chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Cold sore on my lip; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101493330 (Pfizer).  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), for COVID-19 immunization. The following information was reported: ORAL HERPES (non-serious), outcome "unknown", described as "Cold sore on my lip".  Additional information: The patient had an appointment for a booster tomorrow. She got a cold sore on her lip on Friday. She was wondering whether she should have that vaccine tomorrow or postpone. The patient does not want to complete a Questionnaire.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever and chills; Fever and chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid19 vaccine (Dose number: 1, prev dose product=COVID 19, prev dose brand unknown=True, prev dose brand name unknown=COVID19 Vaccine), for Covid-19 immunization; Covid19 vaccine (Dose number: 2, prev dose product=COVID 19, prev dose brand unknown=True, prev dose brand name unknown=COVID19 Vaccine), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious), CHILLS (non-serious) all with onset Oct2021, outcome "recovered" (2021) and all described as "Fever and chills". It was unknown if therapeutic measures were taken as a result of pyrexia, chills.  Additional information: Facility type vaccine was Workplace clinic. It was unknown if the patient received other vaccine in four weeks. It was unknown if the patient had covid prior vaccination. The patient was not tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthma, Dizziness, Dyspnoea, Menstruation irregular
Clinical narrative: Palpitations; Lightheaded; SOB; Asthma; Wheezing; Got my period 2 weeks early; My joints have been super painful; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Oct2021 17:00 (Lot number: Ff2590) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Ehlers danlos syndrome" (unspecified if ongoing). Concomitant medication(s) included: VIT D [VITAMIN D NOS]; IBUPROFEN. The following information was reported: PALPITATIONS (non-serious) with onset 12Oct2021 18:00, outcome "recovering", described as "Palpitations"; DIZZINESS (non-serious) with onset 12Oct2021 18:00, outcome "recovering", described as "Lightheaded"; DYSPNOEA (non-serious) with onset 12Oct2021 18:00, outcome "recovered" (Oct2021), described as "SOB"; ASTHMA (non-serious) with onset 12Oct2021 18:00, outcome "recovering", described as "Asthma"; WHEEZING (non-serious) with onset 12Oct2021 18:00, outcome "recovering", described as "Wheezing "; MENSTRUATION IRREGULAR (non-serious) with onset 12Oct2021 18:00, outcome "recovering", described as "Got my period 2 weeks early"; ARTHRALGIA (non-serious) with onset 12Oct2021 18:00, outcome "recovering", described as "My joints have been super painful". Therapeutic measures were not taken as a result of palpitations, dizziness, dyspnoea, asthma, wheezing, menstruation irregular, arthralgia.  Additional Information: Facility type Vaccine: Pharmacy or Drug Store. No other vaccines in four weeks. No covid prior vaccination. No Covid tested post vaccination. No known allergies.   No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Wheezing
Clinical narrative: Palpitations; Lightheaded; SOB; Asthma; Wheezing; Got my period 2 weeks early; My joints have been super painful; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Oct2021 17:00 (Lot number: Ff2590) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Ehlers danlos syndrome" (unspecified if ongoing). Concomitant medication(s) included: VIT D [VITAMIN D NOS]; IBUPROFEN. The following information was reported: PALPITATIONS (non-serious) with onset 12Oct2021 18:00, outcome "recovering", described as "Palpitations"; DIZZINESS (non-serious) with onset 12Oct2021 18:00, outcome "recovering", described as "Lightheaded"; DYSPNOEA (non-serious) with onset 12Oct2021 18:00, outcome "recovered" (Oct2021), described as "SOB"; ASTHMA (non-serious) with onset 12Oct2021 18:00, outcome "recovering", described as "Asthma"; WHEEZING (non-serious) with onset 12Oct2021 18:00, outcome "recovering", described as "Wheezing "; MENSTRUATION IRREGULAR (non-serious) with onset 12Oct2021 18:00, outcome "recovering", described as "Got my period 2 weeks early"; ARTHRALGIA (non-serious) with onset 12Oct2021 18:00, outcome "recovering", described as "My joints have been super painful". Therapeutic measures were not taken as a result of palpitations, dizziness, dyspnoea, asthma, wheezing, menstruation irregular, arthralgia.  Additional Information: Facility type Vaccine: Pharmacy or Drug Store. No other vaccines in four weeks. No covid prior vaccination. No Covid tested post vaccination. No known allergies.   No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated
