chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Some component in the vaccine actually took away the pain and the weaknessfrom peripheral artery disease in legs; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: ER2613) via an unspecified route of administration (age at vaccination 71-year) on 23Apr2021 13:00 as dose 2, single for COVID-19 immunization. The medical history includes Peripheral artery disease in legs, pain, weakness from peripheral artery disease in legs, all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (lot number was Either EN or FN followed by either 208 or Z08) administered on 19Mar2021 for COVID-19 immunization. On 23Apr2021 the patient experienced some component in the vaccine actually took away the pain and the weakness from peripheral artery disease in legs. The caller is a consumer reporting she did not have any bad effects from the Pfizer Covid Vaccine. The caller states she literally had no bad effects from the Pfizer Covid Vaccine, but the caller had a positive effect. The caller states she can't seem to find a place to report this positive effect. Some component in the vaccine actually took away the pain and the weakness from peripheral artery disease in legs: The caller states some component in the Pfizer Covid Vaccine took away the pain and weakness from the peripheral artery disease in the caller's legs. The caller states this pain removal lasted for about 3 weeks. Caller states it began within; well, the caller received the second dose Pfizer Covid Vaccine around 1300. The caller states she did not have any bad side effects from either dose Pfizer Covid Vaccine, had things set up in the event that the caller did, but the caller did not have any bad side effects. The caller clarifies the pain removal began within hours of receiving the second dose Pfizer Covid Vaccine. The clinical outcome of the event was unknown.  Description of product complaint: The caller states some component in the Pfizer Covid Vaccine took away the pain and weakness from the peripheral artery disease in the caller's legs. Caller states this began after receiving second dose Pfizer Covid Vaccine. Product strength and count size dispensed: N/A. Additional lot numbers: First dose: The caller states the lot number is kind of covered up with a sticker from the second dose on the vaccine card. Either EN or FN followed by either 208 or Z08. Second dose: ER2613. The sample of the product available to be returned was not requested.  A final statement is not entered.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Fatigue, Heart rate
Clinical narrative: Tired; weakness; his is a spontaneous report from a contactable consumer. A 43-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: ER8727 and expiration dates were not reported), dose 1 via an unspecified route of administration in arm left on 13Apr2021 at 14:00 as single dose for COVID-19 immunisation. The patient's medical history included thyroid, hashimoto and allergy to penicillin and Levaquin from an unknown date and unknown if ongoing. The concomitant medication included levothyroxine sodium (SYNTHROID), clonazepam (KLONOPIN), escitalopram oxalate (LEXAPRO) and buspirone hydrochloride (BUSPAR) all products from an unknown date for an unknown indication. On 13Apr2021 at 14:00 the patient experienced tired and weakness for about a week after 1 dose of vaccine. The facility where the most recent COVID-19 vaccine was administered id reported as other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received corrective treatment for the adverse event. The patient underwent lab test and procedure that is Heart rate: increase and blood pressure measurement: 145/95 +/- 10. The outcome of the events were not recovered.   No Follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Inappropriate schedule of product administration
Clinical narrative: wasn't able to take it until recently again and I don't know what's going to happen to me if I take it and it's been almost like 3 months."; Have vestibular issue and it agitated; This is a spontaneous report from a Pfizer sponsored program . A contactable consumer reported for self.   A female patient of an unspecified age, received second dose of BNT162B2 (Solution for injection, Batch/lot number: ER8736) via an unspecified route of administration, on an unknown date in May2021, as dose 2 single for Covid-19 immunization. Medical history included Have vestibular issue. Concomitant medications were not reported. The patient received second dose 2 and a half months after the first, she was Worried about the efficacy because waited longer than 21 days; Took the vaccine in May but she wasn't able to take it until recently. Have vestibular issue and it was agitated . The patient wanted to know if there will be some kind of Adverse reaction to that." The patient stated that I took the vaccine in May but I wasn't able to take it until recently again and I don't know what's going to happen to me if I take it and it's been almost like 3 months." The out-come of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache, after first vaccine; This is a spontaneous report from a contactable consumer (patient) reported for himself. A male patient of an unspecified age received (BNT162B2, Solution for injection, Batch/Lot number was not reported) dose 1 via an unspecified route of administration on 05Aug2021 (Thursday) as 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 headache, after first vaccine. The patient stated that he was afraid, the second shot will be worse, and that was scary. The patient heard that the second shot, was worse than the first shot and all the side effects more with the second shot, than the first shot. The patient wanted to know how long do side effects last. The patient stated that few people that he know who got vaccinated, some people had more side effects than others, and some of the side effects went away quicker. He stated that he specifically had a headache, and last night took paracetamol (TYLENOL) and was effective. Outcome of the event was unknown.  Information about lot/batch number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nasopharyngitis, Pain
