chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Discomfort, Immunisation, Vaccination site pain
Clinical narrative: Soreness at injection sight (left arm) for approx. 24 hours after injection.; Soreness in arm pit of left arm, feels swollen, but upon examination and touch it is not swollen; just uncomfortable.; Dose number 3; Dose number 3; This is a spontaneous report from a contactable consumer or other non hcp.  A 57-years-old female patient received bnt162b2 (BNT162B2, Solution for injection; Batch/Lot Number: EW0164; Expiry date: Unknown), dose 3 via an unspecified route of administration, administered in Arm Left on 29Sep2021 (Batch/Lot Number: EW0164) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. The patient did not have any allergies. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. Medical history included the first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 09Feb2021 at 12:00 (Batch/Lot Number: EM9809) and second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 02Mar2021 at 9:00 (Batch/Lot Number: EN6202) as SINGLE for covid-19 immunisation. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN) taken for an unspecified indication, start and stop date were not reported. On 30Sep2021, the patient experienced soreness at injection sight (left arm) for approx. 24 hours after injection, soreness in arm pit of left arm, feels swollen, but upon examination and touch it is not swollen, and just uncomfortable. The patient did not receive any treatment. The outcome for the events soreness at injection sight (left arm) for approx. 24 hours after injection, soreness in arm pit of left arm, feels swollen, but upon examination and touch it is not swollen, and just uncomfortable was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Feverish; Clammy; Sweating; Nauseous; Felt a bit like a mild flu case; Mild headache; Received my booster on 16Sep2021; Received my booster on 16Sep2021; This is a spontaneous report from a contactable consumer (patient) reported for himself that: A 74-years-old male patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FC3182) via an unspecified route of administration, administered in Arm Left on 16Sep2021 16:00 (Age at Vaccination 74-years-old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. Medical history included none. Concomitant medication(s) included valproate semisodium (DEPAKOTE) taken for an unspecified indication, start and stop date were not reported; quetiapine fumarate (SEROQUEL) taken for an unspecified indication, start and stop date were not reported; colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication, start and stop date were not reported. Past drug included Known allergies: A drug called Avelox. Patient receive did not any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient did not diagnose with COVID-19. Since the vaccination, patient did not test for COVID-19. Previously patient received first dose of dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Gn5318) via an unspecified route of administration, administered in Arm Left on 07-FEB-2021 02:00 PM (Age at Vaccination 74-years-old) as DOSE 1 SINGLE for covid-19 immunization. Patient received second dose of dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Unknown. Obscured by other product labelling) via an unspecified route of administration, administered in Arm Left on 17-JAN-2021 04:00 PM (Age at Vaccination 74-years-old) as DOSE 2 SINGLE for covid-19 immunization. On 16Sep2021 16:00 the patient experienced felt a bit like a mild flu case and mild headache. On 27Sep2021 the patient experienced feverish, clammy, sweating, nauseous. received my booster off label use), received my booster on 16sep2021 (immunisation) on 16Sep2021. It was reported that I received my booster on 16Sep2021, at a nearby withheld. Felt a bit like a mild flu case for about a day and a half. It is now 02Oct2021 and everyday since the booster I have had a nagging but rather mild headache. On 27Sep2021 I was on a day trip, and I suddenly became very feverish, clammy, sweating, pretty bad headache, and felt nauseous. All of that took place over about a two hour period then it went away. However, as I stated earlier this somewhat mild but nagging headache has happened all day every day since I got my booster shot. Patient was did not received treatment. Device Date: 02Oct2021.The outcome of the events Felt a bit like a mild flu case, Feverish, Clammy, Sweating, Nauseous, was recovered in 2021. Mild headache was not recovered. received my booster on 16Sep2021 was unknown.    Follow-Up (11Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discoloured vomit, Headache, Immunisation
