chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Spots on my face, red spots and they continue to get larger and larger; Both side of my face is fiery red and my chin is very rough, its not red but it is very rough; chin is very rough; spots on my face; My arm was sore; Arm was swollen and hard; It was swollen and very firm and I also had a bruise there; My arm was sore; Arm was swollen and hard; It was swollen and very firm and I also had a bruise there; My arm was sore; Arm was swollen and hard; It was swollen and very firm and I also had a bruise there; This is a spontaneous report received from a contactable nurse.  A 87-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0169), dose 1 via an unspecified route of administration, administered in Arm Left on 19Apr2021 (At the age of 87 years) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  Medical history included atrial fibrillation, osteoarthritis, myocardial infarction, three heart attacks and walking aid user from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 19Apr2021, the patient experienced swollen arm and it was hard and very firm. On 20Apr2021, there was bruise on the swollen arm and there spots on the face, red spots and they continue to get larger and larger. On 22Apr2021, both side of the face was fiery red, and chin was very rough. Patient called the family doctor and she ordered Benadryl tablet (treatment) for me and she said before I get the second injection to take one of those before I get the injection. So, I just want you to know about the reaction I had."At the time of reporting the outcome of the events were  unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass
Clinical narrative: had a lump under arm, left arm; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on an unspecified date as a dose 2, single for COVID-19 immunization. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unspecified), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Patient reported, she got a little lump under her neck later clarified the lump was under her arm, left arm, stated where patient received the second dose Pfizer Covid Vaccine. Patient doesn't know if that was from something patient had a long time ago. Seems like it just happened to pop back up. Patient doesn't know if from the Pfizer Covid Vaccine or from detoxing or doesn't know what was going on. Patient detoxed the last couple days, doesn't know if the lump was from the Pfizer Covid Vaccine or the detox. But a lump was there, had a lump a long time ago in right arm, doesn't know where it was from, about to go to the doctor. The clinical outcome for the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vaccination site movement impairment
Clinical narrative: Her neck is swollen; difficulty moving her arm; This is a spontaneous report from contactable consumer (Patient) via Medical Information Team. A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 28Apr2021 (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 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. The patient stated that she got Pfizer 2nd vaccine yesterday. Injection was done a bit higher toward the shoulder joint. Her neck was swollen and have difficulty moving her arm (on an unspecified date). She questioned Anything else than taking Tylenol and putting ice that she could do. Outcome of events was unknown  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chest pain, Pain in extremity, Vaccination site mass, Vaccination site swelling
Clinical narrative: I've felt pain in my arm, lower than where I was injected; I have injection site swelling; The pain spread to the armpit area and part of my chest; The pain spread to the armpit area; I have injection site swelling (small ball); This is a spontaneous report received from a contactable consumer (patient). A 37 years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: unknown), via an unspecified route of administration on 26Apr2021 in arm as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. The patient previously received historical vaccine which included the first dose of bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on an unspecified anatomical location on an unknown date (Batch/Lot number unknown) as dose 1, single for covid-19 immunization. On Monday (26Apr2021), the patient received the second dose of the Pfizer Covid 19 vaccine, since then she had felt pain in her arm, lower than where she was injected, she had injection site swelling (small ball) and the pain spread to the armpit area and part of her chest. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea, Feeling abnormal, Gait disturbance, Headache
Clinical narrative: pain in my left leg; couldn't walk for 3 days; arm is swollen; feel a lot of shortness of breath; I also have headache; vomiting; diarrhea; body pain; I feel very bad overall; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age 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 06Apr2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, patient had received the first dose of Pfizer vaccine on 06Apr2021 and since 07Apr2021 she had pain in her left leg, she could not walk for 3 days, her arm was swollen and she felt a lot of shortness of breath. She also had headache, vomiting, diarrhea, body pain and she felt very bad overall, the worst thing was shortness of breath. She enquired that what could she do? The outcome of all events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Peripheral swelling, Vomiting