Clinical narrative: feeling sick; body ache; cold; This is a spontaneous report from a contactable consumer. This female consumer of unknown age reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 04Aug2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 04 aug2021, Wednesday the patient was vaccinated, on Thursday and Friday she was fine and there was nothing wrong with her, she had not gone to the doctor for 7 years, however on 08Aug2021 Saturday night she started feeling sick, she has body aches and cold. She went sick from nothing. She felt sick as a dog and has been in bed for 3 days, she can't go to the store and can't do anything. She also said that she was not going to take the second dose if she has to go through this again. She would like to know if the shot gave her Covid, if they gave her a Covid shot. She was supposed to receive the second dose of the vaccine on 28Aug she believed so she would like to know what to do by then because she does not want to feel this way again. Caller was upset. She disconnected the call before transfer to Safety. Information on the lot/batch number has been requested.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature abnormal, Chills, Feeling hot, Headache
Clinical narrative: nausea/vomiting/ throwing up; body aches; headache; chills; fever; Caller said that her daughter felt warm last night, but took her temperature just now and her temperature said 100.9; Caller said that her daughter felt warm last night, but took her temperature just now and her temperature said 100.9; nausea; her daughter is really sick since last night; This is a spontaneous report from a contactable consumer (patients mother).  A 16-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unknown route of administration at left arm on 08Aug2021 at 13:00 (lot number: FC3180) (age at vaccination 16-year-old) as dose 1, 0.3ml single for COVID-19 immunization. The patient medical history acne from an unknown date and unknown if ongoing. The patient concomitant medication included doxycycline for acne. The patient did not receive any other vaccines within four weeks prior to the vaccination. The family history and relevant test was found to be none. The patient experienced chills, nausea, vomiting/throwing up, bodyache, headache, really sick since last night, fever, felt warm last night, but took her temperature just now and temperature was 100.9 on 10Aug2021. The patient has not visited the emergency room, but stated that she was going to take her to Urgent Care. The laboratory investigation included temperature was 100.9 on 11Aug2021. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: nausea/vomiting/ throwing up; body aches; headache; chills; fever; Caller said that her daughter felt warm last night, but took her temperature just now and her temperature said 100.9; Caller said that her daughter felt warm last night, but took her temperature just now and her temperature said 100.9; nausea; her daughter is really sick since last night; This is a spontaneous report from a contactable consumer (patients mother).  A 16-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unknown route of administration at left arm on 08Aug2021 at 13:00 (lot number: FC3180) (age at vaccination 16-year-old) as dose 1, 0.3ml single for COVID-19 immunization. The patient medical history acne from an unknown date and unknown if ongoing. The patient concomitant medication included doxycycline for acne. The patient did not receive any other vaccines within four weeks prior to the vaccination. The family history and relevant test was found to be none. The patient experienced chills, nausea, vomiting/throwing up, bodyache, headache, really sick since last night, fever, felt warm last night, but took her temperature just now and temperature was 100.9 on 10Aug2021. The patient has not visited the emergency room, but stated that she was going to take her to Urgent Care. The laboratory investigation included temperature was 100.9 on 11Aug2021. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Bone disorder, Cough, Discomfort, Headache
Clinical narrative: fever bone; fever bone; back pain; headache; general discomfort; body aching; cough; This is a spontaneous report from a contactable consumer (parent). A 13-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on 04Aug2021 as dose 1, single for COVID-19 immunization (at the age of 13-year-old). The patient's medical history and concomitant medications were not reported. The patient was fine but on Monday on an unspecified date patient experienced fever bone, back pain, headache, general discomfort, body aching and on Tuesday started with cough. Caller wanted to know if these might be side effects of the vaccine. Patient received Tylenol, vitamins and fluids. The outcome of the events was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: fever bone; fever bone; back pain; headache; general discomfort; body aching; cough; This is a spontaneous report from a contactable consumer (parent). A 13-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on 04Aug2021 as dose 1, single for COVID-19 immunization (at the age of 13-year-old). The patient's medical history and concomitant medications were not reported. The patient was fine but on Monday on an unspecified date patient experienced fever bone, back pain, headache, general discomfort, body aching and on Tuesday started with cough. Caller wanted to know if these might be side effects of the vaccine. Patient received Tylenol, vitamins and fluids. The outcome of the events was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Breast inflammation, Breast pain, Chest pain, Erythema, Lymphadenopathy
