chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: very big rash on our back; fever; Numbness on the left side the numbness comes and goes its not consistent/left arm where I feeling the numbness; hives; palpitation; rapid heartbeat; This is a spontaneous report from a contactable consumer. This 50-year-old female consumer (patient) reported for herself.  A 50-year-old female patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, after the vaccination patient experienced all this fever and all that from the beginning of the first dose but now what he just breaks into hives, the patient experienced very big rash on back and then on his left side of face. Patient was asking a question can it be normal a little bit like his cheek area underneath his eye can it be become normal its normal a little numb just a little bit. rash has started about a week ago. some weeks a day. The patient wants to be treated because the numbness on the left side comes and goes it's not consistent, but he is feeling a little bit of it especially later underneath of his eye and cheeks. consumer has rash and numbness on the face, consumer stated, "Right on my left side of my face and that she gave me shot on the left side and I can feel it today, underneath my eyes and cheeks and I have the rash, but she does" Patient also have palpitations, rapid heartbeat. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain
Clinical narrative: Pulsing, small pulsing pain under below my left breast and it comes in and it comes in at intermittent intervals; It is like for a minute or half, sometimes every five seconds; This is a spontaneous report from a contactable consumer (patient) reported for herself that a 72-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, batch/lot number: unknown, expiry date: 31Oct2021), via an unknown route of administration on 06Aug2021 (at the age of 75-years-old) as single dose for COVID-19 immunization. The patient's medical history included thyroid from an unknown date to unknown if ongoing. Concomitant medication included thyroid (ARMOUR THYROID) taken for an unknown indication from an unknown date to unknown if ongoing. On an unknown date in Aug2021, the patient experienced pulsing, small pulsing pain under below her left breast and it comes in and it comes in at intermittent intervals; It was like for a minute or half, sometimes every five seconds. Consumer stated, she thought it might be having a reaction, adverse reaction to the shot she got yesterday but she did not know, and wonder if anybody else have had a strange reaction like this. Consumer stated, this was weird, and she have never had anything like this before so that's why she thought that it must be caused by the vaccine, but she meant that was long time to wait, she might, maybe she should call the pharmacist who could see if they had anybody else that have these types of symptoms. 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: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysmenorrhoea, Heavy menstrual bleeding, Menstrual disorder, Muscle spasms
Clinical narrative: Very abnormally heavy menstrual bleeding with abnormally high amounts of clotting and menstrual cycle is happening more frequently. I was always very "regular"/ on time and releasing this much blood; Very abnormally heavy menstrual bleeding with abnormally high amounts of clotting and menstrual cycle is happening more frequently. I was always very "regular"/ on time and releasing this much blood; Very abnormally heavy menstrual bleeding with abnormally high amounts of clotting and menstrual cycle is happening more frequently. I was always very "regular"/ on time and releasing this much blood; Very abnormally heavy menstrual bleeding with abnormally high amounts of clotting and menstrual cycle is happening more frequently. I was always very "regular"/ on time and releasing this much blood; Dizzy; This is a spontaneous report from a contactable consumer (patient).   A 47-years-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EW0198) administered in left arm via an unknown route of administration (at the age of 47 years old) on 14Jul2021 at 16:00 pm as dose 2, single for covid-19 immunisation.  The patient medical history was not reported. There were no concomitant medications. There was no covid prior vaccination and covid tested post vaccination. There was no other vaccine in four weeks and other medication in two weeks. The patient previously received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number: EW0180) administered in left arm via an unknown route of administration on 17Jun2021 at 04:30 am as dose 1, single for covid-19 immunisation and experienced no adverse event. The patient had no known allergies to meds or foods. The patient was very healthy otherwise. On 15Jul2021 at 07:00, the patient experienced very abnormally heavy menstrual bleeding with abnormally high amounts of clotting and menstrual cycle is happening more frequently. i was always very regular on time and releasing this much blood and dizzy. It was reported that the patient had very abnormally heavy menstrual bleeding with abnormally high amounts of clotting and menstrual cycle is happening more frequently. The patient was always very regular / on time and releasing this much blood was very abnormal to me. The patient was also crapping more between periods. During previous cycle which came immediately after the second shot, the patient was bleeding so much that she was dizzy. The patient was making an appointment with my OBGYN to discuss. No treatment was received for the event. The outcome of the events was reported as not recovered. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Lip oedema, Nodule, Type IV hypersensitivity reaction