Clinical narrative: left shoulder still hurts since the injections/ It has seemed to get worse. There are days where it really hurts him. He he can feel it; shoulder pain in the arm of injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 81 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Mar2021 09:45 (Lot number: EL9267) at the age of 80 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Myeloma" (ongoing), notes: He was diagnosed with both of those 10 years ago.; "Melanoma" (ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, First vaccine Lot: EL3247; Left arm), administration date: 09Feb2021, when the patient was 80 years old, for Covid-19 immunization, reaction(s): "The arm pain started maybe a couple of days after the first dose". The following information was reported: CONDITION AGGRAVATED (non-serious) with onset Mar2021, outcome "not recovered", described as "left shoulder still hurts since the injections/ It has seemed to get worse. There are days where it really hurts him. He he can feel it"; ARTHRALGIA (non-serious) with onset Mar2021, outcome "not recovered", described as "shoulder pain in the arm of injection". Therapeutic measures were taken as a result of condition aggravated, arthralgia.  Additional information: There was no additional vaccines administered on same date of the Pfizer Suspect. There was no emergency room visit or physician's office visit due to the adverse events. No prior vaccinations (within 4 weeks) was administered.    Agent reports that ever since, he has been having shoulder pain in the arm of injection which is his left arm for both doses. Agent reports that it hurts some days more than others and sometimes he can't lift his arm over his head. He has tried hot and cold presses on it and it didn't help. it happened after the second dose. He does not have a regular doctor, only has a cancer doctor. It isn't painful, but it hurts. He can't lift his left arm as high as his right. No prescribing doctor. He doesn't have primary care. He has tried hot and cold therapy. He has given it time. He thinks he has given it plenty of time since the injection for it to get better. There are days where he can't lift his arm over his head. He does have two types of cancer. He has Myeloma, blood cancer, and Melanoma, skin cancer.    Follow-up attempts completed. No further information expected..
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Dyspnoea, Fatigue, Gait disturbance
Clinical narrative: Chills; a small fever; Stomach ache; very tired; Very sore arm; breath was short; couldn't walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old patient received bnt162b2 (BNT162B2), administration date 2021 (Lot number: EW0171, Expiration Date: 30Nov2021) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for COVID-19 immunization, reaction(s): "had a sore arm"; Bnt162b2 (dose 2, single), for COVID-19 immunization, reaction(s): "very tired", "big bump on the arm", "sore arm". The following information was reported: CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Chills"; PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "a small fever"; ABDOMINAL PAIN UPPER (non-serious) with onset 2021, outcome "recovered" (2021), described as "Stomach ache"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "very tired"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "Very sore arm"; DYSPNOEA (non-serious) with onset 2021, outcome "recovered" (2021), described as "breath was short"; GAIT DISTURBANCE (non-serious) with onset 2021, outcome "recovered" (2021), described as "couldn't walk".  Additional Information: Patient is a Vet (further clarification unknown), who took the booster vaccine (Further not clarified, hence captured as Unspecified Vaccine) and experienced events for three days. Patient went to withheld with his/her dad who was 85 years old and they told patient that they took it (booster), they said him/her to take it too, If patient have more than six months. Patient had card in the wallet and was eight months out .So patient took the booster vaccine so, eight months from second vaccine, patient would like Pfizer to know that was patient was healthy, never sick, when patient got the other two shots, two vaccines and had a sore arm. The second vaccine, one very tired day with the sore arm, a big bump on the arm but that was the side effects that was it was one sore arm and one tired day. Patient took the booster vaccine and that has every symptoms which are described. Patient don't regret that patient took the booster not calling to complain. Patient just wanted to inform this happened because may be it helps in future to understand the reactions on it. It is helpful to the vaccine to the Pfizer company in general.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Chills; a small fever; Stomach ache; very tired; Very sore arm; breath was short; couldn't walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old patient received bnt162b2 (BNT162B2), administration date 2021 (Lot number: EW0171, Expiration Date: 30Nov2021) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for COVID-19 immunization, reaction(s): "had a sore arm"; Bnt162b2 (dose 2, single), for COVID-19 immunization, reaction(s): "very tired", "big bump on the arm", "sore arm". The following information was reported: CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Chills"; PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "a small fever"; ABDOMINAL PAIN UPPER (non-serious) with onset 2021, outcome "recovered" (2021), described as "Stomach ache"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "very tired"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "Very sore arm"; DYSPNOEA (non-serious) with onset 2021, outcome "recovered" (2021), described as "breath was short"; GAIT DISTURBANCE (non-serious) with onset 2021, outcome "recovered" (2021), described as "couldn't walk".  