chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: Fever of 101; body aches; This is a spontaneous report from a non-contactable consumer (patient's spouse). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (lot number and expiry date: unknown) as dose 1, single, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received his first shot and developed fever of 101 and body aches on unspecified date. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Peripheral swelling
Clinical narrative: had pains in my hands(hands are swollen),in my knee,in my arm,in my shoulder and in the joints of my arm/joint pain in hands/ joint pain in knee/pain in elbow/joint pain in feet/joint pain in shoulder; hands are swollen/Hand swelling; This is a spontaneous report from a contactable consumer (patient himself). An 87-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 10Mar2021 at 14:00 (Batch/Lot Number: EN6198) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included covid-19 from Sep2020 to an unknown date, joint pains from Sep2020 to an unknown date. The patient's concomitant medications were not reported. Prior Vaccinations (within 4 weeks) included the shingles vaccine on 12Feb2021 with no after effects. The patient stated when I had the COVID, had some joint pains and so forth; it somewhat subsided over the month. After I got my first Pfizer shot, (on an unspecified date in Mar2021) I had pains in my hands (hands are swollen), in my knee, in my arm, in my shoulder and in the joints of my arm. He had previously had COVID 19 infection on Sep2020. When he had COVID 19 infection, he had pain in his joints, which has subsided over the months. Since getting the shot he has had pain in his joints, especially his hands and his hands are swollen. He is asking is that a standard side effect, he notices the pain in the elbow and shoulder when he moves. The feet and knee are not as bad as the hands. He is scheduled 31Mar2021 but that is another thing he wants to ask if he should get the second dose. He is unsure when after the shot his joint pain started but it is all persisting. Upon additional information received on 26Mar2021, he reported since he had his shot, he started experiencing joint pains especially on his hands and on his right arm which is still going on until today. He is concerned that he might have a permanent joint pain and wants to know if he should get his 2nd shot. The outcome of all the events was not recovered, at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Vaccination site pain
Clinical narrative: soreness at the injection site; shoulder pain; sore arm right after the first dose; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: 5L9264, Expiration date and NDC number was unknown) via an unspecified route of administration, administered in right arm on 18Feb2021 as dose 1, single (age at vaccination was 63 years) for COVID-19 immunisation. The patient's medical history included Adult-onset mitochondrial myopathy from 2000 to an unknown date and blood pressure from an unknown date and unknown if ongoing. The patient's concomitant medications included hydrochlorothiazide, lisinopril (lisinopril + hidroclorotiazida, taking since 2018-2019) and sertraline (started years ago, like 30 years off and on), both indicated for blood pressure, start and stop date were not reported. On an unspecified date of 2021, patient had first dose, she was fine no problem, very easy shot, maybe a little bit of shoulder pain, soreness at the injection site and sore arm right after the first dose just reminded her that she got the shot. The outcome of all the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Swelling
Clinical narrative: little bit swollen on her face and neck; allergic reaction; This is a spontaneous report from a contactable consumer or other non-Health Care Professional via Pfizer-sponsored program.A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 1 via an unspecified route of administration on 24Feb2021 as DOSE 1, SINGLE for Covid-19 immunization.The patient medical history was not reported.The patient's concomitant medications were not reported.On an unspecified date the patient experienced little bit swollen on her face and neck. On 11Mar2021 the patient experienced allergic reaction. Therapeutic measures were taken as a result of allergic reaction. She will need to take 3 medicines for Tuesday, Prednisone for Wednesday Benedril and Pepcid. The outcome of event was unknown.  No follow-up attempts are possible: information about lot/batch number cannot be obtained.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pruritus, Rash, Rash erythematous, Rash macular
