chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got one and still had the COVID virus weeks later; got one and still had the COVID virus weeks later; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unknown date at single dose for covid-19 immunization. Medical history and Concomitant medication were not reported. It was reported that she was told was supposed to be one shot injection and that she didn't need two, so she had gotten one and still had the COVID virus weeks later and wanted to see how good vaccines are if you can still get it. The outcome of events was unknown.  Information about lot/batch number has been requested.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Product quality issue, SARS-CoV-2 test positive
Clinical narrative: Was diagnosed with Covid/first dose of the vaccine on 23Feb2021, and she took a COVID test and received positive results on 20Mar2021; Was diagnosed with Covid/first dose of the vaccine on 23Feb2021, and she took a COVID test and received positive results on 20Mar2021; batch she received her dose from was bad; This is a spontaneous report from a Pfizer-sponsored program by contactable consumer. An 82-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: CLA266) via unspecified route of administration in arm, on 23Feb2021, as a single dose (at the age of 82-year-old) for COVID-19 immunisation. The patient medical history included high blood pressure (for 40 years well controlled with medication), large intestines are gone, whole family had Covid before she did (her daughter and her two teenage children that live with her had Covid) and Ileostomy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The concomitant medication included amlodipine at a dose of 25 mg for high blood pressure. The patient had undergone COVID-19 test and resulted in positive on 20Mar2021. Patient was calling because she received a letter last week dated 16Mar2021, saying that she had contacted Pfizer, saying that her vaccine was not efficacious before she received her positive results. That makes the patient concerned that maybe the batch she received her dose from was bad. Patient stated she was supposed to get her second dose on 13Mar2021, but she did not go. The patient reported that she didn't have symptoms, at the time of her shot, and she moved out to prevent herself from getting it. Later on, 26th (as reported) she started to have symptoms. The patient was not sure if she could have the second dose according to the CDC (centers for disease control and prevention) she has to wait at least 90 days since she had COVID. The patient received Vitamin D as a treatment to Covid. The patient did not visit physician office and emergency room. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Caller tested positive on 08Mar2021 after receiving the 1st dose last 23Feb2021; Caller tested positive on 08Mar2021 after receiving the 1st dose last 23Feb2021; This is a spontaneous report from a Pfizer-sponsored program. Support and medical information team. A contactable consumer (patient herself) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 23Feb2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, caller tested positive on 08Mar2021 after receiving the 1st dose last 23Feb2021.Would like to know how long she would wait to have the second dose scheduled on 16Mar2021. The patient underwent lab test and procedure which included COVID-19 test: Positive on 08Mar2021. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient herself) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration, first dose on 24Jan2021, second dose on 14Feb2021; Both as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, had the 1st dose of COVID-19 Vaccine (24Jan2021) and 2nd dose (14Feb2021) and then tested positive for COVID (17Feb2021) and experienced mild symptoms, wanted to let us know that's why she's reporting it. Cold transfer to DSU due to longer than normal wait time. The patient underwent lab test and procedure which included tested: Positive on 17Feb2021. The outcome of the events was unknown.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Rash
Clinical narrative: Allergic reaction; splotchy rashes on face and chest, large rash on cheek, with splotchy rashes on forehead; Hands appear red as well; This is a spontaneous report from a contactable consumer (patient). This 21-year-old non-pregnant female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the left arm on 25Mar2021 at 15:00 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history included glycerin allergy from an unknown date and unknown if ongoing. Concomitant medications included medical marijuana from an unknown date for an unknown indication. The patient was not diagnosed with COVID-19 prior to vaccination and had not received any other vaccines within 4 weeks prior to vaccination. On 26Mar2021 at 22:30 the patient experienced what appeared to be an allergic reaction, splotchy rashes on face and chest, large rash on cheek, with splotchy rashes on forehead, and her hands appeared red as well. The events were reported as non-serious and did not require hospitalization. No treatment was provided for the events. The clinical outcomes of allergic reaction; splotchy rashes on face and chest, large rash on cheek, with splotchy rashes on forehead; and her hands appeared red as well were unknown. It was also reported that since vaccination the patient had not been tested for COVID.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain
Clinical narrative: Tightness and mild pain in the left side of the chest; Tightness and mild pain in the left side of the chest; This is a spontaneous report from a contactable consumer (patient). This 48-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EP6955) via an unspecified route of administration in the left arm on 24Mar2021 at 11:45 (at the age of 48-years old, reported as 47-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history or concomitant medications. Prior to vaccination the patient was not diagnosed with COVID-19 and had not received any other vaccines in the 4-weeks prior to the COVID vaccine. On 26Mar2021 at 22:45 the patient experienced tightness and mild pain the left side of the chest. No treatment was received for the events. The clinical outcomes of tightness and mild pain the left side of the chest were not recovered. It was also reported that since vaccination the patient had not been tested for COVID-19.   No follow-up attempts are needed; no further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Herpes zoster, Lymphadenopathy, Pain of skin, Paraesthesia
Clinical narrative: Skin eruption; Lump near my hairline was raised and painful; Lymph nodes had swollen to the size of a golf ball-protruding from my neck; Blister that is tingling and stings sharply; Blister that is tingling and stings sharply; Blister that is tingling and stings sharply; Shingles; This is a spontaneous report from a contactable consumer (patient). This 38-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6201) via an specified route of administration in the left arm on 24Mar2021 at 09:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included allergies to dogs, cats and horses all from unknown dates and unknown if ongoing. The patient had not been diagnosed with COVID prior to vaccination and had not received any other vaccines in the 4-weeks prior to vaccination. Concomitant medications included multi-vitamins from an unknown date for an unknown indication. The patient previously received amoxicillin on an unknown date for an unknown indication and experienced drug allergy; and received the first dose of BNT162B2 (lot number EN6198) on 03Mar2021 at 14:30 (at the age of 38-years-old) for COVID-19 immunisation. The patient reported that on 25Mar2021 at 12:00, about 27-30 hours after receiving the vaccine she noticed a skin eruption near her hairline, about the same hour she noticed her lymph nodes had swollen to the size of a golf ball, and the lymph node on her neck on the left side where she'd received the vaccine was visibly protruding from her neck. She further reported the lump near her hairline was raised and painful and the next day it turned into a blister that was tingling and stung sharply; she reported she was just diagnosed with singles and was an otherwise health adult with no major health issues, and was not under stress. She reported reading that the relationship between BNT162B2 and shingles was disproven but felt that these events were linked. The events were reported as non-serious and did not required hospitalization. The patient was treated with antiviral therapy and monitored by her doctor. The events required a doctor or other healthcare professional office/clinic visit and an emergency room/department or urgent care visit. The clinical outcomes of skin eruption, lump near my hairline was raised and painful, lymph nodes had swollen to the size of a golf ball-protruding from my neck, blister that is tingling and stings sharply, and shingles were not recovered. It was also reported that since vaccination the patient had not been tested for COVID.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin disorder
Clinical narrative: Skin eruption; Lump near my hairline was raised and painful; Lymph nodes had swollen to the size of a golf ball-protruding from my neck; Blister that is tingling and stings sharply; Blister that is tingling and stings sharply; Blister that is tingling and stings sharply; Shingles; This is a spontaneous report from a contactable consumer (patient). This 38-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6201) via an specified route of administration in the left arm on 24Mar2021 at 09:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included allergies to dogs, cats and horses all from unknown dates and unknown if ongoing. The patient had not been diagnosed with COVID prior to vaccination and had not received any other vaccines in the 4-weeks prior to vaccination. Concomitant medications included multi-vitamins from an unknown date for an unknown indication. The patient previously received amoxicillin on an unknown date for an unknown indication and experienced drug allergy; and received the first dose of BNT162B2 (lot number EN6198) on 03Mar2021 at 14:30 (at the age of 38-years-old) for COVID-19 immunisation. The patient reported that on 25Mar2021 at 12:00, about 27-30 hours after receiving the vaccine she noticed a skin eruption near her hairline, about the same hour she noticed her lymph nodes had swollen to the size of a golf ball, and the lymph node on her neck on the left side where she'd received the vaccine was visibly protruding from her neck. She further reported the lump near her hairline was raised and painful and the next day it turned into a blister that was tingling and