chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Blood calcium, Blood calcium increased, Laboratory test
Clinical narrative: elevated calcium level. He has been in the hospital for 3 weeks now; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the parent.  A 17 year-old male patient received bnt162b2 (COMIRNATY), administration date Jan2022 (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 (Her son has taken the first vaccine on Dec and the second one on Jan.), administration date: Dec2021, for Covid-19 immunization. The following information was reported: BLOOD CALCIUM INCREASED (hospitalization) with onset Feb2022, outcome "unknown", described as "elevated calcium level. He has been in the hospital for 3 weeks now". The patient underwent the following laboratory tests and procedures: blood calcium: (Oct2021) normal calcium level, notes: She said last Oct, her son had a normal calcium level; laboratory test: (Feb2022) elevated calcium level, notes: On Feb, her son did a routine laboratory test for something unrelated and noted that he has an elevated calcium level.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the event and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: husband who is positive for Covid-19; husband who is positive for Covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, 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), COVID-19 (medically significant), outcome "unknown" and all described as "husband who is positive for Covid-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  Clinical course: He already administered with the 1st and 2nd dose of the vaccine and also for the booster shot. She wanted to know how to get the prescription PAXLOVID.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Testicular cyst, Testicular disorder, Testicular pain, Testicular swelling
Clinical narrative: testicles swelled extremely large, extremely painful; testicles swelled extremely large, extremely painful; Testicle cysts; testicles, they're smoked, they're not coming back in their former glory; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TESTICULAR SWELLING (non-serious), TESTICULAR PAIN (non-serious), outcome "unknown" and all described as "testicles swelled extremely large, extremely painful"; TESTICULAR CYST (non-serious), outcome "unknown", described as "Testicle cysts"; TESTICULAR DISORDER (non-serious), outcome "unknown", described as "testicles, they're smoked, they're not coming back in their former glory". The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Accidental exposure to product, Corneal abrasion
Clinical narrative: corneal abrasion; patient accidentally had some of the Pfizer COVID-19 Vaccine in her eye; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), ophthalmic (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CORNEAL ABRASION (non-serious), outcome "unknown", described as "corneal abrasion"; ACCIDENTAL EXPOSURE TO PRODUCT (non-serious), outcome "unknown", described as "patient accidentally had some of the Pfizer COVID-19 Vaccine in her eye". Therapeutic measures were taken as a result of corneal abrasion. Additional information: The caller on the line was a non-HCP assistant who was reporting that a patient accidentally had some of the Pfizer COVID-19 Vaccine in her eye. The caller stated that if information could only be given to an HCP she could put Physician Assistant (name withheld) on the line. This HCP then stated that the patient eye was washed for 2 minutes and that the patient had corneal abrasion, but was fine in every other aspect. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Rash, SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19 approximately 5 months after his second dose of the Pfizer BioNTech Covid-19 vaccine; tested positive for Covid-19 approximately 5 months after his second dose of the Pfizer BioNTech Covid-19 vaccine; developed a rash on torso; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from a sales representative.  A 16 year-old male patient received bnt162b2 (BNT162B2) (Lot number: FC3181) as dose 1, single and (Lot number: FC3181) as dose 2, 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), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for Covid-19 approximately 5 months after his second dose of the Pfizer BioNTech Covid-19 vaccine"; RASH (non-serious), outcome "unknown", described as "developed a rash on torso". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got COVID; got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Feb2022 17:30 (Batch/Lot number: unknown) at the age of 55 years as dose 2, single and administration date 18Aug2021 (Lot number: 330258D) as dose 1, 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), COVID-19 (medically significant), outcome "unknown" and all described as "got COVID".  