Clinical narrative: Developed small spots and rashes in different places on her body (hands, ankles, and shoulders); Developed small spots and rashes in different places on her body (hands, ankles, and shoulders); Itchy; Rather small areas that are very itchy, red when scratched; Sometime little red bumps that itch not all a whole rash; I am very tired; This is a spontaneous report from a contactable consumer. A 83-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 08Mar2021 09:50 (age at vaccination 83 years) as dose 1, single for covid-19 immunisation. Medical history included osteoporosis, Allergies (Verbatim: She has sensitive skin States it is thinner than it was before at 83 years old. She has to watch what soaps she uses. When she showers, she uses something she gets from the health food store, Spouts; something gentle with aloe, tea tree oil. Tries to use natural products), thyroid, blood pressure. Concomitant medication(s) included amlodipine besilate (AMLODIPINE (ALS BESILAAT) SANDOZ) taken for blood pressure measurement; levothyroxine sodium (SYNTHROID) taken for thyroid disorder, start and stop date were not reported, PROLIA (denosumab) for osteoporosis. The patient previously took flu and experienced malaise (she felt kind of icky; no fever or anything. Vaccine/Brand Name: Flu Shot/Brand Name, NDC, Lot, Expiry Date Unknown), prolia for osteoporosis (17Feb2021 had a Prolia shot for Osteoporosis, Right Arm). On 13Mar2021 the patient experienced developed small spots and rashes in different places on her body (hands, ankles, and shoulders, and just in different places), itchy, rather small areas that are very itchy, red when scratched, sometime little red bumps that itch not all a whole rash, she was very tired. Reporter stated, Patient not visited emergency room, physician office. noticed events at night 5-6 days after vaccine. She wants to know if this was a normal reaction or if anyone else has reported the same type of side effect. she is due for her second dose on 29Mar2021, and she is wondering if the side effects will be worse after the second dose. Rash occurred 5-6 days after vaccination. Small patches, some are just little bumps, they are very itchy. Has no specific time just that she noticed it at night and tried to ignore it. Patient states that it is persisting, she gets a new spot every once in a while, and that it has not improved, she confirms it is persisting. Patient received treatment for reported events, just putting cream. got some lotion called Curel for itching skin. It's over the counter Curel but it only helps temporarily used different lotions, creams to keep moist, found that Curel Itch Defence for Dry Itchy Skin helps. The outcome of events was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular
Clinical narrative: Developed small spots and rashes in different places on her body (hands, ankles, and shoulders); Developed small spots and rashes in different places on her body (hands, ankles, and shoulders); Itchy; Rather small areas that are very itchy, red when scratched; Sometime little red bumps that itch not all a whole rash; I am very tired; This is a spontaneous report from a contactable consumer. A 83-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 08Mar2021 09:50 (age at vaccination 83 years) as dose 1, single for covid-19 immunisation. Medical history included osteoporosis, Allergies (Verbatim: She has sensitive skin States it is thinner than it was before at 83 years old. She has to watch what soaps she uses. When she showers, she uses something she gets from the health food store, Spouts; something gentle with aloe, tea tree oil. Tries to use natural products), thyroid, blood pressure. Concomitant medication(s) included amlodipine besilate (AMLODIPINE (ALS BESILAAT) SANDOZ) taken for blood pressure measurement; levothyroxine sodium (SYNTHROID) taken for thyroid disorder, start and stop date were not reported, PROLIA (denosumab) for osteoporosis. The patient previously took flu and experienced malaise (she felt kind of icky; no fever or anything. Vaccine/Brand Name: Flu Shot/Brand Name, NDC, Lot, Expiry Date Unknown), prolia for osteoporosis (17Feb2021 had a Prolia shot for Osteoporosis, Right Arm). On 13Mar2021 the patient experienced developed small spots and rashes in different places on her body (hands, ankles, and shoulders, and just in different places), itchy, rather small areas that are very itchy, red when scratched, sometime little red bumps that itch not all a whole rash, she was very tired. Reporter stated, Patient not visited emergency room, physician office. noticed events at night 5-6 days after vaccine. She wants to know if this was a normal reaction or if anyone else has reported the same type of side effect. she is due for her second dose on 29Mar2021, and she is wondering if the side effects will be worse after the second dose. Rash occurred 5-6 days after vaccination. Small patches, some are just little bumps, they are very itchy. Has no specific time just that she noticed it at night and tried to ignore it. Patient states that it is persisting, she gets a new spot every once in a while, and that it has not improved, she confirms it is persisting. Patient received treatment for reported events, just putting cream. got some lotion called Curel for itching skin. It's over the counter Curel but it only helps temporarily used different lotions, creams to keep moist, found that Curel Itch Defence for Dry Itchy Skin helps. The outcome of events was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Body temperature, Hypoaesthesia, Neck pain