Clinical narrative: Delayed hypersensitivity reaction; huge nodules; severe edema to lips; This is a spontaneous report from a contactable other healthcare professional. A female patient of an unspecified age received BNT162B2 (COVID-19 Vaccine - Manufacturer Unknown, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as a dose 2, single for COVID-19 immunization and the patient received HYALURONIC ACID, LIDOCAINE HYDROCHLORIDE (RESTYLANE DEFYNE), via an unspecified route of administration on an unspecified date as a dose unknown. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (COVID-19 Vaccine - Manufacturer Unknown, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunization. It was reported that, on an unspecified date in 2021, the patient experienced delayed hypersensitivity reaction. Stated that, the patient had 2nd COVID-19 vaccine (unspecified), 4 days after having the Restylane Dewne fillers and 2 months later she developed severe hypersensitivity reaction to the Defyne as well as huge nodules and severe edema to lips. The outcome of the events was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: She broke out and got shingles. They did she did say it was in her eye but they lucky enough, they caught in time; I broke out on shingles and symptoms started before that; This is a spontaneous report from a contact female consumer (patient herself) via Pfizer-sponsored program. A 57-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EW0186, expiry date: unknown) via unspecified route of administration, in right arm on 28Jun2021 (age at vaccination: 57-years) as dose 2, single for covid-19 immunisation. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EW0180, expiry date: unknown) via unspecified route of administration, in left arm on 30May2021 (age at vaccination: 57-years) as dose 1, single for covid-19 immunisation. Vaccine facility type was pharmacy. Medical history of patient was not reported. Concomitant medications included levothyroxine, taken for unspecified indication, start and stop date not reported. Caller said she was normally a very heathy person but she got the second dose of the Pfizer covid-19 vaccine and a few days later she broke out and got shingles. They did she did say it was in her eye but they lucky enough, they caught in time and she just called us because she wanted to report this. She said lot of you know people need to be reporting the side effects so we know what is going on so that is the reason she called and she did know that she was being recorded in your department. Consumer stated, she received the Pfizer vaccine and within a month to the day after that I broke out on shingles and symptoms started before that but like she said was just curious that it was within a month that she had shingles and she have never had shingles and was always the healthiest person in the family. Treatment was taken in response to adverse events was with Valacyclovir, as traditional 10 days supply for shingles. Prior vaccination within 4 weeks of getting the Pfizer vaccine patient did not take any other vaccine. The outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Blood pressure measurement, Blood test, Blood test abnormal, Condition aggravated
Clinical narrative: Blood levels increased; blood sugar levels have increased; blood sugar levels have increased; This is a spontaneous report from contactable male consumer (patient) reported for himself. A male patient of unspecified age received first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection, Batch/lot number: Not Provided, Expiry date: Not Provided), via an unspecified route on 09Aug2021 as a single dose for covid-19 immunization. Medical history included patient is diabetic and had his leg amputated in Mar. He was in wheelchair because he had his leg amputated about 5 months ago, before receiving the Covid 19 vaccine. Concomitant medications included blood pressure pills, Losartan Potassium for the heart, Metoprolol and acetylsalicylic acid (ASPIRIN EC). Maybe because last week, since Friday, until yesterday he did not take the Metoprolol. He mentioned that the pharmacy ran out of pills. On an unknown date in Aug2021, after taking first dose patient experienced blood levels increased and blood sugar levels have increased a little bit, yesterday. Patient was asking if this is a side effect with the vaccine. The patient underwent lab test and procedure which included blood pressure measurement: unknown, blood level increased in Aug2021. The clinical outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Diplopia, Eye irritation, Eye pain, Feeling abnormal, Lacrimation increased