Clinical course: Patient stated she lost card but luckily took a picture of it. She thought they do not put that on there. That was the problem why did they not put that on. Patient stated yes for Prior vaccination (within 4 weeks) and when probed to confirm if vaccination was four weeks ago then stated, that was basically six month prior to this one and did not have any sore arm or anything (further not clarified). Just immediately got COVID so, that was bad.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes; Prior to vaccination, was the patient diagnosed with COVID-19?:Yes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 27Feb2021 (Lot number: EN6203) at the age of 37 years as dose 2, single and administered in arm right, administration date 01Feb2021 (Lot number: EL9265) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Migraines (one and off)" (unspecified if ongoing), notes: other medical history: Migraines (one and off). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Prior to vaccination, was the patient diagnosed with COVID-19?:Yes". Clinical course: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was no.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: a little of a month later we both got the Covid virus; a little of a month later we both got the Covid virous; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "a little of a month later we both got the Covid virus".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Rtpcr, result: positive; Rtpcr, result: positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 09Nov2021 (Lot number: 33026bd) at the age of 37 years as dose 3 (booster), single, administered in arm left, administration date 05Apr2021 (Lot number: Ew0151) as dose 2, single and administered in arm right, administration date 15Mar2021 (Lot number: Ep7534) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jan2022, outcome "unknown" and all described as "Rtpcr, result: positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Jan2022) positive, notes: Nasal Swab.  Clinical course: No vaccine received within 4 weeks prior to the Covid-19 vaccines. No any other medication received within 2 weeks of vaccination. The patient was not tested positive for covid 19 prior to vaccination and had been tested post vaccination.  No follow up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Lymphadenopathy, Pain in extremity
Clinical narrative: Rtpcr, result: positive; Rtpcr, result: positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 09Nov2021 (Lot number: 33026bd) at the age of 37 years as dose 3 (booster), single, administered in arm left, administration date 05Apr2021 (Lot number: Ew0151) as dose 2, single and administered in arm right, administration date 15Mar2021 (Lot number: Ep7534) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jan2022, outcome "unknown" and all described as "Rtpcr, result: positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Jan2022) positive, notes: Nasal Swab.  Clinical course: No vaccine received within 4 weeks prior to the Covid-19 vaccines. No any other medication received within 2 weeks of vaccination. The patient was not tested positive for covid 19 prior to vaccination and had been tested post vaccination.  No follow up attempts are possible. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Pruritus, Rash
Clinical narrative: itching; develop a strong skin rash just after my first shot in January last year; 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 73 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Sep2021 (Lot number: EW0172) at the age of 73 years as dose 3 (booster), single, administered in arm left, administration date 02Feb2021 (Lot number: FIV5318) as dose 2, single and administered in arm left, administration date 11Jan2021 (Lot number: EL3249) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Bladder cancer" (unspecified if ongoing); "immunocompromised" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL (ongoing); AMLODIPINE (ongoing); LISINOPRIL (ongoing); PROZAC (ongoing); SYNTHROID taken for thyroid disorder (ongoing). The following information was reported: RASH (non-serious) with onset Jan2021, outcome "not recovered", described as "develop a strong skin rash just after my first shot in January last year"; PRURITUS (non-serious), outcome "unknown", described as "itching". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash, pruritus. Additional information: Patient have received three Pfizer COVID19 vaccine shots. He was about to get number four, but realized that he began to develop a strong skin rash just after first shot in January last year. The rash persists today and has been unresponsive to various treatments by dermatologists. He was about to get a fourth shot because he is immunocompromised and when he was reading the description, disclaimer for the vaccine they asked him if he had any allergic reactions and he have got allergy. He have got a rash all over body that develops after he had the first shot. Now, he have been working with dermatologist to try to figure out what's caused this allergy and have done all sort of things and nothing else makes any sense and this well other then the fact that this is a severe rash caused from the interaction with the vaccine. He is very appreciative that we have this vaccine but its a fact he believe that it is affecting his body. So, he decided not to get the fourth shot and then he asked people whether he could switch to Moderna and since it's a mRNA type vaccine they said no, don't do that. He have taken many gels. He is using many ointment and gels. He is taking a number of ointments to try to alleviate the itching but don't have the names of them here. He have bladder cancer but it's under control right now. So, that's why he is immunocompromised. In his treatment he get an immunotherapy and right now everything is under control.  