Clinical narrative: shoulder and neck pain/left side pain to neck, shoulder, and upper back; shoulder and neck pain/left side pain to neck, shoulder, and upper back; shoulder and neck pain/left side pain to neck, shoulder, and upper back; Numbness in left arm; Fever of 99.5; swelling under left armpit and tonsils/swelling tonsil on left side; she had really bad body aches.; swelling under left armpit and tonsils; This is a spontaneous report received from a contactable pharmacist. A 51-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration in Arm Left on an unspecified date (age at vaccination 51years old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced shoulder and neck pain/left side pain to neck, shoulder, and upper back, numbness in left arm, fever of 99.5, swelling under left armpit and tonsils/swelling tonsil on left side, she had really bad body aches on an unspecified date. Clinical course was reported as She says after she got her first dose, she is still experiencing pain, and is due for her second dose in a week, which she doesn't know if she has to go or if she should wait until side effects clear. She declines to do a re-port and says that she has reported for a week every single day her symptoms, though it wasn't with Pfizer, it was the CDC. She says every day for 7 days they email questions about redness, chills, and muscle pain, which she didn't have that. She says two weeks she had fever of 99.5 (unable to clarify if this was degrees Fahrenheit during call) and the second day she had really bad body aches. She says she got her shot on her left side, which something cleared, then on day 8 she got swelling to her lymph or tonsil on the left side, then 2-3 days that was gone but she still has pain on the left side of her neck, shoulder, and upper back. She says she has been using a heating pad on her left side and taking Tylenol, though she doesn't have a temperature anymore she still has pain, it is better during the day and more intense at night. The patient underwent lab tests and procedures which included body temperature: 99.5 on unspecified date. The clinical outcome of the event numbness in left arm, she had really bad body aches, swelling under left armpit and tonsils was unknown and shoulder and neck pain/left side pain to neck, shoulder, and upper back event was not recovered and other events was recovered. Therapeutic measures were taken as a result of shoulder and neck pain/left side pain to neck, shoulder, and upper back, fever of 99.5.  No follow-up attempts are possible. Information about lot/batch cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Swelling, Tonsillitis
Clinical narrative: shoulder and neck pain/left side pain to neck, shoulder, and upper back; shoulder and neck pain/left side pain to neck, shoulder, and upper back; shoulder and neck pain/left side pain to neck, shoulder, and upper back; Numbness in left arm; Fever of 99.5; swelling under left armpit and tonsils/swelling tonsil on left side; she had really bad body aches.; swelling under left armpit and tonsils; This is a spontaneous report received from a contactable pharmacist. A 51-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration in Arm Left on an unspecified date (age at vaccination 51years old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced shoulder and neck pain/left side pain to neck, shoulder, and upper back, numbness in left arm, fever of 99.5, swelling under left armpit and tonsils/swelling tonsil on left side, she had really bad body aches on an unspecified date. Clinical course was reported as She says after she got her first dose, she is still experiencing pain, and is due for her second dose in a week, which she doesn't know if she has to go or if she should wait until side effects clear. She declines to do a re-port and says that she has reported for a week every single day her symptoms, though it wasn't with Pfizer, it was the CDC. She says every day for 7 days they email questions about redness, chills, and muscle pain, which she didn't have that. She says two weeks she had fever of 99.5 (unable to clarify if this was degrees Fahrenheit during call) and the second day she had really bad body aches. She says she got her shot on her left side, which something cleared, then on day 8 she got swelling to her lymph or tonsil on the left side, then 2-3 days that was gone but she still has pain on the left side of her neck, shoulder, and upper back. She says she has been using a heating pad on her left side and taking Tylenol, though she doesn't have a temperature anymore she still has pain, it is better during the day and more intense at night. The patient underwent lab tests and procedures which included body temperature: 99.5 on unspecified date. The clinical outcome of the event numbness in left arm, she had really bad body aches, swelling under left armpit and tonsils was unknown and shoulder and neck pain/left side pain to neck, shoulder, and upper back event was not recovered and other events was recovered. Therapeutic measures were taken as a result of shoulder and neck pain/left side pain to neck, shoulder, and upper back, fever of 99.5.  No follow-up attempts are possible. Information about lot/batch cannot be obtained.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Blister, Diarrhoea, Erythema
