chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy
Clinical narrative: Lethargic; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left, administration date 05Feb2021 14:00 (Batch/Lot number: unknown) at the age of 60 years as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162B2 (Dose: 1st, Time: 14:00, Anatomical site of injection: Left arm, Route of administration: Intramuscular), administration date: 15Jan2021, for COVID-19 immunisation, reaction(s): "Diarrhea". The following information was reported: LETHARGY (non-serious) with onset 06Feb2021 09:00, outcome "recovered" (07Feb2021), described as "Lethargic". Therapeutic measures were taken as a result of lethargy.  Additional information: The patient had no prior vaccinations. The patient did not undergo relevant tests.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, SARS-CoV-2 test
Clinical narrative: fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 15Feb2021 10:30 (Batch/Lot number: EN6201) as dose 2, single for covid-19 immunisation. Relevant medical history included: "urinary tract infection", start date: 20Jan2021 (unspecified if ongoing), notes: on antibiotics beginning 2 days before first vaccine injection. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, Administration time: 10:50 AM, Route of injection: Intramuscular, Site of injection: Left arm, Batch/Lot number: EL9262), administration date: 22Jan2021, for COVID-19 immunisation, reaction(s): "fever", "joint aches/pain", "muscle aches", "white bump near injection site", "hot at night", "headache". The following information was reported: FATIGUE (non-serious) with onset 17Feb2021, outcome "recovered", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Pain in extremity
Clinical narrative: sore arm; diarrhea, one time, every other day, at night; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program (144508).  A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea, one time, every other day, at night".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea 3-4 times; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program (144508).  A 73 year-old male patient received bnt162b2 (BNT162B2), administration date 26Feb2021 (Batch/Lot number: unknown) at the age of 73 years 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 1), for COVID-19 immunisation, reaction(s): "diarrhea", "sore arm". The following information was reported: DIARRHOEA (non-serious) with onset 27Feb2021, outcome "recovered" (28Feb2021), described as "diarrhea 3-4 times".  Additional information: It was reported that the patient could barely get out of bed and the event stopped the next day.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Pain
Clinical narrative: knees swelled up; pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2), administration date 07Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "knees swelled up" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 14Feb2021, for COVID-19 immunisation. The following information was reported: JOINT SWELLING (medically significant) with onset Mar2021, outcome "unknown", described as "knees swelled up"; PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "pain". The event "knees swelled up" was evaluated at the physician office visit. Therapeutic measures were taken as a result of joint swelling which included fluid was drained from the knees. Clinical course: After the second shot the patient's knees swelled up, which was according to the patient happens periodically. The doctor said he cannot give the patient cortisone shots because he just got the second dose of the vaccine and needed to wait for 2 weeks. The reporter was asking if the patient can take an extra strength paracetamol (TYLENOL) for the pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomiting; This is a spontaneous report received from a contactable consumer for a Pfizer sponsored program.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 10Mar2021 (Batch/Lot number: unknown) 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: VOMITING (non-serious) with onset 10Mar2021, outcome "unknown", described as "vomiting".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Muscle tightness, Neck pain
Clinical narrative: neck was tightening, and it hurts to move it from side to side; hasn't slept since since she's gotten it; headache; neck was tightening, and it hurts to move it from side to side; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Mar2021 14:00 (Lot number: EN6205) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "lupus" (unspecified if ongoing),  "Arthritis" (unspecified if ongoing), ; "high blood pressure" (unspecified if ongoing); " SARS virus", start date: 2019 (unspecified if ongoing). There were no concomitant medications. The following information was reported: MUSCLE TIGHTNESS (non-serious), NECK PAIN (non-serious) all with onset 08Mar2021, outcome "not recovered" and all described as "neck was tightening, and it hurts to move it from side to side"; INSOMNIA (non-serious) with onset 08Mar2021, outcome "not recovered", described as "hasn't slept since since she's gotten it"; HEADACHE (non-serious) with onset 08Mar2021, outcome "recovered" (09Mar2021), described as "headache". Therapeutic measures were taken as a result of muscle tightness, neck pain. Her headache was really bad the first day. The next day was bad but it went away.For the neck tightness and pain Was told to take Prednisone, it helped ease it up, it is working a little bit.States it is a lot better than what it was with the prednisone, she is not crying. Stated seems to be working. No Prior Vaccinations (within 4 weeks).  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chills, Confusional state, Dizziness, Lymphadenopathy
