chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypoaesthesia, Limb injury, Pain in extremity, Vaccination site pruritus
Clinical narrative: red ring around injection site; itchiness around injection site; headache; arm numb; arm pain; covid toe; This is a spontaneous report from a contactable consumer (patient) reported in response to non-HCP letter via follow-up letter. A 60-years-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EW0172) via an intramuscularly administered in arm right (upper) on 30Apr2021 (at the age of 60-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: ER8729) via an intramuscular route of administration in left arm (upper) on 09Apr2021 at 11:30 AM (at the age of 60-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included bacterial infection from an unknown date and unknown if ongoing (prescribed with metronidazole, today she stopped taking it) and lymph nodes surgery under her left arm in 2004. Concomitant medication included metronidazole taken for bacterial infection. On 30Apr2021 at 12:30, the patient had covid toe, arm pain on 30Apr2021 at 20:00, arm numb on 01May2021 at 06:00. On 02May2021 at 06:00, the patient experienced red ring around injection site, itchiness around injection site and headache. Therapeutic measures were taken as a result of arm pain, arm numb treatment taken as Ibuprofen, red ring around injection site, itchiness around injection site, headache treatment taken as hydrocortisone cream. The outcome of events covid toe was recovered on Apr2021, arm pain and arm numb recovered on 04May2021, red ring around injection site, itchiness around injection site, headache were recovered on 10May2021.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site reaction
Clinical narrative: red ring around injection site; itchiness around injection site; headache; arm numb; arm pain; covid toe; This is a spontaneous report from a contactable consumer (patient) reported in response to non-HCP letter via follow-up letter. A 60-years-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EW0172) via an intramuscularly administered in arm right (upper) on 30Apr2021 (at the age of 60-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: ER8729) via an intramuscular route of administration in left arm (upper) on 09Apr2021 at 11:30 AM (at the age of 60-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included bacterial infection from an unknown date and unknown if ongoing (prescribed with metronidazole, today she stopped taking it) and lymph nodes surgery under her left arm in 2004. Concomitant medication included metronidazole taken for bacterial infection. On 30Apr2021 at 12:30, the patient had covid toe, arm pain on 30Apr2021 at 20:00, arm numb on 01May2021 at 06:00. On 02May2021 at 06:00, the patient experienced red ring around injection site, itchiness around injection site and headache. Therapeutic measures were taken as a result of arm pain, arm numb treatment taken as Ibuprofen, red ring around injection site, itchiness around injection site, headache treatment taken as hydrocortisone cream. The outcome of events covid toe was recovered on Apr2021, arm pain and arm numb recovered on 04May2021, red ring around injection site, itchiness around injection site, headache were recovered on 10May2021.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Hypoaesthesia, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: red ring around injection site; itchiness around injection site; headache; arm numb; arm pain; covid toe; This is a spontaneous report from a contactable consumer (patient) reported in response to non-HCP letter via follow-up letter. A 60-years-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EW0172) via an intramuscularly administered in arm right (upper) on 30Apr2021 (at the age of 60-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: ER8729) via an intramuscular route of administration in left arm (upper) on 09Apr2021 at 11:30 AM (at the age of 60-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included bacterial infection from an unknown date and unknown if ongoing (prescribed with metronidazole, today she stopped taking it) and lymph nodes surgery under her left arm in 2004. Concomitant medication included metronidazole taken for bacterial infection. On 30Apr2021 at 12:30, the patient had covid toe, arm pain on 30Apr2021 at 20:00, arm numb on 01May2021 at 06:00. On 02May2021 at 06:00, the patient experienced red ring around injection site, itchiness around injection site and headache. Therapeutic measures were taken as a result of arm pain, arm numb treatment taken as Ibuprofen, red ring around injection site, itchiness around injection site, headache treatment taken as hydrocortisone cream. The outcome of events covid toe was recovered on Apr2021, arm pain and arm numb recovered on 04May2021, red ring around injection site, itchiness around injection site, headache were recovered on 10May2021.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site rash
