chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Pain, Pyrexia
Clinical narrative: Fever; Chilliness; Body Pain; Headache; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, the patient took vaccination on Wednesday around 10:30 AM. It had been 48 hours, the patient got fever in 14 hours and chilliness and body pain. The patient was not having fever today but getting headache. The patient wanted to know whether it was normal. Outcome of the event fever was recovered and other events was unknown.  Information about batch/lot number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Stomatitis, Throat irritation
Clinical narrative: Scratchy throat; Several mouth sores; Flare up in eczema outbreaks; This is a spontaneous report from a contactable consumer (patient). A 44-years-old non pregnant 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 17May2021 at 09:00 in right arm as a single dose for covid-19 immunization. Medical history, concomitant medications received within 2 weeks of vaccination were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine) on 23Apr2021 at 09:00 for COVID-19 immunization. On 24May2021 at 11:45, after the second dose the patient developed scratchy throat, several mouth sores and her eczema outbreaks flared up. Patient was not hospitalized for the events. The patient did not receive any treatment. Device date was reported as 30May2021. The outcome of all the events at the time of last observation was resolving.   No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness in my RIGHT Arm (opposite of Vaccination arm) 24 hours after injection of first shot which lasted; This is a spontaneous report from a contactable consumer (patient).   A 74-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9266), via an unspecified route of administration in left arm on 02Feb2021 as 1ST DOSE, SINGLE for covid-19 immunisation.  Medical history included asthma from an unknown date and unknown if ongoing, allergic to aspirins and sulfa drugs. Concomitant medication included amlodipine besilate (AMLODIPINE BESILATE) for an unspecified indication, start and stop date were not reported.  Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Feb2021, patient experienced soreness in right arm (opposite of Vaccination arm) 24 hours after injection of first shot which lasted. The events resulted in: Physician office visit. The outcome of event was not recovered.  No follow-up attempts are needed
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Gait disturbance, Pain, Pain in extremity
Clinical narrative: Diarrhea; Tossing up; Soreness in arm alternating left right, then behind knee; Soreness in arm alternating left right, then behind knee; I could hardly walk; Intense pain in hand, then elbows, then pack to shoulders alternating, sometimes intense, ache when I don't move intense when I do. It's been three freaking months and the left armached all last night; This is a spontaneous report received from a contactable consumer (patient). A 74-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6205), via an unspecified route of administration, in arm left on 02Feb2021 (at age 74-year-old) as a single dose for COVID-19 immunization. The patient's medical history included asthma. The patient had known allergies to sulfa drugs. The patient's concomitant medications included amlodipine (within 2 weeks of vaccination). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number=EL9266), via an unspecified route of administration in arm left on an unspecified date, as a, single dose for Covid-19 Immunization and experienced Soreness in right arm. Patient previously took acetylsalicylic acid (ASPIRIN) and allergies with it. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that, the patient experienced soreness in his right arm (opposite of vaccination arm) 24 hours after injection of first shot which lasted. Then after second shot, on 16Feb2021, patient experienced diarrhea and tossing up, soreness in arm, alternating left right, then behind knee as he could hardly walk, then intense pain in hand, then elbows, then pack to shoulders alternating, sometimes intense, ache when he didn't move and intense when he does. The patient stated that, it's been three freaking months and the left arm ached all last night. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The reporter classified the events as non-serious. Treatment received for the events was reported as unknown. The outcome of the events was not recovered.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Restlessness
Clinical narrative: Diarrhea; Tossing up; Soreness in arm alternating left right, then behind knee; Soreness in arm alternating left right, then behind knee; I could hardly walk; Intense pain in hand, then elbows, then pack to shoulders alternating, sometimes intense, ache when I don't move intense when I do. It's been three freaking months and the left armached all last night; This is a spontaneous report received from a contactable consumer (patient). A 74-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6205), via an unspecified route of administration, in arm left on 02Feb2021 (at age 74-year-old) as a single dose for COVID-19 immunization. The patient's medical history included asthma. The patient had known allergies to sulfa drugs. The patient's concomitant medications included amlodipine (within 2 weeks of vaccination). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number=EL9266), via an unspecified route of administration in arm left on an unspecified date, as a, single dose for Covid-19 Immunization and experienced Soreness in right arm. Patient previously took acetylsalicylic acid (ASPIRIN) and allergies with it. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that, the patient experienced soreness in his right arm (opposite of vaccination arm) 24 hours after injection of first shot which lasted. Then after second shot, on 16Feb2021, patient experienced diarrhea and tossing up, soreness in arm, alternating left right, then behind knee as he could hardly walk, then intense pain in hand, then elbows, then pack to shoulders alternating, sometimes intense, ache when he didn't move and intense when he does. The patient stated that, it's been three freaking months and the left arm ached all last night. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The reporter classified the events as non-serious. Treatment received for the events was reported as unknown. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Seasonal allergy, Sneezing, Swelling face
Clinical narrative: Stronger pain of headache/Had few pangs of headaches which wasn't long term; Hay fever; Sneezing and blowing; Forehead swelled up/Had to go to Emergency Care because my forehead swelled up; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received second dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Batch/Lot number; NDC number: Unknown, Expiration date: Unknown), via an unspecified route on 19May2021 as a single dose for covid-19 immunization. Medical history included problems with preservatives and histamine. The patient concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine) as a single dose for covid-19 immunization and had a couple days of fatigue. On an unknown date after second dose, patient experienced swelling and had a few pangs of headaches which wasn't long term. She mentioned that 10 days later she ate a chocolate chip cookie and she had to go to Emergency Care because as her forehead swelled up and more headache was from the cookie she ate and more stronger pain of headache. She had a forehead swell up from a Wendy's chocolate chip cookie she ate. There was bleached flour in the cookie. She didn't look up ingredients of the cookie. She did not think about it and she ate it. She had hay fever (the night before), she was sneezing and blowing then her forehead swelled up. She had problems with preservatives and histamine. There was bleached flour in the cookie. She did not look up ingredients of the cookie. The doctor prescribed prednisone for 3 to 5 days for a couple times a day. The swelling went down after 1 prednisone. She had a headache last night but not today. She only going to take 1 pill. She was not going to take any more. She wanted to know if it effects the efficacy of the vaccine if she took 120 mg prednisone, 10 days after the second vaccine. She mentioned that she goes to exercise class and those who has the vaccine, they dont wear the mask and she doesnt feel its safe. She enquired about the duration of protection after the second dose and discussed the response of those who are immunocompromised and those receiving immunosuppressant therapy and asked if older people have a diminished response. There was no PQC (Product quality complaint) present. The clinical outcome of the headache was recovered on an unspecified date in 2021, and outcome of other event was unknown.  Information about batch/lot number is requested.
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Redness around the ankles; This is a spontaneous report received from a non-contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, the patient received the COVID -19 shot of Pfizer and experienced redness around the ankles on an unspecified date. The event was assessed as non-serious by the reporter. The outcome of the event was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 77.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dyspnoea, Fatigue, Respiratory rate increased
Clinical narrative: I was real cold; I'm just tired; I don't want to do anything; I'm fast breathing heartbeat; Dizziness; Shortness of breath; This is a spontaneous report from a contactable consumer (Patient). A 77-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: 0176 (Not clarified); expiration date: unknown), via an unspecified route of administration on 28May2021 as 2nd dose, single dose for COVID-19 immunization. The patient historical vaccine included first dose of BNT162B2 on 07May2021 for COVID-19 immunization. The medical history and concomitant medications were not reported. The patient reported, received the second vaccine this Friday and having effects more than got with the first one. Patient was asking if that was normal or not. Patient had side effects that didn't had with the first shot. Patient stated, Dizziness, was fast breathing heartbeat. Patient did not experience any of this with the first shot, it was the second shot. Dizziness and just like patient said shortness of breath and had chills too and patient just tired, chills and tiredness and didn't wanted to do anything. Consumer stated, when patient first came home had real cold and then arm was (incomplete sentence). The outcome of the event fast breathing heartbeat was not recovered and for rest of the events it was unknown.  Information on the lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: is having headaches; This is a spontaneous report from a contactable consumer (patient's grandchild) from a Pfizer sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date: unknown), via an unknown route of administration on an unknown date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, after first dose, patient started to have headaches. Reporter inquired whether patient could take Tylenol for event. Outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Contusion, Vaccination site discomfort, Vaccination site swelling