Additional Information: Patient is a Vet (further clarification unknown), who took the booster vaccine (Further not clarified, hence captured as Unspecified Vaccine) and experienced events for three days. Patient went to withheld with his/her dad who was 85 years old and they told patient that they took it (booster), they said him/her to take it too, If patient have more than six months. Patient had card in the wallet and was eight months out .So patient took the booster vaccine so, eight months from second vaccine, patient would like Pfizer to know that was patient was healthy, never sick, when patient got the other two shots, two vaccines and had a sore arm. The second vaccine, one very tired day with the sore arm, a big bump on the arm but that was the side effects that was it was one sore arm and one tired day. Patient took the booster vaccine and that has every symptoms which are described. Patient don't regret that patient took the booster not calling to complain. Patient just wanted to inform this happened because may be it helps in future to understand the reactions on it. It is helpful to the vaccine to the Pfizer company in general.   Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Her arm is still sore; having a lot of joint aches. Her joints hurt.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2), administration date 19Jul2021 (Lot number: GWO217) at the age of 76 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Seizures" (unspecified if ongoing). Concomitant medication(s) included: DILANTIN [PHENYTOIN]; PHENOBARBITAL taken for seizure. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 19Jul2021, outcome "not recovered", described as "Her arm is still sore"; ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "having a lot of joint aches. Her joints hurt.". The events "her arm is still sore" and "having a lot of joint aches. her joints hurt." were evaluated at the physician office visit.  Additional Information: The first one she got on 19Jul2021. Her arm was still sore. She has been having a lot of joint aches. Her joints hurt. She didn't connect the two until she read the letter. She has been to the doctor for her yearly check up. Her doctor was in a hurry. There were other things bothering her that she wanted to talk to the doctor about. Since her doctor was in a hurry she didn't get to those side effects.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder, SARS-CoV-2 test
Clinical narrative: Heavy and early menstural cycle; Heavy and early menstural cycle; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18Mar2021 14:00 (Batch/Lot number: unknown) at the age of 36 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MENSTRUAL DISORDER (non-serious), HEAVY MENSTRUAL BLEEDING (non-serious) all with onset 25Mar2021 15:00, outcome "recovered" and all described as "Heavy and early menstural cycle". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstrual disorder, heavy menstrual bleeding.  Additional information: The month the vaccine was administered, a surprising heavy and early menstrual cycle took place. Never had my cycle been anything other than perfect. Prior to vaccination, the patient was not diagnosed with COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pruritus, Urticaria
Clinical narrative: Hives on my back and my chest/I broke out with all over with hives and all my chest; Not feeling good right now; I am itching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101504152 (Pfizer).  A 75 year-old female patient received bnt162b2 (COMIRNATY), administration date 01Nov2021 16:00 (Lot number: FF2593) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, Lot number: EN6199), administration date: 04Mar2021, when the patient was 74 years old, for Covid-19 immunization; Bnt162b2 (2nd dose, Lot number: EN6207, Expiry Date: 31Jul2021), administration date: 25Mar2021, when the patient was 74 years old, for Covid-19 immunization. The following information was reported: URTICARIA (non-serious) with onset 02Nov2021 21:00, outcome "unknown", described as "Hives on my back and my chest/I broke out with all over with hives and all my chest"; MALAISE (non-serious) with onset 02Nov2021 21:00, outcome "not recovered", described as "Not feeling good right now"; PRURITUS (non-serious) with onset 02Nov2021 21:00, outcome "unknown", described as "I am itching". Therapeutic measures were taken as a result of urticaria, malaise, pruritus. The patient took medicine for her itching called Levocetirizine, for itching.   No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Headache, Pyrexia