Clinical narrative: red ring around injection site; itchiness around injection site; headache; arm numb; arm pain; covid toe; This is a spontaneous report from a contactable consumer (patient) reported in response to non-HCP letter via follow-up letter. A 60-years-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EW0172) via an intramuscularly administered in arm right (upper) on 30Apr2021 (at the age of 60-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: ER8729) via an intramuscular route of administration in left arm (upper) on 09Apr2021 at 11:30 AM (at the age of 60-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included bacterial infection from an unknown date and unknown if ongoing (prescribed with metronidazole, today she stopped taking it) and lymph nodes surgery under her left arm in 2004. Concomitant medication included metronidazole taken for bacterial infection. On 30Apr2021 at 12:30, the patient had covid toe, arm pain on 30Apr2021 at 20:00, arm numb on 01May2021 at 06:00. On 02May2021 at 06:00, the patient experienced red ring around injection site, itchiness around injection site and headache. Therapeutic measures were taken as a result of arm pain, arm numb treatment taken as Ibuprofen, red ring around injection site, itchiness around injection site, headache treatment taken as hydrocortisone cream. The outcome of events covid toe was recovered on Apr2021, arm pain and arm numb recovered on 04May2021, red ring around injection site, itchiness around injection site, headache were recovered on 10May2021.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chest discomfort, Headache, Neck pain
Clinical narrative: headache; neckache; chest discomfort; BP was still elvated; elavated my Creatine Kinase CK Level; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 69-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 25Feb2021 09:30 (Batch/Lot Number: EN6198, Expiry date was not reported) (at the age of 69-years-old) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient did not have covid prior to vaccination and covid was not tested post vaccination. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 28Jan2021 09:30 (Batch/Lot Number: EN5318, Expiry date was not reported) covid-19 immunisation and experienced headache, sneezing and nosebleed. On an unspecified date, the patient experienced headache, neckache, chest discomfort, bp was still elevated and elevated my creatine kinase (ck) level (on 28Jan2021 09:45). Laboratory tests on an unspecified date included blood pressure measurement: 170/83 and blood creatinine was elevated. It was reported that 20 mins after shot felt diff and headache started, neck, my left shoulder and arm. At home she took 650mg of Tylenol, 2:15pm a 15 min sneezing fit, stopped up nosebleed, Head and neck became worse and foggy in judgement. 10pm laughing and crying fit for over 60 mins until I fell asleep. nose Headache continued for 25 days 24/7 Pain levels 6 & 7. 2 headache and feeling different, neckache, shoulder arm, backache, chest discomfort less than 15 mins they took my BP at 10am 170/83 they had me take 650 Tylenol I had the Bp would not come down was sent to urgent care the pain as much worse and BP was still elevated. Was sent home to rest and drink lots of H2O. The BP came down by night. The headache continued for 17 days 24/7 and the pain continued and still going 2 mos 2 days It elevated my Creatine Kinase CK Level, had a reaction too Gabapentin to help with pain it stops working at level 6 and that's where we are until the enzyme level come down it as at a level 9 and no narcotics were given. The clinical outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Tenderness
Clinical narrative: supraclavicular lymphadenopathy; tenderness; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613, patient was not pregnant at the time of vaccination), via an unspecified route of administration in the right arm on 12Apr2021 at 16:00 (at the age of 50-year-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications were reported as none. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153), via an unspecified route of administration in the left arm on 22Mar2021 at 07:45 (at the age of 50-year-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Apr2021 at 17:00, the patient experienced supraclavicular lymphadenopathy and tenderness on right side and after noticing tenderness on neck right below right ear/jaw area, the patient was unsure if it started prior to this date or not. The adverse events supraclavicular lymphadenopathy and tenderness resulted in doctor visit. Therapeutic measures were taken as a result of supraclavicular lymphadenopathy and tenderness. The clinical outcome of the events supraclavicular lymphadenopathy and tenderness was not resolved.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported: per DOB and event onset date, update age as 51, Historical Vaccine age is updated, vaccine facility information captured, Concomitant medications were not reported" update to "Concomitant medications were reported as none", 1st dose vaccine location was Left arm, captured wrongly in narrative, updated
