chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Dizziness, Nausea, Oropharyngeal pain
Clinical narrative: Dizziness; Weakness; Chest pain; Nausea; Felt like throwing up; Sore throat; This is a spontaneous report from a contactable consumer or other non hcp (parent). A 15-years-old female patient (daughter) received bnt162b2 (BNT162B2), Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 21Sep2021 (at the age of 15-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (Lot Number: FC3181 and Exp. Date: Oct2021) intramuscular on 27Aug2021 (at the age of 15-years-old) for COVID-19 immunisation. It was reported that on an unspecified date, the patient experienced dizziness, weakness, chest pain, nausea, felt like throwing up and sore throat. Additional information provided as, patient (daughter) got her second shot yesterday and she was almost 16 (Further clarification unknown). She was feeling some of the side effects that is supposed to be reported. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Product administered at inappropriate site, Skin warm, Vaccination site inflammation, Vaccination site pain
Clinical narrative: The person giving it gave it to me in the wrong spot; Ended up with localized inflammation in the area; redness; warm to touch; pain under my arm pits and swelling; pain under my arm pits and swelling; This is a spontaneous report from a contactable other hcp. A 38-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that on an unspecified date, the patient experienced the person giving it gave it to me in the wrong spot, ended up with localized inflammation in the area, redness, warm to touch, pain under my arm pits and swelling, pain under my arm pits and swelling. it was reported that, patient received the 2nd dose of the Pfizer covid vaccine. The person giving it gave it to patient in the wrong spot. Patient was stressing what would happen. Ended up with localized inflammation in the area, redness, warm to touch, pain under patient arm pits and swelling. Yesterday went patient went to the urgent care. They gave patient antibiotics to prevent cellulitis. It was because it was administered wrong. Patient in the middle of trying to get information to write a report to the drug store. It's unfortunate there were multiple people that day that patient gave it to. What about the effectiveness of the 2nd shot since it wasn't administered into the muscle? I've never had issues with shots. The first-time patient really didn't have too much; what seemed like inflammation in patient face (left side of my face) but no drooping or anything like that. patient can almost guarantee if the vaccine was administered correctly patient would not have had a reaction to file. The outcome of event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: The person giving it gave it to me in the wrong spot; Ended up with localized inflammation in the area; redness; warm to touch; pain under my arm pits and swelling; pain under my arm pits and swelling; This is a spontaneous report from a contactable other hcp. A 38-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that on an unspecified date, the patient experienced the person giving it gave it to me in the wrong spot, ended up with localized inflammation in the area, redness, warm to touch, pain under my arm pits and swelling, pain under my arm pits and swelling. it was reported that, patient received the 2nd dose of the Pfizer covid vaccine. The person giving it gave it to patient in the wrong spot. Patient was stressing what would happen. Ended up with localized inflammation in the area, redness, warm to touch, pain under patient arm pits and swelling. Yesterday went patient went to the urgent care. They gave patient antibiotics to prevent cellulitis. It was because it was administered wrong. Patient in the middle of trying to get information to write a report to the drug store. It's unfortunate there were multiple people that day that patient gave it to. What about the effectiveness of the 2nd shot since it wasn't administered into the muscle? I've never had issues with shots. The first-time patient really didn't have too much; what seemed like inflammation in patient face (left side of my face) but no drooping or anything like that. patient can almost guarantee if the vaccine was administered correctly patient would not have had a reaction to file. The outcome of event was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Cough, Secretion discharge
Clinical narrative: cough; mucus; back pain; This is a spontaneous report from a contactable other hcp. A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), via an unspecified route of administration on unspecified date of Aug2021 (at the age of 70 year) as dose number unknown, single for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included Palbociclib (IBRANCE, Tablet 125 mg) (cyclic (125 mg tablet once per day for 21 days on, 7 days off)) taken for Breast cancer from 30Apr2021 (to stop date 06Sep2021 and restarted on Sep2021) to an unspecified stop date. Patient reports Ibrance had been on hold since 06Sep2021 due to symptoms from covid vaccine. On unspecified date of 2021 the patient received the vaccine four weeks ago and had been experiencing cough, mucus, back pain, after the start of Ibrance. Patient will be following MD recommendations on future restart date for Ibrance. Patient was treated with antibiotics. The outcome of the events was recovering.    The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Maternal exposure timing unspecified, Poor quality product administered, Product storage error