Clinical narrative: chills; fever/Temperature was 101; dizziness; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 36 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Nov2021 10:00 (Lot number: FH8028) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose, Route: Injected into his arm), administration date: 2021, for Covid-19 Immunization; Bnt162b2 (Second dose, Route: Injected into his arm, This was 6-8 months ago. He recovered completely.), administration date: 2021, for covid-19 immunization, reaction(s): "fever"; Flu shot (more than one month ago.)  The following information was reported: CHILLS (non-serious) with onset 02Nov2021 20:30, outcome "recovered" (03Nov2021), described as "chills"; PYREXIA (non-serious) with onset 02Nov2021 20:30, outcome "not recovered", described as "fever/Temperature was 101"; DIZZINESS (non-serious) with onset 02Nov2021, outcome "unknown", described as "dizziness"; HEADACHE (non-serious) with onset 02Nov2021, outcome "unknown", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chills, pyrexia, headache.  Additional information: That evening, had chills and fever. Took Tylenol and it subsided. Fever again in the morning. Took one more Tylenol and it subsided. In the afternoon, fever came up again. Took one more Tylenol and it subsided. Temperature was 101. Family Medical History Relevant to AE(s) and Relevant Tests None. Initially caller stated he knows this is related to COVID. Clarified, that caller knows it's related to the COVID-19 Vaccine because he did not take anything else. Confirmed caller did not test positive for COVID-19. Dizziness: States it's subsided, but he still has some lightheadedness in his head because of all of the symptoms.  Headache: Has subsided today, but kind of has a headache feeling. Doesn't know if it will come back again because he is on medication. The Tylenol only has a half-life of 6-8 hours. Not sure if it's going to come back. Patient underwent lab test procedures which included: On 02Nov2021 101 temperature.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: hip joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 22Mar2021 14:30 (Lot number: ER2613) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Breast cancer", start date: 1993, stop date: 1996, notes: Stop Date-1996, Pertinent details: Jan-1996; "Chronic back pain", start date: 2003 (ongoing); "Mastectomy", start date: Jan1996 (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL taken for hypertension (ongoing); LOSARTAN taken for hypertension (ongoing); ROSUVASTATIN taken for blood cholesterol abnormal (ongoing). Vaccination history included: Bnt162b2 (Dose-1, Administration time-15:30, Anatomical site of injection-Right upper arm, Route of administration-Intramuscular, Batch/Lot No-DN6200), administration date: 22Feb2021, for COVID-19 immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 23Mar2021, outcome "recovered" (26Mar2021), described as "hip joint pain". Therapeutic measures were not taken as a result of arthralgia.  Additional information: no prior vaccinations.  No follow-up attempts are possible. No further information is expected. No relevant tests done.  Follow-Up (05Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: headache; Soreness in arm; low grade fever; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Nov2021 13:00 (Lot number: FG3527) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Acne" (unspecified if ongoing), notes: Reaction: Allergy. Concomitant medication(s) included: SPIRONOLACTONE taken for acne, start date: 2004 (ongoing). Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: EP6955, Location of injection: Arm Left, Time: 11:00 AM, Route of administration: Intramuscular), administration date: 24Mar2021, when the patient was 46 years old, for COVID-19 immunisation; Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: EL3247, Location of injection: Arm Left, Time: 11:00 AM, Route of administration: Intramuscular), administration date: 04Mar2021, when the patient was 46 years old, for COVID-19 immunisation; Fluzone quad (Manufacturer: Sanofi, Batch/Lot#: UT7316KA, Route: Intramuscular, Anatomical site of injection: Left Arm), administration date: 03Oct2021, for Immunization. The following information was reported: HEADACHE (non-serious) with onset 03Nov2021 22:00, outcome "recovered" (Nov2021), described as "headache"; PAIN IN EXTREMITY (non-serious) with onset 03Nov2021 22:00, outcome "recovered" (Nov2021), described as "Soreness in arm"; PYREXIA (non-serious) with onset 03Nov2021 12:00, outcome "recovered" (Nov2021), described as "low grade fever"; CHILLS (non-serious) with onset 03Nov2021 12:00, outcome "recovered" (Nov2021), described as "chills". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, pain in extremity, pyrexia, chills.  Additional information: The patient took advil 8 am following day and the fever was gone by lunch time. Headache  was gone by dinner time, Arm soreness lasted for 2 days and Chills only lasted-4 hrs. Patient was not diagnosed with COVID-19 prior to vaccination. Patient was not tested for covid-19 since the vaccination. The vaccine which received within 4 weeks prior was of sanofi-pasteur in left arm. No hospitalization Prolonged. COVID-19 vaccine was administered in Pharmacy or Drug Store  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Pain, Pyrexia