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tongue discomfort
Clinical narrative: Burning tongue; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration in the left arm on 09Mar2021 at 14:15 (at the age of 40-year-old) as a dose 1, single for COVID-19 immunisation. Medical history was reported as none. Concomitant medications included cefalexin monohydrate (LEXIPRO) and mitragyna speciosa (KRATOM), both used for an unknown indication from an unspecified date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 17:00, the patient experienced burning tongue. On 28Apr2021, the patient underwent nasal swab test and the result was negative. The patient did not receive any treatment for the event. The clinical outcome of the event burning tongue was not resolved.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Vaccination facility name/address/City/State and phone number added, Concomitant medications "LEXIPRON" was recoded via WHO drug dictionary and Treatment received ticked as No.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Erythema, Feeling hot, Headache, Peripheral swelling
Clinical narrative: Fever; Chills; Headache; My arm has redness, it has swelling and it is very hot; My arm has redness, it has swelling and it is very hot; My arm has redness, it has swelling and it is very hot; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced fever, chills, headache, my arm has redness, it has swelling and it is very hot. Additional Context: Consumer stated, I am calling because I received my second dose of the Covid vaccine on Friday at 3:00 and today, I am having a lot of side effects. On Friday, I got fever, I got chills and headache. On Saturday and Sunday and today was Monday, my arm has redness, it has swelling and it is very hot and I am having a headache. Consumer further stated, is there another person I can talk to, I don't understand you. I will call again. And hung up abruptly. Limited information was available over the call as consumer hung up abruptly. Hence, product details (LOT, expiration date, NDC, UPC), purchase details and other details were unknown. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; Chills; Headache; My arm has redness, it has swelling and it is very hot; My arm has redness, it has swelling and it is very hot; My arm has redness, it has swelling and it is very hot; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced fever, chills, headache, my arm has redness, it has swelling and it is very hot. Additional Context: Consumer stated, I am calling because I received my second dose of the Covid vaccine on Friday at 3:00 and today, I am having a lot of side effects. On Friday, I got fever, I got chills and headache. On Saturday and Sunday and today was Monday, my arm has redness, it has swelling and it is very hot and I am having a headache. Consumer further stated, is there another person I can talk to, I don't understand you. I will call again. And hung up abruptly. Limited information was available over the call as consumer hung up abruptly. Hence, product details (LOT, expiration date, NDC, UPC), purchase details and other details were unknown. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Urticaria
Clinical narrative: He got the Vaccine he had 102 Fever; then after the fever he broke out in hives; He got the Vaccine he had 102 Fever; then after the fever he broke out in hives; This is a spontaneous report from a contactable consumer (patient's wife). A 58-years-old male patient received bnt162b2 (BNT162B2, solution for injection) dose 1 via an unspecified route of administration, administered in left deltoid (left shoulder) on 06Apr2021 (Batch/Lot Number: unknown) as DOSE 1, SINGLE (age at vaccination was 58 years) for covid-19 immunisation.  Medical history included covid-19 from 01Mar2021 to an unknown date. The patient's concomitant medications were not reported.  When probed for if COVID happened after the first Pfizer shot, reporter stated that they had COVID before it. She had COVID on 27Feb2021 and her husband (patient) had on 01Mar2021. But by 16Mar2021 they both were better. Patient had fever when he had COVID. It was like a low grade fever. When the patient got the Vaccine he had 102 Fever (pyrexia), it faded but then after the fever he broke out in hives (urticaria). The reporter was just wondering does the patient need to take something before getting the Vaccine tomorrow the second Vaccine. It was reported that the patient did not take any treatment for the fever. The outcome of both the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Fatigue, Influenza like illness, Myalgia
