chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Erythema of eyelid, Pruritus, Swelling face, Swelling of eyelid, Urticaria
Clinical narrative: right eyelid is swollen; kind of itchy; had a few hives; eyelid was a little swollen and red; Swollen face; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 30Aug2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Previously patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date as dose 1, single for Covid-19 immunisation and reported I had few hives for the next few weeks, Like 1 hive on the top of my arm, 1 hive on the top of my thigh and then 1 hive on my neck, Itchy all over my skin. On unspecified date the patient experienced right now her right eyelid is swollen. Also reported it's kind of itchy. I had a few hives here and there and last night I noticed my right upper eyelid was a little swollen and red. I woke up this morning even worst and I know that, swollen face can be side effect. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected. Batch/lot number not available for BNT162B2
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A patient, of unspecified age and gender, received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. On unspecified date, patient experienced rash on body and lot of itchiness. Patient stated, "Ok I understand about the risk about this COVID-19. I already did my second injection. I understand about the side effect. Now the side effect that I had with the first time of vaccine was just the lot of itchiness and a rash on my body. It lasted like four maybe five days. Today I went and I took the second vaccine. I kept on reading in the paper they gave me but it doesn't say anything of side effect like you are drinking alcohol. Like they intensify the vaccine or no. Are there any side effects like if I had a beer? I took the second vaccine this morning and now we are in evening and I wanted to drink a beer. Would there be any side effect if I was drinking alcohol?" It was not clarified if consumer was drinking any alcohol. The outcome of the events recovered on unspecified date. The lot number for the vaccine (BNT162B2) not provided and will be requested during follow-up.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Heart rate, Heart rate increased, Palpitations
Clinical narrative: Chest pain, random little pains, with tightness, after first vaccine; Chest pain, random little pains, with tightness, after first vaccine; Heart palpitations, fast beating after first vaccine; Heart palpitations, fast beating after first vaccine; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0179, Expiry date: not reported, at the age of 26 years), dose 1 via an unspecified route of administration, administered in Arm Left on 27Aug2021 18:00 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She never had heart palpitations before. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer Suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No adverse events following prior vaccinations. The patient experienced chest pain, random little pains, with tightness, heart palpitations and fast beating (all throughout the day) 2 days after first vaccine on 29Aug2021. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's parent/reported for son). A 30-year-old male patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot#, NDC/UPC number, expiry date: unknown/not reported), at the age of 30, via an unspecified route of administration, on Sep 3, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Reporter's son had rashes all over his body (on an unspecified date in Sep 2021). The reporter did not know how to go about that so they want to know what Pfizer wants to do to the rashes. The event outcome: unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pruritus, Swelling
Clinical narrative: Got exposure to her son in law that is positive in covid-19; Swelling; Numbing; Itching; This is a spontaneous report from a non-contactable consumer (patient) or other non-healthcare professional. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on 28Aug2021, as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient got exposure to her son in law that was positive in Covid-19. After first dose of vaccination the patient experienced swelling and numbing and also itching. Patient was asked if this was a delayed reaction to the vaccine or a symptom because patient had exposure to a covid-19 positive. Patient said that she will call her doctor first. The clinical outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Pharyngeal swelling, Throat tightness, Vision blurred
