chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Feeling cold, Immunisation, Muscle spasms, Pyrexia
Clinical narrative: fever; muscle spasms; felt really cold; chest pain; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61-year-old female patient received bnt162b2 (BNT162B2), administration date 08Dec2021 (Lot number: EW0187) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: The patient was also on high blood pressure medication, she did not provide details.; "Abdominal pain" (unspecified if ongoing). Concomitant medication(s) included: DOXYCILLIN taken for abdominal pain (ongoing). Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot number: EW0187), administration date: 01Jun2021, when the patient was 60 years old, for COVID-19 immunization; Bnt162b2 (DOSE 1, SINGLE, Lot number: EW0170), administration date: 11May2021, when the patient was 60 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 08Dec2021, outcome "unknown", described as "booster"; PYREXIA (non-serious) with onset 09Dec2021, outcome "recovered" (Dec2021), described as "fever"; MUSCLE SPASMS (non-serious) with onset 09Dec2021, outcome "recovering", described as "muscle spasms"; FEELING COLD (non-serious) with onset 09Dec2021, outcome "recovering", described as "felt really cold"; CHEST PAIN (non-serious) with onset 09Dec2021, outcome "recovering", described as "chest pain". Therapeutic measures were taken as a result of pyrexia, muscle spasms, feeling cold, chest pain.  Additional information: The patient stated she was on high blood pressure medication, did not provide details. A week age (as reported), the patient received the concomitant drug doxycycline hydrochloride. The patient stated she got the shot on 08Dec2021. On 09Dec2021, the patient felt really cold, it was 75 degrees in her house but she felt like it was 20 degrees in there, had a little fever that was gone at the time of reporting, had muscle spasms, took some pills for that and it was  just a little bit there, a little chest pain, and the patient stated it was improving but was still there. The investigation assessment was none.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Immunisation, Skin disorder
Clinical narrative: booster; prickly skin; headache; diarrhea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date 08Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (non-serious) with onset 08Dec2021, outcome "unknown", described as "booster"; SKIN DISORDER (non-serious) with onset Dec2021, outcome "unknown", described as "prickly skin"; HEADACHE (non-serious) with onset Dec2021, outcome "unknown", described as "headache"; DIARRHOEA (non-serious) with onset Dec2021, outcome "unknown", described as "diarrhea".   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Had a sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 13:00 (Lot number: EN6198) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sleep apnea", start date: 2002 (unspecified if ongoing); "migraines", start date: 1985 (unspecified if ongoing). There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "Had a sore arm". The event "had a sore arm" was evaluated at the physician office visit and emergency room visit. No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Administration site hypersensitivity, Lymphoedema, Pruritus, Rash, Skin discolouration
Clinical narrative: Lymphedema; Rashes that looked like little bubbles on her skin; had an allergic reaction to site; softball size welt; discoloration; itching/itching on her inner arms, upper chest and back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Feb2021 16:00 (Lot number: EM9809) at the age of 44 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Breast Cancer", start date: Nov2020 (unspecified if ongoing), notes: radiation treatment from 28Dec2020 to 26Jan2021; "Allergy to pineapple" (unspecified if ongoing); "Allergy to sulfas" (unspecified if ongoing); "Allergy to doxycycline" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). Concomitant medication(s) included: TAMOXIFEN; PROTONIX; MICARDIS; LEXAPRO. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EI9263, Administration time=04:30 PM, Administration location=Left arm), administration date: 20Jan2021, when the patient was 44 years old, for COVID-19 Immunization. The following information was reported: LYMPHOEDEMA (non-serious) with onset Mar2021, outcome "unknown", described as "Lymphedema"; RASH (non-serious) with onset 2021, outcome "recovered" (2021), described as "Rashes that looked like little bubbles on her skin"; ADMINISTRATION SITE HYPERSENSITIVITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "had an allergic reaction to site"; URTICARIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "softball size welt"; SKIN DISCOLOURATION (non-serious) with onset 2021, outcome "recovered" (2021), described as "discoloration"; PRURITUS (non-serious) with onset 2021, outcome "recovered" (2021), described as "itching/itching on her inner arms, upper chest and back". The events "rashes that looked like little bubbles on her skin", "had an allergic reaction to site", "softball size welt", "discoloration" and "itching/itching on her inner arms, upper chest and back" were evaluated at the physician office visit.  