chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lymph node pain, Lymphadenopathy, Pain in extremity
Clinical narrative: Dramatic swelling of lymph node under arm. This is very painful and still has not gone away; Dramatic swelling of lymph node under arm. This is very painful and still has not gone away; My arm was much more sore as well and my shoulder joint was painful too; My arm was much more sore as well and my shoulder joint was painful too; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Oct2021 11:30 (Lot number: FF4481) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Narcolepsy" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "obesity" (unspecified if ongoing); "hypo thyroid" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing); "Known allergies: nitrile gloves" (unspecified if ongoing); "Known allergies: sulfa drugs" (unspecified if ongoing); "sjogrens" (unspecified if ongoing). Concomitant medication(s) included: POTASSIUM; FENOFIBRATE; LEVOTHYROXINE; OMEPRAZOLE; FLU VACCINE VII, start date: 15Sep2021, stop date: 15Sep2021. Past drug history included: Known allergies: prednisone, reaction(s): "Known allergies: prednisone"; Known allergies: ghb, reaction(s): "Known allergies: ghb"; Known allergies: demerol, reaction(s): "Known allergies: demerol"; Known allergies: morphine, reaction(s): "Known allergies: morphine". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7534, Location of injection: Arm Left, Vaccine Administration Time: 12:30 PM), administration date: 15Mar2021, when the patient was 54 years old, for covid-19 immunization, reaction(s): "As with the first two doses I was exhausted for about three days."; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0153, Location of injection: Arm Left, Vaccine Administration Time: 12:30 PM), administration date: 05Apr2021, when the patient was 54 years old, for covid-19 immunization, reaction(s): "As with the first two doses I was exhausted for about three days.". The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 08Oct2021 23:30, outcome "recovering" and all described as "Dramatic swelling of lymph node under arm. This is very painful and still has not gone away"; PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset 08Oct2021 23:30, outcome "recovering" and all described as "My arm was much more sore as well and my shoulder joint was painful too". Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain, pain in extremity, arthralgia. Additional information: No Covid prior vaccination. No Covid tested post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Blood luteinising hormone, Blood luteinising hormone decreased, Chest pain, Dyspnoea, Infertility
Clinical narrative: was not able to ovulate; shortness of breath; chest pains; LH levels for the following three cycles are much lower than they were prior to vaccination; i was infertile; 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 female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Jul2021 (Lot number: FA7484) at the age of 35 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ARMOUR THYROID; UNITHROID; CONCERTA; MAGNESIUM; ZINC; VITAMIN D [COLECALCIFEROL]; SELENIUM; VITRON-C. The following information was reported: OVULATION DISORDER (non-serious) with onset 26Jul2021, outcome "recovered with sequelae" (2021), described as "was not able to ovulate"; INFERTILITY (non-serious) with onset 2021, outcome "recovered with sequelae" (2021), described as "i was infertile"; DYSPNOEA (non-serious) with onset 26Jul2021, outcome "recovered with sequelae" (2021), described as "shortness of breath"; CHEST PAIN (non-serious) with onset 26Jul2021, outcome "recovered with sequelae" (2021), described as "chest pains"; BLOOD LUTEINISING HORMONE DECREASED (non-serious) with onset 26Jul2021, outcome "recovered with sequelae" (2021), described as "LH levels for the following three cycles are much lower than they were prior to vaccination". The events "was not able to ovulate", "i was infertile", "shortness of breath", "chest pains" and "lh levels for the following three cycles are much lower than they were prior to vaccination" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of ovulation disorder, infertility, dyspnoea, chest pain, blood luteinising hormone decreased.  Additional information: Patient was not able to ovulate (she have been tracking her ovulation for 6 months daily and LH levels). Her LH levels during ovulation would not go above A .7 which means she was infertile (this has never happened prior to this). Patient's LH levels for the following three cycles are much lower than they were prior to vaccination (again, all have been tracked). She also started to experience shortness of breath, ches pains etc. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received within 2 weeks of vaccination: armour thyroid, unithroid, concerta, magnesium, zinc, vitamin D, selenium, iron (VITRON-C). Patient was not diagnosed with COVID, prior to vaccination. Patient has not been tested for COVID, since the vaccination. Patient received second dose on 17Aug2021 (lot number: FC3181) in left arm for covid-19 immunisation.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Ovulation disorder