Clinical narrative: vomiting yellow liquid; Severe chills; headache; patient received a third/booster dose; patient received a third/booster dose; This is a spontaneous report from a contactable consumer (patient). A 62-years-old non-pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6204) via an unspecified route of administration, administered in arm right on 01Oct2021 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included cancer from an unknown date and unknown if ongoing. The patient previously received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EF6455) via an unspecified route of administration, administered in arm right on 24Mar2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FC3184) via an unspecified route of administration, administered in arm right on 05Mar2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Unspecified medications the patient received within 2 weeks 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 covid prior vaccination. No covid tested post vaccination. The patient experienced vomiting yellow liquid, severe chills and headache on 01Oct2021 19:00. The patient had third/booster dose (off label use and immunisation) on 01Oct2021. The patient did not receive any treatment for vomiting yellow liquid, severe chills and headache. The outcome of events vomiting yellow liquid, severe chills and headache were reported as recovered in Oct2021.   Follow-up attempts are completed. No further information was expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Arthralgia, Dizziness, Fall
Clinical narrative: nause and wanted to vomit; could not walk; collapsed.; lost taste and smell; lost taste and smell; tired; sore joints; Injection site bruise 2 weeks; freezing cold; dizzy; administration_date=26Aug2021 dose_number=3; administration_date=26Aug2021 dose_number=3; This is a spontaneous report from a contactable consumer (patient). A 70-year-old non pregnant female patient received BNT162b2 (COVID-19 VACCINE; Lot Number: EW0179), via an unspecified route of administration, administered in left arm on 26Aug2021 at 13:30 (at the age of 70 years old) as a DOSE 3 (BOOSTER), SINGLE DOSE for COVID-19 immunisation. Medical history included Multiple myeloma from an unspecified date and unknown if ongoing. The patient has known allergies from an unspecified date and unknown if ongoing. 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 took Zometa infusion, five days after she took the vaccine shot. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received first dose of BNT162b2 (COVID-19 VACCINE; Lot Number: EL9266) on 24Feb2021 at 16:00 in the right arm via an unspecified route of administration for COVID-19 immunisation. The patient received second dose of BNT162b2 (COVID-19 VACCINE; Lot Number: ER8727) on 19Mar2021 at 13:45 in the right arm via an unspecified route of administration for COVID-19 immunisation. On 31 Aug2021 at 14:45 the patient experienced First lost taste and smell, second was tired and had sore joints and Injection site bruise 2 weeks, after third shot the patient experienced tired joints sore, woke freezing cold, dizzy, nausea and wanted to vomit at 03:00. The patient got up but could not walk and collapsed. She was unable to get up. The treatment for the events was unknown reported. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait inability, Immunisation, Nasopharyngitis, Nausea
Clinical narrative: nause and wanted to vomit; could not walk; collapsed.; lost taste and smell; lost taste and smell; tired; sore joints; Injection site bruise 2 weeks; freezing cold; dizzy; administration_date=26Aug2021 dose_number=3; administration_date=26Aug2021 dose_number=3; This is a spontaneous report from a contactable consumer (patient). A 70-year-old non pregnant female patient received BNT162b2 (COVID-19 VACCINE; Lot Number: EW0179), via an unspecified route of administration, administered in left arm on 26Aug2021 at 13:30 (at the age of 70 years old) as a DOSE 3 (BOOSTER), SINGLE DOSE for COVID-19 immunisation. Medical history included Multiple myeloma from an unspecified date and unknown if ongoing. The patient has known allergies from an unspecified date and unknown if ongoing. 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 took Zometa infusion, five days after she took the vaccine shot. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received first dose of BNT162b2 (COVID-19 VACCINE; Lot Number: EL9266) on 24Feb2021 at 16:00 in the right arm via an unspecified route of administration for COVID-19 immunisation. The patient received second dose of BNT162b2 (COVID-19 VACCINE; Lot Number: ER8727) on 19Mar2021 at 13:45 in the right arm via an unspecified route of administration for COVID-19 immunisation. On 31 Aug2021 at 14:45 the patient experienced First lost taste and smell, second was tired and had sore joints and Injection site bruise 2 weeks, after third shot the patient experienced tired joints sore, woke freezing cold, dizzy, nausea and wanted to vomit at 03:00. The patient got up but could not walk and collapsed. She was unable to get up. The treatment for the events was unknown reported. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: nause and wanted to vomit; could not walk; collapsed.; lost taste and smell; lost taste and smell; tired; sore joints; Injection site bruise 2 weeks; freezing cold; dizzy; administration_date=26Aug2021 dose_number=3; administration_date=26Aug2021 dose_number=3; This is a spontaneous report from a contactable consumer (patient). A 70-year-old non pregnant female patient received BNT162b2 (COVID-19 VACCINE; Lot Number: EW0179), via an unspecified route of administration, administered in left arm on 26Aug2021 at 13:30 (at the age of 70 years old) as a DOSE 3 (BOOSTER), SINGLE DOSE for COVID-19 immunisation. Medical history included Multiple myeloma from an unspecified date and unknown if ongoing. The patient has known allergies from an unspecified date and unknown if ongoing. 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 took Zometa infusion, five days after she took the vaccine shot. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received first dose of BNT162b2 (COVID-19 VACCINE; Lot Number: EL9266) on 24Feb2021 at 16:00 in the right arm via an unspecified route of administration for COVID-19 immunisation. The patient received second dose of BNT162b2 (COVID-19 VACCINE; Lot Number: ER8727) on 19Mar2021 at 13:45 in the right arm via an unspecified route of administration for COVID-19 immunisation. On 31 Aug2021 at 14:45 the patient experienced First lost taste and smell, second was tired and had sore joints and Injection site bruise 2 weeks, after third shot the patient experienced tired joints sore, woke freezing cold, dizzy, nausea and wanted to vomit at 03:00. The patient got up but could not walk and collapsed. She was unable to get up. The treatment for the events was unknown reported. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy
Clinical narrative: This is a spontaneous report from a non-contactable consumer (Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: Unknown; Expiration Date: Unknown), via an unspecified route of administration, administered in Arm Left on 30Sep2021, as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included Hashimotos Disease from an unknown date and unknown if ongoing. Concomitant medication(s) included influenza vaccine (FLU) taken for an unspecified indication, start and stop date were not reported received other vaccine in fourweeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: Unknown; Expiration Date: Unknown) on an unspecified date as Dose 1, single and also received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: Unknown; Expiration Date: Unknown) administered in arm right on 24Mar2021 as Dose 2, single for COVID-19 Immunization and dose 2 experienced severe flu like symptoms for two days and headache. No known allergies were reported. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 30Sep2021, booster dose - swelling in lymph node in armpit on same side of shot (immunisation). On 02Oct2021, the patient experienced booster dose - swelling in lymph node in armpit on same side of shot (lymphadenopathy). The patient did not received any treatment for event booster dose - swelling in lymph node in armpit on same side of shot (lymphadenopathy). The clinical outcome of the event not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Episcleritis, Eye inflammation, Eye swelling, Immunisation, Ocular hyperaemia
Clinical narrative: Right eye episcleritis, had to go to the optometrist for diagnosis; Right eye was red; inflamed with a bump; Right eye was red, inflamed with a bump; Dose received: 3; Dose received: 3; This is a spontaneous report from a contactable other healthcare care professional (Patient, reported for herself that).  A 32-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: FC3180), via unspecified route of administration in left arm on 25Sep2021 (at the age of 32-years-old) as a DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The patients medical history and concomitant medications were not reported. Patient had no known allergies. Patient previously received BNT162B2 (COMIRNATY, Batch/Lot Number: EL3249) via unspecified route of administration in arm left on 20Jan2021 as DOSE 2, SINGLE and BNT162B2 (COMIRNATY, Batch/Lot Number: EL0140) on 30Dec2020 as DOSE 1, SINGLE for COVID-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine and had not received any list of any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. On 27Sep2021 patient experienced Right eye episcleritis, had to go to the optometrist for diagnosis. Right eye was red, inflamed with a bump, never had this happen before. she took the vaccine Saturday 25Sep2021 and it occurred a few days later Monday/Tuesday. Its still there, but slowly getting better. Patient had attended Doctor or other healthcare professional office/clinic visit for the events reported. Patient had received Eye exam, retinal imaging, home care instructions for the treatment of events experienced. Events considered as non-serious as per the reporter. Outcome of the events was Recovering and outcome of event Dose received: 3 was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Immunisation