Clinical narrative: redness that is kind of blistering to one foot; he had GI problems the week of getting the shot; had diarrhea for a couple days that went away; joint pain; his skin is all deformed; covid toes; redness that is kind of blistering to one foot; This is a spontaneous report received from a contactable consumer or other non hcp. A 62-years-old male patient received 1st dose of bnt162b2 (Pfizer COVID 19 vaccine,Batch/Lot Number: EN6200), via an unspecified route of administration, administered in Arm Right on 28Feb2021,at the age of 62 years old, as Dose 1,single for covid-19 immunization.Medical history included lower limb fracture from Sep2020 to an unknown date Verbatim: Broken leg , diabetes mellitus from Aug2020 to an unknown date Verbatim: Diabetic and diabetic neuropathy from an unknown date and unknown if ongoing.The patient's concomitant medications were not reported.The patient experienced covid toes on an unspecified date, redness that is kind of blistering to one foot  on Mar2021, redness that is kind of blistering to one foot, he had gi problems the week of getting the shot, had diarrhea for a couple days that went away, joint pain and his skin is all deformed on an unspecified date.Therapeutic measures were taken as a result of redness that is kind of blistering to one foot ,had diarrhea for a couple days that went away.The outcome of the events was unknown.Caller reports covid toes since he got his 1st shot 3 weeks ago on his broken leg, for which he had surgery. He also reported that he is a diabetic.The patient received treatment with Kaopectate for the diarrhea and Gold Bond Diabetic Lotion on the blistering, no further details provided about his lotion. Follow up(18Mar2021) This is a follow up spontaneous report from a contactable consumer. This consumer (patient) reported about the treatment received for diarrohea and blister.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Rash macular, Skin disorder
Clinical narrative: redness that is kind of blistering to one foot; he had GI problems the week of getting the shot; had diarrhea for a couple days that went away; joint pain; his skin is all deformed; covid toes; redness that is kind of blistering to one foot; This is a spontaneous report received from a contactable consumer or other non hcp. A 62-years-old male patient received 1st dose of bnt162b2 (Pfizer COVID 19 vaccine,Batch/Lot Number: EN6200), via an unspecified route of administration, administered in Arm Right on 28Feb2021,at the age of 62 years old, as Dose 1,single for covid-19 immunization.Medical history included lower limb fracture from Sep2020 to an unknown date Verbatim: Broken leg , diabetes mellitus from Aug2020 to an unknown date Verbatim: Diabetic and diabetic neuropathy from an unknown date and unknown if ongoing.The patient's concomitant medications were not reported.The patient experienced covid toes on an unspecified date, redness that is kind of blistering to one foot  on Mar2021, redness that is kind of blistering to one foot, he had gi problems the week of getting the shot, had diarrhea for a couple days that went away, joint pain and his skin is all deformed on an unspecified date.Therapeutic measures were taken as a result of redness that is kind of blistering to one foot ,had diarrhea for a couple days that went away.The outcome of the events was unknown.Caller reports covid toes since he got his 1st shot 3 weeks ago on his broken leg, for which he had surgery. He also reported that he is a diabetic.The patient received treatment with Kaopectate for the diarrhea and Gold Bond Diabetic Lotion on the blistering, no further details provided about his lotion. Follow up(18Mar2021) This is a follow up spontaneous report from a contactable consumer. This consumer (patient) reported about the treatment received for diarrohea and blister.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Erythema, Fatigue, Scratch, Urticaria
Clinical narrative: anxiety; scratched; She felt tired; she got a hive on her breast and the next day on her arms/hives on left breast; redness; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received bnt162b2 (BNT162B2,Solution for injection,Batch/Lot Number: EN6198,Expiry date was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 02Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included breast cancer from 2011 to an unknown date Verbatim: Breast cancer, blood pressure abnormal, lymphadenopathy,mastectomy from an unknown date and unknown if ongoing. On 16Mar2021 the patient experienced she got a hive on her breast and the next day on her arms/hives on left breast, redness, and on an unspecified date anxiety, scratched, felt tired. Patient stated that she had the first dose of the pfizer covid 19 vaccine on 02Mar2021. She stated that on Tuesday she got a hive on her breast and the next day on her arms. Shewanted to know if she should take benadryl. On Monday or Tuesday she had hives on her left breast. Later in the night it was not all over but it was on her breast.  