chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Malaise
Clinical narrative: does not feel well and is tired; does not feel well and is tired; This is a spontaneous report from a Pfizer Sponsored Program COVAX US Support. A contactable male consumer or other non hcp reported. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) dose number unknown via an unspecified route of administration on Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced does not feel well and is tired on unspecified date in Mar2021. Clinical course was reported as Swap from IBCC-he saw on the news yesterday that the Pfizer vaccine has been approved by the FDA and wants to know why now. Also inquired on a list of ingredients in the vaccine, relayed website per FAQ. Also relayed to maybe check FDA website for information. he received the covid- 19 vaccine back in March and at times does not feel well and is tired. He declined to share last name and declined transfer to PSCC. The clinical outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Miliaria, Urticaria
Clinical narrative: Shingles; Heat rash; hives.; This is a spontaneous report from a contactable consumer or other non hcp.  A 53-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 21Jul2021 13:00 (Age at vaccination 53 years old) (Batch/Lot Number: Ew0128) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included herpes virus infection from an unknown date and unknown if ongoing.  There were no concomitant medications. Treatment with Valacyclovir, covid prior vaccination and covid tested post vaccination was no. On an unspecified date the patient experienced Shingles Heat rash/hives. Therapeutic measures were taken as a result of shingles (herpes zoster), heat rash (miliaria), hives. (urticaria). Outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: experienced was a little of a sore arm.; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, mRNA, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 2021 as DOSE 1, SINGLE, received second dose via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced was a little of a sore arm on unspecified date 2021. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected. Batch/lot number not available for BNT162B2.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Headache, Myalgia, Pain in jaw
Clinical narrative: bad headache; muscle pain in her jaw; Jaw pain; he went to withheld and got the 3rd pfizer vaccine; This is a spontaneous report from a contactable consumer. A 68-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 3 via an unspecified route of administration on 23Aug2021 (at the age of 68-years-old) (Batch/Lot Number: FD8448) as dose 3, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 (at the age of 68-years-old) (lot number: EL3246, vaccine location: Right arm) on 07Jan2021 and second dose of BNT162B2 (at the age of 68-years-old) (lot number: EL3246) on 26Jan2021 for covid-19 immunisation. Patient previously took Flu Shot 25 years ago reported to CDC. The patient experienced bad headache and muscle pain in her jaw on 24Aug2021. The patient was administered with 3rd dose of covid-19 vaccine and exposed to off label scenario. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received treatment for the event bad headache. The outcome of the event bad headache and muscle pain in her jaw and jaw pain was not recovered. The outcome of all the other events was unknown.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Limb discomfort
Clinical narrative: This is a spontaneous report from a contactable consumer. This consumer (Patient's wife) reported for a 60-year-old male patient (Reporter's husband) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0183; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 25Aug2021 12:30 (at the age of 60-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Patient's medical history was none. There were no concomitant medications were reported. Patient had not other relevant medical history, other products and Illness/AE. Patient's family medical history relevant to AE(s) was none. Patient had not AE(s) following prior vaccinations. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional vaccines administered on same date of the Pfizer suspect if applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect was none. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: FA7484; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 04Aug2021 (at the age of 60-years-old) as DOSE 1, SINGLE for COVID-19 immunization. On an unspecified date in Aug2021 patient experienced I have a magnetic reaction in both arms, it also happened to her husband too, after the second dose, but for him only in one arm the left arm on injection side and states it should not be doing that, it's not normal. AE(s) did not require a visit emergency room or physician office. Relevant tests was none. The outcome of events was not recovered. Follow-Up (07Sep2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101110375 Same reporter, different patient, same drug/event (split);US-PFIZER INC-202101110878 Same reporter, different patient, same drug/event (split).
