headache; This is a spontaneous report from a contactable consumer. An 80-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on the left arm on 21Sep2020 at a single dose for immunization and influenza vaccine (FLU VACCINE), via an unspecified route of administration on the right arm on 21Sep2020 at an unspecified dose for immunization. Medical history included pneumonia from an unknown date and unknown if ongoing.  There were no concomitant medications. It was reported that the patient received the pneumococcal 13-valent conjugate vaccine and flu vaccine 21Sep2020 and on 22Sep2020, the patient has had a headache ever since. She wanted to know what she can do about the headache and is it safe to take the COVID-19 vaccine or wait until the headaches stops. She has had this headache since she got the pneumococcal 13-valent conjugate vaccine and she has seen several doctors and had a MRI, she's had head scans and chest scans and everything they could think of, the doctors are stumped. Sometimes, she takes Advil and it will go away sometimes it will not go away. She was wondering if others have had that experience and what they have done about it. She does not have any dose information for the pneumococcal 13-valent conjugate vaccine. She said it was the first dose of pneumococcal 13-valent conjugate vaccine. She understands there are 2, you get the first one and later you get a second one. When asked for the indication, she stated that with the COVID virus many people her age was dying from pneumonia. She had pneumonia 40 years ago so she figured it would be a good idea to get the pneumonia vaccine first and then see if it is compatible with the COVID vaccine but she does not want to get the COVID vaccine if she still has a headache. She did not know what the name of the flu vaccine was. She just knew they gave the flu vaccine in the right arm and pneumococcal 13-valent conjugate vaccine in the left arm and she said they would not counteract each other, they were safe, so she took her word for it. Indication for flu vaccine: The doctor wanted her and her husband to get it, he is 88 and she is 80 so the doctor wanted them to get it to protect them through the winter. He wanted them to get it in Sep before the flu season hit. No further information provided. She says there is no other medicines medical conditions or lab results to add. That is what has stumped her. She has been in excellent health for her age. The outcome of the event was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Ear pain, Headache, Neuralgia
Clinical narrative: Low grade fever (99.9) body aches, nerve pain chills, headache, ear pain; Low grade fever (99.9) body aches, nerve pain chills, headache, ear pain; Low grade fever (99.9) body aches, nerve pain chills, headache, ear pain; Low grade fever (99.9) body aches, nerve pain chills, headache, ear pain; Low grade fever (99.9) body aches, nerve pain chills, headache, ear pain; Low grade fever (99.9) body aches, nerve pain chills, headache, ear pain; This is a spontaneous report from a contactable Nurse (patient).  A 51-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number El3248), via an unspecified route of administration in the left arm on 09Jan2021 06:30 at single dose for COVID-19 immunisation at hospital. Medical history included asthma, seasonal allergy, milk allergy, eucalyptus allergy.  Concomitant medication included montelukast sodium (SINGULAIR), levocetirizine dihydrochloride (XYZAL), ciclosporin (RESTASIS, eye drop). The patient previously took tetanus vaccine and experienced drug hypersensitivity.  The patient experienced low grade fever (99.9 F) body aches, nerve pain chills, headache, ear pain on 10Jan2021 08:00 with outcome of recovered. The patient took diphenhydramine hydrochloride (BENADRYL) 25mg every 6 hours and it relieved all symptoms. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Low grade fever (99.9) body aches, nerve pain chills, headache, ear pain; Low grade fever (99.9) body aches, nerve pain chills, headache, ear pain; Low grade fever (99.9) body aches, nerve pain chills, headache, ear pain; Low grade fever (99.9) body aches, nerve pain chills, headache, ear pain; Low grade fever (99.9) body aches, nerve pain chills, headache, ear pain; Low grade fever (99.9) body aches, nerve pain chills, headache, ear pain; This is a spontaneous report from a contactable Nurse (patient).  A 51-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number El3248), via an unspecified route of administration in the left arm on 09Jan2021 06:30 at single dose for COVID-19 immunisation at hospital. Medical history included asthma, seasonal allergy, milk allergy, eucalyptus allergy.  Concomitant medication included montelukast sodium (SINGULAIR), levocetirizine dihydrochloride (XYZAL), ciclosporin (RESTASIS, eye drop). The patient previously took tetanus vaccine and experienced drug hypersensitivity.  The patient experienced low grade fever (99.9 F) body aches, nerve pain chills, headache, ear pain on 10Jan2021 08:00 with outcome of recovered. The patient took diphenhydramine hydrochloride (BENADRYL) 25mg every 6 hours and it relieved all symptoms. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Peripheral swelling
Clinical narrative: I have swelling under my arm (lymph node) after receiving second dose of the Shingrix vaccine.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Nipple pain, Vaccination site pain
Clinical narrative: Headache; Tired; Diarrhea; Sore nipples; Sore injection site; This is a spontaneous report from a contactable healthcare professional (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported), intramuscularly on the left arm on 09Jan2021 (08:15) at a single dose for COVID-19 immunization at the hospital. The patient had no relevant medical history. The patient's concomitant medications were not reported. On 09Jan2021, the patient had headache; was tired; had diarrhea; sore nipples; and sore injection site. The patient did not receive any treatment for the reported events. The outcome of the events, 'headache', 'tired', 'diarrhea', 'sore nipples' and 'sore injection site', was recovering. The patient was not diagnosed with COVID-19 prior to vaccination, and was not tested post-vaccination.  Information about lot and batch number was requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: Body aches; chills; headache; fatigue; This is a spontaneous report from a contactable nurse (patient).  A 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration at right arm on 11Jan2021 at 10:45 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration at left arm on 23Dec2020 at 17:30 at single dose for COVID-19 immunization. On 12Jan2021 at 02:00, the patient experienced body aches, chills, headache and fatigue. The patient outcome of the events was recovering.