chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Formication, Headache, Hypoaesthesia, Lymphadenopathy, Nausea
Clinical narrative: headache; nausea; pain on the injection site; develop little bumps a size of a small pea on the left side of the neck painful and tender/ painful and tender bumps in collar bone cavity and left elbow; a bit feverish; felt numbness on her left leg and feet; she did get itchy and all that like something was crawling on her; did get itchy and all that like something was crawling on her; This is a spontaneous report from a contactable consumer (patient). A 37-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 23May2021 (Batch/Lot number was not reported) as single dose, dose 1 via an unspecified route of administration, administered in Arm Left on 02May2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received both doses of the Pfizer COVID 19 Vaccine - 1st dose was given on 02May2021 and 2nd dose was on 23May2021. She developed headache, nausea, and pain on the injection site. After a few days she started to develop little bumps a size of a small pea on the left side of the neck painful and tender. She also has painful and tender bumps in collar bone cavity and left elbow. She felt numbness on her left leg and feet. It was reported that she has been feeling, aside from all the nausea, headache, a bit feverish, she did get itchy and all that like something was crawling on her and she took anti-allergy for that. Caller relays she got the vaccine in her left arm and right on her left side of her neck she has a really tender to touch and it feels like a little tiny bump or clot type thing. States that also exactly on the left side almost at the collar bone cavity she can literally feel them like little smaller than a pea size about that size and they were quite tender just to touch and it's painful. Caller states she also felt numbing in her left leg and she never felt this before and it was right after the vaccine. No information on the PI about numbness of leg and feet after taking the vaccine. She tried to contact her doctor, no answer yet. She was asking if these are normal side effects and how to manage it. Caller states she got the information sheet but this is not listed and she was concerned and wanted to know if it relates and it seems to be. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Vaccination site pain
Clinical narrative: headache; nausea; pain on the injection site; develop little bumps a size of a small pea on the left side of the neck painful and tender/ painful and tender bumps in collar bone cavity and left elbow; a bit feverish; felt numbness on her left leg and feet; she did get itchy and all that like something was crawling on her; did get itchy and all that like something was crawling on her; This is a spontaneous report from a contactable consumer (patient). A 37-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 23May2021 (Batch/Lot number was not reported) as single dose, dose 1 via an unspecified route of administration, administered in Arm Left on 02May2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received both doses of the Pfizer COVID 19 Vaccine - 1st dose was given on 02May2021 and 2nd dose was on 23May2021. She developed headache, nausea, and pain on the injection site. After a few days she started to develop little bumps a size of a small pea on the left side of the neck painful and tender. She also has painful and tender bumps in collar bone cavity and left elbow. She felt numbness on her left leg and feet. It was reported that she has been feeling, aside from all the nausea, headache, a bit feverish, she did get itchy and all that like something was crawling on her and she took anti-allergy for that. Caller relays she got the vaccine in her left arm and right on her left side of her neck she has a really tender to touch and it feels like a little tiny bump or clot type thing. States that also exactly on the left side almost at the collar bone cavity she can literally feel them like little smaller than a pea size about that size and they were quite tender just to touch and it's painful. Caller states she also felt numbing in her left leg and she never felt this before and it was right after the vaccine. No information on the PI about numbness of leg and feet after taking the vaccine. She tried to contact her doctor, no answer yet. She was asking if these are normal side effects and how to manage it. Caller states she got the information sheet but this is not listed and she was concerned and wanted to know if it relates and it seems to be. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Ear infection, Electrocardiogram, Magnetic resonance imaging, Tinnitus
Clinical narrative: Continuous ear ringing/ ringing/tinnitus, terrible; Lost weight; Ear infection; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 69-years-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 25Mar2021 (at the age of 69-years-old) as single dose for Covid-19 immunization. Historical vaccine of BNT162B2 was given as first dose on 04Mar2021 for via an unspecified route of administration as single dose for Covid-19 immunization. Medical history includes anticoagulant therapy from an unknown date and unknown if ongoing. Concomitant medications included apixaban taken for anticoagulant therapy, start and stop date were not reported. The patient experienced continuous ear ringing/ ringing/tinnitus, terrible, lost weight and ear infection on Mar2021. Caller was reporting "ear ringing/tinnitus, terrible (on Mar2021)" as a side effect of the Pfizer Covid 19 vaccine. He had tried everything and went to all kinds of doctors MRI and CT scan completed. Didn't have it before he got the injection. Never had ear ringing in his life and was 69 years old. The side effect started 1.5-2 days after the second dose. Caller has no other questions about the vaccine. The patient was 250 pounds now  he was down to 225 pounds so he had lost weight (on Mar2021). Consumer stated, " he did get ear infection (on Mar2021) and took Keflex, it was all after the Covid shot. The patient underwent lab tests and procedures which included computerized tomogram, electrocardiogram, magnetic resonance imaging on 2021 and weight as 250 lbs (I was 250 pounds now I am down to 225 Pounds so I have lost weight with this too). Treatment was received with Keflex for ear infection, it was all after the Covid shot. The outcome of the events was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Weight, Weight decreased