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: my niece got a shot, a spoon stuck to her arm; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received unspecified dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration on an unknown dose as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter stated that on an unknown date after shot her niece experienced a spoon stuck to her arm. The outcome of the event was unknown at the time of report.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up#1 (8Sep2021): This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101110877 Same reporter, different patient, same drug/event (split);US-PFIZER INC-202101110375 Same reporter, different patient, same drug/event (split)
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Pain in extremity
Clinical narrative: Sore arm; Have lot of discomfort in my chest and it's getting really hard to breath; Have lot of discomfort in my chest and it's getting really hard to breath; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration on 24Aug2021 (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient got the Pfizer vaccine on 24Aug2021 (yesterday, as reported) and on 25Aug2021 (today, as reported) patient had like you know the normal side effects like sore arm or whatever, but as the day go on patient had lot of discomfort in chest and it's getting really hard to breath. So patient was wondering if patient could see a doctor or just wait and see. The outcome of the event(s) was unknown.  Information on batch/lot number was requested.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Experiencing arm pain; Fever of 101.3; I feel tired; 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, Formulation: solution for injection, Lot number: unknown, Expiration date were not provided), dose 1 via an unspecified route of administration on 25Aug2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient's medical history and Concomitant medications were not reported. The patient experienced experiencing arm pain, fever of 101.3 and i feel tired on Aug2021. Reporter stated, I am calling regarding a side effect to see if it is normal, I had the (first dose) vaccine yesterday. When paraphrased the concern, Reporter stated, I am experiencing arm pain and that's subsiding, but I have a fever of 101.3 and patient asked I feel tired, so is that normal, I feel tired is that normal, I am going to take Tylenol or should I go to the ER (Emergency Room), answer the question, 4th all day should I go to the Emergency Room or just take Tylenol (treatment). I will just over again, this is just "ridiculous" (further not clarified). The patient underwent lab tests and procedures which included fever of 101.3 (body temperature) on Aug2021. The outcome of the events was unknown.  The lot number for the vaccine, was not provided and will be requested during follow-up.
Age: 48.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Herpes zoster, Product use issue, Rash
Clinical narrative: Shingles; rash; Product use for unapproved combination; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: EW0198) via an unspecified route of administration (Age at vaccination 48-year) in left arm on 07Aug2021 as dose 1, single for COVID-19 immunization; patient received influenza vaccine (FLU SHOT) via an unspecified route of administration on 07Aug2021 as dose number unknown, single for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient previously took Keflex, donatol, codeine, and experienced allergies. No Covid prior vaccination was reported. The patient did not tested Covid post vaccination. Ptient received no other vaccine in four weeks. Reported facility type Vaccine was Pharmacy or Drug Store. On 21Aug2021 the patient experienced shingles, rash. It was reported that patient received Flu vaccine same date of COVID-19 vaccine. AE resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of shingles, rash; the patient was treated with Valycyclovir and Mupirocin. The clinical outcome of the events shingles, rash was resolving; while the outcome of another event was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Musculoskeletal stiffness
Clinical narrative: Chills; Headache; Fatigue like stiffing congested; I am not feeling well; Fatigue like stiffing congested; This is a spontaneous report from a contactable consumer (Patient reported for self). A patient of unspecified age and gender received unspecified dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, LOT#:Not reported/ Expiry Date: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. On an unspecified date the patient experienced Chills, Headache, Fatigue like stiffing congested, patient stated "I am not feeling well". Reason for no lot number: of Covid Vaccine: Other: Patient stated, "I don't have it. I have to call back with because I am not feeling well." As Patient was not willing to proceed the call. Limited information available over the call. The outcome of the events was unknown.  Batch/lot number not available for vaccine [BNT162B2]. Follow-up attempts are completed and no further information is expected