She has had hives before and it scared her. It was gone the next morning but she had redness. She did some gardening yesterday and was scratched and had some redness. She is a breast cancer survivor. Her sister said she may have had a reaction to the vaccine. She can't use the left arm because she has no lymph nodes and has had a mastectomy. She was told she might have to use a leg to get the vaccine. She did call Pfizer to confirm the site that could be used. She has anxiety because she has to go Tuesday to get the second shot. The hives are gone. She does not have any itching. She used calamine lotion on it. Yesterday she had an area on her arm. It was definitely hives. She takes a medication for her blood pressure. She does not know what the name is. It starts with the letter C. Is that the same as a blood thinner. She can go to the see her doctor tomorrow if there is an issue. Therapeutic measures were taken as a result of she got a hive on her breast and the next day on her arms/hives on left breast (urticaria).The clinical outcome of the event urticaria was recovered with sequelae, redness with recovering and rest of all event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Headache, Pyrexia
Clinical narrative: inappropriate schedule of vaccine administration (First dose on 17Mar2021/Second dose on 23Mar2021); lack of appetite; Fever; chill; weakness; headache; This is a spontaneous report from a contactable consumer or other HCP (Patient, reported for self). A 42-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: EL3247) via an unspecified route of administration, administered on left arm on 17Mar2021 (at the age of 42-year-old) as dose 1, single. Patient also received second dose via an unspecified route of administration, administered on left arm on 23Mar2021 as dose 2, single (at the age of 42-year-old) for COVID-19 immunization. The Relevant medical history included High blood pressure from an unknown date unknown if it was ongoing. Concomitant medication was not reported. Patient had no known allergies. Patient was not pregnant at the time of vaccination. Patient did not receive any other medications within two weeks and no other vaccine with four weeks. Prior to vaccination, patient was not diagnosed with covid. It was reported that on 17Mar2021 patient experienced Fever, chill, weakness, headache, lack of appetite and inappropriate schedule of vaccine administration (23Mar2021). Patient did not receive any treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the reported events was recovering.  No follow up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Vomiting
Clinical narrative: Fever; Headache; vomiting or puking; This is a spontaneous report from a contactable consumer or other non hcp from a Pfizer-sponsored program. A 76-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 15Mar2021 09:30(at the age of 76-years) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included Blood pressure high. The patient's concomitant medications were not reported. The patient experienced fever headache and vomiting or puking on 15Mar2021. The events were assessed as non-serious. The patient received one Tylenol every four hours, unknown strength, for treatment of fever, headache, and vomiting. The events outcome was reported as unknown.   Additional Context: Consumer says his mom had her first dose of the Pfizer COVID-19 vaccine shot yesterday at 09:30 and when she come home she was fine, then later had fever, headache, and vomiting or puking until now. Caller says he would like to know should he take her to hospital. Consumer says that he does not have his mom's vaccine card to provide NDC/LOT/EXP from it for the Pfizer COVID-19 vaccine. He says that she took one Tylenol every four hours, unknown strength, for treatment of fever, headache, and vomiting. No further details provided about patient's Tylenol. Concomitant Medications/Other Medical Conditions: Caller says his mom takes high blood pressure medication that is it, unable to confirm if this medication is new or not, caller just kept repeating high blood pressure.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain
Clinical narrative: His neck has been killing him; the top of his shoulder and is going to his neck and he can't get any relief from that like it won't stop hurting; His neck has been killing him; the top of his shoulder and is going to his neck and he can't get any relief from that like it won't stop hurting; This is a spontaneous report from a contactable consumer (wife) reporting for a patient (Husband). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/lot number, NDC number, UPC number and Expiry date are unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient's medical history included back (back disorder) from an unspecified date. Concomitant medication included cyclobenzaprine (CYCLOBENZAPRINE, NDC number, UPC number and Expiry date are unknown) taken for back (back disorder), start and stop date were not reported. Reporter (Wife calling on behalf of her husband) stated that she was actually on hold for her husband (Initial captured as UNKNOWN). He is the one that got the vaccine, is that okay? He had a conference call. He was on hold for so long, he gave the phone to her. She asked, So, do you need his information then? He filled out the form online too. But he got the vaccine on Friday and then on Saturday he started getting (incomplete sentence). On an unspecified date, the patient experienced his neck has been killing him since Saturday like it started on the top of his shoulder and is going to his neck and he can't get any relief from that like it won't stop hurting. So, we just did not know if he could take a, he has Cyclobenzaprine, a muscle relaxant for his back, like he normally takes for his back and he has not been taking since he got his vaccine on Friday. So, we did not know if that was something she could take or if that would react with COVID Shot?" The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lymphadenopathy, Mammogram, Nausea
Clinical narrative: Headache; Body aches; Fever; Chills; Nausea; enlarged lymph nodes found in a mammogram.; This is a spontaneous report from a contactable Consumer (patient, reported for self). A 44-years-old (non-pregnant) female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EL3247) via an unspecified route of administration in arm left on 17Mar2021 10:15 (age at vaccination 44 years) as dose 2, single for COVID-19 immunization. Patient was not pregnant at the time of vaccination. The patient medical history was not reported. Patient received no other vaccine in four weeks, had no COVID prior vaccination. Patient had no known allergies. Other medical history were none. Patient received concomitant therapy/ Other medications in two weeks (unspecified). Patient had earlier received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EL3247) via an unspecified route of administration in right arm on 24Feb2021 10:15 (age at vaccination 44 years) as single dose for COVID-19 immunization. On 17Mar2021 23:00, the patient experienced headache, body aches, fever, chills, nausea and enlarged lymph nodes found in a mammogram. Patient had not tested COVID post vaccination. The patient underwent lab test and procedures which includes enlarged lymph nodes found in a mammogram (17Mar2021). Patient had not received treatment for the adverse events. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Headache; Body aches; Fever; Chills; Nausea; enlarged lymph nodes found in a mammogram.; This is a spontaneous report from a contactable Consumer (patient, reported for self). A 44-years-old (non-pregnant) female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EL3247) via an unspecified route of administration in arm left on 17Mar2021 10:15 (age at vaccination 44 years) as dose 2, single for COVID-19 immunization. Patient was not pregnant at the time of vaccination. The patient medical history was not reported. Patient received no other vaccine in four weeks, had no COVID prior vaccination. Patient had no known allergies. Other medical history were none. Patient received concomitant therapy/ Other medications in two weeks (unspecified). Patient had earlier received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EL3247) via an unspecified route of administration in right arm on 24Feb2021 10:15 (age at vaccination 44 years) as single dose for COVID-19 immunization. On 17Mar2021 23:00, the patient experienced headache, body aches, fever, chills, nausea and enlarged lymph nodes found in a mammogram. Patient had not tested COVID post vaccination. The patient underwent lab test and procedures which includes enlarged lymph nodes found in a mammogram (17Mar2021). Patient had not received treatment for the adverse events. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: I feel tired all the time; Running a fever all day long; This is a spontaneous report from a contactable Consumer or other non-health professional (Patient). A female patient of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: EN6198) via an unspecified route of administration on 16Mar2021 as dose 2, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Patient stated that I received the shot on yesterday and I feel tired all the time. Yesterday, I received the shot, and, on this day, I seemed to be running a fever all day long. She was wondering whether running a fever was normal. Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Body temperature, Cough, Drainage