Clinical narrative: Continuous ear ringing/ ringing/tinnitus, terrible; Lost weight; Ear infection; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 69-years-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 25Mar2021 (at the age of 69-years-old) as single dose for Covid-19 immunization. Historical vaccine of BNT162B2 was given as first dose on 04Mar2021 for via an unspecified route of administration as single dose for Covid-19 immunization. Medical history includes anticoagulant therapy from an unknown date and unknown if ongoing. Concomitant medications included apixaban taken for anticoagulant therapy, start and stop date were not reported. The patient experienced continuous ear ringing/ ringing/tinnitus, terrible, lost weight and ear infection on Mar2021. Caller was reporting "ear ringing/tinnitus, terrible (on Mar2021)" as a side effect of the Pfizer Covid 19 vaccine. He had tried everything and went to all kinds of doctors MRI and CT scan completed. Didn't have it before he got the injection. Never had ear ringing in his life and was 69 years old. The side effect started 1.5-2 days after the second dose. Caller has no other questions about the vaccine. The patient was 250 pounds now  he was down to 225 pounds so he had lost weight (on Mar2021). Consumer stated, " he did get ear infection (on Mar2021) and took Keflex, it was all after the Covid shot. The patient underwent lab tests and procedures which included computerized tomogram, electrocardiogram, magnetic resonance imaging on 2021 and weight as 250 lbs (I was 250 pounds now I am down to 225 Pounds so I have lost weight with this too). Treatment was received with Keflex for ear infection, it was all after the Covid shot. The outcome of the events was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: the first shot of the Covid-19 vaccine, he had a headache for one day/He has had lots of headaches starting on 07May2021; This is a spontaneous report from a contactable consumer (patient himself) via Medical Information Team. A 55-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0164) via an unspecified route of administration in left arm on 15Apr2021 as 1st dose, single dose and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0165) via an unspecified route of administration in left arm on 06May2021 13:30-14:00 (as reported) as 2nd dose, single dose for COVID-19 immunization. Patient was 55-years-old at the time of vaccination. Vaccination Facility Type was reported as Megasite. Vaccine was not administered at Military Facility. No prior vaccinations within 4 weeks. On 16Apr2021, patient experienced headache after first dose. Patient received the second dose of the Pfizer Covid 19 vaccine on 06May2021. He has had lots of headaches starting on 07May2021. He has had headaches off and on every day since then. Patient reported that he received the second dose of the Covid-19 vaccine on 06May2021 and has had a lot of headaches. Patient reported that with the first shot of the Covid-19 vaccine, he had a headache for one day. Patient reported that he got the second dose of the Covid-19 vaccine on Thursday (06May2021) and Friday (07May2021) he had a headache all day nonstop. Patient reported that for the past week and a half to 2 weeks, he has been having a headache every day, in and out all day. Patient inquired if it was normal to have a headache for 2 weeks following the Covid-19 vaccine and if he should go to the doctor. Patient reported that the headache has stayed the same since it began on 07May2021.  Patient reported that the headache comes and goes and that he is taking Tylenol to ease the pain. The events did not result in emergency room or physician office visit. The outcome of the event was not recovered.   Follow up attempts are needed. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: little headache; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 2 via an unspecified route of administration on an unspecified date in May2021 as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported) for covid-19 immunisation. Patient stated she received 2nd dose of vaccine on an unspecified date in May2021 (yesterday) and experienced little headache and was wondering if it would be safe to take something like ibuprofen or something. Patient did not clarify if she took something or not. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Vomiting