Clinical narrative: can't swallow/ had a little bit of like something stuck in throat, something in throat, had on day one and difficulty swallowing/ swelling of throat, hard to swallow; tightness in throat; blurred vision/ Little bit of blurry vision and within an hour or two it went away; patient did not even get enough breathing; Swelling of throat; This is a spontaneous report from a contactable consumer (patient) reporting for self.   A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FA7484) via an unspecified route of administration, administered in Arm Left on 17Aug2021 as single dose (at the age of 44) for COVID-19 immunisation. The patient's medical history included blood pressure from an unknown date and ongoing. The patient's concomitant medication included lisinopril taken for blood pressure measurement from an unspecified start date and ongoing and other medications. The patient as cannot swallow/ had a little bit of like something stuck in throat, something in throat, had on day one and difficulty swallowing/ swelling of throat, hard to swallow on 02Sep2021, tightness in throat, blurred vision/ Little bit of blurry vision and within an hour or two it went away on 17Aug2021, patient did not even get enough breathing, swelling of throat both on an unknown date in 2021. The events were reported as non-serious. It was reported that patient called to ask for medical recommendation and medical advice to treat side effects, patient took Pfizer COVID vaccine 1st dose on 17Aug2021, and next hour after 1st dose had a little bit of tightness in throat, blurred vision that went away within an hour or two, could breathe fine but there was tightness in throat eleven days later patient cannot eat, cannot swallow, having difficulty swallowing small pills, and it was difficult to swallow grapes, the grapes skin gets stuck. Therapeutic measures were taken as a result of swelling of throat includes Benadryl. The outcome of the event swelling of throat was not recovered while it was unknown for other events.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash; On my arm it itch really bad; This is a spontaneous report from a contactable consumer (patient).  A patient of an unspecified age and gender received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: FC3182 and expiry date was not reported), via an unspecified route of administration, in Arm, on 07Sep2021, as unknown, a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated, on 07Sep2021, the patient got the Pfizer vaccination today and was getting a rash on arm where the patient's got the vaccination and it was been really bad. The patient experienced on my arm it itches really bad. There was some background voice heard over the call and later consumer hung up abruptly hence further probing could not be done. Thus, limited information available on the call. Outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Limb mass, Pain in extremity
Clinical narrative: States she had the shot in her upper left shoulder.; Lump by upper left back, shoulder blade; Lump by upper left back, shoulder blade; she sees injection site and arm pit pain; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified date as dose 1, single and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. Patient had no relevant medical history. The patient concomitant medications were not reported. The patient had the shot 2 weeks ago and going for the third one in September (details unspecified). The patient reaction was a lump and had the shot in her upper left shoulder. Afterwards, towards her upper left back, shoulder blade and had a lump. The caller asks if this was a side effect then the patient states that she did not saw it listed in the side effects and the patient saw injection site and arm pit pain but nothing like this lump the patient had. The outcome of the events was unknown.   No Follow-up attempts are possible. No information is expected further.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Gait disturbance, Headache, Vision blurred
Clinical narrative: headache; can barely stand; eyes are blurry; I walk, but stop because my head hurts really  bad; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 39-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported), via an unspecified route of administration on 03Sep2021 (at the age of 39 years) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported), via an unspecified route of administration on an unknown date (at the age of 39 years) as dose 1, single for COVID-19 immunization. The patient got 2nd dose on Friday, 03Sep2021, since then she had headaches and now it was worse, she could barely stand up. She walks, but stop because her head hurts really bad, her eyes were blurry, she had a big headache not sure if it had to do with the blurriness or not. The outcome of all the events was unknown.   Follow up attempts are completed. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Exercise lack of, Lung disorder
Clinical narrative: Decreased lung capacity.; Not able to exercise; getting short of breath after only one minute of any type of physical activity.; This is a spontaneous report from a contactable consumer (patient). A 47-years-old male patient reported for himself that he received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9267), via an unspecified route of administration, administered in arm left on 26Feb2021 at 01:00 PM (age at vaccination was 47-year-old) as dose 2, single for COVID-19 immunisation at health clinic facility. No other vaccines were received within four weeks of vaccination. No other medications were received witFhin 2 weeks of vaccination. The patient's medical history was not reported. The patient had known allergies with Codein. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (Batch/Lot Number: EL9265), via an unspecified route of administration, administered in arm left on 29Jan2021 at 05:30 PM (age at vaccination was 47-year-old) as dose 1, single for COVID-19 immunisation. On 10Mar2021 at 12:00 PM, the patient experienced decreased lung capacity. Not able to exercise without getting short of breath after only one minute of any type of physical activity. The events resulted in visit to doctor or other healthcare professional office/clinic visit. No treatment was received. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Bradykinesia, Immune system disorder