Clinical narrative: pain and redness around breast and areola/Left breast pain with inflamed red areola; left breast is inflamed; left arm also hurts/left arm pain; chest hurt for a few minutes; It could be a lymph node; pain and redness around breast and areola/Left breast pain with inflamed red areola; This is a spontaneous report from a contactable nurse (parent). A 13-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FA7484) via an unspecified route of administration, administered in Arm Left on 09Aug2021 19:40 (at the age of 13 years old) as dose 1, single for COVID-19 immunisation at pharmacy. Medical history included peanut allergy from 2017 and ongoing (caller thinks in 2017). There were no concomitant medications. No additional vaccines administered on same date of the Pfizer suspect. Patient did not received any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient experienced pain and redness around breast and areola/left breast pain with inflamed red areola, it could be a lymph node on Aug2021, left arm also hurts/left arm pain, chest hurt for a few minutes, left breast is inflamed on 09Aug2021, pain and redness around breast and areola/left breast pain with inflamed red areola on 10Aug2021. Reported as, "13 year old female experiencing redness and pain around breast and areola after receiving first dose of Pfizer BioNTech Covid-19 Vaccine. Caller asked if the side effects can be stronger after the second dose of the Pfizer BioNTech Covid-19 Vaccine. Caller states a few minutes later, her daughter's chest hurt for a few minutes, left breast was inflamed, and her areola was red and later reports painful. Caller states also the left breast was painful. Caller states she thought, it could be a lymph node. Caller states the side effect sheet, doesn't say anything about the breast, but mentions lymphadenopathy.Caller states her breast is hurting but bearable. Caller states the left breast looks bigger than the right breast. Caller states her daughter's left arm also hurts. Left breast pain with inflamed areola, caller adds that on 10Aug2021 she noticed the redness, but the left breast looked inflamed on 09Aug2021". Outcome of the event chest hurt for a few minutes was recovered on 09Aug2021, not recovered for pain and redness around breast and areola/left breast pain with inflamed red areola, left breast is inflamed, recovering for left arm also hurts/left arm pain, and unknown for it could be a lymph node.  Follow up information has been requested.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain and redness around breast and areola/Left breast pain with inflamed red areola; left breast is inflamed; left arm also hurts/left arm pain; chest hurt for a few minutes; It could be a lymph node; pain and redness around breast and areola/Left breast pain with inflamed red areola; This is a spontaneous report from a contactable nurse (parent). A 13-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FA7484) via an unspecified route of administration, administered in Arm Left on 09Aug2021 19:40 (at the age of 13 years old) as dose 1, single for COVID-19 immunisation at pharmacy. Medical history included peanut allergy from 2017 and ongoing (caller thinks in 2017). There were no concomitant medications. No additional vaccines administered on same date of the Pfizer suspect. Patient did not received any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient experienced pain and redness around breast and areola/left breast pain with inflamed red areola, it could be a lymph node on Aug2021, left arm also hurts/left arm pain, chest hurt for a few minutes, left breast is inflamed on 09Aug2021, pain and redness around breast and areola/left breast pain with inflamed red areola on 10Aug2021. Reported as, "13 year old female experiencing redness and pain around breast and areola after receiving first dose of Pfizer BioNTech Covid-19 Vaccine. Caller asked if the side effects can be stronger after the second dose of the Pfizer BioNTech Covid-19 Vaccine. Caller states a few minutes later, her daughter's chest hurt for a few minutes, left breast was inflamed, and her areola was red and later reports painful. Caller states also the left breast was painful. Caller states she thought, it could be a lymph node. Caller states the side effect sheet, doesn't say anything about the breast, but mentions lymphadenopathy.Caller states her breast is hurting but bearable. Caller states the left breast looks bigger than the right breast. Caller states her daughter's left arm also hurts. Left breast pain with inflamed areola, caller adds that on 10Aug2021 she noticed the redness, but the left breast looked inflamed on 09Aug2021". Outcome of the event chest hurt for a few minutes was recovered on 09Aug2021, not recovered for pain and redness around breast and areola/left breast pain with inflamed red areola, left breast is inflamed, recovering for left arm also hurts/left arm pain, and unknown for it could be a lymph node.  Follow up information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Renal pain
Clinical narrative: Heavy period; I have kidney pain in my other upper left kidney where the injection site that side of the body; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 27Jul2021 (lot number and expiry date: unknown) as dose number unknown, single for Covid-19 immunization. The patient's medical history was not reported. Concomitant medications included unspecified contraceptives. The patient stated that she just had the Pfizer Vaccine on 27Jul2021 and then beginning 04Aug2021, she started having heavy period which she never had for years because she was on contraceptives. It was lot of blood and she was kind of shock because she never had periods for long time. On unspecified date in 2021, the patient also had kidney pain in the other upper left kidney where the injection site was/ side of the body. Outcome of the events was unknown.  Information on lot/batch number has been requested.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Illness, Pyrexia