No follow-up attempts possible. No further information expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Illness, Pyrexia, Swelling
Clinical narrative: I felt sick, fever and headache; I felt sick, fever and headache; I felt sick, fever and headache; I got the booster on the left hand side; on that side, I have a giant like almost softball lump under my armpit like little below my armpit.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2022 (Lot number: LOA615930) at the age of 49 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Aortic stenosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for Immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for Immunization. The following information was reported: ILLNESS (non-serious), PYREXIA (non-serious), HEADACHE (non-serious) all with onset 10Mar2022, outcome "recovered" (12Mar2022) and all described as "I felt sick, fever and headache"; SWELLING (non-serious) with onset Mar2022, outcome "unknown", described as "I got the booster on the left hand side; on that side, I have a giant like almost softball lump under my armpit like little below my armpit.". Therapeutic measures were taken as a result of illness, pyrexia, headache, swelling.  Additional information: Patient received  booster on 09 Mar22 (clarified as 09Mar2022) around 6pm and then the next day he felt sick, fever and headache and then today it went away but he noticed under armpit on the site of, he got the booster on the left hand side, on that side have a giant like almost softball lump under armpit like little below armpit." Therapeutic measures was taken extra strength Acetaminophen. It was like a pain reliever 500mg. He was taking like 2 every 4 hours, 3 times. He took it just 3 time, like one in the day time, one in the night and slept 12 hours and then took 1 more time."
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, SARS-CoV-2 test
Clinical narrative: Going on 5 months extreme fatigue in mornings; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 34 year-old male patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) at the age of 34 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: FEXOFENADINE; MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE]. Past drug history included: Prednisone, reaction(s): "Allergy". The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "recovered with sequelae", described as "Going on 5 months extreme fatigue in mornings". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of fatigue.  Additional Information: The patient did not receive any other vaccines within four weeks. Probiotics used for the treatment of adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 on an unknown date, result was negative (have had over 70 negative rapid tests and 1 negative antibody) and through nasal swab result was negative on Nov2021. The patient had recovered from fatigue with lasting effect.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Hypothyroidism, Thyrotoxic crisis
Clinical narrative: chronic heart problem; hypothyroidism; thyroid storm; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 39 year-old female patient received bnt162b2 (BNT162B2) (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: Covid-19 vaccine (DOSE 1, Unknown Manufacture), for COVID-19 immunization. The following information was reported: CARDIAC DISORDER (hospitalization), outcome "unknown", described as "chronic heart problem"; HYPOTHYROIDISM (medically significant), outcome "unknown", described as "hypothyroidism"; THYROTOXIC CRISIS (medically significant), outcome "unknown", described as "thyroid storm". Clinical course: Caller was a pharmacist calling on behalf of a friend who said upon receiving their second dose of the Pfizer covid vaccine, her and all female members of her family developed thyroid problems (thyroid storm, hypothyroidism,...). Caller stated she forgot to mention that the patient, a 39 year old female had also chronic heart problems currently. She also added ''because she was hospitalised''.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The reported chronic heart problem, hypothyroidism and thyroid storm were most likely concurrent diseases/conditions, and unlikely causally related to the vaccination with  bnt162b2.   The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Feeding disorder, Headache, Lymphadenopathy, Rash, Thyroid mass