Clinical narrative: States first dose of vaccine lowers immunity; Moving a little slower these days; This is a spontaneous report from a Pfizer Sponsored Program via a contactable consumer (patient).  A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: FC3182 and expiry date was not reported), via an unspecified route of administration, in Arm Right, on 18Aug2021 (age at vaccination: 56 years), as a single dose for COVID-19 immunization at clinic. The patient taking Pfizer Covid 19 Vaccine for safety and protection. Vaccine was not administered at Military Facility. The patient's medical history and concomitant medications were not reported. The patient did not have any family medical history relevant to adverse events. The patient stated she had her first knee replacement on 25Aug2021. She had heart arrhythmia wherein she's taking medications. She stated that since her first knee surgery she has been taking Aspirin twice a day to keep her blood thin after the surgery, Tylenol, Ibuprofen, some other medications since the surgery such as Tramadol. The patient stated she was moving a little slower these days. The patient stated that she had first dose of the Pfizer Covid 19 vaccine a week before her knee replacement. She was scheduled to take the second dose of the vaccine yesterday, but did not go. She didn't go because she was having another knee replacement surgery in 4 weeks. She was asking if she can take the second dose now; or can she wait a few weeks or months after her second surgery. The patient stated that she was scheduled for her second knee replacement surgery on 13Oct2021. Since the first dose of the vaccine lowered her immunity on an unspecified date, then the surgery and anesthesia lowered it more; then getting the second dose of the vaccine will lower it even more and asked was that safe going into her second surgery. The adverse events did not require a visit to emergency room and physician office. There was a Product Complaint and description of Product Complaint included stated that vaccine lowers immunity. Product strength and count size dispensed: Pfizer Covid 19 Vaccine; First Dose, Additional lot numbers: FC3182. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Mass, Musculoskeletal stiffness, Rash pruritic, Scar, Urticaria
Clinical narrative: patient had itchy rash with small, raised bumps develop all over her arm (not the arm she received the vaccine in)/ some itchy spots starting to develop on her knee, similar to those on her arm.; Some of these spots grew into larger welts; scars; stiff neck, worse than she has ever experienced before,; raised bumps develop all over her arm (not the arm she received the vaccine in).; This is a spontaneous report from a contactable consumer (patient). A 5-decade-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Approximately 6 days after receiving the first dose of the Pfizer vaccine the patient had itchy rash with small, raised bumps develop all over her arm (not the arm she received the vaccine in). Some of these spots grew into larger welts and have left scars. Vaccination was received approximately one month ago. Patient also reported a very stiff neck, worse than she has ever experienced before, days after receiving the vaccine. On the day patient reported this to me, she also noticed some itchy spots starting to develop on her knee, similar to those on her arm. Patient did go see her doctor about these skin issues after receiving vaccine and received a steroid cream which patient reported did not help very much. A dose of oral steroid did help some. She has not received the second dose of the vaccine and is unsure if she will at this time. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow up (01Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: psoriasis; This is a spontaneous report from a contactable consumer or other non-Health Care Professional.A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number : EW0153 and Expiry date: Unknown), dose 2 via an unspecified route of administration on 14May2021 as DOSE 2, SINGLE for covid-19 immunization. Medical history included; psoriasis from 2010 to an unknown date Patient's Medical History: PSORIASIS IN 2010. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. There were no concomitant medications.The patient previously took bnt162b2 for covid-19 immunization, Humira ac for psoriasis and experienced discomfort. On May2021 the patient experienced psoriasis. The outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: lack of energy/energy zapped/totally wiped out; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9266) via an unspecified route of administration on 19Feb2021 as dose 2, single for COVID-19 immunisation. Medical history included pregnancy from an unknown date and unknown if ongoing, and illness from an unknown date and unknown if ongoing. It was reported that the patient took no prescriptions on a daily basis. The patient had never had a flu shot and never got sick except pregnancy. Concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Lot Number: not reported) via an unspecified route of administration on unspecified date as dose 1, single for COVID-19 immunisation. On 25Feb2021, 6 days after the second Covid vaccination, the patient experienced energy zapped. On day 6 after the second Covid vaccination, she felt totally wiped out which lasted a couple of days. The patient was active, doing Zumba 3 times a week. Walked 4 miles 3 times a week. Cross the finish line of 1 half marathon a year. Run/walk it. The patient thought her immune system seemed normally good was there any reason for her reaction to the second vaccination. Energy zapped 6 days after the 2nd Covid vaccination which she received on 19Feb2021. She felt totally wiped out which lasted a couple of days. But then she did not get her normal energy back until the middle of Aug2021. That was 6 months. The patient was worried about what might happen if she get the 3rd shot and not wanting to experience the lack of energy again or whatever else might happen. The patient mentioned her next 1/2 marathon was on 30Apr2022. She was afraid if she would not have the energy to train and complete this event, which was very important to her. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered, Immunisation, Investigation, Joint swelling, Off label use
Clinical narrative: my D-Dimer was 872 ng/ml, which should be less than 500 ng/ml; my right ankle swelled and spread into my foot; my right ankle swelled and spread into my foot; On 26Aug2021 I received my booster of your vaccine for Covid; On 26Aug2021 I received my booster of your vaccine for Covid; On 26Aug2021 I received my booster of your vaccine for Covid; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 26Aug2021 as dose 3, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 26Aug2021, patient received my booster of your vaccine for Covid. On 30Aug2021 patient right ankle swelled and spread into my foot. On 08Sep2021, patient physician ran a battery of tests and everything came back normal except that my D-Dimer was 872 ng/ml, which should be less than 500 ng/ml. Patient right leg was scanned the following day in search of blood clots. No Clots. Have no cause for this swelling and pain. Only thing out of the norm was the 3rd shot. The outcome of the events was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: my D-Dimer was 872 ng/ml, which should be less than 500 ng/ml; my right ankle swelled and spread into my foot; my right ankle swelled and spread into my foot; On 26Aug2021 I received my booster of your vaccine for Covid; On 26Aug2021 I received my booster of your vaccine for Covid; On 26Aug2021 I received my booster of your vaccine for Covid; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 26Aug2021 as dose 3, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 26Aug2021, patient received my booster of your vaccine for Covid. On 30Aug2021 patient right ankle swelled and spread into my foot. On 08Sep2021, patient physician ran a battery of tests and everything came back normal except that my D-Dimer was 872 ng/ml, which should be less than 500 ng/ml. Patient right leg was scanned the following day in search of blood clots. No Clots. Have no cause for this swelling and pain. Only thing out of the norm was the 3rd shot. The outcome of the events was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Nausea, Oropharyngeal pain, Pain
Clinical narrative: Nausea; Upset stomach; Body aches; Fever; Sore throat; Head ache; This is a spontaneous report from a contactable consumer (patient). A 33-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 14Sep2021 03:45 (at the age of 33-year-old) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included escitalopram oxalate (LEXAPRO). The patient received no other vaccine in 4 weeks. The patient was not diagnosed with COVID-19 prior vaccination. On 14Sep2021 05:00 the patient experienced nausea, upset stomach, body aches, fever, sore throat, and head ache. The patient received no treatment for the events. The patient underwent lab tests and procedures which included SARS-CoV-2 test (Rapid Nasal Swab): negative on 15Sep2021. The outcome of the events was reported as not resolved.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Nausea; Upset stomach; Body aches; Fever; Sore throat; Head ache; This is a spontaneous report from a contactable consumer (patient). A 33-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 14Sep2021 03:45 (at the age of 33-year-old) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included escitalopram oxalate (LEXAPRO). The patient received no other vaccine in 4 weeks. The patient was not diagnosed with COVID-19 prior vaccination. On 14Sep2021 05:00 the patient experienced nausea, upset stomach, body aches, fever, sore throat, and head ache. The patient received no treatment for the events. The patient underwent lab tests and procedures which included SARS-CoV-2 test (Rapid Nasal Swab): negative on 15Sep2021. The outcome of the events was reported as not resolved.