chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing in her ears; 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 female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 1, single and (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: TINNITUS (non-serious), outcome "not recovered", described as "ringing in her ears".  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, Lethargy, Myalgia
Clinical narrative: muscle pain; shivers; was lethargic; 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), administration date 02Feb2021 (Batch/Lot number: unknown) as 1st dose, single for covid-19 immunisation. Relevant medical history included: "Covid", start date: 30Oct2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "muscle pain"; CHILLS (non-serious), outcome "unknown", described as "shivers"; LETHARGY (non-serious), outcome "unknown", described as "was lethargic".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: migraine headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from License Party. The reporter is the patient.  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: MIGRAINE (non-serious), outcome "unknown", described as "migraine headache".  Additional information: Pursuant to the guidelines for post-marketing Reporting of Adverse Drug reactions, effective Mar1992, she was submitting initial information received an adverse event report associated with COVID-19 vaccine, unknown dose. Contact Information, address and phone Number was unknown.  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) : AE-2021-4325
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swelling in my lymph nodes on the same side as my vaccine; I have it only on one side; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 28Feb2021 (Batch/Lot number: unknown) as dose 1, single and administration date 21Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Swelling in my lymph nodes on the same side as my vaccine; I have it only on one side".  Additional information: Reporter seriousness for event was unspecified. After taking the first dose patient experienced above event, so patient wanted to know if she should wait and how long can she wait for the second injection. Later it was confirmed that patient experienced swelling in neck in lymph nodes and had it only on one side. Patient wanted to know if she should wait like delay second vaccine and if so then how long she can delay. Later it was confirmed that after taking second dose she had a lymph node swelling on her neck part that's why she called us.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Gastritis
Clinical narrative: Gastritis; Upset stomach; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  An 83 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Feb2021 12:30 (Lot number: CL9264) at the age of 83 years as dose 1, single and intramuscular, administered in arm left, administration date 07Mar2021 10:00 (Lot number: EN6205) as dose 2, single for covid-19 immunisation. Relevant medical history included: "hypothyroid", start date: 1990 (ongoing), notes: Levoxyl; "hyperparathyroidism" (unspecified if ongoing); "replacement" (unspecified if ongoing); "had supraventricular tachycardia", start date: Feb2016 (ongoing), notes: she had supraventricular tachycardia diagnosed four years ago and had an ablation, Cardiac ablation Jan2017; "Osteopenia", start date: 2017 (ongoing), notes: Prolia; "Myofascial pain", start date: 1996 (ongoing), notes: PT cortisone injection; "shoulder pain", start date: 1996 (ongoing), notes: PT cortisone injection; "bursitis", start date: 1996 (ongoing), notes: PT cortisone injection; "Arm pain" (unspecified if ongoing). Concomitant medication(s) included: LEVOXYL taken for hypothyroidism (ongoing); VITAMIN D2; PREMARIN (ongoing); GABAPENTIN taken for neuropathy peripheral (ongoing); VOLTAREN [DICLOFENAC DIETHYLAMINE] taken for neuropathy peripheral (ongoing); CBD COMPLEX taken for neuropathy peripheral (ongoing); CALCIUM CITRATE (ongoing); MAGNESIUM (ongoing); PROLIA taken for osteopenia; CORTISONE taken for myofascial pain syndrome, arthralgia, bursitis. The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset Mar2021, outcome "not recovered", described as "Upset stomach"; GASTRITIS (non-serious) with onset 16Mar2021, outcome "recovered" (Sep2021), described as "Gastritis". The event "gastritis" was evaluated at the physician office visit. Therapeutic measures were taken as a result of gastritis: GI workup Omeprazole 10 mg BID- Sep2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Influenza like illness
Clinical narrative: Pretty sick yesterday; Flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 18Mar2021 (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), for Covid-19 immunisation.  The following information was reported: ILLNESS (non-serious) with onset 20Mar2021, outcome "unknown", described as "Pretty sick yesterday"; INFLUENZA LIKE ILLNESS (non-serious) with onset 20Mar2021, outcome "unknown", described as "Flu like symptoms".  Additional information: Reporter stated, "he and his wife both had the second vaccine (Unspecified vaccine) on Thursday, and they came down pretty sick yesterday, flu like symptoms and stuff like that. Today he feel little bit better still following plans. He just want to know are we contagious to other people, want to go to church around old people.  No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021320630 same reporter/Vaccine , different patient
Age: 77.0
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Dysstasia