Clinical narrative: Temperature was 101.9 then at 6AM it was 102; Muscle aches; She was hurting everywhere/ Body aches; She feels drained; She had a cough, she has a cough normally any way because she smokes but this was worse than normal.; felt like the flu; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 59-year-old female patient received second dose of BNT162B2 (COMIRNATY, solution for injection, Lot number: EW0171), via an unspecified route of administration, in Arm Left on 24Apr2021 at 11:00 (age at the vaccination 59-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine includes first dose of COVID vaccine (COMIRNATY, solution for injection, Lot number: ER8737) as DOSE 1, SINGLE on 03Apr2021 for covid-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient says she had on Saturday she got her second shot of the vaccine for COVID. Patient says before Saturday, on Thursday and Friday she had a cough, she has a cough normally any way because she smokes but this was worse than normal on an unspecified date in 2021. She got the second dose Saturday and then Saturday evening she felt drained on 24Apr2021 and Sunday morning at about 5AM she woke up, and she needs to preface this by saying her normal temperature is 96.7 which is a couple degrees lower than other people normal, so Sunday morning she woke up at 5AM and she was hurting everywhere on 25Apr2021 and felt like the flu on an unspecified date in 2021, Patient had muscle aches, every piece of her body hurt and her temperature was 101.9 then at 6AM it was 102 on 25Apr2021 and during the day she some Tylenol and some other things to lower her temperature and she took some Aleve for body aches. Patient temperature went down to 99.4 and now today it was 98.6 which is a normal temp for everyone but is not back down to her normal. She thinks what she would like to know is, is it possible that she could have gotten the virus before she took the second dose of the vaccine or are these just side effects to the second shot. The outcome of the events fever and muscle pain was recovering and unknown for other events.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Temperature was 101.9 then at 6AM it was 102; Muscle aches; She was hurting everywhere/ Body aches; She feels drained; She had a cough, she has a cough normally any way because she smokes but this was worse than normal.; felt like the flu; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 59-year-old female patient received second dose of BNT162B2 (COMIRNATY, solution for injection, Lot number: EW0171), via an unspecified route of administration, in Arm Left on 24Apr2021 at 11:00 (age at the vaccination 59-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine includes first dose of COVID vaccine (COMIRNATY, solution for injection, Lot number: ER8737) as DOSE 1, SINGLE on 03Apr2021 for covid-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient says she had on Saturday she got her second shot of the vaccine for COVID. Patient says before Saturday, on Thursday and Friday she had a cough, she has a cough normally any way because she smokes but this was worse than normal on an unspecified date in 2021. She got the second dose Saturday and then Saturday evening she felt drained on 24Apr2021 and Sunday morning at about 5AM she woke up, and she needs to preface this by saying her normal temperature is 96.7 which is a couple degrees lower than other people normal, so Sunday morning she woke up at 5AM and she was hurting everywhere on 25Apr2021 and felt like the flu on an unspecified date in 2021, Patient had muscle aches, every piece of her body hurt and her temperature was 101.9 then at 6AM it was 102 on 25Apr2021 and during the day she some Tylenol and some other things to lower her temperature and she took some Aleve for body aches. Patient temperature went down to 99.4 and now today it was 98.6 which is a normal temp for everyone but is not back down to her normal. She thinks what she would like to know is, is it possible that she could have gotten the virus before she took the second dose of the vaccine or are these just side effects to the second shot. The outcome of the events fever and muscle pain was recovering and unknown for other events.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Insomnia, Movement disorder, Pain