Clinical narrative: I have been puking with cold chills; I have been puking with cold chills; This is a spontaneous report from a contactable consumer (Patient). A 39-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 26May2021 15:15, as a single dose for COVID-19 Immunization at workplace clinic. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and Expiration date was not re-ported), via an unspecified route of administration, administered in Arm Left on 5May2021 21:00, as a single dose for COVID-19 Immunization. On 27May2021 05:15, the patient experienced puking with cold chills. The patient reported that after getting the second dose, he puked in the middle of the night around 5 am. The patient had not tested for COVID-19 since the vaccination. No therapeutic measures were taken as a result of adverse events and the patient did not receive any treatment. The outcome of the events was reported as resolving.  Follow-up (28May2021): New information received from contactable consumer. Clinical course of events updated.  Information about batch/ lot number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Vaccination site pain (1st dose and 2nd dose); This is a spontaneous report received from a contactable consumer (patient). A 58-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number: EW0171), via an unspecified route of administration on arm left on 20Apr2021 10:00 AM (at the age of 58-year-old) at a 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines prior to the COVID vaccine within 4 weeks. The patient experienced vaccination site pain (1st dose and 2nd dose) on an unspecified date in 2021. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any treatment for the event. Outcome of the event was recovered on an unspecified date in 2021.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: flu-like symptoms; soreness in her arm; This is a spontaneous report from a contactable consumer (patient's mother) via Pfizer for Professionals Customer Support Program. A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date (at the age of 36-years-old) as 1st dose, single dose for covid-19 immunisation. The patient medical history included multiple sclerosis (MS) from an unknown date and unknown if ongoing. Concomitant medication included ocrelizumab (OCREVUS) taken for multiple sclerosis, start and stop date were not reported. Patient has a diagnosis of MS and takes ocrevus. On an unspecified date, the patient experienced flu-like symptoms and soreness in her arm. Reporter stated that patient had some reactions to the vaccine in what she stated as flu-like symptoms with both vaccines and soreness in her arm with the first vaccine. Patient HCP was upset that she received the Pfizer Covid 19 Vaccine while taking the immunosuppressant. Patient MD voiced that the vaccines did not take because her immune system was wiped out. Reporter asked if Pfizer has information on individuals with MS or taking immunosuppressants. Reporter questioned if patient who had MS can participate in the Pfizer Covid 19 Clinical Study. Patient HCP had mentioned something to her about the possibility of the Pfizer Booster. At the time of this report the events outcome was unknown.  Information on batch/ lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Drug hypersensitivity, Myalgia, Pruritus, Rash
Clinical narrative: Allergic reactions; Have more muscular pain and main in my knee; Have more muscular pain and main in my knee/joint pain; Itching; Rash; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration Date not reported) via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced allergic reactions, have more muscular pain and main in my knee/ joint pain, itching and rash. The report was received as, the patient states was calling from her daughters phone number. The patient had some allergic reactions after the first dose of the Pfizer COVID 19 vaccine. The reactions were not that bad, I didn't have to go to the hospital or anything like that. The patient called doctor, which was a new doctor that hasn't known me long, because I haven't had a primary care doctor in while, and they said that they thought it would be fine for me to receive the second dose based on my side effects. They couldn't give a definite answer and the patient don't know if she should get the second dose or not. The patient stated as, have more muscular pain and main in my knee since the patient had the vaccine that patient didn't have before. Every time patient move her knee a certain way it hurts, patient also experienced as joint pain. Do you recommend getting the second dose after I had side effects from the first dose. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19, PNC13
Symptoms: Pain in extremity
Clinical narrative: Arm is still sore; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program Pfizer. A 66-year-old Male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration in left arm on 01Feb2021 as 2nd dose, single for COVID-19 immunization. Medical history included ongoing enlarged prostate (he was diagnosed about 3 years ago), ongoing high blood pressure (he was diagnosed six years ago, maybe even longer), ongoing erectile dysfunction (he started taking Viagra, but then his doctor switched him to white pills, but they aren't worth it, says he doesn't know what they are. States he needs to get back to Viagra, and is on the website right now, doesn't know how to order online. Says he was diagnosed ten years ago). Co-suspect medication included pneumococcal 13-val conj vac (dipht crm197 protein) (Prevnar 13). Concomitant medication included sildenafil citrate (VIAGRA CONNECT). Patient previously received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration in left arm on an unspecified date as 1st dose, single for COVID-19 immunization. On 1Feb2021, patient experienced Arm is still sore. Patient stated it is a little bit sore, he can feel it, it's not much, not anything for him to be worried about it feels like it was getting better, it was better than last week, but its still sore, that's been a long time. Patient stated he does not really have one. States he didn't get the shot there. Patient stated he has no one