Clinical narrative: Fever; Chills; He is like sick; This is a spontaneous report from a contactable consumer or other non hcp. A 13-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 04Aug2021(age at vaccination:13 Years) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced fever with outcome of unknown, chills, he is like sick. Therapeutic measures were taken as a result of fever was Tylenol and multivitamins. The outcome of the events pyrexia, chills, illness was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain
Clinical narrative: she is a little sore; swollen lymph nodes in her neck and shoulder; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine) on an unspecified date for covid-19 immunization. The patient stated that she was a little sore and experienced swollen lymph node in her neck and shoulder on an unspecified date. She wanted to know how long does the side effects last. She asked if the events did not go away in 10 days then what should she do and can she take anything for them.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Muscle spasms
Clinical narrative: had a chest cramp; This is a spontaneous report received from a contactable consumer (Patient's mother) reported for her son. A 15-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) via an unspecified route of administration on 15Aug2021 (at the age of 15-year-old) (Batch/Lot number: Not provided) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that caller was calling on behalf her 15-year-old son who received the first dose of the Pfizer Covid-19 vaccine on Sunday. This morning he had a chest cramp on an Aug2021, and it disappeared, he does weights but since she had been told that the vaccine could cause heart disorders she would like to know if this may be related to the vaccine and she would like to know if people after receiving the vaccine should take care of themselves as patients in doing any activity or if it doesn't matter. No information found. Referred caller to their HCP. She also mentioned that before the vaccine she did a medical examination on her son and everything went perfectly, his heart was fine. The patient underwent lab tests and procedures which included investigation: normal on an unspecified date everything went perfectly, his heart was fine. Outcome of event was recovered on an unspecified date in Aug2021.  Follow-up attempts are completed. No further information is expected; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 59-year-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 11Aug2021 (at the age of 59-year-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose of the Pfizer Covid-19 vaccine on 11Aug2021 (reported as yesterday) and within 2 hours developed a headache on 11Aug2021 (reported as within 2 hours). Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101042163 same reporter and drug, similar event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Vaccination site pain
Clinical narrative: After getting the first injection of the Pfizer covid-19 vaccine, she experienced a sore and tender arm; Tingling around her heart and chest; This is a spontaneous report from a Pfizer sponsored program. A contactable female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on Jul2021 (two weeks prior to this report) (Batch/Lot number was not reported) as SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient was asking can it be taken with a product to help with immunity that contains vitamins A, C, D3, E and zinc, selenium, quercetin dihydrate, wellmune yeast, elderberry, echinacea, ginger, turmeric, lactospore, bioperine, acai berry, garlic, response received that did not find information about a potential interaction, or interaction study, or administration with these products/drugs. This may not have been studied. Advised to consult with your doctor or pharmacist for further guidance and ensure that your health care providers know all the medications, including over-the-counter (OTC) products, that you are taking, have recently taken or are planning to take. On 2021, the patient experienced sore arm and tender arm which lasted longer than just a few days and has still not fully recovered and patient also experienced tingling around her heart and chest. Patient was concerned should she get a second injection of the Pfizer covid-19 vaccine because of what she experienced (side effects) after the first dose. She was afraid the second injection might be worse. The outcome of event for sore arm and tender arm was not recovered whereas outcome for tingling around her heart and chest was unknown.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Lethargy, Menstruation irregular, Myalgia, Somnolence
Clinical narrative: heavy, heavy menstrual cycle bleeding; major bleeding; severe muscle pains; Lethargy; just slept it off; felt completely run down/just felt horrible; This is a spontaneous report from a contactable consumer reporting for herself (patient). A female consumer of an unknown age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: unknown, expiration date: unknown), via an unspecified route administered in right arm on 16Apr2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was reported as none and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no history of adverse events with any previous vaccines. No additional Vaccines Administered on Same Date of the Pfizer Suspect. Patient reported she has gotten both Covid vaccines with the first one on 16April2021 and the second one on 07July2021. She waited to get the second one because she had side effects after she took the first dose. On an unspecified date in 2021, the patient