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp. A 56-years-old female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: FA7485), dose 1 via an unspecified route of administration, administered in Arm Left on 03Aug2021 10:00(age at vaccination: 56 Years) as DOSE 1, SINGLE for covid-19 immunisation. Patient didn't received other vaccines within 4 weeks prior to vaccination. Medical history included familial Mediterranean fever from an unknown date and unknown if ongoing, inflammation from an unknown date and unknown if ongoing. Concomitant medications included cortisone (CORTISONE) taken for an unspecified indication, start and stop date were not reported; ibuprofen (IBUPROFEN) taken for inflammation, start and stop date were not reported. The patient experienced injection site pain on Aug2021, feeling something like a mild tingling in her left eye about an hour after vaccination on Aug2021, eye was watering, burning, tearing, and she was experiencing pain and double vision on Aug2021, eye was watering, burning, tearing, and she was experiencing pain and double vision on 03Aug2021, blurriness on Aug2021, she has still felt "poking" on Aug2021 with outcome of not recovered. Therapeutic measures were taken as a result of eye was watering, burning, tearing, and she was experiencing pain and double vision, eye was watering, burning, tearing, and she was experiencing pain and double vision, blurriness. The outcome of the events vaccination site pain, lacrimation increased, eye irritation, diplopia, vision blurred, feeling abnormal was recovered, the outcome of the event feeling abnormal, eye pain was not recovered, the outcome of the event paraesthesia was unknown. No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Vaccination site pain, Vision blurred
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp. A 56-years-old female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: FA7485), dose 1 via an unspecified route of administration, administered in Arm Left on 03Aug2021 10:00(age at vaccination: 56 Years) as DOSE 1, SINGLE for covid-19 immunisation. Patient didn't received other vaccines within 4 weeks prior to vaccination. Medical history included familial Mediterranean fever from an unknown date and unknown if ongoing, inflammation from an unknown date and unknown if ongoing. Concomitant medications included cortisone (CORTISONE) taken for an unspecified indication, start and stop date were not reported; ibuprofen (IBUPROFEN) taken for inflammation, start and stop date were not reported. The patient experienced injection site pain on Aug2021, feeling something like a mild tingling in her left eye about an hour after vaccination on Aug2021, eye was watering, burning, tearing, and she was experiencing pain and double vision on Aug2021, eye was watering, burning, tearing, and she was experiencing pain and double vision on 03Aug2021, blurriness on Aug2021, she has still felt "poking" on Aug2021 with outcome of not recovered. Therapeutic measures were taken as a result of eye was watering, burning, tearing, and she was experiencing pain and double vision, eye was watering, burning, tearing, and she was experiencing pain and double vision, blurriness. The outcome of the events vaccination site pain, lacrimation increased, eye irritation, diplopia, vision blurred, feeling abnormal was recovered, the outcome of the event feeling abnormal, eye pain was not recovered, the outcome of the event paraesthesia was unknown. No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: DNA test for fragile X, Serum ferritin, Serum ferritin increased
Clinical narrative: it made my Ferritin Jump from 53 to 324 so I'm in Iron overload again; This is a spontaneous report from a contactable other hcp (Patient). A 54-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8737), dose 2 via an unspecified route of administration, administered in Arm Right on 18May2021 at 11:00 (age at vaccination: 54 years) as dose 2, single for covid-19 immunisation.  Patient had known allergies of Methotrexate, Naproxen, Azithromycin. other medical history included Hemochromatosis, Ehlers Danlos Syndrome. Concomitant medications included hydrocodone bitartrate, paracetamol (NORCO) 7.5/325; cefixime (FLEXERIL [CEFIXIME) 10mg; levothyroxine sodium (SYNTHROID) 50mg. Patient received dose 1 of BNT162B2 on 27Apr2021 at 09:00 in right arm with lot number ER8732. The patient reported it made her ferritin jump from 53 to 324 so she was in iron overload again (serum ferritin increased) on an unspecified date. Adverse event resulted in clinic visit. No treatment was received for the event. Patient did not have COVID prior vaccination. Since the vaccination the patient was not tested for COVID-19. Patient did not test COVID post vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. Patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient underwent lab tests and procedures which included dna test for fragile x: c282y on 2018 same 2 C282Y genes in Iron overload for 13years, serum ferritin: 53 on, Ferritin went from 1500 to 53, serum ferritin: ferritin jump from 53 to 324 on an unknown date. It was reported that the first Pfizer shot she had a very stiff neck on the side of the shot, Right side, second shot she did fine. The problem was she have Hemochromatosis classic she had a DNA test in 2018 to confirm, same 2 C282Y genes in Iron overload for 13years. After bleeds for 2 years her Ferritin went from 1500 to 53. She was at 53 at the time of her Pfizer vaccines, and it made her Ferritin Jump from 53 to 324 so she was in Iron overload again. Advised to wait 8 more weeks to see if it goes down, if not she will have to to have another unit taken out to get Ferritin down again. The outcome of the event was not recovered.  Device Date was 10Aug2021.  Follow-Up (18Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Body temperature, Eye pain, Feeling abnormal, Headache