Clinical narrative: pain in my left leg; couldn't walk for 3 days; arm is swollen; feel a lot of shortness of breath; I also have headache; vomiting; diarrhea; body pain; I feel very bad overall; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age 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 06Apr2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, patient had received the first dose of Pfizer vaccine on 06Apr2021 and since 07Apr2021 she had pain in her left leg, she could not walk for 3 days, her arm was swollen and she felt a lot of shortness of breath. She also had headache, vomiting, diarrhea, body pain and she felt very bad overall, the worst thing was shortness of breath. She enquired that what could she do? The outcome of all events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Feeling cold, Wheezing
Clinical narrative: Caller states she is "still feeling so weak from her first shot 3 weeks ago.; Right after I got the shot I was weak and so cold; Caller has had abdominal cramping and symptoms of  a UTI since the 1st dose; She has been wheezing since she received the 1st vaccine dose; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution of injection, Lot Number 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 included asthma from an unknown date and if ongoing. The patient concomitant medications were not reported. On an unspecified date, the patient experienced caller states she is "still feeling so weak from her first shot 3 weeks ago, Right after I got the shot I was weak and so cold, Caller has had abdominal cramping and symptoms of a UTI since the 1st dose and she has been wheezing since she received the 1st vaccine dose. The patient reported that the patient went to clinic and to a Urologist and the patient did not have a UTI. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Insomnia, Myalgia, Pain in extremity
Clinical narrative: pain in her joints and muscles; more muscle pain than joint, most notably her back/pain in her joints and muscles; sore arm with her first and second vaccination; having trouble sleeping; more muscle pain than joint, most notably her back; This is a spontaneous report from a contactable consumer or other non hcp (Patient).   A female patient of an unspecified age received bnt162b2 (BNT162B2 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 first dose of bnt162b2 on an unspecified date (Batch/lot number Unknown) for covid-19 immunisation and experienced sore arm. The patient experienced pain in her joints and muscles, more muscle pain than joint, most notably her back, sore arm with her first and second vaccination, having trouble sleeping on an unknown date (on Sunday). It was reported that pain in joints and muscles which has turned into more muscle pain than joint, most notably her back. It was reported that at times her muscle pain eases up but then other times it comes on and sort of wrenches up on her. The patient heard "other people" say they had fever and chills but was unaware muscle pain could be a side effect. The patient wanted to know if it was normal to have lingering muscle pain 4 days post injection and how common this side effect was and how long it might last. The outcome of event sore arm with her first and second vaccination was recovered on an unknown date and outcome of other events reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Joint stiffness
Clinical narrative: fatigued; weak; large joints ache and are stiff; large joints ache and are stiff; This is a spontaneous report from a contactable consumer (patient) via a sales representative. A female patient of an unspecified age received first dose of 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. Medical history included ongoing autoimmune disease from an unknown date. Concomitant medications included Synthroid, a statin, and corticosteroid taken for autoimmune disease. On an unspecified date, patient felt fatigued, weak and her large joints ache and were stiff. Outcome of the events was unknown at the time of reporting.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Blister, Blood test, Computerised tomogram, Pain in extremity
Clinical narrative: pain in his right leg and lower back hurts; rash then he had blisters; rash then he had blisters; pain in his right leg and lower back hurts; This is a spontaneous report from a contactable consumer. This consumer (patient's girlfriend) reported for a male patient that,  A 56-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: ER8733) (at the age of 57 years old), dose 1 via an unspecified route of administration on 25Mar2021 as dose 1, single, dose 2 via an unspecified route of administration on 16Apr2021 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EW0151) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that on an unspecified date, caller stated her boyfriend was the same way, got his Pfizer Vaccines for the first and second dose and he also had pain in his right leg and lower back hurts; had really severe reaction and thought he had poison ivy two days after he had a rash then he had blisters and put Calamine lotion on it and waited till the blisters popped before they went away. She also stated that his rash had kept getting worse and three days ago his lower back was killing him, he could not sleep, sit or lay down and was in the emergency room with back pain and his right leg was kind of like hers but worse and he was kicking it and the leg would not wake up and looked like he was giving birth and went to the emergency room where they did blood work, CT scan and everything and she thought they said he may be having a back spasm and they could not find anything and gave him Lidocaine patches, Flexeril, and Naproxen and he took all of those at the same time but none of them are helping the pain and the pain was only easing away. She also stated that she had no dosages, lot numbers, expiry dates, or NDC numbers for the Lidocaine patches, Calamine lotion, Flexeril patches or Naproxen to provide at that time. The patient underwent lab tests and procedures which included blood test: unknown, computerised tomogram: normal, x-ray: normal on an unspecified date. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of the pfizer suspect. Patient did not have prior vaccination within four weeks. The outcome for the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, X-ray