Clinical narrative: was left in the freezer longer than 14 days; was left in the freezer longer than 14 days; has a red circle on her arm with the size of orange; early pregnant; This is a spontaneous report from a contactable consumer (Patient's husband). This consumer or other non hcp reported information for mother. This is a maternal report. A Pregnant female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration in Sep2021 as DOSE 2, SINGLE for covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient was early pregnant (maternal exposure timing unspecified) in 2021, It was stated that "was left in the freezer longer than 14 days" in Sep2021, has a red circle on her arm with the size of orange in Sep2021. The mother reported she became pregnant while taking bnt162b2.It was further stated that "his wife who received the second dose of the Pfizer Biontech COVID19 (Comirnaty) vaccine two weeks ago and on Saturday, his wife received a phone call from the location where she got the shot. The pharmacist told her that the protocol of storing the vaccine in the freezer for 14 days were not followed and was left in the freezer longer than 14 days. Caller said that his wife was early pregnant and was concerned with potential AE or issues with the administration of the vaccine. Caller stated that there was "nothing weird" but mentioned that his wife has a red circle on her arm with the size of orange for few days. Caller expressed that they are a little nervous hence they are calling for confirmation for any potential issues". The outcome of has a red circle on her arm with the size of orange was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Chills, Facial pain, Headache
Clinical narrative: pain on left side of face from temple, through jaw, down the neck on 29Sep (swollen lymph nodes); pain on left side of face from temple, through jaw, down the neck on 29Sep (swollen lymph nodes); pain on left side of face from temple, through jaw, down the neck on 29Sep (swollen lymph nodes); pain on left side of face from temple, through jaw, down the neck on 29Sep (swollen lymph nodes); Jaw was throbbing; Persistent headache: center forehead on Saturday, back of head on Sunday, perimeter/ring of head Monday-Tuesday; Experienced nausea w/brief period of gagging; Blood pressure reading was 136/77 (higher than normal); Fever (100.2) for two days (Sat &Sun); 99 degrees for 1 day (Mon); Sore arm (Mon-Thurs); Chills for two days (Sat & Sun); body ache 1 day (Sat); This is a spontaneous report from a non-contactable consumer (patient). A 43-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: 301308A) via an unspecified route of administration, administered in left arm on 24Sep2021 (at the age of 43-year-old) as dose 1, single for COVID-19 immunization. Medical history included COVID and lupus. No known allergies. Concomitant medication included hydroxychloroquine sulfate (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]). The patient had COVID prior vaccination and not tested for COVID post vaccination. No other vaccine in four weeks. On 25Sep2021 10:00, the patient experienced fever (100.2) for two days (Sat & Sun); 99 degrees for 1 day (Mon), sore arm (Mon-Thu), chills for two days (Sat & Sun), body ache 1 day (Sat), nausea w/brief period of gagging, blood pressure reading was 136/77 (higher than normal). On 28Sep2021, the patient experienced persistent headache: center forehead on Saturday, back of head on Sunday, perimeter/ring of head Monday-Tuesday. On 29Sep2021, the patient experienced pain on left side of face from temple, through jaw, down the neck (swollen lymph nodes) and jaw was throbbing. The patient underwent lab tests and procedures which included blood pressure: higher (136/77) on 28Sep2021 and fever: 99 degrees on an unspecified date in Sep2021, fever: 100.2 on 24Sep2021. The patient was treated with 20 mg of Prednisone 2x/day for 5 days for treating all the events. Physician Office Visit-Yes. On an unspecified date in Sep2021, the patient recovered from fever (100.2) for two days (Sat & Sun); 99 degrees for 1 day (Mon), chills for two days (Sat & Sun) and body ache 1 day (Sat) and in 2021 sore arm (Mon-Thu) was recovered. The outcome of all other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Lymphadenopathy, Nausea, Neck pain, Pain
