chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cough, Hypersensitivity, Rhinorrhoea, Secretion discharge
Clinical narrative: I have had the cough and running nose; My nose is just like watery; then I have lot of mucous; Allergy; I have had the cough and running nose; 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: EP5534), dose 1 via an unspecified route of administration on Mar2021 as dose 1, single for covid-19 immunisation. Medical history included Congestive heart failure from an unknown date. It was reported that patient take his blood pressure medicine. The patient experienced i have had the cough and running nose (rhinorrhoea and cough), my nose is just like watery; then i have lot of mucous (secretion discharge), allergy on an unspecified date. It was reported that patient have had the first shot at On Sunday and patient have second shot, but she had the cough and running nose. his nose is just like watery and then she has lot of mucous will that shot (Unspecified Vaccine) bother what she got this allergy or whatever. It was reported that patient had 2nd shot on 11Apr2021. It was reported that patient take his blood pressure medicine. patient have been taking Benadryl (Treatment) for this drainage. The patient underwent lab tests and procedures which included blood test: unknown result on Feb2021, blood test: unknown result on Mar2021. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Asthenia, Musculoskeletal stiffness, Potentiating drug interaction
Clinical narrative: Having a lot of muscle pain and stiffness; stiffness is horrible; I noticed that one of the Ingredient in the Pfizer BioNTech Vaccine is potassium chloride, I also take some pills of potassium chloride I take it so, Is this going to affect or something; It's hard getting up; This is a spontaneous report from a contactable consumer (Patient).  A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: EP7533, Expiry Date: Unknown) via an unspecified route of administration ,administered in left arm(Left shoulder) on 30Mar2021 as dose 1, single for COVID-19 immunization: Potassium Chloride (POTASSIUM CHLORIDE, Formulation: Tablet, Lot number: unknown, Expiry: Unknown) via an unspecified route of administration on an unknown date unknown dose and frequency for an unspecified indication and unknown if ongoing. Medical history included Heart disease, Blood pressure high, Cholesterol everything ongoing from an unknown date. Concomitant medications included Metoprolol 12.5mg once a day, Amlodipine 5mg once a day, Apixaban (ELIQUIS) 5mg twice a day, Flecainide Acetate 50mg twice a day all via an unspecified route of administration from an unknown date for an unspecified indication unknown if ongoing. It was reported that "I also take the water pills, 'Hydrochlorothiazide' but I do not take it every day, I was on blood thinner (clarification unknown". It was reported that on an unspecified date patient experienced "Having a lot of muscle pain and stiffness; stiffness is horrible, it's hard getting up". Patient stated Weeks before that he was having muscle tightness, but it got better but the pain came back after taking the vaccine. Also stated he was having a lot of muscle pain and stiffness when he wakes up in the morning and they said it would go away in few days," What's few days, it's painful". "I was fine till I got the vaccine, I was doing good before I took the vaccine". Patient queried that he noticed one of the Ingredient in the Pfizer BioNTech Vaccine was potassium chloride, he also takes some pills of potassium chloride he takes it so, was this going to affect or something. Due date of second shot was on 20Apr2021.Patient did not receive any treatment for the events ("No, when I have muscle tightness, I have to do exercise. I took the Tylenol; it is 500 mg, but I only take half of it. I take it in the morning sometimes in the evening depends on the severity of the pain"). Patient did not receive any treatment for events. The Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: I started having a dry like I was coming down with a cold.; I started getting aches and pain in my body.; I could hardly walk.; My muscles and my joints not so much my joints as much as my muscles were very sore.; Headache; I had slight fever.; My muscles and my joints not so much my joints as much as my muscles were very sore.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 25Mar2021 16:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 Immunization. Medical history included covid-19 from Jul2020 to an unknown date (first of all I need to tell you I had COVID myself the last part of July and I had it for almost four weeks in August and I finally got okay and did not have go to the hospital and didn't have the respiratory issue at that time) fluid around heart, scar tissue from an unknown date and unknown if ongoing (I have fluid around my heart and I have some scar tissue on my lungs). The patient's concomitant medications were not reported. The patient stated, "Well I want to hear not to get the Covid vaccine took the first shot on 25Mar2021, and the doctor recommended that I get the shot. Hence, I wanted to hear not got the vaccine and it was Pfizer vaccine. I came home that evening, we got it in the afternoon it was about 4 o clock in the afternoon when I got the shot but 8 o clock at night, I started having a dry like I was coming down with a cold and I started getting aches and pain in my body. I slept alright that night, it was not that severe, the next day I could hardly walk, my muscles and my joints not so much my joints as much as my muscles were very sore. I had a headache. I had slight fever which I never