Clinical narrative: woke up feeling achy; with flu like symptoms; chills; low fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 02Nov2021 12:00 (Lot number: 320308N) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose number: 2, Time (24): 02:15 PM, Anatomical Site of Injection : Right upper arm, Route of administration : Intramuscular, Batch/lot number: EN6205 Expiry date: 30Jun2021), administration date: 13Mar2021, when the patient was 66 years old, for COVID-19 Immunization; Bnt162b2 (Dose number: 1, Time (24): 12:45 PM, Anatomical Site of Injection: Right upper arm, Route of administration: Intramuscular, Batch/lot number: EL9266 Expiry date: 31May2021), administration date: 22Feb2021, when the patient was 66 years old, for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset 03Nov2021 08:00, outcome "recovering", described as "woke up feeling achy"; INFLUENZA LIKE ILLNESS (non-serious) with onset 03Nov2021 08:00, outcome "recovering", described as "with flu like symptoms"; CHILLS (non-serious) with onset 03Nov2021 08:00, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 03Nov2021 08:00, outcome "recovering", described as "low fever". Therapeutic measures were not taken as a result of pain, influenza like illness, chills, pyrexia.  Additional information: It was reported that previous doses were also Pfizer. No prior vaccination within 4 weeks. No Relevant Tests were reported. no specific relevant test for thromboembolic events With thrombocytopenia were done. The events were non-serious. It was reported that patient feel better from the second day.  No follow-up attempts are possible. No further information is expected.  Follow-up (06Dec2021): Follow-up attempts completed. No further information expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: lymphadenopathy/ lymph node under her left arm is as big as a golf ball; Fever; pain under left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Nov2021 14:00 (Lot number: FF8841) at the age of 59 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 04Nov2021, outcome "unknown", described as "lymphadenopathy/ lymph node under her left arm is as big as a golf ball"; PYREXIA (non-serious) with onset 03Nov2021, outcome "recovering", described as "Fever"; PAIN (non-serious) with onset 03Nov2021, outcome "not recovered", described as "pain under left arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, pain.  Additional information: Reporter stated that she got her first dose on 02Nov2021 on Tuesday and was experiencing lymphadenopathy under her left arm that is as big as golf ball. queried for information regarding this and treatment recommendations. Reporter queried if any reports on abnormal mammograms after getting lymphadenopathy. The lymph node under her left arm is as big as a golf ball. She got the vaccine at the local health department. She was mandated by her employer to get and if she had an abnormal mammogram after this, it will not come out of her pocket. Her left arm started hurting last night and this morning before she went in the shower noticed how big the lymph node was and said this why she had pain in her arm. She had a fever yesterday that has improved. Patient received treatment of taking Tylenol and Advil. Reporter stated that she was healthy. The reason for getting the vaccination had only because it was mandated by the government and her employer had to comply her work full time remotely from home she contracted covid in Sep2020 with very little discomfort she felt work from the shot than she did fron covid she totally disagree with the government forcing to put this vaccination in her body against her will. No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: he did have an allergic reaction with the vaccine/He had the allergic reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 67 year-old male patient received bnt162b2 (COMIRNATY), administration date 11Mar2021 (Lot number: EN6205) at the age of 67 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALLERGY TO VACCINE (non-serious) with onset 11Mar2021, outcome "unknown", described as "he did have an allergic reaction with the vaccine/He had the allergic reaction".  Additional information: Patient was asking how to find out which component of the Pfizer Biontech COVID19 vaccine he is allergic with. Patient said he did have an allergic reaction with the vaccine on 11Mar2021. Patient said his HCP told him to call Pfizer to know where can he get the allergy testing and he needs to know the location. Patient said the testing for the component is not common and does not exist in every state. Patient said he left a detailed message of his reaction on 12Mar2021 over a telephone message machine with CDC and explained that he do not use the internet. Patient mentioned that he had the allergic reaction (Event captured as per verbatim) with vaccine on 11Mar2021. Patient stated, his weight "About 170(not further clarified, hence not captured in tab)." Patient was not prescribed covid19 vaccine at doctor office / It was took it from facility where many, many people to come to in their car, I had it in my car. I think, that is all as true. Patient was stated, "I don't see expiration date."  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Glycosylated haemoglobin increased, Pyrexia, Vaccination site pain