Clinical narrative: pain on left side of face from temple, through jaw, down the neck on 29Sep (swollen lymph nodes); pain on left side of face from temple, through jaw, down the neck on 29Sep (swollen lymph nodes); pain on left side of face from temple, through jaw, down the neck on 29Sep (swollen lymph nodes); pain on left side of face from temple, through jaw, down the neck on 29Sep (swollen lymph nodes); Jaw was throbbing; Persistent headache: center forehead on Saturday, back of head on Sunday, perimeter/ring of head Monday-Tuesday; Experienced nausea w/brief period of gagging; Blood pressure reading was 136/77 (higher than normal); Fever (100.2) for two days (Sat &Sun); 99 degrees for 1 day (Mon); Sore arm (Mon-Thurs); Chills for two days (Sat & Sun); body ache 1 day (Sat); This is a spontaneous report from a non-contactable consumer (patient). A 43-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: 301308A) via an unspecified route of administration, administered in left arm on 24Sep2021 (at the age of 43-year-old) as dose 1, single for COVID-19 immunization. Medical history included COVID and lupus. No known allergies. Concomitant medication included hydroxychloroquine sulfate (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]). The patient had COVID prior vaccination and not tested for COVID post vaccination. No other vaccine in four weeks. On 25Sep2021 10:00, the patient experienced fever (100.2) for two days (Sat & Sun); 99 degrees for 1 day (Mon), sore arm (Mon-Thu), chills for two days (Sat & Sun), body ache 1 day (Sat), nausea w/brief period of gagging, blood pressure reading was 136/77 (higher than normal). On 28Sep2021, the patient experienced persistent headache: center forehead on Saturday, back of head on Sunday, perimeter/ring of head Monday-Tuesday. On 29Sep2021, the patient experienced pain on left side of face from temple, through jaw, down the neck (swollen lymph nodes) and jaw was throbbing. The patient underwent lab tests and procedures which included blood pressure: higher (136/77) on 28Sep2021 and fever: 99 degrees on an unspecified date in Sep2021, fever: 100.2 on 24Sep2021. The patient was treated with 20 mg of Prednisone 2x/day for 5 days for treating all the events. Physician Office Visit-Yes. On an unspecified date in Sep2021, the patient recovered from fever (100.2) for two days (Sat & Sun); 99 degrees for 1 day (Mon), chills for two days (Sat & Sun) and body ache 1 day (Sat) and in 2021 sore arm (Mon-Thu) was recovered. The outcome of all other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pain in jaw, Pyrexia
Clinical narrative: pain on left side of face from temple, through jaw, down the neck on 29Sep (swollen lymph nodes); pain on left side of face from temple, through jaw, down the neck on 29Sep (swollen lymph nodes); pain on left side of face from temple, through jaw, down the neck on 29Sep (swollen lymph nodes); pain on left side of face from temple, through jaw, down the neck on 29Sep (swollen lymph nodes); Jaw was throbbing; Persistent headache: center forehead on Saturday, back of head on Sunday, perimeter/ring of head Monday-Tuesday; Experienced nausea w/brief period of gagging; Blood pressure reading was 136/77 (higher than normal); Fever (100.2) for two days (Sat &Sun); 99 degrees for 1 day (Mon); Sore arm (Mon-Thurs); Chills for two days (Sat & Sun); body ache 1 day (Sat); This is a spontaneous report from a non-contactable consumer (patient). A 43-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: 301308A) via an unspecified route of administration, administered in left arm on 24Sep2021 (at the age of 43-year-old) as dose 1, single for COVID-19 immunization. Medical history included COVID and lupus. No known allergies. Concomitant medication included hydroxychloroquine sulfate (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]). The patient had COVID prior vaccination and not tested for COVID post vaccination. No other vaccine in four weeks. On 25Sep2021 10:00, the patient experienced fever (100.2) for two days (Sat & Sun); 99 degrees for 1 day (Mon), sore arm (Mon-Thu), chills for two days (Sat & Sun), body ache 1 day (Sat), nausea w/brief period of gagging, blood pressure reading was 136/77 (higher than normal). On 28Sep2021, the patient experienced persistent headache: center forehead on Saturday, back of head on Sunday, perimeter/ring of head Monday-Tuesday. On 29Sep2021, the patient experienced pain on left side of face from temple, through jaw, down the neck (swollen lymph nodes) and jaw was throbbing. The patient underwent lab tests and procedures which included blood pressure: higher (136/77) on 28Sep2021 and fever: 99 degrees on an unspecified date in Sep2021, fever: 100.2 on 24Sep2021. The patient was treated with 20 mg of Prednisone 2x/day for 5 days for treating all the events. Physician Office Visit-Yes. On an unspecified date in Sep2021, the patient recovered from fever (100.2) for two days (Sat & Sun); 99 degrees for 1 day (Mon), chills for two days (Sat & Sun) and body ache 1 day (Sat) and in 2021 sore arm (Mon-Thu) was recovered. The outcome of all other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Illness, Movement disorder, Pyrexia