Clinical narrative: was not able to ovulate; shortness of breath; chest pains; LH levels for the following three cycles are much lower than they were prior to vaccination; i was infertile; 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 female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Jul2021 (Lot number: FA7484) at the age of 35 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ARMOUR THYROID; UNITHROID; CONCERTA; MAGNESIUM; ZINC; VITAMIN D [COLECALCIFEROL]; SELENIUM; VITRON-C. The following information was reported: OVULATION DISORDER (non-serious) with onset 26Jul2021, outcome "recovered with sequelae" (2021), described as "was not able to ovulate"; INFERTILITY (non-serious) with onset 2021, outcome "recovered with sequelae" (2021), described as "i was infertile"; DYSPNOEA (non-serious) with onset 26Jul2021, outcome "recovered with sequelae" (2021), described as "shortness of breath"; CHEST PAIN (non-serious) with onset 26Jul2021, outcome "recovered with sequelae" (2021), described as "chest pains"; BLOOD LUTEINISING HORMONE DECREASED (non-serious) with onset 26Jul2021, outcome "recovered with sequelae" (2021), described as "LH levels for the following three cycles are much lower than they were prior to vaccination". The events "was not able to ovulate", "i was infertile", "shortness of breath", "chest pains" and "lh levels for the following three cycles are much lower than they were prior to vaccination" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of ovulation disorder, infertility, dyspnoea, chest pain, blood luteinising hormone decreased.  Additional information: Patient was not able to ovulate (she have been tracking her ovulation for 6 months daily and LH levels). Her LH levels during ovulation would not go above A .7 which means she was infertile (this has never happened prior to this). Patient's LH levels for the following three cycles are much lower than they were prior to vaccination (again, all have been tracked). She also started to experience shortness of breath, ches pains etc. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received within 2 weeks of vaccination: armour thyroid, unithroid, concerta, magnesium, zinc, vitamin D, selenium, iron (VITRON-C). Patient was not diagnosed with COVID, prior to vaccination. Patient has not been tested for COVID, since the vaccination. Patient received second dose on 17Aug2021 (lot number: FC3181) in left arm for covid-19 immunisation.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Nosebleed 3 hours after shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Sep2021 16:30 (Lot number: FC3183) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Endometriosis" (unspecified if ongoing); "known allergies:Yes" (unspecified if ongoing), notes: known allergies: Yes, numerous. There were no concomitant medications. The following information was reported: EPISTAXIS (non-serious) with onset 09Sep2021 19:30, outcome "recovered" (2021), described as "Nosebleed 3 hours after shot". Therapeutic measures were not taken as a result of epistaxis.  Additional information: Numerous known allergies. No covid prior vaccination. Not tested positive for Covid post vaccination. No other vaccine in four weeks. No other medications in two weeks.  Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Depressed mood, Headache, Malaise, Pain
Clinical narrative: feeling run down; achy; feverish; head ache; feeling unwell /malaise; 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 63 year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), administration date 12Oct2021 at the age of 63 years as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: ELIQUIS. Vaccination history included: BNT162B2 (Dose:01), when the patient was 63 years old, for COVID-19 Immunization; BNT162B2 (Dose:02), when the patient was 63 years old, for COVID-19 Immunization. The following information was reported: DEPRESSED MOOD (non-serious) with onset Oct2021, outcome "unknown", described as "feeling run down"; PAIN (non-serious) with onset Oct2021, outcome "unknown", described as "achy"; PYREXIA (non-serious) with onset Oct2021, outcome "unknown", described as "feverish"; HEADACHE (non-serious) with onset Oct2021, outcome "recovered" (Oct2021), described as "head ache"; MALAISE (non-serious) with onset Oct2021, outcome "unknown", described as "feeling unwell /malaise". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Caller reports receiving Pfizer booster dose 12Oct2021 and experiencing feeling run down, achy and feverish. Temperature 10.4. Initially had headache that was gone. Caller stated he was feeling unwell, no muscle pain but malaise. Caller stated he was on a blood thinner Eliquis. Caller asked can he take Tylenol for the symptoms he was experiencing.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (22Oct2021): 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: feeling run down; achy; feverish; head ache; feeling unwell /malaise; 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 63 year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), administration date 12Oct2021 at the age of 63 years as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: ELIQUIS. Vaccination history included: BNT162B2 (Dose:01), when the patient was 63 years old, for COVID-19 Immunization; BNT162B2 (Dose:02), when the patient was 63 years old, for COVID-19 Immunization. The following information was reported: DEPRESSED MOOD (non-serious) with onset Oct2021, outcome "unknown", described as "feeling run down"; PAIN (non-serious) with onset Oct2021, outcome "unknown", described as "achy"; PYREXIA (non-serious) with onset Oct2021, outcome "unknown", described as "feverish"; HEADACHE (non-serious) with onset Oct2021, outcome "recovered" (Oct2021), described as "head ache"; MALAISE (non-serious) with onset Oct2021, outcome "unknown", described as "feeling unwell /malaise". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Caller reports receiving Pfizer booster dose 12Oct2021 and experiencing feeling run down, achy and feverish. Temperature 10.4. Initially had headache that was gone. Caller stated he was feeling unwell, no muscle pain but malaise. Caller stated he was on a blood thinner Eliquis. Caller asked can he take Tylenol for the symptoms he was experiencing.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (22Oct2021): 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Myalgia, Pruritus, Swelling
Clinical narrative: Muscle soreness; swelling; Severe redness with burning and itching; Severe redness with burning and itching; Severe redness with burning and itching; 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 80 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Oct2021 (Lot number: EW0185) at the age of 80 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Heart disease" (ongoing); "flu" (unspecified if ongoing), notes: Got the flu vaccine at (Name) recently, but does not know the exact date. It was more than 2 weeks before the booster. Concomitant medication(s) included: FLU VACCINE VII taken for influenza. Vaccination history included: Bnt162b2 (First Dose , Lot- EN6202 Exp: unknown, administered left upper arm, Vaccine Name: Covid Vaccine , Lot Number / Expiry Date: EN6202 Exp: unknown, Anatomical Location: administered left upper arm , Date: 04Mar2021, Vaccine Name: Covid Vaccine , Lot Number / Expiry Date: ER8730 Exp: unknown, Anatomical Location: administered left upper arm , Date: 25Mar2021), administration date: 04Mar2021, when the patient was 79 years old, for Covid-19 immunization.  The following information was reported: PRURITUS (non-serious), ERYTHEMA (non-serious), BURNING SENSATION (non-serious) all with onset 08Oct2021, outcome "recovering" and all described as "Severe redness with burning and itching"; MYALGIA (non-serious), outcome "unknown", described as "Muscle soreness"; SWELLING (non-serious) with onset 08Oct2021, outcome "recovering", described as "swelling".  Additional information: Two days later after booster dose, later confirmed as on 08Oct2021 she had had something round into the muscle and she had severe redness with extreme burning. It was burning like hell. This continued until about yesterday. She had itching with burning. It first appeared as a red spot, it was hot, and burned so bad. When probed for outcome she stated this was noticeable still. It was still a little itchy, it's not as red. There was still like a pink border where there was swelling and itching. The events did not require emergency room and physician office visit. Prior to vaccination she did not receive vaccines within 4 weeks. At end of call caller commented she did not have a fever or fatigue. She just had the burning real bad. She later added she did have some muscle soreness right after the vaccine, but the intense burning came later. She did have some nurses come look at it.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Rash