Clinical narrative: Internal bruising; Had first dose vaccination and in the same arm had swelling in upper arm muscle tissue; Vaccination area was getting worst; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm on 20May2021 (Batch/Lot Number: EW0176) as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the patient had first Covid vaccine shot on 20May2021 and second shot (dose) vaccine has been scheduled on 10Jun2021. Since the patient had the first dose vaccination, in the same arm the patient had a very bad swelling in upper arm muscle tissue and vaccination area was getting worst. The patient was also having internal bruising. The patient was trying to find out if this was something normal reaction or do the patient need to go and see an Emergency care Physician right away. Outcome of the events was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Cheilitis, Lip erythema, Lip swelling, Paraesthesia oral
Clinical narrative: The upper lip was slightly swollen and tingled.; The upper lip was slightly swollen and tingled.; The gum area above upper teeth and the inside of the top lip were bright red, inflamed, and the had a weird texture when I touched it with my tongue.; The gum area above upper teeth and the inside of the top lip were bright red, inflamed, and the had a weird texture when I touched it with my tongue.; This is a spontaneous report from a non-contactable consumer (patient). A 55-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0186), dose 1 via an unspecified route of administration, administered in arm left on 27May2021 at 10:00 as single dose for COVID-19 immunisation. Medical history included hypothyroidism (diagnosed 3 years ago, but not longer require meds) and was allergic to erythromycin, Keflex and sulfa. The patient's concomitant medications included One a Day Brand Multi Vitamin received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 27May2021 at 15:00, the patient experienced the upper lip was slightly swollen and tingled and "the gum area above upper teeth and the inside of the top lip were bright red, inflamed, and the had a weird texture when I touched it with my tongue". The patient did not received any treatment for the events. The outcome of the events was resolving.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site bruising, Vaccination site haematoma, Vaccination site pruritus
Clinical narrative: Headache; brusing, hematoma, and itching at injection site; brusing, hematoma, and itching at injection site; brusing, hematoma, and itching at injection site; This is a spontaneous report from a contactable Nurse (patient). A 42-year-old female patient (non-pregnant) 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, in arm left on 28May2021 11:45 AM (age at the time of vaccination 42-year-old) at a 2nd dose, single dose for COVID-19 immunization. The patient medical history included hypothyroid, allergy to pcn, vancouver, sulfa drugs. The patient concomitant medication included levothyroxine sodium (SYNTHROID) received within 2 weeks of vaccination. The patient previously took 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 an unspecified date at a 1st dose, single dose for COVID-19 immunization. The patient did not receive other vaccines prior to the COVID vaccine within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not tested for COVID-19 post vaccination. Since the vaccination, the patient has not been tested for COVID-19. On 29May2021 The patient experienced headache, brusing, hematoma, and itching at injection site after vaccination. The patient did not receive any treatment for the event. No serious criteria reported. Device date is 31May2021. Outcome of the events was recovering.  Information about lot/batch has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Hypoacusis, Pruritus, Vaccination site swelling
Clinical narrative: Hearing problem; Arm is swelling and it itches like crazy; Arm is swelling and it itches like crazy; 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), via an unspecified route of administration at left arm on 25May2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Patient reported that, after receiving second dose of vaccine, it will be a week tomorrow (as reported) and then patient's arm was swelling and it itches like crazy on an unspecified date in 2021. Patient was just wanted to know what should be done about it. The patient have hearing problem and did not know what caller said on an unspecified date in 2021. Outcome of all the events were unknown.