chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Contusion, Erythema, Feeling abnormal, Feeling hot
Clinical narrative: Did not even remotely start feeling like myself again until yesterday/Did not feel like herself; Headache; I was bruised and achy everywhere; I was bruised and achy everywhere; Getting hot and then cold, hot and then cold; get really hot, my ears get red, my face, my neck I just start getting hot/Feeling hot in her ears, face and neck; My ears get red; chattering my teeth; sweat; Fever; This is a spontaneous report from contactable consumer (patient) reported for herself. A 48-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received her first dose of the Pfizer-Biontech Covid19 vaccine this past Monday. On an unspecified date, it was reported that she did not even remotely start feeling like myself again until yesterday, the headache was the first thing that came up, but that was gone in the morning then the next day I felt like I'd been hit by a truck, I was bruised and achy everywhere and that yesterday I was pretty good. The lingering symptom that she was asking about, that she did not see in her consumer fact sheet, is I keep getting hot and then cold, hot, and then cold temperature swings, how long is that supposed to go on I get really hot, my ears get red, my face, my neck I just start getting hot. Then I will cool down and get back to normal. There for the first few days I was chattering my teeth, but now I just get hot. I wake up at night with my pillow soaked, had to pull a blanket up on me because I am cold and had to kick them back off again because I am hot. She was asking how long she should expect these symptoms to last. Response received as per attached: (systemic side effects) including fever and chills were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter. Also provided that frequency data is reported in the 7 days following either dose (tables 1 & 2) [LAB-1457-11.0; Revised: 12Aug2021] Referred back to HCP for treatment if needed. It was reported that she had a headache on the first day after the vaccine, and it resolved overnight. Was not feeling like herself and felt better yesterday. The clinical outcome of the events headache, chills, fever on an unspecified date 2021 was resolved and rest of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Headache, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: Did not even remotely start feeling like myself again until yesterday/Did not feel like herself; Headache; I was bruised and achy everywhere; I was bruised and achy everywhere; Getting hot and then cold, hot and then cold; get really hot, my ears get red, my face, my neck I just start getting hot/Feeling hot in her ears, face and neck; My ears get red; chattering my teeth; sweat; Fever; This is a spontaneous report from contactable consumer (patient) reported for herself. A 48-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received her first dose of the Pfizer-Biontech Covid19 vaccine this past Monday. On an unspecified date, it was reported that she did not even remotely start feeling like myself again until yesterday, the headache was the first thing that came up, but that was gone in the morning then the next day I felt like I'd been hit by a truck, I was bruised and achy everywhere and that yesterday I was pretty good. The lingering symptom that she was asking about, that she did not see in her consumer fact sheet, is I keep getting hot and then cold, hot, and then cold temperature swings, how long is that supposed to go on I get really hot, my ears get red, my face, my neck I just start getting hot. Then I will cool down and get back to normal. There for the first few days I was chattering my teeth, but now I just get hot. I wake up at night with my pillow soaked, had to pull a blanket up on me because I am cold and had to kick them back off again because I am hot. She was asking how long she should expect these symptoms to last. Response received as per attached: (systemic side effects) including fever and chills were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter. Also provided that frequency data is reported in the 7 days following either dose (tables 1 & 2) [LAB-1457-11.0; Revised: 12Aug2021] Referred back to HCP for treatment if needed. It was reported that she had a headache on the first day after the vaccine, and it resolved overnight. Was not feeling like herself and felt better yesterday. The clinical outcome of the events headache, chills, fever on an unspecified date 2021 was resolved and rest of the events was unknown.  Information on the lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hot flush, Nausea, Neck pain, Vaccination site haemorrhage
Clinical narrative: Dizzy; Nauseous; Neck hurts; Hot flashes; Site is still bleeding; This is a spontaneous report from a contactable consumer. This 27-year-old female consumer (patient) reported for herself. A 27-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: FA7485), dose 1 via an unspecified route of administration, administered in Arm Left on 14Aug2021 12:00 (at the age of 27-years-old) as a single dose for COVID-19 immunization. Medical history included rubber sensitivity, COVID-19 prior vaccination. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient had allergies with Latex. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 14Aug2021 12:00, the patient experienced dizzy, nauseous, neck hurts, hot flashes, site is still bleeding. The patient underwent lab tests and procedures which included sars-cov-1 test: positive; covid prior vaccination. The patient did not receive any treatment. All the events were reported as non-serious. Outcome of the event was not recovered, at the time of this report. Device Date was 14Aug2021. Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity
Clinical narrative: pains in arms; didn't feel good; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received bnt162b2 (COVID 19 Vaccine), dose 1 via an unspecified route of administration, administered in left arm on 23Jul2021 (Lot number EW0178/ EWD178, further not clarified hence, not captured in tab) as dose 1, single at the age of 69-year-old for COVID-19 immunization. Medical history included glaucoma. Concomitant medications were not reported. No investigation assessment. 3 weeks ago the patient got the 1st Pfizer vaccine, he got pains in arms that he got them in and it didn't feel good for him, no fever nothing like that in 2021. No treatment received. The outcome of events was unknown. The lot number for bnt162b2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Skin burning sensation, Urticaria
Clinical narrative: he got felling hot; Chills; his skin is on fire; got hives or something; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received second dosebnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on Aug2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: not reported) via unspecified route of administration on unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. On 15Aug2021 the patient experienced he got felling hot, chills, his skin is on fire, got hives or something. The outcome of the events feeling hot, chills, skin burning sensation, urticaria was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Crying, Lymphadenopathy, Oropharyngeal pain, Pyrexia
Clinical narrative: Throat hurting; Crying; Lymph nodes are swollen; fever of 99; This is a spontaneous report from a contactable consumer or other non-health care professional. This reported reported for her granddaughter. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 04Aug2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not re-ported. On an unspecified date in Aug2021, the patient experienced throat hurting, crying , lymph nodes are swollen, fever of 99. It was further stated that reporter stated, Well I am calling about my granddaughter. She got her first COVID shot on 04Aug (Confirmed as 04Aug2021) but she is having side effects or something after 3 days. She, her throat hurting she is crying. I need to know what to do about that. I do not have the lot no right now, should she go and see somebody? Obviously right? because it is her lymph nodes are swollen and she has a fever of 99, yesterday she did not have any fe-ver. When asked to provide the medical information department, reporter stated, No that was okay. I will just take her in else somewhere. The patient underwent lab tests and procedures which included pyrexia: normal yesterday she did not have any fever, pyrexia: 99 on an unspecified date. The clinical outcome for all the events was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Adnexa uteri pain, Back pain, Erythema, Gait disturbance
Clinical narrative: I started feeling this like pain on my ovaries like on my abdomen, so I felt it one time first; I started getting this bad pain on my back; I can't even walk, like since yesterday I have to take little steps, you know walking slow; The first 15 minutes my hand was like really evolving in red but it's normal like it's an arm; This is a spontaneous report from a contactable consumer or other non healthcare professional. A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER, UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced to started feeling like pain on her ovaries like on her abdomen, so she felt it one time first causing adnexa uteri pain on an unspecified date with outcome of unknown , she started getting this bad pain on her back causing back pain on an unspecified date with outcome of unknown, she can't even walk, like since the previous day, she had to take little steps, leading to gait disturbance on an unspecified date with outcome of unknown, the first 15 minutes her hand was like really evolving in red but it's normal like it's an arm causing erythema on an unspecified date with outcome of unknown.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Malaise, Pain in extremity, Peripheral swelling
Clinical narrative: my arm is now all red and swollen and hurts; my arm is now all red and swollen and hurts; my arm is now all red and swollen and hurts; I felt like crap for a day or two; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (Pfizer COVID-19 vaccine, Solution for injection, Batch/Lot number: unknown, Expiry Date: unknown), via an unspecified route on 13Aug2021 on Friday, as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date in Aug2021, patient felt like crap for a day or two, but patient was feeling much better and on 16Aug2021, today noticed at a no where arm is now all red and swollen and hurts. Patient just wanted to know if this was common side effect that's all. The clinical outcome of felt like crap was recovering, arm is now all red and swollen and hurts was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Mastication disorder, Pain in jaw
Clinical narrative: Trouble chewing, swallowing, pain in jaw
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Loss of personal independence in daily activities, Menstruation irregular
Clinical narrative: Extremely heavy menstrual flow subsequent to the shot. Bleeding to the point it inhibits my daily activities. I have no prior history of menstrual or reproductive health issues. Also, irregular periods since the vaccine while I was very regular before.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Premature menopause
Clinical narrative: Debilitated and bed ridden for 30 days. Also, early onset of menopause. So fun!