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: Years later, he got the pneumonia shot and got pneumonia; Years later, he got the pneumonia shot and got pneumonia; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A male patient of an unspecified age received pneumococcal 13-val conjugated vaccine (diphtheria crm197 protein), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as an unspecified dose for immunization. The patient's medical history and concomitant medications were not reported. The patient previously took a flu shot; he was sick all year after he got the shot. The patient got a pneumonia shot and got pneumonia. The outcome of the events was unknown.  Pfizer is a marketing authorization holder of pneumococcal 13-val conjugated vaccine (diphtheria crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if an-other marketing authorization holder of pneumococcal 13-val conjugated vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.  Information on the lot/batch number has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Headache, Off label use, Pain, Pain in extremity
Clinical narrative: headache; body aches; sore arm; symptoms of L hand randomly jerking to were I could not hold my cell phon; visual abnormalities where my field of vision would shift; Vaccination was my third (booster); Vaccination was my third (booster); This is a spontaneous report from a contactable other hcp (patient). A 75-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: FE3592), via an unspecified route of administration, administered in Arm Left on 11Sep2021 14:30 (at the age of 75-year-old) as dose 3, single for covid-19 immunisation. Medical history included connective tissue disorder from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration, on an unspecified date as dose 1, single and dose 2, single for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient had COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Sep2021, the patient experienced vaccination was my third. On 11Sep2021 21:00, patient experienced headache, body aches, sore arm, symptoms of l hand randomly jerking to were i could not hold cell phone, visual abnormalities where my field of vision would shift. Within 2-3 days, all symptoms were gone or reduced. No treatment was taken as a result of events. The outcome of the events headache, body aches, sore arm, symptoms of l hand randomly jerking to were i could not hold cell phone, visual abnormalities where my field of vision would shift was recovered on an unspecified date in Sep2021.   Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Visual impairment
Clinical narrative: headache; body aches; sore arm; symptoms of L hand randomly jerking to were I could not hold my cell phon; visual abnormalities where my field of vision would shift; Vaccination was my third (booster); Vaccination was my third (booster); This is a spontaneous report from a contactable other hcp (patient). A 75-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: FE3592), via an unspecified route of administration, administered in Arm Left on 11Sep2021 14:30 (at the age of 75-year-old) as dose 3, single for covid-19 immunisation. Medical history included connective tissue disorder from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration, on an unspecified date as dose 1, single and dose 2, single for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient had COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Sep2021, the patient experienced vaccination was my third. On 11Sep2021 21:00, patient experienced headache, body aches, sore arm, symptoms of l hand randomly jerking to were i could not hold cell phone, visual abnormalities where my field of vision would shift. Within 2-3 days, all symptoms were gone or reduced. No treatment was taken as a result of events. The outcome of the events headache, body aches, sore arm, symptoms of l hand randomly jerking to were i could not hold cell phone, visual abnormalities where my field of vision would shift was recovered on an unspecified date in Sep2021.   Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Malaise
Clinical narrative: received 3rd dose of COVID-19 Vaccine; didn't feel well; This is a spontaneous report from a contactable other HCP (nurse). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and Expiration Date was not reported), via an unspecified route of administration on an unspecified date as dose 3, (booster) single for COVID-19 immunization (at the age of 55-year-old). The patient previously took dose 1 and dose 2 of BNT162B2 via an unspecified route of administration on an unspecified date as single for COVID-19 immunization. Medical history included attention deficit hyperactivity disorder from an unknown date and unknown if ongoing and allergies from Hydrocodone, Norco, Hydrocodon-Acetaminophen. Concomitant medication(s) included ibuprofen (ADVIL [IBUPROFEN]); calcium carbonate; melatonin; paracetamol (TYLENOL); vitamin D3. The patient experienced received 3rd dose of covid-19 vaccine and didn't feel well for 8 days on an unspecified date. Patient stated Doctor was not aware. The outcome of the events was unknown.  This lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Immunisation, Off label use, Peripheral swelling