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: In the shot area it started to itch; In the shot area it was slightly swollen; Some soreness; it was quite swollen very hot; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration date not reported) via an unspecified route of administration on 26May2021 as 2nd dose single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The Historical vaccine included first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration date not reported) via an unspecified route of administration on unspecified date as 1st dose single for COVID-19 immunization. On Wednesday 26May2021 at 11:30 (withheld), the patient received second dose of vaccine and on Friday the patient had itch and it was slightly swollen in the shot area. The patient reported late yesterday it started to swell a lot more and noticed that and a clockwise night (not clarified) it was quite swollen very hot, and it was still hot next morning, and it itches. There was some soreness, and it was not terribly serious. The patient noticed that, if the hand was not moved the itching stops and the patient did not feel anything except it was art (not clarified) the patient can put whole hand with fingers pressed and it covers the whole area of the swelling, the heat and the itching and was not sure what to do about it. The patient did not think it was anything serious as far as concerned but did not know anything about it and do have concern. The patient does not have a computer and the other person made the arrangements for COVID Shot (COVID Vaccine) and the patient received the second one. The patient asked that What to do about it, Will it go away or gradually go away. The patient asked was it okay to keep doing what patient was doing, was it safe for the patient for this to happen, was the patient okay and will it go away. The patient was to have to hang up because not getting anywhere. The patient was getting very, very nervous and very frustrated and the patient was elderly and cannot take this. The patient was going to get a hold of the person who made the arrangements the vaccine and go online use website to reach. The patient was not in a good position, was on oxygen and cannot do that. The outcome of had itch and it was slightly swollen in the shot area was unknown and outcome of some soreness and it was quite swollen very hot was not resolved.   Information on the Lot/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Vitiligo
Clinical narrative: Increased vitligo so fast and it spread quickly across my body; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a patient of unspecified age and gender received BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown) at single dose for covid-19 immunisation. Medical history included ongoing vitiligo. The patient's concomitant medications were not reported. The patient experienced increased vitligo so fast and it spread quickly across the patient's body. The vitiligo was stable before taking vaccine. Therapeutic measures were taken as a result of the event and included treatment with ayurvedic medicine which cured vitiligo. The outcome of the event was unknown. The patient asked whether the ayurvedic medicine was worth studying because lots of people were suffering from it in the world and needed cure.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced rash on an unspecified date. Outcome of the event was unknown.  There is no product complaint associated with this case  Follow-up attempts are needed, further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Chills, Hyperhidrosis
Clinical narrative: joint achiness; weakness; Injection site was extremely tender; low grade fever of 100 degrees F; sweats; chills; This is a spontaneous report from a contactable consumer (patient). A 33-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number and expiry date: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced joint achiness, weakness, injection site was extremely tender, low grade fever of 100 degrees f, sweats, chills. On an unspecified date, the patient underwent lab tests and procedures which included body temperature: 101 F. It was reported that event took place after use of product. The outcome of events was unknown.  Follow-up needed. Information about batch/lot number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: joint achiness; weakness; Injection site was extremely tender; low grade fever of 100 degrees F; sweats; chills; This is a spontaneous report from a contactable consumer (patient). A 33-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number and expiry date: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced joint achiness, weakness, injection site was extremely tender, low grade fever of 100 degrees f, sweats, chills. On an unspecified date, the patient underwent lab tests and procedures which included body temperature: 101 F. It was reported that event took place after use of product. The outcome of events was unknown.  Follow-up needed. Information about batch/lot number has been requested.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Diarrhoea, Flatulence, Influenza virus test
Clinical narrative: gastrointestinal issues mainly diarrhea and flatulence; gastrointestinal issues mainly diarrhea and flatulence; This is a spontaneous report from a contactable consumer (patient) reporting on herself.  