Clinical narrative: Terrible migraine; Eye ball pain; Woke up with the sweats; Vomiting; Blurry; Rash; Sensitivity with teeth; Headache; Fever, high as 101 for about three days; Muscle soreness/Muscle pain; Nauseous; Still in a fog.; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, solution for injection), via an unspecified route of administration, administered in the left arm on 09Aug2021 at 11:00 (at the age of 49-years-old) (Lot Number: FA7484) as dose 1, single for COVID-19 immunisation. Medical history included blood pressure high, had COVID on 22Jun2020 to an unknown date, and ongoing migraine. Concomitant medications included olmesartan (strength: 20 mg) taken for hypertension from an unspecified start date and ongoing and hydrochlorothiazide (strength: 12.5 mg) taken for hypertension from an unspecified start date and ongoing. On 09Aug2021, the patient experienced headache, muscle soreness/muscle pain, fever, and sensitivity with teeth (reported event onset time was at 11:00). It was reported that the patient used kinesiology tape regarding her muscle soreness/muscle pain. On 10Aug2021, the patient had a terrible migraine, was having eyeball pain, woke up with the sweats, vomiting, had blurry feeling, and rash. On an unspecified date, the patient experienced nauseous and still in a fog. Events were treated with Tylenol Extra Strength. The patient underwent lab tests and procedures which included antibody test: 500+ on an unspecified date in Aug2021 and body temperature: 101 on 09Aug2021. It was as high as 101 for about three days. The outcome of the events migraine, fever, muscle soreness/muscle pain, sensitivity with teeth, nauseous, blurry, headache, and still in a fog were not recovered/not resolved. Outcome of the event sweating was unknown. The outcome of the event eyeball pain was recovered on 12Aug2021, outcome of the event vomiting was recovered on an unspecified date in Aug2021 and outcome of the event rash was recovered/resolved on 11Aug2021.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperaesthesia teeth, Hyperhidrosis, Migraine, Myalgia, Nausea
Clinical narrative: Terrible migraine; Eye ball pain; Woke up with the sweats; Vomiting; Blurry; Rash; Sensitivity with teeth; Headache; Fever, high as 101 for about three days; Muscle soreness/Muscle pain; Nauseous; Still in a fog.; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, solution for injection), via an unspecified route of administration, administered in the left arm on 09Aug2021 at 11:00 (at the age of 49-years-old) (Lot Number: FA7484) as dose 1, single for COVID-19 immunisation. Medical history included blood pressure high, had COVID on 22Jun2020 to an unknown date, and ongoing migraine. Concomitant medications included olmesartan (strength: 20 mg) taken for hypertension from an unspecified start date and ongoing and hydrochlorothiazide (strength: 12.5 mg) taken for hypertension from an unspecified start date and ongoing. On 09Aug2021, the patient experienced headache, muscle soreness/muscle pain, fever, and sensitivity with teeth (reported event onset time was at 11:00). It was reported that the patient used kinesiology tape regarding her muscle soreness/muscle pain. On 10Aug2021, the patient had a terrible migraine, was having eyeball pain, woke up with the sweats, vomiting, had blurry feeling, and rash. On an unspecified date, the patient experienced nauseous and still in a fog. Events were treated with Tylenol Extra Strength. The patient underwent lab tests and procedures which included antibody test: 500+ on an unspecified date in Aug2021 and body temperature: 101 on 09Aug2021. It was as high as 101 for about three days. The outcome of the events migraine, fever, muscle soreness/muscle pain, sensitivity with teeth, nauseous, blurry, headache, and still in a fog were not recovered/not resolved. Outcome of the event sweating was unknown. The outcome of the event eyeball pain was recovered on 12Aug2021, outcome of the event vomiting was recovered on an unspecified date in Aug2021 and outcome of the event rash was recovered/resolved on 11Aug2021.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Vision blurred, Vomiting