stung sharply; she reported she was just diagnosed with singles and was an otherwise health adult with no major health issues, and was not under stress. She reported reading that the relationship between BNT162B2 and shingles was disproven but felt that these events were linked. The events were reported as non-serious and did not required hospitalization. The patient was treated with antiviral therapy and monitored by her doctor. The events required a doctor or other healthcare professional office/clinic visit and an emergency room/department or urgent care visit. The clinical outcomes of skin eruption, lump near my hairline was raised and painful, lymph nodes had swollen to the size of a golf ball-protruding from my neck, blister that is tingling and stings sharply, and shingles were not recovered. It was also reported that since vaccination the patient had not been tested for COVID.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza, Insomnia, Nausea, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient). This 33-year-old male patient received the second dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME; lot number unknown) via an unspecified route of administration in the left arm on an unspecified date (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination the patient was not diagnosed with COVID-19 and had not received any other vaccines in the 4 weeks prior to vaccination. The patient previously received the first dose of COVID-19 vaccine (lot number unknown) on an unspecified date for COVID-19 immunisation. The patient reported experiencing extreme flu symptoms, unable to sleep, body aches, fever and nausea on unspecified dates. The clinical outcomes of extreme flu symptoms, unable to sleep, body aches, fever and nausea were not recovered. It was also reported that since vaccination the patient had not been tested for COVID-19. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Lacrimation increased
Clinical narrative: Left eye pain/lacrimation 3 days after vaccination; left eye pain/lacrimation; This is a spontaneous report from a contactable physician (patient). A 47-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 23Mar2021 at 15:00 (at the age of 47-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included rosacea. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not take any concomitant medications. The patient had no allergies to medications, food, or other products. On 26Mar2021 at 06:00 the patient experienced left eye pain and lacrimation. The patient did not receive any treatment for the events. The outcome of left eye pain and lacrimation was not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Bright red rash on trunk of body.  Mainly upper abdomen to upper thighs.; This is a spontaneous report from a contactable healthcare professional (patient). A 48-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8732) via an unspecified route of administration on 26Mar2021 at 12:30 (at the age of 48-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included COVID-19 on an unspecified date prior to vaccination and allergies to neomycin and polymyxin. Concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 (lot number EN6205) on 05Mar2021 at 12:30 as a single dose in the right arm for COVID-19 immunization. On 26Mar2021 the patient experienced a bright red rash on trunk of body, mainly upper abdomen to upper thighs. The patient did not receive any treatment for the events. The outcome of bright red rash on trunk of body, mainly upper abdomen to upper thighs was unknown. It was also reported that since the vaccination the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Lymphadenopathy, Pain in extremity, Pyrexia
Clinical narrative: Left arm extreme sorensss; supraclavicular node swelling; bone and joint pain; bone and joint pain; fever; This is a spontaneous report received from a contactable healthcare professional (patient). A 24-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 26Mar2021 at 11:00 (at the age of 24-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included an allergy to sulfa. The patient was not pregnant at the time of vaccination. The patient had not been diagnosed with COVID-19 prior to the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included spironolactone from an unknown date for an unspecified indication and drospirenone, ethinyl estradiol betadex clathrate (YAZ) from an unknown date for birth control. The patient previously received dose 1 of BNT162B2 on an unspecified date as a single dose for COVID-19 immunization. On 26Mar2021 at 22:00 the patient experienced left arm extreme soreness, supraclavicular node swelling, bone and joint pain, and fever. The patient did not receive any treatment for the events. The outcomes of left arm extreme soreness, supraclavicular node swelling, bone and joint pain, and fever were recovering. It was also reported that since the vaccine, the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Eye swelling, Headache, Lethargy, Lip swelling