Clinical narrative: The booster of the Pfizer covid booster shot; The booster of the Pfizer covid booster shot; Had such pain from all her arthritic joints; Pounding headache; Right arm is still swollen but not terrible; This is a spontaneous report received from a contactable consumer (patient). An 85-year-old female patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: 301308A), via an unspecified route of administration, administrated in right arm on 16Sep2021 11:30 (age at the time of vaccination 85-years-old), as a 0.3ml single dose for COVID-19 immunization. The patient's medical history included Arthritis, at arthritis clinic diagnosed the caller has had this since she was in her 70s. The patient's concomitant medications included Chondroitin once a day, Glucosamine once a day, and Omega 3. Patient previously received first dose of BNT162B2 vaccine (Batch/Lot Number: EN5318), via an unspecified route of administration on 15Feb2021 (age at the time of vaccination 84-years-old), as a single dose for COVID-19 immunization, and second dose of BNT162B2 vaccine, via an unspecified route of administration on 26Feb2021 (age at the time of vaccination 84-years-old), as a single dose for COVID-19 immunization. On 16Sep2021, the patient experienced the booster of the Pfizer covid booster shot, had such pain from all her arthritic joints, pounding headache; and on an unspecified date Sep2021 right arm is still swollen but not terrible. The caller took Chondroitin, glucosamine and two Tylenols and is feeling a little better. Patient did not visit to emergency room or physician office. No Prior Vaccinations within 4 weeks. The outcome of the event the booster of the Pfizer covid booster shot was unknown; and right arm is still swollen but not terrible was recovered on an unspecified date Sep2021; and other events was not recovered.  Follow-Up (22Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Atrial fibrillation, Autoimmune disorder, Blood glucose, Blood glucose fluctuation
Clinical narrative: AFIB ( had to get Pacemaker); Autoimmune type responses; Fever; Extreme joint pain; Difficulty walking without assistance; Chest pain; Weakness in legs; Onset of difficult to manage hypoglycemia with A1C 6.5; Diarrhea; Coordination issues; Fluctuating blood pressure and blood sugar; Fluctuating blood pressure and blood sugar; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 17:00 (at the age of 81-year-old) (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included high blood pressure, stent in heart, osteoarthritis, and COVID-19 (prior to vaccination). The patient received unspecified concomitant medications. The patient previously took REGLAN (metoclopramide hydrochloride) and experienced drug allergy. The patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. The patient experienced short term fever, extreme joint pain, difficulty walking without assistance, and long-term autoimmune type responses, joint pain, AFIB (had to get pacemaker), and chest pain (chest pain) on 20Jan2021 08:00. The patient also had weakness in legs, onset of difficult to manage hypoglycemia with A1C 6.5, diarrhea, coordination issues, and fluctuating blood pressure and blood sugar on 20Jan2021 08:00. The patient was hospitalized all events for 2 days and hospitalization was prolonged (vaccine received during existing hospitalization). The patient receive pacemaker for AFIB and did not receive any treatment for other events. The outcome of the events was not recovered. Since vaccination, the patient had not been tested for COVID.  Information on lot/batch number has been requested.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Blood pressure measurement, Body temperature, Chest pain, Coordination abnormal
Clinical narrative: AFIB ( had to get Pacemaker); Autoimmune type responses; Fever; Extreme joint pain; Difficulty walking without assistance; Chest pain; Weakness in legs; Onset of difficult to manage hypoglycemia with A1C 6.5; Diarrhea; Coordination issues; Fluctuating blood pressure and blood sugar; Fluctuating blood pressure and blood sugar; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 17:00 (at the age of 81-year-old) (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included high blood pressure, stent in heart, osteoarthritis, and COVID-19 (prior to vaccination). The patient received unspecified concomitant medications. The patient previously took REGLAN (metoclopramide hydrochloride) and experienced drug allergy. The patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. The patient experienced short term fever, extreme joint pain, difficulty walking without assistance, and long-term autoimmune type responses, joint pain, AFIB (had to get pacemaker), and chest pain (chest pain) on 20Jan2021 08:00. The patient also had weakness in legs, onset of difficult to manage hypoglycemia with A1C 6.5, diarrhea, coordination issues, and fluctuating blood pressure and blood sugar on 20Jan2021 08:00. The patient was hospitalized all events for 2 days and hospitalization was prolonged (vaccine received during existing hospitalization). The patient receive pacemaker for AFIB and did not receive any treatment for other events. The outcome of the events was not recovered. Since vaccination, the patient had not been tested for COVID.  Information on lot/batch number has been requested.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Gait disturbance, Hypoglycaemia, Muscular weakness, Pyrexia