Clinical narrative: pain in his right leg and lower back hurts; rash then he had blisters; rash then he had blisters; pain in his right leg and lower back hurts; This is a spontaneous report from a contactable consumer. This consumer (patient's girlfriend) reported for a male patient that,  A 56-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: ER8733) (at the age of 57 years old), dose 1 via an unspecified route of administration on 25Mar2021 as dose 1, single, dose 2 via an unspecified route of administration on 16Apr2021 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EW0151) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that on an unspecified date, caller stated her boyfriend was the same way, got his Pfizer Vaccines for the first and second dose and he also had pain in his right leg and lower back hurts; had really severe reaction and thought he had poison ivy two days after he had a rash then he had blisters and put Calamine lotion on it and waited till the blisters popped before they went away. She also stated that his rash had kept getting worse and three days ago his lower back was killing him, he could not sleep, sit or lay down and was in the emergency room with back pain and his right leg was kind of like hers but worse and he was kicking it and the leg would not wake up and looked like he was giving birth and went to the emergency room where they did blood work, CT scan and everything and she thought they said he may be having a back spasm and they could not find anything and gave him Lidocaine patches, Flexeril, and Naproxen and he took all of those at the same time but none of them are helping the pain and the pain was only easing away. She also stated that she had no dosages, lot numbers, expiry dates, or NDC numbers for the Lidocaine patches, Calamine lotion, Flexeril patches or Naproxen to provide at that time. The patient underwent lab tests and procedures which included blood test: unknown, computerised tomogram: normal, x-ray: normal on an unspecified date. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of the pfizer suspect. Patient did not have prior vaccination within four weeks. The outcome for the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Migraine, Pyrexia
Clinical narrative: experienced very severe and uncomfortable migraine; mild headache; Fever; This is a spontaneous report from a contactable consumer (patient sister). A 16-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration on unspecified date as a single dose for COVID-19 immunization. The patient had finished their 2 doses of the PFIZER-BIONTECH COVID-19 VACCINE but had experienced very severe and uncomfortable migraine from Tuesday up until today (2 days from having the vaccine) (as reported). The patient also experienced some mild headache and fever but had resolved immediately. Caller would like to know if this was a common side effect among younger participants (16-year-old) since she read that it should have been resolved normally after 2 days (referring to the severe migraine). Caller would like to know if his brother can take anti-migraine medications alongside tylenol. It was informed that Pfizer was also unable to make recommendations for individual patients who received an invalid vaccine dose; clinical judgment made by the health care provider such as that of physician and any qualify HCP based on medical history and clinical status should dictate the appropriate actions to be taken. Referred to HCP for proper diagnosis and clinical recommendations. Outcome of the events headache, fever was recovered; migraine was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Auditory disorder
Clinical narrative: I started hearing sounds in my head in my ears; This is a spontaneous report from a contactable consumer (patient herself). A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: not reported, expiration date: not reported) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that about 2 weeks ago patient started hearing sounds in her head in her ears, went to the Doctor on Monday, gave me some antibiotics but they are not helping said it could be an allergic reaction, said a lot of people were reporting and saying, cause it started right after second dose. Clinical outcome of the event was reported as unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: swelling; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated he had a long conversation with someone yesterday regarding the large under swelling he had after receiving the Pfizer COVID-19 vaccine. He wanted to know if this was common with the vaccine. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Headache, Myalgia, Pain