Clinical narrative: I had the swollen lymph nodes and feeling unwell; I had the swollen lymph nodes and feeling unwell; Nauseated; Chills; Dizziness; Weakness; I was very confused; 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) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), MALAISE (non-serious), outcome "unknown" and all described as "I had the swollen lymph nodes and feeling unwell"; NAUSEA (non-serious), outcome "unknown", described as "Nauseated"; CHILLS (non-serious), outcome "unknown", described as "Chills"; DIZZINESS (non-serious), outcome "unknown", described as "Dizziness"; ASTHENIA (non-serious), outcome "unknown", described as "Weakness"; CONFUSIONAL STATE (non-serious), outcome "unknown", described as "I was very confused".  Additional information: Batch/lot number, Dates for Covid-19 Vaccine, Expiry Date of Covid-19 Vaccine, Covid-19 Vaccine manufacturer, NDC number of Covid-19 Vaccine, UPC number of Covid-19 Vaccine, Reason for no lot number: of Covid-19 Vaccine: Unknown. Covid-19 Vaccine was a Pfizer product. The patient had a shot (Covid-19 Vaccine by Pfizer) last Monday and had a reaction, the regular stuff with the fluid. The patient went to the hospital but they really didn't do much because the patient didn't have any rash and swelling or anything like that and didn't know if the patient should have the second shot or not, had a doctor's appointment Friday.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Nausea
Clinical narrative: I had the swollen lymph nodes and feeling unwell; I had the swollen lymph nodes and feeling unwell; Nauseated; Chills; Dizziness; Weakness; I was very confused; 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) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), MALAISE (non-serious), outcome "unknown" and all described as "I had the swollen lymph nodes and feeling unwell"; NAUSEA (non-serious), outcome "unknown", described as "Nauseated"; CHILLS (non-serious), outcome "unknown", described as "Chills"; DIZZINESS (non-serious), outcome "unknown", described as "Dizziness"; ASTHENIA (non-serious), outcome "unknown", described as "Weakness"; CONFUSIONAL STATE (non-serious), outcome "unknown", described as "I was very confused".  Additional information: Batch/lot number, Dates for Covid-19 Vaccine, Expiry Date of Covid-19 Vaccine, Covid-19 Vaccine manufacturer, NDC number of Covid-19 Vaccine, UPC number of Covid-19 Vaccine, Reason for no lot number: of Covid-19 Vaccine: Unknown. Covid-19 Vaccine was a Pfizer product. The patient had a shot (Covid-19 Vaccine by Pfizer) last Monday and had a reaction, the regular stuff with the fluid. The patient went to the hospital but they really didn't do much because the patient didn't have any rash and swelling or anything like that and didn't know if the patient should have the second shot or not, had a doctor's appointment Friday.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Breast pain
Clinical narrative: have real sharp pain under left breast; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 10Mar2021 (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 1), for Covid-19 immunisation. The following information was reported: BREAST PAIN (non-serious), outcome "unknown", described as "have real sharp pain under left breast".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain, Pain in extremity
Clinical narrative: felt achy; flu like; some arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a (RA). The reporter is the patient. A female patient received BNT162B2 (BNT162B2) (Batch/Lot number: unknown) 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: PAIN (non-serious), outcome "unknown", described as "felt achy"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "some arm pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: The arm was sore for several days and then things went back to normal; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 11Feb2021 15:30 (Lot number: EL9269) at the age of 71 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOTHYROXINE; TYLENOL; OMEPRAZOLE. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "The arm was sore for several days and then things went back to normal". Therapeutic measures were not taken as a result of pain in extremity.  Additional Information: 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 and has no allergies. Since vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen and sore lymph node right neck; Swollen and sore lymph node right neck; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 07Mar2021 12:15 (Lot number: EN6205) at the age of 67 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SIMVASTATIN; CALCIUM +D. The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 08Mar2021 10:00, outcome "not recovered" and all described as "Swollen and sore lymph node right neck". Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain.  Additional information: This report was received via COVAES. The patient was not pregnant at time of vaccination. The patient had no known allergies. The patient did not undergo COVID-19 prior to vaccination and had not been tested for COVID-19 post vaccination. The patient did not receive other vaccine in four weeks. The patient's concomitant medications SIMVASTATIN; CALCIUM +D; "MULTIVITAMIN"; all taken for an unspecified indication, start and stop dates were not reported.   No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Tremor
Clinical narrative: body aches; shaking; fatigued; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 11:30 (Lot number: EL3248) at the age of 55 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEXAPRO; CITRICAL [CALCIUM]. Vaccination history included: Bnt162b2 (Product=COVID 19, brand=Pfizer , Lot number = EL3247, Administration date=17Feb2021, Administration time= 11:30, Vaccine location= Left arm, Dose number=1), administration date: 17Feb2021, when the patient was 55 years old, for Covid-19 immunisation. The following information was reported: PAIN (non-serious) with onset 09Mar2021 23:00, outcome "not recovered", described as "body aches"; TREMOR (non-serious) with onset 09Mar2021 23:00, outcome "not recovered", described as "shaking"; FATIGUE (non-serious) with onset 09Mar2021 23:00, outcome "not recovered", described as "fatigued". Therapeutic measures were not taken as a result of pain, tremor, fatigue.  Additional information: Patient was not given any other vaccine in four weeks. No Covid prior vaccination. Not covid tested post vaccination. No known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: down in bed for 24 hours aching; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "down in bed for 24 hours aching".  Additional information: The patient was fine to start with and then 2 days later her daughter was down in bed for 24 hours aching, patient was down in bed for 24 hours. That shot was given on a Wednesday and her patient did not go to work on Friday.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: minor fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 08Mar2021 (Batch/Lot number: unknown) 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: FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "minor fatigue".  Additional information: The report was received from a Pfizer-sponsored program. This report is for the reporter's wife.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021662563 Same reporter, suspect product and events; different patient
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Malaise, Nausea
Clinical narrative: don't feel well; feel little bit nauseous; Feeling bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administration date 05Mar2021 (Lot number: EN6198) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "bad prostate" (unspecified if ongoing); "wearing hearing devices" (unspecified if ongoing). The patient took unspecified vitamins as concomitant medications. The following information was reported: MALAISE (non-serious), outcome "not recovered", described as "don't feel well"; NAUSEA (non-serious), outcome "not recovered", described as "feel little bit nauseous"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Feeling bad". Therapeutic measures were taken as a result of nausea; patient was given Aspirin.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash macular, Vaccination site pain, Vaccination site warmth
Clinical narrative: the arm was sore for several days; several reddish, bruised-like blotches appeared on the upper arm; The blotches were accompanied by soreness and warmness; The blotches were accompanied by soreness and warmness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 04Mar2021 11:30 (Lot number: EN6198) at the age of 71 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medications included: LEVOTHYROXINE; TYLENOL; OMEPRAZOLE. Past drug history included: Bnt162b2, start date: 11Feb2021, stop date: 11Feb2021, for Covid-19 immunisation, reaction(s): "arm was sore", notes: Dose 1, lot number: EL9269, administration time: 03:30 PM, vaccine location: Right arm.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 06Mar2021, outcome "not recovered", described as "the arm was sore for several days"; RASH MACULAR (non-serious) with onset 06Mar2021, outcome "not recovered", described as "several reddish, bruised-like blotches appeared on the upper arm"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 06Mar2021, outcome "not recovered" and all described as "The blotches were accompanied by soreness and warmness". Therapeutic measures were not taken as a result of pain in extremity, rash macular, vaccination site pain, vaccination site warmth.  