chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Dry mouth, Oropharyngeal pain, Thirst
Clinical narrative: This parched feeling lasted the entire day and this morning; parched/Using the bathroom a lot from all the drinking/ thirsty; Sore Throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 21Mar2021 (Lot number: ER8730) at the age of 57 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "High Blood Pressure" (ongoing), notes: Diagnosed about 4-5 years ago.; "Cancer" (unspecified if ongoing), notes: Had it removed 12Dec2019.; "Does not make testosterone" (ongoing); "allergy to Sulfa drugs" (unspecified if ongoing), notes: he breaks out in a little rash. Concomitant medication(s) included: EDARBI taken for hypertension, start date: 2020 (ongoing); NORVASC taken for hypertension, start date: 2020 (ongoing); TESTOSTERONE taken for hypogonadism. Vaccination history included: Flu shot (Last one about 5 years ago), administration date: 2016, reaction(s): "Sick", "Sluggish". The following information was reported: DRY MOUTH (non-serious) with onset 21Mar2021, outcome "recovering", described as "This parched feeling lasted the entire day and this morning"; THIRST (non-serious) with onset 21Mar2021, outcome "recovering", described as "parched/Using the bathroom a lot from all the drinking/ thirsty"; OROPHARYNGEAL PAIN (non-serious) with onset 21Mar2021, outcome "not recovered", described as "Sore Throat".  Additional information: The patient had no history of previous immunization with the Pfizer vaccine considered as suspect. The patient did not receive additional vaccines administered on same date of the Pfizer suspect. The patient had no prior vaccinations (within 4 weeks). The vaccine was administered between 09:00-09:15. Clinical course: The patient reported that one of the side effects he had after his vaccination was that he was parched. Started 21Mar2021, 5 minutes after getting the shot. Stated he drank three liters of water when he walked out from his vaccine, that was how thirsty he was, it drained him of anything.  Also mentions he drank 3-4 glasses of water before he went. Stated he had been using the bathroom a lot since he has been drinking a lot. Stated he also had a sore throat. This parched feeling lasted the entire day and this morning. Stated as of now it has improved. The events did not require a visit to emergency room or Physician office visit. The patient did not undergo any relevant tests.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: weakness; tiredness; This is a spontaneous report received from a contactable consumer.  A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 15Mar2021 (Batch/Lot number: unknown) at the age of 77 years 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: ASTHENIA (non-serious) with onset 23Mar2021, outcome "unknown", described as "weakness"; FATIGUE (non-serious) with onset 23Mar2021, outcome "unknown", described as "tiredness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain in extremity
Clinical narrative: arm is been little sore/ pain in arms/ pain in the thumb; pain in wrist; pain in muscles; 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 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm is been little sore/ pain in arms/ pain in the thumb"; ARTHRALGIA (non-serious), outcome "unknown", described as "pain in wrist"; MYALGIA (non-serious), outcome "unknown", described as "pain in muscles".  Additional Information: The patient mentioned that he needs to reschedule the second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nasal congestion, Pain in extremity
Clinical narrative: sore arm; Congestion/feeling congestion and now she feels it in her nose; 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 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 06Mar2021 (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"; NASAL CONGESTION (non-serious) with onset 22Mar2021, outcome "unknown", described as "Congestion/feeling congestion and now she feels it in her nose".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nasal congestion, Nasopharyngitis
Clinical narrative: sore arm; Congestion/feeling congestion and now she feels it in her nose; 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 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 06Mar2021 (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"; NASAL CONGESTION (non-serious) with onset 22Mar2021, outcome "unknown", described as "Congestion/feeling congestion and now she feels it in her nose".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nasal congestion, Pain in extremity
Clinical narrative: cold; congestion; 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 06Mar2021 (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: NASOPHARYNGITIS (non-serious) with onset 23Mar2021, outcome "unknown", described as "cold"; NASAL CONGESTION (non-serious) with onset 23Mar2021, outcome "unknown", described as "congestion". Additional information: 1st dose 06Mar2021. Got cold and congestion today. Wanted to know if she could still take her 2nd dose scheduled on Friday (26Mar2021) given her condition.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nasal congestion, Nasopharyngitis