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Palpitations, Pyrexia
Clinical narrative: Body pain, palpitations, fatigue, fever.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Chest pain, Contusion, Inflammation
Clinical narrative: Bad taste in mouth, swollen lymph nodes, inflammation, palpitations, body aches, edema, rashes, chest pain, easily bruising, anxiety stiff joints, jaw pain, shoulder pain, swelling of face. Knots under arms and groin
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Joint stiffness, Lymphadenopathy, Nodule, Oedema, Pain
Clinical narrative: Bad taste in mouth, swollen lymph nodes, inflammation, palpitations, body aches, edema, rashes, chest pain, easily bruising, anxiety stiff joints, jaw pain, shoulder pain, swelling of face. Knots under arms and groin
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw, Palpitations, Rash, Red blood cell sedimentation rate, Swelling face
Clinical narrative: Bad taste in mouth, swollen lymph nodes, inflammation, palpitations, body aches, edema, rashes, chest pain, easily bruising, anxiety stiff joints, jaw pain, shoulder pain, swelling of face. Knots under arms and groin
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: Bad taste in mouth, swollen lymph nodes, inflammation, palpitations, body aches, edema, rashes, chest pain, easily bruising, anxiety stiff joints, jaw pain, shoulder pain, swelling of face. Knots under arms and groin
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Myalgia
Clinical narrative: Diffuse myalgia, numbness in extremities, symptoms persist 4 weeks after 3rd dose of vaccine. No such symptoms after first or second dose.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: Urinary Tract Infection came on suddenly 5 days after receiving the vaccine; This is a spontaneous report from a contactable consumer (patient). A 63-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 25Apr2021 08:30 (at the age of 63-year-old) as dose 1, single for COVID-19 immunisation. Medical history included allergy to sulfa. Concomitant medication(s) included betacarotene, bioflavonoids nos, biotin, calcium ascorbate, calcium pantothenate, calcium phosphate, choline bitartrate, chromic chloride, colecalciferol, copper sulfate, cyanocobalamin, folic acid, hesperidin, inositol, iron amino acid chelate, lycopene, lysine hydrochloride, magnesium oxide, manganese sulfate, molybdenum trioxide, nicotinamide, phytomenadione, potassium iodide, potassium sulfate, pyridoxine hydrochloride, retinol acetate, riboflavin, selenomethionine, silicon dioxide, colloidal, sodium borate decahydrate, thiamine mononitrate, tocopheryl acid succinate, ubidecarenone, zinc oxide (MULTIVITAMIN & MINERAL) taken for an unspecified indication, start and stop date were not reported. Patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination included multivitamin. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient reported that urinary tract infection came on suddenly 5 days after receiving the vaccine on 30Apr2021 03:30. This was very unusual as she had not had a UTI in 10 or 15 years (estimated). Seriousness of the events was reported as non-serious. Hospitalization prolonged was reported as no. The adverse event resulted in doctor or other healthcare professional office/clinic visit and doctor prescribed antibiotic for the event. The outcome of event was recovered on an unspecified date of 2021.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Infection
Clinical narrative: she is in her 7th month of pregnancy; infection; This is a spontaneous report from a contactable consumer or other non hcp. This consumer or other non hcp reported information for mother. This is a maternal report. A female patient of an unspecified age received first dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number and Expiration date 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 was not reported. My wife was pregnant and she was in her 7th month of pregnancy. Recently she had some infection and she was on antibiotics. She was due for her 2nd Pfizer Covid vaccine shot today. Was there any concern taking shot while also taking the antibiotics. The patient's concomitant medications were not reported. On an unspecified date the patient experienced she is in her 7th month of pregnancy, infection. The mother reported she became pregnant while taking bnt162b2. Therapeutic measures were taken as a result of infection.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Burning mouth syndrome, Gingival bleeding
Clinical narrative: Roof of mouth started to burn/burning mouth syndrome; gums bled; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 63-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 16Apr2021 (Batch/Lot Number: Ew0153) as DOSE 2, SINGLE for covid-19 immunisation at Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine taken for an unspecified indication, start and stop date were not reported. The patient previously took Quinine, Sulfates and experienced the drug sensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine via an unspecified route of administration, administered in Arm Right on 26Mar2021 (Batch/Lot number: Er8730) as DOSE 1, SINGLE for covid-19 immunisation. The patient reported on 16Apr2021, the patient experienced, Roof of moth started to burn, got worse over the next week like I ate hot chili peppers, gums bled, after about a mouth burning lessened, condition comes back without warning, never really goes away. She had been told it was Burning mouth syndrome. The events resulted in visit to Doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the events was not recovered at the time of the report. Device date was 20Aug2021.   Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Face injury, Headache, Nasal congestion