Clinical narrative: minor headache; He got his COVID19 booster yesterday; He got his COVID19 booster yesterday; This is a spontaneous report from a Pfizer sponsored Program reported by contactable Other HCP. A 65-year-old male patient received BNT162b2 (COVID-19 VACCINE; Lot Number: not reported), via an unspecified route of administration on an unspecified date (at the age of 65 years old) as DOSE 3 (BOOSTER), SINGLE DOSE for COVID-19 immunisation. Medical history included Diarrhea from unknown start date and unknown if ongoing and mild dizziness from 28Sep2021 and unknown if ongoing. Concomitant medications were not reported. Historical vaccines included first and second dose of BNT162b2 (COVID-19 VACCINE; Lot Number: unknown), via an unspecified route of administration on an unknown date (at the age of 65 years old) as single dose for COVID-19 immunisation. The patient experienced a minor headache after third dose of BNT162b2 on an unspecified date. The patient received treatment for the events with tylenol. The outcome of the event was considered as resolving.   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Epistaxis, Immunisation
Clinical narrative: Didn't know if it is important or not but 24 hours after my Booster shot (Covid-19 Vaccine); I had a very intense severe and unusual Nose bleed; This is a spontaneous report from a contactable consumer (patient). A 70-year-old patient of an unspecified gender received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and Exp. date: Unknown) on unspecified date as dose 1, single for COVID-19 immunisation and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and Exp. date: Unknown) on unspecified date as dose 2, single for COVID-19 immunisation. The patient experienced didn't know if it is important or not but 24 hours after my booster shot (covid-19 vaccine). I had a very intense severe and unusual nose bleed. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected. Batch/lot number not available for BNT162B2
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Erythema, Immunisation, Musculoskeletal stiffness, Rash
Clinical narrative: developed small blisters and red patches on her chest and her neck; developed small blisters and red patches on her chest and her neck; has about 6 inch rash on the right; her neck feel slightly stiff; there is like a rash on the right side of her neck and last night I noticed there was tiny little blisters like filled with the fluid; some of it itches a little some of it just uncomfortable; Pfizer Coronavirus booster shot on September 26; Pfizer Coronavirus booster shot on September 26; This is a spontaneous report received from a contactable Consumer or other non-health professional. This consumer reported for a female patient (reporter's mother). A 88-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), booster dose on 26Sep2021 (at the age of 88 years old) (Batch/Lot Number: EW0217, Expiry date: Unknown) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. Relevant medical history includes AFib on an unspecified date. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included Eliquis, Metoprolol taken for an unspecified indication, start and stop date were not reported. Historical vaccine includes bnt162b2 (COMIRNATY, Solution for injection) on an unspecified date as dose1 and dose2 for COVID-19 immunization (at the age of 88 years old). On an 01Oct2021, patient experienced small blisters and red patches on her chest and her neck, 6-inch rash on the right, rash on the right side of her neck, tiny little blisters like filled with the fluid, Neck feel slightly stiff, red patch on her chest, quite uncomfortable, some of it itches a little, some of it just uncomfortable, Itchy rash. The patient received treatment for the events small blisters and red patches on her chest and her neck, 6-inch rash on the right, rash on the right side of her neck, tiny little blisters like filled with the fluid, Neck feel slightly stiff, red patch on her chest, quite uncomfortable, some of it itches a little, some of it just uncomfortable, Itchy rash with 1% hydrocortisone cream. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Skin disorder
Clinical narrative: developed small blisters and red patches on her chest and her neck; developed small blisters and red patches on her chest and her neck; has about 6 inch rash on the right; her neck feel slightly stiff; there is like a rash on the right side of her neck and last night I noticed there was tiny little blisters like filled with the fluid; some of it itches a little some of it just uncomfortable; Pfizer Coronavirus booster shot on September 26; Pfizer Coronavirus booster shot on September 26; This is a spontaneous report received from a contactable Consumer or other non-health professional. This consumer reported for a female patient (reporter's mother). A 88-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), booster dose on 26Sep2021 (at the age of 88 years old) (Batch/Lot Number: EW0217, Expiry date: Unknown) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. Relevant medical history includes AFib on an unspecified date. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included Eliquis, Metoprolol taken for an unspecified indication, start and stop date were not reported. Historical vaccine includes bnt162b2 (COMIRNATY, Solution for injection) on an unspecified date as dose1 and dose2 for COVID-19 immunization (at the age of 88 years old). On an 01Oct2021, patient experienced small blisters and red patches on her chest and her neck, 6-inch rash on the right, rash on the right side of her neck, tiny little blisters like filled with the fluid, Neck feel slightly stiff, red patch on her chest, quite uncomfortable, some of it itches a little, some of it just uncomfortable, Itchy rash. The patient received treatment for the events small blisters and red patches on her chest and her neck, 6-inch rash on the right, rash on the right side of her neck, tiny little blisters like filled with the fluid, Neck feel slightly stiff, red patch on her chest, quite uncomfortable, some of it itches a little, some of it just uncomfortable, Itchy rash with 1% hydrocortisone cream. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Immunisation, Off label use
Clinical narrative: I am pregnancy (due date 08Oct2021) and got booster shot last week; got booster shot last week; got booster shot last week; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on Sep2021 as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on Jan2021 as DOSE 1, SINGLE for COVID-19 immunization. Second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on Feb2021 as DOSE 2, SINGLE for COVID-19 immunization. After first and second dose, I am pregnant (due date 08Oct2021) and got my 2 initial COVID doses. On Sep2021 the patient experienced pregnancy (due date 08oct2021) and got booster shot last week, got booster shot last week (off label use), got booster shot last week (immunisation). The mother reported she became pregnant while taking bnt162b2. The mother was due to deliver on 08Oct2021.It was reported that I am pregnant (due date 08Oct2021) and got my 2 initial COVID doses January/February and my booster shot last week. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Muscle spasms, Pain in extremity, Ultrasound scan
Clinical narrative: Muscle Spasm in left thigh; Calf very painful; dose number=3; dose number=3; This is a spontaneous report from a contactable consumer (patient).   A 73-years-old non-pregnant female patient received booster dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FF2588, Expiry date: not reported), via an unspecified route of administration, administered in left arm on 17Sep2021 at 12:00 (Age at vaccination: 73 years old) as dose 3 (booster), single for covid-19 immunization. The patient was not Pregnant at time of Vaccination. Medical history included knee replacement and high blood pressure and Known allergies: penicillin. Concomitant medication(s) included benazepril, escitalopram, potassium and hydrochlorothiazide all taken for an unspecified indication, start and stop date were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL8982, Expiry date: not reported) via an unspecified route of administration, administered in left arm on 01Feb2021 at 12:00 (Age at vaccination: 72 years old) as dose 1, single for covid-19 immunization and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6200, Expiry date: not reported) via an unspecified route of administration, administered in left arm on 23Feb2021 at 01:00 (Age at vaccination: 72 years old) as dose 2, single for covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, patient was not diagnosed with COVID-19 prior to vaccination and patient has not been tested for COVID-19 since the vaccination. Patient took 3rd dose (off label and booster dose) on 17Sep2021 and experienced muscle spasm in left thigh and calf very painful on 18Sep2021 at 07:00 and events resulted in emergency room/department or urgent care. Patient received treatment with shot for pain and muscle relaxer ultrasound. Patient underwent lab tests and procedures which included: ultrasound: unknown result on an unknown date in Sep2021. Hospitalization reported as no. Outcome of events muscle spasm in left thigh and calf very painful was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation
Clinical narrative: she felt very very tired and exhausted; She received the third Pfizer booster shot on Friday 01Oct2021; This is a spontaneous report from a contactable consumer via medical information team. This 90-year-old female consumer (patient) reported.  