Clinical narrative: cold; congestion; 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 06Mar2021 (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: NASOPHARYNGITIS (non-serious) with onset 23Mar2021, outcome "unknown", described as "cold"; NASAL CONGESTION (non-serious) with onset 23Mar2021, outcome "unknown", described as "congestion". Additional information: 1st dose 06Mar2021. Got cold and congestion today. Wanted to know if she could still take her 2nd dose scheduled on Friday (26Mar2021) given her condition.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 12Mar2021 13:00 (Lot number: EN6206) at the age of 65 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Cholesterol" (ongoing); "Vitamin supplementation" (ongoing). Concomitant medication(s) included: ONE-A-DAY [MINERALS NOS;VITAMINS NOS] taken for vitamin supplementation (ongoing); BAYER ASPIRIN (ongoing); PRAVASTATIN taken for blood cholesterol abnormal (ongoing). Vaccination history included: Bnt162b2 (Dose 1: Administered 19Feb2021, Time: 13:00, Lot: EN62 - caller verified this lot number documented in the CDC vaccine), administration date: 19Feb2021, when the patient was 65 years old, for covid-19 immunisation, reaction(s): "had no problems"; Flu shot (AE(s) following prior vaccinations: None), administration date: Sep2020, when the patient was 64 years old, for immunization, reaction(s): "none". The following information was reported: DIARRHOEA (non-serious) with onset 12Mar2021 15:00, outcome "recovered" (13Mar2021), described as "diarrhea". Additional information: The vaccine was administered on the left arm at the shoulder part at about 13:00-13:15. The patient's sister died of cancer about 1.5 years ago.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache
Clinical narrative: Minor headache; Minor pain in the shoulder near the injection site; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162B2 (BNT162B2), administered in arm left, administration date 22Mar2021 (Lot number: ER8727) at the age of 38 years as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 22Mar2021, outcome "recovering", described as "Minor headache"; ARTHRALGIA (non-serious) with onset 22Mar2021, outcome "recovering", described as "Minor pain in the shoulder near the injection site". Therapeutic measures were not taken as a result of headache, arthralgia.  Additional information: The patient did not receive any other vaccine within four weeks of the COVID-19 vaccine. Prior to vaccination, the patient had no history of COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. 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).  A male patient 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: 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: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nasopharyngitis
Clinical narrative: Headache; Chills; Cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 03Mar2021 (Lot number: EL9261) at the age of 77 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 1; Lot Number: EN9581; Intramuscular; Left arm), administration date: 10Feb2021, when the patient was 77 years old, for COVID-19 immunization, reaction(s): "fine after the first COVID-19 Vaccine dose". The following information was reported: CHILLS (non-serious) with onset 03Mar2021, outcome "recovered" (04Mar2021), described as "Chills"; NASOPHARYNGITIS (non-serious) with onset 03Mar2021, outcome "recovered" (04Mar2021), described as "Cold"; HEADACHE (non-serious) with onset 04Mar2021, outcome "recovered" (Mar2021), described as "Headache". Therapeutic measures were taken as a result of headache. Additional information: The vaccine was administered between 09:05 AM-09:10AM on 03Mar2021. The patient had no prior vaccinations within 4 weeks. The patient had chills and cold that night (03Mar2021) and had to put more and more blankets on. She said when she woke up in the morning (04Mar2021), all she had was a little headache, and the headache went away. The patient took 2 aspirin tablets (BAYER ASPIRIN, 325 mg tablets, Lot Number: 86395878 and Expiration Date: Mar2022) as a treatment for headache. The events did not result in an emergency room or physician office visit.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: First COVID-19 vaccine: hands were normal and she could form a fist; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Feb2021 11:30 (Lot number: EL9265, Expiration Date: 31May2021) at the age of 73 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Surgery" (unspecified if ongoing); "Could not bend her fingers to make a fist because so stiff" (ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 06Feb2021 03:00, outcome "unknown", described as "First COVID-19 vaccine: hands were normal and she could form a fist".  Additional information: The patient was calling to report a good effect not a bad effect. The patient had hand surgery and could not bend her fingers to make a fist in her hand because it was so stiff. She had months and months of therapy and she still couldn't make a fist but after the vaccination her hands were normal and she could form a fist. The patient had not received any other vaccines within 4 weeks prior vaccination. The patient had no additional vaccines administered on same day of BNT162B2.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain in extremity, Vaccination site pain