Clinical narrative: Severe joint pain through entire body.; Muscle fatigue; lethargic; Severe headache; Top lip swelled; left eye mild swelling; Temperature of 100°; This is a spontaneous report from a contactable consumer (patient).   A non-pregnant 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 17Mar2021 at 14:00 (Batch/Lot number was not reported) at 61-years-old as a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the suspect vaccine. The patient was not tested for COVID post vaccination. The patient's medical history was reported as none; no allergies to medications, food, or other products. The patient did not have COVID prior to the vaccination. There were no concomitant medications.  The patient previously took bnt162b2 for COVID-19 immunization on 23Feb2021 (Dose number=1; Vaccine location=Left arm; Administration time=13:30; Lot number= Unknown), hyaluronic acid (JUVEDERM) in Jan2019 (location=under left eye), hyaluronic acid (JUVEDERM) (location= top lip) on 02Feb2021. On 23Mar2021 at 05:00, the patient experienced: severe joint pain through entire body, muscle fatigue, lethargic, severe headache, top lip swelled (where she received hyaluronic acid filler on 02Feb2021), left eye mild swelling (at the hyaluronic acid filler injection site from Jan2019), temperature of 100°; all assessed as non-serious. There was no therapeutic measures taken. The clinical outcome of the events was recovering.  The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle fatigue, Pyrexia
Clinical narrative: Severe joint pain through entire body.; Muscle fatigue; lethargic; Severe headache; Top lip swelled; left eye mild swelling; Temperature of 100°; This is a spontaneous report from a contactable consumer (patient).   A non-pregnant 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 17Mar2021 at 14:00 (Batch/Lot number was not reported) at 61-years-old as a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the suspect vaccine. The patient was not tested for COVID post vaccination. The patient's medical history was reported as none; no allergies to medications, food, or other products. The patient did not have COVID prior to the vaccination. There were no concomitant medications.  The patient previously took bnt162b2 for COVID-19 immunization on 23Feb2021 (Dose number=1; Vaccine location=Left arm; Administration time=13:30; Lot number= Unknown), hyaluronic acid (JUVEDERM) in Jan2019 (location=under left eye), hyaluronic acid (JUVEDERM) (location= top lip) on 02Feb2021. On 23Mar2021 at 05:00, the patient experienced: severe joint pain through entire body, muscle fatigue, lethargic, severe headache, top lip swelled (where she received hyaluronic acid filler on 02Feb2021), left eye mild swelling (at the hyaluronic acid filler injection site from Jan2019), temperature of 100°; all assessed as non-serious. There was no therapeutic measures taken. The clinical outcome of the events was recovering.  The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, SARS-CoV-2 test
Clinical narrative: temporary loss of smell/taste; temporary loss of smell/taste; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: ep6955), via an unspecified route of administration, on 26Mar2021 at 11:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced temporary loss of smell/taste on 26Mar2021 at 23:00. The events were reported as non-serious. The events occurred 12 hours after vaccination and was reported to have lasted 8 hours. The patient underwent lab tests and procedures which included COVID-19 nasal swab: negative on 27Mar2021. The patient did not receive any treatment as a result of the events. The clinical outcome of temporary loss of smell/taste was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site mass, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 25Mar2021 at 15:30 (at the age of 58-years-old) as a single dose for COVID-19 immunization. Medical history included high blood pressure. The patient had no known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included losartan (MANUFACTURER UNKNOWN), dexlansoprazole (DEXILANT), hydrocodone bitartrate, paracetamol (NORCO), potassium chloride (KLOR CON), and progesterone (PROMETRIUM). Additional concomitant medications were reported as: AM. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced headache, fatigue, injection site severe pain, and hard knot at injection site on 26Mar2021 at 12:00. The patient did not receive any treatment as a result of the events. The clinical outcome of headache, fatigue, injection site severe pain, and hard knot at injection site was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Low Fever; This is a spontaneous report from a contactable pharmacist, reporting for himself. A 33-year-old male patient received the second dose of the bnt162b2 (BNT162B2; Lot Number: El3248), via an unspecified route of administration in the left arm on 25Mar2021 at 14:00 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. There were no allergies. The patient previously received the first dose (Lot Number: EN6203) of the bnt162b2 on 02Mar2021 at 2:00PM at 33 years of age in the left arm for covid-19 immunization. No other vaccines were given 4 weeks prior to bnt162b2. On 26Mar2021 at 03:00, the patient experienced low fever, which was non-serious. No treatment was given. There was no covid prior to or post vaccination. The clinical outcome of the event was recovered on an unknown date.   No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash across neck, face, back and down left arm; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: WR8733), via an unspecified route of administration in the left arm, on 25Mar2021 at 08:45 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took diphenhydramine hydrochloride (BENADRYL) and experienced allergy. The patient experienced rash across neck, face, back and down left arm on 26Mar2021. The event was reported as non-serious, but annoying per the patient. The patient did not receive any treatment for the events. The clinical outcome of rash across neck, face, back and down left arm was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Lymphadenopathy, Myalgia, Pain, Pyrexia