Clinical narrative: AFIB ( had to get Pacemaker); Autoimmune type responses; Fever; Extreme joint pain; Difficulty walking without assistance; Chest pain; Weakness in legs; Onset of difficult to manage hypoglycemia with A1C 6.5; Diarrhea; Coordination issues; Fluctuating blood pressure and blood sugar; Fluctuating blood pressure and blood sugar; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 17:00 (at the age of 81-year-old) (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included high blood pressure, stent in heart, osteoarthritis, and COVID-19 (prior to vaccination). The patient received unspecified concomitant medications. The patient previously took REGLAN (metoclopramide hydrochloride) and experienced drug allergy. The patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. The patient experienced short term fever, extreme joint pain, difficulty walking without assistance, and long-term autoimmune type responses, joint pain, AFIB (had to get pacemaker), and chest pain (chest pain) on 20Jan2021 08:00. The patient also had weakness in legs, onset of difficult to manage hypoglycemia with A1C 6.5, diarrhea, coordination issues, and fluctuating blood pressure and blood sugar on 20Jan2021 08:00. The patient was hospitalized all events for 2 days and hospitalization was prolonged (vaccine received during existing hospitalization). The patient receive pacemaker for AFIB and did not receive any treatment for other events. The outcome of the events was not recovered. Since vaccination, the patient had not been tested for COVID.  Information on lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Immunisation, Off label use
Clinical narrative: Got pfizer 3rd dose on 13Sep2021; Got pfizer 3rd dose on 13Sep2021; Doesn't know if pain in her hips/right back is because of shot or because of side effects; Doesn't know if pain in her hips/right back is because of shot or because of side effects; This is a spontaneous report from a contactable other healthcare professional. A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 13Sep2021 (at the age of 55-year-old) as dose 3, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 and dose 2 via an unspecified route of administration on an unspecified date for COVID-19 immunisation. The patient reported she has not had side effects but got Pfizer 3rd dose on 13Sep2021. She does not know if pain in her hips/right back was because of shot or because of side effects in Sep2021. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Fatigue, Feeling abnormal, Proteinuria
Clinical narrative: weakness; fatigue; brain fog; collapsed/ Had no control of the body/ just before fainting; imbalance; vertigo; urine foams which is the protein leaked from his kidneys; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received third dose bnt162b2 (BNT162B2), via an unspecified route of administration on 31Aug2021 (Batch/Lot number was not reported) (at 62-year-old) as DOSE 3, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient received first dose and experienced headache, foggy feeling in head, dizziness, second dose and experienced fatigue, joint pain, trouble falling asleep, confusion. The next night following the booster dose, patient tried to get out of bed and collapsed. Had no control of the body, imbalance, vertigo, no control, but was able to get back into the bed. Patient collapsed, just before fainting. If fainting is a 10 he was at a 9.5. He had the feeling and sensation of feeling like fainting. Later some weakness and fatigue, not like first episode. He was still experiencing brain fog and fatigue it's like "somebody gave you a narcotic injection to sleep, like an anesthesia it was bazaar". Patient's urine foams which is the protein leaked from his kidneys and that this is a side effect of the vaccine and he wants to know if it is temporary or reversible. The outcome of faint and brain fog was not recovered, other events outcome was unknown.  The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Urine analysis, Vertigo
Clinical narrative: weakness; fatigue; brain fog; collapsed/ Had no control of the body/ just before fainting; imbalance; vertigo; urine foams which is the protein leaked from his kidneys; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received third dose bnt162b2 (BNT162B2), via an unspecified route of administration on 31Aug2021 (Batch/Lot number was not reported) (at 62-year-old) as DOSE 3, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient received first dose and experienced headache, foggy feeling in head, dizziness, second dose and experienced fatigue, joint pain, trouble falling asleep, confusion. The next night following the booster dose, patient tried to get out of bed and collapsed. Had no control of the body, imbalance, vertigo, no control, but was able to get back into the bed. Patient collapsed, just before fainting. If fainting is a 10 he was at a 9.5. He had the feeling and sensation of feeling like fainting. Later some weakness and fatigue, not like first episode. He was still experiencing brain fog and fatigue it's like "somebody gave you a narcotic injection to sleep, like an anesthesia it was bazaar". Patient's urine foams which is the protein leaked from his kidneys and that this is a side effect of the vaccine and he wants to know if it is temporary or reversible. The outcome of faint and brain fog was not recovered, other events outcome was unknown.  The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.