Clinical narrative: having the throbbing pain in the arm that I administered this shot; so my upper muscle, my wrist muscle, my fingers all have the throbbing pain/through out that hand and the shoulder too; so my upper muscle, my wrist muscle, my fingers all have the throbbing pain/through out that hand and the shoulder too; so my upper muscle, my wrist muscle, my fingers all have the throbbing pain/through out that hand and the shoulder too; 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 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 09Mar2021 (Lot number: EN6202) 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: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "having the throbbing pain in the arm that I administered this shot"; MYALGIA (non-serious), PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset Mar2021, outcome "unknown" and all described as "so my upper muscle, my wrist muscle, my fingers all have the throbbing pain/through out that hand and the shoulder too".  Additional information; Clinical course: Patient had the throbbing pain in the arm that administered this shot, so the upper muscle, wrist muscle, fingers all had the throbbing pain/through out that hand and the shoulder too it come and goes then felt like the nerves were the one that is getting which the patient did not know exactly.   No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Parosmia
Clinical narrative: funny taste in the mouth; kept smelling something that was not there; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) at the age of 59 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: DYSGEUSIA (non-serious), outcome "unknown", described as "funny taste in the mouth"; PAROSMIA (non-serious), outcome "unknown", described as "kept smelling something that was not there".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Blood pressure measurement, Hypertension
Clinical narrative: experience high blood pressure; fluctuations in her blood pressure, with it first increasing substantially before dropping 20-30 points; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 13Mar2021 (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 (1st dose), administration date: 20Feb2021, for COVID-19 immunisation. The following information was reported: HYPERTENSION (non-serious) with onset Mar2021, outcome "unknown", described as "experience high blood pressure"; BLOOD PRESSURE FLUCTUATION (non-serious) with onset Mar2021, outcome "unknown", described as "fluctuations in her blood pressure, with it first increasing substantially before dropping 20-30 points". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hypertension, blood pressure fluctuation.  Additional information: The patient had no family history of high blood pressure. Clinical course: After receiving her 2nd dose, patient began to experience high blood pressure; after speaking with her physician, she was placed on a 2nd medication for the treatment of her high blood pressure. Reported since being placed on the 2nd medication her mother experiences fluctuations in her blood pressure, with it first increasing substantially before dropping 20-30 points.  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-2021331379 Same reporter, suspect drug and events; different patient
Sex: U
Vaccine: COVID19
Symptoms: Confusional state, Disorientation, Malaise
Clinical narrative: 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 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 23Feb2021 (Lot number: EN6200) 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: DISORIENTATION (non-serious), outcome "unknown", described as "Disorientation"; CONFUSIONAL STATE (non-serious), outcome "unknown", described as "Confused"; MALAISE (non-serious), outcome "unknown", described as "I don't feel very good with my head/giving something in my head". No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Blood pressure measurement, Hypertension
Clinical narrative: experience high blood pressure/her brother also experienced the same scenario following his 2nd dose of the vaccine; fluctuations in her blood pressure/her brother also experienced the same scenario following his 2nd dose of the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 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. The following information was reported: HYPERTENSION (non-serious), outcome "unknown", described as "experience high blood pressure/her brother also experienced the same scenario following his 2nd dose of the vaccine"; BLOOD PRESSURE FLUCTUATION (non-serious), outcome "unknown", described as "fluctuations in her blood pressure/her brother also experienced the same scenario following his 2nd dose of the vaccine". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter stated there were no family history of high blood pressure. After receiving 2nd dose, reporter's mother began to experience high blood pressure and since being placed on the 2nd medication, the mother experienced fluctuations in her blood pressure, with it first increasing substantially before dropping 20-30 points. Reporter then stated that her brother also experienced the same scenario following his 2nd dose of the vaccine.  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-2021331362 Same reporter, suspect drug and events; different patient.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site pain, Wrong technique in product usage process