had heavy, heavy menstrual cycle bleeding after the first shot. In the interim, that was why she waited. Also, after the first dose and major bleeding, which is very unusual for her, she had severe muscle pains and lethargy that occurred for 3 weeks afterwards. So, she just slept it off, but felt completely run down. States it also happened again after the second dose. The heavy menstrual bleeding started the second or third week on a Monday and 2 weeks later she started her cycle and called into work. After the second vaccine it happened again. The lethargy and muscle pains and feeling completely run down started the Thursday 3 weeks after the first shot, and she just felt horrible for 4-5 days. The menstrual cycle cleared and then after her second vaccine it started all again. The lethargy and severe muscle pains did improve. The outcome of the events heavy, heavy menstrual cycle bleeding; major bleeding, just slept it off, felt completely run down/just felt horrible was not recovered and outcome of severe muscle pains and lethargy was recovering.  Follow-up attempts completed, information on batch/lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: experiencing tingling throughout my body/ the tingling "feeling comes very randomly" and that its, "like a prickly sensation in my arms, hands, feet, legs, and face."; experiencing tingling throughout my body/ the tingling "feeling comes very randomly" and that its, "like a prickly sensation in my arms, hands, feet, legs, and face."; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 25-year-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on 11Aug2021 at 16:00 as dose 1, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The reporter reported she received the first dose of Covid19 Pfizer vaccine and within about 12 to now 24 hours later (on 12Aug2021) she experienced tingling throughout her bod. She wanted to know if that was a normal side effect or something she should be concerned about. She reported the tingling "feeling comes very randomly" and that its, "like a prickly sensation in my arms, hands, feet, legs, and face". She also stated there were people who said they had experienced this online. She had been feeling like tingling in her body and feet. The outcome of the event was reported as not resolved.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: fever; chills; headache; nausea; This is a spontaneous report from a contactable consumer (parent). A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization (at the age of 16-year-old). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. Patient health details was unaware. The patient experienced fever, chills, headache and nausea on an unspecified date. Event took place after use of product. Side effects lasted about half a day. Outcome of the events was recovered on an unspecified date.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Renal pain
Clinical narrative: kidneys are hurting very bad; his whole body is sore; This is a spontaneous report from report from a contactable consumer (patient) via Pfizer-sponsored program. A male patient of an unspecified age received first dose of  BNT162B2 ((PFIZER-BIONTECH COVID-19, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 10Aug2021, as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On Aug2021, the patient reported that his kidneys were hurting very bad and his whole body was sore and he would also like to know if this happened to other people. The outcome of the events were not recovered.   Follow-up attempts are completed. No further information is expected. Batch/lot number not available for BNT162B2.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: very bad headache; fever of 101.7 Fahrenheit for temperature; This is a spontaneous report from a Pfizer sponsored program . A contactable consumer (parent) reported that a 15-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported, patient was 15-year-old at the time of vaccination), via an unspecified route of administration on 10Aug2021 at 05:30 PM as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), on an unspecified date in 2021 as DOSE 1, SINGLE for covid-19 immunisation. Reported that a day after vaccination at 5:30 PM, after school her son complain that he is having headache and a fever of 101.7 Fahrenheit for temperature. Reporter stated, Yes we got the vaccine last night at about 5:30 no problem at night went to school today, I called him after school his school is 08:30 to 03:00 so, I called him after to check on him the first shot was given several weeks ago and things are very high in (withheld) today and he walks home from school so he tried to take his things to reconsideration so at 3 'O clock he said he had very bad headache so, I said okay so all you can do now is drink a lot of water and lay down and I get off work 5 O' Clock and then I came back home at 5:30. So, I came home 5:30 asked him if he still have the headache. So, I did what I would normally do to cold wash and lay. It was reported that reporter asked if she able to give him Acetaminophen. so, we can try to bring him down or am I not supposed to, I don't know. On 11Aug2021 at 03:00 PM, the patient experienced very bad headache, on 11Aug2021, the patient experienced fever of 101.7 Fahrenheit for temperature. The patient underwent lab tests and procedures which included body temperature: 101.7 Fahrenheit on 11Aug2021. Patient received treatment for event headache. The outcome of 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: Headache