Clinical narrative: back started hurting; could not stand up; 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 patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 77 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: BACK PAIN (non-serious), outcome "unknown", described as "back started hurting"; DYSSTASIA (non-serious), outcome "unknown", described as "could not stand up". Additional information: The patient received the first Pfizer shot on Tuesday morning around 10 o'clock and around 4 o'clock in the afternoon, the patient's back started hurting and by evening and then the next day and Thursday the patient really could not stand up, the patient had to bend over from the waist in order to walk. The patient did not know if this could be a side effect from the shot or with age, did not know if he/she turned something or twisted something. The patient asked if he/she should get the second shot. The patient further stated, "Right, I just read this morning that if you have a strong reaction to the first shot. It could be you are symptomatic and did have COVID-19 and you might not need the second shot." No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Influenza like illness
Clinical narrative: Pretty sick /felt ill; Flu like symptoms; 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 18Mar2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious) with onset 19Mar2021, outcome "recovering", described as "Pretty sick /felt ill"; INFLUENZA LIKE ILLNESS (non-serious) with onset Mar2021, outcome "recovering", described as "Flu like symptoms".  Additional information: Consumer stated, he and his wife both had the second vaccine (Unspecified vaccine) on Thursday, and they came down pretty sick flu like symptoms and stuff like that. Patient felt ill Friday. Today he felt little bit better still following plans. He just wanted to know would they contagious to other people, as they wanted to go to church around old people.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021320612 same reporter/Vaccine, different patient
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dry eye, Injection site pain, Myalgia, Sinus congestion
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 47-year-old female patient received the 2nd dose of BNT162B2 (Comirnaty, 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 BNT162B2 (Comirnaty), for COVID-19 immunisation. The patient experienced dry eye(s), sinus congestion, injection site pain/pain at the injection site,  chills and myalgia/muscle aches; all with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizzy/dizziness; This is a spontaneous report received from a contactable reporter (Consumer or other non- healthcare professional). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 05Mar2021 (Lot number: EN6203) 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: DIZZINESS (non-serious) with onset 05Mar2021, outcome "unknown", described as "dizzy/dizziness".  Additional information: NDC number, UPC number and Expiry Date of COVID-19 vaccine was Unknown. When probed for the concern, consumer stated that when she got her vaccine at (Clinic name) on 05Mar2021 then sat down for a while she was immediately dizzy and then after about 45 minutes it past and it happened experiencing a quick dizziness came to her about 4, 5 times since she have had her shot, so she just wanted to report that.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: just achy; 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. Relevant medical history included: "Kidney transplant" (unspecified if ongoing); "immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "just achy". Additional information: the patient had his COVID vaccine and he is immunocompromised and his reaction was not so much of a reaction. He was just achy and that was it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migraine; This is a spontaneous report from a contactable consumer (Patient).An 43 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 (Lot number: EN6204) at the age of 43 years as 1st dose, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MIGRAINE (non-serious) with onset 20Mar2021, outcome "not recovered", described as "Migraine".Therapeutic measures were taken as a result of migraine.  Additional information: Weight (kg): 95.25. Height (cm): 160.Sex: Female. I had the vaccine yesterday and I have a migraine today and I just want to know if I can take my Relpax with it."Name of vaccine: Pfizer Covid-19 vaccine Consumer was informed about Pfizer Medical information department and was provided with the number. Consumer stated, "They just forwarded me to you and I waited on hold for almost 2 hours." "I am not going to take the number because I know I would be on hold but I do appreciate you trying to help me." Reporter type: Consumer stated, "I do billing for the hospital in the professional setting." (Hence, captured as consumer or other non-health professional). Primary / Prescribing Healthcare Professional details: Consumer stated, "No, I get it because I work at a healthcare setting." Name of facility where the vaccine was administered: Consumer stated, "Facility name." Caller(name) had 1st shot yesterday 19Mar2021, she is taking migraine medication named as Relpax, asking if this would compromise the vaccine. Cold transfer to RA, created manual AE form. Medical Information (Live Operators Only): Were any unaddressed medical questions referred or forwarded to Medical Information? Yes.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Vomiting