Clinical narrative: muscle ache at site of injection; diameter of the needle used was larger than typical/He adds that this was the size the facility told him they were using on him so it might sting a little bit more than normal; diameter of the needle used was larger than typical/He adds that this was the size the facility told him they were using on him so it might sting a little bit more than normal; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 24Feb2021 (Lot number: EN6202) at the age of 50 years as dose 1, single and administered in arm left, administration date 19Mar2021 (Lot number: EP7534) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 24Feb2021, outcome "unknown", described as "muscle ache at site of injection"; WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) all with onset 24Feb2021, outcome "unknown" and all described as "diameter of the needle used was larger than typical/He adds that this was the size the facility told him they were using on him so it might sting a little bit more than normal". Additional information: A couple of hours after the first injection, the patient had muscle ache at the injection site that went away completely unless he pushes hard on the area and can feel it weeks later. Both doses were administered at around 4 or 4:30 PM. The patient had no additional vaccines administered on the same day or prior vaccinations within 4 weeks. The events did not result in an emergency room or physician office visit.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm pain at the site of injection; This is a spontaneous report received from a contactable consumer from a sales representative. The reporter is the patient.  A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 21Mar2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medications included: IRBESARTAN; HCTZ; METOPROLOL; DOXAZOSIN. Vaccination history included: BNT162B2 (dose 1, Batch/Lot number: unknown), for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "Arm pain at the site of injection".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Lymphadenopathy, Wrong technique in product usage process
Clinical narrative: the diameter of the needle used was larger than typical; the diameter of the needle used was larger than typical; swollen lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 51 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm, administration date 19Mar2021 (Lot number: EP7534) at the age of 51 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 1, SINGLE (Lot No: EN6202), in left arm), administration date: 24Feb2021, when the patient was 51 years old, for COVID-19 immunisation. The following information was reported: LYMPHADENOPATHY (non-serious) with onset Mar2021, outcome "unknown", described as "swollen lymph nodes"; WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) all with onset 19Mar2021, outcome "unknown" and all described as "the diameter of the needle used was larger than typical". Therapeutic measures were not taken as a result of lymphadenopathy. Additional information: Both dose of vaccine were reported to be given around 4:00 PM or 4:30 PM. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has no relevant family history.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021331461 Same reporter, suspect drug, and event, different patient.;US-PFIZER INC-2021320011 Same reporter, suspect drug, and event, different patient.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Lethargy, Nervousness, Pain in extremity
Clinical narrative: I had a pain in the left arm; I had a very tiny stomach ache after the vaccination it was very tiny; I have little dizziness and I continued; I felt like little dizzy and I think I was little nervous but it continued little bit; I feel like lethargic from a week or more actually 8 days today; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 64 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 15Mar2021 (Batch/Lot number: unknown) at the age of 64 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Inflammation" (unspecified if ongoing), notes: Takes ginger and turmeric for this condition. The patient took concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 15Mar2021, outcome "recovering", described as "I have little dizziness and I continued"; NERVOUSNESS (non-serious) with onset 15Mar2021, outcome "recovering", described as "I felt like little dizzy and I think I was little nervous but it continued little bit"; LETHARGY (non-serious) with onset 15Mar2021, outcome "recovering", described as "I feel like lethargic from a week or more actually 8 days today"; PAIN IN EXTREMITY (non-serious) with onset 20Mar2021, outcome "recovered" (Mar2021), described as "I had a pain in the left arm"; ABDOMINAL PAIN UPPER (non-serious) with onset 20Mar2021, outcome "recovered" (Mar2021), described as "I had a very tiny stomach ache after the vaccination it was very tiny". Therapeutic measures were not taken as a result of dizziness, nervousness, lethargy, pain in extremity and abdominal pain upper.  Additional information: Consumer stated that she was taking zero medicine. She only took organic vitamins like vitamin D3, B3, A, B, C, D for females and it was a complex that she took once a day. She took ginger and turmeric for inflammation. Consumer had her vaccine on 15Mar and she felt okay. She didn't have any issue. The night she took the shot, she felt like a little dizzy and she thought she was a little nervous, but it continued little bit. She felt like lethargic from a week or more, for 8 days. She felt dizzy when she woke up and when she moved after taking the vaccine. She had pain in the left arm but after 2-3 days it disappeared. She had a very tiny stomachache after the vaccination, more with water and after food but felt it more with water, but it disappeared later like after 3 or 4 days. She doesn't have fever and headache but sometimes felt a little dizzy and had it for exact 8 days. Consumer stated that her second dose was due on 05Apr. She was querying if she should take the second one or not, because of the reaction that she was having. She doesn't know if this was normal, or it was something that she needed to stop.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Feeling cold, Hot flush, Hyperhidrosis, Pain, Pain in extremity