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm is going to be sore; This is a spontaneous report from a Pfizer-sponsored program 159558. A contactable consumer (patient) reported for self. Unspecified age and sex patient received second dose of bnt162b2 (Pfizer BioNTech COVID-19 vaccine, solution for injection, Batch/Lot number: EN0169, expiry date: unknown), dose 2 via an unspecified route of administration on 19Feb2021 as dose 2, single for covid-19 immunisation. Patient historical vaccine included patient received first dose of bnt162b2 (Pfizer BioNTech COVID-19 vaccine, solution for injection, Batch/Lot number: unknown, expiry date: unknown), dose 1 via an unspecified route of administration on 19Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On unspecified date patient experienced arm was going to be sore and he would like to know if he can rub it with an alcohol. The outcome of the vent was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Mouth ulceration, Oral pain
Clinical narrative: Experiencing ulcers in my mouth. Yes. I have two bump on my right cheek, Inside and inside my right, It one only inside of my lip on the left side.; It was the very painful.; This is a spontaneous report from a contactable consumer (Patient). A 31-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), intramuscular, administered in Arm Left on 11Aug2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced ulcers in her mouth. yes. She have two bumps on her right cheek, inside and inside her right, it one only inside of her lip on the left side, it was very painful on an unspecified date. Outcome of events was not resolved.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow-up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Burning sensation, Dyspnoea, Pain, Pain in extremity
Clinical narrative: two bumps in her armpit/and they are really swollen; her breast and they are really swollen; burning sensations there; has a really strong pain if she breathes really deep; has a little pain in her arm; She states that she feels like she cannot breath; she feels like she has tachycardia; This is a spontaneous report from a contactable consumer (Patient). A 44-years-old female patient received bnt162b2 (COMIRNATY, Formulation:Solution for injection, Batch/Lot Number: FD8448) dose 2 via an unspecified route of administration on 26Aug2021 10:00 as dose 2, single (At the age of 44-years) for covid-19 immunisation. Medical history included blood cholesterol and hypersensitivity from an unknown date and unknown if ongoing. The patient concomitant medications was not reported. The patient previously took bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: EC3100) dose 1 via an unspecified route of administration on 05Aug2021 (At the age of 44-years) for covid-19 immunisation. Patient has not taking any medications and has a lot of allergy but all of that she has and maybe some or a bit of cholesterol and triglycerides but that was already under control and states she had no other diseases; states the allergy, cholesterol and triglycerides began prior to the Pfizer Covid vaccine. On 26Aug2021 16:00 the patient experienced two bumps in her armpit/and they are really swollen, her breast and they are really swollen, burning sensations there, has a really strong pain if she breathes really deep, has a little pain in her arm, she states that she feels like she cannot breath, she feels like she has tachycardia. After 2nd dose Symptoms started at 4:00 pm and her symptoms are worse. Therapeutic measures were taken as a result of two bumps in her armpit/and they are really swollen, her breast and they are really swollen, burning sensations there, has a little pain in her arm, she states that she feels like she cannot breath. She states that someone told her to take 800 mg of Tylenol after getting the shot, but the Tylenol didn't even take away 5 percent of the pain. Lot number F200557 and expiration date Feb2022. Symptoms started at 4:00 pm and her symptoms are worse. Caller was given the following information. In general, local side effects; the ones you get on the arm where you got the shot (such as injection site redness and injection site swelling) were mostly mild-to-moderate in severity and resolved within 1 to 2 days. Side effects that you may experience throughout the rest of your body; (systemic side effects) including fever and chills were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter. Swollen lymph nodes (lymphadenopathy), which generally resolved within 10 days, is likely to have resulted from a robust vaccine-elicited immune response. The outcome of the events was not recovered.   Follow up(27Aug2021): This is a spontaneous report included. Event onset dates and some clinically relevant information provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Tachycardia