Clinical narrative: started throwing up; my arm was little bit sore; I started getting chills; This is a spontaneous report from a contactable consumer. A 70 year-old male patient received bnt162b2 (BNT162B2) (Lot number: EN6207) at the age of 70 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medications included: LISINOPRIL; HYDROCHLOROTHIAZIDE. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 21Mar2021, outcome "unknown", described as "my arm was little bit sore"; CHILLS (non-serious) with onset 21Mar2021, outcome "unknown", described as "I started getting chills"; VOMITING (non-serious), outcome "unknown", described as "started throwing up".  Additional information: Consumer stated, "Yesterday, I took the Pfizer shot about 1 o'clock and my arm was little bit sore but then mid night 1 o'clock in the morning or 1:30, I started getting chills and now I started throwing up. So, is that normal. When paraphrased the concern: Consumer stated, "Correct, like 12 hours later little bit more. 12 hours later started having chill then I threw up by 3 or 4 times." Consumer added, "Like the second shot going to be just that bad." Consumer stated, "I take about 6 to 7 pills." Consumer confirmed the vaccine dose as the first one.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: really bad headache; left arm where I received the vaccine is sore; fatigued; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 16Mar2021 (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 Immunization. The following information was reported: HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "really bad headache"; VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "left arm where I received the vaccine is sore"; FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "fatigued".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hyperacusis, Tinnitus
Clinical narrative: I got a bursting sound in my hear; it stops and sometimes it is very loud and sometimes it very low; get a buzz ears like 17-year locust; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 89 year-old female patient received bnt162b2 (BNT162B2) (Lot number: EN6208) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Atrial fibrillation" (unspecified if ongoing); "Bone marrow cancer" (unspecified if ongoing). Concomitant medication(s) included: WARFARIN taken for atrial fibrillation; ACYCLOVIR [ACICLOVIR]; MONTELUKAST; DEXAMETHASON [DEXAMETHASONE]; DEXTROTHYROXINE taken for thyroid disorder. Vaccination history included: Bnt162b2 (Dose 1, Lot number: unknown), for Covid-19 immunization. The following information was reported: HYPERACUSIS (non-serious), outcome "unknown", described as "I got a bursting sound in my hear; it stops and sometimes it is very loud and sometimes it very low"; TINNITUS (non-serious), outcome "unknown", described as "get a buzz ears like 17-year locust". Therapeutic measures were not taken as a result of hyperacusis, tinnitus.  Additional information: Patient had second Pfizer shot on Friday and all over sudden yesterday patient got a bursting sound in my hear actually on Friday night. It was constant sound and it go to the different level of volume. And it casually it stops and sometimes it was very loud and sometimes it was very low. It was kind of like, patient don't know can hear some buzzing sound, it was really loud like that and other time it sounds like a very hard stemmer. Patient was concerned about this as one of the side effects or could be because that's the only thing was difficult in life right now. Patient was trying to find out that could be the cause of the sudden change." Start date: Consumer stated, "On Friday at about 4:40." Reportedly, patient had second shot of Pfizer on Friday around 12:30 and all of a sudden that night patient started to get a buzz ears-familiar with 17-year locust but it said 'hmmmm' sound and something and then it goes sometimes sounding like a very hot steamer with the steam coming out and it can be at different volumes at a very short period time when patient didn't had it at all and that's the only thing that has been different in her life and patient don't know what has caused that and it's not a ringing in the ears it's quite a different sound and maybe it's related to the vaccination and it may not be but patient don't know exactly what to do about it." Treatment: "No, haven't because it was weekend and doctors are not super available here." Lab test: Consumer stated, "Yes, have warfarin level, what is it 'IRN' or something I don't know what it is."  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: mild headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021324940.  A female patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (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) with onset Mar2021, outcome "recovered" (Mar2021), described as "mild headache".  Additional information: This is a spontaneous report from a Pfizer sponsored Program. Verbatim and Event Description: Caller got the first dose of vaccine (19Mar2021). Caller is asking if we have recommended medicine for headache. Caller wants to know if she can take Ibuprofen for her mild headache. Cold transferred to another line and created a manual AE form. PQC Details: Request Name. Upon call back, caller stated she didn't need to take anything and her headache went away. Caller wanted to ask if it is ok to take Ibuprofen after her second dose of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: Very weak; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2), 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: ASTHENIA (non-serious), outcome "unknown", described as "Very weak".  Medical Information: Unaddressed medical questions were not forwarded to Medical Information Reporter's mother was just released from the hospital after receiving 1st vaccine and is very weak and is homebound.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache
Clinical narrative: feeling of - something is going on but not a definitive location.; mild headache; This is a spontaneous report received from a non-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: FEELING ABNORMAL (non-serious), outcome "unknown", described as "feeling of - something is going on but not a definitive location."; HEADACHE (non-serious), outcome "unknown", described as "mild headache".  Additional information: It was reported that the patient had mild headache. Might be increase temperature although he did not take temperature. The patient just overall feeling of - something was going on but not a definitive location.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Vomiting
Clinical narrative: chills; diarrhea; tired/fatigue/couldn't even lift her head off the pillow; vomiting; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the parent.  A 57 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 57 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: CHILLS (non-serious), outcome "unknown", described as "chills"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; FATIGUE (non-serious), outcome "unknown", described as "tired/fatigue/couldn't even lift her head off the pillow"; VOMITING (non-serious), outcome "unknown", described as "vomiting".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: reports sore arm, more than usual, after receipt of vaccination 2; tiredness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), administration date 18Mar2021 (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), for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "reports sore arm, more than usual, after receipt of vaccination 2"; FATIGUE (non-serious), outcome "unknown", described as "tiredness".  Additional Information:Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: feeling extremely tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old patient received bnt162b2 (BNT162B2), administered in arm, administration date 16Mar2021 14:10 (Lot number: fj8762, Expiration Date: Jun2022) at the age of 28 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, Time: 2:25 pm, Anatomical site of injection: Arm, Batch/Lot number: EL3247), administration date: 23Feb2021, when the patient was 28 years old, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 17Mar2021, outcome "unknown", described as "feeling extremely tired". No follow-up attempts are possible. No further information is expected.  Additional information: Patient had no prior vaccinations, no relevant tests and no specific test for thromboembolic events with thrombocytopenia. Patient received the third dose (Batch/Lot number: fj8762) on 01Dec2021 2:05 PM in the arm.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Oropharyngeal pain, Pain in extremity
Clinical narrative: severe arm pain; was very tired day after; sore throat; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 55 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization. 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 "severe arm pain"; FATIGUE (non-serious), outcome "unknown", described as "was very tired day after"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat".  Additional information: The patient experienced severe arm pain, was very tired day after, sore throat felt like she got run over by a truck. She has no underlying conditions, she did have a sore throat the week before, but it came back after getting the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Neck pain
Clinical narrative: Neck started to hurt; pain; Two lumps in her lymph node by the neck on top by the collar bone; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 69-year-old female patient received bnt162b2 (BNT162B2), administration date 18Mar2021 09:15 (Lot number: EN6208) at the age of 69 years as dose 2, single for COVID-19 immunization. Relevant medical history included: "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D [VITAMIN D NOS]; LOSARTAN. Vaccination history included: BNT162B2 (DOSE 1), for COVID-19 immunization. The following information was reported: NECK PAIN (non-serious) with onset 19Mar2021 21:30, outcome "not recovered", described as "Neck started to hurt; pain"; LYMPHADENOPATHY (non-serious) with onset 19Mar2021 21:30, outcome "unknown", described as "Two lumps in her lymph node by the neck on top by the collar bone". Therapeutic measures were taken as a result of neck pain, lymphadenopathy.  Additional Information: The patient takes unspecified blood pressure medication. The patient received her second shot COVID-19 vaccine on Thursday morning at 9:15 AM and had no side effects on Thursday or Friday. Last night (19Mar2021), around 9:30 PM, the patient's neck started to hurt, and it got worse and worse and when she touched her neck, she had two lumps in her lymph node by the neck on top by the collar bone. The patient took some paracetamol (TYLENOL) as treatment. The patient did go and saw that this is part of a side effect from Pfizer and so she just wanted to know if she should put warm compresses or cold compresses on it to help with the pain.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: body ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. This is the first case out of two cases.  A 64 year-old female patient received bnt162b2 (BNT162B2), administration date 14Mar2021 (Lot number: EN6207, Expiration Date: 03Jul2021) at the age of 64 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing). Concomitant medication(s) included: BENAZEPRIL HCL; HYDROCHLOROTHIAZIDE. The following information was reported: PAIN (non-serious) with onset 17Mar2021, outcome "unknown", described as "body ache".  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Skin disorder