Clinical narrative: Nose stuffed up; head/face hurt; head/face hurt; This is a spontaneous report from a contactable consumer or other non hcp. A 63-year-old female patient received first dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number and Expiration date was not reported) via an unspecified route of administration on 15Jul2021 18:15 (age at vaccination 63-year-old) as DOSE 1, SINGLE for covid-19 immunization. Medical history included allergy: mold, allergy: dust. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. There were no other vaccine received within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. 4th day following initial vaccine - Nose stuffed up and head/face hurt. Took a Claritin which did not help - maybe it made it worse.  Stayed in bed all day on 5th day. No vaccination prior to the patient diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19: No. The patient's concomitant medications were not reported. On 19Jul2021 the patient experienced nose stuffed up, head/face hurt, head/face hurt. There were no other vaccine in four weeks. There were no other medications in two weeks. Adverse event 4th day following initial vaccine - Nose stuffed up and head/face hurt. Took a Claritin which did not help - maybe it made it worse: Stayed in bed all day on 5th day. There were no other treatment for ae. There were no other covid prior to vaccination. There were no other covid tested post to vaccination. There were known allergies with mold, dust. Therapeutic measures were taken as a result of head/face hurt, head/face hurt. The outcome of events were recovered on aug2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a Spontaneous report based on the information received by Pfizer from Agency on behalf of Pharmaceuticals, Inc. (Manufacturer Control No: 2021BHV01004) via a contactable consumer (patient).  A 75-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 17Feb2021 (at the age of 75-year-old) as single dose for COVID-19 immunization. Medical history and concomitant medications or past drug history of the patient were not reported. On an unspecified date in 2021, after second dose of vaccination, patient experienced severe headache. Outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dysgeusia, Headache, Nausea
Clinical narrative: Arm pain; headache; body aches; nausea; vomiting; low grade fever; chills; night sweats; Metallic taste in my mouth immediately after injection.; This is a spontaneous report from a contactable nurse. This 54-year-old female Nurse reported for herself that she received bnt162b2 (BNT162B2 Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 23Aug2021 10:15 (Batch/Lot Number: EW0182) as DOSE 1, SINGLE for covid-19 immunisation (54 years at the age of vaccination).  Medical history included covid-19 from an unknown date and unknown if ongoing. Concomitant medication included bupropion hydrochloride (WELLBUTRIN) 150 unk daily taken for an unspecified indication, start and stop date were not reported; acyclovir [aciclovir] (ACYCLOVIR [ACICLOVIR]) taken for an unspecified indication, start and stop date were not reported; estriol (ESTRIOL) taken for an unspecified indication, start and stop date were not reported.  If covid prior vaccination was yes and If covid tested post vaccination was no. The patient experienced Arm pain, headache, body aches, nausea, vomiting, low grade fever, chills , night sweats and Metallic taste in my mouth immediately after injection on 23Aug2021 16:00. The patient underwent lab tests and procedures which included body temperature: low grade fever fahrenheit on 23Aug2021 low grade fever.  Therapeutic measures were taken as a result of all events (Zofran). The outcome of the events was resolving.   Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Pain, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Arm pain; headache; body aches; nausea; vomiting; low grade fever; chills; night sweats; Metallic taste in my mouth immediately after injection.; This is a spontaneous report from a contactable nurse. This 54-year-old female Nurse reported for herself that she received bnt162b2 (BNT162B2 Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 23Aug2021 10:15 (Batch/Lot Number: EW0182) as DOSE 1, SINGLE for covid-19 immunisation (54 years at the age of vaccination).  Medical history included covid-19 from an unknown date and unknown if ongoing. Concomitant medication included bupropion hydrochloride (WELLBUTRIN) 150 unk daily taken for an unspecified indication, start and stop date were not reported; acyclovir [aciclovir] (ACYCLOVIR [ACICLOVIR]) taken for an unspecified indication, start and stop date were not reported; estriol (ESTRIOL) taken for an unspecified indication, start and stop date were not reported.  