Additional information: These events lasted about 2 months. The patient spoke to her dermatologist and internist in the spring and both were confused. The patient believed that there was a correlation. These events were not serious and did not result in death, caused/prolonged hospitalization, disabling/incapacitating and congenital anomaly/birth defect. Prior to vaccination, the patient was diagnosed as COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Lymphedema; Rashes that looked like little bubbles on her skin; had an allergic reaction to site; softball size welt; discoloration; itching/itching on her inner arms, upper chest and back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Feb2021 16:00 (Lot number: EM9809) at the age of 44 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Breast Cancer", start date: Nov2020 (unspecified if ongoing), notes: radiation treatment from 28Dec2020 to 26Jan2021; "Allergy to pineapple" (unspecified if ongoing); "Allergy to sulfas" (unspecified if ongoing); "Allergy to doxycycline" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). Concomitant medication(s) included: TAMOXIFEN; PROTONIX; MICARDIS; LEXAPRO. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EI9263, Administration time=04:30 PM, Administration location=Left arm), administration date: 20Jan2021, when the patient was 44 years old, for COVID-19 Immunization. The following information was reported: LYMPHOEDEMA (non-serious) with onset Mar2021, outcome "unknown", described as "Lymphedema"; RASH (non-serious) with onset 2021, outcome "recovered" (2021), described as "Rashes that looked like little bubbles on her skin"; ADMINISTRATION SITE HYPERSENSITIVITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "had an allergic reaction to site"; URTICARIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "softball size welt"; SKIN DISCOLOURATION (non-serious) with onset 2021, outcome "recovered" (2021), described as "discoloration"; PRURITUS (non-serious) with onset 2021, outcome "recovered" (2021), described as "itching/itching on her inner arms, upper chest and back". The events "rashes that looked like little bubbles on her skin", "had an allergic reaction to site", "softball size welt", "discoloration" and "itching/itching on her inner arms, upper chest and back" were evaluated at the physician office visit.  Additional information: These events lasted about 2 months. The patient spoke to her dermatologist and internist in the spring and both were confused. The patient believed that there was a correlation. These events were not serious and did not result in death, caused/prolonged hospitalization, disabling/incapacitating and congenital anomaly/birth defect. Prior to vaccination, the patient was diagnosed as COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Tendonitis
Clinical narrative: Left Arm Tendonitis; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Oct2021 (Lot number: FF8841) at the age of 49 years as dose 2, single for covid-19 immunisation at pharmacy or drug store. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FE3592, Location of injection: Arm Left), administration date: 29Aug2021, when the patient was 49 years old, for COVID-19 immunization. The following information was reported: TENDONITIS (non-serious) with onset 25Oct2021, outcome "not recovered", described as "Left Arm Tendonitis". Therapeutic measures were not taken as a result of tendonitis.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up (14Dec2021): Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: a persistent head ache that will not go away with Tylenol or other headache meds; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  AA 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 15:45 (Lot number: fh8028) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Gurd" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "known allergies: Peppers" (unspecified if ongoing), notes: known allergies: Peppers. The patient took concomitant medications. The following information was reported: HEADACHE (medically significant) with onset 02Dec2021, outcome "not recovered", described as "a persistent head ache that will not go away with Tylenol or other headache meds". Therapeutic measures were taken as a result of headache. Facility type Vaccine: Doctor's office/urgent care. No other vaccine in four weeks. Patient had a persistent head ache that will not go away with Tylenol or other headache meds. No Covid prior vaccination.Not Covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Insomnia, Pyrexia