Clinical narrative: sore arm; chills; bumps on his legs; 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 male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (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: Covid-19 vaccine (dose 1, manufacturer unknown), for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; CHILLS (non-serious), outcome "unknown", described as "chills"; SKIN DISORDER (non-serious), outcome "unknown", described as "bumps on his legs".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: sore arm near injection site; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (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: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "sore arm near injection site"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache".  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
Clinical narrative: body aches; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunisation. The following information was reported: PAIN (non-serious), outcome "unknown", described as "body aches".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: headache; soreness at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 (Batch/Lot number: unknown) at the age of 60 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 number=1, administration date 25Feb2021,, vaccine location: Left arm), administration date: 25Feb2021, when the patient was 60 years old, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 18Mar2021, outcome "recovered" (Mar2021), described as "headache"; VACCINATION SITE PAIN (non-serious) with onset 18Mar2021, outcome "recovered" (Mar2021), described as "soreness at injection site". Therapeutic measures were not taken as a result of headache, vaccination site pain.  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. Since the vaccination, the patient was not tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Pain
Clinical narrative: Swollen, hard spot at injection site; it's sore; Swollen, hard spot at injection site; it's sore; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (Lot number: EL3247) at the age of 78 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 (There would be Pfizer BioNtech EL3302 that the first one), for Covid-19 immunization. The following information was reported: PAIN (non-serious), INJECTION SITE SWELLING (non-serious), outcome "unknown" and all described as "Swollen, hard spot at injection site; it's sore". Therapeutic measures were not taken as a result of pain, injection site swelling.  Additional information: Patient sated, she got her second vaccine on 17th which was on Wednesday and she woke up yesterday morning injection was given. She was just wondering this was one of the side effects like swollen, hard spot at injection site. When paraphrased the above concern, patient stated, "Yesterday after the vaccine when she woke yesterday morning took the bandage off where she given her vaccine, this was a hard spot, swollen and it's sore." Patient was informed about the role of Pfizer drug safety. Patient was provided with the number of Pfizer Medical Information as # and requested to dial the option 3 and informed about timings as 8 AM to 8 PM from Monday to Sunday. Email Address: Patient stated, No. Patient stated, "she can ask them question. Does a side effects from the injection?" patient stated, "It might be on little card they gave me. There would be Pfizer BioNtech EL3302 that the first one. You want second one. In first she had not any problem. Second one EL3247." Dose: patient stated, "I don't know. I don't see." Treatment: patient stated, "No."  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Decreased appetite
Clinical narrative: hasn't had an appetite; a knot in his stomach; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 16Mar2021 (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: ABDOMINAL PAIN UPPER (non-serious) with onset 16Mar2021, outcome "unknown", described as "a knot in his stomach"; DECREASED APPETITE (non-serious), outcome "unknown", described as "hasn't had an appetite". Additional information: The patient got his first vaccination shot on the 16Mar2021, and he said the first day, he had a knot in his stomach. He hasn't had an appetite at all. The patient wanted to know if Pfizer has heard or seeing this and would like to know if that is something that is usually in like maybe a week might be seen or something.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscle twitching, Paraesthesia