Clinical narrative: two bumps in her armpit/and they are really swollen; her breast and they are really swollen; burning sensations there; has a really strong pain if she breathes really deep; has a little pain in her arm; She states that she feels like she cannot breath; she feels like she has tachycardia; This is a spontaneous report from a contactable consumer (Patient). A 44-years-old female patient received bnt162b2 (COMIRNATY, Formulation:Solution for injection, Batch/Lot Number: FD8448) dose 2 via an unspecified route of administration on 26Aug2021 10:00 as dose 2, single (At the age of 44-years) for covid-19 immunisation. Medical history included blood cholesterol and hypersensitivity from an unknown date and unknown if ongoing. The patient concomitant medications was not reported. The patient previously took bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: EC3100) dose 1 via an unspecified route of administration on 05Aug2021 (At the age of 44-years) for covid-19 immunisation. Patient has not taking any medications and has a lot of allergy but all of that she has and maybe some or a bit of cholesterol and triglycerides but that was already under control and states she had no other diseases; states the allergy, cholesterol and triglycerides began prior to the Pfizer Covid vaccine. On 26Aug2021 16:00 the patient experienced two bumps in her armpit/and they are really swollen, her breast and they are really swollen, burning sensations there, has a really strong pain if she breathes really deep, has a little pain in her arm, she states that she feels like she cannot breath, she feels like she has tachycardia. After 2nd dose Symptoms started at 4:00 pm and her symptoms are worse. Therapeutic measures were taken as a result of two bumps in her armpit/and they are really swollen, her breast and they are really swollen, burning sensations there, has a little pain in her arm, she states that she feels like she cannot breath. She states that someone told her to take 800 mg of Tylenol after getting the shot, but the Tylenol didn't even take away 5 percent of the pain. Lot number F200557 and expiration date Feb2022. Symptoms started at 4:00 pm and her symptoms are worse. Caller was given the following information. In general, local side effects; the ones you get on the arm where you got the shot (such as injection site redness and injection site swelling) were mostly mild-to-moderate in severity and resolved within 1 to 2 days. Side effects that you may experience throughout the rest of your body; (systemic side effects) including fever and chills were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter. Swollen lymph nodes (lymphadenopathy), which generally resolved within 10 days, is likely to have resulted from a robust vaccine-elicited immune response. The outcome of the events was not recovered.   Follow up(27Aug2021): This is a spontaneous report included. Event onset dates and some clinically relevant information provided.
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Headache, Hypoacusis, Lymphadenopathy, Pain
Clinical narrative: right side lymph swelling; right ear pain; could not hear out of her right ear; gently touch the right side of her head and she is in pain; Pain; This is a spontaneous report from a contactable consumer or other non hcp (parent). A 12-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 12Aug2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced right side lymph swelling, right ear pain on 12Aug2021 while could not hear out of her right ear, gently touch the right side of her head and she is in pain, pain on an unspecified date in Aug2021. It was reported that, the mother of the patient on the line calling about the Pfizer Covid-19 vaccine and reported that her daughter received her first dose 12Aug2021. Within 24 hours her daughter had lymph node swelling and what she thought was normal ear pain on the right side. They applied heat and ice. She took her daughter to the doctor on 18Aug2021. The doctor looked in her ears and the patient could not hear out of the right ear. He referred them to the ER. They waited for 2 hours in the ER and they sent her home because it was not an emergency and she was referred to her primary care. The caller reported that her daughter cannot hear anything out of her right ear. Someone was taking her daughter to the clinic to get revaluated. She called the CDC and they referred her to the ER. The patient was in a lot of pain and you can barely touch the side of her neck. Therapeutic measures were taken as a result of events. The outcome for all events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypertension, SARS-CoV-2 test