Clinical narrative: not been able to sleep/can't sleep at all; my brain is very tired; Chills; Fever/High fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 39 year-old female patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 09Dec2021 16:30 (Lot number: FE3594) at the age of 39 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot:30125BA , Location: My right arm), administration date: 18Nov2021, when the patient was 39 years old, for COVID-19 immunisation, reaction(s): "high fever", "feel tired". The following information was reported: PYREXIA (non-serious) with onset Dec2021, outcome "unknown", described as "Fever/High fever"; INSOMNIA (non-serious) with onset 09Dec2021, outcome "unknown", described as "not been able to sleep/can't sleep at all"; FATIGUE (non-serious) with onset Dec2021, outcome "unknown", described as "my brain is very tired"; CHILLS (non-serious) with onset Dec2021, outcome "unknown", described as "Chills". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, chills. Therapeutic measures were not taken as a result of insomnia.  Additional information: Caller stated she received first dose of Pfizer COVD vaccination on 18Nov2021, and second dose on 09Dec2021, she called to report her experience after second dose: "I got the second dose of Pfizer COVID vaccine on Thursday 09Dec2021, and I am calling because since that day I have not been able to sleep at all, I have had insomnia, and the thing is that I am not sleepy, my brain is very tired, but I am not sleepy and I am very alert. I have not been able to (sleep) close even one eye since that day... I was going crazy, I did not know what to do, the thing is that I used to sleep well but this happened from the second dose, the first one did not cause me anything like this, and I have been going crazy I can't find out what to do. I told my husband about this and he did search online, and he says yes, there have been cases of people suffering from insomnia after (vaccination)". Consumer stated, "Because I had my second dose last Thursday on the 9th and since then I haven't been able to sleep at all. I don't know if that's something to do with the vaccine because I was fine, that day after I had the second vaccine, I had the reaction like the first one, I had like the high fever and feel tired but they last maybe like two days but 'being' able to sleep it was since that day like I can't sleep at all, I don't know what else to do." Patient took only Tylenol (treatment) and Motrin (treatment) because had high fever and chills.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Neutrophil count, Neutrophil count increased, Viral infection
Clinical narrative: neutrophils were elevated last week; got sick with a different virus; got sick with a different virus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 14Oct2021 (Lot number: FF8841) as dose 1, single for covid-19 immunisation. Relevant medical history included: "autoimmune issues" (unspecified if ongoing), notes: he has autoimmune issues. The patient's concomitant medications were not reported. The following information was reported: NEUTROPHIL COUNT INCREASED (non-serious) with onset Dec2021, outcome "unknown", described as "neutrophils were elevated last week"; ILLNESS (non-serious), VIRAL INFECTION (non-serious) all with onset 2021, outcome "unknown" and all described as "got sick with a different virus". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: patient received his first Pfizer vaccine (purple cap formula) dose and was supposed to get his 2nd dose on 02Nov2021 but was sick with another illness and did not get it. Patient wanted to know can he still get the second dose. He wanted to know about antibodies being stronger if he get the second dose at 3 weeks vs 12 weeks. It was also reported he got sick with a different virus and wanted to know if he can get the 2nd dose of the Pfizer Covid Vaccine. stated his thing is really that he had spoken to his rheumatologist because he has autoimmune issues and the doctor felt that it is probably fine regarding getting the 2nd dose of the Pfizer Covid vaccine and that is why he is calling and asking if Pfizer has ever studied this or he is kind of like a test subject. stated he does not know his vaccine history or what he had as a child regarding vaccines. He received first dose at hospital research and they had a Pfizer nurse that was administering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: booster; redness at the injection site.; swelling at the injection site; itching at injection site; pain at injection site/ it hurts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 85 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "redness at the injection site."; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "swelling at the injection site"; VACCINATION SITE PRURITUS (non-serious), outcome "unknown", described as "itching at injection site"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain at injection site/ it hurts".   Follow-up attempts completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pain in extremity, Palpitations
Clinical narrative: Severe Arm pain lasting 3 days; heart palpitations that lasted about 4 hours the day after; Dose number 3/ booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Dec2021 16:30 (Batch/Lot number: unknown) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "known_allergies: Amoxicillan". Vaccination history included: Bnt162b2 (Dose Number: 2, Location of injection: Arm Left), administration date: Apr2021, when the patient was 39 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Location of injection: Arm Left), administration date: Apr2021, when the patient was 39 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021 16:30, outcome "unknown", described as "Dose number 3/ booster"; PAIN IN EXTREMITY (non-serious) with onset 10Dec2021, outcome "recovered" (Dec2021), described as "Severe Arm pain lasting 3 days"; PALPITATIONS (non-serious) with onset 10Dec2021, outcome "recovered" (Dec2021), described as "heart palpitations that lasted about 4 hours the day after". Therapeutic measures were not taken as a result of pain in extremity, palpitations.  