Clinical narrative: very sick; a huge fever; couldn't even move; This is a spontaneous report from a contactable other hcp (patient). A female patient of 68 years old received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Batch/Lot number was not reported; Expiry date: Not Provided), dose 2 via an unspecified route of administration on 27Aug2020 as dose 2, single for covid-19 immunization (at the age of 67 years old ). Family history included minor surgery of her husband. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced very sick, a huge fever, couldn't even move. The patient underwent lab tests and procedures which included body temperature: 102.9, she had a huge fever of 102.9. Treatment was provided for the events. The patient was in the original clinical trial as well as the booster clinical trial for the Pfizer BioNTech COVID19 vaccine. She asked about getting clinical trial doses and booster dose put in the (withheld) database. she had the booster because she was very sick. She was sick after dose two and the booster dose. She was so sick she called the hotline for clinical trial adverse events and he took the information down and called the clinical trial people. the doctor called her and told her to take more Tylenol. She reported that she has already reported this to the clinical trial people after the first time when she got sick with second dose. she was an Oncology Nurse. About six hours after she had a huge fever of 102.9 and couldn't even move. Outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This is a spontaneous report from a contactable consumer(patient).  A patient of unspecified age and gender received BNT162B2(PFIZER BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 12Aug2021 (Batch/Lot Number: FC3180) as dose 1 single for COVID-19 immunization.The patient medical history and concomitant medications were not reported. The patient stated, patient was not sure, how they can tell, if patient have a Covid rash from the Shot, patient mean not a Covid rash but a rash from the Covid-19 Vaccine and stated they know what the patient will just pass on all this and patient don't know what it is, it doesn't really matter, so never mind.It was reported that confirm if the rash was from the first dose or second dose vaccination, consumer stated experienced rash from the first shot.The patient experienced rash on an unspecified date in 2021. Outcome of the event was unknown.  No follow-up attempts are possible; No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Lymphadenopathy, Pain in extremity, SARS-CoV-2 test, Tenderness
Clinical narrative: Very tender, sore, and unable to close my arm; pain at injection site is high; lymph nodes under my left arm pit are the size of a baseball./lymph node enlargement; Very tender, sore, and unable to close my arm; unable to close my arm.; This is a spontaneous report from a contactable other health care professional (patient). A 55-years-old male patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: FF2587, expiry date: not reported) via an unspecified route of administration, administered in Arm Left on 05Oct2021 14:15 (at age 55-years-old) of as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation in doctor's office/urgent care. Medical history included Strawberries, Apples allergy (known allergies: strawberries, apples), high lipids, kidney stones, hyperhidrosis. Concomitant medication(s) included allopurinol (ALLOPURINOL); omega-3-acid ethyl ester (LOVAZA) and atorvastatin calcium (LIPITOR) taken for an unspecified indication, start and stop date were not reported.The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0158, expiry date: not reported) via an unspecified route of administration, administered in Arm Left on 07Apr2021 10:30 as DOSE 1, SINGLE for covid-19 immunisation and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0175, expiry date: not reported) via an unspecified route of administration, administered in Arm Left on 28Apr2021 11:00 as DOSE 2, SINGLE for covid-19 immunisation.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.On 05Oct2021 19:30, lymph nodes under my left arm pit are the size of a baseball. Very tender, sore, and unable to close my arm. Also, pain at injection site is high, but the lymph node enlargement was the reason for concern. No treatment was received. No prolonged hospitalization was reported. The patient underwent lab tests and procedures which included Nasal Swab: negative on 13Sep2021. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Very tender, sore, and unable to close my arm; pain at injection site is high; lymph nodes under my left arm pit are the size of a baseball./lymph node enlargement; Very tender, sore, and unable to close my arm; unable to close my arm.; This is a spontaneous report from a contactable other health care professional (patient). A 55-years-old male patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: FF2587, expiry date: not reported) via an unspecified route of administration, administered in Arm Left on 05Oct2021 14:15 (at age 55-years-old) of as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation in doctor's office/urgent care. Medical history included Strawberries, Apples allergy (known allergies: strawberries, apples), high lipids, kidney stones, hyperhidrosis. Concomitant medication(s) included allopurinol (ALLOPURINOL); omega-3-acid ethyl ester (LOVAZA) and atorvastatin calcium (LIPITOR) taken for an unspecified indication, start and stop date were not reported.The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0158, expiry date: not reported) via an unspecified route of administration, administered in Arm Left on 07Apr2021 10:30 as DOSE 1, SINGLE for covid-19 immunisation and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0175, expiry date: not reported) via an unspecified route of administration, administered in Arm Left on 28Apr2021 11:00 as DOSE 2, SINGLE for covid-19 immunisation.