Clinical narrative: very high blood pressure; Dizziness/ Lightheaded; This is a spontaneous report from a contactable consumer, the patient. This 85-year-old non-pregmant female patient reported that she received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6201) via unspecified route in the left arm on 14Feb2021 at 10:00 (at the age of 85-years-old) as a single dose for COVID-19 immunization. Medical history included High Blood Pressure, Back Surgery, and Neurological (as reported). Patient's known allergies include scallops. The patient did not have COVID-19 prior to vaccination. The patient did not receive any other vaccines within four weeks of the COVID-19 vaccine. Concomitant medications received within two weeks included irbesartan 75, pravastatin (PRAVASTAT) 10mg, escitalopram oxalate (LEXAPRO) 5mg, and amlodipine besilate (AMLOPIN) '5m'. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9262) via unspecified route in the left arm on 24Jan2021 at 10:00 (at the age of 85-years-old) as a single dose for COVID-19 immunization. On 14Feb2021, the patient experienced dizziness, lightheaded, diagnoses (Dx) as very high blood pressure. The patient was kept in hospital 8 hours and was given meds to lower blood pressure. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received included blood pressure meds. The outcome of the events was recovered on unspecified date. The patient was tested for COVID post vaccination with nasal swab COVID test in Apr2021 which resulted Negative.   Follow-up (08Sep2021): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: I had chills and headache for 12 hours; I had chills and headache for 12 hours; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), dose unknown via an unspecified route of administration on 27Aug2021 as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medication was none. Patient had chills and headache for 12 hours. It start developing after the 5 hours. The outcome of the event was recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site swelling
Clinical narrative: Hive like swelling around injection site; Hive like swelling around injection site; This is a spontaneous report from a contactable Consumer. This 14-year-old male consumer reported for himself that:  A 14-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Fc3182), via an unspecified route of administration in Arm Left on 27Aug2021 13:30 (at the age of 14-year-old) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Fc3180), via an unspecified route of administration in Arm Left on 06Aug2021 (at the age of 14-year-old) as DOSE 1, SINGLE for covid-19 immunization. On 29Aug2021 patient experienced hive like swelling around injection site. Patient didn't received treatment for the events. The clinical outcome of the event was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dysphemia, Feeling abnormal, Tremor
Clinical narrative: Stuttering; Dizzy; Shaking; Light-headed; Can't understand much of anything; he can't get across what's going on; This is a spontaneous report from contactable consumer. This consumer (parent) reported for her son (patient).  A male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown, Expiration date: unknown), via unspecified rout on 23Aug2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced stuttering, dizzy, shaking, light-headed, can't understand much of anything; he can't get across what's going on. Reporter stated, "The thing is he's stuttering and can't understand much of anything. I had to talk to a fellow students because he can't get across what's going on, My son received the Covid-19 vaccination on 23rd from school and today the last 2 hours he is stuttering, he's dizzy, shaking, light headed, we don't know what to do. If this a reaction to the shot, what do we do. The outcome of the events was unknown.  Follow-up attempts has been completed; No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Feeling abnormal, Herpes zoster, Neuralgia
Clinical narrative: Really knocked out/Thinks the vaccine was just too strong for her; Shingles; Bad burning and nerve pain.; Bad burning and nerve pain.; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 59-years-old female patient received bnt162b2  PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0202  and Expiry date: Unknown), dose 2 via an unspecified route of administration on 27Jun2021 , at the age of 59-years-old as DOSE 2 SINGLE for Covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine.She completed two rounds of antibiotics for a respiratory infection these 2 weeks prior to getting the first dose Pfizer Covid 19 Vaccine. Patient took first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number was not reported) on 06JUN2021for covid-19 immunization. The patient medical history was not reported. On Jun2021 the patient experienced really knocked out/thinks the vaccine was just too strong for her. On 2021 the patient experienced shingles, bad burning and nerve pain. Therapeutic measures were taken as a result of shingles. The outcome of event really knocked out/thinks the vaccine was just too strong for her was recovered on 2021 ,the outcome of event shingles was recovering while the outcome of event was unknown.  No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Hyperventilation