A 18-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: ER8734, Expiration date was unknown), via an unspecified route of administration on 03Apr2021 as 2nd dose, single dose (at the age of 18-years-old) for covid-19 immunisation. Patient had no medical history. Patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EP7534, Expiration date was unknown), via an unspecified route of administration on 13Mar2021 as 1st dose, single dose (at the age of 18-years-old) for covid-19 immunisation. Concomitant medications included cetirizine hydrochloride (ALLERTEC) at a dose of 5 mg, orally taken for hypersensitivity; sarecycline hydrochloride (SEYSARA) at a dose of 60 mg, orally (taking as antibiotic). Patient was also taking antibiotics, route of administration, they were just over the counter. So, the antibiotic was unrelated to this that was for the different health related issues (further clarification unknown). On unspecified date of 2021, patient experienced gastrointestinal issues mainly diarrhea and flatulence for the two months following because of the vaccine. Patient had done like Pro-biotic (TruNature Digestive Probiotic) recommended by her doctor, patient was not sure, it just said there were 10 billion TPCSE (Not clear and not further clarified) in one, she was not sure. It just said one tablet. On May-2021 (recently, last week), patient had blood test and stated that she does not had access to them right now and she do know that her doctor said that everything was negative, and she had them specifically for stomach issues. Patient had got a blood test and flu test and they both were negative, so she was seeing a gastroenterologist like tomorrow (01Jun2021). The outcome of the event was not recovered (still persisting).  Information on the lot/batch number is available; further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Mammogram
Clinical narrative: Lymph nodes were swollen; This is a spontaneous report from a contactable consumer (Patient). A 55-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration in Feb2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCIN, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. On an unspecified date in 2021, after the second shot, patient lymph nodes were swollen. It was reported that patient was scheduled an appointment for a yearly mammogram 8 weeks after the 2nd shot, they confirmed that her lymph nodes were swollen and stated that was probably from the COVID shot. Patient was informed to come back for follow-up 2 months later and it's been 4 months since 2nd COVID shot and lymph nodes are still swollen. The event was reported as non-serious. The outcome of the event was not recovered.  Information about Lot/Batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Menstruation irregular, Musculoskeletal stiffness, Nausea, Neck pain
Clinical narrative: Within a week after this she started her period. She states she just finished her period prior to this and is on birth control so her cycle is very regular; break through bleeding; Stiff neck; Pain in arm; Nausea; Neck pain; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0191and Expiry date: Jul2021), dose 1 via an unspecified route of administration, administered in Arm Left on 25May2021 15:00 as 1st dose, single dose for covid-19 immunization.  Relevant medical history was not included. The patient had no prior vaccinations within last 4 weeks. The patient experienced within a week after this she started her period. she states she just finished her period prior to this and is on birth control so her cycle is very regular on an unspecified date while break through bleeding experienced on 29May2021. Patient also experienced stiff neck, pain in arm, neck pain and nausea on 26May2021. The caller stated that patient had her first Pfizer Covid vaccine dose on 25May2021. Within a week after this she started her period. She states she just finished her period prior to this and was on birth control so her cycle was very regular. Within a few days of getting the shot, she has had some major breakthrough bleeding. She normally did not have that the only thing that changed in her life was that she got the COVID shot. She believes the breakthrough bleeding started Saturday night. It has gotten progressively worse. At first, it was just like a little bit of bleeding but, she full blown had her period. She didn't take her pills late or anything like that. She did not really know what she should do because this was really odd. she was still taking her birth control pills and takes vitamins. Caller mentions at first, she had the normal side effects like a stiff neck and pain in the arm. She also felt nauseas the next day. It was pretty normal stuff, then the breakthrough bleeding happened. The neck pain, pain in arm, and nausea started the next day after receiving the vaccine and lasted like 24 hours. Caller stated just out of curiosity, has anyone else had this issue. She was not asking for people personally if it is a side effect, but she believed everyone should be told about if this was one of the side effects. She wants to know if this had a side effect of the Covid vaccine. Therapeutic measures were taken as a result of events, patient took Advil. The outcome for event within a week after this she started her period. she states she just finished her period prior to this and is on birth control so her cycle is very regular and stiff neck was unknown, while the outcome for pain in arm, neck pain and nausea were recovered on 27May2021. The outcome for break through bleeding was not recovered.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Within a week after this she started her period. She states she just finished her period prior to this and is on birth control so her cycle is very regular; break through bleeding; Stiff neck; Pain in arm; Nausea; Neck pain; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0191and Expiry date: Jul2021), dose 1 via an unspecified route of administration, administered in Arm Left on 25May2021 15:00 as 1st dose, single dose for covid-19 immunization.  