Clinical narrative: slight pain in arm, vaccine was administered; a little feverish; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 28Apr2021 13:00 (Lot number: EW0171) at the age of 55 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "cholesterol", start date: 2015 (ongoing). Family history included: "HBP", start date: 2003 (ongoing); "Diabetes", start date: 2018 (ongoing), notes: Diet and exercise controlled 17Jun2021 - A1C was 6.8 and Glucose mg/DL was 149. Concomitant medication(s) included: COZAAR taken for hypertension, start date: 2012 (ongoing); HCTZ taken for hypertension, start date: 2012 (ongoing); PRAVASTATIN taken for blood cholesterol, start date: 2015 (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Time: 13:00., Anatomical Site of injection: Right arm, Route of administration: Intramuscular, Batch/Lot number:Pfizer EW0151), administration date: 07Apr2021, when the patient was 54 years old, for Covid-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "slight pain in arm, vaccine was administered"; PYREXIA (non-serious), outcome "unknown", described as "a little feverish". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information:The patient did not receive any other vaccines within four weeks prior to the vaccination. Second dose had slight pain in arm, vaccine was administered, a little feverish that night, took one advil. Patient received treatment for the event fever with advil.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose No: 1), for Covid-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "injection site pain".  Additional information: PQC Details: Product: Question: Caller explained he reported his son's AE to agent who referred him for medical inquiries about the Pfizer-BioNTech COVID-19 vaccine. E-transmitting as duplicate. Note that the father's AE below may not have being reported during the initial report. Reporter Subtype: Caregiver. 63-year-old caller explained that his 15-year-old son, Withheld, received the first dose of the Pfiz-er-BioNTech COVID-19 vaccine Wednesday and experienced side effects from the vaccine Thurs-day. He listed the following ones: "mild injection site pain, tiredness almost like weakness, sinus headache, felling unwell, a little nausea, and diarrhea". He specified his "son was not tired to the point of being bedridden" but it interfered with daily activities, and he didn't accept his invitation to go out. He added the weakness was not associated with any signs of anaphylaxis. He explained today, Friday, his son is "better in all these regards". He mentioned he experienced a "little short-ness of breath, the kind you get when you have to take a deep breath" when speaking. He explained they are accustomed to hot and dry weather from (with held) and have move to an area that is "hot and moggy". He specified it is "92 and humid today" and this may have caused the shortness of breath as his son is "overweight". Caller stated he had nothing after getting the first dose of the vaccine, but experienced side effects form the second dose only, as most people do. He specified having injection site pain. He asked if it is normal for his son to have experience side effects from the first dose of the vaccine.  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: Rash, SARS-CoV-2 test
Clinical narrative: developing a rash over various parts of my body- back, arms, legs, stomach, head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 13:00 (Lot number: ER8727) at the age of 57 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: RASH (non-serious) with onset 26Mar2021, outcome "not recovered", described as "developing a rash over various parts of my body- back, arms, legs, stomach, head". The event "developing a rash over various parts of my body- back, arms, legs, stomach, head" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, no other medications within 2 weeks of vaccination. Cream was treatment received for adverse event. The patient was not diagnosed with COVID-19 Prior to vaccination and was been tested since vaccination. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Pruritus, Rash erythematous
Clinical narrative: I start around probably around 1:30, 1:15 something rash like, I am scratching and I am getting all red; It looks like I am getting a side effect of rash; I am not comfortable; I start around probably around 1:30, 1:15 something rash like, I am scratching and I am getting all red; It looks like I am getting a side effect of rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 05Nov2021 (Lot number: FF2593, Expiration Date: 19Nov2021) as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for Covid-19 Immunization; Bnt162b2 (Second Dose), for covid-19 immunization. The following information was reported: PRURITUS (non-serious), RASH ERYTHEMATOUS (non-serious) all with onset 2021, outcome "recovering" and all described as "I start around probably around 1:30, 1:15 something rash like, I am scratching and I am getting all red; It looks like I am getting a side effect of rash"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "recovering", described as "I am not comfortable".  Additional information: The patient stated, "Right now I am very concerned very, very because my two shots before this one and I never have this experience. I am very concerned because is the rash I am having and it's like a side effect from the three vaccine that I have for Covid. So it looks like that I". NDC and UPC number of Covid-19 Vaccine was Unknown.  No follow-up attempts are possible. No further information is expected.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Migraine