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.On 05Oct2021 19:30, lymph nodes under my left arm pit are the size of a baseball. Very tender, sore, and unable to close my arm. Also, pain at injection site is high, but the lymph node enlargement was the reason for concern. No treatment was received. No prolonged hospitalization was reported. The patient underwent lab tests and procedures which included Nasal Swab: negative on 13Sep2021. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore left arm for one hour; The initial case was missing the following minimum criteria: Unspecified number of patients. Upon receipt of follow-up information on 22Oct2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable physician, the patient.  A 59-years-old patient of an unspecified gender received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in the left arm on 08Apr2021 (Batch/Lot Number: ER8737) as dose 1, single (at the age of 59 years-old), dose 2 intramuscular, administered in the left arm on 29Apr2021 (Batch/Lot Number: ER8735) as dose 2, single (at the age of 59 years-old) for COVID-19 immunisation.  Medical history included hyperlipidaemia from 2008 and ongoing, cerebral palsy from 1961 and ongoing (Orthopaedic surgery left arm and leg 1970's and 1960's), and ongoing unusual eye anatomy (from birth). Concomitant medications included atorvastatin taken for hyperlipidaemia from 2008 and ongoing; dorzolamide (DORZOLAMIDE) taken for an unspecified indication from an unspecified start date and ongoing; inositol nicotinate (FLUSH FREE NIACIN) taken for hyperlipidaemia from 2008 and ongoing.  The patient experienced sore left arm for one hour on an unknown date in 2021. The event was reported as non-serious. The outcome of the event sore left arm was recovered on an unknown date in 2021.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Gingival swelling, Pain, Pyrexia
Clinical narrative: Worst was swelling of gums in left side of mouth; plus slight temp; chills; aching over all body; This is a spontaneous report from a contactable consumer. This 87-year-old female consumer (patient) reported that:  A 87-years-old female patient received bnt162b2 (BNT162B2; solution for injection), dose 3 via an unspecified route of administration, administered in Arm Left on 05Oct2021 11:00 (Batch/Lot Number: 59267-1000-2 FF8841) as DOSE 3 (BOOSTER), (at a age of 87-year-old) SINGLE for covid-19 immunisation. The patient previously took bnt162b2 for covid-19 immunisation. Medical history included hypothyroidism, anaemia, aortic aneurysm, allergies with morphine sulfa drugs, and lisinopril. Patient has no covid prior vaccination, and not tested covid post vaccination. On 06Oct2021 08:00, the patient experienced worst was swelling of gums in left side of mouth, plus slight temp, chills, aching over all body. No treatment  received for AE The patient underwent lab tests and procedures which included body temperature slight on 06Oct2021. Outcome of the events were recovering.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Chills
Clinical narrative: After the 2nd dose I experienced waves of discomfort just below my rib cage and above my belly button for 4 days; along with chills and joint pain; along with chills and joint pain; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 69-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6208 and expiration date was not reported), second dose via an unspecified route of administration, administered in Arm Left on 16Mar2021 13:00 (At the age of 69 year) single for covid-19 immunization. Medical history included high cholesterol and atrial fibrillation from an unknown date and unknown if ongoing. Patient had allergy of drug that was not reported. Concomitant medications included Lovastatin (20 MG), Metoprolol (50 MG), Aspirin (acetylsalicylic acid, 81 MG) taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, it was Unknown if the patient diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The COVID-19 vaccine was administered to patient at Pharmacy or Drug Store. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6200 and expiration date was not reported), first dose via an unspecified route of administration, administered in Arm Left on 22Feb2021 10:00 (At the age of 69 year) single for covid-19 immunization leading to headache and joint pain. On 16Mar2021 22:00 the patient experienced waves of discomfort just below my rib cage and above my belly button for 4 days, along with chills and joint pain. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Patient had no Hospitalization Prolonged and Treatment Received. Case was considered as non-serious. The outcome of the events was recovered on unspecified date of 2021.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Chills, Gait inability, Immunisation