Clinical narrative: I had 102.5 fever; I had 102.5 fever, chills I couldn't get up; pulsating feeling in my hands and my feet; hard time falling sleep; painful pulsation pins and needles kind of feeing; feel like I'm stepping on needles; I couldn't get up I had to lay down, pretty much the entire afternoon on; This is a spontaneous report from a contactable consumer (Patient) reported for herself. A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161; Expiration Date: 31Jul2021), dose 2 via an unspecified route of administration, administered in Arm Left on 23Apr2021 (at the age of 50-years-old) as a single dose for covid-19 immunization. The patient's medical history were not reported. Concomitant medications was reported as no medications, the only she had taken was Ibuprofen after but nothing, she was not on any medication. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734; Expiration Date: 31Jul2021), dose 1 via an unspecified route of administration on 02Apr2021 (at the age of 50-years-old) as a single dose for covid-19 immunization. On 24Apr2021, the patient had 102.5 fever, chills, she couldn't get up had to lay down, pretty much the entire afternoon on, what happen the fever went away, and the chills and everything went away but "what I am experiencing that hasn't gone away is I'm experiencing like a pulsating feeling in my hands and my feet and at night like last night I had a really hard time falling sleep cause its like a painful pulsation pins and needles kind of feeing and then even when I got up this morning even just walking I was, Oh my gosh! I feel like I'm stepping on needles almost, so I looked on side effects and I didn't see this and a side effect but I'm hoping that it go away." The patient did not receive any treatment. Outcome of the event was unknown, at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: I had 102.5 fever; I had 102.5 fever, chills I couldn't get up; pulsating feeling in my hands and my feet; hard time falling sleep; painful pulsation pins and needles kind of feeing; feel like I'm stepping on needles; I couldn't get up I had to lay down, pretty much the entire afternoon on; This is a spontaneous report from a contactable consumer (Patient) reported for herself. A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161; Expiration Date: 31Jul2021), dose 2 via an unspecified route of administration, administered in Arm Left on 23Apr2021 (at the age of 50-years-old) as a single dose for covid-19 immunization. The patient's medical history were not reported. Concomitant medications was reported as no medications, the only she had taken was Ibuprofen after but nothing, she was not on any medication. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734; Expiration Date: 31Jul2021), dose 1 via an unspecified route of administration on 02Apr2021 (at the age of 50-years-old) as a single dose for covid-19 immunization. On 24Apr2021, the patient had 102.5 fever, chills, she couldn't get up had to lay down, pretty much the entire afternoon on, what happen the fever went away, and the chills and everything went away but "what I am experiencing that hasn't gone away is I'm experiencing like a pulsating feeling in my hands and my feet and at night like last night I had a really hard time falling sleep cause its like a painful pulsation pins and needles kind of feeing and then even when I got up this morning even just walking I was, Oh my gosh! I feel like I'm stepping on needles almost, so I looked on side effects and I didn't see this and a side effect but I'm hoping that it go away." The patient did not receive any treatment. Outcome of the event was unknown, at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Muscular weakness, Nausea, Presyncope
Clinical narrative: near collapse in parking lot; extreme sweating all over like I fell in swimming pool; Extreme headache; extreme nausea; weakness in legs; This is a spontaneous report from a non-contactable consumer (the patient).      A elderly female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 08Apr2021 12:00 (Batch/Lot Number: ER8727) as single dose, for covid-19 immunisation  .  Medical history included cardiomegaly, mitral valve disease,  glucose tolerance impaired , milk , egg, gluten and soy allergy  , allergy to sunflowers,  smoke sensitivity.     The patient's concomitant medications were not reported.  The patient previously took ether and , codeine and experienced drug hypersensitivity. On 18Mar2021 the patientreceived the first dose  bnt162b2 for covid-19 immunisation.  The patient experienced near collapse in parking lot  (non-serious) on 19Apr2021 01:00 with outcome of recovered , extreme sweating all over like i fell in swimming pool  (non-serious) on 19Apr2021 01:00 with outcome of recovered , extreme headache  (non-serious) on 19Apr2021 01:00 with outcome of recovered , extreme nausea  (non-serious) on 19Apr2021 01:00 with outcome of recovered , weakness in legs  (non-serious) on 19Apr2021 01:00 with outcome of recovered.   The patient was not pregnant at the time of the vaccine. The patient felt going to die because of the event.  No follow-up attempts are Possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Raynaud's phenomenon