Clinical narrative: headache; This is a spontaneous report from a Pfizer sponsored program. This consumer reported for an Unknown female patient that : A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: Unknown), via unspecified route of administration on 11Aug2021 as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 11Aug2021 the patient experienced headache. The caller stated that patient had headache right now because patient got the first dose today as well of Pfizer BioNTech COVID-19 Vaccine and also the caller queried regarding if patient can take a Tylenol for the headache and also if, patient will able to use or take Benadryl because patient had like mosquito bite and got before the vaccine. So, patient want to use Benadryl soap for that mosquito bite as well. Reporter stated, "Yes, Tylenol extra strength (Captured as Tylenol) and Benadryl." Reporter was informed about the role of Pfizer Drug Safety and Pfizer Medical Information. Reporter stated that she got an answer on whether she can get patient medication for itching and for headache. The outcome of the event was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Vaccination site pain
Clinical narrative: little soreness at the injection site/slight pain at injection site; they have vials set already prepared to administered was like a walking setting and they had a couple they are ready to go; This is a spontaneous report from a contactable consumer (patient). A 51-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, solution for injection, Batch/Lot Number: FC3180) intramuscular, administered in right arm on 11Aug2021 (at the age of 51-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The medical his-tory included hypothyroidism. The concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for hypothyroidism. On 11Aug2021, probably later in the evening the patient had a little soreness at the injection site. Patient reported slight pain at injection site. The patient reported that "I got my vaccine yesterday I know they had vials set already prepared to administered was like a walking setting and they had a couple they were ready to go, So I didn't know if there was something to make you guys aware of or not." Patient did not received any treatment of event. The outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected. Batch/lot number available for BNT162B2.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Injection site  area is swollen; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received BNT162B2 (formulation: Solution for injection, Lot Number: EW0165, Expiration Date: 31Aug2021), via an unspecified route of administration on 10Aug2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. The patient experienced injection site area is swollen (vaccination site swelling) on 10Aug2021. The reporter stated that their husband had the shot (Further clarified as COVID 19 Vaccine) on the 10th (Further clarification unknown) and he was just showing that Injection site area is swollen.  The clinical outcome of the event was unknown.  Reporter was unwilling to share further information. Hence further probing could not be done. Limited information available over the call.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Myalgia, Vaccination site pain
Clinical narrative: Muscle soreness; Pain injection site; I think it is my lymph node but they are like swollen and it keep popping over my collar bone and it is kind of like popping out of my chest and popping back in; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, solution for injection, Batch/Lot Number: EWO187), via an unspecified route of administration on 31Jul2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient reported that "I got my vaccine the first dose of the Pfizer vaccine back on 31Jul2021 and after that first and second day everything was cool. I just had the typical muscle soreness and pain at the injection site but recently within the last two days on my left side of my collar bone area, feel like my lymph. I think it was my lymph's node but they were like swollen and it keep popping over my collar bone and it was kind of like popping out of my chest and popping back in and I see there were some of side effects were swollen lymph node and I am just like super freaking out because I already did one to get the vaccine and now this was making me feel like not to take the second shot, just because I had multiple vaccines in my whole entire life and I never had lymph node problem. I was just calling because I was wondering is this like a typical problem that you guys get with like lymph nodes." The outcome of the events were unknown.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dysphonia, Gastrooesophageal reflux disease, Hypoaesthesia, Malaise, Paraesthesia
Clinical narrative: I think it's interfering with my acid reflux sometimes. I have some acid reflux; My voice is sort of hoarse; I threw up; Hand going numb, that affects the tingling but that's better and it was in my elbow; Hand going numb, that affects the tingling but that's better and it was in my elbow; Not feeling good; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: FC3180), via an unspecified route of administration on 12Aug2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer stated, I got the shot, the first shot yesterday, the Pfizer vaccine, on Aug2021, I think it was interfering with my acid reflux sometimes. I have some acid reflux and my voice is sort of hoarse and I threw up at 5:30 and I don't feel like I am going to 'throw my gut out' but I am not feeling so 'hot' today and I had a problem with my hand going numb, that affects the tingling but that's better and it was in my elbow but I think that it's nothing with my acid reflux. I am just not feeling good. So, I want to make sure that it was okay to take some acid reflux (Unspecified Medication) and some ibuprofen. Consumer further stated, If I could take acid reflux, My voice is off. I think it is because of the throwing up and acid reflex, I think that shot (COVID-19 Vaccine) is affecting my acid reflux. I think that's my problem. I don't know if you have that issue but I think that's what going on. The outcome of the events was reported as unknown.