Additional information: Reason for batch/lot number was Unknown as not available/provided to reporter at the time of report completion. Patient did not receive the any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive the any other medications within 2 weeks of vaccination. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19.    The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: a little bit of soreness in his arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 02Jul2021 (Lot number: EW0217) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "acid reflux" (unspecified if ongoing), notes: It was so bad it re-activated the acid reflux he had after 16 years of it being gone. There were no concomitant medications. Past drug history included: Prevacid, notes: he was taking Prevacid and like Accutane back in his college days; Accutane, notes: he was taking Prevacid and like Accutane back in his college days.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Jul2021, outcome "unknown", described as "a little bit of soreness in his arm".  Additional information: He was very healthy prior to 02Jul2021. Aside from growing up and having minor issues, he was taking Prevacid and like Accutane back in his college days, he was very healthy up until 02Jul2021. When the COVID broke out, he was very healthy. He has never taken any vaccines and or shots other than minor shots when he was young. His dad is a chiropractor and they have never believed in a flu shot. He was a healthy young man other than the fact maybe he was having possible potentially relapses from antibiotics he took years before, but he has never experienced anything like he has experienced after the COVID vaccine. No additional Vaccines Administered on Same Date of the Pfizer Suspect. No prior Vaccinations (within 4 weeks).   Follow-up attempts are completed. No further information is expected.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: received a 30 mcg dose of the Pfizer COVID-19 vaccine (adult formulation-purple cap) instead of the recommended dose of 10 mcg from the orange cap; They had a vaccination error, instead of administering Pfizer kids for 11 year old they have administered Pfizer vaccines for 12; has a slight fever; This is a spontaneous report received from a contactable reporter (Pharmacist) from medical information team for a Pfizer sponsored program.  A 10-year-old female patient received bnt162b2 (BNT162B2, solution for injection), intramuscular, administered in deltoid left, administration date 13Dec2021 (Lot number: 33030BD, Expiration Date: 30Dec2021) at the age of 10 years as dose number unknown, 30 ug single for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset Dec2021, outcome "unknown", described as "has a slight fever"; ACCIDENTAL OVERDOSE (non-serious) with onset 13Dec2021, outcome "unknown", described as "received a 30 mcg dose of the Pfizer COVID-19 vaccine (adult formulation-purple cap) instead of the recommended dose of 10 mcg from the orange cap"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 13Dec2021, outcome "unknown", described as "They had a vaccination error, instead of administering Pfizer kids for 11 year old they have administered Pfizer vaccines for 12".  Additional information: A 10-year-old female patient inadvertently received a 30-mcg dose of the Pfizer COVID-19 vaccine (adult formulation-purple cap) on 13Dec2021 between like 3:15 and 3:20 like around that time in afternoon instead of the recommended dose of 10 mcg from the orange cap. NDC number of COVID-19 Vaccine: 59267-1000-01. The patient did not receive any prior vaccinations within 4 weeks of covid vaccine.  Follow-up attempts are completed. No further information is expected
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Dysmenorrhoea, Fatigue, Fluid retention, Heavy menstrual bleeding
Clinical narrative: Severe swelling in upper left inner thigh/both legs were swollen; retaining water; felt fatigued; legs felt uncomfortable; felt "bloated"; periods have been much heavier and more painful; periods have been much heavier and more painful; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient. An 18-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16May2021 13:00 (Lot number: ewo186) at the age of 18 years as dose 2, single for COVID-19 immunization. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Product: COVID 19, brand=Pfizer, lot number: ewo161, administration date: 25Apr2021, administration time: 01:00 PM, dose number: 1, Vaccine location: Left arm), administration date: 25Apr2021, when the patient was 17 years old, for COVID-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 16May2021, outcome "unknown", described as "Severe swelling in upper left inner thigh/both legs were swollen"; FLUID RETENTION (non-serious) with onset 16May2021, outcome "unknown", described as "retaining water"; FATIGUE (non-serious) with onset 16May2021, outcome "unknown", described as "felt fatigued"; LIMB DISCOMFORT (non-serious) with onset 16May2021, outcome "unknown", described as "legs felt uncomfortable"; ABDOMINAL DISTENSION (non-serious) with onset 16May2021, outcome "unknown", described as "felt "bloated""; HEAVY MENSTRUAL BLEEDING (non-serious), DYSMENORRHOEA (non-serious) all with onset 16May2021, outcome "unknown" and all described as "periods have been much heavier and more painful". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of peripheral swelling, fluid retention, fatigue, limb discomfort, abdominal distension, heavy menstrual bleeding, dysmenorrhoea. Additional information: The patient did not receive other vaccines in four weeks. The patient had no other medication in two weeks. The patient reported that she experienced severe swelling in upper left inner thigh within 24 hours of receiving the shot. That swelling subsided overnight, but both legs were swollen and retaining water for approximately a month after receiving the shot. During this time, she felt fatigued and her legs felt uncomfortable. She also felt "bloated" in other parts of her body. In addition, since receiving the second shot, her periods have been much heavier and more painful than they were before she received the shot. The patient had no known allergies. The patient had no COVID-prior vaccination. The patient was tested for COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Peripheral swelling, SARS-CoV-2 test
Clinical narrative: Severe swelling in upper left inner thigh/both legs were swollen; retaining water; felt fatigued; legs felt uncomfortable; felt "bloated"; periods have been much heavier and more painful; periods have been much heavier and more painful; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient. An 18-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16May2021 13:00 (Lot number: ewo186) at the age of 18 years as dose 2, single for COVID-19 immunization. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Product: COVID 19, brand=Pfizer, lot number: ewo161, administration date: 25Apr2021, administration time: 01:00 PM, dose number: 1, Vaccine location: Left arm), administration date: 25Apr2021, when the patient was 17 years old, for COVID-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 16May2021, outcome "unknown", described as "Severe swelling in upper left inner thigh/both legs were swollen"; FLUID RETENTION (non-serious) with onset 16May2021, outcome "unknown", described as "retaining water"; FATIGUE (non-serious) with onset 16May2021, outcome "unknown", described as "felt fatigued"; LIMB DISCOMFORT (non-serious) with onset 16May2021, outcome "unknown", described as "legs felt uncomfortable"; ABDOMINAL DISTENSION (non-serious) with onset 16May2021, outcome "unknown", described as "felt "bloated""; HEAVY MENSTRUAL BLEEDING (non-serious), DYSMENORRHOEA (non-serious) all with onset 16May2021, outcome "unknown" and all described as "periods have been much heavier and more painful". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of peripheral swelling, fluid retention, fatigue, limb discomfort, abdominal distension, heavy menstrual bleeding, dysmenorrhoea. Additional information: The patient did not receive other vaccines in four weeks. The patient had no other medication in two weeks. The patient reported that she experienced severe swelling in upper left inner thigh within 24 hours of receiving the shot. That swelling subsided overnight, but both legs were swollen and retaining water for approximately a month after receiving the shot. During this time, she felt fatigued and her legs felt uncomfortable. She also felt "bloated" in other parts of her body. In addition, since receiving the second shot, her periods have been much heavier and more painful than they were before she received the shot. The patient had no known allergies. The patient had no COVID-prior vaccination. The patient was tested for COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Immunisation, Peripheral swelling, Vaccination site pruritus, Vaccination site rash
Clinical narrative: medium size soft bulge (about the size of a ball of ping-pong) in my right arm pit-swollen ganglion; medium size soft bulge (about the size of a ball of ping-pong) in my right arm pit-swollen ganglion; rash on my right deltoid at about 2 cm below the exact spot where the shot was applied; The area is swollen and it itches; The area is swollen and it itches; The area is swollen and it itches; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 11Dec2021 16:15 (Lot number: Fd7218) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Mild eczema" (unspecified if ongoing); "mild asthma" (unspecified if ongoing), notes: recovering; "sinusitis" (unspecified if ongoing), notes: recovered. Concomitant medication(s) included: CICLESONIDE; ALBUTEROL HFA; CETIRIZINE HYDROCHLORIDE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Ew0170, Location of injection: Arm Left), administration date: 22Apr2021, when the patient was 35 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Er8737, Location of injection: Arm Left), administration date: 31Mar2021, when the patient was 35 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 11Dec2021 05:00, outcome "not recovered", described as "Booster"; AXILLARY MASS (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 