Clinical narrative: Raynauds syndrome left hand only; This is a spontaneous report from a contactable physician. A 45-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via intramuscular route of administration in the left arm on 28Apr2021 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient had no known allergies. On 30Apr2021, 2 days after injection, the patient experienced Raynaud's syndrome in left hand only where she never had this before. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event Raynaud's syndrome in left hand was recovered on an unknown date in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on both arms, wrists and hands.; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0172) via an unspecified route of administration in the left arm on 30Apr2021 at 14:15 as a single dose for COVID-19 immunisation. Medical history included unspecified allergies. Concomitant medications included loratadine (CLARITIN) and vitamin D (MANUFACTURER UNKNOWN). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8729) via an unspecified route of administration in the left arm on 09Apr2021 at 14:15 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02May2021 at 14:30, the patient experienced rash on both arms, wrists and hands. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event rash on both arms, wrists and hands was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Swollen tongue, Throat tightness
Clinical narrative: feeling of throat closure; difficulty swallowing; tongue swelling; This is a spontaneous report from a contactable consumer. This consumer (parent) reported for a 16-Year-old non pregnant female patient received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number EW0179), dose 1 via an unspecified route of administration, administered in Arm Right on 28Apr2021 18:45 as DOSE 1, SINGLE for covid-19 immunisation (Age at vaccination 16 years). Medical history and concomitant medications were not reported. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. No covid tested post vaccination. No known allergies. No other medical history. On 28Apr2021 19:00 (within 10 min of vaccination) patient experienced feeling of throat closure, difficulty swallowing, tongue swelling. Therapeutic measures were taken as a result of feeling of throat closure (throat tightness), difficulty swallowing (dysphagia), tongue swelling (swollen tongue). Feeling of throat closure and difficulty swallowing beginning <10 minutes after receiving the vaccine. She was evaluated by medical personnel at the vaccination side and the symptoms seemed to resolve without treatment within 30 minutes (Benadryl was offered but declined at that time). However, after returning home a short time later, she experienced tongue swelling, feeling of throat closure, and difficulty swallowing. She took 50 mg of Benadryl. Symptoms continued in a remitting/recurring pattern for the next 2 hours. Did not seek emergency treatment because she did not have difficulty breathing. Approximately 2.5 hours after receiving the vaccine, symptoms were definitely lessening, and she went to sleep. The next morning on awakening she had mild residual tongue swelling, which completely resolved by mid-morning. The outcome for all events was recovered in an unspecified date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Pain in extremity
Clinical narrative: Pain on my legs is constant; Pain on the breast comes and goes; This is a spontaneous report from a non-contactable healthcare professional. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0158) via an unspecified route of administration in the left arm on 09Apr2021 at 09:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. The patient did not receive any concomitant medication. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm, on unknown date in 2021, as a single dose for COVID-19 immunisation. On 14Apr2021 the patient experienced pain on the breast (pain on the breast comes and goes) and pain on her legs (pain on her legs was constant). No therapeutic measures were taken as a result of reported events. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pain on the breast and pain on her legs was not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Fatigue, Mobility decreased, Pain, Pain in extremity
Clinical narrative: pain in arm; swelling and pain under left arm; Fever; pain in her body; Tiredness; body was shaking; swelling under arm, I could not lift it; vaccination site pain; vaccination site swelling; This is a spontaneous report from a contactable consumer (Patient). A 52-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 28Apr2021 15:15 (Batch/Lot Number: ER8736; Expiration Date: Jul2021) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included lack of iron and left knee problem. They did MRIs. It was reported that she will be going for surgery on her left knee. The pain was much less now, she had been doing physical therapy for the same. Concomitant medication included FERROUS SULFATE taken for iron deficiency, ATORVASTATIN taken for blood cholesterol increased, B12 VITAMIN, VITAMIN D3, and CALCIUM. The patient experienced vaccination site pain, vaccination site swelling on 