Clinical narrative: Lymph nodes swollen little bit; Something on my thyroid is growing; This thyroid scare me; I cannot eat, little eating is bothering me because like I said, it is on my thyroid and its very hard; It is like swollen something, it is on my thyroid; Little bit headache; Little bit rash; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Lot number: F36369) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1), for Covid-19 Immunization; Bnt162b2 (Dose number: 2), for Covid-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Lymph nodes swollen little bit"; THYROID MASS (non-serious), outcome "unknown", described as "Something on my thyroid is growing; This thyroid scare me"; FEEDING DISORDER (non-serious), outcome "unknown", described as "I cannot eat, little eating is bothering me because like I said, it is on my thyroid and it's very hard; It is like swollen something, it is on my thyroid"; HEADACHE (non-serious), outcome "unknown", described as "Little bit headache"; RASH (non-serious), outcome "unknown", described as "Little bit rash".  Additional information: It was reported, the patient had just lymph nodes swollen little bit and something on thyroid was growing. Patient couldn't eat, little eating was bothering because it was on thyroid and it's very hard. Patient didn't know it was like swollen something, it was on thyroid. Patient had like little bit headache and a little bit rash and 'stuff like this'.  No follow up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got sick; 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.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got sick".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Mental disorder, SARS-CoV-2 test
Clinical narrative: He tested positive for Covid last night; He mentioned he already completed his vaccination and his booster; He said he has a lot of mental conditions; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-healthcare p-professional) for a Pfizer sponsored program (159558). The reporter is the patient. A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: Unknown) as dose 3 (booster), single, (Batch/Lot number: Unknown) as dose 2, single and (Batch/Lot number: Unknown) as dose 1, single for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), outcome "unknown", described as "he tested positive for Covid last night", DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "He mentioned he already completed his vaccination and his booster", MENTAL DISORDER (non-serious) with onset 10Mar2022, outcome "unknown", described as "He said he has a lot of mental conditions". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  Clinical Course: He mentioned he already completed his vaccination and his booster. He said he has a lot of mental conditions. Then the caller said that he already has a prescription for Paxlovid and he took it to his Pharmacy but they do not have it. He was asking what he can do to obtain it.   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Thrombosis
Clinical narrative: blood clot on his lower left leg; pain; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67 year-old male patient received bnt162b2 (BNT162B2), administration date 01Dec2021 (Batch/Lot number: unknown) at the age of 67 years as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunization; Bnt162b2 (dose 2), for COVID-19 immunization. The following information was reported: THROMBOSIS (medically significant) with onset 01Mar2022, outcome "unknown", described as "blood clot on his lower left leg"; PAIN (non-serious) with onset 01Mar2022, outcome "unknown", described as "pain". The events "blood clot on his lower left leg" and "pain" were evaluated at the emergency room visit. Clinical course: The patient had gotten a blood clot on his lower left leg which was diagnosed on 01Mar2022. He went to the emergency room due to the pain. He wanted to ask if the booster dose can cause blood or if there's evidence. He also mentioned that he was turning 68 soon.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Haemangioma
Clinical narrative: hemangiomas; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the parent.  A 26-year-old female patient received bnt162b2 (BNT162B2) (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 (Dose: 1), for COVID-19 immunization. The following information was reported: HAEMANGIOMA (non-serious), outcome "unknown", described as "hemangiomas". The event "hemangiomas" was evaluated at the physician office visit.  Additional information: Caller states that her 26-year-old daughter is experiencing the same side effect and has only received 2 doses of the Pfizer COVID-19 vaccine. Her daughter has been seen by 3 doctors regarding this side effect. All of the providers say that this side effect is either not from the Pfizer COVID-19 vaccine or that it is harmless. Caller asks if it is likely that the same side effects experienced, hemangiomas, would occur again for her daughter if she were to receive a third dose of the Pfizer COVID-19 vaccine. Case assessed as non-serious by the reporter.  The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: Linked Report(s) : US-PFIZER INC-202200411138 Same reporter/drug/event, different patient.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Haemoglobin, Haemoglobin decreased, Iron deficiency, Weight