Additional information: Patient did not have any known allergies. The patient was not pregnant at the time of vaccination. Patient did not receive other vaccine in four weeks. Other medications in two weeks. After first dose patient arm was sore for several days and then things went back to normal. Then the patient received the second dose of the vaccine and again the arm was sore for several days, but things didn't go back to normal. Six days after the vaccine, the blotches were still there, with some sign of improvement. Patient did not diagnose with covid prior vaccination. The patient not tested for covid post vaccination. Patient did not have any known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: Stiffness; It is like I can't turn over or nothing and then it hurts all night; Stiffness; It is like I can't turn over or nothing and then it hurts all night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2), administration date 09Mar2021 (Lot number: EL9267) at the age of 76 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "Diabetes mellitus" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EN9581), administration date: 15Feb2021, when the patient was 76 years old, for Covid- 19 immunisation. The following information was reported: PAIN (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious) all with onset 09Mar2021, outcome "unknown" and all described as "Stiffness; It is like I can't turn over or nothing and then it hurts all night". The event "stiffness; it is like i can't turn over or nothing and then it hurts all night" and "stiffness; it is like i can't turn over or nothing and then it hurts all night" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of pain, musculoskeletal stiffness.  Additional information: Patient has an unspecified blood pressure and diabetes concomitant medications. Patient reported that last night (09Mar2021), she was having problems with her right side where she got the shot at. She got stiffness and she can't (incomplete sentence) it was like she can't turn over or nothing and then it hurts all night. So, she didn't know what was going on and because of this has called the family doctor. He said she had to call Pfizer to find out what might be done for this. Patient inquired on what to do.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Feeling abnormal, Malaise
Clinical narrative: lot of stomach distress; diarrhea; not feeling good; feeling off and on; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 27Jan2021 (Lot number: EL9262) at the age of 77 years as dose 1, single and administration date 22Feb2021 (Lot number: EN6NO) as dose 2, single both for COVID-19 immunisation. Relevant medical history included: "Nerve pain" (unspecified if ongoing); "Thyroid" (unspecified if ongoing); "Herpes" (unspecified if ongoing); "keep the arteries open" (unspecified if ongoing); "for strengthening bones" (unspecified if ongoing). Concomitant medications included: ZOVIRAX taken for herpes virus infection; GABAPENTIN; LEVOTHYROXINE; CRESTOR taken for arterial disorder; FOSAMAX taken for bone disorder. The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "lot of stomach distress"; DIARRHOEA (non-serious) with onset 2021, outcome "not recovered", described as "diarrhea"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "not feeling good"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "feeling off and on ". Therapeutic measures were not taken as a result of abdominal discomfort, diarrhoea, malaise, feeling abnormal.  Additional information: The patient stated that her weight has been between 169 or 170 pounds.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Caller asking if she can be rescheduled for the second dose because she's sick.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 17Feb2021 (Batch/Lot number: unknown) 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: ILLNESS (non-serious), outcome "unknown", described as "Caller asking if she can be rescheduled for the second dose because she's sick.". Additional information: The patient's scheduled second dose should be today (10Mar2021, as per reporting). The patient was also asking if she can take the medication today even if she's sick.   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, Pain
Clinical narrative: whole body aches/ dull pulsing pain on both sides of torso; chills; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 04Mar2021 (Batch/Lot number: unknown) 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: CHILLS (non-serious) with onset 08Mar2021, outcome "unknown", described as "chills"; PAIN (non-serious) with onset 09Mar2021, outcome "unknown", described as "whole body aches/ dull pulsing pain on both sides of torso". Therapeutic measures were taken as a result of chills, pain. Additional information: The patient took paracetamol (TYLENOL) as treatment for the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: tiredness and it has worsened she is so tired all the time.; Stomach pain; Diarrhea; Headache; Tiredness; Injection site pain; Chills; feeling unwell; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administration date 06Mar2021 (Lot number: EL9267) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lung problem" (unspecified if ongoing), notes: prior to the received the COVID vaccine. There were no concomitant medications. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 06Mar2021, outcome "not recovered", described as "Stomach pain"; DIARRHOEA (non-serious) with onset 06Mar2021, outcome "not recovered", described as "Diarrhea"; HEADACHE (non-serious) with onset 06Mar2021, outcome "recovered" (08Mar2021), described as "Headache"; FATIGUE (non-serious) with onset 06Mar2021, outcome "not recovered", described as "Tiredness"; VACCINATION SITE PAIN (non-serious) with onset 06Mar2021, outcome "recovered" (08Mar2021), described as "Injection site pain"; CHILLS (non-serious) with onset 06Mar2021, outcome "recovered" (08Mar2021), described as "Chills"; MALAISE (non-serious) with onset 06Mar2021, outcome "unknown", described as "feeling unwell"; FATIGUE (non-serious), outcome "unknown", described as "tiredness and it has worsened she is so tired all the time.". No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Vaccination site pain
Clinical narrative: tiredness and it has worsened she is so tired all the time.; Stomach pain; Diarrhea; Headache; Tiredness; Injection site pain; Chills; feeling unwell; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administration date 06Mar2021 (Lot number: EL9267) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lung problem" (unspecified if ongoing), notes: prior to the received the COVID vaccine. There were no concomitant medications. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 06Mar2021, outcome "not recovered", described as "Stomach pain"; DIARRHOEA (non-serious) with onset 06Mar2021, outcome "not recovered", described as "Diarrhea"; HEADACHE (non-serious) with onset 06Mar2021, outcome "recovered" (08Mar2021), described as "Headache"; FATIGUE (non-serious) with onset 06Mar2021, outcome "not recovered", described as "Tiredness"; VACCINATION SITE PAIN (non-serious) with onset 06Mar2021, outcome "recovered" (08Mar2021), described as "Injection site pain"; CHILLS (non-serious) with onset 06Mar2021, outcome "recovered" (08Mar2021), described as "Chills"; MALAISE (non-serious) with onset 06Mar2021, outcome "unknown", described as "feeling unwell"; FATIGUE (non-serious), outcome "unknown", described as "tiredness and it has worsened she is so tired all the time.". No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: started experiencing pins and needles feeling in her hands legs and feet, nothing debilitating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 08Mar2021 (Batch/Lot number: unknown) 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: PARAESTHESIA (non-serious) with onset 08Mar2021, outcome "not recovered", described as "started experiencing pins and needles feeling in her hands legs and feet, nothing debilitating". Additional information: The patient got the first dose on 08Mar2021, Monday, and later that same day, she started experiencing pins and needles feeling in her hands legs and feet, nothing debilitating. It was reported that it was still going on, so she was wondering if this was a known side effect of the product, or if she needed to go see her doctor.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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: DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: slight soreness at the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 10Mar2021 13:30 (Lot number: EL3248) at the age of 48 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies: seasonal" (unspecified if ongoing); "known allergies: environmental" (unspecified if ongoing); "known allergies: food" (unspecified if ongoing); "animal allergies" (unspecified if ongoing). Concomitant medication(s) included: ALLEGRA; NASACORT; VIT D. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EL3247, Administration time: 11:30 AM, Vaccine location: Left arm), administration date: 19Feb2021, when the patient was 48 years old, for covid-19 immunisation, reaction(s): "my left arm at the injection site began to feel slightly sore". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 10Mar2021 15:30, outcome "recovered" (11Mar2021), described as "slight soreness at the injection site". Therapeutic measures were not taken as a result of vaccination site pain. Additional information: 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 nor was tested for COVID-19 since vaccination. The patient was also taking an unspecified multi-vitamin. The patient had a slight soreness at the injection site that began approximately 2-3 hours post-dose which resolved the following morning.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient). A 60-year-old male patient received the 2nd dose of BNT162B2 (Comirnaty, bath/lot# EL3248), at the age of 60, left arm, on Mar 10, 2021, at 13:45, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Comirnaty, batch/lot# EL3247), at the age of 60, left arm, on Feb 17, 2021, at 01:45 pm, single dose, for COVID-19 immunisation. The patient had fatigue/tiredness, onset Mar 11, 2021, at  08:00, with outcome of unknown. No therapeutic measures taken as a result of fatigue/tiredness. Additional information: The patient did not have COVID-19 prior vaccination; and was not tested post vaccination. No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: arm is swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 08Mar2021 (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 1, single), for COVID-19 immunisation. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset Mar2021, outcome "unknown", described as "arm is swollen". Therapeutic measures were taken as a result of peripheral swelling.  Additional information: Patient was asking if it was okay that she put ice in a cloth on her arm.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Ocular discomfort