Clinical narrative: Pain in my chest; Breathing a little bit heavier; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced pain in chest, breathing a little bit heavier. When probed for the concern, consumer stated, "The patient got to go and get the shot and the patient felt like patient had pain in chest, He felt like my breathing was a little bit heavier. Patient asked if that was normal." The clinical outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Neck pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's husband). A female patient, of unknown age, received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), via unknown route, on Aug 8, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medication not reported. Since the past 15 days, patient has experienced multiple types of symptoms: pain in forearm, in the palm, in the wrist, pain in the neck, shoulders and back (lower back). The outcome of the event pain in forearm, in the palm, in the wrist: recovering; and all other events unknown. The lot number for the vaccine, BNT162B2, not provided and will be requested during follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Gait disturbance, Pain in extremity
Clinical narrative: I am feeling pain in my leg you know, It's like, I can't even walk very well; It's like getting worst.; My left leg on the bottom, Like strong pain in my bottom. I can't really walk very well.; This is a spontaneous report from contactable consumer. This consumer (Patient) reported.  A patient of an unspecified age and gender received second dose of BNT162B2 (solution for injection, Lot number: unknown) via an unspecified route of administration on 27Aug2021, as dose 2, single for Covid-19 immunization. Medical history and concomitant medications were not report-ed. The patient received first dose of BNT162B2 (solution for injection, Lot number: unknown) via an unspecified route of administration on an unknown date in 2021, as dose 1, single for Covid-19 immunization. The patient stated that after the 2nd shot, patient don't know the vaccine is, What is causing it or left leg on the bottom, Like strong pain in bottom. Patient can't really walk very well. Patient don't know if it has to do with the vaccine. The patient wanted to make sure, It's not some-thing serious cause. Patient can't even walk very well. So, It's like getting worst. If, It has anything to do with vaccine or something different. The patient also stated that they would see, and go to emergency room now. They just want someone, who knows that, Someone can give advice, this is serious or not. The patient was requested to visit the Health care provider in case of emergency. The outcome of the events was reported as not recovered.   The lot number for the vaccine, BNT162B2, was not provided and would be requested during follow up.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, COVID-19, Drug ineffective, Illness, Pain in extremity
Clinical narrative: On 09Feb2021 I got COVID; had the Pfizer shot 22Jan2021. On 09Feb2021 I got COVID; really sick; sore arm; This is a spontaneous report. A 72-year-old female patient (patient herself) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9262, Expiry date was unknown), via an unspecified route of administration, administered in Arm Left on 22Jan2021 as dose 1, single for COVID-19 immunization (Age at Vaccination was 72 years). The patient's medical history included ongoing colitis ulcerative. She was also immunocompromised with ulcerative colitis (but not that immunocompromised; it's in remission), pulmonary embolism, have a history of blood clots in her lungs, migraine prophylaxis, Prophylactic migraine headaches, migraine. Concomitant medications included Topiramate (TOPAMAX) taken for migraine prophylaxis, migraine. The patient previously took Pneumococcal vaccine and experienced Guillain-Barre syndrome. On 09Feb2021, patient experienced three days before her second dose was due, she was tested positive for the COVID-19 virus. On 12Feb2021, she was also on oxygen and nebulizers during that time. On an unspecified date in Feb2021, the patient had experienced really sick and sore arm. The patient underwent lab tests and procedures which included antibody test: 750 on an unspecified date and SARS-COV-2 test: positive on 08Feb2021. Therapeutic measures were taken as a result of events includes an antibody infusion of Bamlanivimab on 12Feb2021, Dexamethasone and Ivermectin. The seriousness of the events really sick and sore arm was non-serious and for the all the other events was serious and medically significant. The outcome of the events was unknown.      Follow-up (01Sep2021): Follow-up attempts completed. No additional information was received from last follow-up attempt.