Clinical narrative: Terrible migraine; Eye ball pain; Woke up with the sweats; Vomiting; Blurry; Rash; Sensitivity with teeth; Headache; Fever, high as 101 for about three days; Muscle soreness/Muscle pain; Nauseous; Still in a fog.; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, solution for injection), via an unspecified route of administration, administered in the left arm on 09Aug2021 at 11:00 (at the age of 49-years-old) (Lot Number: FA7484) as dose 1, single for COVID-19 immunisation. Medical history included blood pressure high, had COVID on 22Jun2020 to an unknown date, and ongoing migraine. Concomitant medications included olmesartan (strength: 20 mg) taken for hypertension from an unspecified start date and ongoing and hydrochlorothiazide (strength: 12.5 mg) taken for hypertension from an unspecified start date and ongoing. On 09Aug2021, the patient experienced headache, muscle soreness/muscle pain, fever, and sensitivity with teeth (reported event onset time was at 11:00). It was reported that the patient used kinesiology tape regarding her muscle soreness/muscle pain. On 10Aug2021, the patient had a terrible migraine, was having eyeball pain, woke up with the sweats, vomiting, had blurry feeling, and rash. On an unspecified date, the patient experienced nauseous and still in a fog. Events were treated with Tylenol Extra Strength. The patient underwent lab tests and procedures which included antibody test: 500+ on an unspecified date in Aug2021 and body temperature: 101 on 09Aug2021. It was as high as 101 for about three days. The outcome of the events migraine, fever, muscle soreness/muscle pain, sensitivity with teeth, nauseous, blurry, headache, and still in a fog were not recovered/not resolved. Outcome of the event sweating was unknown. The outcome of the event eyeball pain was recovered on 12Aug2021, outcome of the event vomiting was recovered on an unspecified date in Aug2021 and outcome of the event rash was recovered/resolved on 11Aug2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Has some diarrhea on day before she had the second shot; This is a spontaneous report from a contactable consumer(parent) reported for a female patient (daughter). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Reporter stated the patient (daughter) last night (incomplete sentence), she found out later that patient had some diarrhea on day before she had the second shot of the Pfizer Vaccine on 30Jun2021. So, they don't think it's anything with the vaccine but talked to our pediatrician to report that up and she gave us the number to call. Upon follow up, consumer also stated that the case got serious and required antibiotics. About LOT#: Reporter stated, "Yeah it was a, two different numbers I guess it looks like 'P'W0179 (Not appropriately clarified, hence not captured in tab) and EW01 looks like 177 for the second dose." The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Drug ineffective, Headache, Pain
Clinical narrative: took Norco; cold and allergy medication; nothing take the headache away; Joint pain/in my hips I am like waking up in the middle of the night crying for some reasons cause my hips hurt so bad; severe headache that will not go away; head will not stop throbbing; I am in so much pain; hips hurt; This is a spontaneous report from a contactable consumer or other non hcp. A contactable patient (consumer) of unspecified age and gender received bnt162b2 (BNT162B2, formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date (age at the time of vaccination was not provided) as DOSE 1, SINGLE for covid-19 immunisation and hydrocodone bitartrate, paracetamol (NORCO), route of administration, start and stop date, batch/lot number and dose were not reported for headache and pain and other Unspecified suspect medications. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the vaccine on Tuesday on an unspecified date and had severe joint pain and a severe headache on an unspecified date that would not go away, the asked what can be taken. The patient mentioned, took Norco, for pain (the pain medication) and headache on an unspecified date. The patient took unspecified cold and allergy medication (Further clarification unknown hence captured as unspecified medications) but nothing took the patient's headache away but in the hips, the patient was like waking up in the middle of the night crying for some reasons cause the hips hurt so bad all on an unspecified date. The patient had Joint pain. The patient mentioned, never experienced anything like this. The patient asked, what can be done, was in so much pain and the head would not stop throbbing on an unspecified date. The action taken in response to the events for hydrocodone bitartrate, paracetamol (NORCO) was unknown. The outcome of the event took NORCO; cold and allergy medication; nothing took the headache away (drug ineffective) was unknown, while for all other it was not recovered. Reason for no lot number: of Covid-19 Vaccine, Norco and Other Unspecified suspect medications: Complainant hung up abruptly/transfer incomplete.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dry mouth, Headache, Oropharyngeal pain, Pain