Clinical narrative: left arm pit really swollen; feeling really cold and with body aches; feeling really cold and with body aches; hot flush-wave on the back; some sweating; arm soreness; 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 (PFIZER-BIONTECH COVID-19 VACCINE) (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: HOT FLUSH (non-serious) with onset 23Mar2021, outcome "unknown", described as "hot flush-wave on the back"; HYPERHIDROSIS (non-serious) with onset 23Mar2021, outcome "unknown", described as "some sweating"; PAIN IN EXTREMITY (non-serious) with onset 23Mar2021, outcome "unknown", described as "arm soreness"; SWELLING (non-serious) with onset 24Mar2021, outcome "unknown", described as "left arm pit really swollen"; FEELING COLD (non-serious), PAIN (non-serious) all with onset 24Mar2021, outcome "unknown" and all described as "feeling really cold and with body aches".  Additional information: Clinical course: Yesterday 23Mar2021 a hot flush-wave on the back, some sweating, arm soreness. Today noticed left arm pit really swollen during morning shower. A couple of hours later started feeling really cold and with body aches. No fever yet.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: left arm pit really swollen; feeling really cold and with body aches; feeling really cold and with body aches; hot flush-wave on the back; some sweating; arm soreness; 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 (PFIZER-BIONTECH COVID-19 VACCINE) (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: HOT FLUSH (non-serious) with onset 23Mar2021, outcome "unknown", described as "hot flush-wave on the back"; HYPERHIDROSIS (non-serious) with onset 23Mar2021, outcome "unknown", described as "some sweating"; PAIN IN EXTREMITY (non-serious) with onset 23Mar2021, outcome "unknown", described as "arm soreness"; SWELLING (non-serious) with onset 24Mar2021, outcome "unknown", described as "left arm pit really swollen"; FEELING COLD (non-serious), PAIN (non-serious) all with onset 24Mar2021, outcome "unknown" and all described as "feeling really cold and with body aches".  Additional information: Clinical course: Yesterday 23Mar2021 a hot flush-wave on the back, some sweating, arm soreness. Today noticed left arm pit really swollen during morning shower. A couple of hours later started feeling really cold and with body aches. No fever yet.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP. A female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of the BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for COVID-19 immunisation. The patient reported fatigue (patient a little tired), and somnolence (just wanted to sleep), with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Vaccination site pain
Clinical narrative: Soreness in the injection site that started about 6 hours after the injection and continued overnight; mild achiness in my body; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 15:00 (Lot number: EL3247) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "ankle joint where I had a previous injury" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "allergies". Vaccination history included: Bnt162b2 (dose 1, single, lot number: EL3247, Administration time: 03:00 PM, Vaccine location: Left arm), administration date: 01Mar2021, when the patient was 42 years old, for Covid-19 immunisation, reaction(s): "Pain and soreness in my arm around the  injection site", "body aches", "tiredness", "pain and stiffness in ankle joint where I had a previous injury", "pain and stiffness in ankle joint where I had a previous injury". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 22Mar2021 21:00, outcome "recovered" (24Mar2021), described as "Soreness in the injection site that started about 6 hours after the injection and continued overnight"; PAIN (non-serious) with onset 22Mar2021 21:00, outcome "recovered" (24Mar2021), described as "mild achiness in my body"; FATIGUE (non-serious) with onset 22Mar2021 21:00, outcome "recovered" (24Mar2021), described as "fatigue". Therapeutic measures were not taken as a result of vaccination site pain, pain, fatigue.  Additional Information: The vaccine was given at a workplace clinic. Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks. Since vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Malaise