had real high fever when I had the disease itself. I had a fever and I thought it would go away well as the days went on but Saturday (date not specified), this I got shot on Thursday and by Saturday and Sunday (dates not specified) I thought I was not even going to be able to walk, it was so bad and it started subsiding and then on Monday (dates not specified) a little bit but it continued with the muscle ache and headache not the severe headache like I had when I had COVID disease but I still had a headache. So, now it finally went away yesterday (dates not specified). I felt better but I still had some underlying issues with the backs of my legs and backs of my arms in the muscle. So now I was supposed to go get the another shot on the 15th and I, I did not know if I should or if I should not get the second shot because I had such a reaction to the first one. I am afraid to go get the second one. So, I was calling to get advice on that." The clinical outcome of the event I had slight fever was recovered on an unspecified date, Headache was not recovered and remaining all other events was unknown at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Headache
Clinical narrative: Headache; Chest pain; This is a spontaneous report from a contactable consumer. A 63-year-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: ER2613), dose 1 via an unspecified route of administration on 24Mar2021 (Batch/Lot Number: ER2613) as dose 1, single for covid-19 immunisation (at the age of 63-year-old). Medical history included High blood pressure from an unknown date and unknown if ongoing. Concomitant medications included paracetamol (TYLENOL) 500mg, felodipine (FELODIPINE) 5 mg, once a day, Vitamins taken for an unspecified indication, start and stop date were not reported. The patient experienced headache, Chest pain. Consumer stated, I have been having side effects from the Pfizer shot that I got. Consumer stated, I took some Aleve one day and then I took some Tylenol. Tylenol don't agree with me, so I have not taken down no more of, so that's about its Aleve and Tylenol, or I can say I have taken that one day (voice feeble). The Tylenol that I took it was 500 mg. The Aleve, they are 220 mg. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: UTI; This is a spontaneous report received from a contactable consumer (patient). A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: EP7534, Expiry Date: Unknown) via an unspecified route of administration, administered in left arm  on 23Mar2021 15:00 (at the age of 60-year-old) as dose 1, single for COVID-19 immunization and Cefalexin (CEPHALEXINE, Capsule, Lot number: unknown, Expiry Date: Unknown) 500mg four times day via orally for 5days indicated for UTI (Urinary tract infection) from 08Apr2021 unknown if ongoing. Medical history included Paraplegic from an unspecified date in 2011 and unknown if ongoing ("diagnosed after a motorcycle accident, he was a T10 complete, and because of that nothing works right below the sternum"). Concomitant medications were there. The patient had not received any other vaccine within 4 weeks or on the same day as getting the COVID-19 vaccine. It was reported that on 08Apr2021 patient experienced UTI ("an Internal Infection"). Reporter stated UTI started several days ago and was diagnosed yesterday. Reporter seriousness for UTI was unspecified. Patient was scheduled for his second COVID-19 shot on 13Apr2021.Reporter wanted to know was it safe to get the second shot with an active UTI infection and while taking antibiotics. Patient also stated he was old, and his eyesight was not so good now. He said that this medication was dispensed in an orange pharmacy bottle, there was some writing that was too small for him to read, it was a standard sized red capsule. Therapeutic measures were taken as a result of the events which included on 08Apr2021 Antibiotic therapy (Cephalexin," started taking it yesterday about noon"). Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Eyelid oedema, Oedema
Clinical narrative: edema on chin and lower eyelids; edema on chin and lower eyelids; This is a spontaneous report from a non-contactable other healthcare professional (patient). A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was previously injected with 1ml Voluma in temples, 3 ml Voluma cheeks, 1 ml Volift midface, 1 ml Volbella tear trough and 3 ml Volux in chin. 2 months later patient also received 0.5 ml non-Allergan dermal filler in lips and a small correction of 0.1 ml in the left tear trough. Following month, patient received a COVID-19 vaccine. Next morning, patient woke up in the morning with oedema on chin and lower eyelids. Outcome of the events was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Inflammation, Loss of personal independence in daily activities, Lymphadenopathy, Swelling