Clinical narrative: Headache/Head will not stop pounding; Dry mouth; Sore throat; Whole entire body is hurting; Should not be hurting that bad; Body is hurting me through every joint on my body; Body is hurting me through every joint on my body; I can't stop 'shaking'; No matter how much water I drink I cannot get, I am thirsty; Throat is starting to swell, it is sore; This is a spontaneous report from two non-contactable consumers (patient included). A female patient of an unspecified age received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, solution for injection; Lot number: SC3181; Expiration date was not reported), via an unspecified route of administration on an unspecified date in 2021 as dose 1, single for COVID-19 immunization at a clinic. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the first COVID vaccine this morning and reported that she was having side effects. The reporters were not sure if it was Pfizer COVID 19 Vaccine. On an unspecified date in 2021, the patient experienced headache, dry mouth, sore throat, everything through, her whole entire body was hurting and she can't stop 'shaking', should not be hurting that bad, no matter how much water she drink she cannot get, she was thirsty, her throat was starting to swell, it was sore, her body was hurting her through every joint on her body, her head will not stop pounding. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Thirst, Tremor
Clinical narrative: Headache/Head will not stop pounding; Dry mouth; Sore throat; Whole entire body is hurting; Should not be hurting that bad; Body is hurting me through every joint on my body; Body is hurting me through every joint on my body; I can't stop 'shaking'; No matter how much water I drink I cannot get, I am thirsty; Throat is starting to swell, it is sore; This is a spontaneous report from two non-contactable consumers (patient included). A female patient of an unspecified age received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, solution for injection; Lot number: SC3181; Expiration date was not reported), via an unspecified route of administration on an unspecified date in 2021 as dose 1, single for COVID-19 immunization at a clinic. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the first COVID vaccine this morning and reported that she was having side effects. The reporters were not sure if it was Pfizer COVID 19 Vaccine. On an unspecified date in 2021, the patient experienced headache, dry mouth, sore throat, everything through, her whole entire body was hurting and she can't stop 'shaking', should not be hurting that bad, no matter how much water she drink she cannot get, she was thirsty, her throat was starting to swell, it was sore, her body was hurting her through every joint on her body, her head will not stop pounding. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis
Clinical narrative: Cold, a nose congestion; Cold, a nose congestion; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient herself) reported that a female patient of an unspecified age received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Solution for injection), via an unspecified route of administration on 24Jul2021 (Batch/Lot number and Expiration date were unknown) as dose 1, single for COVID-19 immunization. Relevant medical history indicated that the patient already had the Covid prior (previous of) getting vaccinated on an unknown date. The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient experienced cold, a nose congestion. The patient wanted to know if she could get the second dose. It was further reported that the patient was supposed to get the second dose (unclear) on next week, but just wanted to make sure that, because she had to go and she didn't have fever or anything; she felt good. She was pretty good and didn't have like nausea or anything like that, but just wanted to make sure that she could still go even if she had it long before. The outcome of the events "cold, a nose congestion" was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chest pain, Dizziness, Infection, Inflammation
Clinical narrative: Severe chest pain; Abdominal pain; inflammatory infection; Inflammatory infection; Nausea; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: FA6780), via an unspecified route of administration, administrated in Left arm on 23Jul2021 16:00 (age at the time of vaccination 29-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 23Jul2021 18:00, the patient experienced Severe chest pain, abdominal pain, inflammatory infection, nausea, and dizziness. The adverse event result in doctor or other healthcare professional office/clinic visit. Treatment received was unknown. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome for all the events was recovering.  Follow-Up (26Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Severe chest pain; Abdominal pain; inflammatory infection; Inflammatory infection; Nausea; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: FA6780), via an unspecified route of administration, administrated in Left arm on 23Jul2021 16:00 (age at the time of vaccination 29-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 23Jul2021 18:00, the patient experienced Severe chest pain, abdominal pain, inflammatory infection, nausea, and dizziness. The adverse event result in doctor or other healthcare professional office/clinic visit. Treatment received was unknown. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome for all the events was recovering.  