Clinical narrative: My left arm kind of itched, burning in the left arm," lasted a little bit"  had a headache, joint pain, "muscle pain is what is working on me a lot."; My left arm kind of itched, burning in the left arm," lasted a little bit"  had a headache, joint pain, "muscle pain is what is working on me a lot."; My left arm kind of itched, burning in the left arm," lasted a little bit"  had a headache, joint pain, "muscle pain is what is working on me a lot."; My left arm kind of itched, burning in the left arm," lasted a little bit"  had a headache, joint pain, "muscle pain is what is working on me a lot."; I still have pain in my crotch and legs; Still having the diarrhea and the muscle pain; I had a bump on my arm and it hurt to lift my arm; This is a spontaneous report from a contactable consumer or other non health care professional (patient). This consumer reported for herself that a 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was EW0164 and expiration date was not reported), via an unspecified route of administration, administered in right arm on 16Apr2021 at 09:30 hours (Age at vaccination was 65 year) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously patient took shingles shot and it did the same thing to her. On an unspecified date, patient experienced left arm kind of itched, burning in the left arm, lasted a little bit, headache, joint pain, muscle pain was what was working on her a lot, Patient Still having the diarrhea and the muscle pain, Patient still had pain in her crotch and legs and She had a bump on her arm and it hurt to lift her arm. Patient suppose to get her another one shot on 07May2021. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: My left arm kind of itched, burning in the left arm," lasted a little bit"  had a headache, joint pain, "muscle pain is what is working on me a lot."; My left arm kind of itched, burning in the left arm," lasted a little bit"  had a headache, joint pain, "muscle pain is what is working on me a lot."; My left arm kind of itched, burning in the left arm," lasted a little bit"  had a headache, joint pain, "muscle pain is what is working on me a lot."; My left arm kind of itched, burning in the left arm," lasted a little bit"  had a headache, joint pain, "muscle pain is what is working on me a lot."; I still have pain in my crotch and legs; Still having the diarrhea and the muscle pain; I had a bump on my arm and it hurt to lift my arm; This is a spontaneous report from a contactable consumer or other non health care professional (patient). This consumer reported for herself that a 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was EW0164 and expiration date was not reported), via an unspecified route of administration, administered in right arm on 16Apr2021 at 09:30 hours (Age at vaccination was 65 year) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously patient took shingles shot and it did the same thing to her. On an unspecified date, patient experienced left arm kind of itched, burning in the left arm, lasted a little bit, headache, joint pain, muscle pain was what was working on her a lot, Patient Still having the diarrhea and the muscle pain, Patient still had pain in her crotch and legs and She had a bump on her arm and it hurt to lift her arm. Patient suppose to get her another one shot on 07May2021. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: I started getting nausea, it is throwing up; I had fever; Chills; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number, Expiry date was not reported), via an unspecified route of administration on 10Apr2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated, I have a question. I had the vaccine on 10Apr2021 and day before yesterday I started getting nausea. It is throwing up and I had fever on an unspecified date and chills and Apr2021, I am wondering, can you get side effects from the vaccine as late as that was 12 or 13 days after I got the shot and about 12 days later I started getting side effects of nausea and chills and fever, that was the first shot. The clinical outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Peripheral swelling, Rash
Clinical narrative: Left arm just below the injection site has rash and it is swollen and warm to touch; Left arm just below the injection site has rash and it is swollen and warm to touch; Left arm just below the injection site has rash and it is swollen and warm to touch; This is a spontaneous report from a contactable consumer or other non hcp.   A 53-years-old female patient received bnt162b2 (BNT162B2), (Formulation: Solution for injection, Batch/Lot Number: EW0158; Expiration Date: Unknown) dose 2, single via an unspecified route of administration, administered in Arm Left on 21Apr2021 (age at vaccination 53 years old) for covid-19 immunisation. The patient medical history was not reported. Concomitant medication was not reported. The historical vaccine was bnt162b2, (Formulation: Solution for injection, Batch/Lot Number: ER8733; Expiration Date: Unknown) dose 1, single via an unspecified route of administration, administered in Arm Left on 31Mar2021 for covid-19 immunisation. On 23Apr2021 and it was persisting patient stated that I am having a reaction to it; My left arm just below the injection site has rash and it was swollen and warm to touch. Treatment received was Benadryl, patient reported that I started it yesterday and I took four times yesterday. The outcome of all events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Myalgia, Swelling, Vaccination site mass, Vaccination site pruritus