Clinical narrative: 101 fever,; Muscle pain; body aches; Swollen lymph nodes; This is a spontaneous report from a contactable consumer, reporting for herself. A 28-year-old non-pregnant female patient received the second dose of the bnt162b2 (BNT162B2; Lot Number: ER2613), via an unspecified route of administration in the left arm on 24Mar2021 at 04:45 at a single dose for covid-19 immunisation. Medical history included obesity. There were no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient previously received the first dose of the bnt162b2 (Lot Number: EN6205) on 03Mar2021 at 3:30PM in the left arm at 28 years of age for covid-10 immunization. There were no other vaccines administered 4 weeks prior to bnt162b2. On 25Mar2021 at 10:30, the patient experienced 101 fever, muscle pain, body aches, and swollen lymph nodes. No therapeutic measures were taken as a result of the event. Lab data included body temperature: 101 on 25Mar2021. There was no covid prior to or post bnt162b2. The clinical outcome of the events was recovered on an unknown date.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Groin pain, Musculoskeletal pain
Clinical narrative: This is a spontaneous report received from a Pfizer sponsored program. A contactable male consumer (patient) reported for himself that an unspecified age male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Expiry date: Unknown), via an unspecified route of administration on 21Mar2021 at SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced Pain in groin area and buttocks with both vaccines. The outcome of the event was unknown. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a Pfizer-sponsored program  from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration on 01Mar2021 (Batch/Lot number unknown) as a single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications were not reported. On 01Mar2021 the patient received the first dose of the vaccination. In Mar2021, she experienced headache for 2-3 days after the first dose. On 07Mar2021 she started taking Doxycycline 40 mg. On 22Mar2021 she received the second dose, but no symptoms were experienced after the second dose. She was wondering if the Doxycycline may have changed the efficacy of the vaccine. The outcome of event headache was recovered.  No follow-up attempts possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: my head and neck turned bright red; My tongue, lips, and inside of my mouth were tingling and became numb; My tongue, lips, and inside of my mouth were tingling and became numb; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER 2613), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient stated after waiting at the facility for 15 minutes after the vaccination, about 10 minutes later, my head and neck turned bright red and heated up like it was on fire on my drive home. My tongue, lips, and inside of my mouth were tingling and became numb. I pulled off the road and sat for another 10 minutes in my car. The symptoms began to subside. The outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear pain, Headache, Scan, Visual impairment
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2, dose 2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Have been to 5 doctors since receiving the Pfizer Covid vaccine series (2 shots). The patient stated she had a bad reaction to first dose and 'horrendous' reaction to second dose. She developed 'tremendous' ear pain and unable to see straight ahead. The patient stated this has been ongoing for over 3 weeks. Also reported that this is day 16 and still no change to her eyes and ears. Stated she developed a bad headache and was throwing up after the 2nd dose. She was unable to look straight without feeling dizzy. Had seen neurologists and had multiple scans; will be having an MRI today. Stated she has no bleeding in the brain. This had affected her daily life; she was unable to work or drive. Took migraine medicine initially. The patient underwent lab tests and procedures which included multiple scans: no bleeding in the brain on an unknown date. The outcome of the events ear pain and unable to see straight ahead was not recovered. The outcome of other event was unknown. The events were reported as non-serious by reporter.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2, dose 2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Have been to 5 doctors since receiving the Pfizer Covid vaccine series (2 shots). The patient stated she had a bad reaction to first dose and 'horrendous' reaction to second dose. She developed 'tremendous' ear pain and unable to see straight ahead. The patient stated this has been ongoing for over 3 weeks. Also reported that this is day 16 and still no change to her eyes and ears. Stated she developed a bad headache and was throwing up after the 2nd dose. She was unable to look straight without feeling dizzy. Had seen neurologists and had multiple scans; will be having an MRI today. Stated she has no bleeding in the brain. This had affected her daily life; she was unable to work or drive. Took migraine medicine initially. The patient underwent lab tests and procedures which included multiple scans: no bleeding in the brain on an unknown date. The outcome of the events ear pain and unable to see straight ahead was not recovered. The outcome of other event was unknown. The events were reported as non-serious by reporter.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Loss of consciousness, Syncope