Clinical narrative: Extreme vertigo onset about 7 days after second shot; The vertigo lasted several days and caused patient to miss work and hobbies; Swelling/inflammation of previous melanoma site and surgical scar on inner left arm (vaccination site was also left arm) - no other scars were inflamed during this time; Swelling/inflammation of previous melanoma site and surgical scar on inner left arm (vaccination site was also left arm) - no other scars were inflamed during this time; Very uncomfortable and alarming side effect; Swollen lymph nodes on left side of neck; This is a spontaneous report from a contactable consumer or other non-health care professional. A 41-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: solution for injection, Batch/Lot Number: EP7534), dose 2 via an unspecified route of administration, administered in left arm on 01Apr2021 (age at the time of vaccination was 41-year-old) as dose 2, single for COVID-19 immunisation. The patient's medical history included previous melanoma, surgical scar on inner left arm. The patient's concomitant medications were not reported. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: solution for injection, Batch/Lot Number: Eh6204), dose 1 via an unspecified route of administration, administered in the left arm on 10Mar2021(age at the time of vaccination was 41-year-old) as dose 1, single for COVID-19 immunisation. It was not reported whether the patient had any other vaccine in 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On an unspecified date in Apr2021, the patient experienced swelling/inflammation of previous melanoma site and surgical scar on inner left arm (vaccination site was also left arm) - no other scars were inflamed during this time. The patient reported that this was the only skin cancer site. The patient described this as very uncomfortable and alarming side effect. On an unspecified date in Apr2021, the patient also experienced swollen lymph nodes on left side of neck. This prompted the patient to seek medical care due to concerns of recurrent cancer. On 08Apr2021, the patient experienced extreme vertigo onset about 7 days after second shot and the vertigo lasted several days and caused patient to miss work and hobbies. The adverse events resulted in doctor/health care professional office/clinic visit. It was reported as unknown for the treatment details of adverse events. The events were considered as non-serious and did not result in death/ Life threatening/Caused/prolonged hospitalization/Disabling/Incapacitating/Congenital anomaly/birth defect. The patient recovered from the events on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Extreme vertigo onset about 7 days after second shot; The vertigo lasted several days and caused patient to miss work and hobbies; Swelling/inflammation of previous melanoma site and surgical scar on inner left arm (vaccination site was also left arm) - no other scars were inflamed during this time; Swelling/inflammation of previous melanoma site and surgical scar on inner left arm (vaccination site was also left arm) - no other scars were inflamed during this time; Very uncomfortable and alarming side effect; Swollen lymph nodes on left side of neck; This is a spontaneous report from a contactable consumer or other non-health care professional. A 41-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: solution for injection, Batch/Lot Number: EP7534), dose 2 via an unspecified route of administration, administered in left arm on 01Apr2021 (age at the time of vaccination was 41-year-old) as dose 2, single for COVID-19 immunisation. The patient's medical history included previous melanoma, surgical scar on inner left arm. The patient's concomitant medications were not reported. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: solution for injection, Batch/Lot Number: Eh6204), dose 1 via an unspecified route of administration, administered in the left arm on 10Mar2021(age at the time of vaccination was 41-year-old) as dose 1, single for COVID-19 immunisation. It was not reported whether the patient had any other vaccine in 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On an unspecified date in Apr2021, the patient experienced swelling/inflammation of previous melanoma site and surgical scar on inner left arm (vaccination site was also left arm) - no other scars were inflamed during this time. The patient reported that this was the only skin cancer site. The patient described this as very uncomfortable and alarming side effect. On an unspecified date in Apr2021, the patient also experienced swollen lymph nodes on left side of neck. This prompted the patient to seek medical care due to concerns of recurrent cancer. On 08Apr2021, the patient experienced extreme vertigo onset about 7 days after second shot and the vertigo lasted several days and caused patient to miss work and hobbies. The adverse events resulted in doctor/health care professional office/clinic visit. It was reported as unknown for the treatment details of adverse events. The events were considered as non-serious and did not result in death/ Life threatening/Caused/prolonged hospitalization/Disabling/Incapacitating/Congenital anomaly/birth defect. The patient recovered from the events on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: She had different allergies; This is a spontaneous report from a Pfizer Sponsored Program via a consumer or other non hcp (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced she had different allergies on an unspecified date. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Joint swelling, Systemic lupus erythematosus
Clinical narrative: she said she was getting lupus flare-ups; she said she was getting lupus flare-ups; Her wrist was swollen and hurting; Her wrist was swollen and hurting; This is a spontaneous report from a Pfizer-sponsored program from a contactable pharmacist reported for a 25-year-old female patient. A 25-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route on 05Apr2021, as a single dose for covid-19 immunization. Medical history included lupus. The patient concomitant medications were not reported. On an unknown date in Apr2021 (on Tuesday or Thursday), she said she was getting lupus flare-ups. The only thing she can attribute it to be the vaccine. Her wrist was swollen and hurting on unknown date in Apr2021. Reporter would like to know whether there was any correlation between the patient lupus flare-up (swelling and pain in the wrist) and the covid vaccine. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the current information available and considering drug-event temporal association a possible contributory role of the suspect BNT162B2 cannot be completely excluded for the reported events of Lupus flare-ups, Swollen wrists and Wrist pain. The case will be reassessed further upon receipt of additional information. 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.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypersensitivity
Clinical narrative: developed an allergic reaction; had difficulty breathing; This is a spontaneous report received from a contactable consumer (parent). A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number and expiration date were not reported), via an unspecified route of administration on 26Mar2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Three days later on 29Mar2021, the patient developed an allergic reaction and she had difficulty breathing. Events were assessed as non-serious by the reporter. The outcome of the events was unknown. The reporter was querying if the patient should get the second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Headache, Pruritus
Clinical narrative: Itching; Exhausted; headache; back pain; This is a spontaneous report received from a contactable consumer (patient). A 42-years-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: En6208, Expiration date was not reported), via an unspecified route of administration in arm left on 12Mar2021 at 11:45 AM (at the age of 42-year-old) as a dose 1, single for COVID-19 immunization. The patient's medical history included lupus, hashimoto. The patient had known allergies to intravenous iodine. The patient's concomitant medications in two weeks included hydroxychloroquine sulfate (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), escitalopram oxalate (LEXAPRO), vit d [vitamin d nos], all were taken for an unspecified indication. It was reported that, the patient was not pregnant at time of vaccination. No other vaccine in four weeks was reported. No covid prior vaccination and no covid tested post vaccination. On 12Mar2021 at 13:45, 2 hours after vaccination, the patient experienced back pain. On 13Mar2021 at 11:45, next day after vaccination, the patient experienced exhausted and headache with still pain. On 15Mar2021 at 11:45, the patient experienced itching (on 3rd day). Treatment was not received for the events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: she took her alendronate Sodium (note she skipped her dose on date of vaccination to avoid interaction) within the hour the injection location swelled up into a hard ball with intense itching; she took her alendronate Sodium (note she skipped her dose on date of vaccination to avoid interaction) within the hour the injection location swelled up into a hard ball with intense itching; Pain and swelling for about 3days at injection location.; Pain and swelling for about 3days at injection location.; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 23Feb2021 at 09:00 (at the age of 65-year-old) as a dose 1, single for COVID-19 immunisation. Medical history included Hashimoto's thyroiditis, osteoarthritis, and osteoporosis. The patient was allergic to medications, food, or other products but unspecified. Concomitant medications included alendronate sodium and levothyroxine sodium (SYNTHROID) both taken for an unspecified indication, start and stop dates were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an 23Feb2021, the patient experienced pain and swelling for about 3 days at injection location. On 01Mar2021, after exactly one week, she took her alendronate Sodium (note she skipped her dose on date of vaccination to avoid interaction), within the hour, the injection location swelled up into a hard ball with intense itching which lasted several days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events pain and swelling for about 3 days at injection location were recovered on 26Feb2021. The clinical outcome of the event injection location swelled up into a hard ball with intense itching were recovered in 2021 on an unknown date. No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: first dose just a sore arm with swelling in the hand and arm; first dose just a sore arm with swelling in the hand and arm; first dose just a sore arm with swelling in the hand and arm; This is a spontaneous report from a contactable consumer (patient).   A 52-years-old (non-pregnant) female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: not reported) via an unspecified route of administration, administered in arm right on 22Mar2021 at 10:30 (at the age of 52-years-old) as dose 1, single for covid-19 immunisation. Patient's medical history was reported as none. Patient had no known allergies. The patient was not pregnant at time of vaccination. Concomitant medication included escitalopram, cetirizine hydrochloride (ZYTREC) (in two weeks). The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not having covid prior vaccination and has not been covid tested post vaccination. On 12Apr2021 at 18.00, the Patient experienced after first dose just a sore arm with swelling in the hand and arm. It was unknown that the patient received the treatment for adverse event. The outcome of the events was unknown.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Lymphadenopathy