Clinical narrative: Redness; Swelling; Muscle pain; Itchiness on the vaccination site; My arm has been itchy; Bump on the vaccination site; This is a spontaneous report from a Sponsored Program Support and contactable consumer (Patient) or other non-HCP, who reported for herself.  A 75-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was not reported (Consumer stated, "I am not sure, I cant read the writing, does it start with the PW0151)  via an unspecified route of administration, administered in Arm Right on 20Apr2021 (at the age of 75-years-old) as DOSE 1, SINGLE dose for COVID-19 immunization. The patient relevant medical history included high blood pressure from an unspecified date. Concomitant medications included Lisinopril 5mg taken from an unspecified date and for an unspecified indication. Consumer stated, "No one prescribed it, I scheduled the shot myself. On an unspecified date, the patient experienced redness, swelling, muscle pain, Itchiness on the vaccination site; My arm has been itchy and bump on the vaccination site. Her concern was, she mentioned that she got her first dose six days ago and after that she is experiencing redness, swelling and muscle pain and they are still there. Also, she was now also experiencing itchiness on the vaccination site and also a bump on the vaccination site. Consumer stated, "I have lots of common side effects that were listed in the sheet that I got when I took the first covid-19 vaccine last Tuesday. So, my arm has been itchy and I am not sure, is that something that comes with it, is that a common side effect or not. Today, a little while ago, I noticed that on the site there is a little bump but it is going down since I have been on the phone. So, I was wondering and asking if that was considered as injection site swelling or is that something different. It was my first one." (manufacturer not clarified, hence is this a Pfizer product tab left unchecked). Consumer stated, "They have improved a little like I said the bump went down but it appeared just today morning and improved. About treatment consumer stated, "No, I didn't know what to do. Consumer further stated, "I just wanted to know whether that was something considered swelling like was that something in the list of side effects or was this something I should worry about or not". The due date for the second shot was on 11Ma2021. The investigation assessment was not provided. The clinical outcome of events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Limb discomfort, Mouth swelling, Myalgia, Oral pain
Clinical narrative: Have kind of pain goes in my hand; Arm Sore; Couldn't sleep both sides whole night; problems starts from shoulder on way to wrist on both sides; it's painful; Experiencing leg inside my knees full of air when walking; From my knees all the way down abnormal; Inside my mouth kind of swelling and really sore; Inside my mouth kind of swelling and really sore; Muscle pain on both sides very hurting pain; messing muscle in both arms are bothering; This is a spontaneous report from contactable consumer (Patient). A 55-year-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: unknown) via an unspecified route of administration on arm left on an unknown date (at the age of 55-year-old),as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. Historical vaccine included the first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: unknown), via an unspecified route of administration on arm left on an unknown date as dose 1, single for COVID-19 immunization. Consumer stated that she was experiencing some kind of pain, she just had a Pfizer shot about a week ago and she thought that's going to go away after 2-3 days but never go away, goes in her hand arm is still sore she couldn't sleep whole night both sides, her problems start from her shoulder on the way to her wrist on both sides painful and the leg inside her knees like full of air when she was walking, it was she was experiencing like that, like we know starting from her knees all the way down, it was abnormal and also the other thing was like inside her mouth kind of swelling and really sore for some reason she didn't know. When paraphrased the concern, consumer stated, a kind of swelling and sore inside her mouth, muscle pain on both sides very hurting pain for the whole week now. she thought was going to go away after 2 to 3 days or night or later its still, she was experiencing it she doesn't know she has to go to Hospital or just need the recommendations. The consumer added she was just wondering what she needs to do, need a recommendation from them for we know if other people experiencing what we ware recommending or she has to wait a little bit more or what to do. She didn't know and messing was specially the muscle in both arms are bothering a lot. The patient did not receive any treatment for adverse event, no Advil, no Tylenol, I didn't take anything. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Have kind of pain goes in my hand; Arm Sore; Couldn't sleep both sides whole night; problems starts from shoulder on way to wrist on both sides; it's painful; Experiencing leg inside my knees full of air when walking; From my knees all the way down abnormal; Inside my mouth kind of swelling and really sore; Inside my mouth kind of swelling and really sore; Muscle pain on both sides very hurting pain; messing muscle in both arms are bothering; This is a spontaneous report from contactable consumer (Patient). A 55-year-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: unknown) via an unspecified route of administration on arm left on an unknown date (at the age of 55-year-old),as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. Historical vaccine included the first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: unknown), via an unspecified route of administration on arm left on an unknown date as dose 1, single for COVID-19 immunization. Consumer stated that she was experiencing some kind of pain, she just had a Pfizer shot about a week ago and she thought that's going to go away after 2-3 days but never go away, goes in her hand arm is