13Dec2021 05:00, outcome "not recovered" and all described as "medium size soft bulge (about the size of a ball of ping-pong) in my right arm pit-swollen ganglion"; VACCINATION SITE RASH (non-serious) with onset 13Dec2021 05:00, outcome "not recovered", described as "rash on my right deltoid at about 2 cm below the exact spot where the shot was applied"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE REACTION (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 13Dec2021 05:00, outcome "not recovered" and all described as "The area is swollen and it itches". Therapeutic measures were not taken as a result of immunisation, axillary mass, peripheral swelling, vaccination site rash, vaccination site swelling, vaccination site reaction, vaccination site pruritus.  Additional information: it was reported that patient did not had covid prior vaccination nor tested covid post vaccination. Patient did not took other vaccine in four weeks.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site reaction, Vaccination site swelling
Clinical narrative: medium size soft bulge (about the size of a ball of ping-pong) in my right arm pit-swollen ganglion; medium size soft bulge (about the size of a ball of ping-pong) in my right arm pit-swollen ganglion; rash on my right deltoid at about 2 cm below the exact spot where the shot was applied; The area is swollen and it itches; The area is swollen and it itches; The area is swollen and it itches; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 11Dec2021 16:15 (Lot number: Fd7218) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Mild eczema" (unspecified if ongoing); "mild asthma" (unspecified if ongoing), notes: recovering; "sinusitis" (unspecified if ongoing), notes: recovered. Concomitant medication(s) included: CICLESONIDE; ALBUTEROL HFA; CETIRIZINE HYDROCHLORIDE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Ew0170, Location of injection: Arm Left), administration date: 22Apr2021, when the patient was 35 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Er8737, Location of injection: Arm Left), administration date: 31Mar2021, when the patient was 35 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 11Dec2021 05:00, outcome "not recovered", described as "Booster"; AXILLARY MASS (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 13Dec2021 05:00, outcome "not recovered" and all described as "medium size soft bulge (about the size of a ball of ping-pong) in my right arm pit-swollen ganglion"; VACCINATION SITE RASH (non-serious) with onset 13Dec2021 05:00, outcome "not recovered", described as "rash on my right deltoid at about 2 cm below the exact spot where the shot was applied"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE REACTION (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 13Dec2021 05:00, outcome "not recovered" and all described as "The area is swollen and it itches". Therapeutic measures were not taken as a result of immunisation, axillary mass, peripheral swelling, vaccination site rash, vaccination site swelling, vaccination site reaction, vaccination site pruritus.  Additional information: it was reported that patient did not had covid prior vaccination nor tested covid post vaccination. Patient did not took other vaccine in four weeks.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Diarrhoea, Dizziness, Joint swelling, Lymphoedema
Clinical narrative: Nominal; lightheadiness; sore arm; loose bowels; have lymphoedema in upper legs; swelling down to ankles; issues getting body to respond to being awake; This is a spontaneous report received from a contactable Consumer or other non-HCP. The reporter is the patient.  A female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Aug2021 12:00 (Lot number: ew0171) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "Known allergies: Cipro"; Streptomycin, reaction(s): "Known allergies: streptymicin". The following information was reported: APHASIA (non-serious) with onset 01Aug2021, outcome "recovered", described as "Nominal"; DIZZINESS (non-serious) with onset 01Aug2021, outcome "recovered", described as "lightheadiness"; PAIN IN EXTREMITY (non-serious) with onset 01Aug2021, outcome "recovered", described as "sore arm"; DIARRHOEA (non-serious) with onset 01Aug2021, outcome "recovered", described as "loose bowels"; LYMPHOEDEMA (non-serious) with onset 01Aug2021, outcome "recovered", described as "have lymphoedema in upper legs"; JOINT SWELLING (non-serious) with onset 01Aug2021, outcome "recovered", described as "swelling down to ankles"; SOMNOLENCE (non-serious) with onset 01Aug2021, outcome "recovered", described as "issues getting body to respond to being awake". Therapeutic measures were not taken as a result of aphasia, dizziness, pain in extremity, diarrhoea, lymphoedema, joint swelling, somnolence. Additional information: The patient did not receive any other vaccine in four weeks and Other medications in two weeks. The patient did not had COVID prior vaccination and post vaccination, patient had not tested with covid 19. Scary concerning - day 2 - week 13 -issues getting body to respond to being awake. Internally, She was awake, aware and alert but could not get my body to respond. Started out taking an hour or so to get body to "wake" in respond to mind being awake. For first couple of weeks, then the time frame would decrease each week till she was waking normally now 13 weeks after taking shot 1. Discussions with doctor was not to take dose 2 since that is the dose symptoms tend to occur versus dose 1. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence
Clinical narrative: Nominal; lightheadiness; sore arm; loose bowels; have lymphoedema in upper legs; swelling down to ankles; issues getting body to respond to being awake; This is a spontaneous report received from a contactable Consumer or other non-HCP. The reporter is the patient.  A female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Aug2021 12:00 (Lot number: ew0171) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "Known allergies: Cipro"; Streptomycin, reaction(s): "Known allergies: streptymicin". The following information was reported: APHASIA (non-serious) with onset 01Aug2021, outcome "recovered", described as "Nominal"; DIZZINESS (non-serious) with onset 01Aug2021, outcome "recovered", described as "lightheadiness"; PAIN IN EXTREMITY (non-serious) with onset 01Aug2021, outcome "recovered", described as "sore arm"; DIARRHOEA (non-serious) with onset 01Aug2021, outcome "recovered", described as "loose bowels"; LYMPHOEDEMA (non-serious) with onset 01Aug2021, outcome "recovered", described as "have lymphoedema in upper legs"; JOINT SWELLING (non-serious) with onset 01Aug2021, outcome "recovered", described as "swelling down to ankles"; SOMNOLENCE (non-serious) with onset 01Aug2021, outcome "recovered", described as "issues getting body to respond to being awake". Therapeutic measures were not taken as a result of aphasia, dizziness, pain in extremity, diarrhoea, lymphoedema, joint swelling, somnolence. Additional information: The patient did not receive any other vaccine in four weeks and Other medications in two weeks. The patient did not had COVID prior vaccination and post vaccination, patient had not tested with covid 19. Scary concerning - day 2 - week 13 -issues getting body to respond to being awake. Internally, She was awake, aware and alert but could not get my body to respond. Started out taking an hour or so to get body to "wake" in respond to mind being awake. For first couple of weeks, then the time frame would decrease each week till she was waking normally now 13 weeks after taking shot 1. Discussions with doctor was not to take dose 2 since that is the dose symptoms tend to occur versus dose 1. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she did not developed antibodies to the virus after the vaccine; tested positive for covid19; This is a spontaneous report received from a contactable reporter(s) (Other healthcare professional) from medical information team.  A female transplanted patient with immunosuppression patient received bnt162b2 (BNT162B2), intravenous (Batch/Lot number: unknown) as dose unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "she did not developed antibodies to the virus after the vaccine"; COVID-19 (medically significant), outcome "unknown", described as "tested positive for covid19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive; antibody test: negative. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Intestinal obstruction
Clinical narrative: intestinal blockage; severe constipation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Mar2021 11:15 (Lot number: ER8736) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "depression" (unspecified if ongoing); "endometriosis" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "known allergies" (unspecified if ongoing). No COVID prior to vaccination and was not tested post vaccination. The patient took unspecified concomitant medications. The following information was reported: INTESTINAL OBSTRUCTION (medically significant) with onset 02Apr2021, outcome "recovered with sequelae", described as "intestinal blockage"; CONSTIPATION (medically significant) with onset 02Apr2021, outcome "recovered with sequelae", described as "severe constipation". The events "intestinal blockage" and "severe constipation" were evaluated at the physician office visit. Treatment for events included enema, laxative, antibiotics. The patient received dose 2 of BNT162B2 administered in arm left, administration date 21Apr2021 16:00 (Lot number: ER8737).  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pain
Clinical narrative: booster dose; increase in pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP) for a Pfizer sponsored program. The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: XELJANZ XR taken for rheumatoid arthritis, start date: 2020 (ongoing). Vaccination history included: Covid-19 vaccine (Dose: 1, manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 2, manufacturer unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "booster dose"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "increase in pain".  Additional information: Patient reported stopping Xeljanz 7 days before and 7 days after receiving covid vaccination doses as per MD instructions, last time was about booster around about 1 month ago.  The lot number for bnt162b2 was not provided and will be requested during follow up.