Clinical narrative: she developed swelling in her lymph nodes; This is a spontaneous report from a contactable consumer. This consumer (patient reported for herself):  A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN6206), via unspecified route of administration, in left arm on 15Mar2021 10:15 (at the age of 36-year-old) as a dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EW0150), via unspecified route of administration, in left arm on 11Apr2021 10:15 as a dose 2, single for COVID-19 immunization. The patient medical history included Crohn's disease. The concomitant medication of the patient included mesalamine (MESALAMINE). On 22Mar2021 the patient experienced swelling in her lymph nodes. The patient stated that 7 days after her first Pfizer COVID vaccine, she developed swelling in her lymph nodes, mainly in the clavicle area. It went down, and it was persisting. Patient stated that yes, I still have it, just persisting, it's less swollen but it is still persisting. It had been about 30 days. Patient was asking if she should seek medical attention. Patient stated that she had her second shot on 11Apr2021. Patient reported that she recently got second vaccine but prior to the second vaccine, the first one patient just noticed in about may be in week or so she just developed some swollen lymph node on her lower neck or on her clavicle area and wanted to ask is that something that should go away soon or it's going to take some time. Patient also stated that she had done blood work don't know the exact date but in early March. She read about the side effects which said that that could occur. Patient wanted to know if she should she seek medical assistance or wait a couple of weeks. Patient was informed about a Safety report and patient stated that she had already spoke with someone from another department today who ask her questions and was told she needed to contact the safety department as well. Patient was ok to report her experience. Patient not received any treatment for the reported event. On an unspecified date of Mar2021 the patient underwent lab tests and procedures which included Blood test (blood work) with unknown results. Outcome for the reported event was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pruritus, Pyrexia
Clinical narrative: Had headache and a temperature of 102.1; Chills; Fever/ temperature of 102.1; Nausea; Reddening in the arm where the injection was administered and like a darkened area; Itching; This is a spontaneous report from a contactable consumer (Patient). A 81-year-old male patient had received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: ER8737, Expiry Date: Unknown) via an unspecified route of administration on 07Apr2021 as DOSE 2, SINGLE for covid-19 immunization (at the age of 81 years).The patient medical history and concomitant were not reported. The patient previously took bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on 17Mar2021 as DOSE 1, SINGLE for covid-19 immunization. On an unspecified date the patient had experienced headache, temperature of 102, chills, fever, nausea, reddening in the arm where the injection was administered and like a darkened area and Itching. The patient reported that, my first inoculation was on 17Mar2021, and I had absolutely no problems. My second dose on 07Apr2021 I had headache and a temperature of 102.1. I had chills, fever, and nausea. Which I understand those are the common side effects. Now, I also noticed the reddening in the arm where the injection was administered and like a darkened area. Now, is this common with the second injection because I had absolutely nothing with the first. My question is can I use Benadryl because it itches though. Reporter stated, In the evening would be better. Not right now. I just want to know what I can do with the itching problem. I just want to know if I can use some medication for stopping itching. That was the only concern that I had. A red area and it's like other area; it is itching; that area that got the injection site has like a bruise, it did look like a bruise (as said no like so did not capture separate event); it's red and flat. Patient further stated, I had several reactions the one I want to ask you about it's like a red area and it's like other area seems to be like, I don't know if it's from the injection site, it is itching, now would I be able to use Benadryl, for itching because I don't want to interfere with the COVID. Can I use the Benadryl for the itching? Pfizer number is ER8737. That is the one where I got all the reaction, I didn't have that with 1st shot but with second one I definitely did." Patient further stated, "I hear a lot of side effects with 2nd not with the first and that is where I don't know what to do. On an unspecified date the patient underwent lab tests and procedures which included body temperature and diagnosed with 102.1. It was reported that patient had a query he could take Benadryl or not, taken treatment is unknown. The outcome of all the events were unknown.  No follow-up attempts are possible. No further information is expected.