Clinical narrative: This is a spontaneous report received from a contactable consumer, for a Pfizer-sponsored program (159558). An adult male patient received unknown dose number of BNT162B2 (Comirnaty, batch/lot# unknown), on Mar 4, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient developed lymphadenopathy/swollen lymph node under his arm and ocular discomfort/his eye feels like there's fluid build-up in tear duct, onset Mar 2021, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information  expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient) for a Pfizer sponsored program (159558). A female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# unknown), on Mar 10, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), single dose, for COVID-19 immunisation. The patient had a slight headache, onset Mar 11, 2021, with outcome of not recovered. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a  sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 06Mar2021 (Batch/Lot number: unknown) 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: HEADACHE (non-serious) with onset 06Mar2021, outcome "unknown", described as "headache". Therapeutic measures were taken as a result of headache: took ibuprofen.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Neuralgia, Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient) for a Pfizer-sponsored program (159558). A male patient received the 1st dose of BNT162B2 (Comirnaty, batch/lot# unknown), administered in arm, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had dizziness/dizzy, neuralgia/nerve pain in mouth/jaw, and pain in extremity/pain in arm used for injection (non-serious), with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Ear pain
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 75-year-old male patient received the 1st dose of BNT162B2 (Comirnaty, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The following patient had ear pain/earache, onset 2021, with outcome of recovered (2021). Therapeutic measures taken as a result of ear pain included aspirin. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Headache
Clinical narrative: Throbbing head ache had to sit in the dark from 3-8pm; No appetite; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 32 year-old male patient received bnt162b2 (BNT162B2), administration date 01Mar2021 (Batch/Lot number: unknown) 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: HEADACHE (non-serious), outcome "unknown", described as "Throbbing head ache had to sit in the dark from 3-8pm"; DECREASED APPETITE (non-serious), outcome "unknown", described as "No appetite".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 09Mar2021 (Batch/Lot number: unknown) 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: The patient was wondering if he could work out and drink alcohol.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Sinus disorder
Clinical narrative: sinus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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: SINUS DISORDER (non-serious) with onset 07Mar2021, outcome "unknown", described as "sinus". Prior to vaccination, the patient was not diagnosed with Covid-19. Since the vaccination the patient has not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 11:00 (Lot number: el3247) at the age of 54 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: PAIN IN EXTREMITY (non-serious) with onset 09Mar2021, outcome "recovered" (2021), described as "sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The patient was not pregnant at time of vaccination. The patient had no known allergies. Other vaccine in four weeks was reported as no. Other medications in two weeks were reported as no. No covid prior vaccination and no covid tested post vaccination. It was reported that, queried to provide a response as soon as possible so that the regulatory compliance with AE reporting could be met.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program (155558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 09Mar2021 (Batch/Lot number: unknown) 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Malaise, Nausea
Clinical narrative: nausea; dizziness; weakness; not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 10Mar2021 (Batch/Lot number: unknown) 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: NAUSEA (non-serious), outcome "unknown", described as "nausea"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness"; ASTHENIA (non-serious), outcome "unknown", described as "weakness"; MALAISE (non-serious), outcome "unknown", described as "not feeling well".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.