Clinical narrative: Iron-deficiency (low hemoglobin) could have been a contributing factor.; weight loss/I lost 10 lbs. (down to 127 lbs measured in Aug 2021)./ I continue to lose more weight (another 10 lbs.) until now. I also experienced a known side effect of fatigue during the same period; Iron-deficiency (low hemoglobin) could have been a contributing factor. This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 (Lot number: OCHD) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IRON DEFICIENCY (non-serious), HAEMOGLOBIN DECREASED (non-serious) all with onset 03Apr2021, outcome "recovering" and all described as "Iron-deficiency (low hemoglobin) could have been a contributing factor."; WEIGHT DECREASED (non-serious) with onset 03Apr2021, outcome "recovering", described as "weight loss/I lost 10 lbs. (down to 127 lbs measured in Aug 2021)./ I continue to lose more weight (another 10 lbs.) until now."; FATIGUE (non-serious) with onset 03Apr2021, outcome "recovering", described as "I also experienced a known side effect of fatigue during the same period". The event "iron-deficiency (low hemoglobin) could have been a contributing factor." was evaluated at the emergency room visit. The events "weight loss/i lost 10 lbs. (down to 127 lbs measured in aug 2021)./ i continue to lose more weight (another 10 lbs.) until now.", "i also experienced a known side effect of fatigue during the same period" and "iron-deficiency (low hemoglobin) could have been a contributing factor." were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of iron deficiency, weight decreased, fatigue, haemoglobin decreased.  Additional information: No other vaccine received in four weeks. The most serious 'potential' side effect may be the unintentional weight loss, which started early Apr2021 (after 1st, before 2nd dose). Patient lost 10 lbs. (down to 127 lbs measured in Aug2021). Patient continued to lose more weight (another 10 lbs.) until now. Patient also experienced a known side effect of fatigue during the same period. Iron-deficiency (low hemoglobin) could have been a contributing factor. Iron supplement seems to help w/this issue.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: Iron-deficiency (low hemoglobin) could have been a contributing factor.; weight loss/I lost 10 lbs. (down to 127 lbs measured in Aug 2021)./ I continue to lose more weight (another 10 lbs.) until now. I also experienced a known side effect of fatigue during the same period; Iron-deficiency (low hemoglobin) could have been a contributing factor. This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 (Lot number: OCHD) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IRON DEFICIENCY (non-serious), HAEMOGLOBIN DECREASED (non-serious) all with onset 03Apr2021, outcome "recovering" and all described as "Iron-deficiency (low hemoglobin) could have been a contributing factor."; WEIGHT DECREASED (non-serious) with onset 03Apr2021, outcome "recovering", described as "weight loss/I lost 10 lbs. (down to 127 lbs measured in Aug 2021)./ I continue to lose more weight (another 10 lbs.) until now."; FATIGUE (non-serious) with onset 03Apr2021, outcome "recovering", described as "I also experienced a known side effect of fatigue during the same period". The event "iron-deficiency (low hemoglobin) could have been a contributing factor." was evaluated at the emergency room visit. The events "weight loss/i lost 10 lbs. (down to 127 lbs measured in aug 2021)./ i continue to lose more weight (another 10 lbs.) until now.", "i also experienced a known side effect of fatigue during the same period" and "iron-deficiency (low hemoglobin) could have been a contributing factor." were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of iron deficiency, weight decreased, fatigue, haemoglobin decreased.  Additional information: No other vaccine received in four weeks. The most serious 'potential' side effect may be the unintentional weight loss, which started early Apr2021 (after 1st, before 2nd dose). Patient lost 10 lbs. (down to 127 lbs measured in Aug2021). Patient continued to lose more weight (another 10 lbs.) until now. Patient also experienced a known side effect of fatigue during the same period. Iron-deficiency (low hemoglobin) could have been a contributing factor. Iron supplement seems to help w/this issue.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Breakthrough pain, Fatigue, Pain, Rheumatoid arthritis