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Had headache and a temperature of 102.1; Chills; Fever/ temperature of 102.1; Nausea; Reddening in the arm where the injection was administered and like a darkened area; Itching; This is a spontaneous report from a contactable consumer (Patient). A 81-year-old male patient had received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: ER8737, Expiry Date: Unknown) via an unspecified route of administration on 07Apr2021 as DOSE 2, SINGLE for covid-19 immunization (at the age of 81 years).The patient medical history and concomitant were not reported. The patient previously took bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on 17Mar2021 as DOSE 1, SINGLE for covid-19 immunization. On an unspecified date the patient had experienced headache, temperature of 102, chills, fever, nausea, reddening in the arm where the injection was administered and like a darkened area and Itching. The patient reported that, my first inoculation was on 17Mar2021, and I had absolutely no problems. My second dose on 07Apr2021 I had headache and a temperature of 102.1. I had chills, fever, and nausea. Which I understand those are the common side effects. Now, I also noticed the reddening in the arm where the injection was administered and like a darkened area. Now, is this common with the second injection because I had absolutely nothing with the first. My question is can I use Benadryl because it itches though. Reporter stated, In the evening would be better. Not right now. I just want to know what I can do with the itching problem. I just want to know if I can use some medication for stopping itching. That was the only concern that I had. A red area and it's like other area; it is itching; that area that got the injection site has like a bruise, it did look like a bruise (as said no like so did not capture separate event); it's red and flat. Patient further stated, I had several reactions the one I want to ask you about it's like a red area and it's like other area seems to be like, I don't know if it's from the injection site, it is itching, now would I be able to use Benadryl, for itching because I don't want to interfere with the COVID. Can I use the Benadryl for the itching? Pfizer number is ER8737. That is the one where I got all the reaction, I didn't have that with 1st shot but with second one I definitely did." Patient further stated, "I hear a lot of side effects with 2nd not with the first and that is where I don't know what to do. On an unspecified date the patient underwent lab tests and procedures which included body temperature and diagnosed with 102.1. It was reported that patient had a query he could take Benadryl or not, taken treatment is unknown. The outcome of all the events were unknown.  No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Myalgia, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Throat Pain, Feels like Swallowing Razor Blades; Mild Fever; Body Aches; Throat Pain, Feels like Swallowing Razor Blades was reported as worsened; sore throat; muscle aches; This is a spontaneous report from a contactable consumer (patient). An 18-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0153, Expiry date: unknown), via an unspecified route of administration in arm right on 08Apr2021 at 14:30 (at the age of 18-years-old) as a dose 1, single for COVID-19 immunization. The family medical history relevant to AE(s) was reported as none. The patient's medical history included ongoing Coxsackievirus, clarified that, she has had Coxsackievirus before and that was what it felt like. There were no concomitant medications. The patient did not took other products. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Additional vaccines administered on same date of the Pfizer suspect was reported as none. Prior Vaccinations within 4 weeks was reported as none. AE following prior vaccinations was reported as none. The caller stated that, she had the vaccine about a week ago and she woke up this morning on 12Apr2021, she experienced body aches and on 13Apr2021, she experienced mild fever and on 14Apr2021, she has much throat pain, feels like she was swallowing razor blades, which was reported as worsened on an unspecified date in Apr2021 and she was achy. The caller asked whether this was normal or if she should go get tested. Clarified that, she has had Coxsackievirus before and that was what it felt like. Clarified that, this was after her first dose. Caller called in because she got the 1st dose of the vaccine on 08Apr2021 and 2 nights ago she started experiencing symptoms. On an unspecified date in Apr2021, she currently has a sore throat and muscle aches. Stated that, she wanted to know whether these are normal side effects and if she needs to test for Covid-19. Any unaddressed medical questions referred or forwarded to the Medical Information was reported as yes. The AE(s) did not require a visit to emergency room and physician office. Patient received treatment with Ibuprofen, yesterday for body aches and cough drops. The outcome for the event body aches was recovering and for mild fever was recovered on 13Apr2021 and for throat pain, feels like swallowing razor blades was not recovered and for sore throat, muscle aches was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Lymphadenopathy, Oropharyngeal pain, Pain
Clinical narrative: whole body pain; sore throat; feels like her glands are swollen; body temperature reached up to 99.5 to 105.5; body temperature reached up to 99.5 to 105.5; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration on 08Apr2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration on 18Mar2021 for COVID-19 immunisation. On an unspecified date, the patient experienced whole body pain, sore throat, feels like her glands are swollen, and body temperature reached up to 99.5 to 105.5. Therapeutic measures were taken as a result of body temperature reached up to 99.5 to 105.5 which included paracetamol (TYLENOL). The outcome of the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: whole body pain; sore throat; feels like her glands are swollen; body temperature reached up to 99.5 to 105.5; body temperature reached up to 99.5 to 105.5; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration on 08Apr2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration on 18Mar2021 for COVID-19 immunisation. On an unspecified date, the patient experienced whole body pain, sore throat, feels like her glands are swollen, and body temperature reached up to 99.5 to 105.5. Therapeutic measures were taken as a result of body temperature reached up to 99.5 to 105.5 which included paracetamol (TYLENOL). The outcome of the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Malaise, Pyrexia