Clinical narrative: Eczema; rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), administration date: Feb2021, for Covid-19 immunization. The following information was reported: ECZEMA (non-serious), outcome "unknown", described as "Eczema"; RASH (non-serious), outcome "unknown", described as "rash". Therapeutic measures were taken as a result of eczema, rash.  Additional information: She mentioned that she already got the Pfizer COVID Vaccine, the first dose and the second dose and she has a schedule for the booster shot but the caller is actually having a medicine or a maintenance that is actually a Prednisone treatment. So she is asking if there will be an obstacle to proceed with her third dose of Pfizer booster vaccine. She had a scheduled for a booster dose."Consumer stated, "I had both of my Pfizer shots in February and March and I am due to get my booster, Saturday however, I started on Prednisone (treatment) 4 to 5 days ago for Eczema because I have a terrible rash from Eczema. Dose of Prednisone: 10mg. Indication: Consumer stated, "I have Eczema and I have a terrible rash from it (Further clarification was unknown if consumer had Eczema and terrible rash from the first and second COVID-19 Vaccine) and we are trying to get it under control. My concern is should I continue to get booster shot this Saturday or wait until I am finished with the steroids?". The lot number for the vaccine, BNT162B2, were not provided and will be requested during follow up. She said that she did not have an issue with Pfizer. Her question was whether she could receive the booster while taking steroids. She never got an answer - spoke to my physician who said it was not a problem. On 16Oct2021 I got the booster and had no side-effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Endoscopy, Lymphadenopathy, Pain in extremity, Peripheral swelling
Clinical narrative: her left arm feels fleshy compared to the right; swelling underneath/below/involving the left arm pit/swelling under her left arm; left arm pit, feels like something is in the way and noted that it is fleshy compared to the right; a little bit of swelling of the lymph node; 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 69 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 10Oct2021 13:00 (Lot number: FF2590) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Tonsillectomy and Adenoids", stop date: 1958, notes: Tonsillectomy 1958 (approx); "Diseased gallbladder", start date: Jun1976, stop date: Dec1981, notes: Cholecystectomy Dec1981; "Cholecystectomy", start date: Dec1981 (unspecified if ongoing), notes: Cholecystectomy Dec1981; "Elevated liver enzymes" (unspecified if ongoing), notes: Liver biopsy; "Barrett's Esophagus", start date: Sep2020 (ongoing), notes: Endoscopy Sep2020; "Hepatitis-C", start date: 2004, stop date: 2014, notes: Regentron Inj. Concomitant medication(s) included: OMEPRAZOLE taken for barrett's oesophagus (ongoing). Vaccination history included: Bnt162b2 (Dose: 1st , Date: 05Feb2021, Time: 3 pm, Site and Route of injection:, Anatomical site of Injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: EL9264), administration date: 05Feb2021, when the patient was 69 years old, for Covid-19 immunization; Bnt162b2 (Dose: 2nd, Date: 28Feb2021, Time: 10 am, Site and Route of injection:, Anatomical site of Injection: Right arm, Route of administration: Intramuscular, Batch/Lot number: EN6198), administration date: 28Feb2021, when the patient was 69 years old, for Covid-19 immunization. The following information was reported: AXILLARY MASS (non-serious) with onset Oct2021, outcome "unknown", described as "swelling underneath/below/involving the left arm pit/swelling under her left arm"; PAIN IN EXTREMITY (non-serious) with onset Oct2021, outcome "unknown", described as "left arm pit, feels like something is in the way and noted that it is fleshy compared to the right"; LYMPHADENOPATHY (non-serious) with onset Oct2021, outcome "unknown", described as "a little bit of swelling of the lymph node"; PERIPHERAL SWELLING (non-serious) with onset 13Oct2021, outcome "unknown", described as "her left arm feels fleshy compared to the right". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The family Medical History Relevant to AE(S): Maternal grandfather- Cancer of tongue, Maternal grandmother- Cancer of liver, Father- Stroke, Mother- Colorectal cancer, Brother- Pancreatic Cancer, Paternal grandfather- Stroke, Paternal grandmother- Stomach cancer.