If covid prior vaccination was yes and If covid tested post vaccination was no. The patient experienced Arm pain, headache, body aches, nausea, vomiting, low grade fever, chills , night sweats and Metallic taste in my mouth immediately after injection on 23Aug2021 16:00. The patient underwent lab tests and procedures which included body temperature: low grade fever fahrenheit on 23Aug2021 low grade fever.  Therapeutic measures were taken as a result of all events (Zofran). The outcome of the events was resolving.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Herpes simplex, Urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp (patient). A 45-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: FC3180), via an unspecified route of administration in left hand on an unspecified date as dose 2, single for COVID-19 immunisation. The medical history of the patient included covid-19. The patient had no known allergies. The concomitant medications of the patient were not reported. The patient was not pregnant at the time of vaccination. The patient previously received first dose of BNT162B2 (solution for injection, Batch/Lot number: FA6780), via an unspecified route of administration in left hand on 19Jul2021 at 05:00 as single dose for COVID-19 immunisation and developed three very distinct mosquito like bites on her left arm. They did not go away, were very scratchy and developed a black dot within them. Her gums swelled and were leaking blood/puss for unknown reasons, and she had heart pain. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was diagnosed with covid-19. Since the vaccination, the patient not been tested with covid-19. On 16Aug2021 at 20:00, the patient experienced now after the second shot, I developed what looks like herpes and hives all over the body and patchy and mimic the exact likings of herpes. The patient did not received treatment for the events. The outcome of the events was reported as unknown. Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Hypokinesia, Pain in extremity
Clinical narrative: upper arm pain which makes it painful to move arms along with hip pain.; upper arm pain which makes it painful to move arms along with hip pain.; painful to move arms/ it wakes me from deep sleep and can hardly move.; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on 06Aug2021 as DOSE 2, SINGLE for COVID-19 immunization. Patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 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 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had received 2nd shot on 06Aug2021 with no reaction until 5 days. Later after 5 days on 11Aug2021 it was reported that, patient have upper arm pain which makes it painful to move arms along with hip pain. Patient enquired could this just be a reaction. As patient continue to move throughout the day the pain becomes easier to deal with; but first thing in the morning it wakes patient from deep sleep and can hardly move. The outcome of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: had a fever of 103F; joint pain; achiness; This is a spontaneous report from a Pfizer-sponsored program, also from a non-contactable consumer (parent). A 23-year-old male patient (reporter's son) received bnt162b2 (COVID 19 Vaccine, mRNA), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation  .  Medical history and concomitant medications were not reported. The patient was tested positive for COVID and then received his first dose of the Pfizer COVID vaccine 4 weeks later. He had major side effects from the vaccine. He had a fever of 103F, joint pain and achiness that lasted for 2-3 days. He's in the military and was forced to get the vaccine. The reporter asked after getting the virus, is there a time frame that a person should wait before getting the vaccine? Is the emergency use vaccine the same ingredients as the one approved by the FDA? The patient underwent lab tests and procedures which included pyrexia: 103 fahrenheit, tested positive for COVID on an unknown date. The outcome of achiness was recovered. The outcome of other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Neuropathy peripheral, Pain in extremity, Paraesthesia
Clinical narrative: Patient has been having major neuropathy arm issues post Pfizer Covid shot; Intermittent numbness and tingling; major dead arm issue since April; Intermittent numbness; This is a spontaneous report from a contactable other healthcare professional via Medical Information Team. A 46-year-old female patient (Non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0150) dose 2, via an Intramuscular route of administration administered in Left arm on 09Apr2021 (at the age of 46 year) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. It was unknown if the patient diagnosed with COVID-19 prior vaccination. It was unknown if the patient been tested for COVID-19 since vaccination. The patient receives any other vaccines within 4 weeks prior to the COVID-19 vaccine remains unknown. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN6207) dose 1, via an Intramuscular route of administration, administered in Left arm on 19Mar2021 as a single dose for COVID-19 immunization. Patient has been having major neuropathy arm issues post Pfizer Covid shot. She has been taking gabapentin & Physical Therapy; and vitamin alpha lipoic for nerve regeneration. She has had this major dead arm issue since Apr2021 right after she got the 2nd shot, intermittent numbness and tingling. She also knows a number of people in her hometown with similar adverse events. Events resulted in Doctor or other healthcare professional office/clinic visit. No prolonged hospitalization. Outcome of the events was not recovered.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Caller reported that she have a friend who was fully vaccinated and ended up in the hospital still with COVID diagnosis.; Caller reported that she have a friend who was fully vaccinated and ended up in the hospital still with COVID diagnosis.; This is a spontaneous report from a non-contactable consumer (patient's friend). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 and dose 2, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller reported that she have a friend who was fully vaccinated and ended up in the hospital still with COVID diagnosis. The 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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Off label use, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: injection site had pain; injection site had swelling; injection site had redness; received third dose of product; Received third dose of product; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 3 via an unspecified route of administration, administered in Arm Left on 27Aug2021 09:30 (at the age of 67years), (Batch/Lot Number: FD0809) as DOSE 3, SINGLE for covid-19 immunisation. Medical history included none from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2, on 15Jan2021 (at the age of 67 years) dose 1 (Batch/Lot Number: EL3247) as DOSE 1, SINGLE for covid-19 immunisation. Dose 2 on 08Feb2021 (at the age of 67 years) as DOSE 2, SINGLE for covid-19 immunisation. She's calling about the Pfizer vaccine. Clarified Pfizer Covid 19 vaccine. She has had her first 2 doses and she used the (withheld) website and after she received her third dose of the Pfizer Covid 19 vaccine, she tried to report her symptoms to the (withheld) website but was having trouble with the online system. She knows reporting information was good and helps back the research. She was calling to report pain, swelling, and redness at the injection site after the third dose for about 7 days. She reports her symptoms began on 28Aug2021. She received the third dose on 27Aug2021. She states at this point she barely feels it at all. The last 2 days she's had not problems with her arm at all. She would say she was completely recovered at this point. The clinical outcome of the event injection site had swelling, injection site had pain, injection site had redness was recovered on 03Sep2021, remaining all other events was unknown at the time of report.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Urticaria
Clinical narrative: Syncopal episode; Urticaria from neck to feet; This is a spontaneous report from a contactable nurse. A 45-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: FC3184) via an unspecified route of administration, administered in Arm Left on 31Aug2021 at 09:00 as DOSE 2, SINGLE (at the age of 45-year-old) for covid-19 immunisation. The patient received first dose on 10Aug2021 at 9:00 AM on left arm (lot number: EW0181) for covid-19 immunisation. Medical history included migraine, hypertension. Concomitant medications included topiramate; lisinopril; hydrochlorothiazide (HCT); metoprolol succinate. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Sep2021 the patient experienced urticaria from neck to feet starting day 4 post injection lasting till present time. Syncopal episode on day 5 (05Sep2021) post injection, resolving once patient hit the floor. It was unknown if patient received the treatment or not. The outcome of the events was not resolved.; Sender's Comments: Based on the temporal relation, the association between the event of syncope and the suspect product of BNT162B2 cannot be completely ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Hypoacusis
Clinical narrative: Muffled ear; This is a spontaneous report from a contactable consumer. A male patient (son) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown), dose 1 via an unspecified route of administration on 01Sep2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reporter stated, my son received the vaccination on Wednesday, and he was complaining of like muffled ear on an unspecified date and wanted to know is that a side effect. The clinical outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymph nodes in left armpit swollen to size of softball; This is a spontaneous report from a contactable other HCP (patient).   A 30-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 05Sep2021 10:00 (at the age of 30-year-old) (Batch/Lot number was not reported) as single dose, dose 2 via an unspecified route of administration, administered in arm left on 05Sep2021 10:00 (at the age of 30-year-old) (Batch/Lot number was not reported) as single dose, for COVID-19 immunisation (as reported). Medical history was none. No known allergies. The patient's concomitant medications were not reported. No other vaccine in fourweeks. No other medications in twoweeks. No patient drug events. The patient was not pregnant. Patient had not COVID prior vaccination. The patient experienced lymph nodes in left armpit swollen to size of softball (medically significant) on 06Sep2021 12:00 AM with outcome of not recovered. No treatment received. COVID was not tested post vaccination.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the event cannot be completely excluded.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Paraesthesia