still sore she couldn't sleep whole night both sides, her problems start from her shoulder on the way to her wrist on both sides painful and the leg inside her knees like full of air when she was walking, it was she was experiencing like that, like we know starting from her knees all the way down, it was abnormal and also the other thing was like inside her mouth kind of swelling and really sore for some reason she didn't know. When paraphrased the concern, consumer stated, a kind of swelling and sore inside her mouth, muscle pain on both sides very hurting pain for the whole week now. she thought was going to go away after 2 to 3 days or night or later its still, she was experiencing it she doesn't know she has to go to Hospital or just need the recommendations. The consumer added she was just wondering what she needs to do, need a recommendation from them for we know if other people experiencing what we ware recommending or she has to wait a little bit more or what to do. She didn't know and messing was specially the muscle in both arms are bothering a lot. The patient did not receive any treatment for adverse event, no Advil, no Tylenol, I didn't take anything. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Ligament sprain, Pruritus, Rash macular
Clinical narrative: Looks like sprain in my right arm; Thursday my left arm started kind of itching a little bit/it was like couple of bumps/last night it felt kind of itchy little bit and then this morning could see there is tiny bumps; Thursday my left arm started kind of itching a little bit/it was like couple of bumps/last night it felt kind of itchy little bit and then this morning could see there is tiny bumps; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in arm right on 15Apr2021 (Batch/Lot number was not reported) (age at vaccination 37-year-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in arm left at three weeks before the second one, on unknown date in Mar2021 (Batch/Lot number was not reported) (age at vaccination 37-year-old) as dose 1, single for covid-19 immunisation. The patient was like a little bit over weekend, a couple of days before that. The patient experienced thursday her left arm started kind of itching a little bit/it was like couple of bumps/last night she thought was like all over her body it felt kind of itchy little bit and then this morning could see there was tiny bumps, It's not over her face but it's all over everywhere on her body on 20Apr2021 and looks like sprain in her right arm on 22Apr2021 with outcome of unknown. Therapeutic measures were taken as a result of thursday my left arm started kind of itching a little bit/it was like couple of bumps/last night i thought was like all over my body it felt kind of itchy little bit and then this morning could see there is tiny bumps included some antihistamine foam in case of Benadryl after better. The outcome of the event looks like sprain in my right arm was unknown and other event recovered on Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Dry eye, Dry mouth, Epistaxis, Nasal discomfort, Nasal dryness
Clinical narrative: his eyes are dry; nose is dry; if he blows his nose the mucous is bloody; his mouth is dry; his nose is still sore; Injection site swelling; Injection site pain; This is a spontaneous report from a contactable consumer (patient).  A 43-years-old male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW01169 and expiration date was not reported) via an unspecified route of administration in left arm on 15Apr2021 (at the age of 43-years-old) as dose 1, single for COVID-19 immunization. The patient had no medical history and concomitant medications. On an unspecified date in Apr2021, the patient stated his eyes, nose and mouth were dry, if he blew the nose the mucous was bloody and had injection site swelling and pain. Patient stated his eyes were really dry, his nose had some bloodiness and was kind of dry too and that was all after he got the vaccine, was wondering if that was normal and was concerned. He confirms it was the Pfizer COVID vaccine. He clarifies if he blew his nose, there was not drainage, it was dry but the mucous has some blood in it. Patient thought it was 2-3 days later that he had swelling pain at the site, like pressure but he noticed the dry eyes and the issues with his nose about 3-4 later, he thought it was the 19 Apr 2021 or the 20 Apr 2021 because the swelling went down, and he noticed as the swelling went away the other symptoms came up on the face. Patient noticed that the dry eyes and bloody mucous were ongoing on the 19Apr2021 or the 20Apr2021 and then it took about a couple days for it to go away. Patient stated that was weird because his nose was not runny but in the mucous there was blood, his eyes and mouth were dry. Patient stated his dry eyes, dry mouth, dry nose and blood in the mucous were not 100 percent gone there was a little bit of mucous blood in the nose, his mouth, nose and eyes were still dry, nose was still sore, it was a little bit better, everything was still the same maybe little bit better, he clarified all of this with his eyes nose and mouth are ongoing but improved. Outcome of the events vaccination site swelling, vaccination site pain was recovered completely on an unspecified date in 2021, Patient stated it was gone, felt better. It hurted, a little bit and was tender to touch but other than that, it was fine, and the rest events were recovering.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: his eyes are dry; nose is dry; if he blows his nose the mucous is bloody; his mouth is dry; his nose is still sore; Injection site swelling; Injection site pain; This is a spontaneous report from a contactable consumer (patient).  