to list. Patient does not have his vaccine card with him and does not know the information. Patient stated he received this in his left arm, and he remembers because he told them you already broke this arm, put the second one in it too. Patient stated his job made him. Says well they did not make him, he worked for his son, and he told me he needed to do it, and he did it. Patient stated he took a high blood pressure pill, it starts with an A, but he cant think of the name, says he has been taking it for six years. Patient stated he took, what do you call it, he takes medicine for benign prostate, says he cant think of the name, he does not have the information, he took it every night for an enlarged prostate. States he had been taking this for three years. Patient stated he started taking Viagra, but then his doctor switched him to white pills, says he does not know what they are. The outcome of the events was recovering.   Information about Lot/Batch number has been requested.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Neoplasm skin, Swelling, Tenderness
Clinical narrative: Now its got the lumps going down it and they are tender; Now they are going down the other arm/lumps on her arms; Now its got the lumps going down it and they are tender; Now they are going down the other arm/lumps on her arms; caller asks does Pfizer have options to get rid of the swelling; This is a spontaneous report from a contactable consumer, the patient. An 84-year-old female patient received BNT162B2 (Pfizer BioNTech Covid 19 mRNA VACCINE BIONTECH), dose 2 via an unspecified route of administration, administered in Arm Right on 21May2021 (Batch/Lot Number: EW0161) (at the age of 84-year-old) as 2nd dose, single dose for covid-19 immunisation. Medical history included ongoing Afib (diagnosed with Afib five years ago) and memory problems. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (Pfizer BioNTech Covid 19 mRNA VACCINE BIONTECH), dose 1 administered in Arm left on 30Apr2021 (Batch/Lot Number: EW0158) for covid-19 immunisation and had lumps down the front of the arm. The patient did not receive any other vaccines within four weeks prior to the vaccination. No additional vaccines administered on same date of the Pfizer suspect. On 22May2021, the patient reported now it got the lumps going down it and they are tender. The patient went ahead and received the second dose Pfizer Covid 19 Vaccine and now its got the lumps going down it and they are tender. They are not really going down, still there. Wondering if there was some kind of anecdote to take care of it? The right arm was not as serious. The marks or lumps are sort of in the same places on both arms, like in the bend of the arm in the elbow. The patient doesn't know anyone else having this problem. Are these lumps on the caller's arms lymph nodes? The caller states she has been concerned about the lumps on her arms but not concerned enough to go to the doctor. The patient stated she has not talked to anyone at her primary care physician's office yet. The patient did not visited to emergency room or physician office. It was suggested the patient go to have the lumps looked at but the patient never did. The patient asked does Pfizer have options to get rid of the swelling, to treat it? Oh, Pfizer doesn't have anything for that, the patient was giving Pfizer a chance to treat it. No relevant tests done. The outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: mouth cold sores; This is a spontaneous report received from a contactable Pharmacist reporting different events under the same suspect product for 10 patients via medical information team. This is one of 2nd report. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date unknown) via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient had an outbreak of mouth cold sores. Outcome of the event was reported as unknown.  Information about lot/batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Taste disorder
Clinical narrative: Still has loss of appetite; Cant taste her food; This is a spontaneous report received from a contactable consumer (patient) reported for herself. A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration Date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date (age at vaccination was unknown) as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The caller mentioned she got flu shot and had a reaction, received pneumovax 23 - had two trips to Emergency Room post administration, and received Prevnar 13 and she was okay with that. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: unknown, Expiration Date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date (age at vaccination was unknown) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. After the first dose of vaccine, the patient experienced tiredness. The caller stated that she had bad side effects from vaccine. First dose didn't have any issues just tiredness. She stated that she still had loss of appetite and can't taste her food. The caller wanted to know if the booster dose of Pfizer vaccine will be the same ingredients as the first two doses. The caller mentioned that she seemed to have a reaction to every vaccine she got. She thought that she had allergies to ingredients, caller wanted to know if that was possible. The case was reported as non-serious. The outcome of the events was not resolved. Information about batch/lot number has been requested.