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: her left arm feels fleshy compared to the right; swelling underneath/below/involving the left arm pit/swelling under her left arm; left arm pit, feels like something is in the way and noted that it is fleshy compared to the right; a little bit of swelling of the lymph node; 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 69 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 10Oct2021 13:00 (Lot number: FF2590) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Tonsillectomy and Adenoids", stop date: 1958, notes: Tonsillectomy 1958 (approx); "Diseased gallbladder", start date: Jun1976, stop date: Dec1981, notes: Cholecystectomy Dec1981; "Cholecystectomy", start date: Dec1981 (unspecified if ongoing), notes: Cholecystectomy Dec1981; "Elevated liver enzymes" (unspecified if ongoing), notes: Liver biopsy; "Barrett's Esophagus", start date: Sep2020 (ongoing), notes: Endoscopy Sep2020; "Hepatitis-C", start date: 2004, stop date: 2014, notes: Regentron Inj. Concomitant medication(s) included: OMEPRAZOLE taken for barrett's oesophagus (ongoing). Vaccination history included: Bnt162b2 (Dose: 1st , Date: 05Feb2021, Time: 3 pm, Site and Route of injection:, Anatomical site of Injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: EL9264), administration date: 05Feb2021, when the patient was 69 years old, for Covid-19 immunization; Bnt162b2 (Dose: 2nd, Date: 28Feb2021, Time: 10 am, Site and Route of injection:, Anatomical site of Injection: Right arm, Route of administration: Intramuscular, Batch/Lot number: EN6198), administration date: 28Feb2021, when the patient was 69 years old, for Covid-19 immunization. The following information was reported: AXILLARY MASS (non-serious) with onset Oct2021, outcome "unknown", described as "swelling underneath/below/involving the left arm pit/swelling under her left arm"; PAIN IN EXTREMITY (non-serious) with onset Oct2021, outcome "unknown", described as "left arm pit, feels like something is in the way and noted that it is fleshy compared to the right"; LYMPHADENOPATHY (non-serious) with onset Oct2021, outcome "unknown", described as "a little bit of swelling of the lymph node"; PERIPHERAL SWELLING (non-serious) with onset 13Oct2021, outcome "unknown", described as "her left arm feels fleshy compared to the right". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The family Medical History Relevant to AE(S): Maternal grandfather- Cancer of tongue, Maternal grandmother- Cancer of liver, Father- Stroke, Mother- Colorectal cancer, Brother- Pancreatic Cancer, Paternal grandfather- Stroke, Paternal grandmother- Stomach cancer.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 13Oct2021 (Lot number: 30155BA) at the age of 32 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Lot Number: FF2587, Anatomical Location: Arm Right), administration date: 21Sep2021, when the patient was 32 years old, for COVID-19 immunisation. The following information was reported: PRURITUS (non-serious) with onset 13Oct2021, outcome "not recovered", described as "Itching".  Additional information: It was reported that the patient had not taken prior vaccinations within 4 weeks. The time the vaccination was given was between 10:30-10:45. She noticed that within the last 10 minutes the event occurred. The reporter confirmed that she started no new medications within the last 2 weeks. The reporter stated that she had been on the same medicine for a while. She referred caller back to her healthcare professional and or vaccine facility for any treatment recommendations or medical advice.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin burning sensation, Skin lesion
Clinical narrative: itching; ripped all the skin off the back from my hand practically because I am itching between my fingers every where on my body; in between my fingers, my shoulders, my joints everything was itching inside and burning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 64-year-old female patient received bnt162b2 (BNT162B2), administration date 08Oct2021 (Lot number: FF8841) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose), administration date: 21Mar2021, for COVID-19 immunization; Bnt162b2 (2nd dose), administration date: 12Apr2021, for COVID-19 immunization.  The following information was reported: PRURITUS (non-serious) with onset Oct2021, outcome "unknown", described as "itching"; SKIN LESION (non-serious) with onset Oct2021, outcome "unknown", described as "ripped all the skin off the back from my hand practically because I am itching between my fingers everywhere on my body"; SKIN BURNING SENSATION (non-serious) with onset Oct2021, outcome "unknown", described as "in between my fingers, my shoulders, my joints everything was itching inside and burning". Therapeutic measures were not taken as a result of pruritus, skin lesion, skin burning sensation.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Chills, Condition aggravated, Cough, Eye pain