A 43-years-old male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW01169 and expiration date was not reported) via an unspecified route of administration in left arm on 15Apr2021 (at the age of 43-years-old) as dose 1, single for COVID-19 immunization. The patient had no medical history and concomitant medications. On an unspecified date in Apr2021, the patient stated his eyes, nose and mouth were dry, if he blew the nose the mucous was bloody and had injection site swelling and pain. Patient stated his eyes were really dry, his nose had some bloodiness and was kind of dry too and that was all after he got the vaccine, was wondering if that was normal and was concerned. He confirms it was the Pfizer COVID vaccine. He clarifies if he blew his nose, there was not drainage, it was dry but the mucous has some blood in it. Patient thought it was 2-3 days later that he had swelling pain at the site, like pressure but he noticed the dry eyes and the issues with his nose about 3-4 later, he thought it was the 19 Apr 2021 or the 20 Apr 2021 because the swelling went down, and he noticed as the swelling went away the other symptoms came up on the face. Patient noticed that the dry eyes and bloody mucous were ongoing on the 19Apr2021 or the 20Apr2021 and then it took about a couple days for it to go away. Patient stated that was weird because his nose was not runny but in the mucous there was blood, his eyes and mouth were dry. Patient stated his dry eyes, dry mouth, dry nose and blood in the mucous were not 100 percent gone there was a little bit of mucous blood in the nose, his mouth, nose and eyes were still dry, nose was still sore, it was a little bit better, everything was still the same maybe little bit better, he clarified all of this with his eyes nose and mouth are ongoing but improved. Outcome of the events vaccination site swelling, vaccination site pain was recovered completely on an unspecified date in 2021, Patient stated it was gone, felt better. It hurted, a little bit and was tender to touch but other than that, it was fine, and the rest events were recovering.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness, Influenza, Pyrexia
Clinical narrative: Fever; Got sick; I am exhausted all time; Feels like I got flu; This is a spontaneous report received from a contactable consumer (patient). A 52-year-old female (patient) received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on 10Apr2021 (age at vaccination: 52 years), as dose 1, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she took her first shot on 10Apr2021 and then a week later that was on Sunday, on 17Apr2021, she got sick, and she was still sick a whole week later. She didn't know like what's going on and what should she do. On an unspecified date in Apr2021, she was exhausted all the time. She means she always got a fever on 18Apr2021. It's felt like she got a flu every day and asked should she go to the doctor. The patient's second shot vaccination due date was 01May2021. The patient took Aspirin, Ibuprofen and cold or Flu medicine as treatment. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hyperhidrosis, Swelling, Vaginal haemorrhage
Clinical narrative: increased sweating after receiving first dose; spotting about two weeks after she received the first dose.; She has had increased swelling since she received the first dose; She feels like she is going through menopause.; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer sponsored program. A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER2613, NDC number and Expiry Date are Unknown), via an unspecified route of administration, administered in Right arm on 23Mar2021 at the age of 71-years-old as dose 1, single for covid-19 immunisation. The patient's medical history including any illness at time of vaccination included Diabetes from 1976 and ongoing, it started as gestational diabetes on unspecified date. It is controlled by diet. She can only hear out of one ear from an unspecified date. Confirmed that this started prior to getting the vaccine. She hasn't seen her doctor about this. She was sweating a little prior to getting the first dose of the vaccine. AE(s) following prior vaccinations included Vaginal bleeding on an unspecified date. Family medical history relevant to AE(s) included Her mother passed away 05May2020 from Covid. She also had a heart condition and hypertension from unspecified date. Her father died of cancer on an unspecified date. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported, unspecified anti-diarrheal medications and unspecified effervescent pain reliever medication from unspecified date. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Relevant tests were none. On an unspecified date in Mar2021, the patient experienced increased sweating after receiving first dose. On an unspecified date in 2021, she started spotting about two weeks after she received the first dose. It stopped and then started again last night. It was not profuse bleeding. She never had symptoms of menopause. On an unspecified date in 2021, she has had increased swelling since she received the first dose. She felt like she was going through menopause. AE(s) did not require a visit to Emergency Room or Physician Office. Reporter seriousness for increased sweating after receiving first dose was unspecified. The outcome of events, increased sweating after receiving first dose and spotting about two weeks after she received the first dose was not recovered while other events was unknown.  No follow-up attempts are needed. No further information is expected.