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: feel a little arthritis pain; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored Programme Covax US Support. A 63-year-old male received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot number: EN6198) via unspecified route of administration in left upper arm received on 22Feb2021 at 11:30 hours (at the age of 63-year-old) as single dose for COVID-19 immunisation. Medical history of the patient included arthritis and allergy to eggs. Concomitant medications were not reported. Patient did not receive any other products. Patient doesn't get the Flu vaccine because he has an allergy to eggs. Patient had no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. On unspecified date of Feb2021 (two or three days after the first vaccine), patient feels a little arthritis pain after the first vaccine. Arthritis pain has doubled, increased and skyrocketed: arthritis includes pain and swelling of hands, thumbs, right shoulder and knees. Patient states that he has been getting a needle, with medication, in his hand, for the pain, and it was not working. Patient could not tolerate the pain of his arthritis, and the needle, with medication, did not helped his pain. Patient states he does not know what medication he was injected with. Patient had physician office visit. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza, Nasopharyngitis, Pain in extremity
Clinical narrative: flu symptoms; aching in arms; chills; cold; This is a spontaneous report from a contactable consumer. A 59-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date as an unknown, single for COVID-19 immunisation. The patient's medical history included Rheumatoid arthritis with rheumatoid factor from an unspecified date in 2015 and unknown if ongoing. The patient's concomitant medications included cyanocobalamin (B12 [CYANOCOBALAMIN]), ibuprofen, metoprolol tartrate (PROLAT). On an unspecified date the patient experienced, the patient recently had COVID-19 vaccine administered and developed flu symptoms, aching in arms, chills and cold. The reporter classified the events as non-serious. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Intermenstrual bleeding
Clinical narrative: Extended menstrual bleeding; spotting; This is a spontaneous report was received from a contactable consumer or other non hcp. This is report 2 of 3. 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, Expiration Date was not reported), via an unspecified route of administration on an unspecified date as 2nd dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization. It was reported that, while reporting on herself caller mentioned that she was talking to 2 girls in her office who also just had the second Pfizer COVID-19 vaccine and are having extended menstrual bleeding. They are not having it to the extent she was they are just having spotting. She wanted to call about that. She saw something online that some people are talking about it and maybe something was happening. It was coincidental that 3 of them in the office had the same thing. The other girls she talked to have extended menstrual cycles, but it was more like spotting that they think goes away but then it comes back. She declines to report on the 2 girls she had mentioned earlier. The one girl may call herself, she called to talk to her physician first. The outcome of the event was unknown.  Follow-up attempts are needed. Further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021618069 same reporter/drug/AE, different patients
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Stomatitis
Clinical narrative: Extreme tiredness; Sore on mouth; Difficulty in breathing; Chills; This is a spontaneous report from a contactable consumer (the patient). A female patient of an unspecified age (approximately age 76) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: unknown) via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included Asthma, Type 2 diabetes, Client's esophagus and Several nodules on her right lung. The patient concomitant medications were not reported. On an unspecified date, several days after the first dose of vaccine, the patient experienced extreme tiredness, sore on mouth, difficulty in breathing, and chills. The outcome of the events was unknown. All the events were reported as non-serious.   Information related lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: muscle pain; severe joint pain in hands and fingers; This is a spontaneous report from a Pfizer-sponsored program Support contactable consumer or other non hcp. A male patient of an unspecified age received a dose of bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unknown date, the patient experienced muscle pain (myalgia), severe joint pain in hands and fingers (arthralgia). The clinical outcome of events was unknown.   It was unknown if the reporter was a health care professional. It was unknown if the reporter was the prescribing HCP.  Information about Lot/Batch number has been requested.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: leg pain; This is a spontaneous report from a contactable other hcp via Pfizer Sponsored Program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), 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. On unspecified dated, the patient experienced leg pain. The physician was aware.  Information about lot/batch number is requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: muscle pain; severe joint pain in hands and fingers; This is a spontaneous report from a Pfizer received via contactable consumer or other non-health care professional. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 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 immunization. The patient medical history and concomitant medications were not reported. The patient experienced muscle pain and severe joint pain in hands and fingers on an unspecified date. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Electrocardiogram, Fatigue, Gait disturbance, Peripheral swelling