Clinical narrative: Headache; Chills; Throat Pain; Bubbles on face and whole body in worse condition; Bubbles on face and whole body in worse condition; Tiredness; Fever; Cough; Eye Watery; Bad food taste; Eyes pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old male patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: EW0183) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 ([{product=COVID 19, brand=Pfizer,, brand unknown=False,, lot number=EW0183,, lot unknown=False, dose number=1,, vaccine location=Left arm}]), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 09Oct2021, outcome "not recovered", described as "Headache"; CHILLS (non-serious) with onset 09Oct2021, outcome "not recovered", described as "Chills"; OROPHARYNGEAL PAIN (non-serious) with onset 09Oct2021, outcome "not recovered", described as "Throat Pain"; BLISTER (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 09Oct2021, outcome "not recovered" and all described as "Bubbles on face and whole body in worse condition"; FATIGUE (non-serious) with onset 09Oct2021, outcome "not recovered", described as "Tiredness"; PYREXIA (non-serious) with onset 09Oct2021, outcome "not recovered", described as "Fever"; COUGH (non-serious) with onset 09Oct2021, outcome "not recovered", described as "Cough"; LACRIMATION INCREASED (non-serious) with onset 09Oct2021, outcome "not recovered", described as "Eye Watery"; TASTE DISORDER (non-serious) with onset 09Oct2021, outcome "not recovered", described as "Bad food taste"; EYE PAIN (non-serious) with onset 09Oct2021, outcome "not recovered", described as "Eyes pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, chills, oropharyngeal pain, blister, condition aggravated, fatigue, pyrexia, cough, lacrimation increased, taste disorder, eye pain.  Additional information: Patient did not receive any other vaccines within 4 weeks and did not receive other medications within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior to vaccination and was tested for COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lacrimation increased, Oropharyngeal pain, Pyrexia
Clinical narrative: Headache; Chills; Throat Pain; Bubbles on face and whole body in worse condition; Bubbles on face and whole body in worse condition; Tiredness; Fever; Cough; Eye Watery; Bad food taste; Eyes pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old male patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: EW0183) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 ([{product=COVID 19, brand=Pfizer,, brand unknown=False,, lot number=EW0183,, lot unknown=False, dose number=1,, vaccine location=Left arm}]), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 09Oct2021, outcome "not recovered", described as "Headache"; CHILLS (non-serious) with onset 09Oct2021, outcome "not recovered", described as "Chills"; OROPHARYNGEAL PAIN (non-serious) with onset 09Oct2021, outcome "not recovered", described as "Throat Pain"; BLISTER (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 09Oct2021, outcome "not recovered" and all described as "Bubbles on face and whole body in worse condition"; FATIGUE (non-serious) with onset 09Oct2021, outcome "not recovered", described as "Tiredness"; PYREXIA (non-serious) with onset 09Oct2021, outcome "not recovered", described as "Fever"; COUGH (non-serious) with onset 09Oct2021, outcome "not recovered", described as "Cough"; LACRIMATION INCREASED (non-serious) with onset 09Oct2021, outcome "not recovered", described as "Eye Watery"; TASTE DISORDER (non-serious) with onset 09Oct2021, outcome "not recovered", described as "Bad food taste"; EYE PAIN (non-serious) with onset 09Oct2021, outcome "not recovered", described as "Eyes pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, chills, oropharyngeal pain, blister, condition aggravated, fatigue, pyrexia, cough, lacrimation increased, taste disorder, eye pain.  Additional information: Patient did not receive any other vaccines within 4 weeks and did not receive other medications within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior to vaccination and was tested for COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Taste disorder