Follow-Up (26Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles appeared on left side midline back to midline front; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 41-year-old 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 13Jul2021 10:45 (Batch/Lot Number: EW0198) as dose 1, single (age at vaccination 41-year-old) for covid-19 immunisation. Medical history included hypertension and herpes zoster from an unknown date and unknown if ongoing (I have been diagnosed with Zoster Herpes in the past. Took Valacyclovir 1 Gram for 7 days - blisters and pain subsided), Known allergies: Statins from an unknown date and unknown if ongoing, COVID prior vaccination: Yes from an unknown date and unknown if ongoing. Concomitant medication(s) included metoprolol (METOPROLOL); zolpidem (ZOLPIDEM); diazepam (DIAZEPAM); estradiol (ESTRADIOL) taken for an unspecified indication, start and stop date were not reported. The patient previously took valacyclovir [valaciclovir] for pain and blister. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. The patient experienced shingles appeared on left side midline back to midline front on 21Jul2021 02:00. Therapeutic measures were taken as a result of event. It was reported shingles - received 1st dose on 13Jul2021 on 21Jul2021 shingles appeared on left side midline back to midline front. Patient have been diagnosed with Zoster Herpes in the past. Took Valacyclovir 1 Gram for 7 days - blisters and pain subsided. The patient second vaccine on 03Aug2021. The outcome for event was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Taste disorder
Clinical narrative: medicine taste in her mouth; weakness; This is a spontaneous report from a contactable nurse (patient herself). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EL9266, Expiration date: Unknown) via an unspecified route of administration, administered in Deltoid Right on 05Mar2021 at 10:00 (56-year-old at vaccination) as Dose 2, Single for Covid-19 immunization. The patient's medical history included Epilepsy from 35 years-old of her age, RSD (reflex sympathetic dystrophy) since having surgery in 2009 and can't take injections in her left arm, Addison's disease from 2019, Hashimoto's disease from 2019. The patient had a lot of medications and would prefer not to provide over the phone. The patient had no adverse event prior to vaccination. The patient had not received any other vaccine 4 weeks prior to covid vaccination. The patient stated that all her family had a vaccination and had no problems. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN5318) via an unspecified route, administered in Deltoid Right on 12Feb2021 at 10:00 (56-year-old at vaccination) as Dose 1, Single for Covid-19 immunization. After receiving the first dose she had no symptoms but after the second dose she did had a medicine taste in her mouth and then had weakness for about three weeks because of her Addison's, but did not have any pain, no fever no chills, just weakness. She could tell her body was fighting. Relevant test was reported as none. No investigation assessment was reported. She stated that she visited emergency room but was not under any treatment. The outcome of the events medicine taste in her mouth, weakness was recovered on an unknown date in 2021.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Off label use, Urinary tract infection
Clinical narrative: he takes while he gets the booster; he takes while he gets the booster; had a urinary tract infection; This is a spontaneous report from a contactable consumer or other non hcp. A 74-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included tofacitinib citrate (XELJANZ XR) (11mg). On an unspecified date, the patient experienced "he takes while he gets the booster (off label use), (extra dose administered), had a urinary tract infection. The patient reported about the booster for the Pfizer vaccine and in talking he said something about injections and had a urinary tract infection and he does not know if he needs to stop the medication Xeljanz XR 11mg that he takes while he gets the booster. The patient verified the information provided by the transferring agent and stated he is a little taken aback and thought he was going to get an answer to his questions and declined to complete the report. Outcome of the event urinary tract infection was unknown.   Information about lot/batch number has been requested.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Electrocardiogram, Joint swelling, Nausea, Pain in extremity
Clinical narrative: his throat felt like it was going to close; nauseous; Legs Aching; ankle swelling; sore arm/experienced leg aching like he has never felt before; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 41-year-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: FA6780), via an unspecified route of administration in deltoid right on 25Jul2021 at 17:30 (at the age of 41-years-old) as dose 1, single for COVID-19 immunisation. The medical history of the patient was reported as none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. The AE(s) following prior vaccinations and Family Medical History Relevant to AE(s) were reported as none. On 25Jul2021, the patient experienced sore arm/experienced leg aching like he has never felt before, on 26Jul2021, the patient experienced ankle swelling and patient experienced his throat felt like it was going to close, nauseous, legs aching on an unspecified date. The patient reported after first dose of Pfizer