Clinical narrative: After dose one she experienced left toe swelling and she could hardly walk./left toe swelled up so much that she could hardly walk; After dose one she experienced left toe swelling and she could hardly walk./left toe swelled up so much that she could hardly walk; fatigue; This is a spontaneous report from contactable consumer (patient).   A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: ER8731, Expiration date: Unknown), via an unspecified route in her left arm on 18Apr2021 at around 13:00, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient did not receive any other vaccinations within four weeks prior to the administration of the first dose. On unknown date Apr2021, after first dose, patient experienced left toe swelled up so much that she could hardly walk. She went to an urgent care (physician office) and told the staff she had received the Covid 19 vaccine but the staff at the urgent care didn't seem to think her swollen toe was related to the Covid 19 vaccine. She also experienced fatigue, so she saw her primary care doctor. It was time for her regular appointment. Therapeutic measures taken as a result of the events included antibiotic which she was prescribed. The patient underwent lab test and procedure which included some routine blood work done, urinalysis and EKG. The clinical outcome of the events was everything came back normal. She was feeling better outcome was unknown.  Follow-up (28May2021): New information received from a contactable consumer included: updated information regarding events after first dose and second dose, time of administration of both doses update and event details about the second dose updated.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis
Clinical narrative: After dose one she experienced left toe swelling and she could hardly walk./left toe swelled up so much that she could hardly walk; After dose one she experienced left toe swelling and she could hardly walk./left toe swelled up so much that she could hardly walk; fatigue; This is a spontaneous report from contactable consumer (patient).   A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: ER8731, Expiration date: Unknown), via an unspecified route in her left arm on 18Apr2021 at around 13:00, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient did not receive any other vaccinations within four weeks prior to the administration of the first dose. On unknown date Apr2021, after first dose, patient experienced left toe swelled up so much that she could hardly walk. She went to an urgent care (physician office) and told the staff she had received the Covid 19 vaccine but the staff at the urgent care didn't seem to think her swollen toe was related to the Covid 19 vaccine. She also experienced fatigue, so she saw her primary care doctor. It was time for her regular appointment. Therapeutic measures taken as a result of the events included antibiotic which she was prescribed. The patient underwent lab test and procedure which included some routine blood work done, urinalysis and EKG. The clinical outcome of the events was everything came back normal. She was feeling better outcome was unknown.  Follow-up (28May2021): New information received from a contactable consumer included: updated information regarding events after first dose and second dose, time of administration of both doses update and event details about the second dose updated.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Vaccination site pain
Clinical narrative: ater she felt what she would equate to shoulder pain, rotator cuff pain; pain extends to her upper back; sore arm at the site, a little dead arm Friday; This is a spontaneous report received from a contactable consumer. A 64-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration in left arm on 20May2021 as single dose for covid-19 immunisation. Medical history included rotator cuff syndrome. The patient's concomitant medications were not reported. On an unspecified date, She has since reported feeling pain in her left shoulder that is similar to rotator cuff pain that she has had in the past, seriousness for sore arm at the site, a little dead arm Friday. The pain extends to her upper back. She wants to know if this is an expected side effect. Caller was told she could only take Tylenol for side effects from the vaccine and was asking can she take ibuprofen. Caller states that later she felt what she would equate to shoulder pain, rotator cuff pain, and she has had that in the past and knows what it is and usually when she gets it across her upper back and in the muscle of her upper arm and she can usually say she lifted something or turned funny. States when they got the vaccine they were told they could only take Tylenol for any side effect type symptoms and she understands why. Caller states she does have a problem with her rotator cuff and she is having difficulty coming up with why it would be acting up. Caller states it is not excruciating pain and she is using ice and heat and that helps get it under control. Caller relays after she hangs up she is going to go buy some topical ointment to get rid of the soreness but it's nothing terrible. Caller states that Tylenol doesn't work for her in this case she needs something like Advil, an anti-inflammatory and she didn't want to take it without seeing first. The outcome of the event was unknown.  Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: one finger and one toe bruising.; This is a spontaneous report from a contactable Nurse via medical information team. A 54-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced one finger and one toe bruising after getting the Covid Vaccine. The reporter was wondering about finger and toe bruising. The reporter wanted to know about if it was a side effect of the vaccine. patient was not on any blood thinner or have bleeding disorder. The reporter stated she read it online about Covid finger; but that seems to be related to having Covid 19. The reporter asked if this was a side effect of the vaccine and it something they should be concerned about when it was time to get the second vaccine. The patient had an eye appointment to go to soon. The reporter considered the event as non-serious. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Taste disorder, Vaccination site pain