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: On 09Feb2021 I got COVID; had the Pfizer shot 22Jan2021. On 09Feb2021 I got COVID; really sick; sore arm; This is a spontaneous report. A 72-year-old female patient (patient herself) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9262, Expiry date was unknown), via an unspecified route of administration, administered in Arm Left on 22Jan2021 as dose 1, single for COVID-19 immunization (Age at Vaccination was 72 years). The patient's medical history included ongoing colitis ulcerative. She was also immunocompromised with ulcerative colitis (but not that immunocompromised; it's in remission), pulmonary embolism, have a history of blood clots in her lungs, migraine prophylaxis, Prophylactic migraine headaches, migraine. Concomitant medications included Topiramate (TOPAMAX) taken for migraine prophylaxis, migraine. The patient previously took Pneumococcal vaccine and experienced Guillain-Barre syndrome. On 09Feb2021, patient experienced three days before her second dose was due, she was tested positive for the COVID-19 virus. On 12Feb2021, she was also on oxygen and nebulizers during that time. On an unspecified date in Feb2021, the patient had experienced really sick and sore arm. The patient underwent lab tests and procedures which included antibody test: 750 on an unspecified date and SARS-COV-2 test: positive on 08Feb2021. Therapeutic measures were taken as a result of events includes an antibody infusion of Bamlanivimab on 12Feb2021, Dexamethasone and Ivermectin. The seriousness of the events really sick and sore arm was non-serious and for the all the other events was serious and medically significant. The outcome of the events was unknown.      Follow-up (01Sep2021): Follow-up attempts completed. No additional information was received from last follow-up attempt.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: I am having, Like a headache.; I am having arm pain.; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 28Aug2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Aug2021, the patient experienced having, like a headache and arm pain. It was reported that consumer stated, "Yes I call a pharmacy, because I had my first shot. My first dose on yesterday so, the paper, they gave me the paper to let me know, What the symptoms are but, when it come down like, checking the medication for stop me, until to call you provider. Like, I have one because I am having arm pain and I am having like a headache and I want to take, like some Tylenol (intent treatment) or something but it told me that, I have to call and you know, I talk to the provider. Well. My doctor's office was not open this morning so, I soon, Get the pharmacy, would be they are not open for today. So, I am calling this line anything to know." The outcome of the events was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time prolonged
Clinical narrative: PTT's drawn and they have all been elevated; This is a spontaneous report from a contactable consumer (patient). A 36-years-old female patient received bnt162b2 (COMIRNATY; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Right on 27Jan2021 (at the age of 35-years-old) as DOSE 2, SINGLE for covid-19 immunisation. This report is not related to a study or programme. The patient was taking Pfizer Covid Vaccine for work. Vaccine was not administered at Facility and Vaccine facility information was available. The patient medical history and concomitant medications included none. The patient previously received first dose of BNT162B2 in right arm on 31Dec2021 (at the age of 35-years-old) as dose 1, single for covid-19 immunisation. Additional vaccines administered on same date of the Pfizer Suspect; Prior Vaccinations (within 4 weeks); AE(s) following prior vaccinations; Family Medical History Relevant to AE(s) included none. The patient experienced PTT's drawn, and they have all been elevated in 2021. The patient underwent lab tests and procedures which included PTT: elevated, PTT: elevated on unspecified dates, PTT: elevated on 24Aug2021. Caller has had three PTT's drawn and they have all been elevated with her most recent one being 24Aug2021. Caller stated she had been to the doctor and they couldn't figure out why. She was wondering if this was something that had been reported before after receiving the Pfizer COVID vaccine. Patient had been to so many doctors over it; but they could not figure out why it was elevated. Stated the rest of her labs were normal. Caller denied any other medications, medical conditions, labs, testing, or treatments relevant to events. No information in PI regarding elevated PTT after receiving the Pfizer COVID vaccine. No exact times of event onset provided. AE(s) require a visit to Physician office and not to Emergency Room. Clinical outcome of event was not recovered.  Information about lot/batch number will be obtained during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: Since then caller was prescribed  Hydroxychloroquine, leucovorin and methotrexate for rheumatoid arthritis; This is a spontaneous report from a contactable consumer (patient). A female patient of unknown age received the second dose of bnt162b2 (lot number: unknown) in Feb2021 via unknown route of administration at single dose for COVID-19 immunisation. Medical histories included immunocompromised. Concomitant medications were not reported. Historical Vaccine included the first dose of bnt162b2 (lot number: unknown) in Jan2021 via unknown route of administration at single dose for COVID-19 immunisation. The reporter was calling about the covid booster vaccine. The reporter had a compromised immune system and had rheumatoid arthritis. The caller was not on these medications with the initial vaccination of the two doses. Consumer wanted to know if it was ok to take the booster dose Pfizer covid vaccine. She received Pfizer covid vaccine first dose in Jan2021 and second dose in Feb2021. Since then reporter was prescribed, Hydroxychloroquine, leucovorin and methotrexate for rheumatoid arthritis. The patient was currently on methotrexate, hydroxychloroquine, and leucovorin. The outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast enlargement, Breast pain, Breast swelling, Menstruation delayed