Clinical narrative: Headache; Chills; Throat Pain; Bubbles on face and whole body in worse condition; Bubbles on face and whole body in worse condition; Tiredness; Fever; Cough; Eye Watery; Bad food taste; Eyes pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old male patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: EW0183) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 ([{product=COVID 19, brand=Pfizer,, brand unknown=False,, lot number=EW0183,, lot unknown=False, dose number=1,, vaccine location=Left arm}]), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 09Oct2021, outcome "not recovered", described as "Headache"; CHILLS (non-serious) with onset 09Oct2021, outcome "not recovered", described as "Chills"; OROPHARYNGEAL PAIN (non-serious) with onset 09Oct2021, outcome "not recovered", described as "Throat Pain"; BLISTER (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 09Oct2021, outcome "not recovered" and all described as "Bubbles on face and whole body in worse condition"; FATIGUE (non-serious) with onset 09Oct2021, outcome "not recovered", described as "Tiredness"; PYREXIA (non-serious) with onset 09Oct2021, outcome "not recovered", described as "Fever"; COUGH (non-serious) with onset 09Oct2021, outcome "not recovered", described as "Cough"; LACRIMATION INCREASED (non-serious) with onset 09Oct2021, outcome "not recovered", described as "Eye Watery"; TASTE DISORDER (non-serious) with onset 09Oct2021, outcome "not recovered", described as "Bad food taste"; EYE PAIN (non-serious) with onset 09Oct2021, outcome "not recovered", described as "Eyes pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, chills, oropharyngeal pain, blister, condition aggravated, fatigue, pyrexia, cough, lacrimation increased, taste disorder, eye pain.  Additional information: Patient did not receive any other vaccines within 4 weeks and did not receive other medications within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior to vaccination and was tested for COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Myalgia, Pyrexia
Clinical narrative: no energy; slight fever; sore muscles; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Oct2021 11:45 (Lot number: FF8839) at the age of 74 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies : Penicillin and sulfa; "Known allergies : Penicillin" (unspecified if ongoing), notes: Known allergies : Penicillin and sulfa. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0151, Location of injection: Arm Left, Vaccine Administration Time: 09:30 AM), administration date: 07Apr2021, when the patient was 73 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7534, Location of injection: Arm Left, Vaccine Administration Time: 09:45 AM), administration date: 17Mar2021, when the patient was 73 years old, for COVID-19 Immunization. The following information was reported: ASTHENIA (non-serious) with onset 12Oct2021 07:00, outcome "recovered" (Oct2021), described as "no energy"; PYREXIA (non-serious) with onset 12Oct2021 07:00, outcome "recovered" (Oct2021), described as "slight fever"; MYALGIA (non-serious) with onset 12Oct2021 07:00, outcome "recovered" (Oct2021), described as "sore muscles". Therapeutic measures were not taken as a result of asthenia, pyrexia, myalgia.  Additional information: Vaccination facility: Public Health Clinic. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. Not tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Pain in extremity, SARS-CoV-2 test
Clinical narrative: I have also had similar pain in my feet.; I am having pain in my hands and fingers.; I am having pain in my hands and fingers.; I have never had arthritis but I have the symptoms of this; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Jul2021 12:00 (Lot number: EL0087) at the age of 59 years as dose 1, single and administered in arm left, administration date 27Aug2021 12:00 (Lot number: EW0217) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PRILOSEC [OMEPRAZOLE]; FLONASE [FLUTICASONE PROPIONATE]. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "I have also had similar pain in my feet."; PAIN IN EXTREMITY (non-serious), PAIN IN EXTREMITY (non-serious), outcome "not recovered" and all described as "I am having pain in my hands and fingers."; ARTHRITIS (non-serious), outcome "not recovered", described as "I have never had arthritis but I have the symptoms of this". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, pain in extremity, pain in extremity, arthritis.  Additional information: Vaccination facility: Hospital. No other vaccine in four weeks. No Covid prior vaccination. patient tested for covid on 22Jul2021 (Nasal Swab) and result was Negative. had no Known allergies. It was reported having pain in hands and fingers. he have never had arthritis but he have the symptoms of this. he have also had similar pain in feet. Never had these symptoms prior to vaccination for Covid.   No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Swelling, Vaccination site erythema, Vaccination site nodule, Vaccination site warmth