Clinical narrative: cough; lost her sense of taste and smell; lost her sense of taste and smell; muscle weakness; fever of 102 degrees; Vomiting; muscles are not working; clear drainage; Feels like she has either sinus or the flu; felt outside of her body; Feels like she has either sinus or the flu; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, lot number: EN6202 and expiration date: May2021) via an unspecified route of administration in arm right on 11Mar2021 (age at vaccination 63 year) as single for COVID-19 immunization. Medical history included adult-onset mitochondrial myopathy from 2000. Concomitant medications included hydrochlorothiazide, lisinopril 12.5 mg for blood pressure from 2018 and sertraline 100 mg for depression. Patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, lot number: EL9264) via an unspecified route of administration in arm right on 18Feb2021 (age at vaccination 63 year) as single dose for COVID-19 immunization and experienced shoulder pain. On 12Mar2021, the patient experienced cough, vomiting, lost her sense of taste and smell, muscle weakness, fever of 102 degrees, felt outside of her body, felt like she has either sinus or the flu, her muscles are not working. On an unspecified date in Mar2021, the patient experienced clear drainage. On 12Mar2021, the patient underwent lab tests and procedures which included body temperature 102. Seriousness of the events were unspecified. The outcome of the events cough, lost her sense of taste and smell, muscle weakness, fever of 102 degrees, vomiting, muscles are not working was not recovered. The outcome of the events felt outside of her body, felt like she has either sinus or the flu was unknown. On an unspecified date in Mar2021, clear drainage resolved.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Malaise, Muscle disorder, Muscular weakness, Pyrexia
Clinical narrative: cough; lost her sense of taste and smell; lost her sense of taste and smell; muscle weakness; fever of 102 degrees; Vomiting; muscles are not working; clear drainage; Feels like she has either sinus or the flu; felt outside of her body; Feels like she has either sinus or the flu; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, lot number: EN6202 and expiration date: May2021) via an unspecified route of administration in arm right on 11Mar2021 (age at vaccination 63 year) as single for COVID-19 immunization. Medical history included adult-onset mitochondrial myopathy from 2000. Concomitant medications included hydrochlorothiazide, lisinopril 12.5 mg for blood pressure from 2018 and sertraline 100 mg for depression. Patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, lot number: EL9264) via an unspecified route of administration in arm right on 18Feb2021 (age at vaccination 63 year) as single dose for COVID-19 immunization and experienced shoulder pain. On 12Mar2021, the patient experienced cough, vomiting, lost her sense of taste and smell, muscle weakness, fever of 102 degrees, felt outside of her body, felt like she has either sinus or the flu, her muscles are not working. On an unspecified date in Mar2021, the patient experienced clear drainage. On 12Mar2021, the patient underwent lab tests and procedures which included body temperature 102. Seriousness of the events were unspecified. The outcome of the events cough, lost her sense of taste and smell, muscle weakness, fever of 102 degrees, vomiting, muscles are not working was not recovered. The outcome of the events felt outside of her body, felt like she has either sinus or the flu was unknown. On an unspecified date in Mar2021, clear drainage resolved.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis, Vomiting
Clinical narrative: cough; lost her sense of taste and smell; lost her sense of taste and smell; muscle weakness; fever of 102 degrees; Vomiting; muscles are not working; clear drainage; Feels like she has either sinus or the flu; felt outside of her body; Feels like she has either sinus or the flu; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, lot number: EN6202 and expiration date: May2021) via an unspecified route of administration in arm right on 11Mar2021 (age at vaccination 63 year) as single for COVID-19 immunization. Medical history included adult-onset mitochondrial myopathy from 2000. Concomitant medications included hydrochlorothiazide, lisinopril 12.5 mg for blood pressure from 2018 and sertraline 100 mg for depression. Patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, lot number: EL9264) via an unspecified route of administration in arm right on 18Feb2021 (age at vaccination 63 year) as single dose for COVID-19 immunization and experienced shoulder pain. On 12Mar2021, the patient experienced cough, vomiting, lost her sense of taste and smell, muscle weakness, fever of 102 degrees, felt outside of her body, felt like she has either sinus or the flu, her muscles are not working. On an unspecified date in Mar2021, the patient experienced clear drainage. On 12Mar2021, the patient underwent lab tests and procedures which included body temperature 102. Seriousness of the events were unspecified. The outcome of the events cough, lost her sense of taste and smell, muscle weakness, fever of 102 degrees, vomiting, muscles are not working was not recovered. The outcome of the events felt outside of her body, felt like she has either sinus or the flu was unknown. On an unspecified date in Mar2021, clear drainage resolved.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Headache, Pyrexia