Clinical narrative: pass out; Vasovagal syncope; passed out again; This is a spontaneous report from a contactable consumer (Patient). A 53-year-old female patient (Non-pregnant) received second dose of BNT162B2 (Pfizer Covid-19 vaccine, Lot number ER8729 expiry date: unknown) via an unspecified route of administration at right arm as a single dose on 09Apr2021 03:00 PM, for Covid-19 immunization. Medical history included Hypothyroid, She had known allergies to Anti-Inflammatory, aspirin, penicillin, codein, ginger and horse radish. Concomitant medications were not reported. The patient received first dose of BNT162B2 (Pfizer Covid-19 vaccine, Lot number: EP7534 expiry date: unknown) via an unspecified route of administration at right arm as a single dose on 19Mar2021 04:00 PM, for Covid-19 immunization. On 10Apr2021 at 03:00 am, she woke to go to the bathroom feeling fine, after getting up from the toilet she saw stars and felt and had a Vasovagal syncope. When she woke up, she tried to get and pass out again. She woke up and was able to walk to my bed and passed out again when she reached the bed. She did not receive treatment for the events. She did not have any other vaccine in four weeks prior to suspect. She did not have Covid prior vaccination nor was she tested for Covid post vaccination. The patient had recovered from the events of pass out, vasovagal syncope and passed out again. No further information was available.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Hypotension, Syncope
Clinical narrative: on the verge of fainting; blood pressure was was 82/48/blood pressure remained low; felt faint/extremely light-headed; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 19Jan2021 06:45 (Batch/Lot Number: EL3248) as single dose for COVID-19 immunisation. Medical history included hypertension, diabetes (well controlled), and fatty liver disease. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Concomitant medications included hydrochlorothiazide; olmesartan medoxomil (BENICAR); and omeprazole (PRILOSEC); and vitamin B complex. The patient previously took the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 28Dec2020 06:30 (Batch/Lot Number: EL1284) at the age of 62 years old as single dose for COVID-19 immunisation. On 20Jan2021 09:15, the patient experienced felt faint and extremely light-headed and on the verge of fainting. The patient laid down and then took her blood pressure. It was 82/48. Her blood pressure remained low throughout the day and did not return completely to normal until 3 days later. No treatment was received for the events. Outcome of the blood pressure was 82/48/blood pressure remained low was recovered on 23Jan2021 while of the remaining events was recovered on 2021.; Sender's Comments: Based on the information currently available, there is a reasonable possibility of an association of the suspect drug administration with the reported events, due to a plausible temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Haematemesis, Headache, Nausea, Pain in extremity
Clinical narrative: with small amounts of blood in vomit; Pain in right arm; back and head ache; back and head ache; nausea; vomiting; This is a spontaneous report from a contactable consumer (patient). A 25-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the right arm on 10Apr2021 at 13:15 (lot number and expiration date: unknown) at a single dose for COVID-19 immunization. Medical history was not reported. Concomitant medication included fluoxetine (FLUOXETINE) taken for an unspecified indication, start and stop date were not reported. The patient had known allergies with Nyquil. The patient had no other vaccine in four weeks, had no COVID prior to vaccination and was not tested post vaccination. The patient experienced pain in right arm, back and head ache, nausea and vomiting, with small amounts of blood in the vomit on 11Apr2021 at 02:00. No treatment was administered for the events. The events were resolving at the time of the report.  Information about lot/batch has been requested.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: with small amounts of blood in vomit; Pain in right arm; back and head ache; back and head ache; nausea; vomiting; This is a spontaneous report from a contactable consumer (patient). A 25-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the right arm on 10Apr2021 at 13:15 (lot number and expiration date: unknown) at a single dose for COVID-19 immunization. Medical history was not reported. Concomitant medication included fluoxetine (FLUOXETINE) taken for an unspecified indication, start and stop date were not reported. The patient had known allergies with Nyquil. The patient had no other vaccine in four weeks, had no COVID prior to vaccination and was not tested post vaccination. The patient experienced pain in right arm, back and head ache, nausea and vomiting, with small amounts of blood in the vomit on 11Apr2021 at 02:00. No treatment was administered for the events. The events were resolving at the time of the report.  