Relevant medical history was not included. The patient had no prior vaccinations within last 4 weeks. The patient experienced within a week after this she started her period. she states she just finished her period prior to this and is on birth control so her cycle is very regular on an unspecified date while break through bleeding experienced on 29May2021. Patient also experienced stiff neck, pain in arm, neck pain and nausea on 26May2021. The caller stated that patient had her first Pfizer Covid vaccine dose on 25May2021. Within a week after this she started her period. She states she just finished her period prior to this and was on birth control so her cycle was very regular. Within a few days of getting the shot, she has had some major breakthrough bleeding. She normally did not have that the only thing that changed in her life was that she got the COVID shot. She believes the breakthrough bleeding started Saturday night. It has gotten progressively worse. At first, it was just like a little bit of bleeding but, she full blown had her period. She didn't take her pills late or anything like that. She did not really know what she should do because this was really odd. she was still taking her birth control pills and takes vitamins. Caller mentions at first, she had the normal side effects like a stiff neck and pain in the arm. She also felt nauseas the next day. It was pretty normal stuff, then the breakthrough bleeding happened. The neck pain, pain in arm, and nausea started the next day after receiving the vaccine and lasted like 24 hours. Caller stated just out of curiosity, has anyone else had this issue. She was not asking for people personally if it is a side effect, but she believed everyone should be told about if this was one of the side effects. She wants to know if this had a side effect of the Covid vaccine. Therapeutic measures were taken as a result of events, patient took Advil. The outcome for event within a week after this she started her period. she states she just finished her period prior to this and is on birth control so her cycle is very regular and stiff neck was unknown, while the outcome for pain in arm, neck pain and nausea were recovered on 27May2021. The outcome for break through bleeding was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Illness, SARS-CoV-2 test
Clinical narrative: Two days later I was very sick.; When was tested and come to find out I had the virus, the Covid- 19 virus.; This is a spontaneous report from a contactable male consumer reported for himself and his wife, this is first of 2 cases, for the reporter self. A male patient of an unspecified age received the first dose of bnt162b2 (BNT162B2; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 07May2021 as single dose for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. In May2021, the patient felt that he was very sick and when the patient was tested and had the virus, the COVID- 19 virus together his wife and he was in quarantine for 14 days which ended this Saturday on 29May2021. He wanted to know whether they could take the second vaccination, since they tested positive after receiving the first vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test: positive in May2021.The clinical outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Balance disorder, Condition aggravated, Diarrhoea, Dizziness
Clinical narrative: Arm hurt; Diarrhea; Knees hurt; Was cold; Mild fever; Felt a little like balance was off; she calls it being fuzzy headed and she felt a little lightheaded; she calls it being fuzzy headed and she felt a little lightheaded; So tired I don't want to do anything; Can't remember words/difficulty remembering words worsened; Can't remember words/difficulty remembering words worsened; This is a spontaneous report from a contactable consumer or other non hcp. An unspecified age female patient received 2nd dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Expiration date: unknown), via unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single for covid-19 immunisation. The patient medical history included difficulty remembering words from an unknown date. Concomitant medications were not reported. consumer stated that on unspecified date, the patient experienced arm hurt, diarrhea, knees hurt, was cold, mild fever and except knees hurt, patient feels normal and fine on next day (15Mar2021) and the top of her neck and the back of her head felt a little like her balance was off, it being fuzzy headed and she felt a little lightheaded. Consumer reported that it goes a little while, then she gets the fuzzy headed feeling, then she was fine.  Consumer reported that she called the pharmacist who informed her that some reactions would go on for a few weeks. consumer reported that the fuzzy headed feeling was now not so much, but she would have a day where she was so tired that she does not want to do anything.  consumer reported that the next day, she would be good to go again.  consumer reported that sometimes she would push herself and do things anyhow, but she does not feel like doing anything. Consumer reported that she was a senior, and most seniors have a problem where they cannot remember a word then blink and can think of it.  consumer reported that her bother was about problem remembering words was getting worse, from her baseline after she received the Covid-19 vaccine, but it has stayed the same since originally worsening from baseline and around the same time that her fuzzy or lightheaded feeling began. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Feeling cold, Memory impairment, Pain in extremity