Clinical narrative: headache; fever of 99 degrees/ fever goes to 100 degrees; joints started to sour/sourness increased; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 45-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6203), via an unspecified route of administration, administered in Arm Left on 17Mar2021 at 15:30/03:30 PM (at the age of 45-years-old) as dose 2, single for COVID-19 immunisation. The patient had no known allergies. No other medical history and no concomitant medications (in two weeks) were reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 25Feb2021 at 10:45 AM (at the age of 45-years-old) as dose 1, single for COVID-19 immunisation. Facility type vaccine was other. The patient did not take other vaccine in four weeks. The patient had no covid prior vaccination, was not covid tested post vaccination. The patient stated that the next morning, on 18Mar2021 at 08:00 AM, she started to feel a headache. Then by noon time (unspecified), she got a fever of 99 degrees and my joints started to sour. By evening, the fever got to 100 degrees and the sourness increased. Treatment taken was with a tablet of Advil. Then on 19Mar2021, she woke up, all the symptoms were done, and she was back to normal. The patient underwent lab test and procedure which included Fever: 99 degrees on 18Mar2021 (noon time), Fever: 100 degrees on 18Mar2021 (By evening). The events outcome was resolved on 19Mar2021.  No follow-up attempts were possible. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Somnolence
Clinical narrative: tired; chills; Sleeping more than ever; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2, DOSE 1, SINGLE for covid-19 immunisation. Patient was a consumer who wanted to know when she will be fully protected after receiving both doses of the Pfizer-BioNTech Covid 19 vaccine? She had both doses when it takes effect. So tired and some chills. Sleeping more than ever. She did take something to help me sleep but I was really sleeping a lot. Can she take all my medications, again? Patient was a consumer who reported feeling tired and some chills after receiving both of her doses of Pfizer-BioNTech Covid 19 vaccine. She also stated that she "takes something to help me sleep" but since receiving the vaccine she was "been sleeping a lot". The clinical outcome of the events was unknown at the time of report. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; This is a spontaneous report received from a 58-years-old female contactable consumer (patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced dizziness on an unspecified date. Caller stated she had dizziness two days after the first dose that went away and she told her primary care doctor and they told her it was okay and she received her second dose yesterday. Caller stated if she had known there was a possibility of unknown side effects she would not have gotten the vaccine. The outcome of event was recovered on an unspecified date.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Taste disorder
Clinical narrative: she got a sweet taste that turned salty and then metallic; tingling sensation; This is a spontaneous report from a contactable consumer (patient's parent) reporting for her daughter (patient). A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter stated that her daughter received the first dose of the Pfizer COVID vaccine the previous day. The reporter stated that after 5 minutes, the patient experienced, she got a sweet taste that turned salty and then metallic within 10 minutes and a tingling sensation on an unspecified date. The reporter stated that they went back into the vaccination facility and was told to contact their primary care provider for assistance. The reporter would like to know if these side effects have been reported? She would like to know if her daughter should receive the second dose? She would like to know if she receives the second dose will her symptoms be more severe? The outcome of events was unknown.  Information about the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Pruritus, Rash
Clinical narrative: Allergies like reddish with itchiness rashes; Allergies like reddish with itchiness rashes; Allergies like reddish with itchiness rashes; Allergies like reddish with itchiness rashes; This is a spontaneous report from a contactable consumer received from a Pfizer Sponsored Program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on 08Mar2021 as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, the caller, (name withheld) called to ask whether she needs to continue taking Zyrtec 10 mg for allergy and to ask about an outdoor immune suppressor medication she heard about. According to (name withheld), she had her first dose of the covid-19 vaccine on 08Mar2021 and since then she had been taking anti-allergy (Zyrtec tablet 10 mg) and stopped, about 2 or 3 days ago, on an unspecified date in Mar2021, she had some allergies like reddish with itchiness rashes after stopping in taking Zyrtec 10 mg 2 or 3 days ago also. In addition, (name withheld) second dose was scheduled on 30Mar2021. Any unaddressed medical questions referred or forwarded to Medical Information was reported as no. The outcome of the events was unknown.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.