Clinical narrative: alteration in taste/salty taste; metallic taste in the tip of the tongue that comes and goes; had soreness to her unknown arm at injection site; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6205 and Batch/Lot Number: EN6207), via an unspecified route of administration in Arm on 05Apr2021 as 2nd dose, single dose for COVID-19 immunisation. Medical history included, ongoing hypothyroidism stated that she has had it since she was a child. Concomitant medication included levothyroxine (LEVOTHYROXINE) 200mcg by mouth every day taken for hypothyroidism from an unspecified start date (started when she was 8 years old) and ongoing, liothyronine (LIOTHYRONINE) 5mcg by mouth every day taken for hypothyroidism from an unspecified start date and ongoing. The patient previously received bnt162b2 (BNT162B2) in 2021 with soreness to unknown arm at injection site. The patient experienced alteration in taste/salty taste on an unspecified date, metallic taste in the tip of the tongue that comes and goes on 17Apr2021, and had soreness to her unknown arm at injection site 05Apr2021. The patient reported as she got the second dose of the Pfizer covid vaccine on April 5th and since then she has alteration in taste, a metallic taste in the tip of the tongue that comes and goes. The patient was not sure whether it is vaccine related or this could be a exposition to the covid 19 virus. In response it was told that alteration in taste has not been reported as a side effect and was suggested to consult her physician or HCP to get some recommendations. The patient stated that she took the Pfizer vaccine first and second dose and had no symptoms prior to it. Stated that after approximately two weeks that she had a metallic, salty taste a lot of times not all of times and she was not eating that the taste was on the tip of her tongue. She was not sure if it is from the vaccine but she is reporting it due to the timing. She had soreness to her unknown arm at injection site. She went to the Center and there were doctor's. The soreness to the injection site lasted the first day and was gone. The second dose was given closer to four weeks instead of three weeks because she could not go on that date. The metallic taste started on 17Apr2021 or 18Apr2021. Her main concern was about a treatment recommendation about the case. Treatment received for the events were none. Outcome of the event taste alteration, metallic taste was not recovered and recovered for soreness to injection site.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal stiffness, Myalgia, Pain
Clinical narrative: had the typical left arm soreness for about a day or two and then nothing; had muscle stiffness and soreness that was around his buttocks and his thighs; had muscle stiffness and soreness that was around his buttocks and his thighs; felt "soreness for a few days afterward; This is a spontaneous report from a contactable consumer or other non hcp. A 64-year-old male patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EW0162, expiration date unspecified), dose 1 via an unspecified route of administration on 26Apr2021 (at the age of 64-year-old) as 1st dose, single dose for COVID-19 immunization. Medical history included atypical pneumonia from an unknown date (twice as reported) and atypical flu from an unknown date. The patient's concomitant medications were not reported. On an unknown date in Apr2021, post vaccination the patient had the typical left arm soreness for about a day or two and then nothing. On an unknown date in May2021, (third week before getting his 2nd dose) the patient had muscle stiffness and soreness that was around his buttocks and his thighs. On 18May2021, the patient reported that his neck pops and he has never had that happen before. He was really healthy for 64 years old and he had no medical or health issues and he worked out all the time. Then he got the 2nd dose and within a day or two he was sore The outcome of the events was reported as unknown at time of report.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pruritus, Rash macular
Clinical narrative: Red, itchy bumps mostly on ankles.; Red, itchy bumps mostly on ankles.; being tired after vaccine; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration date not reported) via an unspecified route of administration on an unspecified date as 2nd dose single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration date not reported) via an unspecified route of administration on an unspecified date as 1st dose single for COVID-19 immunization. After vaccination on 16May2021, the patient was tired. The physicians did not have her Xeljanz to stop for vaccines. The patient reported that, she was been bitten by 9 or 10 mosquitos recently. The patient also experienced Red, itchy bumps mostly on ankles. The patient reported that, the physician was aware that she was taking Neosporin. The outcome of events was unknown.   Information on the lot/ batch number has been requested.