Clinical narrative: Arm hurt; Diarrhea; Knees hurt; Was cold; Mild fever; Felt a little like balance was off; she calls it being fuzzy headed and she felt a little lightheaded; she calls it being fuzzy headed and she felt a little lightheaded; So tired I don't want to do anything; Can't remember words/difficulty remembering words worsened; Can't remember words/difficulty remembering words worsened; This is a spontaneous report from a contactable consumer or other non hcp. An unspecified age female patient received 2nd dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Expiration date: unknown), via unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single for covid-19 immunisation. The patient medical history included difficulty remembering words from an unknown date. Concomitant medications were not reported. consumer stated that on unspecified date, the patient experienced arm hurt, diarrhea, knees hurt, was cold, mild fever and except knees hurt, patient feels normal and fine on next day (15Mar2021) and the top of her neck and the back of her head felt a little like her balance was off, it being fuzzy headed and she felt a little lightheaded. Consumer reported that it goes a little while, then she gets the fuzzy headed feeling, then she was fine.  Consumer reported that she called the pharmacist who informed her that some reactions would go on for a few weeks. consumer reported that the fuzzy headed feeling was now not so much, but she would have a day where she was so tired that she does not want to do anything.  consumer reported that the next day, she would be good to go again.  consumer reported that sometimes she would push herself and do things anyhow, but she does not feel like doing anything. Consumer reported that she was a senior, and most seniors have a problem where they cannot remember a word then blink and can think of it.  consumer reported that her bother was about problem remembering words was getting worse, from her baseline after she received the Covid-19 vaccine, but it has stayed the same since originally worsening from baseline and around the same time that her fuzzy or lightheaded feeling began. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Arm hurt; Diarrhea; Knees hurt; Was cold; Mild fever; Felt a little like balance was off; she calls it being fuzzy headed and she felt a little lightheaded; she calls it being fuzzy headed and she felt a little lightheaded; So tired I don't want to do anything; Can't remember words/difficulty remembering words worsened; Can't remember words/difficulty remembering words worsened; This is a spontaneous report from a contactable consumer or other non hcp. An unspecified age female patient received 2nd dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Expiration date: unknown), via unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single for covid-19 immunisation. The patient medical history included difficulty remembering words from an unknown date. Concomitant medications were not reported. consumer stated that on unspecified date, the patient experienced arm hurt, diarrhea, knees hurt, was cold, mild fever and except knees hurt, patient feels normal and fine on next day (15Mar2021) and the top of her neck and the back of her head felt a little like her balance was off, it being fuzzy headed and she felt a little lightheaded. Consumer reported that it goes a little while, then she gets the fuzzy headed feeling, then she was fine.  Consumer reported that she called the pharmacist who informed her that some reactions would go on for a few weeks. consumer reported that the fuzzy headed feeling was now not so much, but she would have a day where she was so tired that she does not want to do anything.  consumer reported that the next day, she would be good to go again.  consumer reported that sometimes she would push herself and do things anyhow, but she does not feel like doing anything. Consumer reported that she was a senior, and most seniors have a problem where they cannot remember a word then blink and can think of it.  consumer reported that her bother was about problem remembering words was getting worse, from her baseline after she received the Covid-19 vaccine, but it has stayed the same since originally worsening from baseline and around the same time that her fuzzy or lightheaded feeling began. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: pain in her joints after getting her first dose; This is a spontaneous report from a contactable consumer (patient herself). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), via an unspecified route of administration on 24Mar2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced pain in her joints after getting her first dose. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal pain
Clinical narrative: Bit of sore throat; Coughing; This is a spontaneous report from a Pfizer-sponsored program Covax US Support. A contactable consumer reported for herself a unknown age of female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number, Expiry date UNKNOWN), via an unspecified route of administration on 10May2021 as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. Patient was scheduled to get her second shot of Pfizer vaccine today but she was experiencing a bit of sore throat and she was coughing a little bit, but she did not have a fever on an unknown date in 2021. She also mentioned that she came from a camping this weekend and she was not sure if she had Covid because she hasn't been tested yet (consumer was not sure, hence not captured as event). She don't have a chills. Outcome of the events were unknown.   Information on the lot/batch number has been requested.