A 90-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 vaccine, solution for injection, Batch/Lot number was not reported), dose 3 via an unspecified route of administration on 01Oct2021 (90-yerar-old at the time of vaccination) as dose 3 (booster), single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unknown date and patient previously received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unknown date for covid-19 immunisation. On 02Oct2021, the patient she felt very very tired and exhausted. Reporter is a 90 year old, Female, consumer who got the booster dose 01Oct2021. After she got the booster dose she had no relevant reaction to it. However the next day, she felt very tired and exhausted. The Patient reported that she will be having a double root canal tomorrow and is advised to take Amoxicillin an hour before the procedure. The reporter wanted to know if there are any relevant interaction between the booster dose of the COMIRNATY vaccine and that of Amoxicillin (with mainly COMIRNATY affecting the amoxicillin). The patient took Amoxicillin before and she will take it an hour before the dental work. She received the third Pfizer booster shot on Friday 01Oct2021. At first no reaction, then the next day she was really tired and then exhausted. Then the next day she was still tired, but by end of day ok. She is going to have a double root canal tomorrow. She takes Amoxicillin. She is not sure if the booster shot would have any effect on medication she will receive from dentist. The reporter clarified that she has taken Amoxicillin before and she will take it an hour before the dental work. Amoxicillin is ok with other things. 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: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, White blood cell count, White blood cell count increased
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient third dose (booster) of BNT162B2 (COMIRNATY, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date (age at vaccination: 68 years), as dose 3 (booster) single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first and dose of BNT162B2 (COMIRNATY, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date (age at vaccination: 68 years), as dose 1 and dose 2, single dose for COVID-19 immunisation. The patient reported that can the Booster shot increase white blood cell count. He had a booster shot and had taken blood tests the following day on an unspecified date. His white count was 16000. He normally run between 11 and 12000. The patient stated that there was a potential increase in his white blood cell count after getting the booster dose of the Pfizer BioNtech Covid-19 Vaccine and that both of his doctors weren't sure if this was brought about by the vaccine. He was advised by the doctors to see a hematologist. The patient underwent lab test and procedure included white blood cell count was 16000. I normally run between 11 and 12000 on an unspecified date. Outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Nausea, Vaccination site pain
Clinical narrative: Within 12 hours of the shot, I've got a SEVERE headache; nausea; Shot site soreness.; This is a spontaneous report from a contactable consumer via Pfizer-sponsored program  (patient reported for self). This is one of the two reports.  A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 03Oct2021 (age at vaccination not reported) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient had earlier received first dose of BNT162B2 (Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on unspecified date as dose 1, single for Covid-19 Immunization and experienced Severe Headache and Shot site soreness. The patient reported that, the patient just got 2nd vaccine, yesterday afternoon. Within 12 hours of the shot, patient got a severe headache, nausea and shot site soreness, within 12 hours of the shot, patient got a severe headache, nausea and shot site soreness on 03Oct2021. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Rash
Clinical narrative: dose number: 3; dose number: 3; generalized skin rash; This is a spontaneous report from a contactable consumer or other non hcp.  A 80-years-old male patient received booster dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: 301558A, Expiry date: not reported) via an unspecified route of administration, administered in left arm on 29Sep2021 at 09:00 (Age at vaccination: 80 years old) as dose 3 (booster), single for covid-19 immunization. The patient medical history was unknown and concomitant medication included unspecified medication taken in two weeks along with Covid vaccine. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL1283, Expiry date: not reported) via an unspecified route of administration, administered in left arm on 10Jan2021 at 11:00 (Age at vaccination: 80 years old) as dose 1, single for covid-19 immunization and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL8982, Expiry date: not reported) via an unspecified route of administration, administered in left arm on 31Jan2021 at 11:00 (Age at vaccination: 80 years old) as dose 2, single for covid-19 immunization. Patient did not take other vaccine in four weeks, patient was not tested for covid prior vaccination and not tested for Covid post vaccination. On 29Sep2021, patient took 3rd dose (off label and booster) and experienced generalized skin rash at 09:00. Patient received treatment for rash with Prednisone dose pack 5mg. Outcome of event generalized skin rash was recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Immunisation, Off label use