Clinical narrative: did not feel well; fever; This is a spontaneous report from a contactable nurse and a consumer via a Pfizer-sponsored program,  Xeljanz Program. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from an unspecified date at dose number unknown, single for Covid-19 immunization; and tofacitinib citrate (XELJANZ XR), oral from 2018 (Batch/Lot number was not reported; Expiration Date: 30Jan2023) to an unspecified date, at 11 mg, daily for arthropathic psoriasis, and psoriasis vulgaris. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient reported she did not feel well, and she had a fever when she took her covid vaccine on an unspecified date. The action taken in response to the event for tofacitinib citrate was unknown. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain
Clinical narrative: feeling some aches after the second vaccine, but she attributed to the vaccine instead of being off xeljanz; This is a spontaneous report from a contactable consumer(Patient) from a Pfizer sponsored. A 75-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Lot Number: unknown), via an unspecified route of route of administration in Feb2021 (age at vaccination was 75 years) as dose 2, single for COVID-19 immunization and tofacitinib citrate (XELJANZ XR) ongoing since 14Jan2021 at dose of 11 mg once daily via oral route of administration for an unspecified indication. Medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Lot number: unknown) via an unspecified route of administration on unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, the patient feeling some aches after the second vaccine, but she attributed to the vaccine instead of being off xeljanz. The patient was feeling great with xeljanz. Being on xeljanz now consistently after receiving her covid vaccine in February. md is aware. She also reported being off xeljanz for 8 days when she got her second covid vaccine. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: diarrhea; Nausea; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date were not reported) via an unspecified route of administration, administered in the left arm on 06Apr2021 00:45 (at the age of 25 years old) as dose 1, single for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS). The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included buspirone and fluoxetine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Apr2021 10:30, the patient experienced nausea and diarrhea. The events resulted in Emergency room/department or urgent care. The patient was treated with IV and prescription of 15 tablets of ondansetron. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash and itchiness in the back; Rash and itchiness in the back; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: ER8729) via an unspecified route of administration, administered in left arm on 12Apr2021 at 09:15 (at the age of 29-year-old) as dose 1, single for covid-19 immunization. No medical history reported. Patient had no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had been not tested for COVID-19 since the vaccination. On 13Apr2021 at 12:00 the patient experienced rash and itchiness in the back. The case was reported as non-serious. The patient was treated with Benadryl for the events. Outcome of the events were not resolved.  Follow-up attempts completed. No further information expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lethargy
Clinical narrative: Severe joint pain, very lethargic after a week from first vaccination; Severe joint pain, very lethargic after a week from first vaccination; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received BNT162B2 dose 1 via an unspecified route of administration, administered in Arm Right on 22Feb2021 (Batch/Lot number was unknown) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included fibromyalgia treated with savella. The patient's concomitant medications were not reported.  The patient experienced severe joint pain, very lethargic after a week from first vaccination with outcome of unknown. If other vaccine in four weeks: No. if treatment AE: Unknown. if Covid prior vaccination: No. if Covid tested post vaccination: No. Known allergies No.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Ear infection, Headache, Vertigo
Clinical narrative: after second dose, severe headache; continued ear infections; vertigo; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: ER8727) via an unspecified route of administration on 31Mar2021 (at the age of 52-years-old) on left arm as dose 2, single for COVID-19 immunization. Medical history included penicillin allergy. Concomitant medications were reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19 and was not tested for covid post vaccination. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6206) via an unspecified route of administration on an unknown date in Mar2021 at 09:45 (at the age of 52-years-old) on left arm as dose 1, single dose for COVID-19 immunization. On an unknown date the patient experienced severe headache and continued ear infections with added vertigo. Patient was now post-vaccination two weeks. The events resulted in doctor or other healthcare professional office/clinic visit. Steroid treatment was started 5 days after 2nd dose of vaccine. The patient had not recovered.  No follow-up attempts were needed. No further information was expected.