Information about lot/batch has been requested.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: DVT; This is a spontaneous report from a contactable consumer reporting for a patient. An 88-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 24Feb2021 (Batch/Lot Number: EN6200) as SINGLE DOSE for covid-19 immunisation, at 88 years old. Medical history included High blood pressure from an unknown date. No COVID prior vaccination. Not tested for COVID post vaccination. No known allergies. The patient received the first dose of BNT162B2 (Lot number el9264) on 03Feb2021 for Covid-19 immunization. Concomitant medication included simvastatin (ZOCOR); terazosin; carvedilol; ranitidine, taken for an unspecified indication, start and stop date were not reported (Other medications in two weeks). Lower right leg swelling was noted beginning approximately on 01Mar2021 without injury or pain that worsened through 04Mar2021. Patient was taken to ER on 05Mar2021 when DVT was diagnosed. Therapeutic measures were taken as a result of DVT includes XARELTO. Outcome of the event was recovering.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Chills, Fatigue, Headache, Lymphadenopathy
Clinical narrative: diagnosed with Bells Palsy; fever; muscle aches; headache; throwing up; chills; swollen lymph nodes/swollen glands; swollen injection site; tired; mouth ulcers; extreme nerve pain; This is a spontaneous report from a contactable consumer.   A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on left arm on 08Apr2021 15:00 (Batch/Lot number was not reported) at single dose (at the age of 47 years old) for COVID-19 immunisation.  Medical history included "if covid prior vaccination: Yes". Concomitant medications included potassium, vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), cetirizine and chlorthalidone, all taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 for COVID-19 immunisation. The patient reported, "fever, muscle aches, headache, throwing up, chills, swollen lymph nodes, swollen injection site, tired. After chills, fever, throwing up, mouth ulcers. On day 7 I have extreme nerve pain, swollen glands, and paralysis on left side of face. Went to DR and they diagnosed with Bells Palsy. Left side of face does not move at all", 09Apr2021 09:00. The patient received no treatment. The outcome of bells palsy, extreme nerve pain, mouth ulcers and swollen lymph nodes/ swollen glands were not recovered and other events was recovering.   Information about lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth ulceration, Myalgia, Neuralgia, Pyrexia, Vaccination site swelling
Clinical narrative: diagnosed with Bells Palsy; fever; muscle aches; headache; throwing up; chills; swollen lymph nodes/swollen glands; swollen injection site; tired; mouth ulcers; extreme nerve pain; This is a spontaneous report from a contactable consumer.   A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on left arm on 08Apr2021 15:00 (Batch/Lot number was not reported) at single dose (at the age of 47 years old) for COVID-19 immunisation.  Medical history included "if covid prior vaccination: Yes". Concomitant medications included potassium, vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), cetirizine and chlorthalidone, all taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 for COVID-19 immunisation. The patient reported, "fever, muscle aches, headache, throwing up, chills, swollen lymph nodes, swollen injection site, tired. After chills, fever, throwing up, mouth ulcers. On day 7 I have extreme nerve pain, swollen glands, and paralysis on left side of face. Went to DR and they diagnosed with Bells Palsy. Left side of face does not move at all", 09Apr2021 09:00. The patient received no treatment. The outcome of bells palsy, extreme nerve pain, mouth ulcers and swollen lymph nodes/ swollen glands were not recovered and other events was recovering.   Information about lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: diagnosed with Bells Palsy; fever; muscle aches; headache; throwing up; chills; swollen lymph nodes/swollen glands; swollen injection site; tired; mouth ulcers; extreme nerve pain; This is a spontaneous report from a contactable consumer.   A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on left arm on 08Apr2021 15:00 (Batch/Lot number was not reported) at single dose (at the age of 47 years old) for COVID-19 immunisation.  Medical history included "if covid prior vaccination: Yes". Concomitant medications included potassium, vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), cetirizine and chlorthalidone, all taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 for COVID-19 immunisation. The patient reported, "fever, muscle aches, headache, throwing up, chills, swollen lymph nodes, swollen injection site, tired. After chills, fever, throwing up, mouth ulcers. On day 7 I have extreme nerve pain, swollen glands, and paralysis on left side of face. Went to DR and they diagnosed with Bells Palsy. Left side of face does not move at all", 09Apr2021 09:00. The patient received no treatment. The outcome of bells palsy, extreme nerve pain, mouth ulcers and swollen lymph nodes/ swollen glands were not recovered and other events was recovering.   Information about lot/batch number has been requested.