Clinical narrative: she experienced tingling on the right side of her face.; Then she said her eye was twitching very slightly; small degree of numbness on her right side of the face; 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 42 year-old female patient received bnt162b2 (BNT162B2) (Lot number: EN5318) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "penicillin" (unspecified if ongoing), notes: verbatim: She is allergic to penicillin. Concomitant medication(s) included: SYNTHROID. The following information was reported: PARAESTHESIA (non-serious), outcome "unknown", described as "she experienced tingling on the right side of her face."; MUSCLE TWITCHING (non-serious), outcome "unknown", described as "Then she said her eye was twitching very slightly"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "small degree of numbness on her right side of the face".  Additional Information: About 15 minutes or so after receiving the Covid vaccine, (Name) told me she experienced tingling on the right side of her face. Then she said her eye was twitching very slightly, with maybe a small degree of numbness on her right side of the face.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity
Clinical narrative: fatigue; pain in left arm; body aches; 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 female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as unknown dose, 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), outcome "unknown", described as "fatigue"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain in left arm"; PAIN (non-serious), outcome "unknown", described as "body aches".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: Nauseous; Tiredness; 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), administration date 17Mar2021 11:00 (Lot number: EN6204) 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, Lot Number: EN6202), for COVID-19 Immunisation. The following information was reported: NAUSEA (non-serious) with onset 19Mar2021, outcome "unknown", described as "Nauseous"; FATIGUE (non-serious) with onset 17Mar2021, outcome "unknown", described as "Tiredness".  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Arm is achy; Headache; 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), administration date 19Mar2021 12:15 (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, for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm is achy"; HEADACHE (non-serious), outcome "unknown", described as "Headache".  Additional Information: Characterization of drug role: Suspect, Proprietary medicinal product name: Covid-19 Vaccine Batch/lot number: Unknown; Expiry Date of Covid-19 Vaccine: Unknown. Reason for no lot number: of Covid-19 Vaccine: Caller unwilling to complete the report. Consumer stated, "I got my second shot yesterday. I need to ask you a couple of questions? My arm is achy and I woke up with a headache. So what do I do, do I take Tylenol? What do I do? I took it (Covid 19 vaccine) yesterday around 12:15." Limited information was available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Vomiting
Clinical narrative: headache; chills; vomiting; This is a spontaneous report received from a contactable reporter(s) (Physician).   A 64 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 64 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: HEADACHE (non-serious) with onset Feb2021, outcome "unknown", described as "headache"; CHILLS (non-serious) with onset Feb2021, outcome "unknown", described as "chills"; VOMITING (non-serious) with onset Feb2021, outcome "unknown", described as "vomiting". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: I first saw him on 25Feb. His initial presentation included headache and chills.  his mother-in-law also had similar symptoms + vomiting.  He completed the second Pfizer COVID vaccination on 08Feb. He never had abdominal pain, but he did develop icteric sclera, jaundice, acholic stools and dark urine.  A workup included a negative viral hep panel including two HAV IgM, negative ANA, A1AT and a normal CT with normal GB and bile ducts.  TB peaked at 5.5 with AST 916 alt 1865.  He began to feel better the last week of Feb2021 and repeat labs on March 10, 2021, showed TB 1.3 ast 29 alt 102 ap 134.It is unclear if this was an infectious process that was not captured but I worried enough that this could be related to the vaccine he received 1.5 weeks earlier enough to send this report.   The adverse event did not result in doctor or other healthcare professional office/clinic visit. No treatment received for the adverse event. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was Unknown. The patient receive any other vaccines within 4 weeks prior to the COVID vaccine was Unknown. No Allergies to medications, food, or other   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: sleepy; This is a spontaneous report from a contactable consumer. This consumer reported similar event for 3 patients. This is 2nd of three reports. This consumer reported for a (Age: 83; units: Unknown) female patient (mother) that:  A female 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: SOMNOLENCE (non-serious), outcome "unknown", described as "sleepy".  Additional information: I have heard (withheld) from my mother, she is 83 (age unit was not specified). I went online for her, she lives about 30 miles from me. And I went online and they contacted her and she got an appointment and she also got the Pfizer shot. My mother and I talked to other people they said they had the same response. Let me tell you, I was sleepy for three or four days.   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-2021320975 same reporter/drug/event, different patients;US-PFIZER INC-2021321063 same reporter/drug/event, different patients
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) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (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 "headache".  Additional information: Patient wanted to know if she can take over the counter medications such as pain killers.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.