28Apr2021. She had pain after the shot about 2 hours after and swelling. She said that it increased more and affected her more until now. She said she took the vaccine and didn't feel much, then it was gradually increasing 1-2 hours after getting the vaccine. On 29Apr2021 she experienced fever, pain in her body, tiredness, body was shaking, swelling under arm, could not lift it. It was reported that after she slept because she felt tired and then woke up. Her body was shaking around 03:00PM, she took two Advil, she thinks they were 250mg or 300mg. On 30Apr2021 she experienced swelling and pain under left arm. On an unspecified date she experienced pain in arm. The outcome of fever was recovered on unspecified date. The outcome of pain in her body, vaccination site pain, vaccination site swelling, swelling and pain under left arm, Tiredness, body was shaking, swelling under arm, I could not lift it, and pain in arm was unknown. The patient underwent lab tests and procedures which included blood test which showed normal results in 2021. Therapeutic measures were taken as a result of fever.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Tremor, Vaccination site pain, Vaccination site swelling
Clinical narrative: pain in arm; swelling and pain under left arm; Fever; pain in her body; Tiredness; body was shaking; swelling under arm, I could not lift it; vaccination site pain; vaccination site swelling; This is a spontaneous report from a contactable consumer (Patient). A 52-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 28Apr2021 15:15 (Batch/Lot Number: ER8736; Expiration Date: Jul2021) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included lack of iron and left knee problem. They did MRIs. It was reported that she will be going for surgery on her left knee. The pain was much less now, she had been doing physical therapy for the same. Concomitant medication included FERROUS SULFATE taken for iron deficiency, ATORVASTATIN taken for blood cholesterol increased, B12 VITAMIN, VITAMIN D3, and CALCIUM. The patient experienced vaccination site pain, vaccination site swelling on 28Apr2021. She had pain after the shot about 2 hours after and swelling. She said that it increased more and affected her more until now. She said she took the vaccine and didn't feel much, then it was gradually increasing 1-2 hours after getting the vaccine. On 29Apr2021 she experienced fever, pain in her body, tiredness, body was shaking, swelling under arm, could not lift it. It was reported that after she slept because she felt tired and then woke up. Her body was shaking around 03:00PM, she took two Advil, she thinks they were 250mg or 300mg. On 30Apr2021 she experienced swelling and pain under left arm. On an unspecified date she experienced pain in arm. The outcome of fever was recovered on unspecified date. The outcome of pain in her body, vaccination site pain, vaccination site swelling, swelling and pain under left arm, Tiredness, body was shaking, swelling under arm, I could not lift it, and pain in arm was unknown. The patient underwent lab tests and procedures which included blood test which showed normal results in 2021. Therapeutic measures were taken as a result of fever.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Dizziness
Clinical narrative: Left side Chest pain and light headed with low back pain x4 weeks now; Left side Chest pain and light headed with low back pain x4 weeks now; Left side Chest pain and light headed with low back pain x4 weeks now; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 39-year-old non-pregnant female 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 06Apr2021 13:15 (Batch/Lot number was not reported) as dose 1, single (age at vaccination 39-year-old) for covid-19 immunisation. Medical history included none from an unknown date. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No known allergies. No other medication in two weeks. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced left side chest pain and lightheaded with low back pain x4 weeks now on 07Apr2021. Therapeutic measures were taken as a result of events included Prednisone and muscle relaxer. The outcome for all events was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Gait disturbance, Hypoaesthesia, Paraesthesia, Peripheral coldness