Clinical narrative: She got the booster shot today, without even knowing, her son was diagnosed positive and she was exposed to his like there is no face mask.; She got the booster shot today, without even knowing, her son was diagnosed positive and she was exposed to his like there is no face mask.; She got the booster shot today, without even knowing, her son was diagnosed positive and she was exposed to his like there is no face mask.; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program Pfizer with Regulatory Authority support.  An unspecified age of female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on unspecified date as dose 3 (booster), single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received dose 3 (booster) of bnt162b2 (off label use, immunisation). She got the booster shot today, without even knowing, her son was diagnosed positive, and she was exposed to his like there is no face mask on unspecified date. No PQC present. However, on Sunday, they were with their son who was recently diagnosed with COVID-19 and is symptomatic. Having been exposed this way, we were planning to visit a friend with a weakened condition. She was wondering if she could safely visit her, asking could she be carrying the virus. Caller wanted to know if this matters now that she got the booster. Caller hung up before survey could be offered. Caller said that she had been on hold for an hour already and wouldn't mind holding again. She wanted to know if in case they would not be infected, they would be visiting a person, who was immunocompromised, who was vaccinated as well. She wants to know, and she wanted to ask if there are possibility, they could carry the virus even though the immunocompromised person was already vaccinated. At the time of reporting, the outcome of the events was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Body temperature increased, Chills, Fatigue
Clinical narrative: getting just exhausted feeling; pain in my joints and everything; I start chilling; took my temperature; its a 102.3; this shot made me sick; I had the COVID booster shot yesterday; I had the COVID booster shot yesterday; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration on 03Oct2021 as dose 3 (booster), single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received two doses of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE in Feb2021 for covid-19 immunisation. The patient had the COVID booster shot on 03Oct2021 at the pharmacy and has been fine up until about 2 O'clock this afternoon and started really getting just exhausted feeling, everything and then the patient just had pain in the joints and everything, then when the patient got home and started chilling, the patient just took the temperature probably about 15 minutes ago and it's a 102.3 and he/she didn't what to do. The patient hasn't been sick in and didn't know when but this shot made him/her sick. The patient has already had the two Pfizer shot back, the series, back in Feb2021. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Immunisation
Clinical narrative: getting just exhausted feeling; pain in my joints and everything; I start chilling; took my temperature; its a 102.3; this shot made me sick; I had the COVID booster shot yesterday; I had the COVID booster shot yesterday; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration on 03Oct2021 as dose 3 (booster), single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received two doses of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE in Feb2021 for covid-19 immunisation. The patient had the COVID booster shot on 03Oct2021 at the pharmacy and has been fine up until about 2 O'clock this afternoon and started really getting just exhausted feeling, everything and then the patient just had pain in the joints and everything, then when the patient got home and started chilling, the patient just took the temperature probably about 15 minutes ago and it's a 102.3 and he/she didn't what to do. The patient hasn't been sick in and didn't know when but this shot made him/her sick. The patient has already had the two Pfizer shot back, the series, back in Feb2021. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chills, Immunisation
Clinical narrative: Patient experienced chills the day after shot #3.; increased anxiety the following day; dose number: 3; This is a spontaneous report from a contactable consumer or other non hcp. A elderly male patient received third dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration on 02Oct2021 as dose 3 (booster), single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. The patient previously took first dose and second dose of bnt162b2 (BNT162B2, Solution for injection, Lot No was not reported) on an unspecified date for COVID-19 immunization. On 03Oct2021, the patient experienced chills the day after shot #3 and increased anxiety the following day. It was unknown if the patient was taken treatment for the events. The outcome of the events was recovering.   No Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy
Clinical narrative: This is a spontaneous report from a contactable consumer reported for herself. A 42-year-old female patient (non-pregnant) received third (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot#30145BA), at the age of 42, intramuscularly, in right arm, Oct 4, 2021, at 20:00, single dose, for COVID-19 immunisation. The patient's medical history included ulcerative colitis. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications not reported. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# EL3247), at the age of 42, intramuscularly, in right arm, Feb 22, 2021, at 11:30, single dose; and dose 2, on Mar 15, 2021, at 11:30, for COVID-19 immunisation. On Oct 6, 2021, at 06:00, patient experienced swollen lymph nodes (right-side). No treatment received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient has not tested for COVID-19. At the time of report, the outcome of the event: recovering. Follow-up attempts completed. No further information expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Immunisation, Nausea, Vomiting
Clinical narrative: Nausea; vomiting; headache; joint psin; dose number: 3; dose number: 3; This is a spontaneous report from a contactable consumer or other non-health care professional (patient, reported himself). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number FE3590), via an unspecified route of administration in Left arm on 03Oct2021 12:00 (at the age of 70-year-old)as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. Medical history included Panhypopituitayanism from an unknown date and unknown if ongoing. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number En6201), via an unspecified route of administration in Left arm on 02Feb2021 01:00 PM (at the age of 65-year-old) as DOSE 1, SINGLE and BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number En6208), via an unspecified route of administration in Left arm on unspecified date in Mar2021 12:00 PM (at the age of 65-year-old)as DOSE 2, SINGLE for covid-19 immunization. Patient had not received any other vaccine in four weeks and not received any other medications in two weeks. Patient had no known allergies. Patient not had covid prior vaccination and patient not had undergone covid tested post vaccination. The concomitant medication was not reported. On 04Oct2021, the patient experienced Nausea, vomiting, headache, joint pain. Patient had not received any treatment for the events reported. The outcome of the events was recovering and outcome of event dose number: 3 was unknown.  Follow-up attempts were completed. No further information was expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Injection site pain, Lymphadenopathy, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Pain and lymph node swelling in armpit and upper arm on injection side; Pain and lymph node swelling in armpit and upper arm on injection side; Pain and lymph node swelling in armpit and upper arm on injection side; dose_number=3; dose_number=3; This is a spontaneous report from a  contactable other HCP. This 61-year-old female other HCP reported for herself that: A 61-years-old female (non-pregnant) patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: FF2589), dose 3 via an unspecified route of administration, administered in Arm Left on 02Oct2021 13:45 (61-year-old at the time of vaccination) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included connective tissue disorder from an unknown date and unknown if ongoing. Concomitant medication(s) included hydroxychloroquine (HYDROXYCHLOROQUINE) taken for an unspecified indication, start and stop date were not reported; fluoxetine (FLUOXETINE) taken for an unspecified indication, start and stop date were not reported; fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) taken for an unspecified indication, start and stop date were not reported;  TURMERIC taken for an unspecified indication, start and stop date were not reported. The patient previously took bnt162b2, (BNT162B2, solution for injection, Batch/Lot Number: EL0142), dose 1 via an unspecified route of administration, administered in Arm Right on 05Jan2021 03:00 PM (61-year-old at the time of vaccination) as DOSE 1 for covid-19 immunisation and bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EL9265), dose 2 via an unspecified route of administration, administered in Arm Right on 27Jan2021 01:00 PM (61-year-old at the time of vaccination) as DOSE 2 for covid-19 immunisation, tetanus antitoxin and experienced hypersensitivity. The historical vaccine included Flulaval quad (Lot Number: NDC-19515-0818-52) via an unspecified route of administration, administered in Arm Right on 25Sep2021.The patient experienced pain and lymph node swelling in armpit and upper arm on injection side on 03Oct2021 07:00. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 08Sep2021 Nasal Swab. The outcome of all event was not recovered.  Follow-up (15Oct2021): Follow-up attempts are completed. No further information is expected.