covid vaccine 25Jul2021 in which he experienced a sore arm, ankle swelling after 4-5 days he experienced leg aching like he has never felt before, his throat felt like it was going to close. He went to the emergency department and they found nothing wrong with him. He wanted to know if these are common side effects after the first dose and if it is safe for him to receive the second dose of Pfizer covid vaccine. He stated he had an EKG and all kinds of stuff, and blood work for blood clotting. He doesn't know if he should take the second one. He clarified that his legs still ache a little bit, but it could be his allergies or from his lower back now, but it wasn't from his lower back that week. His right arm was sore after the vaccine that day and was recovered by the next day. The patient underwent lab tests and procedures which included blood test: unknown results, electrocardiogram: unknown results, weight: 157-158lbs all on unspecified date. Therapeutic measures were taken as a result of events that included taking Ibuprofen and Tylenol. The patient recovered from the nauseous and his throat felt like it was going to close on an unspecified date, recovered from sore arm/experienced leg aching like he has never felt before on 26Jul2021, recovered from joint swelling on 27Jul2021, the outcome of the event legs aching was reported as resolving.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Throat tightness, Weight
Clinical narrative: his throat felt like it was going to close; nauseous; Legs Aching; ankle swelling; sore arm/experienced leg aching like he has never felt before; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 41-year-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: FA6780), via an unspecified route of administration in deltoid right on 25Jul2021 at 17:30 (at the age of 41-years-old) as dose 1, single for COVID-19 immunisation. The medical history of the patient was reported as none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. The AE(s) following prior vaccinations and Family Medical History Relevant to AE(s) were reported as none. On 25Jul2021, the patient experienced sore arm/experienced leg aching like he has never felt before, on 26Jul2021, the patient experienced ankle swelling and patient experienced his throat felt like it was going to close, nauseous, legs aching on an unspecified date. The patient reported after first dose of Pfizer covid vaccine 25Jul2021 in which he experienced a sore arm, ankle swelling after 4-5 days he experienced leg aching like he has never felt before, his throat felt like it was going to close. He went to the emergency department and they found nothing wrong with him. He wanted to know if these are common side effects after the first dose and if it is safe for him to receive the second dose of Pfizer covid vaccine. He stated he had an EKG and all kinds of stuff, and blood work for blood clotting. He doesn't know if he should take the second one. He clarified that his legs still ache a little bit, but it could be his allergies or from his lower back now, but it wasn't from his lower back that week. His right arm was sore after the vaccine that day and was recovered by the next day. The patient underwent lab tests and procedures which included blood test: unknown results, electrocardiogram: unknown results, weight: 157-158lbs all on unspecified date. Therapeutic measures were taken as a result of events that included taking Ibuprofen and Tylenol. The patient recovered from the nauseous and his throat felt like it was going to close on an unspecified date, recovered from sore arm/experienced leg aching like he has never felt before on 26Jul2021, recovered from joint swelling on 27Jul2021, the outcome of the event legs aching was reported as resolving.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Headache, Nausea, Pain in extremity
Clinical narrative: Chills; Headache; Nausea; Arm pain; Felt some burning; Subtherapeutic response; 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 an unspecified date, as single dose (Batch/Lot number was not reported) for covid-19 immunisation. The patient also received salicylic acid (GOLD BOND ULTIMATE MULTI SYMPTOM PSORIASIS RELIEF)(Lot Number: 218107) from an unknown date, via an unspecified route of administration at three times per day for an unspecified indication. Medical history included vertigo and the patient had an injury on her back and could only move her arms to a certain point, having arthritis on her hand and had surgery as well. The patient's concomitant medications were not reported. The patient shared her experience with the Pfizer vaccine and had really terrible side effects. On an unknown date, the patient experienced non-serious chills, headache and nausea, arm pain, also felt some burning and sub therapeutic response. The patient stated she had the problem all day long. She said she was in pain but she didn't take any pain killers. she also had the Gold bond ultimate firming neck and chest but it only worked on her neck, doesn't help her chest. It was not reported if the patient received a corrective treatment for the events. Action taken with salicylic acid was unknown. The outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.