Clinical narrative: Entire body became numb/Her legs are numb and tingly when shes walking, and her arms.; Fingertips and toes are ice cold/ her fingers are ice cold; Having a hard time moving her legs/ it feels like she is walking through water or sand on the beach; Her entire body went numb and tingly, all extremities; Shes moving in slow motion; Shes a little stressed; This is a spontaneous report from a contactable consumer (patient) via Medical Information team. A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0175) dose 1 via an unspecified route of administration in left arm on 03May2021 at 09:00 (at the age of 36-year-old) as single dose for COVID-19 immunisation. Medical history was none. Concomitant medications included ongoing multivitamin gummy to have vitamins. No prior vaccinations within 4 weeks. No events following prior vaccinations. She received the first dose this morning at 9 am on 03May2021. She waited at the vaccination site for 15 minutes and she felt fine. About 20 minutes after as she walked to her car her entire body became numb and her fingertips and toes were ice cold and she was having a hard time moving her legs. It felt like she was walking through water or sand on the beach. This has persisted since leaving the vaccination site. She would also like to know if she should receive the second dose due to her reaction. She does not have a doctor or health insurance so she feels like she is being left alone to deal with her reaction. She was trying to follow directions in getting vaccinated. She was calling to make sure some side effects are normal. About 15 minutes ago, her entire body went numb and tingly, all her extremities. It was like she was moving in slow motion, little stressed, she needs to make sure its normal or if she needs to go to the doctor. Her legs were numb and tingly when she was walking, and her arms. Her fingers are ice cold. All of her symptoms are on-going and persisting. She would like to know if she should go to a doctor for her reaction the Pfizer COVID vaccine. A visit to emergency room or physician office was not required. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Stress
Clinical narrative: Entire body became numb/Her legs are numb and tingly when shes walking, and her arms.; Fingertips and toes are ice cold/ her fingers are ice cold; Having a hard time moving her legs/ it feels like she is walking through water or sand on the beach; Her entire body went numb and tingly, all extremities; Shes moving in slow motion; Shes a little stressed; This is a spontaneous report from a contactable consumer (patient) via Medical Information team. A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0175) dose 1 via an unspecified route of administration in left arm on 03May2021 at 09:00 (at the age of 36-year-old) as single dose for COVID-19 immunisation. Medical history was none. Concomitant medications included ongoing multivitamin gummy to have vitamins. No prior vaccinations within 4 weeks. No events following prior vaccinations. She received the first dose this morning at 9 am on 03May2021. She waited at the vaccination site for 15 minutes and she felt fine. About 20 minutes after as she walked to her car her entire body became numb and her fingertips and toes were ice cold and she was having a hard time moving her legs. It felt like she was walking through water or sand on the beach. This has persisted since leaving the vaccination site. She would also like to know if she should receive the second dose due to her reaction. She does not have a doctor or health insurance so she feels like she is being left alone to deal with her reaction. She was trying to follow directions in getting vaccinated. She was calling to make sure some side effects are normal. About 15 minutes ago, her entire body went numb and tingly, all her extremities. It was like she was moving in slow motion, little stressed, she needs to make sure its normal or if she needs to go to the doctor. Her legs were numb and tingly when she was walking, and her arms. Her fingers are ice cold. All of her symptoms are on-going and persisting. She would like to know if she should go to a doctor for her reaction the Pfizer COVID vaccine. A visit to emergency room or physician office was not required. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Caller has fever; This is a spontaneous report received from a Pfizer Sponsored Program from a contactable consumer (patient herself).  A female patient of an unspecified age received 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 DOSE 1, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. It was reported that the caller has appointment for today it is their 2nd dose it is scheduled for late evening. Caller has fever in the last seven days (unspecified date in Apr2021) that lasted 2 days hasn't had fever after. Caller wanted to know if it was safe to have 2nd vaccine. Read ISI. Faxed AE due to fever after 1st vaccine. The outcome of the event was recovered on an unknown date in 2021 (duration: 2 days).  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever of 102.3 F; This is a spontaneous report from a Pfizer sponsored program by a contactable consumer. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via unknown route of administration on 28Apr2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 Immunization. The patient had fever of 102.3 F on 29Apr2021. The outcome of event was unknown.  No Follow-up attempts are needed. Information about lot/batch number cannot be obtained.