Clinical narrative: Off-label use; Booster; after the 3rd dose I experienced chills; joint pain; very sore soles of my feet - felt like burning - I couldn't walk; very sore soles of my feet - felt like burning - I couldn't walk; This is a spontaneous report from a contactable consumer (Patient).  A 69-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: 301558A ), dose 3 via an unspecified route of administration, administered in Arm Left on 06Oct2021 at 09:15 (Age at vaccination: 69 years old) as DOSE 3 (BOOSTER), SINGLE for covid-19 im-munisation at pharmacy or drug store . Medical history included blood cholesterol increased, atrial fibrillation. Concomitant medications included Lovastatin 20 mg; Metoprolol 50 mg; aspirin [acetylsalicylic acid] 81 mg . Historical vaccine included bnt162b2 (COMIRNATY) as dose 1 on 22Feb2021, Batch/Lot No: EN6200, Location of injection: Arm Left Vaccine, Administration Time: 10:00 AM for covid-19 immunisation. Historical vaccine included bnt162b2 (COMIRNATY) as dose 2 on 16Mar2021, lot number: EN6208, Location of injection: Arm Left Vaccine Administration Time: 01:00 PM for covid-19 immunisation. It was stated that "After the 2nd dose I experienced waves of discomfort just below my rib cage and above my belly button for 4 days along with chills and joint pain on 16Mar2021 at 22:00". after the 1st dose she just felt a headache and joint pain. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported "after the 3rd dose i experienced chills, joint pain, very sore soles of my feet - felt like burning - i couldn't walk in Oct2021, off-label use and booster on 06Oct2021 at 09:15. Adverse events resulted in doctor's office visit. Since the vaccination the patient was not tested for COVID-19.No treatment was recived for the events. The outcome of the events was recovered in Oct2021.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: Off-label use; Booster; after the 3rd dose I experienced chills; joint pain; very sore soles of my feet - felt like burning - I couldn't walk; very sore soles of my feet - felt like burning - I couldn't walk; This is a spontaneous report from a contactable consumer (Patient).  A 69-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: 301558A ), dose 3 via an unspecified route of administration, administered in Arm Left on 06Oct2021 at 09:15 (Age at vaccination: 69 years old) as DOSE 3 (BOOSTER), SINGLE for covid-19 im-munisation at pharmacy or drug store . Medical history included blood cholesterol increased, atrial fibrillation. Concomitant medications included Lovastatin 20 mg; Metoprolol 50 mg; aspirin [acetylsalicylic acid] 81 mg . Historical vaccine included bnt162b2 (COMIRNATY) as dose 1 on 22Feb2021, Batch/Lot No: EN6200, Location of injection: Arm Left Vaccine, Administration Time: 10:00 AM for covid-19 immunisation. Historical vaccine included bnt162b2 (COMIRNATY) as dose 2 on 16Mar2021, lot number: EN6208, Location of injection: Arm Left Vaccine Administration Time: 01:00 PM for covid-19 immunisation. It was stated that "After the 2nd dose I experienced waves of discomfort just below my rib cage and above my belly button for 4 days along with chills and joint pain on 16Mar2021 at 22:00". after the 1st dose she just felt a headache and joint pain. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported "after the 3rd dose i experienced chills, joint pain, very sore soles of my feet - felt like burning - i couldn't walk in Oct2021, off-label use and booster on 06Oct2021 at 09:15. Adverse events resulted in doctor's office visit. Since the vaccination the patient was not tested for COVID-19.No treatment was recived for the events. The outcome of the events was recovered in Oct2021.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Urinary tract infection
Clinical narrative: She has urinary tract infection; This is a spontaneous report from a contactable consumer or other non hcp.   A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation; ciprofloxacin (CIPRO [CIPROFLOXACIN]), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at UNK, 2x/day for urinary tract infection. The patient medical history and concomitant medications were not reported. It was reported that, she was scheduled to get her third dose on Thursday however she just filled the prescription Cipro, she had urinary tract infection or UTI (unspecified vaccine) actually she also has additional medical inquiry if she will be taking instead of taking booster shot if she will be having the medicines and she is on infection.So, already informed her that the Pfizer Medical Information will be open tomorrow and already provided the number.The outcome of the event urinary tract infection on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of she has urinary tract infection (urinary tract infection).  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.  Follow-up (21Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chronic obstructive pulmonary disease, Dyspnoea, Fatigue, Feeling abnormal