Clinical narrative: rheumatoid arthritis breakthrough; mild achiness; fatigue; breakthrough pain; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4308908-00.  A 56 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Mar2021 (Batch/Lot number: unknown) at the age of 55 years as dose 1, single and intramuscular, administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "rheumatoid arthritis breakthrough"; PAIN (non-serious), outcome "unknown", described as "mild achiness"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; BREAKTHROUGH PAIN (non-serious), outcome "unknown", described as "breakthrough pain". The action taken for upadacitinib was dosage permanently withdrawn.  Clinical course: The patient stated that her doctor was doing a trial of being off of Rinvoq and she experienced a breakthrough. Prior to that she had been experiencing breakthrough pain. She had mild achiness and fatigue following covid-19 vaccines. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Concomitant drugs and dates of administration (exclude those used to treat event): Concomitant Drugs Not Reported  Causality for Rinvoq (Upadacitinib): The reporter's causality for the event(s) of rheumatoid arthritis breakthrough, achiness and fatigue was not provided.  Causality for Pfizer BioNTech Covid-19 Vaccine (Tozinameran) (Tozinameran): The reporter's causality for the event(s) of ache and fatigue was possible. The reporter's causality for the event(s) of Rheumatoid arthritis flare up was not provided.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Limb injury
Clinical narrative: My arm is injured; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 11Oct2021 at 01:00 (Lot number: 301558A) at the age of 62 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing). The patient received unspecified concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: N6200, Anatomical location: Left arm, Time of administration: 00:15), administration date: 24Feb2021, when the patient was 62 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: ER8727, Anatomical location: Left arm, Time of administration: 01:00), administration date: 18Mar2021, when the patient was 62 years old, for COVID-19 immunisation. The following information was reported: LIMB INJURY (non-serious) with onset 11Oct2021 at 01:00, outcome "not recovered", described as "My arm is injured". The event "My arm is injured" was evaluated at the physician's office visit. Therapeutic measures were taken as a result of limb injury.  Additional Information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Treatment included pain medications (unspecified) and cortisone shot for LIMB INJURY.  Since the vaccination, the patient had not been tested for COVID-19.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Dec2021 15:30 (Lot number: 330308D) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Stone fruit allergy" (unspecified if ongoing), notes: Stone fruit allergy. There were no concomitant medications. Vaccination history included: Bnt162b2 (Name of Drug as: Pfizer, Dose Number: 2 Batch/Lot No: EW0178 Location of, injection: Arm Left), administration date: 07Jun2021, when the patient was 29 years old, for COVID-19 Immunization; Bnt162b2 (Name of Drug as: Pfizer, Dose Number: 1 Batch/Lot No: EW0177 Location of, injection: Arm Left), administration date: 17May2021, when the patient was 29 years old, for COVID-19 Immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 21Dec2021 10:00, outcome "recovered", described as "Flu like symptoms". Therapeutic measures were not taken as a result of influenza like illness. No follow-up attempts are possible. No further information is expected.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Sex: U
Vaccine: IPV, MNQ
Symptoms: Product storage error
Clinical narrative: is reported as potential AE because of temperature excursion; Initial information received on 08-Mar-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown demographic and unknown gender patient who experienced is reported as potential ae because of temperature excursion while receiving vaccines IPV (VERO) [IPOL] and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U7211AA and suspect IPV (VERO) lot U7191AB.  On an unknown date the patient developed a non-serious is reported as potential ae because of temperature excursion (product temperature excursion issue) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and (unknown latency) following the administration of IPV (VERO).  It was reported "that she doubts an excursion actually happened and most likely might have been a glitch since it triggered after the data logger was plugged in and the back up data loggers did not record any temperatures out of range. See related case 01009162 for opened IPOL Additional Description of event Adverse events :Nurse is requesting stability information for unopened MENACTRA and opened IPOL after the data logger recorded 30.5 degrees F lasting for 14 minutes".  Action taken:not applicable.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was Unknown.