Clinical narrative: headache; tingling in my scalp; This is a spontaneous report from a contactable consumer reported that. A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 22Aug2021 10:30 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization (Age at vaccination 45 years). The patient was not pregnant at the time of vaccination. The patient past Medical history included known allergies: sulfa from an unknown date and unknown if ongoing. Concomitant medication(s) included progesterone (PROMETRIUM [PROGESTERONE, strength 100mg) taken for an unspecified indication, and Multivitamin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. After the administration of vaccine, the patient developed a headache on day one which has persisted every day since coming and going and tingling in her scalp on 23Aug2021. The events result in Doctor or other healthcare professional office/clinic visit. No treatment was received. The event outcome was not recovered.     The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Ophthalmic herpes simplex
Clinical narrative: Flare up of Herpes Simplex Keratitis in left eye.  No other reason for immediate flare up 1 day after receiving shot #2.; This is a spontaneous report from a contactable consumer (patient).   A 39-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 05Sep2021 11:15 (Lot Number: FC8448) as single dose for covid-19 immunisation.  The patient had received the first dose of the same vaccine on 15Aug2021 11:15 AM via unspecified route at the left arm from lot FC3181. Medical history included epilepsy, penicillin hypersensitivity. Concomitant medication included influenza vaccine (FLU) taken for immunization on 15Aug2021 at the Right Arm.  The patient experienced flare up of herpes simplex keratitis in left eye on 06Sep2021 06:00 with outcome of recovering.  Therapeutic measures were taken as a result of flare up of herpes simplex keratitis in left eye. The patient was not tested positive for the Covid post vaccination. No covid prior vaccination.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dyspnoea, Pharyngeal swelling, Swelling face, Syncope
Clinical narrative: Anaphylactic reaction; fainted on the floor; Throat and face swell until cannot breathe; Throat and face swell until cannot breathe; Throat and face swell until cannot breathe; This is a spontaneous report from a non-contactable consumer (patient).   A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced anaphylactic reaction, throat and face swell until cannot breathe fainted on the floor. Patient stated that "need see allergist do blood test then they said I also allergic to some other stuffs I am not aware of. Been prescribed with 2 Epipens after that". The 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.
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: seizure; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced seizure. Reporter stated warning this video shows a mom have a seizure after taking the jab. I trust this gives you all the information you need at this time for this event. Please contact me for further information if required. The outcome of the event seizure was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No fur-ther information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Rheumatoid arthritis
Clinical narrative: after two weeks of receiving 2nd shot I developed severe joint pain in hands shoulder calf knees feet it comes and goes moderate to severe.; I tested positive for Rhumatoid Arthritisand I am waiting; This is a spontaneous report from a contactable consumer (patient) received via Regulatory Authority. A 42-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left in Mar2021 (Batch/Lot number was not reported) (at the age of 42-year-old) as single dose for COVID-19 immunisation.  Medical history included atrial fibrillation (AFib), high cholesterol, high blood pressure (BP) and gluten sensitive, all from an unknown date and unknown if ongoing. No known allergies.  The patient did not experienced COVID-19 before vaccination and not tested positive to COVID-19 since vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, in Mar2021 (Batch/Lot number was not reported) (at the age of 42-year-old) as single dose for COVID-19 immunisation.  The patient reported that: "after two weeks of receiving 2nd shot (in Apr2021), I developed severe joint pain in hands shoulder calf knees feet it comes and goes moderate to severe. I tested positive for rheumatoid arthritis and I am waiting for treatments". The events were reported as serious, disabling. The events required doctor or other healthcare professional office/clinic visit. The patient outcome of the events was not recovered.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.