Clinical narrative: Having problems with the breathing; I felt kind of bad; I had a temperature over 100 but it didn''t last long; I was just tired; my arm is still sore, feel like it is going to fall off; I think, I have COPD; Pfizer COVID-19 Vaccine (Booster).; Pfizer COVID-19 Vaccine (Booster).; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: FE3592), dose 3 via an unspecified route of administration, administered in Arm Left on 08Oct2021 as dose 3 (booster dose), single for covid-19 immunisation (at the age of 79-years-old).  Medical history included diabetes. Concomitant medication included influenza vaccine (FLU VACCINE VII) taken for an unspecified indication from 24Sep2021 to 24Sep2021; atenolol (ATENOLOL) (50 mg); lisinopril (10 mg); furosemide (40mg); glimepiride (4 mg) taken for Diabetes. Historical Vaccine included 1st and 2nd dose of BNT162B2 for COVID-19 immunisation. On 08-oct-2021, the patient experienced pfizer covid-19 vaccine (booster), "i felt kind of bad" on 10Oct2021, i had a temperature over 100 but it didn''t last long on 10Oct2021, i was just tired on 10Oct2021, my arm is still sore, feel like it is going to fall off on 08Oct2021, i think, i have copd on an unspecified date, having problems with the breathing on an unspecified date. The patient underwent lab tests and procedures which included body temperature: over 100 . Therapeutic measures were taken as a result of, i think, i have copd (chronic obstructive pulmonary disease). The patient reported she had never had anything hurt like it is. It must be because it's her right arm, or she was not sure. She was not sure but, she wanted to go to the lung doctor to find that out and going to the lung therapy. Outcome of the event I felt kind of bad and Fever was recovered on an unspecified day in 2021, and that of other events were unknown.   Follow-up attempts are completed. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Off label use, Pain in extremity, Pyrexia
Clinical narrative: Having problems with the breathing; I felt kind of bad; I had a temperature over 100 but it didn''t last long; I was just tired; my arm is still sore, feel like it is going to fall off; I think, I have COPD; Pfizer COVID-19 Vaccine (Booster).; Pfizer COVID-19 Vaccine (Booster).; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: FE3592), dose 3 via an unspecified route of administration, administered in Arm Left on 08Oct2021 as dose 3 (booster dose), single for covid-19 immunisation (at the age of 79-years-old).  Medical history included diabetes. Concomitant medication included influenza vaccine (FLU VACCINE VII) taken for an unspecified indication from 24Sep2021 to 24Sep2021; atenolol (ATENOLOL) (50 mg); lisinopril (10 mg); furosemide (40mg); glimepiride (4 mg) taken for Diabetes. Historical Vaccine included 1st and 2nd dose of BNT162B2 for COVID-19 immunisation. On 08-oct-2021, the patient experienced pfizer covid-19 vaccine (booster), "i felt kind of bad" on 10Oct2021, i had a temperature over 100 but it didn''t last long on 10Oct2021, i was just tired on 10Oct2021, my arm is still sore, feel like it is going to fall off on 08Oct2021, i think, i have copd on an unspecified date, having problems with the breathing on an unspecified date. The patient underwent lab tests and procedures which included body temperature: over 100 . Therapeutic measures were taken as a result of, i think, i have copd (chronic obstructive pulmonary disease). The patient reported she had never had anything hurt like it is. It must be because it's her right arm, or she was not sure. She was not sure but, she wanted to go to the lung doctor to find that out and going to the lung therapy. Outcome of the event I felt kind of bad and Fever was recovered on an unspecified day in 2021, and that of other events were unknown.   Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Immunisation, Off label use
Clinical narrative: Chills; Fever; aches; headache; exhaustion; Booster; Off-label use; This is a spontaneous report from a contactable other hcp (patient). A 72-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: 30130BA), dose 3 via an unspecified route of administration, administered in Arm Left on 29Sep2021 as dose 3 (booster), single for covid-19 immunization (at the age of 72-years-old ). Medical history included, High blood pressure. Patient had Known allergies. Patient received no other vaccine in four weeks. Concomitant medication included hydrochlorothiazide, losartan potassium (LOSARTAN POTASSIUM AND HCTZ); temazepam. Historical Vaccine included BNT162B2 (Lot NUMBER: EN6202) as dose 2, single on 08Feb2021 and BNT162B2 (Lot NUMBER: EL9269) as dose 1, single on 01Mar2021 for COVID-19 immunisation (at the age of 71 years). On 29Sep2021, the patient experienced chills, fever, aches, headache, exhaustion, off label use and booster.  It was reported that the events went on for nearly 10 days. Each time she got another shot the side effects are worse and last longer. Patient received no treatment for the events. The patient was not COVID prior vaccination and did not test for COVID post vaccination. Outcome of the events were recovering.   Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Chills; Fever; aches; headache; exhaustion; Booster; Off-label use; This is a spontaneous report from a contactable other hcp (patient). A 72-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: 30130BA), dose 3 via an unspecified route of administration, administered in Arm Left on 29Sep2021 as dose 3 (booster), single for covid-19 immunization (at the age of 72-years-old ). Medical history included, High blood pressure. Patient had Known allergies. Patient received no other vaccine in four weeks. Concomitant medication included hydrochlorothiazide, losartan potassium (LOSARTAN POTASSIUM AND HCTZ); temazepam. Historical Vaccine included BNT162B2 (Lot NUMBER: EN6202) as dose 2, single on 08Feb2021 and BNT162B2 (Lot NUMBER: EL9269) as dose 1, single on 01Mar2021 for COVID-19 immunisation (at the age of 71 years). On 29Sep2021, the patient experienced chills, fever, aches, headache, exhaustion, off label use and booster.  It was reported that the events went on for nearly 10 days. Each time she got another shot the side effects are worse and last longer. Patient received no treatment for the events. The patient was not COVID prior vaccination and did not test for COVID post vaccination. Outcome of the events were recovering.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chest discomfort, Chills, Dyspepsia, Headache
Clinical narrative: chest tightness no SOB; left extremity numbness; hR 54; headache; could not lay in one position for long due to the pain; fever 100.7; chills; myalgias; 9-14 received booster at 9am; 9-14 received booster at 9am; heartburn; nausea; This is a spontaneous report from a contactable pharmacist (patient).  A patient of unspecified age and gender received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via an unspecified route of administration on 14Sep2021 at 09:00 as dose 3 (booster), single for COVID-19 immunization. Medical history included PCOS, menopausal symptoms (Currently taking estradiol patch and progesterone 1 po qd for menopausal symptoms) and PCN allergy. Concomitant medication(s) included ongoing estradiol (ESTRADIOL TRANSDERMAL) and progesterone (PROGESTERONE) taken for menopausal symptoms. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 14Feb2021 as dose 2, single for COVID-19 immunization patient experienced similar but not quite as severe reaction after dose 2. On 14Sep2021 at 09:00, patient experienced fever 100.7, chills, myalgias and 9-14 received booster at 9am, on 15Sep2021 headache, could not lay in one position for long due to the pain, on Sep2021 nausea and heartburn, on 17Sep2021 at 01:00, chest tightness no sob, left extremity numbness, hr 54. On 14Sep2021, patient underwent lab tests and procedures which included body temperature resulted 100.7, on 17Sep2021, heart rate resulted 54. Patient took ibuprofen 800mg for headache. The outcome of event headache, nausea and heartburn was not recovered, myalgias was recovered on 16Sep2021, left extremity numbness recovered on 17Sep2021, 9-14 received booster at 9am and hR 54 was unknown, rest all events was recovered on Sep2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Heart rate abnormal, Hypoaesthesia, Immunisation, Myalgia
Clinical narrative: chest tightness no SOB; left extremity numbness; hR 54; headache; could not lay in one position for long due to the pain; fever 100.7; chills; myalgias; 9-14 received booster at 9am; 9-14 received booster at 9am; heartburn; nausea; This is a spontaneous report from a contactable pharmacist (patient).  A patient of unspecified age and gender received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via an unspecified route of administration on 14Sep2021 at 09:00 as dose 3 (booster), single for COVID-19 immunization. Medical history included PCOS, menopausal symptoms (Currently taking estradiol patch and progesterone 1 po qd for menopausal symptoms) and PCN allergy. Concomitant medication(s) included ongoing estradiol (ESTRADIOL TRANSDERMAL) and progesterone (PROGESTERONE) taken for menopausal symptoms. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 14Feb2021 as dose 2, single for COVID-19 immunization patient experienced similar but not quite as severe reaction after dose 2. On 14Sep2021 at 09:00, patient experienced fever 100.7, chills, myalgias and 9-14 received booster at 9am, on 15Sep2021 headache, could not lay in one position for long due to the pain, on Sep2021 nausea and heartburn, on 17Sep2021 at 01:00, chest tightness no sob, left extremity numbness, hr 54. On 14Sep2021, patient underwent lab tests and procedures which included body temperature resulted 100.7, on 17Sep2021, heart rate resulted 54. Patient took ibuprofen 800mg for headache. The outcome of event headache, nausea and heartburn was not recovered, myalgias was recovered on 16Sep2021, left extremity numbness recovered on 17Sep2021, 9-14 received booster at 9am and hR 54 was unknown, rest all events was recovered on Sep2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.