Clinical narrative: sick; he just felt bad and unwell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 10Mar2021 (Lot number: EN6204) at the age of 82 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Allergic to Mercury" (unspecified if ongoing), notes: including thiomersal or thimerosal. The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset Mar2021, outcome "unknown", described as "sick"; MALAISE (non-serious) with onset Mar2021, outcome "unknown", described as "he just felt bad and unwell". Additional information: The patient weighs "around 170 lbs or something" and stands "5 ft. 9 in. or 5 ft. 10 in". The patient's allergy to mercury was confirmed when his doctor did a test using mercury on the left shoulder and mercuric oxide on the other shoulder and he broke out from his neck to buttocks. He wanted to know if the vaccine contains thiomersal or thimerosal. He was scheduled to received the second dose on 31Mar2021.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: very fatigued; This is a spontaneous report received from a contactable reporter(s) (nurse). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (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: FATIGUE (non-serious), outcome "unknown", described as "very fatigued". Additional information: The event occurred 24 hours after the second dose vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness after COVID 19 vaccine; This is a spontaneous report received from a contactable consumer via a Pfizer colleague. The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm soreness after COVID 19 vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Back hurt; 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 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (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: BACK PAIN (non-serious), outcome "unknown", described as "Back hurt".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: muscle soreness at injection site; fatigue; 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 male patient received bnt162b2 (BNT162B2), administration date 20Mar2021 (Batch/Lot number: unknown) at the age of 36 years as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 22Mar2021, outcome "recovered" (Mar2021), described as "muscle soreness at injection site"; FATIGUE (non-serious) with onset 22Mar2021, outcome "recovered" (Mar2021), described as "fatigue". Therapeutic measures were not taken as a result of vaccination site pain, fatigue. Additional information: The patient had no COVID prior vaccination and was not covid tested post vaccination. The patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Lethargy, Presyncope
Clinical narrative: felt very light headed; really came very close to fainting/ she really thought she was gonna fall out of the chair; felt lethargic and fatigued on and off since the vaccine; felt lethargic and fatigued on and off since the vaccine/ at times more tired than normal; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 16Mar2021 (Lot number: ER2613, Expiration Date: 31Jul2021) at the age of 57 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Diabetes Type II", start date: 2011 (unspecified if ongoing), notes: 10 years; "Blood pressure high" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "kidney stones" (unspecified if ongoing); "had 2 kidney surgeries" (unspecified if ongoing), notes: for stones. Concomitant medications included: METFORMIN taken for diabetes mellitus; ALLOPURINOL taken for nephrolithiasis; LISINOPRIL taken for hypertension; LIPITOR [ATORVASTATIN] taken for blood cholesterol increased; POTASSIUM CITRATE. The following information was reported: DIZZINESS (non-serious) with onset 16Mar2021, outcome "recovered" (17Mar2021), described as "felt very light headed"; PRESYNCOPE (non-serious) with onset 16Mar2021, outcome "recovered" (17Mar2021), described as "really came very close to fainting/ she really thought she was gonna fall out of the chair"; LETHARGY (non-serious) with onset Mar2021, outcome "not recovered", described as "felt lethargic and fatigued on and off since the vaccine"; FATIGUE (non-serious) with onset Mar2021, outcome "not recovered", described as "felt lethargic and fatigued on and off since the vaccine/ at times more tired than normal". Therapeutic measures were not taken as a result of dizziness, presyncope, lethargy, fatigue.  Additional information: About 5 minutes after getting the vaccine, the patient started having side effects. The bigger side effect she felt was she felt very light headed and she really came very close to fainting. Fatigue and lethargy had been also a side effect, the long term side effect. The lightheadedness has gone away but the fatigue and lethargy stayed with her really for about a week. She couldn't drive safely on 16Mar2021 but she did drive on 17Mar2021 with no problem. She had somewhere to be on 16Mar2021 she had to call a friend to come and get her because she was not gonna to drive. The patient also mentioned she had a physical in Nov2020 which showed same result it shown forever, so her medication did not changed at all.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Illness, Vertigo
Clinical narrative: Not being able to hold her head up and complaints of headache; dizziness/lightheadedness; she said she can not get out of bed; when she lays on her back her room spins.; I am very sick, when I first got the shot I was dizzy little bit but now and then it got worse.; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 523587.  A female patient received BNT162B2 (COMIRNATY, solution for injection) (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: ABDOMINAL PAIN (non-serious), outcome "not recovered", described as "Abdominal pain"; ABDOMINAL PAIN UPPER (non-serious), outcome "not recovered", described as "Abdominal pain upper"; DIARRHOEA (non-serious), outcome "not recovered", described as "Diarrhoea"; NAUSEA (non-serious), outcome "not recovered", described as "Nausea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.