Clinical narrative: Severe migraines the following day non stop since the first dose.; Is pregnant Yes, last menstrual date 06Jul2021; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 36 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administration date 31Aug2021 (Batch/Lot number: unknown) at the age of 36 years as dose 1, single and administration date 21Sep2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Date of last menstrual period: 06Jul2021. The patient was 8 weeks pregnant at the time of exposure to bnt162b2. The patient was 12 weeks pregnant at the event onset. The patient is expected to deliver a baby(s). There were no concomitant medications. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 2021, outcome "unknown", described as "Is pregnant Yes, last menstrual date 06Jul2021"; MIGRAINE (non-serious) with onset 01Sep2021, outcome "not recovered", described as "Severe migraines the following day non stop since the first dose.". The event "severe migraines the following day non stop since the first dose." was evaluated at the physician office visit. Therapeutic measures were taken as a result of migraine.  Additional Information: No Seriousness criteria-Results in death. No Seriousness criteria-Life threatening. No Seriousness criteria-Caused/prolonged hospitalization. No Seriousness criteria-Disabling/Incapacitating. No Seriousness criteria-Congenital anomaly/birth defect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.The patient had no Allergy history. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  No follow up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Body temperature, Body temperature increased, Chills
Clinical narrative: Elevated temp; Sore armpit; Night sweats; Left arm pit is also swollen; Chills; aches; Headache; Sore shoulder at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Nov2021 11:00 (Lot number: EW0217) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN5318, Vaccine Administration Time: 09:00 AM), administration date: 16Feb2021, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN5318, Vaccine Administration Time: 09:00 AM), administration date: 27Jan2021, for COVID-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 05Nov2021 23:00, outcome "recovered" (06Nov2021), described as "Chills"; PAIN (non-serious) with onset 05Nov2021 23:00, outcome "recovered" (06Nov2021), described as "aches"; HEADACHE (non-serious) with onset 05Nov2021 23:00, outcome "recovering", described as "Headache"; ARTHRALGIA (non-serious) with onset 05Nov2021 19:00, outcome "not recovered", described as "Sore shoulder at injection site"; BODY TEMPERATURE INCREASED (non-serious) with onset 07Nov2021, outcome "recovering", described as "Elevated temp"; AXILLARY PAIN (non-serious) with onset 06Nov2021, outcome "not recovered", described as "Sore armpit"; NIGHT SWEATS (non-serious) with onset 06Nov2021, outcome "recovering", described as "Night sweats"; PERIPHERAL SWELLING (non-serious) with onset 05Nov2021 23:00, outcome "recovering", described as "Left arm pit is also swollen". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pain, headache, arthralgia, body temperature increased, axillary pain, night sweats, peripheral swelling. Additional information: Patient had no known allergies. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Facility type vaccine: Workplace clinic  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Night sweats, Pain, Peripheral swelling
Clinical narrative: Elevated temp; Sore armpit; Night sweats; Left arm pit is also swollen; Chills; aches; Headache; Sore shoulder at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Nov2021 11:00 (Lot number: EW0217) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN5318, Vaccine Administration Time: 09:00 AM), administration date: 16Feb2021, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN5318, Vaccine Administration Time: 09:00 AM), administration date: 27Jan2021, for COVID-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 05Nov2021 23:00, outcome "recovered" (06Nov2021), described as "Chills"; PAIN (non-serious) with onset 05Nov2021 23:00, outcome "recovered" (06Nov2021), described as "aches"; HEADACHE (non-serious) with onset 05Nov2021 23:00, outcome "recovering", described as "Headache"; ARTHRALGIA (non-serious) with onset 05Nov2021 19:00, outcome "not recovered", described as "Sore shoulder at injection site"; BODY TEMPERATURE INCREASED (non-serious) with onset 07Nov2021, outcome "recovering", described as "Elevated temp"; AXILLARY PAIN (non-serious) with onset 06Nov2021, outcome "not recovered", described as "Sore armpit"; NIGHT SWEATS (non-serious) with onset 06Nov2021, outcome "recovering", described as "Night sweats"; PERIPHERAL SWELLING (non-serious) with onset 05Nov2021 23:00, outcome "recovering", described as "Left arm pit is also swollen". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pain, headache, arthralgia, body temperature increased, axillary pain, night sweats, peripheral swelling. Additional information: Patient had no known allergies. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Facility type vaccine: Workplace clinic  No follow-up attempts are possible. No further information is expected.