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: I think it's interfering with my acid reflux sometimes. I have some acid reflux; My voice is sort of hoarse; I threw up; Hand going numb, that affects the tingling but that's better and it was in my elbow; Hand going numb, that affects the tingling but that's better and it was in my elbow; Not feeling good; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: FC3180), via an unspecified route of administration on 12Aug2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer stated, I got the shot, the first shot yesterday, the Pfizer vaccine, on Aug2021, I think it was interfering with my acid reflux sometimes. I have some acid reflux and my voice is sort of hoarse and I threw up at 5:30 and I don't feel like I am going to 'throw my gut out' but I am not feeling so 'hot' today and I had a problem with my hand going numb, that affects the tingling but that's better and it was in my elbow but I think that it's nothing with my acid reflux. I am just not feeling good. So, I want to make sure that it was okay to take some acid reflux (Unspecified Medication) and some ibuprofen. Consumer further stated, If I could take acid reflux, My voice is off. I think it is because of the throwing up and acid reflex, I think that shot (COVID-19 Vaccine) is affecting my acid reflux. I think that's my problem. I don't know if you have that issue but I think that's what going on. The outcome of the events was reported as unknown.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Tired; headache like behind my eyes, it was really strange, behind my eyes and it was a headache, very achy; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. The patient previously took BNT162B2 on unspecified date dose 1 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In 2021, the patient stated, "I just wanted to report, so I had really got very tired after that vaccine the second one that I had and I also had that was really strange of that I had a headache like behind my eyes, it was really strange, behind my eyes and it was a headache, very achy, yeah." The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: had it like 3 or 4 days rapid heart beat; rapid heart beat; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FA7485; Expiration Date: 31Oct2021) via an unspecified route of administration, administered in arm right on 06Aug2021 17:00 (at the age of 59-year-old) at dose 1, single for covid-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. On 06Aug2021 the patient experienced had it like 3 or 4 days rapid heart beat; rapid heart beat. Concern: Reporter stated, I wanted to be found out that, I have been reporting. I've been reporting everyday about my side effects (further not clarified) but is the rapid heart beat suppose to be one of the side effect. I want them to document, report it, rapid heart beat, I had my 1st shot. Well, I had it like 3 or 4 days rapid heart beat. When probed for date of administration, reporter stated, 06Aug2021, I have started heart rate. When probed for expiration date, reporter stated, 31Oct2021, 30th. Anatomical location: Reporter stated, On my right arm, my right upper arm. Medications and Medical conditions: Reporter stated, No. Time of the vaccine: Reporter stated, About 5 o' clock in the afternoon, 5pm at withheld. Route of administration: Reporter stated, No When probed if received any other vaccine: Reporter stated, No, haven't had any vaccine. The patient underwent lab tests and procedures which included heart rate: rapid on 06Aug2021.Patient did not receive treatment for the adverse event. Outcome of the event was resolved on an unspecified date in Aug2021.  Follow-Up (27Aug2021): Follow-up attempts are completed. No further information is expected.