Clinical narrative: My breasts also appear more full as if they have grown; My Period has been noticeably late since the vaccine; The swelling and pain in my breasts is noticeable and not normal for my cycle; The swelling and pain in my breasts is noticeable and not normal for my cycle; Specifically, very sore within the areolas all the way to my armpits which is completely abnormal for me; This is a spontaneous report from a non-contactable consumer (patient). A 37-year-old non-pregnant female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0171, Expiry date: unknown, at the age of 37 years), dose 2 via an unspecified route of administration, administered in Arm Left on 26Apr2021 as dose 2, single for covid-19 immunisation. The medical history was not reported. There were no concomitant medications. No known allergies. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8737, Expiry date: unknown, at the age of 37 years), dose 1 via an unspecified route of administration, administered in Arm Left on Apr2021 as dose 1, single for covid-19 immunisation. 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. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced her period has been noticeably late since the vaccine, the swelling and pain in her breasts is noticeable and not normal for her cycle, specifically, very sore within the areolas all the way to her armpits which is completely abnormal for her. Her breasts also appeared more full as if they had grown. Her period had always been regular prior to this shot. No other changes in her health, eating, exercise, stress, medication to explain the odd changes on 08May2021. The patient did not receive any treatment for the event. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Cartilage injury, Rotator cuff syndrome, SARS-CoV-2 test
Clinical narrative: Rotator cuff tendonitis; torn cartilage in shoulder; This is a spontaneous report from a contactable consumer (patient). This 33-year-old non-pregnant female consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number ER8737) on 06Apr2021 at 09:30, at the age of 33 years, as the second single dose, for COVID-19 immunisation. Medical history included epilepsy. Known allergies: no. COVID prior vaccination: no. The patient received the first dose of BNT162B2 vaccine on 16Mar2021 at 09:00 AM, lot EN6208, in left arm, at the age of 33 years. Concomitant medication included lamotrigine. No other vaccine was administered in 4 weeks. The patient experienced rotator cuff tendonitis and torn cartilage in shoulder on 06Apr2021 at 10:00 AM. The events resulted in Doctor or other healthcare professional office/clinic visit and required treatment with steroid shot, physical therapy and Aleve for 2 weeks. The patient had not recovered. COVID was tested post vaccination with nasal swab: negative on 18Aug2021.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Gait inability, Muscle spasms, Walking aid user
Clinical narrative: severe lower back pain; , the pain is been so bad that I couldn't walk, I have to crawl to go to the bathroom; I can't walk; I am walking with a cane right now, because I still get back spasms; I am walking with a cane right now, because I still get back spasms; This is a spontaneous report from a contactable consumer (Patient reported for self). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/lot number and Expiry Date: Unknown), via an unspecified route of administration on 26Aug2021 as dose 1, single for COVID-19 immunisation. The patient reported, (on unspecified date) starting yesterday at 4 clock in the afternoon patient had severe lower back pain; the patient stated "the pain is been so bad that I couldn't walk, I have to crawl to go to the bathroom and today is the pain is subsided a bit but I am walking with a cane right now, because I still get back spasms." Patient was not concerned about that so much as the second dose which is schedule for September 16th, patient was told that this second dose that the side effects are more severe so patient queried if it was possible for patient to push up second dose until the 20Sep. Patient hung up abruptly hence details could not be probed,limited information was available over the call. The outcome of the events was unknown.  Batch/lot number not available for vaccine [BNT162B2]. Follow-up attempts are completed and no further information is expected.