Sex: U
Vaccine: DTAP
Symptoms: Pertussis
Clinical narrative: whooping cough; Initial information received on 11-Mar-2022 regarding an unsolicited valid serious case was received from other health professional.  This case involves Adult and unknown gender patient who experienced whooping cough while receiving vaccine diphtheria, tetanus and acellular pertussis vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect diphtheria, tetanus and acellular pertussis vaccine produced by unknown manufacturer (lot number and expiry date: not reported) in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed a serious whooping cough (pertussis) (unknown latency) following the administration of diphtheria and tetanus and acellular pertussis vaccine. This event was assessed as medically significant.  Action taken with diphtheria, tetanus and acellular pertussis vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (whooping cough).  At time of reporting, the outcome was Unknown for the event whooping cough.; Sender's Comments: Sanofi company comment dated 14-Mar-2022: This case concerns an adult and unknown gender patient who experienced whooping cough after receiving vaccine diphtheria, tetanus and acellular pertussis vaccine. A significant temporal relationship cannot be established due to lack of information on event onset date and vaccination date. Information regarding condition at the time of vaccination, medical history, concomitant medication, would be needed to rule out the alternative etiology. Based on the reported information, the role of an individual vaccine cannot be assessed.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Sensory disturbance, Vaccination site erythema, Vaccination site pain, Vaccination site rash
Clinical narrative: she is feeling something moving in the left arm; rash; the arm she received the injection in was red; pain; Initial information received on 09-Mar-2022 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional (hcp).  This case involves a 74-year-old female patient who had rash, the arm she received the injection in was red, pain and she is feeling something moving in the left arm while on treatment with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.   On 14-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE produced by Sanofi Pasteur Inc. (0.7 mL via intramuscular route in Left Arm) as prophylactic vaccination.  On 14-Oct-2021, the patient received the Fluzoe Quadrivalent High Dose experiencing an injection reaction, to the left arm, that has continued to get worse described as having an area of redness, a rash, and pain (vaccination site erythema) (vaccination site rash)(vaccination site pain)(latency: same day). The patient reported that the rash and redness have gone away but the pain has never stopped; that the arm has gotten worse and  she is feeling something moving in the left arm(feeling abnormal)(latency: unknown); that she was using the opposite hand to lift the arm; that she had not had a health care professional look at the arm; that she was never given the LOT number from the vaccine.  Action Taken: Not applicable   It was not reported if the patient received a corrective treatment for the events (rash, the arm she received the injection in was red, pain, she is feeling something moving in the left arm).  At time of reporting, the outcome was Recovered / Resolved on an unknown date for vaccination site rash, vaccination site erythema; was Not Recovered / Not Resolved for vaccination site pain and was Unknown feeling abnormal.
Sex: U
Vaccine: IPV
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event, Poor quality product administered
Clinical narrative: 2 doses of IPOL were give to two different patients , doses were given on 11Feb2022 and 1Mar2022 with no adverse event; 2 doses of IPOL were give to two different patients, product was no longer viable with no adverse event; Initial information received on 11-Mar-2022 regarding an unsolicited non-valid  non-serious case received from a other health professional.    This case involves two patients of unknown demographics for whom it was reported that 2 doses of ipol were given to two different patients, product was no longer viable with no adverse event and doses were given on 11-Feb-2022 and 01-Mar-2022  with no adverse event while receiving IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Feb-2022 and on 01-Mar 2022, the patients received a dose (Twice Drug Treatment Duration) of suspect IPV (VERO) (dose, strength, formulation, route, administration site: unknown, lot U1C571 expiry date 17-Jun-2023) for Immunization.   On 11-Feb-2022 it was reported that 2 doses of ipol were give to two different patients, product was no longer viable with no adverse event (poor quality product administered) (Latency: same day). On 01-Mar-2022 it was reported that doses were given on 11-Feb-2022 and 01-Mar-2022 (inappropriate schedule of product administration) (Latency:21 days)  Action taken was not applicable.  Outcome: unknown    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.