Clinical narrative: Left deltoid tender; Left armpit is swollen and painful; Left armpit is swollen and painful; Left arm is red, warm and raised surrounding injection site (approx 2-3 inch diameter).; Left arm is red, warm and raised surrounding injection site (approx 2-3 inch diameter).; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Oct2021 15:45 (Lot number: FF2500) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm left, administration date 11Oct2021 (Batch/Lot number: unknown) as dose 1, single for immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (prev dose product=COVID 19, prev dose brand=Pfizer, prev dose brand unknown=False, prev dose lot number=EK9231, prev dose lot unknown=False, prev dose administration date=30Dec2020, prev dose dose number=1, prev dose vaccine location=Left arm), administration date: 30Dec2020, when the patient was 37 years old, for Covid-19 immunization; Bnt162b2 (prev dose product=COVID 19, prev dose brand=Pfizer, prev dose brand unknown=False, prev dose lot number= EL9261, prev dose lot unknown=False, prev dose administration date=19Jan2021, prev dose dose number=2, prev dose vaccine location=Left arm), administration date: 19Jan2021, when the patient was 37 years old, for Covid-19 immunization. The following information was reported: VACCINATION SITE NODULE (non-serious) with onset 12Oct2021, outcome "recovering", described as "Left deltoid tender"; SWELLING (non-serious), LYMPH NODE PAIN (non-serious) all with onset 12Oct2021, outcome "not recovered" and all described as "Left armpit is swollen and painful"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 12Oct2021, outcome "not recovered" and all described as "Left arm is red, warm and raised surrounding injection site (approx 2-3 inch diameter).". Therapeutic measures were not taken as a result of vaccination site nodule, swelling, lymph node pain, vaccination site erythema, vaccination site warmth.  Additional information: Patient received other medications in two weeks. No other vaccine in four weeks, no Covid prior vaccination, no Covid tested post vaccination and had no known allergies. The arm/armpit area symptoms began about 12-18 hours after injection and have increased in severity since onset.  Follow-up attempts are completed. No further information is expected.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: itchy hives on inside of left leg, left arm, and back over a  period of several months; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 81 year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6203), administered in arm left, administration date 04Mar2021 15:15 at the age of 81 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Pre hypertension" (unspecified if ongoing); "BPH" (unspecified if ongoing); "bladder cancer" (unspecified if ongoing), notes: bladder cancer 15 years remission; "tonsillectomy" (unspecified if ongoing); "appendectomy" (unspecified if ongoing); "gall bladder removal" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE; TERAZOSIN. Vaccination history included: BNT162B2 (Dose received: 1, Lot number: EL3302, Administration date:10Feb2021, Administration time: 03:15 PM, Vaccine location-Left arm), administration date: 10Feb2021, when the patient was 81 years old, for covid-19 immunization. The following information was reported: URTICARIA (non-serious) with onset Apr2021, outcome "unknown", described as "itchy hives on inside of left leg, left arm, and back over a period of several months". The event "itchy hives on inside of left leg, left arm, and back over a period of several months" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of urticaria.  Follow-Up (27Oct2021): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Thyroid function test
Clinical narrative: diarrhea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): EC-2021-099746.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (initial pfizer dose), single for covid-19 immunisation; lenvatinib mesilate (LENVIMA), since 06Sep2021 (Batch/Lot number: unknown) for endometrial cancer; pembrolizumab (KEYTRUDA) (Batch/Lot number: unknown) for endometrial cancer. Relevant medical history included: "Endometrial Cancer" (unspecified if ongoing), notes: Started Lenvima 10mg on 9/6/2021. Also on Keytruda. The patient's concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for lenvatinib mesilate and pembrolizumab was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional Information: Patient report changes to her finger nails of thinning and some linear dark nail lines.She also reports hoarseness and continued fatigue. Fatigue and mouth sores are improving. She reports diarrhea for one day after COVID booster las week and is unsure if the Lenvima, Keytruda, or COVID shot caused the diarrhea. She also reports a previous wound on leg, that was present prior to Lenvima, has slowed down in healing since starting Lenvima. She reports normal Thyroid levels at this time. She does believe the other issues mentioned are related to Lenvima. PI reviewed. Medical History:C54.1 Endometrial Cancer. Started Lenvima 10mg on 9/6/2021. Also on Keytruda.